Agilia SP PCA

Agilia SP PCA WiFi

Syringe Infusion Pumps
Applicable to software version 3.1

Technical Manual
Symbol Descriptions

Warning Name and address of the manufacturer / Date of

(Refer to the Instructions for Use) manufacture

Refer to the Instructions for Use Name and address of the manufacturing facility

Product reference / part number Protection against electric shock: class II

Product serial number Non-ionizing electromagnetic radiation

Input terminal - connector Fragile, handle with care

Output terminal - connector This way up

Electrical fuses Keep away from rain

Alternating Current (AC) Temperature limitation

Direct Current (DC) Humidity limitation

Index of protection against ingress of water or

IP22 Atmospheric pressure limitation
particulate matter

Ingress protection against water when immersed up

IP67 to 1 m deep. Rating applies to patient handset but General symbol for recyclable material
not to the handset connector.

Part included in a recycling process Eco packaging symbol

Protection against leakage current; defibrillation-

CE mark
proof type CF applied part 0123

Device Identification Label:

The UDI (Unique Device Identifier) is represented in AIDC (Automatic Identification and Data Capture) and readable text:
 (01) Product Identifier GTIN
 (21) Product Serial Number
 (11) Date of Manufacture
 (240) Product Reference

Warning of a potential hazard that could result in serious personal injury and/or product damage if the written
instructions are not followed.

Recommendations to be followed.

2 13608-1_TM_Agilia_SP_PCA_Eng
Table of Contents

1 INTRODUCTION 6

1.1 SCOPE ................................................................................................................................................... 6

1.2 INTENDED USE ....................................................................................................................................... 6
1.3 INTENDED USERS.................................................................................................................................... 6
1.4 CONTRAINDICATIONS ............................................................................................................................... 6
1.5 USE ENVIRONMENT ................................................................................................................................. 6

2 DESCRIPTION 7

2.1 PHYSICAL DESCRIPTION .......................................................................................................................... 7

2.1.1 Housing ...................................................................................................................................................... 7
2.1.2 Keypad ....................................................................................................................................................... 9
2.1.3 Display Board ........................................................................................................................................... 10
2.1.4 CPU Board ............................................................................................................................................... 13
2.1.5 Power Supply Board................................................................................................................................. 17
2.1.6 AC Power Board....................................................................................................................................... 20
2.1.7 Interface board ......................................................................................................................................... 21
2.1.8 Wi-Fi Board .............................................................................................................................................. 22
2.1.9 Back View................................................................................................................................................. 23
2.1.10 Patient Handset........................................................................................................................................ 23
2.1.11 Mechanical Framework Assembly............................................................................................................ 23
2.1.12 Mechanical Plunger Driver Assembly....................................................................................................... 23
2.2 PRINCIPLES OF OPERATION ................................................................................................................... 24
2.3 OPERATION DIAGRAMS ......................................................................................................................... 25

3 FUNDAMENTALS 27

3.1 TRAINING .............................................................................................................................................. 27

3.2 MAINTENANCE SCHEDULE ..................................................................................................................... 27
3.3 ACCESSING / EXITING THE OPERATING FUNCTIONS ................................................................................ 28

4 PROFILE MENU 29

4.1 ACCESSING THE PROFILE MENU ............................................................................................................ 29

4.2 PROFILE MENU FUNCTIONS ................................................................................................................... 29

5 BASIC PROFILE CONFIGURATION 30

5.1 ACCESSING THE BASIC PROFILE CONFIGURATION .................................................................................. 30

5.2 BASIC PROFILE CONFIGURATION FUNCTIONS ......................................................................................... 30

6 MAINTENANCE OPERATIONS 36

6.1 MAINTENANCE OPTIONS ........................................................................................................................ 36

6.2 RUNNING TESTS ................................................................................................................................... 37
6.2.1 Accessing the Tests Menu ....................................................................................................................... 37
6.2.2 Test 1: Identification ................................................................................................................................. 38
6.2.3 Test 2: Maintenance................................................................................................................................. 39
6.2.4 Test 3: Maintenance Messages ............................................................................................................... 39
6.2.5 Test 4: Events .......................................................................................................................................... 40
6.2.6 Test 5: Force ............................................................................................................................................ 41
6.2.7 Test 6: Displacement................................................................................................................................ 43
6.2.8 Test 7: Syringe Barrel Clasp .................................................................................................................... 45
6.2.9 Test 8: Battery Info ................................................................................................................................... 48
6.2.10 Test 9: Indication ...................................................................................................................................... 49

3
 6.2.11 Test 10: Keypad ....................................................................................................................................... 49
6.2.12 Test 11: Ageing Test ................................................................................................................................ 50
6.2.13 Test 12: Battery Life ................................................................................................................................. 51
6.2.14 Test 13: Battery Test ................................................................................................................................ 51
6.2.15 Test 16: Cover.......................................................................................................................................... 53
6.2.16 Test 17: Patient handset .......................................................................................................................... 54
6.2.17 Test 20: Pump Code ................................................................................................................................ 55
6.2.18 Test 21: Power Info .................................................................................................................................. 55
6.2.19 Test 22: LCD Voltage ............................................................................................................................... 57
6.2.20 Test 23: Temperature............................................................................................................................... 57
6.2.21 Test 24: Watchdog ................................................................................................................................... 58
6.2.22 Test 25: Wi-Fi Module Information ........................................................................................................... 59
6.2.23 Checking the Pressure Limit Alarm .......................................................................................................... 60
6.2.24 Control the plunger head detection finger and anti-siphon arms movement............................................ 61
6.2.25 Control the disengagement and plunger head alarms ............................................................................. 63
6.2.26 Checking the End of Infusion Alarm ......................................................................................................... 65
6.2.27 Checking the AC Power Supply / Battery Operation ................................................................................ 65
6.2.28 Electrical Test........................................................................................................................................... 65
6.3 QUALITY CONTROL PROCEDURE............................................................................................................ 66
6.3.1 Running a Quality Control ........................................................................................................................ 66
6.3.2 Quality Control Certificate ........................................................................................................................ 69
6.4 TESTING THE FLOW RATE ..................................................................................................................... 70

7 TROUBLESHOOTING AND MESSAGES 72

7.1 ALARM DESCRIPTIONS .......................................................................................................................... 72

7.2 ALARM MESSAGES AND INFORMATION SIGNALS ..................................................................................... 72
7.3 AUDIO-ONLY INFORMATION SIGNALS ...................................................................................................... 74
7.4 TROUBLESHOOTING GUIDE .................................................................................................................... 75
7.5 ERROR CODES ..................................................................................................................................... 76

8 INTERVENTION PROCEDURES 80

8.1 PROCEDURE #1: PATIENT HANDSET ...................................................................................................... 81

8.2 PROCEDURE #2: BATTERY AND BATTERY DOOR - BOOST CAPACITOR DISCHARGE.................................. 81
8.3 PROCEDURE #3: CLEAR PROTECTIVE COVER ........................................................................................ 83
8.4 PROCEDURE #4: LEFT HINGE KIT ........................................................................................................... 84
8.5 PROCEDURE #5: REAR COVER .............................................................................................................. 86
8.6 PROCEDURE #6: INTERFACE BOARD ...................................................................................................... 88
8.7 PROCEDURE #7: COVER DETECTION FLEXIBLE CIRCUIT .......................................................................... 90
8.8 PROCEDURE #8: PUSHER PROTECTION WITH LOCK KIT ........................................................................... 92
8.9 PROCEDURE #9: UPPER CASE .............................................................................................................. 95
8.10 PROCEDURE #10: DISPLAY BOARD/LCD DISPLAY .................................................................................. 98
8.11 PROCEDURE #11: CPU BOARD ........................................................................................................... 102
8.12 PROCEDURE #12: POWER SUPPLY BOARD AND AC POWER BOARD ..................................................... 106
8.13 PROCEDURE #13: WI-FI BOARD .......................................................................................................... 109
8.14 PROCEDURE #14: SYRINGE BARREL CLASP......................................................................................... 112
8.15 PROCEDURE #15: SYRINGE DETECTION SYSTEM ................................................................................. 118
8.16 PROCEDURE #16: MOTOR ................................................................................................................... 124
8.17 PROCEDURE #17: DISENGAGEMENT FLEXIBLE CIRCUIT ........................................................................ 127
8.18 PROCEDURE #18: FORCE SENSOR + RIBBON CABLE KIT ..................................................................... 132
8.19 PROCEDURE #19: LINEAR SENSOR KIT................................................................................................ 138
8.20 PROCEDURE #20: PLUNGER COVER AND LEVER KIT ............................................................................ 143
8.21 PROCEDURE #21: PLUNGER KIT .......................................................................................................... 146
8.22 PROCEDURE #22: CARRIAGE KIT ........................................................................................................ 151

4
9 DEVICE STORAGE 156

10 CLEANING AND DISINFECTING 157

11 POWER MANAGEMENT 158

12 TECHNICAL CHARACTERISTICS 159

12.1 POWER SUPPLY .................................................................................................................................. 159

12.2 BATTERY ............................................................................................................................................ 159
12.3 POWER CONSUMPTION ....................................................................................................................... 159
12.4 COMMUNICATION PORT ....................................................................................................................... 159
12.5 INFRARED COMMUNICATION ................................................................................................................ 160
12.6 AGILIA USB CABLE ............................................................................................................................. 160
12.7 PATIENT HANDSET .............................................................................................................................. 160
12.8 COMPLIANCE ...................................................................................................................................... 160
12.9 DIMENSIONS - WEIGHT ........................................................................................................................ 161
12.10 ELECTRONIC BOARDS ......................................................................................................................... 161
12.11 MATERIAL CHARACTERISTICS ............................................................................................................. 162

13 SPECIFICATIONS 163

14 RECYCLING 164

15 WARRANTY 165

16 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 166

16.1 TABLE 1 - GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC EMISSIONS ............... 166
16.2 TABLE 2 - GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY ................. 167
16.3 TABLE 4 - GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY ................. 168
16.4 TABLE 6 - RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION
EQUIPMENT AND AGILIA PUMP ............................................................................................................. 169
16.5 EMC TEST DEVIATIONS AND SUPPLEMENTARY TESTS ......................................................................... 170

17 SPARE PARTS CATALOG 172

18 ORDERING INFORMATION 173

18.1 DATA MANAGEMENT CABLES............................................................................................................... 173

18.2 ASSOCIATED SOFTWARE ..................................................................................................................... 173
18.3 DISPOSABLES ..................................................................................................................................... 173

19 GLOSSARY OF TERMS 174

INDEX 175

5
1 Introduction

1.1 Scope
This technical manual is applicable to the Agilia SP PCA and Agilia SP PCA WiFi pumps. These devices
are referred to throughout this manual as the "Agilia SP PCA".
The user must adhere to the instructions specified in this technical manual. Failure to adhere to these
instructions may result in damage to the equipment, injury to patients or injury to users.

WARNING
Check that this technical manual is applicable to the current software version of the device.
 The software version of the device is displayed on the startup screen.
 The software version described in this technical manual is displayed in the Release Notes at the end
of this document.

1.2 Intended Use

The Agilia SP PCA syringe pump is primarily intended for PCA therapy, for the administration of analgesic
drugs under the patient’s or the clinician’s control.
The Agilia SP PCA syringe pump can also be used for general infusions on adults, pediatrics, and
neonatal patients for the intermittent or continuous delivery of parenteral fluids (such as solutions, colloids,
parenteral nutrition), medications (such as diluted drugs, chemotherapy, anesthesia drugs), blood and
blood derivatives, and medications through clinically accepted routes of administration.
It is intended for use by trained healthcare professionals in clinical healthcare facilities. In PCA therapy, it
is also intended for use by the patient in order to self administer doses of analgesic agent, after receiving
appropriate training and instructions from the clinical staff.
It is not intended for use during pre-hospital medical ground transportation.
The Agilia SP PCA range is intended for use on only one patient at a time. It can be reused indefinitely on
multiple patients throughout its lifetime.
For more information, refer to the Instructions for Use of the Agilia SP PCA.

1.3 Intended Users

The pump must only be used by qualified and trained healthcare professionals, including but not limited
to: nurses (primary users), physicians, nurse practitioners and physician assistants.
Service and maintenance must only be performed by biomedical engineers or technicians, or by IT
specialists.
Technical maintenance tasks (including inspections and checks) are performed by trained biomedical
engineers, or by dedicated medical rental and/or service organizations who have been trained and
approved by the manufacturer.
For training, contact your Fresenius Kabi sales representative.

1.4 Contraindications
While being serviced, the device must not be connected to a patient.
Do not modify the pump (except in the case of operations recommended by Fresenius Kabi).
For more information, refer to the Instructions for Use of the Agilia SP PCA.

1.5 Use Environment

Pumps must be used in the operating conditions (temperature, pressure, humidity and altitude) specified
in their Instructions for Use. Refer to the Instructions for Use of the Agilia SP PCA.

6
2 Description

2.1 Physical Description

2.1.1 Housing
2 15
1 14
13
4

8
6
3
9 10 11 12

5
1

2
4

6
7
Figure 2.1: Housing

Legend
1 Cover 9 Syringe barrel clasp

2 Angle Bracket 10 Syringe flange cradle

3 Base 11 Plunger driver

4 Syringe guard 12 Disengagement lever

5 Patient handset 13 Clear protective cover locking system

6 Clear protective cover 14 Patient handset cable reel

7 Cover left hinge 15 Patient handset holder

8 Keypad

7
 The Agilia SP PCA range of pumps is made up of 7 main parts: a cover, a base, an angle bracket, a
syringe guard, a clear protective cover, a patient handset and a cover left hinge.
 The cover contains the following:
- Display board
- Keypad
 The base supports the following:
- CPU board
- Mechanical framework assembly
- Plunger driver unit
- Wi-Fi board (for Wi-Fi infusion pumps)
 The angle bracket supports the following:
- Power supply board
- AC power board
- Battery
- Fixing clamp system
- Fixing clamp locking system
 The syringe guard supports the following:
- Interface board
- Clear protective cover locking system
- Clear protective cover detection sensor
- Patient handset holder
- Patient handset cable reel

8
2.1.2 Keypad

1
2 17
3
16
4 15

14

5 6 7 8 9 10 11 12 13
Figure 2.2: Keypad description

Legend
1 Screen 10 Decrement

2 Battery charge status Indicator 11 Fast decrement

3 Power supply indicator 12 Confirm value / Move to next field

4 Wi-Fi symbol (for Wi-Fi pumps only) 13 Stop

5 On / Off 14
3 Cancel value / Move back to previous field

6 Bolus / Prime 15
3 Menu

7 Fast increment 16
3 PCA history

8 Increment 17
3 Alarm silence

9 Infusion indicator lights

9
2.1.3 Display Board
The display board is located under the front of the command panel, and contains all essential parts for
human-machine interaction:
 Keypad
 Synoptics and control indicators
 LCD screen
This board is connected to other parts with the connectors shown below.

J2

J1

J3

Figure 2.3: Display Board

Legend
J1 J1 Connector to Keypad

J2 J2 Connector to CPU Board

J3 J3 Connector to LCD Display

10
J1 Connector to Keypad
Pin n° Signal Description
1 GND Ground
2 KBD_COL_0 Column 0
3 KBD_COL_1 Column 1
4 KBD_COL_2 Column 2
5 KBD_LINE_0 Line 0
6 KBD_LINE_1 Line 1
7 KBD_LINE_2 Line 2
8 TON/OFF On/Off key
9 KBD_LINE_3 Line 3
10 GND Ground
11 GND Ground
12 GND Ground

J2 Connector to CPU Board

Pin n° Signal Description
1 GND Ground
2 PRES_BOARD/ HMI board presence detection
3 +3V3 +3.3V power supply
4 +3V3 +3.3V power supply
5 ANA_VLCD LCD charge pump voltage
6 GND Ground
7 S_ANA_DOOR Door close detection
8 RESET/ Global reset
9 GND Ground
10 CS_LED-KBD/ LED or keypad selection
11 CS_LCD/ LCD selection
12 GND Ground
LCD type of the interface cycle:
13 LCD_CD
Control/Data (0:control, 1:data)
14 LCD_MS LCD mode selection
15 GND Ground
16 HMI_MOSI_SDA SPI data written / I²C data for HMI board
17 GND Ground
18 HMI_MISO SPI data read for HMI board
19 GND Ground
20 HMI_SCK_SCL SPI/I²C clock for HMI board
21 GND Ground
22 KON-OFF On/Off key
23 +5V +5V power supply
24 +5V +5V power supply
25 CMD_FAIL LED command failure
26 GND Ground

11
J3 Connector to Display
Pin n° Signal Description
1 GND Ground
2 A Anode of the backlight (+5V)
3 K Cathode of the backlight
4 GND Ground
5 SCK SPI clock (HMI_SCK_SCL signal)
6 GND Ground
7 SDA SPI data (MOSI) (HMI_MOSI_SDA signal)
8 GND Ground
9 CD Control/Data (0:control, 1:data) (LCD_CD signal)
10 GND Ground
11 /RST Reset (RESET/ signal)
12 GND Ground
13 CS0 Chip select (CSLCD/ signal)
14 GND Ground
15 BM0/DB13 Mode select (LCD_MS signal)
16 GND Ground
17 VLCD Charge pump voltage (ANA_VLCD signal)
18 GND Ground
19 +3V3 +3V3 power supply
20 GND Ground
21 GND Ground
22 GND Ground

12
2.1.4 CPU Board
The CPU board consists of a main microcontroller, FLASH and RAM memories, and various analog or
power functions, such as:
 One single-step bipolar motor command
 Adjustment of and acquisition from different detectors
 Different lines of communication (synchronous and asynchronous serial links).
The CPU Board is connected to the Display Board with the J3 connector.
A ribbon cable connects it to the Power Supply Board with the J6 connector.
The CPU Board is connected to the Interface Board with the J9 connector.

J1 J2

J3

J5
J4

J9

J6 J7 J8
Figure 2.4: CPU Board (Front View)

J10

Figure 2.5: CPU Board (Back View)

Legend
J1 J1 Connector - Connection to Syringe Barrel J6 J6 Connector - Connection to Power Supply Board
Clasp (potentiometer and flange switch)
J2 J2 Connector - Connection to Linear Displacement J7 J7 Connector - Connection to Motor
Potentiometer
J3 J3 Connector - Connection to Display Board J8
J1 J8 Connector - Connection to JTAG Connector
(micro programming)
J4 J4 Connector - Connection to Wi-Fi Board if one is J9 J9 Connector - Connection to Interface Board
present
J5 J5 Connector - Connection to Opto Motor J10 J10 Connector - Connection to Plunger Driver
(force sensor and disengagement opto switch)

13
J1 Connector to Syringe Barrel Clasp
Pin n° Signal Description
1 GND Ground
2 SW_OUT Flange switch state
3 SW_IN Flange switch power supply
4 DIA+ +3.3 V power supply
5 DIA_OUT Syringe barrel clasp potentiometer value
6 DIA- Ground

J2 Connector to Displacement Linear Potentiometer

Pin n° Signal Description
1 DISP- Ground
2 DISP_OUT Displacement potentiometer status
3 DISP+ +3.3 V power supply

J3 Connector to Display Board

Pin n° Signal Description
1 GND Ground
2 A Anode of the backlight (+5V)
3 K Cathode of the backlight (K_BACKL signal)
4 GND Ground
5 SCK SPI clock (HMI_SCK_SCL signal)
6 GND Ground
7 SDA SPI data (MOSI) (HMI_MOSI_SDA signal)
8 GND Ground
9 CD Control/data (0:control, 1:data) (LCD_CD signal)
10 GND Ground
11 /RST Reset (RESET/ signal)
12 GND Ground
13 CS0 Chip select (CSLCD/ signal)
14 GND Ground
15 BM0/DB13 Mode select (LCD_MS signal)
16 GND Ground
17 VLCD Charge pump voltage (ANA_VLCD signal)
18 GND Ground
19 +3V3 +3V3 power supply
20 GND Ground
21 GND Ground
22 GND Ground

14
J4 Connector to Wi-Fi Board (for Wi-Fi pumps only)
Pin n° Signal Description
1 Floating Not used on Agilia VP range. Leave floating
2 Floating Not used on Agilia VP range. Leave floating
3 GND Ground
4 Floating Not used on Agilia VP range. Leave floating
5 Floating Not used on Agilia VP range. Leave floating
6 GND Ground
7 WIFI_VCC +3V3 Wi-Fi power supply
8 WIFI_VCC +3V3 Wi-Fi power supply
9 UART-RxD Receive data
10 UART-TxD Transmit data
11 UART-RTS Hardware flow control (request to send)
12 UART-CTS Hardware flow control (clear to send)
13 GND Ground
14 GND Ground

J5 Connector to Opto Motor

Pin n° Type Signal Description
1 Power GND Ground
2 Input OP_OPTO Analog output signal of the photomicrosensor (photo-transistor collector)
3 Power GND Ground (photo-transistor emitter)
4 Power GND Ground (photo-diode cathode)
5 Output OP_CD_OPTO Power supply signal of the photomicrosensor (photo-diode anode)
6 Power GND Ground

J6 Connector to Power Supply Board

Pin n° Signal Description
1 GND Ground
2 PRES_BOARD/ HMI board presence detection
3 +3V3 +3V3 power supply
4 +3V3 +3V3 power supply
5 ANA_VLCD LCD charge pump voltage
6 GND Ground
7 S_ANA_DOOR Door close detection
8 RESET/ Global reset
9 GND Ground
10 CS_LED-KBD/ LED or keypad selection
11 CS_LCD/ LCD selection
12 GND Ground
13 LCD_CD LCD type of the interface cycle: Control/data (0:control, 1:data)
14 LCD_MS LCD mode selection
15 GND Ground
16 HMI_MOSI_SDA SPI data written/I²C data for HMI board
17 GND Ground
18 HMI_MISO SPI Data read for HMI board
19 GND Ground
20 HMI_SCK_SCL SPI/I²C clock for HMI board
21 GND Ground
22 KON-OFF On/Off key
23 +5V +5V power supply
24 +5V +5V power supply
25 CMD_FAIL LED command failure
26 GND Ground

15
J7 to Motor Connector
Pin n° Signal Description
1 MOTP_OUT1B Output B of the coil 1
2 MOTP_OUT1A Output A of the coil 1
3 MOTP_OUT2A Output A of the coil 2
4 MOTP_OUT2B Output B of the coil 2
5 GND Ground
6 GND Ground

J8 to JTAG Connector (micro programming)

Pin n° Signal Description
1 GND Ground
2 +3V3 +3.3V power supply
3 TRST/ Test reset
4 TDO Test data output
5 GND Ground
6 TDI Test data input
7 MR/ Manual reset
8 TMS Test mode select
9 TCK Test clock
10 GND Ground

J9 Connector to Interface Board

Pin n° Type Signal Description
1 Power GND Ground
2 Output MOSI Master Output, Slave Input (output from master)
3 Input MISO Master Input, Slave Output (output from slave)
4 Power GND Ground
5 Output CSBT/ Chip Select Bluetooth
6 Output CSADCLED/ Chip Select Analogical digital Converter LED
7 Power +5V +5V power supply
8 Power +5V +5V power supply
9 Output SCK Serial Clock
10 Power GND Ground
11 Output IRQBT/ Interrupt Request Bluetooth
12 Power GND Ground
13 Power J_FIX1 Ground
14 Power J_FIX2 Ground

J10 Connector to Plunger Driver

Pin n° Signal Description
1 GND Ground
2 PLGH_OPTO/ Analog output signal of the piston photomicrosensor
3 FORCE - Negative input of the force sensor
4 FORCE + Positive input of the force sensor
5 +3V3 3V3 power supply of force sensor
6 DSG_OPTO/ Analog output signal of the release photomicrosensor
7 PLGHDSG_CD_OPTO Power supply signal of the photomicrosensors
8 DSG_SW_ON/ Analog output signal of the release switch
9 DSG_SW_OFF/ Analog output signal of the release switch
10 GND Ground

16
2.1.5 Power Supply Board
The power supply board consists of he following:
 An ATtiny26L secondary microcontroller associated with the one on the CPU board.
 Different analog or power functions, including:
- Power supply management for all boards
- Battery charger
- Infrared interface
- Separate lines of communication (internal and external) to the boards
- Speaker
- Buzzer
- Super-capacitor
The power supply board is located on the angle bracket. See figure 2.1, page 7. It supplies power to the
electronic unit from the 100 V - 240 V AC network, or from 9 V DC. It also charges a 2.2 Ah battery. This
board is connected to other parts with the connectors shown below.

J1

J2

Figure 2.6: Power Supply Board (Front View)

J5
J3

J4

Figure 2.7: Power Supply Board (Back View)

Legend
J1 Connector - Connection to CPU Board J4 Connector - Connection to Secondary
J1 J4
Microcontroller
J2 Connector - Connection to microphone, J5 Connector - Connection to AC Power Board
J2 speaker and external plug (RS232 Communication J5
Port and DC Power Input/Output)
J3 J3 Connector - Connection to Internal Battery

17
J1 Connector to CPU Board
Pin n° Signal Description
1 GND Ground
2 +5V +5V power supply
3 +5V +5V power supply
4 GND Ground
5 +VCOMM Common power supply (main or external +10V)
6 +VCOMM Common power supply (main or external +10V)
7 GND Ground
8 SO_ANA_SPEAK Speaker analog output
9 +3V3-PERM Permanent +3.3V power supply (battery backup)
10 GND Ground
11 PWR_SCL I²C clock for POWER board
12 GND Ground
13 PWR_SDA I²C data for POWER board
14 GND Ground
15 IRDA_TX Infrared data transmission
16 PWR_CD_PRI_VCOMM Primary microcontroller common power supply switch
17 IRDA_RX Infrared data received
18 SO_CD_SHDN/ Speaker shutdown command
19 SO_ANA_MIC Analog microphone input
20 GND Ground
21 EXT_TX External transmit data
22 PRES_BOARD/ HMI and UC board presence detection
23 EXT_RX External receive data
24 CMD_FAIL LED command failure
25 KON-OFF On/Off key
26 GND Ground

J2 Connector to External plug

Pin n° Signal Description
1 SP- Negative connection to the speaker
2 SP+ Positive connection to the speaker
3 GND Ground - Terminal 2 of the microphone
4 MIC_TERM1 Microphone terminal 1 signal
5 GND Ground
6 VEXT_IN 10 VDC input
7 GND Ground
8 RELAY Nurse call output
9 GND Ground
10 5V0_OUT 5 VDC output
11 RXD RxD communication line
12 TXD TxD communication line
13 GND Ground
14 GND Ground

18
J3 Connector to Internal Battery
Pin n° Signal Description
1 VBAT Positive output of the smart battery
2 BAT_DATA One-wire communication link between the SMP and the battery
3 GND Ground (negative output of the smart battery)
4 GND Ground
5 GND Ground

J4 Connector to ATtiny 26 Secondary Microcontroller

Pin n° Signal Description
1 MISO Secondary microcontroller SPI data input
2 +3V3-PERM Secondary microcontroller power supply
3 SCK Secondary microcontroller SPI clock
4 MOSI Secondary microcontroller SPI data output
5 RST/ Secondary microcontroller reset
6 GND Ground

J5 Connector to AC Power Board

Pin n° Signal Description
1 Neutral Neutral wire
2 Line Hot wire
3 GND Ground

19
2.1.6 AC Power Board
The AC power board contains the power cord inlet, the ECM filter, and the F1 line fuse.
It is the interface of the power supply. The AC power board is located on the angle bracket.
See figure 2.1, page 7. This allows the power supply board to be changed without the need for soldering.
This board is connected to other parts with the connectors shown below.

J1

Figure 2.8: AC Power Board (Front View)

J2

F1 1

Figure 2.9: AC Power Board (Back View)

Legend
J1 J1 Connector - Connection to Power Supply F1
J1 Line Fuse F1
Board
J2 J2 Connector - Power Cord Inlet 1
J1 Fuse Identification Label

J1 Connector to Power Supply Board

Pin n° Signal Description
1 Neutral Neutral wire
2 Line Hot wire
3 GND Ground

J2 Connector to AC Power
Pin n° Signal Description
1 Neutral Neutral wire
2 Line Hot wire
3 GND Ground

20
2.1.7 Interface board
The Interface board receives data coming from cover locking detection sensor and patient handset and
transmits these data to the CPU board.

J1 J2

Figure 2.10: Interface Board

Legend
J1 J1 Connector - Connection to CPU Board J2 J2 Connector - Connection to cover lock flexible
circuit

J1 Connector to CPU board

Pin n° Type Signal Description
1 Power GND Ground
2 Output MOSI Master Output, Slave Input (output from master)
3 Input MISO Master Input, Slave Output (output from slave)
4 Power GND Ground
5 Output CSBT/ Chip Select Bluetooth
6 Output CSADCLED/ Chip Select Analogical digital Converter LED
7 Power +5V +5V power supply
8 Power +5V +5V power supply
9 Output SCK Serial Clock
10 Power GND Ground
11 Output IRQBT/ Interrupt Request Bluetooth
12 Power GND Ground
13 Power J_FIX2 Ground
14 Power J_FIX1 Ground

J2 Connector to cover lock flexible circuit

Pin n° Type Signal Description
1 Power GND Ground
2 Power LED_A LED anode
3 Power LED_K LED cathode
4 Power GND Ground
5 Power GND Ground
6 Input SW_PRESS Switch pressed
7 Input SW_REL Switch released
8 Power GND Ground
9 Power +3V3-F +3V3 power supply
10 Power GND Ground
11 Input SHELL_ANA_DIR Analogical input
12 Power GND Ground
13 Power J_FIX2 Ground
14 Power J_FIX1 Ground

21
2.1.8 Wi-Fi Board
For Agilia Wi-Fi pumps only.
The Wi-Fi board is securely fixed to a holder above the CPU Board.
A ribbon cable connects it to the CPU Board with the J1 connector.

Figure 2.11: Wi-Fi Board (Front View)

J1

Figure 2.12: Wi-Fi Board (Back View)

Legend
J1 J1 Connector - Connection to CPU Board

J1 Connector to CPU Board

Pin n° Signal Description
1 Floating Not used on Agilia VP range. Leave floating
2 Floating Not used on Agilia VP range. Leave floating
3 GND Ground
4 Floating Not used on Agilia VP range. Leave floating
5 Floating Not used on Agilia VP range. Leave floating
6 GND Ground
7 WIFI_VCC +3V3 Wi-Fi power supply
8 WIFI_VCC +3V3 Wi-Fi power supply
9 UART-RxD Receive data
10 UART-TxD Transmit data
11 UART-RTS Hardware Flow Control (Request to send)
12 UART-CTS Hardware Flow control (Clear to send)
13 GND Ground
14 GND Ground

22
2.1.9 Back View

9
8

BOLUS
7

6
1
2 3 4 5
Figure 2.13: Back View

Legend
1 Cord stowage 63 RS232 Communication Port

21 Patient handset and holder 73 Power Cord Inlet

3 Release Button 63
8 Infrared Cell

4 Pole clamp lock 63

9 Attachment Lock Knob

53 Rotating Pole Clamp

2.1.10 Patient Handset

1
J1
2

Figure 2.14: Patient Handset

Legend
1 Bolus start button J1 J1 Connector - Connection to patient handset

21 LED on when patient handset is connected to

pump

J1 Connector to Patient Handset

Pin n° Type Signal Description
1 Input SW_NC Analogical input
2 Input SW_NO Analogical input
3 Power GND (SW_CMD) Ground
4 Power LED_K LED cathode
5 Power LED_A LED anode

2.1.11 Mechanical Framework Assembly

The mechanical framework assembly is made up of a motor-reducer unit which drives a rack screw-nut
assembly, made up of 2 flanges and a linear sensor.
The mechanical assembly also contains a photo-electric cell dedicated to monitoring the motor’s rotation.

2.1.12 Mechanical Plunger Driver Assembly

The mechanical plunger driver assembly is located on the mechanical framework. The framework ensures
the displacement of the plunger via a screw-nut system.
The plunger driver is equipped with a disengagement control which allows it to disassociate from the
screw-nut system.

23
2.2 Principles of Operation
From an operational point of view, the Agilia SP PCA range of pumps is made up of 3 sub-assemblies:
 Syringe test and maintenance
 Motory
 External connection

2.2.1 Syringe Test and Maintenance Sub-assembly

The syringe is positioned in its housing and held in place by the syringe barrel clasp.
Detection of the syringe size (50/60 mL, 30 mL, 20 mL, 10 mL or 5 mL) is ensured by the potentiometric
sensor positioned on the syringe barrel clasp.
The correct positioning of the syringe flanges in the groove is checked by detecting the flanges.

2.2.2 Motor Sub-assembly

The motor sub-assembly ensures the displacement of the syringe piston.
It is set in motion by a motor-reducer linked to a screw-nut system.
Rotation control is ensured by a pinion attached to a motor shaft end and connected to an opto-electric
sensor.
A linear potentiometer mounted on an aluminum profile uses a rolling ball contact to ensure plunger
displacement control.
A micro-switch allows the disengagement mechanism position to be checked.
Correct positioning of the piston against the plunger driver is tested by the anti-siphon arms.
A force sensor integrated into the plunger driver detects the force exerted on the piston, and triggers an
alarm when the limit has been reached.

2.2.3 External Connection Sub-assembly

The Agilia SP PCA range of pumps has two plugs located at the back of the angle bracket. See figure 2.13,
page 23.
 AC power supply plug
 8-pin binder plug which, together with various specific Fresenius Kabi accessories, enables the
following:
- Continuous external power supply
- Serial link

24
2.3 Operation Diagrams
Communication between interface board processor and CPU board
Opening Magnet Hall effect
arms sensor

Clear protective cover

Plunger driver
head

Lock

Magnet

Hall effect
sensor

Syringe guard

Cover detection
Lock detection
Electronic Electronic
interface interface
Communication

Electronic interface
DC supply Handset
Electronic
interface
CPU BOARD
INTERFACE BOARD

Connector

LED

Switch

Patient
HANDSET handset

25
Other communications with CPU board
Opening Optical sensor
levers (plunger driver
head)
Switch (detection) Plunger driver head
Opening
arms

Potentiometer

Force
Syringe barrel clasp
sensor

Switch
(disengagement)

Half nuts

Gear Optical sensor

box (disengagement)

Optical
sensor

Stepper Linear
motor potentionmeter

Pumping mechanism Syringe installation Position sensor Plunger head

DISPLAY BOARD
Force sensor
LEDs Optical sensor
Motor driver
Electronic Electronic Electronic
interface interface interface interface
Integrated
amplifier

Interface

Internal communication
watchdog
Flash memory
Main microprocessor
Display Keypad RAM memory

Temperature sensor
Supervisory circuit
Sound Communication
management interface
Wi-Fi BOARD communication Watchdog
CPU BOARD
(if present)

Microphone
Secondary Battery/Battery
microprocessor charger
HP

Speaker
IrDa Battery
Interface Communication
communication Internal watchdog

RS232 to USB cable

External connector
AC/DC
DC supplies converter
Different
voltages
Power supply

Safety management

POWER SUPPLY BOARD

EMC filter AC
power supply

AC POWER BOARD

26
3 Fundamentals

3.1 Training
The following three training levels outline the specifics needed to maintain and preserve the equipment.

Training level Prerequisites

Training intended for users for on-site maintenance, using the technical documentation of the pump and
specific tools:
1  Mechanical and electrical knowledge
 Biomedical structure knowledge
This degree of maintenance does not need an important inventory.
Training intended for technicians specialized in maintenance performed with specific tools and
procedures:
2
 Good mechanical and electronics knowledge
 Two years experience minimum in a biomedical department
Training intended for technicians specialized in maintenance performed with specific tools and
procedures:
3
 Good mechanical and electronics knowledge
 Two years experience minimum in a biomedical department

INFORMATION
For training, contact your Fresenius Kabi sales representative.

3.2 Maintenance Schedule

3.2.1 Preventive Maintenance
Any abnormal functioning or failures must be reported to the qualified technical staff in your organization,
or to your Fresenius Kabi representative. In these instances, the pump should not be used.

WARNING
In order to maintain the pump’s performance, a preventive maintenance inspection must be carried out at
least once every 3 years. This procedure, which includes changing the battery, should be carried out by
trained and qualified technical personnel in compliance with this document and procedures. Only
authorized personnel should attempt to repair the device.
If these maintenance procedures are not observed, the pump’s correct operation will be impaired.

INFORMATION
The preventive maintenance inspection must be carried out with Agilia Partner maintenance software.

3.2.2 Quality Control

Upon request by the healthcare facility, a quality control check can be performed on the device every
12 months.
A regular quality check (not included in the guarantee) consists of various inspection operations listed in
this document. See section 6.2, page 37.
The quality control check can be performed without Agilia Partner maintenance software. See section 6.3,
page 66.

INFORMATION
These control checks must be performed by trained technical personnel, and are not covered by any
contracts or agreements provided by Fresenius Kabi.
For more information, contact your Fresenius Kabi sales representative.

27
3.3 Accessing / Exiting the Operating Functions
The Options menu gives access to the functions for operating the pump. The Options menu allows the
operator to customize the pump, edit infusion and maintenance parameters, and run tests.
The Options menu comprises the following:
 Pump Settings
 Basic Profile Configuration
 Profile Menu
 Maintenance

3.3.1 Accessing the Options Menu

When the pump is powered off, simultaneously press both and to access the Options menu.

Options Menu Access code? Description

Pump Settings No (unless modified by Test 20) Please refer to the IFU.
Profile Yes Section 4, page 29.
Basic Profile Configuration Yes Section 5, page 30.
Maintenance Yes Section 6, page 36.

INFORMATION
If the wrong access code is entered, Error is displayed.
As long as the pump remains powered on, the code does not need to be entered again.

Commands
Operation Key
Scroll options and change selected value (increasing/decreasing) Arrow keys

Confirm Value / Move to Next Field Confirmation key

Select -Deselect  Fast Increment key

Go to parent menu (if any) and cancel option Menu key

3.3.2 Exiting the Options Menu

Power the pump off and on again to exit the Options menu and return to standard operation.
All data, including newly selected and entered option, is saved to memory when the pump is powered off.

28
4 Profile Menu

4.1 Accessing the Profile Menu

1. Access the Options menu. See section 3.3, page 28.
2. Press the arrow keys to select Profile menu.
3. Press enter.
4. Enter the Profile menu access code "0080".
5. Press OK.

4.2 Profile Menu Functions

Function Choice Action
Pro 1: Default profile Basic Profile Displays the active profile name, and gives access
Profile 1 to the profile menu by the confirmation key.
Profile 2 Selects and loads a profile. See procedure below.
...
Pro 2: Select profile at power on Select  - Deselect  Activates or deactivates profile selection at startup.
- Restores the Basic Profile factory settings to the
Pro 3: Restore Basic Profile (Factory settings)
pump.
Select  - Deselect  Activates or deactivates Data set screen at startup.
Pro 4: Data set info. at power on This configuration is displayed only if a Data set is
loaded in the pump.
- Displays data set information (modification date,
Pro 5: Data set
writing date and version)

Selecting and loading a profile

1. Access the Profile menu.
2. Press the arrow keys to select Pro1: Default profile.
3. Press enter.
4. Press the arrow keys to select the profile name in the list provided.

5. Press OK.
The relevant profile information is displayed:
 Profile name
 Author
 Creation date
 Modification date
 Version

INFORMATION
In addition to Basic Profile, the default profile names are available if specified with Agilia Vigilant Master Med.
Agilia Vigilant Master Med may not be available in some countries. Contact your Fresenius Kabi sales
representative.

6. Press OK to confirm the loading operation, or C to change the profile.

The drug library associated with the selected profile is loaded.

29
5 Basic Profile Configuration

The Basic Profile Configuration menu is available only if Basic Profile has previously been selected as the
default profile. See section 4, page 29.
5.1 Accessing the Basic Profile Configuration
1. Access the Options menu. See section 3.3, page 28.
2. Press the arrow keys to select Basic Profile configuration.
3. Press enter.

4. Enter the Basic Profile configuration access code "0200".

5. Press OK.

6. Press the arrow keys to select the setting category (User or Ward).
7. Press enter.

5.2 Basic Profile Configuration Functions

Function Setting Description Range of Settings
User 1: Displays the battery logo on the Enabled / Disabled
Battery logo
Screen options infusion monitoring screen.
Displays the pressure logo on the Enabled / Disabled
Pressure logo
infusion monitoring screen.
Displays the volume-dose on the Enabled / Disabled
Vol-dose information
infusion monitoring screen.
Displays the remaining infusion time Enabled / Disabled
Time information
on the infusion monitoring screen.
Displays the battery life information Enabled / Disabled
Battery life information
on the infusion monitoring screen.
Displays a man as infusion in Enabled / Disabled
Logo man
progress indicator
Displays a syringe as infusion in Enabled / Disabled
Logo syringe
progress indicator
User 2: Profile Displays or hides menu items Enabled / Disabled
Pro
Menu items available for Basic Profile.
Volume limit VL

Volume/Time V/T
or Dose/Time D/T

Pause
Patient
Programmed bolus
Clinician bolus
Alarm volume
Vol-dose history
View event log

View PCA event log

PCA treatment
Library information
Data Set DS

30
 Function Setting Description Range of Settings
User 4: Pressure Mode Selects the mode. 3 levels / Variable
 Variable: One initial pressure
value that can be adjusted during
infusion.
 3 levels: 3 fixed pressure limits
that can be selected during
infusion.
DPS Activates or deactivates the DPS Yes / No
(Dynamic Pressure System) mode
while an infusion is in progress.
Unit Selects the pressure unit. mmHg / kPa (for
Japanese market only) /
PSI
Maximum pressure value If Mode = Variable, defines the 500  900 mmHg
maximum pressure allowed during
an infusion.
High pressure value If Mode = 3 levels, defines the 300  750 mmHg
maximum pressure allowed during
an infusion.
Medium pressure value If Mode = 3 levels, defines the 150  600 mmHg
medium pressure allowed during an
infusion.
Low pressure value If Mode = 3 levels, defines the low 50  300 mmHg
pressure allowed during an infusion.
Limit stored If enabled, the last pressure limit Enabled / Disabled
adjustment is automatically stored in
memory for the next startup.
If disabled, the user has to enter
pressure limit for the next startup.
Limit If Limit stored is disabled, sets the 50 mmHg  "Maximum
maximum pressure allowed during pressure value"
an infusion.
If Limit stored is enabled, the limit is
set to ’---’ and cannot be changed.
Drop threshold If DPS = Yes, sets a pressure drop ’----’ (No drop pressure
threshold. A message is generated if monitoring) or:
the pressure drops below this 100  500 mmHg
threshold.
Raise threshold If DPS = Yes, defines a pressure rise 100  200 mmHg
threshold. A message is generated if
the pressure rises above this
threshold.
DPS stored If DPS = Yes and DPS stored is Enabled / Disabled
enabled, the latest DPS adjustments
during infusion are saved
automatically at power off for the
next startup.
If DPS stored is disabled, the DPS
adjustments must be entered at the
next startup.
User 5: KVO KVO1 Sets the KVO1 flow rate. 0.1  5 mL/h
KVO2 Sets the KVO2 flow rate. 0.1  5 mL/h
Continuous Activates the Continuous function. Yes / No
After the VTBI is completed, the
infusion continues at the
programmed flow rate.
Silence duration Sets the silence duration alarm in 1 min  12 hours
KVO.
User 10: PCA mode Continuous rate only Sets the PCA infusion mode Enabled / Disabled
PCA bolus only
PCA bolus + continuous
PCA bolus + variable

31
 Function Setting Description Range of Settings
User 12: View flow rate history Displays or hides menu item: View Enabled / Disabled
Graph items flow rate history.
View pressure history Displays or hides menu item: View Enabled / Disabled
pressure history.
Par 1: Key press sound Turns the key press sound on or off. Enabled / Disabled
Key press sound
Par 2: Alarm Volume Sets the volume for alarms. 7 volume levels
Alarm Volume
Par 3: Drug and parameters: Saves the drug name only, or all Enabled / Disabled
Store infusion  Store drug name only infusion parameters, or nothing.
parameters  Store param. infusion
Same infusion screen: If Displayed is enabled, enables the Enabled / Disabled
Displayed display of the same infusion screen.
Same infusion screen:Time Duration of context backup. 1  24 hours
Par 4: Maximum rate for 50 mL Sets the maximum infusion rate for 0.1  1200 mL/h
Maximum rate syringe 50 / 60 mL syringes.
Maximum rate for 30 mL Sets the maximum infusion rate for 0.1  600 mL/h
syringe 30 mL syringes.
Maximum rate for 20 mL Sets the maximum infusion rate for 0.1  600 mL/h
syringe 20 mL syringes.
Maximum rate for 10 mL Sets the maximum infusion rate for 0.1  350 mL/h
syringe 10 mL syringes.
Maximum rate for 5 mL Sets the maximum infusion rate for 0.1  250 mL/h
syringe 5 mL syringes.
Par 7: Infusion start: Mandatory Displays a Mandatory prime Enabled / Disabled
Infusion start prime message, an Advised prime
Infusion start: Advised message, or no message prior to Enabled / Disabled
prime starting an infusion.
Par 8: Empty syringe mode If Empty syringe mode is enabled, Enabled / Disabled
Empty syringe an "Empty syringe mode" banner
starts blinking after the
acknowledgement of a medium-
priority "End of infusion" alarm.
Par 9: 50 mL Sets the bolus rate for 50 mL 0.1  1200 mL/h
Bolus rates syringes.
30 mL Sets the bolus rate for 30 mL 0.1  600 mL/h
syringes.
20 mL Sets the bolus rate for 20 mL 0.1  600 mL/h
syringes.
10 mL Sets the bolus rate for 10 mL 0.1  350 mL/h
syringes.
5 mL Sets the bolus rate for 5 mL 0.1  250 mL/h
syringes.
Par 10: 50 mL Sets the bolus rate for 50 mL 0.1  1200 mL/h
PCA Bolus rates syringes.
30 mL Sets the bolus rate for 30 mL 0.1  600 mL/h
syringes.
20 mL Sets the bolus rate for 20 mL 0.1  600 mL/h
syringes.
10 mL Sets the bolus rate for 10 mL 0.1  350 mL/h
syringes.
5 mL Sets the bolus rate for 5 mL 0.1  250 mL/h
syringes.
Par 12: Max. dose left Sets the remaining dose that triggers 0  15 % of the
Near end of the Maximum dose nearly Maximum dose
maximum dose reached !! infusion alarm (for a PCA programmed
therapy only).
Par 15: Syringe name Displays the syringe or ward name in Enabled / Disabled
Syringe/ward name Ward name the Infusion monitoring screen.
displays

32
 Function Setting Description Range of Settings
Par 16: General infusion: Auto-lock Locks or not the keyboard when the Enabled / Disabled
Cover keyboard at cover close cover is closed and a general
infusion is selected.
General infusion: Auto- Unlocks or lets the keyboard locked Enabled / Disabled
unlock keyboard at cover when the cover is opened and a
open general infusion is selected.
PCA: Install mandatory If Install mandatory is enabled, a Enabled / Disabled
PCA therapy cannot be runned if the
clear protective cover is not installed.
PCA: Infusion without lock If Infusion without lock is enabled, Enabled / Disabled
a PCA therapy can be runned
irrespective of the clear protective
cover status (locked or unlocked).
PCA: Lock mandatory If Lock mandatory is enabled, a Enabled / Disabled
PCA therapy cannot be runned if the
clear protective cover is unlocked.
PCA: Auto-lock keyboard at Locks automatically (or lets Enabled / Disabled
cover close unlocked) the pump keyboard when
the cover is closed and a PCA
therapy is selected.
PCA: Auto-unlock keyboard Unlocks automatically (or lets Enabled / Disabled
at cover open locked) the pump keyboard when the
cover is opened and a PCA therapy
is selected.
Par 17: Sound for patient bolus If Sound for patient bolus request Enabled / Disabled
Patient handset request is enabled, the handset emits a
sound when pressing the handset
button.
Blinking light for PCA bolus If Blinking light for PCA bolus is Enabled / Disabled
enabled, the handset LED flashes for
a few seconds when pressing the
handset button.
Par 18: Screen brightness low Brightens or darkens the screen at Enabled / Disabled
Day/Night mode next night mode startup.
Infusion indicators low Brightens or darkens the infusion Enabled / Disabled
indicators at next night mode startup.
Key press sound off Turns on or off the key press sound Enabled / Disabled
at next night mode startup.
Manual mode Displays or hides "Day/Night mode" Enabled / Disabled
menu item.
Auto mode Enables/disables the ability to Enabled / Disabled
automatically activate night mode.
Day/Night mode If Auto mode is enabled, press OK 00h00  23h59
to set a daily period for the automatic 00:00  23:59
activation of night mode.
Par 19: Direct bolus Activates or deactivates the Direct Enabled / Disabled
Other functions bolus function.
Loading dose Activates or deactivates the Loading Enabled / Disabled
dose function.
Programmed bolus Activates or deactivates the Enabled / Disabled
Programmed bolus function.

