MGA21324 - DefiMonitor XD - GB - J

www.primedic.
de
DefiMonitor XD
Operating instructions
21324 / GB / J
Masthead
Publisher
METRAX GmbH
Phone: +49 (0)741/257-0
Email: [email protected]
Web: www.primedic.de
Address: Rheinwaldstr. 22
D-78628 Rottweil
Germany
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).
21324 / GB / J
Table of contents
Table of contents
1 Introduction 1
1.1 Foreword..................................................................................................................... 1
1.2 Validity ........................................................................................................................ 1
1.3 Warranty ..................................................................................................................... 1
1.4 Disclaimers .................................................................................................................. 2
1.5 Symbols used in these operating instructions ............................................................... 3
1.6 Pictograms on the device ............................................................................................. 4
1.7 Pictograms on SavePads .............................................................................................. 5
2 Intended use 6
2.1 Indication/Contraindication for Defibrillation ............................................................... 8
2.2 Possible complications ................................................................................................. 9
2.3 Users ........................................................................................................................... 9
3 Safety information 10

3.1 General information................................................................................................... 10
3.2 General safety instructions ......................................................................................... 11
3.3 Safety notes for you, the user .................................................................................... 12
3.4 Safety notes for protection of the patient................................................................... 13
3.5 Safety notes for the protection of third parties ........................................................... 14
3.6 Safety notes for protection of the device.................................................................... 15
4 Description of device 16

4.1 General description .................................................................................................... 16
4.2 Description of device details ...................................................................................... 18
4.3 Capacity display ........................................................................................................ 24
4.4 Data management ..................................................................................................... 25
4.5 Description of the accessories .................................................................................... 26
4.5.1 Paddles .......................................................................................................... 26
4.5.2 PRIMEDICTM SavePads Connect cable ............................................................. 27
4.5.3 PRIMEDICTM SavePads (optional) .................................................................... 28
4.5.4 ECG patient cable, 3-pin................................................................................. 28
4.5.5 ECG patient cable, 2-pin................................................................................. 29
4.5.6 SpO2-Sensor (only for PRIMEDIC™ DefiMonitor XD3/XD30/XD300/XD330) 29
5 Preparatory measures before (initial) start-up 30

5.1 Unpacking .................................................................................................................30
5.2 Inserting / Changing the SaveCard ............................................................................ 30
5.3 Inserting / Changing the power supply unit (Battery) ................................................. 31
5.3.1 Inserting the battery ....................................................................................... 32
5.3.2 Removing the power module from the device ................................................ 33
5.4 Charging the battery (AkuPak) .................................................................................. 33
5.4.1 Charging the battery in the optional Primedic Charger ................................... 34
5.5 Connecting the mains cable ....................................................................................... 34
5.6 Inserting paper in the printer ..................................................................................... 35
6 Device self-test 36

6.1 Self-test when the PRIMEDIC™ DefiMonitor XD is switched on ................................ 36
6.2 Automatic, periodic self-tests ..................................................................................... 36
7 Operating the PRIMEDIC™ DefiMonitor XD 37

7.1 Switching on / off ..................................................................................................... 37
7.1.1 Switching the PRIMEDIC™ DefiMonitor XD on .............................................. 37
7.1.2 Switching the PRIMEDIC™ DefiMonitor XD off ............................................. 37
7.2 Selecting the operating mode .................................................................................... 38
7.2.1 Operating modes ........................................................................................... 38
I
Table of contents
7.2.2 Auto mode (AED mode) ................................................................................ 38

7.2.3 Manual mode (MAN Mode) .......................................................................... 38
7.3 Changing the configuration/setup............................................................................. 38
7.4 Parameter list menu .................................................................................................. 39
7.4.1 Changing the configuration – Example: time .................................................. 40
7.4.2 MMI Test (Man-Machine Interaction) ............................................................ 40
7.5 Alarms ...................................................................................................................... 40
7.5.1 ECG Alarm ..................................................................................................... 40
7.5.2 VF Alarm ....................................................................................................... 41
7.5.3 SPO2 Alarm ................................................................................................... 41
7.6 Event button ............................................................................................................. 42
7.7 Operating the printer ................................................................................................ 42
7.7.1 Log of the ECG signal .................................................................................... 42
7.8 Automatic printout after each shock (Autoprint)........................................................ 44
7.9 Printing out the Event Memory ................................................................................. 44
8 Applying the electrodes 45

8.1 Undressing the patient .............................................................................................. 45
8.2 Positioning ................................................................................................................ 45
8.2.1 Positioning self-adhesive electrodes and paddles ............................................ 45
8.2.2 Positioning the ECG self-adhesive electrodes.................................................. 46
8.2.3 Positioning the SavePads (Connect) for pacing ............................................... 46
8.3 Removing hair growth from chest ............................................................................. 48
8.4 Drying the skin.......................................................................................................... 48
8.5 Attaching the electrodes ........................................................................................... 49
8.6 Checking the electrodes ............................................................................................ 50
8.7 Changeover of ECG source ....................................................................................... 50
9 Auto mode (AED mode) 51

9.1 Voice output by the device / Preliminary examination of the patient ......................... 51
9.2 Carrying out ECG analysis in Auto mode ................................................................... 52
9.3 Defibrillation required ............................................................................................... 53
9.4 Defibrillation not required ......................................................................................... 55
9.5 Keeping the defibrillator ready for use ....................................................................... 55
10 Manual mode 56

10.1 Carrying out defibrillation ......................................................................................... 56
10.1.1 Power selection ............................................................................................. 56
10.1.2 Charging ....................................................................................................... 57
10.1.3 Triggering defibrillation .................................................................................. 57
10.2 SYNC and ASYNC mode ........................................................................................... 58
10.3 Keeping the defibrillator ready for use ....................................................................... 59
11 Attaching the SpO2 sensor 60
12 Operating the pacer 61

12.1 General information on operating the Pacer XD ........................................................ 61
12.2 Setting the Pacer operating modes ............................................................................ 62
12.3 Setting the stimulation rate ....................................................................................... 63
12.4 Setting the stimulation intensity ................................................................................ 64
12.5 Starting and stopping pacing ..................................................................................... 65
12.6 Defibrillation during pacing / Defibrillation via self-adhesive electrodes ..................... 67
13 Cleaning, maintenance and dispatch 68

13.1 Cleaning ................................................................................................................... 68
13.2 Servicing ................................................................................................................... 69
13.2.1 Servicing check list ......................................................................................... 69
13.3 Dispatching the PRIMEDIC™ DefiMonitor XD .......................................................... 70
14 Disposal 71
15 Technical Data 72
21324 / GB / J
Table of contents
16 Accessories 76
17 Warranty conditions 77
18 Depiction of the current time function 78
19 Rhythm detection system in AED mode 84
20 General information on the use of pulse oximeters 86
21 Guidelines and manufacturer's declaration – Electromagnetic emissions 88
22 General information and rules for use of the battery 92
23 Safety checks 94
24 Index of diagrams 95
III
Introduction
1 Introduction
1.1 Foreword
Dear User,
You are faced with the task of using the PRIMEDIC™ DefiMonitor XD in a medical
emergency on human beings.
To ensure that you can react quickly and correctly in this special situation and can
optimally use the options given with the device, it is necessary for you to read through
these operating instructions in your own time beforehand to familiarise yourself with
the device, its functions and the areas of application.
Keep these operating instructions near the device so that you consult any queries
which may arise.
If you should have any questions regarding the device or other PRIMEDIC™ products,
we are at your entire disposal.
You will find our contact address on the masthead at the start of these operating
instructions.
1.2 Validity
The information given in these operating instructions applies to all models in the
defibrillator range
PRIMEDIC™ DefiMonitor XD
made by METRAX GmbH.
Please note that, depending on its specific configuration, your device may not
correspond in all details to the information given in these operating instructions. See
the start dialogue of your PRIMEDIC™ DefiMonitor XD for the exact configuration of
your device.
1.3 Warranty
The warranty period is 24 months, beginning on the date of purchase. Please keep the
invoice as proof of purchase.
The general guarantee and warranty provisions of METRAX GmbH are applicable.
Any repairs or changes to the device may only be carried out by the manufacturer or
by a person or company authorised by the manufacturer.
21324 / GB / J 1
Introduction
1.4 Disclaimers
Liability claims in the event of damages to people or property are excluded if they are
based on one or more of the following reasons:
 Using the device in a manner for which it was not intended.

 Improper use and maintenance of the device.
 Operating the device with the protective covers removed or when there is obvious
damage to cables and/or electrodes.
 Non observance of the advice given in these operating instructions with regard to
operation, maintenance and repair of the device.
 Using accessories and spare parts made by other manufacturers.
 Autonomous intervention, repairs or constructional changes to the device.
 Autonomous overrunning of the performance limits.
 Lack of monitoring parts that are subject to wear and tear.
 Treatment of patients without prior indication.
2 Operating instructions DefiMonitor XD 21324 / GB / J

Introduction
1.5 Symbols used in these operating instructions
DANGER
Texts marked DANGER indicate an extraordinarily serious,
actual danger which will definitely lead to serious injury or
even death if no preventative measures are adopted.
It is imperative that you follow these instructions!
WARNING
Texts marked WARNING indicate extraordinarily serious,
possible dangers which, should no preventative measures be
taken, may lead to serious injury or even death.
It is imperative that you follow these instructions!
CAUTION
Texts marked with CAUTION indicate a possible dangerous
situation which could lead to minor injuries or damage to
property.
It is imperative that you pay attention to these texts.
This symbol indicates text which contains important advice / comments or

Note tips.
This point identifies the first step of a sequence of actions you should take.
Second step of an action you should take.
etc.
 This line marks lists
(3) Numbers in brackets refer to items in diagrams.
< ... > Texts set in angle brackets denote acoustic information / instructions of
the device which are shown simultaneously on the monitor, depending on
the device model.
21324 / GB / J 3
Introduction
1.6 Pictograms on the device
IP33 Protection against foreign bodies > 2.5 mm

Protection against spray water (60° to the vertical)
Please observe the operating instructions.
Do not dispose of device in domestic refuse.
Dangerous electric voltage (high voltage)
Degree of protection CF in connection with ECG patient cable:

10µA patient leakage current (NC – normal condition)
50µA patient leakage current (SFC – single fault condition)
100µA patient leakage current (SFC – defibrillation outputs)
according to IEC60601-1 and IEC60601-2-4
If patient
unconscious
min. 8 years, 25 kg Not breathing
Position
electrodes
When ready –
administer shock
Fig. 1: Brief instructions on use of devices with AED mode

Introduction
If patient unconscious
Not breathing
Position
electrodes
When ready –
administer shock
Fig. 2: Brief instructions on use of devices without AED mode
1.7 Pictograms on SavePads
Not to be reused
Expiry date
Batch ID
Only for adults
Order number
Storage temperature in Celsius and Fahrenheit
21324 / GB / J 5
Intended use
2 Intended use
This device is intended for use by appropriately trained medical personnel and doctors,
both in emergency medical services and in everyday clinical applications, in compliance
with applicable national legislation.
The device is frequently used in brief applications in the course of emergency medical
treatment (typically up to 2 hours).
It can be powered either by a rechargeable internal power source (battery) or from the
mains.
The device is used for transthoracic defibrillation. The main application is defibrillation
in asynchronous manual mode, while a further possible application is the cardioversion
of atrial fibrillation in synchronous manual mode after sedation of the patient. In
manual mode, the user decides whether it is necessary to administer a shock, while in
AED mode, the device automatically recommends defibrillation.
In automatic mode, the energy levels for the first, second and third shocks are
predetermined by the set current values 20A, 25A and 30A and the capacitor voltage
which depends on the patient impedance, while in manual mode, the energy levels 5J,
10J, 20J, 30 J, 50J, 100J, 200J, 300J, 360 J can be selected in order to allow the doctor
to define the defibrillation charge according to the weight of the patient. This means
that in manual mode, defibrillation can also be carried out on children if suitable pads
are used.
The device can also be used to record and display electrocardiograms. When the
electrodes are used as intended, the derivation from the defibrillation electrodes is in
the Einthoven II derivation. If an ECG cable and standard ECG electrodes are used
instead of the defibrillation pads, dual channel monitoring is possible. A random
(appropriate) selection of 2 signals from the Einthoven I, II, III or Goldberger aVR, aVL,
aVF – analogue derivations can be displayed. This requires correct positioning of the
electrodes as described in the operating instructions.
A further configuration of the device is to equip it with an SPO2 module and an SPO2
sensor to allow the oxygen saturation graph to be displayed in addition to the ECG
function.
A printer allows documentation of the current ECG graphs before and where
necessary, after defibrillation for comparison and evaluation in emergency medical
treatment. The quality of the ECG printout corresponds to that shown on the display,
as this was the only basis for deciding on the appropriate treatment in the specific
emergency situation. Graphic evaluation of the ECG printout is possible by displaying a
1 mV calibration.
In a further configuration of the device, a pacer module with adjustable modes Fix
(analogous to the S00 Mode), Demand (inhibiting, corresponds to SSI Mode) or
Overdrive can be added in manual mode, allowing transthoracic stimulation via self-
adhesive electrodes.
The transthoracic pacer can only be used Ii the event of bradycardia after sedating the
patient.

Intended use
A further area of application is transthoracic stimulation when the heart first begins to
beat bradycardially after defibrillation, in order to allow the necessary oxygen
saturation of the bloodstream to develop.
The device is designed for use anywhere, inside buildings and in the open and special
mounting fixtures are available allowing it to be carried in emergency rescue vehicles,
rescue helicopters or planes. It is designed to be able to accompany the patient from
the site of an accident or emergency to the hospital without changing the electrodes.
The device must not be used in locations where there is potential danger of an
explosion (e.g. explosive anaesthetic gas mixes).
NMR equipment or the radio equipment used by emergency services personnel can
cause interference as a result of the increased electromagnetic emission. In this case,
the limitations described in the operating instructions apply or where possible, shut off
or screen the sources of the interference.
WARNING
Any use above or beyond this is not considered as intended
use and can lead to personal injury or damage to property.
The PRIMEDIC™ DefiMonitor XD may only be used as
described and under the conditions detailed in these
operating instructions.
21324 / GB / J 7
Intended use
2.1 Indication/Contraindication for Defibrillation
WARNING
The defibrillator unit of the PRIMEDIC™ DefiMonitor XD

may only be used when dysrhythmia, such as ventricular
fibrillation/flutter or certain types of arterial and ventricular
tachycardia occur, accompanied by the following symptoms
(indication):
 patient is unconscious
 patient is not breathing normally
WARNING
The defibrillator unit of the PRIMEDIC™ DefiMonitor XD

must not be used if
 the patient is conscious or

 the patient is breathing normally or
 a normal pulse can be felt or
 asystolia or
 electrical activity without a pulse is detected
 For automatic mode: is a child under the age of 8 or
weighing less than 25 kg respectively.

