Amika+

Enteral feeding pump

Software version 1.0

Instructions For Use

Symbol descriptions
Warning (Refer to the Instructions For
Use) 0123CE mark

Refer to the Instructions For Use Medical electrical system weight (kg)

Product reference / part number Product serial number

Name and address of the
Name and address of the manufacturing facility
manufacturer / Date of manufacture
Battery specification Protection against leakage current;
defibrillation-proof type CF applied part
Direct Current (DC) Alternating Current (AC)

Output terminal - connector Input terminal - connector

Fragile, handle with care This way up

Keep away from rain Temperature limitation

Humidity limitation Atmospheric pressure limitation

General symbol for recyclable

Eco packaging symbol
material
IP32 Holder: IP32-Index of protection against solid foreign objects (> 2.5 mm) and dripping liquids
IP35 Pump: IP35-Index of protection against solid foreign objects (> 2.5 mm) and water jets from
any direction
AC/DC Adapter: IP41-Index of
Protection against electric shock:
IP41 protection against solid foreign
class II
objects (> 1 mm) and dripping liquids

Part included in a recycling process

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

Information: recommendations to be followed.

INFORMATION
Please refer to the Use environment section for additional information on
temperature, pressure and humidity limitations.

2
Table of contents
1 Introduction 5
1.1 Scope....................................................................................................................5
1.2 Intended use..........................................................................................................5
1.3 Intended user population.......................................................................................5
1.4 Intended patient population...................................................................................5
1.5 Principles of Operation..........................................................................................6
1.6 Contraindications...................................................................................................6
1.7 Use environment...................................................................................................6
1.8 Specificities for Homecare Environments..............................................................7

2 Description 8
2.1 System definition...................................................................................................8
2.2 Packaging content.................................................................................................8
2.3 General description...............................................................................................8
2.4 Detailed description...............................................................................................9
2.5 Display description..............................................................................................10

3 Installation and removal 13

3.1 Installation...........................................................................................................13
3.2 Removal..............................................................................................................17

4 Operations 19
4.1 Use of internal battery.........................................................................................19
4.2 Basic operations..................................................................................................20

5 Pump menu 31
5.1 Access menus.....................................................................................................31
5.2 Feeding mode and settings.................................................................................32
5.3 Night mode..........................................................................................................34
5.4 Sound..................................................................................................................35
5.5 Settings lock........................................................................................................35
5.6 Cumulative feeding volume counter....................................................................36
5.7 Alarm history........................................................................................................37
5.8 Feeding history....................................................................................................38
5.9 Contrast / Brightness...........................................................................................38
5.10 Set time between two alarm sounds..................................................................39
5.11 Set time for target volume almost reached message........................................39
5.12 Technical information.........................................................................................40
5.13 Reset manufacturing settings............................................................................40

3
6 Cleaning and disinfection 42
6.1 Prohibited cleaning or disinfection agents...........................................................42
6.2 Precautions..........................................................................................................42
6.3 Recommended cleaning and disinfection agents................................................42
6.4 Cleaning and disinfection guidelines and protocol..............................................42

7 Quick check protocol 45

8 Alarms and safety features 47

8.1 Alarms / Actions...................................................................................................47
8.2 Troubleshooting...................................................................................................52

9 Technical information 54
9.1 Performance........................................................................................................54
9.2 Technical characteristics......................................................................................55

10 Transport, storage and recycling conditions 63

10.1 Storage and transport conditions.......................................................................63
10.2 Storage..............................................................................................................63
10.3 Recycling and disposal......................................................................................64

11 Guidance and manufacturer’s declaration on EMC 65

11.1 Electromagnetic compatibility and interference guidance..................................65
11.2 Guidance and manufacturer’s declaration - Electromagnetic immunity............66
11.3 Recommended separation distances between portable and mobile RF
communication equipment and pump........................................................................66

12 Services 67
12.1 Warranty............................................................................................................67
12.2 Quality control....................................................................................................67
12.3 Maintenance requirements................................................................................68
12.4 Service policy and rules.....................................................................................68

13 Ordering information 69
13.1 Instructions for use............................................................................................69
13.2 Giving sets.........................................................................................................69
13.3 Accessories.......................................................................................................69

14 Glossary of terms 71

4
1 Introduction
Amika+ is an enteral feeding pump with a holder and disposables dedicated to enteral
feeding and hydration. The intended use of Amika+ pump and sets is to deliver nutrition
and hydration fluids to the patient through a feeding tube, in a safe, instinctive and convenient
manner.

1.1 Scope
These Instructions for Use (IFU) are applicable to the Amika+ pump referred to as pump
with software version 1.0.

WARNING
■ Check that these IFU are applicable to the current Amika+ software version.
■ The software version of the pump is displayed in the technical information
menu described in Technical information on page 40.
■ The user must follow the instructions specified in this IFU. Failure to observe
these instructions may result in damage to the equipment, injury to patients
or injury to users. Specific texts are highlighted using the symbols described
in Symbol descriptions on page 2.

1.2 Intended use

Amika+ enteral feeding pump is intended for use on adults and pediatrics to deliver nutrition
and hydration fluids to the patient through an enteral route of administration using a feeding
tube.
It is intended for use by both qualified and trained healthcare professionals in clinical
healthcare facilities, in ambulatory use with an Amika Backpack and in pre-hospital medical
ground transportation and home users in homecare.

1.3 Intended user population

WARNING
Keep the pump, sets and AC/DC adapter away from unsupervised children
(and animals).

The pump must only be used and cleaned by trained healthcare professionals, patients or
patient relatives.
It is recommended that users attend a single training session of about 60 minutes (For
training, contact your Fresenius Kabi sales representative).

1.4 Intended patient population

The pump can be used on one patient at a time and on multiple patients during its lifetime.
The pump can be used on patients requiring enteral feeding and enteral hydration.

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The intended patient population includes patients who get enteral nutrition parallel to IV
insulin administration. Those patients require special attention during the feeding process.

1.5 Principles of Operation

The device is a peristaltic pump dedicated to enteral feeding.
The pump is used to administer to patient (humans only) a volume of nutrition at a
programmed flow rate.
The feeding can be administered continuously (Continuous mode) or sequentially (Bolus
mode).
The pump is designed to administer fluids through trans-nasal or percutaneous feeding
tube.
The pump is designed to administer any kind of enteral nutrition fluids, including drinking
water (still and sparkling), tea, soda, fresh water and the whole product range of ready
nutrition from Fresenius Kabi.

1.6 Contraindications
DO NOT USE:
■ for the intravenous administration of infusion fluids;
■ if enteral feeding is contraindicated by medical prescription;
■ with premature (born < 37 weeks of pregnancy) and neonates (<1 month);
■ in Magnetic Resonance Imaging (MRI) environments;
■ in ambulances, helicopters, aircrafts and hyperbaric chambers;
■ in areas where there is a risk of explosion.

1.7 Use environment

The Amika+ AC/DC adapter is not meant to be used outdoors (such as in the garden, on
the patio).

WARNING
■ Keep away from heat sources, dust, fluff, direct and prolonged light
exposure.
■ The pump should be used under specified operational, storage and transport
conditions listed below to ensure pump performance.
■ At the limit of the operating temperature range, physical properties of set’s
tube may change; in such condition, alarms are more likely to happen.

■ Temperature operating range: 10°C to 40°C

■ Storage and transport temperature: -20°C to +45°C
■ Pressure operating range: 700 hPa to 1060 hPa
■ Storage and transport pressure: 500 hPa to 1060 hPa
■ Humidity operating range: 30% to 85%, no condensation
■ Storage and transport humidity: 10% to 90%, no condensation

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■ Altitude: maximum 3000 m.
In case of refrigerated products, allow the product to reach the operating temperature range
before use.
When the pump is stored at extreme temperature (-20°C and +45°C), wait for 2 hours to
allow the product to reach the operating temperature range before using the pump. An
intempestive alarm can be triggered if the pump/giving set temperature is too low or too
high.

