Defimonitor XD: Operating Instructions
Defimonitor XD: Operating Instructions
Defimonitor XD: Operating Instructions
Operating instructions
MGA21324 / GB / K05
Masthead
Publisher
METRAX GmbH
Phone: 0741/257-0
Email: info@primedic.com
Web: www.primedic.com
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).
Table of contents
Table of contents
1 Introduction 6
1.1 Foreword 6
1.2 Validity 6
1.3 Warranty 6
1.4 Disclaimers 7
1.5 Symbols used in these operating instructions 8
1.6 Pictograms on the device 9
1.7 Pictograms on SavePads 10
1.8 Image mark on the encompassing packaging 10
2 Intended use 11
2.1 Indication/Contraindication for Defibrillation 13
2.2 Possible complications 13
2.3 Users 14
3 Safety information 15
3.1 General information 15
3.2 General safety instructions 16
3.3 Safety notes for you, the user 17
3.4 Safety notes for protection of the patient 17
3.5 Safety notes for the protection of third parties 19
3.6 Safety notes for protection of the device 19
4 Description of device 20
4.1 General description 20
4.2 Description of device details 22
4.3 Capacity display 33
4.4 Data management 34
4.5 Description of the accessories 35
4.5.1 Paddles 35
4.5.2 PRIMEDICTM SavePads Connect cable 36
4.5.3 PRIMEDICTM SavePads 36
4.5.4 ECG patient cable, 3-pin 37
4.5.5 SpO2-Sensor (only for PRIMEDIC™ DefiMonitor
XD3/XD30/XD300/XD330) 38
5 Preparatory measures before (initial) start-up 39
5.1 Unpacking 39
5.2 Inserting / Changing the SaveCard 39
5.3 Power supply 40
5.3.1 Inserting PRIMEDIC™ AkuPak 41
5.3.2 Removing PRIMEDIC™ AkuPak 42
5.4 Loading the PRIMEDIC™ AkuPak 43
5.4.1 Charging the AkuPak in the optional PRIMEDIC™ Charger Basis /
Charger Comfort 44
5.5 Connecting the mains cable 44
5.6 Inserting paper in the printer 45
6 Device self-test 46
6.1 Self-test when the PRIMEDIC™ DefiMonitor XD is switched on 46
6.2 Automatic, periodic self-tests 46
7 Operating the PRIMEDIC™ DefiMonitor XD 47
Table of contents
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.
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-compliance with the instructions in these operating instructions with regard to
operation, maintenance and repair of the equipment.
• 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.
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 tips.
Note
This point identifies the first step of a sequence of actions you should take.
Second step of an action you should take. etc.
< ... > The text in pointed brackets are acoustic instructions / arrangements of the
equipment which are simultaneously shown on the monitor, depending on
the equipment variant.
Fig. 1: Brief instructions on use of devices Fig. 2: Brief instructions on use of devices
with AED mode without AED mode
Not to be reused
Expiry date
Batch ID
Order number
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 SPO 2 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.
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.
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.
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 2010
Resuscitation.
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.
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.
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:
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.
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. PRIMEDIC(TM) Basic / Comfort charger serves as a
power supply for charging the batteries.
A wide range of accessories are available.
The wall bracket and accessories are described in separate operating instructions.
Fig. 12: Panel foil PRIMEDIC™ DefiMonitor XD 1/10/3/30 (completely manual defibrillators)
Fig. 13: Panel foil PRIMEDIC™ DefiMonitor XD 100 / 110 / 300 / 330
Note In order to ensure that the device is always ready for immediate operation,
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.
The saved data can be viewed with the help of a PC / laptop and the PRIMEDIC TM 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.
Wherever possible, the data saved on the SaveCard should be downloaded 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.
