www.primedic.de
HeartSave PAD
Operating instructions
MGA 22289/ GB / C
Masthead
Publisher
METRAX GmbH
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).
MGA 22289 / GB / C
Table of contents
Table of contents
1 Introduction 3
1.1 Foreword ..................................................................................................................... 3
1.2 Validity ........................................................................................................................ 3
1.3 Warranty ..................................................................................................................... 3
1.4 Disclaimers .................................................................................................................. 4
1.5 Symbols used in these operating instructions ............................................................... 5
1.6 Pictograms on the device ............................................................................................. 6
1.7 Pictograms on SavePads .............................................................................................. 6
2 Intended use 7
2.1 Indication/Contraindication for Defibrillation ............................................................... 8
2.1.1 Indications ........................................................................................................ 8
2.1.2 Contraindications ............................................................................................. 8
3 Safety information 9
3.1 General information..................................................................................................... 9
3.2 General safety instructions ......................................................................................... 11
3.3 Safety notes for you, the user .................................................................................... 11
3.4 Safety notes for protection of the patient ................................................................... 12
3.5 Safety notes for the protection of third parties ........................................................... 14
3.6 Safety notes for the protection of the device .............................................................. 14
4 Description of device 15
4.1 General description .................................................................................................... 15
4.2 Description of device details ...................................................................................... 16
4.3 Status display ............................................................................................................ 19
4.4 Data management ..................................................................................................... 20
4.5 Description of the accessories .................................................................................... 21
4.5.1 Primedic SavePads .......................................................................................... 21
4.5.2 Optional accessories ....................................................................................... 21
5 Preparatory measures before (initial) start-up 22
5.1 Unpacking ................................................................................................................. 22
5.2 Inserting / Changing the SaveCard ............................................................................ 23
5.3 Inserting / Changing the power supply unit (Battery) ................................................. 24
5.3.1 Inserting the battery ....................................................................................... 24
5.3.2 Removing the battery from the device ............................................................ 25
5.4 PRIMEDIC™ Battery .................................................................................................. 26
6 Device self-test 27
6.1 Self-test after switching on the HeartSave PAD .......................................................... 27
6.2 Automatic, periodic self-tests ..................................................................................... 27
7 Operating the device and sequence of reanimation 28
7.1 Switching the PRIMEDIC™ HeartSave PAD on / off .................................................. 28
7.1.1 Switching the PRIMEDIC™ HeartSave PAD on ............................................... 28
7.1.2 Switching the PRIMEDIC™ HeartSave PAD off .............................................. 28
7.2 Voice output by the device / Preliminary examination of the patient .......................... 29
7.3 Undressing the patient ............................................................................................... 29
7.4 Determining the position of the electrodes ................................................................. 30
7.5 Removing hair growth from chest .............................................................................. 30
7.6 Drying the skin .......................................................................................................... 30
7.7 Opening SavePads and positioning electrodes ........................................................... 31
7.8 Plugging in the electrode plugs .................................................................................. 32
7.9 Checking the electrodes ............................................................................................. 33
7.10 Carrying out the ECG analysis .................................................................................... 34
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Table of contents
7.11 Defibrillation required ............................................................................................... 34
7.12 Defibrillation not required ......................................................................................... 35
7.13 Keep the defibrillator ready for use ............................................................................ 36
8 Cleaning, maintenance and dispatch 37
8.1 Cleaning ................................................................................................................... 37
8.2 Servicing ................................................................................................................... 38
8.2.1 Servicing check list ......................................................................................... 38
8.3 Dispatching the PRIMEDIC™ HeartSave PAD ........................................................... 39
9 Disposal 40
10 Technical Data 41
11 Warranty conditions 43
12 Depiction of the current time function 44
13 Rhythm detection system 46
14 Guidelines and manufacturer's declaration – Electromagnetic emissions 48
15 Safety checks 53
16 Index of diagrams 54
17 Use of devices on ships 55
17.1 Use of PRIMEDIC™ HeartSave devices with PRIMEDIC™ Battery on merchant navy
ships: 55
17.2 Use of PRIMEDIC™ HeartSave devices with PRIMEDIC™ AkuPak on merchant navy
ships: 55
Contact details 56
MGA 22289 / GB / C
Introduction
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Operating instructions HeartSave PAD 22289 / GB / C
Introduction
1 Introduction
1.1 Foreword
Dear User,
You are faced with the task of using the PRIMEDIC™ HeartSave PAD 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 descriptions in these operating instructions refer to the Primedic HeartSave PAD
made by METRAX GmbH.
1.3 Warranty
The warranty period is 24 months and starts on the day of purchase. It is important to
keep the receipt 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.
Operating instructions HeartSave PAD 22289 / GB / C
3
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.
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Operating instructions HeartSave PAD 22289 / GB / C
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 pay attention to these texts.
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 pay attention to these texts.
Note
CAUTION
Texts marked with CAUTION indicate a possible dangerous
situation which could lead to minor injuries or damage to
This symbol indicates text which contains important advice / comments or
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.
property.
It is imperative that you pay attention to these texts.
Operating instructions HeartSave PAD 22289 / GB / C
5
Introduction
1.6 Pictograms on the device
IP55
Protection against contact and dust deposits on the inside
and against jets of water (nozzle) from any angle.
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
GERMANISCHER LLOYD type approval certificate
no. 75 449-09 HH
1.7 Pictograms on SavePads
Not to be reused
Expiry date
Batch ID
Only for adults
Order number
Storage temperature information
in Celsius and Fahrenheit
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Operating instructions HeartSave PAD 22289 / GB / C
Intended use
2 Intended use
The PRIMEDIC™ HeartSave PAD is intended to be used by non-experts and trained
first-aiders. It may only be used on patients who are unconscious and who are not
breathing.
The main application is to carry out transthoracic defibrillation in asynchronous mode.
The decision about the necessity of applying a shock is carried out automatically by the
device.