33
 Function Setting Description Range of Settings
Par 20: Concentration units Sets the available concentration Enabled / Disabled
Authorized units units: nanog, µg, mg, g, mmol, munit,
unit, cal, kcal, mEq, /mL, /XmL
Dose rate units Sets the available dose units: Enabled / Disabled
nanog/h, nanog/kg/min, nanog/kg/h,
µg/h, µg/min, µg/kg/min, µg/kg/h,
mg/min, mg/h, mg/24h, mg/kg/min,
mg/kg/h, mg/kg/24h, mg/m2/h,
mg/m2/24h, g/h, g/kg/min, g/kg/h,
g/kg/24h, mmol/h, mmol/kg/h,
mmol/kg/24h, munit/min,
munit/kg/min, munit/kg/h, unit/min,
unit/h, unit/kg/min, unit/kg/h, kcal/h,
kcal/24h, kcal/kg/h, mEq/min,
mEq/h, mEq/kg/min, mEq/kg/h
Par 22: mL/h / mL Sets the available modes for the Enabled / Disabled
Programming modes profile.
Mass flow / Dose Sets the available modes for the Enabled / Disabled
profile.
Par 23: Min weight (kg) Sets the lower programmable limit of 0.25 kg 
Patient parameters patient weight. "Max weight (kg)"
Max weight (kg) Sets the upper programmable limit of "Min weight (kg)" 
patient weight. 350 kg
Default weight (kg) Sets the patient default weight. "Min weight (kg)" 
"Max weight (kg)"
Min surface (m²) Sets the lower programmable limit of 0.05 m² 
patient BSA. "Max surface (m²)"
Max surface (m²) Sets the upper programmable limit of "Min surface (m²)"
patient BSA.  4.5 m²
Default surface (m²) Sets the default patient BSA. "Min surface (m²)"

"Max surface (m²)"
Par 25: Same therapy screen Displays the same therapy screen Yes / No
Same therapy when changing current drug.
screen
Par 26: General infusion Gives access to general infusion Enabled / Disabled
Therapeutic therapies
functions PCA Gives access to PCA therapies Enabled / Disabled
Mandatory PCA code Sets a passcode entry for accessing Enabled / Disabled
a PCA therapy
Par 29: Continuous only Sets the avalaible infusion modes of Enabled / Disabled
PCA modes PCA bolus only a PCA therapy. Enabled / Disabled
Patient bolus + continuous Enabled / Disabled
Patient bolus + variable Enabled / Disabled
Mode stored Stores or not the last infusion mode Enabled / Disabled
selected of a PCA therapy.
Loading dose PCA If Loading dose PCA is enabled, Enabled / Disabled
allows to request a loading dose
when a PCA therapy is selected.
Clinician bolus If Clinician bolus is enabled, allows Enabled / Disabled
to request a clinician bolus when a
PCA therapy is selected.

34
 Function Setting Description Range of Settings
Par 30: Enable modifications during Allows or prevents parameter Enabled / Disabled
PCA options treatment modifications while a PCA therapy is
in progress.
Display PCA bolus Displays or hides if a patient is Enabled / Disabled
available or not during the lockout
period.
Display lockout time Displays or hides the remaining Enabled / Disabled
lockout time on the PCA infusion
screen.
Auto dose rate unit If Auto dose rate unit is enabled, Enabled / Disabled
the flow rate unit is automatically set
from the concentration unit selected.
If Auto dose rate unit is disabled,
the flow rate unit and concentration
units are selected by the user.
Maximum PCA bolus If Maximum PCA bolus is enabled, Enabled / Disabled
enable allows to set a maximum number of
boluses that can be administered to
a patient over a rolling period of time.
Par 31: Time Sets the remaining time that triggers 1  30 min
Near end of infusion the Near end of infusion alert.
alert
Par 34: While stopped only If While stopped only is enabled, Enabled / Disabled
Rate titration allows rate modification after an
infusion stop only.
If Choice in menu is enabled, the
Automatic lock menu item is
Choice in menu available to program an automatic Enabled / Disabled
Par 39: lock of the keyboard. To unlock
Automatic keypad keypad, a code is necessary.
lock Automatic lock If Automatic lock is enabled, the Enabled / Disabled
keypad is automatically locked if no
Duration before lock user action is done at end of the 15 s to 60 s
Duration before lock.
Note:
 The displayed menu may change depending on the pump configuration and destination country.
 µ = mc or micro.

35
6 Maintenance Operations

6.1 Maintenance Options

6.1.1 Accessing the Maintenance Options Menu
1. Access the Options menu. See section 3.3, page 28.
2. Press the arrow keys to select Maintenance.
3. Press enter.
4. Enter the Maintenance access code.
5. Press OK.

6. Press the arrow keys to select Maintenance options.

7. Press enter.

6.1.2 Maintenance Date

1. Access the Maintenance options menu. See section 6.1.1, page 36.
2. Press the arrow keys to select Svc 1: Maintenance date.
3. Press enter.
The next scheduled maintenance date is displayed.
4. Press exit to return to the Maintenance options menu.

INFORMATION
This date corresponds to the next preventive maintenance date to be carried out.
See section 3.2.1, page 27.
The date is displayed for consultation only, and cannot be changed here.

6.1.3 Initial Set up

1. Access the Maintenance options menu. See section 6.1.1, page 36.
2. Press the arrow keys to select Svc 2: Initial set up.
3. Press enter.
4. Select Yes using the arrow keys to ask for the initial configuration to be
loaded at the next pump startup. Otherwise, select No.
5. Press OK to confirm the selection.

6.1.4 Data Log Event

1. Access the Maintenance options menu. See section 6.1.1, page 36.
2. Press the arrow keys to select Svc 3: Data log event.
3. Press enter.
4. Use the arrow keys to select the desired clinical or technical event.

5. Press enter.
The details of the event are displayed.
6. Press exit to return to the Maintenance options menu.

36
6.1.5 Maintenance Information
1. Access the Maintenance options menu. See section 6.1.1, page 36.
2. Press the arrow keys to select Svc 4: Maintenance information.
3. Press enter.

4. Press to allow or disallow the display of a Maintenance info. screen at the

next pump startup.
5. Press OK to confirm the selection.

6.2 Running Tests

INFORMATION
Before running Tests/Controls from the pump, it is recommended to work with a pump configured with the
Basic Profile and with Factory (default) settings. Load the Basic Profile from the pump’s maintenance
Profile menu: "Pro 3:Restore Basic Profile". See Profile Menu Functions, section 4.2, page 29.

You must systematically run tests after calibrating sensors.

At the end of a full test cycle, you can obtain certificates. See section 6.3.2, page 69.

Calibration Associated Tests

Force sensor  Occlusion alarm
Syringe barrel clasp  Syringe barrel clasp
Displacement  Displacement

6.2.1 Accessing the Tests Menu

1. Access the Options menu. See section 3.3, page 28.
2. Press the arrow keys to select Maintenance.
3. Press enter.

4. Enter the Maintenance access code.

5. Press OK.

6. Press the arrow keys to select Tests.

7. Press enter.

The Tests screen is displayed.

37
List of Tests
Tests Tests
Test 1 Identification. See section 6.2.2, page 38. Test 12 Battery life. See section 6.2.13, page 51.
Test 2 Maintenance options. See section 6.2.3, page 39. Test 13 Battery test. See section 6.2.14, page 51.
Maintenance messages.
Test 3 Test 16 Cover. See section 6.2.15, page 53.
See section 6.2.4, page 39.
Test 4 Events. See section 6.2.5, page 40. Test 17 Patient handset. See section 6.2.16, page 54.
Test 5 Force. See section 6.2.6, page 41. Test 20 Pump code. See section 6.2.17, page 55.
Test 6 Displacement. See section 6.2.7, page 43. Test 21 Power information. See section 6.2.18, page 55.
Test 7 Syringe barrel clasp. See section 6.2.8, page 45. Test 22 LCD voltage. See section 6.2.19, page 57.
Test 8 Battery information. See section 6.2.9, page 48. Test 23 Temperature. See section 6.2.20, page 57.
Test 9 Indication. See section 6.2.10, page 49. Test 24 Watchdog. See section 6.2.21, page 58.
Wi-Fi module information.
Test 10 Keypad. See section 6.2.11, page 49. Test 25
See section 6.2.22, page 59.
Test 11 Ageing test. See section 6.2.12, page 50.

6.2.2 Test 1: Identification

Test Description
This test checks that the Identification parameters of the pump are correct. The Identification
parameters are displayed for information only. They cannot be modified here.

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 1: Identification.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Pump name
 Pump version or revision with software generation date
 Pump serial number
 CPU board serial number
 Power supply board serial number
 Power supply board software version or software revision with the
generation date
 Battery serial number

 For each language available:

- Language name
- Language file version or revision
- Language file creation date
 For each parameter zone:
- Parameter zone number + version or revision
- Parameter zone creation date
- Last manual modification date

38
  Boot version or revision
 Boot creation date

 Embedded software version or software revision with the generation date

5. Press exit to return to the Tests menu.

6.2.3 Test 2: Maintenance

Test Description
Run this test to check that the pump maintenance data is correct.

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 2: Maintenance.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Duration: Running time since last preventive maintenance in hours (if less
than 72 hours), in days (if less than 120 days) or in months
 Date: Last preventive maintenance date
 Total duration: Total running time in hours (if less than 72 hours), in days
(if less than 120 days) or in months.
 Total distance: Total running distance of the plunger’s driver in m.

5. Press exit to return to the Tests menu.

6.2.4 Test 3: Maintenance Messages

Test Description
Run this test to check the maintenance messages entered. The maintenance message is
displayed for information only. It cannot be modified here.

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 3: Maintenance messages.
3. Press enter.
Informational messages stored by After Sales Service are displayed.

4. Press exit to return to the Tests menu.

39
6.2.5 Test 4: Events
Test Description
Run this test to consult the list of pump events, and the details of each recorded technical event.
The clinical events are not displayed here.

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 4: Events.
3. Press enter.
The technical events are listed.
4. Press the arrow keys to select an event.

5. Press enter.
The selected event is displayed in detail.
6. Press the arrow keys to scroll through the event detail screen.

7. Press exit to return to the list of events.

40
6.2.6 Test 5: Force
Test Description
The syringe force sensor is used to monitor the pressure and detect occlusions in the syringe.
Run this test to validate the accuracy of the force sensor.
This test checks the pressure inside the syringe when an occlusion alarm is triggered.

Force sensor
Force sensor
Main
microprocessor Integrated
amplifier
CPU BOARD

The force sensor works properly and is correctly calibrated.

This test failed if one of these two conditions is encountered:
 The force sensor is not calibrated. Calibrate the force sensor using Agilia Partner
maintenance software.
 The force sensor is defective, or not correctly connected to the CPU board. This
problem leads to an error code 22:
- Check the cable connection to CPU board (J9 connector). See figure 2.4,
page 13.
- Replace the force sensor. See section 8.18, page 132.

Required Tools and Equipment

 1 Dynamometer

Prerequisites
 The dynamometer’s calibration certificate is valid.

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 5: Force.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Conversion: Sensor value in mV. The displayed voltage value depends on
the pressure applied on the sensor
 Force: Force value expressed in g
 0 sensor: Sensor offset value expressed in mV. Value saved during last
calibration
 Force = 0 kg: Calibration at 0 kg (0 PSI or 0 bar) in mV. Value saved
during last calibration
 Force = 5 kg: Calibration at 5 kg (11.6 PSI or 0.8 bar) in mV.Value saved during last calibration
 Date: Date of last calibration displayed in the following format:
Month/Day/Year (mm/dd/yyyy)
 Number: Last calibration number
5. Press the arrow keys to display the Conversion/Force screen.
6. Unlock the pump cover to open the cover.
7. Push the disengagement lever down and move the plunger driver to the right.
8. Apply a force to the sensor, then release it.
9. Check that the Force value is between -200 g and +200 g.

41
 10.Open the syringe barrel clasp, push the disengagement lever down, and move the plunger driver to
the right.
11.Place the dynamometer in the syringe cradle, with the flanges correctly inserted in the provided slot.
12.Secure the dynamometer with the syringe barrel clasp.
13.Slide the arms spacer to the left.
14.Push the disengagement lever, and move the plunger driver gently to the left until it is in contact with
the plunger head of the dynamometer.
15.Release the disengagement lever.
The arms must not be in contact with the arms spacer.

Figure 6.1: Installation of dynamometer

16.Apply a force of 0.4 bar.

17.Check that the Force value is between +2200 g and +2800 g.
18.Press exit to return to the Tests menu.
19.Open the syringe barrel clasp, push the disengagement lever down,
and move the plunger driver to the right to zero the pressure.
20.Start an infusion at 1000 mL/h.
21.Check that the pump triggers an "Occlusion" pre alarm, then an "Occlusion" alarm in less than
60 seconds when 10.88 PSI (0.75 bar) < Pressure < 12.33 PSI (0.85 bar).

22.Press to silence the alarm.

23.Press to stop the infusion.

24.Open the syringe barrel clasp, push the disengagement lever down, and move the plunger driver to
the right.
25.Remove the dynamometer.
26.Close the cover by pushing it until you feel and hear it click into place.

42
6.2.7 Test 6: Displacement
Test Description
The Displacement sensor is a linear potentiometer used to control the linear motion of the
plunger driver and to determine the remaining volume in the syringe.
Run this test to validate the accuracy of the displacement sensor.

Displacement Linear potentiometer

Main sensor
microprocessor
Interface

CPU BOARD

The plunger’s driver displacement is correctly calibrated.

This test failed if one of these two conditions is encountered:
 The displacement sensor is not calibrated. Calibrate the displacement sensor using
Agilia Partner maintenance software.
 The displacement sensor is defective or not correctly connected to the CPU board.
This problem leads to an error code 21:
- Check the cable connection to CPU board (J2 connector).
See figure 2.4, page 13.
- Replace the displacement sensor. See section 8.19, page 138.

Required Tools and Equipment

 1 displacement verification gauge, 2.56 in (65 mm) long

Prerequisites
 The calibration certificate of the displacement verification gauge is valid.

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 6: Displacement.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Conversion: Sensor value in mV. The displayed voltage value depends on
the plunger head position
 Position: Plunger head position value in mm
 Low (20 mm): Sensor value in mV when the plunger head is positioned at
20 mm (0.79 in). Value saved during last calibration
 High (115 mm): Sensor value in mV when the plunger head is positioned
at 115 mm (4.53 in). Value saved during last calibration
 Date: Date of last calibration displayed in the following format:
Month/Day/Year (mm/dd/yyyy)
 Number: Last calibration number
 Linearization: Date of last calibration that included a linearization. This
date is displayed in the following format: Month/Day/Year (mm/dd/yyyy)
5. Press the arrow keys to display the Conversion/Position screen.
6. Unlock the pump cover to open the cover.
7. Push the disengagement lever down, and move the plunger driver gently to the right stop.
8. Close the cover by pushing it until you feel and hear it click into place.

43
 Figure 6.2: Plunger driver to the right stop position

9. Check the value displayed for Position. The value must be between 4.67 in and 5.41 in
(118.5 mm and 137.5 mm).
10.Unlock the pump cover to open the cover.
11.Push the disengagement lever down, and move the plunger driver gently to the left stop.
12.Close the cover by pushing it until you feel and hear it click into place.

Figure 6.3: Plunger driver to the left stop position

13.Check the value displayed for Position. The value must be between 0.39 in and 0.60 in
(10 mm and 15.2 mm).
14.Unlock the pump cover to open the cover.
15.Open the syringe barrel clasp and place the 2.56 in (65 mm) gauge in the syringe cradle, with the
flanges correctly inserted in the provided slot and the 2.56 in (65 mm) part positioned to the right.
16.Secure the gauge with the syringe barrel clasp.
17.Push the disengagement lever down, and move the plunger driver gently to the left until it is in contact
with the gauge.
18.Close the cover by pushing it until you feel and hear it click into place.

Figure 6.4: Installation of the 2.56 in (65 mm) displacement gauge

44
 19.Check the value displayed for Position. The value must be between
2.5 in and 2.62 in (63.5 mm and 66.5 mm).
20.Unlock the pump cover to open the cover.
21.Open the syringe barrel clasp.
22.Push the disengagement lever down and move the plunger driver to the right.
23.Remove the 2.56 in (65 mm) displacement gauge.
24.Close the cover by pushing it until you feel and hear it click into place.
25.Press exit to return to the Tests menu.

6.2.8 Test 7: Syringe Barrel Clasp

Test Description
The Syringe barrel clasp sensor is used to maintain the syringe in the pump, to detect the good
positioning of the syringe and to measure the diameter of the syringe.
Run this test to check:
 correct measurement for the syringe diameter
 correct functioning of the syringe fastening system
Optical sensor - disengagement
Opening levers (plunger head)
Switch (syringe
detection) Opening arms

Syringe barrel Potentiometer

clasp

Syringe
Main installation
microprocessor
Interface

CPU BOARD

The plunger’s driver displacement is correctly calibrated.

This test failed if one of these two conditions is encountered:
 The syringe barrel clasp sensor is not calibrated. Calibrate the syringe barrel clasp
sensor using Agilia Partner maintenance software.
 The syringe barrel clasp sensor is defective or not correctly connected to the CPU
board. This problem leads to an error code 20:
- Check the cable connection to CPU board (J1 connector). See figure 2.4,
page 13.
- Replace the displacement sensor. See section 8.14, page 112.

45
 Required Tools and Equipment
 V1 diameter verification gauge, 11.5 mm (0.45 in) diameter
 V2 diameter verification gauge, 15.5 mm (0.61 in) diameter
 V4 diameter verification gauge, 28 mm (1.10 in) diameter

Prerequisites
 The calibration certificates of the diameter verification gauges are valid.

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 7: Syringe barrel clasp.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Conversion: Sensor value in mV. The displayed voltage value depends on
the syringe diameter installed
 Diameter: Syringe diameter in mm. Value measured by the sensor.
 Low (11 mm): Sensor value in mV when the C1 calibration tool
(diameter = 11 mm) is installed. Value saved during last calibration
 Middle (22.9 mm): Sensor value in mV when the C2 calibration tool
(diameter = 22.9 mm) is installed. Value saved during last calibration
 High (33 mm): Sensor value in mV when the C3 calibration tool
(diameter = 33 mm) is installed. Value saved during last calibration
 Date: Date of last calibration
 Number: Last calibration number

5. Press the arrow keys to display the Conversion/Diameter screen.

6. Unlock the pump cover to open the cover.
7. Open the syringe barrel clasp, push the disengagement lever down, and move the plunger driver to
the right.
8. Place the V1 diameter verification gauge in the syringe cradle, with the flanges correctly inserted in
the provided slot.
9. Secure the V1 diameter verification gauge with the syringe barrel clasp.
10.Close the cover by pushing it until you feel and hear it click into place.

Figure 6.5: Installation of V1 diameter verification gauge

11.Check the value displayed for Diameter. The value must be equal to 10.5 mm ± 1.5 mm
(0.35 in to 0.47 in).

46
12.Unlock the pump cover to open the cover.
13.Open the syringe barrel clasp, and remove the V1 diameter verification gauge.
14.Place the V2 diameter verification gauge in the syringe cradle, with the flanges correctly inserted in
the provided slot.
15.Secure the V2 diameter verification gauge with the syringe barrel clasp.
16.Close the cover by pushing it until you feel and hear it click into place.

Figure 6.6: Installation of V2 diameter verification gauge

17.Check the value displayed for Diameter. The value must be equal to 15.5 mm ± 1.5 mm
(0.55 in to 0.70 in).
18.Unlock the pump cover to open the cover.
19.Open the syringe barrel clasp, and remove the V2 diameter verification gauge.
20.Place the V4 diameter verification gauge in the syringe cradle, with the flanges correctly inserted in
the provided slot.
21.Secure the V4 diameter verification gauge with the syringe barrel clasp.
22.Close the cover by pushing it until you feel and hear it click into place.

Figure 6.7: Installation of V4 diameter verification gauge

23.Check the value displayed for Diameter. The value must be equal to 28 mm ± 1.5 mm
(1.04 in to 1.16 in).
The test fails if one of these three Diameter values is outside the tolerance zone.
24.Press exit to return to the Tests menu.
25.Unlock the pump cover to open the cover.
26.Open the syringe barrel clasp, and remove the V4 diameter verification gauge.
27.Close the cover by pushing it until you feel and hear it click into place.

47
6.2.9 Test 8: Battery Info
Test Description
This test provides information about battery usage time, voltage output, current output, and
temperature.
Run this test to check that the battery data is correct.

The battery capacity is acceptable.

If this test fails:
 Connect the pump to an AC power supply to charge the battery.
 Run the test again. If the test fails, replace the battery.
See section 8.3, page 83.

Required Tools and Equipment

 No specific tools or equipment are required

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 8: Battery info.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Duration: Battery operating time in hours, days and months
 Cycles: Number of charge/discharge cycles, equivalent to Duration (in
hours) divided by 7
 Since: Date of the first use on battery
 Conversion and Voltage: Voltage value at the battery terminals in V, and
conversion into mV
 Conversion and Temperature: Battery temperature in °C, and conversion
into LSB
 Conversion and Current: Battery charge/discharge current in mA, and
conversion into LSB

5. Check that the displayed values are within the limits shown in the table below.

Value Limits
Voltage 5.0 V to 8.7 V
Current - Connected to an AC power supply, battery being charged -135 mA to -165 mA
(battery charge status indicator is flashing)
Current - Connected to an AC power supply, battery fully charged -50 mA to +50 mA
(battery charge status indicator is lit permanently)
Current - Pump running on battery -50 mA to -200 mA
(battery charge status indicator is off)
Temperature +2 °C to +48 °C (+35.6 °F to +118.4 °F) for normal
room temperatures

6. Press exit to return to the Tests menu.

48
6.2.10 Test 9: Indication
Test Description
Run this test to check the correct functioning of display, battery charge status indicator, power
supply indicator, infusion indicator lights, microphone and buzzer.

The pump screen, indicators, microphone and buzzer work properly.

If this test fails, replace the display board and LCD display. See section 8.10, page 98.

Required Tools and Equipment

 No specific tools or equipment are required

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 9: Indication.
3. Press enter.
4. Check that:
 A white screen is displayed.
 The battery charge status indicator, power supply indicator, infusion
indicator lights are lit.
 OK is blinking in the bottom-right corner of the screen.
5. Press OK.
6. Check that:
 A blue Indication screen is displayed.
 The battery charge status indicator, power supply indicator, infusion
indicator lights are flashing.
 Exit is displayed in the bottom-right corner.
 The microphone and buzzer sound.
7. Press exit to return to the Tests menu.
If you do not press exit in the next 10 seconds, the pump returns automatically to Tests menu.

6.2.11 Test 10: Keypad

Test Description
Run this test to check the correct functioning of all pump keys.

The keypad works properly.

If this test fails, replace the upper case that supports the keypad.
See section 8.3, page 83.

Required Tools and Equipment

 No specific tools or equipment are required

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 10: Keypad.
3. Press enter.
4. Press all keys one by one, and check that the corresponding circle on the
screen is highlighted.

5. Press for at least 5 seconds to exit and return to the Tests menu.

49
6.2.12 Test 11: Ageing Test
Test Description
The Ageing test checks that the motor unit is functioning correctly by carrying out
displacements between the 115 mm (4.52 in) and 20 mm (0.79 in) positions.

The motor unit is functioning correctly.

If the test fails, replace the motor unit. See section 8.16, page 124.

Required Tools and Equipment

 No specific tools or equipment are required

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 11: Ageing test.
3. Press enter.
4. Press the arrow keys to enter the flow rate to be applied in mL/h.
Available range: 0.1 to 1500 mL/h.
5. Press OK.

6. Press the arrow keys to enter the motor command mode (Current).
Available options: Low, High, Maximum or Auto.
7. Press OK.

8. Press the arrow keys to select the displacement type Advance or Go/return.
9. Press OK to start the test.
If a battery alarm is present, the test cannot be launched (the OK button is not
available).
The pump starts moving the plunger forward.
While an ageing test is in progress, the pump displays the following information:
 Flow rate in mL/h
 Motor command mode (Current = Low, High, Maximum or Auto)
 Animation representing the plunger displacement
The test ends when:
 The plunger reaches the 20 mm (0.79 in) position (Displacement = Advance).
 The plunger reaches the 115 mm (4.52 in) position (Displacement = Go/return). The plunger
starts moving backwards when it reaches the 20 mm position.
 The user presses the exit key.

INFORMATION
During the test, the motor rotation is tested and the pump triggers an error if a problem is detected.

At end of test, the pump displays the following information:

 Flow rate in mL/h
 Motor command mode (Low, High, Maximum or Auto)
 The test status (Finish)
10.Press exit at end of test to return to the Test screen.

50
6.2.13 Test 12: Battery Life
Test Description
This test provides information on the current battery charge percentage, and displays results of
the last battery discharge test (last run of "Test 13: Battery test").

The battery capacity is acceptable.

If the charge is low, connect the pump to an AC power supply to charge the battery.
If the displayed "Alarm" is less than 01h30 (01:30), replace the battery.
See section 8.2, page 81.

Required Tools and Equipment

 No specific tools or equipment are required

Prerequisites
 Run test 13: "Battery test" on the pump before launching this test.
See section 6.2.14, page 51.

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 12: Battery life.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Charge: Battery charge current rate (in %)
 Auto Off: Date of last automatic cut off (value saved during last battery
test)
 Pre alarm: Duration between transition to battery and pre alarm (value
saved during last battery test)
 Alarm: Duration between transition to battery and alarm (value saved
during last battery test)
 Cut off: Duration from alarm to automatic pump power off (value saved
during last battery test)
5. Press exit to return to the Tests menu.

6.2.14 Test 13: Battery Test

Test Description
During this test, a battery discharge is performed. Pre alarm, alarm and cut off times are
determined and registered so that it is possible to evaluate if the battery works correctly.
At the end of a battery test, the results are recorded and can be checked by running
"Test 12: Battery life". Then the pump powers off.

The battery capacity is acceptable.

Replace the battery.
See section 8.2, page 81.

Required Tools and Equipment

 No specific tools or equipment are required

Prerequisites
 The pump is disconnected from the AC power supply.

51
 1. Access the Tests menu. See section 6.2.1, page 37.
2. Press the arrow keys to select Test 13: Battery test.
3. Press enter.

INFORMATION
If the pump is connected to an AC power supply, the test does not start and the
following screen is displayed.
Disconnect the pump from the AC power supply. The test is automatically initiated.

While a battery test is in progress, the pump displays the following information:
 Pre alarm: Duration from transition to battery until pre alarm in hours and
minutes (hh:mm).
This duration increases up to the pre alarm triggering time, then stops.

 Alarm: Duration from transition to battery until alarm in hours and minutes
(hh:mm).
This duration:
- is equal to ’--:--’ as long as the pre alarm is not triggered,
- starts from the pre alarm triggering time, then increases up to the alarm
triggering time, and finally stops.
 Cut off: Duration from alarm to automatic pump power off.
This duration:
- is equal to ’--:--’ as long as the alarm is not triggered,
- is reset to ’00:00’ when the alarm is triggered,
- increases up to the pump cut off.

INFORMATION
If the pump is connected to an AC power supply while a battery test is running,
the test stops and the following screen is displayed.
Press exit to return to the Tests menu.

4. At end of test, display the "Pre alarm", "Alarm" and "Cut off" stored in memory:
 Connect the pump to an AC power supply
 Power on the pump
 Run test 12 (Battery life)
 Check that the displayed "Alarm" is equal to or greater than 01h30 (01:30).
If not, replace the battery. See section 8.2, page 81.
5. Press exit to return to the Tests menu.

52
6.2.15 Test 16: Cover
Test Description
This test checks that the clear protective cover is properly installed and locked.

The clear protective cover is properly installed.

If the test fails, re-install and re-lock the clear protective cover.
Replace the clear protective cover.
See section 8.3, page 83.
Replace the Pusher protection with lock kit.
See section 8.8, page 92.

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 16: Cover.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Conversion: Hall effect cover detection sensor value in mV. The
displayed voltage value is updated according to the Hall effect sensor
 Cover: Cover installation state (installed or missing) according to the
Hall effect sensor measurement
 Conversion: Hall effect cover lock sensor value in mV. The displayed
voltage value is updated according to the Hall effect sensor
 Status: Cover lock state (locked or opened) according to the Hall effect
sensor measurement
5. Install/remove the clear protective cover and check that the Conversion value displayed in mV is
within the limits shown in the table below.
6. Lock/unlock the clear protective cover and check that the Conversion value displayed in mV is within
the limits shown in the table below.
7. Press exit to return to the Tests menu.

Value (cover detection sensor) Limits

Clear protective cover installed 0 mV to 1300 mV or 2000 mV to 3300 mV
Clear protective cover missing 1300 mV to 2000 mV

Value (cover lock sensor) Limits

Clear protective cover locked 0 mV to 1300 mV or 2000 mV to 3300 mV
Clear protective cover opened 1300 mV to 2000 mV

53
6.2.16 Test 17: Patient handset
Test Description
This test checks that the patient handset is correctly detected by the pump and that the patient
handset LEDs work properly.

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 17: Patient handset.
3. Press enter.
The following data is displayed:
 Handset: Handset connection state (connected or missing)
 Status: Handset button status (pressed or released)
4. Disconnect the handset from the pump and check that missing is displayed
for Handset.

5. Connect the handset to the pump and check that connected is displayed for
Handset.

6. Press and hold the handset button and check that pressed is displayed for
Status.

7. Release the handset button and check that released is displayed for Status.

8. Check the Light box.

The handset LED lights on at a maximum intensity

9. Check the Night mode box.

The handset LED lights on at a low intensity.

10.Uncheck the Light box.

The handset LED lights off.

11.Uncheck the Night mode box.

12.Press exit to return to the Tests menu.

54
6.2.17 Test 20: Pump Code
Test Description
Run this test to display and modify the code which gives access to the Pump Settings from the
Options menu. See section 3.3, page 28.

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 20: Pump code.
3. Press enter.
The current Pump Settings access code is displayed.
4. Enter the code.
5. Press OK to confirm.
6. Press exit to return to the Tests menu.

INFORMATION
If you do not want to protect access to the Pump settings by a code, enter "0000".

6.2.18 Test 21: Power Info

Test Description
Run this test to display power source information on the following parts:
 DC voltage
 Battery DC voltage charging value
 Backup capacitor voltage and temperature
 5 V booster voltage.

INFORMATION
The backup capacitor voltage and temperature must be systematically checked during the maintenance
protocol.

The AC power board and power supply boards work properly.

DC voltage out of limits:
 Check the connections between power supply board (J5 connector) and AC power
board.
 Check the fuse on AC power board.
 Replace the power supply board.
See section 8.12, page 106.
 Replace the angle bracket supporting the AC power board.
See section 8.12, page 106.
Backup capacitor voltage and/or 5 V booster voltage out of limits:
 Connect the pump to an AC power supply and wait for 30 minutes.
 Check the backup capacitor voltage.
 Replace the power supply board if the voltage is outside the limits.
See section 8.12, page 106.
A too high voltage may result in damage to the equipment.

55
 1. Access the Tests menu. See section 6.2.1, page 37.
2. Press the arrow keys to select Test 21: Power info.
3. Press enter.
The DC voltage is displayed:
 Conversion: DC voltage conversion value (in mV)
 DC voltage: DC voltage charging value (in V)
4. Connect and disconnect the pump from the power source, and check that the DC voltage value
changes:
 With a pump connected to an AC power supply:

 With a pump running on battery:

5. Press the arrow keys to scroll through the other information screens:
 Conversion: Backup capacitor conversion value in mV
 Backup capacitor: Backup capacitor voltage in V

 Conversion: Backup capacitor temperature conversion value in mV

 Backup temperature: Backup capacitor temperature in °C

 Conversion: 5 V booster conversion value in mV

 5 V booster: 5 V booster voltage in V

6. Check that the displayed values are within the limits shown in the table below.

Value Limits
DC Voltage - Pump connected to an AC power supply 9.5 V to 10.5 V
DC Voltage - Pump running on battery -0.5 V to 0.5 V
Backup capacitor 2.3 V to 2.7 V
Backup temperature -20 °C to +110 °C (-4 °F to +230 °F)
5 V booster 4600 mV to 5920 mV

7. Press exit to return to the Tests menu.

56
6.2.19 Test 22: LCD Voltage
Test Description
Run this test to display the charge voltage of the pump’s LCD screen (for information only).

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 22: Lcd Voltage.
3. Press enter.
The following data is displayed:
 Conversion: This conversion voltage value is the LCD charge pump
voltage measured at the CPU board input terminals.
 Voltage: This voltage value is the measured LCD charge pump voltage.
4. Press exit to return to the Tests menu.

6.2.20 Test 23: Temperature

Test Description
Run this test to display the temperature measured by the NTC thermistor (for information only).

The CPU board works properly.

If this test fails, replace the CPU board. See section 8.11, page 102.
If the problem persists, contact the Fresenius Kabi Technical Service.

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 23: Temperature.
3. Press enter.
The following data is displayed:
 Conversion: The temperature conversion value measured in mV by the
NTC thermistor on the CPU board.
 Temperature: The temperature measured in °C by the NTC thermistor on
the CPU board.
4. Check that the displayed value is within the limits shown in the table below.

Values Limit
Temperature -20 °C to +80 °C (-4 °F to +176 °F)

57
6.2.21 Test 24: Watchdog
Test Description
This test checks the status of the pump’s microprocessor (free or busy) every 2 seconds.

The pump’s microprocessor is not too busy to carry out infusions correctly.
If the test fails, it means that the pump’s microprocessor is too busy.
An infusion is likely not to be carried out correctly.

Required Tools and Equipment

 No specific tools or equipment are required

Prerequisites
 The pump must be used on battery with the AC power cord disconnected.

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 24: Watchdog.
3. Press enter.
If the pump is connected to the AC power supply:

 Disconnect the AC power cable.

The OK button becomes available.
 Press OK.

4. Press OK to confirm.

The pump starts checking the fault mode.

5. Check that all red LEDs light up and that the buzzer sounds between 1.0 second and 2.25 seconds.
If the test fails, a message "Watchdog not functional return to After Sales Service" is displayed.
6. Press key for 5 seconds to stop the alarm and return to Tests screen.

INFORMATION
The Watchdog test must be systematically carried out after each maintenance procedure.

58
6.2.22 Test 25: Wi-Fi Module Information
Test Description
This test displays for information the Wi-Fi parameters saved on the pump. Run this test to
check that all parameters are correct.
If they are not, upload the Wi-Fi configuration to the pump using Agilia Partner maintenance
software.

Prerequisites
 The pump must be equipped with Wi-Fi.

INFORMATION
When powering on a pump, it may take a few minutes for the Wi-Fi module information to refresh.
If some data are not displayed when performing this test, wait a few minutes for the pump to refresh Wi-Fi
module information (without powering off the pump), then run the test again.
If after a prolonged period where no information is displayed, contact your Biomed or IT service
department.

1. Access the Tests menu. See section 6.2.1, page 37.

2. Press the arrow keys to select Test 25: Wi-Fi module information.
3. Press enter.
The following data is displayed for information:
 Network SSID (Service Set IDentifier)
 MAC address
 IP address
 Subnet mask address
 Gateway address
 RSSI: value in dBm
 SNR: value in dBm

 Data rate: value in Mbps.

 Date and time of last connection to server

 Version of Wi-Fi module application firmware

 Version of Wi-Fi module Bootloader firmware

 Version of Wi-Fi module Radio firmware

4. Press exit to return to the Tests screen.

59
6.2.23 Checking the Pressure Limit Alarm
Test Description
Run this test to check the triggering of an occlusion alarm when the pressure downstream the
pump exceeds the pressure limit stated in the Pressure management menu.

Required Tools and Equipment

 1 Dynamometer

Prerequisites
 The dynamometer’s calibration certificate is valid.

1. Access the Basic Profile configuration. See section 5.1, page 30.
2. Press the arrow keys to select User.
3. Press enter.
4. Press the arrow keys to select User 4: Pressure.
5. Press enter.
6. Select:
 Mode = 3 levels
 High = 900 mmHg (17.4 PSI or 1.20 bar)
 Medium = 500 mmHg (9.67 PSI or 0.67 bar)
 Low = 200 mmHg (3.87 PSI or 0.27 bar)
7. Power the pump off and on again to exit the Options menu and return to standard operation.
8. Open the syringe barrel clasp, push the disengagement lever down, and move the plunger driver to
the right.
9. Place the dynamometer in the syringe cradle, with the flanges correctly inserted in the provided slot.
10.Secure the dynamometer with the syringe barrel clasp.
11.Slide the arms spacer to the left.
12.Push the disengagement lever, and move the plunger driver gently to the left until it is in contact with
the plunger head of the dynamometer.
13.Release the disengagement lever.
The arms must not be in contact with the arms spacer.

Figure 6.8: Installation of dynamometer

60
 14.Press C to change the syringe.

15.Press the arrow keys to select "BD Precise 50 mL".

16.Press OK.

17.Press or .

18.Press the arrow keys to select .

19.Select a Medium limit of 500 mmHg. (9.67 PSI or 0.67 bar).

20.Select a flow rate of 120 mL/h.

21.Start the infusion at 120 mL/h.
22.Check for the absence of an occlusion alarm.
23.Check that the infusion LEDs are flashing.
24.Check that the occlusion alarm is triggered at an "x" pressure value of:
430 mmHg (8.31 PSI or 0.6 bar) < x < 570 mmHg (11.02 PSI or 0.8 bar).
25.Open the syringe barrel clasp, push the disengagement lever down, and move the plunger driver to
the right.
26.Remove the dynamometer.

6.2.24 Control the plunger head detection finger and anti-siphon arms movement
1. Press the disengagement lever.

2. Check that the anti-siphon arms move towards

the syringe.

3. Release the disengagement lever.

4. Check that the anti-siphon arms move partially
back.
5. Check that the arms are symmetrical and in
contact.

6. Press the plunger head detection finger.

A "click" is to be heard.

61
 7. Check that the anti-siphon arms move back
towards the plunger driver (the finger detects the
presence of the syringe and the arms lock it against
the plunger driver).

CONFORM
8. If the anti-siphon arms do not move back or if the
plunger head detection finger remains depressed,
the control is not conform.

NOT CONFORM
9. If this test is not conform, either:
 replace the plunger kit for Agilia SP (see section 8.21, page 146),
or
 disassemble the plunger driver and remove the upper and lower anti-siphon arms,
 clean and grease their axes with "Polylub GLI151" ref. Z171423,

 grease the inside of the left helico lever with "Polylub GLI151" ref. Z171423,

 reassemble the parts paying attention to the correct positioning of the (white) left helico gear,
(black) right helico gear and left helico lever.

10.Perform the following calibrations using Agilia Partner maintenance software.

 Force sensor
 Displacement
11.Perform the regular servicing tests. See Quality Control Procedure, section 6.3, page 66.

62
6.2.25 Control the disengagement and plunger head alarms
1. If needed, exit the Maintenance mode
pressing "OFF" .
2. Install a 50mL syringe and secure it with
the syringe barrel clasp.
3. Move the plunger driver and position it in
contact with the syringe plunger head.
4. Close the anti-siphon arms on the
syringe plunger.
5. Let the protective cover open.
6. Press "ON" .
7. Select a profile.
8. Select "General infusion".

9. Check that a "50mL" syringe is

displayed with no alarm being triggered.
10.Confirm selection of syringe.

11.Program an infusion (refer to the IFU for

detailed procedure according to profile).
The message "Cover opened" is
displayed.

12.Confirm by pressing "OK".

The alert “Cover opened. Lock the cover
or confirm start” is displayed.
13.Confirm by pressing "start".
The infusion starts.

14.Press the disengagement lever.

15.Check that the "Disengagement
mechanism !!!" message is displayed.

16.Move back the plunger driver and

release the disengagement lever.
17.Check that the "Plunger head alarm !!!"
message is displayed.

18.Press "Alarm silence" key.

19.Press and hold the plunger head
detection finger.
20.Check that the "Plunger head alarm !!!"
message disappears and is replaced by
the "Cover opened" message.

63
 21.Release the plunger head detection
finger.
22.Check that the "Plunger head alarm !!!"
message reappears.

23.if this test is not conform, either:

 replace the plunger kit for Agilia SP (see section 8.21, page 146),
or
 disassemble the plunger driver and remove the upper and lower anti-siphon arms,
 clean and grease their axes with "Polylub GLI151" ref. Z171423,

 grease the inside of the left helico lever with "Polylub GLI151" ref. Z171423,

 reassemble the parts paying attention to the correct positioning of the (white) left helico gear,
(black) right helico gear and left helico lever.

24.Perform the following calibrations using Agilia Partner maintenance software.

 Force sensor
 Displacement
25.Perform the regular servicing tests. See Quality Control Procedure, section 6.3, page 66.

64
6.2.26 Checking the End of Infusion Alarm
1. Power the pump off and on again to exit the Options menu and return to standard operation.
2. Push the disengagement lever down and move the plunger to the right.
3. Install a "BD Precise" 50 mL syringe.
4. Secure the syringe with the syringe barrel clasp.
5. Position the syringe piston at a remaining VTBI value of at least 10 mL.
6. Push the disengagement lever down, and move the plunger driver gently to the left until it is in contact
with the syringe, with the anti-siphon arms positioned on the syringe piston.
7. Release the disengagement lever.
8. Select a flow rate of 200 mL/h.

9. Start the infusion and check that the end of infusion pre alarm is triggered.

10.Wait for the End of infusion alarm.

11.Run Test 6 Displacement.

12.Note the Position value and check that Position = 17.7 mm ± 0.5 mm
(0.7 in ±0.02 in).

6.2.27 Checking the AC Power Supply / Battery Operation

Test Description
Run this test to check the power supply indicator state while switching from AC power supply
to battery.

The power supply indicator works properly.

If this test fails, replace the upper case that supports the keypad.
See section 8.3, page 83.
1. Disconnect the pump’s AC power cord.
2. Check that the plug-shaped power supply indicator is off.
3. Connect the pump to an AC power supply.
4. Check that the plug-shaped power supply indicator lights up green.

6.2.28 Electrical Test

Test Description
This test checks the electrical safety of the pump according to the IEC 60601-1 medical
electrical equipment standard.

The pump is compliant with the IEC 60601-1 medical electrical equipment standard.
Contact your biomedical department or your Fresenius Kabi sales representative.

Required Tools and Equipment

 No specific tools or equipment are required
Run the electrical safety test according to the IEC 60601-1 medical electrical equipment standard.