The SaveCard supplied with the device is already formatted and can be used straight away. in
case of problems with the present SaveCard, as well as in case of a new CF-card, it must be
formatted using FAT16 or FAT32 file system. To attain the greatest possible degree of safety
here, please proceed as follows:
For Windows 2000, Windows XP, Windows Vista, Windows 7
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:
for SaveCards up to 2GB= format f: /U /FS:FAT /X /V:savecard
for SaveCards up to 2GB= format f: /U /FS:FAT32 /X /V:savecard
(where f: stands for the drive letter of the of the CF card reading device which you may
have to adjust).
4.5.1 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. 15: Locking the adult paddles in place over the electrodes for children
Note Do not use the child-sized electrodes on adults, as they will not provide adequate
defibrillation.
DANGER
Definitely do not use the device if you know of any damage.
Endangering health cannot be ruled out.
Satisfy yourself that the scope of delivery is complete in accordance with the enclosed delivery
note.
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 (3)
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 SaveCard can now be
removed.
Then close the cover.
Replace the power module in the device. The device now boots and performs a self-
test.
Note Wherever possible, the data saved on the SaveCard should be downloaded
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.
Note If you operate the PRIMEDIC™ DefiMonitor XD exclusively via power from the
mains, then you must ensure that the PRIMEDIC™ AkuPak 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. If
necessary, PRIMEDIC™ AkuPak should be recharged. If this is
not possible, make sure you always have a second, fully charged
PRIMEDIC™ AkuPak at hand.
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.
Note The device switches on automatically when the PRIMEDIC™ AkuPaks battery is
inserted and 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.
Note Only change the power module when the device is switched off and
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.
Note Of the two charging possibilities mentioned above, PRIMEDIC™ AkuPak, will be
automatically recharged in case the charge should fall below 80 % of its charging
capacity.
This 80 %-limit can temporarily be made inoperative by pressing 3 seconds on push
button (2), i.e., the PRIMEDIC™AkuPak can be recharged even before reaching
this limit. This, for example, is practical if you wish to fully recharge
PRIMEDIC™AkuPak prior to next use, independent of its current charge status.
After recharging, the programmed 80 %-limit is operative for the next automatic full
recharge.
Note A completely discharged PRIMEDIC™ AkuPak battery must be charged for at least
2.5 hours. Too short a charge duration can lead to misinterpretation of charge by
the equipment. Trouble-free functioning of the equipment cannot be assured.
Note Charging PRIMEDIC™ AkuPak battery pack at operating temperatures outside the
prescribed range can damage the battery. Allow the battery to reach the ambient
temperature before charging it, or charging may be interrupted prematurely.
Note Ensure that the PRIMEDIC™ AkuPak battery is inserted in the power
module slot. This is vital to ensure fault-free operation of the PRIMEDIC™
DefiMonitor XD via the mains. The 3-pin cable provided must be used.
Note The cover is designed to spring out of its position without damage if great
pressure is exerted from the outside.
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
PRIMEDIC™ AkuPak battery in the device. The self-test checks all important functions and
signalling devices. Automatically full self-test is initiated in case an internal error is found by
the equipment. Please proceed to follow the device instructions.
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
7.5 Alarms
Depending on the equipment, the PRIMEDIC™ DefiMonitor XD monitors the heart rate from
the ECG signal and the oxygen saturation of the patient from the data of 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 SPO 2 Alarm differ.
The alarms are always activated when the PRIMEDIC™ DefiMonitor XD 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.
7.5.2 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
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.
DANGER
There is no acoustic warnings if the alarms are turned off in case
one of the monitored parameters is beyond the permissible
range. Hence, regularly check the patients and the equipment
indicators so as to react rapidly to changes.
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 ECG sequence 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.
Note The printing format for the Memo print is always 3-channel print. The signal
graphs displayed on the monitor at the time of the event are printed out.
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:
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 minimum
Note
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.
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.
Note Data in the Event Memory remains stored even after printout. It can be
printed out as often as required.
Printer error
8.2 Positioning
CAUTION
Medicinal plasters must be removed before attaching the defibrillation
electrodes.