The operator is guided by spoken instructions and clear written and pictorial
information. After switching on the device, the patient is connected to it using the
enclosed adhesive electrodes. After this, automatic rhythm analysis is carried out by the
device. Only if a rhythm is detected by the device as being ventricular fibrillation
(=shockable) does it suggest treatment with a high energy shock. All other rhythms are
classified as not requiring a shock. The time from the start of analysis until the shock is
applied is less than 30s.
The energy levels of the first, second and third shock are predefined by the maximum
set points for the electric current 20A, 25A and 30A, as well as by the capacitor voltage
which depends on the patient impedance.
For safety reasons, no shock is given with asystolia, as no therapeutic effect is to be
expected. Controlled ventricular electrical activity caused by supraventricular
tachycardia such as atrial fibrillation, atrial flutter, ventricular extra-systoles and
idioventricular rhythms does not lead to a shock being applied.
The device supports the user in the reanimation process depending on the factorysetting in accordance with the current guidelines from the European Resuscitation
Councils (ERC) from 2005 or the American Heart Association (AHA) from 2005 for
immediate lifesaving measures to be taken when using an automatic defibrillator. This
includes acoustic instructions for carrying out artificial respiration and heart massage as
well as the cyclical process of rhythm analyses and, where necessary, the application of
further shock therapy according to the recommendation by the device.
Note
The operator of the HeartSave PAD has to make sure that the HeartSave PAD is only
used by authorised specialist personnel.
The PRIMEDIC™ HeartSave PAD devices may only be used as described and
under the conditions detailed in these operating instructions.
WARNING
Any use above or beyond this is not considered as intended
use and can lead to personal injury or damage to property.
Operating instructions HeartSave PAD 22289 / GB / C
Improper use of the defibrillator can lead to ventricular
fibrillation, asystolia or other dangerous dysrhythmia.
7
Intended use
2.1 Indication/Contraindication for Defibrillation
2.1.1 Indications
The PRIMEDIC™ HeartSave PAD may only be used if the patient:
is unconscious and
not breathing
2.1.2 Contraindications
The PRIMEDIC™ HeartSave PAD may not be used if the patient:
is conscious or
breathing normally or
a normal pulse can be felt or
is a child under the age of 8 or weighing less than 25 kg respectively.
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Operating instructions HeartSave PAD 22289 / GB / C
Safety information
3 Safety information
3.1 General information
Both in conjunction with its accessories and the optional accessories, and also
individually, the PRIMEDIC™ HeartSave PAD fulfils the currently applicable safety
standards and complies with the provisions of the medical products regulations.
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
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™ HeartSave PAD may only be used by
trained and authorised personnel. Reading the operating
instructions does not replace training.
The PRIMEDIC™ HeartSave PAD is not licensed for use in
explosive areas.
Operating instructions HeartSave PAD 22289 / GB / C
9
Safety information
Note
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.
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,
Observe the information and rules in the appendix on using the PRIMEDIC™
HeartSave PAD.
of influencing active implants,
of burns from incorrectly applied electrodes.
Apart from that, the device can be damaged or destroyed
through improper use.
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Operating instructions HeartSave PAD 22289 / GB / C
Safety information
3.2 General safety instructions
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.
DANGER
3.3 Safety notes for you, the user
Only use the device on a patient if
you have been authorised to do so as a result of training!
you have ensured its operational safety before you use it
and that it is in good condition.
the state of the patient requires or allows an application.
Before using it, check whether the device is in 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
gels, blood or salt solutions) and metallic objects around the
patient (such as bed frame or traction devices) which present
unintended paths for the defibrillation current.
WARNING
Operating instructions HeartSave PAD 22289 / GB / C
11
Safety information
3.4 Safety notes for protection of the patient
DANGER
Only use the device on a patient if
you have been authorised to do so as a result of training.
you have ensured its operational safety before using it
and that it is in good condition.
Before using it, check whether the device is in the operating
temperature range. This applies for example, if the
defibrillator is stored in a rescue vehicle in the winter.
Do not use the device if it is defective (e.g. if the housing or
the defibrillation cable are 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. These conditions are
fulfilled by all original PRIMEDIC™ accessories and wearing
parts.
Use new, undamaged and unexpired defibrillation electrodes
for every patient to avoid any possible burns to the skin!
Only connect the adhesive electrodes to the PRIMEDIC™
HeartSave PAD. Using the electrodes with other devices can
cause the patient to be given dangerous leakage currents.
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™ HeartSave PAD
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™ HeartSave PAD
and disrupt the way it operates. For this reason, disconnect
the patient from the connections of the interfering devices.
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Operating instructions HeartSave PAD 22289 / GB / C
Safety information
DANGER
During defibrillation, disconnect the patient from all other
medically used devices which do not have a defibrillation
resistance application part.
Keep the defibrillation electrodes away from other electrodes
and from metallic parts which are in contact with the patient.
Do not use the device on children under the age of 8 or on
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.
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™ HeartSave PAD
is analysing the ECG.
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 gels, blood or salt solutions)
and
metallic objects around the patient (such as bed frame or
traction devices) which present unintended paths for the
defibrillation current.
Operating instructions HeartSave PAD 22289 / GB / C
13
Safety information
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.
3.6 Safety notes for the protection of the device
CAUTION Damage to property
Repairs, changes, extensions and installations of the
PRIMEDIC™ HeartSave PAD may only be carried out by
personnel authorised and trained by METRAX
The PRIMEDIC™ HeartSave PAD does not have any
parts that can be repaired by the user.
The device may only be equipped and operated with
original accessories from PRIMEDIC™.
Only clean the device when it is switched off and the
electrodes have been removed and only clean it in the
prescribed manner.
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Operating instructions HeartSave PAD 22289 / GB / C
Description of device
4 Description of device
4.1 General description
The PRIMEDIC™ HeartSave PAD (PAD = P
external defibrillator (AED) with an integrated single channel ECG.