Intended use
2.2 Possible complications
WARNING
 Irritation of the skin or even burns if, for example,

insufficient defibrillation gel is used.
 Possible damage to the myocardium as a result of the
defibrillation charge
 Cardiac arrhythmia (e.g. atrial fibrillation or flutter) may
occur after successful defibrillation or cardioversion.
2.3 Users
In manual mode, the PRIMEDIC™ DefiMonitor XD is to be used exclusively by

specially trained medical personnel.
In automatic mode, the PRIMEDIC™ DefiMonitor XD can be used by trained medical
personnel. Use of the equipment must be ordered by a doctor.
Improper use of the defibrillator can lead to ventricular fibrillation, asystolia or other
dangerous dysrhythmia.
The operator of the PRIMEDIC™ DefiMonitor XDs is responsible for ensuring that the
PRIMEDIC™ DefiMonitor XD is only used by authorised and trained specialist
personnel.
Note
The guidelines governing the application of emergency treatment in the
event of cardiac arrest may change. The device described in this operating
manual complies with the guidelines of the European Resuscitation Council
with Guidelines 2005 Resuscitation (2005) 67S1, S7—S23. [f1]
21324 / GB / J 9
Safety information
3 Safety information
3.1 General information

Both in conjunction with its accessories and the optional accessories, and also
individually, the PRIMEDIC™ DefiMonitor XD fulfils the currently applicable safety
standards and complies with the provisions of the medical products regulations
93/42/EC.
The device and its accessories are safe when used as intended and taking into account
the descriptions and information detailed in these operating instructions.
Despite this, if used incorrectly, the device and its accessories can be dangerous to the
user, the patient or third parties.
DANGER
For this reason, we emphatically advise that before using for

the first time, all those who are supposed to use this device
or want to use it
 must be instructed in a training session about the
medical background of defibrillation and the indications
or contraindications and thus need to be authorised.
 need to read and take note of these operating
instructions and in particular the safety tips and
warnings detailed in them.
WARNING
The PRIMEDIC™ DefiMonitor XD is not licensed for use in

explosive areas.
DANGER
Not using the device as intended or using it improperly,

exposes the user, the patient or third parties to the danger
 of an electric shock from the high voltage generated by
the device,
 of influencing active implants,
 of burns from incorrectly applied electrodes.
Apart from that, the device can be damaged or destroyed
through improper use.

Safety information
Note
Observe the information and rules in the appendix on using the PRIMEDIC™
DefiMonitor XD.
When carrying the DefiMonitor XD in a vehicle, the paddles must be secured
in the attachment provided and the device must be secured stored in a wall
bracket.
Applicable for Europe:
 The device complies with the Medical Device Directive (MDD).
Also applicable for Germany and Austria:
 The device complies with the Medical Devices Law (MPG) and is subject to the
Ordinance on the Operation and Use of Medical Devices (MPBetreibV).
 According to the Ordinance on the Operation and Use of Medical Devices
(MPBetreibV), the device is to be subjected to the regular checks explained in the
appendix.
 According to the Ordinance on the Operation and Use of Medical Devices
(MPBetreibV), a medical devices log needs to be kept for the device. Regular
checks of the device are to be documented in it.
For the other states in the European Community, national regulations for operating
medical devices apply.
3.2 General safety instructions
DANGER
The device may not be used in the vicinity of flammable

materials (e.g. cleaning solvents or similar) or in an
atmosphere enriched with oxygen or flammable
gases/vapours.
Monitor the use of the device at all times.
21324 / GB / J 11
Safety information
3.3 Safety notes for you, the user
WARNING
Only use the device on a patient if
 you have ensured its operational safety before using it

and that it is in good condition.
 the state of the patient requires or allows an application.
Before using the device, ensure that the temperature is within

the operating temperature range. This applies for example, if
the defibrillator is stored in a rescue vehicle.
Do not apply the device if it has been damaged or is
defective (e.g. if the defibrillator cable is damaged or the
housing has been damaged)
Do not touch the patient during defibrillation. Avoid any
contact between
 parts of the patient's body (such as bare skin on head or

legs), as well as
 conductible liquids (such as gel, blood or salt solutions)
and
 metal objects around the patient (such as the bed frame
or traction devices)
which present unintended paths for the defibrillation current!
Although the DefiMonitor XD and its original accessories are

defibrillation-protected, we recommend that you do not
touch them while defibrillation is being carried out with
another device.

Safety information
3.4 Safety notes for protection of the patient
DANGER
Do not use the device on a patient unless you have ensured
its operational safety before using it and that it is in good
condition!
Before using the device, ensure that the temperature is within
the operating temperature range. This is important, for
example, when the device is stored in an emergency services
vehicle in winter.
Do not use the device if it is defective (e. g. if the
defibrillation cable is damaged).
Only use the device with accessories, wearing parts and
disposable items which have proven to be completely safe to
use by being tested by a testing authority
licensed to test the device when equipped ready for use.
Use new, undamaged and unexpired defibrillation electrodes
for every patient to avoid any possible burns to the skin!
Only connect the self-adhesive electrodes with the
PRIMEDIC™ PRIMEDIC™ DefiMonitor XD. Use of the
electrode system with other devices can lead to dangerous
impedance currents for the patient!
Do not use the device in the immediate vicinity of other
sensitive equipment (e.g. measuring equipment that is
sensitive to magnetic fields) or strong sources of interference
which could affect the way the PRIMEDIC™ DefiMonitor XD
works. Keep a sufficient distance away from other
therapeutic and diagnostic energy sources (e.g. diathermy,
high frequency surgery, magnetic resonance tomography).
These devices can affect the PRIMEDIC™ DefiMonitor XD
and disrupt the way it operates. For this reason, disconnect
all other devices from the patient before carrying out
defibrillation.
During defibrillation, disconnect the patient from all other
medically used devices which do not have a defibrillation
resistant application part.
Keep the defibrillation electrodes and the ECG electrodes
away from other electrodes, metal objects and earthed
objects!
Do not use the device in AED mode on children under the
age of 8 or children with an estimated body weight of less
than 25 kg!
Position the electrodes precisely according to the description.
Dry the chest and carefully remove any large amount of hair
on the patient before applying the defibrillation electrodes.
Do not place the defibrillation electrodes directly over an
implanted pacemaker to avoid a possible misinterpretation by
the device and to avoid any damage to the pacemaker from
the defibrillation impulse.
21324 / GB / J 13
Safety information
Do not touch the patient during the ECG analysis and avoid
any vibrations.
If the ECG analysis is being carried out in a vehicle, the
vehicle has to stop and switch off the engine to guarantee a
correct analysis.
Stop any reanimation while the PRIMEDIC™ DefiMonitor XD
is analysing the ECG.
In the case of extreme fluctuations in the power supply, the
device should be disconnected from the mains, i.e. the mains
plug pulled out, and the device should be operated via the
integrated battery.
Strong sunlight may make it difficult to read the display.
The use of several medical devices simultaneously may
present a danger to the patient as a result of the
accumulation of patient currents.
3.5 Safety notes for the protection of third parties
DANGER
Warn people in the vicinity loudly and clearly before the

defibrillation so that they step back from the patient and are
no longer in contact with him.

Safety information
3.6 Safety notes for protection of the device
CAUTION Damage to property
 Repairs, changes, extensions and installations of the

PRIMEDIC™ DefiMonitor XD may only be carried out by
personnel authorised and trained by METRAX
 The PRIMEDIC™ DefiMonitor XD does not have any
parts that can be repaired by the user.
 Use only accessories which meet the requirements of the
relevant laws, EU directives and other standards. This
applies in particular to the SPO2 sensor, self-adhesive
electrodes and replacement batteries. These conditions
are fulfilled by all original PRIMEDIC™ accessories and
wearing parts.
 Only clean the device when it is switched off and the
electrodes have been removed and only clean it in the
prescribed manner.
21324 / GB / J 15
Description of device
4 Description of device
4.1 General description

The PRIMEDIC™ DefiMonitor XD is an external defibrillator with integrated 6-channel
ECG. The ECG can be recorded either via the PRIMEDIC™ SavePads, the defibrillation
paddles or the three-pin patient cable with self-adhesive ECG electrodes. The
PRIMEDIC™ DefiMonitor XD is available in various configurations. The respective
model is displayed in the start dialogue on the monitor.
In automatic mode (Auto mode), the ECG is analysed via the implemented algorithm.
If potentially fatal arrhythmia is detected, the device recommends defibrillation and
generates the necessary electric shock for reanimation when enabled by the user. No
electric shock is generated if the device does not detect an abnormal rhythm requiring
defibrillation.
In manual mode, the doctor or trained user decides whether defibrillation is necessary.
The following models are available:
 DefiMonitor XD1 Basic model with monitor and 6 channel ECG

 DefiMonitor XD3 Model with monitor and 6 channel ECG and pulse oximeter
 DefiMonitor XD10 Model with monitor and 6 channel ECG and pacer
 DefiMonitor XD30 Model with monitor and 6 channel ECG, pulse oximeter and
pacer
 DefiMonitor XD100 Model with monitor and 6 channel ECG and automatic mode
 DefiMonitor XD300 Model with monitor and 6 channel ECG, pulse oximeter and
automatic mode
 DefiMonitor XD110 Model with monitor and 6 channel ECG, pacer and automatic
mode
 DefiMonitor XD330 Model with monitor and 6 channel ECG, pacer, pulse
oximeter and automatic mode
The PRIMEDIC™ DefiMonitor XD - Generation has been designed to be safe and

quick to use in an emergency. All functional units are operating elements subject to the
following principles:
 Clear organisation of functional units

 Reduction of functions to what is necessary
 Intuitive and logical operator guidance
 Clear, self-explanatory operating elements
 Ergonomic layout.
The ECG monitor has a high-resolution graphics display which offers high image
contrast even in difficult lighting conditions.
The display on the PRIMEDIC™ DefiMonitor XD is only intended for the purpose of
identifying ECG rhythms in the course of emergency medical treatment.
The defibrillator unit has been optimised to be safe and quickly ready to use.

The PRIMEDIC™ DefiMonitor XD is powered by rechargeable batteries with nickel-

cadmium cells or via a power supply unit, independent of the respective model. The
charging electronics incorporate state-of-the-art technology, ensuring maximum
service life of the batteries used.
The PRIMEDIC™ DefiMonitor XD can be stored on an optional wall bracket which can
be affixed to a wall or in the ambulance. The electrical connections (mains voltage or
DC on board power supply voltage) can be accommodated in the wall bracket.
Amongst other functions, the console provides the power supply for charging the
battery.
A wide range of accessories are available.
The wall bracket and accessories are described in separate operating instructions.
21324 / GB / J 17
4.2 Description of device details
Fig. 3: PRIMEDIC™ DefiMonitor XD – front view

1 Carrying handle
2 Paddle
3 Paddle cable, detachable
4 Operating membrane
5 Monitor
6 Microphone
7 Status display

Fig. 4: PRIMEDIC™ DefiMonitor XD – rear view

1 Opening for hook of the one-hand quick release.
2 Specification plate
3 Quality seal
Fig. 5: PRIMEDIC™ DefiMonitor XD – view from below

1 SaveCard cover
2 Release button (to remove the power module)
3 Power module
21324 / GB / J 19
Fig. 6: PRIMEDIC™ DefiMonitor XD – side view

1 Loudspeaker
2 Jack for electrode connectors
3 Jack for SpO2 sensor (optional)
4 Jack for paddle cable
Fig. 7: PRIMEDIC™ DefiMonitor XD – side view

1 Unlocking lever for printer cover
2 Printer cover
3 Mains connection jack
4 Attachment device for bag (optional)

Fig. 8: PRIMEDIC™ DefiMonitor XD – status display
Display. Meaning Action to be taken

 Battery capacity  Device ready to use.
sufficient
 Battery low  Device can be used, battery
 Symbol also appears may need to be charged or
if no power module replaced
is inserted!  Insert power module.
 Battery capacity  Carry out extensive self-test
sufficient by reinserting battery or
 Device defective switching device on again
 Have the device repaired by
a dealer.
 Battery fully  Charge battery
discharged  Carry out major self-test by
 Device defective reinserting the battery or
switching the device on
again.
 Have device repaired by
authorised dealer
21324 / GB / J 21
Fig. 9: Operating membrane
1 Device On / Off button

2 Mode changeover switch AED/Manual with LED
3 SYNC button
4 Charging button for use with SavePads, can only be operated in manual mode
5 Energy level in joules (at 50 Ohm)

6 Menu keys
Select / confirm key
Key used to scroll upwards in the monitor menu or to increase parameters

and to select the derivation of the upper ECG graph
Key used to scroll downwards in the monitor menu or to decrease parameters

and to select the derivation of the lower ECG graph
7 Mains connection LED display

8 LED display Charge battery

9 Trigger button (shock button)
10 Printer On/Off (online print)
11 Paper feed
12 Event Marker
13 ECG source changeover switch
14 Alarm acknowledgement button, heart rate
15 Alarm acknowledgement button SpO2

16 Pacer XDxe On / Off button
17 Pacer mode changeover button DEMAND/FIX/OVERDRIVE
18 Stimulation rate +/-
19 Stimulation intensity +/-
20 Stimulation Start/Stop button with LED
21324 / GB / J 23
Abb. 10: Monitor display

1 Turn on time indicator / Energy level indicator / Pacer parameters
2 Mode AUTO/Manual
3 ECG channel display
4 Heart frequency and alarm settings display
5 Display SpO2 and alarm settings display
6 Status line displaying patients impedance, time, microphone, battery status ,paper status
7 Display ECG and SpO2 curve (max.2 )
8 SpO2 curve, informations
9 Calibration mark, height equals 1mV, size of illustration depends on ECG-sensitivity-setting
4.3 Capacity display

The charging status of the PRIMEDIC™ DefiMonitor XD is shown on the display. The
different possible images displayed have the following meaning:
Image on display Meaning
100 % charged
50% discharged
partly discharged or with reduced capacity
0% (device runs on until charge is exhausted)
Battery communication faulty or battery has reached the

end of its service life

The charging status of the battery is monitored electronically to ensure optimum

display of the capacity.
 In addition to this display, the PRIMEDIC™ DefiMonitor XD issues a warning

when the battery charge is running very low.
 If the battery is damaged (e.g. as a result of the memory effect), this is shown in
the screened area on the left side of the capacity display.
If the device is being used, the corresponding audible warning will be repeated once a
minute in the selected language.
Voice message Display on monitor

