Primedic HeartSave AED User manual

Operating Manual HeartSave AED / AED-M
20439 / 03.04 / 03 / engl. I
by METRAX GmbH
This operating manual or any part thereof shall not be reproduced, transmitted, saved
on electronic media or translated into any human or computer language without our
approval. Any violations of this restriction not only infringe our copyright, but also
limit our ability to provide accurate and up-to-date information to the user and the
operator of this device.
Right to make changes to this operating manual are reserved.
METRAX GmbH
Rheinwaldstrasse 22
D-78628 Rottweil
Tel.: + 49 (0)741 257-0
Fax.: + 49 (0)741 257-235
www.metrax.de
Printed in Germany

HeartSave AED / AED-M Operating Manual
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Contents
Chapter Topic Page
1Introduction 1
1.1 Foreword 1
1.2 Scope 1
1.3 Intended Use 1
1.4 Guarantee 1
1.5 Liability Exemptions 2
1.6 Indications 2
1.7 Contraindications 2
1.8 Symbols In This Operating Manual 3
1.9 Symbols On The Device 4
1.10 Symbols On The SavePads 4
2Safety Instructions 5
2.1 General Instructions 5
2.2 General Safety Instructions 6
2.3 Safety Instructions For You, The User 6
2.4 Safety Instructions for the Patient 6
2.5 Safety Instructions For A Third Person 7
2.6 Safety Instructions For The Device 7
3Device description 8
3.1 General Description 8
3.2 Detailed Description 9
3.3 Capacity Display 14
3.4 Data Management 15
3.5 Signal Enhancement 15
3.6 Accessorie Description 15
3.6.1 SavePads 15
4Preparatory Measures Before (First) Operation 16
4.1 Unpacking 16
4.2 Inserting / Changing The SaveCard 16
4.2.1 Inserting the SaveCard 16
4.2.2 Changing The SaveCard 17
4.3 Inserting / Changing the Power Supply Unit (Power Module) 17
4.3.1 Inserting The Power Module 18
4.3.2 Removing The Power Module From The Device 19
4.4 Battery 20
4.5 Charging The AkuPak 20
4.5.1 Charging The AkuPak With The Plug-In Power Pack 21
4.5.2 Charging The AkuPak In The Optional Wall Mount Rack 21
4.6 Connecting The Power Pack (PowerLine) (Optional Accessory) 21
4.7 Device Self Test 22
4.7.1 Self Test After Switch On Of HeartSave 22

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4.7.2 Periodical self test 22
4.8 Configuration Of PRIMEDIC™ HeartSave AED 23
4.8.1 Configuration Of PRIMEDIC™ HeartSave AED (Without Monitor) 23
4.8.2 Configuration Of PRIMEDIC™ HeartSave AED-M (With Monitor) 23
5Operation Of The Device And Resuscitation 25
5.1 Switching PRIMEDIC™ HeartSave AED On And Off. 25
5.1.1 Switching PRIMEDIC™ HeartSave AED On 25
5.1.2 Switching PRIMEDIC™ HeartSave AED Off 25
5.2 Voice Prompts / Preliminary Examination Of The Patient 26
5.3 Undressing The Patient 26
5.4 Determining The Position Of Electrodes 27
5.5 Opening SavePads 27
5.6 Removing the Chest Hair 27
5.7 Removing The SavePads From The Electrodes And Connecting
The Electrodes’ Connector 28
5.8 Pulling Off The Protective Sheet On The Electrodes And Placing the Electrodes 28
5.9 Check Electrodes 29
5.10 Carrying Out The ECG Analysis 30
5.11 Defibrillation Required 30
5.12 Defibrillation Not Required 31
5.13 Keeping The Defibrillator Ready For Use 31
6Cleaning, Servicing And Despatching 32
6.1 Cleaning 32
6.2 Servicing 32
6.3 Despatching PRIMEDIC™ HeartSave AED 33
7Disposal 33
8Technical Data 34
9Scope of Delivery 36
10 Warranty Conditions 37
A1 Sudden Cardiac Arrest 38
A2 Representation of the Current-Time Function 40
A3 System of Rhythm Detection 43
A4 Guidelines And Manufacturer’s Statement – Electromagnetic Emissions –45
A5 General Instructions And Rules For Using The Optional AkuPak 49
A6 Recommended Safety Checks 51

