Primedec Defibrillator Operating Manual PDF

Operating Manual HeartSave AED / AED-M
 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
20439 / 03.04 / 03 / engl. I

HeartSave AED / AED-M Operating Manual
Contents
Chapter Topic Page
1 Introduction 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
2 Safety 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
3 Device 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
4 Preparatory 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
II 20439 / 03.04 / 03 / engl.

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
5 Operation 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
6 Cleaning, Servicing And Despatching 32

6.1 Cleaning 32
6.2 Servicing 32
6.3 Despatching PRIMEDIC™ HeartSave AED 33
7 Disposal 33
8 Technical Data 34
9 Scope 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
20439 / 03.04 / 03 / engl. III

1 Introduction
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.
20439 / 03.04 / 03 / engl. 1

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).
2 20439 / 03.04 / 03 / engl.

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!
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!
Texts marked with the word VORSICHT (CAUTION) warn against a possibly dan-
gerous situation that could lead to minor injuries or material damage!
This symbol indicates texts containing important instructions / comments or tips.
z This dot describes processes to be carried out by you.
– This dash indicates lists.
Ì This star indicates cross references.

If cross references to other chapters are required within the text, then a smaller font is
used for clarity.
Example: (Ì 2 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.
20439 / 03.04 / 03 / engl. 3

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
4 20439 / 03.04 / 03 / engl.

2 Safety 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!
z Follow 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.
20439 / 03.04 / 03 / engl. 5

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.
6 20439 / 03.04 / 03 / engl.

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!
20439 / 03.04 / 03 / engl. 7

3 Device 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.
8 20439 / 03.04 / 03 / engl.

3.2 Detailed Description
1 Handle
2 Flap to take off the device cover with the SavePads
3 Device cover
4 Status display
Illustration 1 PRIMEDIC™ HeartSave AED – Front View
1 Microphone opening
2 Retainer opening for the fixation hooks
3 Type plate
4 Infrared window
Illustration 2 PRIMEDIC™ HeartSave AED – Rear View
20439 / 03.04 / 03 / engl. 9

1 Release button (to take out the power module)

2 Power module
Illustration 3 PRIMEDIC™ HeartSave AED – View from the bottom
1 Key pad without monitor 4 Lower latch

2 SavePads 5 Groove for the lower latch
3 Upper latch 6 Groove for the upper latch
Illustration 4 PRIMEDIC™ HeartSave AED without Monitor, with the cover off
10 20439 / 03.04 / 03 / engl.

1 Key pad with a monitor 4 Lower latch

2 SavePads 5 Groove for the lower latch
3 Upper latch 6 Groove for the upper latch
Illustration 5 PRIMEDIC™ HeartSave AED with Monitor, with the cover off
1 On-off button 5 Speaker grill

2 Key pad with the patient symbol 6 Electrodes’ connector socket
3 Electrode symbol with LED 7 Trigger button for defibrillation
4 Symbol lights up during the ECG 8 Blind plug
analysis – Do not touch the patient
Illustration 6 PRIMEDIC™ HeartSave AED without Monitor
20439 / 03.04 / 03 / engl. 11

1 On-off button 6 Speaker grill

2 Key pad with monitor 7 Electrodes’ connector socket
3 Button to scroll up in the monitor menu 8 Trigger button for defibrillation
and / or to increase parameters 9 Blind plug
4 Selection and Confirmation Button
5 Button to scroll down in the monitor menu
and /or to reduce parameters
Illustration 7 PRIMEDIC™ HeartSave AED with Monitor
1 Device cover
2 Tools holder with manual, artificial respiration cloth and shaver
3 Defibrillation electrodes
4 Rubber hand gloves (unsterilised)
Illustration 8 PRIMEDIC™ SavePads
12 20439 / 03.04 / 03 / engl.

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

2 Status display
Illustration 10
20439 / 03.04 / 03 / engl. 13

Displayed Symbol Meaning Measure
– Discharged accumu- – Charge accumulator or

lator replace with a charged ac-
cumulator
– Device defect – Get the device repaired from

the dealer / Metrax
– Device ready for – Device can be used

OK operation
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.
14 20439 / 03.04 / 03 / engl.

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
1 Plug of Defibrillation-Electrodes
2 Defibrillation-Electrode with protecting cover
Abb. 11 PRIMEDIC TM Defibrillation electrodes SavePads AED
20439 / 03.04 / 03 / engl. 15

4 Preparatory Measures Before (First) Operation

4.1 Unpacking
z After delivery, check the packing and the device for any damage during transport.
z In 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.
z Check the accompanying delivery note and make sure that all the equipment has
been delivered.
z Dispose 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
z Before 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.
z Put 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-
16 20439 / 03.04 / 03 / engl.

vant for your use. Then HeartSave begins operation and runs the self-test. After the
file is loaded by HeartSave, SaveCard does not delete it. Create a backup of the file
afterwards. As the file uses about 4 MB of the storage space, we recommend that
you delete the file with the help of a PC to create more space on the SaveCard.
After each use, the data stored on the SaveCard should be archived on external me-
dia as soon as possible. No further data can be stored if there is no space left on the
SaveCard. PRIMEDIC™ HeartSave can be used even if there is no space to store data
and even without the SaveCard.
4.2.2 Changing The SaveCard

To be able to remove / change the SaveCard, the power module must be removed
first!
z Push in button (1) completely – thereby a part of the SaveCard(2) is pushed out of
the slot.
z Remove the SaveCard from the device completely, transfer the data (if required)
to a PC and insert this card or a new one with the connector side into the device
first.
z Press in the card lightly until the button (1) juts out from the opening.
z Then put the power module back into the device.
4.3 Inserting / Changing the Power Supply Unit (Power Module)

PRIMEDIC™ HeartSave AED can be operated on three different power modules.
- non-rechargeable LiMnO2 battery,
- rechargeable AkuPak (optional) or
- PowerLine (optional)
Before using PRIMEDIC™ HeartSave AED for the first time, the power module must
be inserted in the compartment provided for it.
z Check the power supply after every use. Check whether the battery should be
replaced with a new one or the AkuPak should be charged. If this is not possible,
another charged AkuPak should be available to ensure ready usability!
20439 / 03.04 / 03 / engl. 17

4.3.1 Inserting The Power Module
Illustration 13 PRIMEDIC™ HeartSave AED – Inserting the Power Module
The HeartSave is always supplied with a power module.