Battery < Charge status of battery is low, please Charge status of
charge > battery is low,
please charge
In order to ensure that the device is always ready for immediate operation,
Note we recommend that you have a charged replacement battery with you at all
times. Depending on the situation in which this voice message is issued, you
should consider replacing the battery.
4.4 Data management
The device records all the data on a removable SaveCard and also records all
Note noises in the surroundings via a microphone.
The saved data can be viewed with the help of a PC / laptop and the PRIMEDICTM ECG
Viewer software, but must not be used for diagnosis or therapy of the patient! This
data is only intended for administrative or legal purposes. In the software there is a
deployment protocol into which further patient data can be entered.
The data saved on the SaveCard should be filed externally after every deployment if
possible. If the memory capacity of the SaveCard is full, then no further data will be
saved. The device is ready for use both with an exhausted memory and also without a
SaveCard.
Operating the software is described separately.
21324 / GB / J 25
The SaveCard supplied with the device is already formatted and can be used straight
away. If you have any problems with the available SaveCard or new CF cards, you
have to format them with the FAT32 file system.
To attain the greatest possible degree of safety here, please proceed as follows:
Windows 2000, Windows XP, Windows Vista
Start a command line window using "Start->Run" and in the entry field, enter
" cmd.exe ". The command line window will then open.
There you enter the following: format f: /U /FS:FAT /X /V:savecard (where f:

stands for the drive letter of the of the CF card reading device which you may
have to adjust).
4.5 Description of the accessories
The accessories need to be secured appropriately before being transported.
4.5.1 Paddles
The PRIMEDIC™ DefiMonitor XD features ergonomically shaped defibrillation paddles
with integrated child paddles for the defibrillation of children.
To access the child paddles, unscrew the large electrodes on both paddles by turning
them anticlockwise. You now have a reduced electrode surface suitable for children.
The adult paddles are screwed on in clockwise direction over the child paddles.
Clean the child paddles after use and before screwing on the adult paddles again.
Make sure that the adult paddles engage securely over the child paddles to ensure
good contact

Fig. 11: Locking the adult paddles in place over the electrodes for children
Do not use the child-sized electrodes on adults, as they will not provide
Note adequate defibrillation.
4.5.2 PRIMEDICTM SavePads Connect cable
2
.
Fig. 12: PRIMEDIC SavePads Connect cable, 2 pin

1 Connector
2 Connecting clips for SavePads Connect
21324 / GB / J 27
4.5.3 PRIMEDICTM SavePads (optional)
Fig. 13: PRIMEDICTM SavePads, 2-pin

1 Connector
2 SavePads (defibrillation electrodes with protective film)
4.5.4 ECG patient cable, 3-pin
Fig. 14: ECG patient cable, 3-pin

1 3-pin ECG electrode cable with connector
2 Electrode clips (red, green, yellow)
3 ECG electrodes (Ag/AgCl)

4.5.5 ECG patient cable, 2-pin
Fig. 15 ECG patient cable, 2-pin

1 2-pin ECG electrode cable with connector
2 Electrode clips (red, green)
3 ECG electrodes (Ag/AgCl)
4.5.6 SpO2-Sensor (only for PRIMEDIC™ DefiMonitor

XD3/XD30/XD300/XD330)
Fig. 16: SpO2 sensor and adapter cable

1 Cable for SpO2 sensor
2 Reusable SpO2 sensor
3 Plug (for connecting the sensor cable to the adapter cable)
4 Jack (with locking device)
5 Plug (for connecting the adapter cable to the device)
6 Adapter cable
21324 / GB / J 29
Preparatory measures before (initial) start-up
5 Preparatory measures before (initial) start-up
5.1 Unpacking
After delivery, first of all check the packaging and the device for transport damage.
If you notice any damage to the device, immediately contact your transport company,
dealer or directly contact technical services at METRAX GmbH, stating the device
number and describing the damage to the device.
DANGER
Definitely do not use the device if you know of any damage.
Endangering health can not be ruled out.
Satisfy yourself that the scope of delivery is complete in accordance with the enclosed
delivery note.
5.2 Inserting / Changing the SaveCard
Fig. 17: PRIMEDIC™ DefiMonitor XD – SaveCard

1 SaveCard slot
2 SaveCard removal button
3 Cover

Procedure:
Lay the device on its back and remove the power module
Open the SaveCard slot by sliding the cover towards the power module slot
Push the SaveCard into the slot (1) provided. Press the SaveCard in carefully until
button (2) protrudes from the opening. To remove the SaveCard, press button
(2) in fully – the SaveCard now protrudes from the holder. The card can now be
removed.
Then close the cover.
Replace the power module in the device. The device now boots and performs a
self-test.
Wherever possible, the data saved on the SaveCard should be downloaded

Note and filed externally after each deployment. Once the storage capacity of the
SaveCard is exhausted, no further data will be saved. The device remains
ready for operation even if the memory is exhausted and even without a
SaveCard.
5.3 Inserting / Changing the power supply unit (Battery)
The PRIMEDIC™ DefiMonitor XD can be operated with two different power modules.
 the rechargeable battery(AkuPak) or

 the internal power pack with mains cable.
If you operate the PRIMEDIC™ DefiMonitor XD exclusively via the internal

Note power pack, you must ensure that the battery is inserted in the power
module slot. Without this, the PRIMEDIC™ DefiMonitor XD is not
operational.
WARNING
Whenever the device has been used, check the power level.
It may also be necessary to recharge the battery. If this is not
possible make sure you always have a second, fully charged
battery to hand to ensure that the device is always ready for
use!
21324 / GB / J 31
5.3.1 Inserting the battery
Fig. 18: PRIMEDIC™ DefiMonitor XD – Inserting the battery
Procedure:
Lay the device on its back.

Push the (new) power module into the device in the direction shown by the arrow
(1) until it rests against the left-hand stop.
Press the front of the power module into the slot in the direction shown by the
arrow (2) until you hear a "click" as the unlocking device engages securely with
the tongue on the power module.
The power module should now be in fully inserted position, flush with the front
housing of the device. It should not fall out when the device is moved. If it does, it is
not securely engaged.
The device switches on automatically when the battery is inserted and

Note performs an automatic self-test.
Monitor the Status Display. If the display is showing "OK", the device is
ready to use.
Switch it off (if required) by pressing the On / Off button.
CAUTION
If the display does not read "OK" or if a fault message

appears on the monitor, remedy the cause or contact your
nearest service station. The device will switch itself off.

5.3.2 Removing the power module from the device
Fig. 19: PRIMEDIC™ DefiMonitor XD – Removing the power module
Only change the power module when the device is switched off and the
Note defibrillation electrode plug is disconnected.
Procedure:
Lay the device on its back and press the release button in the direction shown by
the arrow (1.) until the tongue on the power module is released and the power
module snaps out of the slot.
Turn the power module in the direction of arrow 2 and then pull it out of the
device.
5.4 Charging the battery (AkuPak)
The battery can be charged in two different ways:
 with the integrated power pack and / or

 in the Primedic Charger (optional).
The integrated discharge monitoring function protects the battery from being fully
discharged. If the battery charge is too low, both a visual and an acoustic signal are
issued.
21324 / GB / J 33
A completely discharged battery must be charged for at least 2.5 hours. The
Note design of the battery means that if you don't charge it long enough, the
device may give you a faulty reading of the charge status. The charge display
will then indicate (incorrectly) that the battery is fully charged. Safe operation
of the device may not be possible.
Ensure that the ambient temperature is between 0 - 45°C during charging.
Charging the battery at operating temperatures outside this range can

Note damage the battery. Allow the battery to reach the ambient temperature
before charging it, or charging may be interrupted prematurely.
If the device registers excessive temperatures, it will interrupt charging the

battery until the temperature is within the valid range. This prevents harmful
overcharging of the battery. If the battery is not charged, the PRIMEDIC™
DefiMonitor XD can be operated using the integrated mains power pack. The battery is
then charged automatically during operation of the PRIMEDIC™ DefiMonitor XD. This
increases the charging time.
For further information on NiCd batteries and how to charge them, see Chapter A5.
5.4.1 Charging the battery in the optional Primedic Charger
See the separate operating manual for the Primedic Charger.
5.5 Connecting the mains cable
Procedure:
Plug the cable into the jack on the device.

Plug the mains plug into a properly earthed safety socket with the correct voltage.
Ensure that the battery is inserted in the power module slot. This is vital to
Note ensure fault-free operation of the PRIMEDIC™ DefiMonitor XD via the
mains. The 3-pin cable provided must be used.

5.6 Inserting paper in the printer
Procedure:
Press the release button above the paper compartment. The printer cover can
now be folded forward.
Prepare the roll of paper provided (remove adhesive strip, unroll approx. 5cm of
paper)
Insert the roll of paper into the printer so that the side with the check pattern
faces upwards.
Close the cover.
The cover is designed to spring out of its position without damage if great
Note pressure is exerted from the outside.
21324 / GB / J 35
Device self-test
6 Device self-test
6.1 Self-test when the PRIMEDIC™ DefiMonitor XD is

switched on
The self-test is triggered by switching on the PRIMEDIC™ DefiMonitor XD or by

inserting the battery in the device. The self-test checks all important functions and
signalling devices. If the power module has been changed and if the device had
previously found a fault, then the full self-test (FULL) is automatically triggered. Please
proceed to follow the device instructions.
6.2 Automatic, periodic self-tests
The device carries out automatic self-tests to ensure that it is always ready for
operation. Self-testing is only possible if the PRIMEDIC™ DefiMonitor XD is either
connected to the mains or if a charged battery has been inserted.
Frequency Scope of test

SHORT Daily Software, operating membrane, ECG calibration,
clock, internal voltage supply and HV part at
0V
MEDIUM First day of the month Software, operating membrane, ECG calibration,
clock, internal voltage supply and HV part at
300 V
st st
LONG On July 1 and January 1 every Software, operating membrane, ECG calibration,
year clock, internal voltage supply and HV part at
1600 V
FULL After changing the power Software, operating membrane, ECG calibration,
module or detection of an clock, internal voltage supply and HV part at
internal fault 1600 V, microphone test

Operating the PRIMEDIC™ DefiMonitor XD
7 Operating the PRIMEDIC™ DefiMonitor XD
7.1 Switching on / off
7.1.1 Switching the PRIMEDIC™ DefiMonitor XD on
The device is switched on by pressing the On / Off button. Directly after switching it
on, an internal self-test is carried out to check important functions and signal devices. If
the self-test is successful, the device is immediately ready for operation in the
corresponding mode (manual for the DefiMonitor XD1, XD3, XD10, XD30 or
automatic for the PRIMEDIC™ DefiMonitor XD100, XD110, XD300, XD330).
Standby is confirmed by a beep. It is important to ensure that the buzzer is working.
7.1.2 Switching the PRIMEDIC™ DefiMonitor XD off
The device can be switched off in different ways:

 By pressing the On / Off button for approximately 2 seconds. A continuous
warning beep will sound simultaneously.
 If 10 minutes elapse without the device detecting any signal source or if no button
is pressed for 10 minutes, it switches off automatically.
 If the device detects a fault it will automatically switch off to avoid possible
injuries.
21324 / GB / J 37
7.2 Selecting the operating mode
7.2.1 Operating modes
Depending on the specific model, it is possible to select one of two operating modes:
 AUTO mode and
 manual mode (MAN Mode)
7.2.2 Auto mode (AED mode)
In this operating mode, the device automatically analyses the cardiac rhythm.
If potentially fatal arrhythmia is detected, the device recommends defibrillation and
generates the necessary electric shock for reanimation when enabled by the user. No
electric shock is generated if the device does not detect an abnormal rhythm requiring
defibrillation. The device recommends cardiopulmonary resuscitation. For further
information, see Chapter 9.
7.2.3 Manual mode (MAN Mode)
Pressing the MAN/AUTO button switches the PRIMEDIC™ DefiMonitor XD to manual

operating mode. Manual mode is now activated. The orange LED lights up to indicate
this status. For further information, see Chapter 10.
The device switches to Auto Mode:

Note
 when it is switched off and back on again or
 when the MAN/AUTO button is pressed.
7.3 Changing the configuration/setup
The device is configured at the factory.

Certain parameters can be changed in the setup menu. The new configuration remains
stored until it is changed again, irrespective of whether the device is switched off or the
power module replaced.
Press the selection / confirmation key during operation to open the setup menu .
Press the  key (up) or the  key (down) to navigate within the menu and to increase
or reduce a selected parameter value and press the  key to select a parameter and
confirm the new entry.