The ECG is recorded using the PRIMEDIC™ SavePads. The algorithm implemented
recognises potentially fatal heart arrhythmia. The defibrillator generates the electric
shock necessary to reanimate a patient with a shockable ECG rhythm. This method is
the generally recognised therapy.
The PRIMEDIC™ HeartSave product family 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 defibrillator unit has been optimised to be safe and very quickly ready to use. The
loading time for a defibrillation is approx. 12 seconds with a battery capacity of
approx. 90 % of the rated value.
The power supply of the PRIMEDIC™ HeartSave PAD comes from a disposable lithium
battery.
The PRIMEDIC™ HeartSave PAD can be stored on a PRIMEDIC™ wall mount rack
which can be affixed to a wall or in the ambulance. It is easy and quick to remove the
PRIMEDIC™ HeartSave PAD when you need it, using the one-hand quick release.
ublic Access Defibrillator) is an automatic
Note
Operating instructions HeartSave PAD 22289 / GB / C
The wall bracket and accessories are described in separate operating instructions.
15
4.2 Description of device details
Fig. 1: HeartSave PAD front view
(1) Carry handle
(2) Cover of device
(3) Strap to pull the cover off the device (with expiry date SavePads)
(4) Status display
Fig. 2: HeartSave PAD rear view
(1) Receptacle opening for hook of the wall bracket
(2) Specification plate
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Operating instructions HeartSave PAD 22289 / GB / C
Fig. 3: HeartSave PAD View from underneath
(1) Release button for SaveCard
(2) Slot for SaveCard
(3) Release button
(4) Contacts for power module
Fig. 4: HeartSave PAD operating controls
(1) On/Off button
(2) Electrode symbol with LED
(3) Membrane keyboard with patient symbol
(4) "Do not touch patient" symbol (lights up during ECG analysis)
(5) Jack for electrode connector plug
(6) Loudspeaker
(7) Trigger button for defibrillation
(8) Status display
Operating instructions HeartSave PAD 22289 / GB / C
17
Fig. 5: Primedic utensils carrier with SavePads
(1) Primedic SavePads (defibrillation electrodes)
(2) Artificial respiration cloth and razor
(3) Quick instructions, several languages
(4) Rubber gloves, not sterilised
(5) Primedic utensils carrier with expiry date SavePads
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Operating instructions HeartSave PAD 22289 / GB / C
4.3 Status display
In the table below is a list of the possible things displayed in the status display and their
meanings.
Display. Meaning. Measures to be taken.
Sufficient battery
capacity.
Device ready to use.
The battery is monitored using an electronic charge balance process.
Once the battery is exhausted, a warning tone will sound in connection with an
audible warning.
Note
Low battery capacity.
Audible warning.
Battery. < Battery low, please replace battery >
If the device is being used, the corresponding audible warning will be
repeated regularly in the selected language. The battery symbol in the status
display is activated.
No power module
inserted.
Sufficient battery
capacity.
Device defective.
Device defective. Carry out major self-test by
Device can be used.
Nearly time to exchange battery.
Insert power module.
Carry out major self-test by
reinserting the battery or
switching the device on again.
Have the device repaired by a
dealer.
reinserting the battery or
switching the device on again.
Have the device repaired by a
dealer.
Operating instructions HeartSave PAD 22289 / GB / C
19
4.4 Data management
Note
The data saved can be displayed with the aid of a PC / Laptop and the software
PRIMEDIC
diagnostic purposes or for therapy for the patient. It should only be used 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.
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 FAT16 file system. Therefore, when you are formatting,
ensure that you do not accidentally transfer the FAT32 file system onto a Windows XP
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
There you enter the following: format f: /U /FS:FAT /X /V: (where f: stands for
The device automatically records all the data on a removable SaveCard and
also records all noises in the surroundings via a microphone.
TM
ECG Viewer (optional accessory). However, this data may not be used for
"cmd.exe". The command line window will then open.
the drive letter of the of the CF card reading device which you may have to
adjust).
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Operating instructions HeartSave PAD 22289 / GB / C
4.5 Description of the accessories
The accessories need to be secured appropriately before being transported.
4.5.1 Primedic SavePads
Fig. 6: Primedic SavePads
(1) Plug of the defibrillation electrodes (Primedic SavePads)
(2) Defibrillation electrodes with protective film
4.5.2 Optional accessories
PRIMEDIC™ ECG Viewer (read out and documentation software)
Order No.: 96468
PRIMEDIC™ HeartSave Bag Order No.: 96379
PRIMEDIC™ SaveBox Basic Order No.: 96740
PRIMEDIC™ SaveBox Advanced Order No.: 96776
Information signs “Defibrillator” Order No.: 96595
Subject to change without notice.
Operating instructions HeartSave PAD 22289 / GB / C
21
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
Satisfy yourself that the scope of delivery is complete in accordance with the enclosed
delivery note.
Dispose of the packaging material in an environmentally-friendly manner.
Definitely do not use the device if you know of any damage.
Endangering health can not be ruled out.
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Operating instructions HeartSave PAD 22289 / GB / C
Preparatory measures before (initial) start-up
5.2 Inserting / Changing the SaveCard
Fig. 7: Inserting / Changing the SaveCard
To remove the SaveCard or to change it, you first of all have to remove the power
module.
Procedure:
Press the button (1) in fully – this pushes the SaveCard (2) slightly out of its
holder.
Completely remove the SaveCard from the device and transfer the data (if
applicable) onto a PC and insert this card or a new one into the device with the
pin end first.
Gently press the card in until the button (1) projects slightly out of the device.
Finally insert the power module into the device again.
After this, the device will carry out a self-test and is ready to use.
Note
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.
To read out the saved data, you can use the software PRIMEDIC™ ECG
Viewer which is available as an optional accessory.