Note Incorrect positioning of the electrodes, defective or dry electrodes can lead
to faulty readings. For this reason, always use ECG self-adhesive
electrodes approved by Metrax.
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:
1. First, connect the SavePads Connect cable with the electrode clip
to the self-adhesive electrodes placed on the patient. To do this,
open the locking lever on the clip and insert the metal-plated
connection tab into the slit in the electrode clip
2. Snap the upper part of the clip back in place to fix the connection.
3. Observe the colour marking showing the polarity of the electrode
chips when attaching them to the respective electrodes
4. Connect the cable with the PRIMEDIC™ DefiMonitor XD.
Note If it should become necessary during pacing to defibrillate the patient, 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).
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!
Note To be able to unplug the electrode plug, you have to push on the top part of the
locking pin while at the same time pulling the plug out.
Note Do not touch the floor, other objects, clothing or other parts of the body with the
exposed electrodes – this could remove the conducting layer of gel from the
electrodes.
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.
Note With the model SpO2, message < check electrodes > is supressed in the display.
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.
Note In case of PRIMEDICTM DefiMonitor XD, the ERC-guidelines for the sequence have
been preconfigured in the factory.
When the device is switched on and has successfully completed self-testing, it is ready for
operation.
DANGER
Take care that during the analysis phase, the Auto switch is not continuously
pressed as otherwise safety shutdown of the equipment is effected.
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.
Once the capacitor is charged, power for the defibrillation pulse is available for 15 seconds.
This is signalled by a continuous acoustic warning, the voice message
< Stand clear of patient. Deliver shock now >,
signalled by a continuous beep and the trigger button lighting up green. If you do not
defibrillate within this period, an internal safety discharge will follow and the ECG will be
analysed again.
Turn on green lit trigger key to give shock.
Hold the button pressed until the shock has been administered. Avoid contact with the jacks on
the device during defibrillation.
Note Pressing the trigger key during power charging (before it turns green) does not
result in release of shock, rather it leads to internal safety discharge.
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)!
After defibrillation, the device once again undertakes cardio pulmonary resuscitation (CPR)
cycle, 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.
Note If a fault occurs during capacitor charging, an intermittent warning signal is sounded
and the device automatically carries out internal discharge of the capacitor.
CAUTION
When the message < Charge battery >, the device still has enough
energy for at least 3 discharges at maximum power. The power module
should be replaced immediately once this message appears.
Note If, when the device is switched on, for 10 minutes no ECG is done, no SpO 2 signal
is recorded or no button is pressed, the device automatically switches off. Approx.
30 seconds before the switch-off this is signalised by an interrupted warning tone.
Pressing any button 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.
Note When the device is switched on and has successfully carried out a self-test, it is in
Auto mode. If your device is only equipped with manual mode (XD1, XD3. XD10,
XD30), you will not need to change mode.
CAUTION
Check that the energy level you have selected is shown on the display.
Note The energy level required for defibrillation / cardioversion depends on the size,
weight and condition of the patient.
10.1.2 Charging
Note The way in which the shock is administered depends on where you initiate charging.
If you load a charge 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 Connect.
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 Connect, and the charging operation has
ended, the green trigger button lights up and a warning signal is sounded.
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 an error 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.
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, the
Note
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 < Charge battery > 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 immediately once this
message appears.
Note In synchronous mode, ECG markings are displayed on the monitor. To ensure 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.
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 effected. If the trigger button is pressed only
briefly or no synchromarker has emerged while the button is pressed, the energy is retained in
the capacitor for 15 seconds and is then automatically discharged within the equipment.
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.
Note If the cardioversion markers do not appear on the screen or appear in the 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 PRIMEDIC™
AkuPak battery.
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.
Note To disconnect from the device, first lift the sleeve with the arrow slightly and then
pull the connector out of the jack.
Note If you try to activate the Pacer XD when the SavePads Connect cable is not yet
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 SpO 2 module).