The method of inserting the power module is the same in case of all the three vari-
ants.
z Place the device on its rear side.

z Push the (new) power module (2) in the direction of the arrow (1.) into the device
until it fits at the back (3) as shown in the illustration.
z Then press the power module in the front in the direction of the arrow (2.) into
the compartment (1) until the release button (4) the tab of the power module are
locked securely.
z Push in the power module into the device completely until you hear the ‘click’ of
the locking and the power module is locked evenly on the outer side of the de-
vice. If the power module falls out when the device is moved, it has not been
locked correctly.
18 20439 / 03.04 / 03 / engl.

If the power module was placed correctly, the device starts automatically. Follow the
acoustic / visual prompts of the device and switch the device off afterwards. Now the
HeartSave is ready to be used.
z Watch the Status-display. If the display shows "OK", the device is ready to be
used
z Switch the device (if necessary) off by pressing the On/Off button or place the
cover on the device.
z Does the display not show "OK", resp. an error message appears on the Monitor,
remove the cause or call your next service partner.
The device switches off itself.
4.3.2 Removing The Power Module From The Device
Illustration 14 PRIMEDIC™ HeartSave AED – Removing the Power Module
20439 / 03.04 / 03 / engl. 19

z Change the power module only when the device is switched off and the connec-
tor of the defibrillation electrodes is removed.
z Place the device on its rear side and press the release button (1) in the direction of
the arrow (1.) until the tab of the power module (2) is released and a part of the
power module (3) springs out of the compartment (4).
z Turn the power module slightly in the direction of the arrow (2.) and pull it out of
the device in the direction of the arrow (3.).
4.4 Battery
The battery is a non-rechargeable Lithium battery and is fully charged on delivery.
This material is based on the latest technology and was selected due to its very long
durability and power storage function. The contacts are protected with a self-
adhesive sheet in order to prevent any automatic discharge or short circuit. Pull off
the protective sheet before inserting the battery.
Never try to recharge the battery. There is a risk of explosion.
Use the battery before the expiry date.
After using HeartSave, the battery should be replaced with a new battery. (to guaran-
tee a complete duration of operation on the next use)
Always refer to the supplement on the battery and keep it with the operating manual.
z If the device has to be sent for servicing, remove the battery from the defibrillator
and put a scotch tape on the contacts.
z Follow the special instructions for despatch while sending the battery.
4.5 Charging The AkuPak

The AkuPak can be charged in two ways:
– with the plug-in power pack and / or
– in the wall mount rack (optional).
The integrated end-of-discharge detection protects the accumulator from total dis-
charge. The end of charging is detected through the end-of-discharge voltage.
Charging the AkuPak at temperatures other than at the given operating temperatures
can damage the accumulator.
A completely empty accumulator must be charged for at least 30 minutes. Owing to
the type of the accumulator, a very small charging time can lead to errors in interpret-
ing charging by the device. The charging display can show a full accumulator by mis-
take. Safe operation of the device is also not guaranteed.
20 20439 / 03.04 / 03 / engl.

4.5.1 Charging The AkuPak With The Plug-In Power Pack
1 Power plug 2 plug

3 socket at AkuPak 4 AkuPak
5 Marking“red dot“ 6 plug
Illustration 15
The AkuPak must be put into the device.

z Turn the connector (2) on the charging cable of the plug-in power pack (1) so
that its red dot is in line (5) with the red dot on the socket (3) of the AkuPak (4).
z Push in the connector (2) into the socket until it can go no further.
z Connect the plug-in power pack with the plug (6) into a socket.
The accumulator begins to charge automatically if the remaining power in the
AkuPak is less than 30 percent of its nominal capacity. The AkuPak is charging if
the LED on the charging device lights up. The time required for charging is around
one hour.
Nickel-cadmium accumulators are subject to natural wear and tear and should be re-
placed at least every two years if the usage is high.
4.5.2 Charging The AkuPak In The Optional Wall Mount Rack

z Refer to the separate operating manual of the Wall Mount Rack for this.
4.6 Connecting The Power Pack (PowerLine) (Optional Accessory)

z Insert the power pack plug in a socket near the patient. The power cable is around
three metres long.
20439 / 03.04 / 03 / engl. 21

4.7 Device Self Test
4.7.1 Self Test After Switch On Of HeartSave

The self test will either be activated when switching on the HeartSave or inserting
the energy module into the device and passes immediately the device self test to
check all important functions and signal settings.
If the energy module was changed and the HeartSave has located a failure the auto-
matic self test (FULL) will take place. Follow the instructions of the HeartSave.
4.7.2 Periodical self test
Cycle Test
SHORT Daily Software, keyboard, battery, ECG
calibration, clock, internal voltage
supply and HV part at 0 V
MEDIUM First day of the month Software, keyboard, battery, ECG
calibration, clock, internal voltage
LONG On July 1st and January Software, keyboard, battery, ECG
1st of each year calibration, clock, internal voltage
22 20439 / 03.04 / 03 / engl.

4.8 Configuration Of PRIMEDIC™ HeartSave AED
4.8.1 Configuration Of PRIMEDIC™ HeartSave AED (Without Monitor)

PRIMEDIC™ HeartSave AED is configured by the factory.
Changes to this setting are not possible.
4.8.2 Configuration Of PRIMEDIC™ HeartSave AED-M (With Monitor)

PRIMEDIC™ HeartSave AED-M is configured by the factory.
Certain parameters in the Setup Menu (displayed on the monitor) can be changed.
This configuration is stored and retained until a new change is carried out, whether
the device is off or the power supply is changed.
z To activate the Setup Menu, press the Selection and Confirmation button dur-
ing operation.
z Use
– the S button (upwards) or
– the T button (downwards)
to navigate in the menu and to increase or to reduce a selected parameter and the
button (to select a parameter and confirm the changed value).
Changing The Configuration – Example

Following parameters can be changed on the two pages of the Setup Menu:
Page 1:
LanguageGerman / English / French / Spanish / Portuguese / Italian
Date DD.MM.YY
Time hh.mm.ss
Volume 25 %, 50 %, 75 %, 100 %
Contrast 0 – 100
Microphone On-Off
Page 2:
Data Source Module
Operation Selection "Name"
Storage activate
Delete activate
20439 / 03.04 / 03 / engl. 23

On entering the Setup Menu, the first item in the menu is selected.
z For example, if you want to update the time, move the selection downwards by
pressing the W button once or more until the item Time is selected.
z Confirm the selected menu item Time by pressing the button. The selection
jumps to hours.
z Change the hour by pressing the V or W button.
z Confirm the correct value with the button. The selection then jumps to minutes
and then to seconds.
z Change these values in the manner described above. After the final confirmation
with the button, the selection once again jumps to the menu item Time.
z Now carry out any other changes (if required) in the same manner.
z To exit the Setup Menu, move the selection with the V or W button to the menu
item END and confirm this with the button.
PRIMEDIC™ HeartSave AED is then ready for operation again.
24 20439 / 03.04 / 03 / engl.