7.4 Parameter list menu
Page 1:
Alarm SpO2: Lower limit, upper limit of SPO2 alarm
Alarm SpO2: [On / Off]
Alarm ECG: Lower limit, upper limit of ECG alarm
Alarm ECG: [On / Off]
Print form: [ 1-channel / 3-channel / 6-channel]
Sensitivity: [5 mm/mV, 10mm/mV, Optimal, 15mm/mV]
Derivation: I II III aVL aVR aVF
Page 2:
Contrast: from 60 to 180
Microphone: [On / Off]
BLS Advices: [On / Off]
CPR Cycles: Number can be selected 1-5
CPR Tones: 0% / 25% / 50% / 75% / 100%
Sound Vol: 0% / 25% / 50% / 75% / 100%
Systole Sound: 0% / 25% / 50% / 75% / 100%
Page 3:
Auto print: [On / Off]
Memo print : Printing from printer memory, see Chapter 7.9
Printing speed: [25 mm/s / 50 mm/s]
Language: (depends on installed language packages)
Time: 00:00 in 24-hr. format
Date: in format DD/MM/YYYY
Guide line: ERC/AHA
MMI test Interactive testing of operating membrane, see Chapter
7.4.2
Page 4:
ARM SW: Version number – Check sum Date (e.g. Jul. 11 2005)
DSP SW: Version number – Check sum Date (e.g. Jul. 11 2005)
MSP SW: Version number - check sum Date (e.g. Jul. 11 2005)
ULF: Check sum 8-digit
Serial No. xxxxxxx
Page 5:
BQ SW Version: x.x
BQ serial number: xxxxxxx
Ext. MSP SW: Version number - check sum
Ext. MSP HW: Version number
SpO2 version: xxxx
Pacer version SW: xxxx
Pacer version HW: xxxx
21324 / GB / J 39
7.4.1 Changing the configuration – Example: time
If, for example, you want to update the time, move the highlighted section upward by
pressing the  button repeatedly until the menu item Time is highlighted.
Select the highlighted menu item Time by pressing the  key. The hour is then
highlighted.
Change the hour by pressing the  or  key.
Confirm the correct value with the  key. The minute is now highlighted.
Change this entry as described above. When this value is confirmed by pressing  , the
menu item Time is highlighted again.
If required, you can now make other changes in the same way.
To exit the setup menu, use the key  or  to move the highlighted section to the
menu item END Setup and confirm with  . 
The device is now ready for operation again.
7.4.2 MMI Test (Man-Machine Interaction)
In the MMI Test, the buttons, the display and the acoustic system of the DefiMonitor
are tested for correct functioning. This function is mainly used for safety inspections
and servicing purposes.
7.5 Alarms
Depending on the equipment, the PRIMEDIC™ DefiMonitor XDxe monitors the heart
rate from the ECG signal and the oxygen saturation of the patient from the SPO2
sensor. If the SPO2 sensor only is connected to the patient, the heart rate displayed is
that determined from the SPO2 signal. Accordingly the equipment ECG, VF Alarm and
SPO2 Alarm differ.
The alarms are always activated when the PRIMEDIC™ DefiMonitor XDxe is switched
on. The alarm limits can be specifically configured by the user in the Setup menu and
are retained after the monitor has been switched off. Generally the alarm is both
acoustic and visual, but departures from this may occur, depending on the operating
situation, and these are explained in the following sections.
7.5.1 ECG Alarm

The range of adjustment of the ECG Alarm is from 30 – 300 beats per minute [bpm].
The lower alarm limit can be selected in the range 30 – 99 beats per minute. The upper
alarm limit cannot be lower than the lower limit and the value selected can be up to
300 beats per minute. The lower and upper alarm limits are displayed on the monitor.
Changes can only be made in the Setup menu. When one of the set limits is attained
an ECG Alarm is initiated. If no valid heart rate can be obtained (e.g. on the occurrence
of an asystole (cardiac arrest) an alarm is likewise initiated. In this case the heart rate is
indicated in the form of dashes.

The Alarm in the event of an asystole (cardiac arrest) and on exceeding the set ECG
limits takes the form of a loud tone, alternating quickly between 2 pitch levels of
approx. 5 seconds duration. This alarm is repeated every 20 seconds. At the same time
a bell symbol and the heart rate flash on the display.
The ECG Alarm button is used to acknowledge the ECG Alarm. The acoustic Alarm is
suppressed for the duration of one minute. During this period of time the bell symbol
on the display is crossed out. Pressing the button again during this period reactivates
the Alarm. The alarm limits are retained.
The ECG Alarm can be deactivated in the Setup menu. When the ECG Alarm is
deactivated the bell symbol is permanently crossed out. If in this case the alarm limits
are exceeded no acoustic alarm is initiated, but the bell symbol and heart rate flash, in
order to inform the user.
Note: If the equipment is operated with PRIMEDIC™ SavePads Connect-Electrodes on
the patient, in auto mode the bell symbol for the ECG Alarm is always crossed out, in
order to indicate that in this condition no ECG Alarm occurs. By this means interfering
messages are avoided during the repetition of the HLW request.
7.5.2 VF Alarm
The VF Alarm only occurs during ECG monitoring with ECG electrodes / ECG cable, by
means of which shocks cannot be applied. With the VF Alarm eight gong-type muffled
tones are heard over a period of approx. 5 seconds, which are repeated every 20
seconds and accompanied by the verbal message
< Analysis recommended, use SavePads >.
If the ECG Alarm is activated, the acoustic Alarm takes place with the ECG Alarm tone.
The speech output is always provided.
The VF Alarm requires, that the ECG cable and the ECG electrodes are replaced by the
PRIMEDIC™ SavePads Connect-Cable with SavePads Connect defibrillation electrodes,
or otherwise no defibrillation can take place. Whilst defibrillation can take place via the
paddles parallel to the ECG electrodes in the manual mode, in the Auto mode
defibrillation is only possible via SavePads Connect-Electrodes.
The VF Alarm cannot be suppressed by the Mute button.
Warning: Defibrillation cannot take place via an ECG monitoring cable. If shock-driven
rhythms (e.g. VF) occur during the ECG monitoring, the use of the SavePad Connect-
Cable with defibrillation electrodes is necessary.
7.5.3 SPO2 Alarm

The SPO2 Alarm is only available for equipment with SPO2 functionality. The adjustment
range for the SpO2 alarm is 70-100%. The lower and upper alarm limits of the SpO2
value are displayed on the monitor. Changes can only be made in the Setup menu.
When one of the set limits is exceeded the SpO2 Alarm is initiated.
The Alarm on exceeding the set SPO2 limits takes place in the form of a deep interval
tone, quickly alternating between 2 pitch levels of approx. 5 seconds duration. This
alarm is repeated every 20 seconds. At the same time the bell symbol and the SpO2
value flash on the display.
The SpO2 Alarm button is used to acknowledge the SpO2 Alarm. The acoustic Alarm is
suppressed for the duration of one minute. During this period of time the bell symbol
on the display is crossed out. Pressing the button again during this period reactivates
the Alarm. The alarm limits are retained.
The SpO2 Alarm can be deactivated in the Setup menu. When the ECG Alarm is
deactivated the bell symbol is permanently crossed out. If in this case the alarm limits
are exceeded no acoustic alarm is initiated, but the bell symbol and heart rate flash, in
order to inform the user.
21324 / GB / J 41
7.6 Event button
Pressing the event button puts a mark on the ECG which triggers storage of the ECG
for 5 seconds before and 5 seconds after the event. This event can then be printed out
later from the event memory and/or viewed on the computer monitor in the stored
patient file via the ECG Viewer.
The printing format for the Memo print is always 3-channel print. The signal
Note graphs displayed on the monitor at the time of the event are printed out.
7.7 Operating the printer
The printer can only be operated or used in manual mode.

Note
7.7.1 Log of the ECG signal
The PRIMEDIC™ DefiMonitor XD is equipped with a high-resolution printer. ECG

printout of 3 to 6 channels simultaneously is possible. Printing speeds of 25 and 50
mm/s can be selected.
The online print function for logging the ECG graph during monitoring is activated by
pressing the printer On/Off button.
Pressing the printer On/Off button again stops the log printout. ECG printout is made
with the parameters selected in the setup menu. The following settings can be
selected:

Printing parameter Meaning

1 channel print prints the upper ECG channel displayed on the monitor. If SpO2
measurement is active, the SpO2 pulse graph is also displayed.
3 channel print prints 2 ECG channels + 1 channel SpO2 simultaneously,
depending on which monitoring is displayed.
6 channel print prints the maximum possible number of derivations I, II, III,
aVR, aVL, aVF simultaneously, depending on the electrodes
attached, with a maximum of 3 derivations, each 5 seconds
before and 5 seconds after pressing the button.
25 mm/s - printer speed Printout is produced at 25 mm/s.
50 mm/s - printer speed Printout is produced at 50 mm/s.
The following relevant parameters are printed out in a header:
 Date, time
 Speed
 Scale
 Heart rate
 Filter
 Energy (Joule)
 Mode
 SpO2 value (only on models XD3, XD30, XD300 and XD330)
There is a time lag of 7 seconds between the monitor display and the printout, i.e.
events which occurred before activation of the printout function can be displayed. If
the printout is stopped, printout also ends with data recorded 7 seconds previously.
On models with SpO2 measurement, it is possible to show the SpO2 pulse graph in the
log printout.
Use the integrated cutting edge on the printer cover to tear off the ECG log printout.
Tear off the strip upwards and to the side.
Careful selection of data to be printed out and keeping printing time to a

Note minimum saves energy and paper and means that the device can be operated
for a longer not on the mains. This applies especially to printing at a speed of
50 mm/s.
Charging interrupts all print modes.

Note
If the ECG monitoring is changed during online printing, the printer is stopped
immediately, the header is reprinted and the printout is then continued. Data still
stored at the time of the changeover are discarded, the new printout starts at the time
of the changeover.
21324 / GB / J 43
7.8 Automatic printout after each shock (Autoprint)
The PRIMEDIC™ DefiMonitor XD allows you to record the event automatically each
time defibrillation or cardioversion is performed. Data from 5 seconds before and 5
seconds after the shock was administered are recorded.
The Autoprint function can be switched on and off in the setup menu. When the
device is delivered, the function is switched off.
If the Autoprint function is activated in the setup menu, it remains active even if the
defibrillator is switched off or the battery replaced.
7.9 Printing out the Event Memory
The PRIMEDIC™ DefiMonitor XD automatically stores the last 30 defibrillations /

cardioversions / events in an Event Memory. It stores the ECG (5 seconds before and 5
seconds after each shock) and the pulse graph (only on XD 3, XD30, XD300 or XD330
if SpO2 active) as well as all relevant parameters.
A new event will then “push” the oldest event out of the memory.
The memory content, starting with the last recorded event, is printed out in the setup
menu.
Procedure:
Open the setup menu and select the menu item “Memo Print” with the cursor
keys.
Press Enter.
The Memo Print function is activated. To stop the printout, press the printer On/Off
button. Printout is produced at 25 mm/s.
Data in the Event Memory remains stored even after printout. It can be
Note printed out as often as required.
Fault messages on the display:
Symbol on the display Cause
No paper
Printer error

Applying the electrodes
8 Applying the electrodes
8.1 Undressing the patient
If during your preliminary examination, you have ascertained that the patient needs
defibrillation, undress his upper body to be able to position the electrodes.
8.2 Positioning
8.2.1 Positioning self-adhesive electrodes and paddles
Fig. 20: Positioning the defibrillation electrodes on the patient
The defibrillation electrodes are positioned

 On the right chest area, below the collar bone (1) and
 On the left chest area above the apex of the heart on the axillary line (2).
Incorrectly positioned electrodes can lead to faulty readings.
CAUTION
Medicinal plasters must be removed before attaching the
defibrillation electrodes.
21324 / GB / J 45
Note The PRIMEDIC™ DefiMonitor XD carries out automatic impedance measurement.

Defibrillation can only be carried out if the patient is within the permissible impedance
range. See Chapter "Technical Data“. Ensure that the electrodes have good contact.
8.2.2 Positioning the ECG self-adhesive electrodes
Fig. 21: Positioning the electrodes on the patient
The correct positions for the ECG self-adhesive electrodes are:
1 red (R) directly below the centre of the right clavicle (medioclavicular)
2 green (F) directly below the left chest muscle on the medioclavicular line
3 yellow (L) directly below the centre of the left clavicle (medioclavicular)
Incorrect positioning of the electrodes, defective or dry electrodes can lead to

Note faulty readings. For this reason, always use ECG self-adhesive electrodes
approved by Metrax.
8.2.3 Positioning the SavePads (Connect) for pacing
Two different electrode positions have proved effective for cardiac stimulation:
 anterior - posterior position.

 anterior - anterior position,
The positioning and the polarity of the electrodes has a significant influence on the
intensity of the stimulation required.
The preferred position is the anterior - posterior position.

Position
Anterior Green (F) ( - ) front left of chest, between sternum and
left nipple and (roughly V2/V3 position)
Posterior Red (R) ( + ) back left of chest, between tip of
shoulder blade and spine
The anterior-posterior position offers the advantage that the intensity of the
stimulation required is often lower, which means that the chest muscles are subjected
to less stimulation.
If the anterior-posterior position is contraindicated (e.g. if ventricular fibrillation is
expected to occur), the anterior - anterior position can be used as an alternative.
The positions correspond to those of the self-adhesive electrodes for defibrillation.
Position
Anterior Green (F) ( - ) corresponding apex position, left side of
chest, above the apex of the heart on the
axillary line
Anterior Red (R) ( + ) corresponding sternum position, right side
of chest below the clavicle
Note
Pacing is only advisable and possible in manual mode with self-adhesive
electrodes
DANGER
It is important to attach the self-adhesive electrodes in the
following order to avoid danger to the user as a result of the
stimulation pulse:
First, connect the pacer/defibrillation cable to the self-

adhesive electrodes on the patient with the electrode
clip. To do this, open the locking lever on the clip and
insert the metal-plated connection tab into the slit in the
electrode clip
Snap the upper part of the clip back in place to fix the
connection.
Observe the colour marking showing the polarity of the
electrode chips when attaching them to the respective
electrodes
Connect the cable with the PRIMEDIC™ DefiMonitor
XD.
21324 / GB / J 47
If it should become necessary during pacing to defibrillate the patient,

Note defibrillation can be carried out via the self-adhesive electrodes. Make sure
the electrodes are correctly positioned for defibrillation.
DANGER
Adults must only be paced with the appropriate self-adhesive
electrodes for adults, children only with smaller, child-sized
self-adhesive electrodes.
Always use original PRIMEDIC™ SavePads (Connect).
8.3 Removing hair growth from chest
Hair at the point of attachment of the electrodes increases the transition resistance and
impairs the adhesion of the electrodes. If the patient has a lot of hair growing where
the electrodes need to be positioned, you must remove it.
Use a razor to remove the hair from the electrode positions.
8.4 Drying the skin
In certain situations (e.g. after an acute myocardial infarction), it may be necessary to

dry the skin in the respective positions. A dry surface is essential for the adhesive
electrodes to stick on.

8.5 Attaching the electrodes
Fig. 22: Removing the protective film from the electrodes

1 Protective film
2 Electrode coated with electrolyte gel
In automatic mode, the PRIMEDIC™ DefiMonitor XD gives voice commands
instructing you to attach the defibrillation electrodes to the patient.
Please proceed as follows:
Open the SavePads packaging by tearing open the protective cover along the tear
strip.
First, remove the protective film (1) from one electrode (2) and them immediately
place the electrode on the position you had ascertained previously.
Proceed to remove the protective film from the second electrode and place it in its
position.
Smooth the electrodes onto the patient ensuring there are no air bubbles under
the electrodes!
Plug the connector of the electrode cable into the socket of the device, which is
switched on. Make sure that the locking pin locks into place.
The message < Check electrodes > should no longer be displayed.
To be able to unplug the electrode plug, you have to push on the top part of
Note the locking pin while at the same time pulling the plug out.
Do not touch the floor, other objects, clothing or other parts of the body with
Note the exposed electrodes – this could remove the conducting layer of gel from
the electrodes.
21324 / GB / J 49
WARNING
A reduced layer of gel could cause irritation or burns to the
skin under the electrodes during defibrillation!
Observe the brief instructions for use on the packaging of the

self-adhesive electrodes.
8.6 Checking the electrodes
CAUTION
The message <Check electrodes> can be issued by the device
for several reasons:
 There is contact between the defibrillation electrodes or
a conductive gel connection.
 Patient's body hair has not been removed and is causing
high transition resistance.
 Air pockets between skin and defibrillation electrodes
cause a bad contact.
 Dried out electrodes.
 Electrode plugs not plugged in
Remedy the cause of the fault.
On models with SpO2, this message does not appear on the display.
Note
8.7 Changeover of ECG source
The ECG can be recorded via the defibrillation paddles or via the self-adhesive
electrodes. Press the ECG source changeover button to switch to paddles or self-
adhesive electrodes.