65
6.3 Quality Control Procedure
6.3.1 Running a Quality Control
Print the form provided. See section 6.3.2, page 69.
This form can only be used for a Quality Control Procedure. To perform the Preventive Maintenance
Procedure, Agilia Partner maintenance software is mandatory.
Run Test 2: Maintenance. See section 6.2.3, page 39.
 Enter the following maintenance data in the form:
- Running time in hours since last preventive maintenance date
- Last preventive maintenance date
 Fix the next preventive maintenance date. Add a maximum of 3 years to the date of last preventive
maintenance.
 Fill the Next maintenance date in the form.
1. Run Test 1: Identification. Identification and general appearance check. See section 6.2.2, page 38.
 Check housing, clear protective cover and patient handset.
 Check AC power cord.
 Check the product code REF and serial number SN on the pump
identification label.
 Fill the pump identification data in the form:
- Pump type
- Product code
- Serial number
BOLUS

2. Check the attachment lock knob and rotating pole clamp (locking system test).

66
3. Check the LCD contrast and adjust if necessary:
 Access the Pump Settings menu in the Options menu.
 Select User 3: Contrast.
4. Run Test 9: Indication. See section 6.2.10, page 49.
Check backlight, all pump LEDs, power supply indicator, battery charge indicator. Check that the
speaker and buzzer are functioning correctly.
5. Run Test 10: Keypad. See section 6.2.11, page 49.
Check the keypad.
6. Run Test 16: Cover. See section 6.2.15, page 53.
Check the clear protective cover (detection and lock systems).
7. Run Test 17: Patient handset. See section 6.2.16, page 54.
Check the patient handset (connection and proper working order).
8. Run Test 24: Watchdog. See section 6.2.21, page 58.
 Check that all red LEDs light up and that the buzzer sounds between 1.0 second and 2.25 seconds.
 Press for 5 seconds to stop the alarm and power off the pump.
9. Run Test 7: Syringe Barrel Clasp. Check the syringe barrel clasp sensor.
See section 6.2.8, page 45.
 Position the V1 diameter verification gauge.
 Check the value displayed for Diameter. The value must be equal to 10.5 mm ± 1.5 mm
(0.35 in to 0.47 in).
 Position the V2 diameter verification gauge.
 Check the value displayed for Diameter. The value must be equal to 15.5 mm ± 1.5 mm
(0.55 in to 0.70 in).
 Position the V4 diameter verification gauge.
 Check the value displayed for Diameter. The value must be equal to 28.0 mm ± 1.5 mm
(1.04 in to 1.16 in).
 If one of these values is outside the tolerance zone, run a calibration of the syringe barrel clasp
sensor using Agilia Partner.
10.Run Test 5: Force (occlusion alarm test). See section 6.2.6, page 41.
 Install a dynamometer.
 Start an infusion at 1000 mL/h.
 Check that the pump triggers an "Occlusion" pre alarm, then an "Occlusion" alarm in less than
60 seconds when 10.88 PSI (0.75 bar) < Pressure < 12.33 PSI (0.85 bar).
If not, calibrate the force sensor using Agilia Partner.
 Press to silence the alarm.
 Press to stop the infusion.
11.Run Test 6: Displacement. Check the displacement sensor. See section 6.2.7, page 43.
 Move the plunger driver to the right stop.
 Check the value displayed for Position. The value must be between 118.5 mm and 137.5 mm
(4.67 in and 5.41 in).
 Install the 65 mm (2.56 in) displacement gauge.
 Check the value displayed for Position. The value must be equal to 65 mm ± 1.5 mm
(2.56 in ± 0.06 in).
 Move the plunger driver to the left stop.
 Check the value displayed for Position. The value must be between 10 mm and 15.2 mm (0.39 in
and 0.60 in).
 If one of these values is outside the tolerance zone, run a calibration of the displacement sensor
using Agilia Partner.

67
 12.Control the plunger head detection finger and anti-siphon arms movement.
See section 6.2.24, page 61.
13.Control the disengagement and plunger head alarms. See section 6.2.25, page 63.
14. Check the AC power disconnection:
 Disconnect the pump’s AC power cord.
 Check that the plug-shaped power supply indicator is off.
 Connect the pump to an AC power supply.
 Check that the plug-shaped power supply indicator lights up green.
15. Check the battery life:
 Connect the pump to an AC power supply.
 Recharge the battery for 8 hours (pump switched off).
 Run Test 13: Battery test. See section 6.2.14, page 51.
 At end of test:
- Connect the pump to an AC power supply
- Power on the pump
- Run Test 12: Battery life. See section 6.2.13, page 51.
- Check that the displayed "Alarm" is equal to or greater than 01h30 (01:30).
If not, replace the battery. See section 8.1, page 77.
In the Quality Control Procedure, this test is not mandatory.
16. Run the electrical test according to EN/IEC 60601-1 standard. See section 6.2.28, page 65.
17. Enter the following identification data in the form:
 Result (Pass/Fail) for each test
 Global result for Quality control (Pass/Fail)
 Biomedical name
 Ward name
 Name
 Technical department
 Date and signature

68
6.3.2 Quality Control Certificate
Pump type: Product code: Serial number:
Hospital name: Running time since last Date of last preventive maintenance:
preventive maintenance date:
Ward name: Date of next preventive maintenance:

No. Procedure Pass Fail

1 Test 1: Identification and general appearance check.
Pump housing, protective cover, patient handset, AC power cord, product code, serial number.
2 Locking system test. Check the attachment lock knob and rotating pole clamp.
3 LCD display test. Check/adjust the LCD contrast (Pump settings > User 3).
4 Test 9: Indication. Backlight, LEDs, indicators and buzzer test.
5 Test 10: Keypad. Keypad test.
6 Test 16: Cover. Cover test.
7 Test 17: Patient handset. Patient handset test.
8 Test 24: Watchdog.Watchdog.
Default mode triggered in seconds (between 1.0 second and 2.25 seconds).
9 Test 7: Syringe Barrel Clasp. Check the syringe barrel clasp sensor.
Tool V1 - Diameter: mm (between 9.0 mm and 12.0 mm (0.35 in and 0.47 in)).
Tool V2 - Diameter: mm (between 14 0 mm and 17.0 mm (0.55 in and 0.70 in)).
Tool V4 - Diameter: mm (between 26.5 mm and 29.5 mm (1.04 in and 1.16 in)).
10 Test 5: Force. Occlusion alarm test
Triggering of an occlusion alarm in less than 60 seconds at PSI
(between 10.88 PSI (0.75 bar) and 12.33 PSI (0.85 bar)).
11 Test 6: Displacement calibration test. Checking the displacement sensor
Right stop - Position: mm (between 4.67 in and 5.41 in (118.5 mm and 137.5 mm)).
65 mm gauge - Position: mm (between 2.50 in and 2.62 in (63.5 mm and 66.5 mm)).
Left stop - Position: mm (between 0.39 in and 0.60 in (10.0 mm and 15.2 mm)).
12 Check the plunger head detection finger and anti-siphon arms movement.
If not conform, replace the plunger driver kit or clean and grease the moving parts.
13 Check the disengagement and plunger head alarms.
If not conform, replace the plunger driver kit or clean and grease the moving parts
14 Power indicator test. AC power disconnection.

Not executed
15 Battery life. Test 13: Battery test and Test 12: Battery life.
Displayed "Alarm": : (greater than 01h30 (01:30))

16 Electrical tests.

Pass
Fail
Name: Date: Signature:

Technical department:

Observations:

69
6.4 Testing the Flow Rate
Test Description
During this flow rate test an infusion is carried out at a certain flow rate, and the delivered
volume is reported.
The volume reported is compared to the theoretical volume, and the flow rate test is stated as
passed if the calculated flow rate error is between -3 % and +3 %.

The flow rate is correctly calibrated.

If the test fails, calibrate the displacement using Agilia Partner maintenance software.

Required Tools and Equipment

 1 Scale with a sensitivity of 0.01 g and a beaker
 1 Catheter extension with a Luer lock end: length 40 in (100 cm), interior diameter 0.1 in (2.5 mm)
 1 Needle: type G18 or G21 (flow rate > 30 mL/h), or G26 (flow rate < 30 mL/h)
 1 Luer Lock syringe (brand new)
 1 Chronometer
 Distilled water, oil.

Prerequisites
 The scale’s calibration certificate is valid.

Recommended temperatures for flow rate accuracy:

 Room temperature: 10 °C to 30 °C (50 °F to 86 °F)
 Temperature of the water in the syringe: 10 °C to 30 °C (50 °F to 86 °F)

INFORMATION
 Do not recycle distilled water.
 The test procedure below can be performed with all syringe sizes (50/60 mL, 30 mL, 20 mL, 10 mL,
5 mL).

1. Setup the equipment:

 Fill the syringe with distilled water at the maximum of its volume.
 Prime the syringe to eliminate air bubbles.
 Connect the catheter extension to the syringe.
 Connect the cannula to the other end of the catheter extension.
 Install the syringe on the pump.
 Place the beaker at the center of the scale platform.
 Place the cannula inside the beaker.
 Fill the beaker with some water, making sure the cannula is dipped in the water (> 1 cm (0.4 in)).
 Add several drops of oil to create a greasy film on the surface of the water. This way the user will
avoid any measurement error due to evaporation of the water.
 Power on the pump.

70
 1

ml
10

20

30

40

50
0.4 in

60
(1 cm)
2
3
Figure 6.9: Flow rate test using a scale

Legend
1 Catheter extension bracket support 3 Anti-vibration measuring table

2 Scale

INFORMATION
Check that the installation surface is level.

2. Prime the syringe and the extension set using the key.
Refer to the Instructions for Use of the relevant pump.
3. Check for the absence of air bubbles.
4. On the pump, select a flow rate and start a first infusion to stabilize it.
For a flow rate of less than 5 mL/h, wait at least one hour.
For higher rates, wait between 10 and 30 minutes.
5. Stop the infusion when the stabilization time is elapsed.
6. Zero the scale or write down the initial weight.
7. Simultaneously re-start the infusion with the same flow rate and start the chronometer.
8. After the infusion time (e.g. 10 minutes, 15 minutes, 1 hour), stop the infusion.
9. At the end of infusion, weigh the beaker with water and write down this new value.
If the scale was not zeroed at start of infusion, calculate the difference with the initial weight.
10.Divide the infused volume in mL (for water: 1 mL for 1 g) by the infusion time in hours: this gives the
measured value for the flow rate in mL/h.
11.Calculate the difference between the theoretical value and the measured value according to the
following formula:

(Measured value - Theoretical value)

x100 = Error percentage
Theoretical value

The flow rate test is stated as passed if the calculated flow rate error is between -3 % and +3 %.

71
7 Troubleshooting and Messages

7.1 Alarm Descriptions

There are several levels of alarm priorities:
 High-priority alarms
 Medium-priority alarms
 Low-priority alarms
 Information signals
Alarm Priority Required Operator Response Description
 The infusion stops.
High (!!!) Immediate response  An alarm description is displayed on the
pump screen.
Medium (!!) Prompt response
 The infusion continues.
Low (!) Awareness
 The infusion continues.
Information
Awareness  An information message is displayed on the
Signals pump screen.

7.2 Alarm Messages and Information Signals

Displayed Message Priority Problem / Resolution
ERxx(yyyy) !!! High (!!!) Technical alarm. See section 7.5, page 76.
Battery alarm !!! The battery is discharged.
High (!!!) The pump will power OFF automatically within 5 minutes.
 Connect the pump to a power supply immediately.
In PCA therapy only, if the protective cover is mandatory,
message displayed if it is not installed.
Cover missing !!! High (!!!)
 Install the cover or confirm start of infusion without the
cover.
If the protective cover is mandatory, message displayed if it is
left open.
Cover opened !!! High (!!!)
 Close the cover or confirm start of infusion without the
cover.
Very low battery !!! Very low battery.
High (!!!)  Connect the pump to a power supply and allow time to
charge.
End of infusion !!! High (!!!) The infusion is completed (simple rate).
Occlusion alarm !!! The pressure in the infusion line has reached the threshold
level.
High (!!!)
 Check whether the infusion line is occluded. If necessary,
readjust the pressure threshold.
Syringe installation !!! The syringe is not installed correctly (plunger driver, syringe
High (!!!) barrel clasp or flange detection).
 Check the syringe installation.
End of volume limit !!! High (!!!) The volume limit is reached.
End of volume/time !!! High (!!!)
The VTBI is completed.
End of dose/time !!! High (!!!)
Plunger head alarm !!! The plunger head is missing or incorrectly inserted.
High (!!!)
 Check the syringe installation.
Disengagement mechanism !!! The Disengagement mechanism is open after selection of a
High (!!!) syringe.
 Check the syringe installation.
Battery pre-alarm !! Low battery.
Medium (!!)
 Connect the pump to a power supply.

72
 Displayed Message Priority Problem / Resolution
Occlusion pre-alarm !! In-line pressure has reached the following value:
 25 mmHg / 2.5 kPa / 0.5 PSI below the programmed
threshold (from 50 to 75 mmHg).
Medium (!!)  50 mmHg / 5 kPa / 1 PSI below the programmed threshold
(over 100 mmHg).
 Check the infusion line.
 Set the correct pressure threshold.
Near end of infusion !! The time remaining is less than the defined time duration (adjustable
Medium (!!) between 1 and 30 minutes), and the remaining volume of fluid in the
syringe has dropped to less than 10% of the syringe capacity.
Near end of volume limit !! The time remaining is less than the defined time duration
(adjustable between 1 minute and 30 minutes), and the
Medium (!!)
remaining VTBI until the volume limit has dropped to less than
10% of the syringe capacity.
Near end of volume/time !! Medium (!!) The time remaining is less than the defined time duration
Near end of dose/time !! (adjustable between 1 and 30 minutes), and the remaining
Medium (!!) VTBI has dropped to less than 10% of the syringe capacity.
Check settings !! The flow rate (or dose) has been modified using the keys, but
Medium (!!) has not been confirmed.
 Check the flow rate (or dose) and press OK to confirm.
Waiting settings !! A value must be entered.
Medium (!!)
 Enter a value and press OK to confirm.
Waiting start !! The infusion settings have been entered, but have not been
Medium (!!) confirmed with start.
 Check the infusion settings, and press start to start the infusion.
Cover present !! Cover is installed on the pump while an infusion is in progress
Medium (!!) or stopped.
 Remove the cover from the pump, or close it.
Cover opened !! In general infusion, the protective cover is opened during
Medium (!!) infusion.
 Silence the alarm and close the cover.
End of volume limit ! The volume limit is reached and the end of infusion setting is
Low (!)
set as "KVO" or "continuous".
End of volume/time ! Low (!) The VTBI is completed and the end of infusion setting is set as
End of dose/time ! Low (!) "KVO" or "continuous".
Pressure increase ! The pressure is increasing in the infusion line.
Low (!)
 Check for occlusions in the infusion line.
Drop in pressure ! The pressure is decreasing in the infusion line.
Low (!)  Check the downstream Luer lock connection and the
integrity of the entire line.
High internal temperature ! Temperature increase.
Low (!)  Check device environment.
 Send the pump for maintenance.
AC power failure ! The power supply is inconsistent.
Low (!)
 Contact your Technical Service.
If the pump is not used during an extended period, connect to a
Low (!)
power supply and wait until the battery is charged.
Alarm reporting not available The pump is mounted on a Link+ Agilia rack that has not been
on the Link ! upgraded.
Low (!)
 Contact your qualified technician or your Fresenius Kabi
Technical Service.
Remove completely syringe ! Preventive auto-test on potential failure of plunger head.
Low (!)
 Remove and reinstall syringe.
Patient handset not connected The patient handset is missing or not connected although the
Low (!) handset is mandatory.
 Connect the patient handset to the pump.
Upper soft max The upper soft limit is exceeded, according to the drug settings
Information signal
defined in the drug library.
Lower soft min The lower soft limit is exceeded, according to the drug settings
Information signal
defined in the drug library.

73
 Displayed Message Priority Problem / Resolution
Reached hard limit Information signal The upper or lower hard limit is reached.
Power disconnection The pump is disconnected from the AC power. A single beep is
emitted.
 Press to acknowledge.
Information signal
 Check that the battery life is sufficient for the expected
infusion duration.
 If the disconnection was unintentional, check the power connection.
Keypad lock status The keypad is locked.
Information signal
 Unlock the keypad.
Keypad locked The keypad is locked and the syringe barrel clasp was opened
Unlock keypad to continue Information signal and closed.
 Unlock the keypad.
Cover opened If the protective cover is not mandatory, the message is
Information signal displayed if it is left open.
 Remove cover or press OK to acknowledge cover is open.
Cover installed If the protective cover is not mandatory, the message is
Close or remove the cover Information signal displayed if it is installed during infusion.
 Close the cover.
Cover opened If the protective shell is not mandatory, message displayed if it
Lock the cover or confirm Information signal is left open, and acknowledged.
start  Close the cover or confirm start of infusion without the cover.

In the case of a system malfunction, the alarm sounds and an error message Erxx(yyyy) !!! is
displayed.
1. Record the error message Erxx(yyyy) !!!.
2. Disconnect the pump from the power supply.

3. Reset the device by pressing the key for 10-15 seconds, and release it when the device powers off.

WARNING
If the alarms persist when the pump is powered on again, do not use the device on a patient, and contact
qualified biomedical engineering staff in your healthcare facility, or your Fresenius Kabi sales
representative.

7.3 Audio-only Information Signals

Type Comment Stops Infusion? Activation
Power on or off Beep until key is released No Beep starts when action is not allowed
End of loading dose 3 beeps No At the end of the loading dose
End of programmed bolus 3 beeps No At the end of a programmed bolus
Start infusion at the end of At the end of a pause, when the infusion
3 beeps N/A
pause automatically starts
End of pause 4 beeps N/A At the end of pause - repeated
AC power connection 1 beep No When power is connected
Forbidden key 1 beep No Repeated until key is released
Key beep 1 beep No For each key pressed
Non validation beep 1 beep No For each key pressed
Manual bolus 1 beep No Repeated for each mL infused
Syringe prime 1 beep N/A When purge reached end after 5ml
Patient handset button
1 beep No Repeated until key is released
continuously pressed
Patient handset button is pressed and
PCA bolus accepted 1 specific beep No
PCA bolus is available
Patient handset button is pressed and
PCA bolus refused 1 specific beep No
PCA bolus is not available.

74
7.4 Troubleshooting Guide
Description Cause Recommended Action
End of infusion detected too early (at The installed syringe doesn't  Replace or confirm the right syringe brand.
approximately 10 mL). correspond to the selected  Calibrate the displacement sensor using
No end of infusion pre-alarm and alarm syringe. Agilia Partner maintenance software.
Flow rate or displacement drift. The installed syringe doesn't  Replace or confirm the right syringe brand.
correspond with the selected  Check the displacement calibration.
syringe.  If necessary, recalibrate the displacement sensor
The position sensor calibration using Agilia Partner maintenance software.
values have drifted.  Replace the displacement sensor.
See section 8.19, page 138.
Occlusion alarm after the pump has been Wrong calibration of the force  Recalibrate the force sensor using
turned on. sensor. Agilia Partner maintenance software.
Force sensor is out of order.  Replace the force sensor and ribbon cable kit.
Flexible circuit is cut. See section 8.18, page 132.
Occlusion alarm during the infusion. The pressure limit selected is too  Select a higher pressure limit (Pressure
low. management menu ).
Wrong calibration of the force  Recalibrate the force sensor using
sensor. Agilia Partner maintenance software.
Flexible circuit is cut.  Replace the force sensor and ribbon cable kit.
See section 8.18, page 132.
Disengagement alarm after the pump has The disengagement micro-switch  Replace the disengagement flexible circuit.
been turned on or during the infusion. is defective. See section 8.17, page 127.
Carriage flexible circuit is cut.
Unjustified alarm involving plunger head Optical switch and/or anti-siphon  Check the anti-siphon system.
position. arms finger detection are  Check the plunger driver internal mechanism.
defective.  Replace the force sensor.
Flexible circuit is cut. See section 8.18, page 132.
Unjustified alarm involving syringe barrel Defective syringe barrel clasp  Check the syringe barrel clasp.
clasp and/or syringe body. potentiometer. Run test 7. See section 6.2.8, page 45.
Flat ribbon cable is defective.  If the error remains, replace the syringe barrel
Switch or flat ribbon cable flange clasp.
detection is defective.  Calibrate the syringe barrel clasp using
Agilia Partner maintenance software and
check the pump functionality.
Display defect: LED, LCD display. Control transistors, LED and/or  Check the display board.
connections are defective.  Check the connections between CPU board
and display board.
 Replace the display board/LCD display.
See Section 8.10, page 98.
The power supply indicator doesn't light Battery is totally discharged.  Connect the pump to the AC power supply.
up.  Replace the battery.
Power supply board is defective. See section 8.2, page 81.
 Check the power cord and AC power supply.
 Replace the power supply board.
See section 8.12, page 106.
Battery alarm even though it has been The power supply board is  Replace the power supply board.
completely charged. damaged. See section 8.12, page 106.
The pump turns ON or OFF by itself. Defective keypad.  Replace the upper case. See section 8.3,
Power supply board is damaged. page 83.
 Check the keypad by running test 10.
See section 6.2.11, page 49.
 Replace the power supply board if necessary.
See section 8.12, page 106.
Some keys of the keypad do not work. Defective keypad.  Replace the upper case.
See section 8.3, page 83.
 Check the keypad by running test 10.
See section 6.2.11, page 49.
Mechanical elements are damaged. After a fall.  Check the status of the casings and the
mechanical system.
 The pump must not be used.

75
7.5 Error Codes
Error Code Description Recommended Actions
01 Motor rotation  Check correct functioning of the motor.
 Check the ribbon cable connection between the optical switch
and the CPU board (J5 connector). See figure 2.4, page 13.
 Check the correct functioning of the motor rotation optical switch.
 Replace the CPU board. See section 8.11, page 102.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
02 Displacement  Check the displacement sensor calibration.
Run test 6 Displacement. See section 6.2.7, page 43.
 Check the displacement sensor connection to CPU board
(J2 connector). See figure 2.4, page 13.
 Replace the CPU board. See section 8.11, page 102.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
10 RAM  Replace the CPU board.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
11 Flash memory (deleting or  Replace the CPU board. See section 8.11, page 102.
programming problem)  Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
12 Resources  Carry out a complete configuration for the pump using the
Agilia Partner maintenance software.
If the problem cannot be resolved:
 Replace the CPU board. See section 8.11, page 102.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
13 Secondary Crc16  Carry out a complete configuration/calibration/control cycle using
microcontroller - version is Agilia Partner maintenance software.
incorrect
14 Secondary microcontroller  Replace the Power supply board. See section 8.12, page 106.
restarting - Watchdog
problem
15 Secondary microcontroller  Check the ribbon cable connection between Power supply board
communication (J1 connector) and CPU board (J6 connector).
See figure 2.4, page 13.
See figure 2.6, page 17.
 Replace the Power supply board. See section 8.12, page 106.
16 Disconnected battery  Check the battery connection to power supply board
(J3 connector). See section 2.1.5, page 17.
 Check the battery charging voltage. Run test 12.
See section 6.2.13, page 51.
 Replace the battery. See section 8.2, page 81.
17 Battery charge  Check the battery charging voltage. Run test 12.
See section 6.2.13, page 51.
 Replace the battery. See section 8.2, page 81.
18 AC power presence  Remove the battery door. See section 8.2, page 81.
 Check the status of the AC power fuse.
 Replace the Power supply board. See section 8.12, page 106.
19 Battery temperature  Check the battery status. Run test 8.
See section 6.2.9, page 48.
 Replace the battery. See section 8.2, page 81.

76
Error Code Description Recommended Actions
20 Syringe barrel clasp  Check the syringe barrel clasp calibration. Run test 7.
potentiometer See section 6.2.8, page 45.
 Calibrate the syringe barrel clasp using Agilia Partner
maintenance software.
 If the error remains, check the cable connection to CPU board
(J1 connector). See figure 2.4, page 13.
 If the error remains, replace the syringe barrel clasp.
See section 8.14, page 112.
 Calibrate the syringe barrel clasp using Agilia Partner
maintenance software and check the pump functionality.
21 Displacement linear  Check the displacement calibration. Run test 6.
potentiometer See section 6.2.7, page 43.
 Calibrate the displacement using Agilia Partner maintenance
software.
 If the error remains, check the cable connection to CPU board
(J2 connector). See figure 2.4, page 13.
 If the error remains, replace the displacement sensor.
See section 8.19, page 138.
 Calibrate the displacement using Agilia Partner maintenance
software and check the pump functionality.
22 Force sensor  Check the force sensor calibration. Run test 5.
See section 6.2.6, page 41.
 Calibrate the force sensor using Agilia Partner maintenance
software.
 If the error remains, check the cable connection to CPU board
(J9 connector). See figure 2.4, page 13.
 If the error remains, replace the force sensor and ribbon cable kit.
See section 8.18, page 132.
 Calibrate the force sensor using Agilia Partner maintenance
software and check the pump functionality.
23 Syringe flanges switch  Check the syringe flanges switch is functioning correctly by
running test 7. See section 6.2.8, page 45.
 Check the cable connection to CPU board (J1 connector).
See figure 2.4, page 13.
 Replace the syringe barrel clasp flexible circuit.
See section 8.14, page 112.
24 Disengagement switch  Check the functionality of the disengagement switch.
 Check the cable connection to CPU board (J9 connector).
See figure 2.4, page 13.
 Replace the disengagement flexible circuit.
See section 8.17, page 127.
25 Syringe head detection  Check the functionality of the syringe head optical switch by
optical switch running test 7. See section 6.2.8, page 45.
 Check the cable connection to CPU board (J9 connector).
See figure 2.4, page 13.
 Replace the plunger kit.See section 8.21, page 146.
26 Board missing  Check the connection between Display board and CPU board.
See section 2.1.3, page 10.
See section 2.1.4, page 13.
 Check the connection between Power supply board and CPU
board.
See section 2.1.4, page 13.
See section 2.1.5, page 17.
 Replace the faulty part(s).
27 LCD backlight missing  Check the connection between Display board (J3 connector) and
LCD display. See section 2.1.3, page 10.
 Replace the LCD display. See section 8.10, page 98.
 If the problem cannot be resolved, replace the Display board.

77
 Error Code Description Recommended Actions
28 Keypad  Run test 10 to check the keypad. See section 6.2.11, page 49.
 Replace the upper case. See section 8.3, page 83.
 Run test 10 to check the keypad.
 If the problem cannot be resolved, replace the Display board.
See section 8.10, page 98.
29 Analog/digital converter  Replace the CPU board. See section 8.11, page 102.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
30 Time keeper  Replace the Power supply board supporting the secondary
microcontroller. See section 8.12, page 106.
 Replace the CPU board. See section 8.11, page 102.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
31 Syringe parameters  Carry out a complete configuration using Agilia Partner
maintenance software.
33 Disengagement optical  Check the functionality of the disengagement switch.
switch  Check the cable connection to CPU board (J9 connector).
See figure 2.4, page 13.
 Replace the disengagement flexible circuit.
See section 8.17, page 127.
34 Infusion flow rate  Carry out a complete configuration using Agilia Partner
maintenance software.
35 Motor period  Carry out a complete configuration using Agilia Partner
maintenance software.
36 Motor rotation direction  Carry out a complete configuration using Agilia Partner
maintenance software.
37 OFF key.  Check that you have not pressed the OFF key too repeatedly.
Reading status problem or  Replace the Power supply board to check the functionality of the
key pressed too repeatedly secondary microcontroller. See section 8.12, page 106.
 Replace the Display board. See Section 8.10, page 98.
 Replace the CPU board to check the functionality of the main
microcontroller.See section 8.11, page 102.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
38 Locked OFF key  Run test 10 to check the functionality of the keypad, and
especially the OFF key. See section 6.2.11, page 49.
 Replace the upper case. See section 8.3, page 83.
 Replace the Power supply board to check the secondary
microcontroller functionality. See section 8.12, page 106.
39 Impossible to power off  Replace the Power supply board. See section 8.12, page 106.

43 LCD communication failure  Replace the Display board. See Section 8.10, page 98.

44 LCD driver failure  Replace the Display board. See Section 8.10, page 98.

45 Defective LCD voltage  Replace the Display board. See Section 8.10, page 98.

46 Backup capacitor  Contact the Fresenius Kabi Technical Service.

temperature too high
47 Backup capacitor  Contact the Fresenius Kabi Technical Service.
temperature out of range
48 Pump temperature out of  Place the pump in normal operating temperature.
range Please refer to the Instructions for Use of the relevant pump.
49 Backup capacitor and safety  Replace the Power supply board. See section 8.12, page 106.
5 V booster charging circuit
defective
50 Power supply board voltage  Replace the Power supply board. See section 8.12, page 106.
out of range
51 Defective speaker  Check the connection to Power supply board (J2 connector).
See section 2.1.5, page 17.
 Replace the speaker and flexible circuit.

78
Error Code Description Recommended Actions
52 Defective buzzer Buzzer sound level too low or defective speaker (see error code 51).
 Replace the Power supply board supporting the buzzer.
See section 8.12, page 106.
53 Battery parameter in  Contact the Fresenius Kabi Technical Service.
coulometer EPROM
54 Secondary microcontroller /  Contact the Fresenius Kabi Technical Service.
coulometer power supply
board communication
55 Defective profile  Carry out a complete configuration check using Agilia Partner
maintenance software.
56 CMDFAIL  Replace the Power supply board. See section 8.12, page 106.
Autotest failure on starting  Replace the Display board. See section 8.10, page 98.
up the pump.  Replace the CPU board. See section 8.11, page 102.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
57 ADC converter - Interface  Check connection of Interface board to CPU board
board (J9 connector).
 Replace the Interface board. See section 8.6, page 88.
 Replace the CPU board. See section 8.11, page 102.
58 Patient handset  Check connection of patient handset to the pump and to Interface
board through the cover lock flexible circuit. See section 8.5,
page 86.
 Replace the patient handset. See section 8.2, page 81.
 Replace the Interface board. See section 8.6, page 88.
59 Cover (presence and lock  Replace the pusher protection with lock kit. See section 8.8,
system detections) page 92.
 Replace the Interface board. See section 8.6, page 88.
95 Internal flash  Replace the CPU board. See section 8.11, page 102.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
96 Defective detection of pump  Replace the CPU board. See section 8.11, page 102.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
97 Defective oscillator  Replace the CPU board. See section 8.11, page 102.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
98 Defective reset circuit  Replace the CPU board. See section 8.11, page 102.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
99 Activation of the watchdog  Replace the Power supply board to check the functionality of the
secondary microcontroller. See section 8.12, page 106.
 Replace the CPU board to check the functionality of the main
microcontroller.
 Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.

79
8 Intervention Procedures

This section details all dismantling and re-assembling procedures.

WARNING
 ONLY use the recommended accessories and spare parts delivered with the pump. NO PART IS
REPAIRABLE. When replacing components, only use Fresenius Kabi spare parts. Refer to the
"Spare Parts Catalog" for ordering information.
 Any instruments or devices used for maintenance must be regularly checked or re-calibrated
according to their specifications and local regulations.
 Disconnect the battery, and discharge the boost capacitor before opening the pump (see
procedure no.2). A risk of electric shock exists when touching a charged boost capacitor.
 For safety reasons, the technician should not intervene when the pump is connected to an AC power
supply:
- Unplug the power supply cord from the AC power supply.
- Power off the pump.
 When working with electronic components, we recommend wearing an anti-static bracelet
connected to earth and working on an anti-static mat.
 Do not touch the electronic boards with your hands.

Procedure Requested test

Procedure #1: Patient Handset, page 81. Test 17: Patient handset, page 54.
Test 8: Battery Info, page 48.
Procedure #2: Battery and Battery Door - Boost Capacitor Discharge, page 81. Test 13: Battery Test, page 51.
Test 21: Power Info, page 55.
Procedure #6: Interface Board, page 88. Test 16: Cover, page 53.
Tests of interface board and cover locking
Procedure #8: Pusher protection with lock kit, page 92. detection sensor
Test 16: Cover, page 53.
Procedure #9: Upper Case, page 95. Test 9: Indication, page 49.
Procedure #10: Display Board/LCD Display, page 98. Test 9: Indication, page 49.
All tests, refer to List of Tests in section
Procedure #11: CPU Board, page 102.
Accessing the Tests Menu, page 37.
Procedure #12: Power Supply Board and AC Power Board, page 106. Test 21: Power Info, page 55.
Procedure #13: Wi-Fi Board, page 109. Test 25: Wi-Fi Module Information, page 59.
Procedure #14: Syringe Barrel Clasp, page 112. Test 7: Syringe Barrel Clasp, page 45.
Procedure #15: Syringe Detection System, page 118. Test 7: Syringe Barrel Clasp, page 45.
Procedure #16: Motor, page 124. Test 6: Displacement, page 43.
Procedure #17: Disengagement Flexible Circuit, page 127. Test 6: Displacement, page 43.
Procedure #18: Force Sensor + Ribbon Cable Kit, page 132. Test 5: Force, page 41.
Test 6: Displacement, page 43.
Procedure #19: Linear Sensor Kit, page 138.
Test 7: Syringe Barrel Clasp, page 45.
Test 6: Displacement, page 43.
Procedure #20: Plunger Cover and Lever Kit, page 143.
Test 7: Syringe Barrel Clasp, page 45.
Test 6: Displacement, page 43.
Procedure #21: Plunger Kit, page 146.
Test 7: Syringe Barrel Clasp, page 45.
Test 6: Displacement, page 43.
Procedure #22: Carriage Kit, page 151.
Test 7: Syringe Barrel Clasp, page 45.

80
8.1 Procedure #1: Patient Handset
Maintenance level
Level 3 specialist technician.
Dismantling
1. Unplug the patient handset.
To disconnect the handset, hold the connector by the plastic ring [1].
Do not attempt to pull the cord, you will damage the connector.
2. Remove the handset [2].

2
1

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
2. Perform the regular servicing tests. See Quality Control Procedure, page 66.

8.2 Procedure #2: Battery and Battery Door - Boost Capacitor Discharge
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
The battery must be only replaced by a qualified person.
See section 3.1, page 27.
Dismantling
1. Unscrew the 2 screws [1] that hold the battery door in place.
2. Remove the battery door [2].
3. Power on the pump.

81
 2

1 1
4. Disconnect the [J3] connector and remove the battery [3].
The boost capacitor starts to discharge.
The buzzer sounds and red LEDs light during this discharge (approximately 20 minutes).

J3

INFORMATION
If the identification labels of the fuse [4] and the battery [5] are damaged, they must be replaced.
Contact Fresenius Kabi to get new labels.
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
2. Insert the battery in the correct direction.
3. Perform a charge/discharge cycle.
4. Perform the regular servicing tests. See Quality Control Procedure, page 66.

82
8.3 Procedure #3: Clear Protective Cover
Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Dismantling
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
2. Perform the regular servicing tests. See Quality Control Procedure, page 66.

83
8.4 Procedure #4: Left hinge kit
Required Tools and Equipment
 1 Torx T-10 screwdriver

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Dismantling
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Unscrew the 2 screws [2].

84
5. Remove the left hinge kit [3].

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
2. Perform the regular servicing tests. See Quality Control Procedure, page 66.

85
8.5 Procedure #5: Rear Cover
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
1. Remove the screw cap [1].
2. Unscrew the screw [2].

1 2

3. Remove the patient handset cable reel [3].

4. Unscrew the 4 screws [2].

5. Remove the rear cover assembly [5], being careful not to pull out cable [6].
6. Disconnect cable [6] from cover lock flexible circuit [7].

7
6

86
7. Unscrew the 4 screws [8].

8. Remove the patient handset support [9].

9. Dislodge and remove patient handset cable strand [10] from the rear cover [11].

11

10

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
2. Perform the regular servicing tests. See Quality Control Procedure, page 66.

87
8.6 Procedure #6: Interface Board
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Remove the screw cap [1].
5. Unscrew the screw [2].

1 2

88
6. Remove the patient handset cable reel [3].
7. Unscrew the 4 screws [4].

8. Remove the rear cover [5], being careful not to pull out cable [6].
9. Disconnect cable [6] from cover lock flexible circuit [7].

7
6

5
10.Disconnect CPU board flat cable from the interface board [8] at [J1].
11.Dislodge carefully the interface board [8].
12.Disconnect cover detection flexible circuit [9] from interface board at [J2].

8 J1 9 J2

J1 J2

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
2. Perform the regular servicing tests. See Quality Control Procedure, page 66.

89
8.7 Procedure #7: Cover detection flexible circuit
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

4. Remove the screw cap [1].

5. Unscrew the screw [2].

1 2

90
 6. Remove the patient handset cable reel [3].
7. Unscrew the 4 screws [4].

8. Remove the rear cover [5], being careful not to pull out cable [6].
9. Disconnect cable [6] from cover lock flexible circuit [7].

7
6

5
10.Disconnect CPU board flat cable from the interface board [8] at [J1].
11.Dislodge carefully the interface board [8].
12.Disconnect cover detection flexible circuit [9] from interface board at [J2].

8 J1 9 J2

13.Push the tab [a] and dislodge the cover lock flexible circuit [9] by sliding it out as shown below.

9 a
9

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
2. Perform the regular servicing tests. See Quality Control Procedure, page 66.

91
8.8 Procedure #8: Pusher protection with lock kit
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
1. Unlock the protective cover and remove the key.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Remove the screw cap [1].
5. Unscrew the screw [2].

1 2

92
 6. Remove the patient handset cable reel [3].
7. Unscrew the 4 screws [4].

8. Remove the rear cover [5], being careful not to pull out cable [6].
9. Disconnect cable [6] from cover lock flexible circuit [7].

7
6

5
10.Disconnect CPU board flat cable from the interface board [8] at [J1].
While doing this, pay attention to the position of flat cable connected to [J1].
11.Dislodge carefully the interface board [8].
12.Disconnect cover lock flexible circuit [9] from interface board at [J2].
While doing this, pay attention to the position of cable [9] connected to [J2].
13.Remove the interface board [8].

8 J1 9 J2

14.Push the tab [a] and dislodge the cover lock flexible circuit [9] by sliding it out as shown
below.

9 a

93
 15.Unscrew the 2 screws [4].

16.Dislodge the pusher protection with lock kit [10] by sliding it out toward the right as shown
below.

10

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
2. Perform the regular servicing tests. See Quality Control Procedure, page 66.

94
8.9 Procedure #9: Upper Case
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Unscrew the 2 screws [2].

95
 5. Remove the left hinge kit [3].

6. Unscrew and remove the 2 screws [4].

4
4

7. Remove the angle bracket [6], being careful not to pull out the CPU board flat cable [8].
8. Disconnect CPU board flat cable [8] at [J1].
9. Unscrew the 2 screws [5] that hold the upper case [7] to the base.
10.Remove the upper case [7], being careful not to pull out the display board flat cable.

8
J1

5
5

96
 11.Disconnect the display board flat cable at [J2].
12.Disconnect the display board / keypad cable (connection at [J1]).
13.Unscrew the 4 screws [9] that fasten the display board unit to the upper case.

9 9

J1

9 J2 9
14.Remove the hood hook [10] and the display board unit [11] from the upper case [7].

11

9
10

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the regular servicing tests. See Quality Control Certificate, page 69.

97
8.10 Procedure #10: Display Board/LCD Display
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Unscrew the 2 screws [2].

98
 5. Remove the left hinge kit [3].

6. Unscrew and remove the 2 screws [4].

4
4

7. Remove the angle bracket [6], being careful not to pull out the CPU board flat cable [8].
8. Disconnect CPU board flat cable [8] at [J1].
9. Unscrew the 2 screws [5] that hold the upper case [7] to the base.
10.Remove the upper case [7], being careful not to pull out the display board flat cable.

8
J1

5
5

99
 11.Disconnect the display board flat cable at [J2].
12.Disconnect the display board / keypad cable (connection at [J1]).
13.Unscrew the 4 screws [9] that fasten the display board unit to the upper case.

9 9

J1

9 J2 9
14.Remove the hood hook [10] and the display board unit [11] from the upper case [7].

11

9
10

15.Disconnect the display board / LCD display connection at [J3].

16.Unclip and separate the LCD display [12] from the display board [11].

11

J3

100
 12

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibration using Agilia Partner maintenance software:
 LCD contrast
3. Perform the regular servicing tests. See Quality Control Certificate, page 69.

101
8.11 Procedure #11: CPU Board
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
If a Wi-Fi pump is used, remove the Wi-Fi board, then dislodge the CPU board as described
later in this procedure.
To remove the Wi-Fi board: See section 8.13, page 109.
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Unscrew the 2 screws [2].

102
 5. Remove the left hinge kit [3].

6. Unscrew and remove the 2 screws [4].

4
4

7. Remove the angle bracket [6], being careful not to pull out the CPU board flat cable [8].
8. Disconnect CPU board flat cable [8] at [J1].
9. Unscrew the 2 screws [5] that hold the upper case [7] to the base.
10.Remove the upper case [7], being careful not to pull out the display board flat cable.

8
J1

5
5

103
 11.Disconnect the display board flat cable at [J2].

J1

J2

12.Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] [J7] and [J9].
13.Unscrew and remove the screw [9].

J1 J2
J3
J1

J5

J9 9

J6 J7

14.Remove the CPU board [10].

While doing this, take care not to pull out the flat cable on the inside.
15.Disconnect the flat cable from CPU board at [J10].

J10

104
 10

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
 Force sensor
 Syringe barrel clasp
 Displacement
 Date
 LCD contrast
3. Perform the regular servicing tests. See Quality Control Certificate, page 69.
INFORMATION
When replacing the CPU board, carry out a complete configuration of the pump (calibrations and tests).
Each pump has its own CPU board model. Be careful not to mix up the different pump references.

105
8.12 Procedure #12: Power Supply Board and AC Power Board
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.

Dismantling
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Unscrew the 2 screws [2].

106
 5. Remove the left hinge kit [3].

6. Unscrew and remove the 2 screws [4].

4
4

7. Remove the angle bracket [6], being careful not to pull out the CPU board flat cable [8].
8. Disconnect CPU board flat cable [8] at [J1].
9. Unscrew the 2 screws [5] that hold the upper case [7] to the base.
10.Remove the upper case [7], being careful not to pull out the display board flat cable.

8
J1

5
5

107
 11.Disconnect the display board flat cable at [J2].

J1

J2
12.Disconnect flat cable from power supply board at [J2].
13.Unscrew and remove screw [9].
14.Remove the power supply board:
 Pull the board out by its corner edge to dislodge it from securing clip [10].
 Dislodge the power supply board from slot [11].

J2
10 11

Re-assembling
1. Place the black insulator part [12] on the AC supply board.
2. Insert the power supply board in slot [11].
3. Locate securing clip [10] then press the power supply board down, locking the board into
position with the securing clip.
4. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.

12

11
10

5. Perform the regular servicing tests. See Quality Control Certificate, page 69.

108
8.13 Procedure #13: Wi-Fi Board
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Prerequisites
 This procedure is only applicable to pumps equipped with a Wi-Fi module.
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Unscrew the 2 screws [2].

109
 5. Remove the left hinge kit [3].

6. Unscrew and remove the 2 screws [4].

4
4

7. Remove the angle bracket [6], being careful not to pull out the CPU board flat cable [8].
8. Disconnect CPU board flat cable [8] at [J1].
9. Unscrew the 2 screws [5] that hold the upper case [7] to the base.
10.Remove the upper case [7], being careful not to pull out the display board flat cable.

8
J1

5
5

110
 11.Disconnect the display board flat cable at [J2].

J1

J2
12.Disconnect the flat cable connected to the CPU board at [J4] (Wi-Fi board connection).
13.Unscrew and remove the screw [9] that holds the Wi-Fi board holder [10] to the CPU
board.
14.Dislodge the Wi-Fi board holder from the right flange slot [11].

10

11

J4

15.Dislodge the Wi-Fi board [12] from the holder [10].

16.Disconnect flat cable [13] from Wi-Fi board [12] (connection at [J1]).

12 12 J1
10

13
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the regular servicing tests. See Quality Control Certificate, page 69.

111
8.14 Procedure #14: Syringe Barrel Clasp
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 flat screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Unscrew the 2 screws [2].

112
 5. Remove the left hinge kit [3].

6. Remove the screw cap [4].

7. Unscrew the screw [5].

4 5

8. Remove the patient handset cable reel [6].

9. Unscrew the 4 screws [7].

10.Remove the rear cover [8], being careful not to pull out cable [9].
11.Disconnect cable [9] from cover lock flexible circuit [10].

10
9

113
 12.Disconnect CPU board flat cable from the interface board [11] at [J1].
While doing this, pay attention to the position of flat cable connected to [J1].
13.Dislodge carefully the interface board [11].
14.Disconnect cover detection flexible circuit [12] from interface board at [J2].
While doing this, pay attention to the position of cable [12] connected to [J2].
15.Remove the interface board [11].

11 J1 12 J2

16.Unscrew the 2 screws [7].

17.Dislodge the pusher protection with lock kit [13] by sliding it out toward the right as shown
below.

13

18.Unscrew and remove the screw [7].

114
 19.Remove the angle bracket [14], being careful not to pull out the CPU board flat cable [16].
20.Disconnect CPU board flat cable [16] at [J1].
21.Unscrew the 2 screws [7] that hold the upper case [15] to the base.
22.Remove the upper case [15], being careful not to pull out the display board flat cable.

14

16
J1

7 7

15

23.Disconnect the display board flat cable at [J2].

J1

J2

24.Disconnect the cable that connects the CPU board to displacement linear potentiometer at
[J2].

J2

115
 25.Push the disengagement lever [17] down and move the plunger driver to its maximum.
26.Remove the 2 plastic caps [18] using a flat screwdriver.
27.Unscrew and remove the 2 screws.
28.Unclip and remove the syringe flange cradle [19].
29.Unscrew and remove the screw [7] that holds the base.
30.Remove the base [20].
While removing the base [20], pay attention to the position of angle bracket clip kit [21]
between the base and the aluminum profile. When re-assembling the base, make sure to
position this part as it was originally.

17 21

18 7 21
18
19

20

20
31.Unscrew and remove the 2 screws [22].
32.Remove the syringe barrel clasp bridle [23].

22 22

23

23

116
 33.Unclip and remove clip [26].
34.Pull syringe barrel clasp kit [24] out of its base location.
35.Disconnect the syringe detector [25] from the syringe barrel clasp kit [24].
36.Remove syringe barrel clasp kit [24]

24 26 25 24 26

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Do not forget to clip part [26] into the groove of syinge barrel clasp before attaching bridle
[23].
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibration using Agilia Partner maintenance software:
 Syringe barrel clasp
3. Perform the regular servicing tests. See Quality Control Certificate, page 69.

117
8.15 Procedure #15: Syringe Detection System
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 flat screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Unscrew the 2 screws [2].

118
 5. Remove the left hinge kit [3].

6. Remove the screw cap [4].

7. Unscrew the screw [5].

4 5

8. Remove the patient handset cable reel [6].

9. Unscrew the 4 screws [7].

10.Remove the rear cover [8], being careful not to pull out cable [9].
11.Disconnect cable [9] from cover lock flexible circuit [10].

10
9

119
 12.Disconnect CPU board flat cable from the interface board [11] at [J1].
While doing this, pay attention to the position of flat cable connected to [J1].
13.Dislodge carefully the interface board [11].
14.Disconnect cover detection flexible circuit [12] from interface board at [J2].
While doing this, pay attention to the position of cable [12] connected to [J2].
15.Remove the interface board [11].