Note If the device detects a deviation of ± 30 % from the set intensity, it automatically
interrupts the pacing process. One possible cause is that patient resistance is too
high.
DANGER
If, for example, the QRS-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 PRIMEDIC™ AkuPak battery. 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.
Note If more than 3 minutes elapse without the PRIMEDIC™ Pacer being operated, it
switches off automatically.
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.
Note The operating mode cannot be changed during pacing. For example, in order 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.
WARNING
If for some reason, DEMAND pacing is not possible, the FIX mode can be
used. Thereby, it is necessary to synchronise the stimulation frequency to the
present status. This should be carried out by a doctor.
Note Too slow and not effective stimulation in FIX mode can lead to ventricular fibrillation
if the pacemaker impulse is released during heart's vulnerable phase.
WARNING
The ECG should be monitored closely when the stimulation rate is
changed to observe possible reactions of the patient to the new
stimulation parameters.
Procedure:
Press the 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 Start/Stop button. This is confirmed by a short acoustic
signal. The display text stops flashing.
After starting stimulation using Start/Stop switch, stimulation is effected 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.
Note Both, the frequency as well as the intensity can be changed during pacing by
pressing the buttons.
During pacing, the ECG alarm is effective provided it was not earlier deactivated in the setup
menu. However, it is not possible to make changes in the setup menu during pacing.
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 SavePads Connect cable is unplugged from self-adhesive electrodes
or pulled out 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 selected energy can thereafter be immediately be loaded.
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.
Note Defibrillation can also be carried out via the paddles, even though the 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.
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.
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.
Note For more detailed information on the regular safety and metrological checks in
accordance with the Ordinance on the Operation and Use of Medical Devices
(MPBetreibV), refer to Chapter 24
Error
code Error text Cause(s) User action
50 HV, Internal FSM error Error during the shock appliance - return the device for servicing
51 HV, CPLD error Error during the shock appliance - return the device for servicing
- charge and/or replace the
Error in the voltage supply, power module
possibly due to an empty - if the error persists: Return the
52 HV, +5V voltage failed accumulator/battery device for servicing
- charge and/or replace the
Error in the voltage supply, power module
possibly due to an empty - if the error persists: Return the
53 HV, +5VSW voltage failed accumulator/battery device for servicing
- charge and/or replace the
Error in the voltage supply, power module
possibly due to an empty - if the error persists: Return the
54 HV, +24V voltage failed accumulator/battery device for servicing
55 HV, VREF voltage failed Error in voltage reference - return the device for servicing
- charge and/or replace the
Error in the voltage supply, power module
HV, HVPWR voltage possibly due to an empty - if the error persists: Return the
56 failed accumulator/battery device for servicing
- charge and/or replace the
Error in the voltage supply, power module
possibly due to an empty - if the error persists: Return the
57 HV, RLPWR voltage failed accumulator/battery device for servicing
Error when setting the current
HV, Current setup DAC specifications - Failure in the
58 failed high voltage section - return the device for servicing
- restart the device
HV, RTCCLK error was Error in generation of system - if the error persists: Return the
59 detected cycle device for servicing
- restart the device
HV, MCLK error was - if the error persists: Return the
60 detected Dropout in system cycle device for servicing
HV, HVHALT event was Emergency shutdown during the
61 detected shock application - return the device for servicing
HV, HVHALT net error Error during the test of the
62 was detected emergency shutdown - return the device for servicing
HV, Disarm cannot be Error during the internal
63 performed discharge, impossible to - return the device for servicing
error measurement
Error during the hardware
141 XtBoard err - platform detection - return the device for servicing
15 Disposal
In accordance with the founding principles of the company Metrax GmbH, your product has
been developed and made using high quality materials and components which are recyclable.
At the end of its 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: 73450404.
CAUTION
Improper disposal of the device or its individual parts can lead to injury.