Auto mode (AED mode)
9 Auto mode (AED mode)

If your device has AED mode, it will start in AUTO mode after being turned on in order
to enable treatment by trained non-experts as well as first-aiders.
The device is designed for reanimation procedure as recommended by the guidelines of
the European Resuscitation Council (2005) International Guidelines 2005 for CPR and
ECC and American Heart Association (AHA), 2005: American Heart Association
(Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
(CPR) 2005).
In the PRIMEDIC™ DefiMonitor XD is the ERC-guideline factory-provided

Note preconfigured. A change of the guideline is possible in setup-menu.
When the device is switched on and has successfully completed self-testing, it is ready
for operation.
In automatic mode, defibrillation is exclusively enabled by the PRIMEDIC™

Note DefiMonitor XD after it has detected ventricular fibrillation (VF). The paddles,
energy level selection buttons, source selection buttons, pacer buttons, the
printer and charging buttons are disabled in AUTO mode. An acoustic
warning signal is sounded if these buttons are pressed while the device is in
automatic mode.
9.1 Voice output by the device / Preliminary examination of

the patient
During the course of the voice output, you will be asked to examine the patient.
After the self-test has been successfully performed by the device, the following
instructions are given:
< Check patient >

< Call emergency services >
< Open airways, carefully overstretch head >
< Check breathing >
< If there is no breathing, Give 30 chest compressions >
< Give 2 rescue breaths >
< Apply electrodes to patients bare chest >
< Plug in electrode cable >
Before positioning the electrodes on the patient, carry out the actions as
Note instructed.
21324 / GB / J 51
When the electrodes are attached to the patient and the plug is plugged into
Note the device, the instructions are automatically interrupted.
The first instructions can also be suppressed in the setup menu via "BLS information
off“. In this case, the first instruction issued by the device is
< Check electrodes >.
9.2 Carrying out ECG analysis in Auto mode
If the defibrillation electrodes have been applied, the device will automatically start the
analysis. Automatic analysis can only be carried out via the self-adhesive defibrillation
electrodes (SavePads).
Now the patient has to be put in an immobile position and may no longer be touched.
The device issues the instruction:
< Do not touch the patient, analysing rhythm >
The algorithm of the device programming now checks the ECG for a shockable
rhythm. This process can take up to 12 seconds. If the device detects ventricular
fibrillation (VF), it recommends defibrillation.
DANGER
Please note that the trigger button must not be pressed
permanently during the analysis phase since this will cause
the device to initiate an internal safety cut-off.
DANGER
Observe the patient during the entire reanimation.
It is possible at any time that the patient may regain
consciousness and does not need to be defibrillated.
If that is the case, do not carry out the defibrillation under
any circumstances.
The rhythm identification detector continuously analyses the ECG in the background,
even after a rhythm in need of defibrillation has been identified. If a rhythm which
does not require defibrillation is detected while the capacitor is charging or when the
required charge is already pending, internal safety discharge is triggered.

9.3 Defibrillation required
If the device has detected VF, it recommends defibrillation and automatically makes
the necessary preparations.
The device issues the instruction:
< Shock advised >

< Device is charging >
< Do not touch patient >
< Device is charging >
< Shock advised >
Once the capacitor is charged, the power for the defibrillation pulse is available for 15
seconds. This is signalled by a continuous acoustic warning, the voice message
< Stand clear of the patient, press lit shock button now >
and a green flashing trigger button. If you do not defibrillate within this period, an
internal safety discharge will follow and the ECG will be analysed again.
Press the trigger button to enable defibrillation.

Hold the button pressed until the shock has been administered. Avoid contact with the
sockets on the device during defibrillation.
If the trigger button is pushed while the capacitor is charging (before the
Note button turns green) no shock will be released and an internal safety discharge
will be initiated instead.
DANGER
Before pressing the trigger button, disconnect all equipment
which is not defibrillation-proof from the patient!
Before and during energy discharge, all persons involved in

reanimation must stand clear of the patient and avoid
touching the patient or conductive objects (e. g. parts of the
stretcher)!
After defibrillation, the device recommends a block of 2 minutes of cardiopulmonary

resuscitation (CPR), before carrying out renewed analysis. The CPR time is shown on
the PRIMEDIC™ DefiMonitor in the form of a display bar.
The charge time of the capacitor for defibrillation depends on the available battery
capacity. Charging may take longer if the power module is partly discharged.
21324 / GB / J 53
If a fault occurs during capacitor charging, an intermittent warning signal is

Note sounded and the device automatically carries out internal discharge of the
capacitor.
CAUTION
When the message < Charging status battery low, please
recharge > appears, the device still has enough energy for at
least 3 discharges at maximum power. The power module
should be replaced when this message appears.
If, when the device is switched on, for 10 minutes no ECG is done, no SpO2
Note signal is recorded or no button is pressed, the device automatically switches
off. An intermittent warning beep is signalled for approx. 30 seconds before
switching off. Pressing any button or any other activity will abort the
switching off process.
In basic state, a dashed line appears on the display and the acoustic message < Check
electrodes > is issued if the electrodes are not connected up. As soon as a reading is
activated via the electrodes, the ECG signal appears on the monitor.

9.4 Defibrillation not required
If the device can not find a shockable rhythm, then it recommends two minutes of
cardiopulmonary resuscitation (CPR).
< No shock advised >

< Cardiopulmonary resuscitation >
< Give 30 chest compressions >
< Give 2 rescue breaths >
etc.
When the CPR time (defined by the set number of CPR cycles) has elapsed, the device
resumes ECG analysis.
9.5 Keeping the defibrillator ready for use
After a reanimation, clean the device, replace the SavePads, check and if necessary
replace the power supply unit to ensure that the device is ready for operation again as
quickly as possible. Charge the battery to ensure that sufficient energy is available for
the device to be used again.
If any malfunctions or noticeable problems occur, please contact your nearest service
station.
21324 / GB / J 55
Manual mode
10 Manual mode
All PRIMEDIC™ DefiMonitor XD devices have a manual mode.
Using the device in manual mode requires a certain degree of medical knowledge. It is
therefore not advisable for non-medical personnel to operate the device in manual
mode. Only doctors and trained medical personnel should operate the device as a
manual defibrillator.
To activate manual mode, press the MAN/AUTO button once. The monitor confirms
the "MAN" mode. All keys which are disabled in automatic mode are now enabled.
The LED above the MAN/AUTO button lights up to indicate that the device is in
manual mode.
If your device is a purely manual device you can see this on the permanent flashing
LED above the MAN key. It can’t be switched off. When you push the MAN key the
device reports an acoustical error.
When the device is switched on and has successfully carried out a self-test, it
Note is in Auto mode. If your device is only equipped with manual mode (XD1,
XD3. XD10, XD30), you will not need to change mode.
10.1 Carrying out defibrillation
Unlike automatic mode, where the device programming algorithm analyses the ECG
and recommends defibrillation, in manual mode, the user must examine the ECG to
determine whether it displays a shockable rhythm. There are two ways of triggering
the defibrillation pulse.
 Via the SavePads

 Via the paddles
10.1.1 Power selection
First, select a suitable energy level of 5, 10, 20, 30, 50, 100, 200, 300 or 360 joules for
defibrillation.
The selected energy level is displayed on the monitor to confirm your selection.
CAUTION
Check that the energy level you have selected is shown on
the display.
The energy level required for defibrillation / cardioversion depends on the

Note size, weight and condition of the patient.

Manual mode
10.1.2 Charging
The way in which the shock is administered depends on where you initiate
Note charging. If you charge the shock by pressing a paddle button, the shock can
only be administered via the paddles. If you press the charge button on the
membrane keyboard, the shock is administered via the SavePads.
Press the charge button for your chosen method (see above) (paddle button or charge
button). A shock of the preset energy level is charged by pressing the power charging
button, and shortly afterwards, the device is ready to perform defibrillation.
If the shock is to be administered via the SavePads, the green trigger button lights up
and a warning signal is sounded when the device is ready to perform defibrillation.
If the shock is to be administered via the paddles, a warning signal is sounded.
In both cases, the following voice message is also issued:
< Deliver shock now >
The selected charge is available for 15 seconds. If defibrillation is not carried out within
this space of time, internal safety discharge is performed. The energy can also be
discharged internally by pressing the energy charging button again during the 15
seconds.
DANGER
Before pressing the trigger button, disconnect all equipment
which is not defibrillation-proof from the patient!
Before and during energy discharge, all persons involved in
reanimation must step clear of the patient and avoid
touching the patient or conductive objects (e. g. parts of the
stretcher)!
Capacitor charging time for defibrillation depends on the available battery capacity.
Charging may take longer if the power module is partly discharged.
If a fault occurs during charging, an intermittent warning signal is sounded, followed
by the voice message < Internal error >. The capacitor is discharged internally and the
devices switches off automatically. The Service symbol appears on the display.
10.1.3 Triggering defibrillation
Press the trigger button or the two paddle buttons simultaneously to enable
defibrillation, which is carried out immediately after the button is pressed. Hold the
button pressed until the shock has been administered. Avoid contact with the jacks on
the device during defibrillation.
If the charge is loaded via the charge button on the device, the shock can only be
administered via the SavePads. If the charge is loaded via the paddle buttons, the
shock can only be administered via the paddles.
21324 / GB / J 57
Manual mode
CAUTION
Before defibrillation, the contact surfaces of the paddles must
be coated with sufficient defibrillation gel to prevent skin
burns.
After performing defibrillation, you must examine the ECG again for shockable heart
rhythms and if necessary, trigger further defibrillation(s) (or carry out further
reanimation procedures).
If the wrong energy level has been selected and the shock already charged,
Note the fault can be corrected by pressing the new energy level. The device
automatically adjusts the charge to the level selected.
Alternatively, you can trigger internal discharge by pressing the charge button on the
membrane keyboard again. An internal safety discharge is performed. Then select the
correct energy level and press the charge button again.
CAUTION
When the message < Charging status battery low, please
recharge > appears for the first time, the device still has
enough energy for at least 3 discharges at maximum power.
The power module should be replaced when this message
appears.
10.2 SYNC and ASYNC mode
If the medical emergency requires cardioversion (operation of the defibrillator in

synchronous mode), this mode must be consciously selected by pressing the SYNC
button. The defibrillator must be returned to manual mode before you can switch to
SYNC mode. Then, SYNC mode can be activated by pressing the SYNC button.
Synchronous operation mode is indicated on the ECG monitor with “SYNC”.
Synchronisation is only possible in manual mode.

Note
We recommend synchronisation via the self-adhesive defibrillation electrodes to ensure

smooth synchronisation. This largely excludes movement artefacts. However,
synchronisation is also possible via the paddles. To do this, the ECG must be recorded
via the paddles, as far as possible without movement artefacts, in order to ensure
undistorted synchronisation. It is vital to ensure that the energy is applied using the
same method used to record the ECG.
After synchronised energy transfer (cardioversion), the defibrillation unit switches back
to asynchronous mode.

Manual mode
In synchronous mode, ECG markings are displayed on the monitor. To ensure

Note safe synchronous operation, these cardioversion markers must appear directly
next to an R-wave in each QRS complex. Precondition for this is a clear,
artefact-free ECG signal.
Synchronisation is performed exclusively via derivation II.

The delay time between detection of a QRS complex (synchronous pulse) and energy
transfer is less than 60 ms.
DANGER
Before initiating cardioversion, observe the monitor display
to check that the cardioversion markers are clearly assigned
to the R waves and not, for example, reacting to pacemaker
pulses or artefacts.
In synchronous mode, the trigger button must be held pressed until the cardioversion
time is reached. An acoustic signal sounds during this time. If the trigger button is
released during this time, cardioversion is not performed. If the button is held pressed
and synchronisation is not performed within 3 seconds, internal discharge is carried
out. If the trigger button is only pressed briefly or no synchromarker has occurred while
the button is pressed, the energy is maintained in the capacitor for 15 seconds and is
then automatically discharged.
The energy levels used for cardioversion are usually lower than for asynchronous
defibrillation, as it is not necessary to depolarise all heart muscle cells.
The energy required depends roughly on the weight of the patient. However, the
indications remain the decisive factor. The following rules of thumb apply:
Ventricular tachycardia with instable pulse: 50 Joule, for each further cardioversion,
select the next highest energy level (100 J, 200 J, 300J...) supraventricular tachycardia:
50 - 100 Joule Atrial flutter: 50 Joule Atrial fibrillation: 100 Joule
The values given above are merely recommendations for possible procedure in the
event of the corresponding indications.
If the cardioversion markers do not appear on the screen or appear in the

Note wrong position, this may be the result of extreme fluctuations in the mains
supply. In this case, the device should be disconnected from the mains, i.e.
the mains plug should be pulled out of the socket and the device operated via
the integrated battery.
10.3 Keeping the defibrillator ready for use
After a reanimation, clean the device, replace the SavePads, check and if necessary
replace the power supply unit to ensure that the device is ready for operation again as
quickly as possible. Charge the battery to ensure that sufficient energy is available for
the device to be used again.
In the event of faults or doubts, contact your nearest service station as soon as
possible.
21324 / GB / J 59
Attaching the SpO2 sensor
11 Attaching the SpO2 sensor
Fig. 23: Attaching the SpO2 sensor

1 Bend protection sleeve
2 SpO2 sensor
3 Surfaces for opening the sensor
Procedure:
Insert the plug of the SpO2 sensor into the device so that the arrow on the plug is
in line with the arrow on the device jack. Ensure that the connector is fully
inserted.
Press the two surfaces (3) on the SpO2 sensor together and slide the opened
sensor over any of the patient's fingers with the cable / jack side of the sensor on
the fingernail side of the finger.
The sensor can remain in one measuring point for a maximum of 4 hours, provided
that the skin characteristics and the correct seating of the sensor are checked regularly.
As on some patients, the sensor may cause skin irritation at the measuring point after a
while, it may be necessary to move the sensor more frequently.
To disconnect from the device, first lift the sleeve with the arrow slightly and
Note then pull the connector out of the jack.

