DefiMonitor EVO 18 MGA22955

www.primedic.
com
DefiMonitor EVO
Operating Instructions
MGA22955 / GB /
Masthead
Publisher
METRAX GmbH
Rheinwaldstr. 22
D-78628 Rottweil
Germany
+49 (0)741 257-0
[email protected]
www.primedic.com
Proprietary note
Metrax GmbH reserves all rights to these operating instructions. Without approval from
Metrax GmbH, these operating instructions may not be duplicated or made accessible to
third parties. The same applies to individual parts or excerpts of these operating instructions.
Non-compliance with this gives rise to a right to claim damages and can have consequences
under criminal law (refer to DIN 34).
Operating Instructions PRIMEDIC™ DefiMonitor EVO

2 MGA22955 / GB / A
Directive
 The content of this manual are subject to change without notice.
 The contents of this manual should be correct. If, for some reason, there are any
questionable points, please do not hesitate to contact our service center.
 The manual will be replaced if any pages are missing or collation is incorrect.
Warranty
 The warranty period is 24 months, beginning on the date of purchase.
 Device failure or damage related to the following situations during the
guarantee period is not covered by this warranty:
o Installation, transfer installation, maintenance and repairs by any person
other than an authorized employee or technician by Metrax GmbH.
o Damage sustained to the Metrax GmbH product(s) caused by product(s)
from another company excluding products delivered by Metrax GmbH.
o Damage – caused by mishandling and/or misuse – is the responsibility of
the user.
o Maintenance and repairs utilizing maintenance components that are not
specified by Metrax GmbH.
o Device modifications or use of accessories not recommended by Metrax
GmbH.
o Damage caused by accidents or natural disasters (earthquakes, flooding,
etc.).
o Damage resulting from usage where caution statements and operating
instructions shown in this manual have not been followed.
o Damage due to neglect of specified maintenance checks.
 This warranty only covers the hardware of the PRIMEDIC™DefiMonitor EVO. The
warranty does not cover the following selections:
o Whatever damage or loss results from the attachment of accessories or
their operation.
o In the event of a defect in the product, contact our technical service
department or your local sales representative.
 The PRIMEDIC™ DefiMonitor EVO conforms to the EMC standard IEC60601-1-2.
Mobile phones should not be used in the vicinity of the PRIMEDIC™

Note
DefiMonitor EVO.
Any device not complying to the EMC standard that is used with the
Note
PRIMEDIC™ DefiMonitor EVO renders the PRIMEDIC™ DefiMonitor EVO as
non-compliable to the EMC standard.
Trademark
I
Trademark
Product brand names shown in this manual are likely to be the trademark or
registered trademark of the company concerned.
The PRIMEDIC™ DefiMonitor EVO is equipped with epoch-making ECG

monitoring function incorporating the cutting edge software for analysis of
electrocardiograms developed by the University of Glasgow in UK, which
includes signal processing, diagnostic interpretation of electrocardiograms from
individuals of all ages and analysis of cardiac rhythm.

2 MGA22955 / GB / A
Table of contents
1 Safety Information 9
1.1 General Safety Information .................................................................................................................... 9
1.2 Warnings ........................................................................................................................................................ 9
1.3 Cautions ........................................................................................................................................................ 17
2 Introduction 19
2.1 Intended Use for the PRIMEDIC™ DefiMonitor EVO ................................................................. 19
2.2 Indications for Use ................................................................................................................................... 19
2.3 About this Manual .................................................................................................................................... 20
2.4 Identifying the PRIMEDIC™ DefiMonitor EVO Configurations .............................................. 21
3 Description of the PRIMEDIC™ DefiMonitor EVO 22

3.1 Front Panel Components ....................................................................................................................... 22
3.2 Paddle Components ................................................................................................................................ 24
3.3 Rear Panel Components ........................................................................................................................ 24
3.4 Left Panel Components .......................................................................................................................... 25
3.5 Right Panel Components ....................................................................................................................... 26
3.6 Display ........................................................................................................................................................... 28
4 Setting up the PRIMEDIC™ DefiMonitor EVO 31

4.1 Unpacking and Inspection .................................................................................................................... 31
4.2 List of Components .................................................................................................................................. 32
4.3 Power Cable Connections ..................................................................................................................... 33
4.3.1 AC Power ....................................................................................................................................... 33
4.3.2 DC Power ....................................................................................................................................... 34
4.4 Measurement Cable Connections...................................................................................................... 35
4.4.1 ECG Cables and Leads .............................................................................................................. 35
4.4.2 Defibrillator Paddle and Pads ............................................................................................... 36
4.4.3 NIBP Hoses and Cuffs (if configured with NIBP option) ............................................ 36
4.4.4 SpO2 Cables and Sensors (if configured with SpO2 option) .................................... 36
4.4.5 Temperature Probes (if configured with Temperature option) .............................. 36
4.4.6 CO2 Sensor (if configured with CO2 option) ................................................................... 37
4.4.7 IBP Transducers (if configured with IBP option) ........................................................... 37
5 Battery Operation 38
5.1 Operating the DefiMonitor EVO on Battery Power .................................................................... 39
5.2 Battery Status Indication........................................................................................................................ 40
6 Using the PRIMEDIC™ DefiMonitor EVO 42

6.1 Turning on the DefiMonitor EVO ....................................................................................................... 44
6.2 Setting Date and Time ............................................................................................................................ 45
6.3 Continued use ............................................................................................................................................ 46
6.4 Setting the Main Screen ........................................................................................................................ 46
7 Alarms and Limits 49

7.1 General .......................................................................................................................................................... 49
7.1.1 Changing Alarm Volume......................................................................................................... 49
7.2 Alarm Priority and Messages ............................................................................................................... 50
7.2.1 High Priority Alarms .................................................................................................................. 50
7.2.2 Medium Priority Alarms .......................................................................................................... 50
7.2.3 Low Priority Alarms ................................................................................................................... 52
7.2.4 Informative Messages .............................................................................................................. 53
7.2.5 Defibrillator messages ............................................................................................................. 54
III
Table of contents
7.3 Visual Alarm Indication .......................................................................................................................... 55

7.4 Audible Alarm Indication ...................................................................................................................... 56
7.5 Verifying Audible Alarm Indication ................................................................................................... 56
7.6 Changing Alarm Limits ........................................................................................................................... 57
7.6.1 Setting Alarm Limit via Limit Menu.................................................................................... 57
7.6.2 Alarm Limits Ranges ................................................................................................................. 58
7.7 Audio Paused and OFF........................................................................................................................... 60
8 ECG Monitoring 62
8.1 General .......................................................................................................................................................... 63
8.2 Setup Connections ................................................................................................................................... 64
8.3 12-lead ECG ................................................................................................................................................ 65
8.3.1 General ........................................................................................................................................... 65
8.3.2 ECG Wave Recognition ........................................................................................................... 66
8.3.3 Processing ..................................................................................................................................... 66
8.3.4 QRS typing.................................................................................................................................... 66
8.3.5 Selection of Required QRS Class ......................................................................................... 66
8.3.6 Averaging ...................................................................................................................................... 67
8.3.7 Wave Measurement.................................................................................................................. 67
8.3.8 QRS Components ...................................................................................................................... 69
8.3.9 ST segment ................................................................................................................................... 69
8.3.10 P and T waves .............................................................................................................................. 69
8.3.11 Interval Measurement .............................................................................................................. 70
8.3.12 Normal Limits .............................................................................................................................. 70
8.4 Preparing the 12-lead ............................................................................................................................. 70
8.5 Calculation Feature .................................................................................................................................. 71
8.5.1 Preliminary Comments ............................................................................................................ 71
8.5.2 Measurement Parameter ........................................................................................................ 71
8.5.3 Results on QRS Wave Analysis ............................................................................................. 71
8.5.4 Results on ST and T Wave Analysis .................................................................................... 72
8.5.5 Rhythm Statements .................................................................................................................. 72
8.5.6 Measurement Matrix ................................................................................................................ 72
8.6 12 Lead Display ......................................................................................................................................... 73
8.7 Description of HR/PR Menu Functions ........................................................................................... 74
8.7.1 HR/PR Source .............................................................................................................................. 75
8.7.2 Pacer Detect ................................................................................................................................. 75
8.7.3 Filter Select ................................................................................................................................... 76
8.7.4 Limit Alarm Pause ...................................................................................................................... 76
9 AED (Automated External Defibrillator) Mode 77

9.1 General .......................................................................................................................................................... 78
9.1.1 Sudden Cardiac Arrest (SCA) ................................................................................................ 78
9.1.2 Heart Rhythm .............................................................................................................................. 79
9.1.3 Detecting Fibrillation ................................................................................................................ 79
9.1.4 Rhythm Recognition Performance ..................................................................................... 79
9.2 Preparing for Defibrillation................................................................................................................... 79
9.3 Operating the AED Mode of the PRIMEDIC™ DefiMonitor EVO .......................................... 80
9.4 2010 AHA/ERC Guidelines for CPR and ECC ................................................................................. 80
9.5 Major changes in the 2010 AHA Guidelines for CPR and ECC .............................................. 81
9.6 Major changes in the 2010 ERC Guidelines for CPR and ECC ............................................... 81
9.7 CPR Guidelines 2010 ............................................................................................................................... 81
9.7.1 Using AED Mode........................................................................................................................ 82
9.8 AHA/ERC 2010 configuration .............................................................................................................. 84
9.9 Description of AED Mode Menu Functions ................................................................................... 85

4 MGA22955 / GB / A
10 Manual Mode 87
10.1 General .......................................................................................................................................................... 87
10.2 Preparing for Defibrillation ................................................................................................................... 88
10.3 Operating the Manual Mode of PRIMEDIC™ DefiMonitor EVO ........................................... 88
10.4 Defibrillating (async mode) .................................................................................................................. 89
10.5 Synchronized Cardioversion (sync mode) ...................................................................................... 90
10.6 Description of Manual Mode Menu Functions ............................................................................ 91
10.6.1 12-Lead .......................................................................................................................................... 94
10.6.2 Setup ............................................................................................................................................... 95
10.6.3 Alarm Limit.................................................................................................................................... 96
10.6.4 Patient Info ................................................................................................................................... 96
10.6.5 Sync.................................................................................................................................................. 97
11 Pacing Mode 98
11.1 General .......................................................................................................................................................... 99
11.2 Demand Mode (Sync Mode) and Async Mode ............................................................................ 99
11.3 Operating the Pacing Mode of DefiMonitor EVO ....................................................................... 99
11.4 Demand Mode (Sync Mode) pacing .............................................................................................. 100
11.5 Async Mode pacing .............................................................................................................................. 101
11.6 Description of Pacing Mode Menu Functions ........................................................................... 101
11.6.1 Pause Pacing ............................................................................................................................. 104
11.6.2 Setup ............................................................................................................................................ 104
11.6.3 Alarm Limit................................................................................................................................. 106
11.6.4 Patient Info ................................................................................................................................ 106
11.6.5 Async ............................................................................................................................................ 106
12 Monitor Mode 107

12.1 General ....................................................................................................................................................... 107
12.2 Operating the Monitor Mode of PRIMEDIC™ DefiMonitor EVO ....................................... 107
12.3 Description of Monitor Mode Menu Functions ........................................................................ 108
12.3.1 12-Lead ....................................................................................................................................... 111
12.3.2 Setup ............................................................................................................................................ 111
12.3.3 Alarm Limit................................................................................................................................. 113
12.3.4 Patient Info ................................................................................................................................ 113
13 NIBP Monitoring 114

13.1 General ....................................................................................................................................................... 116
13.2 Theory of Operation ............................................................................................................................. 116
13.2.1 Overview ..................................................................................................................................... 116
13.2.2 Overall Accuracy Discussion ............................................................................................... 117
13.2.3 Oscillometric Method............................................................................................................ 117
13.3 Setup Connections ................................................................................................................................ 118
13.4 Description of NIBP Menu Functions ............................................................................................ 120
13.4.1 Inflate Pressure......................................................................................................................... 121
13.4.2 Auto Interval.............................................................................................................................. 121
13.4.3 Patient Type............................................................................................................................... 121
13.4.4 Limit Alarm Pause ................................................................................................................... 121
14 SpO₂ Monitoring 122

14.1 General ....................................................................................................................................................... 124
14.2 Theory of Operation ............................................................................................................................. 124
14.2.1 Functional versus Fractional Saturation......................................................................... 125
14.2.2 Measured versus Calculated Saturation ........................................................................ 125
14.3 Setup Connections ................................................................................................................................ 126
14.4 Description of SpO2 Menu Functions ............................................................................................ 127
V
Table of contents
15 Respiration Monitoring 129

15.1 General ........................................................................................................................................................129
15.2 Theory of Operation ..............................................................................................................................129
15.3 Setup Connections .................................................................................................................................130
15.4 Description of Respiration Menu Functions ................................................................................130
15.4.1 Respiration..................................................................................................................................131
15.4.2 RR Source ....................................................................................................................................132
15.4.3 Size.................................................................................................................................................132
15.4.4 Apnea time setting ..................................................................................................................132
15.4.5 Limit Alarm Pause ....................................................................................................................132
16 Capnography Monitoring 133

16.1 General ........................................................................................................................................................135
16.3.1 Calibrating the CO2 Sensor ..................................................................................................136
16.3.2 Mainstream Operation ..........................................................................................................136
16.3.3 Sidestream Operation ............................................................................................................137
16.4 Description of EtCO2 Menu Functions ...........................................................................................138
16.4.1 EtCO2 .............................................................................................................................................139
16.4.2 EtCO2 Setting .............................................................................................................................139
17 Temperature Monitoring 141

17.1 General ........................................................................................................................................................141
17.4 Description of Temperature Menu Functions ............................................................................142
18 IBP Monitoring 143

18.1 General ........................................................................................................................................................144
18.4 Description of IBP 1 Menu Functions.............................................................................................145
18.4.1 Zero Setting ...............................................................................................................................147
18.4.2 Scale ..............................................................................................................................................147
18.4.3 Label ..............................................................................................................................................147
18.5 Description of IBP 2 Menu Functions.............................................................................................147
18.5.1 Zero Setting ...............................................................................................................................148
18.5.2 Scale ..............................................................................................................................................148
18.5.3 Label ..............................................................................................................................................148
19 Self-test Function 150

19.1 General ........................................................................................................................................................150
19.1.1 Manual Self-test .......................................................................................................................150
19.1.2 Auto Self-test.............................................................................................................................150
19.1.3 Button test ..................................................................................................................................150
19.2 Functions to be tested in Self-test ..................................................................................................150
19.3 Self-test result transmission(if configured with Wireless module option) .....................151
19.4 Self-test result printing ........................................................................................................................151
19.5 Trouble shooting ....................................................................................................................................151
19.6 Button test .................................................................................................................................................152

6 MGA22955 / GB / A
20 Event 153
20.1 General ....................................................................................................................................................... 153
20.2 Event Data List Display ........................................................................................................................ 153
20.3 Event Review Display............................................................................................................................ 153
20.4 12Lead Record Display ........................................................................................................................ 154
20.5 ID#................................................................................................................................................................ 154
21 Menu Structure 156

21.1 Manual Mode Menu ............................................................................................................................. 156
21.2 AED Mode Menu.................................................................................................................................... 160
21.3 Pacing Mode Menu .............................................................................................................................. 161
21.4 Monitor Mode Menu ........................................................................................................................... 164
21.5 HR/PR Menu ............................................................................................................................................ 169
21.6 SpO2 Menu .............................................................................................................................................. 169
21.7 NIBP Menu................................................................................................................................................ 169
21.8 IBP1 Menu................................................................................................................................................. 171
21.9 IBP2 Menu................................................................................................................................................. 171
21.10 EtCO2 Menu ............................................................................................................................................. 172
21.11 Respiration Menu .................................................................................................................................. 172
21.12 Temperature Menu ............................................................................................................................... 173
21.13 Date Time Menu..................................................................................................................................... 173
22 Printing 175
22.1 General ....................................................................................................................................................... 175
22.2 Printer settings ........................................................................................................................................ 175
22.2.1 Print on alarm ........................................................................................................................... 175
22.2.2 Print on shock ........................................................................................................................... 175
22.2.3 12 lead auto printing ............................................................................................................. 175
22.2.4 Analyze auto printing ............................................................................................................ 175
22.3 Print-out .................................................................................................................................................... 175
22.3.1 Print-out ...................................................................................................................................... 175
22.3.2 Print-out on shock .................................................................................................................. 176
22.3.3 Print-out on 12 lead ECG data .......................................................................................... 176
22.3.4 Print-out on setting information ...................................................................................... 177
23 External Interface 178

23.1 General ....................................................................................................................................................... 178
23.1.1 USB Host Type.......................................................................................................................... 178
23.1.2 SD Memory Card ..................................................................................................................... 178
23.1.3 Central System Communication ....................................................................................... 178
24 Maintenance 179
24.1 Recycling and Disposal........................................................................................................................ 180
24.2 Returning the PRIMEDIC™ DefiMonitor EVO and System Components (except
rechargeable battery) ...................................................................................................................................... 181
24.3 Returning the PRIMEDIC™ AkuPak EVO ...................................................................................... 181
24.4 Service ........................................................................................................................................................ 182
24.5 Periodic Safety Checks......................................................................................................................... 182
24.6 Cleaning ..................................................................................................................................................... 182
24.7 Battery Maintenance ............................................................................................................................ 183
24.8 Loading Printer Paper .......................................................................................................................... 184
25 Troubleshooting 185
25.1 General ....................................................................................................................................................... 185
25.2 Obtaining Technical Assistance ....................................................................................................... 185
VII
Table of contents
25.3 EMI (Electromagnetic Interference) ................................................................................................185
26 Factory Defaults 188

26.1 General ........................................................................................................................................................188
26.2 Parameter Ranges and Default Settings .......................................................................................188
27 Specification 197
27.1 Display.........................................................................................................................................................197
27.2 Controls ......................................................................................................................................................197
27.3 Alarms .........................................................................................................................................................197
27.4 Physical Characteristics and Printer ................................................................................................197
27.5 Electrical .....................................................................................................................................................198
27.6 Enviromental Conditions .....................................................................................................................199
27.7 Tone Definiton .........................................................................................................................................199
27.8 Measurement Parameters ...................................................................................................................200
27.8.1 Pacing Mode ..............................................................................................................................200
27.8.2 Defibrillator ................................................................................................................................201
27.8.3 Manual Mode ............................................................................................................................201
27.8.4 ECG ................................................................................................................................................201
27.8.5 Respiration..................................................................................................................................203
27.8.6 NIBP ...............................................................................................................................................203
27.8.7 IBP ..................................................................................................................................................204
27.8.8 SpO2 ..............................................................................................................................................205
27.8.9 Capnography .............................................................................................................................206
27.8.10Temperature ..............................................................................................................................206
27.9 Events ..........................................................................................................................................................207
27.10 Defibrillator (Technical specification) .............................................................................................208
27.10.1AED Mode ...................................................................................................................................208
27.10.2Manual Mode ............................................................................................................................209
27.10.3ECG Analysis Performance ...................................................................................................210
27.11 Biphasic Waveform Characteristics .................................................................................................211
27.12 Compliance ...............................................................................................................................................222
27.13 Manufacturer´s Declaration................................................................................................................227
28 Index 231
28.1 Figures .........................................................................................................................................................231
28.2 Tables ..........................................................................................................................................................233
29 Contact details 235

8 MGA22955 / GB / A
1 Safety Information
1.1 General Safety Information

This section contains important safety information related to general use of the
PRIMEDIC™ DefiMonitor EVO defibrillator/monitor. Other important safety
information appears throughout the manual. The PRIMEDIC™ DefiMonitor EVO
defibrillator/monitor will be referred to as the PRIMEDIC™ DefiMonitor EVO
throughout this manual.
Important! Before use, read this manual carefully, the directions for use of
all accessories, all precautionary information and specifications.
1.2 Warnings
WARNING
Warnings are identified by this WARNING symbol. Warnings alert you to
potential serious outcomes (death, injury, or adverse events) to the
patient or user.
It is imperative that you pay attention to these texts.
WARNING
Do not take into or use the PRIMEDIC™ DefiMonitor EVO in locations
where highly combustible anesthetics, gasoline or flammable gases or
materials are used. Do not use the device in high-pressure oxygen rooms
or inside oxygen tents, as this may cause a flammable explosion. Be
careful when operating this device close to oxygen sources (such as bag-
valve-mask devices or ventilator tubing). Turn off the gas source or move
the source away from patient during defibrillation.Do not use the device
near the place of a spill of gasoline or other volatile substances, as this
may cause an explosion.
WARNING
When using the defibrillator/monitor with anesthetics, nitrous oxide or
high concentrations of oxygen, connect the gas outlet to a scavenger
system.
WARNING
When using the PRIMEDIC™ DefiMonitor EVO with a commercial electric
power source, use the PRIMEDIC™ DefiMonitor EVO with an electric
power wall socket with a grounding wire for medical use. Not doing so
could cause electric shock.
WARNING
Do not connect grounding wire to gas pipes. This could cause fire.
WARNING
9
Only physicians and officially certified medical personnel should use this
PRIMEDIC™ DefiMonitor EVO. Do not allow patients to touch this
PRIMEDIC™ DefiMonitor EVO. Allowing patients to touch this
PRIMEDIC™ DefiMonitor EVO could cause accidents.
WARNING
The PRIMEDIC™ DefiMonitor EVO conforms to the requirements of the
EMC standard (IEC60601-1-2), and may therefore be used
simultaneously with pacemakers and other electrical simulators. It
should, however, be noted that the PRIMEDIC™ DefiMonitor EVO may be
affected by electrical scalpels and microwave therapeutic apparatus.
Please check operation of the PRIMEDIC™ DefiMonitor EVO during and
after use of such equipment.
WARNING
Do not take mobile phones or transceivers into a room where this
PRIMEDIC™ DefiMonitor EVO is installed, as such devices may cause
accidents.
WARNING
Do not use any unauthorized accessories or options. The use of
accessory equipment not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety of
the resulting system. Consideration relating to the choice shall include
the use of the accessory in the patient vicinity. Make sure that the safety
certification of the accessory has been performed in accordance with the
appropriate IEC (EN) 60601-1 and/or IEC (EN) 60601-1-1 harmonized
national standards.
WARNING
Thoroughly read the instruction manuals supplied with accessories and
options to ensure correct use. This instruction manual does not carry the
caution selections for such equipment.
WARNING
Do not open cover or disassemble the PRIMEDIC™ DefiMonitor EVO.
Doing so could cause electric shock or fire. The device contains no
operator serviceable components and dangerous high voltages may be
present. Contact authorized service personnel for repair. It is prohibited
by law to modify the PRIMEDIC™ DefiMonitor EVO without
authorization.
WARNING
Do not use power source other than the specified voltage, (100-
240V~50/60Hz) as this may cause fire or electric shock.
WARNING
Pre-use inspection and preventive maintenance must be performed for
safe use.

10 MGA22955 / GB / A
WARNING
The PRIMEDIC™ DefiMonitor EVO may be used with electrical surgical
equipment. Follow the instruction manuals for medical instruments –
notably electrosurgical and diathermy instruments – when used, as their
high–frequency energy units may cause burns to patients via
attachments.
WARNING
The PRIMEDIC™ DefiMonitor EVO is protected against the discharge of
a defibrillator. However, do not touch the PRIMEDIC™ DefiMonitor EVO
when a defibrillator is being discharged (electrified), as doing so may
cause electric shock.
WARNING
The following cautions apply when connecting the PRIMEDIC™
DefiMonitor EVO with other equipment.
1. Ensure that the connected equipment is in accordance with the
IEC60601-1 or IEC safety standards, so that the system
complies with IEC60601-1.
2. Employ additional protective measures (e.g. additional
protective earthing) as necessary.
WARNING
Do not connect devices that do not meet medical safety standards
(such as commercial PCs), as they may cause electric shock. The
PRIMEDIC™ DefiMonitor EVO meets the restricted level of leakage
current required for medical devices. Therefore, the PRIMEDIC™
DefiMonitor EVO cannot be connected to a device that would give a
combined total of leakage current beyond the restricted level.
WARNING
Avoid connecting the patient to several devices at once. Leakage
current limits may be exceeded. Do not use a second defibrillator on the
patient while pacing with the PRIMEDIC™ DefiMonitor EVO.
WARNING
Do not place anything on top of the PRIMEDIC™ DefiMonitor EVO. If
something is spilled over the PRIMEDIC™ DefiMonitor EVO or gets into
it, such spillage may cause fire or electric shock. If fluid gets into the
PRIMEDIC™ DefiMonitor EVO accidentally, disconnect power cord, wipe
dry immediately, and have the PRIMEDIC™ DefiMonitor EVO serviced to
make sure that no hazard exists.
WARNING
Do not place heavy objects on the power cord, as doing so may cause
fire or electric shock.
11
WARNING
Before conducting maintenance work, turn the power Off, unplug the
power cord from the wall socket to prevent electric shock.
WARNING
When the following occur, turn the power Off immediately and unplug
the power cord from the wall socket. Continued use in such situations
may cause fire or electric shock.
 There is smoke or a strange odor leaking out of the device.
 The device has been dropped or impacted by an object.
 Liquid or foreign matter gets inside the device.
 Device failure has occurred.
Also, when any of the above occurs, promptly do the following:
 Check to see that the power cord has been unplugged from
the wall socket.
 Place an “Out of Order” sign on the device and do not use it.
WARNING
Do not connect more than one patient to the PRIMEDIC™ DefiMonitor
EVO. Do not connect more than one PRIMEDIC™ DefiMonitor EVO to a
patient.
WARNING
The PRIMEDIC™ DefiMonitor EVO is a prescription device and is to be
operated by qualified personnel only.
WARNING
As with any medical equipment, carefully route patient cabling to
reduce the possibility of patient entanglement or strangulation.
WARNING
Never lift the PRIMEDIC™ DefiMonitor EVO by the sensor cable, blood
pressure hose, power cord, or any other accessory. Such accessories
could detach, causing the PRIMEDIC™ DefiMonitor EVO to fall on the
patient.
WARNING
Do not make any clinical judgments based on the PRIMEDIC™
DefiMonitor EVO’s measurement only.
WARNING
Emergency defibrillation should be performed only by appropriately
trained, skilled and qualified personnel who are aware of the protocol
for handling a patient in medical emergency such as cardiac arrest and
have been certified in Advanced Cardiac Life Support (ACLS) or Basic
Life Support (BLS).

12 MGA22955 / GB / A
WARNING
Synchronized electrical cardioversion should be performed only by
skilled personnel trained in Advanced Cardiac Life Support (ACLS) and
practiced in equipment operation. The precise cardiac arrhythmia must
be determined prior to performing defibrillation.
WARNING
The defibrillator delivers up to 360 Joules of electrical energy. Unless
properly used as described in this manual, this electrical energy may
cause serious injury or death. Do not attempt to operate the
PRIMEDIC™ DefiMonitor EVO unless thoroughly familiar with this
manual and the functions of all controls, indicators, connectors and
accessories.
WARNING
Do not discharge standard paddles on top of pads or ECG electrodes.
Do not allow standard paddles (or pads) to touch each other, ECG
electrodes, lead wires, dressings, transdermal patchers, etc. Such contact
can cause electrical arcing and patient skin burns during defibrillation
and may divert defibrillating energy away from the heart muscle.
WARNING
Discharging the defibrillator with the standard paddle surfaces shorted
together can pit or damage the paddle electrode surface. Pitted or
damaged paddle surfaces may cause patient skin burns during
defibrillation. Discharge the PRIMEDIC™ DefiMonitor EVO only as
described in theses operating instructions.
WARNING
If a person is touching the patient, bed, stretcher, or any conductive
material in contact with the patient during defibrillation, the delivered
energy may be partially discharged through that person. Clear
everything away from contact with the patient, bed, and other
conductive material before discharging the PRIMEDIC™ DefiMonitor
EVO.
WARNING
Do not discharge the defibrillator into the open air. To remove an
unwanted charge, change the energy selection, or change the mode, or
turn off the defibrillator.
WARNING
Conductive gel on the paddle handles can allow the electrical energy to
discharge through the operator during defibrillation. Completely clean
the paddle electrode surfaces, handles, and storage area after
defibrillation.
13
WARNING
A gel pathway on the skin between the standard paddles will cause
defibrillating energy to arc between paddles and delivery energy away
from the heart muscle. Do not allow conductive gel (wet or dry) to
become continuous between paddle sites.
WARNING
During defibrillation checks the discharged energy passes through the
cable connectors. Securely attach cable connectors to the simulator.
WARNING
Do not touch the patient or any equipment connected to the patient
during defibrillation. Warn all persons around patient to NOT TOUCH
THE PATIENT prior to defibrillation.
WARNING
The defibrillator should be out of contact with water puddles. It may
cause electrical shocks and device failure. Electrical safety of the
PRIMEDIC™ DefiMonitor EVO may not work properly when wet.
WARNING
Defibrillation may cause implanted devices to malfunction. Place
standard paddles or pads away from implanted devices if possible.
Check implanted device function after defibrillation.
WARNING
Implanted pacemakers may cause the heart rate meter to count the
pacemaker rate during incidents of cardiac arrest or other arrhythmias.
Pacemaker patients should be carefully observed. Check the patient’s
pulse; do not rely solely on heart rate meters. Dedicated pacemaker
detection circuitry may not detect all implanted pacemaker spikes.
Patient history and physical exam are important in determining the
presence of an implanted pacemaker.
WARNING
To ensure patient electrical isolation, connect only to other equipment
with circuits that are electrically isolated.
WARNING
To avoid risk of electric shock, the device must only be connected to
supply mains with protective earth.
WARNING
The PRIMEDIC™ DefiMonitor EVO may be equipped with a RF telemetry
module which transmits with 50dBm power in the 2.5GHz, depending
on actual device configuration. The module has been tested and
certified to be equipped safely.

14 MGA22955 / GB / A
WARNING
The PRIMEDIC™ DefiMonitor EVO may be equipped with a RF telemetry
module which transmits with 50dBm power in the 2.5GHz, depending
on actual device configuration. The module has been tested and
certified to be equipped safely.
WARNING
Do not immerse any portion of the PRIMEDIC™ DefiMonitor EVO in
water or other fluids. Avoid spilling any fluids on defibrillator or
accessories. Spilled liquids entering the interior of the device may cause
the defibrillator and accessories to perform inaccurately or fail. Do not
clean with ketones or other flammable agents. Do not autoclave or
sterilize this defibrillator or accessories unless otherwise specified.
WARNING
If you are monitoring a patient and using the system connector, all
equipment connected to the system connector must be battery
powered or electrically isolated from AC power according to EN 60601-
1. If in doubt, disconnect the patient from the defibrillator before using
the system connector. Only use Metrax recommended data
transmission cables. For more information, contact Metrax Technical
Support.
WARNING
The defibrillator/monitor delivers up to 360 joules of electrical energy.
When discharging the defibrillator, do not touch the paddle electrode
surfaces or disposable paddle/pads electrodes. Do not attempt to
perform this test unless you are qualified by training and experience
and are thoroughly familiar with these operating instructions.
WARNING
Electric shock hazards exist internally. Do not remove assembly screws.
Refer servicing to qualified personnel.
WARNING
Monitors, defibrillators, and their accessories (including electrodes and
cables) contain ferromagnetic materials. As with all ferromagnetic
equipment, these products must not be used in the presence of the
high magnetic field created by a Magnetic Resonance Imaging (MRI)
device. The high magnetic field created by an MRI device will attract the
equipment with a force sufficient to cause death or serious personal
injury to persons between the equipment and the MRI device. This
magnetic attraction may also damage the equipment. Skin burns will
also occur due to heating of electrically conductive materials, such as
patient leads and pulse oximeter sensors. Consult the MRI manufacturer
for more information.
WARNING
Medical electrical equipment which does not incorporate defibrillator
protection should be disconnected during defibrillation.
15
WARNING
Operating the PRIMEDIC™ DefiMonitor EVO or its accessories in
conditions outside the environmental specifications can result in device
or accessory malfunction. The PRIMEDIC™ DefiMonitor EVO should be
allowed to stabilize within the operating temperature range prior to
operation.

16 MGA22955 / GB / A
1.3 Cautions
CAUTION
Cautions are identified by this CAUTION symbol. Caution statements
identify conditions or practices that could result in damage to the
equipment or other property.
It is imperative that you pay attention to these texts.
CAUTION
Always check that the PRIMEDIC™ Defi-Monitor EVO functions properly
and is in proper condition before use.
CAUTION
Federal law restricts this device to sale by or on the order of a physician.
CAUTION
The PRIMEDIC™ DefiMonitor EVO may not operate properly if it is
operated or stored at conditions outside the ranges stated in this
manual, or subjected to excessive shock or dropping.
CAUTION
When connecting the PRIMEDIC™ DefiMonitor EVO to any instrument,
verify proper operation before clinical use. Both the PRIMEDIC™
DefiMonitor EVO and the instrument connected to it must be connected
to a grounded outlet.
CAUTION
Accessory equipment connected to the PRIMEDIC™ DefiMonitor EVO’s
data interface must be certified according to IEC60950 for data-
processing equipment or IEC60601-1 for electromedical equipment. All
combinations of equipment must be in compliance with IEC60601-1-1
system requirements. Anyone who connects additional equipment to the
signal input or signal output port configures a medical system and is
therefore responsible that the system complies with the requirements of
IEC 60601-1-1 and the electromagnetic compatibility system standard
IEC60601-1-2. If in doubt, consult Metrax GmbH Technical Support
Representative.
CAUTION
Risk of explosion if battery is replaced by an incorrect type.
17
CAUTION
Where the integrity of the external protective conductor in the
installation or its arrangement is in doubt, equipment shall be operated
from its internal electrical power source.

18 MGA22955 / GB / A
2 Introduction
WARNING
Patient conditions may result in erroneous readings. If the
measurements are suspect, verify the reading using another clinically
accepted measurement method.
2.1 Intended Use for the PRIMEDIC™ DefiMonitor EVO

The PRIMEDIC™ DefiMonitor EVO is intended for use by trained medical
technician, doctor, nurse or medical specialist in outdoor and indoor
emergency care settings including ambulance cars within the environmental
conditions specified. The PRIMEDIC™ DefiMonitor EVO is intended to be used
during ground transportation except when specified otherwise. Manual and
Automated external defibrillation, External pacing and the other monitoring
functions Electrocardiography (ECG),functional arterial oxygen
saturation(SpO2), respiration(RESP), temperature(TEMP), invasive blood
pressure(IBP) and end tidal CO2(EtCO2)) are intended for use on adult and
pediatric patients. Non-invasive blood pressure is intended for use on adult,
pediatric and neonatal patients.
2.2 Indications for Use

Indications Contraindications
Manual Manual defibrillation is Defibrillation is
Defibrillation indicated for the termination of contraindicated in the
certain potentially fatal treatment of Pulseless
arrhythmias, such as ventricular Electrical Activity (PEA),
fibrillation and symptomatic such as indioventricular
ventricular tachycardia. Delivery or ventricular escape
of this energy in the rhythms, and in the
synchronized mode is a treatment if asystole.
method for treating atrial
fibrillation, atrial flutter,
paroxysmal supraventricular
tachycardia, and, in relatively
stable patients, ventricular
tachycardia.
Automated External AED Mode is to be used only AED Mode is not
Defibrillation on patients in cardiopulmonary intended for a patient
arrest. The patient must be who is conscious and has
unconscious, pulseless, and not a pulse.
breathing normally before
using the defibrillator to
analyze the patient’s ECG
rhythm.
External Pacing External pacing is indicated for External pacing is
symptomatic bradycardia in contraindicated for the
patients with a pulse. treatment of ventricular
fibrillation and asystole.
Electrocardiography The 12-lead electrocardiogram No known
is used to identify, diagnose contraindications
and treat patients with cardiac
disorders and is useful in the
early detection and prompt
treatment of patients with
acute myocardial infarction
(STEMI).
19
Indications Contraindications
Noninvasive Blood Noninvasive blood pressure Noninvasive Blood
Pressure monitoring is intended for Pressure is not intended
detection of hypertension or for use with severe
hypotension and monitoring BP arrhythmia. Noninvasive
trends in patient conditions Blood Pressure is not
such as, but not limited to, intended for patients
shock, acute dysrhythmia, or who are experiencing
major fluid imbalance. convulsion or tremors.
Pulse Oximetry The PRIMEDIC™ DefiMonitor Pulse Oximetry is not
EVO pulse oximetry monitoring intended for use with
is intended to be used to severe peripheral
monitor functional arterial vascular disease and
oxygen saturation and pulse severe anemia
rate. (decreased Hemoglobin).
Invasive Blood The PRIMEDIC™ DefiMonitor No known
Pressure EVO invasive pressure monitor contraindications
is indicated for use in
measuring arterial, venous,
intracranial and other
physiological pressures using
and invasive catheter system
with a compatible transducer.
End-Tidal CO2 The PRIMEDIC™ DefiMonitor No known
EVO EtCO2 monitoring is contraindications
indicated for detection of
trends in the level of expired
CO2. It is used for monitoring
breathing efficacy and
treatment effectiveness in acute
cardiopulmonary care, for
example, to determine if
adequate compressions are
being performed during CPR or
to rapidly detect whether an
endotracheal tube has been
placed successfully. It is
intended for use on adult and
pediatric patients.
Temperature Temperature monitoring is No known
indicated for use in patients contraindications
who require continuous
monitoring of body
temperature.
2.3 About this Manual

This manual explains how to set up and use the PRIMEDIC™ DefiMonitor EVO.
Read the entire manual including the Safety Information section, before you
operate the PRIMEDIC™ DefiMonitor EVO.