1.8 Specificities for Homecare Environments

The responsibility of using the pump is shared between the healthcare professional and the
patient. All pump settings must be performed according to the medical prescription.
If any doubt, patient or patient relatives should call healthcare professional to confirm correct
handling of the device.

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2 Description
2.1 System definition
The Amika+ system is composed of the following components:
■ Amika+ pump: enteral feeding pump with pump holder and AC/DC adapter.
■ Amika+ disposable (applied part): giving sets.
■ Amika+ accessories.
For more information on accessories, refer to their respective accompanying documents.

2.2 Packaging content

The Amika+ packaging contains the following elements:
■ 1 Amika+ pump
■ 1 pump holder COM
■ 1 AC/DC adapter
■ 1 Amika Nurse call Cable
■ User documents
Packaging consists of: recycled cardboard.
Symbols used on Amika+ packaging are described in Symbol descriptions on page 2.

2.3 General description

Legend
1

1 Pump

2 Giving set (sold separately)

3
3 Pump holder

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2.4 Detailed description
Pump description

4
5 6

7
2

8
3 12

11
1
10

9
Legend
1 Tube guides
2 Pinch clamp slot
3 Pumping mechanism
4 Status light indicator
5 Front panel (keypad)
6 Door lever
7 Pump door
8 Pump identification label
9 Speaker
10 Rails for installation on pump holder
11 Contact pins for pump to holder connection
12 Pump door identification label

9
Holder COM description

Legend
1 AC/DC adapter’s connector
2
2 Clamp handle
3 Pole clamp
4 Grey locking lever
3
5 Contact pins for pump to holder
4 connection (Power supply)
8 6 Holder identification labels
1
5 7 Slot for cable
8 Jack 3.5 mm Nurse Call port
9 9 Mini USB port
6 7 Near the power cable inlet of the
holder, description in Power supply
specifications on page 55

Front panel (keypad) description

2 3 4 Legend
1 Display (description next page)
2 Mute key
5 3 Keypad lock key
4 Menu key
6
1 5 Mains supply light indicator
6 Power ON/OFF key
7
7 Flow rate Up
8
8 Flow rate Down / Scroll up in Menu
9 9 Target volume Up
10 Target volume Down / Scroll down
10
in Menu
11 Priming function key
12 Stop / Cancel / Back key
13 Start / Enter / OK key

13 12 11

2.5 Display description

Status Bar icons

Sound level icons Alarm icon

10
 Battery icon Muted alarm icon

Keypad locked icon Settings lock icon

Continuous mode setting screen layout

Legend
2
1 Pumping status indicator:

Pumping is stopped
1 3

Pumping is in progress
2 Status bar
4 3 Flow rate
5 4 Target volume
6 Remaining feeding time
5

6 Progress bar showing volume

delivered / total volume

Bolus mode setting screen layout

Legend
2
1 Pumping status indicator:

Pumping is stopped
1 3

Pumping is in progress
4
2 Status bar
3 Flow rate
5
4 Current bolus / Bolus number
6
Bolus mode is activated.
7
5 Volume per bolus
6 Remaining feeding time of all
boluses
7 Progress bar showing volume
delivered / total volume

11
Menu display layout

Legend
1 Menu list
2 Menu access
3 Scroll bar
4 Back

12
3 Installation and removal
Installation and removal must only be done when the patient is not connected.

3.1 Installation
3.1.1 Global installation
Ensure that the appropriate positions between patient, pump, giving set and container are
maintained.

WARNING
■ Do not vary the pump height while a patient is connected to it. This may
lead to false alarms and will alter flow rate accuracy.
■ Check the stability of the whole system. If the container is positioned lower
than 0.5 m beneath the pump, this can lead to flow rate deviation.
■ Give particular attention to the risk of strangulation with cables and sets,
and with the small parts that could be swallowed or inhaled.

Figure 1: Recommended installation Figure 2: Possible installation

Place the container above the pump The container can be placed down to 0.5 m
beneath the pump
Do not place the pump below the patient or more than 1.3 meter above the patient.

3.1.2 Using the pole clamp

The holder can be attached universally, vertically and horizontally.
Turn the pole clamp to the suitable position.

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3.1.3 Positioning the holder on a rail, pole, bed or wheelchair
Ensure the holder is positioned so that the display is at the suitable height to ensure good
visibility and orientation in the reading direction (the contact pins are at the bottom).
X, Y min = 10 mm
X, Y max = 35 mm
Ø Ø min = 8 mm
Ø max = 40 mm

X
Y

1. Fasten pole clamp firmly on the pole or rail to avoid any movement of the pump.
2. Ensure that the pump is securely attached and positioned.

3.1.4 Positioning the holder on a table

The holder can be placed on a flat and horizontal
table as indicated in the figure.
Ensure the pump is positioned away from table
edges to avoid being accidentally pushed off the
table.

3.1.5 Positioning the pump

Slide the pump down until the grey locking lever
locks the position.

3.1.6 Electrical connection

Ensure AC/DC adapter is not damaged and is compatible with local voltage range.
To charge battery or to use the pump on the mains power supply:

14
1. Connect AC/DC adapter to the holder.
2. Plug the AC/DC adapter to the mains socket.
When connecting to the mains, ensure that the AC/DC adapter and the power socket
are easily accessible.
The mains power supply is indicated by a green light on the pump's front panel (keypad).

3.1.7 Connection to the Nurse Call System and Removal

The Amika Holder COM and Nurse Call cable allow the connection of an Amika+ pump to
an external Nurse Call system to transmit an Amika+ pump alarm state.
The Nurse Call connection is functional only if:
■ the pump is correctly installed on the holder.
■ the holder is connected to the power supply.
■ the Nurse Call cable is correctly plugged.
If the Nurse Call is not functional, Amika+ pump alarm state is not transmitted.
The Nurse Call system availability and technical compliance are the responsibility of the
hospital.

15
1. Connect the terminated Nurse Call cable to the holder Nurse Call connector.
2. Pinch the cable into the slot provided for this purpose.
3. Check that the nurse call system is functional by generating an alarm (eg: start the pump
with no giving set installed). Ensure the pump alarm is transmitted on the connected
Nurse Call system.
4. To disconnect, unplug the Nurse Call cable.

INFORMATION The nurse call cable is delivered with an unterminated side,

which will require customization to the hospital-specific nurse call system by a
trained technician. See Amika Holder COM Nurse Call IFU or Amika+ technical
manual for further information.

3.1.8 USB connection and removal

INFORMATION
■ Use ONLY cables recommended by Fresenius Kabi. Refer to Ordering
information on page 69.
■ 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.
■ Do not disconnect communication cables while data is being transferred.

1. Connect the terminated USB cable to the holder mini USB connector.
2. Connect the other side of the USB cable to the third party system.
3. Check communication status.
4. To disconnect, unplug the USB PC cable.

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3.1.9 Data communication overview

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, please contact
your IT or biomedical department.

Amika+ data communication feature allows:

■ Communication between a hospital information system server and 1 pump.
■ Connection of 1 pump to a PC for the following purposes: Maintenance (via Amika
Partner software).

3.2 Removal
3.2.1 Removing the pump from the pump holder
1. Push the grey locking lever.
2. Pull the pump up.
2

3.2.2 Removing the pump holder

3.2.3 Electrical disconnection

1. Remove AC/DC adapter from power socket.
17
 ■ A beep is emitted by the pump when the AC/DC adapter is disconnected.
■ To store the pump, see Storage on page 63.

2. Remove AC/DC adapter from holder.

3.2.4 Attaching / Removing the Quick Guide

A quick guide can be easily attached and removed
from the pump holder.

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4 Operations
4.1 Use of internal battery
4.1.1 Battery precautions
Before using the pump on battery for the first time, charge the battery until it is fully charged
(approximately 6 hours).
Keeping the pump connected to mains when not in use is recommended in order to maintain
battery charge. The battery is charging continuously ensuring its maximum capacity.