Operating the pacer
12 Operating the pacer
12.1 General information on operating the Pacer XD
The following operating sequence must be observed when using the PRIMEDIC™
Pacer XD:
Switch the PRIMEDIC™ DefiMonitor XD on. The pacer can only be used in
manual mode. Set the mode accordingly.
Attach the self-adhesive electrodes to the patient.
Connect the self-adhesive electrodes to the SavePadsConnect cable using
electrode clips. See Chap. 8.2.3
Insert Pacer / defibrillation cable on the PRIMEDIC™ DefiMonitor XD into the
jack.
Activate the Pacer XD unit by briefly pressing the Pacer On / Off button (At this
point in time, the Pacer XD is not yet emitting stimulation pulses).
Set parameters:
- Operating mode
- Stimulation rate
- Stimulation intensity
Activate Pacer by pressing the START/STOP button
The Pacer XD is switched off by pressing the Pacer On /Off button. At the same time,
a warning signal is sounded.
When the Pacer unit is switched on, "Pacemaker Init" may appear on the top left of
the Pacer display, together with a progress bar. This indicates that the Pacer is currently
performing an internal self-test routine. After a few seconds, the Pacer is ready for
configuration.
If you try to activate the Pacer XD when the Pacer / defibrillation cable is not
Note plugged into the socket on the Pacer, a warning signal is sounded and the
message "Check electrodes" appears on the screen (only on devices without
SpO2 module).
If the device detects a deviation of ± 30 % from the set intensity, it

Note automatically interrupts the pacing process. One possible cause is that patient
resistance is too high.
21324 / GB / J 61
Operating the pacer
DANGER
If, for example, the markers do not appear on the screen or
appear in the wrong position, this may be the result of
extreme fluctuation in the mains supply. In this case, the
device should be disconnected from the mains, i.e. the mains
plug should be pulled out of the socket and the device
operated via the integrated battery. For this reason, it is
important to keep an eye on the capacity reading on the
display during pacing.
If the message < Charge battery > appears, the battery must
be recharged or replaced before stimulation can continue. If
this is not done, there may be danger to the patient as a
result of the device failing.
If more than 3 minutes elapse without the PRIMEDIC™ Pacer being

Note operated, it switches off automatically.
12.2 Setting the Pacer operating modes
The Pacer can be operated in three different modes:
 DEMAND (default setting)

 FIX
 OVERDRIVE
Operating mode Meaning

DEMAND (Default) Stimulation is only carried out “as required”. i.e. only if
the spontaneous heart rate falls below the set DEMAND
rate.
FIX Fixed-rate stimulation. Independent of the spontaneous
heart rate, a fixed heart rate is imposed.
OVERDRIVE Overstimulation of the heart with high-frequency fixed-
rate stimulation (max. 250 1/min) to stop, for example,
ventricular tachycardia.
The operating mode DEMAND is automatically activated when the Pacer is switched
on. The operating mode is displayed in clear text on the monitor.
To select a different operating mode, press the operating mode button once or
repeatedly until the desired operating mode appears on the monitor.
No stimulation pulses are emitted while the operating modes are being set.

Operating the pacer
The operating mode cannot be changed during pacing. For example, in order
Note to change from FIX to DEMAND mode, the Pacer must be stopped first.
If the Pacer is started up again without the operating mode having been changed, the
last set stimulation values are applied. If the Pacer operating mode is changed or if the
Pacer is switched off and then back on, the basic setting is activated again.
If for some reason, DEMAND pacing is not possible, the FIX mode can be used.
12.3 Setting the stimulation rate
Depending on the Pacer operating mode, various stimulation rates (number of Pacer
pulses per minute) are available:
FIX, DEMAND 30 ... 180 1/min (beats per minute)
OVERDRIVE 30 ... 250 1/min
The following values are preset when the respective modes are activated:
FIX, DEMAND 70 1/min

OVERDRIVE 200 1/min
To select a different stimulation rate, this value can be changed by pressing the Rate
Pulse/min   button.
Each time the button is pressed, the value is increased or decreased in steps of 5 (each
of 5 1/min). The stimulation rate can also be changed during pacing.
The stimulation rate should only be changed if this is absolutely necessary.
The ECG should be monitored closely when the stimulation rate is changed to
Note observe possible reactions of the patient to the new stimulation parameters.
21324 / GB / J 63
Operating the pacer
12.4 Setting the stimulation intensity
When the Pacer is switched on, a current of 10 mA (peak value) is preset, independent
of the selected operating mode or stimulation rate.
The stimulation intensity can be changed within a range of 10 mA to 180 mA using the
buttons stimulation intensity + and stimulation intensity - . (See also
Fig. 9: Operating membrane) The intensity is increased or decreased in 5mA steps

(each 5 MA) every time the button is pressed. The stimulation intensity can also be
changed during pacing.
The selected stimulation intensity depends on the patient's physical constitution. The
current selected should result in the effect of the stimulation being clearly visible on the
monitor.
The stimulation intensity is a compromise between good and effective stimulation of
the heart and the possible necessity of sedating the patient. Once the effect of the
stimulation is clearly recognisable on the ECG, the intensity can carefully be reduced to
find the "optimum" intensity.
Pacing results in a contraction of the skeletal muscles. This is not a sign of effective
heart stimulation. Watch the ECG on the monitor to determine when the intensity is
sufficient.

Operating the pacer
12.5 Starting and stopping pacing
The Pacer operating mode must be selected before pacing is started. The
Note operating mode cannot be changed once pacing has started. The operating
mode is displayed on the monitor.
Procedure:
Press the Stimulation Start/Stop button. Stimulation with the preset values. A
signal tone is issued to confirm this.
The operating mode display text on the monitor starts to flash. When stimulation
pulses are emitted, the LED next to the Start/Stop button lights up.
To enable better ECG monitoring, the display of the first ECG channel automatically
jumps to derivation II.
To stop stimulation, briefly press the Stimulation Start/Stop button. This is confirmed
by a short acoustic signal. The display text stops flashing.
Limited duration of stimulation in OVERDRIVE mode:

Note
To prevent dangerous, overlong stimulation in OVERDRIVE mode,
stimulation time without intervention by the operator is limited to 15
seconds.
When started via the Stimulation Start/Stop button, stimulation is performed with the
preset values. Stimulation ends after 15 seconds if neither the pacer intensity nor the
pacer rate are changed. If one of these buttons is pressed, the 15 seconds are counted
again.
Stimulation can be stopped before the 15 seconds have elapsed by pressing the
Stimulation Start/Stop button.
Both the stimulation rate and the intensity can be changed during pacing by
Note pressing the +/- -buttons.
During pacing, the heart alarms can also be used for additional monitoring. However, it
is not possible to make changes in the setup menu during pacing.
21324 / GB / J 65
Operating the pacer
DANGER
To prevent danger to the user as a result of the stimulation
pulse, do not touch the conductive surfaces of the electrodes
or the patient during pacing. After completing the treatment,
remove the self-adhesive electrodes from the patient or
ensure that the Pacer / defibrillation cable (SavePadsConnect
cable) is no longer connected to the device.
If the Pacer / defibrillation cable is interrupted or unplugged

from the device during pacing, stimulation is immediately
stopped. A warning signal sounds, the cause of the fault is
displayed on the monitor and a voice message is issued:
< Check electrodes >
When the fault has been remedied and the device restarted,
the Pacer is reactivated.
If an energy button is pressed during pacing, pacing is

interrupted and a warning signal sounds to indicate that the
process has been interrupted. The energy selection is reset.
The patient's ECG must be monitored continually during

pacing to ensure that the stimulation is effective.
The patient must not be left unattended during pacing.
The actual active patient current is monitored. If it falls below

70% of the set current, the pulse emission is stopped and a
fault message issued.

Operating the pacer
12.6 Defibrillation during pacing / Defibrillation via self-

adhesive electrodes
If ventricular fibrillation occurs during pacing, it must be stopped immediately through

defibrillation. Defibrillation can be carried out via the attached self-adhesive electrodes.
Press the required energy button. A warning signal sounds, as pressing the energy
selection button stops stimulation.
Press the Charge button on the control panel to prepare the defibrillation charge.
Trigger defibrillation via the adhesive electrodes by pressing the trigger button on the
control panel.
To reactivate the Pacer after defibrillation, it must be switched on again.
Defibrillation can also be carried out via the paddles, even though the
Note adhesive electrodes are attached. Load the selected energy charge by briefly
pressing one of the paddle trigger buttons and trigger defibrillation by
pressing the buttons simultaneously.
21324 / GB / J 67
Cleaning, maintenance and dispatch
13 Cleaning, maintenance and dispatch
13.1 Cleaning
WARNING
Only clean the device when it is switched off and with the
electrodes unplugged. Before cleaning, remove the power
module from the device or unplug the mains plug!
Do not use any dripping wet cloths to clean it. Never pour
liquids over the device and do not immerse it in any liquids!
Clean the device and all its accessories, such as the wall bracket, with commercially
available household cleaners.
Use a slightly damp, clean cloth.
Use normal disinfectant to disinfect it
(e.g. Gigasept FF, Bacillol or Spitacid).
WARNING
Clean the paddles after every use. Soiling as a result of gel
residue can result in danger to the user and patients. Always
remove all traces of gel from the paddles.

13.2 Servicing
Independently of the use of the device, we recommend regular visual inspection /

servicing of the PRIMEDIC™ DefiMonitor XD and the accessories by the user / service
technician at least once a year.
Make sure that the housing, cable, SavePads and all the other accessories are
undamaged.
13.2.1 Servicing check list
Check the expiry date
o of the SavePads
o of the battery pack (optional) and
o if necessary replace the parts.
Check whether
o the status display "OK" is showing.

o you can switch on the device.
o the device automatically carries out the self-test after being switched on.
o the slot for the power supply is clean.
o the device is fully equipped.
When doing so, pay attention to the following:
DANGER
 If parts of the housing or insulation are damaged, they

must be repaired or exchanged immediately.
 If parts of the housing or insulation are damaged, do not
use the device or switch it off immediately.
 Have the device repaired as soon as possible by the
manufacturer.
For more detailed information on the regular safety and metrological checks
Note in accordance with the Ordinance on the Operation and Use of Medical
Devices (MPBetreibV), refer to Chapter 23
21324 / GB / J 69
13.3 Dispatching the PRIMEDIC™ DefiMonitor XD
If you want to return the device for additional equipping or for a service, it is
Note important that you remove the power module from the device first and
include it with the device, but packaged separately.
Where possible, use the original box.

Disposal
14 Disposal
Fig. 24: Disposal
In accordance with company policy of the Metrax GmbH, your product has been
developed and made using high-quality materials and components which can be
recycled and reused.
At the end of its serviceable 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: 25658828.
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.
21324 / GB / J 71
Technical Data
15 Technical Data
Defibrillation
Operating modes asynchronous, external in Auto/Manual mode
Patient impedance: 23 – 200 Ohm
Synchronisation: SYNC only in manual mode
Impulse shape: Biphasic, current regulated (CCD)
Output power in AUTO mode at:

Patient impedance 1st stage 2nd stage 3rd stage
25 Ohm 143 J 201 J 277 J
50 Ohm 281 J 350 J 360 J
75 Ohm 348 J 360 J 360 J
100 Ohm 344 J 343 J 343 J
125 Ohm 314 J 316 J 317 J
150 Ohm 290 J 293 J 293 J
175 Ohm 269 J 272 J 272 J
Accuracy: All data is subject to a tolerance of +/- 15%
Impulse length: Positive phase 11.25 ms, negative phase 3.75 ms
Discharges: 60 discharges at 20 °C with new, fully charged battery with 200J
Charge time: 12 +/-3 seconds with a rechargeable battery / battery with 90%
of the rated capacity
Pacemaker (Pacer)
Operating modes Fix, Demand, Overdrive
Stimulation rate 30-180 pulses/min, in Fix and Demand mode
30-250 pulses/min, in OverDrive mode
Tolerance: ± 0.5%
Stimulation intensity 10mA-180mA, tolerance: ± 10% or +3/-1 mA
Pulse width: 20ms, tolerance: ± 100 µs
Refractory period: 340ms for stimulation rate < 100 beats/min
240ms for stimulation rate >= 100 beats/min
Tolerance: ± 10ms
ECG

Technical Data
Derivation: 2 derivations from I, II, III, aVL, aVR, aVF
Heart frequency: 30 – 270 min-1
Input: Class CF, defibrillation protected
Input resistance: > 5 MOhm @ 10 Hz
CMRR: > 85 dB
Input d.c. voltage: ± 0.5 V
Bandwidth: 0.5 – 44 Hz (- 3 dB) SR = 101 samples/s
SpO2 NELLCOR® Pulse oximetry

module
Indication range: 100 %
Calibration range: 100 ... 50 %
Accuracy: SpO2
Adults 100 ... 70 % +/- 3 digits
New-born babies 95 ... 70 %+/- 3 digits
Contact the manufacturer for further details on test procedures.
Wavelength: Red: 660 nm , Infrared: 890 nm
Light intensity: 0.5 lumen/cm2
Operating mode: continuous
Refreshing time: < 2 sec.
Impedance measurement
Defibrillation/Pacing: 23 ... 200 Ohm
Monitoring: 500 – 2500 Ohm
Measurement frequency: 30 kHz
Measuring precision: ±15%
Alarms
System: EKG, SpO2,, defibrillator, power supply, data memory
21324 / GB / J 73
Technical Data
Physiological: Ventricular fibrillation (VF)
Analysis duration: one battery Approx. 7 s until VF is recognised at a rated capacity of 90%
Monitor
Monitor type: high-resolution LCD monitor
Monitor size: 115 x 86 mm (diagonal 144 mm, 5.7")
Resolution: 320 x 240 pixels (pixel size 0.36 x 0.36 mm)
Displays: Heart rate, number of defibrillations, number of detected VF, reanimation

duration, date, time, battery capacity
Defibrillation / pacing electrodes
SavePads, SavePads Connect Pacing: 1h pacing, operation at 120 pulses/min at 140 mA

8h pacing, operation at 60 pulses/min at 70 mA
10 minutes, operation OverDrive pacing at 200
pulses/min at 180 mA
Defibrillation: Up to 50 defibrillations and/or 24h monitoring
Monitoring: Up to 24 h
Power supply
Battery: NiCd, 12 V / 1.4 Ah
Integrated mains power pack: 100 ... 240 Volt, 50 / 60 Hz
Data storage
Memory type: CompactFlashCard 32MB-4GB possible
Safety
Classification: Medical product of class IIb, protection class I, Type CF, defi-proof,
Identification: 0123
The device is a medical product and complies with the

EC Directive 93 / 42 / EEC
Other

Technical Data
operating conditions: 0 ... 50 °C, 30 ... 95 % rel. humidity, however without condensation 700
hPa ... 1060 hPa continuous operation
Storage conditions: 20 ... 70 °C, 20 ... 95 % rel. humidity, however without condensation,
500 hPa ... 1060 hPa continuous operation
Dimensions: 33 x 16 x 29 cm (W x D x H)
Weight: 5.3 kg (without power module)
Standards applied Standards (for licensing in the EU the corresponding harmonised

European standards EN were used instead of the IEC standards):
IEC 60601-1:1988 + A1:1991 + A2:1995

IEC 60601-1-2:2001
IEC 60601-1-4:1996 + A1:1999
IEC 60601-2-4:2002
IEC 60601-2-27:1994
CEN EN ISO 9919:2005 (only for XD3, XD30, XD300, XD330)
EN1789:2003
Subject to change without notice.
21324 / GB / J 75
Accessories
16 Accessories
The PRIMEDIC™ DefiMonitor XD is supplied with the following accessories fitted at

the factory:
 Paddle set
 SavePads
 Power module: Battery
For details of further accessories, see separate list of accessories / price list.