11 J1 12 J2

16.Unscrew the 2 screws [7].

17.Dislodge the pusher protection with lock kit [13] by sliding it out toward the right as shown below.

13

18.Unscrew and remove the 2 screws [7].

120
 19.Remove the angle bracket [14], being careful not to pull out the CPU board flat cable [16].
20.Disconnect CPU board flat cable [16] at [J1].
21.Unscrew the 2 screws [7] that hold the upper case [15] to the base.
22.Remove the upper case [15], being careful not to pull out the display board flat cable.

14

16
J1

7 7

15

23.Disconnect the display board flat cable at [J2].

J1

J2

24.Disconnect the cable that connects the CPU board to displacement linear potentiometer at
[J2].

J2

121
 25.Push the disengagement lever [17] down and move the plunger driver to its maximum.
26.Remove the 2 plastic caps [18] using a flat screwdriver.
27.Unscrew and remove the 2 screws.
28.Unclip and remove the syringe flange cradle [19].
29.Unscrew and remove the screw [7] that holds the base.
30.Remove the base [20].
While removing the base [20], pay attention to the position of angle bracket clip kit [21]
between the base and the aluminum profile. When re-assembling the base, make sure to
position this part as it was originally.

17 21

18 7 21
18
19

20

20
31.Unscrew and remove the 2 screws [22].
32.Remove the syringe barrel clasp bridle [23].

22 22

23

23

122
 33.Unclip and remove clip [25].
34.Pull syringe barrel clasp kit [24] out of its base location.
35.Disconnect the syringe detector [26] from the syringe barrel clasp kit [24].
36.Remove the syringe detector [26].
37.Remove membrane [27].
The syringe detection system [28] comprises syringe detector [26] and membrane [27].

26 27

24

27

25

25 26 28

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Do not forget to clip part [25] into the groove of syinge barrel clasp before attaching bridle
[23]. Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibration using Agilia Partner maintenance software:
 Syringe barrel clasp
3. Perform the regular servicing tests. See Quality Control Certificate, page 69.

123
8.16 Procedure #16: Motor
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Unscrew the 2 screws [2].

124
 5. Remove the left hinge kit [3].

6. Unscrew and remove the 2 screws [4].

4
4

7. Remove the angle bracket [6], being careful not to pull out the CPU board flat cable [8].
8. Disconnect CPU board flat cable [8] at [J1].
9. Unscrew the 2 screws [5] that hold the upper case [7] to the base.
10.Remove the upper case [7], being careful not to pull out the display board flat cable.

8
J1

5
5

125
 11.Disconnect the cable that connects the motor to the CPU board at [J7].
12.Unscrew and remove the 4 screws [9] that hold the motor [10] to the mechanical framework.

J7

10

9 9

9 9

13.Remove the motor [10].

10

Re-assembling
1. Place the motor in position being careful not to damage the gear wheel teeth. While doing
this, pay attention to reconnect the opto motor ground loop [11] on the inside at screw [9b]
level (see the sketch below).
2. Engage the 2 gear wheels together without forcing, and turn them slightly.
3. Tighten the 4 motor fixing screws, following the order [9a], [9b], [9c], [9d] given in the
sketch below.

9d
9b
9c

9a 9b 9a

9d 9c
11
4. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
5. Perform the following calibration using Agilia Partner maintenance software:
 Displacement
6. Perform the regular servicing tests. See Quality Control Certificate, page 69.

126
8.17 Procedure #17: Disengagement Flexible Circuit
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
If a Wi-Fi pump is used, remove the Wi-Fi board, then dislodge the CPU board as described
later in this procedure.
To remove the Wi-Fi board: See section 8.13, page 109.
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Unscrew the 2 screws [2].

127
 5. Remove the left hinge kit [3].

6. Unscrew and remove the 2 screws [4].

4
4

7. Remove the angle bracket [6], being careful not to pull out the CPU board flat cable [8].
8. Disconnect CPU board flat cable [8] at [J1].
9. Unscrew the 2 screws [5] that hold the upper case [7] to the base.
10.Remove the upper case [7], being careful not to pull out the display board flat cable.

8
J1

5
5

128
 11.Disconnect the display board flat cable at [J2].

J1

J2

12.Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] [J7] and
[J9].
13.Unscrew and remove the screw [9] that holds the CPU board to the flange..

J1 J2
J3
J1

J5

J9 9

J6 J7
14.Remove the CPU board.
While doing this, take care not to pull out the flat cable on the inside.
15.Disconnect the flat cable from CPU board at [J10].

J10

129
 16.Unscrew the upper screw [9] that holds the board disengagement flexible circuit to the
carriage kit [10].

10

17.Remove self-locking ring [11] using a flat screwdriver. This self-locking ring holds the board
disengagement flexible circuit to the carriage kit.

11 11 11

18.Disconnect the plunger driver flat cable [12] from the board [13].
19.Unscrew and remove the screw [14] that holds the upper 1/2 band to the lower 1/2 band.

14 13

14

12

130
 20.Dislodge the disengagement flexible circuit [15].

15

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
Insert aperture [16] in spur [17].
Replace self-locking ring [11] with a new one when assembling the board disengagement
flexible circuit to the carriage kit.

17 16

2. Perform the following calibration using Agilia Partner maintenance software:

 Displacement
3. Perform the regular servicing tests. See Quality Control Certificate, page 69.

131
8.18 Procedure #18: Force Sensor + Ribbon Cable Kit
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 flat screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.

Dismantling
If a Wi-Fi pump is used, remove the Wi-Fi board, then dislodge the CPU board as described
later in this procedure.
To remove the Wi-Fi board: See section 8.13, page 109.
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Unscrew the 2 screws [2].

132
 5. Remove the left hinge kit [3].

6. Unscrew and remove the 2 screws [4].

4
4

7. Remove the angle bracket [6], being careful not to pull out the CPU board flat cable [8].
8. Disconnect CPU board flat cable [8] at [J1].
9. Unscrew the 2 screws [5] that hold the upper case [7] to the base.
10.Remove the upper case [7], being careful not to pull out the display board flat cable.

8
J1

5
5

133
 11.Disconnect the display board flat cable at [J2].

J1

J2

12.Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] [J7] and [J9].
13.Unscrew and remove the screw [9] that holds the CPU board to the flange..

J1 J2
J3
J1

J5

J9 9

J6 J7
14.Remove the CPU board.
While doing this, take care not to pull out the flat cable on the inside.
15.Disconnect the flat cable from CPU board at [J10].

J10

134
 16.Push the disengagement lever down [10] and move the plunger driver to its maximum.
17.Remove the 2 plastic caps [11] using a flat screwdriver.
18.Unscrew and remove the 2 screws.
19.Unclip and remove the syringe flange cradle [12].
20.Unscrew and remove the 2 screws [13] that hold the base.
21.Remove the base [14].
While removing the base [14], pay attention to the position of angle bracket clip kit [15]
between the base and the aluminum profile. When re-assembling the base, make sure to
position this part as it was originally.
22.Unscrew and remove the 3 screws [16] that hold the right flange assembly to the aluminum
profile.
23.Take the unit apart.

10 15

16

11 13 15
11
12

14

16 16 14

135
 24.Remove the self-locking ring [17].
25.Unscrew and remove the linking band that holds screw [18].
26.Disconnect the flat cable [19].
27.Remove the carriage kit [20].
28.Remove the 2 plastic caps [21] using a flat screwdriver.
29.Unscrew then remove the 2 screws that hold the plunger cover in place.
30.Remove the plunger cover and lever kit [22].

22
21 22

21

18

20

17

19

31.Unscrew and remove the 2 screws [23] that hold the pressure sensor support [24].
32.Remove the pressure sensor support [24].
While removing the pressure sensor support [24], pay attention to the position of
spring [25]. Do not forget to position this spring as it was before re-fixng the support.
33.Rotate part [26] in the direction shown in the sketch.

27 28

23

24

23

25 26

136
34.At the same time, dislodge boards [27] and [28] and pull out the force sensor and ribbon
cable kit [29].
While pulling out the force sensor and ribbon cable kit, pay attention to the position of the
boards [27] and [28]. Also pay attention to the springs that maintain part [26]. Do not forget
to position all these elements as they were before re-assembling the unit.

27

29

28

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibration using Agilia Partner maintenance software:
 Force sensor
3. Perform the regular servicing tests. See Quality Control Certificate, page 69.

137
8.19 Procedure #19: Linear Sensor Kit
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 flat screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
If a Wi-Fi pump is used, remove the Wi-Fi board, then dislodge the CPU board as described
later in this procedure.
To remove the Wi-Fi board: See section 8.13, page 109.
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Unscrew the 2 screws [2].

138
 5. Remove the left hinge kit [3].

6. Unscrew and remove the 2 screws [4].

4
4

7. Remove the angle bracket [6], being careful not to pull out the CPU board flat cable [8].
8. Disconnect CPU board flat cable [8] at [J1].
9. Unscrew the 2 screws [5] that hold the upper case [7] to the base.
10.Remove the upper case [7], being careful not to pull out the display board flat cable.

8
J1

5
5

139
 11.Disconnect the display board flat cable at [J2].

J1

J2

12.Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] [J7] and
[J9].
13.Unscrew and remove the screw [9].

J1 J2
J3
J1

J5

J9 9

J6 J7
14.Remove the CPU board.
While doing this, take care not to pull out the flat cable on the inside.
15.Disconnect the flat cable from CPU board at [J10].

J10

140
 16.Push the disengagement lever down [10] and move the plunger driver to its maximum.
17.Remove the 2 plastic caps [11] using a flat screwdriver.
18.Unscrew and remove the 2 screws.
19.Unclip and remove the syringe flange cradle [12].
20.Unscrew and remove the 2 screws [13] that hold the base.
21.Remove the base [14].
While removing the base [14], pay attention to the position of angle bracket clip kit [15]
between the base and the aluminum profile. When re-assembling the base, make sure to
position this part as it was originally.
22.Unscrew and remove the 3 screws [16] that hold the right flange assembly to the aluminum
profile.
23.Take the unit apart.

10 15

16

11 13 15
11
12

14

16 16 14

24.Remove the self-locking ring [17].

25.Remove gear wheel [18].

17

17 18

141
 26.Unscrew and remove the 3 screws [19] that hold the linearity sensor kit in place.
27.Remove the linearity sensor kit [21] being careful not to pull out the flat cable [20].

19

20

19 19

21

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections and to reconnect the opto motor
ground loop when assembling.
2. Perform the following calibration using Agilia Partner maintenance software:
 Displacement
3. Perform the regular servicing tests. See Quality Control Certificate, page 69.

142
8.20 Procedure #20: Plunger Cover and Lever Kit
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 flat screwdriver
 1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.

Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
1. Unlock the protective cover and remove the key.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Remove the screw cap [1].
5. Unscrew the screw [2].

1 2

143
 6. Remove the patient handset cable reel [3].
7. Unscrew the 4 screws [4].

8. Remove the rear cover [5], being careful not to pull out cable [6].
9. Disconnect cable [6] from cover lock flexible circuit [7].

7
6

5
10.Disconnect CPU board flat cable from the interface board [8] at [J1].
While doing this, pay attention to the position of flat cable connected to [J1].
11.Dislodge carefully the interface board [8].
12.Disconnect cover detection flexible circuit [9] from interface board at [J2].
While doing this, pay attention to the position of cable [9] connected to [J2].
13.Remove the interface board [8].

8 J1 9 J2

14.Unscrew the 2 screws [4].

144
15.Dislodge the pusher protection with lock kit [10] by sliding it out toward the right as shown
below.

10

16.Remove the 2 plastic caps [11] using a flat screwdriver.

17.Unscrew then remove the 2 screws that hold the plunger cover in place.
18.Remove the plunger cover and lever kit [12].

11

11 12

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
2. Perform the following calibrations using Agilia Partner maintenance software:
 Force sensor
 Displacement
3. Perform the regular servicing tests. See Quality Control Certificate, page 69.

145
8.21 Procedure #21: Plunger Kit
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 flat screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
If a Wi-Fi pump is used, remove the Wi-Fi board, then dislodge the CPU board as described
later in this procedure.
To remove the Wi-Fi board: See section 8.13, page 109.
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Unscrew the 2 screws [2].

146
 5. Remove the left hinge kit [3].

6. Unscrew and remove the 2 screws [4].

4
4

7. Remove the angle bracket [6], being careful not to pull out the CPU board flat cable [8].
8. Disconnect CPU board flat cable [8] at [J1].
9. Unscrew the 2 screws [5] that hold the upper case [7] to the base.
10.Remove the upper case [7], being careful not to pull out the display board flat cable.

8
J1

5
5

147
 11.Disconnect the display board flat cable at [J2].

J1

J2

12.Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] [J7] and [J9].
13.Unscrew and remove the screw [9].

J1 J2
J3
J1

J5

J9 9

J6 J7
14.Remove the CPU board.
While doing this, take care not to pull out the flat cable on the inside.
15.Disconnect the flat cable from CPU board at [J10].

J10

148
 16.Push the disengagement lever down [10] and move the plunger driver to its maximum.
17.Remove the 2 plastic caps [11] using a flat screwdriver.
18.Unscrew and remove the 2 screws.
19.Unclip and remove the syringe flange cradle [12].
20.Unscrew and remove the 2 screws [13] that hold the base.
21.Remove the base [14].
While removing the base [14], pay attention to the position of angle bracket clip kit [15]
between the base and the aluminum profile. When re-assembling the base, make sure to
position this part as it was originally.
22.Unscrew and remove the 3 screws [16] that hold the right flange assembly to the aluminum
profile.
23.Take the unit apart.

10 15

16

11 13 15
11
12

14

16 16 14

149
 24.Remove the self-locking ring [17].
25.Unscrew and remove the linking band that holds screw [18].
26.Disconnect the flat cable [19].
27.Remove the carriage kit [20].
28.Take apart the plunger kit [21] using a rotating movement to remove the pin from the
plunger cover.

18

20

17

19

21

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
 Force sensor
 Displacement
3. Perform the regular servicing tests. See Quality Control Certificate, page 69.

150
8.22 Procedure #22: Carriage Kit
Required Tools and Equipment
 1 Torx T-10 screwdriver
 1 flat screwdriver
 1 anti-static bracelet

Maintenance level
Level 3 specialist technician.
See section 3.1, page 27.
Prerequisites
 The patient handset is removed. See section 8.1, page 81.
 The battery is disconnected and the boost capacitor discharged. See section 8.2, page 81.
Dismantling
If a Wi-Fi pump is used, remove the Wi-Fi board, then dislodge the CPU board as described
later in this procedure.
To remove the Wi-Fi board: See section 8.13, page 109.
1. Unlock the protective cover.

2. Slide protective cover [1] to the right to unhinge it.

3. Remove the protective cover.

1
4. Unscrew the 2 screws [2].

151
 5. Remove the left hinge kit [3].

6. Unscrew and remove the 2 screws [4].

4
4

7. Remove the angle bracket [6], being careful not to pull out the CPU board flat cable [8].
8. Disconnect CPU board flat cable [8] at [J1].
9. Unscrew the 2 screws [5] that hold the upper case [7] to the base.
10.Remove the upper case [7], being careful not to pull out the display board flat cable.

8
J1

5
5

152
 11.Disconnect the display board flat cable at [J2].

J1

J2

12.Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] [J7] and
[J9].
13.Unscrew and remove the screw [9].

J1 J2
J3
J1

J5

J9 9

J6 J7
14.Remove the CPU board.
While doing this, take care not to pull out the flat cable on the inside.
15.Disconnect the flat cable from CPU board at [J10].

J10

153
 16.Push the disengagement lever down [10] and move the plunger driver to its maximum.
17.Remove the 2 plastic caps [11] using a flat screwdriver.
18.Unscrew and remove the 2 screws.
19.Unclip and remove the syringe flange cradle [12].
20.Unscrew and remove the 2 screws [13] that hold the base.
21.Remove the base [14].
While removing the base [14], pay attention to the position of angle bracket clip kit [15]
between the base and the aluminum profile. When re-assembling the base, make sure to
position this part as it was originally.
22.Unscrew and remove the 3 screws [16] that hold the right flange assembly to the aluminum
profile.
23.Take the unit apart.

10 15

16

11 13 15
11
12

14

16 16 14

154
 24.Remove the self-locking ring [17].
25.Unscrew and remove the linking band that holds screw [18].
26.Disconnect the flat cable [19].
27.Remove the carriage kit [20].

18

20

17

19

20

Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
 Force sensor
 Displacement
3. Perform the regular servicing tests. See Quality Control Certificate, page 69.

155
9 Device Storage

Refer to the Instructions for Use of the relevant pump for the following information:
 Precautions for storage
 Storage and transport conditions
 Preparing the device for storage
 Using the device after storage

156
10 Cleaning and Disinfecting

Refer to the Instructions for Use of the relevant pump for the following information:
 When to clean and disinfect the pump
 Recommended and prohibited agents
 Instructions for cleaning and disinfecting

157
11 Power Management

Refer to the Instructions for Use of the relevant pump for the following information:
 AC power supply precautions
 Battery precautions
 Battery operating mode

158
12 Technical Characteristics

12.1 Power Supply

Use the power supply cord supplied with the pump.
For use in the US, it is mandatory to use an Agilia power cord compliant with USA standards and with the
IEC 60227 standard.
Maximum admissible apparent electrical cable network impedance: 50 Ω.
The power cord conductor must have a cross section of at least 0.75 mm2.

Power supply
100 V - 240 V ~ / 50 / 60 Hz with functional earth
AC Power Maximum consumption 10-15 VA
Protective fuse 1 X T1.6AH 250V accessible in the battery compartment
External
Power Supply
9 VDC / Power > 15 W
(Available in a
Future Release)
Length: 3.00 m
Maximum length: 3.00 m
Cord Type: SJT3x18AWG
Technical data: 3x18AWG (Green, black, white), dielectric strength: 2 kVac, 1 min
Standard: UL62 CSA 22.2 No. 49
Type: HG/TR
Plug Technical data: 15A - 12.5V AC.
Standard: NEMA 5-15 Hospital Grade
Type: C13
Connector Technical data: 10A - 250V UL CSA
Standard: EN 60320-1 C22.2 N°21 UL 817

12.2 Battery
Disconnect the battery before opening the device. Avoid short circuits and extreme temperatures.
If the device is not used for more than 3 months, the date is erased (all other settings are stored
permanently). When you power on the pump, you must set the date again.

Characteristics 7.2 V 2.2 Ah - Li-ion Smart battery

Weight Approximately 100 g
Flow Rate Wi-Fi Battery Life
Battery Life 5 mL/h  >6h
5 mL/h  > 11 h
Battery Recharge Pump OFF: < 6 h / Pump ON: < 20 h
 = Wi-Fi enabled
 = Wi-Fi disabled or not used

12.3 Power Consumption

The infusion pump typically consumes about 3.5 W in standard operating conditions.

12.4 Communication Port

The connector located at the back of the device allows data communication with a PC.

Serial Cable TTL output

Power Input 10 V / 15 W to power supply the product

Power Output 5 VDC / 150 mA to power Agilia USB cable

159
12.5 Infrared Communication
The pump is equipped with an infrared cell located at the back of the device.

Mode Wireless optical communication using infrared light

Compatibility Asynchronous Serial Infrared (SIR) physical layer irPHY 1.0, baseband no carrier

Transport
Proprietary
Protocol
Speed 115.2 kb/s max

Wavelength 880 nm to 900 nm infrared band with 45 nm spectral bandwidth

Eye Safety Class 0 of IEC 62471

12.6 Agilia USB Cable

Function Allows communication between a pump and a computer on the USB port

Connector 8-pin proprietary connector / Male A USB connector

Input / Output
250 mW
power (pump)
Input / Output
100 mW
Power (PC)
Compatibility USB 2.0 compliant.

Insulation 1500 V, compliant with UL standard

Speed 19.2 kb/s max

Length 85 in (2.15 m)

Maximum Length 110 in (2.8 m)

12.7 Patient Handset

Connector 5-pin male connector

Power Supply 5 VDC / 20 mA

Housing IP27

12.8 Compliance
IP 22 (pump)
Compliant with the following standards:
ElectroMedical IP 27 (handset Index of protection against ingress of water or
 IEC 60601-1
Equipment Safety except particulate matter
 IEC 60601-1-8 connector)
EMC
Compliant with the following standards: Protection against leakage current:
(ElectroMagnetic
 IEC 60601-1-2 Defibrillation-proof type CF applied part*
Compatibility)

Particular  IEC 60601-2-24 Protection against electric shocks: class II

Standards  ANSI/AAMI ID26 Functional earth**

* After a defibrillation, the pump recovery time is around 2 seconds.

** The functional earth is directly connected to the power suply cord. It reduces residual current that may disturb ECG or EEG devices.

160
12.9 Dimensions - Weight
Pump dimensions and weight without protective cover
H/W/D 150 x 350 x 195 mm

Weight Approximately 2.5 kg

Screen Size 70 x 35 mm

Pump dimensions and weight with protective cover

H/W/D 150 x 350 x 210 mm

Weight Approximately 2.7 kg

Patient handset dimensions and weight

H/W/D 20 x 35 x 115 mm (without cable) or 20 x 35 x 1960 mm (with cable)

Weight Approximately 65 g

12.10Electronic Boards
The Agilia SP PCA, Agilia SP PCA WiFi pumps are equipped with 5 electronic boards:
 Power supply board
 AC Power board
 Interface board
 CPU board
 Display board
For the Agilia SP PCA WiFi pump, an additional electronic board is present:
 Wi-Fi board

161
12.11 Material Characteristics
Component Material
1 Screw cap (2) Polyamide
2 Nut bolt button Polyamide
3 M8 molded screws Polyamide
4 Angle bracket ABS
5 Battery door ABS
6 Light guide Polycarbonate
7 Window Polycarbonate
8 Molded base ABS
9 Cover hook Polyamide 6
10 Infrared window Polycarbonate
11 Eccentric bolt POM
12 Bolt front case POM
13 Bolt rear case POM
14 Bolt button POM
15 Bolt button pen POM
16 Molded lever + hooks Polyarylamide
17 Motor silent blocks Elastomere
18 Back foot LSR
19 Front foot LSR
20 Syringe barrel clasp stop Polyamide
21 Connector stopper TPE EPTR
22 Right and left flange Polycarbonate
23 Wi-Fi board support Polycarbonate
24 Plunger driver body Polycarbonate
25 Plunger driver flange Polycarbonate
26 Plunger driver flange stop Polycarbonate
27 Wing switch support Polycarbonate
28 Syringe barrel clasp bridle Polycarbonate
29 Molded syringe barrel clasp Polycarbonate
30 Dual syringe wings holder Polycarbonate
31 Syringe protective cover Aromatic polyester
32 Left hinge ABS
33 Pusher protection ABS
34 Rear cover ABS
35 Patient handset cable reel ABS
36 Left hinge ABS
37 Patient handset housing ABS

162
13 Specifications

Refer to the Instructions for Use of the relevant pump for the following information:
 Infusion Rate
 Volume To Be Infused (VTBI)
 Infusion Tme
 Flow Rate Accuracy
 Occlusion Alarm Response Time
 Occlusion Alarm Threshold
 Pressure Management
 Trumpet and Start-up Curves
Essential Features
Feature Refer to
Flow rate accuracy IFU
Time to Detect Occlusion IFU
Bolus Volume After Occlusion Release IFU
Management of High-priority Alarms IFU

163
14 Recycling

Before disposal, remove the battery from the device. Batteries and devices with this label must not be
disposed of with the general waste. They must be collected separately and disposed of according to local
regulations.

INFORMATION
 For more information on waste processing regulations, contact your local Fresenius Kabi
organization or the local distributor.
 For more information on dismantling the device, refer to the chapter "Intervention Procedures" in this
document.
 Follow healthcare facility policy regarding proper disposal after use.

164
15 Warranty

Refer to the Instructions for Use of the relevant pump for the following information:
 General conditions of warranty
 Limited warranty
 Warranty conditions for accessories

165
16 Guidance and Manufacturer's Declaration on EMC

Refer to the Instructions for Use of the relevant pump for the following information:
 Electromagnetic compatibility
 Electrostatic discharge (ESD) information and ESD precautions to be taken
 Electromagnetic compatibility and interference guidance

Wi-Fi compatibility
The Agilia pumps include RF transmitters whose effective radiated power (EIRP power) is defined below:
 Frequency band 2.4 GHz: 20 dBm.
 Frequency band 5 GHz: 17 dBm.

16.1 Table 1 - Guidance and Manufacturer's Declaration - Electromagnetic Emissions

WARNING
The Agilia pump and its accessories are intended to be used in the electromagnetic environments
specified below.
The customer or the user of the Agilia pump should ensure that it is used in such environments.

Compliance Obtained
Emission Test Electromagnetic Environment - Guidance
by the Device
The Agilia pump only uses RF energy for its internal operation. Its RF
RF emissions CISPR 11 Group 1 emissions are therefore very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions CISPR 11 Class B
Harmonic emissions
Class A The Agilia pump is suitable for use in all establishments other than
IEC61000-3-2
domestic and those directly connected to the public low-voltage power
Voltage fluctuations supply network that supplies buildings used for domestic purposes.
Flicker emissions Comply
IEC 61000-3-3
Conducted emissions
150 kHz - 108 Mhz Class 5
CISPR25
The Agilia pump is suitable for use in automotive environments.
Radiated emissions
150 kHz - 2.5 Ghz Class 3
CISPR25

166
16.2 Table 2 - Guidance and Manufacturer's Declaration - Electromagnetic Immunity
WARNING
The Agilia pump and its accessories are intended to be used in the electromagnetic environments
specified below.
The customer or the user of the Agilia pump should ensure that it is used in such environments.

IEC 60601-1-2
-------------- Compliance Level
Immunity Test IEC 60601-2-24 Obtained by the Electromagnetic Environment - Guidance
and ANSI/AAMI ID26 Device
Test Level
± 6 kV contact Floor coverings made from wood, tiles and concrete,
± 8 kV air with relative humidity level at least 30 %, make it
Electrostatic -------------- possible to guarantee the necessary level of
± 8 kV contact
Discharge (ESD) conformity. If it is not possible to guarantee this
± 15 kV air
IEC 61000-4-2 ± 8 kV contact environment, additional precautions must be taken,
± 15 kV air such as: use of anti-static equipment, preliminary user
discharge and the wearing of antistatic clothing.
± 2 kV for power supply ± 2 kV for power supply
Electrical fast
lines lines AC power quality should be that of a typical
Transient / burst
± 1 kV for input output ± 1 kV for input output commercial or healthcare facility environment.
IEC 61000-4-4
lines lines
± 1 kV ± 1 kV
Surge differential mode differential mode AC power quality should be that of a typical
IEC 61000-4-5 ± 2 kV ± 2 kV commercial or healthcare facility environment.
common mode common mode
< 5% Ut < 5% Ut
(> 95% dip in Ut) (> 95% dip in Ut)
for 0.5 cycles for 0.5 cycles
Voltage dips, short 40% Ut 40% Ut AC power quality should be that of a typical
interruptions and (60% dip in Ut) (60% dip in Ut) commercial or healthcare facility environment.
voltage variations for 5 cycles for 5 cycles
on power supply 70% Ut 70% Ut For short and long interruptions (< than battery life) of
input lines (30% dip in Ut) (30% dip in Ut) AC power, the internal battery provides continuity of
IEC 61000-4-11 for 25 cycles for 25 cycles service.
< 5% Ut
< 5% Ut
(> 95% dip in Ut) for
(> 95% dip in Ut) for 5 s
5s
Power frequency 3 A/m 400 A/m If necessary, the power of the magnetic field should be
(50/60 Hz) -------------- measured in the intended installation location to
magnetic field 400 A/m ensure that it is lower than compliance level.
IEC 61000-4-8 If the measured field in the location where the
Agilia pump is used exceeds the applicable magnetic
field compliance level above, observe the Agilia pump
to verify that it is operating normally. If you notice
abnormal performance, additional measures may be
necessary, such as reorienting or relocating the
Agilia pump, or installing magnetic shielding.
Note: "Ut" is the AC Power voltage prior to applying the test level.

167
16.3 Table 4 - Guidance and Manufacturer's Declaration - Electromagnetic Immunity
WARNING
The Agilia pump and its accessories are intended to be used in the electromagnetic environments
specified below.
The customer or the user of the Agilia pump should ensure that it is used in such environments.

IEC 60601-1-2
--------------
Compliance Level
Immunity Test IEC 60601-2-24 Obtained by the Electromagnetic Environment - Guidance
and ANSI/AAMI ID26 Device
Test Level
Portable and mobile RF communication equipment
should be used no closer to any part of the Agilia pump
(including cables), than the recommended separation
distance calculated from the transmitter frequency
equation.
3 Vrms
Recommended separation distance:
Conducted RF 150 kHz to 80 MHz
3 Vrms D = 0.35  P,
IEC 61000-4-6 --------------
for a frequency of 150 kHz to 80 MHz
Not applicable

D = 0.35  P,
for a frequency of 80 MHz to 800 MHz
D = 0.7  P,
for a frequency of 800 MHz to 2.5 GHz
3 V/m P is the maximum output power rating of the transmitter
80 MHz to 2.5 GHz in Watts (W) according to the transmitter manufacturer,
Radiated RF
-------------- 10 V/m and D is the recommended separation distance in
IEC 61000-4-3
10 V/m meters (m).
80 MHz to 2.5 GHz Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey (a),
should be less than compliance level (b).
Interference may occur in the vicinity of equipment
marked with the following symbol:
Notes:
 At 80 MHz and 800 MHz, the highest frequency range applies.
 These guidelines may not apply to all situations. Absorption and reflection from structures, objects and people may affect the electromagnetic
propagation.
 (a) Field strengths from fixed transmitters, such as base stations for radio (cell / cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcasts and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment
due to the fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location where the
Agilia pump is used exceeds the applicable RF compliance level above, the Agilia pump should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Agilia pump, or installing
magnetic shielding.
 (b) Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

168
16.4 Table 6 - Recommended Separation Distances Between Portable and Mobile RF
Communication Equipment and Agilia pump
WARNING
 The Agilia pump and its accessories are intended for use in electromagnetic environments in which
radiated RF disturbances are controlled.
 Users of the Agilia pump may prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communication equipment (transmitters) and the
Agilia pump as recommended below, and according to the maximum output power of the
communication equipment (transmitters).
 The device should not be used next to other equipment. If adjacent use is necessary, observe the
device to verify that it operates normally in the configuration in which it will be used (pump with a AC
power cord, an RS232 cable).

Separation Distance According

Rated Maximum Output to Transmitter Frequency in Meters (m)
Power of Transmitter (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
D = 0.35  P D = 0.35  P D = 0.7  P
0.01 0.04 0.04 0.07
0.1 0.11 0.11 0.22
1 0.3 0.3 0.7
10 1.1 1.1 2.2
100 3.5 3.5 7

For transmitters rated at a maximum output power not listed above, the recommended separation distance
D in meters (m) can be estimated using the equation applicable to the transmitter frequency, where P is
the maximum output power rating of the transmitter in watts (W) as designated by the transmitter
manufacturer.

INFORMATION
 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

169
16.5 EMC test deviations and supplementary tests
To ensure compatibility with the new EMC standard IEC / EN 60601-1-2 Ed4 and special environments,
specific, additional or deviating tests are listed below with respect to the basic tests, in accordance to
manufacturer risk analysis.
IEC 60601-1-2
Compliance level obtained Electromagnetic
Immunity test IEC 60601-2-24
by the device environment – guidance
Test level
Wooden, tiled or concrete flooring,
with a relative humidity level at least
± 8 kV contact ± 8 kV contact 30%, makes it possible to guarantee
the level of necessary conformity. If
Discharge (ESD) it is not possible to guarantee this
IEC 61000-4-2 environment, the additional
precautions must be taken, such as:
± 15 kV air ± 15 kV air use of anti-static material,
preliminary user discharge and
wearing anti-static clothing.
Portable and mobile RF
communications equipment should
be used no closer to any part of the
Agilia pump, including cables, than
the recommended separation
distance calculated from the
Radiated RF
10 V/m, 80 MHz at 2.7 GHz 10 V/m, 80 MHz at 2.7 GHz equation applicable to the frequency
IEC 61000-4-3
and power of transmitter
For standard commuication services
and equipment, the specific
frequencies were tested for a
minimum approach distance of
30 cm and 10 cm (see below)
385 MHz, PM 18Hz, 27 V/m Not tested For minimal distance approach
450 Mhz, 1 KHz, 28 V/m Not tested 30 cm (12 inches)
710 MHz, PM 217 Hz, 9 V/m Not tested
"Not tested" frequencies are
745 MHz, PM 217 Hz, 9 V/m Not tested
replaced by IEC 61000-4-39 test
780 MHz, PM 217 Hz, 9 V/m Not tested method and reduced minimal
810 MHz, PM 18 Hz, 28 V/m Not tested distance approach (see below)
Near field radiated 870 MHz, PM 18 Hz, 28 V/m Not tested
RF Portable and mobile RF
930 MHz, PM217 18 Hz, 28V/m Not tested
IEC 61000-4-3 communications equipment should
test method 1720 MHz, PM 217 Hz, 28 V/m Not tested
be used no closer to any part of the
1845 MHz, PM 217 Hz, 28 V/m Not tested Agilia pump, including cables, than
1970 MHz, PM 217 Hz, 28 V/m Not tested the recommended minimal
2450 MHz, PM 217 Hz, 28 V/m 2450 MHz, PM 217 Hz, 28 V/m separation distance (30 cm) for
5240 MHz, PM 217 Hz, 9 V/m 5240 MHz, PM 217 Hz, 9 V/m these frequencies
5500 MHz, PM 217 Hz, 9 V/m 5500 MHz, PM 217 Hz, 9 V/m
5785 MHz, PM 217 Hz, 9 V/m 5785 MHz, PM 217 Hz, 9 V/m
450 MHz, PM 217 Hz, 28 V/m 450 MHz, PM 217 Hz, 28 V/m For minimal distance approach
710 MHz, PM 217 Hz, 28 V/m 710 MHz, PM 217 Hz, 28 V/m 10 cm
787 MHz, PM 217 Hz, 28 V/m 787 MHz, PM 217 Hz, 28 V/m 250 mW average power for 28 V/m
810 MHz, PM 217 Hz, 44 V/m 810 MHz, PM 217 Hz, 44 V/m test level
830 MHz, PM 217 Hz, 44 V/m 830 MHz, PM 217 Hz, 44 V/m
Near field radiated 600 mW average power for 44 V/m
RF - special test 870 MHz, PM 217 Hz, 44 V/m 870 MHz, PM 217 Hz, 44 V/m
test level
IEC 61000-4-39 1750 MHz, PM 217 Hz, 28 V/m 1750 MHz, PM 217 Hz, 28 V/m
test method 1875 MHz, PM 217 Hz, 28 V/m 1875 MHz, PM 217 Hz, 28 V/m Portable and mobile RF
1970 MHz, PM 217 Hz, 28 V/m 1970 MHz, PM 217 Hz, 28 V/m communications equipment should
be used no closer to any part of the
2560 MHz, PM 217 Hz, 28 V/m 2560 MHz, PM 217 Hz, 28 V/m Agilia pump, including cables, than
2655 MHz, PM 217 Hz, 28 V/m 2655 MHz, PM 217 Hz, 28 V/m the recommended minimal
separation distance (10 cm) for
these frequencies

170
 IEC 60601-1-2
Compliance level obtained Electromagnetic
Immunity test IEC 60601-2-24
by the device environment – guidance
Test level
Electrical Fast ± 2 kV for power supply lines ± 2 kV for power supply lines Electricity power quality should be
transient / Burst ± 1 kV for input output lines ± 1 kV for input output lines that of a typical domestic,
IEC 61000-4-4 100 KHz repetition 100 KHz repetition commercial or hospital environment
Electricity power quality should be
that of a typical domestic,
± 1 kV commercial or hospital environment.
± 1 kV
Surge differential mode For very exposed establishments or
differential mode
IEC 61000-4-5 ± 2 kV buildings with the lightning, a
Does not apply
common mode protection must be installed on
electricity power. Class II product
and no earth connexion.
Portable and mobile RF
communications equipment should
be used no closer to any part of the
3 Vrms 3 Vrms
Agilia pump including cables, than
Conducted RF 150 KHz to 80 MHz 150 KHz to 80 MHz
the recommended separation
IEC 61000-4-6 And 6 Vrms in the ISM and And 6 Vrms in the ISM and
distance calculated from the
amateur radio bands amateur radio bands
equation applicable to the frequency
and power of transmitter (see
table 6).
If necessary, the power magnetic
field should be measured in the
intended installation location to
make sure it is lower than the
compliance level.
If the measured field in the location
Power frequency where the Agilia pump is used
(50 / 60 Hz) exceeds the applicable magnetic
400 A / m 400 A / m
magnetic field field compliance level above, the
IEC 61000-4-8 Agilia pump should be observed to
verify normal operation. If abnormal
performance is observed, additional
measures may be necessary, such
as reorienting or relocating the
Agilia pump, or installing magnetic
shielding.
Electricity power quality should be
0 % Ut 0 % Ut that of a typical domestic,
(100% dip in Ut) (100% dip in Ut) commercial or hospital environment.
for 0,5 cycle for 0,5 cycle
For short and long interruptions
at 0°, 45°, 90°, 135°,180°, 225°, at 0°, 45°, 90°, 135°,180°,
(< than battery autonomy) of
270°,and 315° 225°, 270°,and 315°
Voltage dips, short electricity power supply, the internal
interruptions and battery provides the continuity of
0% Ut 0% Ut
voltage variations on service.
(100% dip in Ut) (100% dip in Ut)
power supply input
for 1 cycle for 1 cycle For very long (> than battery
lines
IEC 61000-4-11 autonomy) interruptions of electricity
70% Ut 70% Ut power supply, the Agilia pump must
(30% dip in Ut) (30% dip in Ut) be powered from an external
for 25 cycles at 50 Hz for 25 cycles at 50 Hz Uninterruptible Power Supply
for 30 cycles at 60 Hz for 30 cycles at 60 Hz (UPS).
at 0° at 0° Note: Ut is the a/c mains voltage
prior to application of the test level.

171
17 Spare Parts Catalog

Refer to the spare parts catalog of the relevant pump.

172
18 Ordering Information

For more information, contact your Fresenius Kabi sales representative.

18.1 Data Management Cables

Refer to the Instructions for Use of the relevant pump

18.2 Associated Software

Refer to the Instructions for Use of the relevant pump

18.3 Disposables
Refer to the Instructions for Use of the relevant pump

173
19 Glossary of Terms

L
A lb(s) Pound(s)
A Amperes LED Light Emitting Diode
AC Alternating Current LSB Least Significant Bit
Ah Ampere-hours M
AM Amplitude Modulation
mA Milliamperes
B mEq Milliequivalents
BSA Body Surface Area mL/h Milliliters per hour
C mmHg Millimeters of mercury
MOS Metal Oxyde Semiconductor
CCU Critical Care Unit
MRI Magnetic Resonance Imaging
CDC Centers for Disease Control
mW/sr Milliwatts per steradian
CIS Clinical Information System
Special International Committee on Radio N
CISPR
Interference NAM North America
CT Scan Computed Tomography NICU, PICU Neonatal and Pediatric Intensive Care Units
D NMR Nuclear Magnetic Resonance
dBA Decibels O
DC Direct Current OCS Occlusivity Check System
DECT Digital Enhanced Cordless Telecommunications OR Operating Room
DEHP Di(2-ethylhexyl) phthalate
P
DERS Dose Error Reduction Software
PACU Post-Anesthesia Care Unit
DI Dose Infused
PC Personal Computer
DPS Dynamic Pressure System
PE Protective Earth
DUR Duration
PSI Pounds per Square Inch
E R
ECG Electrocardiogram
RAM Random Access Memory
ECMO ExtraCorporeal Membrane Oxygenation
REF Product reference / part number
ED Emergency Department
RF Radio Frequency
EEG Electroencephalogram
RFID Radio Frequency IDentification
EMC Electromagnetic compatibility
Rest Of the World (Other countries than US and
ErXX Error message ROW
Canada)
ESD Electrostatic Discharge
RS232 Serial interface connector
F S
FM Frequency Modulation S/N Serial Number
ft Feet SELV Safety Extra Low Voltage
G SIR Asynchronous Serial Infrared
GPL General Public License U
H USB Universal Serial Bus
H/W/D Height / Width / Depth USB 2.0 OTG USB On-The-Go
HF High Frequency Ut Test specification level
hPa Hectopascals V
HTTP HyperText Transfer Protocol
V Volts
Hz Hertz
VA Volt-Amperes
I VDC Volts Direct Current
IEC International Electrotechnical Commission VI Volume Infused
IFU Instructions for Use VTBI Volume to Be Infused
in Inches W
IT Information Technology W Watts
IV Intravenous
K
kg Kilograms
KVO Keep Vein Open

174
Index

A M
AC Power Board Maintenance
Description 20 Date 36
Dismantle/Re-assemble 106 Display Startup Screen 37
Ageing Test 50 Schedule 27
Alarms 72 Maintenance Options Menu 36
Maintenance Test 39
B Material Characteristics 162
Motor 124
Basic Profile Configuration 30
Battery
Dismantle/Re-assemble 81 O
Test 48, 51 Operation Diagram 25
Options Menu 29
C
Carriage Kit 151 P
CPU Board Plunger Cover 143
Description 13 Plunger Kit 146
Dismantle/Re-assemble 102 Power Information 55
Power Supply Board
D Description 17
Dismantle/Re-assemble 106
Disengagement Flexible Circuit 127
Pressure Limit Alarm Test 60
Displacement Sensor Test 43
Pump Code 55
Display Board
Pump Identification 38
Description 10
Dismantle/Re-assemble 98
Q
E Quality Control
Certificate 69
Error Codes 76
Maintenance 27
Events
Data Log 36
Test 40 R
Release Notes 177
F Ribbon Cable Kit 132
Force Sensor
Dismantle/Re-assemble 132 S
Test 41 Symbol Descriptions 2
Syringe Barrel Clasp
I Dismantle/Re-assemble 112
Test 45
Indication Test 49
Syringe Detection System 118
K
T
Keypad
Description 9 Table of Contents 3
Technical Characteristics 159
Test 49
Temperature Test 57
Tests
L Access Menu 37
LCD Display List 38
Dismantle/Re-assemble 98 Training 27
Voltage 57 Troubleshooting 75
Lever Kit 143
Linear Sensor Kit 138 U
Upper Case 83

175
 W
Watchdog 58
Wi-Fi Board
Description 22
Dismantle/Re-assemble 109
Wi-Fi Module Information 59

176
Release Notes

Date Software Version Revision Description

April 2018 0 Creation
6.2 Running Tests: Information symbol is added.
3.1 7.2 Occlusion pre-alarm !!: Update of the values.
June 2018 1
8 Intervention Procedures: a chart is added to help the user
to perform all the tests.

This document may contain inaccuracies or typographical errors.

Modifications may thus be made, and included in later editions.
Due to the evolution of standards, and of legal texts and materials, the characteristics indicated in the text and images of this document are
applicable only to the device with which it is included.

The screenshots and illustrations in this document are for illustrative purposes only. Screen contents may vary based on individual configurations
and minor software modifications; therefore, some screenshots may appear slightly different from what you see on the product.

This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi. Vigilant® and Agilia® are registered
trademarks in the name of Fresenius Kabi in selected countries.

Made in France
Revision date: June 2018

www.fresenius-kabi.com
0123

First CE Mark: 2018

177
Local Contacts for Servicing

13608-1_TM_Agilia_SP_PCA_Eng

Fresenius Kabi AG Fresenius Vial S.A.S

61346 Bad Homburg Le Grand Chemin
Germany 38590 Brézins - France
Agilia SP PCA
Agilia SP PCA WiFi
Syringe Infusion Pumps
Applicable to software version 3.1

Instructions For Use

For Use in Healthcare Facilities
Symbol Descriptions

Warning Name and address of the

(Refer to the Instructions for Use) manufacturer / Date of manufacture

Name and address of the

Refer to the Instructions for Use
manufacturing facility

Protection against electric shock:

Product reference / part number
class II
Non-ionizing electromagnetic
Product serial number
radiation

Input terminal - connector Fragile, handle with care

Output terminal - connector This way up

Electrical fuses Keep away from rain

Alternating Current (AC) Temperature limitation

Direct Current (DC) Humidity limitation

Ingress protection against solid

foreign objects (> 12.5 mm) and
IP22 Atmospheric pressure limitation
dripping liquids. Rating applies to
pump.
Ingress protection against water
when immersed up to 1 m deep. General symbol for recyclable
IP27
Rating applies to patient handset but material
not to the handset connector.

Part included in a recycling process Eco packaging symbol

Protection against leakage current;

CE mark
defibrillation-proof type CF applied 0123
part

Warning of a potential hazard that

could result in serious personal
Recommendations to be followed.
injury and/or product damage if the
written instructions are not followed.