Operating instructions HeartSave PAD 22289 / GB / C
23
Preparatory measures before (initial) start-up
5.3 Inserting / Changing the power supply unit (Battery)
Before using the PRIMEDIC™ HeartSave PAD for the first time, the battery has to be
inserted in the appropriate slot.
Note
5.3.1 Inserting the battery
The HeartSave PAD is always supplied with a battery.
Check the status display every time after you have used the device. If
necessary, the battery should be exchanged for a new one.
Note
Fig. 8: Inserting the battery
Procedure:
Lay the device on its back.
Push the (new) battery (3) in the direction of the arrow (1st) into the device until
it reaches its end position as shown in the diagram.
Then press the battery at the front in the direction of the arrow (2nd) into the
power module slot until the release button (4) locks the power module tongue
securely into position.
Press the power module completely into the device until you hear the "click"
when it slots into place and the power module is flush with the outside edge of
the device.
If the battery has been installed correctly, the device will start independently
once the cover of the housing has been removed and it will run a self-test.
Now follow the acoustic instructions from the device and then switch it off.
Now the device is ready to use.
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Operating instructions HeartSave PAD 22289 / GB / C
Preparatory measures before (initial) start-up
Monitor the Status Display. If the display is showing "OK",
the device is ready to use.
(If applicable), switch it off using the on / off button or put
the device cover back on.
If the display does not show "OK", remedy the cause or
contact your nearest service station.
The device will switch itself off.
CAUTION
5.3.2 Removing the battery from the device
Note
Only change the power module when the device is switched off and the
defibrillation electrode plug is disconnected.
Fig. 9: Removing the battery
Procedure:
Lay the device on its back and press the release button (as described in 5.3.1) to
the right until the tongue of the power module is released and the power module
snaps out of the slot.
Twist the power module slightly in the direction of the arrow (1st) and then pull it
in the direction of the arrow (2nd) out of the device.
Operating instructions HeartSave PAD 22289 / GB / C
25
Preparatory measures before (initial) start-up
5.4 PRIMEDIC™ Battery
The battery is a disposable lithium battery. It is fully charged when delivered. This type of battery
is state-of-the-art and was selected due to its extremely long service life and power storage.
WARNING
On no account try to charge the battery.
There would be risk of an explosion!
Note
CAUTION
Use the battery before its use-by date expires.
In any event, heed the instruction leaflet enclosed with the battery and keep it safe
with these operating instructions.
If the device has to be sent away to technical services, remove the battery
before sending it and put some adhesive insulation tape over its contacts.
When sending the battery, observe the separate shipping regulations.
After using the device, the battery should be (if necessary)
exchanged for a new one (to guarantee a full period of
operation when next deployed).
26
Operating instructions HeartSave PAD 22289 / GB / C
Device self-test
6 Device self-test
6.1 Self-test after switching on the HeartSave PAD
The self-test is triggered by switching on the PRIMEDIC™ HeartSave PAD or by
inserting the battery in the device. The HeartSave PAD runs a device self-test to check
all the important parameters and signal mechanisms.
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 Primedic HeartSave PAD automatically carries out self-tests to ensure that it is
ready to use.
SHORT
MEDIUM
LONG
FULL
Daily Software, operating membrane, ECG calibration,
First day of the month Software, operating membrane, ECG calibration,
On July 1
every year
After changing the power
module or detection of an
internal fault
Frequency Effect of test
clock, internal voltage supply and HV part at 0 V
clock, internal voltage supply and HV part at 300
V
st
and January 1st
Software, operating membrane, ECG calibration,
clock, internal voltage supply and HV part at 1600
V
Software, operating membrane, ECG calibration,
clock, internal voltage supply and HV part at 1600
V, microphone test
Operating instructions HeartSave PAD 22289 / GB / C
27
Operating the device and sequence of reanimation
7 Operating the device and sequence of reanimation
Note
7.1 Switching the PRIMEDIC™ HeartSave PAD on / off
7.1.1 Switching the PRIMEDIC™ HeartSave PAD on
The sequence of reanimation has been devised in accordance with the
recommended guidelines of the European Resuscitation Council
(Resuscitation (2005) 67S1, p7—p23 ) in the device. Ensure that you have
completed appropriate training before using the device.
The device is automatically activated by removing its cover. If the device is not
switched on automatically, switch it on by pressing the on / standby button. After this,
all buttons are activated, apart from the trigger button. Triggering defibrillation is only
activated once ventricular fibrillation (VF) has been ascertained.
Directly after switching it on, an internal self-test is carried out to check important
functions and signal devices. Standby is confirmed by a beep. It is important to ensure
that the loudspeaker is working.
7.1.2 Switching the PRIMEDIC™ HeartSave PAD off
The PRIMEDIC™ HeartSave PAD can be switched off in different ways:
By pressing the on/off button for approx. 3 seconds. A warning beep will sound
simultaneously. This time has been chosen to avoid it being switched off
accidentally.
By closing the cover of the device.
If the device does not recognise a signal for 10 minutes and if no button is
pressed, it switches off automatically.
If the device detects a fault it will automatically switch off to avoid possible injuries.
28
Operating instructions HeartSave PAD 22289 / GB / C
Operating the device and sequence of reanimation
7.2 Voice output by the device / Preliminary examination of
the patient
Note
After the self-test has been successfully performed by the device, the following BLS instructions
are given:
During the course of the voice output, you will be asked to examine the
patient.
For this, you will need to take the rubber gloves out of the cover of the
device and put them on.
< Talk to patient >
< Call emergency services >
< Open up airways, carefully overstretch head >
< Check breathing >
< If there is not breathing, Give 30 chest compressions >
< Give 2 x rescue breaths >
< Apply electrodes to patients bare chest >
< Plug in electrode cable >
7.3 Undressing the patient
Note
If during your preliminary examination, you have ascertained that the patient
may need defibrillation, undress the upper body to be able to position the
electrodes.