20 MGA22955 / GB / A
2.4 Identifying the PRIMEDIC™ DefiMonitor EVO
Configurations
The following table identifies PRIMEDIC™ DefiMonitor EVO configurations and
how they are indicated. The reference number and serial number are located
on the back of the product.
All information in this manual, including the illustrations, is based on a device
configured with the 12lead ECG, Nellcor SpO2 module, Omron Non-Invasive
Blood Pressure (NIBP) module, Temperature (TEMP) module, Respironics
Capnography module (EtCO2 and InCO2; Mainstream or Sidestream), IBP
module and Printer module.
Brand Product Description
Code
EVO I Basic (12 lead ECG, Printer)
PRIMEDIC™ EVO II Basic + SpO2 + NIBP + TEMP

DefiMonitor EVO EVO III Basic + SpO2 + NIBP + TEMP + EtCO2
EVO IV Basic + SpO2 + NIBP + TEMP + EtCO2 + IBP
21
3 Description of the PRIMEDIC™ DefiMonitor
EVO
3.1 Front Panel Components
2
6
3
7, 8, 9
10
11
1
12
4 14, 15, 16, 17
3
5 1
8
Figure 1 Front panel components
Figure 2: Front panel components
1 Paddles (Sternum + Apex) 10 SHOCK button
2 Status LEDs 11 Multi function knob
3 LCD Display 12 Pacing Mode buttons
4 Soft key 13 NIBP button
5 Printer cover 14 PRINT button
6 Mode Select Switch 15 ALARM button
7 ANALYZE button 16 LEAD button
8 JOULE button 17 SIZE button
9 CHARGE button 18 Speaker

22 MGA22955 / GB / A
Table 1: PRIMEDIC™ DefiMonitor EVO Front Panel Controls
Symbols Description
Mode Select Switch
Selects five modes of operation:
 AED: Automated External Defibrillation
 MAN: Manual Defibrillation
 MONITOR: Patient monitoring mode
 OFF
 PACER: External Pacing Mode
ANALYZE button
Analyzes the patient’s ECG to determine whether
or not to deliver a shock
JOULE button
Selects the defibrillation energy level
CHARGE button
Charges to the desired energy level
SHOCK button
Delivers a shock
Multi function knob

Provides user interaction with the DefiMonitor
EVO to control the functions
Rotate knob to select menu entries, change values
etc.
Press knob to confirm settings or values set
before
Rate button
Adjusts the rate of pacing waveform
mA button
Adjusts the current of pacing waveform
NIBP button
Toggles between starting and stopping NIBP
measurements.
PRINT button
Prints measured data.
ALARM button
Pauses the audible alarm temporarily. Turns off
the audible alarm by pressing over 2 seconds.
LEAD button
Selects to display the desired ECG lead on the
screen.
SIZE button
Adjusts and selects the amplitude of an ECG
23
Symbols Description
waveform.
3.2 Paddle Components
Figure 3: Paddle Components
Table 2: PRIMEDIC™ DefiMonitor EVO paddle controls
Symbols Description
APEX Paddle SHOCK button
To deliver shock
REC button
Prints the measured data
CHARGE button
charges to the desired energy level automatically.
LED indicates completion of charging process.
STERNUM Paddle SHOCK button
To deliver shock
Energy Level buttons

+: increases. the defibrillation energy level
-: decreases the defibrillation energy level
3.3 Rear Panel Components

24 MGA22955 / GB / A
1 2 3 4 5 6
Figure 4: Rear Panel Components
1 AC connector 4 Lock plates
2 GND terminal 5 Charger contacts
3 Power supply 6 Rechargeable battery
3.4 Left Panel Components
1 4
2 5
3 6
Figure 5: Left Panel Components
25
1 Temperatur 1 connector 4 Temperatur 2 connector
2 EtCO₂ connector 5 IBP 1 connector
3 NIBP connector 6 IBP 2 connector
3.5 Right Panel Components
1
2
3 4
Figure 6: Right Panel Components
1 Paddle/Pads connector 3 ECG connector

2 USB/SD Card Slot 4 SpO2 connector
Table 3: Panel and Label Symbols
Symbol Description Symbol Description

AC indicator IP55 Dust and water resistance
Direct current CE mark
Battery charging status
Consult Instructions for use
indicator
Service indicator Separate Collection
Type CF- Defibrillator Proof Manufacturer
NIBP connector Date of manufacture
Temperature 1 connector Reference number
Temperature 2 connector Serial number
Environmental
IBP 1 connector shipping/storage altitude
limitations
Environmental
IBP 2 connector shipping/storage humidity
limitations

26 MGA22955 / GB / A
Environmental
EtCO2 connector shipping/storage temperature
limitations
SpO2 connector Fragile
ECG connector Keep dry
AC power input rating This way up
Equipotential terminal Single patient use only
Class II equipment
27
3.6 Display
1 2 3 4 5 6
14
7
13
10
11
12 15
16
Figure 7: Display
1 Shock count number/Icon 9 SpO2 waveform

2 Defibrllator message area 10 IBP waveform
3 Battery status icons 11 EtCO2 waveform
4 Elapsed time (power on) 12 Alarm/informative message
area
5 WiFi/3G icon 13 Waveform area
6 Title of numeric area 14 Numerical area
7 Title of waveform parameter 15 Date/Time
8 ECG waveform 16 Soft key menu
Table 4: Display Symbols
Symbols Description Symbols Description
ECG source: Paddle Temperature unit: Celsius
ECG source: Lead l Temperature unit:

Fahrenheit
ECG source: Lead ll SpO2 unit or EtCO2 unit: %
ECG source: Lead lll Respiration icon
ECG source: Lead aVL NIBP or IBP or EtCO2unit:

mmHg
ECG source: Lead aVR NIBPor IBP or EtCO2unit:

kPa
ECG source: Lead aVF Pulse amplitude indicator
ECG source: Lead V Respiration source: AW
ECG source: Lead V1 Respiration source: IM

28 MGA22955 / GB / A
Symbols Description Symbols Description
ECG source: Lead V2 NIBP auto mode Interval
ECG source: Lead V3 NIBP elapsed time since

last measurement in
hh:mm
ECG source: Lead V4 HR/PR icon& unit
ECG source: Lead V5 Communication source:

3G
ECG source: Lead V6 Communication method:

Wi-Fi
ECG source: Pads Shock count number icon
NIBP icon : Noninvasive

Elapsed time icon
Blood Pressure
SpO2 waveform icon Neonatal icon
Impedance respiration
DC power input icon
waveform icon
EtCO2 icon : End-tidal
carbon dioxide Battery status icon
concentration
InCO2 icon: Inspired AC power input icon
carbon
dioxide concentration
IBP1 waveform icon Time display
IBP1 waveform icon Alarm active
IBP2 waveform icon Audio pause
Audio off or Limit alarm

IBP2 waveform icon
pause
IBP2 waveform icon Pacer pulse detection icon
IBP 2 waveform icon ECG gain
Temperature 1 icon
Temperature 2 icon
Table 5: Display Colors Factory Defaults
Function Color
ECG Waveform Green
SpO2 Waveform Cyan
Respiration Waveform Light Blue
EtCO2 Waveform Light Purple
ECG Green
NIBP White
SpO2 Cyan
Respiration Rate Light Blue
EtCO2 Light Purple
Temperature 1 Pink
Temperature 2 Pink
IBP 1 Red
29
IBP 2 Yellow
General background Black
Alarm/Informative message Black background, Green font
Defibrillator message Black background, White font
Low priority alarm message Black background, Yellow font
Medium priority alarm message Black background, Yellow font
High priority alarm message Black background, Red font
Battery status icon (normal) White
Battery status icon (low battery) Yellow or Red (refer to Table 8)
The display colors can only be changed by authorized personnel via the
Note
Service Menu. The detailed information is described in the service manual.

30 MGA22955 / GB / A
4 Setting up the PRIMEDIC™ DefiMonitor EVO
WARNING
Do not immerse any portion of the PRIMEDIC™ DefiMonitor EVO in
water or other fluids. Avoid spilling any fluids on defibrillator or
accessories. Spilled liquids entering the interior of the device may cause
the defibrillator and accessories to perform inaccurately or fail. Refer to
technical specifications in chapter 27.
WARNING
The PRIMEDIC™ DefiMonitor EVO should not be used adjacent to or
stacked with other equipment. If adjacent or stacked use is necessary,
the PRIMEDIC™ DefiMonitor EVO should be observed to verify normal
operation in the configuration it is to be used.
WARNING
Make sure that the PRIMEDIC™ DefiMonitor EVO speaker is not
obstructed. Failure to do so could result in an inaudible alarm tone.
CAUTION
Recharging the battery is strongly recommended when the battery has
not been recharged for 6 or more months.
CAUTION
Follow local government ordinances and recycling instructions regarding
disposal or recycling of device components, including batteries.
CAUTION
The use of accessories, cables, transducers and sensors sourced from
manufacturers, which Metrax GmbH has not recommended may cause
incorrect analysis.
CAUTION
Electrical installation of the room or the building in which the
defibrillator/monitor is to be used must comply with regulations
specified by the country in which the equipment is to be used.
4.1 Unpacking and Inspection

The PRIMEDIC™ DefiMonitor EVO is shipped in one carton. Examine the carton
carefully for evidence of damage. Contact Metrax GmbH Technical Support
Representative immediately if any damage is discovered. Refer to chapter 24
for instructions on returning damaged items.
Refer to the Performance Verification section in the service manual for

Note
detailed information.
31
Set the PRIMEDIC™ DefiMonitor EVO to the user’s intended position where the
user can easily recognize the visual and audible monitoring conditions.
Normally it is recommended to set at a distance of 1m from the user. Also the
viewpoint is at any point within the base of a cone by an angle of 30° to the
center of the monitoring display.
4.2 List of Components

Part number Name
97213 Power Supply
21876 Power supply cord
22994 SD-Card DefiMonitor EVO
97214 PRIMEDIC™ AkuPak EVO
97215 12 Lead ECG Cable
96592 ECG-electrodes (30 pieces per pack) (Box of 10)
97216 Adapter Cable SavePads
96446 SavePadsConnect cable II (3.6m)
96516 PRIMEDIC SavePads connect
96343 SavePads (1 Pair)
97217 Paddles
97218 Printer Paper (Box of 10)
97219 Bag for EVO (left)
97220 Bag for EVO (right)
97221 Adapter cable SpO2 finger sensor
96892 Nellcor SpO2 Finger Sensor
97223 Extension Hose for Blood Pressure Cuff
97312 Blood Pressure Cuff Small (13-22 cm )
97313 Blood Pressure Cuff Medium (22-32cm )
97222 Blood Pressure Cuff Large (32-42cm )
97314 Blood Pressure Cuff X-Large (42-50cm )
97315 Cover for Blood Pressure Cuff Small (13-22 cm )
97316 Cover for Blood Pressure Cuff Medium (22-32cm )
97317 Cover for Blood Pressure Cuff Large (32-42cm )
97318 Cover for Blood Pressure Cuff X-Large (42-50cm )
97225 Multipurpose Temerature Sensor, Adult
97330 Protective Cover for Temperature Sensor (Box of 10)
97228 IBP Transducer Set
97229 IBP Adapter Cable
97230 IBP Monitoring System (Box of 10)
97322 IBP Monitoring System with Patient Extension (Box of 10)

97224 CAPNOSTAT 5 Mainstran Sensor (*)
97249 Single Use Adult Airway Adapter (Box of 10) (*)
97282 Reusable Adult Airway Adapter (*)
97281 Single Patient Use Neonatal Airway Adapter (Box of 10) (*)
97283 Reusable Neonatal Airway Adapter (*)
97284 LoFlo Sidestream Module (**)
97285 Airway Adapter Set - ET >4.0 mm (Box of 10) (**)
32 MGA22955 / GB / A
97286 Airway Adapter Set - ET =< 4.0 mm (Box of 10)(**)
97289 PRIMEDIC™ WallMount EVO
97243 PRIMEDIC™ Charger EVO
22955 Operating Instructions
97244 Shoulder strap
97321 Adapter Cable for Pediatric Defibrillation
97300 SavePads mini
97326 Adapter Cable for Internal Defibrillation
97323 Pulse One™ (-) self-adhesive Electrode for Internal Defibrillation
97324 Pulse One™ (+) Electrode for Internal Defibrillation, Adult
97325 Pulse One™ (+) Electrode for Internal Defibrillation, Pediatric
4.3 Power Cable Connections
WARNING
Do not connect to an electrical outlet controlled by a wall switch or
dimmer because the device may be accidentally turned off.
CAUTION
If the integrity of the AC power source is in doubt, the DefiMonitor EVO
must be operated from its internal battery.
4.3.1 AC Power
Make sure that the AC outlet is properly grounded and supplies the specified
voltage and frequency (100-240V~ 50/60 Hz).
Figure 8: AC Power Connection
Connect the female type connector end of the AC power cord to mains connector
of the PRIMEDIC™ PowerLine EVO on the PRIMEDIC™ DefiMonitor EVO’s
rear panel.
Plug the male type connector end of the AC power cord into a properly grounded
mains outlet.
If necessary, connect grounding wire. Connect the grounding wire connector to the
equipotential terminal on the rear panel. Now attach the clip end of the
grounding wire to the medical equipment grounding terminal on the wall.
Verify that the Battery charging status LED and AC/DC in LED on the PRIMEDIC™
DefiMonitor EVO’s front panel is lit.
33
Even if the PRIMEDIC™ DefiMonitor EVO is not turned on, the Battery
Note
charging status LED is lit when the AC power cord is connected into a
mains outlet.
4.3.2 DC Power
When used together with PRIMEDIC™ Charger EVO the PRIMEDIC™
DefiMonitor EVO can also be supplied by DC power. This setup allows the
operation e.g. in ambulance cars and other emergency settings.
Figure 9: DC Power Connection
1. Connect the PRIMEDIC™ DefiMonitor EVO to the wall-mount PRIMEDIC™

Charger EVO as described in the instructions for use of the PRIMEDIC™
Charger EVO.
2. Verify that the DC power input icon appears on the screen, Battery
charging status LED and AC/DC in LED on the PRIMEDIC™ DefiMonitor
EVO’s front panel is lit.
Battery A charging status LED indicates battery A is installed and being

Note
charged by the AC power and Battery B charging status LED indicates
battery B is installed and being charged by the AC or DC power.
Even if the PRIMEDIC™ DefiMonitor EVO is not turned on, the Battery
Note
charging status LED is lit when the PRIMEDIC™ Charger EVO is connected
to a DC power source.
If the Battery charging status LED is not lit, check:

Note
 the power cord
 the connection of the PRIMEDIC™ Charger EVO to its DC power
source
 the AC input connector
 the electrical contact between the PRIMEDIC™ DefiMonitor EVO’s
DC power contacts and the DC output contacts of the PRIMEDIC™
Charger EVO
 the power/ mains outlet if no Battery is installed
If the Battery charging status LED still is not lit although no problem is
Note
found, contact qualified service personnel or your local supplier for
assistance.

34 MGA22955 / GB / A
4.4 Measurement Cable Connections
WARNING
For best product performance and measurement accuracy, use only
accessories supplied or recommended by Metrax GmbH. Use
accessories according to the manufacturer’s directions for use and your
facility’s standards. Use only accessories that have passed the
recommended biocompatibility testing in compliance with ISO10993-1.
WARNING
Connect the sensor, probe, cuff/hose or transducer firmly into socket
and do not use a damaged sensor, probe, cuff/hose or transducer.
WARNING
To avoid damage to the cable, always hold by the connector rather than
the cable, when connecting or disconnecting either end.
WARNING
The sensor connector should not be connected to anything other than a
sensor.
Both frequent checks by the operator on a daily basis and more

Note
comprehensive technical checks less frequently are covered by this
requirement in order to detect mechanical damage and damage to cables,
etc.
4.4.1 ECG Cables and Leads

Connect an ECG cable to the “ECG” connector on the right connector panel
of the PRIMEDIC™ DefiMonitor EVO making sure that the mechanical
codings of connector and plug are matching.
Figure 10: ECG cable connector - match of

mechanical coding of connector and plug
35
4.4.2 Defibrillator Paddle and Pads
Figure 11: Connecting the Paddle/Pads

connector to the defibrillator’s plug
1. Connect the paddle or the adapter cable for connection to

adhesive pads to paddle / pads connector on the on the right
connector panel of the PRIMEDIC™ DefiMonitor EVO.
2. Use LEAD button to select pads. (If paddle is connected, the mode
is automatically changed to paddle.)
3. Apply conductive material to paddles.
4. Apply paddles or pads to patient’s bare skin.
4.4.3 NIBP Hoses and Cuffs (if configured with NIBP option)
1. Select an appropriate cuff size for the patient (refer to chapter 13).
2. Connect the hose to the “NIBP” connector on the left connector panel
of the PRIMEDIC™ DefiMonitor EVO making sure to tighten the
connector in clockwise direction.
3. Attach the cuff to the end of the hose.
Refer to chapter 2.4 for the configurations of the PRIMEDIC™ DefiMonitor

Note
EVO which are equipped with this option.
4.4.4 SpO2 Cables and Sensors (if configured with SpO2 option)
1. Select an appropriate sensor for the patient and desired application
(refer to chapter 14).
2. Connect the extension cable to the “SpO2” connector on the right
connector panel of the PRIMEDIC™ DefiMonitor EVO (see Figure 6:
Right Panel Components).
3. Attach the sensor to the end of the cable.
4.4.5 Temperature Probes (if configured with Temperature

option)
1. Select the appropriate probe(s) for the desired application (refer to
chapter 17).
2. Connect the temperature probes to the “Temperature” connector on
the left connector panel of the PRIMEDIC™ DefiMonitor EVO (see
Figure 5: Left Panel Components).

36 MGA22955 / GB / A
4.4.6 CO2 Sensor (if configured with CO2 option)
1. Select the appropriate CO2 sensor according to the operational mode
(refer to the chapter Capnography Monitoring16).
2. Connect Mainstream or Sidestream sensor to the “EtCO2” connector
on the left connector panel of the PRIMEDIC™ DefiMonitor EVO (see
Figure 5: Left Panel Components).
4.4.7 IBP Transducers (if configured with IBP option)

1. Connect the interface cable(s) for the transducer(s) to the “IBP”
connector on the left connector panel of the PRIMEDIC™ DefiMonitor
EVO (see Figure 5: Left Panel Components). An interface cable for the
transducer has to be selected correctly as it depends on the
transducer type (refer to chapter 18).
2. Set up the patient circuit according to the directions for use of the
transducer, monitoring kit and IV set (6pin, red round connector).
If leadwire cable, cuff/hose cable, sensor, probe and transducer are not
Note
connected firmly, the monitor could lose signal from patient.
37
5 Battery Operation
WARNING
Do not disassemble, puncture, crush, heat above 100°C (212°F), or
incinerate the battery. Be careful not to short the battery terminals
because this could result in a fire hazard.
WARNING
Metrax GmbH has no information regarding the performance or
effectiveness of the PRIMEDIC™ DefiMonitor EVO if other
manufacturers’ batteries or battery chargers are used. Using other
manufacturers’ batteries or battery chargers may cause the device to
perform improperly and invalidate the safety agency certifications. Use
only PRIMEDIC™ AkuPak EVO rechargeable batteries and use the
PRIMEDIC™ PowerLine EVO AC/DC power supply or the PRIMEDIC™
Charger EVO DC-charging unit for charging.
WARNING
Grounding reliability can only be achieved when the equipment is
connected to an equivalent receptacle marked “HOSPITAL ONLY” or
“HOSPITAL GRADE”. If the grounding integrity of the line cord or AC
receptacle is in doubt, operate on battery only.
CAUTION
Recharging the battery is strongly recommended when it has not been
fully recharged for 6 or more months.
CAUTION
Do not install the battery into the PRIMEDIC™ DefiMonitor EVO when
storage may exceed 90 days. Battery damage may occur.
CAUTION
When the voltage of the battery is very low, there is the possibility of not
operating.
CAUTION
Check for the battery-in-use indication when the PRIMEDIC™
DefiMonitor EVO is operating on mains and apply corrective action.
CAUTION
Do not operate the PRIMEDIC™ DefiMonitor EVO without a battery.
Keep a fully charged spare battery pack with the device at all times.
CAUTION
Partial charge of battery results in a shortened service life.

38 MGA22955 / GB / A
CAUTION
Storing at temperatures above 40°C (104°F) for extended periods of time
will significantly reduce a battery’s life-expectancy.
CAUTION
Using an improperly maintained battery to power the PRIMEDIC™
DefiMonitor EVO may cause power failure without warning. Charge the
battery in the PRIMEDIC™ DefiMonitor EVO using an appropriate
external power source.
CAUTION
Battery pins in the PRIMEDIC™ DefiMonitor EVO may be damaged if
batteries are dropped or forced into battery wells. Inspect pins routinely
for signs of damage. Keep batteries installed at all times expect when
device is removed from service for storage.
CAUTION
When storing the PRIMEDIC™ DefiMonitor EVO for an extended period
of time, the battery should be removed from the device.
CAUTION
Stored batteries lose charge. Failure to charge a stored battery before
use may cause device power failure without warning. Always charge a
stored battery before placing it in active use.
It is recommended to keep AC power source connected to the PRIMEDIC™

Note
DefiMonitor EVO when not in use. This will ensure a fully charged battery
whenever it is needed.
As the battery is used and recharged over a period of time, the amount of
Note
time between the onset of the low battery alarm and thePRIMEDIC™
DefiMonitor EVO shut-off may become shorter. It is recommended for
service personnel to check periodically or replace the battery if necessary.
5.1 Operating the DefiMonitor EVO on Battery Power

The PRIMEDIC™ DefiMonitor EVO has a rechargeable battery that can be used
to power the device when AC power source or a DC power supply by the
PRIMEDIC™ Charger EVO is not available. The battery status icon appears on
the screen when the DefiMonitor EVO is on battery power.
The PRIMEDIC™ DefiMonitor EVO can be powered by two batteries when a

Note
battery is inserted instead of AC power supply (SMPS). When the
PRIMEDIC™ DefiMonitor EVO is equipped with two batteries, two battery
status icons appear on the screen.
39
Figure 12: Battery Placement
Turn off the DefiMonitor EVO.

Push the SMPS/battery push button
Insert the battery into the PRIMEDIC™ DefiMonitor EVO carefully.
Table 6: Front Panel Indications for Power Source
Power Connections Front Panel Indications
AC source Battery charge icon is displayed on the screen.

AC/DC in LED is lit.
DC source Battery charge icon is displayed on the screen.

DC power input icon appears on the screen.
AC/DC in LED is lit.
Battery Battery status icon appears on the screen.
The PRIMEDIC™ DefiMonitor EVO cannot operate with a completely

discharged battery. Before turning on the PRIMEDIC™DefiMonitor EVO with a
battery that has been completely discharged, plug the PRIMEDIC™DefiMonitor
EVO into an AC outlet to charge the battery for a minimum of 3 minutes. The
PRIMEDIC™ DefiMonitor EVO may then be powered on.
A new, fully charged battery will provide 5 hours monitoring operation under
the following conditions:
 Operation of ECG monitoring or defibrillation mode (Standard option)

 No audible alarm condition
 No external communication operating
 No recording
 Ambient temperature at 25°C±5°C
If there is the combination of battery A and B in the PRIMEDIC™
Note
DefiMonitor EVO, two new, fully charged batteries will provide 10 hours
monitoring operation.
5.2 Battery Status Indication

When operating on batteries, the battery status icon in the upper part of the
display indicates the battery charge condition. (Table 7)

40 MGA22955 / GB / A
Table 7: The PRIMEDIC™ DefiMonitor EVO Battery Status Icon
Battery Status Icons Battery Status Icon Color

White (normal condition)
Yellow (low battery)
Red (critically low battery)
White (charging)
A low priority alarm occurs when the remaining battery power is only enough
for 15 minutes of operation. The “Low battery” message is displayed on the
screen. Connect the AC power or replace the battery with a fully charged
battery immediately when alarm occurs.
This alarm cannot be paused while running on battery power. Connecting the
PRIMEDIC™ DefiMonitor EVO to AC power will stop the alarm.
A high priority alarm occurs for about 5 minutes before the PRIMEDIC™
DefiMonitor EVO shuts off. The “SYSTEM: Critically low battery condition”
message is displayed on the screen. Connect the PRIMEDIC™ DefiMonitor EVO
to an AC power source immediately to avoid any loss of trend data or settings.
The battery will not be charged for safety if the operating temperature
Note
exceeds 40℃.
41
6 Using the PRIMEDIC™ DefiMonitor EVO
WARNING
Each time the PRIMEDIC™ DefiMonitor EVO is used, check alarm limits
to make sure that they are appropriate for the patient being monitored.
WARNING
If different alarm presets are used for the same or similar equipment in
any single area, e.g. an intensive care unit or cardiac operating room, a
potential hazard can exist.
WARNING
Keep patients under close surveillance when monitoring. It is possible,
although unlikely, that radiated electromagnetic signals from sources
external to the patient and the PRIMEDIC™ DefiMonitor EVO can cause
inaccurate measurement readings. Do not rely entirely on the
PRIMEDIC™ DefiMonitor EVO readings for patient assessment.
WARNING
Be aware of patient cables, including ECG monitoring equipment when
used with high frequency surgical equipment.
WARNING
Do not analyze in a moving vehicle. Motion artifact may affect the ECG
signal resulting in an inappropriate SHOCK or NO SHOCK ADVISED
message. Motion detection may delay analysis. Stop vehicle and stand
clear of patient during analysis.
WARNING
To avoid risk of electrical shock, do not touch gelled area of the pads
while pacing or shock. When defibrillating with paddles use your
thumbs to operate the SHOCK buttons in order to avoid inadvertent
operator shock. No portion of the hand should be near the paddle
plates.
WARNING
Pediatric defibrillation energy levels should be set based on site-specific
clinical protocols.
WARNING
The metronome sounds do not indicate information regarding the
patient’s condition. Because patient status can change in a short time,
the patient should be assessed at all times. Do not perform CPR on a
patient who is responsive or is breathing normally.

42 MGA22955 / GB / A
WARNING
Place the patient on a firm surface before performing CPR.
WARNING
Ventricular fibrillation may be induced with improper synchronization.
Do not use the ECG from another monitor (slaving) to synchronize the
PRIMEDIC™ DefiMonitor EVO’s discharge. Always monitor the patient’s
ECG directly through the PRIMEDIC™ DefiMonitor EVO’s ECG cable or
pad cable.
WARNING
Pitted or damaged paddles may cause patient skin burns during
defibrillation.
WARNING
The ECG rhythm analysis function does not warn the operator of patient
asystole, as itis not a shockable rhythm.
WARNING
Determination of electrical capture should only be performed by
viewing the ECG on the screen with its ECG cable directly attached to
the patient.
WARNING
Connect the device only to a three-wire, grounded, hospital grade
receptacle. The three conductor plug must be inserted into a properly
wired three-wire receptacle; if a three-wire receptacle is not available, a
qualified electrician must install one in accordance with the governing
electrical code. Do not under any circumstances remove the grounding
connector from the power plug. Do not use extension cords or adapters
of any type. The power cord and plug must be intact and undamaged.
CAUTION
The defibrillator does not automatically adjust energy when using
pediatric electrodes. Manually select the appropriate energy prior to
defibrillating the patient.
CAUTION
Only use thumbs to depress the paddle SHOCK button. Failure to do so
could result in the inadvertent depression of the energy select buttons,
causing the defibrillator to disarm itself.
CAUTION
Do not discharge the defibrillator except as indicated in the instructions.
43
CAUTION
Do not permit gel to accumulate between the paddle electrodes on the
chest wall (gel bridge). This could cause burns and reduce the amount of
energy delivered to the heart.
CAUTION
Changing the selected energy while the PRIMEDIC™ DefiMonitor EVO is
charging or charged will cause the defibrillator to disarm itself. Press the
CHARGE button again to charge the PRIMEDIC™ DefiMonitor EVO.
CAUTION
If using defibrillation pads, make sure that the size of the pad is large
enough to cover the entire paddle electrode area.
CAUTION
Pads should be replaced after 50 defibrillations, 8 hours of continuous
pacing or 24 h of monitoring to ensure maximum patient benefit.
CAUTION
Be sure to safely discharge external paddles.
6.1 Turning on the DefiMonitor EVO

Before using the PRIMEDIC™ DefiMonitor EVO, confirm that it is working
properly and is safe to use as described below.
CAUTION
Look for display motion before accepting any displayed data as a current
measurement.
If unusual sound like buzzer can be heard, do not use the DefiMonitor EVO.
Note
Instead, please contact qualified service personnel or your local supplier.
Figure 13: Mode Select Knob
Rotate Mode Select Knob to desired mode.

The DefiMonitor EVO is turned on in selected mode.

44 MGA22955 / GB / A
 AED Mode - to enable AED Mode for semi-automated external
defibrillation.
 Manual Mode - to enable Manual Mode for asynchronous or
synchronous defibrillation.
 Monitor Mode - to enable Monitor Mode for up to 12-lead ECG
monitoring and acquisition and vital signs trending, or monitoring of
optional parameters.
 Pacing Mode - to enable Pacing Mode for demand (sync) or fixed mode
pacing.
Monitoring capabilities can be used in every mode.

Note
6.2 Setting Date and Time

You may set the date and time displayed on the screen and printed on the
reports.
1. Rotate the Multi function knob to highlight Date/Time, and then press the
Multi function knob to select Date/Time Menu.
Figure 14: Select Date/Time Menu
2. Soft key Menu will be changed to Date Format, Set Date, Set Time and Return.
When the soft key is pressed, the relevant Menu will appear. Rotate and press
the Multi function knob to change the desired format or number.
Table 8: Date/Time Menu
Level 1 Menu Level 2 Menu or Response

Date format YY/MM/DD
MM/DD/YY
DD/MM/YY
Return
Set Date Year
Month
Day
Return
45
Set Time Hour
Minute
Second
Return
Return
6.3 Continued use

The PRIMEDIC™ DefiMonitor EVO retains the previous settings when it is
turned off for less than 10 seconds. And if the PRIMEDIC™ DefiMonitor EVO
was not turned off and less than 10 minutes have elapsed since the operation
mode was last used, the defibrillator/monitor retains the previous settings of
last operation mode.
6.4 Setting the Main Screen

You may select the main screen to be displayed; 4 waveform screen, large
numeric screen or Black-white invert screen.
1. Press Setup soft key to change main screen (4 waveform screen) to large
numeric screen or black-white invert screen.
2. Select Display mode menu. Display mode menu will be displayed on
screen.
3. Rotate and press the Multi function knob to change the desired display
mode.
Large numeric screen can only be selected in Monitor Mode.

Note
Figure 15: Setup: Display mode Menu
4-ch Wave Screen: ECG + SpO2 + ABP + EtCO2

46 MGA22955 / GB / A
Figure 16: Normal Screen (4 waveform, Defibrillation mode, Full option)
47
Large Numeric Screen
Figure 17: Large Numeric Screen (2 waveform, Defibrillation mode, Full option)
Black-white Invert Screen (Mono-color screen)
Figure 18: Black-white Screen (4 waveform, Defibrillation mode, Full option)

48 MGA22955 / GB / A
7 Alarms and Limits
WARNING
Each time the PRIMEDIC™ DefiMonitor EVO is used, check alarm limits
to make sure that they are appropriate for the patient being monitored.
WARNING
WARNING
Always respond immediately to a system alarm since the patient may
not be monitored during certain alarm conditions.
CAUTION
Do not cover the holes for the speaker which allows the alarm sound to
exit the PRIMEDIC™ DefiMonitor EVO. Also do not disable audible
alarms when it is not appropriate to do so.
7.1 General
When the PRIMEDIC™ DefiMonitor EVO detects certain conditions that require
user attention, the PRIMEDIC™ DefiMonitor EVO enters an alarm state. The
PRIMEDIC™ DefiMonitor EVO response is indicated by:
 Audible alarm indication

 Physiological alarms including identification of out-of-limit vital signs
 Technical alarms
The audible and visual alarms on the PRIMEDIC™ DefiMonitor EVO, used in
Note
conjunction with clinical signs and symptoms, are the primary source for
notifying medical personnel that a patient alarm condition exists.
Each key-control should result in some audible tone to prevent invalid key-
Note
controls of being ignored. Have the PRIMEDIC™ DefiMonitor EVO serviced
if the key-controls fail.
7.1.1 Changing Alarm Volume

User can select an alarm volume level of 1 to 8.
1. Select the Setup soft key and then the Setup menu will be displayed.
2. Rotate the Multi function knob to highlight Volume and then press the
Multi function knob to select Volume Menu.
3. Rotate the Multi function knob to highlight desired menu.
4. Selected menu is activated by pressing the Multi function knob.
5. Rotate the Multi function knob to adjust the volume.
6. Press the Multi function knob to save the desired volume and to select
the other menu.
49
7. Press the Return soft key. Then the current menu returns to the previous
menu.
Volume
Alarm
Beep
Button
Figure 19: Volume Menu Display
7.2 Alarm Priority and Messages

There are three possible priorities for visual and audible alarms: High, Medium,
and Low. The high, medium, and low priority messages and informative
messages are displayed in the alarm/informative message area and the
defibrillator messages are displayed in the defibrillator message area. A
message is displayed alternatively every 2 seconds when the PRIMEDIC™
DefiMonitor EVO is in multiple alarm conditions. Refer to chapter 25 for
recommended actions.
7.2.1 High Priority Alarms

A high priority alarm indicates that immediate operator response is required.
Table 9: High Priority Alarms
High Priority Alarm Message

Parameter Condition Messages
ECG Asystole ECG: Asystole
V-FIB ECG: V-FIB
%SpO2 Loss of Pulse from SpO2 or SpO2 Loss of Pulse
No valid ECG and no motion
artifact
IBP Loss of pulse from IBP {label}: Loss of pulse
(ex {label}: P1, P2, ABP, CVP,
PAP, LAP)
EtCO2 APNEA EtCO2: APNEA
Resp Loss of Respiration Signal RESP: Loss of respiration
signal
SYSTEM Critically Low-Battery SYSTEM: Critically low-

condition battery condition
7.2.2 Medium Priority Alarms

A medium priority alarm indicates that prompt operator response is required.
Table 10: Medium Priority Alarms
Medium Priority Alarm Message

50 MGA22955 / GB / A
HR/PR High Heart Rate/Pulse Rate limits High Heart Rate/Pulse Rate limits
violated violated
Low Heart Rate/Pulse Rate limits Low Heart Rate/Pulse Rate limits
violated violated
ECG ECG Signal Saturation ECG Signal Saturation
%SpO2 High SpO2 limits violated High SpO2 limits violated
Low SpO2 limits violated Low SpO2 limits violated
NIBP High Systolic blood pressure NIBP-High Systolic blood pressure

limits violated limits violated
High Diastolic blood pressure NIBP-High Diastolic blood pressure

High MAP blood pressure limits NIBP-High MAP blood pressure

violated limits violated
Low Systolic blood pressure NIBP-Low Systolic blood pressure

Low Diastolic blood pressure NIBP-Low Diastolic blood pressure

Low MAP blood pressure limits NIBP-Low MAP blood pressure limits
violated violated
Resp High Respiration Rate limits High Respiration Rate limits violated
violated
Low Respiration Rate limits Low Respiration Rate limits violated

violated
IBP IBP Over the systolic upper limit {label}: High systolic blood pressure
limit violated
(ex {label}: P1, P2, ABP, CVP, PAP,
LAP)
IBP Under the systolic lower limit {label}: Low systolic blood pressure
limit violated
LAP)
IBP Over the diastolic upper limit {label}: High diastolic blood
pressure limit violated
LAP)
IBP Under the diastolic lower {label}: Low diastolic blood pressure
limit limit violated
LAP)
IBP Over the mean upper limit {label}: High MEAN blood pressure
limit violated
LAP)
IBP Under the mean lower limit {label}: Low MEAN blood pressure
limit violated
LAP)
EtCO2 High EtCO2 limits violated EtCO2 - High EtCO2 limits violated
Low EtCO2 limits violated EtCO2 - Low EtCO2 limits violated
51
Medium Priority Alarm Message

High InCO2 limits violated EtCO2 - High INCO2 limits violated
Low InCO2 limits violated InCO2 - Low INCO2 limits violated
Temp High Temperature limits violated TEMP1: High Temperature limits

violated
TEMP2: High Temperature limits

violated
Low Temperature limits violated TEMP1: Low Temperature limits

violated
TEMP2: Low Temperature limits

violated
7.2.3 Low Priority Alarms

A low priority alarm indicates that operator awareness is required.
Table 11: Low Priority Alarms
Low Priority Alarm Message

ECG Leads Off ECG Leads off
ECG
Chest Lead off Chest lead off
Temperature Probe Disconnect TEMP1: Probe disconnect
TEMP2: Probe disconnect

Temp
Temperature – Out of range TEMP1: Out of range
TEMP2: Out of range
Abnormal Cuff NIBP – Abnormal cuff / EEE 11
NIBP – Abnormal cuff / EEE 21
Measurement Fail NIBP – Measurement fail / EEE 12
NIBP – Measurement fail / EEE 14
NIBP NIBP – Measurement fail / EEE 18
Overpressure NIBP – Overpressure / EEE 19
Artifact NIBP – Artifact / EEE 13
NIBP – Artifact / EEE 16
Time-Out NIBP – Time-out / EEE 17
Failed in zero calibration {label}: Unable to zero calibration.

LAP)
IBP
Out of range {label}: Out of range.
LAP)

52 MGA22955 / GB / A
Low Priority Alarm Message

Cable/Sensor disconnected {label}: Cable/Sensor disconnected.
LAP)
SpO2- Technical Error SpO2Error – EEE001

~ SpO2 Error – EEE511
SpO2: Module reset
SpO2: Reconnect / Replace SpO2

sensor
%SpO2
SpO2: Reposition / Replace SpO2
sensor
SpO2: Replace SpO2 Sensor
SpO2 Cable/Sensor Disconnect SpO2 Cable/Sensor disconnect
Sensor Off from SpO2 Sensor SpO2 Sensor off
Resp Respiration Leads Off RESP: Leads off
Adapter Calibration Failed EtCO2: Adapter Calibration Failed
Check Adapter EtCO2: Check Adapter
Faulty Sensor EtCO2: Faulty Sensor
Occlusion or Leak EtCO2: Occlusion or Leak
EtCO2 Out of Range EtCO2: Out of Range
Sample Line Disconnected EtCO2: Sample Line Disconnected
Sensor Disconnected EtCO2: Sensor Disconnected
Adapter Calibration Failed EtCO2: Adapter Calibration failed
Check Adapter EtCO2: Check Adapter
Printer out of paper SYSTEM: Printer out of paper

System
Low Battery SYSTEM: Low Battery
7.2.4 Informative Messages

Informative messages indicate a system condition that needs to be corrected.
Table 12: Informative Messages
Condition Messages
SpO2 Pulse search SpO2: Pulse search
SpO2 Motion interference SpO2: Motion interference
IBP No zero reading. {label}: No zero reading.

LAP)
IBP Zero CAL in progress. {label}: Zero CAL in progress.

LAP)
Copyright © 2011 All rights Copyright © 2011 All rights reserved

reserved
53
Condition Messages
Abnormally shut down last time SYSTEM : Abnormally shut down last
time
Audio Off SYSTEM : Audio Off
Demo Mode SYSTEM : Demo Mode
Abnormally shut down last time SYSTEM : Abnormally shut down last
time
Printer is not available SYSTEM : Printer is not available
Not Enough Memory Not Enough Memory
Not Enough Memory (Internal Not Enough Memory (Internal

Memory) Memory)
There may be other informative messages that are not listed above.
Note
7.2.5 Defibrillator messages

Defibrillator messages indicate a condition related to Manual Mode, AED Mode
and Pacing Mode.
Table 13: Defibrillator Messages
Condition Messages
Check for response Check response

(Voice prompt: Check patient)
Call for help Call for help

(Voice promp: Call emergency
services)
Open the airway Open airway

(Voice prompt: Open airway)
Attach pads to bare chest Attach pads to bare chest

(Voice prompt: Remove clothes from
the patient's chest. Apply electrodes
one after the other to patient's bare
chest. Press electrodes firmly to
patient's chest.)
Check pads Check pads
Analyzing ECG Analyzing heart rhythm

(Voice prompt: Analyzing rhythm.
Do not touch the patient.)
Do not touch the patient Do not touch the patient
No Shock advised No Shock advised

(Voice prompt: No shock advised.)
Shock advised Shock advised

(Voice prompt: Shock advised.)
Press SHOCK button Press SHOCK button

(Voice prompt: Press lit shock button
now.)