Warranty conditions
17 Warranty conditions
The warranty period is 24 months, beginning on the date of purchase. Please keep the
invoice as proof of purchase.
Within this time period, METRAX will remedy any defects in the device free of charge
if they are based on material or manufacturing errors. The device can be reinstated to
its original condition as selected by METRAX either by repair or replacement.
A claim under warranty does not extend the original warranty period.
Warranty and also legally entitled warranty claims are not applicable if the usefulness
of the device is only negligibly affected, or in the case of normal wear and tear (e.g.
consumables such as battery pack) or damage caused after transfer of risk as a result of
incorrect or negligent handling, excessive wear or are caused by special external
influences which are not provided for according to the contract. The same applies if
inappropriate changes or incorrect repair work is carried out by the buyer or by a third
party.
All other claims against METRAX are excluded out unless such claims are based on
intent or gross negligence or compulsory legal liability standards.
Warranty claims made by the buyer against the seller (dealer) are not affected by this
guarantee.
In the case of a warranty claim, please return the device with proof of purchase (e.g.
invoice) stating your name and address to your dealer or to METRAX.
METRAX After-Sales Service is glad to be at your disposal, even after the warranty
period has expired.
21324 / GB / J 77
Depiction of the current time function
18 Depiction of the current time function

The following diagrams show the graphs for the defibrillation pulse in manual mode,
depending on the load resistance.
5J 10 J 20 J 30 J 50 J
25 Ohm
30 Ohm
50 Ohm
75 Ohm
100 Ohm
125 Ohm

5J 10 J 20 J 30 J 50 J
150 Ohm
175 Ohm
200 Ohm
21324 / GB / J 79
100 J 200 J 300 J 360 J

25 Ohm
30 Ohm
50 Ohm
75 Ohm
100 Ohm
125 Ohm

100 J 200 J 300 J 360 J

50 Ohm
175 Ohm
200 Ohm
21324 / GB / J 81
Level 1 Level 2 Level 3
The following diagrams show the graphs for the defibrillation pulse in AUTO mode,
displayed depending on the load resistance.
Level 1 Level 2 Level 3
25 Ohm
30 Ohm
50 Ohm
75 Ohm

100 Ohm
125 Ohm
150 Ohm
175 Ohm
200 Ohm
21324 / GB / J 83
Rhythm detection system in AED mode
19 Rhythm detection system in AED mode
The rhythm detection system of the PRIMEDIC™ DefiMonitor XD analyses the

patient's ECG and recommends procedure based on whether the device detects a
shockable rhythm or not.
The device's rhythm detection system includes:

Ascertaining the electrode contact
Automatic evaluation of the ECG
Operator control of the defibrillation shock therapy
The transthoracic impedance of the patient is measured by the defibrillation electrodes.
If the baseline impedance is greater that the maximum critical value, then the device
ascertains whether the electrodes are not in good enough contact with the patient or if
they are not connected properly to the device. ECG analysis and dispensation of
defibrillation shocks are therefore prevented. The voice output says "Check electrodes"
if the contact of the electrodes is insufficient.
Automatic Interpretation of the ECG

The rhythm detection system of the device is designed to recommend defibrillation
when the system detects a shockable rhythm
With all other ECG rhythms, including asystolia and normal sinus rhythms, the rhythm
detection system in the device does not recommend defibrillation.
Operator control of the output of defibrillation shocks

The device's rhythm detection system triggers automatic charging of
power if the device ascertains a shockable cardiac rhythm. Optical and acoustic
messages are emitted to show you that the device recommends giving a defibrillation
shock. If a defibrillation shock is recommended, you decide whether and when the
shock is to be given.
The Algorithm:
 Observes the ECG rhythm across a continuous recording of 10 seconds, of which 7

seconds have been used for an initial diagnosis or to display the message "Shock
recommended."
 Measures symmetry and energy content of the signal
 Filters and measures artefacts and interference
 Detects pacemakers
 Measures the QRS rate

Rhythm detection system in AED mode
Cardiac rhythms used to test the rhythm detection system in the device
To validate the databases used: AHA and MIT
Performance results (weighted average, rhythms identified in the databases as VF are
evaluated as being shockable):
Sensitivity 99.30%
Specificity 99.88%
False positive rate 0.04 %
Real predictive value 97.93 %
The databases used have a total length of 10,004 minutes. The calculation was made
in accordance with IEC60601-2-4-2003.
Sensitivity
= Number of "correct shockable" algorithm decisions
Total number of ECGs in which dispensing an impulse is clinically recommended
Specificity
= Number of "correct not shockable" algorithm decisions
Total number of ECGs where shock is not clinically recommended
False positive rate
= Number of "incorrect shockable" algorithm decisions
Total number of ECGs where the device does not recommend shock therapy
Positive predictive value
= Number of "correct shockable" algorithm decisions
Total number of ECGs where the device recommends VF shock therapy
21324 / GB / J 85
General information on the use of pulse oximeters
20 General information on the use of pulse

oximeters
What is pulse oximetry?

A pulse oximeter measures the SpO2 value (oxygen saturation) using optical
measuring procedures. With this procedure, light of different wavelengths is passed
through tissue and blood vessels.
The elements of the blood which are decisive for SpO2 measurement are the
oxygenated haemoglobin and the deoxygenated haemoglobin, i.e. the components
which play an important role in supplying the organism with oxygen.
Body tissue and blood vessels are "x-rayed" with the help of transmitter and receiver
elements in an SpO2 sensor. The amount of light which reaches the receiver side varies
according to the oxygen saturation of the blood. High-precision components and
calibrated sensors allow very accurate measurement of the SpO2 value.
The normal attachment points for sensors are:
 Fingertip
 Toe
 Earlobe
 Heel
Why are different types of sensor used?

Different sensors must be used for different patients in order to ensure precise and
reliable measurement.
The following factors should be considered when selecting which type of sensor to use:
 Weight of the patient

 Degree of activity of the patient
 Duration of measurement
 Perfusion of extremities
 Possible measurement point
 Patient's condition
 Sterile measurement necessary?
It stands to reason that no sensor will fulfil all these sometimes

conflicting requirements. The different types of SpO2 sensor are designed for specific
requirements.
As an example, take the DS-100 A or D-YS sensor from NELLCOR®.
The DS-100 A is extremely quick and easy to use and has a sophisticated mechanism
allowing it to be fitted simply and easily on fingers of different sizes. The geometry of
the sensor makes it unsuitable for use on children. It is also not suitable for use on
patients who move around, a lot as the mechanism of the casing cannot prevent the
sensor slipping off the finger.

General information on the use of pulse oximeters
As the D-YS sensor has no housing, it can be used over a greater weight range, is
suitable for attachment in various positions and can be fixed in position with
adhesive tape. This, however, means that it takes longer to attach.
What factors can influence the SpO2 value?
As the oxygen saturation is measured optically, the following factors may impair the
result:
 Direct sunlight
 Strong ambient lighting (e. g. operating theatre lamps)
 Infrared lamps
 UV lamps (bilirubin lamps)
The influence of these factors can be minimised by ensuring that the sensor is attached
correctly and by covering the sensor with opaque material.
Further possible influences are:
 Contamination of measurement point by dirt

 Insufficient cleaning of the sensor
 If light cannot pass through or colours are distorted at the measurement point, e.
g. by nail varnish
 The patient moves around a lot
 Injected contrast media (e. g. indiocyanine green or methylene blue)
 High quantity of dysfunctional haemoglobin (e. g. carboxihaemoglobin)
 Incorrect location of sensor (e. g. where there is a venous pulse)
 Use of the pulse oximeter near strong energy sources, such as MRT scanners
 Sensor fitted too tightly
 Arterial occlusion in the vicinity of the sensor
 Blood stasis, e. g. as a result of arterial catheter or blood pressure cuff.
Some of these factors are easily identified (e. g. nail varnish) and can be eliminated or
an alternative measurement point can be used to provide a reproducible result.
Other points (e. g. contrast media or defects in the blood serum) are not easily
recognisable.
Due to the wide range of factors which can have a negative effect, SpO2
measurement should not be the only way that vital functions are monitored. Other
parameters must also be monitored (e. g. ECG, blood pressure, respiration ...).
However, if it is used correctly, if the sensor-specific warnings and information
provided are observed and the clinical symptoms taken into consideration, SpO2
measurement is an important instrument in the evaluation of a patient's condition.
21324 / GB / J 87
Guidelines and manufacturer's declaration – Electromagnetic emissions
21 Guidelines and manufacturer's declaration –

Electromagnetic emissions
TM
The PRIMEDIC DefiMonitor XD is intended for operation in an environment as described below. The customer or
TM
user of the PRIMEDIC DefiMonitor XD -Family should ensure that it is only operated in a suitable environment.
Emitted interference Conform-
Electromagnetic environment - code of practice
measurements mance
HF emissions
The PRIMEDICTM DefiMonitor XD uses HF energy exclusively for internal
as per CISPR 11
Group 1 functions. This means that its HF emission is very low and it is unlikely that
equipment in the vicinity will be disrupted.
HF emissions
Class B
as per CISPR 11
Emission of The PRIMEDICTM DefiMonitor XD is suitable for use in all facilities,
harmonics according Class B including residential areas and those which are directly connected to a
to IEC 61000-3-2 public supply network which also supplies buildings that are used for
Emission of voltage residential purposes.
fluctuations /
Compliant
flickering according
to IEC 61000-3-3

The PRIMEDICTM DefiMonitor XD is designed for operation in the electromagnetic environment described
TM
below. The customer or user of the PRIMEDIC DefiMonitor XD -Family should ensure that it is only operated
in a suitable environment.
Interference IEC 60601 Conform- Electromagnetic environment
resistance tests impulse test level mance level guidelines
Corridor floors should be made
Electrostatic ± 6 kV contact discharge of wood or concrete or be
discharge (ESD) ± 6 kV contact discharge covered with ceramic tiles. If the
according to floor is covered with a synthetic
IEC 61000-4-2 ± 8 kV air discharge material, the relative air humidity
± 8 kV air discharge
should be at least 30%.
Quick transient ± 2 kV for AC power
electrical The quality of the voltage supply
lines ± 2 kV for AC power lines should correspond to that of a
interference/bursts
according to typical business and hospital
± 1 kV for input and
environment.
IEC 61000-4-4 output lines
± 1 kV normal mode ± 1 kV normal mode
voltage voltage The quality of the voltage supply
Surges according to should correspond to that of a
IEC 61000-4-5 typical business and hospital
± 2 kV common mode ± 2 kV common mode environment.
voltage voltage
< 5 % UT < 5 % UT
(>95 % dip in the UT ) (>95 % dip in the UT )
The quality of the voltage supply
for ½ cycle for ½ cycle
should correspond to that of a
typical business and hospital
40 % UT 40 % UT
Voltage dips, short environment. If the user of the
(60 % dip in the UT ) (60 % dip in the UT )
breaks and PRIMEDICTM DefiMonitor XD
for 5 cycles for 5 cycles
fluctuations in the requires continued functioning
supply voltage even when disruptions in the
70 % UT 70 % UT
according to power supply occur, it is
(30 % dip in the UT ) (30 % dip in the UT )
IEC 61000-4-11 recommended that the
for 25 cycles for 25 cycles TM
PRIMEDIC DefiMonitor XD is
fed from a power supply free of
< 5 % UT < 5 % UT
disruptions or a battery.
(>95 % dip in the UT ) (>95 % dip in the der UT )
for 5 seconds for 5 seconds
Magnetic field at Magnetic fields at the mains
the supply 3 A/m 3 A/m frequency should correspond to
frequency (50/60 the typical values found in a
Hz) according to commercial or hospital
IEC 61000-4-8 environment.
COMMENT UT is the a.c. supply voltage before applying the impulse test levels.
21324 / GB / J 89
The PRIMEDICTM DefiMonitor XD is designed for operation in the electromagnetic environment described below. The
TM
customer or user of the PRIMEDIC DefiMonitor XD -Family should ensure that it is only operated in a suitable
environment.
Interference IEC 60601 impulse Conformance Electromagnetic environment guidelines
resistance test level level
tests
Portable and mobile radio transceivers should not be used closer
to the PRIMEDICTM DefiMonitor XD, including its cables, than the
recommended protective distance which is calculated according
to the equation applicable to transmission frequencies.
Recommended protective distance
d  1,2 P
Conducted 3 Veff 3V
HF 150 kHz to 80 MHz d 4 P
interference outside the ISM
according to bands
IEC 61000- d  0,6 P 80 MHz to 800 MHz
4-6
10 Veff 3V
150 kHz to 80 MHz d  1,2 P 800 MHz to 2.5 GHz
in the ISM bands
With P as the maximum power rating of the transmitter in Watts
(W) in accordance with information provided by the
Radiated HF
10 Veff 20 V/m manufacturer of the transmitter and d as the recommended
interference b
protective distance in metres (m).
according to 80 MHz to 2.5 GHz
The field strength of stationary radio transmitters should be less
IEC 61000-
that the conformance level for all frequencies in accordance with
4-3
an inspection on location.d
Interference is possible in the vicinity of devices which have the
following pictogram.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
COMMENT 2 These guidelines will not be applicable in all cases. The spread of electromagnetic factors is affected by
absorption and reflections from buildings, objects and people.
a
The ISM frequency ranges (for industrial, scientific and medical applications) between 150 kHz and 80 MHz are 6.765
MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz.
b
The conformance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency band from 80
MHz to 2.5 GHz are defined to reduce the probability that mobile/portable communication devices can cause
interference, if they are unintentionally brought into the vicinity of the patient. For this reason, an additional factor of
10/3 is allowed for when calculating the recommended safety distances in these frequency ranges.
c
The field strength of stationary transmitters, such as base stations of wireless telephones and mobile field radio
transmitters, amateur radio stations, AM and FM radio and television transmitters can theoretically not be precisely
determined in advance. To determine the electromagnetic environment with regards to the stationary transmitters, a
study of the location should be considered. If the field strength measured at the location in which the PRIMEDIC™
DefiMonitor XD is operated exceeds the conformance levels for HF listed above, the PRIMEDIC™ DefiMonitor should be
monitored to ensure that it is functioning correctly. If unusual performance characteristics are observed, then it may be
TM
necessary to take additional measures, such as change the orientation or the location where the PRIMEDIC
DefiMonitor XD is being used.
d
Above the frequency range of 150 kHz to 80 MHz, the field strength should be less than 3 V/m.