Operating instructions HeartSave PAD 22289 / GB / C
29
Operating the device and sequence of reanimation
7.4 Determining the position of the electrodes
Fig. 10: Positions of electrodes on the patient
The positions of the electrodes are:
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).
7.5 Removing hair growth from chest
If the patient has hair growing where the electrodes need to be positioned, you must
remove it.
Use the enclosed razor to remove the hair from the electrode positions.
Note
Excessive hair can greatly increase the resistance between the adhesive electrodes and
the surface of the skin thus reducing the effectiveness of the electric shock.
7.6 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.
30
Operating instructions HeartSave PAD 22289 / GB / C
Operating the device and sequence of reanimation
7.7 Opening SavePads and positioning electrodes
Fig. 11: Removing the film from the electrodes
(1) Protective film on electrodes
(2) SavePads adhesive electrodes
The PRIMEDIC™ HeartSave PAD will give spoken instructions for you to
apply the defibrillation electrodes to the patient. < Apply electrodes to patients bare
chest >
Procedure:
Open the defibrillation electrodes bag by tearing open the protective cover along
the tear strip.
Remove the protective film (1) from one of the electrodes (2) and then
immediately place the electrode on the position you had ascertained previously.
Refer to label stuck on the back of the electrodes.
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! Display < Apply electrodes to patients bare chest > must go out.
Do not touch the floor, other objects, clothing or other parts
of the body with the electrodes (after removing the
protective film) as it may remove the conducting layer of gel
on the electrodes.
Operating instructions HeartSave PAD 22289 / GB / C
A reduced layer of gel could cause burns on the skin under
the electrodes during defibrillation.
Please make sure that the red electrodes symbol LEDs on the
membrane keyboard go out.
DANGER
31
Operating the device and sequence of reanimation
7.8 Plugging in the electrode plugs
Note
Note
Fig. 12: Plugging in the electrode plugs
Procedure:
Before positioning the electrodes on the patient, carry out the BLS actions as
instructed.
After the voice message asks you to < Plug in electrode cable >, insert the plug of
the electrode cable into the jack on the HeartSave PAD as shown in the diagram
above.
Make sure that the locking pin locks into place.
Once the electrodes are connected to the patient and the electrode plug is
plugged in, the BLS instructions are automatically interrupted.
To be able to unplug the electrode plug, you have to push firmly on the top
part of the locking pin while at the same time pulling the plug up.
32
Operating instructions HeartSave PAD 22289 / GB / C
Operating the device and sequence of reanimation
7.9 Checking the electrodes
If the device notifies a fault, this could be for several reasons:
Electrode plug not plugged in
There is contact between the defibrillation electrodes or
a conductive gel connection.
Hair on patient has not been removed
Air pockets between skin and defibrillation electrodes cause a bad contact.
Dried out electrodes.
Remedy the cause of the fault.
Operating instructions HeartSave PAD 22289 / GB / C
33
Operating the device and sequence of reanimation
7.10 Carrying out the ECG analysis
If the defibrillation electrodes have been applied, the device will automatically start the
analysis.
Now the patient has to be put in an immobile position and may no longer be touched.
The device announces: < Do not touch the patient, Analysing rhythm >
The algorithm of the device program will now check the ECG for ventricular fibrillation. This
process takes approx. 7 - 12 seconds. If the device identifies VF, it will recommend 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
The rhythm identification detector continuously analyses the ECG, even after a rhythm in need
of defibrillation has been identified.
consciousness and does not need to be defibrillated.
If that is the case, do not carry out the defibrillation under
any circumstances.
7.11 Defibrillation required
If the device clearly identifies VF, then it will recommend defibrillation which is
automatically prepared inside the device.
The device announces:
< Shock advised >
< Device is charging >
< Do not touch the patient >
< Device is charging >
< Do not touch the patient >
Once the capacitor has been loaded internally, the energy for the defibrillation impulse
is available for 15 seconds and is 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.
34
Operating instructions HeartSave PAD 22289 / GB / C
Operating the device and sequence of reanimation
< Stand clear of patient, Press lit shock button now >
Note
If the trigger button is pushed while the capacitor is charging (before the
button turns green) no shock will be released and an internal safety discharge
will be initiated instead.
Before pressing the trigger button, ensure that all devices
connected to the patient are removed if they are not
defibrillation protected.
Before and during the energy discharge all those participating
in the reanimation have to step back and all contact with the
patient or conductive parts (e.g. a stretcher) must be
avoided.
DANGER
This process is repeated in accordance with the ERC Guidelines 2005. After that, there
will be a pause, depending on the set-up setting for cardiopulmonary resuscitation
(CPR).
The charge time of the capacitor for defibrillation depends on the available battery
capacity. If the power module is slightly discharged, the charge time can be slightly
longer.
If an error should occur during charging, an intermittent warning beep will sound.
Note
If, when the device is switched on, no ECG is done for 10 minutes 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 interrupt the switching off
process.
7.12 Defibrillation not required
If the device can not find a shockable rhthym, then it recommends cardiopulmonary
resuscitation (CPR).
< No shock advised >
< Cardiopulmonary resuscitation >
< Give 30 chest compressions >
< Give 2 rescue breaths >
Once the CPR time has expired, the device returns to ECG analysis.
Operating instructions HeartSave PAD 22289 / GB / C
35
Operating the device and sequence of reanimation
7.13 Keep the defibrillator ready for use
At the end of a reanimation, clean the device, replace the SavePads and check or if
necessary exchange the power supply unit so that the PRIMEDIC™ HeartSave
PAD is ready to use again for the next time as soon as possible.
If any malfunctions or noticeable problems occur, please contact your nearest
service station.
36
Operating instructions HeartSave PAD 22289 / GB / C
Cleaning, maintenance and dispatch
8 Cleaning, maintenance and dispatch
8.1 Cleaning
WARNING
Only clean the device when it is switched off and with the
electrodes unplugged. Beforehand, remove the power
module from the device
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).