Operating Manual HeartSave AED / AED-M
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1Introduction
1.1 Foreword
Dear User,
You have the task of using PRIMEDIC™ HeartSave AED to help a patient in a medical
emergency!
In such a situation, you have to react quickly and correctly and use the functions of-
fered by this device optimally. Therefore, it is important that you read this operating
manual fully and thoroughly so that you are familiar with the device, its functions and
its various applications.
Please keep this operating manual near the device for future reference!
Contact us for any queries on the device or other PRIMEDIC™ products.
Our contact details are given on the first page of this operating manual.
1.2 Scope
The information in this operating manual refers to the
HeartSave AED and
HeartSave AED-M
of METRAX GmbH.
1.3 Intended Use
PRIMEDIC™ HeartSave AED-(M) must only be used under conditions described in
this operating manual and only in the manner described!
Any other use that is beyond the scope of such use shall be deemed as improper
and can lead to personal or material damage!
1.4 Guarantee
METRAX GmbH offers a guarantee of 24 months on PRIMEDIC™ HeartSave AED-
(M) starting from the date of delivery.
The general terms and conditions for guarantee and warranty of METRAX GmbH will
apply.
Any repairs or modifications to the device can be carried out only by the manufac-
turer or any person or company authorised by the manufacturer.

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1.5 Liability Exemptions
The company is excluded from all liability arising out of personal or material damage
caused due to:
–Use other than for the purpose intended.
–Improper operation and servicing of the device.
–Operation without the protective covers or obvious damage to the cable and / or
electrodes.
–Non-compliance of the instructions given in this operating manual with respect to
the operation, servicing and repairs of the device.
–Use of accessories and spare parts manufactured by other companies.
–Unauthorised interventions, repairs or structural changes to the device.
–Exceeding the authorised performance limits
–Deficient monitoring of parts subject to wear and tear.
–Treatment of patients without any prior indications.
1.6 Indications
The PRIMEDIC™ HeartSave AED-(M) shall ony be used, if the patient is
–Unconscious and
–is not breathing and
–has no pulse.
1.7 Contraindications
The PRIMEDIC™ HeartSave AED-(M) shall not be used, if the patient is
–is conscious or
–is breathing or
–has a detectable pulse or other signs od circulations or
–Is a child under 8 years or less than 25 kg weight. (Per AHA Guidelines 2000 for
Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, I-64, 2000).

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1.8 Symbols In This Operating Manual
Texts marked with this symbol contain very important instructions including in-
structions to prevent any health risks.
These instructions must be followed without fail!
Texts marked with the word GEFAHR (DANGER) warn against a very high degree of
current risk, which, in the absence of precautions, will definitely cause severe inju-
ries or will even result in death!
These instructions must be followed without fail!
Texts marked with the word WARNUNG (WARNING) warn against a very high de-
gree of possible risk, which, in the absence of precautions, could cause severe inju-
ries or could even result in death!
These instructions must be followed without fail!
Texts marked with the word VORSICHT (CAUTION) warn against a possibly dan-
gerous situation that could lead to minor injuries or material damage!
These instructions must be followed without fail!
This symbol indicates texts containing important instructions / comments or tips.
zThis dot describes processes to be carried out by you.
–This dash indicates lists.
ÌThis star indicates cross references.
If cross references to other chapters are required within the text, then a smaller font is
used for clarity.
Example: (Ì2 Safety Instructions)
This means: Refer to chapter 2 on Safety Instructions for this topic.
If the cross reference refers to a page, illustration or item number, then this informa-
tion is included at the end of the cross reference.
(3) Numbers in brackets refer to items in illustrations.
< ... > Texts put in angle brackets are voice prompts / instructions from the device.
In case of the HeartSave AED-M model, the instructions are simultaneously displayed
on the monitor.