16 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
Patient Tolerance
mode at: 1. stage
impedance 2. stage 3. stage
25 Ohm ± 15 % 143 J 201 J 277 J
50 Ohm ± 15 % 281 J 350 J 360 J
75 Ohm ± 15 % 348 J 360 J 360 J
100 Ohm ± 15 % 344 J 343 J 343 J
125 Ohm ± 15 % 314 J 316 J 317 J
150 Ohm ± 15 % 290 J 293 J 293 J
175 Ohm ± 15 % 269 J 272 J 272 J
Output energy in MAN Energy
Tolerance 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 175Ω
mode depending upon to:
the patient impedance: 5J ±3J 5J 5J 5J 5J 5J 5J 5J
10 10 10
10 J ±3J 10 J 10 J 10 J 10 J
J J J
20 20 20
20 J ±3J 20 J 19 J 16 J 15J
J J J
30 30 30
30 J ± 15 % 30 J 28 J 24 J 23 J
J J J
50 50 50
50 J ± 15 % 50 J 41 J 38 J 34 J
J J J
98 100 100 100
100 J ± 15 % 83 J 75 J 68 J
J J J J
195 200 200 200 170 154 141
200 J ± 15 %
J J J J J J J
290 300 300 300 262 236 214
300 J ± 15 %
J J J J J J J
340 360 360 360 314 287 242
360 J ± 15 %
J J J J J J J
ECG
Derivation: 2 derivations from I, II, III, aVL, aVR, aVF
Heart frequency: 30 – 270 min-1
Input: Class CF, defibrillation-proof
Input resistance: > 5 MOhm @ 10 Hz
CMRR: > 85 dB
Input d.c. voltage: ± 0.5 V
Bandwidth: 0.5 – 40 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
30 kHz
frequency:
Measuring precision: ±15 %
Alarms
System: EKG, SpO2,, defibrillator, power supply, data memory
Physiological: schockable rhythm
Analysis duration: one approx. 7 sec to identify schockable rhythm for a battery with 90 %
battery of the nominal capacity
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 Pacing: 1h pacing, operation at 120 pulses/min at 140 mA
Connect 8h pacing, operation at 60 pulses/min at 70 mA
10 minutes, operation OverDrive pacing at 200
pulses/min at 180 mA
Data storage
Memory type: CompactFlashCard 32MB – 4GB possible
Safety
Classification: Medical product of class IIb, protection class I, Type CF, defi-proof,
Identification: 0
123
Other
operating conditions: 0 ... 50 °C, 30 ... 95 % rel. humidity, but without condensation
700 hPa ... 1060 hPa continuous mode
Storage conditions: - 20 ... 70 °C, 20 ... 95 % rel. humidity, but without condensation
500 hPa ... 1060 hPa continuous mode
Dimensions: 33 x 16 x 29 cm (W x D x H)
Weight: 5.3 kg (without power module)
17 Accessories
The PRIMEDIC™ DefiMonitor XD is supplied with the following accessories fitted at the
factory:
• Paddle set
• PRIMEDIC™ SavePads Connect
• Power module: PRIMEDIC™ AkuPak
For details of further accessories, see separate list of accessories / price list.
18 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 claims 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 PRIMEDIC™ AkuPak) or damages caused after transfer of risk as a result of incorrect
or negligent handling, excessive wear or 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.
100 Joule @ 50 Ohm 100 Joule @ 75 Ohm 100 Joule @ 100 Ohm
I/A
100 Joule @ 125 Ohm 100 Joule @ 150 Ohm 100 Joule @ 175 Ohm
I/A
200 Joule @ 100 Ohm 200 Joule @ 125 Ohm 200 Joule @ 150 Ohm
I/A
200 Joule @ 175 Ohm 300 Joule @ 25 Ohm 300 Joule @ 50 Ohm
I/A
300 Joule @ 75 Ohm 300 Joule @ 100 Ohm 300 Joule @ 125 Ohm
I/A
300 Joule @ 150 Ohm 300 Joule @ 175 Ohm 360 Joule @ 25 Ohm
I/A
360 Joule @ 50 Ohm 360 Joule @ 75 Ohm 360 Joule @ 100 Ohm
I/A
360 Joule @ 125 Ohm 360 Joule @ 150 Ohm 360 Joule @ 175 Ohm
I/A
The following diagrams show the graphs for the defibrillation pulse in AUTO mode, displayed
depending on the load resistance.