54 MGA22955 / GB / A
Condition Messages
Press paddle shock button Press paddle shock button.
Shock delivered Shock delivered

(Voice prompt: Shock delivered.)
It is sate to touch the patient It is safe to touch the patient

(Voice prompt: It is now safe to
touch the patient.)
Begin CPR Begin CPR

(Voice prompt: Give 30 chest
compressions.)
Press CHARGE button Press CHARGE button
Disable Sync Disable Sync
Remove paddle Remove paddle
Poor Pads Contact Poor Pads Contact
Poor Paddles Contact Poor Paddles Contact
DEFIB Pads short DEFIB Pads Short
DEFIB Paddles short DEFIB Paddles short
Release shock Release shock
Remove Sync to Analyze Remove Sync to Analyze
Analysis Halted Analysis Halted
Retry Analysis Retry Analysis
ECG Lead Off ECG Lead Off
ECG 12 Lead Acquiring ECG 12 Lead Acquiring
Select BPM Select BPM
Select mA Select mA
Pacing paused Pacing paused
7.3 Visual Alarm Indication

Table 14: Visual Alarm Characteristics
Alarm Color Flashing Period Duty Cycle

Category
High priority Red 700 ms (about 1.43 Hz) 57% (On: 400ms / Off:
300ms)
Medium priority Yellow 2000 ms (about 0.5 Hz) 60% (On: 1200 md / Off:
800 ms)
Low priority Yellow - 100% (Always on On)
When a high priority alarm is activated, a non-flashing alarm message is

displayed. The numerical area will flash red.
When a medium priority alarm is activated, a non-flashing alarm message is
displayed.
55
The numerical area will flash yellow.
When a low priority alarm is activated, a non-flashing alarm message is
displayed. The numerical area will change to yellow.
7.4 Audible Alarm Indication
WARNING
Do not turn off the audible alarm or decrease its volume if patient
safety could be compromised.
WARNING
Make sure that the DefiMonitor EVO speaker is not obstructed. Failure
to do so could result in an inaudible alarm tone.
Table 15: Audible Alarm Characteristics
Tone Pitch Beep Rate

Alarm Category
IEC60601-1-8 IEC60601-1-8
High priority ~976 Hz 10 beeps in 15 sec

Medium priority ~697 Hz 3 beeps in 15 sec
Low priority ~488 Hz 1 beeps in 30 sec
Audible alarms may be decreased in volume as described in chapter 7.1.1

Note
or temporarily paused.
7.5 Verifying Audible Alarm Indication

If the PRIMEDIC™ DefiMonitor EVO fails to perform as specified in this test,
contact qualified service personnel or your local supplier for assistance.
You can verify the alarm operation for all parameters like ECG, SpO2, NIBP,
Temp, EtCO2, IBP and Respiration by following the below procedures.
1. Connect the PRIMEDIC™ DefiMonitor EVO to an AC power source.

2. Rotate the Mode select knob to turn on the PRIMEDIC™ DefiMonitor EVO.
3. Connect the simulator to the sensor input cable and connect cable to the
PRIMEDIC™ DefiMonitor EVO.
4. Set the simulator to a smaller value than the lower alarm limit on the
5. Verify the following PRIMEDIC™ DefiMonitor EVO reaction:
a. The PRIMEDIC™ DefiMonitor EVO begins to track the physiological
signal from the simulator.
b. After about 10 to 20 seconds, the PRIMEDIC™ DefiMonitor EVO
displays the value measured as specified by the simulator. Verify
values are within the tolerances specified in chapter 27 for each
parameter.
c. Audible alarm sounds.
d. “Low limits violated” message is displayed.
e. The numerical area flashes, indicating the parameter has violated
default alarm limits.

56 MGA22955 / GB / A
The maximum mean time of the alarm delay is less than 10 seconds unless
Note
otherwise specified in this manual.
7.6 Changing Alarm Limits
WARNING
Each time the DefiMonitor EVO is used, check alarm limits to make sure
that they are appropriate for the patient being monitored.
WARNING
CAUTION
Do not set the alarm limits to extreme values that can cause the alarm to
become useless.
You can change alarm limits from default values, if necessary.

Alarm limits or Limit Alarm Pause may be set in two ways:
 Via interaction with HR/PR, SpO2, NIBP, Respiration, EtCO2, IBP and
Temperature Menu
or
 Via interaction with the Alarm/Limits Menu that presents the limits in
all the parameters at one time
7.6.1 Setting Alarm Limit via Limit Menu

1. Soft key is displayed on the lower of the normal screen (Refer to
Figure 20).
2. Press the Alarm Limit soft key located lower right corner of the
screen.
3. Select the parameter menu to be changed by pressing the Multi
function knob.
4. Change the alarm limit by rotating the Multi function knob.
5. Selected parameter menu is returned to normal screen by pressing
the Return soft key.
6. When the menu is returned, the other menu can be selected.
57
Figure 20: Alarm Limit Menu
7.6.2 Alarm Limits Ranges

Table 16 describes the possible alarm limits. The PRIMEDIC™ DefiMonitor EVO
is shipped with factory default settings.
Authorized personnel can define the way to save the power-up default
Note
settings. The detailed information is described in the service manual.
Table 16: Alarm Limits Ranges
Parameters Upper Limit, Default Lower Limit, Default Resolution
HR/PR (BPM)
Adult/Pediatric 25 ~ 300 BPM, 120 20 ~ 295 BPM, 50 BPM 5 BPM

BPM
NIBP Systolic (mmHg, kPa)
35 ~ 270 mmHg, 160 30 ~ 265 mmHg, 90

mmHg mmHg 5 mmHg
Adult/Pediatric
(4.6 ~ 36.0 kPa, 21.3 (4.0 ~ 35.3 kPa, 12.0 (0.6 or 0.7 kPa)
kPa) kPa)
45 ~ 130 mmHg, 90 40 ~ 125 mmHg, 40

mmHg mmHg 5 mmHg
Neonatal
(6.0 ~ 17.3 kPa, 12.0 (5.3 ~ 16.6 kPa, 5.3 (0.6 or 0.7 kPa)
kPa) kPa)
NIBP Diastolic (mmHg, kPa)
Adult/Pediatric 25 ~ 260 mmHg, 110 20 ~ 255 mmHg, 60

mmHg mmHg 5 mmHg
(3.3 ~ 34.6 kPa, 14.6 (2.6 ~ 34.0 kPa, 8.0 (0.6 or 0.7 kPa)
kPa) kPa)
Neonatal 25 ~ 90 mmHg, 60 20 ~ 85 mmHg, 20

mmHg mmHg 5 mmHg
(3.3 ~ 12.0 kPa, 8.0 (2.6 ~ 11.3 kPa, 2.6 (0.6 or 0.7 kPa)
kPa) kPa)
NIBP MAP (mmHg, kPa)

58 MGA22955 / GB / A
Adult/Pediatric 25 ~ 260 mmHg, 110 20 ~ 255 mmHg, 60

mmHg mmHg 5 mmHg
(3.3 ~ 34.6 kPa, 14.6 (2.6 ~ 34.0 kPa, 8.0 (0.6 or 0.7 kPa)
kPa) kPa)
Neonatal 35 ~ 110 mmHg, 70 30 ~ 105 mmHg, 30

mmHg mmHg 5 mmHg
(4.6 ~ 14.6 kPa, 9.3 (4.0 ~ 14.0 kPa, 4.0 (0.6 or 0.7 kPa)
kPa) kPa)
SpO2 (%)
Adult/Pediatric 21 ~ 100 %, 100 % 20 ~ 99 %, 85 % 1%
Respiration (BPM)
Adult/Pediatric IM: 4 ~ 120 BPM, 30 IM: 3 ~ 119 BPM, 8 1 BPM

BPM BPM
AW: 1 ~ 150 BPM, 30 AW: 0 ~ 149 BPM, 8
BPM BPM
Temperature1 (°C, °F)
0.1 ~ 50.0°C, 39.0 °C 0.0 ~ 49.9 °C, 36.0 °C

0.1°C
Adult/Pediatric (32.2 ~ 122.0°F, (32.0 ~ 121.8°F, 96.8°F
(0.1°F or 0.2°F)
102.2°F) )
Temperature2 (°C, °F)
0.1 ~ 50.0°C, 39.0 °C 0.0 ~ 49.9 °C, 36.0 °C

0.1°C
Adult/Pediatric (32.2 ~ 122.0°F, (32.0 ~ 121.8°F, 96.8°F
(0.1°F or 0.2°F)
102.2°F) )
EtCO2 (mmHg, kPa, %)
1 ~ 150 mmHg, 80 0 ~149 mmHg, 0

mmHg mmHg 1 mmHg
Adult/Pediatric (0.13 ~ 20.0 kPa, 10.7 (0 ~ 19.9 kPa, 0 kPa) (0.13 kPa)
kPa) (0 ~ 19.9 %, 0 %) (0.13 %)
(0 ~ 20.0 %, 10.5 %)
InCO2 (mmHg, kPa, %)
1 ~ 20 mmHg, 20 0 ~19 mmHg, 0

mmHg mmHg
1 mmHg
(0.13 ~ 2.7 kPa, 2.7 (0 ~ 2.5 kPa, 0 kPa)
Adult/Pediatric (0.13 kPa)
kPa) (0 ~ 2.5 %, 0%)
(0.13%)
(0.13 ~ 2.6 %, 2.6 %)
P1 Systolic (mmHg, kPa)
-45~300 mmHg, -50 ~ 295 mmHg, 70

5 mmHg
Adult/Pediatric 120mmHg mmHg
(0.6 or 0.7 kPa)
(16.0 kPa) (9.3 kPa)
P1 MEAN (mmHg, kPa)
-45~300 mmHg, 90 -50 ~ 295 mmHg, 50

5 mmHg
Adult/Pediatric mmHg mmHg
(0.6 or 0.7 kPa)
(12.0 kPa) (6.7 kPa)
P1 Diastolic (mmHg, kPa)
-45~300 mmHg, 90 -50 ~ 295 mmHg, 50

5 mmHg
(0.6 or 0.7 kPa)
(12.0 kPa) (6.7 kPa)
P2 Systolic (mmHg, kPa)
59
-45~300 mmHg, -50 ~ 295 mmHg, 70

5 mmHg
Adult/Pediatric 120mmHg mmHg
(0.6 or 0.7 kPa)
(16.0 kPa) (9.3 kPa)
P2 MEAN (mmHg, kPa)
-45~300 mmHg, 90 -50 ~ 295 mmHg, 50

5 mmHg
(0.6 or 0.7 kPa)
(12.0 kPa) (6.7 kPa)
P2 Diastolic (mmHg, kPa)
-45~300 mmHg, 70 -50 ~ 295 mmHg, 40

5 mmHg
(0.6 or 0.7 kPa)
(9.3 kPa) (5.3 kPa)
7.7 Audio Paused and OFF
WARNING
Do not pause the audio or decrease its volume if patient safety could be
compromised.
WARNING
If an alarm condition occurs while in the Audio Off state, the only alarm
indication on the PRIMEDIC™ DefiMonitor EVO will be visual displays
related to the alarm condition.
WARNING
Default startup setup is with Audio off on Power ON. If Audio Alarms
are required, make sure to activate audio alarm ON for the patient
being monitored.
WARNING
Check the audible alarm silence duration before temporarily silencing
the audible alarms.
When an alarm occurs, you can pause the audio for the audio paused period (3
min, 5 min, 10 min or Indefinite) selected via Service menu. However, visual
alarms continue during this time. The factory default for audio paused period is
30 seconds.
Table 17: Bell Icon
Alarm Active Audio paused Audio Off Limit alarm pause
To pause an audio alarm:

60 MGA22955 / GB / A
1. Press the Alarm button to immediately pause the alarm tone. The
alarm resumes after the audio paused period if the alarm condition
has not been corrected.
2. Check the patient and provide appropriate care.
During the audio paused period, you can press the Alarm button again to re-
enable the audio tones. Also, if another alarm occurs during the audio paused
period, the audio tones will be automatically re-enabled. You can pause the
audio tones for the other alarm by pressing the Alarm button.
The audio alarm paused by some technical errors may be canceled by

Note
pressing the Alarm button. However, battery failure and physiological
alarms cannot be canceled until the alarm condition is corrected.
To turn off an audio alarm:
1. For turning an audible alarm off, press the Alarm button and hold it
for at least 2 seconds.
2. For cancelling an audible alarm off condition, press the Alarm button
for 2 seconds again.
This action disables audible alarms for a user-defined audio off period (3 min, 5
min, 10 min or Indefinite) selected via the Service menu.
If audio off period is set to 3, 5 or 10minutes, the audible alarm is not activated
for the specified time interval and the Audio Off icon is displayed.
You may disable limit violation alarms of each vital sign via the HR/PR,
Note
SpO2, NIBP, Respiration, EtCO2, IBP, Temperature or Alarm/Limits menus.
The periods can only be changed by authorized personnel via the Service
Note
menu.
Alarm Off may disable the visual alarm manifestation if sensors, probes, or
Note
modules are intentionally disconnected by operator.
61
8 ECG Monitoring
WARNING
facility’s standards. It may cause burns to the patients or device failure
to use of pacing/defibrillation pads or adapters from sources other than
Metrax GmbH.
WARNING
Line isolation PRIMEDIC™ DefiMonitor EVO transients may resemble
actual cardiac waveforms and thus inhibit heart rate alarms. Such
transients may be minimized by proper electrode and cable placement,
as specified in this manual and electrode directions for use.
WARNING
Do not use damaged ECG leads. Do not immerse ECG leads completely
in water, solvents, or cleaning solutions. Do not sterilize ECG leads by
irradiation, steam, or ethylene oxide. Follow the manufacturer’s
directions for use.
WARNING
Do not use ECG electrodes with expired dates. Do not use defective ECG
electrodes. These might cause improper performance.
WARNING
ECG cables may be damaged if they are connected to a patient during
defibrillation. Cables that have been connected to a patient during
defibrillation should be checked for functionality before being used
again.
WARNING
It is possible for the patient to receive a burn due to an improperly
connected electrosurgical unit. Additionally, the DefiMonitor EVO could
be damaged or measurement errors could occur. Place the ECG cable
and leads as far as possible from the site of the electrosurgical unit and
from the electrosurgical cables. This will minimize interference and the
risk of burns to the patient.
WARNING
For pacemaker patients, the PRIMEDIC™ DefiMonitor EVO may continue
to count pacemaker rate during occurrences of cardiac arrest or some
arrhythmias. To reduce the likelihood of this, ensure that the Pacer
Detect setting is On in the ECG waveform Menu when monitoring such
patients. Do not rely entirely upon the PRIMEDIC™ DefiMonitor EVO
alarms. Keep pacemaker patients under close surveillance.

62 MGA22955 / GB / A
WARNING
To ensure patient safety, the conductive parts of the ECG electrodes
(including associated connectors) and other patient-applied parts
should not contact other conductive parts, including earth ground, at
any time.
WARNING
Correct the electrode placement. Improper electrode placement may
cause incorrect result. User must be aware of proper device operation.
WARNING
Use only high quality ECG electrodes. ECG electrodes are for rhythm
acquisition only. Do not attempt to defibrillate or pace through ECG
electrodes.
WARNING
Precordial lead electrodes and lead wires may interfere with the
placement of standard paddles or pads. Before defibrillation, remove
any interfering precordial lead electrodes and lead wires.
WARNING
The PRIMEDIC™ DefiMonitor EVO may be used in conjunction with and
must not be damaged by typical electrosurgical equipment operation.
8.1 General
The process of depolarization and repolarization of the myocardium generates
electric potentials that are sensed by ECG electrodes on the skin surface. The
PRIMEDIC™ DefiMonitor EVO processes and amplifies these signals and
presents the ECG waveform on the screen. Also, the PRIMEDIC™ DefiMonitor
EVO computes the minute heart rate at least every second by moving average.
In addition to the acquisition of the QRS complex, the circuitry performs a
number of other functions. The PRIMEDIC™ DefiMonitor EVO can display:
 Heart rate in beats per minute

 Detection of a “lead off” condition if an electrode is disconnected or
poorly connected
 Detection of the presence of pacemaker signals within the ECG
waveform complex
Occasionally, electromagnetic interference beyond the range guaranteed

Note
from the manufacturer’s declaration may cause the PRIMEDIC™
DefiMonitor EVO to display a "Check ECG Leads & Electrodes" alarm. This
occurrence is rare, and duration should be short. When the interference
ceases, the DefiMonitor EVO removes the "Check ECG Leads & Electrodes"
alarm. Refer to chapter 27.
63
8.2 Setup Connections
Metrax GmbH recommends the use of silver/silver chloride electrodes
Note
(Ag/AgCl). When dissimilar metals are used for different electrodes, the
electrodes may be subject to large offset potentials due to polarization,
which may be severe enough to prevent obtaining an ECG trace. Using
dissimilar metals may also increase recovery time after defibrillation.
1. Select the electrodes to be used. Use only one type of electrode on

the same patient to avoid variations in electrical resistance. Prepare
the electrode sites according to the electrode manufacturer’s
instructions. See Figure 21 and Figure 22 for electrode placement
configurations.
Figure 21: Standard 3 electrode placement
Figure 22: 5 electrode placement
One of 5-1 to 5-6 Lead electrode placement sites for the fifth lead.
Note
2. Connect the ECG lead.

3. Connect the ECG lead to the ECG connector on the PRIMEDIC™
DefiMonitor EVO’s right connector panel.
4. Attach the leads to the electrodes, and then apply the electrodes to
the patient, using the color-code guide in Table 18. Verify that the
desired Lead Selection is active in the ECG waveform area. Refer to
Table 19. Lead II is best suited for most monitoring situations.

64 MGA22955 / GB / A
Table 18: ECG Lead Colors
Lead AAMI IEC
1. Right arm White (RA) Red (R)
2. Left arm Black (LA) Yellow (L)
3. Left leg Red (LL) Green (F)
4. Right leg Green (RL) Black (N)
5-1 to 5-6. V (Chest) Brown (V) White (C)
Table 19: ECG Lead Pairs
Lead-Selection Electrode Differential Electrode Differential

(AAIM) (IEC)
I RA LA R L
II RA LL R F
III LA LL L F
V (Chest) (RA+LA+LL)/3 Chest (V) (R+L+F)/3 Chest (C)
aVR – (Lead I + Lead III/2) – (Lead I + Lead III/2)
aVL (Lead I – Lead III)/2 (Lead I – Lead III)/2
aVF (Lead II + Lead III)/2 (Lead II + Lead III)/2
8.3 12-lead ECG
WARNING
Using previously unpackaged electrodes or electrodes past the Use by
date may impair ECG signal quality. Remove electrodes from a sealed
package immediately before use and follow the procedure for applying
the electrodes.
WARNING
Computerized ECG interpretive statements should not be used
withholds or prescribes patient treatment without review of the ECG
data by qualified medical personnel. Always confirm interpretive
statements by over-reading the ECG data.
8.3.1 General
The 12 lead ECG function, using the GLA algorithm, is available in Monitor
Mode and allows you to Acquire, Setup, 12 lead On and Patient Info. In
addition, the 12 lead function provides computerized ECG analysis. A report
with measurements and interpretive statements from the analysis is displayed,
stored and printed, as configured. Patient age and gender are used to define
normal limits for heart rate, axis deviation, time intervals, and voltage values,
for interpretation accuracy in tachycardia, bradycardia, prolongation or
shortening of PR and QT intervals, hypertrophy, early repolarization,
myocardial infarction and culprit artery detection.
In a 12-lead ECG using 10 electrodes, an electrode is placed on the right arm,

left arm, right leg and left leg. Six V/C electrodes are placed on the chest as
65
shown in Fehler! Verweisquelle konnte nicht gefunden werden.. The right
leg electrode is the neutral electrode.
This PRIMEDIC™ DefiMonitor EVO is equipped with epoch-

making ECG monitoring function incorporating the cutting
edge software for analysis of electrocardiograms developed by the University
of Glasgow in UK, which includes signal processing, diagnostic interpretation of
electrocardiograms from individuals of all ages and analysis of cardiac rhythm.
8.3.2 ECG Wave Recognition

The methodology for ECG waveform measurement is described in general
terms in an earlier publication from the Glasgow Laboratory. 10s of ECG data is
input to the software for analysis and all leads require to have been acquired
simultaneously.
8.3.3 Processing
Initially, a 50Hz or 60Hz notch filter is applied to remove any AC interference, if
such a filter has not already been applied within the acquiring device. The first
stage of the analysis is to compute any missing limb leads from the minimum
of two leads that need to be provided. The ECG data is then filtered to
minimize the effects of noise. The next step in the analysis is to calculate a form
of spatial velocity combining the first difference of each lead. From this
function, the approximate locations of all the QRS complexes are derived.
Allowance has to be made for pacemaker stimuli, which are ideally detected by
the front end equipment and passed to the program in the form of a list of
“spike” locations.
Given the QRS locations, it is then possible to check the quality of the
recording for noise and baseline drift. If the drift is excessive, it is removed by
using a cubic spline technique to obtain, for each lead affected, the baseline
trend, which is then subtracted from the original data. If the noise is excessive,
it is possible to remove a whole lead from the analysis or alternatively, 5
seconds of all leads are removed either from the first or second half of the
recording.
8.3.4 QRS typing

Thereafter, the various QRS complexes are typed according to their
morphology. An iterative process is used. Effectively, the first complex in lead I
is compared with the second using first differences of each cycle. The
comparison takes the form of moving one beat over the other and when the
difference is minimal, optimal alignment is present. This alignment point is
used for averaging as discussed below. If the difference between beats is less
than a threshold value, they are deemed to belong to the same class. The
procedure is repeated with the third beat being compared with the second and
so on. If a new morphology is detected, i.e. if the threshold is exceeded, a new
class is established. The procedure continues with five leads being used in the
typing process.
8.3.5 Selection of Required QRS Class

If more than one class of beat is present, then a decision has to be made as to
which morphology will be used for the averaging procedure, i.e. the cycle to be
interpreted has to be selected. A complex logic is used for this purpose. It has
to allow for a single normally conducted beat in the midst of demand
pacemaker beats for example. It also needs to take account of the QRS
durations of different beat classes, RR intervals to exclude extrasystoles, and to
a limited extent, the number of beats in each morphological class. The net
66 MGA22955 / GB / A
effect is to choose one class of beats, of a similar morphology, that are
regarded as being conducted in the normal sequence through the ventricles.
8.3.6 Averaging
All beats in the selected class are averaged so that 12 such beats, one from
each lead, are then available. The “average” beat can be computed in several
ways. Common to this are the alignment points detected when wave typing
was undertaken. They are used as reference points in the averaging process.
The average beat can be a straight average of all corresponding aligned points,
it can be a median calculated from the same points or it can be a weighted
average – the so called modal beat introduced into the program in 1977. In
practice, the program forms the straight average, which is compared to
individual beats in the same class. If there is a significant difference at any
point, then the median beat is used. The modal beat is regarded as being
computationally excessive, though it is undoubtedly the best approach to use.
8.3.7 Wave Measurement

From the 12 average beats, a single combined function is formed and a
provisional overall QRS onset and termination is determined by thresholding
techniques. The provisional onset and termination are then used as starting
points for a search for QRS onset and termination within each individual lead.
Basically the approach conforms to the recommendations of the CSE working
party (of which one of the Glasgow team was a member), which were
published in 1985.
Figure 23: Varying choice of baselines
67
Figure 24: Baseline at the level of QRS onset as used by the Glasgow program
In each individual lead, the QRS onset is taken as the baseline and hence Q, R,
S, R' waves are measured with respect to the QRS onset as shown in the
accompanying figures from the CSE paper.
Figure 25: Illustration of isoelectric segments I and K
Isoelectric segments at the beginning of a QRS complex, i.e. a flat segment

between the provisional overall onset and the onset of an individual lead are
excluded from the first component (Q or R) of the QRS complex as
recommended by the CSE group. Similar considerations apply at the end of the
QRS complex (Figure 25). A sorting algorithm is then applied to all 12 onsets
to determine the global QRS onset as follows. The earliest onset is excluded
and the next onset that also lies within 20 ms of the next again is then selected
68 MGA22955 / GB / A
as the overall onset. This ensures that any true outliers are excluded. The
reverse process is used to find the overall QRS termination.
8.3.8 QRS Components

Within the QRS complex, the amplitude and duration of the various Q, R, S, R’
waves are then measured. In keeping with the CSE recommendations, the
minimum wave acceptable has to have a duration >8 ms and an amplitude >20
µV. With respect to global QRS duration, the Glasgow program measures QRS
duration from the global QRS onset to the global QRS termination. This means
that an isoelectric segment within one particular QRS complex by definition will
lead to a shorter QRS duration for that lead compared to the global QRS
duration.
Figure 26: Definitions for QRS end / ST junction
8.3.9 ST segment
The ST segment has several measurements made. Figure 26 shows the J point
as used in the diagnosis of ST elevation myocardial infarction. However,
measurements are also made at equal intervals throughout the ST segment,
e.g. 1/8 ST-T, 2/8 ST-T etc.
8.3.10 P and T waves

A search for the P wave is made in the interval preceding the QRS complex. A P
wave may not always be found in certain arrhythmias. P onset and termination
are found using a method involving second differences but the same P onset
and termination is used over all 12 leads in view of the difficulty in detecting
low amplitude P waves in many leads. P wave amplitude is determined with
respect to the same baseline as for Q, R, S amplitudes, namely the QRS onset.
This was found to be more reliable than fitting a straight line between P onset
and P termination even in cases where the P wave was superimposed on the T
wave in the case of a tachycardia.
T end is determined for each lead using a template method. The global T end
is derived in a similar fashion to the global QRS offset. The other components
of the ECG waveform, namely the ST and T wave amplitudes, are also measured
with respect to QRS onset. Thus, the ST junction and the various ST amplitude
measurements, such as ST 60 and ST 80 as well as the positive and negative
components of the T wave, are all measured with respect to the QRS onset. The
reason for this is that it is the most straightforward approach to measurement.
69
8.3.11 Interval Measurement
With respect to intervals, the global QT interval is measured from the global
QRS onset to the global T end. On the other hand, because the P onset is taken
as being simultaneous in all 12 leads, the global PR interval measurement is
from the P onset to the global QRS onset.
8.3.12 Normal Limits

The above methods were used to determine the normal limits of QRS
waveforms from an adult database of over 1500 normal, published in
Comprehensive Electrocardiology, 1989 and a pediatric database derived from
1750 neonates, infants and children, published in part in 1989 and 1998 and
which will be published in much more detail in the next edition of
Comprehensive Electrocardiology. These normal limits are essentially an
integral part of the diagnostic software.
Figure 27: 12 lead Placement
8.4 Preparing the 12-lead

Proper skin preparation and electrode placement are the most important
elements in producing a high quality 12 lead ECG. The patient should be
supine and relaxed when an ECG is acquired. In preparation for acquiring the
ECG:
1. Attach the electrodes to the patient, as above Figure 27Figure 27: 12

lead Placement.
2. Attach the 12 lead cable lead wires to the electrodes on the patient.
3. Attach the 12 lead cable to the PRIMEDIC™ DefiMonitor EVO right
connector panel.
4. Turn on the Manual Mode of DefiMonitor EVO by rotating the Mode
select knob to Manual Mode.
5. Enter patient information.
6. Check the patient’s pulse.

70 MGA22955 / GB / A
8.5 Calculation Feature
Figure 28: Measurement Reference
Figure 28 shows the parameters obtained in ECG waveform to analyze the ECG.
Overall P onset, P offset, QRS onset, QRS offset and T termination are
determined from all 12 leads. Individual lead wave amplitudes are then
obtained. P+, P-, Q, R, S, R’, S’, T+ and T- amplitudes are measured with respect
to a horizontal line through the lead QRS onset. Durations are measured
between relevant points. Areas are measured in units of millivolts x
milliseconds (mV x ms). Units of measure are not specified when an area
measurement appears in the criteria. Isoelectric components between the
overall QRS onset and an individual lead onset are not included in a Q or R
duration.
ECG analysis results were categorized and categories include: PRELIMINARY

COMMENTS, measurement, Results on QRS wave analysis, Results on ST and T
wave analysis, MISCELLANEOUS, RHYTHM STATEMENTS. And the results in
diagnosis will be printed.
8.5.1 Preliminary Comments

Preliminary comments includes the effects to the statement of ECG input signal
and diagnosis.
 LEAD REVERSAL/DEXTROCARDIA
 RESTRICTED ANALYSIS
 MISCELLANEOUS PRELIMINARY STATEMENTS
8.5.2 Measurement Parameter

Measurement parameters are fundamentally obtained after ECG analysis.
 HEART RATE
 INTERVALS
 ATRIAL ABNORMALITIES
 QRS AXIS DEVIATION
8.5.3 Results on QRS Wave Analysis

Results on QRS wave analysis show diagnosis results of QRS waveform and
measurement values
 CONDUCTION DEFECTS
o WOLFF-PARKINSON-WHITE PATTERN
o BRUGADA PATTERN
 HYPERTROPHY
71
o LEFT VENTRICULAR HYPERTROPHY
o RIGHT VENTRICULAR HYPERTROPHY
o BIVENTRICULAR HYPERTROPHY
8.5.4 Results on ST and T Wave Analysis

Results on ST and T wave analysis show diagnosis results of ST and T waveform
and measurement values
 MYOCARDIAL INFARCTION
o INFERIOR INFARCTION
o LATERAL INFARCTION
o ANTEROSEPTAL INFARCTION
o ANTERIOR INFARCTION
o SEPTAL INFARCTION
o POSTERIOR INFARCTION
o ANTEROLATERAL INFARCTION
o EXTENSIVE INFARCTION
 ST ABNORMALITIES
 ST-T ABNORMALITIES (ISCHAEMIA ETC).
8.5.5 Rhythm Statements

Rhythm statements include diagnosis results according to occurrence of beats,
etc
 DOMINANT RHYTHM
 SUPPLEMENTARY RHYTHM
8.5.6 Measurement Matrix

The electrocardiographs can be programmed so that the Measurement Matrix
is written out after the analysis report. The Measurement Matrix consists of 12
columns which contain measurements for the twelve standard leads. These
columns are labelled I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6.
Table 20: Measurement Matrix
Measurement Meaning
PON Time in milliseconds from the beginning of recording to the
beginning of the first P wave.
PDUR P wave duration in milliseconds.
QRSON Time in milliseconds from the beginning of recording to the
beginning of the QRS complex.
QRSDUR QRS duration in milliseconds.
QDUR Q wave duration in milliseconds.
RDUR R wave duration in milliseconds.
SDUR S wave duration in milliseconds.
RPDUR R' wave duration in milliseconds.
SPDUR S' wave duration in milliseconds.
P+DUR P+ wave duration in milliseconds.

72 MGA22955 / GB / A
Measurement Meaning
QRSDEF Intrinsicoid deflection time.
P+AMP P+ wave amplitude in microvolts.
P-AMP P- wave amplitude in microvolts.
QRSP2P Peak to peak amplitude of the QRS complex.
QAMP Q wave amplitude in microvolts.
RAMP R wave amplitude in microvolts.
SAMP S wave amplitude in microvolts.
RPAMP R' wave amplitude in microvolts.
SPAMP S' wave amplitude in microvolts.
STAMP ST wave amplitude in microvolts.
1/8STT Amplitude in microvolts at a point which is 1/8 of the ST-T
interval.
interval.
interval.
T+AMP T+ wave amplitude in microvolts.
T-AMP T- wave amplitude in microvolts.
QRSAR Total area of the QRS complex in microvolts/millisecond.
TMORPH T wave morphology.
RWNCH R wave notch count.
DWCON Probability (in %) of the presence of a delta wave.
STSLOP ST slope in degrees.
TON Time in milliseconds from the beginning of the recording to the
beginning of the T wave.
8.6 12 Lead Display

The 12 lead display allows you to see real-time 12 lead ECG data and verify
signal quality before acquiring the ECG. As shown in Figure 29, it displays
patient information and approximately 2.5 seconds of each of the 12 leads
acquired. Waveforms are presented at a rate of 25mm/sec and the configured
wave size. A dashed line is displayed if a lead cannot be derived. The message
(Lead-Wire) Lead Off is displayed if an electrode is not making adequate
contact with the patient.
The Patient info menu of 12 lead mode includes ID, name, age and gender.
The Event ID is displayed until you enter the patient’s ID. Age and sex are
displayed once entered.
Although waveforms for monitored parameters such as ECG, SpO2, Invasive
Pressures and EtCO2 are not visible on the Preview Screen, related alarms,
measurements and alarm messages remain active and are reported in
Parameter Blocks 1 and 2 and the general status area.
73
Figure 29: 12-Lead ECG Preview Screen
8.7 Description of HR/PR Menu Functions

The calculated Heart Rate/Pulse Rate may be derived from different sources
(ECG, SpO2, NIBP or IBP) as shown by the icon in the HR/PR numerical area.
1
2
3
4 5 6 7
Figure 30: HR/PR Display
1. HR/PR icon 5. ECG size
2. HR/PR source icon 6. HR/PR value
3. Pacer pulse detection 7. Bell icon

icon
4. HR/PR unit
1.
2.
3.
Figure 31: ECG Waveform Display
1. ECG waveform icon 3. ECG lead pair

2. ECG waveform

74 MGA22955 / GB / A
HR/PR source Pacer Detect Filter Select Alarm Limit Return
Figure 32: HR/PR Menu
Table 21: HR/PR Menu
HR/PR Source Auto
HR
PR
Return
Pacer Detect Enable
Disable
Return
Filter Select 0.5Hz ~ 21Hz
0.05Hz ~ 40Hz
1Hz ~ 21Hz
Return
Alarm Limit ▲: HR/PR Upper Limit adjust

▼: HR/PR Lower Limit adjust
Limit Alarm Pause: On,Off
Return
Return
8.7.1 HR/PR Source

You may select Auto, HR or PR to decide the source of the heart rate or pulse
rate. If you select Auto, the PRIMEDIC™ DefiMonitor EVO automatically derives
the heart rate or pulse rate from one of the monitoring parameters in this
order of priority: ECG, IBP, SpO2 or NIBP. When HR is selected, the heart rate
(HR) is measured from ECG. When PR is selected, the pulse rate (PR) is
measured from IBP, SpO2 or NIBP. The color of the HR/PR icon and HR/PR
source icon will be changed according to the current source. If the pulse rate is
derived from NIBP, the value will be displayed for only 180 minutes after the
NIBP measurement, then the value will be changed to “---”. The HR/PR tone
volume can be adjusted in the Setup menu.
8.7.2 Pacer Detect

Pacer detect should always be Enable for patients with pacemakers (refer to
the warning in this section). When Pacer detect is Enable, the DefiMonitor EVO
detects and filters pacemaker-generated signals so that they will not be
calculated in determining a patient’s heart rate. When monitoring patients
without pacemakers, Pacer detect should be set to Disable to avoid
misdiagnosis.
75
8.7.3 Filter Select
The PRIMEDIC™ DefiMonitor EVO can filter ECG waveform noise with different
ranges of frequency response:
0.5 Hz to 21 Hz: Expands the range to display very low frequencies down to 0.5
Hz.
0.05 Hz to 40 Hz: Choose this mode to see just the ECG waveform monitoring.
1 Hz to 21 Hz: Generally called a filter mode, it reduces ECG waveform noise.
The sub-clause 50.102.8 Frequency and impulse response and

Note
50.102.15Heart rate range, accuracy and QRS detection range of IE60601-2-
27:2005 are tested only for ECG Monitoring with the setting 0.05Hz to
40Hz of ECG filter.
8.7.4 Limit Alarm Pause

When the Limit Alarm Pause is set to On, the audible alarm for HR/PR limit
violation is paused.
When the measurement value is invalid, ‘---‘ shall be displayed.