12098-5_master_ifu_agilia_sp_pca_eng
Table of Contents

1 INTRODUCTION 10
1.1 SCOPE .................................................................................................10
1.2 INTENDED USE ......................................................................................10
1.3 PRINCIPLES OF OPERATION ...................................................................10
1.4 INTENDED PRODUCTS TO BE INFUSED ....................................................11
1.5 INTENDED USERS ..................................................................................11
1.6 INTENDED PATIENTS .............................................................................12
1.7 CONTRAINDICATIONS .............................................................................13
1.8 USE ENVIRONMENT ...............................................................................13

2 AGILIA CONNECT INFUSION SYSTEM 15

3 DESCRIPTION 16
3.1 PUMP FRONT VIEW ...............................................................................16
3.2 PUMP BACK VIEW .................................................................................17
3.3 PUMP BOTTOM VIEW (DEVICE IDENTIFICATION LABEL) ...........................17
3.4 PATIENT HANDSET ................................................................................18
3.5 KEYPAD DESCRIPTION ...........................................................................18
3.6 DISPLAY AND SYMBOLS .........................................................................20
3.7 PACKAGING ..........................................................................................22

4 FUNDAMENTALS 23
4.1 DEFINITIONS OF TERMS USED IN PCA THERAPY ....................................23
4.2 PCA MODES .......................................................................................24
4.3 GENERAL INFUSION MODES...................................................................27
4.4 DERS INTERFACE ................................................................................27

5 INSTALLATION 31
5.1 TYPES OF INSTALLATIONS .....................................................................31
5.2 USING THE ROTATING POLE CLAMP.......................................................32
5.3 ATTACHING THE PUMP ..........................................................................33
5.4 INSTALLING AND REMOVING THE PROTECTIVE COVER ............................35
5.5 CONNECTING AND DISCONNECTING THE PATIENT HANDSET ..................35

3
6 GETTING STARTED 36
6.1 FLOWCHART .........................................................................................36
6.2 USING THE PUMP FOR THE FIRST TIME ..................................................36
6.3 POWERING ON ......................................................................................37
6.4 INSTALLING A SYRINGE..........................................................................39
6.5 PUMP HEIGHT .......................................................................................41

7 PROGRAMMING A PCA INFUSION 42

7.1 PCA INFUSION FLOWCHARTS ................................................................42
7.2 SELECTING A PROFILE ..........................................................................46
7.3 SELECTING A THERAPY .........................................................................46
7.4 SELECTING THE PRESCRIPTION UNIT (VOLUME / DOSE) .........................47
7.5 SELECTING A SYRINGE ..........................................................................47
7.6 SELECTING A DRUG ..............................................................................48
7.7 SELECTING DRUG CONCENTRATION.......................................................48
7.8 SPECIFYING THE PATIENT’S CHARACTERISTICS ......................................50
7.9 PRIMING THE SYRINGE AND THE EXTENSION SET ...................................50
7.10 PROGRAMMING A PCA LOADING DOSE ..................................................52
7.11 SELECTING THE PCA MODE ..................................................................53
7.12 PROGRAMMING A PCA BOLUS...............................................................53
7.13 PROGRAMMING A CONTINUOUS RATE ....................................................54
7.14 PROGRAMMING A PCA INFUSION WITH VARIABLE RATES ........................54
7.15 PROGRAMMING AN INFUSION BEYOND SOFT LIMITS ................................55
7.16 SETTING THE CUMULATED LIMITS ..........................................................56
7.17 REVIEWING THE PCA INFUSION SETTINGS .............................................57
7.18 STARTING A PCA INFUSION ...................................................................58
7.19 SUPERVISING PCA THERAPY ................................................................58
7.20 MODIFYING A RUNNING PCA INFUSION ..................................................62
7.21 ADMINISTERING A BOLUS ......................................................................63
7.22 HANDLING PCA ALARMS AND ALERTS DURING PROGRAMMING ...............66

8 PROGRAMMING A GENERAL INFUSION 69

8.1 PROGRAMMING A GENERAL INFUSION BY FLOW RATE ............................69
8.2 PROGRAMMING A GENERAL INFUSION BY DOSE RATE ............................70
8.3 SELECTING A PROFILE ..........................................................................71
8.4 SELECTING A THERAPY .........................................................................71

4
 8.5 SELECTING A PROGRAMMING MODE (FLOW RATE OR DOSE RATE).........71
8.6 SELECTING A SYRINGE ..........................................................................71
8.7 SELECTING A DRUG ..............................................................................71
8.8 SELECTING DRUG CONCENTRATION.......................................................71
8.9 SELECTING THE PATIENT’S CHARACTERISTICS .......................................72
8.10 PROGRAMMING AN INFUSION BY DOSE ...................................................72
8.11 PROGRAMMING AN INFUSION BY FLOW RATE .........................................74
8.12 PROGRAMMING AN INFUSION BEYOND SOFT LIMITS ................................74
8.13 STARTING AN INFUSION .........................................................................75
8.14 MONITORING AN INFUSION .....................................................................75
8.15 ADJUSTING THE INFUSION RATE (RATE TITRATION) ................................76
8.16 ADMINISTERING A BOLUS ......................................................................77
8.17 ADVANCED INFUSION PROGRAMMING MODES.........................................79
8.18 PRE-PROGRAMMING THE PUMP .............................................................81

9 ENDING AN INFUSION 82
9.1 STOPPING THE INFUSION IN PROGRESS .................................................82
9.2 COMPLETING AN INFUSION ....................................................................82
9.3 UNLOCKING THE PUMP KEYPAD .............................................................84
9.4 POWERING OFF THE PUMP ....................................................................84

10 MENUS 85
10.1 OVERVIEW ............................................................................................85
10.2 PROFILE ...............................................................................................87
10.3 PRESSURE ............................................................................................87
10.4 KEYPAD LOCK STATUS ..........................................................................89
10.5 KEYPAD AUTOMATIC LOCK ....................................................................91
10.6 BATTERY LIFE .......................................................................................92
10.7 VOLUME INFUSED / DOSE INFUSED ........................................................92
10.8 PAUSE ..................................................................................................93
10.9 PROGRAMMED BOLUS ...........................................................................94
10.10 CLINICIAN BOLUS ..................................................................................94
10.11 PATIENT ...............................................................................................95
10.12 DAY/NIGHT MODE .................................................................................96
10.13 VOLUME/TIME AND DOSE/TIME ..............................................................97
10.14 VOLUME LIMIT.......................................................................................97

5
 10.15 ALARM VOLUME ....................................................................................98
10.16 VOLUME-DOSE HISTORY .......................................................................98
10.17 VIEW FLOW RATE HISTORY ...................................................................99
10.18 VIEW PRESSURE HISTORY ..................................................................100
10.19 VIEW PCA HISTORY ...........................................................................100
10.20 VIEW PCA TREATMENT INFORMATION .................................................101
10.21 VIEW PCA EVENT LOG .......................................................................101
10.22 VIEW EVENT LOG................................................................................102
10.23 SYRINGE.............................................................................................103
10.24 DATE / TIME .......................................................................................103
10.25 MAINTENANCE ....................................................................................104
10.26 LIBRARY INFORMATION ........................................................................104
10.27 CLINICAL INFORMATION .......................................................................105
10.28 DATA SET ...........................................................................................105

11 ADVANCED PUMP CONFIGURATION 106

11.1 ACCESSING THE PUMP CONFIGURATION OPTIONS ................................106
11.2 OPTION GROUPS ................................................................................106
11.3 PUMP SETTINGS .................................................................................107

12 DATA COMMUNICATION 108

12.1 OVERVIEW ..........................................................................................108
12.2 COMMUNICATION VIA AGILIA CABLES ...................................................108
12.3 COMMUNICATION VIA WI-FI .................................................................109
12.4 DATA SET UPLOAD .............................................................................109

13 USER TEST 110

14 ALARMS AND SAFETY FEATURES 111

14.1 INTRODUCTION ....................................................................................111
14.2 ALARM DESCRIPTIONS ........................................................................111
14.3 GENERAL REMARKS ............................................................................112
14.4 LIST OF ALARMS .................................................................................112

15 SYRINGES 119
15.1 SYRINGE LIST .....................................................................................119
15.2 PREPARING A SYRINGE .......................................................................119

6
 15.3 OPERATIONS FOR SYRINGES ...............................................................121
15.4 GRAVITY INFUSION IN PARALLEL WITH A PUMP .....................................122

16 SPECIFICATIONS 123
16.1 ESSENTIAL FEATURES .........................................................................123
16.2 PUMP ACCURACY...............................................................................123
16.3 FLOW RATE SETTINGS ........................................................................125
16.4 VOLUME TO BE INFUSED (VTBI) SETTINGS .........................................125
16.5 DOSE TO BE INFUSED (DTBI) SETTINGS .............................................126
16.6 INFUSION TIME DISPLAY ......................................................................126
16.7 CONCENTRATION ................................................................................126
16.8 PATIENT DATA ....................................................................................127
16.9 PRESSURE MANAGEMENT ...................................................................127
16.10 UNITS AND CONVERSION RULES .........................................................128

17 CLEANING AND DISINFECTION 131

17.1 RECOMMENDED AND PROHIBITED AGENTS ...........................................131
17.2 QUICK CLEANING PROCEDURES ..........................................................131
17.3 WHEN TO CLEAN AND DISINFECT THE PUMP AND THE PATIENT HANDSET ...
132
17.4 INSTRUCTIONS FOR CLEANING AND DISINFECTION ................................132

18 POWER MANAGEMENT 136

18.1 AC POWER SUPPLY PRECAUTIONS......................................................136
18.2 BATTERY PRECAUTIONS ......................................................................136
18.3 BATTERY OPERATING MODE ...............................................................137

19 TECHNICAL CHARACTERISTICS 138

19.1 POWER SUPPLY ..................................................................................138
19.2 BATTERY ............................................................................................138
19.3 POWER CONSUMPTION........................................................................138
19.4 COMMUNICATION PORT .......................................................................138
19.5 INFRARED COMMUNICATION.................................................................139
19.6 SOUND LEVELS ...................................................................................139
19.7 COMPLIANCE ......................................................................................140
19.8 DIMENSIONS AND WEIGHT ...................................................................140
19.9 TRUMPET AND START-UP CURVES .......................................................140

7
 19.10 OCCLUSION ALARM ACCURACY AND BOLUS VOLUME AT OCCLUSION
RELEASE143

20 WI-FI 144
20.1 GENERAL INFORMATION ......................................................................144
20.2 USAGE RESTRICTIONS IN EUROPE .......................................................145
20.3 TECHNICAL SPECIFICATIONS ................................................................145
20.4 ELECTROMAGNETIC COMPATIBILITY .....................................................145
20.5 PROTOCOLS AND STANDARDS .............................................................146

21 TROUBLESHOOTING 147

22 DEVICE STORAGE, TRANSPORT, AND RECYCLING 149

22.1 PRECAUTIONS FOR STORAGE ..............................................................149
22.2 STORAGE AND TRANSPORT CONDITIONS..............................................149
22.3 PREPARING THE DEVICE FOR STORAGE ...............................................149
22.4 USING THE DEVICE AFTER STORAGE ...................................................149
22.5 RECYCLING AT END OF LIFE ................................................................150

23 WARRANTY 151
23.1 GENERAL WARRANTY CONDITIONS ......................................................151
23.2 LIMITED WARRANTY ............................................................................151
23.3 WARRANTY CONDITIONS FOR ACCESSORIES ........................................151

24 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 152

24.1 ELECTROMAGNETIC COMPATIBILITY .....................................................152
24.2 ELECTROSTATIC DISCHARGE (ESD) AND PRECAUTIONS TO BE TAKEN .152
24.3 EMC AND ESSENTIAL PERFORMANCE ..................................................153
24.4 ELECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE ......153

25 SERVICING 155
25.1 INFORMATION ON DEVICE SERVICING ...................................................155
25.2 MAINTENANCE REQUIREMENTS ............................................................155
25.3 QUALITY CONTROL .............................................................................156

8
26 GLOSSARY OF TERMS 157

APPENDIX: FACTORY CONFIGURATION 159

INDEX 160

9
1 Introduction

1.1 Scope
These Instructions for Use (IFU) are applicable to the Agilia SP PCA and
Agilia SP PCA WiFi pumps. These devices are referred to throughout this manual
as the "Agilia SP PCA".
The user must adhere to the instructions specified in this IFU. Failure to adhere to
these instructions may result in damage to the equipment, injury to patients or injury
to users.
WARNING
Check that this IFU is applicable to the current software version of the
device.
 The software version of the device is displayed on the start-up screen.
 The software version described in this IFU is displayed on the cover
page and in the Release Notes, page 166.

1.2 Intended Use

The Agilia SP PCA syringe pump is primarily intended for PCA therapy, for the
administration of analgesic drugs under the patient’s or the clinician’s control.
The Agilia SP PCA syringe pump can also be used for general infusions on adults,
pediatrics, and neonatal patients for the intermittent or continuous delivery of
parenteral fluids (such as solutions, colloids, parenteral nutrition), medications
(such as diluted drugs, chemotherapy, anesthesia drugs), blood and blood
derivatives, and medications through clinically accepted routes of administration.
It is intended for use by trained healthcare professionals in clinical healthcare
facilities. In PCA therapy, it is also intended for use by the patient in order to self
administer doses of analgesic agent, after receiving appropriate training and
instructions from the clinical staff.
It is not intended for use during pre-hospital medical ground transportation.

1.3 Principles of Operation

Agilia SP PCA is a programmable electronic medical system dedicated to
administering a pre-determined volume of a syringe at a programmed rate. This
syringe pump ensures a fluid delivery, by pushing the syringe plunger and
advancing the liquid to the patient through an extension set (applied part).
Agilia SP PCA is a transportable and reusable device that can be used every day.
The size of a syringe can be 5, 10, 20, 30 or 50/60 mL.
For a comprehensive list, refer to the System Components booklet and information
provided in Section 15.1, page 119.
Agilia SP PCA can be used for bolus administration or continuous infusions.

10
Agilia SP PCA is used with the patient handset (applied part) for PCA therapy

Agilia SP PCA is intended for use on only one patient at a time. It can be reused
indefinitely on multiple patients throughout its lifetime.

1.4 Intended Products to be Infused

The pump administers products through clinically accepted routes. These products
include but are not limited to the following:

General
Infusion products PCA
infusion
 Analgesic drugs  
 Antibiotics  -
 Chemotherapy  -
 Catecholamines  -
Medication
 Short acting drugs  -
 Anesthesia drugs  -
 Diluted drugs  -
 Other diluted IV drugs  -
 Standard solutions  -
Parenteral fluids  Colloids  -
 Parenteral nutrition  -
 Blood  -
 Red blood cells  -
Transfusion  Platelets  -
 Plasma  -
 Albumin  -

When using Agilia SP PCA to infuse critical medications, ensure that adequate
monitoring is provided, and that backup pumps and syringes are available for
immediate use.
Only use Agilia SP PCA for the infusion of fluids that are intended for infusion
pumps.
Administration Routes
The system allows infusion via the following access routes:
 IV access with any device that administers a medical fluid to a vein and is
equipped with a female Luer lock,
 Subcutaneous access.

1.5 Intended Users

The pump must only be used by qualified and trained healthcare professionals
including but not limited to: nurses (primary users), physicians, nurse practitioners
and physician assistants.

11
The only bolus function with the handset can be used safely by patients, who must
have the proper physical and mental abilities and have received appropriate
training by the clinical staff.

The typical initial training duration for healthcare professionals is:

 1 hour for the PCA interface.
 1 hour for general infusion.
It is recommended that healthcare professionals attend a refresher training session
of about 30 minutes every year.
For training, contact your Fresenius Kabi sales representative.

1.6 Intended Patients

Agilia SP PCA is intended to be used in accordance with the healthcare facility’s
protocols on patients with the following characteristics:
PCA therapy General infusion
Male
Sex
Female

Neonates
Pediatrics
Pediatrics
Age Adults
Adults
Elderly
Elderly

Weight 0.25 kg to 350 kg

Body surface area 0.05 m² to 4.5 m²

When using the pump with a very sensitive population such as the neonates, make
sure to:
 Switch to night mode.
 Set the alarm volume to the minimum level.
WARNING
Specific attention for infusing high risk and life sustaining medication
therapies: use the smallest compatible syringe size necessary to deliver
the fluid or medication; this is especially important when infusing high risk
or life-sustaining medications at low infusion rates (e.g., less than 5 mL per
hour, and especially flow rates less than 0.5 mL per hour). Using a larger
syringe when infusing at low rates can lead to inadequate syringe pump
performance including delivery inaccuracies, delay of therapy, and
delayed generation of occlusion alarms. This is due to the increased
friction and compliance of the syringe plunger head with larger syringes.

12
1.7 Contraindications
The use of the Agilia SP PCA for PCA therapy requiring the patient handset is
contra-indicated for neonates, and for patients that have physical or mental
inabilities to handle the handset.

1.8 Use Environment

Agilia SP PCA is intended for use in healthcare facilities, under the supervision of
trained healthcare personnel.
The pump must be used in the following operating conditions to ensure proper
performance:
 Operating temperature range: 5 °C to 40 °C
 Operating pressure range: 700 hPa (525 mmHg / 10.15 PSI) to 1060 hPa
(795 mmHg / 15.37 PSI)
 Operating humidity range: 20 % to 90 % with no condensation
 Altitude: up to 3000 m above sea-level
WARNING
Do not modify the pump (except in the case of operations recommended
by Fresenius Kabi).
WARNING
Do not use the pump with the following fluids:
 Flammable liquids
 Fluids not suitable for infusion
WARNING
Do not use the pump in the following environments:
 Explosive or flammable environments
 High humidity environments (shower, bath, etc.)
 Ultrasonic environments
 Ambulances
 Magnetic Resonance Imaging (MRI)
 Hyperbaric chambers
WARNING
Do not use the pump for the following purposes:
 Infusion in association with a dialyzer or ECMO
 Enteral nutrition
WARNING
While the pump is infusing a patient, do not connect a computer installed
with Agilia Partner software to perform technical operations.

13
WARNING
The functionality of the pump can be affected by pressure variations,
mechanical shocks, heat ignition sources, and so on.
INFORMATION
For more information on using the device in specific conditions, contact
your Fresenius Kabi representative.

14
2 Agilia Connect Infusion System

Agilia range Description

Volumetric Infusion Pump
Pumps designed to deliver the contents of parenteral
Agilia VP range
infusion container (bag or bottle) through a line connected
Pump to a patient.
Syringe Infusion Pump
Agilia SP range Pumps designed to deliver the contents of a syringe through
a line connected to a patient.
Medication Safety Solution
DERS or Dose Error Reduction Software designed to
Vigilant Master Med
create, customize and manage data sets to be uploaded to
the Agilia VP and SP infusion pumps.
Maintenance Software
Agilia Partner Software designed to maintain, configure, test and calibrate
the Agilia VP and SP infusion pumps.
Software Distribution Server
Software intended to distribute data sets to Agilia infusion
Centerium
pumps and centralize information coming from infusion
pumps for post analysis and reporting.
Infusion Data Reporting Software
Software designed to improve the accuracy of clinical
Vigilant Insight
settings included into a data set. It provides reports about
the use of infusion pumps.
Stacking Rack Systems
Rack systems designed to stack 4, 6 or 8 Agilia infusion
Agilia Link
Rack pumps. Agilia Link is designed to centralize the power
Link+ Agilia
supply. Link+ Agilia is designed to centralize the power
supply and to centrally replicate infusion pump signalling.
Syringes
Disposables See Section 15, page 119
(applied part)
Two Channel Accessory
Accessories Agilia Duo Accessory designed to stack 2 Agilia infusion pumps and
centralize the power supply.

INFORMATION
For a list of compatible accessories, disposables and software, and for
ordering information, refer to the System Components booklet.

INFORMATION
The Agilia Connect Infusion System is made up of medical devices that
are subject to medical device regulations and market authorizations.
Some devices, including software products, may not be available in your
country at the time of publishing this document.

15
3 Description

3.1 Pump Front View

This section shows the Agilia SP PCA pump with the cover closed and with the
cover open.

8 7 Legend

1 1 Handle

BOLUS
21 Syringe barrel clasp
6 3 Cover clasp

41 Plunger driver

53 Disengagement lever

63 Syringe guard

7 Patient handset

2 3 4 5 8 Cover lock

Figure 3.1: Front view with cover closed

Legend
BOLUS
1 Clear protective cover

21 Cover clasp

3 Syringe flange cradle

1 2 3
Figure 3.2: Front view with cover open

16
3.2 Pump Back View
Legend

9 1 Cord stowage

21 Patient handset and holder

8
3 Release button
7 Pole clamp lock
BOLUS
41

6 53 Rotating pole clamp

63 RS232 communication port

1
7 Power cord inlet
2 3 4 5 8 Infrared cell

9 Attachment lock knob

Figure 3.3: Back View

Symbol Location Description

Warning
Near power cord inlet See Section 19, page 138

Near RS232 Warning

communication port See Section 12, page 108

3.3 Pump Bottom View (Device Identification Label)

BOLUS

Figure 3.4: Bottom view

For information on symbols used on the device identification label, see Symbol
Descriptions, page 2.
17
3.4 Patient Handset
2 Legend
1 BOLUS
1 Bolus start button

Blue LED on when

patient handset is
connected to pump
3 21 (stays lit at all times to
enable patient to locate
handset)

3 Cable gland
4
4 Wrist strap

Figure 3.5: Patient handset and wrist strap

3.5 Keypad Description

1
2 17
3
16
4 15

14

5 6 7 8 9 10 11 12 13
Legend

1 Screen 7 Fast increment 13 Stop

Battery charge status Cancel value / Move

21 8 Increment 14
indicator back to previous field

3 Power supply indicator 9 Infusion indicator lights 15 Menu

41 Wi-Fi symbol 10 Decrement 16 PCA history

53 On / Off 11 Fast decrement 17 Alarm silence

Confirm value / Move to

63 Bolus / Prime 12 next field
Figure 3.6: Keypad description

18
3.5.1 Keypad Details
Table 3.7: Selection Keys
Key Description
Arrow keys
Keys for setting volume, time, flow rate and other values.

+ Fast access to maximum value or top of a list

+ Fast access to minimum value or bottom of a list

Note:
 Pressing and holding any of the arrow keys results in faster increment or decrement.

Table 3.8: Infusion Indicator Lights

Indicator Description

Infusion in progress (flashing green)

Low-priority alarm (constant yellow)

Medium-priority alarm (flashing yellow)

High-priority alarm (flashing red)

Note:
 Infusion indicator lights provide information about the infusion: in progress, or with a low, medium
or high-priority alarm.
 Green indicator lights will continuously flash from right to left while the infusion is running.
 Low and medium priority yellow lights can be combined with green flashing lights, which indicates
infusion is still running.
 The frequency of flashing varies according to flow rate.

Table 3.9: Status Indicators

Indicator Description
Power supply indicator
When the device is attached to an active power supply, the indicator light is
a constant green. If the pump is not connected to the AC power, it does not
light up.
Battery charge status indicator
When the device is attached to an active power supply, the indicator light
provides information about battery charge status:
 If the indicator is blinking, the battery is being charged.
 If the indicator is lit permanently, the battery is fully charged.
If the pump is not connected to the AC power, it does not light up.

19
3.6 Display and Symbols
Table 3.10: Infusion status
Symbol Description
Infusion in progress (Basic Profile + custom profiles with a drug list)
Symbols for infusion in progress.
Infusion in progress (custom profiles with a drug library)
Animated symbol displayed when the pump is infusing a drug from a drug library.

Infusion stopped
STOP remains in the center of the screen until the user starts the infusion again.

Table 3.11: Screen options

Symbol Description
Battery logo
 This symbol shows three different charge levels.
< 30 % battery charge
30 % - 70 % battery charge
> 70 % battery charge
 If the ‘Battery logo’ option is enabled, this symbol is displayed constantly.
 If the ‘Battery logo’ option is disabled, this symbol is only displayed when the
pump is operating on battery.
Pressure logo
This symbol gives information about pump pressure settings and measured
pressure levels.
Keypad locked symbol
This symbol informs the user that the keypad is locked.
Wi-Fi module status
 The Wi-Fi signal strength is high.
 The Wi-Fi signal strength is medium.
 The Wi-Fi signal strength is low.
 No Wi-Fi signal (the Wi-Fi module is activated).
 The Wi-Fi module is not activated.

Table 3.12: Navigation Buttons

Symbol Description

start Start

end End

OK Confirm

enter Access function

New ? Access function and clear settings

exit Exit function

20
 Symbol Description

C Change selection

prog Program function

Select / Deselect

Review PCA settings

Edit PCA settings

prev. Move to the previous step/screen

next Move to the next step/screen

back Move to the previous screen

See more information

/ Zoom in / Zoom out

/ Move the event marker to the left / right

Table 3.13: Alarms and Safety Features

Symbol Description
Power disconnection

Alarm silenced

Pressure increase

Drop in pressure
Note: For more information on alarms, see Section 14, page 111.

Table 3.14: Infusion Features

Symbol Description
PCA therapy
Displayed when programming PCA infusion or during PCA infusion.
PCA bolus+continuous mode
Displayed when PCA therapy includes PCA boluses and a continuous rate.
Continuous only mode (in PCA therapy)
Displayed when the PCA therapy includes a continuous rate only.
PCA bolus only mode
Displayed when the PCA therapy includes PCA boluses only.
PCA bolus+variable rates mode
Displayed when PCA therapy includes PCA boluses and variable infusion rates.
Loading dose (PCA therapy)
Displayed when programming or during infusion of a PCA loading dose.
Programming mode (general infusion)
Displayed when selecting the programming mode for a general infusion.

21
 Symbol Description
Loading dose (general infusion)
Displayed when programming a loading dose.
Clinician bolus (PCA therapy)
Displayed when programming or during infusion of a clinician bolus.

Table 3.15: Data Communication

Symbol Description
Data set uploaded
A new data set has been uploaded to the pump.

3.7 Packaging
The Agilia SP PCA packaging contains the following:
 1 Agilia SP PCA pump and its protective cover.
 1 patient handset with a cable and connector, and a wrist strap.
 1 Instructions for Use manual (this document + System Components booklet).
 1 power cord for the pump.
Packaging weight: approximately 515 g.
Packaging consists of: recycled cardboard, expanded foam.

INFORMATION
 It is the healthcare facility’s responsibility to check the pump integrity
upon reception.
 If the packaging contents are incomplete or damaged, contact your
Fresenius Kabi sales representative.

22
4 Fundamentals

4.1 Definitions of Terms Used in PCA Therapy

PCA or Patient Controled Analgesia
Refers to administration of an analgesic through the IV route (or SC route) by the
patient using a special device.
Patient handset
The Agilia SP PCA pump is equipped with a patient handset connected to the
pump, intended for the patient to use to trigger a PCA bolus.
Also called patient pendant, patient handset, bolus handle, dose request cord.
PCA bolus
Refers to a dose of analgesic prescribed and programmed by the clinician, that the
patient can self-administer outside of the lockout time using the patient handset
connected to the pump.
Also called patient bolus, demand bolus, bolus dose, PCA dose, incremental dose.
Lockout time
Time interval programmed by the clinician and activated by a bolus, during which
the pump cannot administer a PCA bolus. The lockout time starts from the end of
the bolus up until the beginning of the next authorized bolus.
Also called lockout interval, PCA lockout, PCA time interval.
Clinician bolus
Refers to a dose of drug administered by the pump, that can be allowed inside or
outside the lockout time.
Loading dose
Refers to a bolus of analgesic administered before starting the PCA cycle to test the
patient’s reaction, sometimes also called "titration", "test dose" or "initial bolus".
The loading dose can be repeated to obtain pain relief.
Continuous rate
Refers to the continuous infusion (flow rate or dose rate) of analgesic that can be
programmed by the clinician, and administered to the patient during the PCA cycle.
Also called basal rate, continuous delivery rate, continuous infusion, background
infusion.
Variable rates
Refers to continuous infusions of analgesic that can be programmed to start at
different times of the day with a different rate for each one. The clinician can
program up to three infusion rates (in volume or dose) to be administered daily to
the patient.

23
Cumulated limits
Refer to the maximum amount of drug, programmed by the clinician, that can be
administered to the patient over a rolling period of time. This maximum amount can
be specified in terms of total dose or of number of boluses. The cumulated limits are
calculated and updated by taking into account all doses administered: the PCA
boluses, the continuous infusion, the clinician boluses, but not the loading dose.
DERS or Dose Error Reduction Software
Dose error reduction software is used to create drug definitions and pump
configurations. By defining limits on parameters such as drug concentration,
maximum dose, pressure limits or even disabling certain functions, the DERS
reduces the potential for human error.
The Agilia SP PCA pump is designed to interface with a DERS to offer a selection
of profiles and drug names. The clinician can select a drug and adjust the infusion
parameters only within the limits defined by the DERS.

4.2 PCA Modes

A PCA infusion can be programmed with one of the following modes:
 PCA bolus, see Figure 4.1, page 25
 Continuous rate, see Figure 4.2, page 25
 PCA bolus + continuous rate, see Figure 4.3, page 26
 PCA bolus + variable rate, see Figure 4.4, page 26
INFORMATION
 In all PCA modes, it is possible to program cumulated safety limits on
the maximum dose and the maximum number of boluses.
 In all PCA modes, the clinician can administer a bolus, including during
lockout periods, as explained in Section 7.21.2, page 64.

24
4.2.1 PCA Bolus Only Mode
The clinician programs the allowed PCA bolus, and specifies the lockout time and
the cumulated dose limits. The patient can self-administer a bolus outside of the
lockout time as shown below. The clinician can administer a bolus at any time.

rate

time

PCA Clinician lockout

P P C P
bolus bolus time

Figure 4.1: PCA bolus infusion mode

4.2.2 Continuous Rate Only Mode

The clinician programs a continuous only infusion rate and specifies the cumulated
limits. In addition, the clinician can initiate a bolus at any time, but the patient cannot
self-administer boluses, as shown below.

PCA Clinician P P C P
bolus bolus

Figure 4.2: Continuous rate infusion mode

25
4.2.3 PCA Bolus + Continuous Mode
The clinician programs the allowed PCA bolus in volume or dose, a continuous
infusion rate, and the cumulated limits.
The patient can self-administer a bolus outside of the lockout time, as shown below.
The clinician can administer a bolus at any time.
rate

time

PCA Clinician lockout

P P C P
bolus bolus time

Figure 4.3: PCA bolus + continuous infusion mode

4.2.4 PCA Bolus + Variable Rates Mode

The clinician programs up to three different continuous flow rates or dose rates to
start at specified times of the day over a 24 hour period. The clinician also programs
the PCA bolus, and the lockout time.
The patient can self-administer a bolus outside of the lockout time as shown below.
The clinician can administer a bolus at any time.
rate

time

PCA Clinician lockout

P P C P
bolus bolus time

Figure 4.4: PCA bolus + variable rate mode

26
4.3 General Infusion Modes
A general infusion can be programmed with one of the following modes:
Infusion mode Description
Infusion with a programmed flow rate (mL/h) or dose rate (for example,
Simple rate
mg/h, microg/kg/min) of the full contents of the syringe.
Infusion of a programmed volume (mL) or dose (for example mg, microg/kg)
Volume/Time
over a programmed period of time. The flow rate or dose rate is
Dose/Time
automatically computed.
Infusion with a programmed flow rate (mL/h) or dose rate (for example,
Rate + Volume Limit
mg/h, microg/kg/min) with a limitation on the volume or dose to be infused.

4.4 DERS Interface

This section explains the functions implemented in the pump so that it can interface
with drug error reduction software (DERS).
4.4.1 Profiles
You can program the pump using the Basic Profile provided, or a custom profile.
Custom Profiles
Custom profiles can be created and uploaded to the pump using a compatible
DERS. A custom profile contains the following:
 A specific device configuration that controls mechanical functions such as
alarm volume, or pressure limits.
 A drug library (a set of drug entries with limits on infusion parameters) or drug
list (a list of drugs without limits on infusion parameters).
INFORMATION
 We recommend using a custom profile when infusing critical drugs.
 We recommend that you create and upload profiles in order to limit
usage errors, and to better adapt the use of the pump to the local
practices of the different care units. For example, make sure to limit
flow rates for sensitive populations.
 We recommend creating a specific profile per patient population and/or
care unit, therapy, protocol, and so on.
 For pumps used on only one group of patients, we recommend
disabling the ability to select the profile to lock the pumps to the
selected profile.

27
Basic Profile
The pump is delivered with one default profile called Basic Profile. Basic Profile
does not include a drug list or drug library.
Basic Profile has the following characteristics:
 All infusion settings are to be defined.
 DERS safeguards are unavailable:
- The infusion is programmed without a drug name.
- There are no limits on drug infusion parameters.
It is the caregiver’s responsibility to adapt the pump configuration and infusion
settings available in Basic Profile to the patient and to the protocol.

4.4.2 Drug Libraries

A drug library is a list of drug entries that include limits on drug infusion parameters.
It can include drugs intended for PCA therapy and drugs intended for general
infusion.
INFORMATION
 Each drug library can support a number of drug entries that are defined
and validated by healthcare professionals in accordance with the
protocols used at the healthcare facility and/or ward level.
 Drug settings may be adjusted on the pump within pre-defined
programming limits, such as dose limits.
 Infusion modes defined in a custom drug entry are not adjustable on
the pump.

4.4.3 Drug Lists

A drug list is a list of drugs that does not include limits on drug infusion parameters.

28
4.4.4 Drug Entries
Drug entries created in a DERS specify a number of parameters and values. Some
parameters are mandatory. They are summarized in the table below.
Parameters PCA General infusion
Drug name Value to be provided (no default value)
Type of therapy PCA infusion General infusion
Drug concentration Value to be provided for infusions programmed in dose rate
PCA bolus only Simple rate
Continuous only Volume/Time
Infusion mode
PCA bolus + continuous Dose/Time
PCA bolus + variable Rate + Volume Limit
Prescription unit /
Volume or Dose Flow rate or dose rate
Infusion rate
Limits on dose Hard limits and soft limits (mininmum and maximum values)
selection or flow rate on a range of values or on finite values
Values to be provided for a single
PCA limits N/A
PCA bolus and cumulated limits

There is a special entry called Drug X that has no predefined parameters, see
Section 4.4.5, page 30.
Hard Limits and Soft Limits
Programming limits can be set on flow rate or on drug concentration for each drug
within a drug library. Two types of limits can be set:
 Hard limits: limits that cannot be overridden when programming an infusion.
 Soft limits: limits that can be overridden within an authorized range when
programming an infusion. Additional confirmation is required.
The limits can define a range or finite values, as shown in the illlustrations below.

Authorized range Legend

Unauthorized range Hard limits

Programmable range Soft limits

Authorized range Default value

Authorized finite values

Default value Finite value

29
Limits for PCA therapy
In PCA therapy, in addition to the limits on flow rate and dose rate, it is possible to
impose limits on PCA specific parameters:
 Limits on PCA bolus: hard and soft limits on volume or dose infused in a
single bolus, minimum and maximum lockout time.
 Cumulated limits: maximum number of boluses, and/or maximum dose
assessed over a specified period of time.

4.4.5 Drug X
Drug X entries with a flow rate or dose rate are open entries that can be selected if
the intended drug is not found in the drug library. Their characteristics are:
 Fewer limits than the other drugs in the library.
 No safeguards imposed by a DERS.
It is strongly recommended to use Drug X entries in a limited number of clinical
cases and under close patient monitoring by the clinical staff. In each custom
profile, the healthcare facility can enable or disable Drug X entries.

4.4.6 Data Set

A data set is a combination of custom profiles that can be uploaded to the pump. A
pump can manage up to 20 profiles: 1 Basic Profile and up to 19 custom profiles.

Device Device Device Device Device

Configuration Configuration Configuration Configuration Configuration
(factory) 2 3 4 20

Drug Library Drug List Drug Library Drug Library

A B C S

Profile 1
(Basic)
Profile 2
(Custom)
Profile 3
(Custom)
Profile 4
(Custom)
... Profile 20
(Custom)
Data Set

If there is no data set uploaded to the pump, the pump can be used with the Basic
Profile.

30
5 Installation

5.1 Types of Installations

A pump can be installed on any of the following:
Location Comments
 See Section 5.3, page 33

On a pole Pole specifications:

 Diameter: from 0.6 to 1.6 in (15 to 40 mm)

 See Section 5.3, page 33

On a rail Rail specifications:

 Height: from 1.0 to 1.4 in (25 to 35 mm)
 Depth: from 0.3 to 0.4 in (8 to 10 mm)
 Refer to the Agilia Link accompanying
documents.

On an
Agilia Link
rack

 See Section 5.3, page 33

On a table Only install a pump on a table if it is not

possible to attach it to a pole, a rail or
recommended Agilia accessory.
 See Section 5.3, page 33

On another
pump

 Refer to the Agilia Duo accompanying

documents.

On an Agilia
Duo

Do not use accessories that appear to be damaged. For more information on

accessories, refer to their respective accompanying documents.
31
 WARNING
 The pump must be used in a horizontal and stable position to function
properly.
 Use recommended Agilia accessories to ensure stability and prevent
the pump from falling. Do not stack the pump with equipment other than
those recommended.
 When the pump is installed onto an Agilia Link rack, make sure that it
is correctly plugged in (hook clipped) so as to prevent the pump from
falling.
INFORMATION
Connect the patient handset to the pump before stacking the pump on
another pump or in an Agilia Link rack or Agilia Duo because the handset
connector is placed under the pump.

5.2 Using the Rotating Pole Clamp

The rotating pole clamp is located at the back of the pump. When installing the
pump on a pole or a rail, fasten the rotating pole clamp firmly to avoid any
movement of the pump.
3 Legend
Screw clamp
Pole clamp folded up 1
1
Release button
21
2 3 Rotating pole clamp
4
Lock on screw clamp
41
Pole clamp folded out

Figure 5.1: Rotating pole clamp system

You can secure the rotating pole clamp vertically or horizontally by folding it outward
until the release button clicks into the locked position as shown in Figure 5.2, Figure
5.3 and Figure 5.4.
You can fold the clamp down as follows:
1. Push the release button.
2. Fold the clamp outward.

Figure 5.2: Folding the clamp down (outward)

32
 You can fold the clamp up as follows:
1. Push the release button.
2. Fold the pole clamp inward toward the
pump.

Figure 5.3: Folding the clamp up (inward toward the pump)

You can rotate the clamp as follows:
1. Fold the clamp up (see above).
2. Rotate the clamp to a vertical position.
3. If necessary, fold the clamp outward (see
above).

Figure 5.4: Rotating the clamp

5.3 Attaching the Pump

Attaching the Pump to a Pole
1. Fold the pole clamp down to the horizontal
position, as shown in Section 5.2, page 32.
2. Unscrew the clamp, attach to the pole, and
screw the clamp until the pump is firmly
secured to the pole.
3. Make sure that the pump is securely
attached.
4. Lock the clamp and remove the key.

Locked Unlocked

WARNING
When installed on a rolling stand, do not tip over the system more than
5°: it may fall.
Attaching the Pump to a Rail
Only single pumps can be attached to a bed rail or gurney rail
1. Rotate the pole clamp to the vertical
position, as shown in Section 5.2, page 32.
2. Unscrew the clamp, attach to the rail, and
screw the clamp until pump is fully secured
to the rail.

33
 3. Make sure that the pump is securely
attached.
4. Lock the clamp and remove the key.

Setting up the Pump on a Flat Surface

1. Fold the pole clamp up, as shown in

Section 5.2, page 32.
2. Place the pump far enough from the edge
to prevent it from accidentally being
pushed off.

Attaching Several Pumps Together

You can attach up to three pumps together, for transport or to fix them to a pole.

1. Fold both pumps’ pole clamps up, as

shown in Section 5.2, page 32.
2. Slide the slot on the bottom of the upper
pump onto the handle of the lower pump.

3. Turn the attachment lock knob on the

lower pump handle clockwise until the
locked symbol lines up with the marker.
Unlocked Locked
4. Make sure the pumps are securely
attached together. Repeat steps 1 to 3 to
attach a third pump to the other two.
5. If needed, fold the pole clamps down and
secure them tightly to the pole.
6. Lock the pole clamp on the Agilia SP PCA
pump and remove the key.

34
5.4 Installing and Removing the Protective Cover
The protective cover is recommended for PCA therapy but not mandatory.
1. Place the hinges of the protective cover
opposite the holders on the pump casing.
2. Slide the cover to the left until it clicks into
place.

3. To remove the protective cover, unlock it to

open it, then slide it to the right to unhinge
it.

5.5 Connecting and Disconnecting the Patient Handset

1. Plug the handset into the connector placed
under the handset holder.
BOLUS

The connector is keyed. You will feel and

hear it click into place when properly
connected and a beep will be emitted.
When the pump is on, a LED placed above
the bolus button lights up.
2. To disconnect the handset, hold the
connector by the plastic ring.
Do not attempt to pull the cord, you will
Connection damage the connector.

Disconnection
INFORMATION
To ensure proper operation, use only the Fresenius Kabi patient handset
provided with the pump.
INFORMATION
Do not connect or disconnect the patient handset after starting an infusion.

35
6 Getting Started

6.1 Flowchart
Once the pump is installed at the bedside, you must follow the steps below in order
to install a syringe and power on the pump.

Preparing and priming the syringe and the extension set

Section 15.2, page 119

Powering on
Section 6.3, page 37.

Installing the syringe

Section 6.4, page 39

Programming an infusion
PCA therapy, see Section 7, page 42; general infusion, see Section 8, page 69

INFORMATION
In order to ensure that all the safety features of the device are activated,
make sure that the following instructions are applied:
 The pump is powered on prior to being connected to the patient.
 The pump is not connected to the patient during the setup.

6.2 Using the Pump for the First Time

1. Make sure the pump is correctly installed at the bedside, as explained in
Section 5, page 31.
2. Plug the pump into the AC power supply. See Section 18.1, page 136 for
precautions. Do not power on the pump.
3. Before starting the pump for the first time, charge the battery for approximately
6 hours.
Wait until the battery is fully charged. Do not use the pump during the first
charge.
4. Power on the pump following the instructions in Section 6.3, page 37.
5. Install a syringe in the pump, as explained in Section 6.4, page 39.
6. Make sure the patient handset is connected and the protective cover is in place
if you intend to use the pump for PCA therapy. See Section 5.4, page 35.

36
6.3 Powering on
INFORMATION
 The pump can operate on battery; however, it is recommended to
connect it to an AC power supply as often as possible to ensure that
the battery remains charged.
 When the pump is connected to the power supply, check that the power
supply indicator lights up green, and that the power cord and the
wall plug are accessible.

1. Press the Start/Stop button on the keypad.

An auto-test checks the functionality of the pump.
Legend
Start/Stop button
1
Confirm button
21

1 2

2. Make sure that all LED lights blink.

3. Successively acknowledge the screens listed in the table below by pressing the
confirm button , if they are displayed.

Screen after powering on Description

Startup screen: the following information is
displayed:
 Product name and version number
 Ward name
 Wi-Fi module status for Wi-Fi pumps
 Date and time

 Maintenance reminder message (optional).

 Displayed if the pump is operating on battery.

 The symbol shows three different charge
levels:
< 30 % battery charge
30 % - 70 % battery charge
> 70 % battery charge

37
Screen after powering on Description
 Profile selection screen displayed if several
profiles are available.

 No syringe is installed on the pump.

 Syringe installation !!! is displayed on
top of the screen.
 Install a syringe.
See Section 6.4, page 39.

 New patient screen (in PCA therapy, optional).

Select Yes to clear the previous infusion
settings, including the PCA history.

 Same infusion screen (in general infusion

therapy, optional)
Select Yes to keep the previous infusion
settings.

 Profile confirmation screen (optional).

Press Ok to confirm the profile.

Note: This screen is associated with the "New

patient" function above.

 Data set information (optional).

38
6.4 Installing a Syringe
WARNING
Installing a syringe must only be done when the patient is not connected.

1. Unlock the pump cover to open

the cover.

2. Open the syringe barrel

clasp [A].
3. Push the disengagement
lever [B] down and move the
plunger driver to the right.
B

4. Place the syringe in its cradle,

with the flanges correctly
inserted in the slot.

39
 5. Secure the syringe with the
syringe barrel clasp [A].

6. Press the disengagement lever

A B C and move the plunger driver
gently to the left until it is in
contact with the plunger head.

7. Close the cover by pushing it

until you feel and hear it click
into place.
8. Remove the key and keep it in
a safe place.
9. Check the general installation.

INFORMATION
Do not use the syringe pump with the protective cover if the cover is
damaged. The cover must be changed if it is damaged.
INFORMATION
The protective cover is recommended for PCA therapy but not mandatory.
The pump’s behavior in relation with the protective cover can be
configured in the pump options.

40
6.5 Pump Height
WARNING
Ideally, the syringe pump should be level with the distal tip of the catheter
(the site of fluid delivery). If accessing a central line, the syringe pump
should be at the level of the patient’s heart. If the pump height is raised
relative to the distal tip of the catheter (e.g., during patient transport), the
increase in height of the syringe pump can result in a temporary increase
in fluid delivery or bolus until the flow rate stabilizes. Alternatively, if the
pump is lowered relative to the distal tip of the catheter, the decrease in
height of the syringe pump can result in a decrease in delivery or under-
infusion until the flow rate stabilizes.

Precautions for pump position

 If using multiple syringe pumps and it is not clinically feasible to have all pumps
level with the distal tip of the catheter (or the site of fluid delivery), place the
high risk or life-sustaining medications as close to level with the distal tip of the
catheter as possible. When infusing multiple high risk or life-sustaining
medications, consider placing the ones infusing at the lowest rates as close to
the level with the distal tip of the catheter as possible.
 Minimize the height difference between the pump and the patient and avoid
changes in the height of the pump (for example, during transport of critically ill
patients) to prevent unintended fluctuations in the flow rate.

41
7 Programming a PCA Infusion
This section explains how to program a PCA infusion with the Agilia SP PCA pump.

7.1 PCA Infusion Flowcharts

The following flowchart shows the steps to follow for all PCA modes.

Selecting a profile
Section 7.2, page 46

Basic Profile Custom profile Custom profile

Section 4.4.1, page 27 with a drug list with a Drug Library
Section 4.4.1, page 27 Section 4.4.1, page 27

Selecting a therapy
Section 7.3, page 46

PCA infusion

Selecting the prescription unit: volume or dose

Section 7.4, page 47.

Selecting a syringe
Section 7.5, page 47

Selecting a drug
Section 7.6, page 48

Selecting concentration
Section 7.7, page 48

Programming a loading dose

Section 7.10, page 52

Selecting the PCA mode

Section 7.11, page 53

PCA bolus only Continuous rate PCA bolus + PCA bolus +

only continuous variable rates

42
7.1.1 Programming PCA Infusion in PCA Bolus Only Mode

PCA infusion: PCA bolus only mode

Programming PCA bolus (volume or dose)

Section 7.12, page 53

Setting PCA limits

Section 7.16, page 56

Validating PCA infusion settings

Section 7.17, page 57

Starting the PCA infusion

Section 7.18, page 58

Monitoring the PCA infusion

Section 7.19, page 58

7.1.2 Programming PCA Infusion in Continuous Only Mode

PCA infusion: continuous only mode

Programming continuous infusion (vol. or dose / hour)

Section 7.13, page 54

Setting PCA limits

Section 7.16, page 56

Validating PCA infusion settings

Section 7.17, page 57

Starting the PCA infusion

Section 7.18, page 58

Monitoring the PCA infusion

Section 7.19, page 58

43
7.1.3 Programming PCA Infusion in PCA Bolus + Continuous Mode
PCA infusion: continuous mode

Programming PCA bolus (volume or dose)

Section 7.12, page 53

Programming continuous infusion (vol. or dose / hour)

Section 7.13, page 54

Setting PCA limits

Section 7.16, page 56

Validating PCA infusion settings

Section 7.17, page 57

Starting the PCA infusion

Section 7.18, page 58

Monitoring the PCA infusion

Section 7.19, page 58

44
7.1.4 Programming PCA Infusion in PCA Bolus+Variable Rates Mode

PCA infusion: PCA bolus + variable rates

Programming PCA bolus (volume or dose)

Section 7.12, page 53

Programming continuous infusion with a variable rate

Section 7.13, page 54

Setting PCA limits

Section 7.16, page 56

Validating PCA infusion settings

Section 7.17, page 57

Starting the PCA infusion

Section 7.18, page 58

Monitoring the PCA infusion

Section 7.19, page 58

45
7.2 Selecting a Profile
Profiles are available for selection if previously uploaded to the pump.