4.1.2 Battery operating mode

The icon is always displayed in the status bar. The device can be used while battery
is charging.
Battery life 24 hours ± 5% until 125 mL/h and a minimum of 8 hours for flow rates above
125 mL/h (in standard feeding conditions, at 22.5°C ± 2.5°C)

When the pump is connected to the mains (see Electrical connection on

page 14)
(green)
► Battery charges automatically, also during operation

When the pump is disconnected from the mains (see Electrical disconnection
on page 17)
► Pump switches to Battery Mode automatically

The battery is fully charged

The battery is partially charged

The battery is nearly empty.

(flashing) ►A visual information is triggered (see Alarms / Actions on page 47).
When battery is empty (less than 10 minutes left), an alarm is triggered (see
Alarms / Actions on page 47.)

INFORMATION
■ To optimize battery life, set the flow rate at 125 mL/h maximum and use
the pump in battery mode several times until battery is discharged (
flashing).
■ If battery is failing, do not use the device. Return device to Fresenius Kabi
sales representative as soon as possible.
■ Battery replacement must be performed by qualified and trained technical
personnel in compliance with the technical manual and procedures.

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4.2 Basic operations
Before using the pump, proceed to Quick Check Protocol (see Quick check protocol on
page 45).

4.2.1 Switch-on
When using a pump on patient requiring special attention, ensure that a backup pump or
gravity set are available for immediate use.
When switching on the pump, check that the auto test sequence is as described below.
Before switching on the pump, install holder and pump, see Installation on page 13.

Figure 3: Auto test

During the 2-second autotest:

■ red, yellow and green LEDs blink;
■ beep sounds (if sound level is low, melody is playing on low, if sound level is high, melody
is on high).

4.2.2 Installing the giving set

4.2.2.1 Preparing the giving set
In order to protect user health, please follow clean aseptic handling procedures for container,
set or feeding tube disposal.

WARNING
■ Only Fresenius Kabi giving sets can guarantee pump reliability. Please refer
to the compatible giving sets (see Giving sets on page 69) and compatible
nutrition fluids (see Intended use on page 5).
■ Check the giving set's intended use regarding the feeding protocol, especially
for patients requiring special attention.
■ Check giving set and patient connection integrity before use.

20
 CAUTION
The fluid in the giving set and the bag/bottle must be within normal temperature
conditions: +10°/+40°C.

4.2.2.2 Description of the pinch clamp

Pinch clamp is open Pinch clamp is closed

INFORMATION
Patient must not be connected to the set when the pinch clamp is open.

4.2.2.3 Installing the giving set in the pump

To connect / disconnect / change the container and feeding tube to the set, refer to the
giving set "Instructions for use" on primary packaging.

WARNING
For patients requiring special attention, another giving set must always be
available.

1. Push up the lever to unlock the door . Open the door .

2. Position the pinch clamp using the arrow marks indicating the direction of the flow .
Insert the pinch clamp until you hear the ‘CLIC’ .

21
3. On the sides of the pump, place the tube straight inside tube guides.

WARNING
Check that the giving set is correctly installed to avoid patient harm such as
overfeeding, underfeeding.

4. Close the door . Push down the lever to lock the door .

22
 INFORMATION
When opening the pump door, the tube clamp is automatically closed (free-flow
prevention system).

4.2.3 Priming the giving set

WARNING
Patient must not be connected to the pump when priming is performed.

INFORMATION
■ To proceed to giving set priming, fill drip chamber half full by pressing gently.
■ Ensure that liquid is flowing in the drip chamber after starting the pump.
■ For giving sets without drip chamber, use only automatic priming.
■ A beep sound will be heard every 30 seconds during priming.

4.2.3.1 Priming with the pump

Amika+ pump allows two priming modes:
■ automatic priming: Amika+ pump automatically fills in the giving set at maximum rate

by depressing the automatic priming key ;

■ semi-automatic priming: Amika+ pump fills in the giving set at maximum rate as long as
the semi-automatic priming key is kept depressed.

INFORMATION
Automatic and semi-automatic priming fill the giving set at a rate of 600 mL/h
and are stopped after 17 mL (factory settings).

Make sure that priming is correctly completed before starting feeding.

Automatic priming

Auto priming can be stopped at any time:

23
At the end of automatic priming, it is possible to continue the priming using the semi-automatic
priming function as defined below.

Semi-automatic priming

Press key to access to the priming modes. Press key to launch the priming.
Keep it depressed during priming. Release it once priming is complete.

Press to go back to setting screen.

WARNING
At the end of priming, check that the set is correctly primed.

4.2.3.2 Priming without the pump (Manual priming)

Remove the giving set from the pump (see Removing/Changing the giving set from the
pump on page 28).
1. Close pinch clamp.
2. Connect food container to giving set and hang up.
3. Fill drip chamber half full by pressing gently.
4. Open pinch clamp and prime to the end of the giving set.
5. Close pinch clamp.
Install the set in the pump to start feeding (see Installing the giving set on page 20).

24
4.2.4 Change feeding setting

INFORMATION
■ A longer keypress provides faster scrolling.
■ The flow rate of delivery must be adapted individually to the patient. Regular
checks are required.

■ Adjust feeding rate (mL/h)

Press or key to set the feeding rate.

■ Adjust target volume (mL)

Press or key to set the target volume.

INFORMATION
In bolus mode, the target volume is adjusted per bolus.

■ Solve incompatible values (for bolus feeding)

25
 If the feeding is impossible due to incompatible values with the Bolus
parameters programming (Flow rate and Volume values are not
possible with the time interval between boluses programmed in the
bolus menu):
– The bolus volume and the flow rate are blinking
– The start key is inactive and the forbidden key beep is triggered
– The remaining time is not displayed
In homecare, prescription values can be confirmed by calling
healthcare provider or healthcare professional.
Modify bolus feeding parameters. To modify bolus settings, see Bolus
mode settings on page 33.
When the setting is OK for running with the correct values according
to the prescription:
– Start key is functional
– Remaining time is displayed
– Feeding can be started

WARNING
Make sure feeding parameters are checked before starting feeding
(programming error can lead to overfeeding, underfeeding or delay of therapy).

4.2.5 Start feeding

1. Connect the giving set to the patient's enteral feeding tube. Ensure that the giving set is
not stucked in any way.
2. Make sure that priming is correctly completed before starting feeding.

3. Check power supply before starting feeding.

■ Green light indicator if supplied by mains, or
■ Battery icon filled up if supplied by the battery.
Keypad lock is recommended for bolus feeding in order to avoid misusage.

26
4.2.6 Terminate feeding
■ Stop feeding

When feeding is stopped, flow rate and target volume parameters can be adjusted. Then,
feeding can resume.
■ Reset the progress bar.

When the pump is stopped, progress bar can be reset by depressing the key for
2 seconds.

4.2.7 Switch off pump

Feeding shall be stopped before switching off the pump.

27
 INFORMATION

■ When feeding is on-going, the key is inactive: the forbidden key beep
is triggered but feeding continues.
■ When switched off, the pump retains the following information:
– flow rate, volume and progress bar on the setting screen;
– cumulative feeding volume;
– bolus settings;
– remaining time;
– target volume mode;
– sound level, key beep activation / deactivation;
– contrast and brightness;
– feeding and Alarm history;
– settings lock activation / deactivation;
– time between 2 alarm sounds;
– time for target volume almost reached message;
– technical information.
■ This information is saved even if the battery is disconnected with no time
limit.
■ Feeding history and Alarm history allow the record of the 250 latest events
for each history.
■ In the case of a powering down, the time of powering down is not retained
in the history.

4.2.8 Removing/Changing the giving set from the pump

The mechanical properties of the administration set in association with the pump are designed
to maintain pumping performance for a maximum of 5 L or a 24-hour period.
Replace the administration set according to your healthcare facility's protocol or CDC
guidelines.
Administration sets are supplied sterile and are indicated for single use.
28
 WARNING
■ The use of the same set for more than 24 hours can lead to therapeutic
issues, such as infection, and uncontrolled flow.
■ For patients requiring special attention, another giving set must always be
available.

1. Push up the lever to unlock the door .

2. Open the door .

3. Remove giving set 3 .

Install a new giving set in the pump (see Installing the giving set on page 20).

4.2.9 Keypad lock

Keypad lock prevents from unintentional tampering of pump settings.