Note

76 MGA22955 / GB / A
9 AED (Automated External Defibrillator)
Mode
WARNING
The PRIMEDIC™ DefiMonitor EVO will only administer a shock if it is
needed. A voice prompt will tell you when to press the SHOCK button
to administer defibrillation therapy.
WARNING
The PRIMEDIC™ DefiMonitor EVO should not be used in AED mode on
someone who is responsive when shaken or breathing normally.
WARNING
Do not use pads if the adhesive gel is dried or damaged. Pads that are
dried out or damaged may cause electrical arcing and patient skin
burns during defibrillation. Do not use pads that have been removed
from foil package for more than 24 hours. Do not use electrodes pads
beyond expiration date. Check that pads adhesive is intact and
undamaged. Do not reuse disposable pads that are labeled for single
patient use.
WARNING
Do not use pediatric pads on adults or larger children. Delivery of
defibrillation energies equal to or greater than 100 joules (typically used
on adults) through these smaller pads increases the possibility of skin
burns.
WARNING
Do not use paddles for AED Mode. AED Mode is enabled only with
pads.
WARNING
Disconnect non-defibrillation protected electronic devices or equipment
from patient before defibrillation.
WARNING
Do not administer a shock using the electrode monitoring cable.
WARNING
Do not place adult pads in the anterior-posterior position when
operating the PRIMEDIC™ DefiMonitor EVO in AED Mode. A SHOCK or
NO SHOCK decision may be inappropriately advised. The shock
advisory algorithm requires the electrodes to be placed in the anterior-
lateral (Lead II) position.
77
WARNING
The Adult pads must be used on patients over 8 years old. The Pediatric
pads must be used on patients less than 8 years old or less than 25 kg
(55lb). Do not use the PRIMEDIC™ DefiMonitor EVO in AED Mode on
patients less than 1 years old.
WARNING
Be sure that the electrodes do not come in contact with other
conductive materials, especially when connecting or disconnecting the
electrodes to or from the patient.
WARNING
Heart rate alarms are temporarily paused in AED Mode. Heart
ratealarms are also paused while the PRIMEDIC™ DefiMonitor EVO is
charging for defibrillation and delivering a shock.
The AED Mode of the PRIMEDIC™ DefiMonitor EVO is designed for the
treatment of sudden cardiac arrest (SCA). It should only be used to treat
someone who may be a victim of a SCA and is:
 unresponsive to stimulus,
 not breathing,
 exhibiting no signs of life.
If the person is unresponsive but you are unsure that he or she has suffered
from a SCA begin CPR. When appropriate apply the defibrillator and follow the
audible instructions.
9.1 General
Defibrillation therapy is the definitive method for termination of a variety of
potentially fatal arrhythmias. The PRIMEDIC™ DefiMonitor EVO’s Automated
External Defibrillation (AED) Mode is designed to guide you through standard
treatment algorithms for cardiac arrest. The PRIMEDIC™ DefiMonitor EVO
provides therapy through the application of a brief biphasic pulse of electricity
to the cardiac muscle. This electrical energy is transferred through disposable
multifunction pads applied to the patient’s bare chest.
Configuration choices allow you to customize AED Mode to better meet the
unique needs of your organization or resuscitation team. This chapter
describes how to use AED Mode. It explains the prompts that guide you
through the defibrillation process and describes how prompts vary depending
upon the condition of the patient and the configuration of your device.
9.1.1 Sudden Cardiac Arrest (SCA)

Sudden cardiac arrest is a condition in which the heart suddenly stops
pumping effectively due to a malfunction of the heart's electrical system. Often
victims of SCA have no prior warning signs or symptoms. SCA can also occur in
people with previously diagnosed heart conditions. Survival for an SCA victim
depends on immediate cardio-pulmonary resuscitation (CPR). The use of an
external defibrillator within the first few minutes of collapse can greatly
improve the patients' chances of survival. Heart attack and SCA are not the
same, though sometimes a heart attack can lead to a SCA. If you are

78 MGA22955 / GB / A
experiencing symptoms of a heart attack (pain, pressure, shortness of breath,
squeezing feeling in chest or elsewhere in the body) seek emergency medical
attention immediately.
9.1.2 Heart Rhythm

The normal electrical rhythm by which the heart muscle contracts to create
blood flow around the body is known as Normal Sinus Rhythm (NSR).
Ventricular Fibrillation (VF) caused by chaotic electrical signals in the heart is
often the cause of SCA, but a shock can be administered to re-establish normal
sinus rhythm. This treatment is called defibrillation. The AED Mode is designed
to automatically detect ventricular fibrillation (VF) and perform defibrillation on
victims of sudden cardiac arrest.
9.1.3 Detecting Fibrillation

The electrical rhythm by which the heart muscle contracts can be detected and
used for medical diagnosis and the resulting reading is called an
Electrocardiogram (ECG). The AED Mode is designed to analyze a patient’s ECG
in order to detect ventricular fibrillation (VF) in the heart. If ventricular
fibrillation (VF) is detected, the PRIMEDIC™ DefiMonitor EVO will deliver a
carefully engineered electrical shock designed to stop the chaotic electrical
activity experienced within the heart muscle during SCA. This may allow the
victim's heart to return to a normal sinus rhythm.
9.1.4 Rhythm Recognition Performance

The ECG database for validation of rhythm recognition performance includes
ventricular fibrillation (VF) rhythms of varying amplitudes, ventricular
tachycardia (VT) rhythms of varying rates and QRS width, various sinus rhythms
including supraventricular tachycardias, atrial fibrillation and atrial flutter, sinus
rhythms with PVC (premature ventricular contraction), asystole, and pacemaker
rhythms.
9.2 Preparing for Defibrillation
WARNING
The AED algorithm is not designed to handle erratic spiking problems
caused by a properly or improperly functioning pacemaker. In patients
with cardiac pacemakers, the PRIMEDIC™ DefiMonitor EVO may have
reduced sensitivity and not detect all shockable rhythms
1. Confirm that the patient is:

 unresponsive to stimulus,
 not breathing,
 exhibiting no signs of life.
2. Remove clothing to expose the patient’s chest. Wipe moisture from
the patient’s chest and if the patient has an excessively hairy chest,
shave the area where the electrodes are about to be applied.
3. Make sure the pads packaging is intact and within the expiration date
shown.
4. Apply pads to the patient as directed on the pads package. Use the
anterior-anterior (anterior-lateral) pads placement.
5. If not pre-connected, insert the pads cable into paddle/pads
connector located on the right connector panel of the device. Push
until you hear it click into place.
79
Successful resuscitation is dependent on many variables specific to the
Note
patient’s physiological state and the circumstances surrounding the patient
incident. Failure to have a successful patient outcome is not a reliable
indicator of PRIMEDIC™ DefiMonitor EVO’s performance. The presence or
absence of a muscular response to the transfer of energy during electrical
therapy is not a reliable indicator of energy delivery or device performance.
9.3 Operating the AED Mode of the PRIMEDIC™

DefiMonitor EVO
WARNING
Do not let the multifunction pads touch each other or other monitoring
electrodes, lead wires, dressings, transdermal patches, etc. Such contact
can cause electrical arcing and patient skin burns during defibrillation
and may divert defibrillation current away from the heart.
WARNING
During defibrillation, air pockets between the skin and multifunction
pads can cause patient skin burns. To help prevent air pockets, make
sure defibrillation pads completely adhere to the skin. Do not use dried-
out multifunction pads.
CAUTION
Aggressive handling of multifunction pads in storage or prior to use can
damage the pads. Discard the pads if they become damaged.
Impedance is the resistance between the defibrillator’s pads or paddles that

Note
the defibrillator must overcome to deliver an effective discharge of energy.
The degree of impedance differs from patient to patient and is affected by
several factors including the presence of chest hair, moisture, and lotions or
powders on the skin.
The low-energy biphasic waveform is an impedance-compensating
waveform that is designed to be effective across a wide range of patients.
However, if you receive a "Poor Pads Contact" message, check that the
patient’s skin has been washed and dried and that any chest hair has been
clipped. If the message persists, change the pads and/or the pads cable.
9.4 2010 AHA/ERC Guidelines for CPR and ECC

The 2010 AHA/ERC Guidelines for CPR and ECC are based on the most current
and comprehensive review of resuscitation literature ever published, the 2010
ILCOR International Consensus on CPR and ECC Science with Treatment
Recommendations. Bystanders, first responders and healthcare providers all
play key roles in providing CPR for victims of cardiac arrest. In addition,
advanced providers can provide excellent periarrest and postarrest care.
The software may be upgraded and changed without notice because of the
Note
update of AHA/ERC guidance for CPR and ECC. Please contact your
sales/service representative for more information.

80 MGA22955 / GB / A
9.5 Major changes in the 2010 AHA Guidelines for CPR
and ECC
 The BLS algorithm has been simplified, and “Look, Listen and Feel” has
been removed from the algorithm. Performance of these steps in
inconsistent and time consuming.
 Encourage Hands-only (compression only) CPR for the untrained lay
rescuer. Hands-Only CPR is easier to perform by those with no
training and can be more readily guided by dispatchers over the
telephone.
 Initiate chest compressions before giving rescue breaths.
(Compression-Airway-Breathing rather than Airway-Breathing-Chest
compressions)
 There is an increased focus on methods to ensure that high-quality
CPR is performed. Adequate chest compressions require that
compressions be provided at the appropriate depth and rate, allowing
complete recoil of the chest after each compression and an emphasis
on minimizing any pauses in compressions and avoiding excessive
ventilation.
9.6 Major changes in the 2010 ERC Guidelines for CPR

and ECC
 Encourage Hands-only (compression only) CPR for the untrained lay
rescuer. Hands-Only CPR is easier to perform by those with no
training and can be more readily guided by dispatchers over the
telephone.
 There is an increased focus on methods to ensure that high-quality
CPR is performed. Adequate chest compressions require that
compressions be provided at the appropriate depth and rate, allowing
complete recoil of the chest after each compression
 There is great emphasis on minimizing any pauses in compressions
and avoiding excessive ventilation. This applies for the pre- and post-
shock pauses and the pauses for ventilation. In case of defibrillation,
continuation of compressions during charging of the defibrillator is
recommended, so the interruption in chest compressions for delivery
of defibrillation could be held below 5s.
9.7 CPR Guidelines 2010
Person not responsive?

No signs of life?
Perform CPR Address person and shake on shoulder!

Call for help, get AED Engage other people to help you and alternate
CPR!
Open the airway.
Check for breathing!
“Look, listen and feel” is

Note
removed from the CPR
sequence for assessment of
breathing after opening the
airway in 2010 guidelines. But 81
2010 guideline recommends
that the healthcare provider
Look, listen and feel
Perform CPR until an AED is available or arrival of

emergency physician
30 Compressions, 2
Breaths UNTIL EMC
ARRIVE
If the AED is available, turn on and follow
instructions
ANALYSIS SHOCK DECISION
YES NO
Alternate with second
person after one cycle or 2
minutes DELIVER SHOCK
Continue CPR for 2 minutes/ 5 cycles
9.7.1 Using AED Mode

1. Turn on the AED Mode of PRIMEDIC™ DefiMonitor EVO by rotating
the Mode select knob.
2. Verify the AED Mode of PRIMEDIC™DefiMonitor EVO is activated
normally and follow audio guidance and STEP icon.
STEP 1
< Check patient. >
< Call emergency services. >
If pads are connected to
PRIMEDIC™ DefiMonitor EVO
during STEP 1, the device will go
on to STEP 4 directly.
STEP 2
< Open airway. >
< Check Breathing. >
during STEP 1, the device will go
on to STEP 4 directly.
STEP 3
< It is now safe to the patient
>
< Give thirty chest
compressions > [Beep]
< Give two rescue breaths. >
< Stop chest compression. >
during STEP 3, DefiMonitor EVO
will go on to STEP 4 directly.

82 MGA22955 / GB / A
STEP 4
< Remove clothes from the
patient's chest. Apply
electrodes one after the other
to the patient's bare chest.
Press electrodes firmly to
patient's chest. >
STEP 5
< Analyzing rhythm. Do not
touch the patient. >
If a shockable rhythm has been
detected:
< Shock advised. >
< Device is charging. Do not
touch the patient. >
If no shockable rhythm has been
detected:
< No shock advised. >
Step 5 should
Note
be performed
at first when
the AED Mode
of the
PRIMEDIC™
DefiMonitor
EVO is turned
on and the
pads are
attached
correctly to the
patient.
STEP 6
< Press lit shock button now!
>
< Shock delivered. >
STEP 7
If shock has been delivered:
>
< Give thirty chest
compressions > [Beep]
If no shock has been advised:
>
< If there is no breathing, give
30 chest compressions. >
83
Step 1 to 3 may be disabled for display if configured accordingly in the
Note
service menu. This depends on your organization’s or resuscitation team’s
protocol.
If you hear the following voice prompts while the AED Mode of PRIMEDIC™
Note
DefiMonitor EVO is analyzing you should perform the following actions:
1. < Shock button not pressed. > or

< Preparation for shock terminated.>:
Move to Step 7  ECG analyzing again  non-shockable rhythm  move
to Step 7
2. < Low battery, insert fresh battery. >:
Move to Step 1 after replacing the new battery or connect the PRIMEDIC™
DefiMonitor to AC power or place it on the PRIMEDIC™ Charger EVO (DC-
DC adaptor).
9.8 AHA/ERC 2010 configuration

The AHA/ERC 2010 guidelines conforming CPR sequence will begin with the
following voice prompts:
< It is now safe to the patient >
< Give thirty chest compressions >
Use the metronome sound from the PRIMEDIC™ DefiMonitor EVO in AED
Mode for compression rate – the PRIMEDIC™ DefiMonitor EVO emits 100
beeps per minute and < Give two rescue breaths. > voice prompt as a guide
to CPR.
At least more than 100 beats per minutes is the recommended rate to perform
compressions under AHA/ERC 2010 guidelines.
The PRIMEDIC™ DefiMonitor EVO will remain in CPR mode for 2 minutes or 5
cycles. After 2 minutes of CPR you will hear the following voice prompt:
The PRIMEDIC™ DefiMonitor EVO in AED Mode will then return to Step 4.
Ensure that no-one is in contact with the patient and proceed as before.

84 MGA22955 / GB / A
9.9 Description of AED Mode Menu Functions
Figure 33: AED Mode Menu
Table 22: AED Mode Menu
Level 1 Menu Level 2 Menu or Level 3 Menu or Level 4 Menu or

Response Response Response
Patient Info ID
Name
Age
Gender None
Male
Female
Return
Event records Data review Print
Return
ID# ID
Name
Age
Gender
Return
Return
ID, Name, Age or Gender of patients can be entered in this Menu. ID and
Name can be up to 14 characters long, Age can be up to 3 digit numbers and
Gender can be selected between Male and Female.
85
Figure 34: Patient Info: ID Menu
For more details for Data Review and ID# in Event Records Menu, please
refer to chapter 20.
The following menu entries in AED Mode may be activated in the service
Note
menu:
 12 Lead
 Setup
 Alarm limit
Please refer to chapter 21 for layout of these menus.

86 MGA22955 / GB / A
10 Manual Mode
WARNING
Make sure that the ECG signal quality is good and that sync marks are
correctly display above each QRS complex prior to performing
synchronized defibrillation (cardioversion).
WARNING
Artifact introduced by paddle movement may resemble an R-wave and
trigger a defibrillation shock when performing synchronized
defibrillation (cardioversion).
WARNING
Disconnect non-defibrillation-proof electronic devices or equipment
from patient before defibrillation.
WARNING
The PRIMEDIC™ DefiMonitor EVO has a mechanism to inhibit its output
when the impedance of human body which can be measured by paddle
is out of range between 15 and 250 Ohm.
CAUTION
Whenever possible, Metrax GmbH recommends that the user performs
synchronized defibrillation (cardioversion) procedures while directly
monitoring the patient through the defibrillator’s electrodes or lead
inputs.
This section explains how to prepare for and perform asynchronous

defibrillation and synchronous defibrillation (cardioversion) using multifunction
electrode pads or external paddles.
10.1 General
Defibrillation therapy is the definitive method for termination of a variety of
potentially fatal arrhythmias. The PRIMEDIC™ DefiMonitor EVO provides this
therapy through the application of a brief biphasic waveform of electricity to
the cardiac muscle. This electrical energy is transferred through attached
paddles or disposable multifunction pads applied to the patient’s bare chest.
In Manual Mode, you must assess the ECG, decide if defibrillation or
cardioversion is indicated, select the appropriate energy setting, charge the
PRIMEDIC™ DefiMonitor EVO, and deliver the shock. The entire defibrillation
process is under your control. Voice prompts are not present. However, text
messages on the display provide relevant information throughout the process.
It is important to be attentive to these messages when displayed.
Defibrillation is always performed through paddles or pads. However,

Note
during defibrillation you may choose to monitor the ECG using an alternate
ECG source (3-, 5-, or 12- lead monitoring electrodes).
Defibrillating asystole can inhibit the recovery of natural pacemakers in the

Note
heart and completely eliminate any chance of recovery. Asystole should not
87
be routinely shocked.
Successful resuscitation is dependent on many variables specific to the

Note
patient’s physiological state and the circumstances surrounding the patient
event. Failure to have a successful patient outcome is not a reliable
indicator of PRIMEDIC™ DefiMonitor EVO’s performance. The presence or
absence of a muscular response to the transfer of energy during electrical
therapy is not a reliable indicator of energy delivery or device performance.
10.2 Preparing for Defibrillation

Using adult paddles
1. External paddles are placed on the device.
2. Remove the paddles from the paddle tray by twisting the paddles
towards the central handle and pull them out of the paddle tray.
3. Apply conductive matter to the paddle electrodes. Do not distribute
conductive matter by rubbing the paddle electrodes together.
4. Apply paddles to the patient’s bare chest.
Using pediatric paddles

1. The PRIMEDIC™ DefiMonitor EVO external paddles come with
pediatric paddles included.
2. Remove the paddles from the paddle tray by twisting the paddles
towards the central handle and pull them out of the paddle tray.
3. To access the pediatric paddles, unscrew the large electrodes on both
paddles by turning them anticlockwise.
4. Apply conductive matter to the paddle electrodes. Do not distribute
conductive matter by rubbing the paddle electrodes together.
5. Apply paddles to the patient’s bare chest.
Using multifunction pads

1. Attach the adapter cable for PRIMEDIC™ SavePads to the PRIMEDIC™
DefiMonitor EVO.
2. Unpack the PRIMEDIC™ SavePads and plug in their connector to the
adapter cable.
3. Remove the protective film from the adhesive pads and place them
on the patient’s bare chest according to the positions indicated on
the back side of the electrodes.
10.3 Operating the Manual Mode of PRIMEDIC™

DefiMonitor EVO
1. Select Manual Mode of PRIMEDIC™ DefiMonitor EVO by rotating the
Mode select knob.
2. When the Manual Mode of PRIMEDIC™ DefiMonitor EVO is activated
normally, the energy select display will be displayed on the top of the
screen and other parameter information will be displayed.

88 MGA22955 / GB / A
Figure 35: Manual Mode Screen
Defibrillation is always performed through paddles or pads. However,

Note
during defibrillation you may choose to monitor the ECG using an alternate
ECG source (3-, 5-, or 10- lead monitoring electrodes).
Defibrillating asystole can inhibit the recovery of natural pacemakers in the

Note
heart and completely eliminate any chance of recovery. Asystole should not
be routinely shocked.
10.4 Defibrillating (async mode)

If the device and pads/paddles are prepared for defibrillation, perform the
following steps:
1. To select the energy setting, press the JOULE button and rotate the
Multi function knob to the desired energy level. Energy choices
range from 1 to 200. (To choose higher value than 200J, enter the
Service Menu by using extra passcode). If using external paddles, you
may also increase or decrease the energy by the Energy
increase/decrease buttons on the Sternum paddle.
If you do not press the JOULE button, the PRIMEDIC™ DefiMonitor EVO
Note
has default energy level setting. To change default setting, enter the Service
Menu.
Clinicians must select an appropriate energy level for defibrillation of

Note
pediatric patients.
2. To charge the energy, press the CHARGE button. If using external

paddles, the CHARGE button on the Apex paddle or on the front
panel can be used.
You may increase or decrease the selected energy at any time during
Note
charging or after charging is complete.
89
3. There are two ways of applying the energy to the patient:
a. If using multifunction pads, press the SHOCK button which
is placed on the front side of device.
b. If using external paddles, simultaneously press the SHOCK

buttons located on both paddles.
If paddles are used, the SHOCK button on the front side does not work.
Note
Only the SHOCK buttons on the paddles work.
Defibrillation current can cause operator or bystander injury. Do not touch

Note
the patient, or equipment connected to the patient, during defibrillation.
10.5 Synchronized Cardioversion (sync mode)

Synchronized Cardioversion allows you to synchronize delivery of the shock
with the R-wave of the ECG being monitored in Wave Sector 1. You may
choose to perform synchronized cardioversion through either multifunction
pads, or external paddles.
When using paddles, you should monitor the ECG through monitoring
electrodes connected to a 3-, 5- or 12- lead ECG cable and a PRIMEDIC™
DefiMonitor EVO. You may choose to monitor through an alternate source
when using pads, as well. Cardioversion is still delivered through either pads or
paddles.
If the device and paddles are prepared for defibrillation, perform the following
steps:
1. To activate Sync mode, press the Sync soft key located lower right
corner of the screen.
2. Confirm that the Sync marker appears with each R-wave.
3. To select the energy setting, press the JOULE button and rotate the
Multi function knob to the desired energy level. Energy choices
range from 1 to 200. (To choose higher value than 200J, enter the
Service Menu by using extra passcode). If using external paddles, you
may also increase or decrease the energy by the Energy
increase/decrease buttons on the Sternum paddle.
a.
b.
Physicians or other qualified medical personnel must select an appropriate

Note
energy level for defibrillation of pediatric patients.
4. To charge the energy, press the CHARGE button. If using external

paddles, the CHARGE button on the Apex paddle may be used
instead.

90 MGA22955 / GB / A
You may increase or decrease the selected energy at any time during
Note
charging or after charging is complete.
5. There are two ways of applying the energy to the patient:

a. If using multifunction pads, press the SHOCK button which
is placed on the front side of device.
b. If using external paddles, simultaneously press the SHOCK

buttons located on both paddles.
It is important to continue to hold the SHOCK button (or the paddle

Note
SHOCK buttons) until the shock is delivered. The defibrillator shocks with
the next detected R-wave.
Defibrillation current can cause operator or bystander injury. Do not touch

Note
the patient, or other equipment connected to the patient, during
defibrillation.
If additional synchronized shocks are indicated, perform the following steps;
1. Make sure the Sync function is still enabled, as indicated by the

presence of the Sync message in the upper right corner of the Wave
Sector 1.
2. Repeat Steps 2-5 above.
To turn off the Sync function of the DefiMonitor EVO, press the Sync soft key.
The maximum time delay between synchronization pulse and delivery of

Note
energy does not exceed 60ms.
10.6 Description of Manual Mode Menu Functions
Figure 36: Manual Mode Menu
91
Table 23: Manual Mode Menu
Level 1 Menu Level 2 Menu or Level 3 Menu or Level 4 Menu or Level 5 Menu or
Response Response Response Response
12 Lead Acquire
Setup Filter 0.05Hz ~ 40Hz
0.05Hz ~ 150Hz
Return
Transmission
Return
12 lead ON
Patient info ID
Name
Age
Gender None
Male
Female
Return
12 lead records Print
Transmission
ID # ID
Name
Age
Gender
Return
Return
Return
Return
Setup Volume Alarm
Beep
Button
Return
Printer Setting Print on alarm On
Off
Print on shock On
Off
12 lead auto On
printing
Off
Analyze auto On
printing
Off
Return

92 MGA22955 / GB / A
Erase data Erase 12 lead Yes

records
No
Erase event Yes

records
No
Erase internal Yes

memory
No
Return
Waveform 2
nd
Waveform ECG I, II, III, aVL, aVF, aVR,
setting Pads, V1, V2, V3, V4,
V5, V6
SpO2
RESP
IBP1
IBP2
EtCO2
rd
3 Waveform ECG I, II, III, aVL, aVF, aVR,
Pads, V1, V2, V3, V4,
V5, V6
SpO2
RESP
IBP1
IBP2
EtCO2
th
Pads, V1, V2, V3, V4,
V5, V6
SpO2
RESP
IBP1
IBP2
EtCO2
Return
Display Mode Large numeric

display
Black-white
Invert Mode
Return
Clinical action list Items 1-10 on

Clinical Action
List
Return
Manual self-test
Button test
93
Service menu (Display 3 digit

code)
Return
Alarm Limit ▲: Upper Alarm

Limit
▼: Lower Alarm
Limit
Limit Alarm On, Off

Pause
Patient Info ID
Name
Age
Gender None
Male
Female
Return
ID# ID
Name
Age
Gender None
Male
Female
Return
Return
Return
Return
Sync On
Off
Return
10.6.1 12-Lead
Acquire
To acquire the 12 lead ECG data, press the Acquire soft key.
Setup
This menu allows you to set Filter and Transmission. Filter can be selected
between 0.05hz~40Hz and 0.05Hz~150Hz. 12 lead ECG can be transmitted to
external devices via wireless communication from the PRIMEDIC™ DefiMonitor
EVO, if a wireless communication module is installed on the device. To transmit
the result of 12 lead ECG diagnosis, press the Transmission soft key.

94 MGA22955 / GB / A
12 lead ON
This menu allows you to set 12 lead display.
Patient info
ID, Name, Age or Gender of patients can be entered in this menu. ID and
10.6.2 Setup
Figure 37: Setup Menu
Volume
The Volume options allow you to adjust the volume of Alarm, Beep and
Button. Alarm volume can be set at level 1 to 8 and Beep volume and Button
volume can be set at level 1 to 7 or Off.
1. Rotate the Multi function knob to highlight Alarm volume, Beep

volume or Button volume.
2. Press the Multi function knob. Levels of Alarm volume, Beep
volumeor Button volume will appear.
3. Rotate the Multi function knob to select a volume level.
4. Press the Multi function knob to enter a desired volume into the
Printer setting
This menu allows you to set Print on alarm, Print on shock, 12 lead auto
printing or Analyze auto printing.
1. Rotate the Multi function knob to highlight Printer on alarm, Print on

shock, 12 lead auto printing or Analyze auto printing.
2. Press the Multi function knob. Multi function knob toggles between
On and Off.
Erase data
To Erase 12lead records, Erase event records or Erase internal memory in
the PRIMEDIC™ DefiMonitor EVO, select the desired item with the Multi
function knob, press it and select Yes or No with the Multi function knob.
Pressing the Multi function knob will then perform the selected action.
Waveform setting
nd
This menu allows you to select the physiological signal to be displayed as 2 ,
rd th
3 or 4 waveform on the display by selecting the trace and the physiological
signal using the Multi function knob. For ECG, the PRIMEDIC™ DefiMonitor
EVO automatically detects the attached monitoring cable type. For example,
95
lead type can be selected only from Lead I, II and III when a 3 leads cable is
attached. You can select the desired ECG lead type.
Display Mode
This menu allows the user to change a display format of Black-white invert
mode. Large numeric screen can only be selected in Monitor Mode.
Clinical Action List

This menu indicates the information of drug administration. Only authorized
personnel are allowed to set the Clinical Action List in the Service Menu. Refer
to the service manual for instructions.
Manual self-test
This menu allows the user to perform a Self-test manually. Refer to the chapter
19.
Button test
The user can check buttons for proper functioning. This can be performed by
‘Button Test’ function in the Setup Menu.
Service Menu
Only authorized personnel are allowed to change the Service Menu settings. A
3 digit code is required for access. Refer to the service manual for instructions.
10.6.3 Alarm Limit
Press the Multi function knob to select Alarm limits. The PRIMEDIC™
DefiMonitor EVO will display all alarm limits that are currently in effect for all
monitored parameters. Select the alarm limits to set.
10.6.4 Patient Info


96 MGA22955 / GB / A
Figure 39: Patient Info Menu
10.6.5 Sync
Press the Sync soft key to operate the Sync mode.
97
11 Pacing Mode
WARNING
Use demand mode (sync mode) pacing whenever possible. Use async
mode pacing when motion artifact or other ECG noise makes R-wave
detection unreliable.
WARNING
Observe the patient continuously while the pacemaker is in use. Patient
response to pacing therapy (for example, capture threshold) may
change over time.
WARNING
Prolonged invasive pacing may cause patient skin irritation and burns,
especially with higher pacing current levels. Discontinue noninvasive
pacing if skin becomes burned and another method of pacing is
available.
WARNING
The ECG size must be properly adjusted so that the patient’s own beats
are detected. If ECG size is set too high or too low, pacing pulses may
not be delivered when required. Adjust ECG size so that pacing pulse
mark is placed on the patient’s QRS complexes.
WARNING
If you are using the pacing function with battery power and the low
battery appears, plug the device into AC power. When the device
powers back up, pacing is no longer activated. Press Pacer to re-activate
the pacing function.
WARNING
Using other manufacturers’ combination pads with this device could
cause a decrease in pacing efficacy or the inability to pace because of
unacceptably high impedance levels and invalidate the safety agency
certifications. Use only the pads that are specified in these operating
instructions.
WARNING
Use of other ECG monitoring devices may provide misleading
information due to the presence of pace artifacts.
WARNING
Under certain conditions it may not be possible to properly
defibrillate/monitor or pace while electrosurgical apparatus is operating.

98 MGA22955 / GB / A
11.1 General
Pacing therapy is used to deliver pace pulses to the heart. Pace pulses are
delivered through multifunction electrode pads that are applied to the
patient’s bare chest.
Use only approved lead sets when pacing with the PRIMEDIC™ DefiMonitor
Note
EVO
Waveforms, ECG monitoring, measurements, and most alarms remain active

Note
and retain their settings when you convert from Manual Mode or Monitor
Mode to Pacing Mode.
11.2 Demand Mode (Sync Mode) and Async Mode

The PRIMEDIC™ DefiMonitor EVO can deliver paced pulses in either Demand
Mode (Sync Mode) or Async Mode.
1. In Demand Mode, the PRIMEDIC™ DefiMonitor EVO only delivers
paced pulses when the patient’s heart rate is lower than the
selected pacing rate.
2. In Async Mode, the PRIMEDIC™ DefiMonitor EVO delivers pace
pulses at the selected rate.
Use Demand Mode (Sync Mode) pacing whenever possible. Use Async
Note
Mode pacing when motion artifact or other ECG noise makes R-wave
detection unreliable or when monitoring electrodes are not available.
The DefiMonitor EVO requires a 3-, 5-, 12-lead ECG cable and monitoring
electrodes as the source of the ECG during standard pacing. Pace pulses are
delivered through the multifunction electrode pads. However, the pads cannot
be used for monitoring of the ECG and deliver pace pulses simultaneously.
11.3 Operating the Pacing Mode of DefiMonitor EVO

Turn on the Pacing Mode of PRIMEDIC™ DefiMonitor EVO by rotating the Mode
Select Switch.
When the Pacing Mode of PRIMEDIC™ DefiMonitor EVO is activated normally, the
pace rate and current value will be displayed on the top of the screen and
other parameter information will be displayed.
99
Figure 40: Pacing Mode screen
11.4 Demand Mode (Sync Mode) pacing

When the Pacing Mode is turned on by rotating the Mode Select Switch, the
Demand Mode (Sync Mode) is operated automatically.
1. When the RATE button is pressed, each color of pulse rate value is
changed and it can be modified.
2. The ‘Select BPM’ defibrillator message is displayed.

3. Press and rotate the Multi function knob to select the desired value
of pace pulses per minute. The value is changed by 2 bpm.
4. When the mA button is pressed, each color of output value is
changed and the output value can be modified.
5. The ‘Select mA’ defibrillator message is displayed.

6. Press and rotate the Multi function knob to select the desired output
value. The value is changed by steps of 2 mA.
7. When selected value of pace pulse per minute or below are detected,
relevant current (mA) is delivered to patient.
The pulse rate value in bpm unit is modified between 30 bpm and 180 bpm
Note
and the output value is modified between 0 mA and 140 mA.
When pacing in Demand Mode (Sync Mode), the ECG cable must be
Note
directly connected from the patient to the PRIMEDIC™ DefiMonitor EVO.
If you are using the pacing function with battery power and the low battery
Note
alarm is annunciated, connect the device to external power or insert a fully
charged battery.

100 MGA22955 / GB / A
11.5 Async Mode pacing
After the Pacing Mode is turned on by rotating the Mode Select Switch, press
the Async soft key to operate the Async Mode pacing.
1. When the RATE button is pressed, each color of Pulse rate value is
changed and it can be modified.
2. The ‘Select BPM’ defibrillator message is displayed.

3. Press and rotate the Multi function knob to select the desired
number of pace pulses per minute. The value is changed by steps of 2
bpm.
4. When the mA button is pressed, each color of output value is
changed and the output value can be modified.
5. The ‘Select mA’ defibrillator message is displayed.

6. Press and rotate the Multi function knob to select the desired
output. The value is changed by 2 mA.
7. The set current value is delivered continuously.
To pause pacing, press Pause Pacing soft key and to resume pacing, press
Note
Pause Pacing soft key again.
11.6 Description of Pacing Mode Menu Functions
Figure 41: Pacing Mode Menu
101
Table 24: Pacing Mode Menu
Pause Pacing
Setup Volume Alarm
Beep
Button
Return
Off
Print on shock On
Off
12 lead auto On
printing
Off
Analyze auto On
printing
Off
Return

records
No
Erase event Yes

records
No
Erase internal Yes

memory
No
Return
Waveform 2
nd
V5, V6
SpO2
RESP
IBP1
IBP2
EtCO2
rd
Pads, V1, V2, V3, V4,
V5, V6
SpO2
RESP
IBP1
IBP2
EtCO2
th
Pads, V1, V2, V3, V4,
V5, V6

102 MGA22955 / GB / A
SpO2
RESP
IBP1
IBP2
EtCO2
Return

display
Black-white
Invert Mode
Return

Clinical Action
List
Return
Manual self-test
Button test

code)
Return

Limit
▼: Lower Alarm
Limit
Limit Alarm On, Off

Pause
Patient Info ID
Name
Age
Gender None
Male
Female
Return
ID# ID
Name
Age
Gender None
Male
Female
Return
Return
103
Return
Return
Async On
Off
Return
11.6.1 Pause Pacing

If pacing is operating, pacing will be paused when the Pause Pacing soft key
is pressed.
If pacing is not operating, pacing will be resumed when the Pause Pacing soft
key is pressed.
11.6.2 Setup
Figure 42: Setup Menu Window
Volume
1. Rotate the Multi function knob to highlight Alarm volume, Beep

volume or Button volume.
2. Press the Multi function knob. Levels of Alarm volume, Beep
volumeor Button volume will appear.
3. Rotate the Multi function knob to select a volume level.
4. Press the Multi function knob to enter a desired volume into the
Printer setting
1. Rotate the Multi function knob to highlight Printer on alarm, Print

on shock, 12 lead auto printing or Analyze auto printing.
2. Press the Multi function knob. Multi function knob toggles between
On and Off.
Erase data

104 MGA22955 / GB / A
Waveform setting
nd
rd th
Display Mode

Manual self-test
19.
Button test
The user can check buttons for proper functioning. It can be performed by
Service Menu
105
11.6.3 Alarm Limit
11.6.4 Patient Info

11.6.5 Async
Press the Async soft key to operate the Async Mode pacing.

106 MGA22955 / GB / A
12 Monitor Mode
12.1 General
In Monitor Mode, the user can monitor Electrocardiography (ECG) acquired
using a 3-, 5-, or 10-lead ECG electrodes cable. Optional monitoring of
functional arterial oxygen saturation (SpO2), respiration (RESP), temperature
(TEMP), invasive blood pressure (IBP), noninvasive blood pressure (NIBP), and
end tidal CO2 (EtCO2), invasive blood pressure (IBP) are also available.
Measurements from these parameters are presented on the display and alarms
are available to alert you to changes in the patient’s condition. Monitor Mode
also provides a large numeric screen display format. However, Monitor Mode
cannot provide the defibrillator functions including selection energy to be
delivered, ECG analysis, charging of defibrillation energy, delivery of the shock
and showing defibrillator messages on the display.
12.2 Operating the Monitor Mode of PRIMEDIC™

DefiMonitor EVO
1. Turn on the Monitor Mode of PRIMEDIC™ DefiMonitor EVO by
rotating the Mode select knob.
2. When the Monitor Mode of PRIMEDIC™ DefiMonitor EVO is activated
normally, the display will look like shown in Figure 45, according to
pre-defined settings.
Figure 45: Monitor Mode Screen
107
12.3 Description of Monitor Mode Menu Functions
Figure 46: Monitor Mode Menu
Table 25: Monitor Mode Menu
12 Lead Acquire
Setup Filter 0.05Hz ~ 40Hz
0.05Hz ~ 150Hz
Return
Transmission
Return
12 lead ON
Patient info ID
Name
Age
Gender None
Male
Female
Return
12 lead records Print
Transmission
ID # ID
Name
Age
Gender
Return
Return
Return

108 MGA22955 / GB / A
Return
Setup Volume Alarm
Beep
Button
Return
Off
Print on shock On
Off
12 lead auto On
printing
Off
Analyze auto On
printing
Off
Return

records
No
Erase event Yes

records
No
Erase internal Yes

memory
No
Return
Waveform 2
nd
V5, V6
SpO2
RESP
IBP1
IBP2
EtCO2
rd
Pads, V1, V2, V3, V4,
V5, V6
SpO2
RESP
IBP1
IBP2
EtCO2
th
Pads, V1, V2, V3, V4,
V5, V6
SpO2
109
RESP
IBP1
IBP2
EtCO2
Return

display
Black-white
Invert Mode
Return

Clinical Action
List
Return
Manual self-test
Button test

code)
Return

Limit
▼: Lower Alarm
Limit
Limit Alarm On, Off

Pause
Patient Info ID
Name
Age
Gender None
Male
Female
Return
ID# ID
Name
Age
Gender None
Male
Female
Return
Return

110 MGA22955 / GB / A
Return
Return
Sync On
Off
Return
12.3.1 12-Lead
Acquire
To acquire the 12 lead ECG data, press the Acquire soft key.
Setup
This menu allows you to set Filter and Transmission. Filter can be selected
between 0.05hz~40Hz and 0.05Hz~150Hz. 12 lead ECG is transmitted to
external devices via wireless communication from the defibrillator/monitor. To
transmit the result of 12 lead ECG diagnosis, press the Transmission soft key.
12 lead ON
This menu allows you to set 12 lead display.
Patient info
12.3.2 Setup
Figure 47: Setup Menu
Volume
Rotate the Multi function knob to highlight Alarm volume, Beep volume or
Button volume.
Press the Multi function knob. Levels of Alarm volume, Beep volumeor Button
volume will appear.
Rotate the Multi function knob to select a volume level.
111
Press the Multi function knob to enter a desired volume into the PRIMEDIC™
DefiMonitor EVO.
Printer setting
Rotate the Multi function knob to highlight Printer on alarm, Print on shock, 12
lead auto printing or Analyze auto printing.
Press the Multi function knob. Multi function knob toggles between On and Off.
Erase data
Waveform setting
nd
rd th
Display Mode

Manual self-test
19.
Button test
The user can check buttons for proper functioning. It can be performed by
Service Menu

112 MGA22955 / GB / A
12.3.3 Alarm Limit
12.3.4 Patient Info

113
13 NIBP Monitoring
WARNING
facility’s standards.
WARNING
Inaccurate measurements may be caused by incorrect cuff application
or use. This can include placing the cuff too loosely on the patient,
using the incorrect cuff size, or not placing the cuff at the same level as
the heart, leaky cuff or hose or excessive patient motion.
WARNING
In some cases, rapid, prolonged cycling of oscillometric measurements,
the cuff has been associated with any or all of the followings: ischemia,
purpura, or neuropathy. Periodically observe the patient’s limb to make
sure that the circulation is not impaired for a prolonged period of time.
Also make sure the cuff is placed according to directions in this manual
and the cuff directions for use.
WARNING
Do not place the cuff, the catheter or SpO2 sensor on an extremity
being used for intravenous infusion or any area where circulation is
compromised or has the potential to be compromised. Never fit NIBP
system with Luer Lock adapters.
WARNING
As with all automatically inflatable blood pressure devices, continual
cuff measurements can cause injury to the patient being monitored.
Weigh the advantages of frequent measurement and/or use of CONT
mode against the risk of injury.
WARNING
Ensure the patient is quiet with minimal movement during NIBP
readings; minimize the patient’s shivering.
WARNING
Never use an adult monitor setting or cuff for an NIBP measurement on
a neonatal patient. Adult inflation limits can be excessive for neonatal
patients, even if a neonatal cuff is used.
WARNING
Do not pull the hose because this could cause the disconnection of the
hose from the PRIMEDIC™ DefiMonitor EVO and can cause a
measurement error.