Do not use any dripping wet cloths to clean it. Do not spill
any
liquids over the device and do not immerse it in any liquids.
Operating instructions HeartSave PAD 22289 / GB / C
37
Cleaning, maintenance and dispatch
8.2 Servicing
Independently of the use of the device, we recommend regular visual inspection /
servicing of the PRIMEDIC™ HeartSave PAD 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.
8.2.1 Servicing check list
Check the expiry date
of the SavePads
of the battery pack (optional) and
if necessary replace the parts.
Check whether
the status display "OK" is showing.
you can switch on the device.
the device automatically carries out the self-test after being switched on.
the slot for the power supply is clean.
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.
Note
38
Operating instructions HeartSave PAD 22289 / GB / C
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 the Appendix.
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.
Cleaning, maintenance and dispatch
8.3 Dispatching the PRIMEDIC™ HeartSave PAD
Note
If you want to return the device for additional equipping or for a service, it is
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.
Operating instructions HeartSave PAD 22289 / GB / C
39
Disposal
9 Disposal
Fig. 13: 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).
For Germany, in accordance with the law on bringing electrical and electronic
equipment onto the market, taking back and disposing of in an environmentally
friendly manner
(Electrical and Electronic Equipment Act– ElektroG) Metrax is registered with EAR
(register of old electronic equipment) under the number: 25658828 . [f8]
CAUTION
Improper disposal of the device or its individual parts can lead
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.
to injury.
40
Operating instructions HeartSave PAD 22289 / GB / C
Technical Data
10 Technical Data
Defibrillation
Operating modes: Asynchronous, external
Patient impedance: 23 – 200 Ohm
Impulse shape: Biphasic, current regulated (CCD)
Output power in AUTO mode at:
Patient impedance 1
st
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: 50 discharges, at 20
°C, with a new battery
Charge time: 12 +/-3 seconds with a battery at 90% of the rated capacity
ECG
Lead: II
Heart frequency: 30 – 300 min
-1
(Accuracy +/- 1/min, 1 %)
Input: Class BF, for 2-pin patient cable, defibrillation protected
Input resistance:
CMRR:
> 5 MOhm @ 10 Hz
> 85 dB
Input d.c. voltage: ± 0.5 V
Bandwidth: 0.5 – 44 Hz (- 3 dB) SR = 101 samples/s
Impedance measurement
Defibrillation: 23 ... 200 Ohm (accuracy +/-20
Measurement frequency:
30 kHz
%)
Operating instructions HeartSave PAD 22289 / GB / C
41
Technical Data
Alarms
System: ECG, defibrillator, power supply, data storage
Physiological: Ventricular fibrillation (VF)
Analysis duration:
Power supply
Battery LiMnO
Data storage
Approx. 7 s until VF is recognised at 90
15V, 2.0Ah (0° to 20°) service life in device is 3 years at 20 °C
2
% rated capacity
Memory type: CompactFlashCard 32 – 256 MB possib le
Safety
Classification:
Identification:
Medical product in class IIb, Protection category I, Type BF, Defi-resistant,
0123
The device is a medical product and complies with the
EC Directive 93 / 42 / EEC
Other
0 ... 50
operating conditions:
°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:
Weight:
Standards applied
28 x 25 x 9 cm (W x H x D)
approx. 2 kg (without power supply)
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 60601-2-4:2002
EN1789:2003
Subject to change without notice.
42
Operating instructions HeartSave PAD 22289 / GB / C
Warranty conditions
11 Warranty conditions
The warranty period is 24 months and starts on the day of purchase. It is important to
keep the receipt 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.
Operating instructions HeartSave PAD 22289 / GB / C
43
Depiction of the current time function
12 Depiction of the current time function
Below you can see the graph shapes of the defibrillation impulse in manual mode
depending on the load resistance.
Stage 1 Stage 2 Stage 3
25 Ohm
30 Ohm
50 Ohm
75 Ohm
44
Operating instructions HeartSave PAD 22289 / GB / C
Depiction of the current time function
Stage 1 Stage 2 Stage 3
100 Ohm
125 Ohm
150 Ohm
175 Ohm
200 Ohm
Operating instructions HeartSave PAD 22289 / GB / C
45
Rhythm detection system
13 Rhythm detection system
The rhythm detection system of the PRIMEDIC
TM
HeartSave PAD analyses the patient's
ECG and supports you if the device identifies a shockable or a non-shockable rhythm.
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 device's rhythm detection system has been designed so that a defibrillation shock
is recommended if the system has been connected up to a patient who is unconscious,
not breathing and has no pulse and the system ascertains 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.
46
Operating instructions HeartSave PAD 22289 / GB / C
Rhythm detection system
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 symmetry and energy content of the signal
Filters and measures artefacts and interference
Detects pacemakers
Measures the QRS rate
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 in which dispensing an impulse is clinically not recommended
False positive rate
= Number of "incorrect shockable" algorithm decisions
Total number of ECGs in which dispensing an impulse by the device is not
recommended
Positive predictive value
= Number of "correct shockable" algorithm decisions
Total number of ECGs in which dispensing an impulse is recommended by the
device VF
%
%
Operating instructions HeartSave PAD 22289 / GB / C
47
Guidelines and manufacturer's declaration – Electromagnetic emissions
14 Guidelines and manufacturer's declaration –
Electromagnetic emissions
The PRIMEDIC
user of the PRIMEDIC
Emitted interference
measurements
HF emission
according to CISPR
11
HF emissions
according to CISPR
11
Emission of
harmonics according
to
IEC 61000-3-2
Emission of voltage
fluctuations /
flickering according
to
IEC 61000-3-3
TM
HeartSave family is designed for operation in an environment as described below. The customer or
TM
HeartSave should ensure that it is used in an environment of this kind.