5 Operation Of The Device And Resuscitation

The process of resuscitation by this device has been devised in accordance with the
American Heart Association (AHA) and European Resuscitation Council (ERC) guide-
lines.
5.1 Switching PRIMEDIC™ HeartSave AED On And Off.
5.1.1 Switching PRIMEDIC™ HeartSave AED On

The device is activated automatically on removing the cover. If the device is not
switched on automatically, switch it on by pressing the
On / Standby button.
All buttons except the trigger button are then enabled.
Defibrillation is triggered only after ventricular fibrillation (VF) and ventricular tachy-
cardia (VT) have been detected.
Immediately after it has been switched, the device runs an internal self-test to check
the important functions and signal equipment. A signal tone confirms that the device
is ready for operation. Always check the functioning of the speaker.
5.1.2 Switching PRIMEDIC™ HeartSave AED Off

PRIMEDIC™ HeartSave AED can be switched off in many ways:
– By pressing the On / Standby button for about three seconds. At the same time,
there are three warning tones. This time is selected so that the device is not
switched off by mistake.
– By replacing the cover of the device.
– If the device does not detect a signal for ten minutes or if no button is pressed, it
is switched off automatically.
If the device detects any defect, it switches off automatically to prevent any possible
injuries.
20439 / 03.04 / 03 / engl. 25

5.2 Voice Prompts / Preliminary Examination Of The Patient

The voice prompts instruct you to examine the patient.
z For this, first put on the rubber gloves from the cover of the device.
After the device has completed the self-test successfully, the following instructions
are given:
< Check responsiveness >
< Call emergency >
< Check circulation >
< Open airway, check mouth cavity and respiratory tracks >
< Carefully overstretch head >
< Check breathing >
< If no breathing, give twice respiration >
< put the plug in >
< Place electrodes >
z Carry out the instructed tasks before placing the electrodes on the patient!
The line-up of tasks is automatically interrupted if the electrodes are applied to
the patient.
5.3 Undressing The Patient

z If, after the preliminary examination, the patient needs to be defibrillated, un-
dress the upper part of his body to be able to place the electrodes.
26 20439 / 03.04 / 03 / engl.

5.4 Determining The Position Of Electrodes
Illustration 16 Position of Electrodes on the Patient
The electrodes are positioned

– in the region of the right breast, below the collarbone (1) and
– in the region of the left breast above the apex of the heart on the axillary line (2).
5.5 Opening SavePads

The tools holder contains one pair of electrodes, one shaver, one artificial respiration
cloth and one pair of disposable gloves.
z Open the packing of the electrodes by tearing open the protective covering.
5.6 Removing the Chest Hair

z If the patient has hair on the electrodes’ positions, then it must be shaved off.
z Shave off the hair at the electrodes’ positions with the given shaver.
20439 / 03.04 / 03 / engl. 27

5.7 Removing The SavePads From The Electrodes And Connecting The
Electrodes’ Connector
Illustration 17 Insert the electrode connector into the socket of HeartSave
z Remove the electrodes from the SavePads pack.

z Insert the connector (1) of the electrode cable in the socket (2) on HeartSave.
z Pay attention that the lock (2) engages.
In order to remove the defibrillation electrode plug you must push firmly on the
upper part of the catch and simultaneously pull out the plug.
5.8 Pulling Off The Protective Sheet On The Electrodes And Placing the
Electrodes
Illustration 18 Pulling off the Protective Sheet on the Electrodes
28 20439 / 03.04 / 03 / engl.

PRIMEDIC™ HeartSave AED instructs you to place the defibrillation electrodes on the
patient through voice prompts.
Proceed in the following manner:
z First pull off the protective sheet (1) from one electrode (2) and then place the
electrode directly on the position determined earlier.
z Then pull off the protective sheet of the second electrode and place it on its posi-
tion.
Here, any of the electrodes can be placed on any position.
z Press the electrodes on the patient so that there is no air cushion under the elec-
trodes!
z Do not the touch the ground, objects, clothing or other parts of the body with the
electrodes (after the protective sheet has been removed). This might remove the
conductible gel coating on the electrodes.
An insufficient coating of gel could lead to burns on the skin under the electrodes
during defibrillation!
Please check that

– in case of the model without the monitor, the red electrode indicator is off.
– in case of the model with the monitor, the indicator in the display is off.
5.9 Check Electrodes

If the device detects an error, it can be due to several reasons:
– There is a contact and / or a conductive gel connection between the defibrilla-
tion electrodes.
– The hair on the patient’s body has not been shaved.
– Trapped air between the skin and the defibrillation electrodes causes a bad con-
tact.
– Electrodes have dried out.
z Eliminate the cause of the problem!
20439 / 03.04 / 03 / engl. 29

5.10 Carrying Out The ECG Analysis

The device starts the analysis automatically if the defibrillation electrodes are placed
correctly.
Now the patient must be kept still and not be touched.
The device prompts

< Do not touch the patient, rhythm analysis >
The algorithm of the device program now checks the ECG for ventricular tachycardia
and for pulseless ventricular fibrillation. This process takes about twelve seconds. The
device recommends a defibrillation if it detects VF and VT.
Observe the patient constantly during the entire process of resuscitation.

The patient might regain consciousness at any time and must not be defibrillated.
Stop the defibrillation immediately!
The rhythm detection system analyses the ECG constantly and continues the analysis
even after a rhythm requiring defibrillation is detected.
5.11 Defibrillation Required

If the device clearly detects VF or VT, it recommends a defibrillation and prepares for
it internally and automatically. As a signal of the preparation, the release button
blinks green.
The device prompts

< Shock recommended, do not touch the patient >
If the capacitor is charged internally, energy required for a defibrillation pulse for 15
seconds is available and is indicated by a continuous tone and the ‘green’ trigger but-
ton. The model with the monitor also shows the time left. If defibrillation is not car-
ried out within this time, a safety discharge takes place internally and the ECG analy-
sis is carried out once again.
z Before activating the release button, remove all devices connected to the patient
that are not protected against defibrillation!
Before and during the discharge of energy, all persons participating in the resuscita-
tion measures must step back and all contact with the patient or conductible objects
(e.g. a stretcher) must be avoided!
z Activate the trigger button to enable defibrillation, which begins immediately after
the button is pressed.
30 20439 / 03.04 / 03 / engl.

