Gima PRIMEDIC HEART SAVE AED M, PRIMEDIC HEART SAVE AED User guide

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www.primedic.com

HeartSave AED / AED-M

Operating Instructions

21212 / GB / E02

Masthead

Publisher / contact data

METRAX GmbH Rheinwaldstr. 22 D-78628 Rottweil Germany

Tel.: + 49 (0)741 257-0 Fax.:+ 49 (0)741 257-235 info@primedic.com www.primedic.com

Proprietary note

These operating instructions may not be reproduced, transferred, electronically saved or translated into a human or computer language in whole or in part without our permission. Violations of this prohibition not only infringe our copyright, but also reduce our possibilities to provide the users and operators of the device with precise and punctual information.

We reserve the right to make amendments to these operating instructions.

MGA21212 / GB / E02

Table of contents

1 Introduction 1

1.1 Foreword ..................................................................................................................... 1

1.2 Validity ........................................................................................................................ 1

1.3 Warranty ..................................................................................................................... 1

1.4 Disclaimers .................................................................................................................. 2

1.5 Symbols used in these operating instructions ................................................................ 2

1.6 Pictograms on the device ............................................................................................. 3

1.7 Pictograms on PRIMEDICTM SavePads .......................................................................... 4

2 Intended use 4

2.1 Indications ................................................................................................................... 6

2.2 Contraindications ......................................................................................................... 6

3 Safety information 6

3.1 General information ..................................................................................................... 6

3.2 General safety instructions: .......................................................................................... 7

3.3 Safety notes for the user .............................................................................................. 8

3.4 Safety notes for protection of the patient ..................................................................... 8

3.5 Safety notes for the protection of third parties ............................................................. 9

3.6 Safety notes for protecting the device ........................................................................ 10

4 Description of device 10

4.1 General description .................................................................................................... 10

4.2 Description of device details ....................................................................................... 11

4.3 Symbols in the status display ...................................................................................... 14

4.4 Capacity display on the monitor ................................................................................. 15

4.5 Data management ..................................................................................................... 16

4.6 Description of the accessories .................................................................................... 17

4.6.1 PRIMEDICTM SavePads AED ............................................................................ 17

4.6.2 PRIMEDICTM battery ....................................................................................... 17

4.6.3 PRIMEDIC™ ECG-patient cable, 2-core (Optional accessory for PRIMEDICTM

AED-M) ......................................................................................................... 18

5 Preparatory measures before (initial) start-up 19

5.1 Unpacking ................................................................................................................. 19

5.2 Inserting / Changing the PRIMEDICTM SaveCard ........................................................ 19

5.2.1 Inserting the PRIMEDICTM SaveCard ............................................................... 20

5.2.2 Changing the PRIMEDICTM SaveCard .............................................................. 20

5.3 Inserting / replacing the energy module ..................................................................... 20

5.3.1 Inserting the power module ............................................................................ 21

5.3.2 Removing the power module from the device ................................................ 22

5.4 PRIMEDICTM battery ................................................................................................... 23

5.5 PRIMEDIC™ AkuPak (optional) ................................................................................. 23

5.5.1 Charging the PRIMEDICTM AkuPak with the PRIMEDICTM ClipCharger ............ 25

5.5.2 Loading the PRIMEDIC TM battery pack in the optional charger Basic /

Comfort. ........................................................................................................ 26

5.5.3 Connecting up the PRIMEDIC TM PowerLine (optional accessory) .................... 26

5.6 Periodic device self-test .............................................................................................. 26

5.6.1 Self-test after switching on the PRIMEDICTM HeartSave devices ...................... 26

5.6.2 Periodic self-tests ........................................................................................... 27

5.7 Configuration of the PRIMEDIC™ HeartSave ............................................................. 27

5.7.1 Configuration of the PRIMEDIC™ HeartSave AED (without monitor) ............. 27

5.7.2 Configuration of the PRIMEDIC™ HeartSave AED-M (with monitor) ............. 27

5.8 Simple change of configuration – example: Time ....................................................... 29

5.9 Changing the PIN ...................................................................................................... 29

5.10 Calling up/activating a profile .................................................................................... 30

HeartSave AED / AED-M I

Table of contents

5.11 Saving menu parameters in a profile .......................................................................... 30

6 Operating the device and sequence of reanimation 31

6.1 Switching the PRIMEDIC™ HeartSave on / off .......................................................... 31

6.1.1 Switching the PRIMEDIC™ HeartSave on ...................................................... 31

6.1.2 Switching off the PRIMEDIC™ HeartSave ...................................................... 31

6.2 Voice prompts from device / Preliminary examination of patient according to

standards .................................................................................................................. 32

6.3 Undressing the patient .............................................................................................. 32

6.4 Determining the position of the electrodes ................................................................ 33

6.5 Opening PRIMEDIC™ SavePads ............................................................................... 33

6.6 Removing hair growth from chest ............................................................................. 33

6.7 Removing protective film from PRIMEDIC™ SavePads. ............................................. 34

6.8 Plug in electrode plug ................................................................................................ 35

6.9 Checking the electrodes ............................................................................................ 36

6.10 Carrying out the ECG analysis ................................................................................... 36

6.11 Defibrillation required ................................................................................................ 37

6.12 Defibrillation not required ......................................................................................... 38

6.13 Keeping the defibrillator ready for use ....................................................................... 39

6.14 Monitoring the patient with the PRIMEDICTM AED-M ................................................ 39

7 Cleaning, maintenance and dispatch 40

7.1 Cleaning ................................................................................................................... 40

7.2 Servicing ................................................................................................................... 40