Confor-
mance
Electromagnetic environment - code of practice
TM
HeartSave family uses HF energy exclusively for its
Group 1
The PRIMEDIC
internal functioning. This means that its HF emission is very low and it is
unlikely that equipment in the vicinity will be disrupted.
Class B
Class B
The PRIMEDICTM HeartSave family is suitable for use in all facilities,
including residential areas and those which are directly connected to a
public supply network which also supplies buildings that are used for
residential purposes.
Compliant
48
Operating instructions HeartSave PAD 22289 / GB / C
Guidelines and manufacturer's declaration – Electromagnetic emissions
The PRIMEDICTM HeartSave family is designed for operation in the electromagnetic environment as described below. The
customer or user of the PRIMEDIC
Interference
resistance tests
Electrostatic
discharge (ESD)
according to
IEC 61000-4-2
Quick transient
electrical
interference/bursts
according to
IEC 61000-4-4
impulse test level
± 6 kV contact discharge
± 8 kV air discharge
± 2 kV for AC power
lines
± 1 kV for input and
output lines
TM
HeartSave should ensure that it is used in an environment of this kind.
IEC 60601
Confor-
Electromagnetic environment code of
mance level
Corridor floors should be made of wood or
± 6 kV contact discharge
± 8 kV air discharge
concrete or be covered with ceramic tiles. If
the floor is covered with a synthetic material,
the relative air humidity should be at least
30%.
± 2 kV for AC power
lines
The quality of the supply voltage should
correspond to that of a typical commercial or
hospital environment.
practice
Operating instructions HeartSave PAD 22289 / GB / C
49
Guidelines and manufacturer's declaration – Electromagnetic emissions
Surges according to
IEC 61000-4-5
Voltage dips, short
breaks and
fluctuations in the
supply voltage
according to
IEC 61000-4-11
Magnetic field at
the supply
frequency (50/60
Hz) according to
IEC 61000-4-8
COMMENT U
± 1 kV normal mode
voltage
± 2 kV common mode
voltage
< 5 % U
(>95 % dip of U
T
)
T
for ½ period
40 % U
(60 % dip of U
T
)
T
for 5 periods
70 % U
(30 % dip of U
T
)
T
for 25 periods
< 5 % U
(>95 % dip of U
T
)
T
for 5 seconds
± 1 kV normal mode
voltage
± 2 kV common mode
voltage
< 5 % U
(>95 % dip of U
T
)
T
for ½ period
40 % U
(60 % dip of U
T
)
T
for 5 periods
70 % U
(30 % dip of U
T
)
T
for 25 periods
< 5 % U
(>95 % dip of U
T
)
T
for 5 seconds
The quality of the supply voltage should
correspond to that of a typical commercial or
hospital environment.
The quality of the supply voltage should
correspond to that of a typical commercial or
hospital environment. If the user of the
PRIMEDIC
functioning even when disruptions in the
power supply occur, it is recommended that
the PRIMEDIC
power supply free of disruptions or a battery.
3 A/m
3 A/m
Magnetic fields at the mains frequency
should correspond to the typical values found
in a commercial or hospital environment.
is the a.c. supply voltage before applying the impulse test levels.
TM
HeartSave requires continued
TM
HeartSave is fed from a
50
Operating instructions HeartSave PAD 22289 / GB / C
Guidelines and manufacturer's declaration – Electromagnetic emissions
The PRIMEDIC
customer or user of the PRIMEDIC
Interference
resistance
tests
Conducted
HF
interference
according to
IEC 610004-6
Radiated HF
interference
according to
IEC 610004-3
TM
HeartSave family is designed for operation in the electromagnetic environment as described below. The
IEC 60601
impulse test level
3 V
eff
150 kHz to 80 MHz
outside the ISM
bands
10 V
eff
150 kHz to 80 MHz
in the ISM bands
10 V
eff
80 MHz to 2.5 GHz
TM
HeartSave should ensure that it is used in an environment of this kind.
Conformance
Electromagnetic environment code of practice
level
Portable and mobile radio transceivers should not be used closer
to the PRIMEDIC
TM
HeartSave, including its cables, than the
recommended protective distance which is calculated according
to the equation applicable to transmission frequencies.
Recommended protective distance
Pd 2,1
3 V
Pd 4
80 MHz to 800 MHz
Pd 6,0
3 V
800 MHz to 2.5 GHz
20 V/m
With P as the maximum power rating of the transmitter in Watts
(W) in accordance with information provided by the
manufacturer of the transmitter and d as the recommended
protective distance in metres (m).
The field strength of stationary radio transmitters should be less
that the conformance level for all frequencies in accordance with
an inspection on location.
Pd 2,1
b
d
Interference is possible in the vicinity of devices which have the
following pictogram.
COMMENT 1 At 80 MHz and 800 MHz the higher frequency range is applicable.
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 ca n c a use
interference, if they are unintentionally brought into the vicinity of the patient. For this reason, the additional factor of
10/3 is applied when calculating the recommended protective 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 at which the PRIMEDIC™
HeartSave is being used exceeds the conformance levels for HF listed above, then the PRIMEDIC™ HeartSave should be
observed to prove that it is functioning as intended. 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 PRIMEDICTM HeartSave
is being used.
d
Above the frequency range of 150 kHz to 80 MHz, the field strength should be less than 3 V/m.
Operating instructions HeartSave PAD 22289 / GB / C
51
Guidelines and manufacturer's declaration – Electromagnetic emissions
Recommended protective distances between portable and mobile HF telecommunication devices and the
PRIMEDIC
The PRIMEDICTM HeartSave family is designed for use in an electromagnetic environment in which the HF interference
is controlled. The customer or user of the PRIMEDIC
maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the
PRIMEDICTM HeartSave – independently of the output power of the communication device, as shown below.
Power rating
of transmitter
in W
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.
COMMENT 1 At 80 MHz and 800 MHz the higher frequency range is applicable.