After defibrillation, the analysis starts again. If the algorithm again detects
VF or VT, it enables the defibrillator again. This process is repeated three times in all,
after which there is a one-minute interval for the cardiopulmonary resuscitation
(CPR).
The time required to prepare for defibrillation depends on the available capacity of
the battery / accumulator. The charging time can be a little more in case of a partly
discharged power module.
If there is an error during charging, there is a continuous warning tone.
– In case of the message “Charge accumulator”, there is still a five-minute energy

discharge with maximum energy. The power module should be replaced if this
message appears.
– If an ECG is not recorded or no button is pressed for ten minutes after the device
has been switched on, it switches off automatically. There is a continuous warn-
ing tone for about 30 seconds before it switches off. Any random operation stops
the automatic switch-off.
– When the electrodes are not connected, the model with the monitor shows a
straight line with the instruction ‘Check electrodes’ in its initial state. As soon as
there is a lead through the electrodes, the ECG signal is displayed on the monitor.
5.12 Defibrillation Not Required

If the device does not detect a rhythm requiring defibrillation, it recommends cardio-
pulmonary resuscitation.
< One minute cardiopulmonary resuscitation >
After the CPR sequence has finished the HeartSave will start the ECG analysis auto-
matically again.
5.13 Keeping The Defibrillator Ready For Use

z Clean the device after a resuscitation, replace the SavePads and check and / or
change the power supply unit if required, so that PRIMEDIC™ HeartSave can be
used as fast as possible on the next use. Charge the AkuPak for sufficient power
on the next use.
z Contact the nearest service station in case of any faults or irregularities as soon as
possible.
20439 / 03.04 / 03 / engl. 31

6 Cleaning, Servicing And Despatching

6.1 Cleaning
z Clean the device only when it is switched off and the electrodes have been dis-
connected. For this, first remove the power module from the device or remove
the plug (in case of the optional power pack) from the socket!
z Do not use a dripping wet cloth for cleaning. Do not pour
any liquids on the device and / or do not dip it into any liquids!
z Clean PRIMEDIC™ HeartSave AED and all accessories such as the Wall Mount
Rack with any commercially available household cleaner.
z Use a slightly damp and clean cloth for cleaning.
z Use a standard disinfectant solution for disinfecting
(e. g. Gigasept FF)
6.2 Servicing
We recommend a regular inspection / servicing of PRIMEDIC™ HeartSave AED and
all accessories irrespective of the frequency of use by the user / service technician at
least once a year.
Check whether the casing, the cable, the SavePads and the accessories are not dam-
aged in any way.
Check List
z Check the expiry date
– the SavePads,
– the battery
– AkuPak (optional) and
replace the parts if required!
z Check if
– the status display shows ‘OK’
– the device can be switched on!
– the device automatically runs the self-test after it has been switched on!
– the compartment of the power supply unit is clean!
– the device is fully equipped!
– the internal battery is older than 10 years
z Hereby, pay attention to the following aspects:

– If any parts of the casing and / or the insulations are damaged, then
get them repaired or replaced immediately.
– If any parts of the casing and / or the insulations are damaged, do not
operate the device or switch it off immediately! – Get the device
repaired immediately from the manufacturer!
32 20439 / 03.04 / 03 / engl.

Details on the regular safety and metrological checks according to the Medical De-
vices Operator Ordinance (MPBetreibV) are available in the Appendix.
6.3 Despatching PRIMEDIC™ HeartSave AED

If PRIMEDIC™ HeartSave has to be sent for upgrades or servicing, then always re-
move the power module from the device and send it with the device in a separate
packing.
7 Disposal
The device must be sent for recycling at the end of its service life (in accordance with
the local recycling regulations of each place).
In case of any doubts, detailed inquires can be made at the local recycling office.
20439 / 03.04 / 03 / engl. 33

8 Technical Data
Defibrillation
Operating Modes: asynchronous, external in Auto Mode
Pulse Form: biphasic, current-controlled (CCD)
Output energy in case of:
Patient impedance 1. Step 2. Step 3. Step
25 Ohm 143 J 201 J 277 J
50 Ohm 281 J 350 J 360 J
75 Ohm 348 J 368 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 figures are subject to a tolerance of +/- 15%)

Impulse length positive phase 11,25 ms, negative phase 3,75 ms
Discharges: – 70 discharges at 20 °C with a new fully charged
accumulator
– 100 discharges at 20 °C with a new battery
Charging Time: 12 seconds with a full accumulator and / or with a full bat-
tery
12 seconds with an accumulator and / or a battery
with 90 percent of its nominal capacity
ECG
Lead: II
Heart rate: 30 – 300 per minute
Input: Class BF, for 2-pole patient cable, defibrillation proof
Input impedance: > 5 MOhm @ 10 Hz
CMRR: > 85 dB
Input direct voltage: ± 0,5 V
Bandwidth: 0,5 – 44 Hz (- 3 dB) SR = 101 Hz
Impedance measurement
Impedance range: 0 ... 240 Ohm
Measure frequency: 1 Hz
Signal amplification The signal amplification of the ECG on the monitor

takes place automatically.
34 20439 / 03.04 / 03 / engl.