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1.9 Symbols On The Device
Safety Class II (only valid in connection with PRIMEDICTM PowerLine)
IP55
Jet-proof
Please follow the instructions in the operating manual!
Safety level BF, opening is protected against defibrillation
Dangerous electric voltage (high voltage)
Safety level CF in conjunction with an ECG patient cable
1.10 Symbols On The SavePads
Not reusable
Expiry date
Lot number
Serial number
Manufacturing date
Only for adults
Item number
Storage temperature in Celsius and Fahrenheit

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2Safety Instructions
2.1 General Instructions
The PRIMEDIC™ HeartSave AED defibrillator and its standard as well as optional ac-
cessories fulfil all safety norms currently valid and meet all the criteria of the guide-
lines for medical devices.
The device and its accessories are safe if they are used for the purpose intended as
described and instructed in this manual.
Nevertheless, the device and its accessories and their incorrect use can be dangerous
for you, the patient or any other person!
Therefore, we absolutely insist that before using it for the first time, all the persons
who need to or want to use this device, must
– be authorised through training by briefing them about the medical background
of defibrillation and the indications and contraindications!
– read this operating manual and moreover, follow the safety instructions
and the warnings given in it!
PRIMEDIC™ HeartSave AED must be operated by trained and authorised persons
only. Reading the operating manual is not a substitute for training.
PRIMEDIC™ HeartSave AED must not be used in areas where there is a danger of
explosions.
In case of improper use or use for a purpose other than for the intended purpose,
the user (you), the patient or any other person is exposed to the
– risk of an electric shock through the high voltage generated by the device,
– risk of getting affected by active implants
– risk of burns if the electrodes are placed incorrectly
Moreover, the device can be damaged or destroyed due to improper use!
zFollow the rules and instructions listed in the appendix while using PRIMEDIC™
HeartSave AED!
The following regulations that apply in the Federal Republic of Germany are:
–The device fulfils the provisions of the Medical Devices Act (MPG – Medizinpro-
duktegesetz) and is subject to the Medical Devices Operator Ordinance (MPBe-
treibV – Medizinprodukte-Betreiberverordnung).
–According to the Medical Devices Operator Ordinance (MPBetreibV), the device is
subject to regular checks described in the appendix.
–According to the Medical Devices Operator Ordinance (MPBetreibV), a medical
device book must be maintained for the device. Regular checks of the device must
be recorded in it.
In case of other countries of the European Union, the national regulations covering
the operation of medical devices will apply.

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2.2 General Safety Instructions
z Do not use the device in presence of flammable substances (e.g. petroleum ether
etc.) or in an atmosphere enriched with oxygen or combustible gases / vapours!
2.3 Safety Instructions For You, The User
z Use the device to treat a patient only if
– you have been authorised to use it by a training!
– you are convinced of the functional safety and the proper condition of
the device before using it!
– the condition of the patient requires and / or permits using the device.
z Before using the device, check if the device is in the operating temperature
range. This, for example, applies if the defibrillator is kept in an ambulance.
z
Do not use the device in case of any defect (e.g. if the defibrillation cable is
damaged).
z
The infrared interface emits invisible optical radiation. The sending diode even
during continuous operation in the circuit used is ‘Eye Save’ according to IEC
60825-1 Class 1.
2.4 Safety Instructions for the Patient
z Use the device to treat a patient only if
– you have been authorised to use it by a training!
– you are convinced of the functional safety and the proper condition of
the device before using it!
– the device clearly detects ventricular fibrillation (VF) and
ventricular
tachycardia (VT) and recommends a defibrillation!
z Before using the device, check if the device is in the operating temperature
range. This, for example, applies if the defibrillator is kept in an ambulance in
winter.
z
Do not use the device in case of any defect (e.g. if the defibrillation cable is
damaged).
z Use the device only with accessories, wearing parts and expendable articles
whose suitability with regard to their safe use has been proved by a body
authorised to test the ready usability of devices. All original PRIMEDIC™ acces-
sories and wearing parts fulfil these conditions.
z
To avoid possible skin burns, use new and undamaged defibrillation electrodes
falling within the expiry date for each patient!
z Connect the adhesive electrodes only to PRIMEDIC™ HeartSave AED. The use of
electrode systems with other devices can cause harmful leakage current to emit
on to the patient.
z
Do not operate the device in the immediate proximity of other sensitive equip-
ment (e.g. measuring instruments that react sensitively to magnetic fields) or
strong sources of interference that are likely to affect the functioning of
PRIMEDIC™ HeartSave AED. Maintain adequate distance from other therapeutic
and diagnostic energy sources (e.g. diathermy, high frequency surgery, magnetic
spin tomography). These devices can affect PRIMEDIC™ HeartSave AED and in-
terfere with its functioning.