When keypad is locked:

■ is displayed in the status bar;

■ is the only active key. If other keys are depressed, the forbidden key beep (2
beeps) is triggered, no action is undertaken and feeding continues.

Keypad can be unlocked by depressing the keypad lock key for 2 seconds.

29
Unlocking the keypad is required to stop feeding, change feeding settings and enter the
menu.

4.2.10 Mute alarm

To temporarily release alarm sound, press .

When a medium priority alarm is muted:

■ the mute icon is displayed in the status bar;

■ the alarm symbol is displayed and the yellow LED keeps flashing until a corrective action
is performed;
■ the alarm sound is off for 2 minutes.
When a low priority alarm is muted:

■ the mute icon is displayed in the status bar;

■ the alarm symbol is displayed and the yellow LED is lit;
■ the alarm sound is off and an information signal sound (2 beeps) is emitted every 30
minutes.
For further information about alarms, see Alarms / Actions on page 47.

30
5 Pump menu
INFORMATION
■ The menu is accessible when feeding is stopped.
■ A beep sound is triggered when a forbidden key (not active in specific
screens) is depressed.

■ During a procedure, press ( ) to validate the choice and go back

to the setting screen.

■ Press ( ) to go back to the previous screen (without validation).

5.1 Access menus

Menu descriptions

Menus Description

Select feeding mode and Continuous mode activated:

settings Deactivate / activate target volume mode (the access code is required,
if the settings lock is activated)

Bolus mode activated:

Deactivate / activate flushing information
Enter the bolus settings (number of bolus, time interval between
boluses)
(the access code is required, if the settings lock is activated)

Night mode Night mode activation / deactivation

Sound Adjust sound level

Deactivate / activate key beep

Settings lock Deactivate / activate settings lock

Cumulative feeding volume Display cumulative feeding volume

counter
Clear cumulative feeding volume

Alarm history Consult the last 250 alarm events

Feeding history Consult the last 250 feeding events

Contrast / Brightness Contrast setting

Brightness setting

Time between 2 alarm Consult time between 2 alarm sounds

sounds
Set time between 2 alarm sounds (the access code is required)

31
 Menus Description

Time for target volume Consult time for target volume almost reached message
almost reached message
Set time for target volume almost reached message (the access code
is required)

Technical information Consult technical information of the pump

Reset manufacturing setting Set pump to factory settings

Menu navigation

Press then press , to scroll up / down between submenus.

Press to enter the submenu.

5.2 Feeding mode and settings

5.2.1 Feeding mode selection
On this screen, continuous mode is activated .

32
Press to select Feeding mode and settings.

Press to activate Continuous mode or to activate Bolus mode.

5.2.2 Continuous mode settings

On this screen, target volume mode is activated . If you programme a feeding with no
target volume and a feeding with target volume with respectively different flow rates, the
respective flow rates are saved.

Press to select target volume mode in the menu. Press or to deactivate /

activate target volume mode (defaut setting: activated). Press to validate.

INFORMATION
■ When target volume mode is deactivated, the target volume and the progress
bar disappear from the display.
■ If the settings lock is activated, the access code is required to activate /
deactivate target volume.

5.2.3 Bolus mode settings

On this bolus mode menu , flushing information is deactivated .

33
Press the upper to activate Bolus mode in feeding mode menu. Press or to

deactivate / activate flushing information (defaut setting: deactivated). Press to validate.

Press or to set the bolus number.

INFORMATION
The bolus number is adjustable from 1 to 24. If is selected, the pump
performs boluses until the replacement of the container. In this case, if the
pump is switched off during a bolus, the complete volume of bolus will be
delivered when starting feeding again.

Press or to set the time interval between boluses. Press to validate.

5.3 Night mode

On this screen, night mode is activated .

Press to select Night or Day Mode. Press to activate Day Mode or to activate

Night Mode. Press to validate Night or Day Mode.

INFORMATION
■ When night mode is activated, display backlight and power LED are set to
minimum level.
■ In case of alarm, the backlight turns back to normal.
■ Night mode is automatically deactivated after switching OFF the pump.

34
5.4 Sound

The pump is set by default to the highest sound level . It can be reduced to a lower

sound level .

Press to select the sound level and key beep sound.

Press / to select low or high sound level. Press to deactivate key beep or press

to activate key beep.

Press to validate the sound level and key beep sound ON or OFF (default setting ON).

WARNING
Audible alarm signal level is adjustable. However, please ensure the user can
hear alarms, especially when the pump is used on battery.

5.5 Settings lock

Press key to configure Settings lock. Press key to enter the access code.

35
Enter the access code by adjusting each digit (0 to 9) using and keys and validate

each digit by pressing . If you enter the wrong code, it is reset to 0 0 0.

Press to activate settings lock function.

When settings lock is activated:

■ is displayed in the status bar;

■ target volume and flow rate cannot be changed;
■ Accessible keys are:

, with restrictions.

INFORMATION
■ To get the access code, contact your Fresenius Kabi sales representative.
■ Settings lock activation / deactivation isn’t modified after switching OFF the
pump.
■ When settings lock is activated, keypad lock can still be activated /
deactivated.

5.6 Cumulative feeding volume counter

Press to display the cumulative feeding volume. The total feeding volume since last
reset is displayed.

If needed, press then to clear the cumulative feeding volume (default setting).

36
5.7 Alarm history
Alarm events are automatically saved in the pump memory.

Press to display the alarm events.

Press , to switch from one alarm event to another.

INFORMATION
Alarm history indicates the type of alarm and the time elapsed since the event
happened.

Example: a battery alarm occurred 4 days, 1 hour and 0 minute

ago.

37
5.8 Feeding history

Press to display the feeding events.

Press , to switch from one feeding event to another.

INFORMATION
Feeding history indicates the delivered volumes, their associated flow rate and
the time elapsed since their delivery.

Example: a volume of 1224 mL was administered at a flow

rate of 580 mL/h split on 4 boluses, 5 days and 25 minutes ago.

5.9 Contrast / Brightness

Press . Press to set the contrast or the brightness.

Press to validate.

38
5.10 Set time between two alarm sounds

Press . Press to set the time between two alarm sounds. Press to
validate.

INFORMATION
The access code is required to set time between two alarm sounds.

WARNING
Time between 2 alarms can be adjusted from 2.5 to 30 seconds with steps of
0.5 seconds. This adjustment can modify the perception of an alarm (Default
value 2.5 seconds).

5.11 Set time for target volume almost reached message

Press . Press or to set the time for target volume almost reached message.

Press to validate.

INFORMATION
■ Time between target volume almost reached message and target volume
reached alarm can be adjusted from 0 to 59 min., with steps of 1 min (default
setting 5 min.).
■ Access code is required to set time for target volume almost reached
message.

39
5.12 Technical information

Press to access the technical information.

NOTE : the technical information menu displays:

Pump serial number

Software version
Production date (mm/dd/yyyy)
Last maintenance date (mm/dd/yyyy)

Total delivered volume

Total functioning time

5.13 Reset manufacturing settings

Reset manufacturing settings is recommended to facilitate the transition from one patient
to another.

Press to access the reset menu.

Press again to reset to manufactory settings. The Reset symbol is flashing for 2
seconds.
■ All prior settings are erased
40
■ All pump settings revert back to factory settings

INFORMATION
The access code is required to reset manufacturing settings.

41
6 Cleaning and disinfection
6.1 Prohibited cleaning or disinfection agents
Do not use cleaning or disinfection agents that contain the following substances as these
aggressive agents may damage the plastic parts of the device and cause the device to
malfunction:
■ trichloroethylene
■ abrasive detergents

6.2 Precautions
Clean pump and pump holder as soon as they become contaminated with tube feed or
drugs, and at least once a week.
After cleaning, the pump should be left to dry for approximately 5 minutes before being
started or reconnected to the mains.
The pump must be cleaned after each patient usage by a trained nurse or assistant nurse.