Alarms
System: ECG, defibrillator, power supply, data storage
Physiological: Ventricular fibrillation (VF),
pulseless ventricular tachycardia (VT)
Duration of Analysis: max. 12 seconds till the detection of VF / VT with a fully
charged accumulator or battery
max. 10 seconds till the detection of VF / VT with an
accumulator or battery with 90 percent of its nominal
capacity
Monitor (Only In AED-M)

Monitor Type: High-resolution LCD monitor
Monitor Size: 95 x 72 mm (Diagonal 120 mm, 4.7")
Resolution: 320 x 240 Pixel (pixel size 0.36 x 0.36 mm)
Displays: Heart rate, number of defibrillations, number of detected
VF / VT, duration of resuscitation, date, time, accumulator
capacity
Power Supply
Batterie: LiMnO2, 15 V, 2,8 Ah (0 º … 20 ºC), life cycle 5 years @ 20°C
AkuPak: NiCd,10.8 V / 1.7 Ah
PowerLine: 90 ... 260 Volt, 50 / 60 Hz
Data Storage
Memory type: CompactFlashCard (Industrial grade) 16 – 64 MB
possible
Bandwidth ECG: 0,05 Hz … 150 Hz (-3 dB) SR = 506 Hz
Safety
Classification: Safety Class II, Type BF, Defi-proof, medical de
vice of Class IIb
Designation: 0123
The device is a medical device and meets the

EU Directive 93 / 42 / EEC
Miscellaneous
Operating conditions: 0°... 55° C, 30... 95 % rel. humidity, but without condensation
500 hPa ... 1060 hPa continuous operation
Storage conditions: - 20 ... 70 °C, 20 ... 95 % rel. humidity,
but without condensation
500 hPa ... 1060 hPa ...
Dimensions: 28 x 25 x 9 cm (width x depth x height)
Weight around 2 kg (without power supply)
20439 / 03.04 / 03 / engl. 35

Used Norms
– IEC 60601-1:1988 + A1:1991 + A2:1995
– IEC 601-2-4:2002
– IEC 60101-1-2:2001
– AAMI DF 39:1993
– RTCA / DO-160D: 1997
– EN1789
– Germ. Lloyd
Right to make changes reserved.
9 Scope of Delivery
Description Article No.
– PRIMEDIC™ HeartSave AED consisting of: 96370

1 PRIMEDIC™ HeartSave AED
1 PRIMEDIC™ battery
1 SavePads AED
1 Patient cable, 2-pole
1 SaveCard 16 MB
1 Viewer PC software
1 Medical device book
1 Operating manual of HeartSave AED
1 Instruction log
– PRIMEDIC™ HeartSave AED-M consisting of: 96371

1 PRIMEDIC™ HeartSave AED-M
1 PRIMEDIC™ battery
1 SavePads AED
1 Patient cable, 2-pole
1 SaveCard 16 MB
1 Viewer PC software
1 Medical device book
1 Operating manual of HeartSave AED-M
1 Instruction log
Refer to the separate list of accessories and prices for other accessories.
36 20439 / 03.04 / 03 / engl.

10 Warranty Conditions
As the manufacturer, METRAX offers a two-year guarantee on this device from the
date of purchase. METRAX will repair or replace the device free of cost within two
years of the purchase if it is found to be defective in material or manufacturing. Re-
pairs or replacement will be at METRAX’s sole discretion.
Any repairs or replacements under guarantee do not extend the original guarantee
period.
Guarantee claims and any legal claims based on defects do not arise due to any minor
impairment of usability, natural wear and tear or damages due to passing of the risk
owing to improper or negligent handling, excessive strain or extraordinary outside in-
fluences not provided for under the contract, This also applies to any improper modi-
fications or repairs carried out by the buyer or any other person.
Any other claims against METRAX will be excluded unless the claims are based on
malicious intent or gross negligence or mandatory liability rules.
All claims of the buyer against the seller (dealer) based on defects are not affected by
this guarantee.
To avail guarantee, send the device along with a proof of purchase (e.g. the invoice)
and your name and address to your dealer or to METRAX.
The METRAX customer service is at your service even after the guarantee period!
20439 / 03.04 / 03 / engl. 37

A1 Sudden Cardiac Arrest

Sudden Cardiac Arrest or Heart Attack
– This leads to a fall in the blood pressure, the pulse stops and within seconds the
patient becomes unconscious.
In Germany alone, more than 100,000 people die of sudden heart disease
every year and more than ten every hour.
– The heart attack is caused mechanically; normally due to the obstruction of a
coronary artery. Owing to poor and / or no blood supply, the affected part of the
heart muscle (myocardium) begins to die. The heart attack can, but need not lead
to sudden cardiac arrest, but in either case, the patient must be examined by a
doctor.
Ventricular Fibrillation (VF)

Some of these ‘arrhythmias’ are not noticed, some are troubling, and few can cause
unconsciousness. Among these ‘arrhythmias’, ventricular fibrillation (VF) is the most
frequent cause of sudden cardiac arrest.
Ventricular fibrillation occurs when the integrated ‘electrical system’ in the heart (the
nerves / conductive cells integrated in the heart) does not function correctly. Due to
the uncontrolled independent electrical impulse of the heart, no blood with oxygen is
pumped to the body. Due to the inadequate blood supply especially to the brain, the
person affected will collapse within seconds.
This information is no substitute for professional consultation with or treatment by

trained and established doctors.
We request all users with health problems to consult a doctor in case of need. If you
have any questions about your health, we recommend that you consult the doctor
you trust and not begin, change or discontinue treatment on your own.
Indications Speaking In Favour Of Using PRIMEDIC™ HeartSave AED
If you find a patient with the following indications, namely,

– sudden unconsciousness and
– no reaction to light movement and
– abnormal breathing, i.e. the patient is not breathing normally during examina-
tion and
– no pulse or signal of normal blood circulation,
Immediately inform the rescue service and start cardiopulmonary resuscitation
(CPR).
Use PRIMEDIC™ HeartSave AED only if you suspect VF and VT, and the above-
mentioned indications are observed in the patient.
The condition of the patient must be assessed after defibrillation and the ECG moni-
tor must be observed. Irrespective of the result, it may be necessary to repeat defi-
brillation in quick succession.
Manual or pharmacological measures can also be required under the responsibility
and instructions of an emergency doctor.
38 20439 / 03.04 / 03 / engl.

Contraindications Under Which PRIMEDIC™ HeartSave AED Must Not Be Used
Do not use the AED under any circumstances if

– the patient is conscious, or
– he is breathing, or
– a pulse or any sign of normal blood circulation is detected.
– Is a child under 8 years or less than 25 kg weight.
20439 / 03.04 / 03 / engl. 39

A2 Representation of the Current-Time Function

The following diagrams show the defibrillation pulses in relation to the terminating
resistance in wave form.
step 3
step 2
step 1
40 20439 / 03.04 / 03 / engl.

Ohm
Ohm
Ohm
25
50
75
step 3
step 2
step 1
Ohm
Ohm
Ohm
100
125
150
20439 / 03.04 / 03 / engl. 41

step 3
step 2
step 1
Ohm
175
42 20439 / 03.04 / 03 / engl.