114 MGA22955 / GB / A
WARNING
Do not place the cuff over a wound as this could cause further injury
when pressurized.
WARNING
Application of the cuff to any limb where intravascular access or therapy
or an arterio-venous (A-V) shunt is present could result in injury due to
the temporary interference of blood flow during pressurization.
WARNING
The application of the cuff to the arm on the same side as a
mastectomy should be avoided.
CAUTION
In Automatic Mode, the PRIMEDIC™ DefiMonitor EVO displays results of
the last blood pressure measurement until another measurement starts.
If a patient’s condition changes during the time interval between
measurements, the PRIMEDIC™ DefiMonitor EVO will not detect the
change or indicate an alarm condition.
CAUTION
Any excessive patient motion may cause inaccurate measurements of
non-invasive blood pressure. Minimize motion to improve blood
pressure measurements.
CAUTION
Do not apply the blood pressure cuff to the same extremity as the one
to which the SpO2 sensor is attached. Cuff inflation can disrupt SpO2
monitoring and lead to nuisance alarms.
CAUTION
Make sure that heavy objects are not placed on the cuff hose. Avoid
crimping or undue bending, twisting, or entanglement of the hose.
CAUTION
The sensor disconnect error message and associated alarm indicate the
sensor is either disconnected or the wiring is faulty. Check the sensor
connection and, if necessary, replace the sensor.
Blood pressure measurements can be affected by the position of the

Note
patient, the patient’s physiological condition and other factors.
Blood pressure measurements determined with the PRIMEDIC™

Note
DefiMonitor EVO are equivalent to those obtained by a trained observer
using the cuff/stethoscope auscultatory method, within the limits
prescribed by the American National Standard for manual, electronic, and
automated sphygmomanometers.
115
13.1 General
The PRIMEDIC™ DefiMonitor EVO performs Non-Invasive Blood Pressure
measurements using the oscillometric measuring technique. A motorized
pump inflates the cuff to initially blocking the flow of blood in the extremity.
Then, under PRIMEDIC™ DefiMonitor EVO control, the pressure in the cuff is
gradually reduced, while a pressure transducer detects air pressure and
transmits a signal to the NIBP circuitry.
When the cuff pressure is still above systolic pressure, small pulses or
oscillations in the cuff pressure begin to be sensed by the transducer. As the
cuff continues to deflate, oscillation amplitude increases to a maximum and
then decreases. When maximum oscillation amplitude occurs, the cuff pressure
at that time is measured as mean arterial pressure (MAP). The systolic and
diastolic pressures are calculated based on analysis of the oscillation amplitude
profile.
13.2 Theory of Operation
13.2.1 Overview
The oscillometric technique does not use Korotkoff sounds to determine blood
pressure. The oscillometric technique monitors the changes in cuff pressure
caused by the flow of blood through the artery. The PRIMEDIC™ DefiMonitor
EVO inflates the cuff to a pressure that occludes the artery. Even when the
artery is occluded, the pumping of the heart against the artery can cause small
pressure pulses in the cuff baseline pressure. The PRIMEDIC™ DefiMonitor EVO
lowers cuff pressure at a controlled rate. As the cuff pressure goes down, blood
starts to flow through the artery. The increasing blood flow causes the
amplitude of the pressure pulses in the cuff to increase. These pressure pulses
continue to increase in amplitude with decreasing cuff pressure until they
reach a maximum amplitude at which point they begin to decrease with
decreasing cuff pressure. The cuff pressure at which the pulse amplitude is the
greatest is known as Mean Arterial Pressure (MAP). The manner in which the
pulse amplitudes vary is often referred to as the pulse envelope. The envelope
is an imaginary line that connects the peak of each pressure pulse and forms
an outline. The shape of the envelope is observed by the PRIMEDIC™
DefiMonitor EVO using a variety of techniques to determine the diastolic and
systolic blood pressure.
MAP
Distole Oscillometric
Systole Response
(Pressure
Pulses)
TIME
Systole
Distole
MAP
Systole
MAP
Distole
Cuff Pressure
TIME

116 MGA22955 / GB / A
Figure 50: Connection between cuff pressure
and oscillometric response during
measurement.
13.2.2 Overall Accuracy Discussion

Overall system accuracy shall be determined by considering various influences
of the pressure sensor accuracy, motion artifacts, other artifact created by
pressure valve, technical errors of electrical components, and the origin error of
oscillometric method. The origin error of oscillometric comes from the basic
theory of that the MAP is determined by the pulse. Therefore, there might be
an error of the time between two pulses. In another words, the greatest
amplitude point of pulses could not represent the MAP point exactly.
On clinical trial perspective, overall system accuracy is not easy to be
determined. The clinical trial test protocols have been tried and have been
described in many treatises, and international standards. So, there are many
methods to determine the overall system accuracy of Automated
Sphygmomanometer using the oscillometric method. But, there are no
absolute test protocols to determine the overall system accuracy of the
Automated Sphygmomanometer using oscillometric method. Usually, the Gold
standards of Blood pressure measurement techniques for obtaining reference
values are the intra-arterial pressure and the auscultatory method.
The popular standard for the overall system accuracy is AAMI, SP-10
2002+A1;2003 (Electronic or automated sphygmomanometers).
The main test conditions are as follow:
A. Data comparing the Intra-arterial or the auscultatory by the clinical
experts with the automated sphygmomanometer.
B. For data collection and the data analysis, Bland-Altman Plot is used.
C. On the systolic, diastolic, and MAP, the Deltas of all measurements shall
be met under +/- 5mmHg of mean difference (MD), and +/- 8mmHg of
standard deviation (SD).
(Delta = Intra-arterial or Auscultatory – Automated sphygmomanometer)
Figure 51: Balnd-Altman plot of oscillometric blood pressure measurements.
13.2.3 Oscillometric Method

The blood pressure values are determined by measuring the small oscillations
(changes) in the cuff pressure caused by the heart’s contractions as the
117
pressure in the cuff is released. The measurement technology used in the
PRIMEDIC™ DefiMonitor EVO utilizes a unique deflation technique, Dynamic
Linear Deflation. This cuff deflation technique allows the PRIMEDIC™
DefiMonitor EVO to measure each small change in the cuff pressure
oscillations that directly correspond to the measurement’s systolic, mean and
diastolic blood pressure values.
The cuff is first increased in pressure until it reaches a pressure above arterial
occlusion. As the cuff starts to deflate, the pulse rate of the patient is
determined and the deflation speed of the cuff is modified to create a patient
specific deflation speed. As the pressure decreases, small cuff pressure
oscillations are recorded that correspond to the applied pressure of the blood
under the cuff as the heart contracts. These oscillations increase in strength as
the cuff pressure approaches the systolic blood pressure value. A sudden
increase in oscillation amplitude indicates that the patient’s systolic blood
pressure is now able to push blood completely through beneath the cuff. The
oscillation amplitude continues to increase as the pressure in the cuff is
decreased until the mean blood pressure value is reached.
The oscillation strength then starts to diminish and finally drop off as the
diastolic blood pressure value is reached.
The oscillometric method does not determine an instantaneous blood pressure
reading like the auscultatory method employing a microphone-type auto
blood pressure defibrillator/monitor but, as described above, determines blood
pressure from an uninterrupted changing curve, which means that the
oscillometric method is not easily effected by external noise and electrosurgical
instruments.
Figure 52: Comparison of signals for several blood

pressure measurement techniques.
This equipment is suitable for use in the presence of electro-surgery.

Note

Measure the patient’s limb and select a proper size cuff. As a general rule, cuff
width should span approximately two-thirds of the distance between the
patient’s elbow and shoulder.
Connect the cuff hose to the connector on the PRIMEDIC™ DefiMonitor EVO’s left
connector panel and turn to right to lock.

118 MGA22955 / GB / A
Connect a cuff to the cuff hose and turn the connector to right to lock the hoses
together. Firm connection must be made.
Patient should be seated with back comfortably and arms supported.
Patient should have their legs uncrossed, feet flat on the floor with their back and
arms supported.
Wrap the cuff around a hare arm or around an arm covered in thin clothing. Thick
clothing or a rolled up sleeve will cause a major discrepancy in the blood
pressure reading.
Wrap the cuff around the patient’s arm so that the center of the cuff’s rubber
bladder sits on the artery of the upper arm. The hose should be brought
out from the peripheral side without bending (The Brachial artery is
located on the inside of the patient’s upper arm.) At this time, check that
the index line on the edge of the cuff sits inside the range. Use a different
sized cuff if the index line is outside of the range because this will cause a
major discrepancy in blood pressure reading.
CAUTION
The adult cuff should be wrapped around the arm tightly enough so that
only two fingers can be inserted under it, above and below the cuff.
CAUTION
Refrain from talking during the measurement procedure, and at least 5
minutes should elapse before the first reading is taken.
Maintain the height of the cuff-wrapped upper arm artery to that of the heart’s
right ventricle during measurement.
Follow the cuff directions for use when applying the cuff to the arm.
Obtaining NIBP readings can be more difficult in patients with arrhythmias.

Note
These arrhythmias increase the beat-to-beat pressure fluctuations, which
increases the variability of the NIBP readings. Temporarily verify pressure
using another method if it becomes difficult to obtain readings in the
presence of arrhythmias.
Table 26: Cuff models and sizes
Model Number Arm circumference (cm)

Pediatric HEM-CS23 13 to 22
Adult HEM-CR23 22 to 32
HEM-CL23 32 to 42
HEM-CX23 42 to 50
119
13.4 Description of NIBP Menu Functions
1 2 3 4 5
6 7 8 9 10
Figure 53: NIBP Display
1 NIBP icon 6 Systolic pressure value

2 NIBP unit 7 MAP value
3 NIBP auto mode interval 8 Initial pressure value
4 NIBP total monitoring time 9 Diastolic pressure value
(hh:mm format)
5 Bell icon 10 Neonatal icon
Inflate Pressure Auto Interval Patient Type Alarm Limit Return
Figure 54: NIBP Menu Display
In order to access the NIBP Menu, select the NIBP parameter window on the right side
of the monitoring display using the Multi function knob. The selected parameter
window is highlighted.
Table 27: NIBP Menu

Inflate Pressure 120, 140, 160, 180, 200, 220, 240, 260, 280
(mmHg) (Adult/Pediatric)
80, 100, 120, 140 (mmHg) (Neonatal)
Return
Auto Interval OFF, 1, 2.5, 3, 5, 10, 15, 30, 60, 90 (min)

Return
Patient Type Adult/Pedi
Neonatal
Return
Alarm Limit ▲ :SYS (Systolic) Upper Limit Adjust
▼ :SYS (Systolic) Lower Limit Adjust
Limit Alarm Pause: On, Off
▲ :MAP Upper Limit Adjust
▼ :MAP Lower Limit Adjust
▲ :DIA (Diastolic) Upper Limit Adjust
▼ :DIA (Diastolic) Lower Limit Adjust

120 MGA22955 / GB / A
Return
Return
Initial Inflate Pressures shown above are for Adult patient mode. In order to
Note
set alarm limits to Neonatal mode, change Patient type via the Setup Menu.
The NIBP unit can only be changed by authorized personnel via the Service
Note
Menu.
13.4.1 Inflate Pressure

The inflating pressure can be set from 120 to 280 mmHg for adult and
pediatric, or from 80 to 140 mmHg for neonatal.
If measurement was stopped because measurement time exceeded blood
Note
pressure measurement might be repeated up to 2 times.
13.4.2 Auto Interval

The NIBP measurement interval can be selected as Off, Cont, 1, 2.5, 3, 5, 10, 15,
30, 60 or 90 min. The total measurement time will be integral multiple of the
selected interval starting from 0 minute.
13.4.3 Patient Type

The patient type can be selected as Adult/Pedi or Neonatal.

When the Limit Alarm Pause is set to On, the audible alarm for NIBP systolic,
MAP and diastolic limit violation is paused.
121
14 SpO₂ Monitoring
WARNING
accessories manufactured by Nellcor® or supplied by Metrax GmbH.
Use accessories according to the manufacturer’s directions for use and
your facility’s standards.
WARNING
Tissue damage can be caused by incorrect application or use of a SpO 2
sensor. Harm can be caused, for example, by wrapping the sensor too
tightly, by applying supplemental tape, or by leaving a sensor on too
long in one place. Inspect the sensor site as directed in the sensor
directions for use to ensure skin integrity, correct positioning, and
adhesion of the sensor.
WARNING
Do not use damaged SpO2 sensors. Do not use a SpO2 sensor with
exposed optical components. Do not immerse sensor completely in
water, solvents, or cleaning solutions because the sensor and
connectors are not waterproof. Do not sterilize SpO2 sensors by
irradiation, steam or ethylene oxide. Refer to the cleaning instructions in
the directions for use for reusable SpO2 sensors.
WARNING
Inaccurate measurements may be caused by:
 incorrect sensor application or use
 significant levels of dysfunctional hemoglobin (such as
carboxyhemoglobin or methemoglobin)
 intravascular dyes such as indocyanine green or methylene
blue
 exposure to excessive illumination, such as surgical lamps
(especially ones with a xenon light source), bilirubin lamps,
fluorescent lights, infrared heating lamps, or direct sunlight
 excessive patient movement
 high-frequency electrosurgical interference and defibrillators
 venous pulsations
 placement of a sensor on an extremity with a blood pressure
cuff, arterial catheter, or intravascular line
 patient conditions such as hypotension, severe
vasoconstriction, severe anemia, hypothermia, cardiac arrest,
or shock
 arterial occlusion proximal to the sensor
 environmental conditions
 unspecified length of the extension cable
WARNING
Do not attach any cable to the sensor port connector that is intended
for computer use.

122 MGA22955 / GB / A
WARNING
Do not pull the cable because pulling this could cause the
disconnection of the cable from the PRIMEDIC™ DefiMonitor EVO and
can cause a measurement error.
WARNING
Do not use a damaged sensor or cable. Do not alter the sensor or cable
in any way. Alternations or modification may affect performance and/or
accuracy. Never use more than one cable between the pulse oximeter
and the sensor to extend the length.
WARNING
Sensors exposed to ambient light when incorrectly applied to a patient
may exhibit inaccurate saturation readings. Securely place the sensor on
the patient and check the sensor’s application frequently to help ensure
accurate readings.
WARNING
Do not rely solely on SpO2 reading: assess the patient at all times. SpO2
readings may be inaccurate in the presence of significant levels of
carboxyhemoglobin or methemoglobin, in patients with restricted
blood flow to the extremities (such as those in severe shock or
hypothermia), or in the presence of excessive motion.
WARNING
Failure to apply the sensor properly may reduce the accuracy of the
SpO2 measurement.
WARNING
Inspect the sensor application site at least every two hours for changes
in skin quality, correct optical alignment, and proper sensor application.
If skin quality is compromised, change the sensor site. Change the
application site at least every four hours. More frequent checking may
be required due to individual patient’s condition.
WARNING
Severe anemia, methemoglobin, intravascular dyes that change usual
blood pigmentation, excessive patient movement, venous pulsations,
electrosurgical interference, exposure to irradiation and placement of
the sensor on an extremity that has a blood pressure cuff, intravascular
line, or externally applied coloring (such as nail polish) may interfere
with oximeter performance. The operator should be thoroughly familiar
with the operation of the oximeter prior to use.
WARNING
The pulsations from intra-carotic balloon support can be additive to the
pulse rate on the oximeter pulse rate display. Verify patient’s pulse rate
against the ECG heart rate.
123
WARNING
Prolonged, continuous use of a sensor may cause irritation, blistering, or
pressure necrosis of the skin. Check the sensor site regularly based on
patient condition and type of sensor. Change the sensor site if skin
changes occur. Do not use tape to hold the sensor in place as this may
cause inaccurate readings or damage to the sensor or skin.
WARNING
Carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
WARNING
Carboxyhemoglobin and methemoglobin may erroneously increase
SpO2 readings. The amount that SpO2 increases is approximately equal
to the amount of carboxyhemoglobin or methemoglobin that is
present.
CAUTION
connection and, if necessary, replace the sensor, extension cable or both.
CAUTION
Reusable sensors may be used on the same site for a maximum of 4
hours, provided the site is inspected routinely to ensure skin integrity
and correct positioning.
14.1 General
The PRIMEDIC™ DefiMonitor EVO uses pulse oximetry to measure functional
oxygen saturation in the blood. Because a measurement of SpO2 is dependent
upon light from the SpO2 sensor, excessive ambient light can interfere with this
measurement. SpO2 and Pulse rate are updated every second. The PRIMEDIC™
DefiMonitor EVO measures functional saturation - oxygenated hemoglobin
expressed as a percentage of the hemoglobin that can transport oxygen. It
does not detect significant amounts of dysfunctional hemoglobin, such as
carboxyhemoglobin or methemoglobin.

The PRIMEDIC™ DefiMonitor EVO uses pulse oximetry to measure functional
oxygen saturation in the blood. Pulse oximetry works by applying a Nellcor™
pulse oximetry sensor to a pulsating arteriolar vascular bed, such as a finger or
toe. The sensor contains a dual light source and a photodetector. Bone, tissue,
pigmentation, and venous vessels normally absorb a constant amount of light
over time. The arteriolar bed normally pulsates and absorbs variable amounts
of light during the pulsations. The ratio of light absorbed is translated into a
measurement of functional oxygen saturation (SpO2). Ambient conditions,
sensor application, and patient conditions can influence the ability of the pulse
oximeter to accurately measure SpO2. Pulse oximetry is based on two
principles: oxyhemoglobin and deoxyhemoglobin differ in their absorption of
red and infrared light (measured using spectrophotometry), and the volume of
124 MGA22955 / GB / A
arterial blood in tissue (and hence, light absorption by that blood) changes
during the pulse (registered using plethysmography). The PRIMEDIC™
DefiMonitor EVO determines SpO2 by passing red and infrared light into an
arteriolar bed and measuring changes in light absorption during the pulsatile
cycle. Red and infrared low-voltage light-emitting diodes (LED) in the sensor
serve as light sources; a photo diode serves as the photo detector. Since
oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of
red and infrared light absorbed by blood is related to hemoglobin oxygen
saturation. The PRIMEDIC™ DefiMonitor EVO uses the pulsatile nature of
arterial flow to identify the oxygen saturation of arterial hemoglobin. During
systole, a new pulse of arterial blood enters the vascular bed, and blood
volume and light absorption increase. During diastole, blood volume and light
absorption reach their lowest point. The defibrillator/monitor bases its SpO2
measurements on the difference between maximum and minimum absorption
(measurements at systole and diastole). By doing so, it focuses on light
absorption by pulsatile arterial blood, eliminating the effects of nonpulsatile
absorbers such as tissue, bone, and venous blood.
14.2.1 Functional versus Fractional Saturation

The PRIMEDIC™ DefiMonitor EVO measures functional saturation where
oxygenated hemoglobin expressed as a percentage of the hemoglobin that
can transport oxygen. It does not detect significant amounts of dysfunctional
hemoglobin, such as carboxyhemoglobin or methemoglobin. In contrast,
hemoximeters such as the IL482 report fractional saturation where oxygenated
hemoglobin expressed as a percentage of all measured hemoglobin, including
measured dysfunctional hemoglobin. To compare functional saturation
measurements to those from an instrument that measures fractional saturation,
fractional measurements must be converted using the listed equation.
( )
14.2.2 Measured versus Calculated Saturation

When calculating saturation from a blood gas partial pressure of oxygen (PO2),
the calculated value may differ from the SpO2 measurement of the PRIMEDIC™
DefiMonitor EVO. This usually occurs when saturation calculations exclude
corrections for the effects of variables such as pH, temperature, the partial
pressure of carbon dioxide (PCO2), and 2,3-DPG, that shift the relationship
between PO2 and SpO2.
Figure 55: Oxyhemoglobin Dissociation Curve
125
1 % Saturation Axis 3 Increased pH; Decreased temperature, PCO2, and 2,3-
DPG
2 PO2 (mmHg) Axis 4 Decreased pH; Increased temperature, PCO2, and 2,3-
DPG

When selecting a sensor, consider the patient’s weight and activity, adequacy
of perfusion, availability of sensor sites, need for sterility, and anticipated
®
duration of monitoring. Refer to Table 26, or contact Nellcor or Metrax GmbH
sales department for ordering information.
Select the proper sensor for the patient.

Connect the extension cable to the SpO2 connector on the PRIMEDIC™
DefiMonitor EVO’s right connector panel and lock it.
Connect the sensor to the extension cable and lock it.
Carefully apply the sensor to the patient, as described in the sensor directions for
use. Observe all warnings and cautions in the directions for use.
Refer to directions for use to ensure the proper placement for various types
Note
of SpO2 sensors.
Periodically check to see that the sensor remains properly positioned on

Note
the patient and that skin integrity is acceptable. Refer to the sensor
directions for use.

126 MGA22955 / GB / A
Table 28: SpO2 Sensors
Sensor Model Patient Size

®
OXIMAX oxygen transducer (Sterile, single-use MAX-N <3 or >40 kg
only) MAX-I 3 to 20 kg
MAX-P 10 to 50 kg
MAX-A >30 kg
MAX-AL >30 kg
MAX-R >50 kg
®
OXIMAX Oxiband oxygen transducer OXI-A/N <3 or >40 kg
(Reusable with disposable non-sterile adhesive) OXI-P/I 3 to 40 kg
®
OXIMAX Durasensor Oxygen transducer DS-100A >40 kg
(Reusable, non-sterile)
®
OXIMAX OxiCliq oxygen transducers P 10 to 50 kg
(Sterile, single-use only) N <3 or >40 kg
I 3 to 20 kg
A >30 kg
OXIMAX Dura-Y® multisite oxygen transducer D-YS >1 kg
(Reusable, non-sterile)
For use with the Dura-Y sensor:
 Ear clip (Reusable, non-sterile) D-YSE >30 kg
 Pedi-Check™ pediatric Spot Check clip
(Reusable, non-sterile) D-YSPD 3 to 40 kg
®
OXIMAX MAX-FAST adhesive reflectance oxygen MAX-FAST >40 kg
transducer
14.4 Description of SpO2 Menu Functions
3
2
4
Figure 56: SpO2 Display
1 SpO2 icon 3 SpO2 value

2 Pulse amplitude indicator 4 Bell icon
Figure 57: SpO2 Waveform
1 SpO2 waveform icon 2 SpO2 waveform
Puls Amplitude Indicator
127
The pulse amplitude indicator is the segmented display within the SpO2
numerical area that shows the relative strength of the detected pulse. A
stronger pulse causes a larger amplitude indicator.
Alarm Limit Return
Figure 58: SpO2 Menu Display
In order to access the SpO2 Menu, select the SpO2 parameter window on the
right side of the monitoring display using the Multi function knob. The
selected parameter window is highlighted.
Table 29: SpO2 Menu

Alarm Limit ▲ :% SpO2 Upper Alarm Limit
▼ :% SpO2 Lower Alarm Limit
Return
Return
Limit Alarm Pause

When the Limit Alarm Pause is set to On, the audible alarm for SpO2 limit

128 MGA22955 / GB / A
15 Respiration Monitoring
WARNING
facility’s standards.
WARNING
The PRIMEDIC™ DefiMonitor EVO does not detect apnea when the
respiration signal is measured by trans-thoracic impedance.
WARNING
Keep patients under close surveillance when monitoring respiration.
Respiration signals are relatively more sensitive to interference from
radiated electromagnetic signals. Thus, it is possible, although unlikely,
that radiated electromagnetic signals from sources external to the
patient and the PRIMEDIC™ DefiMonitor EVO can cause inaccurate
respiration readings. Do not rely entirely on the PRIMEDIC™
DefiMonitor EVO respiration readings for patient assessment. If
measured waveforms are not appropriate readings, check external
conditions to ensure there is no equipment causing electromagnetic
interference.
CAUTION
Impedance respiration technology is very sensitive to any artifacts. If
impedance respiration is doubtful due to artifacts, it is not
recommended to assess the clinical state of patient only with impedance
respiration parameter.
15.1 General
The Patient’s respiration is detected by using two of the three leads of the ECG
electrodes and cable. Real-time respiratory information is presented as a
waveform and numeric data; Impedance respiration source (IM).
The airway respiration measurement uses gases coming into the airway
adapter in case of the CO2 equipped. The DefiMonitor EVO detects respiration
rate by computing each breath cycle form the continuous EtCO2 waveform;
Airway respiration source (AW).

The impedance-based respiration monitoring is designed to use the variation
of the thoracic impedance. The chest contains various materials, ranging from
bone to air. Each of these materials has different electrical properties and is
located in a different portion of the chest. The materials of the chest vary in
electrical resistivity (the amount of electrical resistance between opposite faces
of a cube of that material), which is an important determinant of electrical
impedance in the body.
Two of the major components of the chest, blood and air, are at opposite ends
of the scale. Furthermore, the volume of each of these materials varies with
time over the cardiac and breathing cycles. The variation of the thoracic
impedance is caused by the difference between air and blood in the thoracic
129
impedance. Blood has relatively low resistivity, which varies over the cardiac
cycle owing to changing blood volumes in the heart and in the vascular
compartment. Air, on the other hand, has high electrical resistivity and hence
impedance and it undergoes wide volume changes in the lungs during normal
breathing. i.e. the impedance of blood is 150 ohm/cm and the one of air is
5.000 ohm/cm.
The patient’s respiration is detected by using two of the three leads of the ECG
(RA and LA, or RA and LL). The electrical impedance between a pair of
electrodes is determined by dividing the voltage difference between the two
electrodes by the current that passes between them. When the electrodes are
placed on the actual structure, respective structures change.
A low-level excitation signal is applied to these leads, and the variation of the
thoracic impedance caused by the breathing is sensed and processed for
display and measurement. This variation is processed to the voltage value for
the measurement.
In order to transfer the thoracic impedance by a transformer, a sine wave
carrier signal with a minimum constant current is used. The transferred thoracic
impedance is changed to a voltage signal by using bridge circuit and
differential amplifier. Then, ECG signal is removed by filter, and carrier
frequency is removed by full wave rectifier and filter in order to extract only
thoracic impedance in amplifying at the definite level of signal. This extracted
thoracic impedance signal is used to measure the respiration by digital signal
processing.

Refer to the chapter 8 for how to acquire the respiration signal by patient
impedance using the ECG electrodes, leads and cable.
The performance of impedance respiration can be improved by the particular
placement of the Left arm (LA) and Right arm (RA) electrodes (see Standard
ECG electrode placement in Figure 27.
Refer to chapter 16 section to detect the respiration signal by the airway
adapter in case that the CO2 equipped.
Impedance respiration monitoring is active only if the paddles are not

Note
connected to the PRIMEDIC™ DefiMonitor EVO or if pads are not
connected to pads cable. In case pads or paddles are connected, the
respiration rate is displayed as “---” and waveform of respiration is not
displayed on the screen.
15.4 Description of Respiration Menu Functions
1 4
2
3 5
Figure 59:Respiration Display
1 Respiration rate icon 4 Respiration icon

2 Respiration rate source icon 5 Measurement value
3 Bell icon
1
130 MGA22955 / GB / A
2
Figure 60: Respiration Waveform Display
1 Respiration waveform icon 2 Respiration waveform
Respiration
Respiration Apnea time setting Alarm Limit Return
Setting
Figure 61: Respiration Menu Display
In order to access the Respiration Menu, select the Respiration parameter

window on the right side of the monitoring display using the Multi function
knob. The selected parameter window is highlighted.
Table 30: Respiration Menu

Respiration On
Off
Return
Respiration Setting RR Source Auto (Airway > Impedance)
Impedance
Airway
Return
Size X 0.5
X1
X 1.5
X2
Return
Return
Apnea Time Setting Off, 10, 20, 30, 40, 50, 60
(seconds)
Return
Alarm Limit ▲ :RR Upper Limit Adjust
▼ :RR Lower Limit Adjust

Return
Return
15.4.1 Respiration
When respiration is set to On, the measurement value for respiration rate and
respiration waveform are displayed on the screen. When the respiration is set
to Off, respiration rate is not measured and respiration value is displayed with
131
“---”. Respiration rate source icon is only displayed when the respiration is set
to On.
15.4.2 RR Source
User can select either Airway or Impedance for source of the respiration rate.
If the Auto option is selected, the PRIMEDIC™ DefiMonitor EVO will
automatically derive the respiration rate from one of the monitoring
parameters in this order of priority: First Airway and then Impedance.
You can select Airway as the source only when capnography module is
Note
installed.
15.4.3 Size
Size allows you to adjust the waveform size. Size can be selected
as X 0.5, X 1, X 1.5 or X 2.0.
15.4.4 Apnea time setting

When the patient’s breath is not detected from the airway measurement for
the selected time setting, the PRIMEDIC™ DefiMonitor EVO will activate an
apnea alarm. When 60 seconds is selected, the PRIMEDIC™ DefiMonitor EVO
will generate two tones after 20 seconds without any breath detected. Then
three tones are generated again after 20 seconds, and after another 20
seconds an apnea alarm will be activated. If Off is selected, the monitor does
not detect an apnea alarm.
When the monitor does not detect a respiration signal from the impedance
measurement for 40 seconds, the monitor will activate a loss of respiration
alarm.
Check the condition of the patient, then check the connections of the patient
cables.

When Limit Alarm Pause is set to On, the audible alarm for respiration rate
limit violation is paused.

132 MGA22955 / GB / A
16 Capnography Monitoring
WARNING
accessories according to your facility’s standards and the manufacturer’s
recommendation. Always refer to the manufacturer’s Directions for Use
for instruction about operation, cleaning, and replacement.
WARNING
The EtCO2 readings do not always correlate closely with blood gas
values, especially in patients with pulmonary disease, pulmonary
embolism or inappropriate ventilation.
WARNING
If you are uncertain about the accuracy of any measurement, first check
the patient’s vital signs by alternate means, and then make sure the
PRIMEDIC™ DefiMonitor EVO is functioning correctly.
WARNING
The PRIMEDIC™ DefiMonitor EVO should not be used as an apnea
monitor.
WARNING
To ensure patient safety, do not place the PRIMEDIC™ DefiMonitor EVO
in any position that might cause it to fall on the patient.
WARNING
To ensure accurate performance and prevent device failure, do not
expose the PRIMEDIC™ DefiMonitor EVO to extreme moisture, such as
rain.
WARNING
The use of accessories, transducers, sensors and cables other than those
specified may result in increased emission and/or decreased immunity
of the equipment and/or system.
WARNING
CO2 readings and respiratory rate can be affected by sensor application
errors, certain ambient environmental conditions, and certain patient
conditions.
WARNING
The PRIMEDIC™ DefiMonitor EVO is a prescription device and is to be
operated by qualified healthcare personnel only.
133
WARNING
Ensure that the components of the airway are secure. If they become
loose, external air may be sucked in the tube and the sampling gas will
be diluted, causing incorrect measurement values.
WARNING
Ensure that selection of a volatile anesthetic is done carefully. If an
improper selection is made, the measurement values may be incorrect.
WARNING
Do not use accessories other than which are specified. Different
sampling tube lengths or inside diameters may have an effect on the
measurement.
WARNING
The mainstream/sidestream capnography module should not be used in
the presence of flammable anesthetics or other flammable gases. Use of
this device in such an environment may present an explosion hazard.
WARNING
Do not use device without rectifying a gas calibration failure, as correct
measurement readings will not be obtained.
WARNING
Do not use device on patients that cannot tolerate the withdrawal of 50
ml/min ±10 ml/min from airway.
WARNING
CO2 should not be measured in the presence of aerosolized
pharmaceuticals.
WARNING
Do not use a damaged airway adapter.
CAUTION
In high-altitude environments, EtCO2 values may be lower than values
observed at sea level, as described by Dalton's law of partial pressures.
When using the PRIMEDIC™ DefiMonitor EVO in high-altitude
environments, it is advisable to consider adjusting EtCO2 alarm settings
accordingly.
CAUTION
Do not operate the Capnostat sensor when it is wet. Do not immerse the
device in water.

134 MGA22955 / GB / A
CAUTION
Do not operate the Capnostat sensor if it appears to have been
damaged or if it fails to operate properly.
CAUTION
If the patient’s airway is configured with a closed suctioning system,
make sure the airway adapter is placed closed to the suctioning system
(on the ventilator side). This will help ensure that the sampling adapter is
not impaired during and after suctioning.
CAUTION
The disposable airway adapter, nasal and nasal/oral sampling cannulas,
and the airway adapter kit are intended for single patient use. Do not
reuse or sterilize these disposable adapters, because system
performance will be compromised.
CAUTION
Do not insert any object other than the sidestream sample cell into the
inlet port of the CO2 module.
CAUTION
Inspect the mainstream CO2 sensor and airway adapter connection to
ensure correct positioning.
CAUTION
Position sidestream airway adapter with the tubing in an upright
position. This help keep patient secretions from pooling into the tubing.
CAUTION
To prevent moisture from during into the mainstream airway or into the
sidestream airway adapter tubing, do not place the adapter in a gravity
dependent position.
CAUTION
It is recommended that the mainstream airway adapter and the
sidestream airway adapter are removed from the circuit whenever an
aerosolized medication is delivered. The increased viscosity of the
medication may contaminate the sensor windows, causing the sensor to
fail prematurely.
16.1 General
The PRIMEDIC™ DefiMonitor EVO capnography option supports mainstream
and sidestream gas analysis designed to measure the concentration of carbon
dioxide in a gas mixture and to aid in determining the patient’s ventilatory,
circulatory, and metabolic status. Mainstream (nondiverting) and sidestream
(diverting) capnography are highly accurate methods of measuring respiratory
135
gas values. When monitoring capnography, the PRIMEDIC™ DefiMonitor EVO
automatically compensates for the ambient barometric pressure to ensure
accurate readings.

The CO2 sensor measures CO2 by using the infrared technique. The principle is
based on the fact that CO2 molecules absorb infrared (IR) light energy of
specific wavelengths, with the amount of energy absorbed being directly
related to the CO2 concentration. When an IR beam is passed through a gas
sample containing CO2, the electronic signal from the photodetector (which
measures the remaining light energy) is measured. This signal is then
compared to the energy of the IR source and adjusted to accurately reflect CO2
concentration in the sample. The CO2 sensor’s response to a known
concentration of CO2 is stored at the factory in the sensor’s memory. A
reference channel accounts for optical changes in the sensor, allowing the
system to remain in calibration without user intervention.

The DefiMonitor EVO has one capnography sensor receptacle which may be
used for a mainstream capnography sensor or a sidestream capnography
sensor.
Capnography is not analyzed during unit warm-up. However, the

Note
capnograph does display values to indicate that the monitor is working
properly.
The typical initial warm-up period can take up to two minutes. This time
Note
varies based of the temperature of the sensor at the start of the initial
warm-up.
The airway adapter may require cleaning or replacement if the capnograph

Note
is used on patients that emit excessive mucus.
16.3.1 Calibrating the CO2 Sensor

You must calibrate the CO2 sensor the first time it is connected to the
PRIMEDIC™ DefiMonitor EVO, when the CO2 sensor is changed. You do not
need to calibrate the sensor when you power on the monitor. Once calibrated,
the sensor may be disconnected and reconnected without calibration.
To maintain optimum performance of the sensor and capnograph, you

Note
should perform a sensor calibration verification at least once a week.
16.3.2 Mainstream Operation

Mainstream monitoring uses an external, self-calibrating CO2 sensor to ensure
continuous monitoring without interruption of connection. Reusable,
lightweight, or single-use airway adapters are available for both adult and
neonatal (low dead space) patients. Respiration can be monitored via an airway
adapter and endotracheal or tracheostomy tube using the mainstream function
of the module.
The external capnography device includes a small, lightweight sensor that
continuously measures the end-tidal and minimum carbon dioxide levels in the
patient’s airway. The sensor head contains a small infrared transducer that
accurately measures the CO2 in the airway. The sensor is connected to the

136 MGA22955 / GB / A
airway by a disposable or reusable airway adapter. These adapters are available
in adult and neonatal size.
Figure 62: Connection for mainstream
1 Y-piece 4 Elbow
2 Airway adapter 5 Mainstream CO2 sensor
3 Patient connector (Adult/Pedi)
16.3.3 Sidestream Operation

Sidestream monitoring uses an external, sidestream sensor that plugs into the
capnography port on the PRIMEDIC™ DefiMonitor EVO. Adult, pediatric, or
infant sampling lines are then plugged into the sensor receptacle. Respiration
can be monitored for intubated or non-intubated patients via an airway
adapter, nasal cannula, or nasal/oral cannula using the sidestream function of
the module. Sidestream monitoring diverts patient gases at a rate of 50 ml/min
(±10ml/min).
The sidestream sampling lime consists of a sample cell on one end that into
the sidestream sensor receptacle on the monitor. The other end of sampling
line is connected to the patient either via a cannula or a sample-T, as shown in
Figure 63.
Figure 63: Connection for sidestream
1 Cannula 3 Sampling-T
2 Sampling cell 4 Sidestream CO2 sensor
137
16.4 Description of EtCO2 Menu Functions
1 5
2 6
3 7
Figure 64: EtCO2 Display
1 EtCO2 icon 5 EtCO2 unit

2 EtCO2 value 6 Bell icon
3 InCO2 icon 7 InCO2 unit
4 InCO2 value
Figure 65: EtCO2 Waveform Display
1 EtCO2 waveform icon 2 EtCO2 waveform
Figure 66: EtCO2 Menu Display
In order to access the EtCO2 Menu, select the EtCO2 parameter window on the
right side of the monitoring display using the Multi function knob. The
selected parameter window is highlighted.
Table 31: EtCO2 Menu
Level 1 Menu Level 2 Menu or Response Level 3 Menu or Response
EtCO2 On
Off
Return
EtCO2 Setting N2O Gas On
Off
Return
O2 Gas On
Off
Return
Zero Setting Enter
Return
Return
Scale 0 ~ 40 mmHg
0 ~ 60 mmHg
0 ~ 80 mmHg

138 MGA22955 / GB / A
Level 1 Menu Level 2 Menu or Response Level 3 Menu or Response
Auto
Return
Alarm Limit ▲: EtCO2 Upper Limit Adjust
▼: EtCO2 Lower Limit Adjust
▲: InCO2 Upper Limit Adjust
▼: InCO2 Lower Limit Adjust
Return
Return
The EtCO2 unit can only be changed by authorized personnel via the
Note
Service Menu.
16.4.1 EtCO2
If capnography is activated using the EtCO2 soft key, display of EtCO2 (end-
tidal partial pressure of carbon dioxide in respiratory gases) value and InCO2
(inspired carbon dioxide) value and display of capnogram are activated.
16.4.2 EtCO2 Setting
O2 Gas
As the N2 in the sample gas is replaced by O2, the effect is a decrease in IR
absorption. This results in a lower than actual measured CO2 value (CO2
measured).
It is recommended O2 Gas is set to On to correct for the O2 effect when the O2
concentration is greater than 50%. At O2 levels equal to or less than 50%, the
correction should not be used.
N2O Gas
As the N2O in the sample gas, an assumption is made: if N2O is administered to
the patient, then the remaining balance of the administered mixture is O 2. The
combined effect of these gases is two-fold: O2 presence decreases IR
absorption, and N2O presence increases absorption. Though N2O does not
directly absorb the filtered IR energy, it causes the CO2 molecule to absorb and
pass along some of its energy to the N2O molecule of similar molecular weight.
By passing off some of this energy, the CO2 molecule is free to absorb even
more energy which leads to an increase in absorption. Since the increased
absorption effect due to N2O presence is greater than the decrease due to O2
presence, an optimal administered mixture of 25% N2O and 75% O2 effectively
cancels the combined effect. The effect of desflurane on the CO 2 measurement
is similar to the effect of N2O. It is recommended N2O Gas is set to On when
N2O or desflurane concentrations is above 12%.
Zero Setting
Zero setting the capnography module is a quick procedure that adjusts the
sensor to the optical characteristics of each compatible airway adapter, cannula
or sample line. Typical time for zero is 15-20 seconds.
®
In case of using a mainstream CAPNOSTAT CO2 sensor Zero Setting has to be
performed under the following conditions:
139
1. Procedure is necessary with the first use of the sensor.
2. When switching the mainstream sensor from one airway adapter type
to another, such as when switching from a disposable to a reusable
airway adapter.
3. When requested by the PRIMEDIC™ DefiMonitor EVO.
Zeroing is not required when switching from the same type of airway
Note
adapter, such as a disposable to a disposable airway adapter.
®
In case of using a sidestream LoFlo CO2 sensor Zero Setting has to be
performed under the following conditions:
1. Procedure is necessary with the first use of the sensor.
2. When requested by the PRIMEDIC™ DefiMonitor EVO.
A sample cell zero is not required when switching from one sampling
Note
accessory to another.
® ®
Never zero the CAPNOSTAT sensor or LoFlo sensor without an adapter
Note
or sampling kit installed. When zeroing, always remove the adapter or
cannula from the patient and keep all sources of CO2 away from the sensor,
including your own breath (CO2 is heavier than air).
® ®
CAPNOSTAT and LoFlo are registered trademarks of Respironics, Inc. and
Note
its affiliates, the manufacturer of the capnometry modules.
Scale
The user can select the scale of capnogram waveform. When Auto is selected,
the monitor will automatically set the scale according to the measured values.