WARNING
■ The pump is not intended to be sterilized, it may damage the pump. The
Amika+ is a non-sterile medical device.
■ The Amika backpack must be cleaned before inserting the pump. Please
refer to its specific accompanying documents.
■ Make sure to use the original door when replacing it on the pump (check
the serial number on the pump is the same as on the door). A door switch
between pumps can lead to major pumping errors.

6.3 Recommended cleaning and disinfection agents

Didecyldimethylammonium chloride (example: Wip'Anios Excel by Anios).
Please contact the appropriate service, responsible for cleaning and disinfection products
in your establishment for further details.

6.4 Cleaning and disinfection guidelines and protocol

INFORMATION
■ Do not immerse pump and pump holder in liquids or let liquids enter device’s

housing.
■ Pump and pump holder are resistant to recommended cleaning agents (see
Recommended cleaning and disinfection agents on page 42).

42
6.4.1 Cleaning Instructions
Prerequisites
■ The pump is switched off.
■ The power cord and all other cables are unplugged.
■ The pump is disconnected from the holder.
■ The air is at room temperature (20 to 25 °C).
■ The operator is wearing suitable protective equipment.
Protocol
1. Place the pump and the holder on a cleaned surface or disposable underlay. The door
can be removed from the pump to facilitate the cleaning.

NOTE : The door can be immersed. Clean it separately with running water.
2. During cleaning, do not turn the pump over to avoid liquid leak in the battery door.
3. Use a ready-to-use wipe to remove any major grime.
4. Thoroughly wipe down all exposed surfaces (housing, keypad, screw area, holder
connection area, etc.) of the pump, from top to bottom. Gently wipe down the pump
exposed mechanism and sensor area (tube guide, purple insert).
A minimum cleaning of 1 minute is recommended (allow to remain visibly wet for 1
minute), until all organic matter is dissolved and removed. Do not allow liquids to run,
leak, or drip into the pump housing. Use cotton wool to clean the contact peans.

5. Repeat step 4 with the pump door (housing, lever, counter door) and holder (pole clamp
screw, housing, etc.)
6. Using a fresh ready-to-use wipe, thoroughly wipe down all exposed surfaces. A minimum
cleaning of 1 minute is recommended (allow to remain visibly wet for 1 minute), until all
organic matter is dissolved and removed.
7. Wipe down the power cord.
8. Allow the device to dry completely at room temperature.

43
9. Make sure to use the original door when replacing it on the pump (check the serial number
on the pump is the same as on the door).

6.4.2 Disinfection instructions

Prerequisites
■ The cleaning protocol has been performed.
■ The pump is switched off.
■ The power cord and all other cables are unplugged.
■ The pump is disconnected from the holder.
■ The air is at room temperature (20 to 25 °C).
■ The operator is wearing suitable protective equipment.
Protocol
1. Place the previously cleaned pump and holder on a cleaned surface or disposable
underlay. The door can be removed from the pump to facilitate the disinfection.
2. During disinfection, do not turn the pump over to avoid liquid leak in the battery door.
3. Use a ready-to-use wipe to wipe down all exposed surfaces of the pump, holder and
pump door (as described in cleaning protocol), making sure to cover all cracks, crevices,
and hard-to-reach areas. Do not allow liquids to run, leak, or drip into the pump housing.
4. Using a fresh ready-to-use wipe, repeat steps 3. Ensure that the minimum contact time
for each step is 3 minutes for bactericide activity (surface remain visibly wet for 3 minutes).
Respect the indicated contact time from the manufacturer recommendations for the
required antimicrobial activity.
5. Wipe down the power cord.
6. Allow the pump to dry completely at room temperature.
7. Make sure to use the original door when replacing it on the pump (check the serial number
on the pump is the same as on the door).

44
7 Quick check protocol
WARNING
■ The following checks allow users to confirm device behaviour according to
these instructions for use. Fresenius Kabi recommends performing these
tests before connecting Amika+ pump to patients.
■ If one or more checks do not comply with the right pump behaviour, please
contact the appropriate department or Fresenius Kabi sales representative
for additional verification.

Action Yes

Before use

1 - Check if the Amika+ pump, holder and AC/DC adapter are not damaged in any
way

2 - Check the general status of the display

3 - Install the Amika+ pump on the holder

4 - Connect holder to the mains

5 - Switch on the pump

6 - Check the autotest sequence

(LCD display intact, speaker, LED and the back light). Do not use with damaged
screens.

7 - Check the mains LED lights up

8 - Remove the Amika+ from the holder and check the battery symbol on the display

9 - Install the Amika+ pump on the holder

10 - Check that the pump and its holder are securely attached or positionned

11 - Check that all menu settings are adapted to the next patient

12 - Connect a set to a filled container, install the set in the pump and close the door

13 - Prime the set

14 - Set at the prescribed flow rate and target volume

15 - Start feeding

16 - Check the feeding information (droplet animation)

17 - Check that pumping is effective

After use

1 - Check if pump, holder and AC/DC adapter are not damaged in any way

45
 Action Yes

2 - Clean the pump, holder and AC/DC adapter

3 - Check the membrane of Amika+ pump is intact (no cracks, no wear)

Once a year

Check the following alarms and messages

(symbol on the display, beep sound, blinking status light indicator)

1 - Set installation alarm

2 - Door alarm

3 - Upstream occlusion alarm

4 - Downstream occlusion alarm

5 - Empty bag / Air in Line alarm

6 - Target volume almost reached message

7 - Battery nearly empty message

8 - Check the flow rate by measuring the delivered volume

46
8 Alarms and safety features
8.1 Alarms / Actions
The Amika+ pump has a continuous inspection system that operates as soon as it is in use.
It is recommended that the user should be in front of the Amika+ pump, for best visibility of
alarm display.
Please make sure the appropriate reaction to alarm is undertaken. A wrong or delayed
reaction leads to a delay in therapy.

WARNING
The pump emits audible alarm signals. Audible alarm signals from medical
devices may be masked by environmental noise.
Ensure the alarm sound level is audible by the user, taking into account the
environment.

The alarm sound level measures are:

Settings Pump on its holder Pump inside a backpack

High, medium, Low Level > 50 dB(A) > 45 dB(A)

low priority
alarms High Level > 60 dB(A) > 50 dB(A)

NOTE : dB(A) is the Level average pressure mesured following ISO 3744

8.1.1 The different types of information signal or alarm

Information signal sound Information signal Feeding continues
(2 beeps)

Information signal sound Information signal Feeding continues

(1 beep)

Flashing yellow LED and Information signal Feeding continues

alarm sound (sequences of
2 beeps)

Fixed yellow LED and alarm Prior information to alarm Feeding continues
sound (sequences of 3 (Low priority alarm)
beeps).

Flashing yellow LED and Functional alarm Feeding stops

alarm sound (sequences of (Medium priority alarm)
3 beeps)

47
Flashing red LED and alarm Technical alarm Feeding stops
sound (sequences of 10 (High priority alarm)
beeps)

Flashing red LED and Fail safe technical alarm Feeding stops
buzzer sound (High priority alarm)

When a functional alarm or prior information to alarm occurs:

■ to mute alarm sound, press , see Mute alarm on page 30;

■ detect the specific problem causing the alarm or prior information to alarm condition, by
looking at the drawing displayed on the pump;

■ to release alarm, press ;

■ make a corrective action (see table below);

■ restart feeding using the key.

WARNING
Identify displays, symbols and status in the table below, to understand the
meaning and conduct the appropriate action.

8.1.2 Alarm descriptions

Line control

Symbol Meanings Actions

Medium priority - Yellow LEDs are flashing

Giving set Missing giving set or giving set not ■ Check position of giving set above
properly installed or wrong set installed. and below the pump mechanism
and insert correctly if necessary.
■ Check that the proper set is used
(Amika+ giving sets only).
▷ See Installing the giving set on page
20.

Area where pinch clamp is inserted is ■ Remove dirt with cloth and soapy
contaminated. water or as directed by hospital
policy.
■ Allow the pump to dry.
▷ See Disinfection instructions on page
44.

48
 Symbol Meanings Actions

Door open Pump door not properly closed at start. ■ Close pump door.
▷ See Installing the giving set on page
20.