A3 System of Rhythm Detection

The rhythm detection system of HeartSave analyses the ECG of the patient and in-
forms you if HeartSave has detected a shockable rhythm and vice versa.
This system enables a person not trained in the analysis of ECG rhythms to use defi-
brillation measures for victims of ventricular fibrillation, pulseless ventricular tachycar-
dia.
The rhythm detection system of HeartSave:

z Detects the electrode contact
z Analyses the ECG automatically
z Guides the operator during the defibrillation shock therapy
The transthoracic impendence of the patient is measured by the defibrillation elec-
trodes. If the base line impedance is higher than the maximum limiting value, Heart-
Save determines if the electrodes do not have adequate contact with the patient or
have not been connected to HeartSave properly. The ECG analysis and the delivery of
defibrillation shocks are therefore stopped. The voice prompt instructs the user to
‘Check electrodes’, if the contact of electrodes is not sufficient.
Automatic Interpretation of the ECG

The rhythm detection system of HeartSave was so designed that a defibrillation shock
is recommended if the system was connected to a patient who is unconscious, not
breathing, does not have a pulse and the system detects:
z Ventricular fibrillation – if the peak to peak amplitude is higher than the asystole
threshold value (0.2 mV nominal)
z Ventricular tachycardia
For all other ECG rhythms that do not meet these criteria, including asystole and
normal sinus rhythms, the rhythm detection system of HeartSave does not recom-
mend defibrillation.
ECG analysis is carried out on a sample ECG of at least seven seconds.
20439 / 03.04 / 03 / engl. 43

Operator Control to Deliver Defibrillation Shocks

The rhythm detection system of HeartSave charges HeartSave automatically if Heart-
Save detects a shockable rhythm. Optical and voice messages are generated to indi-
cate that HeartSave is recommending a defibrillation shock. If a defibrillation shock is
recommended, decide if the shock should be delivered and when it should be deliv-
ered.
The algorithm:
- observes the ECG rhythm over a continuous history of ten seconds, of which
seven seconds are used for the first diagnosis or to display the message ‘Shock
Recommended’.
- Measuring the symmetry and energy content of the signal
- Filtering and measuring artefacts and sounds
- Detecting pacemakers
- Measuring the QRS rate and width
Cardiac rhythms used to test the rhythm detection system of HeartSave
Rhythm Class Specifications
Shockable rhythm – VF HeartSave fulfils the AAMI DF 39 re-

quirements and the AHA recommenda-
tion for the sensitivity > 90 %
Shockable rhythm – VT HeartSave fulfils the AAMI DF 39 re-
Rhythm not shockable – normal sinus HeartSave fulfils the AAMI DF 39 re-
rhythms quirements for the specificity > 95 %
and the AHA recommendation for the
sensitivity > 99 %
Rhythm not shockable - asystole HeartSave fulfils the AAMI DF 39 re-
Rhythm not shockable – all other HeartSave fulfils the AAMI DF 39 re-
rhythms that are not shockable quirements and the AHA recommenda-
Databases used for validation: AHA, MIT and CUDB
Number of „Absolutely shockproof“ algorithm decisions

Sensitivity =
Total number of ECGs, wherby delivery of pulse is clinically recommended
Number of ' Absolutely non - shockproof' algorithm decisions

Spezificity =
Total number of ECGs, whereby delivery of pulse is not clinically recommended
44 20439 / 03.04 / 03 / engl.

A4 Guidelines And Manufacturer’s Statement – Electromagnetic

Emissions –
PRIMEDIC™ HeartSave is meant for operation in any of the environments given below: The customer
or the user of PRIMEDIC™ HeartSave should ensure that it is operated in such an environment.
Measurement of RFI Emis- Compliance Electromagnetic Environment - Guideline
sions
HF emissions according to Group 1 PRIMEDIC™ HeartSave uses HF energy exclu-
CISPR 11 sively for its internal function. Therefore, its
HF emission is very less and it is not likely that
any neighbouring electronic devices are dis-
turbed.
HF emissions according to Group 2 PRIMEDIC™ HeartSave must emit electro-
CISPR 11 magnetic energy to guarantee its intended
function. Neighbouring electromagnetic de-
vices can be affected.
HF emissions according to Class B
CISPR 11
Emissions from harmonic n.a. for battery PRIMEDIC™ HeartSave is suitable for use in
oscillations according to IEC all equipment, including equipment in living
61000-3-2 quarters and all such places that have a direct
connection from the public mains supply that
Emissions from voltage fluc- n.a. for battery also supplies to buildings used for residential
tuations / flickers according purposes.
to IEC 61000-3-3
20439 / 03.04 / 03 / engl. 45

PRIMEDIC™ HeartSave is meant for operation in any of the environments given below: The customer
or the user of PRIMEDIC™ HeartSave should ensure that it is operated in such an environment.
Interference Resis- IEC 60601 Test Compliance Electromagnetic Environment -
tance Test Level Level Guidelines
Discharge of static ± 6 kV contact dis- ± 6 kV Floors should be wooden or of ce-
electricity (ESD) ac- charge ment or should have ceramic tiles.
cording to IEC 61000- If the floor is made of synthetic
± 8 kV air discharge
4-2 ± 6 kV Air material, then the relative air hu-
midity must be at least 30 %.
Quick transient elec- ± 2 kV for power n.a. for battery The quality of the supply voltage
trical disturbances / lines should correspond with the supply
bursts according to voltage of a typical business or
± 1 kV for input and
IEC 61000-4-5 hospital environment.
output lines
Surge voltages ± 1 kV push-pull n.a. for battery The quality of the supply voltage
(surges) according to voltage should correspond with the supply
IEC 61000-4-5 voltage of a typical business or
± 2 kV common
hospital environment.
mode voltage
Voltage drops, short- < 5% Ut (> 95% n.a. for battery The quality of the supply voltage
time interruptions and drop in the Ut) for ½ should correspond with the supply
fluctuations in the cycle voltage of a typical business or
supply voltage accord- hospital environment. If the user of
40% Ut (60% drop
ing to IEC 61000-4-11 PRIMEDIC™ HeartSave requires
in the Ut ) for 5 cy-
continuous functioning even when
cles
there are interruptions in power
70% Ut (30% drop supply, PRIMEDIC™ HeartSave
in the Ut ) for 25 cy- must be powered with power sup-
cles ply without interruptions or with a
battery.
< 5% Ut (> 95%
drop in the Ut) for 5
seconds
Magnetic field at sup- 3 A/m 3 A/m Magnetic fields at the supply fre-
ply frequency (5060 quency should correspond with the
Hz) according to IEC typical values in business or hospi-
61000-4-8 tal environments.
Note: Ut is the AC line voltage before the test level is applied.
46 20439 / 03.04 / 03 / engl.