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z During defibrillation, detach all other electronic devices used for medical pur-
poses from the patient that do not have a defibrillation-proof user component.
z
Keep the defibrillation electrodes away from other electrodes and metallic parts
that are in contact with the patient!
z Do not use the device for children under eight years or for children weighing less
than 25 kg!
z
Place the electrodes exactly as described
z Before placing the defibrillation electrodes, dry the patient’s chest and carefully
shave off any dense growth of hair.
z Do not place the defibrillation electrodes directly over an implanted pacemaker.
This will cause the device to interpret incorrectly and damage the pacemaker due
to the defibrillation pulses.
z Do not touch the patient during the ECG analysis and avoid any vibrations!
z If the ECG analysis is conducted in a vehicle, then for a correct analysis, the ve-
hicle must be stopped and the engine must be switched off.
z Stop resuscitation while PRIMEDIC™ HeartSave AED is carrying out the ECG
analysis.
z Do not touch the patient during defibrillation! Avoid any contact between
– any parts of the patient’s body (such as the bare skin of the head or the
legs), as well as
– conductive fluids (such as gels, blood or salt solution) and
– metallic objects in the patient’s surroundings (such as the bed frame or
the stretcher) that represent an unintentional path for the defibrillation
current!
2.5 Safety Instructions For A Third Person
z Before defibrillation, give a clear warning to any persons standing around to
move away from the patient and not touch him!
2.6 Safety Instructions For The Device
– Any repairs, modifications, enhancements and installations of PRIMEDIC™
HeartSave AED must only be carried out by persons authorised and trained by
METRAX!
– No parts of PRIMEDIC™ HeartSave AED can be repaired by the user!
– The device must be equipped and operated with original accessories from
PRIMEDIC™ only!
– Clean the device only when it has been switched off and the electrodes have
been removed and only in the instructed manner!

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3Device description
3.1 General Description
PRIMEDIC™ HeartSave AED is an automatic external defibrillator (AED) with inte-
grated one-channel ECG. The ECG is carried out by the PRIMEDIC™
SavePads. The algorithm used detects the potentially fatal cardiac arrhythmias. The
defibrillator generates the electric shock required to revive the patient with an ECG
rhythm treatable with a shock. This method is the generally recognised treatment.
The range of devices has a modular design. There are different models:
–HeartSave AED Basic model without a monitor
–HeartSave AED-M Basic model with a monitor
The PRIMEDIC™ HeartSave series was conceived and designed for quick and safe
use in emergency situations. All the functional units and operating elements are sub-
ject to the following basic principles:
–Clear classification of functional units
–Limiting the functions to what is required
–Intuitive and logical operator guidance
–Clear, self-explanatory operating elements
–Ergonomic design
The ECG monitor has a high-resolution graphic display with a high image contrast
even when the light is not good. The ECG monitor can be viewed easily in all posi-
tions, e.g. for use in the open and in upright positions in low positions in ambulances.
The defibrillator unit is optimised for safe and very quick operability. The charging
time for a defibrillation is approximately twelve seconds for an accumulator capacity
and / or a battery capacity of around 90 percent of the nominal value.
The power supply for PRIMEDIC™ HeartSave AED takes place either from single-use
lithium batteries or from rechargeable accumulators with nickel cadmium cells or
through a power pack common for all models. The electronic charging is based on
the latest technology and thus enables the maximum life of the accumulator used.
When not in use, the HeartSave AED can be kept in a wall unit that can fixed to a
wall or in an ambulance. When required, it can be removed quickly and easily with
the help of an (optional) one-hand release.
The electrical connections (power supply voltage or DC voltage) can be accommo-
dated in the wall unit. The console also serves as power supply for charging the ac-
cumulators.
An extensive range of accessories is available.
The Wall Mount Rack and the accessories have been described separately in operat-
ing manuals.

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3.2 Detailed Description
1Handle
2Flap to take off the device cover with the SavePads
3Device cover
4Status display
Illustration 1 PRIMEDIC™ HeartSave AED – Front View
1Microphone opening
2Retainer opening for the fixation hooks
3Type plate
4Infrared window
Illustration 2 PRIMEDIC™ HeartSave AED – Rear View

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1Release button (to take out the power module)
2Power module
Illustration 3 PRIMEDIC™ HeartSave AED – View from the bottom
1Key pad without monitor 4 Lower latch
2SavePads 5 Groove for the lower latch
3Upper latch 6 Groove for the upper latch
Illustration 4 PRIMEDIC™ HeartSave AED without Monitor, with the cover off