Pump door opened after start. ■ Close pump door.

▷ See Installing the giving set on page
20.

Pump door removed from its anchoring. ■ Re-hang door.

Door mechanism is faulty. ■ Contact your biomedical

department.

Upstream Upstream flowpath is blocked between ■ Open the door, check set
occlusion the container and the pump. installation.
▷ See Installing the giving set on page
20.
■ Check that the set is not kinked.
■ Check that upstream clamp is open.
■ Flush tube if necessary.
■ Check the absence of upstream /
downstream occlusion in the line.

Downstream Downstream flowpath is blocked after ■ Open the door, check the set
occlusion the pump, at the patient side. installation, close the door.
▷ See Installing the giving set on page
20.
■ Check that the set is not kinked.
■ Re-position and verify that food
flows freely after adjustment.
■ Check that the feeding tube is clear.
■ Flush tube if necessary.
■ Check the absence of upstream /
downstream occlusion in the line.

Feeding control

Symbol Meanings Actions

Low priority - Yellow LEDs are fixed

49
 Symbol Meanings Actions

End of bolus Displayed in feeding bolus mode only The flushing information can be
reached if the flushing information is activated. activated/deactivated in the menu.
The flushing information will be ▷ See Bolus mode settings on page 33.
displayed at the end of the pumping
■ To clear the flushing information,
period of a bolus (except the last bolus).
press .

Target volume Target volume will be reached. The time of message before target
almost reached Remaining time is flashing. volume is reached can be set in the
menu.
▷ See Set time for target volume almost
reached message on page 39.
■ End feeding or continue feeding.

Medium priority - Yellow LEDs are flashing

Target volume Alarm ■ End feeding or proceed to the next

reached The target volume is reached. step.
(Complete progress bar)

Function control

Symbol Meanings Actions

Low priority - Symbol battery is fixed yellow

Battery empty Minimum battery voltage is not This message appears 30 min. before
available. the empty battery alarm.
fixed
■ Connect the pump to the mains via
the pump holder. Recharge battery
to resume pump operation.

Medium priority - Symbol battery is flashing yellow

50
 Symbol Meanings Actions

Battery empty Alarm medium This alarm appears 10 min. before

Minimum battery voltage is not battery is fully discharged.
available.
■ Connect the pump to the mains via
the pump holder. Recharge battery
to resume pump operation.

flashing

Medium priority - Yellow LEDs are flashing

Empty bag / Air in Feed container is empty. ■ End feeding or connect to a filled
line feed container.

Air is in the giving set. ■ Fill giving set to the end.

▷ See Priming the giving set on page
23.

Dirt in sensor area (lower tube guide). ■ Open the door and remove dirt with
cloth and soapy water or as directed
by hospital policy (see Cleaning and
disinfection on page 42). Allow the
pump to dry.

Giving set not properly connected to the ■ Check position of giving set and
container. insert correctly if necessary.
▷ See Installing the giving set on page
20.

High priority - Red LEDs are flashing - Alarm sound

Technical alarm A technical alarm code is displayed with ■ Note the technical Error code (Err
the “Pump error alarm” drawing. xyz).
■ To release technical alarms, press

or for 2 seconds. The

pump will then switch off instantly
(no count-down).
■ Contact your biomedical
department.

51
 Symbol Meanings Actions

Battery technical The last battery technical alarm that ■ Note the technical Error code (Err
alarm occurred before switch OFF is reminded xyz).
at the next switch ON. ■ Contact your biomedical
department.

Fail safe Pump stops immediately. ■ Contact your biomedical

technical alarm department.

Information signal - Yellow LEDs are flashing

Start reminder Pump is switched on but not operating ■ Proceed to next step or switch
for 2 minutes (2 beeps) pump off.

NOTE : The maximum volume infused between the alarm condition and the technical
alarms generation is 35 mL.

8.1.3 Maximum alarm raising delay

Time between alarm condition and alarm generation is less than 5 seconds, except for
Giving set, Upstream and Downstream occlusions and Empty bag / Air in Line alarms (see
Performance on page 54).

INFORMATION
When two alarms are raised at the same time, the pump software prioritizes
the alarms.

8.2 Troubleshooting
Issue description Recommended action

Pump is not stable when ■ Check that the clamp handle is fastened
mounted

52
 Issue description Recommended action

Pump or holder is ■ Remove AC/DC adapter

damaged, noisy, smoking ■ Do not use the device
or with an abnormally hot ■ Contact your biomedical department or Fresenius Kabi sales
part. representative immediately
Pump screen is damaged

Pump has been dropped ■ Do not use the device

■ Contact your biomedical department or Fresenius Kabi sales
representative

Pump does not start after ■ Connect pump to the mains supply in case the battery is fully
switched ON discharged
■ Contact your biomedical department or Fresenius Kabi sales
representative if problem remains

Flow rate variance is higher ■ Check giving set configuration

than flow rate accuracy ■ Check fluid viscosity
■ Check the fluid is within normal temperature conditions
■ Contact your biomedical department or Fresenius Kabi sales
representative if problem remains

Front panel problem (keys, ■ Check the general state of the front panel (keypad)
LEDs) ■ Check the contrast
■ Contact your biomedical department or Fresenius Kabi sales
representative if problem remains

The mains connection LED ■ Connect pump to the mains supply

does not light up ■ Check that the LED on the AC/DC adapter lights. If not, unplug and
plug it again in the mains socket.
■ Contact your biomedical department or Fresenius Kabi sales
representative if problem remains

The device switches off on ■ Connect pump to the mains supply

its own ■ Contact your biomedical department or Fresenius Kabi sales
representative if problem remains

Battery alarm when pump ■ Check mains supply voltage

has been correctly charged ■ Contact your biomedical department or Fresenius Kabi sales
representative if problem remains

The device switches off ■ Battery is completely discharged: Charge the battery
when it is disconnected ■ Contact your biomedical department or Fresenius Kabi sales
from the mains representative if problem remains

Bolus volume and flow rate ■ Check bolus feeding parameters, see Feeding mode and settings
are blinking and feeding can on page 32.
not start in bolus mode.

The Nurse Call system ■ Check Nurse Call cable installation

does not replicate pump ■ Check holder is connected to the power supply
alarms. ■ Contact your biomedical department or Fresenius Kabi sales
USB connection is not representative if problem remains.
functional.

53
9 Technical information
9.1 Performance
9.1.1 Essential performance
Essential pump performance is defined as follows in standard operating conditions:
■ flow rate accuracy (± 7% at 50 mL/h with medical water);
■ occlusion detection time (< 6 min at 50 mL/h with medical water);
■ management of medium and high priority alarms, see The different types of information
signal or alarm on page 47.

WARNING
Flow rate accuracy can be influenced by giving set configuration, tube stretching,
fluid viscosity, fluid temperature, container height and feeding settings.

9.1.2 Flow Rate range

Range From 1 mL/h to 600 mL/h (default setting 50 mL/h)

Increments 1 mL/h from 1 mL/h to 600 mL/h

Accuracy ± 7% at 50 mL/h, ± 10% for the whole range of flow rates

Test initial conditions following 60601-2-24. Cumulative volume measured on a two-hour

period, with 25 mL minimum volume.
Container height: 50 cm.

9.1.3 Volume range

Range From 1 mL to 5000 mL (default setting 500 mL)

Increments 1 mL from 1 mL to 5000 mL

9.1.4 Upstream and downstream occlusions

Occlusion alarm response time at different flow rates.
Threshold available for triggering downstream occlusion alarm:
■ Occlusion will be detected for pressure 787.6 mmHg, ± 262.5 mmHg.

Occlusion detection time

Flow rate Downstream occlusion (1 m after Upstream occlusion (5 cm before

the pump) the pump)

1 mL/h 5 hours 1 hour 40 min.

25 mL/h 9 min. 4 min.

54
NOTE : Maximum occlusion pressure for the pump is 1875 mmHg, ± 225 mmHg.

9.1.5 Volume Accuracy

Accuracy

Limit to detect Upstream ≤ 25 mL

Occlusion*

Bolus volume at Rate < 5 mL

Occlusion Release* 25 mL/h

*Test condition: Back pressure: 0 mmHg, Container height: 50 cm

NOTE : A bolus ( ± 5mL) may occur during pump movement from 0 to 1 m above the
patient, and before occlusion release.