When Limit Alarm Pause is set to On, the audible alarm for EtCO2 or InCO2 or

140 MGA22955 / GB / A
17 Temperature Monitoring
WARNING
For best product performance and measurement accuracy, use only YSI
400 and 700 series temperature probes recommended by Metrax
GmbH. Use accessories according to the manufacturer’s directions for
use and your facility’s standards.
17.1 General
Measurement of patient temperature is accomplished by processing the signal
from a probe containing a resistance element whose impedance is temperature
dependent. These devices are called thermistors. The measuring time required
to obtain accurate readings at the specific body site is about 10 seconds.

Temperature measurement used by the PRIMEDIC™ DefiMonitor EVO is based
on a thermistor whose resistance is inversely proportional to its temperature.
By measuring the thermistor’s resistance, its temperature can be calculated.
The resistance of the thermistor is measured by passing a current through it
and measuring the voltage developed across it.
The PRIMEDIC™ DefiMonitor EVO is designed to accept the signals from a
range of electrically isolated temperature probes from YSI-400 and YSI-700
series. The probes may be used for skin or rectal temperature measurement.
Probes are furnished with a standard 10-feet lead; extension leads are
available. The signal from the probe is conditioned by the PRIMEDIC™
DefiMonitor EVO input circuitry, processed, and used to drive the numeric
display.

The PRIMEDIC™ DefiMonitor EVO is designed to accept signals from
temperature probes, YSI 400 series and 700 series for skin, rectal or etc.
Insert a body temperature probe into the temperature probe connector on the
PRIMEDIC™ DefiMonitor EVO’s left connector panel (see Figure 5).
Follow the directions for use accompanying the temperature probe.
Table 32: Temperature Sensors
Sensor Description
YSI YSI 401 or compatible Mono, rectal type

s
e YSI 409 or compatible Mono, skin type
n
s YSI 701 or compatible Stereo, rectal type
o
r YSI 709 or compatible Stereo, skin type
s
141
17.4 Description of Temperature Menu Functions
1 5
2 6
3 7
4
Figure 67: Temperature Display
1 Temperature1 icon 5 Temperature1 unit

2 Temperature1 value 6 Bell icon
3 Temperature2 icon 7 Temperature2 unit
4 Temperature2 value
Alarm Limit Return
Figure 68: Temperature Menu Display
In order to access the Temperature Menu, select the Temperature parameter

window on the right side of the monitoring display using the Multi function
knob. The selected parameter window is highlighted.
Table 33: Temperature Menu
Menu Level 2 Menu or Response

Alarm Limit ▲: Temperature1 Upper Limit Adjust
▼: Temperature1 Lower Limit Adjust
▲: Temperature2 Upper Limit Adjust
▼: Temperature2 Lower Limit Adjust
Return
Return
The temperature unit can only be changed by authorized personnel via the
Note
Service Menu.

When the Limit Alarm Pause is set to On, the audible alarm for Temperature

142 MGA22955 / GB / A
18 IBP Monitoring
WARNING
Proper measurements may not be possible,
 If improper zero calibration was performed.
 If air bubbles are mixed into the patient circuit.
 If the height of the three-way tap for zero calibration and the
right auricle have changed.
WARNING
If the pressure transducer has been dropped or subjected to strong
physical shock, check for faults before use.
WARNING
Be sure to thoroughly read the instruction manuals for each item - such
as the transducer, monitoring kit and transfusion set - that are used in
invasive blood pressure measurements before using them. The cautions
and warnings for such items are not included in this manual.
WARNING
Use a CE certified transducer with a sensitivity of 5μV/V/mmHg at an
excitation voltage of 5 VDC, and a measurement range of -50 to
300mmHg.
WARNING
Do not reuse disposable (single use) transducers.
WARNING
Check the time limit on the package not to use transducers with expired
dates.
WARNING
Ensure that reusable transducers are sufficiently sterilized.
WARNING
To ensure patient safety, do not contact any conductive parts to the
applied part.
WARNING
Never install or remove the IBP module while the PRIMEDIC™
DefiMonitor EVO is powered on. It is likely to break when installing or
removing it while powered on.
143
WARNING
Do not perform the pressure zero setting while measuring the patient.
WARNING
If air bubbles appear in the pressure line or transducer, flush the system
with the solution to be infused again.
WARNING
Invasive pressure alarms (and pulse alarm, if they are being derived
from the invasive pressure) are turned off while the transducer is
zeroing. The alarms turn back on 30 seconds after the zeroing is
finished.
WARNING
Make sure the correct label has been selected before you set the alarm
limits. The alarm limits you set are valid only for labels in the current
group.
Changing the label could change the alarm limits.
CAUTION
connection and, if necessary, replace the sensor.
CAUTION
Zeroing is necessary before IBP monitoring can begin.
CAUTION
Verify the IBP zero (per hospital procedures) and alarm at least once
daily and whenever the patient’s position changes to ensure that IBP
measurements are accurate.
CAUTION
Zero the pressure transducer to atmospheric pressure to ensure pressure
readings are accurate.
18.1 General
The invasive blood pressure measurement measures the systolic pressure,
mean pressure, diastolic pressure and pulse rate for up to two blood pressure
line channels using blood pressure transducers, and displays the blood
pressure waveform.

144 MGA22955 / GB / A
The pressure transducer is connected to a pressure line which, by means of a
catheter is invasively connected to the patient blood stream. The force of
movement of the blood in the patient vessels is transported by the fluid
column in the pressure line to the transducer. This movement cause an
electrical signal to be generated which is then amplified to display the pressure
wave and the numeric for the systolic, diastolic and mean pressure values.
The blood pressure is influenced by the respiratory system. This occurs in
spontaneous breathing patients, but is more apparent in positive pressure
ventilated patients. To reduce this respiration artifact the module uses a
variable weight filter technique in the processing of the pressure values.

Connect the interface cable for the transducer to the IBP connector (6pin, red
round connector) on the PRIMEDIC™ DefiMonitor EVO’s left connector panel.
An interface cable for the transducer has to be selected correctly as it depends
on the transducer type used.
Set up the patient circuit according to the directions for use of the transducer,
monitoring kit and IV set.
The drawing below shows an example.
Figure 69: IBP Connections
1 Pressure bag 3 Interface cable

2 Transducer 4 To patient
18.4 Description of IBP 1 Menu Functions
1 4
2 5
3 6
Figure 70: IBP 1 Display
145
1 IBP 1 label icon 4 IBP 1 unit
2 Systolic value 5 Diastolic value
3 Mean arterial pressures value 6 Bell icon
Figure 71: IBP 1 Waveform Display
1 IBP 1 label icon 2 IBP 1 waveform
Zero Setting Scale Label Alarm Limit Return
Figure 72: IBP 1 Menu Display
In order to access the IBP 1 Menu, select the P1 parameter window on the right
side of the monitoring display using the Multi function knob. The selected
parameter window is highlighted.
Table 34: IBP 1 Menu

Zero Setting Enter
Return
Scale 0 ~ 50mmHg
0 ~ 100mmHg
0 ~ 200mmHg
0 ~ 300mmHg
Auto
Return
Label P1
ABP
Return
Alarm Limit ▲: SYS Upper Limit Adjust
▼SYS Lower Limit Adjust
▲: MEAN Upper Limit Adjust
▼: MEAN Lower Limit Adjust
▲: DIA Upper Limit Adjust
▼: DIA Lower Limit Adjust
Return
Return

146 MGA22955 / GB / A
18.4.1 Zero Setting
When Zero Setting is set to Enter, IBP 1 channel is calibrated to eliminate the
influence of the barometric pressure on the measurement. Also refer to
directions for use of the transducer for information on zero setting of the IBP
measurement system.
18.4.2 Scale
The user-selectable pressure waveform scale allows you to adjust the scale of a
pressure waveform. The scale can be selected as 0 to 0 ~ 50mmHg, 0 ~
100mmHg, 0 ~ 200mmHg, 0 ~ 300mmHg or Auto. If Auto is selected, the
PRIMEDIC™ DefiMonitor EVO automatically sets the scale upon the IBP
measurement value.
18.4.3 Label
The label can be selected from P1 and ABP (Arterial Blood Pressure).

When the Limit Alarm Pause is set to On, the audible alarm for IBP 1 limit
18.5 Description of IBP 2 Menu Functions
1 4
2 5
3 6
Figure 73: IBP 2 Display
1 IBP 2 label icon 4 IBP 2 unit

2 Mean arterial pressures value 5 Bell icon
3 Systolic value 6 Diastolic value
Figure 74: IBP 2 Waveform Display
1 P2 (CVP, PAP, LAP) icon 4 P2 waveform
Zero Setting Scale Label Alarm Limit Return
Figure 75: IBP 2 Menu Display
In order to access the IBP 2 Menu, select the P2 parameter window on the right
side of the monitoring display using the Multi function knob. The selected
parameter window is highlighted.
147
Table 35: IBP 2 Menu

Zero Setting Enter
Return
Scale 0 ~ 50mmHg
0 ~ 100mmHg
0 ~ 200mmHg
0 ~ 300mmHg
Auto
Return
Label P2
CVP
PAP
LAP
Return
Alarm Limit ▲: SYS Upper Limit Adjust
▼SYS Lower Limit Adjust
▲: MEAN Upper Limit Adjust
▼: MEAN Lower Limit Adjust
▲: DIA Upper Limit Adjust
▼: DIA Lower Limit Adjust
Return
Return
18.5.1 Zero Setting

When Zero Setting is set to Enter, IBP 2 channel is calibrated to eliminate the
influence of the barometric pressure on the measurement. Also refer to
directions for use of the transducer for information on zero setting of the IBP
measurement system.
18.5.2 Scale
The user-selectable pressure waveform scale allows you to adjust the scale of a
pressure waveform. The scale can be selected as 0 ~ 50mmHg, 0 ~
100mmHg, 0 ~ 200mmHg, 0 ~ 300mmHg or Auto. If Auto is selected, the
PRIMEDIC™ DefiMonitor EVO automatically sets the scale upon the IBP
measurement value.
18.5.3 Label
The label can be selected as P2, CVP (Central Venous Pressure), PAP
(Pulmonary Arteria Pressure) or LAP (Left Atrial Pressure).

148 MGA22955 / GB / A
When the Limit Alarm Pause is set to On, the audible alarm for IBP 2 limit
149
19 Self-test Function
19.1 General
The PRIMEDIC™ DefiMonitor EVO incorporates a Self-test function. The
PRIMEDIC™ DefiMonitor EVO should be checked at regular intervals so that it
will always be ready-to-use for emergency situations. There are three modes:
Manual Self-test, Auto Self-test and Button test.
19.1.1 Manual Self-test

If the user wants to perform a Self-test manually, it can be performed by
‘Manual Self-test’ function in the Setup Menu.
19.1.2 Auto Self-test

When the PRIMEDIC™ DefiMonitor EVO has been turned off, Auto Self-test (or
scheduled Self-test) is operated automatically according to the user’s setting.
The Self-test interval can be selected as Off, 24, 48, and 72 hours. If the residual
of battery power is less than 60% without using the AC or DC power supply,
the Self-test will not be performed.
If the PRIMEDIC™ DefiMonitor EVO is in use at the time of a scheduled Auto
Self-test, the Auto Self-test will be canceled. If the PRIMEDIC™ DefiMonitor
EVO is turned on when the Auto Self-test is in process, the Auto Self-test will
be canceled and the device will be operating normally.
The setting of the Auto self-test (time and interval) can only be changed by
Note
authorized personnel via the Service Menu.
19.1.3 Button test

The PRIMEDIC™ DefiMonitor EVO also has a Button Test function. The user can
check buttons for proper functioning by pressing the button in person. It can
be performed by ‘Button Test’ function in the Setup Menu.
19.2 Functions to be tested in Self-test

The PRIMEDIC™ DefiMonitor EVO Self-test performs 11 test steps. Lists and
descriptions of the tests are indicated below.
Figure 76: Auto Self-test display
Table 36: Self-test functions
No Test Description
1 High-Voltage module To check if the High-Voltage module is

150 MGA22955 / GB / A
No Test Description
operational test operational and available to communicate.
2 Body Impedance test To check impedance of internal fixed
resistance from 25Ω to 175Ω
3 ECG circuit and algorithm To check the result of diagnosis for normal
test sinus rhythm and Ventricular Fibrillation for
ECG input.
4 Internal Shock test To check the energy accuracy for discharge
of set energy to internal discharge
resistance.
5 Internal Pacing output test To check the normal condition of pacing
output of fixed value of current and bmp.
6 Pads/Paddle connection To check if paddles or pads are connected
test correctly.
7 System ROM test To check if the internal program is normal.
8 System RAM test To check if the Read/Write performance of
RAM is normal.
9 Battery test To check the status of the battery.
10 Real time clock test To check the accuracy of the time.
11 Installed module alive test To check if installed measurement
parameter modules are operational and
working correctly.
19.3 Self-test result transmission(if configured with

Wireless module option)
The result of the Self-test can be transmitted to a hospital biomedical engineer
by using the 3G/Wi-Fi module and can also be printed out by the printer
module.
19.4 Self-test result printing
Printing the result of a Self-test can be set as On or Off in the Service menu by
authorized personnel as described in the service manual.
19.5 Trouble shooting

After finishing the auto self-test, the PRIMEDIC™ DefiMonitor EVO will turn off
again automatically. If there has been no fail, the service LED will be blinking.
But if any fail was detected, service LED and buzzer sound will be generated (if
the PRIMEDIC™ DefiMonitor EVO is using AC or DC power, the result of auto
self-test will be displayed). If the residual of battery power has dropped below
60%, the LED and buzzer will be turned off for saving power.
Table 37: Trouble shooting of Self-test
LED Situation What to do

condition
151
LED Situation What to do
condition
LED OFF Possibility 1: The self-test has Turn on the PRIMEDIC™ DefiMonitor
not been performed. EVO (connect it to AC or DC power if
Possibility 2: The self-test has it is not connected) and perform the
been performed but the manual self-test via setup menu.
residual of battery has dropped
below 60%, so the device
turned off the LED and buzzer
by itself.
LED Blink The self-test was finished, and Turn on the PRIMEDIC™ DefiMonitor
no failure was detected. EVO and use it safely.
LED Fixed The self-test was finished and If AC or DC power is connected, check
any failure was detected. If AC the failed item of self-test and contact
or DC power is connected, self- qualified service personnel or your
test result will be displayed, local supplier.
and buzzer sound will be If the device is using battery power
generated. If the PRIMEDIC™ only, turn on the PRIMEDIC™
DefiMonitor EVO is using DefiMonitor EVO and check the failed
battery power only, the buzzer item. After then, contact qualified
sound will be generated service personnel or your local
without display screen. supplier.
19.6 Button test

The PRIMEDIC™ DefiMonitor EVO has a button test function. By this, the user
can check whether buttons of the device are working correctly. It can be
performed by ‘Button Test’ function in Setup Menu.
Button test is to check button is working correctly by pressing the denoted
buttons. Button test can be divided into two types: Front panel and paddles.
‘SHOCK’, ‘CHARGE’, ‘ANALYZE’, ‘JOULE’, ‘RATE, and ‘mA’ buttons can be
checked on the front panel, and ‘SHOCK’, ‘CHARGE’, ‘ENERGY +’, ‘ENERGY -’,
and ‘REC’ buttons can be checked on the paddles.
It is recommended to run the ‘Button test’ manually once a week.

Note

152 MGA22955 / GB / A
20 Event
20.1 General
rd
Trend data in either graphical or tabular format may be displayed on 3 and
th
4 waveform display area.
Press the Patient Info soft key.
Rotate the Multi function knob to ‘Event records’ on the screen and press the
Multi function knob to display.
The event data is stored in memory. When the PRIMEDIC™ DefiMonitor EVO
turns on and starts to measure vital signs, it saves data of elapsed time before
and after 10 seconds from the point of event generation. The events are
including Defibrillation, Pacer mode, Heart rate alarm, and VF alarm. Also, the
PRIMEDIC™ DefiMonitor EVO saves all NIBP measurements events. The data
remains in memory even if the PRIMEDIC™ DefiMonitor EVO is powered off.
After the PRIMEDIC™ DefiMonitor EVO has stored 250 trend data, “SYSTEM:
Not enough memory” message or “SYSTEM : Not enough memory(Internal
memory)” message will be displayed on the screen.
20.2 Event Data List Display

The PRIMEDIC™ DefiMonitor EVO presents event information in tabular format
for all monitored parameters. Event type, Patient ID, name, age, gender and
time are displayed. The newest data appears at the top of tabular trends. To
scroll the event data list, rotate the Multi function knob when the event data
list is displayed.
In case of NIBP events the latest measurement is displayed.
Figure 77: Event Data List Display
20.3 Event Review Display

Event information in graphical format for ECG data is displayed in a graph. The
PRIMEDIC™ DefiMonitor EVO displays the event information for a 10 seconds
time frame before and after the event occurred. When printing the event
information, all the parameters like ECG, SpO2, NIBP, Temp, EtCO2, IBP and
Respiration are printed.
The event review display of each parameter is indicated by the symbols
specified in table. The vertical range of a graphical trend is presented with fixed
153
value, and the horizontal range is 20 seconds. The newest data appears at the
right of graphical trend. Use the scroll function to view more data.
Figure 78: Event Review Display
20.4 12Lead Record Display
The 12 lead data is displayed in tabular format as shown in Figure Figure 79.
Patient ID, name, age, gender and time are displayed. The newest data appears
at the top of tabular trends. To scroll the event data list, rotate the Multi
function knob when the 12 lead data list is displayed.
Figure 79: 12 Lead Record Display
20.5 ID#
To display the ID Menu, press the ID# soft key on the lower side of Event
records. ID Menu is displayed equal to Patient Info Menu.

154 MGA22955 / GB / A
Patient Info
ID
ID : MDR000001
Name : Kim
Age : 23
Gender : F
155
21 Menu Structure
21.1 Manual Mode Menu

- 12 lead
- - Acquire
- - Setup
- - - Filter
- - - - 0.05 Hz ~ 40 Hz
- - - - 0.05 Hz ~ 150Hz
- - - - Return
- - - Transmisson
- - - Return
- - 12 lead ON
- - - On
- - - Off
- - Patient info
- - - ID
- - - - Confirm
- - - - Return
- - - Name
- - - - Confirm
- - - - Return
- - - Age
- - - - Confirm
- - - - Return
- - - Gender
None
- - - - Male
- - - - Female
- - - - Return
- - - 12 lead records
- - - - Print
- - - - Tranmission
- - - - ID #
- - - - Return
- - Return
- Setup
- - Volume
- - - Alarm
- - - Beep
- - - Button
- - - Return
- - Printer setting

156 MGA22955 / GB / A
- - - Print on alarm
- - - - On
- - - - Off
- - - Print on shock
- - - - On
- - - - Off
- - - 12 lead auto printing
- - - - On
- - - - Off
- - - Analyze auto printing
- - - - On
- - - - Off
- - - Return
- - Erase data
- - - Erase 12lead redords
- - - - Yes
- - - - No
- - - Erase event records
- - - - Yes
- - - - No
- - - Erase internal memory
- - - - Yes
- - - - No
- - - Return
- - Waveform setting
- - - 2nd Waveform
- - - - ECG
- - - - - I
- - - - - II
- - - - - III
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - Pads
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
157
- - - - EtCO2
- - - 3rd Waveform
- - - - ECG Waveform
- - - - - I
- - - - - II
- - - - - III
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - Pads
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - 4th Waveform
- - - - - I
- - - - - II
- - - - - III
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - Pads
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - Return
- - Display Mode
- - - Large Numeric

158 MGA22955 / GB / A
display
- - - Off
Black-white Invert
- - -
Mode
- - - On
- - - Off
- - - Return
Clinical action
- -
list
Manual self-
- -
test
- - Button test
- - Service Menu
- - - Display 3 digit code
- - - Return
Alarm „Alarm limits adjustment/Limit Alarm Pause for

-
Limit each parameters“
HR/PR SpO2 RESP EtCO2 InCo2 TEMP1 TEMP2
120 100 30 80 20 39.0 39.0
50 90 8 0 0 36.0 36.0
- -
- - On On On On On On On
- -
- - Off Off Off Off Off Off Off
NIBP P1 CVP
SYS MAP DIA SYS MEAN DIA SYS MEAN DIA
160 110 90 120 90 70 120 90 70
90 60 50 70 50 40 70 50 40
- -
- - On On On On On On On On On
- -
- - Off Off Off Off Off Off Off Off Off
- - Return
- Patient Info
- - ID
- - - Confirm
- - - Return
- - Name
- - - Confirm
- - - Return
- - Age
- - - Confirm
- - - Return
159
- - Gender
- - - Male
- - - Female
- - Event records
- - - Data review
- - - - Print
- - - - Return
- - - ID #
- - - - ID
- - - - Name
- - - - Age
- - - - Gender
- - - - Return
- - - Return
- - Return
- Sync
- - On
- - Off
- - Return
21.2 AED Mode Menu

- Patient
info
- - ID
- - - Confirm
- - - Return
- - Name
- - - Confirm
- - - Return
- - Age
- - - Confirm
- - - Return
- - Gender
- - - Male
- - - Female
- - - Return
- - Event
records
- - - Data review
- - - - Print
- - - - Return
- - - ID #
- - - - ID
- - - - Name
- - - - Age
- - - - Gender

160 MGA22955 / GB / A
- - - - Return
- - - Return
- - Return
21.3 Pacing Mode Menu

Pause
-
Pacing
- Setup
- - Volume
- - - Alarm
- - - Beep
- - - Button
- - - Return
- - Printer setting
- - - - On
- - - - Off
- - - - On
- - - - Off
- - - - On
- - - - Off
- - - - On
- - - - Off
- - - Return
- - Erase data
- - - - Yes
- - - - No
- - - - Yes
- - - - No
- - - - Yes
- - - - No
- - - Return
- - - 2nd Waveform
- - - - ECG
- - - - - I
- - - - - II
- - - - - III
161
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - Pads
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - 3rd Waveform
- - - - - I
- - - - - II
- - - - - III
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - Pads
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - 4th Waveform
- - - - - I
- - - - - II
- - - - - III
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - Pads

162 MGA22955 / GB / A
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - Return
- - Display Mode
Large Numeric
- - -
display
- - - Off
Black-white
- - -
Invert Mode
- - - On
- - - Off
- - - Return
Clinical action
- -
list
Manual self-
- -
test
- - Button test
- - Service Menu
- - - Return
Alarm „Alarm limits adjustment/Limit Alarm Pause for

-
Limit each parameters“
120 100 30 80 20 39.0 39.0
50 90 8 0 0 36.0 36.0
- -
- -
NIBP P1 CVP
163
160 110 90 120 90 70 120 90 70
90 60 50 70 50 40 70 50 40
- -
- -
- - Return
- Patient Info
- - ID
- - - Confirm
- - - Return
- - Name
- - - Confirm
- - - Return
- - Age
- - - Confirm
- - - Return
- - Gender
- - - Male
- - - Female
- - Event records
- - - Data review
- - - - Print
- - - - Return
- - - ID #
- - - - ID
- - - - Name
- - - - Age
- - - - Gender
- - - - Return
- - - Return
- - Return
- Async
- - On
- - Off
- - Return
21.4 Monitor Mode Menu

- 12 lead
- - Acquire
- - Setup
- - - Filter
- - - - 0.05 Hz ~ 40 Hz
- - - - 0.05 Hz ~ 150Hz
- - - - Return

164 MGA22955 / GB / A
- - - Transmisson
- - - Return
- - 12 lead ON
- - - On
- - - Off
- - Patient info
- - - ID
- - - - Confirm
- - - - Return
- - - Name
- - - - Confirm
- - - - Return
- - - Age
- - - - Confirm
- - - - Return
- - - Gender
None
- - - - Male
- - - - Female
- - - - Return
- - - 12 lead records
- - - - Print
- - - - Tranmission
- - - - ID #
- - - - Return
- - Return
- Setup
- - Volume
- - - Alarm
- - - Beep
- - - Button
- - - Return
- - Printer setting
- - - - On
- - - - Off
- - - - On
- - - - Off
- - - - On
- - - - Off
- - - - On
165
- - - - Off
- - - Return
- - Erase data
- - - - Yes
- - - - No
- - - - Yes
- - - - No
- - - - Yes
- - - - No
- - - Return
- - - 2nd Waveform
- - - - ECG
- - - - - I
- - - - - II
- - - - - III
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - Pads
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - 3rd Waveform
- - - - - I
- - - - - II
- - - - - III
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - Pads
- - - - - V1

166 MGA22955 / GB / A
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - 4th Waveform
- - - - - I
- - - - - II
- - - - - III
- - - - - aVL
- - - - - aVF
- - - - - aVR
- - - - - Pads
- - - - - V1
- - - - - V2
- - - - - V3
- - - - - V4
- - - - - V5
- - - - - V6
- - - - SpO2
- - - - RESP
- - - - IBP1
- - - - IBP2
- - - - EtCO2
- - - Return
- - Display Mode
Large Numeric
- - -
display
- - - Off
Black-white Invert
- - -
Mode
- - - On
- - - Off
- - - Return
Clinical action
- -
list
Manual self-
- -
test
- - Button test
167
- - Service Menu
- - - Return
Alarm „Alarm limits adjustment/Limit Alarm Pause for each

-
Limit parameter“
120 100 30 80 20 39.0 39.0
50 90 8 0 0 36.0 36.0
- -
- -
NIBP P1 CVP
160 110 90 120 90 70 120 90 70
90 60 50 70 50 40 70 50 40
- -
- -
- - Return
- Patient Info
- - ID
- - - Confirm
- - - Return
- - Name
- - - Confirm
- - - Return
- - Age
- - - Confirm
- - - Return
- - Gender
- - - Male
- - - Female
- - Event records
- - - Data review
- - - - Print
- - - - Return
- - - ID #
- - - - ID
- - - - Name
- - - - Age

168 MGA22955 / GB / A
- - - - Gende
r
- - - - Return
- - - Return
- - Retur
n
21.5 HR/PR Menu

- HR/PR Source
- - Auto
- - HR
- - PR
- - Retur
- Pacer n
Detect
- - Enable
- - Disable
- - Return
- Filter Select
- - 0.5 Hz ~ 21
- - Hz
0.05 Hz ~ 40
- - HzHz ~ 21 Hz
1
- - Return
- Alarm limit
- - HR/PR
120
50
On
Off
- - Return
- Return
21.6 SpO2 Menu

- Alarm limit
- - SpO2
100
90
On
Off
- - Return
- Return
21.7 NIBP Menu

- Inflate Pressure
169
„Adult/Pedi“
- - 120 mmHg
- - 140 mmHg
- - 160 mmHg
- - 180 mmHg
- - 200 mmHg
- - 220 mmHg
- - 240 mmHg
- - 260 mmHg
- - 280 mmHg
- - Return
- - “Neonatal”
- - 80 mmHg
- - 100 mmHg
- - 120 mmHg
- - 140 mmHg
- - Return
- Auto Interval
- - Off
- - 1 min
- - 2,5 min
- - 3 min
- - 5 min
- - 10 min
- - 15 min
- - 20 min
- - 30 min
- - 60 min
- - 90 min
- - Return
- Patient Type
- - Adult/Pedi
- - Neonatal
- - Return
- Alarm limit
- - NIBP
SYS MAP DIA
160 110 90
90 60 50
On On On
Off Off Off

- - Return
- Return

170 MGA22955 / GB / A
21.8 IBP1 Menu
- Zero Setting
- - Enter
- - Return
- Scale
- - 0~50mmHg
- - 0~100mmHg
- - 0~200mmHg
- - 0~300mmHg
- - Auto
- - Return
- Label
- - P1
- - ABP
- - Return
- Alarm limit
SYS MAP DIA
120 90 70
70 50 40
On On On
Off Off Off

- - Return
- Return
21.9 IBP2 Menu

- Zero Setting
- - Enter
- - Return
- Scale
- - 0~50mmHg
- - 0~100mmHg
- - 0~200mmHg
- - 0~300mmHg
- - Auto
- - Return
- Label
- - P2
- - CVP
- - PAP
- - LAP
- - Return
- Alarm limit
SYS MAP DIA
120 90 70
70 50 40
171
On On On
Off Off Off

- - Return
- Return
21.10 EtCO2 Menu

- EtCO2
- - On
- - Off
- - Return
- Average
- - 1 breaths
- - 10 seconds
- - 20 seconds
- - 30 seconds
- - Return
- Alarm limit
EtCo2 InCO2
80 20
0 0
On On
Off Off
- - Return
- Return
21.11 Respiration Menu

- Respiration
- - On
- - Off
- - Return
- Respiration Setting
- - RR Source
- - - Auto
- - - Impedance
- - - Airway
- - - Return
- - Size
- - - X 0.5
- - - X1
- - - X1.5
- - - X2
- - - Return

172 MGA22955 / GB / A
- - Return
- - Apnea Time Setting
- - - Off
- - - 10 seconds
- - - 20 seconds
- - - 30 seconds
- - - 40 seconds
- - - 50 seconds
- - - 60 seconds
- - Return
- Alarm limit
Resp
30
8
On
Off
- - Return
- Return
21.12 Temperature Menu

- Alarm limit
TEMP1 TEMP2
39.0 39.0
36.0 36.0
On On
Off Off
- - Return
- Return
21.13 Date Time Menu

- Date Format
- - YY/MM/DD
- - MM/DD/YY
- - DD/MM/YY
- - Return
- Set Date
- - Year
- - Month
- - Day
173
- - Return
- Set Time
- - Hour
- - Minute
- - Second
- - Return
- Retur
n

174 MGA22955 / GB / A
22 Printing
22.1 General
The PRIMEDIC™ DefiMonitor EVO prints real-time graphical and numeric
information after that event in accordance with current mode until Print soft
key is pressed. Printing may be set in two ways:
When the print is displayed on the screen, select the Print soft key.
To start printing, press the PRINT button and to stop printing during print out,
press the PRINT button again (Refer to Figure ?).
22.2 Printer settings

Press the Setup soft key. (Setup is displayed on the initial screen of each mode.)
Rotate the Multi function knob to highlight printer setting via Setup Menu, and
then press the Multi function knob to select printer setting.
Figure 81: Printer setting Menu
Set Print on alarm, Print on shock, 12 lead auto printing and Analyze auto printing.
22.2.1 Print on alarm

If Print on alarm is set to On, the PRIMEDIC™ DefiMonitor EVO will
automatically print out when a physiological alarm condition is activated.
22.2.2 Print on shock

If Print on shock is set to On, the PRIMEDIC™ DefiMonitor EVO will
automatically print out information for a time frame of 10 seconds before and
after the shock has been delivered.
22.2.3 12 lead auto printing

If 12 lead auto printing is set to On, the PRIMEDIC™ DefiMonitor EVO will
automatically print out after 12 lead ECG is acquired.
22.2.4 Analyze auto printing

If Analyze auto printing is set to On, the PRIMEDIC™ DefiMonitor EVO will
automatically print out analyzing data for 10 seconds after starting the analyze.
.
22.3 Print-out
22.3.1 Print-out
The PRIMEDIC™ DefiMonitor EVO prints numeric data and waveforms by
pressing PRINT button.
175
Figure 82: Print-out
22.3.2 Print-out on shock

The PRIMEDIC™ DefiMonitor EVO prints shock information by pressing SHOCK
button. Shock can be delivered when the PRIMEDIC™ DefiMonitor EVO is
turned on in Manual or AED Mode.
Figure 83: Print-out on shock
22.3.3 Print-out on 12 lead ECG data

If 12 lead auto printing is set to On, the PRIMEDIC™ DefiMonitor EVO prints
the 12 lead ECG data automatically after 12 lead ECG analysis. When the
PRIMEDIC™ DefiMonitor EVO displays 12 lead records, desired 12 lead ECG
analysis can be printed by pressing PRINT button.

176 MGA22955 / GB / A
Figure 84: Print-out on 12 lead ECG data
22.3.4 Print-out on setting information

When the PRIMEDIC™ DefiMonitor EVO is in Service Menu, the PRIMEDIC™
DefiMonitor EVO will print out all internal settings by pressing the PRINT
button. Refer to the service manual for the detailed instructions.
Figure 85: Print-out on setting information
177
23 External Interface
23.1 General
The PRIMEDIC™ DefiMonitor EVO provides external connectors on the right
panel to support communication with external equipment and functions such
as software upgrade or data download.
WARNING
Any connections between this PRIMEDIC™ DefiMonitor EVO and other
devices must comply with applicable medical systems safety standards
such as IEC 60601-1. Failure to do so could result in unsafe leakage
current and grounding conditions.
WARNING
Inserting or removing the data card while the PRIMEDIC™ DefiMonitor
EVO is on or reading and writing onthe data card can corrupt the data
card and prevent the unit from powering on again. If this occurs, see
Troubleshooting Tips in chapter 25.
WARNING
Use only a Metrax GmbH defibrillator-compatible SD Card. These cards,
or other types of cards (such as memory cards) will not work, and may
cause the PRIMEDIC™ DefiMonitor EVO to malfunction.
23.1.1 USB Host Type

The USB Host is used to download data. Only memory stick can be used for the
USB Host.
23.1.2 SD Memory Card

The SD Memory Card is used to extend the memory capacity, to install the new
system software and to load voice prompt data.
23.1.3 Central System Communication

The transmitted data by using the 3G/Wi-Fi module option is divided as
follows;
 All vital signs are transmitted to the medical person in the hospital.
 The self-test result and the log file are transmitted to the biomedical
engineer in the hospital.
The defibrillator condition, service action according to the self-test and the
history of the key pressing are transmitted by the 3G/Wi-Fi module network.
All vital sign can be transmitted in real-time.

178 MGA22955 / GB / A
24 Maintenance
WARNING
The cover should be removed only by qualified service personnel. There
are no internal user-serviceable parts.
WARNING
Do not use the PRIMEDIC™ DefiMonitor EVO when the case appears
damaged.
WARNING
Do not spray, pour, or spill any liquid on the PRIMEDIC™ DefiMonitor
EVO, its accessories, connectors, switches or openings in the chassis.
WARNING
Unplug the power cord from the PRIMEDIC™ DefiMonitor EVO before
cleaning the PRIMEDIC™ DefiMonitor EVO.
CAUTION
Disposal of the PRIMEDIC™ DefiMonitor EVO with the battery inserted
presents a potential shock hazard.
CAUTION
Do not autoclave, ultrasonically clean, or immerse the PRIMEDIC™
DefiMonitor EVO. Do not use abrasive cleaners or strong solvents such
as acetone or acetone-based cleaners.
CAUTION
Do not ultrasonically clean or immerse the paddles and paddles cables.
CAUTION
Do not ultrasonically clean, immerse, autoclave or steam sterilize the
pads cable.
CAUTION
Do not ultrasonically clean, immerse, autoclave or steam sterilize the ECG
cable. Do not clean the ECG cable with alcohol. Alcohol can cause the
plastic to become brittle and may cause the cable to fail prematurely.
CAUTION
Do not clean any part of this PRIMEDIC™ DefiMonitor EVO or accessories
with bleach dilution or phenolic compounds. Do not use abrasive or
flammable cleaning agents. Do not attempt to sterilize this PRIMEDIC™
DefiMonitor EVO or any accessories unless otherwise specified in
179
accessory operation instructions.
CAUTION
Do not soak or immerse the sensors or cables in any liquid solution. Do
not attempt to sterilize.
24.1 Recycling and Disposal
Figure 86: Disposal
In accordance with the founding principles of the company Metrax GmbH, your
product has been developed and made using high quality materials and
components which are recyclable.
At the end of its service life, recycle the device through disposal companies
registered under public law (council recycling facilities). Proper disposal of this
product helps with environmental protection.
Through registration of Metrax GmbH with the responsible authorities, we
ensure that the disposal and utilisation of electronics devices introduced onto
the market by us is secure in accordance with the EU directive on the disposal
of electronic and electrical equipment (WEEE-directive).
In Germany, in accordance with legislation on the sale, return and
environmentally friendly disposal of electrical and electronic devices (Elektro-
und Elektronikgerätegesetz – ElektroG), (Electrical and Electronic Equipment
Act– ElektroG) Metrax is registered with EAR (register of old electronic
equipment) under the number: 73450404.
CAUTION
Improper disposal of the device or its individual parts can lead
to injury.
For business customers in the European Union

Please contact your dealer or supplier if you want to dispose of electrical and
electronic equipment. He will have further information on this for you.
Information for disposal in countries outside the European Union
This symbol is only applicable within the European Union.
The PRIMEDIC™ DefiMonitor EVO should be disposed of separately from

Note
the municipal waste stream via designated collection facilities appointed by
the government or the local authorities.
The correct disposal of your old appliance will help prevent potential
Note
negative consequences for the environment and human health.
For more detailed information about disposal of your old appliance, please
Note
contact your city office, waste disposal service or the shop where you
purchased the defibrillator/monitor.