PRIMEDIC™ HeartSave is meant for operation in any of the environments given below: The customer or
the user of PRIMEDIC™ HeartSave should ensure that it is operated in such an environment.
Interference Resistance IEC 60601 Test Compliance Electromagnetic Environment - Guide-
Test Level Level lines
Portable and mobile radio devices should
be used only at the recommended safe
Conducted HF distur- 3 Veff n.a. for bat- distance from PRIMEDIC™ HeartSave
bance according to IEC 150 kHz to 80 tery and its wires. This safe distance is calcu-
61000-4-6 MHz outside the lated according to the equation applica-
a
ISM bands ble to the transmit frequency.
n.a.
3 Veff Recommended Safe Distance”
150 kHz to 80
MHz outside the  3,5 
a d=  P
ISM bands  V1 
Radiated HF distur- 10 V/m 10 V/m for  12 
d=  P
bances according to IEC 80 MHz to 2 battery V 2 
61000-4-3 GHz
 12 
d =   P for 80 to 800 MHz
 E1
 23 
d =   P for 800 MHz to 2.5 GHz
 E1
where P is the maximum nominal power
of the transmitter in watts (W) according
to the information given by the transmit-
ter manufacturer and d is the recom-
b
mended safe distance in meters (m).
According to an on the spot examina-
tion, the field strength of stationary radio
transmitters is less than the compliance
levels.
Disturbances are possible
around devices with the fol-
lowing symbol.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all cases. The dispersion of electromagnetic content is influ-
enced by the absorption and reflection of buildings, objects and human-beings.
a
The ISM frequency bands (for industrial, scientific and medical application) 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 compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency
range of 80 MHz to 2.5 GHz are meant to lower the probability that mobile and/or portable communica-
tion devices can cause interference when they are brought into the patient’s vicinity unintentionally. Due
to this reason, the additional factor of 10/3 is used in the calculation of recommended safe distances in
these frequency bands.
c
Theoretically, the field strength of stationary transmitters such as base stations of mobile telephones be-
tween 150 kHz and 80 MHz and mobile terrestrial radio equipment, amateur radio stations, AM and FM
radio and television broadcasters cannot be accurately determined in advance. In order to determine the
electromagnetic environment vis-à-vis stationary transmitters, a study of the location should be con-
ducted. If the field strength measured on the location at which PRIMEDIC™ HeartSave is used exceeds
the compliance level given above, PRIMEDIC™ HeartSave should be observed to prove the intended
function. If any unusual characteristics are observed, certain steps can be taken, such as a modified
alignment or another location of PRIMEDIC™ HeartSave.
20439 / 03.04 / 03 / engl. 47

Recommended separation distances between portable and

mobile RF communication equipment and PRIMEDICTM HeartSave
The PRIMEDICTM HeartSave is intended for use in an electromagnetic environment in which radiated RF dis-
turbances are controlled. The customer ort he user of the PRIMEDICTM HeartSave can help prevent elctro-
magnetic interference by maintaining a minimum distance between portable or mobile RF communicationse-
TM
quipment (transmitters) and the PRIMEDIC HeartSave as recommended below, according to the maximum
output power of the communications equipment.
Separation distances between portable and mobile RF com-
munications equipment and the PRIMEDICTM HeartSave
m
Rated maximum output power
of transmitter 80 MHz to 800 MHz 800 MHz to 2,5 GHz
W
 12   23 
d =  P d=  P
 E1  E1
0,01 0,12 0,23

0,1 0,32 0,73
1 1,2 2,3
10 3,8 7,3
100 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P
is the maximum output power rating of the transmitter in watts (W)according to the transmitter manufac-
turer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance fort he higher frequency range applies.
NOTE 2 The ISM (industrial, scientific and medical) bands 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.
NOTE 3 An additional factor of 10/3 is used in calculating the recommended separation distance for trans-
mitters in the ISM frequency bands between 150 kHz and 80 MHz and 2,5 GHz to decrease the likelihood
that mobile/portable communications equipment could cause interference if it is inadvertently brought into
patient areas.
NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorp-
tion and reflection from structures, objects and people.
48 20439 / 03.04 / 03 / engl.

A5 General Instructions And Rules For Using The Optional

AkuPak
A nickel cadmium accumulator (NiCd accumulator) has been selected for the opera-
tion of PRIMEDIC™ HeartSave AED because in practice, this type of an accumulator
has more advantages compared to other types.
The NiCd accumulator has a higher energy density, that is, the PRIMEDIC™ accumu-
lator of the same size is able to give a considerably higher number of defibrillations
and / or has a longer operational ability than, for example, a comparable lead accu-
mulator.
Using a NiCd accumulator is next to unproblematic. Due to a modern, microprocessor
controlled charging connection, like the one used in the PRIMEDIC™ AkuPak, the
charging time required is very short and the life of the battery can also be prolonged.
If the NiCd accumulator is recharged without discharging it fully over a long period of
time, a typical phenomenon called the ‘Memory Effect’ occurs. Owing to the ‘Mem-
ory Effect’, inspite of having an ostensibly large capacity, the accumulator functions
as if it were a smaller accumulator with a smaller capacity.
An example for clarification

An accumulator has a capacity of 70 defibrillations. The device is used for five defi-
brillations, after which the accumulator is charged again. If this method of operation
continues over a long period of time, the ‘memory effect’ can set in. It means that the
capacity of the accumulator has reduced to five or six defibrillations because the ac-
cumulator was ‘trained’ for five defibrillations’
Reversing the ‘Memory Effect’ can be very expensive. So, the accumulator cannot be
used properly if its ‘residual capacity’ remains below a practicable value.
Preventing the ‘Memory Effect’