9.1.6 Empty bag / Air in Line alarm response time at different flow
rates
Time mentioned is applicable only if the set has been previously filled.
Empty bag / Air in Line detection time

Flow rate Air volume = 3.5 mL

1 mL/h 3 hours 30 min. maximum

25 mL/h 10 min. maximum

100 mL/h 3 min. maximum

9.1.7 Giving set alarm response time at different flow rates

Flow rate Giving set alarm detection time

1 mL/h 8 minutes maximum

25 mL/h 30 seconds maximum

100 mL/h 10 seconds maximum

9.2 Technical characteristics

9.2.1 Operation mode
The Amika+ pump is a reusable device. The pump ensures fluid delivery in a continuous
and sequential feeding mode, using pumping and clamping fingers to push the liquid to the
patient.

9.2.2 Power supply specifications

The AC/DC adapter must be connected directly to the mains power socket.
Protection against electric shocks: class II

55
AC/DC adapter input AC input voltage: 100-240 Vac ± 10%
AC input frequency: 50-60 Hz
AC input current: 110 mA-205 mA

AC/DC adapter output 9 Vdc ± 5 % / 1.0 A

AC/DC adapter cord Approximately 2.5 m

length

9.2.3 Battery specifications

Characteristics NiMH (Nickel-Metal Hydride)
4.8V 2.2 Ah Ni-MH

Weight Approximately 100 g

Maximum charging time 6 hours

9.2.4 Power consumption

Consumption of the pump in standard operating conditions: maximum 9 W.

9.2.5 USB connector specifications

Input/output 5 Vdc / 0.5 A.

Electrical insulation 1.5 kV insulation.

9.2.6 Nurse call connector specifications

Holder COM output 24 Vdc SELV (Safety Extra Low Voltage) / 0.5 A
24 Vac / 0.5 A

Electrical insulation 1.5 kV insulation

9.2.7 Dimensions - Weight

Weight Dimensions (H x W x D)

Pump 610 g 138 x 128 x 48 mm

Holder COM and cables 600 g 200 x 110 x 90 mm

Cable length: 2 m

AC/DC adapter 200 g -

Packaging 500 g -

9.2.8 Trumpet curves

The trumpet curves show the variations in the mean flow accuracy over specific observation
periods. The variations are presented on the maximum and minimum deviations of 5 pumps
and 1 pump from the overall mean flow within the observation window.
56
The test protocol used to obtain these results is described in 60601-2-24.
The curves can be helpful in determining the suitability of feeding parameters for specific
nutrition programmes.
Giving set used: Amika Varioline
Fluid used: distilled water, and Fresubin energy drink (1 mL/h only)
9.2.8.1 Minimum flow rate: 1 mL/h
Sampling time: 30 seconds

Start up and instantaneous flow rate (1 mL/h, over first 2h of the test period)

Trumpet curves for 2, 5, 11, 19, 31 minute observation windows (1 ml/h over second hour
of the test period)
Sampling time: 30 seconds

57
Instantaneous rate (1 mL/h, over last 2 hours of set change interval, 24 hours)

Trumpet curves for 2, 5, 11, 19, 31 minute observation windows (1 mL/h, over last hour of
the set change interval, 24 hours)
Sampling time: 15 minutes

58
Instantaneous flow rate (1 mL/h, over set change interval 24 hours)

Trumpet curves for 15, 60, 150, 330, 570, 930 minute observation windows (1 mL/h, over
set change interval, 24 hours)
9.2.8.2 Intermediate flow rate: 25 mL/h
Sampling time: 30 seconds

Start up and instantaneous at intermediate flow rate (25 mL/h, over first 2h of the test period)

59
Trumpet curves for 2, 5, 11, 19, 31 minute observation windows (25 mL/h over second hour
of the test period)

Instantaneous rate (25 mL/h, over last 2 hours of set change interval, 24 hours)

60
Trumpet curves for 2, 5, 11, 19, 31 minute observation windows (25 mL/h, over last hour of
the set change interval, 24 hours)
Sampling time: 15 minutes

Instantaneous flow rate (25 mL/h, over set change interval 24 hours)

Trumpet curves for 15, 60, 150, 330, 570, 930 minute observation windows (25 mL/h, over
set change interval, 24 hours)

9.2.9 Compliance with standards

General requirements for basic safety and essential Conform to IEC 60601-1
performance for Medical electrical equipment

Electromagnetic compatibility- Requirements and tests Conform to IEC 60601-1-2

for Medical electrical equipment

Particular requirements for the basic safety and Conform to IEC 60601-2-24
essential performance of infusion pumps and
controllers

61
General requirements, tests and guidance for alarm Conform to IEC 60601-1-8
systems in medical electrical equipment and medical
electrical systems

Requirements for medical electrical equipment and Conform to IEC 60601-1-11

medical electrical systems used in the home healthcare
environment

Conform to the 93/42/EEC Medical

directive
0123 : Notified body number (TÜV SÜD
Product Service GmbH, Ridlerstrasse. 65,
80339 München, Germany)

NOTE : The full list of applicable standards is available upon request. The device is
protected against leakage current and does not disturb ECG or EEG devices.

62
10 Transport, storage and recycling conditions
10.1 Storage and transport conditions
During transport, the Amika+ pump shall not be removed from its pole or rail when carrying
feeding devices, especially when feeding is running.
Check that the AC/DC adapter is connected and operational after transport of the pump.
The pump should be used under specified storage and transport conditions listed below to
ensure pump performance and to avoid pump malfunction.
For further information about storage and transport, see Use environment on page 6.

10.2 Storage
Please make sure the pump is stored in an appropriate manner so as to avoid pump
malfunctioning.

INFORMATION
■ The storage area must be clean, organized and compliant with the storing
conditions mentioned above.
■ The Amika+ pump must be handled with care during storage.

WARNING
■ If the device is not used for longer than 2 months, remove the battery and
store it as per storage conditions above.
■ If the device is stored without removing the battery, charge it at least once
a month by connecting it to the mains for at least 6 hours.
■ Amika+ must be cleaned and disinfected prior to storage (see Cleaning and
disinfection on page 42).

10.2.1 Prepare the device for storage

In order to prepare the device before storage, proceed as specified below:
1. Be sure the pump is not being used on a patient.
2. Switch pump OFF and remove installed giving set (see Removing/Changing the giving
set from the pump on page 28).
3. Disconnect pump power cord (see Electrical disconnection on page 17).
4. Remove the pump and its holder from pole or rails (see Removing the pump from the
pump holder on page 17).
5. Clean the pump (see Cleaning and disinfection on page 42).
6. Handle the pump with care and store it in a compliant area.

63
10.2.2 Install the device after storage

INFORMATION
■ If the battery has been removed for storage, please contact your biomedical
department in order to replace the battery into the device prior to using the
pump.
■ We recommend charging the battery, by leaving the device connected to
the mains power supply for at least 6 hours. After prolonged storage, a few
minutes may be required before using the pump (an hourglass will be
displayed).
■ We recommend that the "Amika+ Quick check protocol" is performed when
the device is installed after transport, in case of prolonged storage, or before
being used on a new patient.

10.3 Recycling and disposal

Before disposal, remove battery from the device. Batteries, accessories 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.

For further information regarding waste processing regulations and dismantling, contact
your local Fresenius Kabi sales representative.

64
11 Guidance and manufacturer’s declaration on
EMC
The Amika+ pump is intended to be used in the electromagnetic environment specified
below.
The customer or the user of the Amika+ pump should ensure that it is used in such an
environment.
Excluding the cases described in this manual, the pump operation must systematically be
checked by a qualified operator, should the pump be installed in the vicinity of other electrical
devices.
For further information on EMC compliance, please refer to the Amika+ Technical Manual.