1. Press the On/Off button to power on the

pump, and acknowledge all screens displayed
until you reach the Select profile screen.
2. Press the arrow keys to select a profile that
corresponds to the target group of patients.
The lighthouse symbol indicates a drug from a
drug library.
3. Press OK to confirm.
The selected profile information is displayed.
4. Press OK to confirm the drug library version, or
C to change the profile.
The drug library is loaded for the selected profile.

7.3 Selecting a Therapy

After selecting Basic Profile, the programming interface can take you to the Select
therapy screen where you must choose between:
 PCA
 General infusion
Note: By default, this choice is disabled in the pump configuration and this screen
is not displayed. You must enter the PCA code as explained below to continue.

1. Press the arrow keys to select the therapy you

want for the patient, and select OK.
If you select PCA, you must enter a passcode in
the following screen displayed.

2. Enter the 4-digit passcode using the keys below

the numbers on the screen.

46
7.4 Selecting the Prescription Unit (Volume / Dose)
After selecting PCA therapy, the Prescription unit screen is displayed.
Note: This screen is not displayed if you previously selected a custom profile,
because the prescription unit is pre-defined.

1. Use the arrow keys to select the prescription unit,

and press OK to confirm
The example in this chapter shows how to
program a PCA infusion in dose.
The syringe selection screen is displayed.

7.5 Selecting a Syringe

After selecting the prescription unit, the screen displays the syringe type installed in
the pump. You must make sure the display is correct.

WARNING
During programming and prior to starting an infusion, verify that the
syringe size and model on the syringe pump’s display screen match the
syringe size and model loaded in the syringe pump.
1. Press OK to confirm the displayed syringe, or the
edit symbol to change it.

2. If you chose edit to select another syringe, press

the arrow keys to select a new syringe in the list.
3. Press OK to confirm the new syringe.
A clinical advisory message may appear, if one is
configured for the selected syringe.

4. If necessary, press OK to acknowledge the

clinical advisory message, or C to return to the
syringe selection screen.
When you choose OK, the drug selection screen
is displayed.

47
7.6 Selecting a Drug
After you confirm the syringe type, the screen displays a drug selection menu.
Note: This screen is not displayed if you previously selected the Basic Profile that
does not offer a pre-defined drug list.
Drug names are sorted alphabetically with Drug X displayed at the top of the list:
 Drug X  G  I  P  R
 A  C  J  L  S  U
 D  F  M  O  V  Z
1. Use the arrow keys to scroll to the first letter of
the drug name you want, and press OK.
A list of drugs is displayed.

2. Use the arrow keys to scroll to the drug you want,

and press OK.
A clinical advisory message may appear, if
configured for the selected drug. See next step.
If not, the Concentration screen is displayed.

3. Press OK to acknowledge the clinical advisory

message and continue programming, or the
cancel key to change the drug.
When you choose OK, the Concentration
screen is displayed.

7.7 Selecting Drug Concentration

If the prescription unit you selected in step 7.4 is Dose, you must specify the drug
concentration. Depending on the profile previously selected see:
 Basic Profile and Custom Profiles with a Drug List, page 48
 Custom Profiles with a Drug Library, page 49
If you selected Volume in step 7.4, go to Section 7.10, page 52.

7.7.1 Basic Profile and Custom Profiles with a Drug List

After selecting the drug in a drug list,or directly after selecting the prescription unit
if using the Basic Profile, the Concentration screen is displayed.

48
 1. Use the arrow keys to select the concentration
unit, and press OK.

2. Use the arrow keys to specify the values required

for mass and/or volume and press OK to confirm
each value.
The concentration is automatically calculated
and displayed in the unit previously selected.
3. Press OK to confirm the concentration.
If the PCA loading dose screen is displayed, see
Section 7.9 to prime the syringe before infusing
the drug.
If the Dose rate screen is displayed, select the
appropriate dose rate unit as explained in
Section 8.10.1, page 72.

7.7.2 Custom Profiles with a Drug Library

After selecting a drug from a drug library, if you are allowed to adjust the drug
concentration, the Concentration screen is displayed. The concentration can be
ajusted:
 Within an authorized range
 At authorized finite values (up to 5)
For information on the limits that can be predefined in a custom profile, see Section
4.4.2, page 28.
Note: This screen is not displayed if you are not allowed to adjust the concentration
of the selected drug.

Range Finite values

1. Use the arrow keys to adjust the drug concentration within the authorized range
or among the authorized finite values.
2. Press OK to confirm.
If the Patient characteristics screen is displayed, see below; if the PCA loading
dose screen is displayed, see Section 7.10, page 52.

49
7.8 Specifying the Patient’s Characteristics
After selecting a drug and a drug concentration, the Patient screen can be
displayed to allow you to specify the patient’s body weight.

1. Use the arrow keys to enter the patient's weight.

2. Press OK to confirm.
If the PCA loading dose screen is displayed, see
Section 7.9 to prime the syringe before infusing
the drug.
If the Dose rate screen is displayed, select the
appropriate dose rate unit as explained in
Section 8.10.1, page 72.
INFORMATION
 The weight entry screen is displayed only if the selected drug uses
weight for dose rate calculations.
 Custom profiles define a default body weight.

7.9 Priming the Syringe and the Extension Set

The pump includes a prime function that can be configured in Basic Profile (see the
Technical manual) and in custom profiles. The following settings are available:
 Mandatory: A message is displayed and the user is required to prime the line
before infusion.
 Advised: A message is displayed to encourage the user to prime the line
before infusion.
 Not displayed: The pump does not remind the user to prime the line before
infusion.
INFORMATION
We strongly recommend to always use the prime function, especially for
life-sustaining drugs. Priming the syringe and the extension set removes
all the mechanical gaps and ensures that the programmed flow rate is
reached within the smallest delay once the start button is pressed.
If the mandatory or advisory message is not displayed, the right time to use the
prime function is before infusing a loading dose, or before starting the infusion if you
do not want to administer a loading dose.
WARNING
Priming the syringe must only be done when the patient is not connected.

50
 1. During infusion programming, before infusing a
loading dose, or before starting the infusion,
press the bolus key .
2. Select Purge.
The Prime set screen is displayed.

3. Make sure the extension set is not connected to

the patient, as indicated on the screen, and press
OK to proceed.

4. Press and hold the key to prime.

You can monitor priming in progress on the
screen.
5. To end priming, release the key.
The prime volume is displayed.

6. Make sure there is no air in the extension set.

If necessary, press the bolus key again and
repeat the procedure until there is no air left in
the extension set.

INFORMATION
 Priming is only accessible prior to starting the infusion.
 The key is not active when the menu screen is displayed.
 During priming, the occlusion pressure level is set to its maximum
value 900 mmHg / 120 kPa / 17.4 PSI.
 Priming is limited to 5 mL maximum. Above 5 mL, you must release
and press the key again to restart priming.

Quick-Start
Quick-start is designed to decrease the delay of therapy when the pump’s prime
function is not used.
When quick-start is triggered, the infusion starts at a high flow rate (120 mL/h) until
the pump’s plunger driver starts pushing the syringe plunger head. The flow rate
then automatically switches to the programmed value.

51
At the beginning of an infusion, quick-start is triggered or not triggered in the
following situations:
Prime Function Configuration Quick-start Trigger Rule
Mandatory  Not triggered
Advised  Triggered if flow rate is equal or inferior to 50 mL/h and
automatic priming has not been done.
 Not triggered if automatic priming has been done by the
Not displayed user.

INFORMATION
Priming the line automatically ensures better pump performance than
using quick-start.

WARNING
If priming has not been performed, a quick start could result in an
undesired bolus in some cases. Always prefer the automatic prime
function for life-sustaining drugs.

7.10 Programming a PCA Loading Dose

After selecting the drug concentration, and maybe the patient characteristics, the
Loading dose PCA screen is displayed.

INFORMATION
 You can request a PCA loading dose at any time during PCA infusion
programming by pressing the bolus key .
1. Select yes to program a loading dose, or no if
you do not need it.
If you select no, the PCA delivery mode screen is
displayed. See Section 7.11.

2. Use the arrow keys to enter a value for the dose,

in this example in mg. The VTBI is automatically
adjusted based on the dose settings.
3. Press OK to confirm the dose.

4. Use the arrow keys to enter the duration of the

loading dose.
The flow rate is automatically adjusted based on
the duration setting.
5. Press OK to confirm the duration.

52
 6. See Section 7.18, page 58 for precautions to
take before starting the infusion.
7. Select start to administer the loading dose.
If you need to adjust the settings, press .

8. Monitor the progression of the loading dose on

the screen.
9. At the end of the infusion of the loading dose,
you can choose to administer another loading
dose.
If you choose no, the PCA delivery mode screen
is displayed. See Section 7.11.

7.11 Selecting the PCA Mode

After dismissing the loading dose screen, the PCA mode screen is displayed. You
can program a PCA infusion with the following infusion modes:
 Continuous rate only
 PCA bolus only
 PCA bolus + continuous
 PCA bolus + variable
INFORMATION
 Check that the patient handset is connected before starting an infusion
that authorizes PCA boluses.
1. Press the arrow keys to scroll to the delivery
mode that you want, and press OK.
For Continuous rate only, see Section 7.13,
page 54.
For all other modes, see Section 7.12.

7.12 Programming a PCA Bolus

After selecting a PCA mode that includes bolus, the PCA bolus screen is displayed.
1. Press the arrow keys to enter a value for the
dose, mL or mg, depending on the prescription
unit previously selected.
When entering a value for a dose, the
corresponding volume is automatically displayed.
2. Press OK to confirm the dose.

53
 3. Use the arrow keys to set the bolus lockout time.
4. Press OK to confirm the lockout time.
If the Continuous rate screen is displayed, see
Section 7.13. If the Cumulated limits screen is
displayed, see Section 7.16, page 56.

7.13 Programming a Continuous Rate

If you selected a PCA mode that includes a continuous rate, the Continuous rate
screen is displayed.
1. Use the arrow keys to enter a value for the rate,
in mL/h or mg/h depending on the prescription
unit previously selected.
2. Press OK to confirm the continuous rate.
The Cumulated limits screen is displayed. See
Section 7.16, page 56.

7.14 Programming a PCA Infusion with Variable Rates

If you selected the PCA bolus + variable mode, after programming the PCA
boluses, the date/time screen is displayed. It is important to check the current date
and time are correct before you program the start time for varying infusion rates.
While programming, the current date and time are shown at the bottom of the
screen.

1. Press OK to validate the current date and time,

or press to correct the information displayed.
When you press OK to confirm the last element
of the time display, the variable rates screen is
displayed.

2. Use the arrow keys to enter a value for the first

dose, in mL/h or mg/h depending on the
prescription unit previously selected.
3. Press OK to confirm the dose rate.
4. Set the start time, and press OK.

54
 5. Set the value and start time of the second and
third dose rate if required, and press OK to
confirm each value.
The Cumulated limits screen is displayed. See
Section 7.16.

7.15 Programming an Infusion Beyond Soft Limits

A drug that is part of a drug library in a custom profile can have predefined limits on
flow rate and dose settings. For information on the limits that can be defined, see
Section 4.4.2, page 28.
If you reach a limit when programming an infusion, the pump displays a message
at the top of the screen. You can override soft limits but not hard limits, as shown in
the examples below.
Overriding a soft limit
The procedure below shows an example of soft limit reached when programming a
PCA bolus, and how to acknowledge it.

1. Use the arrow keys to reduce the dose, or press

OK to confirm it.
If you attempt to increase the dose, the hard limit
alert is displayed.

2. If you press OK, an alert message is displayed

allowing you to cancel the dose, or to confirm it
again.
The next programming screen is displayed and
you can continue programming the infusion.

Acknowledging a hard limit

The figures below show an example of upper hard limit reached and of lower hard
limit reached when programming a PCA bolus.

The figure opposite shows the screen displayed

when you try to increment the value of Dose.
Press OK to acknowledge the hard limit.
The high dose alert is displayed as shown above.

55
 The figure opposite shows the screen displayed
when you try to reduce the value of Lockout time.
Press OK to acknowledge the hard limit.
The next programming screen is displayed and you
can continue programing the infusion.

7.16 Setting the Cumulated Limits

After setting the PCA mode and doses, the Cumulated Limit(s) screen is displayed
to allow you to set safety limits. For a specified time period, you must set a limit on
maximum dose, and you can set a limit on the maximum number of PCA boluses.

1. Use the arrow keys to select yes or no, for

setting a limit on the maximum number of
boluses that the patient can receive.
2. Press OK to confirm your choice and move the
cursor to the next field.

3. Use the arrow keys to set the time period for

assessing the cumulated limits.
By default, the time period is 24 hours.
4. Press OK to confirm the time period.

5. Use the arrow keys to set the maximum value for

the dose in mL or in mg for the specified time
period.
6. Press OK to confirm the value and move the
cursor to the next field.

7. Use the arrow keys to set the maximum number

of PCA boluses that the patient can self-
administer during the specified time period.
8. Press OK to confirm the number.
All the PCA settings you made are displayed for
review and validation. See Section 7.17.

INFORMATION
The Max Nb PCA boluses field is not displayed if the PCA mode is
Continuous only.

56
7.17 Reviewing the PCA Infusion Settings
After setting the parameters for PCA infusion, you must review and validate them.
1. Press OK to confirm the PCA mode, the bolus
dose, and the background rate if applicable.
To change a setting, press the cancel key
and see Section 7.20, page 62.

2. Press OK to confirm the lockout time and the

maximum limits, if applicable.
To change a setting, press the cancel key
and see Section 7.20, page 62.

3. Press OK to confirm the information displayed on

the screen, or press the cancel key to change
the settings.
When you press OK, the infusion start screen is
displayed .

4. Before you press start, see Section 7.18 for

precautions to take.
When you start the infusion, the keypad is
automatically locked (see Section 9.3 to unlock
the keypad).

INFORMATION
The estimated duration of the infusion is based on the assumption that the
patient gets a PCA bolus after each lockout period.

57
7.18 Starting a PCA Infusion
After reviewing the PCA settings, check the following before starting the infusion.
1. Check that there is no air in the syringe or in the extension set.
For information on priming the extension set, see Section 7.9, page 50.
2. Connect the extension set to the patient's access device.
3. Check the integrity of the delivery path.
4. If necessary, make sure the protective cover is closed and remove the key.
5. Press start to start the infusion.
If the protective cover is open or missing, you will be prompted to confirm start.
The keypad is automatically locked when you start the infusion.
6. If PCA boluses are allowed, give the handset to the patient, and explain how to
use the bolus button.
For information on using the patient handset, see Section 7.21.1, page 63.
WARNING
When connecting the extension set to the patient's access device, always
use an aseptic technique in accordance with your healthcare facility’s
policy.

WARNING
Before actually starting the infusion, you must close the protective cover
and remove the key to avoid tampering or drug theft.

7.19 Supervising PCA Therapy

To supervise PCA therapy, you can:
 Monitor a running infusion directly on the screen (see below).
 Press the key to view the total dose infused since the start of infusion.
 Display the history of PCA infusions for patient, see Section 7.19.2, page 61.
7.19.1 Monitoring the Running PCA Infusion
After starting a PCA infusion, you can monitor the infusion on the screen. Green
lights indicate the infusion has started.
Infusion started in PCA bolus only mode
When an infusion is started in PCA bolus only mode, BOLUS ONLY is displayed on
the screen. The green LED shows the infusion has started although the pump is not
currently infusing.

58
 Legend
1 PCA therapy indicator

1 2 21 Drug name and/or concentration

3 Bolus only infusion mode

3 4 41 PCA bolus indicator

5 6 53 Summary of PCA settings

Indication of PCA bolus available or
63 lockout
One green LED lit: infusion started
7 7 but not currently infusing
Figure 7.1: PCA infusion in bolus only mode (started but not currently infusing)
Infusion running in PCA bolus + continuous mode
When an infusion is started in PCA bolus + continuous mode, the green infusion
indicator lights flash regularly to indicate the pump is infusing. The flashing speed
reflects the flow rate.
Legend
1 PCA therapy indicator
1 2 Drug name and/or concentration
21
3 3 Dose rate and/or flow rate
4
41 PCA bolus indicator
5 6 53 Summary of PCA settings
Indication of PCA bolus available or
63 lockout
7 Green LEDs flashing regularly to
7 indicate infusion in progress
Figure 7.2: PCA infusion in progress in bolus + continuous mode - bolus available
INFORMATION
Display of infusion PCA bolus availability depends on the settings defined
for this drug (custom profile) or on the pump configuration (Basic Profile).

59
PCA Bolus in progress
When the patient requests a PCA bolus, and it is delivered, the screen displays a
progression bar, and a countdown of time and dose. The indicator lights flash fast.
Legend
1 Drug name and/or concentration
1 21 PCA bolus in progress
2
Dose countdown during bolus
3 3 infusion
4 41
Progress bar showing percentage
5 of bolus infused
Time countdown during bolus
53 infusion
Green LEDs flashing fast to indicate
7 7 bolus in progress

Figure 7.3: PCA bolus in progress

60
7.19.2 Displaying PCA History
PCA infusion data is saved on the pump for 24 hours. During PCA infusion, or after
it has ended, you can display information on the PCA treatment received by a
patient.

INFORMATION
PCA infusion data is not saved when the pump is turned off.

1. Press the PCA history key to display the

PCA infusion data.
The time shown corresponds to the duration
programmed for the cumulated limits. You can
see the total dose and number of PCA boluses
administered over this time.

2. Press enter to access the detailed PCA history.

A time scale since the beginning of treatment is
displayed above the PCA infusion data. The
screen also shows the number of clinician
boluses administered, if any, as well as the total
number of boluses requested.

3. Press the magnifying glass to zoom in on

a narrower time frame.
The PCA infusion data corresponding to the new
time frame is displayed.

4. Use the back and forward double arrow buttons

to navigate through the PCA data recorded since
the beginning of treatment.
5. Use the magnifying glass to zoom out of
the time frame observed.

6. Press the cancel key or the menu key on

the keypad twice to dismiss the PCA history.
INFORMATION
Dose or Total dose in the PCA history represents the addition of the
continuous rate, of clinician and PCA boluses, and of loading doses, if any,
over the period displayed.

61
7.20 Modifying a Running PCA Infusion
At any time during a PCA infusion, you can modify the infusion settings. You must
enter the passcode for PCA therapy if prompted.

1. Press Stop on the keypad to interrupt the

PCA treatment.
2. Press the left fast increment key to select the
summary of PCA settings (list icon) above it on
the screen.
The current PCA delivery mode is displayed.
3. Do you want to change the PCA delivery mode?
 No: select next.
The current PCA bolus settings are displayed.
See next step.
 Yes: press the edit icon .
See Section 7.11, page 53.
4. Do you want to change the PCA bolus settings?
 No: select next.
The current continuous rate settings are
displayed. See next step.
 Yes: press the edit icon .
See Section 7.12, page 53.
5. Do you want to change continuous rate settings?
 No: press next.
The current cumulated limits settings are
displayed. See next step.
 Yes: press the edit icon .
See Section 7.13, page 54.
6. Do you want to change the cumulated limits?
 No: select OK.
The settings review screen is displayed. See
next step.
 Yes: press the edit icon .
See Section 7.16, page 56.
7. Review and validate the new settings, as
explained in Section 7.17, page 57.
8. Press start to resume the infusion with the new
settings.

62
The message below is displayed if you attempt to change PCA infusion settings
without stopping the infusion in progress.

Figure 7.4: Alert message requiring to stop infusion

After 3 seconds, the message disappears.

7.21 Administering a Bolus

The patient and the clinician can administer a bolus.
7.21.1 Administering a PCA Bolus
The patient can self-administer a PCA bolus if allowed by the PCA infusion
programmed on the pump. The handset comes with a strap so that it can be
attached to the patient’s wrist, as shown.

BOLUS BOLUS

BOLUS BOLUS

You must explain to the patient how to use the handset.

BOLUS
BOLUS

63
1. Hold the device in the palm of your hand, with the bolus button facing up.
2. To trigger a bolus, press the bolus button on the handset.
The pump beeps and the blue LED above the bolus button flashes for a few
seconds (default behavior).
If a PCA bolus is not available due to the lockout period between two consecutive
boluses, or because the maximum number of boluses allowed has been reached,
on pressing the bolus button, the pump beeps and the LED on the patient handset
flashes but the pump does not deliver the bolus.
By default, the pump display shows when a PCA bolus is available. This feature can
be disabled in the pump configuration, as explained in Section 11.3, page 107.

Bolus available Bolus not available

7.21.2 Administering a Clinician Bolus

As the clinician, you can administer a bolus during the PCA infusion in progress. In
the example below, the patient cannot self-administer a bolus due to the lockout
period, but you can administer a clinician bolus.

1. Press the Bolus key on the keypad.

The screen displays the choice of a PCA bolus
or Clinician bolus.

2. Select the clinician bolus using the confirmation

key.
3. Enter the passcode for PCA therapy if prompted.

64
 4. Set the value of the dose that you want to
administer to the patient.
If you have already administered a PCA bolus,
the previous dose is displayed.
5. Press OK to confirm the dose.
See Section 7.22.4, page 67 if the dose to be
infused exceeds the maximum dose specified in
the cumulated limits.
6. Press start to administer the bolus, the edit key
to modify the dose, or exit to cancel the clinician
bolus.

7. Monitor the progress of the bolus on the screen.

7.21.3 Viewing the Availability of a PCA Bolus

During the lockout period, and if the Display PCA bolus feature has been enabled
in the pump options, you can see if a patient bolus is available or not.

PCA bolus availability disabled PCA bolus availability enabled

If a PCA bolus is not available, you can view the remaining time until it becomes
available again.

1. Press the Bolus key on the keypad.

The screen displays the choice of a Clinician
bolus or PCA bolus.

65
 2. Select PCA bolus using the confirmation key.
A message is displayed with the remaining
lockout time. After 10 seconds, the message
disappears and the monitoring screen is shown
again.

If the Display lockout time feature has also been enabled in the pump options, and
a PCA bolus is not available, the actual lockout time is shown directly at the bottom
of the monitoring screen.

7.22 Handling PCA Alarms and Alerts during Programming

This section shows the alerts and alarms that can be reported by the Agilia SP PCA
pump during infusion programming.

7.22.1 Low Remaining Volume

The messages below are displayed when you start the PCA infusion if the volume
remaining in the syringe is less than 10% of the syringe capacity.

Figure 7.5: Remaining volume too low message

Select OK in each screen to acknowledge the alert.

66
7.22.2 Low Remaining Bolus
The messages below are displayed when you start the PCA infusion if the volume
remaining in the syringe represents less than 5 PCA boluses.

Figure 7.6: Remaining number of boluses too low message

Select OK in each screen to acknowledge the alert.

7.22.3 Short Remaining Duration

The messages below are displayed when you start the PCA infusion if the volume
remaining in the syringe represents less than 30 minutes of infusion time.

Figure 7.7: Remaining duration too low message

Select OK in each screen to acknowledge the alert.

7.22.4 Administering a Clinician Bolus beyond Maximum Dose

When you program a clinician bolus, before you start the infusion, the pump adds
the value of the bolus to the cumulated dose already infused. If the result exceeds
the maximum dose authorized, the following alert message is displayed.

1. Select OK to acknoweldge the alert and continue

without modifying the dose, or select the pencil
icon to modify the dose.
When you select OK, the alert is displayed again.

2. To administer the bolus although the maximum

cumulated dose will be exceeded, press start.
To modify the value of the dose, press the edit
icon .
3. Monitor the progression of the bolus on the
screen.

67
At the end of the bolus, an information message is
displayed.

It is followed by a high-priority maximum dose alarm,

and the PCA infusion is stopped. See Table 14.6,
page 114.

68
8 Programming a General Infusion
The Agilia SP PCA syringe pump can be used for general infusions as well as for
PCA therapy.
This section presents the general workflow for programming an infusion, and the
procedures for general infusions with a flow rate or a dose rate.

8.1 Programming a General Infusion by Flow Rate

Basic Profile Custom profile Custom profile
Section 4.4.1, page 27 with a drug list (with a drug library)
Section 4.4.1, page 27 Section 4.4.1, page 27

Selecting a therapy
Section 7.3, page 46

General infusion

Programming mode: flow rate

Section 8.5, page 71

Selecting a syringe
Section 8.6, page 71

Selecting a drug
Section 8.7, page 71

Programming a flow rate

Section 8.11, page 74

Starting the Infusion

Section 8.13, page 75

69
8.2 Programming a General Infusion by Dose Rate
Basic Profile Custom profile Custom profile
Section , page 28 with a drug list (with a drug library)
Section , page 27 Section , page 27

Selecting a therapy
Section 8.4, page 71

Therapy: general infusion

Programming mode: dose rate

Section 8.5, page 71

Selecting a syringe
Section 8.6, page 71

Selecting a drug
Section 8.7, page 71

Selecting concentration
Section 8.8, page 71

Selecting the dose unit

Section 8.10.1, page 72

Patient characteristics (optional)

Section 8.9, page 72

Setting the value of the dose

Section 8.10.2, page 72

Programming a loading dose

Section 8.10.3, page 73

Starting the infusion

Step 8.13, page 75

70
8.3 Selecting a Profile
Profiles are available for selection if previously uploaded to the pump. See Section
7.2, page 46 for explanations on how to select a profile.

8.4 Selecting a Therapy

After selecting Basic Profile, the programming interface takes you to the Select
therapy screen where you must choose General Infusion. See Section 7.3,
page 46 for detailed explanations.
Note: By default, this choice is disabled in the pump configuration and this screen
is not displayed.

8.5 Selecting a Programming Mode (Flow Rate or Dose Rate)

After selecting General Infusion therapy, you are prompted to select the
Programming mode for the infusion, in volume (flow rate) or in mass (dose rate).
Note: This screen is not displayed if you previously selected a custom profile,
because the programming mode is pre-defined.
1. Use the arrow keys to select the programming
mode, and press OK to confirm.
The syringe selection screen is displayed.

8.6 Selecting a Syringe

After selecting the programming mode, the screen displays the syringe type
installed in the pump. You must make sure the display is correct, as explained in
Section 7.5, page 47.
WARNING
During programming and prior to starting an infusion, verify that the
syringe size and model on the syringe pump’s display screen match the
syringe size and model loaded onto the syringe pump.

8.7 Selecting a Drug

After you confirm the syringe type, the screen displays a drug selection menu. See
Section 7.6, page 48 for explanations on how to select a drug.
Note: This screen is not displayed if you previously selected the Basic Profile that
does not offer a pre-defined drug list.

8.8 Selecting Drug Concentration

If the programming mode you selected in step 8.5 is Dose rate, you must specify
the drug concentration. See Section 7.7, page 48 for detailed explanations.
If you selected Flow rate in step 8.5, go to Section 8.11, page 74.

71
8.9 Selecting the Patient’s Characteristics
After selecting a drug and a drug concentration, the Patient screen can be
displayed to allow you to specify the patient’s body weight or surface. See Section
7.8, page 50 for detailed explanations.
INFORMATION
 The weight entry screen is displayed only if the selected drug uses
weight for dose rate calculations.
 The body surface area entry screen is displayed only if the selected
drug uses body surface area for dose rate calculations.
 Custom profiles define a default weight or body surface area.
8.10 Programming an Infusion by Dose
When programming an infusion by dose, you will be prompted, as necessary, to:
 Select the dose rate and the value of the dose
 Program a loading dose, if required
8.10.1 Selecting the Dose Rate
After selecting the drug concentration, the Dose rate screen is displayed.
Note: This screen is not displayed if you previously selected a custom profile from
a drug library because the dose rate is pre-defined.
1. Press the arrow keys to select the dose rate.
2. Press OK to confirm.
The next screen displayed allows you to set the
dose to be infused. See Section 8.10.2.

8.10.2 Selecting the Value of the Dose

After selecting the dose rate, or after setting the patient characteristics, you must
set the value of the dose to be infused.
INFORMATION
At this stage in the workflow, instead of selecting the value of the dose as
explained in this section, you can select a volume limit or a dose/time
program as explained in Section 8.17, page 79.

DrugX Drug from a drug library

1. Press the arrow keys to program the dose rate value.
2. Press OK to confirm.
The Loading dose screen is displayed. See Section 8.10.3, page 73.
72
8.10.3 Programming a Loading Dose
After setting the value of the dose, you can program a loading dose.
At this stage in the infusion programming sequence, before infusing the loading
dose, you must prime the extension set. You can use the pump to prime the
extension set as explained in Section 7.9, page 50.
Note: In custom profiles, the loading dose feature can be deactivated. Therefore,
the loading dose screen is not always displayed.
1. On the loading dose screen, press Yes if you
want a loading dose.
If you press no, you can start the infusion as
explained in Section 8.13, page 75.

2. Select a mass unit for the loading dose, and

press OK to confirm.

3. Use the arrow keys to enter a value for the dose,

and press OK to confirm.
4. Use the arrow keys to enter the duration of the
loading dose, and press OK to confirm.
The VTBI and the flow rate are automatically
calculated based on dose and duration settings.

5. Before you press start to initiate the loading

dose, see Section 8.13, page 75 for precautions
to take.
If needed, press C or the cancel key to
change the loading dose settings before starting.

6. Monitor the progression of the loading dose

infusion on the screen.
Once the loading dose is finished, the pump
automatically starts the programmed infusion.

INFORMATION
The loading dose is only available with the first start of an infusion. If no is
pressed inadvertently, power the pump off and then on to access the
loading dose again.

73
Interrupting a Loading Dose

1. To pause the loading dose, press .

The screen displays Continue?
2. Press no or to stop the loading dose and
proceed to the programmed infusion.
Once you have stopped the loading dose, you
cannot restart it. Alternatively, press start to
continue the loading dose.

8.11 Programming an Infusion by Flow Rate

If the programming mode you selected in step 8.5 is Flow rate, the Flow rate screen
is displayed to allow you to set the value.
INFORMATION
At this stage in the worflow, instead of selecting the value of the flow rate
as explained in this section, you can select a volume limit or a volume/time
program as explained in Section 8.17, page 79.

1. Use the arrow keys to set the value of the flow

rate.
2. Before you press start, see Section 8.13,
page 75 for precautions to take.

8.12 Programming an Infusion Beyond Soft Limits

A drug that is part of a drug library can have predefined limits on flow rate and dose
settings. For information on the limits that can be defined, see Section 4.4.4,
page 29.
If you reach a limit when programming an infusion, the pump displays a message
at the top of the screen. You can override soft limits but not hard limits, as shown in
Section 7.15, page 55.

74
8.13 Starting an Infusion

Flow rate Dose

1. Check that there is no air in the syringe or in the extension set.

For information on priming the extension set, see Section 7.9, page 50.
2. Connect the syringe’s extension set to the patient's access device.
3. Check the integrity of the delivery path.
4. Check the infusion settings prior to starting the infusion.
5. Press start to start the infusion.
The keypad is automatically locked.
WARNING
 When connecting the syringe’s extension set to the patient's access
device, always use aseptic technique according to your healthcare
facility policy.
 During programming and prior to starting an infusion, verify that the
syringe size and model on the syringe pump’s display screen matches
the syringe size and model loaded onto the syringe pump.

WARNING
If the protective cover is necessary, before actually starting the infusion,
you must close it and remove the key.

8.14 Monitoring an Infusion

8.14.1 Monitoring an Infusion Programmed by Flow Rate
Legend
Drug name and/or concentration if
1 1 available
If present, lighthouse indicates
2 21 drug selected from drug library
4 Remaining infusion time in hours
3 3 and minutes, at the curent rate
5 Flow rate (displayed with largest
41 font size)
Syringe name / ward name
53 (configurable)

Figure 8.1: Infusion programmed by flow rate in progress

75
 INFORMATION
 To change the flow rate during infusion, see Section 8.15, page 76.
 Display of infusion remaining time depends on the predefined settings
for this drug.

8.14.2 Monitoring an Infusion Programmed by Dose

Legend
1 Drug name and/or concentration
1 Lighthouse indicates drug selected
21 from drug library
2 5 Patient characteristics
3
3 6 41
Syringe name / ward name
(configurable)
4 53
Flow rate (displayed with largest
font size)
6 Infusion flow rate

Figure 8.2: Infusion programmed by dose in progress

INFORMATION
 To change the dose during infusion, see Section 8.15, page 76.
 Display of patient body surface area or weight depends on the
predefined settings for this drug.

8.15 Adjusting the Infusion Rate (Rate Titration)

You can adjust the infusion rate (flow rate or dose rate) during the infusion.
Depending on your pump configuration, stopping the infusion may be required
before modifying the infusion rate.
1. If required, stop the infusion by pressing , as
explained in Section 9.1, page 82.

2. Press the arrow keys to modify the flow rate or

dose.
3. Press start to continue the infusion with the new
infusion rate.

76
8.16 Administering a Bolus
A bolus is an extra dose that a pump can deliver during an infusion. There are two
ways to deliver a bolus dose during a general infusion:
 Direct bolus, using the bolus key
 Programmed bolus, using the bolus key or the menu key
During bolus administration, the occlusion pressure level is set to its maximum
value: 900 mmHg / 120 kPa / 17.4 PSI.

INFORMATION
 The bolus volume is added to the Volume Infused (VI).
 The key is not active when the menu screen is displayed.

8.16.1 Direct Bolus

At any time during infusion, you can administer a bolus using the bolus key.
Note: This feature can be deactivated in Basic Profile (see the Technical manual)
and in custom profiles. Therefore, the Bolus screen is not displayed for all drugs.
1. During the infusion, press the bolus key .
2. Select Direct bolus on the screen to access the
bolus function.
The screen shows the infusion rate for the bolus.

3. Following the instructions on the screen, press

and hold the bolus key to administer a direct
bolus.
The bolus starts and the screen shows the
volume (or dose) infused.

4. While holding the bolus key, monitor the volume

(or dose) infused displayed on the screen.
5. Release the bolus key when you reach the
volume (or dose) desired.

The volume (or dose) infused is displayed for a few

seconds on the screen. The infusion resumes its
previous rate after the bolus is delivered.

77
8.16.2 Programmed Bolus
At any time during infusion, you can program a bolus in one of the following ways.
 Press , then Programmed bolus.
 Press , and select in the menu. Press enter to confirm.
Note: This feature can be deactivated in Basic Profile (see the Technical manual)
and in custom profiles. Therefore, the Programmed bolus screen is not displayed
for all drugs.
1. During the infusion, press the bolus key .
The bolus screen is displayed.
2. Select Programmed bolus on the screen to
access the programmed bolus function.
The Programmed bolus screen is displayed.

3. Use the arrow keys to set the volume or the dose

for the bolus, and press OK to confirm.
4. Use the arrow keys to set the duration of the
bolus, and press OK to confirm.
The flow rate is calculated automatically. The
programmed bolus start screen is displayed.
5. At this stage, you can:
 Press start to administer the bolus immediately.
 Press exit to save the settings without
administering the bolus.
 Press edit to change the bolus settings.

6. Monitor the progression of the bolus infusion on

the screen.
The infusion resumes its previous rate after the
bolus has been delivered.

INFORMATION
If you press the bolus key again, and select Programmed bolus, the
settings of the last bolus are displayed.
Interrupting a Programmed Bolus
1. Press to interrupt the bolus.
2. Answer the question: Continue?
 Press no or to stop the bolus and resume the
infusion.
 Press start to continue the programmed bolus.

78
8.17 Advanced Infusion Programming Modes
The Agilia SP PCA pump offers the following advanced programming modes:
 Volume/Time and Dose/Time
 Volume limit
Note: The availability of these infusion modes depends on the pump configuration
and the selected drug. They are not available for PCA therapy.
8.17.1 Volume/Time and Dose/Time
You can use this infusion mode to program a volume or dose to be infused (VTBI
or DTBI) over a programmed period of time. When the VTBI / DTBI is reached, an
alarm is triggered.
1. Press the menu key , then press the arrow
keys to select V/T (or D/T ).
2. Press enter.
The Volume/time (or Dose/time) screen is
displayed.

3. Press the arrow keys to set the volume or dose

to be infused (VTBI / DTBI), and press OK.
The infusion rate is automatically calculated.
4. Press the arrow keys to set the infusion time, and
press OK.
The infusion rate is automatically readjusted.
5. Press the arrow keys to configure the end of
infusion settings and press OK to confirm.
 Stop: The infusion stops when the VTBI is
completed.
 Keep Vein Open (KVO): After the VTBI is
completed, the infusion continues at a preset
flow rate to keep the access device open.
 Continuous: After the VTBI is completed, the
infusion continues at the programmed flow rate.
6. Press start to start the infusion.
If the loading dose screen is displayed, see
Section 8.10.3, page 73. The loading dose is
included in the volume or the dose that you
programmed.
When the infusion starts the remaining VTBI and
remaining time are displayed on the screen and
updated every minute.

79
8.17.2 Volume Limit
You can use this infusion mode to set a limit to the volume infused. When the limit
is reached, an alarm is triggered.

1. Press the menu key , then press the arrow

keys to select VL .
2. Press enter.
The Volume limit screen is displayed.

3. Press the arrow keys to set the volume to be

infused, and press OK.
The infusion rate is automatically calculated.

4. Press the arrow keys to configure the end of

infusion setting and press OK to confirm.
 Stop: The infusion stops when the VTBI is
completed.
 Keep Vein Open (KVO): After the VTBI is
completed, the infusion continues at a preset
flow rate to keep the access device open.
 Continuous: After the VTBI is completed, the
infusion continues at the programmed flow rate.
5. Press the arrow keys to set the value of the flow
rate or dose rate, and press OK.
6. Press start to start the infusion.
If the loading dose screen is displayed, see
Section 8.10.3, page 73. The loading dose is
included in the volume limit that you
programmed.
When the infusion starts, the volume infused
over the programmed volume limit is displayed.
INFORMATION
 If you program a volume limit that exceeds the actual volume in the
syringe, you must replace the syringe when it is empty, as explained in
Section 15.3.2, page 121.
 The volume already infused (VI) before accessing the volume limit
mode is taken into account.

80
8.18 Pre-programming the Pump
If necessary, you can program the pump before installing the syringe.
Note: You cannot pre-program the pump for PCA therapy. This programming mode
is available for general infusion only.
You can program the pump before installing the syringe:

1. Press to power on the pump.

Syringe installation !!! is displayed on top
of the pump screen.
2. Make sure the syringe barrel clasp is folded up
against the pump.
The prog symbol is displayed.
3. Program the infusion.
See Section 8.5, page 71.
4. Press exit to confirm.
5. When ready, install the syringe.
6. Confirm or correct the syringe type.
See Section 8.6, page 71.
7. Press start to start the infusion.

81
9 Ending an Infusion
This section explains how to stop an infusion in progress, how to complete an
infusion that runs until the end of the syringe, and how to power off the pump.

9.1 Stopping the Infusion in Progress

You can stop the infusion in progress at any time, for example to move the patient,
or to modify the infusion settings.

1. To interrupt the PCA treatment, press .

After 2 minutes, an alarm is generated as a
reminder that the infusion is stopped.
2. Perform the task that requires the infusion to be
stopped.
3. Press start to resume PCA treatment.

9.2 Completing an Infusion

Two alarms are generated as the running infusion gets close to the end:
 A near end of infusion alarm
 An end of infusion alarm
9.2.1 Near End of Infusion
Before the end of an infusion, a Near end of infusion alert is automatically
triggered. The following happens:
 An audible alarm is triggered.
 An alarm message appears on the pump screen.
 The infusion indicator lights flash yellow.
The near end of infusion alert is triggered when the two criteria below are reached
simultaneously:
 Time before end of infusion < specified threshold (value between 1 mn and
30 mn, by default, 5 mn), AND
 Remaining volume of fluid in syringe < 10% of syringe capacity
Near end of infusion alert settings are configurable in Basic Profile (see the
Technical manual) and in custom profiles.

82
Silencing the Near End of Infusion Alert

1. Press to silence the alarm.

2. If required, press OK to confirm the empty
syringe mode.

Empty syringe mode

Depending on the pump configuration, after the plunger reaches the tip of the
syringe, the following happens:
 Regular end of infusion: the infusion stops, the syringe is not completely
emptied.
 Empty syringe mode: the flow rate decreases when the plunger reaches the tip
of the syringe and the infusion continues until the syringe is completely
emptied.
The empty syringe mode is available only for infusions in Simple Rate mode.

9.2.2 End of Infusion

When the infusion is complete, an End of infusion alert is automatically triggered.
The following happens:
 An audible alarm is triggered.
 An alarm message appears on the pump screen.
 The infusion indicator lights flash red.
End of infusion settings are configurable in Basic Profile (see the Technical Manual)
and in custom profiles.
Silencing the Alarm

1. Press to silence the alarm.

2. Prepare a new syringe, and adjust the settings
for a new infusion.

83
9.3 Unlocking the Pump Keypad
There are two possible methods for unlocking the keypad of the Agilia SP PCA
syringe pump.
 By using the keypad lock status menu, as explained in Section 10.4, page 89.
 By opening the protective cover (if it is in use and if the auto-unlock on opening
cover has been enabled in the pump options), as explained below.
.

1. To interrupt the infusion in progresss, press .

2. Use the key to open the protective cover.
3. If necessary, press the alarm suppression key to
silence the cover open alarm.

4. Press and perform the task that requires the

keypad to be unlocked.

5. When you have finished, close the cover, remove

the key, and press start.

9.4 Powering off the Pump

If the keypad is locked, you must first unlock it, as explained in Section 10.4,
page 89.
To power off the pump, you must first unlock the keypad.

1. Press to stop the infusion.

2. Press and hold until the pump powers off.

84
10 Menus

10.1 Overview
10.1.1 Using the Keypad
Operation Key

Access menu or exit menu

Direct access to PCA history

Select option, increment or decrement value

Confirm choice displayed above key

Select  / Deselect (toggle)

10.1.2 Menu Description

The menu displayed depends on the pump configuration. For information on factory
configuration, refer to Appendix: Factory Configuration, page 159.
Stop
Menu Symbol Infusion Associated Procedure
Required

Profile Pro NO  Displaying active profile information, page 87

Pressure NO  Modifying the pressure limit, page 87

Keypad lock status NO  Locking / Unlocking the keypad, page 89

Keypad automatic lock NO

 Activating / Deactivating the keypad automatic lock,
page 91

Battery life NO  Viewing the battery life, page 92

Volume Infused  Viewing and clearing the volume or dose infused,

Dose Infused
mL? NO
page 92

Pause YES  Programming a pause, page 93

Programmed bolus NO  Programming a bolus, page 94

Clinician bolus YES  Programming a clinician bolus, page 94

PCA history NO  Viewing PCA history, page 100

PCA treatment NO  Viewing PCA treatment information, page 101

PCA event log NO  Viewing PCA event log, page 101

85
 Stop
Menu Symbol Infusion Associated Procedure
Required

Patient NO
 Changing a patient’s weight or body surface area,
page 95

Day/Night mode NO
 Switching between day mode and night mode,
page 96

Volume/Time V/T YES

 Programming a Volume/Time or Dose/Time infusion,
page 97
Dose/Time D/T YES

Volume limit VL YES  Programming a Volume Limit infusion, page 97

Alarm volume NO  Adjusting the alarm volume, page 98

Volume-Dose history YES  Viewing the infusion history, page 98

View flow rate history NO  Viewing flow rate history, page 99

View pressure history NO  Viewing pressure history, page 100

Syringe NO  Displaying on-pump syringe information, page 103.

View event log NO  Viewing the event log, page 102

Date / Time NO  Setting the date and time, page 103

Maintenance NO  Displaying maintenance information, page 104

Library information NO  Displaying drug library information, page 104

Clinical information NO
 Viewing time remaining before clinical information is
displayed, page 105

Data Set DS NO  Displaying active data set information, page 105

86
10.2 Profile
Symbol Pro
Procedure Displaying active profile information

INFORMATION
The Profile function is not available in PCA therapy.

You can display the active profile name as follows:

1. Press .

2. Press the arrow keys to select Pro .

3. Press enter.
The active profile information is displayed.

10.3 Pressure
Symbol

Procedure Modifying the pressure limit

The pump pressure limit is pre-defined in the pump options in one of the following
modes:
 3 levels (low , medium , high ).
The pressure limit is adjustable according to 3 pre-set values.
 Variable
The pressure limit is adjustable within a pre-defined range.
When the pressure limit is reached, an occlusion alarm is triggered. You must
silence the alarm, resolve the occlusion and start the infusion again.
To consult the pressure settings, see Section 16.9, page 127.

87
 WARNING
When addressing or clearing an occlusion:
 Ensure the fluid flow to the patient is OFF to prevent administering an
unintended bolus. An occlusion may pressurize the infusion tubing and
syringe, which can result in an unintended bolus of drug when the
occlusion is cleared. In order to prevent this additional bolus,
disconnect the tubing, or relieve the excess pressure through a
stopcock, if present. The health care professional should weigh the
relative risks of disconnection with the risks of an unintended bolus of
drug.
 Be aware that using larger size syringes on a high plunger force setting
may produce a larger post occlusion bolus due to excessive syringe
plunger head compliance.
You can modify the pressure limit as follows:

1. Press the menu key , then press the arrow

keys to select .
2. Press enter to access the pressure limit settings.

3. Press the arrow keys to increase or decrease the

pressure threshold.
4. Press OK to validate.

5. Press to enable or disable the DPS

function (optional).
6. Press OK to confirm.