In order to prevent the ‘Memory Effect’, the accumulator must be discharged fully
from time to time, so that in the meantime, a complete charging cycle can be carried
out. In practice, this can be done in a number of ways:
– Do not recharge the accumulator immediately if it was discharged only fraction-
ally. Most of the times, there is still enough energy to continue using the device
with the remaining energy at a later time. The PRIMEDIC™ AkuPak does not al-
ways recharge an accumulator immediately. The accumulator is charged only after
a certain threshold value has been crossed.
– Before recharging the accumulator, the remaining capacity should be used up, for
example, through several defibrillations. This is not required each time the accu-
mulator is charged, but only from time to time (weekly or monthly, depending
upon how often it is used).
– The optimal care for an accumulator is a fully automatic charging and discharging
device, whereby a specific amount of discharging takes place each time the accu-
mulator is charged. For reasons of safety, this method of charging is not used in
case of accumulators that are loaded in the defibrillator directly. Otherwise, this
can lead to an unfavourable scenario where the defibrillator is required at just the
time when the accumulator has been completely discharged.
The fully automatic charging and discharging device has been implemented as the
Accu-Care function in the charging console of the PRIMEDIC™ Defi-Monitor. With
this option (can also be retrofitted), a second PRIMEDIC™ Accu can be loaded,
whereby due to the Accu-Care function, the ‘Memory Effect’ can be successfully
avoided.
20439 / 03.04 / 03 / engl. 49

Other Effects of Accumulators

Accumulators have two other features in the daily operation:
– Self-discharge
– Aging after longer use
In practical application, the self-discharge of an accumulator means that a full accu-
mulator loses it charge slowly but steadily. After about four weeks, only 90 percent of
the capacity is available. Generally, this effect needs to be considered, only if several
accumulators were charged as ‘reserves’.
PRIMEDIC™ AkuPak observes this self-discharge effect and balances it with a charge
conservation circuit.
Even with optimum care, after a period of 2 – 3 three years (depending on the fre-
quency of use), an aging effect is seen in accumulators. After 500 – 1000 charging
cycles (depending on the type), an accumulator can no longer transfer the absorbed
electrical energy to the chemical storage component. As a result, the accumulator can
no longer be used and must be replaced by a new one.
50 20439 / 03.04 / 03 / engl.

A6 Recommended Safety Checks

According to the Medical Devices Operator Ordinance (MPBetreibV) § 6 (Safety
Checks), the user is required to undertake regular checks. By the Medical Devices
Operator Ordinance (MPBetreibV) § 6, METRAX prescribes these checks every twelve
months.
These safety checks must be assigned to only those persons, who by virtue of their
training, their knowledge and their experience gained from practice, can carry out
these checks correctly and independently.
If the safety-related checks show any defects that can harm the patients, operators or
any other person, then according to the Medical Devices Operator Ordinance (MPBe-
treibV) § 3, the person carrying on the checks must inform the relevant authorities
immediately.
The following information must be entered in the medical device book required to
maintained under the Medical Devices Operator Ordinance (MPBetreibV) § 7:
– time of the tasks
– name of the person and / or company carrying out the tasks and
– the measures carried out.
METRAX is responsible for the data given in the operating manual only. This applies
especially to any new settings, repairs and changes to the device.
During the regular checks, the service technician must carry out the following tasks
and tests:
1. Check the device for any external damage
– Is the casing intact?
– Are the SavePads intact? Check the expiry date!
– Are the SavePads – Input socket and contact plugs intact?
– Is the type plate on the rear of the device and the back side of the power
supply unit readable?
2. Examine the device for any damaged operating elements.
– Is the key pad readable and intact?
– Are the buttons intact and functioning?
3. Check the display elements
– Are all the LEDs active for about two seconds after the defibrillator is
switched on?
– Does the warning buzzer sound for about two seconds after the defibrillator
is switched on?
4. Measure the charging time
5. Measure the output
While checking the defibrillation energy, a deviation of ± 15 % at 50 Ω is allowed.
20439 / 03.04 / 03 / engl. 51

6. Function of the ECG monitor.

– Are all the parameters displayed in the monitor?
z Feed an ECG signal with known frequency from an ECG simulator (Defi-
Tester) through a service cable.
– Is the heart rate displayed with a tolerance of ± 10 %?
7. Function of the accumulator / charging circuit

Charging indicator on the charging device lights up after the AkuPak in the defi-
brillator is connected.
8. Measure the leakage and patient auxiliary current according to IEC 601 – 1.
z Select standard leads and carry out measurements for type BF.
52 20439 / 03.04 / 03 / engl.

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Operating Manual HeartSave AED / AED-M

Right to make changes to this operating manual are reserved.

Tel.: + 49 (0)741 257-0

20439 / 03.04 / 03 / engl. I

4 Preparatory Measures Before (First) Operation 16

II 20439 / 03.04 / 03 / engl.

4.7.2 Periodical self test 22

5 Operation Of The Device And Resuscitation 25

6 Cleaning, Servicing And Despatching 32

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

20439 / 03.04 / 03 / engl. III

1.3 Intended Use

20439 / 03.04 / 03 / engl. 1

1.5 Liability Exemptions

2 20439 / 03.04 / 03 / engl.

1.8 Symbols In This Operating Manual

This symbol indicates texts containing important instructions / comments or tips.

z This dot describes processes to be carried out by you.

– This dash indicates lists.

Ì This star indicates cross references.

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

20439 / 03.04 / 03 / engl. 3

1.9 Symbols On The Device

Safety Class II (only valid in connection with PRIMEDICTM PowerLine)

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

Only for adults

Storage temperature in Celsius and Fahrenheit

4 20439 / 03.04 / 03 / engl.

PRIMEDIC™ HeartSave AED must be operated by trained and authorised persons

20439 / 03.04 / 03 / engl. 5

2.2 General Safety Instructions

2.3 Safety Instructions For You, The User

2.4 Safety Instructions for the Patient

6 20439 / 03.04 / 03 / engl.

2.5 Safety Instructions For A Third Person

2.6 Safety Instructions For The Device

20439 / 03.04 / 03 / engl. 7

8 20439 / 03.04 / 03 / engl.

3.2 Detailed Description

Illustration 1 PRIMEDIC™ HeartSave AED – Front View

Illustration 2 PRIMEDIC™ HeartSave AED – Rear View

20439 / 03.04 / 03 / engl. 9

1 Release button (to take out the power module)

Illustration 3 PRIMEDIC™ HeartSave AED – View from the bottom

1 Key pad without monitor 4 Lower latch

10 20439 / 03.04 / 03 / engl.

1 Key pad with a monitor 4 Lower latch

1 On-off button 5 Speaker grill

Illustration 6 PRIMEDIC™ HeartSave AED without Monitor

20439 / 03.04 / 03 / engl. 11