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 40.66 MHz to
40.70 MHz.
COMMENT 3 The conformance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the
frequency band of 80 MHz and 2.5 GHz are defined to reduce the probability that mobile/portable comm unication
devices can cause interference, if they are unintentionally brought into the vicinity of the patient. For this reason, the
additional factor of 10/3 is applied when calculating the recommended protective distances in these frequency ranges.
COMMENT 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.
TM
HeartSave family
150 kHz to 80 MHz
outside the
ISM bands
TM
HeartSave can help avoid electromagnetic interference by
Protective distance depends on the transmission frequency
m
150 kHz to
80 MHz in the
ISM bands
Pd 2,1
Pd 4
80 MHz to
800 MHz
800 MHz to
2.5 GHz
Pd 6,0
Pd 2,1
52
Operating instructions HeartSave PAD 22289 / GB / C
Safety checks
15 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."
Operating instructions HeartSave PAD 22289 / GB / C
53
Index of diagrams
16 Index of diagrams
Fig. 1: HeartSave PAD front view ............................................................................................. 16
Fig. 2: HeartSave PAD rear view .............................................................................................. 16
Fig. 3: HeartSave PAD View from underneath .......................................................................... 17
Fig. 4: HeartSave PAD operating controls ................................................................................ 17
Fig. 5: Primedic utensils carrier with SavePads .......................................................................... 18
Fig. 6: Primedic SavePads ........................................................................................................ 21
Fig. 7: Inserting / Changing the SaveCard ................................................................................ 23
Fig. 8: Inserting the battery ...................................................................................................... 24
Fig. 9: Removing the battery .................................................................................................... 25
Fig. 10: Positions of electrodes on the patient .......................................................................... 30
Fig. 11: Removing the film from the electrodes ........................................................................ 31
Fig. 12: Plugging in the electrode plugs ................................................................................... 32
Fig. 13: Disposal ...................................................................................................................... 40
54
Operating instructions HeartSave PAD 22289 / GB / C
Use of devices on ships
17 Use of devices on ships
17.1 Use of PRIMEDIC™ HeartSave devices with
PRIMEDIC™ Battery on merchant navy ships:
The use of PRIMEDIC™ HeartSave devices like
PRIMEDIC ™ HeartSave PAD (M250),
PRIMEDIC ™ HeartSave AED (M250),
PRIMEDIC ™ HeartSave AED-M (M250),
PRIMEDIC ™ HeartSave 6 (M250),
PRIMEDIC ™ HeartSave 6S (M250)
with the power supply module
PRIMEDIC™ Battery 15VDC 2,8Ah LiMnO4
meet the EMC requirements of “Bridge and open deck zone” according to “Guidelines for the
Performance of Type Approvals” respectively “Test Requirements for Electrical / Electronic
Equipment and Systems” of the “Rules for Classification and Construction”, Book VI “Additional
Rules and Guidelines” of ”Germanischer Lloyd,” 2003.
17.2 Use of PRIMEDIC™ HeartSave devices with
PRIMEDIC™ AkuPak on merchant navy ships:
PRIMEDIC™ HeartSave devices have been EMC tested together with a PRIMEDIC™ Battery to
fulfill the “Test Requirements for Electrical / Electronic Equipment and Systems” of ”Germanischer
Lloyd,” 2003.
As the “PRIMEDIC™ AkuPak 12VDC 1,2Ah NiCd” behaves as the “PRIMEDIC™ Battery” during
supply of PRIMEDIC™ HeartSave (M250) devices, the experience of the all EMC tests results can
be transferred to the combinations PRIMEDIC™ AkuPak / PRIMEDIC™ HeartSave (M250)
devices.
These combinations meet the EMC requirements of “Bridge and open deck zone” during supply
operation.
The recharging of PRIMEDIC™ AkuPak requires PRIMEDIC™ PowerPak as a charging device.
Recharging must be executed in a dry room which is separated from the “Bridge and open deck
zone” by metal shielding.
The device combination will meet the EMC levels of “General Power distribution zone” during
charging and charging parallel operation in any case.
Operating instructions HeartSave PAD 22289 / GB / C
55
Use of devices on ships
Contact details
METRAX GmbH
Rheinwaldstr. 22
D-78628 Rottweil
Phone: +49 (0) 741/257-0
Email: sales@primedic.de
Web: www.primedic.de
56
Operating instructions HeartSave PAD 22289 / GB / C
About Us.
q
METRAX GmbH is specialised in
developing state-of-the-art devices
for emergency medicine. Established
in 1973 in Rottweil, today Metrax is
considered to be an outstanding
example of the strengths in German
development technology: Innovative
vision, top quality and complete
dedication in research and
development have been the
company's distinguishing features
for the last 30 years. The result of
this is high precision and extremely
reliable
Your dealers
high-tech devices which are so user
friendly that they set new standards.
With the brand PRIMEDIC™,
Metrax offers a reliable program for
emergency medicine:
Professional defibrillators and mobile
ultrasound scanners. Emergency
rescue services around the world are
familiar with PRIMEDIC
guarantor for the highest
TM
as a
uality and
innovative medical technology.
Headquarter/Manufacturing:
METRAX GmbH
Rheinwaldstr. 22
D-78628 Rottweil
Germany
Tel.: +49 741 257-0
Fax: +49 741 257-235
www.primedic.de
sales@primedic.de
METRAX GmbH
Shanghai Rep. Office
Unit B, 11/F First Trade Tower
No.985 Dongfang Road,
Pudong New Area
Shanghai 200122
China
Tel.: +86 21 632846-66
Fax: +86 21 633656-90
sro@metraxchina.com
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
sales@metraxindia.com
METRAX GmbH
Moskau Rep. Office
Ul. Vavilowa 5, corpus 3
119334 Moskau
Russland
Tel.: +7 95 23170-61
Fax: +7 95 23170-62
info@metrax.ru
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