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 advised."
• Measures the symmetry of the ECG signal by several wave form factors and area
above and below the moving average of the signal. Shockable rhythms show
greater symmetry than non-shockable rhythms.
• Measures the ratio of the signal energy content in a frequency band typical for
shockable rhythms and the total of the signal energy content. For shockable
rhythms the signal energy concentrates in a specific frequency band and its
fraction with respect to the total signal energy is higher.
• Derives from these two signal processing steps two parameters and compares
them to a threshold. If both parameters drop below their respective threshold for a
specific amount of time, the device will rate the heart rhythm shockable. However,
if one of the parameters exceeds its higher threshold value, this shocking
recommendation is retracted.
• Filters and measures artefacts and interference. If a specific artefact level is
exceeded no reliable signal analysis is possible and the heart rhythm is rated non-
shockable.
• Detects pacemaker pulses and removes them from the ECG signal before
analysing rhythm.
• Measures the heart rate. If it drops below a threshold, the heart rhythm is rated
non-shockable.
Cardiac rhythms used to test the rhythm detection system in the device
To validate the databases used:
• AHA Database for Evaluation of Ventricular Arrhythmia Detectors (80 records
with 35 min length each)
• MIT-BIH Arrhythmia Database (48 records with 30 min length each)
• European ST-T Database (48 records with 120 min length each)
These databases contain ECG rhythms with ventricular fibrillation (VF) of varying amplitudes,
ventricular tachycardia and sinus rhythms with – amongst others – supraventricular
tachycardias, atrial fibrillation/flutter, sinus rhythm with premature ventricular contractions
(PVC), asystolia and pacemaker pulses. All records are valid for evaluation of the VT-/VF-
rhythm detector with respect to used electrode systems and ECG signal processing
characteristics. For validation the ECG was converted to an analogue signal and put out to the
device under test. The detection result was than read back by the validation system and
compared to the reference annotation.
As shockable rhythms, in calculation, we look at the characteristic values of the sections in the
ECG datasets of the above databases, which are marked with the PysioBank Annotationscode
for ventricular flutter ("[" Begin, "]" End; also refer www.physionet.org) using the PhysioBank
Annotationscode.
These sections also contain ventricular tachycardia that however are not separately annotated
and therefore cannot form part of the statistic.
For evaluation, the test and reference annotations of segments with a length of 12 seconds
were compared to each other. Segments containing a shift between shockable and non-
shockable rhythms were not taken into account.
Performance results (weighted average):
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
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.
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.
HF emissions
Class B
as per CISPR 11
Emission of
harmonics
Class B
according to IEC The PRIMEDICTM DefiMonitor XD is suitable for use in all
61000-3-2 facilities, including residential areas and those which are
Emission of directly connected to a public supply network which also
voltage supplies buildings that are used for residential purposes.
fluctuations /
Compliant
flickering
according to IEC
61000-3-3
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 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 necessary to take additional
measures, such as change the orientation or the location where the PRIMEDIC TM 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.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 3 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 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.
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.
Note After 4 weeks, NiCd batteries are still at approximately 60 % capacity. 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™ AkuPak battery automatically begins a recharging cycle every 2
weeks, thus automatically compensating for the loss of charge.
If you are using several PRIMEDIC™ AkuPak 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 over a long period and then recharged, the
typical "Memory" effect takes place. 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. The "memory" effect may set in if this mode of operation is continued over a
long period. i. e. the capacity of the battery is reduced to 5 to 6 defibrillations, as the battery
has been "trained” to perform 5 defibrillations.
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™ AkuPak the date of manufacture stored. After 2.5
years, the device issues the voice message < Charging status battery low, please recharge >.