180 MGA22955 / GB / A
24.2 Returning the PRIMEDIC™ DefiMonitor EVO and
System Components (except rechargeable battery)
Pack the PRIMEDIC™ DefiMonitor EVO with sensors, cables or other accessory
items in its original shipping carton. If the original carton is not available, use a
suitable carton with appropriate packing material to protect the PRIMEDIC™
DefiMonitor EVO during shipping.
24.3 Returning the PRIMEDIC™ AkuPak EVO

Rechargeable Lithium-ion cells and batteries are classified as hazardous goods. The
transport regulations are based on the UN Recommendations for the Transport of
Hazardous Goods. The transport of hazardous goods is internationally regulated by
 the technical instructions of the International Civil Aviation Organization
(ICAO)
 the regulations of the International Air Transport Association (IATA) for
hazardous goods
 the International Maritime Dangerous Goods (IMDG) Code.
In addition, the national hazardous goods regulations also apply. Please investigate
which regulations are specifically applicable in your country.
The safety requirements and test regulations for Lithium-ion batteries are defined in
the UN Manual of Test and Criteria, Part III, Subsection 38.3 (UN Transport Test).
Because of the fact that the PRIMEDIC™ AkuPak EVO has an energy content less than
100 Wh, and has passed the UN Transport Test, it is released from the necessity for
transporting as hazardous goods.
The transport of Lithium-ion batteries is regulated under various different UN
numbers, depending whether it is transported alone, or together with additional
equipment. For the PRIMEDIC™ AkuPak EVO the following UN numbers are to be
used:
 UN3480 – despatch unit contains only PRIMEDIC™ AkuPak EVO
 UN3481 – despatch of PRIMEDIC™ AkuPak EVO together with PRIMEDIC™

DefiMonitor EVO
Depending on the type of transport, there are various different packaging regulations
that are derived from the -UN number. The significant requirements are summarised
below, whilst no guarantee can be given for its completeness. Consult your transport
service provider for clarification of any questions or for further information.
When sending the PRIMEDIC™ AkuPak EVO, please note the following
Note
points:
 If possible, use the original packaging. Otherwise, make sure that
the external packaging is sturdy and can withstand being dropped
from a height of 1.2 m, without releasing the contents, and so that
the content is displaced to cause content of the batteries.
 If you send the PRIMEDIC™ AkuPak EVO together with the
PRIMEDIC™ DefiMonitor EVO, please remove it from the unit and
pack it separately. Please observe the safety instructions below.
 The gross weight of the shipment must not exceed 30 kg if the
PRIMEDIC™ AkuPak LITE is sent together with the PRIMEDIC™
DefiMonitor EVO. If just the PRIMEDIC™ AkuPak LITE is sent, the
gross weight must not exceed 10 kg.
 When sending, please make sure that the required amount of
postage stickers are attached to the external packaging for the
method of transport selected.
 In the transport paperwork, indicate that
o Lithium-ion batteries are enclosed
o the package needs to be handled with special care and
181
that there will be a danger of fire if it is damaged
o special requirements need to be fulfilled in the event of
damage which facilitate safe examination and re-
packaging by qualified personnel
 further information is available at the following telephone number:
+49 (0) 741 257-268
WARNING
Never send mechanically defective PRIMEDIC™ AkuPak EVO units where
there is a danger that the cells or connection contacts could be short-
circuited!
Use appropriate packaging or other measures (taping over the contacts
etc.) to make sure that there cannot be any short-circuits at any of the
interfaces of the PRIMEDIC™ AkuPak EVO during transport.
If you send the PRIMEDIC™ AkuPak EVO together with a defibrillator or
other items, you should wrap it completely in a non-conducting
material so that they cannot come into contact with it.
24.4 Service
The PRIMEDIC™ DefiMonitor EVO requires no routine service other than
cleaning, battery maintenance, and service activity which is mandated by the
user’s institution. For more information, refer to the PRIMEDIC™ DefiMonitor
EVO service manual. Qualified service personnel in the user’s institution should
perform periodic inspections of the PRIMEDIC™ DefiMonitor EVO. If service is
necessary, contact qualified service personnel or your local supplier.
24.5 Periodic Safety Checks

It is recommended that the following checks be performed every year.
 Inspect the equipment for mechanical and functional damage.
 Inspect the external safety labels for legibility.
24.6 Cleaning
The PRIMEDIC™ DefiMonitor EVO may be surface-cleaned by using a soft cloth
dampened with either a commercial, nonabrasive cleaner or one of the
solutions listed below. Lightly wipe the top, bottom and front surfaces of the
 Quatemary Ammonium (fungicidal, bactericidal and virucidal against
enveloped viruses)
 70% Isopropyl alcohol
 10% Chlorine bleach solution
 PDI sani-system
The cleaning method for paddles and paddle plates are same as
defibrillator/monitor.
For cables, sensors, cuffs, and probes, follow the cleaning instructions in the
directions for use shipped with those components.
Avoid spilling liquid on the PRIMEDIC™ DefiMonitor EVO, especially in
connector areas. If liquid is accidentally spilled on the PRIMEDIC™ DefiMonitor
EVO, clean and dry thoroughly before reuse. If in doubt about PRIMEDIC™
DefiMonitor EVO safety, refer the unit to qualified service personnel for
checking.

182 MGA22955 / GB / A
24.7 Battery Maintenance
CAUTION
Recharging the battery is strongly recommended when the battery has
not been recharged for 6 or more months.
CAUTION
Follow local government ordinances and recycling instructions regarding
disposal or recycling of PRIMEDIC™ DefiMonitor EVO components,
including batteries.
CAUTION
Do not short-circuit the battery, as it may generate heat. To avoid short-
circuiting, do not let the battery come in contact with metal objects at
any time, especially when transporting.
CAUTION
Do not solder the battery directly. Heat applied during soldering may
damage the safety vent in the battery’s positive cover.
CAUTION
Do not deform the battery by applying pressure. Do not throw, hit, drop,
fold or impact the battery.
CAUTION
Do not connect the battery reversed in positive (+) and negative (-)
terminals. Do not charge the battery with polarities reversed, as it may
swell or explode.
CAUTION
Do not use any chargers not specified by Metrax GmbH.
CAUTION
Do not use the battery with other maker’s batteries, different types or
models of batteries such as dry batteries, nickel-metal hydride batteries,
or Li-ion batteries together, as they might leak electrolyte heat or
explode.
CAUTION
Do not mistreat the battery, or use the battery in applications not
recommended by Metrax GmbH.
CAUTION
183
Keep the battery out of reach of babies and children to avoid any
accidents.
CAUTION
If there are any problems with the battery, immediately put the battery in
a safe place and contact qualified service personnel:
If the PRIMEDIC™ DefiMonitor EVO has not been used for 6 months, the Li-ion
battery will need charging. To charge the battery, connect the PRIMEDIC™
DefiMonitor EVO to an AC or DC power source as described in the Battery
Operation section.
Storing the PRIMEDIC™ DefiMonitor EVO for a long period without
Note
charging the battery may degrade the battery capacity. It would take
about5 hours to fully charge the battery from the moment that low battery
alarm is activated.
The battery should be removed from the PRIMEDIC™ DefiMonitor EVO if

Note
placed in storage or if it will not be used for a long period.
It is strongly recommended to replace the PRIMEDIC™ DefiMonitor

EVO’s Li-ion battery every 24 months. Refer to the service manual for
battery replacement and general service instructions.
24.8 Loading Printer Paper
CAUTION
Using othermanufacturers’ printer paper may cause the printer to
function improperly ordamage the print head. Use only Metrax GmbH
printer paper.
Load printer paper as follows:

1. Pull the printer door open.
2. Pick out the paper.
3. Insert new printer paper.
4. Push the printer door closed.
Make sure that the paper is aligned in the slot and has not been pinched in
Note
the door.
Figure 87: Printer Paper Replacement

184 MGA22955 / GB / A
25 Troubleshooting
WARNING
If you are uncertain about the accuracy of any measurement, check the
patient’s vital signs by alternate means; then make sure the PRIMEDIC™
DefiMonitor EVO is functioning correctly.
WARNING
The cover should be removed only by qualified service personnel. There
are no user-serviceable parts inside.
WARNING
The large current draw required for defibrillator charging may cause the
PRIMEDIC™ DefiMonitor EVO to reach a shutdown voltage level with no
low battery indication.
25.1 General
If the PRIMEDIC™ DefiMonitor EVO detects an error or potential problem
during use, it displays a system or momentary message. If service is necessary,
contact qualified service personnel. Before calling to qualified service personnel
or your local supplier, make sure that environmental conditions provided in the
manual are met as temperature, humidity, altitude and so on.
For repair instructions or for additional technical information, refer to the
Note
PRIMEDIC™ DefiMonitor EVO Service Manual.
25.2 Obtaining Technical Assistance

For technical information and assistance, or to order a service manual, call your
local supplier. The service manual provides information required by qualified
service personnel when servicing the PRIMEDIC™ DefiMonitor EVO.
When calling your local supplier, you may be asked to provide the software
version number of your PRIMEDIC™ DefiMonitor EVO. The software version can
be confirmed in the service menu.
25.3 EMI (Electromagnetic Interference)
WARNING
Keep patients under close surveillance when monitoring. It is possible,
although unlikely, that radiated electromagnetic signals from sources
external to the patient and the PRIMEDIC™ DefiMonitor EVO can cause
inaccurate measurement readings. Do not rely entirely on the
defibrillator/monitor readings for patient assessment.
WARNING
It is possible that any radio frequency transmitting equipment and other
nearby sources of electrical noise may result in disruption in the
PRIMEDIC™ DefiMonitor EVO operation. Operator’s manual is attached
for the minimum recommended separation distance between the RF
emitting equipment and the device.
185
WARNING
It is possible, although unlikely, that large equipment using a switching
relay for its power on/off may affect PRIMEDIC™ DefiMonitor EVO
operation. Do not operate the PRIMEDIC™ DefiMonitor EVO in such
environments.
WARNING
Using cables, electrodes or accessories not specified for use with this
device may result in increased emissions or decreased resistance to
electromagnetic interference which could affect the performance of this
PRIMEDIC™ DefiMonitor EVO or of equipment in close proximity. Use
only parts and accessories specified in this manual.
WARNING
The PRIMEDIC™ DefiMonitor EVO may cause electromagnetic
interference (EMI) especially during charge and energy transfers. EMI
may affect the performance of equipment operating in close proximity.
If possible, verify the effects of defibrillator discharge on other
equipment prior to using the PRIMEDIC™ DefiMonitor EVO in an
emergency situation.
WARNING
Operating high frequency electrosurgical equipment in the vicinity of
the PRIMEDIC™ DefiMonitor EVO can produce interference in the
PRIMEDIC™ DefiMonitor EVO and cause incorrect measurements.
WARNING
Do not use the PRIMEDIC™ DefiMonitor EVO with nuclear spin
tomography (MRT, NMR, NMT) as the function of the PRIMEDIC™
DefiMonitor EVO may be disturbed.
This device has been tested and found to comply with the limits for medical
devices to the IEC60601-1-2, and the Medical Device Directive 93/42/EEC.
These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation.
However, because of the proliferation of radio-frequency transmitting
equipment and other sources of electrical noise in health care environments
(such as electrosurgical equipment, defibrillator, cellular phones, mobile two-
way radios, electrical appliances, and high-definition television), it is possible
that high levels of such interference due to close proximity or strength of a
source may affect PRIMEDIC™ DefiMonitor EVO operation.
WARNING
The PRIMEDIC™ DefiMonitor EVO is designed for use in environments
in which the signal can be obscured by electromagnetic interference.
During such interference, measurements may seem inappropriate or the
PRIMEDIC™ DefiMonitor EVO may not seem to operate correctly.
PRIMEDIC™ DefiMonitor EVO disruption may be indicated by erratic readings,

cessation of operation, or other incorrect functioning. If this occurs, survey the

186 MGA22955 / GB / A
site to determine the source of this disruption. Try the following actions to see
if they eliminate the disruption:
 Turn equipment in the vicinity off and on to isolate the offending
equipment.
 Reorient or relocate the interfering equipment.
 Increase the separation between the interfering equipment and the
The PRIMEDIC™ DefiMonitor EVO generates, uses, and can radiate radio
frequency energy. If the PRIMEDIC™ DefiMonitor EVO is not installed and used
in accordance with these instructions, the PRIMEDIC™ DefiMonitor EVO may
cause harmful interference with other devices in the vicinity.
If assistance is required, contact your local supplier.
187
26 Factory Defaults
26.1 General
The PRIMEDIC™ DefiMonitor EVO is shipped with factory default settings.
Authorized personnel can use the procedures described in the service manual
to change default settings.
26.2 Parameter Ranges and Default Settings

Table 38: Parameter Ranges and Factory Defaults.
Parameter Ranges/Selections (Adjust step) Factory

Defaults
ECG Menu
HR/PR Source Auto, HR, PR Auto
AC line filter 50 Hz, 60 Hz, Off 60 Hz
Pacer Detect Enable, Disable Disable
ECG size x0.5, x1, x1.5, x2, x3 X1
Filter Select 0.5 to 21 Hz, 0.5 to 27 Hz, 1 to 21 Hz 0.5 to 21 Hz
HR/PR High Alarm 25 to 300 BPM (5 BPM steps) 120 BPM
Limits
HR/PR Low Alarm 20 to 295 BPM (5 BPM steps) 50 BPM
Limits
Auto transmit* On, Off Off
Print on 12 lead On, Off Off
measurement
Print on 12 lead On, Off Off
interpretation
Setting print lead I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, I
- 1st waveform* V5, V6
Setting print lead I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, II
- 2nd waveform* V5, V6
Setting print lead I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, III
- 3rd waveform* V5, V6
12 lead frequency 0.05 Hz ~ 40 Hz, 0.05 Hz ~ 150 Hz 0.05 Hz ~ 40 Hz

response*
Print 2 copies 12 lead On, Off Off
12 lead print second 2.5 sec, 10 sec 2.5 sec
12 lead print speed 25mm/s, 50mm/s 25mm/s
SpO2 Menu
% SpO2 High Alarm 21 to 100 % (1 % steps) 100 %
Limits
% SpO2 Low Alarm 20 to 99 % (1 % steps) 85 %
Limits
NIBP Menu
Inflate Pressure 80, 100, 120, 120, 140 160, 180, 200, 180 mmHg
220, 240, 260, 280 mmHg

188 MGA22955 / GB / A
Defaults
Auto Interval 1, 2.5, 3, 5, 10, 15, 30, 60, 90, Off Off
Patient type Adult/Pedi, Neonatal Adult/Pedi
NIBP Unit* mmHg, kPa mmHg
NIBP SYS High Alarm adult/pediatric adult/pediatric
Limits 35 to 270 mmHg 160 mmHg
(4.7 to 36.0 kPa) (21.3 kPa)
neonatal neonatal
45 to 130 mmHg 90 mmHg
(6.0 to 17.3 kPa) (12 kPa)
(5 mmHg, 0.6 or 0.7kPa steps)
NIBP SYS Low Alarm adult/pediatric adult/pediatric
(4.0 to 35.3 kPa) (12.0 kPa)
neonatal neonatal
(5.3 to 16.7 kPa) (5.3 kPa)
NIBP DIA High Alarm adult/pediatric adult/pediatric
(2.0 to 33.3 kPa) (12.0 kPa)
neonatal neonatal
(3.3 to 12.0 kPa) (8.0 kPa)
NIBP DIA Low Alarm adult/pediatric adult/pediatric
(1.3 to 32.7 kPa) (6.7 kPa)
neonatal neonatal
(2.7 to 11.3 kPa) (2.6 kPa)
NIBP MAP High Alarm adult/pediatric adult/pediatric
(3.3 to 34.7 kPa) (14.7 kPa)
neonatal neonatal
(4.7 to 14.7 kPa) (9.3 kPa)
NIBP MAP Low Alarm adult/pediatric adult/pediatric
(2.7 to 34.0 kPa) (8.0 kPa)
neonatal neonatal
(4.0 to 14.0 kPa) (4.0 kPa)
IBP1 Menu
189
Defaults
IBP1: Scale Auto, 0~50mmHg, 0~100mmHg, Auto
0~200mmHg, 0~300mmHg
IBP1: Label P1, ABP P1
IBP 1 SYS High Alarm adult/pediatric adult/pediatric
Limits -45 to 300 mmHg 160 mmHg
(-6 to 40 kPa) (21.3 kPa)
IBP 1 SYS Low Alarm adult/pediatric adult/pediatric
Limits -50 to 295mmHg 90 mmHg
(-6.7 to 39.3 kPa) (12.0 kPa)
IBP 1 DIA High Alarm adult/pediatric adult/pediatric
(-6 to 40 kPa) (12.0 kPa)
IBP 1 DIA Low Alarm adult/pediatric adult/pediatric
(-6.7 to 39.3 kPa) (6.7 kPa)
IBP 1 MEAN High adult/pediatric adult/pediatric
Alarm Limits -45 to 300 mmHg 110 mmHg
(-6 to 40 kPa) (14.7 kPa)
IBP 1 MEAN Low adult/pediatric adult/pediatric
(-6.7 to 39.3 kPa) (8.0 kPa)
IBP2 Menu
IBP2: Scale Auto, 0~50mmHg, 0~100mmHg, Auto
0~200mmHg, 0~300mmHg
IBP2: Label P2, CVP, PAP,LAP P2
IBP 2 SYS High Alarm adult/pediatric adult/pediatric
(-6 to 40 kPa) (21.3 kPa)
IBP 2 SYS Low Alarm adult/pediatric adult/pediatric
(-6.7 to 39.3 kPa) (12.0 kPa)
IBP 2 DIA High Alarm adult/pediatric adult/pediatric
(-6 to 40 kPa) (12.0 kPa)
IBP 2 DIA Low Alarm adult/pediatricl adult/pediatric
(-6.7 to 39.3 kPa) (6.7 kPa)

190 MGA22955 / GB / A
Defaults
IBP 2 MEAN High adult/pediatric adult/pediatric
(-6 to 40 kPa) (14.7 kPa)
IBP 2 MEAN Low adult/pediatric adult/pediatric
Alarm Limits -50 to 295mmHg 60 mmHg
(-6.7 to 39.3 kPa) (8.0 kPa)
IBP unit* mmHg, kPa mmHg
EtCO2
EtCO2 On, Off ON
N2O Gas On, Off OFF
O2 Gas On, Off OFF
0~40 mmHg, 0~60 mmHg, 0~80
Scale Auto
mmHg, Auto
Average 1 breath, 10 seconds, 20 seconds, 30 1 breath
seconds
EtCO2 High Alarm adult/pediatric adult/pediatric
Limits 1 to150 mmHg 80 mmHg
(0.13 to 20.0 kPa), (0.13 to 20.0 %) (10.7 kPa), (10.5
(1 mmHg, 0.13 kPa, 0.13 % steps) %)
EtCO2 Low Alarm adult/pediatric adult/pediatric

(0 to 19.87 kPa), (0 to 19.9 %) (0 kPa), (0 %)
(1 mmHg, 0.13 kPa steps)
InCO2 High Alarm adult/pediatric adult/pediatric
(0.13 to 2.7 kPa), (0.13 to 2.6 %) (2.7 kPa), (2.6 %)
InCO2 Low Alarm adult/pediatric adult/pediatric
(0 to 2.5 kPa), (0 to 2.5 %) (0 kPa), (0 %)
EtCO2 unit mmHg, kPa, % mmHg
Temperature Menu
TEMP1 High Alarm 0.1 to 50.0 °C 39.0 °C
Limits (32.2 to 122.0 °F) (102.2 °F)
(0.1°C, 0.1 or 0.2°F steps)
TEMP1 Low Alarm 0.0 to 49.9 °C 36.0 °C
Limits (32.0 to 121.8 °F) (96.8 °F)
(0.1°C, 0.1 or 0.2°F steps)
TEMP2 High Alarm 0.1 to 50.0 °C 39.0 °C
Limits (32.2 to 122.0 °F) (102.2 °F)
(0.1°C, 0.1 or 0.2°F steps)
191
Defaults
TEMP2 Low Alarm 0.0 to 49.9 °C 36.0 °C
Limits (32.0 to 121.8 °F) (96.8 °F)
(0.1°C, 0.1 or 0.2°F steps)
TEMP Unit* °C, °F °C
Respiration Menu
Respiration ON ON
OFF
RR Source Auto Auto
Impedance
Airway
Size x0.5, x1, x1.5, x2 x1
Apnea time setting Off, 10 seconds, 20 seconds, 30 10 seconds
seconds
40 seconds, 50 seconds, 60 seconds
RR High Limits IM: 4 to 120 BPM (1 BPM step) 30 BPM
AW: 1 to 150 BPM (1 BPM step)
RR Low Limits IM: 3 to 119 BPM (1 BPM step) 8 BPM
AW: 0 to 149 BPM (1 BPM step)
Manual, AED, Pacing, Monitor Mode Menu
Alarm Volume 1, 2, 3, 4, 5, 6, 7, 8 5
Beep Volume OFF, 1, 2, 3, 4, 5, 6, 7 4
Button Volume OFF, 1, 2, 3, 4, 5, 6, 7 4
nd
2 Waveform ECG I, ECG II, ECG III, ECG aVL, ECG SpO2 Waveform
aVF, ECG aVR, ECG V1, ECG V2, ECG
V3, ECG V4, ECG V5, ECG V6, Pads,
SpO2, RESP, IBP1, IBP2, EtCO2
rd
3 Waveform ECG I, ECG II, ECG III, ECG aVL, ECG IBP1 Waveform
aVF, ECG aVR, ECG V1, ECG V2, ECG – P1
th
4 Waveform ECG I, ECG II, ECG III, ECG aVL, ECG EtCO2 Waveform
aVF, ECG aVR, ECG V1, ECG V2, ECG
Print on alarm On, Off Off
Print on shock On, Off Off
12 lead auto printing On, Off On
Analyze auto printing On, Off Off
Elapsed time display* Enable, Disable Enable
CPR guide display* Enable, Disable Disable
Message display* Enable, Disable Enable
Voice prompt* Enable, Disable Enable
Basic auto energy Enable, Disable Enable
escalation*
Above 200J setting* Enable, Disable Disable

192 MGA22955 / GB / A
Defaults
Manual mode shock 1~200J 125J
st
energy – 1 energy*
nd
rd
Analyze continuous On, Off On
mode*
Auto charge* On, Off On
Remain in sync mode On, Off On
after shock*
Charging hold time* 15 sec, 60 sec 60 sec
ECG display under On, Off On
paddle open*
Setup Menu* Enable, Disable Disable
Alarm Limit Menu* Enable, Disable Disable
12 Lead Menu* Enable, Disable Disable
AED display setting – Enable, Disable Enable
Waveform display*
AED display setting – Enable, Disable Enable
Icon display*
AED display setting – Enable, Disable Disable
Value display*
AED step 1 display*
AED step 2 display*
AED step 3 display*
AED shock energy – Enable, Disable Disable
Above 200J setting*
AED shock energy – 1~200J 125J
1st energy*

2nd energy*
3rd energy*
Async Pacing* On, Off Off
Pace Pulse Rate* 30 ~ 180 bpm 70 bpm
Default Pacing 0, 30, 70, 100, 140 mA 0 mA
Energy*
Others
Parameters Color - 00FA00(Green), FAFAFA(White), 00FA00(Green)
ECG* 64FAFA(Cyan), 6464FA(Light blue),
FA96FA(Pink), FA0000(Red),
193
Defaults
FAFA00(Yellow), 9696C8(Light purple),
FA9600, 0096FA, FA00FA, 96FA32,
C8C8C8, 0096C8, C89600, C8C832
Parameters Color - 00FA00(Green), FAFAFA(White), FAFAFA(White)
NIBP* 64FAFA(Cyan), 6464FA(Light blue),
FA9600, 0096FA, FA00FA, 96FA32,
C8C8C8, 0096C8, C89600, C8C832
Parameters Color - 00FA00(Green), FAFAFA(White), 64FAFA(Cyan)
SpO2* 64FAFA(Cyan), 6464FA(Light blue),
FA9600, 0096FA, FA00FA, 96FA32,
C8C8C8, 0096C8, C89600, C8C832
Parameters Color - 00FA00(Green), FAFAFA(White), 9696C8(Light
RESP* 64FAFA(Cyan), 6464FA(Light blue), blue)
FA9600, 0096FA, FA00FA, 96FA32,
C8C8C8, 0096C8, C89600, C8C832
Parameters Color - 00FA00(Green), FAFAFA(White), FA96FA(Pink)
TEMP* 64FAFA(Cyan), 6464FA(Light blue),
FA9600, 0096FA, FA00FA, 96FA32,
C8C8C8, 0096C8, C89600, C8C832
Parameters Color - IBP 00FA00(Green), FAFAFA(White), FA0000(Red)
1* 64FAFA(Cyan), 6464FA(Light blue),
FA9600, 0096FA, FA00FA, 96FA32,
C8C8C8, 0096C8, C89600, C8C832
Parameters Color - IBP 00FA00(Green), FAFAFA(White), FAFA00(Yellow)
2* 64FAFA(Cyan), 6464FA(Light blue),
FA9600, 0096FA, FA00FA, 96FA32,
C8C8C8, 0096C8, C89600, C8C832
Parameters Color - 00FA00(Green), FAFAFA(White), 9696C8(Light
EtCO2* 64FAFA(Cyan), 6464FA(Light blue), purple)
FA9600, 0096FA, FA00FA, 96FA32,
C8C8C8, 0096C8, C89600, C8C832
Audio pause time* 30 sec, 60 sec, 90 sec, 120 sec 60 sec
Audio off time* 3 min, 5 min, 10 min, Indefinite Indefinite
Alarm reminder tone* 3 min, 10 min, Off 3 min
Alarm activate at Enable, Disable Enable
power up*
Voice recording* On, Off Off
Auto self-test : 0 ~ 23 o‘clock 0 o‘clock
Self-test time*

194 MGA22955 / GB / A
Defaults
Auto self-test : 24 hours, 48 hours, 72 hours, Off Off
Self-test time interval*
Auto self-test : 5J, 10J, 20J, 30J, 40J, 50J, 100J, 200J 50 J
Internal shock energy*
Clinical action list* None, CPR, EPI, Atrop, DOPA, PHEN, None
Bicarb, Aspirin, Oxygen, IV, Morphine,
Valium, β-block, LIDO, Mag Sulf,
Thrombo, Sedation, Heparin, Procain,
Cordar, Thiamine, Dilantin, Intubate,
Narcan, Atrovent, Adenosin, Fentanyl,
Digoxin, Vasopr, Dextrose, Paralytic,
Nitro, Albuterol, Amrinon, Benadryl,
Demerol, Oral Glu, Lasix, Calcium
Manual mode Disable, Confirm, Passcode Disable
protection*
Manual mode locking 000~999 (Passcode)
passcode*
Pacing mode Disable, Confirm, Passcode Disable
protection*
Pacing mode locking 000~999 (Passcode)
passcode*
Service menu 000~999 (Passcode)
passcode*
Print on charge On, Off Off
Print on mark On, Off Off
Print on BP On, Off Off
Print on self-test On, Off Off
Power on waveform ECG I, ECG II, ECG III, Pads ECG I
st
select – 1 waveform*
Power on waveform ECG I, ECG II, ECG III, ECG aVL, ECG SpO2
nd
select – 2 waveform* aVF, ECG aVR, ECG V1, ECG V2, ECG
Power on waveform ECG I, ECG II, ECG III, ECG aVL, ECG IBP1
rd
Power on waveform ECG I, ECG II, ECG III, ECG aVL, ECG EtCO2
th
Wi-Fi* On, Off Off
Wireless Channel* Channel 1 ~ 13 Channel 1
Wireless security None, WEP, WPA, WPA2, Return None
mode*
Wireless WEP key* WEP key 1, WEP key 2, WEP key 3, WEP key 1
WEP key 4
WEP key length* 64 bit (10 hex digits), 128 bit (24 hex 64 bit (10 hex
digits) digits)
195
An asterisk (*) by a parameter in the above table indicates that the parameter can
Note only be changed by authorized personnel as described in the service manual

196 MGA22955 / GB / A
27 Specification
27.1 Display
Screen Size 8.4” measured diagonally across the TFT-LCD screen

Screen Type Liquid Crystal Display (LCD) Color
Size 170 x 128 mm
Number of 4 waveforms
Traces
27.2 Controls
Standard Multi function knob; Mode select knob (Off, AED, Manual,
Pacing and Monitor); 11 buttons (Shock, Joule, Charge,
Analyze, NIBP, LEAD, Alarm, Size, Print, Rate, mA); 5 soft keys
27.3 Alarms
Categories Patient Status and System Status

Priorities Low, Medium and High Priorities
Notification Audible and Visual
Setting Default and Individual
Alarm Volume 45 to 85 dB
Level
27.4 Physical Characteristics and Printer

Instrument
Dimensions 350 × 430 × 220 (mm) (W×H×D)

including battery and excluding paddles, options and
accessories
Weight Approx. 7 (kg)

excluding battery, paddles and accessories.
Degree of ECG: Type CF with defibrillator protection

Protection SpO2: Type CF with defibrillator protection
against Electric Temperature: Type CF with defibrillator protection
Shock
EtCO2: Type CF with defibrillator protection
NIBP: Type CF with defibrillator protection
IBP: Type CF with defibrillator protection
Paddle, Defibrillation
197
pads: Type BF with defibrillator protection
Mode of Continuous
Operation
Classification Class IIb (MDD Annex IX Rule10:MEDDEV 2.4/1 Rev.8)
Printer
Type Thermal
Weight 190 g
Number of 1 to 3 channels
Channels
Paper Type Thermal
Paper Width 80 mm
Printer Speed 25 mm/s, 50 mm/s
27.5 Electrical
Instrument
Power AC Mains
Requirements 100 to 240 V, 50/60 Hz, 160 VA
DC Mains
Use PRIMEDIC™ Charger EVO with DC/DC adapter (Input:
12-16Vdc, 160VA, Output: 18Vdc, 7.0A)
For 120 Volt applications, use only UL

Note
Listed detachable power cord with
NEMA configuration 5-15P type
(parallel blades) plug cap. For 240 Volt
applications use only UL Listed
Detachable power supply cord with
NEMA configuration 6-15P type
(tandem blades) plug cap.
Battery (option)
Type Li-ion battery
Dimension 150 × 90 × 20 (mm) (W×H×D)
Voltage/Capacity 4S2P 14.4V/5200mAh
Discharge A minimum of 200 shocks at 200 Joules (per battery)
Operating time 5 hours (per battery)

At the following condition:
no printing
no external communication
no audible alarm sound
room temperature : 25°C

198 MGA22955 / GB / A
Recharge Over 5 hours with PRIMEDIC™ DefiMonitor EVO turned
on/off
(It would take about 5 hours to fully charge the battery
from the moment that low battery alarm is activated.)
Life Cycle 24 months, new battery fully-charged

(- The battery life cycle may vary with the number of
recharging, operating temperature, and storage
condition.Typically, about 80% capacity of battery may
remain after 300 cycles of recharge.If one cycle of
recharging would be about 2 or 3 days, the battery may
have 80% capacity after about 24 months.
- The battery is designed not to be charged for safety
reason when it reaches 40°C.)
After 2 months storage the DefiMonitor EVO would run
for 50% of stated battery life.
27.6 Enviromental Conditions

Operation
Temperature 0 to 50°C (32 to 122°F)
Humidity 15 to 95% RH, non-condensing
Altitude -170 to 4,877m (-557 to 16,000 ft)
The system may not meet its performance specifications if

Note
stored or used outside the specified temperature and
humidity range.
The battery will not be charged for safety if the operating

Note
temperature exceeds 40°C.
Shipping and Storage (in shipping container)
Temperature −20°C to 70°C (−4°F to 158°F)
Humidity 15 to 95% RH, non-condensing
Altitude -304 to 6,096m (1,000 to 20,000ft)
The system may not meet its performance specifications if

Note
stored or used outside the specified temperature and
humidity range.
27.7 Tone Definiton

High Priority Alarm Tone
Volume level Adjustable (level 1~8)
Pitch (± 48.8Hz) 976 Hz
Pulse width (± 210 msec

10msec)
Number of pulses 10 pulses per 4 sec, 10 sec inter burst (IEC60601-1-8)
Repetitions Continually
Medium Priority Alarm Tone
199
Pitch (± 34.85Hz) 697 Hz
Pulse width (± 10 210 msec

msec)
Number of pulses 3 pulses per 1 sec, 15 sec inter burst (IEC60601-1-8)
Low Priority Alarm Tone
Pitch (± 9.4Hz) 488 Hz
Pulse width (± 10 210 msec

msec)
Number of pulses 1 pulse per 0.25 sec, 30 sec inter burst (IEC60601-1-8)
Alarm Reminder Tone
Volume level Not changeable
Pitch (± 40Hz) 800 Hz

10msec)
Number of pulses 1 pulse per 1 second, 3 min, 10 min inter burst
HR/PR Tone
Volume level Not changeable
Pitch (± 32.5Hz) 650 Hz (ECG)

(162 + 5*SpO2) Hz

5msec)
Number of pulses N/A
Repetitions No repeat
Key Beep
Volume level Adjustable (Off, level 1~7)
Pitch 440 (± 22)Hz (valid)

168 (± 8.4)Hz (invalid)

5msec)
Number of pulses N/A
Repetitions No repeat
27.8 Measurement Parameters
27.8.1 Pacing Mode

Pacing Mode
Pacing rate Variable from 30 bpm to 180 bpm ± 1.5% (increments or

200 MGA22955 / GB / A
decrements by a value of 2 bpm)
Resolution 2 bpm
Accuracy ± 1.5 %
Output current 0 mA to 140 mA
Resolution 2 mA
Accuracy ±5% or 5 mA, whichever is greater
Pulse Type 40 ms constant current pulse
Pulse Amplitude Variable 0 mA to 140 mA ± 5% or 5 mA, whichever is

greater. Digitally displayed on the monitor (increments or
decrements by a value of 2 mA)
27.8.2 Defibrillator
AED Mode
Lead Lead ll
Patient Impedance 25 to 175 Ohm
Heart Rate 20 to 300 BPM
Accuracy 1 per min
Detection V/F ≤ 200 µV

V/T ≤ 160 per min
Charging Time to Within 6 seconds with rated main voltage/DC main
200J* voltage
*Charging time for other cases, refer to Manual Mode
technical specification
27.8.3 Manual Mode

Manual Mode
Shock Energy Level External paddles:

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 75, 100, 125,
150, 175, 200, 300, 360 J
Automatic Discharge 60 seconds

Time
Charging Time to Within 8 seconds with rated main voltage/DC main

360 J voltage
*Charging time for other cases, refer to defibrillator
(technical specification)
27.8.4 ECG
Heart Rate
Measurement Range 0, 20 to 300 BPM
Resolution 1 BPM
Accuracy ± 5 bpm
Average Response Time 5 seconds (from 80 to120 BPM)

9 seconds (from 80 to 40 BPM)
Tall T-wave Rejection maximum T-wave amplitude 1.8 mV
201
ECG (Electrocardiograph)
Leads 3 / 5 / 12 Lead
Lead I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6,
Paddle, Pads
Lead Off Detection Detected and displayed
Pacer Detection Detect pacer pulses of ±2mV to ±700mV with pulse

widths of 0.1 to 2msec and rise times 10% of width
not to exceed 100msec
Input
Input Impedance 5 MOhm or more
Input Dynamic Range ±5 mV AC, ±300 mV DC
Voltage Range ±0.5 mV ~ ±5 mV
Signal Width 40 to 120 ms (Q to S)
Output
Filter mode 0.5 to 21 Hz

0.05 to 40 Hz
1 to 21 Hz
ECG Size Auto, 5.0, 10.0, 15.0, 20.0, 30.0 mm/mV
Display Sweep Speeds 25.0 mm/sec
Wave Size x0.5, x1, x1.5, x2, x3
Display Sensitivity 10 mm/mV (×1)
Pacing Pulse Detection On, Off
Electrode Disconnect Display and/or sound

Alarm
CMRR 90 dB or more
Defibrillator Discharge <5 sec per IEC60601-2-27

Recovery
Defibrillator Protection Protected
ECG (Arrhythmia Supplemental Information as required by AAMI EC13)
Respiration, leads-off amp 0.03 µA

sensing, and active common 0.25 µA
noise suppression
Tall T-wave rejection Maximum T-Wave amplitude 1.8 mV

capability
Accuracy of input Displacement: 0.1 mV

signal reproduction Slope: 0.1 mV/s
Heart rate meter Provides correct heart rates, as follows:

accuracy and response Ventricular bigeminy: 39 bpm
to irregular rhythm Slow alternating ventricular bigeminy: 29 bpm
Rapid alternating ventricular bigeminy: 115~120bpm
Bidirectional systoles: 84~94 bpm
Response time of heart HR change from 80 to 120 bpm: 3.16 sec

rate meter to change HR change from 80 to 40 bpm: 3.05 sec
in heart rate
Time to alarm for Vent Tachycardia 1 mVpp, 206 bpm:

tachycardia

202 MGA22955 / GB / A
Amplitude 0.5mV, Alarm activated time 6.79 sec
Amplitude 1mV, Alarm activated time 9.80 sec
Amplitude 2mV, Alarm activated time 8.19
Vent Tachycardia 2 mVpp, 195 bpm:

Time to alarm for Average: 3.28 sec

cardiac standstill
Time to alarm for heart Low heart rate: average:3.05 sec

rate High heart rate: average: 3.16 sec
Time base selection 10 successive peaks: 10 mm

and accuracy 20 successive peaks: 20 mm
40 successive peaks: 40 mm
Pacemaker pulse Rejection of pacemaker pulses with amplitudes from

rejection capability ±2mV to ±700mV with pulse widths of 0.1 to 2msec
Overshoot time constant 4 ms, Test method B (with
overshoot)
Pacer pulse detector Slew rate: 595mV/s

rejection of fast ECG
signals
27.8.5 Respiration
IM Respiration
Technique Impedance Pneumography
Range 0, 3 to 120 breaths/min
Resolution 1 breaths/min
Leads RA to LA
Base impedance 500 to 2000 ohm
Delta impedance 0.5 to 3 ohm
Lead Off Condition Detected and displayed
Defibrillator Protected
Protection
Display Sweep 25 mm/s

Speeds
Wave Size x0.5, x1, x1.5, x2
AW Respiration
Technique Nondispresive Infrared Spectroscopy
Range 0 to 120 breaths/min
Accuracy ±1 breaths/min
27.8.6 NIBP
Pulse Rate
Pulse Rate Range Adult/Pediatric 40to200 BPM
203
Neonatal 40 to 240 BPM
Resolution 5 BPM
Pulse Rate Accuracy ±2 BPM or ±2%, whichever is greater
NIBP (Non-Invasive Blood Pressure)
Technique Oscillometric Measurement
Measurement Modes Off, 1, 2.5, 3, 5, 10, 15, 30, 60, 90 minutes
Measurement Range Adult/Pediatric

SYS 60 to 250 mmHg
MAP 45 to 235 mmHg
DIA 40 to 200 mmHg
Neonatal
SYS 40 to 120 mmHg
MAP 30 to 100 mmHg
DIA 20 to 90 mmHg
NIBP Accuracy Mean error and standard deviation per ANSI/AAMI

SP10:2002+A1:2003+A2:2006, IEC 60601-2-30:2009, EN
1060-4:2004
Pressure Display Adult/Pediatric 0 to 300 mmHg

Range Neonatal 0 to 150 mmHg
Pressure Display Within ±3 mmHg or 2%

Accuracy
Initial Cuff Inflate Adult/Pediatric

Pressure 120, 140, 160, 180, 200, 220, 240, 260, 280 mmHg
(16.0, 18.7, 21.3, 24.0, 26.7, 29.3, 32.0, 34.7, 37.3 kPa)
Neonatal
80, 90, 100, 110, 120, 130, 140 mmHg
(10.7, 12.0, 13.3, 14.7, 16.0, 17.3, 18.7 kPa)
Automatic Cuff Measurement time exceeding 180s in adult/pediatric

Deflation (90s in neonatal) or maximum pressure value exceeding
300 mmHg in adult (150 mmHg in neonatal).
Overpressure Adult/Pediatric: 300 mmHg

Protector Neonatal: 150mmHg
Measurement Speed About 20 seconds

At the following condition:
Adult
Cuff size 12 cm
SYS 120 mmHg
MAP 90 mmHg
DIA 80 mmHg/ PR 80 BPM
Manual Measurements (180 mmHg)
27.8.7 IBP
Pulse Rate
Pulse Rate Range 20 to 250 BPM
Accuracy ± 1 % or ± 1 bpm

204 MGA22955 / GB / A
Pulse Rate 1 BPM
Resolution
IBP (Invasive Blood Pressure)
Parameter P1, ABP

Displayed P2, CVP, PAP, LAP
Measurement -50 mmHg to 300 mmHg

Range 20 bpm to 250 bpm
Resolution 1 mmHg
Accuracy ± 3 mmHg
Input sensitivity 5µV/V/mmHg

3
Transducer Volume 0.1mm /100mmHg
Displacement
Zero calibration ± 100mmHg

range
Frequency response DC - 10 Hz ± 1 Hz, -3db
Wave Size 0 to 50, 0 to 100, 0 to 200, 0 to 300, Auto Size
Display Sweep 25.0 mm/s

Speeds
Defibrillator Protected
Protection
27.8.8 SpO2
Measurement Ranges
SpO2 saturation 1% to 100%

range
Pulse rate range 20 to 300 beats per minute (bpb)
Perfusion range 0.03% to 20%
Display sweep 25.0 mm/s

speed
Measurement Accuracy
Pulse rate accuracy 20 to 250 beats per minute (bpm) ±3 digits
SpO2 saturation 70% to 100% ±2 digits, neonates: ±3 digits

accuracy
SpO2 saturation accuracy - Monitoring system
Note
measurements are statistically distributed; about two-
thirds of monitoring system measurements can be
expected to fall in this accuracy (ARMS) range. Reference
the Clinical Studies section for test results. For a complete
listing of SpO2 accuracy across the full line of available
Nellcor™ sensors, contact Covidien, a local Covidien
representative, or locate it online at www.covidien.com.
Operating Range and Dissipation
Red Light Approximately 660 nm

Wavelength
Infrared Light Approximately 900 nm
205
Wavelength
Optical Output Less than 15 mW

Power
Power Dissipation 52.5 mW
27.8.9 Capnography
Capnography
Parameter Displayed EtCO2, InCO2
Range 0 mmHg ~ 150 mmHg (0kPa ~ 20kPa, 0% ~ 20%)
Accuracy 0-40mmHg ±2mmHg of reading

41-70mmHg ±5% of reading
Display Accuracy ±2mmHg
Response Time Mainstream: Less than 60ms

Sidestream: Less than 3sec.
Baromatric Pressure -152.4 to 4572 meters

Correction (-500 to 15,000 feet),
775 to 429 mmHg, Automatic
Gas Compensation User selective at O2 >60% and N2O >50%
Stability and drift Short term drift: Less than 0.8 mmHg over 4 hours.
Long term drift: Accuracy specification will be
maintained over a 120 hour period.
Accuracy Change for 0-40 mmHg ±1 mmHg additional error

interfering Gases and 41-70 mmHg ±2.5% additional error
Vapors Anesthetic and
71-100 mmHg ±4% additional error
interfering agents
101-150 mmHg ±5% additional error
Additional worst case error when compensation for O2

and N2O is correctly selected for actual fractional gas
constituents present.
Warm Up Time 2 minutes maximum
Sweep Speeds 25.0 mm/s
Sound Noise Level Less than 41dB when ambient sound pressure level is
22dB
27.8.10 Temperature
Thermistor Temp
Probe Type Thermistor probe YSI compatible type
Measurement Method Thermistor
Range 0 to 50°C (32.0 to 122°F)
Accuracy 25 to 45 °C (77 to 113°F): ±0.2°C
Resolution 25 to 45 °C (77 to 113°F): ±0.1°C

206 MGA22955 / GB / A
27.9 Events
Type 12 lead, Event
Data storage Internal memory, SD card
Memory 12 lead
 saves total 100 data
 saves ECG waveform
 saves ECG analysis result data
 saves ECG analysis date and time
 saves HR/PR, NIBP, SpO2, Respiration,
 Temperature, IBP 1, IBP 2, EtCO2 numeric data
 saves alarm condition
Event
 saves total 250 data
 saves defibrillation shock information (number
of shock,
 energy level, actual passed energy, impedance)
 saves pacing information (pace rate, pace
current, async mode)
 saves action list
 saves 1 channel ECG waveform
 saves Event date and time
 saves HR/PR, NIBP, SpO2, Respiration,
Temperature, IBP 1, IBP 2, EtCO2 numeric data
 saves alarm condition
207
27.10 Defibrillator (Technical specification)
27.10.1 AED Mode

AED Mode
Charging Time - 200J Charging condition Time (sec)
With Rated Mains Voltage 5.8
With DC Mains Voltage 5.9
With fully charged battery 6.4
Charging Time - 200J Charging condition Time (sec)
(including time from the
initiation of rhythm analysis
with a clear ECG signal to With DC Mains Voltage 18.4
readiness for discharge.) With fully charged battery 19.3
With Mains Voltage of 90% of the Rated
18.1
value
With DC Mains Voltage of 90% of the Rated
18.8
value
After 15 maximum energy discharges taken
19.6
from a new fully charged battery
value, but measured from initially switching
26.4
power on to ready for discharge at
maximum energy
With DC Mains Voltage of 90% of the Rated
26.3
maximum energy
from a new fully charged battery, but
26.7
measured from initially switching power on
to ready for discharge at maximum energy
A used battery normally takes more time

Note
than the charging time specified in above.