WARNING
■ 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.
■ In the case of electromagnetic disturbances, if the essential performances,
see Essential performance on page 54, are lost or degraded, the
consequences for the patient can be: overfeeding, underfeeding, delay of
therapy, trauma.

11.1 Electromagnetic compatibility and interference guidance

The Amika+ 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.
The Amika+ is classified as a Class B device according to CISPR 11 emitted radiation. The
user might be required to take mitigation measures, such as relocating or re-orienting the
equipment.
Use of accessories and cables other than those recommended by Fresenius Kabi, could
result in increased emissions and / or decreased immunity of the Amika+ system.
If the Amika+ is placed near devices such as HF surgical equipment, X-ray equipment,
NMR, 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 Amika+ and this equipment (see Recommended separation distances between portable
and mobile RF communication equipment and pump on page 66). If the Amika+ causes
harmful interference or if it is itself disrupted, the user is encouraged to try to correct the
interference by one of the following actions:
■ reorient or relocate the Amika+ or patient or disruptive equipment;
65
■ change the routing of cables;
■ connect the Amika+ mains plug on protected / backed-up / filtered supply or directly on
UPS circuit (uninterruptible power supply);
■ increase the separation between the Amika+ and patient or disruptive equipment;
■ connect the Amika+ into an outlet on a different circuit from that 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 right setup and good location.

11.2 Guidance and manufacturer’s declaration - Electromagnetic

immunity
The Amika+ pump is intended to be used in the electromagnetic environment specified in
the Technical Manual.
The customer or the user of the Amika+ pump should ensure that it is used in such an
environment.

11.3 Recommended separation distances between portable and

mobile RF communication equipment and pump
The Amika+ pump is intended to be used in an electromagnetic environment in which
radiated RF disturbances are controlled.
Users of the Amika+ may prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and
the Amika+ as recommended below and according to the maximum output power of the
communication equipment (transmitters).

WARNING
■ 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.
■ The device should not be used next to other equipment. If adjacent use is
necessary, the device should be observed to verify normal operation in the
configuration in which it will be used (Amika pump with a AC/DC adapter,
a USB cable and a nurse call cable).

66
12 Services
12.1 Warranty
12.1.1 General conditions of warranty
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.

12.1.2 Limited warranty

To benefit from the materials and workmanship guarantee from our sales representative or
agent authorized by Fresenius Kabi, the following conditions must be respected:
■ Fresenius Kabi is not liable for loss or damage to the device during transport.
■ the device must have been used according to the instructions described in this user
guide and other accompanying documents;
■ the device must not have been damaged when in storage, at the time of repair, or show
signs of improper handling;
■ the device must not have been altered or repaired by non-qualified 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 (ID/N°) must not have been altered, changed, or erased.

INFORMATION
■ In case of failure to comply with these conditions, Fresenius Kabi will prepare
an estimate for repairs covering the parts and labour required.
■ When a return and/or a repair of the device are required, please contact
your Fresenius Kabi sales representative.

12.1.3 Warranty conditions for battery and accessories

Batteries and accessories may have specific conditions of warranty.
Please contact your Fresenius Kabi sales representative for additional information.

12.2 Quality control

Upon request by the hospital, a quality control check can be performed on the Amika+
every 12 months.
A regular quality control (not included in the guarantee) consists of various inspection
operations listed in the technical manual. Please refer to the technical manual or contact
your Fresenius Kabi sales representative.

INFORMATION
■ These checks must be performed by trained technical personnel and are
not covered by any contract or agreement provided by Fresenius Kabi.
67
 ■ For more information, please contact our Fresenius Kabi sales
representative.

12.3 Maintenance requirements

WARNING
■ Perform preventive maintenance at least once every 2 years. This includes
battery and membrane replacement. To avoid pumping performance
deterioration, it is important to follow maintenance requirements.
■ Preventive maintenance must be performed by qualified and trained technical
personnel in compliance with the technical manual and procedures.
■ The qualified personnel must be informed if the device is dropped or if any
malfunction occurs. In this case, the device must not be used. Please contact
your biomedical department or Fresenius Kabi.
■ When replacing components, only use Fresenius Kabi spare parts.
■ When using the device on a patient, no maintenance action must be
performed.

Life cycle of Amika+ pump: 10 years provided that the maintenance is properly performed
as described above.

12.4 Service policy and rules

For further information concerning device servicing or use, please contact our sales
representative or our Customer service.
If the device must be sent for servicing, contact Fresenius Kabi to have packaging shipped
to your facility.
Clean and disinfect the device, because of potential harm or risks to staff health. Then pack
it in the provided packaging and ship to Fresenius Kabi.

INFORMATION
Fresenius Kabi is not liable for loss or damage to the device during transport.

68
13 Ordering information
Amika+ pump is available in several countries, contact your Fresenius Kabi sales
representative for orders.

13.1 Instructions for use

Several 'Instructions for use' documents translated into local languages are available. Please
contact your Fresenius Kabi sales representative for orders.

13.2 Giving sets

Do not use Amika giving sets to deliver liquids using gravity method, except the Amika set
Varioline Comfort that can be used either for feeding by pump or by gravity.
Giving sets are single use. Whatever the giving set, the performance of the pump is
maintained.
ENFit Transition Sets, ENFit ISO Sets,
ENPlus ENPlus

Amika EasyBag 7752085T 7751917

Amika Easy Bag without Medication port 7752086T 7751918

Amika EasyBag Two Line 7752089T 7751994

Amika EasyBag mobile 7752087T 7751916

Amika Varioline 7752088T 7751919

Amika Bag 7751715T 7751914

Amika Bag mobile 7752046T 7751915

13.3 Accessories
Do not use the device with damaged accessories.

WARNING
Use ONLY recommended accessories described below or delivered with the
device. Patient must not be connected to the set when installing the pump with
accessories. Please refer to its specific instructions for use.

Accessories Reference

Amika Backpack Large 7752323

Amika Backpack Small 7752343

Amika Universal Table Top Stand 7751082

Amika AC Adapter / Charger Z200651**

69
 Accessories Reference

Amika USB Cable Z044905

*Several country kits are available.

**Additional power cords, AC adapter/charger, wall plug must be ordered separately. Each
Product reference includes its own appropriate wall plug, depending on the country.
Please contact your Fresenius Kabi sales representative for orders.

70
14 Glossary of terms
Term Description

°C Celsius Degree

A Amper

AC Alternating Current

Ah Ampere hours

Amika+ Enteral feeding and hydratation pump manufactured by Fresenius

Kabi

CE mark European Conformity Mark

CISPR Special International Committee on Radio Interference

cm Centimeters

dB Decibel

DECT Digital Enhanced Cordless Telecommunications

ECG Electrocardiogram

EEG Electroencephalogram

EMC Electromagnetic compatibility

EXX Error message

g Gram

h Hours

HxWxD Height / Width / Depth

HF High Frequency

hPa Hecto Pascal

Hz Hertz

ID/N° Serial number

IEC International Electrotechnical Commission

IFU Instructions for Use

IV Intravenous

LED Light Emitting Diode

m Meters

MHz MegaHertz

min Minutes

71
 Term Description

mL Milliliter

mL/h Milliliter per hour

mm Millimeters

MRI Magnetic Resonance Imaging

NiMH Nickel-Metal Hydride

NMR Nuclear Magnetic Resonance

RF Radio Frequency

RFID Radio Frequency Identification

sec Seconds

UPS Uninterruptable Power Supply

V Volt

Vac Volt Alternating Current

Vdc Volt Direct Current

W Watt

72
Release notes
Date Software version Description

May 2018 1.0 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.
This document may not be reproduced in whole or in part without the written consent of
Fresenius Kabi. Amika® is a registered trademark in the name of Fresenius Kabi in selected
countries.
Made in France
Revision date: May 2018
Reference: 13886-0_ifu_Amika+_ENG-GB

http://www.fresenius-kabi.com 0123 First CE Mark: 2018

73
Local contacts for servicing

13886-0_ifu_Amika+_ENG-GB

Fresenius Kabi AG Fresenius Vial S.A.S

61346 Bad Homburg Le Grand Chemin
Germany 38590 Brézins - France