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1Key pad with a monitor 4Lower latch
2SavePads 5Groove for the lower latch
3Upper latch 6Groove for the upper latch
Illustration 5 PRIMEDIC™ HeartSave AED with Monitor, with the cover off
1On-off button
2Key pad with the patient symbol
3Electrode symbol with LED
4Symbol lights up during the ECG
analysis – Do not touch the patient
Illustration 6 PRIMEDIC™ HeartSave AED without Monitor
5 Speaker grill
6 Electrodes’ connector socket
7 Trigger button for defibrillation
8 Blind plug

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1On-off button
2Key pad with monitor
3Button to scroll up in the monitor menu
and / or to increase parameters
4Selection and Confirmation Button
5Button to scroll down in the monitor menu
and /or to reduce parameters
Illustration 7 PRIMEDIC™ HeartSave AED with Monitor
1Device cover
2Tools holder with manual, artificial respiration cloth and shaver
3Defibrillation electrodes
4Rubber hand gloves (unsterilised)
Illustration 8 PRIMEDIC™ SavePads
6Speaker grill
7Electrodes’ connector socket
8Trigger button for defibrillation
9Blind plug

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1Tools holder with manual, artificial respiration cloth and shaver
Illustration 9 PRIMEDIC™ HeartSave AED – SavePads
1Language selection button
2Status display
Illustration 10

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Displayed Symbol Meaning Measure
– Discharged accumu-
lator
– Charge accumulator or
replace with a charged ac-
cumulator
– Device defect – Get the device repaired from
the dealer / Metrax
OK – Device ready for
operation
– Device can be used
3.3 Capacity Display
The charge level is shown in the display of HeartSave AED-M. The six possible display
levels mean the following:
••••• > 80% ... 100%
•••• > 60% ... 80%
••• > 40% ... 60%
•• > 20% ... 40%
• > 0% ... 20%
0% (Device continues to function till the battery is over)
The battery and the optional AkuPak are monitored with the help of an electronic
charge balance to ensure the best possible capacity display.
-In addition to this display, all HeartSave devices give a warning before the battery
is completely exhausted.
-If the device is in the standby function, the speaker gives a ten-second tone at an
interval of one minute.
If the device is in use, every minute, there is a voice prompt in the selected language.
Voice Prompt Display in the Monitor
AkuPak < Accumulator charge low, please charge > Charge the accumulator
Battery < Battery charge low, please change > Change battery
The battery symbol in the status display is activated.

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3.4 Data Management
The device automatically records all ECG data and all audio communication and sur-
rounding sounds with a microphone. The stored data can be displayed with the help
of a PC or Laptop and theECG Viewer software. The data is analysed exclusively for
administrative or legal purposes and cannot be used for the diagnosis or treatment of
the patient. The software has a job log in which further data about the patient can
be entered.
If possible, data stored on the SaveCard should be archived on external media after
each use. If the storage capacity of the SaveCard is exhausted, no further data will be
stored. PRIMEDIC™ HeartSave can be used even if there is no space to store data
and even without the SaveCard.
The operation of the software is described separately.
3.5 Signal Enhancement
In case of models with monitors, signal enhancement of the ECG on the monitor is
automatic.
3.6 Accessorie Description
3.6.1 SavePads
1Plug of Defibrillation-Electrodes
2Defibrillation-Electrode with protecting cover
Abb. 11 PRIMEDICTM Defibrillation electrodes SavePads AED

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4Preparatory Measures Before (First) Operation
4.1 Unpacking
zAfter delivery, check the packing and the device for any damage during transport.
zIn case you determine any damage to the device, contact your shipper, dealer or
even the technical service of METRAX GmbH immediately. Give your serial num-
ber and describe the damage to the device.
z
Do not operate the device if any damage is detected. This can be physically dan-
gerous.
zCheck the accompanying delivery note and make sure that all the equipment has
been delivered.
zDispose off the packaging material in a non-polluting manner.
4.2 Inserting / Changing The SaveCard
1 SaveCard release button 2 SaveCard
Illustration 12 PRIMEDIC™ SaveCard
4.2.1 Inserting the SaveCard
zBefore switching on the device for the first time, insert the SaveCard in the slot
provided for it. Drücken Sie die SaveCard soweit leicht ein, bis die Taste (1) aus der
Öffnung herausragt.
zPut in the power module now.
A file that is loaded automatically after switching on and / or after inserting the
power module is saved on the SaveCard. This file contains the four languages rele-