Recommended protective distances between portable and mobile HF telecommunication devices and the
TM
PRIMEDIC DefiMonitor XD product family
The PRIMEDICTM DefiMonitor XD family is designed for use in an electromagnetic environment in which the
TM
HF interference is controlled. The customer or user of the PRIMEDIC DefiMonitor XD can help avoid
electromagnetic interference by maintaining the minimum distance between portable and mobile HF
telecommunication devices (transmitters) and the PRIMEDICTM DefiMonitor XD – independently of the output
power of the communication device, as shown below.
Protective distance depends on the transmission frequency

m
Power rating
of transmitter
in W 150 kHz to 80 MHz 150 kHz to
80 MHz to
outside the 80 MHz in the 800 MHz to
800 MHz
ISM bands ISM bands 2.5 GHz
d  1,2 P d  0,6 P
d 4 P d  1,2 P
0.01 0.12 0.4 0.06 0.12

0.1 0.37 1.26 0.19 0.36
1 1.17 4.00 0.60 1.15
10 3.69 12.65 1.90 3.64
100 11.67 40.00 6.00 11.50
For transmitters with a maximum power rating that is not given in the table above, the distance can be
determined by using the equation that belongs to the respective column, whereby P is the maximum power
rating of the transmitter in Watts (W) according to the manufacturer of the transmitter.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
COMMENT 2 The ISM frequency ranges (for industrial, scientific and medical applications) between 150 kHz
and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz and
40.66MHz to 40.70 MHz.
NOTE 3 b The conformance level in the ISM frequency bands between 150 kHz and 80 MHz and in the
frequency range of 80 MHz and 2.5 GHz are intended to reduce the likelihood of mobile/portable
communication devices causing interference if they are unintentionally carried into the treatment area. For this
reason, an additional factor of 10/3 is allowed for when calculating the recommended safety distances in these
frequency ranges.
NOTE 4 These guidelines may not be applicable in all cases. The spread of electromagnetic factors is affected
by absorption and reflections from buildings, objects and people.
21324 / GB / J 91
General information and rules for use of the battery
22 General information and rules for use of the

battery
A nickel-cadmium rechargeable battery (NiCd battery) has been selected to power

PRIMEDIC™ defibrillators in the DefiMonitor XD and PRIMEDIC™ HeartSave series.
Very short charging times with low strain on the battery are possible through the use
of a state-of-the-art, micro-processor-controlled charging function. NiCd rechargeable
batteries are subject to natural wear and ageing.
Self-discharge
The self-discharge of a battery means that a fully charged battery slowly and
continually loses its charge, even if it is not used.
After 4 weeks, NiCd batteries are still at approximately 60% capacity.

Note Batteries in storage must therefore be recharged after approximately 6-8
weeks.
If the device is on a charging fixture or if the defibrillator is running in standby mode

with mains connection, the PRIMEDIC™ battery automatically begins a recharging
cycle every 2 weeks, thus compensating for the drop in capacity.
If you are using several batteries, use the reserve batteries in rotation to replace the
battery in the device in order to avoid long storage times.
Memory effect
If the NiCd battery is only slightly discharged and then recharged over a longer period
of time, the typical "Memory” effect occurs. The practical consequence of the
"Memory” effect is that the battery, although it has a large nominal charging capacity,
behaves like a small battery with low capacity.
An example to illustrate this:
A battery has a capacity for 50 defibrillations. 5 defibrillations are performed and the
battery is then recharged. If this is repeated over a longer period, the "Memory" effect
may occur, i. e. the capacity of the battery is reduced to 5 to 6 defibrillations, as the
battery has been "trained” to perform 5 defibrillations.
Avoiding the "Memory" effect

To avoid the "Memory" effect, the battery must be completely discharged from time
to time and then fully recharged.
The optimum way to achieve this is with a fully automatic discharger / charger, which
performs defined discharging before every charging process.
The fully automatic discharger / charger is available as the Care Function in the
PRIMEDIC™ Charger for PRIMEDIC™ DefiMonitor/HeartSave. This optional accessory
(it can also be retrofitted) allows you to charge a second PRIMEDIC™ battery, and the
battery Care Function prevents the occurrence of the "Memory" effect.

General information and rules for use of the battery
Ageing
Even with optimum care, a rechargeable battery will show signs of ageing after 2 – 3
years. After approx. 200 – 500 charging cycles, a NiCd battery is no longer able to
chemically store the electrical energy. The battery is thus rendered useless and must be
replaced with a new one. For this reason, the PRIMEDIC™ battery has the date of
manufacture stored. After 2.5 years, the device issues the voice message < Battery
charge low, please recharge >. At the same time, the battery symbol appears on the
status display. The battery should be replaced.
Faults and how to remedy them
Fault Action to be taken

The battery has been charged with the Charge the device again with the
PowerPack/Charger, but when the Powerpack/Charger. The charging
Charge LED goes out, the switched-on process may have been terminated due to
device does not display full battery overheating.
capacity.
Charge LED flashes continuously The Powerpack is in pulse charging mode.
The battery is charged with a gentle
charging cycle.
Charge LED does not light up There may be a delay of up to 5 min
immediately after plugging in the before the charging cycle begins.
Powerpack/Charger Continue to monitor the Charge LED
Charge LED does not light up after 5 Battery charging is only performed when
minutes, even though the the capacity falls below 80%. Check the
Powerpack/Charger is plugged in battery capacity shown on the display. If
the charging cycle does not begin even
though the capacity is low (< 80%), the
battery is defective and must be replaced.
The battery is not used and is completely The battery capacity falls continually.
discharged after several weeks After approx. 10 weeks, it is completely
discharged (self-discharge). Please charge
the battery.
The battery remains unused for more The battery is defective and must be
than 10 weeks and cannot be charged replaced.
21324 / GB / J 93
Safety checks
23 Safety checks
In accordance with the Ordinance on the Operation and Use of Medical Devices
(MPBetreibV) § 6 (Safety checks) the user is obliged to have regular checks carried out.
In accordance with the Ordinance on the Operation and Use of Medical Devices
(MPBetreibV) § 6, METRAX stipulate these checks be carried out in a 24-month cycle.
The safety checks may only be assigned to people who, because of their training, their
knowledge and their experience gained through practical activity, can carry the checks
out properly and do not need instruction to do so.
If defects are found during a safety check which could endanger
patients, device users or third parties, in accordance with the Ordinance on the
Operation and Use of Medical Devices (MPBetreibV) § 3, the operator must
immediately inform the responsible authority.
In the medical products log to be kept in accordance with the Ordinance on the
Operation and Use of Medical Devices (MPBetreibV) § 7, the following data is to
entered:
 Time of carrying out the work

 Name of person or company carrying out the work
 Measures taken.
The responsibility of METRAX only covers the information provided in the operating
instructions. This applies in particular for readjustments, repairs and changes to the
device.
To always be able to keep the records up to date, you will find our STK test reports on
the Internet at
www.primedic.de
in the area "Service."

Index of diagrams
24 Index of diagrams
Fig. 1: Brief instructions on use of devices with AED mode ......................................................... 4

Fig. 2: Brief instructions on use of devices without AED mode .................................................... 5
Fig. 3: PRIMEDIC™ DefiMonitor XD – front view..................................................................... 18
Fig. 4: PRIMEDIC™ DefiMonitor XD – rear view ...................................................................... 19
Fig. 5: PRIMEDIC™ DefiMonitor XD – view from below .......................................................... 19
Fig. 6: PRIMEDIC™ DefiMonitor XD – side view ...................................................................... 20
Fig. 7: PRIMEDIC™ DefiMonitor XD – side view ...................................................................... 20
Fig. 8: PRIMEDIC™ DefiMonitor XD – status display ................................................................ 21
Fig. 9: Operating membrane ....................................................................................................22
Fig. 10: Locking the adult paddles in place over the electrodes for children ............................... 27
Fig. 11: PRIMEDIC SavePads Connect lead, 2 pin ..................................................................... 27
Fig. 12: PRIMEDICTM SavePads, 2-pin .................................................................................... 28
Fig. 13: ECG patient lead, 3-pin ............................................................................................... 28
Fig. 14 ECG patient lead, 2-pin ................................................................................................ 29
Fig. 15: SpO2 sensor and adapter lead ....................................................................................... 29
Fig. 16: PRIMEDIC™ DefiMonitor XD – SaveCard .................................................................... 30
Fig. 17: PRIMEDIC™ DefiMonitor XD – Inserting the battery ................................................... 32
Fig. 18: PRIMEDIC™ DefiMonitor XD – Removing the power module...................................... 33
Fig. 19: Positioning the defibrillation electrodes on the patient ................................................. 45
Fig. 20: Positioning the electrodes on the patient ..................................................................... 46
Fig. 21: Removing the protective film from the electrodes ........................................................ 49
Fig. 22: Attaching the SpO2 sensor .......................................................................................... 60
Fig. 23: Disposal ....................................................................................................................... 71
21324 / GB / J 95
About Us.
METRAX GmbH is specialised in high-tech devices which are so user Headquarter/Manufacturing:

developing state-of-the-art devices friendly that they set new standards.
METRAX GmbH
for emergency medicine. Established With the brand PRIMEDIC™, Rheinwaldstr. 22
in 1973 in Rottweil, today Metrax is Metrax offers a reliable program for D-78628 Rottweil
considered to be an outstanding emergency medicine: Professional Germany
Tel.: +49 741 257-0
example of the strengths in German defibrillators and mobile ultrasound
Fax: +49 741 257-235
development technology: Innovative scanners. Emergency rescue services www.primedic.de
vision, top quality and complete around the world are familiar with [email protected]
dedication in research and PRIMEDICTM as a guarantor for the
development have been the highest quality and innovative METRAX GmbH
company's distinguishing features medical technology. Shanghai Rep. Office
for the last 30 years. The result of Unit B, 11/F First Trade Tower
No.985 Dongfang Road,
this is high precision and extremely Pudong New Area
reliable Shanghai 200122
China
Tel.: +86 21 632846-66
Fax: +86 21 633656-90
[email protected]
METRAX GmbH
India Rep. Office
B-1, Lower Grownd Floor,
Growne Palza Surya
New Friends Colony
New Delhi - 110065
Indien
Tel.: +91 11 26841741
Fax: +91 11 26841742
[email protected]
Your dealers
METRAX GmbH
Moskau Rep. Office
Ul. Vavilowa 5, corpus 3
119334 Moskau
Russland
Tel.: +7 95 23170-61
Fax: +7 95 23170-62
[email protected]

MGA21324 - DefiMonitor XD - GB - J

Uploaded by

Copyright:

Available Formats

MGA21324 - DefiMonitor XD - GB - J

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

MGA21324 - DefiMonitor XD - GB - J

Uploaded by

Copyright:

Available Formats

www.primedic.

3 Safety information 10

4 Description of device 16

5 Preparatory measures before (initial) start-up 30

6 Device self-test 36

7 Operating the PRIMEDIC™ DefiMonitor XD 37

7.2.2 Auto mode (AED mode) ................................................................................ 38

8 Applying the electrodes 45

9 Auto mode (AED mode) 51

10 Manual mode 56

11 Attaching the SpO2 sensor 60

12 Operating the pacer 61

13 Cleaning, maintenance and dispatch 68

15 Technical Data 72

17 Warranty conditions 77

18 Depiction of the current time function 78

19 Rhythm detection system in AED mode 84

20 General information on the use of pulse oximeters 86

21 Guidelines and manufacturer's declaration – Electromagnetic emissions 88

22 General information and rules for use of the battery 92

23 Safety checks 94

24 Index of diagrams 95

 Using the device in a manner for which it was not intended.

2 Operating instructions DefiMonitor XD 21324 / GB / J

1.5 Symbols used in these operating instructions

This symbol indicates text which contains important advice / comments or

 This line marks lists

(3) Numbers in brackets refer to items in diagrams.

1.6 Pictograms on the device

IP33 Protection against foreign bodies > 2.5 mm

Do not dispose of device in domestic refuse.

Dangerous electric voltage (high voltage)

Degree of protection CF in connection with ECG patient cable:

Fig. 1: Brief instructions on use of devices with AED mode

4 Operating instructions DefiMonitor XD 21324 / GB / J

Fig. 2: Brief instructions on use of devices without AED mode

1.7 Pictograms on SavePads

Only for adults

Storage temperature in Celsius and Fahrenheit

6 Operating instructions DefiMonitor XD 21324 / GB / J

2.1 Indication/Contraindication for Defibrillation

The defibrillator unit of the PRIMEDIC™ DefiMonitor XD

The defibrillator unit of the PRIMEDIC™ DefiMonitor XD

 the patient is conscious or

8 Operating instructions DefiMonitor XD 21324 / GB / J

2.2 Possible complications

 Irritation of the skin or even burns if, for example,

In manual mode, the PRIMEDIC™ DefiMonitor XD is to be used exclusively by

3.1 General information

For this reason, we emphatically advise that before using for

The PRIMEDIC™ DefiMonitor XD is not licensed for use in

Not using the device as intended or using it improperly,

10 Operating instructions DefiMonitor XD 21324 / GB / J

Applicable for Europe:

 The device complies with the Medical Device Directive (MDD).

Also applicable for Germany and Austria:

3.2 General safety instructions

The device may not be used in the vicinity of flammable

3.3 Safety notes for you, the user