INFORMATION
 The Dynamic Pressure System (DPS) informs the user of any sudden
rise or drop in pressure before the pressure limit is reached.
 If variable pressure mode is enabled, a pre alarm is triggered when the
pressure reaches 50 mmHg below maximum pressure (25 mmHg
when maximum pressure is 50 mmHg).
 If other pumps are used in parallel, it is recommended that their
pressure limits be adjusted to the same level.

88
 WARNING
To avoid the presence of air and to minimize the amount of time it takes
the pump to recognize an occlusion and generate an alarm while infusing
at low rates (less than 5 mL per hour, and especially less than 0.5 mL per
hour):
 Consider occlusion pressure threshold setting and adjust it, as
necessary. The lower the occlusion pressure threshold setting, the
shorter the occlusion detection time. However, when infusing viscous
or thick fluids (e.g., lipids), the occlusion pressure threshold setting
may need to be adjusted to reduce false alarms.
 Use the smallest compatible syringe size necessary to deliver the fluid
or medication. This minimizes the amount of friction and compliance
(i.e., stiffness) of the syringe plunger head. Because syringe pumps
infuse fluids by precisely controlling the plunger, smaller syringes
provide more precise fluid delivery than larger syringes.
 Use the prime feature on the pump when changing a syringe and/or
tubing.
 Use extension sets which have the smallest internal volume or
deadspace (e.g., use microbore tubing when infusing at low rates,
shorter length of tubing, etc.).

10.4 Keypad Lock Status

Symbol

Procedure Locking / Unlocking the keypad

You can use this feature to avoid inadvertent key presses.

The following features can be activated or deactivated in the pump options:
 Automatic lock: the keypad will lock automatically at infusion start, or after a
time-out.
 Unlock code: the user must enter a code to unlock the keypad.
Locking the Keypad
You can lock the keypad as follows:

1. Press .

2. Press the arrow keys to select .

3. Press enter.

89
 4. Press to lock the keypad.
The keypad is locked and the screen
displays .
5. Press OK to confirm.

Unlocking the Keypad

You can unlock the keypad as follows:

1. Press .

2. Press the arrow keys to select .

3. Press enter.

4. If a code is required, press the keys to enter the

unlock code.
The keypad is unlocked.

5. If no code is required, press .

The keypad is unlocked and the screen
displays .
6. Press OK to confirm.

INFORMATION
 The and keys remain functional when the keypad is locked.
 During keypad lock, the key is functional when an alarm occurs, or
at the end of infusion.
 The keypad locked status is memorized when the pump is powered off.
 In case of forgotten unlock code, contact your biomedical department.

90
10.5 Keypad Automatic Lock

Symbol

Procedure Activating / Deactivating the keypad automatic lock

You can use this feature to avoid inadvertent key presses. Depending on the device
configuration, the keypad automatic lock feature may or may not be available.
If keypad automatic lock is selected, the keypad will lock automatically at infusion
start or after a time-out.
Activating the Keypad Automatic Lock
You can activate the keypad automatic lock as follows:

1. Before starting the infusion, press .

2. Press the arrow keys to select .

3. Press enter.
4. Press the arrow keys to set the Automatic lock to
"yes".
5. Press OK.
The keypad will lock automatically at infusion
start. If the keypad is unlocked during the
infusion, it will lock again automatically after a
configured time-out.

Deactivating the Keypad Automatic Lock

To deactivate the keypad automatic lock:
1. Unlock the keypad: see Unlocking the Keypad, page 90.
2. Press .

3. Press the arrow keys to select .

4. Press enter.
5. Press the arrow keys to set the Automatic lock to "no".
6. Press OK.

91
10.6 Battery Life
Symbol

Procedure Viewing the battery life

You can view the battery life as follows:

1. Press .
2. Use the arrow keys to select .
The time remaining under current flow rate
conditions is displayed.

The bar graph shows a visual representation of battery life. The symbol displayed
shows the following:
 : The pump is plugged into the AC power supply.
 : The pump is operating on battery.

10.7 Volume Infused / Dose Infused

Symbol mL?
Procedure Viewing and clearing the volume or dose infused

You can view and clear the volume or dose infused as follows:

1. Press .

2. Press the arrow keys to select mL? .

The total volume, or total dose, infused includes
the programmed infusion, loading doses and
boluses. The length of time over which they were
infused is also displayed.
3. To clear the volume or dose infused, press enter.
4. Press OK to confirm.

INFORMATION
When the pump is powered off or a new drug is selected, the volume or
dose infused is cleared.

92
10.8 Pause
Symbol

Procedure Programming a pause

INFORMATION
The Pause function is not available in PCA therapy.

You can program a pause as follows:

1. Press to stop the infusion.

2. Press , then press the arrow keys to
select .
3. Press enter.

4. Press the arrow keys to program the pause

duration in hours and minutes.
5. Press the arrow keys to select "yes" or "no" to
activate the "Start infusion at pause end" feature.
6. Press OK to begin the programmed pause.
The display shows the pause in progress.
7. To restart the infusion before the end of the
pause period, press end and then start.

INFORMATION
If you do not activate the "Start infusion at pause end" option, an audible
alarm is generated at the end of the pause. The infusion must be started
manually to continue the infusion.

93
10.9 Programmed Bolus
Symbol

Procedure Programming a bolus

INFORMATION
The programmed bolus function is not available in PCA therapy.

1. Press , then press the arrow keys to

select .
2. To program a bolus, see Section 8.16.2, page 78.

10.10Clinician Bolus
Symbol

Procedure Programming a clinician bolus

You can program and start a clinician bolus as follows.

1. Press , then press the arrow keys to

select .
The screen displays the default settings for a
clinician bolus, or the values programmed in the
last clinician bolus administered.

2. To modify the settings, unlock the keypad, as

explained in Section 10.4.
The keypad will lock automatically again within
15 seconds.
3. Display the Clinician bolus screen again.
The enter button is now available.
4. Press enter.
5. Set the value of the dose.
The volume is automatically adjusted.
6. Press OK to confirm the settings.
The clinician bolus start screen is displayed.

94
 7. Choose one of the options:
- Press start to start infusion of the clinician
bolus
- Press exit to save the settings without
administering the bolus
- Press C to modify the settings.

10.11Patient
Symbol

Procedure Changing a patient’s weight or body surface area

INFORMATION
 If the selected dose rate unit is weight-based (kg), the screen displays
the patient’s weight.
 If the selected dose rate unit is body surface area-based (m²), the
screen displays the patient’s body surface area.
You can change the patient’s weight or body surface area as follows:

1. Press , then press the arrow keys to

select .
2. Press enter.
3. Press OK to change the patient’s weight or body
surface area.
4. Press OK to confirm the infusion settings.

95
10.12Day/Night Mode
Symbol

Procedure Switching between day mode and night mode

This function switches between day mode and night mode .

The default night mode settings are as follows:
 The key-press beep is silenced.
 Infusion indicators and screen brightness are dimmed.
Depending on your pump configuration, the switch between day and night mode
may be managed either through this menu (manual mode), or according to pre-
defined settings (auto mode). For more information, refer to the technical manual.
Switching from Day Mode to Night Mode

1. Press .
2. Press the arrow keys to select .
3. Press enter.

4. Press to activate night mode.

The screen displays .
5. Press OK to confirm.

Switching from Night Mode to Day Mode

1. Press .
2. Press the arrow keys to select .
3. Press enter.

4. Press to activate day mode.

The screen displays .
5. Press OK to confirm.

96
10.13Volume/Time and Dose/Time
V/T
Symbols
D/T
Procedure Programming a Volume/Time or Dose/Time infusion

INFORMATION
The V/T and D/T functions are not available in PCA therapy.

1. Press .

2. Press the arrow keys to select V/T (or D/T ).

3. Press enter.

4. To program a Volume/Time or Dose/Time

infusion, see Section 8.17.1, page 79.

10.14Volume Limit
Symbol VL
Procedure Programming a Volume Limit infusion

INFORMATION
The VL function is not available in PCA therapy.

1. Press , then press the arrow keys to

select VL .
2. Press enter.
3. To program a volume limit infusion, see Section
8.17.2, page 80.

97
10.15Alarm Volume
Symbol

Procedure Adjusting the alarm volume

You can adjust the alarm volume as follows:

1. Press , then press the arrow keys to

select .
2. Press enter.
3. Press the arrow keys to select the alarm volume.
The pump emits an alarm at the selected volume
level.
4. Press OK.

10.16Volume-Dose History
Symbol

Procedure Viewing the infusion history

This function allows the user to view the infusion history on the pump.
You can view the infusion history as follows:

1. Press , then press the arrow keys to

select .
2. Press enter.

3. Press the arrow keys to select an infusion.

The selected infusion’s details are displayed:
- Drug name and drug concentration
- Volume or dose infused
- Infusion total duration
- Infusion date & time
4. Press exit to return to the menu.

98
10.17View Flow Rate History
Symbol

Procedure Viewing flow rate history

This function allows the user to check the current infusion’s history information in
order to verify the dose administered.
You can view flow rate history as follows:

1. Press , then press the arrow keys to

select .
2. Press enter.
The following information is displayed:
- An event marker (cursor)
- The event details (time and flow rate)
- The measured flow rate (solid line)
3. Press the and buttons to browse the
events.
4. Press to view information about the
selected event.

INFORMATION
 The history is not refreshed while the history screen is displayed. To
refresh the history data, exit and select the history again.
 Flow rate history is not stored after powering off.

99
10.18View Pressure History
Symbol

Procedure Viewing pressure history

This function allows the user to check the current infusion’s history information in
order to verify changes in pressure. You can view pressure history as follows:
1. Press , then the arrow keys to select .
2. Press enter.
The following information is displayed:
- An event marker (cursor)
- The event details (time and pressure limit)
- The pressure limit (dotted line)
- The measured pressure (solid line)
3. Press the and buttons to browse the
events.
4. Press to view information about the
selected event.

INFORMATION
 The history is not refreshed while the history screen is displayed. To
refresh the history data, exit and select the history again.
 Pressure history is not stored after powering off.

10.19View PCA History

Symbol

Procedure Viewing PCA history

You can view the PCA infusion history as follows:

1. Press , then the arrow keys to select .
The data for the time period specified in the
cumulated limits is displayed.
2. Press enter for details on treatment in progress.
The time scale since beginning of treatment is
displayed above the PCA infusion data.
3. Use the arrow buttons or the zoom in and zoom
out buttons to display previous time periods, or a
different length of time, as explained in Section
7.19.2, page 61.

100
10.20View PCA Treatment Information
Symbol

Procedure Viewing PCA treatment information

You can view information on the PCA treatment in progress as follows:

1. Press , then press the arrow keys to
select .
Summary information on the PCA treatment
administered is displayed: total dose infused,
number of PCA boluses and clinician boluses,
time since the beginning of treatment.
2. If you want to reset the count to zero on these
indicators, press the confirm key once to
highlight the CLEAR option, then press the
confirm key again to validate.

INFORMATION
The PCA history and PCA event log keep the information that is erased
from the PCA treatment screen. The PCA treatment reset is an event that
is shown in the event log.

10.21View PCA Event Log

Symbol

Procedure Viewing PCA event log

The PCA event log shows all the actions related to the PCA therapy in progress. It
is a subset of the pump event log. It can store up to 1500 events. When it is full,
older events are overwritten. Events are stored in the log even after the pump is
powered off and on again.
Note: When the AC power is disconnected for a period of time, or when the
batteries are not operating, the log file is kept in a non-volatile memory for
approximately 10 years.
You can view the PCA event log as follows:
1. Press , then the arrow keys to select .
A list of events is displayed.
2. Press enter.
The first event in the list is highlighted.

101
 3. Press the arrow keys to scroll through the list and
to select an event.
4. Press enter.
Details of the selected event are displayed.

5. Press exit to return to the event list. Press

or twice to return to the infusion screen.

10.22View Event Log

Symbol

Procedure Viewing the event log

The event log displays details of the last events that occurred on the pump. The log
can store up to 1500 events. When it is full, older events are overwritten. Events are
stored in the log even after the pump is powered off and on again.
Note: When the AC power is disconnected for a period of time, or when the
batteries are not operating, the log file is kept in a non-volatile memory for
approximately 10 years.
You can view the event log as follows:
1. Press , then press the arrow keys to
select .
2. Press enter.

3. Press the arrow keys to select the desired event.

4. Press enter.
The details of the event are displayed.

5. Press exit to return to the previous screen.

102
10.23Syringe
Symbol

Procedure Displaying on-pump syringe information

You can display on-pump syringe information as follows:

1. Press , then press the arrow keys to

select .
2. Press enter.
The following information is displayed:
- Syringe capacity
- Syringe brand / name

10.24Date / Time
Symbol

Procedure Setting the date and time

INFORMATION
In PCA therapy, the Date/Time function is disabled during infusion to
avoid affecting time based safety limits.
You can set the date and time as follows:

1. Press , then press the arrow keys to

select .
2. Press enter.
3. Press the arrow keys to set the day, month, year,
hours, and minutes.
4. Press OK to confirm each setting.

103
10.25Maintenance
Symbol

Procedure Displaying maintenance information

You can display maintenance information as follows:

1. Press , then press the arrow keys to

select .
2. Press enter.
3. Press the arrow keys to scroll through the
maintenance information.
- Pump serial number
- Next maintenance date (dd/mm/yyyy)
- Pump model
- Software version
- Total operating time since last maintenance

10.26Library Information
Symbol

Procedure Displaying drug library information

You can display drug library information as follows:

1. Press , then press the arrow keys to

select .
The number of drugs contained in the
drug library is displayed.
2. Press enter.
All the drugs in the drug library are listed.
3. Press the arrow keys to select a drug.
4. Press to view information on the selected
drug.

104
10.27Clinical Information
Symbol

Procedure Viewing time remaining before clinical information is displayed

For drugs selected from a custom profile, clinical information messages can be
displayed.
You can view the time remaining before clinical information is displayed, as follows:

1. Press , then press the arrow keys to

select .
The screen shows the remaining time before
clinical information is displayed.
2. Press enter.
The clinical information message is displayed.

10.28Data Set
Symbol DS
Procedure Displaying active data set information

You can display active data set information as follows:

1. Press , then press the arrow keys to

select DS .
2. Press enter.
The active data set information is displayed.

105
11 Advanced Pump Configuration
This section describes the options available to configure the pump’s behavior and
the menus displayed.

11.1 Accessing the Pump Configuration Options

Display the pump configuration options as follows:

1. Starting with the pump off, simultaneously

press + .
The Options screen is displayed. See Section
11.3 for details on the Pump settings options.
For information on other options, refer to the
technical manual.

Using the Keypad

Operation Key

Options access +

Option selection

Confirm (corresponds to enter on the screen)

Select  / Deselect 

Selected current values are stored when the device is powered off after programming.
To display the user menus, after programming, power off then power on again.

11.2 Option Groups

Four different option groups are available on the pump. This manual describes the
"Pump Settings" group.
Option Access code? Description location

Pump Settings Optional Section 11.3, page 107

Basic Profile Configuration Yes Technical Manual

Profile Yes Technical Manual

Maintenance Yes Technical Manual

INFORMATION
If the wrong access code is entered, error is displayed.

106
11.3 Pump Settings
You can use the functions listed below to customize your Agilia SP PCA pump.

Default
Function Choice
pump setting
[User 1]:
Screen options  Enable/Disable framing of editable values Enabled

[User 2]:
 Maintenance: display or hide maintenance Hide
Menu items
 Date / Time: display or hide date/time menu Hide

[User 3]:  Adjustment of screen contrast using the fast

Medium level
Contrast increment and decrement keys

[User 7]:  Date selection: dd/mm/yyyy Production plant date

Date/Time  Time selection: __ h __ and time

[User 8]: Official language of the

Language
 A scrolling list with all available languages target country
[User 14]:
 Enable/Disable the Wi-Fi module Enabled
Wi-Fi module
[Par 5]:  Enable/Disable selected syringe confirmation
Enabled
Syringe selection screen
[Par 6]:  Checkbox list with the names of available Specific to product code
Syringes syringes, and other syringes sizes
[Par 13]:  Enable/Disable "AC power disconnection"
AC power message and "Device operating on battery" Enabled
disconnection alert message at power on
[Par 28]:
Automatic power on
 Enable/Disable automatic power on with Enabled
disengagement
with disengagement
 Enable/Disable removal of trailing 0 (display of
Enabled
the decimal "0" after a dose value)
[Par 35]:
Dose display format  Enable/Disable removal of trailing 0 during
programming (display of the decimal "0" after Disabled
a dose value)
[Par 37]:  Enable/Disable preventive silence for alarm Enabled
Alarm system system
[Par 38]:  Set or disable keypad unlock code (4-digit). 1234 (Enabled)
Keypad unlock code Disable value: 0000

107
12 Data Communication

12.1 Overview
Cable Communication Wi-Fi Communication
Communication between a hospital information
Connection of 1 pump to a PC for:
system server and pumps for:
 Data set upload
 Data set upload
 Maintenance  Pump history retrieval

INFORMATION
 Ensure that all hospital information systems have been approved by
Fresenius Kabi. For more information, contact your technical services
representative.
 Before connecting the pump to a hospital information system, ask your
IT or biomedical department to configure the device.

12.2 Communication via Agilia Cables

12.2.1 Data Communication Cables
INFORMATION
 Only use recommended Agilia cables.
 All connections and disconnections must be performed by qualified
and appropriately trained staff.
 All IT devices (including computers, hubs and switches) inside the
patient area (< 1.5 m) must comply with IEC/EN 60601-1 (leakage
current).
 IT devices connected outside the patient area (> 1.5 m) must be at
least IEC/EN 60950 compliant.

12.2.2 Using the Communication Port

1. Remove the protective cap from the pump’s
RS232 communication port.

2. Connect the cable to the RS232 communication

port by turning the cable wheel.

INFORMATION
Do not disconnect communication cables while data is being transferred.

108
12.3 Communication via Wi-Fi
The Wi-Fi option allows the pump to connect to a hospital information system
without cables.
To know if your pump is equipped with a Wi-Fi module, check for the presence of
the Wi-Fi logo on the pump keypad.

Wi-Fi pump Non Wi-Fi pump

To activate or deactivate the Wi-Fi module, see Section 11.3, page 107.
For more information on the Wi-Fi module, refer to the technical manual.

INFORMATION
Wi-Fi pumps can be configured with Wi-Fi module enabled or disabled.

12.4 Data Set Upload

A new data set may be uploaded to the pump while it is infusing. The new data set
will be installed at the next pump start-up.
When a new data set has been uploaded since the last start-up of the pump, the
symbol is displayed on the screen.

1. Power on the pump.

2. Press OK to acknowledge.
The data set information is displayed.

3. Press OK to acknowledge this information, or C

to return to the previous screen.
The data set is installed in the pump.

INFORMATION
It is the hospital's responsibility to define a data set and upload it to the
device.

109
13 User Test
The following protocol provides a quick integrity check guide to ensure that the
pump and patient handset are functional. Perform this user test before each use of
the pump and patient handset.
1. Check the external appearance of the pump including the protective cover for
the absence of cracks or other visible damage.
2. Check the patient handset including the cable gland and cable connector for
the absence of cracks or other visible damage.
3. Check that the locks on the protective cover and on the rotating pole clamp are
functional.
4. Check for the absence of visible damage on the power cord inlet and the power
cord.
5. When used on a pole or a rail, check that the pump is securely attached.
6. Connect the pump to the AC power supply, and check that the power indicator
lights up and a beep is emitted.
7. Power on the pump, and wait for the auto-test to complete. Check the display
and light indicators.
8. Press any key and listen for a key beep (if key beep is activated).
9. Connect the patient handset and check that the LED above the bolus button
lights up.
10.Before programming an infusion, press the bolus button on the patient handset
and listen for a beep.

INFORMATION
If any one of the above tests is not satisfactory, do not use the pump or
handset.

110
14 Alarms and Safety Features

14.1 Introduction
Agilia SP PCA has a continuous monitoring system that begins when the pump is
started.
When an alarm is triggered, a message is displayed on the pump screen. We
recommend that the user stand in front of the pump to read the message before
acknowledgment.

WARNING
Audible alarm signals from medical devices may be masked by
environmental noise. Make sure to set the alarm volume high enough so
that you can hear the alarm signal above environmental noise.

14.2 Alarm Descriptions

There are several levels of alarm priorities:
 High-priority alarms
 Medium-priority alarms
 Low-priority alarms
 Information signals

Required
Alarm Priority operator Description
response
 The infusion stops.
Immediate
 The infusion indicator lights flash red.
High (!!!)
response
 The pump emits audible alarm signals.
 An alarm description is displayed on the pump screen.
 The key silences the alarm (for two minutes).
Prompt  The infusion continues.
Medium (!!)
response  The infusion indicator lights flash yellow.
 The pump emits audible alarm signals.
Low (!) Awareness  The key silences the alarm (for no time limit).
 The infusion continues.
Information signals Awareness  An information message is displayed on the pump
screen.

111
14.3 General Remarks
 When two alarms occur at the same time, the higher priority alarm is displayed.
 When two alarms with the same priority level are triggered at the same time,
the pump software assigns them a priority.
 When the cause of a high-priority alarm has been fixed, the red indicators
switch off. However, the message remains displayed at the top of the screen as
a reminder of the cause of the alarm.
 The device guarantees the triggering of high-level priority alarms in every use
condition.
 A maximum of 1 mL may be infused due to a single fault condition.
 For all alarms (except occlusion alarms), the amount of time between the alarm
condition and the alarm generation is less than 5 seconds.
 If the AC power is disconnected and if the battery is discharged, the alarms
settings are not modified and are stored indefinitely.

14.4 List of Alarms

Table 14.1: Syringe Alarms
Stops
Message Priority Problem / Resolution
Infusion?
The syringe is not installed correctly (plunger
Syringe driver, syringe barrel clasp or flange
installation !!!
High (!!!) Yes detection).
 Check the syringe installation.
The plunger head is missing or incorrectly
Plunger head inserted.
alarm !!!
High (!!!) Yes
 Check the syringe installation.
Disengagement Disengaged mechanism.
High (!!!) Yes
mechanism !!!  Check the syringe installation.
Preventive auto-test on potential failure of
Remove completely plunger head.
syringe !
Low (!) No
 Remove and reinstall the syringe.

Table 14.2: Protective Cover Alarms

Stops
Message Priority Problem / Resolution
Infusion?
In PCA therapy only, if the protective cover is
mandatory, message displayed if it is not
Cover missing !!! High (!!!) Yes installed.
 Install the cover or confirm start of infusion
without the cover.

112
 Stops
Message Priority Problem / Resolution
Infusion?
If the protective cover is mandatory, message
displayed if it is left open.
Cover opened !!! High (!!!) Yes
 Close the cover or confirm start of infusion
without the cover.
Cover is installed on the pump while an
infusion is in progress or stopped.
Cover installed !! Medium (!!) No
 Remove the cover from the pump, or close
it.
In general infusion, the protective cover is
Cover opened !! Medium (!!) No opened during infusion.
 Silence the alarm and close the cover.
If the protective cover is not mandatory,
Information message displayed if it is left open.
Cover opened No
signal  Remove cover or press OK to
acknowledge cover is open
If the protective cover is not mandatory,
Cover opened message displayed if it is left open, and
Information acknowledged.
Lock the cover or No
confirm start signal
 Close the cover or confirm start of infusion
without the cover.
If the protective cover is not mandatory,
Cover installed Information message displayed if it is installed during
Close or remove the No infusion.
cover signal
 Close the cover.

Table 14.3: Patient Handset Alarms

Stops
Message Priority Problem / Resolution
Infusion?

Patient handset not The patient handset is missing or not

plugged in the Medium (!!) No connected although the handset is mandatory.
pump!!
 Connect the patient handset to the pump.

Table 14.4: Volume Limit Alarms

Stops
Message Priority Problem / Resolution
Infusion?
End of volume
limit !!!
High (!!!) Yes The volume limit is reached.

The time remaining is less than the defined

time duration (adjustable between 1 and
Near end of volume
limit !!
Medium (!!) No 30 minutes), and the remaining VTBI until the
volume limit has dropped to less than 10% of
the syringe capacity.

113
 Stops
Message Priority Problem / Resolution
Infusion?
The volume limit is reached and the end of
End of volume
limit !
Low (!) No infusion setting is set as "KVO" or
"continuous".

Table 14.5: Volume/Time Alarms

Stops
Message Priority Problem / Resolution
Infusion?
End of
volume/time !!!
High (!!!) Yes The VTBI is completed.

End of dose/time !!! High (!!!) Yes The VTBI is completed.

The time remaining is less than the defined
time duration (adjustable between 1 and
Near end of
volume/time !!
Medium (!!) No 30 minutes), and the remaining VTBI has
dropped to less than 10 % of the syringe
capacity.
The time remaining is less than the defined
time duration (adjustable between 1 and
Near end of
dose/time !!
Medium (!!) No 30 minutes), and the remaining VTBI has
dropped to less than 10 % of the syringe
capacity.
The VTBI is completed and the end of infusion
End of volume/time ! Low (!) No
setting is set as "KVO" or "continuous".
The VTBI is completed and the end of infusion
End of dose/time ! Low (!) No
setting is set as "KVO" or "continuous".

Table 14.6: Infusion Alarms

Stops
Message Priority Problem / Resolution
Infusion?
End of infusion !!! High (!!!) Yes The infusion is completed (simple rate).
In PCA therapy, the maximum dose specified
in the cumulated limits is reached or, in the
case of a clinician bolus, exceeded.
Max cumulated  Wait until the time you can restart the
High (!!!) Yes
dose !!! infusion.
 Or, modify the infusion settings to increase
the cumulated dose limit, and restart the
infusion.

114
 Stops
Message Priority Problem / Resolution
Infusion?
In PCA therapy, the maximum number of PCA
boluses specified has been infused.
 Wait until the time a PCA bolus becomes
Maximum Nb PCA
boluses!!
Medium (!!) No avalaible again.
 Or, modify the infusion settings to increase
the cumulated limit on the number of
boluses, and restart the infusion.
In PCA therapy, the maximum dose specified
in the cumulated limits is nearly reached.
Maximum cumulated  Wait until the time a PCA bolus becomes
dose nearly Medium (!!) No avalaible again.
reached !!
 Or, modify the infusion settings to increase
the cumulated dose limit to allow more
PCA boluses, and restart the infusion.
The time remaining is less than the defined
time duration (adjustable between 1 and
Near end of
infusion !!
Medium (!!) No 30 minutes), and the remaining volume of fluid
in the syringe has dropped to less than 10 %
of the syringe capacity.
The flow rate (or dose) has been modified
using the keys, but has not been confirmed.
Check settings !! Medium (!!) No
 Check the flow rate (or dose) and press OK
to confirm.
A value must be entered.
Waiting settings !! Medium (!!) No
 Enter a value and press OK to confirm.
The infusion settings have been entered, but
have not been confirmed with start.
Waiting start !! Medium (!!) No
 Check the infusion settings, and
press start to start the infusion.
Displayed after administration of a clinician
Clinician bolus bolus in excess of the maximum dose
Low (!) Yes
ended! specified in the cumulated limits. Alternates
with the maximum dose high priority alarm
Information The upper soft limit is exceeded, according to
Upper soft max No
signal the drug settings defined in the drug library.
Information The lower soft limit is exceeded, according to
Lower soft min No
signal the drug settings defined in the drug library.
Information
Reached hard limit No The upper or lower hard limit is reached.
signal

115
Table 14.7: Pressure Alarms
Stops
Message Priority Problem / Resolution
Infusion?
The pressure in the infusion line has reached
the threshold level.

Occlusion alarm !!! High (!!!) Yes  Check whether the infusion line is
occluded. If necessary, readjust the
pressure threshold. See Section 10.3,
page 87.
In-line pressure has reached the following
value:
 25 mmHg / 2.5 kPa / 0.5 PSI below the
programmed threshold (from 50 to
Occlusion
Medium (!!) No 75 mmHg).
pre alarm !!  50 mmHg / 5 kPa / 1 PSI below the
programmed threshold (over 100 mmHg).
 Check the infusion line.
 Set the correct pressure threshold.
The pressure is increasing in the infusion line.
Pressure increase ! Low (!) No
 Check for occlusions in the infusion line.
The pressure is decreasing in the infusion line.

Drop in pressure ! Low (!) No  Check the downstream Luer lock

connection and the integrity of the entire
line.

Table 14.8: Battery Alarms

Stops
Message Priority Problem / Resolution
Infusion?
The battery is discharged.
 The pump will power OFF automatically
Battery alarm !!! High (!!!) Yes within 5 minutes.
 Connect the pump to a power supply
immediately.
Very low battery.
Very low battery !!! High (!!!) Yes  Connect the pump to a power supply and
allow time to charge.
Low battery.
Battery pre alarm !! Medium (!!) No
 Connect the pump to a power supply.
If the pump is not used during an extended
Low (!) No period, connect to a power supply and wait
until the battery is charged.

116
Table 14.9: Power Alarms
Stops
Message Priority Problem / Resolution
Infusion?
The power supply is inconsistent.
AC power failure ! Low (!) No
 Contact your technical support.
The pump is disconnected from the AC power.
A single beep is emitted.
 Press to acknowledge.
Information
Power disconnection
signal
No  Check that the battery life is sufficient for
the expected infusion duration.
 If the disconnection was unintentional,
check the power connection.

Table 14.10: Keypad Alarms

Stops
Message Priority Problem / Resolution
Infusion?
Information The keypad is locked.
Keypad lock status No
signal  Unlock the keypad.
Keypad locked The keypad is locked and the syringe barrel
Information clasp was opened and closed.
Unlock keypad to No
signal
continue  Unlock the keypad.

Table 14.11: Technical Error Alarms

Stops
Message Priority Problem / Resolution
Infusion?
Technical alarm.
Erxx(yyyy) !!! High (!!!) Yes  Contact your qualified technician or your
Fresenius Kabi sales representative.
High internal Temperature increase.
Low (!) No
temperature !  Check device environment.
The pump is mounted on a Link+ Agilia rack
Alarm reporting not that has not been upgraded.
available on the Low (!) No
Link !  Contact your qualified technician or your
Fresenius Kabi sales representative.
In the case of a system malfunction, the alarm sounds and an error message
Erxx(yyyy) !!! is displayed.
1. Record the error message Erxx(yyyy) !!!.
2. Disconnect the pump from the power supply.
3. Reset the device by pressing the key for 10-15 seconds, and release it
when the device powers off.

117
 WARNING
If the alarms persist when the pump is powered on again, do not use the
device on a patient, and contact qualified biomedical engineering staff in
your healthcare facility, or your Fresenius Kabi sales representative.

Table 14.12: Audio-only Information Signals

Stops
Type Comment Activation
Infusion?
Beep until key is
Power on or off No Beep starts when action is not allowed
released
End of loading dose 3 beeps No At the end of the loading dose
End of programmed
3 beeps No At the end of a programmed bolus
bolus
Start infusion at the end At the end of a pause, when the infusion
3 beeps N/A
of pause automatically starts
End of pause 4 beeps N/A At the end of pause - repeated
AC power connection 1 beep No When power is connected
Forbidden key 1 beep No Repeated until key is released
Key beep 1 beep No For each key pressed
Non validation beep 1 beep No For each key pressed
Manual bolus 1 beep No Repeated for each mL infused
Syringe prime 1 beep N/A When purge reached end after 5ml
Patient handset button
1 beep No Repeated until key is released
continuously pressed
Patient handset button is pressed and
PCA bolus accepted 1 specific beep No
PCA bolus is available
Patient handset button is pressed and
PCA bolus refused 1 specific beep No
PCA bolus is not available.

118
15 Syringes

15.1 Syringe List

INFORMATION
 The pump offers a maximum of 100 syringes of different types, brands
and sizes. For a list of compatible syringes, and for ordering
information, refer to the System Components booklet.
 The list of available syringes on your pump is accessible from the pump
options.
 For general information on syringes (such as expiration date, storage,
sterility), refer to the syringe manufacturer’s instructions.

WARNING
 Fresenius Kabi cannot accept responsibility for any flow rate errors that
are due to changes to syringe specifications introduced by the
manufacturer.
 Ensure syringe sizes and models are compatible with the syringe
pump, refer to the System Components booklet. Use of incompatible
syringes can cause injury to the patient and improper pump operation
resulting in inaccurate fluid delivery, insufficient occlusion sensing, and
other potential problems.

15.2 Preparing a Syringe

1. Prepare the fluid to be infused according to your
healthcare facility’s protocol.
2. Select a syringe.
3. Check the syringe and access device integrity.
4. Connect the extension set to the syringe
according to local practices.
5. If necessary, fill the syringe and check that it is
watertight.

6. Manually prime the extension set according to

your healthcare facility’s protocol.
7. Confirm that there is no air in the syringe or in the
extension set.

119
 INFORMATION
 The fluid in the syringe and the syringe must be within normal operating
temperature conditions: +18 °/+30 °C.
 It is recommended to prime the set immediately before starting the
infusion.
 Do not use in conjunction with positive pressure infusion devices that
could generate back pressure higher than 2000 hPa (1500 mmHg):
doing so will damage the administration set and the pump.
 Some extension sets may have components such as a filter that
require special instructions.
 Certain drugs may require specific extension sets.
 Connect the infusion line in accordance with procedures in your
healthcare facility using good medical practices. It is recommended to
use a Luer lock system to reduce the risk of disconnection, leakage,
air-in-line, or contamination.
 Manually prime the syringe and extension set to remove all air, before
connecting to the pump.

Precautions for the use of extension sets

 Use extension sets which have the smallest internal volume or “deadspace” to
minimize residual volumes between the syringe and the patient when
administering medications or fluids at low infusion rates (e.g., less than 5mL
per hour, and especially flow rates less than 0.5 mL per hour). This reduces the
amount of time it takes for fluid to reach the patient, maintains delivery
accuracy, and reduces occlusion detection times.
For example:
- Tubing internal diameter: Small bore or microbore tubing is recommended
when infusing at low rates
- Tubing length: Tubing length should be minimized, when possible
- Filters: Internal volume (deadspace) of in-line filters should be minimized
- Connection sites: The number of connection sites such as stopcocks and Y-
sites should be limited, and high risk or life-sustaining solutions should be
connected as close to the intravenous access site as possible.
 Avoid use of extension sets with ports containing high pressure valves. High
pressure valves require additional pressure (e.g., 50-200 mmHg) to open and
allow fluid flow. These high pressure valves may cause a significant delay in
therapy followed by a sudden bolus once the valve is opened, particularly at
low infusion rates (e.g., less than 5 mL per hour, and especially flow rates less
than 0.5 mL per hour).

120
15.3 Operations for Syringes
15.3.1 Removing a Syringe
1. Press to stop the infusion.
2. Disconnect the extension set from the patient’s access device in accordance
with the healthcare facility’s protocol.
3. Open the syringe barrel clasp.
4. Press to silence the audible signal for 2 minutes.
5. Push the disengagement lever down and remove the syringe from its cradle.
6. Disconnect the syringe from its extension set.

15.3.2 Changing a Syringe

1. Remove the syringe.
See section 15.3.1, page 121.
2. Prepare a new syringe and follow the steps described in the flowchart.
See section 6.1, page 36.
3. After the new syringe is installed, respond to the Same therapy? prompt
(optional screen).

WARNING
Electronically prime the syringe pump system after replacing a near-empty
syringe with a replacement syringe to avoid the presence of air and
minimize the amount of time it takes the pump to recognize an occlusion
and generate an alarm while infusing at low rates.
 Verify the fluid flow to the patient is OFF, and if available, use the prime
function on the syringe pump to remove any mechanical slack in the
system.
 Using the syringe pump’s prime feature engages the mechanical
components of the pump and decreases the syringe’s friction and
compliance (i.e., stiffness) to minimize startup delays and delivery
inaccuracies, especially at low infusion rates.
Failure to use the prime feature on the syringe pump after every syringe
change and/or tubing change can significantly delay the infusion delivery
startup time and lead to delivery inaccuracies.

INFORMATION
Properly dispose of used syringes.

15.3.3 Syringe Replacement Interval

Replace the syringe according to your healthcare facility’s protocol or CDC
guidelines.

121
15.4 Gravity Infusion in Parallel with a Pump
You can infuse the contents of a fluid container via gravity, in parallel with the pump.

ml
10

20

30

40

50

60

Figure 15.1: Gravity Infusion (in parallel with a pump)

INFORMATION
 Fresenius Kabi recommends the use of a back check valve or positive
pressure infusion devices when an infusion on the pump is connected
to a gravity line. This will prevent the back-up of IV fluid or medication
into the gravity line.
 If there is no back check valve on a gravity infusion line during a multi-
line infusion, it will be impossible to detect patient-side occlusions.
Such an occlusion could cause the pumped drug to back up into the
gravity line, and later be infused in an uncontrolled manner when the
occlusion is released.
 Be careful about drugs interactions and incompatibilites during a multi-
line infusion. Fresenius Kabi recommends infusing the critical drugs
first.

122
16 Specifications
This chapter describes all of the parameters that you can use to program an
infusion with the Agilia SP PCA pump as well as the essential features that classify
it as a medical device.

INFORMATION
The range of settings and default values described in this section
correspond to the factory configuration. The range of settings and default
values can be adjusted in Basic Profile (see the Technical manual) and in
custom profiles. Increment rules can be modified in custom profiles.

16.1 Essential Features

In standard operating conditions (see Section 1.8, page 13), the pump’s essential
features are:
Feature Refer to

Flow Rate Accuracy Section 16.2.1, page 123 and Section 19.9, page 140

Time to Detect Occlusion Section 19.10, page 143

Bolus Volume After Occlusion Release Section 19.10, page 143

Management of High-priority Alarms Section 14, page 111

16.2 Pump Accuracy

WARNING
Accuracy (flow rate, time, volume infused, pressure) can be influenced by
syringe model, syringe configuration, extension set configuration, fluid
viscosity, and fluid temperature.

Note: All tests below are in accordance with the IEC 60601-2-24 standard
and ANSI/AAMI ID26.
Values are representative of syringes used during internal tests and are
provided as indicators only.

16.2.1 Flow Rate Accuracy

Accuracy

Flow Rate ± 3%

Test conditions: Flow rate: 5mL/h

123
16.2.2 Effects of Pressure Variations on Accuracy
Changes in the position of the pump in relation to the patient’s access device can
affect the accuracy of the pump as shown below.

Accuracy
Back Pressure
(Deviation From Mean Values)
+ 39.9 kPa (299.3 mmHg) ~ - 3%
+ 13.33 kPa (100 mmHg) ~ - 1.5%
- 13.33 kPa (100 mmHg) ~ + 1.5%

16.2.3 Bolus Volume Accuracy

WARNING
Accuracy may be reduced when the infusion flow rate is below 1 mL/h.

Target Volume

0.1 mL 1.8 mL

Average 0.11 mL 1.83 mL

Direct Bolus Min deviation -7 % -0.02 %
Max deviation +18 % +0.04 %

Average 0.09 mL 1.8 mL

Programmed Bolus Min deviation -30 % -0.03 %
Max deviation +3 % +0.02 %

Test condition: 25 measurements, Back pressure: 0 mmHg, Temperature: 20 °C, Extension set length:
60 in (150 cm), Syringe: BD Precise.

16.2.4 Pressure Accuracy

Below 500 mmHg Above 500 mmHg

Accuracy ± 75 mmHg ± 15 %

124
16.3 Flow Rate Settings
Syringe
Minimum
Unit
50 mL/
30 mL 20 mL 10 mL 5 mL
Increment
60 mL

0.1 0.1 0.1 0.1 0.1 0.01 (0.10  9.99)

Infusion rate mL/h      0.1 (10.0  99.9)
1200 600 600 350 250 1 (100  1200)
50 50 50 50 50
Direct bolus*      50
mL/h 1200 600 600 350 250
PCA bolus**
200 120 120 60 60 Default values

Programmed bolus
Clinician bolus 0.1 0.1 0.1 0.1 0.1 0.01 (0.10  9.99)
mL/h      0.1 (10.0  99.9)
Loading dose 1200 600 600 350 250 1 (100  1200)
PCA loading dose
Priming mL/h 1200 600 600 350 250 Not adjustable

0.1 0.1 0.1 0.1 0.1

KVO*** mL/h      0.1
5 5 5 5 5
* Direct bolus default value = Upper flow rate value for each syringe size.
** PCA bolus default value: 200 mL/h.
*** KVO defaut value = 1 mL/h.

16.4 Volume To Be Infused (VTBI) Settings

Default Minimum
Unit Range of Settings
Value Increment
0.1 (0.1  99.9)
Volume Limit mL 0.1  999 N/A 1 (100  999)

Volume/Time mL 0.1  99.9 N/A 0.1

PCA bolus
Clinician bolus mL 0.1  99.9 N/A 0.01
PCA loading dose
Direct bolus mL 0.1  50 N/A 0.1

Programmed bolus
mL 0.1  99.9 N/A 0.01
Loading dose
Applicable for all syringe sizes.

125
16.5 Dose To Be Infused (DTBI) Settings
Default Minimum
Unit Range of Settings
Value Increment
0.001 (0.010  0.999)
0.001 (1.00  9.99)
Dose All 0.01  9999 N/A 0.01 (10.0  99.9)
1 (100  9999)
Programmed bolus
PCA bolus 0.001 (0.010  0.999)
0.001 (1.00  9.99)
Clinician bolus All 0.01  9999 N/A 0.01 (10.0  99.9)
PCA loading dose 1 (100  9999)
Loading Dose
Applicable for all syringe sizes.

16.6 Infusion Time Display

Default Minimum
Format Range of Settings
Value Increment
00h00min01
Infusion Rate __h__ min__  N/A 00h00min01
96h00min00
Programmed bolus
PCA bolus 00h00min01
Clinician bolus __h__ min__  00h02min00 00h00min01
PCA loading dose 24h00min00
Loading Dose
KVO Silence Alarm
__ h __ 00h01  12h00 00h01 00h01
Duration
Pause __ h __ 00h01  24h00 00h01 00h01

Lockout time __ min 1  120 N/A 1 min

Applicable for all syringe sizes.

16.7 Concentration
The settings available for concentration shown below apply for PCA therapy and
general infusion.
Default Minimum
Unit Range of Settings
Value Increment
0.001 (0.010  0.999)
0.001 (1.00  9.99)
Concentration Dose unit 0.01  70000 N/A 0.01 (10.0  99.9)
1 (100  9999)
Volume of Diluent mL 1  60 N/A 1

Applicable for all syringe sizes.

126
16.8 Patient Data
The patient body surface area is not a parameter available in PCA therapy.
Default Minimum
Unit Range of Settings
Value Increment
0.01 (0.25  9.99)
Patient Weight kg 0.25  350 N/A 0.1 (10.0  19.9)
1 (20  350)

Patient Body
m² 0.05  4.5 N/A 0.01
Surface Area

16.9 Pressure Management

Setting Description Setting Format Default Value

Mode Infusion pressure mode. 3 levels / Variable Variable

Allows DPS option activation
DPS Yes / No Yes
on the pump pressure menu.
Unit Pressure unit selection. mmHg / kPa / PSI mmHg
The last pressure limit setting
Limit Stored is stored in memory for the Enabled / Disabled Disabled
next startup.
The last DPS setting is stored
DPS Stored Enabled / Disabled Disabled
in memory for the next startup.

Default Minimum
Unit Range of Settings
Value Increment

Low mmHg 50  300 100 50

3 Levels

Medium mmHg 150  600 250 50

High mmHg 250  900 500 50

25 (50  250)
Full Range mmHg 50  900 50  900
Variable

50 (250  900)

Maximum
mmHg 500  900 750 50
Limit

Raise
mmHg 50  400 100 50
Threshold
DPS

Drop
mmHg 100  400 100 50
Threshold
Note: 1 bar = 750 mmHg = 100 kPa = 14.5 PSI.

127
16.10 Units and Conversion Rules
16.10.1 Prescription Units
In PCA therapy, you can select the prescription units listed in the table below to
program an infusion. You cannot select the prescription unit for a general infusion.
Volume Dose

Default units for

PCA mode in Basic - microg, mg
Profile
nanog, microg, mg, g, microg/kg,
mg/kg,
Available by mmol
mL
configuration mUnit, Unit
cal, kcal
mEq

16.10.2 Concentration Units

mL --mL

Default units for

PCA mode in Basic mg/mL et microg/mL -
Profile
nanog, microg, mg, nanog/--mL, microg/--mL, mg/--mL,
nanog/mL, microg/mL, mg/mL, g/mL
g g/--mL

mmol mmol/mL mmol/--mL

mUnit, Unit mUnit/mL, Unit/mL mUnit/--mL, Unit/--mL

cal, kcal cal/mL, kcal/mL cal/--mL, kcal/--mL

mEq mEq/mL mEq/--mL

128
16.10.3 Dose Rate Units
The table below shows all the dose rate units available on the pump.
min h 24h

Default units for

microg/h
PCA mode in Basic - -
mg/h
Profile
nanog - nanog/h
nanog/kg nanog/kg/min nanog/kg/h

microg microg/min microg/h

microg/kg microg/kg/min microg/kg/h

mg mg/min mg/h mg/24h

mg/kg mg/kg/min mg/kg/h mg/kg/24h
mg/m² - mg/m²/h mg/m²/24h

g - g/h -
g/kg g/kg/min g/kg/h g/kg/24h

mmol - mmol/h -
mmol/kg - mmol/kg/h mmol/kg/24h

mUnit mUnit/min -
mUnit/kg mUnit/kg/min mUnit/kg/h

Unit Unit/min Unit/h

Unit/kg Unit/kg/min Unit/kg/h

kcal/h
kcal - kcal/24h
kcal/kg/h
kcal/kg - -

mEq mEq/min mEq/h

mEq/kg mEq/kg/min mEq/kg/h

mL/kg mL/kg/min mL/kg/h mL/kg/24h

16.10.4 Conversion of Units

The pump uses the following conversions of units:
 1 micro unit = 1000 nano unit
 1 m unit = 1000 micro unit
 1 k unit = 1000 unit
 1 unit/h = 24 unit/24 h
 1 unit/min = 60 unit/h

129
16.10.5 Conversion of Concentrations and Dose Rates
When you start an infusion, the pump converts the parameters you programmed
into a volume and a flow rate using the equations below.
Conversion Equation

Conversion of a dose rate including unit/kg into unit/kg/h (dose rate) × kg (weight)
mL/h =
volume flow rate (mL/h) unit/mL (concentration)

Conversion of a dose rate including unit/m2 into unit/m2/h (dose rate) × m2 (body surface area)
mL/h =
volume flow rate (mL/h) unit/mL (concentration)

Conversion of a dose rate unit into a volume unit/h (dose rate)

mL/h =
flow rate unit/mL (concentration)

Conversion of a dose including unit/kg into volume unit/kg (dose) × kg (weight)

mL =
(mL) unit/mL (concentration)

Conversion of a dose including unit/m2 into volume unit/m2 (dose) × m2 (body surface area)
mL =
(mL) unit/mL (concentration)

unit (dose)
Conversion of a dose into a volume (mL) mL =
unit/mL (concentration)

130
17 Cleaning and Disinfection
To avoid the risks of infection and microbial transmission, make sure to adequately
clean and disinfect the equipment.
WARNING
 The disinfection procedure must be done immediately after cleaning.
Disinfecting the pump without prior cleaning is not effective.
 The pump is not intended to be sterilized; sterilization may result in
damage to the pump.
 In case of contamination by blood or bodily fluids when the pump and
handset are in use, and if allowed by your local practices and
healthcare facility policies, immediately perform the quick cleaning
procedures described below. Always follow your local protection rules.