At the same time, the battery symbol appears on the status display. If necessary, PRIMEDIC™
AkuPak should be replaced.
24 Safety checks
Additionally to the maintenance activities of the operator (see chapter 13.2), Metrax GmbH
also prescribes every two years a technical safety check by Metrax or by a person authorised
by Metrax. The test protocols necessary for the checks can be provided by Metrax. Only
authorised persons can operate the device. Please consider also the national directives in your
country about safety technical checks.
25 Index of diagrams
Fig. 1: Brief instructions on use of devices with AED mode ............................................ 9
Fig. 2: Brief instructions on use of devices without AED mode ....................................... 9
Fig. 3: PRIMEDIC™ DefiMonitor XD 1 / 3 – Front view ................................................ 22
Fig. 4: PRIMEDIC™ DefiMonitor XD 10 / 30 – Front view ............................................ 23
Fig. 5: PRIMEDIC™ DefiMonitor XD 100 / 300 – Front view ........................................ 24
Fig. 6: PRIMEDIC™ DefiMonitor XD 110 / 330 – Front view ........................................ 25
Fig. 7: PRIMEDIC™ DefiMonitor XD – rear view .......................................................... 26
Fig. 8: PRIMEDIC™ DefiMonitor XD – view from below ............................................... 26
Fig. 9: PRIMEDIC™ DefiMonitor XD – side view .......................................................... 27
Fig. 10: PRIMEDIC™ DefiMonitor XD – side view ........................................................ 28
Fig. 11: PRIMEDIC™ DefiMonitor XD – status display ................................................. 28
Fig. 12: Panel foil PRIMEDIC™ DefiMonitor XD 1/10/3/30 (completely manual defibrillators)
.................................................................................................................................. 30
Fig. 13: Panel foil PRIMEDIC™ DefiMonitor XD 100 / 110 / 300 / 330 ......................... 30
Fig. 14: Monitor display ................................................................................................. 32
Fig. 15: Locking the adult paddles in place over the electrodes for children ................ 35
Fig. 16: PRIMEDIC™ SavePadsConnect cable, 2-pin .................................................. 36
Fig. 17: PRIMEDICTM SavePads Connect ..................................................................... 36
Fig. 18: ECG patient cable, 3-pin .................................................................................. 37
Fig. 20: SpO2 sensor and adapter cable ........................................................................ 38
Definitely do not use the device if you know of any damage. Endangering health cannot be
ruled out. ................................................................................................................... 39
Fig. 21: PRIMEDIC™ DefiMonitor XD – SaveCard ....................................................... 39
Fig. 22: PRIMEDIC™ DefiMonitor XD – Inserting PRIMEDIC™ AkuPak ..................... 41
Fig. 23: PRIMEDIC™ DefiMonitor XD – Removing the power module ......................... 42
Fig. 24: PRIMEDIC™ AkuPak Battery charge indicator ................................................ 43
Fig. 25: Positions of defibrillation electrodes (SavePads Connect) on the patient........ 57
Fig. 26: Positions of ECG electrodes on the patient ..................................................... 58
Fig. 27: Removing the protective film from the electrodes ............................................ 60
Fig. 28: Attaching the SpO2 sensor ............................................................................... 72
Fig. 29: Disposal ............................................................................................................ 87
Contact details
METRAX GmbH
Rheinwaldstr. 22
D-78628 Rottweil
Tel.: 0741/257-0
info@primedic.com
www.primedic.com
METRAX GmbH
METRAX GmbH
Your dealers Representative office
Представительство в
Ul. Vavilowa 5, corpus 3 странах СНГ
Office 406-3 119334 Москва Россия
119334 Moscow ул.Вавилова, д.5, корп.3,
Russia офис 406-3
Tel.: +7 495 722 1705 тел.: +7 495 722 1705
116 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH
www.primedic.com.ru www.primedic.com.ru
info@metrax.ru info@metrax.ru