208 MGA22955 / GB / A
Waveform parameters The PRIMEDIC™ DefiMonitor EVO delivers shocks to load
impedances from 25 to 175 ohms. The duration of each pulse of
the waveform is dynamically adjusted based on delivered
charge, in order to compensate for patient impedance
variations, as shown below:
(When 200J is selected)
Load resistance (Ω) Delivered energy(J)
25 195
50 200
75 196
100 199
125 199
150 200
175 200
27.10.2 Manual Mode

Manual Mode
Charging Time – 200J Charging condition Time (sec)
5.8
value
With DC Mains Voltage of 90% of the
6.4
Rated value
6.6
11.7
maximum energy
Rated value, but measured from initially
11.9
switching power on to ready for discharge
at maximum energy
12.5
Note: A used battery normally takes more time than the
charging time specified in above.
209
Charging Time – 360J Charging condition Time (sec)
7.4
value
8.0
Rated value
8.5
13.0
maximum energy
Rated value, but measured from initially
14.0
switching power on to ready for discharge
at maximum energy
14.3
A used battery normally takes more time

Note
than the charging time specified in above.
Number of discharges The number of maximum energy discharges which are
available from a new and fully charged battery at 20°C
ambient temperature is above 200 times for 360J and 250
times for 200J
27.10.3 ECG Analysis Performance
Rhythm class ECG analysis performance

Shockable rhythm, Complies with IEC60601-2-4:2002
Ventricular (sensitivity > 90%)
Fibrillation
Shockable rhythm, Complies with IEC60601-2-4:2002
Ventricular (sensitivity > 75%)
Tachycardia
Non-Shockable Complies with IEC60601-2-4:2002
rhythm (specificity > 95%)
Database for ECG Analysis
From AHA (American Heart Association) official database

From MIT (Massachusetts institute Technology) official database
(MIT-BIH Arrhythmia Database and Creighton University Ventricular
Tachyarrhythmia Database)
ECG rhythm to determine if a shock is appropriate

210 MGA22955 / GB / A
Ventricular Fibrillation at an amplitude greater than or equal to
0.2mV
Ventricular Tachycardia at a heart rate greater than or equal to160
bpm
27.11 Biphasic Waveform Characteristics

The efficiency of the biphasic waveform used in the PRIMEDIC™ DefiMonitor
EVO has been clinically verified during a ventricular fibrillation (VF) and
ventricular tachycardia (VT) defibrillation study. This study and the findings are
described below.
Table 39: Delivered Energy at Every Defibrillator Settings into a Range of Loads
Selecte Load [Ohm] Accurac

d y
25 50 75 100 125 150 175
Energy
1J 1.0 1.0 1.0 1.0 1.0 1.0 1.0 15%
2J 2.0 2.0 2.0 2.0 2.0 2.0 2.0 15%
3J 3.0 3.0 3.0 3.0 3.0 3.0 3.0 15%
4J 4.0 4.0 4.0 4.0 4.0 4.0 4.0 15%
5J 5.0 5.0 5.0 5.0 5.0 5.0 5.0 15%
6J 6.0 6.0 6.0 6.0 6.0 6.0 6.0 15%
7J 7.0 7.0 7.0 7.0 7.0 7.0 7.0 15%
8J 8.0 8.0 8.0 8.0 8.0 8.0 8.0 15%
9J 9.0 9.0 9.0 9.0 9.0 9.0 9.0 15%
10J 11. 10. 10. 10. 10. 10. 10. 15%
0 0 0 0 0 0 0
15J 16. 15. 15. 15. 15. 15. 15. 15%
0 0 0 0 0 0 0
20J 21. 20. 20. 20. 20. 20. 20. 15%
0 0 0 0 0 0 0
30J 31. 30. 30. 30. 30. 30. 30. 15%
0 0 0 0 0 0 0
40J 41. 40. 40. 40. 39. 39. 39. 15%
0 0 0 0 0 0 0
50J 51. 50. 50. 50. 49. 49. 49. 15%
0 0 0 0 0 0 0
75J 77. 76. 75. 75. 74. 74. 74. 15%
0 0 0 0 0 0 0
100J 99. 99. 99. 15%
102 101 101 100
0 0 0
125J 127 126 126 124 124 122 123 15%
150J 152 151 150 150 148 147 148 15%
175J 177 174 173 173 173 172 172 15%
200J 203 198 200 199 198 197 197 15%
300J 304 302 300 298 296 297 296 15%
360J 370 371 365 363 363 356 356 15%
The following figures show the biphasic waveforms that are produced when
the PRIMEDIC™ DefiMonitor EVO is discharged into loads of 25, 50, 75, 100,
211
125, 150 and 175 Ohms at each energy setting (360, 300, 200, 175, 150, 125,
100, 75, 50, 40, 30, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 and 1 Joule[s]).
The vertical axis shows the voltage in volts (V); the horizontal axis shows the
duration in milliseconds (ms).
Figure 88: Biphasic Waveforms at 300 Joules and 360 Joules
Figure 89: Biphasic Waveforms at 200 Joules

212 MGA22955 / GB / A
213

214 MGA22955 / GB / A
215

216 MGA22955 / GB / A
217

218 MGA22955 / GB / A
219

220 MGA22955 / GB / A
221
27.12 Compliance
Item Standard Description
Classification IEC60601- Class I (on AC power)

1:1988+A1:1991+A2:1995, Internally powered (on
EN60601-1:1996 battery power)
Type of protection IEC60601- Type CF – Applied part

1:1988+A1:1991+A2:1995, (ECG, SpO2,
EN60601-1:1996 Temperature, EtCO2,
NIBP, IBP)
Type BF – Applied part
(Paddle, Defibrillation
Pads)
Mode of operation IEC60601- Continuous

1:1988+A1:1991+A2:1995,
EN60601-1:1996
Degree of protection IEC60529:2001, IP55 (provided by

EN60529:1991 enclosures)
+A1:2000
General 93/42/EEC as amended by Directives for medical

2007/47/EC devices
21CFR820 Code of federal

regulations
2002/96/EC Waste electrical and

electronic equipment
directive (WEEE)
93/86/EEC Battery disposal

directive
2006/66/EC as amended by Battery directive

2008/103/EC
ISO13485:2003, Quality systems -

EN ISO13485:2003 Medical Devices -

222 MGA22955 / GB / A
Requirements for
regulating purposes
ISO14971:2007, Risk analysis

EN ISO14971:2009 managements – medical
devices
IEC60601- General requirements

1:1988+A1:1991+A2:1995, for safety of medical
EN60601-1:1996 electrical equipment
IEC60529:2001, Degree of protection

EN60529:1991 provided by enclosures
+A1:2000 (IP55)
ISO14155-1:2011, Clinical investigation of

EN ISO14155-1:2011 medical devices for
human subjects – Good
clinical practice
AAMI HE75:2009 Human factors

engineering guidelines
and preferred practices
for the design of
medical devices
IEC60601-1-1:2000, Collateral standard for

EN60601-1-1:2001 medical electrical
systems

EN60601-1-4:1996+A1:1999 programmable medical
systems

EN60601-1-6:2007 usability
ISO10993-1:2009, Biological evaluation of

EN ISO10993-1:2009 medical devices – Part 1:
Evaluation and testing

EN ISO10993-5:2009 medical devices – Part 5:
Tests for in vitro
cytotoxicity

EN ISO10993-10:2010 medical devices – Part
10: Tests for irritation
and delayed-type
hypersensitivity
IEC60601-2-49:2001, Particular requirements

EN60601-2-49:2001 for multifunction patient
monitoring equipment
IEC62366:2007 Medical devices –

EN62366:2008 Application of usability
engineering to medical
devices
IEC60601-1-9:2007 Medical electrical

EN60601-1-9:2008 equipment - Part 1-9:
General requirements
for basic safety and
essential performance -
223
Collateral Standard:
Requirements for
environmentally
conscious design
IEC62304:2006 Medical device software

EN62304:2006 – Software life-cycle
processes
Ambulance EN1789:2007+A1:2010 Medical vehicles and

their equipment – road
ambulance
EN13718-1:2008 Medical vehicles and

their equipment – Air
ambulances –
Part1:Requirements for
medical devices used in
air ambulances.
RTCA/ DO-160F Environmental

Conditions and Test
Procedures for Airborne
Equipment
Alarms IEC60601-1-8:2006, Alarm systems

EN60601-1-8:2007 requirements, tests and
guidance in medical
electrical equipments
systems
Electrocardiograph IEC60601-2-27:2005, Particular requirements

EN60601-2-27:2006 for the safety of
Electrocardiographic

EN60601-2-25:1995 for the basic safety and
essential performance of
electrocardiographs
AAMI EC13:2002 Cardiac monitors, heart

rate meters and alarms
AAMI EC53A:1998/(R)2008 ECG cable and leads
Non-invasive blood AAMI Electronic or automated

pressure SP10:2002+A1:2003+A2:2006 sphygmomanometers
EN1060-1:1995 Non-invasive
+A2:2009 sphygmomanometers
EN1060-3:1997 Supplementary
+A2:2009 requirements for
electrical-mechanical
blood pressure
measuring systems
EN1060-4:2004 Non-invasive
sphygmomanometers -
Test procedures to
determine the overall
system accuracy of
automated non-invasive
sphygmomanometers

224 MGA22955 / GB / A
EN60601-2-30:2000 for the safety, including
essential performance,
of automatic cycling
indirect blood pressure
Oxygen saturation ISO9919:2005, Basic safety & essential

EN ISO 9919:2009 performance of pulse
oximeter for medical use
Temperature EN12470-4:2000 +A1:2009 Performance of electrical

monitoring thermometers for
continuous
Measurement
Invasive blood IEC60601-2-34:2000 Particular requirements

pressure EN 60601-2-34:2000 for the safety, including
essential performance,
of invasive blood
pressure monitoring
equipment
Capnography ISO21647:2004, Particular requirements

EN ISO 21647:2009 for the basic safety and
essential performance of
respiratory gas monitors
Defibrillator IEC 60601-2-4:2002 Safety of cardiac

EN 60601-2-4:2003 defibrillators
AAMI DF80:2003 Safety of cardiac

defibrillators (including
automated external
defibrillators)
Electromagnetic IEC60601-1, sub clause 36, Electromagnetic

compatibility and compatibility-
IEC60601-1-2:2007, requirements & test
EN60601-1-2:2007
IEC61000-3-2:2009, Harmonic emission Ed

EN61000-3-2:2006 +A2:2009 3.2
IEC61000-3-3:2008, Voltage
EN61000-3-3:2008 fluctuations/Flicker
emission Ed 2.0
IEC61000-4-2:2008, Electrostatic discharge

EN61000-4-2:2009 Ed 2.0
IEC61000-4-3:2010, Radiated RF
EN61000-4-3:2006 electromagnetic field Ed
+A1:2008+A2:2010 3.1
IEC61000-4-4:2012, Electrical fast

EN61000-4-4:2004+A1:2010 transient/burst Ed 2.0
IEC61000-4-5:2005, Surge current Ed 2.0

EN61000-4-5:2006
IEC61000-4-6:2008, Conducted disturbances,

EN61000-4-6:2009 induced by RF field Ed
3.0
IEC61000-4-8:2009, Power frequency

EN61000-4-8:2010 (50/60Hz) magnetic field
225
Ed 2.0
IEC61000-4-11:2004, Voltage dips, short

EN61000-4-11:2004 interruption and voltage
variation on power
supply input lines Ed 2.0
CISPR11:2009 +A1:2010 Limits and methods of

EN55011:2009+A1:2010 measurement of radio
disturbance
characteristics of
industrial scientific and
medical (ISM) radio-
frequency equipment RF
Emissions Group 1, Class
B
Package ISTA (Procedure 1A, 2001) Pre-Shipment test

procedures (Package)
ASTM D4169:2005 Standard practice for

performance testing of
shipping containers and
system
IEC60068-1:1998 +A1:1992 Environmental testing,

EN 60068-1:1994 Part1: General guidelines
IEC60068-2-1:2007 Environmental testing -

EN60068-2-1:2007 Part 2-1: Tests - Test A:
Cold

EN60068-2-2:2007 Part 2-2: Tests - Test B:
Dry heat

EN60068-2-30:2005 Part 2-30: Tests - Test
Db: Damp heat, cyclic
(12 h + 12 h cycle)
Reliability IEC60068-2-27:2008, Environmental testing –

EN60068-2-27:2009 Shock
IEC60068-2-6:2007, Environmental testing –

EN60068-2-6:2008 Vibration
IEC60068-2-64:2008, Environmental testing:

EN60068-2-64:2008 vibration, broad-band
random (digital control)
and guidance
Labeling EN1041:2008 Information supplied by

the manufacturer with
medical devices
Marking IEC /TR60878:2003 Graphical symbols for

electrical equipment in
medical practice
EN980:2008 Graphical symbols for

use in the labeling of
medical devices
ISO7000:2004 Graphical symbols for

use on equipment-index
and synopsis

226 MGA22955 / GB / A
EN50419:2006 Marking of electrical and

electronic equipment in
accordance with article II
(2) of directive
2002/96/EC (WEEE)
27.13 Manufacturer´s Declaration

WARNING
facility’s standards. The use of accessories, transducers, and cables other
than those specified may result in increased emission and/or decreased
immunity of the PRIMEDIC™ DefiMonitor EVO.
The PRIMEDIC™ DefiMonitor EVO is suitable for use in the specified

electromagnetic environment. The customer and/or user of the PRIMEDIC™
DefiMonitor EVO should assure that it is used in an electromagnetic
environment as described below.
Table 40: Electromagnetic Emissions (IEC60601-1-2)
Emission Test Compliance Electromagnetic Environment

RF emission Group 1, The defibrillator/monitor is suitable for use
CISPR 11 Class B in all establishments
Harmonic emissions Class A The defibrillator/monitor is suitable for use

IEC 61000-3-2 in all establishments.
Voltage fluctuations/flicker Complies The defibrillator/monitor is suitable for use

emission in all establishments.
IEC 61000-3-3
Table 41: Electromagnetic Immunity (IEC60601-1-2)
Immunity Test IEC 60601-1-2 Compliance Electromagnetic

Test Level Level Environment Guidance
Electrostatic ±6 kV contact ±6 kV contact Floor should be wood,

discharge (ESD) ±8 kV air ±8 kV air concrete, or ceramic tile. If
IEC 61000-4-2 floors are covered with
synthetic material, the relative
humidity should be at least 30
%.
Electric fast ±2 kV for power ±2 kV for Mains power quality should be

transient/burst IEC supply lines power supply that of a typical commercial
61000-4-4 ±1 kV for lines and/or hospital environment
input/output ±1 kV for
lines input/output
lines
Surge ±1 kV differential ±1 kV Mains power quality should be

IEC 61000-4-5 mode differential that of a typical commercial
±2 kV mode and/or hospital environment
common mode ±2 kV
common mode
227
Voltage dips, short <5 % U T <5 % U T Mains power quality should be
interruptions and (>95 % dip in UT (>95 % dip in that of a typical commercial
voltage variations ) for 0.5 cycle U T) for 0.5 and/or hospital environment. If
on power supply cycle the user of the PRIMEDIC™
DefiMonitor EVO requires
IEC 61000-4-11 40 % U T 40 % U T continued operation during
(60 % dip in UT ) (60 % dip in U power mains interruption, it is
for 5 cycles T) for 5 cycles recommended that the
70 % U T 70 % U T
be powered from an
(30 % dip in UT ) (30 % dip in
uninterruptible power supply
for 25 cycles UT) for 25
or battery.
cycles
<5 % U T <5 % U T
(95 % dip in UT ) (95 % dip in
for 5 sec. UT) for 5 sec.
Power frequency 3 A/m 3 A/m It may be necessary to position

(50/ 60 Hz) the PRIMEDIC™ DefiMonitor
magnetic field EVO further from the sources
of power frequency magnetic
fields or to install magnetic
IEC 61000-4-8
shielding. The power frequency
magnetic field should be
measured in the intended
installation location to assure
that it is sufficiently low.
Note: UT is the AC mains voltage prior to application of the test level.
Table 42: Electromagnetic Immunity (IEC60601-1-2)
Immunity Test IEC 60601-1-2 Compliance Electromagnetic

Test Level Level Environment Guidance
The PRIMEDIC™ DefiMonitor EVO is intended for use in the electromagnetic

environment specified below. The customer or the user of the defibrillator/monitor
should assure that it is used in such an environment.
Portable and mobile RF

communications equipment
should be used no closer to
any part of the
defibrillator/monitor including
cables, than the recommended
separation distance calculated
from the equation appropriate
to the frequency of the
transmitter.
Recommend separation
distance
Conducted RF 3 Vrms 3 Vrms d = 1.2 p

IEC 61000-4-6 150 kHz to 80
MHz
Radiated RF 3 V/m 3 V/m d = 1.2 p 80 MHz to 800

MHz
IEC 61000-4-3 80 MHz to 800

228 MGA22955 / GB / A
MHz
3 V/m 3 V/m d = 2.3 p 800 MHz to 2.5

GHz
800 MHz to 2.5
GHz
where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in metres (m).
Field strengths from fixed RF

transmitters as deter-mined by
an electromagnetic site
survey,a should be less than
the compliance level in each
frequency range.b
Interference may occur in the

vicinity of equipment marked
with the following symbol:
Note: At 80 MHz and 800 MHz, the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects, and people.
a Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radio, AM and FM radio broadcast,
and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which
the defibrillator/monitor is used exceeds the applicable RF compliance level above,
the defibrillator/monitor should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-
orienting or relocating the defibrillator/monitor.
b Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3
V/m
Table 43: Electro-surgical Unit Interference (IEC60601-2-27, IEC60601-2-30)
Interference Test IEC 60601 Test Level Complies with
Test in cut mode Output power 300W, 5 times IEC60601-2-2
Test in coagulation Output power of 100W,

mode Working frequency of 400 kHz
±10% , 5 times
Table 44: Recommended Separation Distances
Recommended separation distance between portable and mobile RF

communications equipment and the PRIMEDIC™ DefiMonitor EVO
The PRIMEDIC™ DefiMonitor EVO is intended for use in an electromagnetic

environment in which radiated RF disturbances are controlled. The customer or the
user of the defibrillator/monitor can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the defibrillator/monitor as recommended below,
according to the maximum output power of the communications equipment.
Rated Maximum Separation distance according to frequency of transmitter

Output Power of in meter
229
Transmitter in watt 150 kHz to MHz 80 MHz to 800 MHz 800 MHz to 2.5GHz
d = 1.2 p d = 1.2 p d = 2.3 p
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
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 frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note: At 80MHz and 800MHz, the separation distance for the higher frequency
range applies
Note: These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects, and people.
Table 45: Cables (IEC60601-1-2)
Cables and Sensors Maximum Complies with

Length
AC Power Cable 2.5m
 RF emissions, CISPR 11, Class B/
DC In Cable 1.8 m
Group 1
NIBP Hose 3.5 m  Harmonic emissions, IEC 61000-
Cuff Hose 0.5 m 3-2
 Voltage fluctuations/flicker
IBP Cable 3.0 m
emission, IEC 61000-3-3
ECG Lead Cable 3.0 m  Electrostatic discharge (ESD),
Defibrillator/AED Cable 3.0 m IEC 61000-4-2
 Electric fast transient/burst, IEC
Temperature Cable 3.0 m 61000-4-4
EtCO2 Cable 2.0 m  Surge, IEC 61000-4-5
 Conducted RF IEC 61000-4-6
SpO2 Cable 4.0 m
 Radiated RF, IEC 61000-4-3
SpO2 Sensor 1.0 m

230 MGA22955 / GB / A
28 Index
28.1 Figures
Figure 1 Front panel components ........................................................................................................................ 22
Figure 2: Front panel components ....................................................................................................................... 22
Figure 3: Paddle Components ................................................................................................................................ 24
Figure 4: Rear Panel Components ........................................................................................................................ 25
Figure 5: Left Panel Components .......................................................................................................................... 25
Figure 6: Right Panel Components ....................................................................................................................... 26
Figure 7: Display ........................................................................................................................................................... 28
Figure 8: AC Power Connection ............................................................................................................................. 33
Figure 9: DC Power Connection ............................................................................................................................. 34
Figure 10: ECG cable connector - match of mechanical coding of connector and plug ............... 35
Figure 11: Connecting the Paddle/Pads connector to the defibrillator’s plug .................................. 36
Figure 12: Battery Placement .................................................................................................................................. 40
Figure 13: Mode Select Knob.................................................................................................................................. 44
Figure 14: Select Date/Time Menu ....................................................................................................................... 45
Figure 15: Setup: Display mode Menu ................................................................................................................ 46
Figure 16: Normal Screen (4 waveform, Defibrillation mode, Full option) .......................................... 47
Figure 17: Large Numeric Screen (2 waveform, Defibrillation mode, Full option) ........................... 48
Figure 18: Black-white Screen (4 waveform, Defibrillation mode, Full option) .................................. 48
Figure 19: Volume Menu Display .......................................................................................................................... 50
Figure 20: Alarm Limit Menu................................................................................................................................... 58
Figure 21: Standard 3 electrode placement ..................................................................................................... 64
Figure 22: 5 electrode placement ......................................................................................................................... 64
Figure 23: Varying choice of baselines ............................................................................................................... 67
Figure 24: Baseline at the level of QRS onset as used by the Glasgow program ............................. 68
Figure 25: Illustration of isoelectric segments I and K ................................................................................. 68
Figure 26: Definitions for QRS end / ST junction ........................................................................................... 69
Figure 27: 12 lead Placement .................................................................................................................................. 70
Figure 28: Measurement Reference ..................................................................................................................... 71
Figure 29: 12-Lead ECG Preview Screen............................................................................................................. 74
Figure 30: HR/PR Display .......................................................................................................................................... 74
Figure 31: ECG Waveform Display ........................................................................................................................ 74
Figure 32: HR/PR Menu ............................................................................................................................................. 75
Figure 33: AED Mode Menu .................................................................................................................................... 85
Figure 34: Patient Info: ID Menu............................................................................................................................ 86
Figure 35: Manual Mode Screen............................................................................................................................ 89
Figure 36: Manual Mode Menu ............................................................................................................................. 91
Figure 37: Setup Menu .............................................................................................................................................. 95
Figure 38: Alarm Limit Menu ................................................................................................................................... 96
Figure 39: Patient Info Menu .................................................................................................................................. 97
Figure 40: Pacing Mode screen ........................................................................................................................... 100
Figure 41: Pacing Mode Menu ............................................................................................................................ 101
Figure 42: Setup Menu Window ......................................................................................................................... 104
Figure 43: Alarm Limit Menu ................................................................................................................................ 106
Figure 44: Patient Info Menu ............................................................................................................................... 106
Figure 45: Monitor Mode Screen ....................................................................................................................... 107
Figure 46: Monitor Mode Menu ......................................................................................................................... 108
231
Figure 47: Setup Menu ........................................................................................................................................... 111
Figure 48: Alarm Limit Menu ................................................................................................................................ 113
Figure 50: Connection between cuff pressure and oscillometric response during
measurement. ..................................................................................................................................................... 117
Figure 51: Balnd-Altman plot of oscillometric blood pressure measurements. ............................. 117
Figure 52: Comparison of signals for several blood pressure measurement techniques. ......... 118
Figure 53: NIBP Display .......................................................................................................................................... 120
Figure 54: NIBP Menu Display ............................................................................................................................. 120
Figure 55: Oxyhemoglobin Dissociation Curve ............................................................................................ 125
Figure 56: SpO2 Display .......................................................................................................................................... 127
Figure 57: SpO2 Waveform ................................................................................................................................... 127
Figure 58: SpO2 Menu Display............................................................................................................................. 128
Figure 59:Respiration Display .............................................................................................................................. 130
Figure 60: Respiration Waveform Display ...................................................................................................... 131
Figure 61: Respiration Menu Display ................................................................................................................ 131
Figure 62: Connection for mainstream ............................................................................................................ 137
Figure 63: Connection for sidestream .............................................................................................................. 137
Figure 64: EtCO2 Display ....................................................................................................................................... 138
Figure 65: EtCO2 Waveform Display .................................................................................................................. 138
Figure 66: EtCO2 Menu Display ........................................................................................................................... 138
Figure 67: Temperature Display .......................................................................................................................... 142
Figure 68: Temperature Menu Display............................................................................................................. 142
Figure 69: IBP Connections ................................................................................................................................... 145
Figure 70: IBP 1 Display .......................................................................................................................................... 145
Figure 71: IBP 1 Waveform Display ................................................................................................................... 146
Figure 72: IBP 1 Menu Display ............................................................................................................................. 146
Figure 73: IBP 2 Display .......................................................................................................................................... 147
Figure 74: IBP 2 Waveform Display ................................................................................................................... 147
Figure 75: IBP 2 Menu Display ............................................................................................................................. 147
Figure 76: Auto Self-test display ........................................................................................................................ 150
Figure 77: Event Data List Display ...................................................................................................................... 153
Figure 78: Event Review Display ......................................................................................................................... 154
Figure 79: 12 Lead Record Display .................................................................................................................... 154
Figure 81: Printer setting Menu .......................................................................................................................... 175
Figure 82: Print-out .................................................................................................................................................. 176
Figure 83: Print-out on shock .............................................................................................................................. 176
Figure 84: Print-out on 12 lead ECG data ....................................................................................................... 177
Figure 85: Print-out on setting information .................................................................................................. 177
Figure 86: Disposal ................................................................................................................................................... 180
Figure 87: Printer Paper Replacement ............................................................................................................. 184
Figure 88: Biphasic Waveforms at 300 Joules and 360 Joules ............................................................... 212
Figure 89: Biphasic Waveforms at 200 Joules ............................................................................................... 212
Figure 94: Biphasic Waveforms at 75 Joules ................................................................................................. 215

232 MGA22955 / GB / A
28.2 Tables
Table 1: PRIMEDIC™ DefiMonitor EVO Front Panel Controls.................................................................... 23
Table 2: PRIMEDIC™ DefiMonitor EVO paddle controls.............................................................................. 24
Table 3: Panel and Label Symbols ........................................................................................................................ 26
Table 4: Display Symbols .......................................................................................................................................... 28
Table 5: Display Colors Factory Defaults ............................................................................................................ 29
Table 6: Front Panel Indications for Power Source ........................................................................................ 40
Table 7: The PRIMEDIC™ DefiMonitor EVO Battery Status Icon .............................................................. 41
Table 8: Date/Time Menu ......................................................................................................................................... 45
Table 9: High Priority Alarms .................................................................................................................................. 50
Table 10: Medium Priority Alarms ........................................................................................................................ 50
Table 11: Low Priority Alarms ................................................................................................................................. 52
Table 12: Informative Messages ............................................................................................................................ 53
Table 13: Defibrillator Messages ........................................................................................................................... 54
Table 14: Visual Alarm Characteristics ................................................................................................................ 55
Table 15: Audible Alarm Characteristics ............................................................................................................. 56
Table 16: Alarm Limits Ranges ............................................................................................................................... 58
Table 17: Bell Icon ........................................................................................................................................................ 60
Table 18: ECG Lead Colors ....................................................................................................................................... 65
Table 19: ECG Lead Pairs ........................................................................................................................................... 65
Table 20: Measurement Matrix .............................................................................................................................. 72
Table 21: HR/PR Menu............................................................................................................................................... 75
Table 22: AED Mode Menu ...................................................................................................................................... 85
Table 23: Manual Mode Menu ............................................................................................................................... 92
Table 24: Pacing Mode Menu .............................................................................................................................. 102
Table 25: Monitor Mode Menu ........................................................................................................................... 108
Table 26: Cuff models and sizes ......................................................................................................................... 119
Table 27: NIBP Menu ............................................................................................................................................... 120
Table 28: SpO2 Sensors........................................................................................................................................... 127
Table 29: SpO2 Menu .............................................................................................................................................. 128
Table 30: Respiration Menu .................................................................................................................................. 131
Table 31: EtCO2 Menu ............................................................................................................................................. 138
Table 32: Temperature Sensors .......................................................................................................................... 141
Table 33: Temperature Menu .............................................................................................................................. 142
Table 34: IBP 1 Menu ............................................................................................................................................... 146
233
Table 35: IBP 2 Menu ............................................................................................................................................... 148
Table 36: Self-test functions ................................................................................................................................. 150
Table 37: Trouble shooting of Self-test ........................................................................................................... 151
Table 38: Parameter Ranges and Factory Defaults. .................................................................................... 188
Table 39: Delivered Energy at Every Defibrillator Settings into a Range of Loads ........................ 211
Table 40: Electromagnetic Emissions (IEC60601-1-2)................................................................................ 227
Table 41: Electromagnetic Immunity (IEC60601-1-2) ................................................................................ 227
Table 42: Electromagnetic Immunity (IEC60601-1-2) ................................................................................ 228
Table 43: Electro-surgical Unit Interference (IEC60601-2-27, IEC60601-2-30) ............................... 229
Table 44: Recommended Separation Distances .......................................................................................... 229
Table 45: Cables (IEC60601-1-2)......................................................................................................................... 230

234 MGA22955 / GB / A
29 Contact details
METRAX GmbH
Rheinwaldstr. 22
D-78628 Rottweil
Germany
Tel.: +49 741 257-0
Fax: +49 741 257-235
www.primedic.com
[email protected]
235
About us
The METRAX GmbH is a specialist in High-Tech equipment, whose Headquarters/Manufacturing:

userfriendliness
development of highly modern
METRAX GmbH
sets new standards. With Rheinwaldstr. 22
equipment for emergency
medicine. the brand PRIMEDIC™, Metrax D-78628 Rottweil
Germany
Founded in Rottweil in the year offers a reliable program of Tel.: +49 741 257-0
Fax: +49 741 257-235
1973, Metrax is considered a prime emergency medicine:
www.primedic.com
example of the strength of German Professional-level defibrillators and [email protected]
development technichnology: spirit mobile ultrasonic equipment.

METRAX GmbH
of innovation, highest quality and Emergency rescuers all over the
Shanghai Rep. Office
complete commitment in research world know PRIMEDICTM as a Unit B, 11/F First Trade Tower
No. 985 Dongfang Road,
and development distinguishes the guarantee for highest quality and Pudong New Area
undertaking since the past 30 years. innovative medical technology. Shanghai 200122
P. R. China
The results are precise and reliable Tel.: +86 21 632846-66
Fax: +86 21 633656-90
www.primedic.cn
[email protected]
METRAX GmbH
Moskau Rep. Office
Ul. Vavilowa 5, corpus 3
119334 Moskau
Russland
Tel.: +7 95 23170-61
Your dealer Fax: +7 95 23170-62
www.primedic.ru
[email protected]

MGA22955 / GB / A
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DefiMonitor EVO 18 MGA22955

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Operating Instructions PRIMEDIC™ DefiMonitor EVO

Mobile phones should not be used in the vicinity of the PRIMEDIC™

The PRIMEDIC™ DefiMonitor EVO is equipped with epoch-making ECG

Operating Instructions PRIMEDIC™ DefiMonitor EVO

3 Description of the PRIMEDIC™ DefiMonitor EVO 22

4 Setting up the PRIMEDIC™ DefiMonitor EVO 31

6 Using the PRIMEDIC™ DefiMonitor EVO 42

7 Alarms and Limits 49

7.3 Visual Alarm Indication .......................................................................................................................... 55

9 AED (Automated External Defibrillator) Mode 77

Operating Instructions PRIMEDIC™ DefiMonitor EVO

12 Monitor Mode 107

13 NIBP Monitoring 114

14 SpO₂ Monitoring 122

15 Respiration Monitoring 129

16 Capnography Monitoring 133

17 Temperature Monitoring 141

18 IBP Monitoring 143

19 Self-test Function 150

Operating Instructions PRIMEDIC™ DefiMonitor EVO

21 Menu Structure 156

23 External Interface 178

25.3 EMI (Electromagnetic Interference) ................................................................................................185

26 Factory Defaults 188

29 Contact details 235

Operating Instructions PRIMEDIC™ DefiMonitor EVO

1.1 General Safety Information

Operating Instructions PRIMEDIC™ DefiMonitor EVO

Operating Instructions PRIMEDIC™ DefiMonitor EVO

Operating Instructions PRIMEDIC™ DefiMonitor EVO

Operating Instructions PRIMEDIC™ DefiMonitor EVO

Operating Instructions PRIMEDIC™ DefiMonitor EVO

2.1 Intended Use for the PRIMEDIC™ DefiMonitor EVO

2.2 Indications for Use

2.3 About this Manual

Operating Instructions PRIMEDIC™ DefiMonitor EVO

PRIMEDIC™ EVO II Basic + SpO2 + NIBP + TEMP

3.1 Front Panel Components

Figure 1 Front panel components

Figure 2: Front panel components

1 Paddles (Sternum + Apex) 10 SHOCK button

2 Status LEDs 11 Multi function knob

3 LCD Display 12 Pacing Mode buttons

4 Soft key 13 NIBP button

5 Printer cover 14 PRINT button

6 Mode Select Switch 15 ALARM button

7 ANALYZE button 16 LEAD button

8 JOULE button 17 SIZE button

9 CHARGE button 18 Speaker

Operating Instructions PRIMEDIC™ DefiMonitor EVO

Multi function knob

3.2 Paddle Components

Figure 3: Paddle Components

Table 2: PRIMEDIC™ DefiMonitor EVO paddle controls

Energy Level buttons

3.3 Rear Panel Components

Operating Instructions PRIMEDIC™ DefiMonitor EVO

Figure 4: Rear Panel Components