17.1 Recommended and Prohibited Agents

We recommend the following cleaning and disinfection agents:
Table 17.1: Recommended Agents
Recommended Active Agent Example of product
Wip’Anios Excel ready-to-use wipes
Cleaning Didecyldimethylammonium chloride
by Anios
Wip’Anios Excel ready-to-use wipes
Disinfecting Didecyldimethylammonium chloride
by Anios
The following cleaning and disinfection agents are prohibited:
 Trichloroethylene
 Abrasive detergents
 Undiluted alcohol
These aggressive agents may damage the plastic parts of the pump and cause it to
malfunction.

17.2 Quick Cleaning Procedures

Quick cleaning procedures can be done at any time, whenever you notice soiling.
17.2.1 Quick Cleaning for the Pump
WARNING
When the cleaning is performed while the infusion pump is running, the
keyboard should be locked to avoid any unintended modification of the
infusion parameters.
INFORMATION
A quick cleaning of the pump during infusion does not replace the need for
a complete cleaning procedure.
1. Make sure the keypad is locked in order to avoid unintended modification of the

131
 infusion parameters. Do not move the pump.
2. Use ready-to-use wipes to wipe down all exposed surfaces of the pump.
3. At the end of the infusion, perform the complete cleaning protocol, as explained
in Section 17.4.1, page 133.

17.2.2 Quick Cleaning for the Patient Handset

INFORMATION
A quick cleaning of the patient handset during infusion does not replace
the need for a complete cleaning procedure as described in Section 17,
page 131.
1. Press the stop key on the pump in order to avoid an unintended bolus while
cleaning the patient handset.
2. Use ready-to-use wipes to wipe down all exposed surfaces of the patient
handset, cable gland, and cable.
3. Restart the infusion.
4. At the end of the infusion, perform the complete cleaning protocol, as explained
in Section 17.4.1, page 133.

17.3 When to Clean and Disinfect the Pump and the Patient
Handset
Thoroughly clean and disinfect the pump in the following cases.
 After each patient use.
 Before any maintenance.
 On a routine basis when the pump is not in use.
 Before storage.

17.4 Instructions for Cleaning and Disinfection

Follow the instructions provided to ensure effective cleaning and disinfection of the
equipment.
 Use the agents according to the manufacturer's instructions. This may include
wearing personal protective equipment (gloves, lab coat, glasses, and so on),
or diluting the agent according to the manufacturer's guidelines.
 For disinfectants, respect the contact time required for the antimicrobial agents
to act (the time the agent must be left on the pump for disinfection to be
effective).
The following warning is provided to protect staff against electric shock, and to

132
protect the pump from damage that can cause it to malfunction.
WARNING
 Only trained staff can clean and disinfect the pump.
 Do not place the pump in an autoclave or immerse it in liquid. Do not
immerse the handset connector.
 Do not spray liquids directly on connectors. Instead, use a cleaning
cloth or disposable wipes.

17.4.1 Cleaning Instructions

Prerequisites
 The pump is powered off.
 The power cord and all other cables (including the patient handset) are
unplugged.
 The ambiant air temperature is between 20 and 25 °C.
 The operator is wearing suitable protective equipment.
Protocol for the pump
1. Place the pump on a clean surface or disposable underlay.
2. Use a ready-to-use wipe to remove any major grime.
3. Thoroughly wipe down all exposed surfaces (housing, protective cover and
keylock, keyboard, syringe barrel area, syringe guard, plunger driver,
disengagement lever, syringe barrel clasp, etc.) of the pump, from top to
bottom. You can use the silver handle to lift and move the pump.
- When wiping down the sides, avoid wetting the connector sockets.
- Do not allow liquids to run, leak, or drip into the pump housing.
4. Make sure the pump remains damp for at least 1 minute.
5. Set down the pump and wipe down the silver handle, the handset holder and
cable stowage, the attachment lock knob, the screw clamp and the release
button.
6. Use a fresh ready-to-use wipe to gently wipe down the back side of the syringe
barrel clasp and all exposed surfaces in the syringe barrel area.
7. Make sure the pump remains damp for at least 1 minute to dissolve all organic
matter.
8. Use a swab to gently scrub the exposed surfaces of the pump. Be sure to scrub
along the seams and edges of the control panel, and the narrow or hard-to-
reach areas.
9. Wipe down the power cord and any pump accessories.
10. Allow the pump to dry completely at room temperature.

133
Protocol for the patient handset
1. Place the patient handset on a clean surface or disposable underlay.
2. Use a ready-to-use wipe to remove any major grime.
3. Thoroughly wipe down all exposed surfaces (housing, blue button area, strap,
cable gland, cable, and connector).
- Do not allow liquids to run, leak, or drip into the housing or the connector.
4. Make sure the patient handset remains damp for at least 1 minute to dissolve
all organic matter.
5. Allow the device to dry completely at room temperature.

17.4.2 Disinfection Instructions

Prerequisites
 The cleaning protocol has been performed.
 The pump is powered off.
 The power cord and all other cables (including the patient handset) are
unplugged.
 The ambiant air temperature is between 20 and 25 °C.
 The operator is wearing suitable protective equipment.
Protocol for the pump
1. Place the previously cleaned pump on a clean surface or disposable underlay.
2. Use a ready-to-use wipe to wipe down all exposed surfaces of the pump,
making sure to cover all cracks, crevices, and hard-to-reach areas. You can
use the silver handle to lift and move the pump.
- When wiping down the sides, avoid wetting the connector sockets.
- Do not allow liquids to run, leak, or drip into the pump housing.
3. Set down the pump, and wipe down the silver handle, the handset holder and
cable stowage, the attachment lock knob, the screw clamp and the release
button.
4. Use a fresh ready-to-use wipe to gently wipe down the back side of the syringe
barrel clasp and all exposed surfaces in the syringe barrel area.
5. Using a fresh ready-to-use wipe, repeat steps 2 to 4.
6. Leave the disinfection agent on the pump for at least 3 minutes.
7. Wipe down the power cord and any pump accessories.
8. Allow the pump to dry completely at room temperature.
Protocol for the patient handset
1. Place the previously cleaned patient handset on a clean surface or disposable
underlay.

134
2. Use a ready-to-use wipe to wipe down all exposed surfaces making sure to
cover all hard-to-reach areas.
- Do not allow liquids to run, leak, or drip into the housing or the connector.
3. Using a fresh ready-to-use wipe, repeat step 2.
4. Leave the disinfection agent on the patient handset for at least 3 minutes.
5. Wipe down the power cord and any pump accessories.
6. Allow the device to dry completely at room temperature.

135
18 Power Management

18.1 AC Power Supply Precautions

Check that the AC power supply voltage corresponds to the value indicated on the
label on the bottom of the device. Do not exceed the permitted voltage.
The power outlet must remain accessible at all times to allow emergency power
supply disconnection.

WARNING
 The pump and its accessories can only be connected to the AC power
supply with the power cord supplied by Fresenius Kabi, or with a power
supply accessory from the Agilia product range.
 Do not use an extension cord when connecting the pump to the AC
power supply.
 Pumps must be plugged into a medical grade power strip if one is used.

18.2 Battery Precautions

The device uses a Lithium-ion rechargeable battery.
The following actions may cause leakage, overheating, smoke, explosion or fire;
which could result in deterioration of performance, failure, damage to the equipment
or injury to the user:
 Incorrect handling of a Lithium-ion battery.
 Replacement of the battery by inadequately trained personnel.
INFORMATION
 Do not replace with a battery other than the one provided by
Fresenius Kabi.
 Do not use the pump without the battery connected.
 Do not disconnect the battery when the device is operating on AC or
battery power. Disconnect the power cord and power off the device
before disconnecting the battery.
 Do not incinerate or place near a flame.
 Do not drop, crush, puncture, modify or disassemble the battery.
 Do not use a battery that is severely scratched or damaged.
 Do not short the terminals.
 Do not expose to high temperatures or very low temperatures: refer to
the operating conditions for use, and the storage instructions.
 Do not try to charge or discharge the battery outside of the device.
 For more information on replacing the battery, refer to the technical
manual.

136
18.3 Battery Operating Mode
The device is provided with an internal battery that automatically provides power to
the device in case of power failure or disconnection from the AC power supply. The
battery charges when the pump is connected to AC power supply.
Before starting for the first time, charge the battery for approximately 6 hours by
plugging in the power supply cord with the pump powered off.

INFORMATION
During operation, leave the device connected to the power supply in order
to maintain the battery's charge and maximum capacity, and to maximize
battery lifetime and performance.

137
19 Technical Characteristics

19.1 Power Supply

It is mandatory to use an Agilia power cord compliant with USA standards and with
the IEC 60227 standard.
The power cord conductor must have a cross section of at least 0.75 mm².

100 V - 240 V ~ / 50 / 60 Hz with functional

Power supply
earth
AC Power Maximum consumption 10-15 VA
1 X T1.6AH 250V accessible in the battery
Protective fuse
compartment

19.2 Battery
Disconnect the battery before opening the device. Avoid short circuits and extreme
temperatures.
If the device is not used for more than 3 months, the date is erased (all other
settings are stored permanently). When you power on the pump, you must set the
date again.
Characteristics 7.2 V 2.2 Ah - Li-ion Smart battery

Weight Approximately 100 g

WiFi enabled WiFi disabled or not used

Battery life*
>6h > 11 h

Battery recharge Pump OFF: < 6 h / Pump ON: < 20 h

*For a flow rate of 5 mL/h

19.3 Power Consumption

The pump typically consumes about 3.5 W in standard operating conditions.

19.4 Communication Port

The connector located at the back of the pump allows data communication with a
PC.
Serial Cable TTL output

Power Input 10 V / 15 W to power supply the product

Power Output 5 VDC / 150 mA to power Agilia USB cable

138
19.5 Infrared Communication
The pump is equipped with an infrared cell located at the back of the device.

Mode Wireless optical communication using infrared light

Asynchronous Serial Infrared (SIR) physical layer irPHY 1.0, baseband no

Compatibility
carrier

Transport Protocol Proprietary

Speed 115.2 kb/s max

Wavelength 880 nm to 900 nm infrared band with 45 nm spectral bandwidth

Eye Safety Class 0 of IEC 62471

19.6 Sound Levels

Table 19.1: Operating Pump Sound Levels (without alarms)
Flow Rate (mL/h) Sound Level (dBA)

0 21

1 23

20 27

100 30

400 49

1200 32

Note: These values are provided for information purposes only.

Table 19.2: Alarm Sound Levels

Sound Level (dBA)
Alarm Priority
min Max

High-priority 55 63

Medium-priority 50 57

Low-priority 45 52

139
19.7 Compliance
Compliant with the
IP 22 (pump) Index of protection against
ElectroMedical following standards:
IP 27 (handset ingress of water or
Equipment Safety  IEC 60601-1 except connector) particulate matter
 IEC 60601-1-8
EMC Compliant with the Protection against leakage
(Electromagnetic following standard: current: Defibrillation-proof
compatibility)  IEC 60601-1-2 type CF applied part*

Protection against electric

Particular  IEC 60601-2-24 shocks: class II
Standards  ANSI/AAMI ID26
Functional earth**

* After a defibrillation, the pump recovery time is around 2 seconds.

** The functional earth is directly connected to the power supply cord. It reduces residual current that
may disturb ECG or EEG devices.

19.8 Dimensions and Weight

Table 19.3: Pump dimensions and weight without protective cover
H/W/D 150 x 350 x 195 mm

Weight Approximately 2.5 kg

Screen Size 70 x 35 mm

Table 19.4: Pump dimensions and weight with protective cover

H/W/D 150 x 350 x 210 mm

Weight Approximately 2.7 kg

Table 19.5: Patient handset dimensions and weight

H/W/D 20 x 35 x 115 mm (without cable) or 20 x 35 x 1960 mm (with cable)

Weight Approximately 65g

19.9 Trumpet and Start-up Curves

The trumpet curve shows the variation of the mean flow rate accuracy over specific
observation periods. The variations are presented only as maximum and minimum
deviations from the overall mean flow within the observation window.
Trumpet curves are presented below for a number of representative flow rates. The
test protocol used to obtain these results is described in ANSI/AAMI ID26.
The curves can be helpful in determining the suitability of infusion parameters for
specific drugs and concentrations.

140
Syringe used: BD Precise 50 mL
Fluid used: distilled water
Recommendations to improve performances and safety when the pump is
commonly used at low flow rates (≤ 20 mL/h):
 Limit the range of available flow rates in accordance with the maximum flow
rate to be used.
 Lower the pressure limit in order to gain in time to detect occlusion.

19.9.1 Flow rate: 1 mL/h

Legend
2
Instantaneous
flow rate
Set flow rate

Sampling time: 10 s
Flow rate (mL/h)

0
0 10 20 30 40 50 60 70 80 90 100 110 120
Time (minutes)

Figure 19.6: Start-up and instantaneous flow rate

(1 mL/h over 2 hours)

Legend
10
Measured
variance from
flow rate
6,0
3,9 Error
5
Flow rate
Flow rate (mL/h)

1,0
1,1

0 Sampling time: 10 s

-1,6
-1,9
-5
-4,4

-6,5
-8,6
-10
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30

Time (minutes)

Figure 19.7: Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows
(1 mL/h over 2 hours)

141
19.9.2 Flow rate: 5 mL/h
10 Legend
Instantaneous
9 flow rate
8 Set flow rate

Sampling time: 10 s
Flow rate (mL/h)

0
0 10 20 30 40 50 60 70 80 90 100 110 120

Time (minutes)

Figure 19.8: Start-up and instantaneous flow rate

(5 mL/h over 2 hours)

10
Legend
Measured
variance from
flow rate
Error
5
Flow rate
1,7 0,2
Flow rate (mL/h)

0,7 0,4
1,0
0 Sampling time: 10 s
-0,3
-0,7 -0,5
-1,0
-1,9

-5

-10
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30

Time (minutes)

Figure 19.9: Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows
(5 mL/h over 2 hours)

142
19.10Occlusion Alarm Accuracy and Bolus Volume at
Occlusion Release
The time to detect an occlusion varies depending on syringe size, flow rate and
pressure, as shown in the table below. Note that this time is always better with a
smaller syringe and lower pressure.
Pressure 900
Pressure 50 mmHg
mmHg
0.1 mL/h < 5 hours < 28 hours
50mL syringe 1 mL/h < 30 minutes < 3 hours
5 mL/h < 7 minutes < 30 minutes

0.1 mL/h < 4 hours < 14 hours

20mL syringe 1 mL/h < 20 minutes < 75 minutes
5 mL/h < 5 minutes < 15 minutes

Test conditions: Temperature: 20 °C, Extension set length: 150 cm, Syringe: BD Precise

Volume

Syringe** Rate Bolus Volume at Occlusion Release

Bolus Volume at
Occlusion 50 mmHg 900 mmHg
Release*
50 mL 5 mL/h -0.05 ≤ X ≤ 0.35 mL -0.05 ≤ X ≤ 0.35mL

*Test conditions: Back pressure: 0 mmHg,

**Syringe: BD Precise 50 mL
 A back flow pumping is provided to reduce the bolus volume at occlusion release.
 During pump movement from 0 to 1 m above the patient, a bolus (-0.05 ≤ X ≤ 0.35 mL) may occur.

143
20 Wi-Fi

20.1 General Information

The Agilia Connect Infusion System includes an IEEE 802.11 radio-frequency
transmitter incorporated in the Agilia Wi-Fi pumps. It operates using the following
standards and frequencies:
 IEEE 802.11a: 5 GHz Frequency Band
 IEEE 802.11b: 2.4 GHz Frequency Band
 IEEE 802.11g: 2.4 GHz Frequency Band
 IEEE 802.11n: 2.4 and 5 GHz Frequency Band
INFORMATION
For more information on differentiation between Wi-Fi and non Wi-Fi
pumps, see section 12.3, page 109.
The Wi-Fi module incorporated in the Agilia Wi-Fi pumps is intended to perform the
following, via periodic communication cycles:
 Transfer data sets (from Centerium server to pump).
 Transfer pump history (from pump to a server).
 Communicate general information on the operating status of the pump..
Agilia infusion pumps contain transmitters with the following IDs:
 FCC ID: XF6-RSWC301
 IC ID: 8407A-RSWC301
Agilia Wi-Fi pumps must be installed to provide a separation distance of at least 8 in
(20 cm) from all persons and must not be co-located or operating in conjunction with
any other antenna or transmitter.

WARNING
Agilia Wi-Fi pumps must be configured by qualified and appropriately
trained staff.
INFORMATION
If communication with the wireless network is interrupted, the pump can
be used as intended. For more information, contact your Fresenius Kabi
sales representative.

144
20.2 Usage Restrictions in Europe
The Wi-Fi pumps are restricted to indoor use in the following countries.

AT BE BG HR CZ CY DK
EE FI FR DE EL HU IE
IT LV LT LU MT NL PL
PT RO SI SK ES SE UK

Austria (AT), Belgium (BE), Bulgaria (BG), Croatia (HR), Czech Republic (CZ),
Cyprus (CY), Denmark (DK), Estonia (EE), Finland (FI), France (FR),
Germany (DE), Greece (EL), Hungary (HU), Ireland (IE), Italy (IT), Latvia (LV),
Lithuania (LT), Luxembourg (LU), Malta (MT), Netherlands (NL), Poland (PL),
Portugal (PT), Romania (RO), Slovenia (SI), Slovakia (SK), Spain (ES),
Sweden (SE) and United Kingdom (UK).

20.3 Technical Specifications

Technology IEEE 802.11 a/b/g/n
 2.400  2.500 GHz (2.4 GHz is ISM band)
Frequency Band
 4.900  5.850 GHz (High Band)
Modulation OFDM with BPSK, QPSK, 16-QAM, and 64-QAM 802.11b with CCK and DSSS

Wireless Security WPA/WPA2-Entreprise, WPA/WPA2-PSK

Network Protocols TCP, IPv4, DHCP, HTTP

 17 dBm for 802.11b DSSS
Typical Transmit  17 dBm for 802.11b CCK
Power (± 2 dBm)  15 dBm for 802.11g/n OFDM
 12 dBm in 802.11a mode

20.4 Electromagnetic Compatibility

For information on electromagnetic compatibilty, see section 24, page 152.
USA - FCC Notice

INFORMATION
Changes or modifications not expressely approved by the party
responsible for compliance could void the user's authority to operate the
equipment.
Europe - Radio Equipment Directive
This product is designed as a radio device that uses harmonized frequencies and
power levels for Europe.
145
20.5 Protocols and Standards
This wireless functionality is compliant with the following protocols and standards:
 IEEE 802.11a/b/g/n standard
 WPA/WPA2-Entreprise, WPA/WPA2-PSK (Wi-Fi protected access) is a long-
term security solution for wireless networks. For more information, refer to the
IEEE 802.11.
 TCP (Transmission Control Protocol / Internet Protocol), IPv4 (Internet Protocol
Version 4), DHCP (Dynamic Host Configuration Protocol) and HTTP (Hypertext
Transfer Protocol) are standard data transport protocols used for the internet
and other similar networks.
Agilia infusion pumps do not require an active wireless communication to function
as intended (infuse). Wireless transactions are initiated by the pump and are
periodic. The absence of connection (for example, out of range) does not affect the
device ability to infuse. Pending data is stored and re-transmitted when the
connection becomes available. Data integrity and quality of service are inherent in
the design. The system should be ensured and maintained by a qualified and
trained technical user, or a Fresenius Kabi representative.

146
21 Troubleshooting

Issue Recommended Actions

The pump is unstable when mounted.  Check that the rotating pole clamp is fastened.
The pump is damaged, or you notice  Remove the power cord.
something abnormal (unusual noise,  Contact your biomedical department or Fresenius Kabi
abnormal heat or smoke). support immediately.
The pump has been dropped or was  Do not use the pump.
subjected to a force that may have  Contact your biomedical department or Fresenius Kabi
produced internal damage. support.

The pump cannot be installed or

 Check the rotating pole clamp position.
 Contact your biomedical department or Fresenius Kabi
removed from the Agilia Link.
support.
 Check that the Agilia Link is connected to the mains.
 Check the pump is correctly slotted in the Agilia Link. You
should hear a beep.
The power supply indicator does not
light up when the pump is racked into
 If the problem persists, check that the AC power supply
indicator lights up when the pump is connected directly to
the Agilia Link.
the mains.
 Contact your biomedical department or Fresenius Kabi
support.
The lock on the pump for the  Contact your biomedical department or Fresenius Kabi
protective cover is jammed. support.
 Make sure the lock on the pole clamp is unlocked.
The pump cannot be removed from
the pole.
 Contact your biomedical department or Fresenius Kabi
support.
 Connect the pump to the AC power supply to see if the
The pump does not start after battery is fully discharged.
pressing .  Contact your biomedical department or Fresenius Kabi
support.
 Check the cable connector.
Data communication cables cannot be  Check the pump connector.
connected or removed from the pump.  Contact your biomedical department or Fresenius Kabi
support.
 Check the infusion line configuration.
 Check the fluid viscosity.
Flow rate variance is higher than flow  Check that the fluid temperature is within the
rate accuracy. recommended range.
 Contact your biomedical department or Fresenius Kabi
support.
 Check the general condition of the keypad.
 Check the contrast.
Keypad problem (keys, LEDs).
 Contact your biomedical department or Fresenius Kabi
support.

147
 Issue Recommended Actions
 Connect the pump to the AC power supply.
The power supply indicator does not
light up.
 Contact your biomedical department or Fresenius Kabi
support.
 Connect the pump to the AC power supply.
The pump powers off on its own.  Contact your biomedical department or Fresenius Kabi
support.
 Check the AC power voltage.
The battery alarm is ON even though
the pump has been correctly charged.
 Contact your biomedical department or Fresenius Kabi
support.
The pump powers off when it is  The battery is completely discharged: charge the battery.
disconnected from the AC power  Contact your biomedical department or Fresenius Kabi
supply. support.
 Check that the handset is connected to the pump and that
the pump is On.
 Check that the handset connector is correctly plugged in
The LED on the patient handset does and that the cable is not damaged.
not light up.  Connect the handset connector to another Agilia SP PCA
pump to see if the problem persists.
 Contact your biomedical department or Fresenius Kabi
support.
 Check that the handset is connected to the pump and that
the pump is On.
No beep when pressing the bolus  Check that the bolus button beep is enabled in the pump
button on the patient handset. configuration.
 Contact your biomedical department, or Fresenius Kabi
support.

Wi-Fi communication error.

 Contact your IT or biomedical department, or
Fresenius Kabi support.
 Connect the pump to the AC power supply. Then, wait few
minutes without touching the keypad until the message
At start-up, the pump displays:
disappears and the pump starts as usual.
"Software is upgrading...".
 Contact your biomedical department, or Fresenius Kabi
support.

148
22 Device Storage, Transport, and Recycling

22.1 Precautions for Storage

 Handle the device with care during storage.
 Store the device in a cool, dry place. The storage area must be clean and
organized.
 Clean and disinfect the device prior to storage.
WARNING
If the device is not used for an extended period (longer than 2 months),
it is recommended that the battery be removed from the device and put
in storage by authorized personnel. If the battery cannot be removed, or
the device will be used in less than 2 months, charge the battery at least
once a month by connecting the device to the AC power supply for at
least hours.

22.2 Storage and Transport Conditions

Observe the following conditions for storage and transport:
 Temperature: -10 °C to +60 °C
 Pressure: 500 hPa (375 mmHg / 7.25 PSI) to 1060 hPa (795 mmHg /
15.37 PSI)
 Relative humidity: 10 % to 90 % without condensation
 Altitude: Up to 3000 m

22.3 Preparing the Device for Storage

Prepare the device for storage as follows:
1. Power the pump OFF and remove the disposable.
2. If necessary (long-term storage), disconnect the pump’s power cord and all
data communication cables.
3. Remove the pump from its mounting point.
4. Clean the pump.
5. Handle the pump with care, and store it in a compliant area.
For detailed instructions, refer to the related chapters in this document.

22.4 Using the Device After Storage

The device can be used immediately after storage without any cooling or warm up
period.
If the battery has been removed for long-term storage, contact your biomedical
department in order to reinstall the battery prior to use.

149
We recommend charging the battery for at least hours.
We recommend that the "User test" is performed when the device is installed after
storage, and before being used on a patient, see section 13, page 110.

22.5 Recycling at End of Life

Before disposal, remove the battery from the device. Batteries and
devices with this label must not be disposed of with the general waste.
They must be collected separately and disposed of according to local
regulations.

INFORMATION
 For more information on waste processing regulations, contact your
Fresenius Kabi sales representative or the local distributor.
 For more information on dismantling the device, refer to the technical
manual.
 Follow healthcare facility policy regarding proper disposal after use.

150
23 Warranty

23.1 General Warranty Conditions

Fresenius Kabi guarantees that this product is free from defects in material and
workmanship during the period defined by the accepted sales conditions, except for
the batteries and the accessories.

23.2 Limited Warranty

To benefit from the materials and workmanship guarantee from our
Fresenius Kabi sales representative or authorized agent, make sure to observe
the following conditions:
 The device must have been used according to the instructions described in this
document and in other accompanying documents.
 The device must not have been damaged while being stored or repaired, and
must not show signs of improper handling.
 The device must not have been altered or repaired by unqualified personnel.
 The internal battery of the device must not have been replaced by a battery
other than that specified by the manufacturer.
 The serial number (SN) must not have been altered, changed or erased.
INFORMATION
 If one or more of these conditions have been violated, Fresenius Kabi
will prepare a repair estimate covering all required parts and labor.
 To repair or return a device, contact your Fresenius Kabi sales
representative.

23.3 Warranty Conditions for Accessories

Batteries and accessories may have specific warranty conditions.
Contact your Fresenius Kabi sales representative for more information.

151
24 Guidance and Manufacturer's Declaration on
EMC

24.1 Electromagnetic Compatibility

WARNING
 The Agilia pump and its accessories are intended to be used in the
electromagnetic environments specified in the Technical Manual..
 The customer or the user of the Agilia pump should ensure that it is
used in such environments.
 The Agilia pump must not be used in the presence of intense
electromagnetic fields, such as those generated by certain electrically
powered medical devices. Do not use the pump in MRI.
 Prolonged exposure to X-ray environments can damage the electronic
components of the device and influence the flow rate accuracy. For a
safe usage, we recommend to:
- always put the device at the maximum distance from the patient and
the source
- limit the presence of the device in such environments.
When mounted on the Link+ Agilia, the pump is intended to be used in the
electromagnetic environment specified in the Link+ Agilia IFU.
Excluding the cases described in this manual, pump operation must be
systematically checked by a qualified operator, if the pump is installed in the vicinity
of other electrical devices.
Points (for example, screws or battery contacts) and surfaces that are only
accessible for maintenance also require precautions.

24.2 Electrostatic Discharge (ESD) and Precautions To Be

Taken
INFORMATION
 Electronic components and semiconductors can be destroyed by
electrostatic discharge (ESD). In particular, components made with
metal oxide semiconductor (MOS) can be damaged from direct or
indirect discharges. Damage caused by ESD may not be immediately
identifiable, and malfunctions can even occur after a longer period of
operation.
 Exceeding and / or repeating the test level attained in guidance &
manufacturer's declaration on EMC may permanently damage the
device and / or cause serious malfunctions (for example, loss of
communication and system failures).
The following environmental conditions related to electrostatic sensitive
components (ESD standards) must be observed:
 Floors coated with wood, tiles or concrete
 Relative humidity of at least 30%

152
If it is not possible to guarantee this environment, the following additional
precautions must be taken:
 Use of anti-static equipment
 Preliminary user discharge (explained below)
 Anti-static clothing
The best precaution is preliminary user discharge on a grounded metal object such
as a rail, a pole or a metal part located at the rear of the Agilia pump.
For maintenance operations performed on the Agilia pump, place the device on a
conductive working surface, and wear a special ESD conductive wristband.

24.3 EMC and Essential Performance

In standard operating conditions (see Section 1.8, page 13), the essential
performance of the Agilia pump is defined in Section 16.1, page 123.
In the event of electromagnetic disturbances above the limits defined in the
applicable EMC standards, if the essential performance is lost or degraded, the
consequences for the patient are: overdose, underdose, delay of therapy, electric
shock.
It is the responsibility of the customer or user to check the equipment before use as
described in Section 13, page 110, and to consider the EMC guidance of Section
24.4.

24.4 Electromagnetic Compatibility and Interference Guidance

The Agilia pump has been tested in accordance with the electromagnetic
compatibility standards applicable to medical devices. Its immunity is designed to
ensure correct operation. Limitation of the emitted radiation avoids undesirable
interference with other equipment.
Agilia SP PCA is classified as a Class B device according to CISPR 11 emitted
radiation.

153
 WARNING
 Use of the Agilia pump adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If such
use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.
 Use of accessories, transducers and cables other than those specified
or provided by the manufacturer of the Agilia pump could result in
increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
 Portable RF communications equipment (including peripherals such as
antenna cables, internal and external antennas) should be used no
closer than 10 cm for cell phones and 30 cm for other equipments, to
any part of the Agilia pump, including cables specified by the
manufacturer. Otherwise, degradation of the essential performances of
Agilia pump could result. Electrosurgical equipment (including base
unit, cables, electrodes) should be used no closer than 30 cm to any
part of the Agilia pump, including cables specified by the manufacturer.
Otherwise, degradation of the essential performance of Agilia pump
could result.
The user might be required to take mitigation measures, such as relocating or re-
orienting the equipment.
If the Agilia pump is placed near RF communication equipment such as cell phones,
DECT phones or wireless access points, portable RFID reader, large scale RFID
reader and RFID tags, it is essential to observe a minimum distance between the
Agilia pump and this equipment.
If the Agilia pump causes harmful interference or if it is itself disrupted by external
interference, try the following:
 Reorient or relocate the Agilia pump, the patient or disruptive equipment.
 Change the routing of cables.
 Connect the Agilia pump power plug to a protected / backed-up / filtered supply
or directly to the UPS circuit (uninterruptible power supply).
 Increase the separation between the Agilia pump and disruptive equipment.
 Plug the Agilia pump into an outlet on a different circuit from the one to which
the patient or disruptive equipment is connected.
 In any case, whatever the context, the user should conduct interoperability
testing in a real situation to find the correct setup and location.
If the problem persists, the pump shall not be used in such environment.
For further information on EMC compliance, please refer to the Agilia pump
Technical Manual.

154
25 Servicing

25.1 Information on Device Servicing

If the device must be sent for servicing, proceed as follows:
1. Contact Fresenius Kabi to have packaging shipped to your facility.
2. Clean and disinfect the device.
3. Pack the device in the provided packaging.
4. Ship the device to Fresenius Kabi.

INFORMATION
 Fresenius Kabi is not liable for loss or damage to the device during
transport.
 For more information on servicing, contact your Fresenius Kabi sales
representative.

25.2 Maintenance Requirements

WARNING
 Perform preventive maintenance at least once every 3 years. This
includes replacing the battery.
 When using the device on a patient, no maintenance action must be
performed.
To ensure the device continues to operate normally, follow the instructions below:
 Preventive maintenance should be performed by trained and qualified technical
personnel in compliance with the technical manual and procedures. Only
authorized service personnel should attempt to repair the device.
 The qualified personnel must be informed if the device is dropped or if any
malfunctions occur. In this case, do not use the device and contact your
biomedical department or Fresenius Kabi.
 Failure to comply with these maintenance procedures could damage the device
and lead to a functional failure. Internal inspection of the device requires
compliance with special procedures to avoid damage to the device.
 When replacing components, only use spare parts from Fresenius Kabi.
The life cycle of the pump is 10 years provided that the maintenance is properly
performed as described above.

155
 INFORMATION
If the device needs upgrading, Fresenius Kabi or its representative will
provide relevant instructions. It is the healthcare facility's responsibility to
follow Fresenius Kabi’s instructions.

25.3 Quality Control

Upon request by the healthcare facility, a quality control check can be performed on
the device every 12 months.
A regular quality control check (not included in the guarantee) consists of various
inspection operations listed in the technical manual.

INFORMATION
 These control checks must be performed by trained technical
personnel, and are not covered by any contract or agreement provided
by Fresenius Kabi.
 For more information, refer to the technical manual, or contact your
Fresenius Kabi sales representative.

156
26 Glossary of Terms
EEG Electroencephalogram
A
EMC Electromagnetic compatibility
A Amperes
ErXX Error message
AC Alternating Current
ESD Electrostatic Discharge
Ah Ampere-hours
AIDC Automatic Identification and F
Data Capture FCC Federal Communications
AM Amplitude Modulation Commission
A/m Amperes per meter FM Frequency Modulation
ft Feet
B
BPSK Binary Phase Shift Keying G
BSA Body Surface Area GPL General Public License
GTIN Global Trade Item Number
C
cal Calorie H
CCK Complementary Code Keying H/W/D Height / Width / Depth
CDC Centers for Disease Control HF High Frequency
CISPR Special International Committee hPa Hectopascals
on Radio Interference HTTP HyperText Transfer Protocol
CT Computed Tomography Hz Hertz
Scan
I
D IC Industry Canada
dBA Decibels
IEC International Electrotechnical
dBm Decibels-Milliwatts Commission
DC Direct Current IEEE Institute of Electrical and
DECT Digital Enhanced Cordless Electronics Engineers
Telecommunications IFU Instructions for Use
DEHP Di(2-ethylhexyl) phthalate in Inches
DERS Dose Error Reduction Software IT Information Technology
DHCP Dynamic Host Configuration IV Intravenous
Protocol
K
DI Dose Infused
kg Kilograms
DPS Dynamic Pressure System
KVO Keep Vein Open
DSSS Direct Sequence Spread
Spectrum L
DTBI Dose to Be Infused lb(s) Pound(s)
DUR Duration LED Light Emitting Diode
E M
ECG Electrocardiogram mA Milliamperes
ECMO ExtraCorporeal Membrane mEq Milliequivalents
Oxygenation
mL/h Milliliters per hour

157
mmHg Millimeters of mercury V
mmol Millimole V Volts
MOS Metal Oxyde Semiconductor V/m Volts per meter
MRI Magnetic Resonance Imaging VA Volt-Amperes
mW/sr Milliwatts per steradian VDC Volts Direct Current
N VI Volume Infused
N/A Not Applicable Vrms Root Mean Square Voltage
NMR Nuclear Magnetic Resonance VTBI Volume to Be Infused
O W
OCS Occlusivity Check System W Watts
OFDM Orthogonal Frequency Division WPA Wi-Fi Protected Access
Multiplexing
OR Operating Room
P
PC Personal Computer
PCA Patient Controlled Analgesia
PSI Pounds per Square Inch
PSK Phase Shift Keying
Q
QAM Quadrature Amplitude
Modulation
QPSK Quadrature Phase Shift Keying
R
REF Product reference / part number
RF Radio Frequency
RFID Radio Frequency IDentification
RS232 Serial interface connector
S
SN Serial Number
SELV Safety Extra Low Voltage
SIR Asynchronous Serial Infrared
T
TCP Transmission Control Protocol
U
UDI Unique Device Identifier
USB Universal Serial Bus
Ut Test specification level

158
Appendix: Factory Configuration

Feature Default setting Feature Default setting

Profile Disabled Continuous only Enabled

Pressure Enabled PCA bolus only Enabled

Keypad lock PCA bolus +
Enabled Enabled
status continuous
PCA modes PCA bolus +
Battery life Enabled Disabled
variable
Volume infused /
Enabled Clinician bolus Enabled
Dose infused
Pause Enabled PCA loading dose Disabled
Programmed
Enabled Simple Rate Enabled
bolus
General
infusion Volume/Time
Clinician bolus Enabled Enabled
modes Dose / Time
Patient Disabled Volume Limit Enabled

Day/Night mode Enabled Loading Dose Disabled

Volume/Time Programmed
Enabled Enabled
Dose/Time Bolus
Volume Limit Enabled Direct bolus Enabled

Alarm volume Enabled KVO Enabled

Menus General
Volume-Dose infusion
Enabled Prime Set Disabled
history features
View flow rate
Enabled Empty syringe Disabled
history
View pressure Dynamic Pressure
Disabled Enabled
history System (DPS)
Near end of max
Syringe Disabled Enabled
dose
View event log Disabled Install mandatory Enabled
View PCA event
Enabled lock mandatory Enabled
log
Auto-lock
PCA treatment Enabled Cover keyboard at cover Enabled
close
Auto-unlock
Date / Time Disabled keyboard at cover Enabled
open
Sound for PCA
Maintenance Disabled Patient Enabled
bolus request
handset
Library Blinking light for
Disabled Enabled
information PCA bolus
Clinical
Disabled Continuous rate ?
information
PCA bolus
Data Set Disabled 200 mL/h
Flow rate PCA loading dose
Direct bolus
1200 mL/h
Programmed bol.
KVO 1mL/h

Features not enabled in the factory configuration can be enabled in the pump options or in custom
profiles. Otherwise, they can be enabled on request.

159
Index
A Continuous Rate
Definition 23
Agilia Connect Infusion System 15
Illustration 25
Alarm
Adjust Volume 98 Programming 54
Contraindications 13
End of Infusion 82
Cumulated Limits
List 112
Priorities 111 Definition 24
Setting 56
Priority 19
Silencing 83
Sound Level 139
D
Data Communication 108
B Data Set
Definition 30
Background Infusion 23
Display Information 105
Basal Rate 23
Basic Profile 28 Upload 109
Upload Symbol 22
Configuration 159
Date/Time 54, 107
Battery
Characteristics 138 Setting 103
Day Mode 96
Charge Level 19, 37, 92
Delivery Package 22
Full Charge Time 36
Operating Mode 137 DERS
Definition 24
Bolus 77
Drug 29
Clinician 23, 64, 94
Direct 77 Dimensions and Weight 140
Disinfection 131
Pause 78
Displaying Dose Infused 92
PCA 23, 63
Programmed 78, 94 Displaying Profile Information 87
Displaying Volume Infused 92
Stop 78
Dose Error Reduction Software
Bolus Cord
Connecting and Disconnecting 35 Definition 24
Dose Infused
Definition 23
Display and Clear 92
Description 18
Using 63 Dose Rate
Monitoring 76
Bolus in Progress
Programming 72
Monitoring 60
Dose/Time 79, 97
C Drug
Select 48, 71
Cables
Select Concentration 48
Data Communication 108
Drug Entry 29
Power Supply 138
Drug Library 28
Charging the Battery 36
Display Information 104
Cleaning 131
Drug List 28
Clinical Information Message 105
Drug X 30
Clinician Bolus 94
Administration 64
Definition 23
E
Electromagnetic Guidance 152
Empty Syringe Mode 83
End of Infusion 82
End of Infusion Alarm 83

160
Environment 13 Infusion Limits 24
Essential Features 123 Acknowledging 55
Event Log Hard and Soft 29
All Infusions 102 Overriding 55, 74
PCA Infusions 101 PCA 30
Programming 56
F Review 57
Factory Configuration 159 Infusion Mode 29
First Use 36 Continuous Rate 23, 25
Flow Rate Dose Rate 72
Monitoring 75 Dose/Time 79, 97
Programming 74 Flow Rate 74
General Infusion 27
G PCA Bolus 25
General Infusion PCA Bolus + Continuous 26
Main Steps 69, 70 PCA Bolus + Variable Rates 26
Pre-programming 81 PCA Therapy 24
Start 75 Select 53, 71
Glossary 157 Variable Rates 23
Graphics Volume Limit 80, 97
Flow Rate History 99 Volume/Time 79, 97
Pressure History 100 Infusion Programming
Continuous Mode 43
H Continuous Rate 54
Handset Dose Rate 70, 72
Connecting and Disconnecting 35 Flow Rate 69, 74
Definition 23 PCA Bolus 53
Description 18 PCA Bolus + Continuous Mode 44
Using 63 PCA Bolus + Variable Rates 45
Hard Limit 29 PCA Bolus Mode 43
Height 41 Variable Rates 54
History Data Installation 31
Flow Rate 99 Intended Use 10
General Infusion 98
PCA 61, 100 K
Pressure 100 Keypad
Description 18
I Lock / Unlock 89
Infusion Unlock 84
Change Infusion Rate 76 Unlock Code 107
End 82 KVO 79, 80
Modify Parameters 62
Monitor 58, 75 L
Pause 93 Language Selection 107
Pre-programming 81 Limits
Start 58, 75 General Infusion 74
Status Symbols 20 Hard and Soft 29
Stop 82 PCA 30
View History 98, 100

161
Loading Dose Patient Controled Analgesia
Pause 74 Bolus 23
PCA 23 Definition 23
Programming 52 Patient Handset
Stop 74 Alarms 113
Locking/Unlocking the Keypad 89 Connecting and Disconnecting 35
Lockout Time Definition 23
Definition 23 Description 18
Display 65 Using 63
Pausing an Infusion 93
M PCA
Maintenance 155 Definition 23
Display Information 104 Loading Dose 23
Reminder Message 37 Lockout Time 23
Requirements 155 Time Interval 23
Menu Titration 23
Customization 107 PCA Alarms
List 85 During Programming 66
Modifying Infusion Parameters Patient Handset 113
General Infusion 76 Protective Cover 112
PCA 62 PCA Bolus
Modifying the Pressure Limit 87 Administration 63
Monitoring Definition 23
Bolus in Progress 60 Illustration 25
Dose 76 Lockout 64
Flow Rate (ml/h) 75 Monitoring 58
PCA Bolus + Continuous Mode 59 Programming 53
PCA Bolus Mode 58 PCA Bolus + Continuous
Illustration 26
N Monitoring 59
Navigation Buttons 20 PCA Bolus + Variable Rates
Near End of Infusion Alert 82 Illustration 26
Night Mode 96 PCA Code 46
PCA History 61, 100
O PCA Infusion
Occlusion Main Steps 42
Clearing 88 Modify Parameters 62
Pressure Limits 89 Start 58
Operating Conditions 13 PCA Limits
Operational Tests 110 Acknowledging 55
Options Definition 24
Pump Configuration 106 Overriding 55
User Menu 85 Setting 56
PCA Lockout 23, 65
P PCA Modes 24
Select 53
Packaging 22
Patient Characteristics 127 PCA Parameters
Review 57
Change 95
PCA Treatment 101
Description 12
Setting 50, 72 Pole Installation 32

162
Power Cord 138 Silencing an Alarm 83
Power Supply Soft Limit 29
Characteristics 138 Software Version 166
Symbols 19 Sound Levels 139
Powering Off 84 Starting a General Infusion 75
Powering On 37 Starting a PCA Infusion 58
Pre-programming an Infusion 81 Stopping an Infusion 82
Prescription Unit Storage 149
Select 47 Symbol Descriptions 2
Pressure Syringe 119
DPS 88 Change 121
Management 127 Display Information 102
Modify Limit 87 Installation 39
Operating Range 13 List 119
Priming Remove 121
Manual Prime 119 Replacement Interval 121
Prime With Pump 50 Select 47, 71
Profile
Basic Profile 28 T
Custom 27 Table of Contents 3
Custom Profile 27 Temperature
Definition 27 Operating Range 13
Display Information 87 Testing the Pump 110
Select 46, 71 Therapy
Programming Mode Select 46, 71
Select 71 Titration
Protective Cover General Infusion 76
Alarms 112 PCA 23, 52
Unlock Keypad 84 Training 12
Pump Configuration 106 Treatment in Progress
Default Settings 107 Clear Data 101
Pump Configuration Menu Display Data 92, 101
Access 106 Troubleshooting 147
Trumpet Curves 140
Q
Quick-Start 51 U
Units 128
R Unlocking Keypad 84
Rail installation 33 User Test 110
Release Notes 166
Reviewing Infusion Parameters 57 V
Rotating Pole Clamp 32 Variable Rates
Definition 23
S Programming 54
Screen Volume Infused
Contrast 107 Display and Clear 92
Display and Symbols 20 Volume Limit 80, 97
Screen options 107 Volume/Time 79, 97
Servicing 155 VTBI 79, 125
Setting Date and Time 54, 103

163
W
Warranty 151
Wi-Fi 109, 144
Enabling or Disabling 107
Symbol Display 20
Wireless Communication 109

164
165
Release Notes

Date Software Version Description

May 2018 3.1 Creation

This document may contain inaccuracies or typographical errors.

Modifications may thus be made, and included in later editions.
Due to the evolution of standards, and of legal texts and materials, the characteristics indicated in the
text and images of this document are applicable only to the device with which it is included.

The screenshots and illustrations in this document are for illustrative purposes only. Screen contents
may vary based on individual configurations and minor software modifications; therefore, some
screenshots may appear slightly different from what you see on the product.

This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi.
Vigilant® and Agilia® are registered trademarks in the name of Fresenius Kabi in selected countries.

Made in France
Revision date: May 2018

www.fresenius-kabi.com 0123

First CE Mark: 2018

166
Local Contacts for Servicing

12098-5_master_ifu_agilia_sp_pca_eng

Fresenius Kabi AG Fresenius Vial S.A.S

61346 Bad Homburg Le Grand Chemin
Germany 38590 Brézins - France