7.3 Dispatching the PRIMEDICTM HeartSave .................................................................... 41

8 Disposal 41 9 Technical Data 42 10 Warranty conditions 44 11 Depiction of the current time functions 45 12 Rhythm detection system 47 13 Guidelines and manufacturer's declaration – Electromagnetic emissions 49

14 General information and rules for use of the optional PRIMEDIC

15 Safety checks 54 16 Using the equipment on ships 55

16.1 Use of PRIMEDIC™ HeartSave units together with a PRIMEDIC™ battery on ships in

the merchant navy: ................................................................................................... 55

16.2 Use of PRIMEDIC™ HeartSave units together with a PRIMEDIC™ AkuPak on ships in

the merchant navy: ................................................................................................... 55

battery pack 52

MGA21212 / GB / E02

Introduction

1 Introduction

1.1 Foreword

Dear User,

You are preparing to face the task of using the PRIMEDIC™ HeartSave in a medical emergency on human beings.

So that you react quickly and properly in these special circumstances and make optimal use of the opportunity the device provides you with , it is necessary for you to take your time and read through these operating instructions beforehand, thus familiarising yourself with the device, its functions and applications.

Keep these operating instructions near the device so that you consult any queries which may arise.

If you have any questions regarding the device or other PRIMEDIC™ products, we would be glad to be at your disposal.

You will find our contact address on the masthead at the start of these operating instructions.

1.2 Validity

The descriptions in these operating instructions refer to the PRIMEDIC

PRIMEDICTM HeartSave AED-M

made by METRAX GmbH.

1.3 Warranty

The warranty period is 24 months and starts on the day of purchase. Please keep the invoice as proof of purchase. The general guarantee and warranty provisions of METRAX GmbH are applicable. Any repairs or changes to the device may only be carried out by the manufacturer or by a person or company authorised by the manufacturer.

HeartSave AED und

HeartSave AED / AED-M, 21212 / GB / E02

Introduction

1.4 Disclaimers

Liability claims in the event of damages to people or property are excluded if they are based on one or more of the following reasons:

 Using the device in a manner for which it was not intended.  Improper use and maintenance of the device.  Operating the device with the protective covers removed or when there is obvious

damage to cables and/or electrodes.

 Non-compliance with the instructions in these operating instructions with regard

to operation, maintenance and repair of the equipment.

 Using accessories and spare parts made by other manufacturers.  Autonomous intervention, repairs or constructional changes to the device.  Autonomous overrunning of the performance limits.  Lack of monitoring parts that are subject to wear and tear.  Treatment of patients without prior indication.

1.5 Symbols used in these operating instructions

DANGER

Texts marked DANGER indicate an extraordinarily serious, actual danger which will definitely lead to serious injury or even death if no preventative measures are adopted.

It is imperative that you follow these instructions!

WARNING

Texts that are marked with WARNING are there to warn you of an extremely dangerous potential hazard which - if no measures are taken to prevent this hazard, could lead to serious injury or even death!

It is imperative that you follow these instructions!

CAUTION

Texts marked with CAUTION indicate a possible dangerous situation which could lead to minor injuries or damage to property.

It is imperative that you pay attention to these texts.

Note

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

This symbol indicates text which contains important advice / comments or

Introduction

tips.

This point identifies the first step of a sequence of actions you should take. Second step of an action you should take.

etc.

 This line marks lists

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

< ... > The text in pointed brackeys are acoustic instructions / arrangements of

the equipment which are simultaneously shown on the monitor, depending on the equipment variant.

1.6 Pictograms on the device

Protection against contact and dust deposits on the inside and against water spray (jet)

IP55

IP53

IP33

from any angle (only in combination with battery)

in connection with PRIMEDIC™ BatteryPack

in connection with PRIMEDIC™ PowerLine

Please observe the operating instructions.

Do not dispose of device in domestic refuse.

Dangerous electric voltage (high voltage)

Degree of protection BF defi-resistant in connection with ECG patient cable

Type certification GERMANISCHER LLOYD in accordance with Certificate No. 75 449-09 HH

HeartSave AED / AED-M, 21212 / GB / E02

Intended use

1.7 Pictograms on PRIMEDICTM SavePads

Not to be reused

Expiry date

Batch ID

Only for adults

Order number

Storage temperature information in Celsius and Fahrenheit

2 Intended use

PRIMEDIC

This device is intended to be used by non-experts and trained first-aiders. It may only be used on patients who are unconscious and who are not breathing.

The main application is to carry out transthoracic defibrillation in asynchronous mode. The decision on the necessity of applying a shock is carried out automatically by the device.

The operator is guided by spoken instructions and clear written and pictorial information. After switching on the device, the patient is connected to it using the enclosed adhesive electrodes. After this, automatic rhythm analysis is carried out by the device. Only if a rhythm is detected by the device as being ventricular fibrillation (=shockable), does it suggest treatment with a high energy shock. All other rhythms are classified as not requiring a shock. The time from the start of analysis until the shock is applied is less than 30 s.

The energy levels of the first, second and third shock are predefined by the maximum set points for the electric current 20A, 25A and 30A, as well as by the capacitor voltage which depends on the patient impedance.

For safety reasons, no shock is given with asystolia, as no therapeutic effect is to be expected. Controlled ventricular electrical activity caused by supraventricular tachycardia such as atrial fibrillation, atrial flutter, ventricular extra-systoles and idioventricular rhythms does not lead to a shock being applied. After administering a shock, the rhythm is analysed by the device again. If other rhythms that can be treated with a high energy shock are found (ventricular fibrillation), then a recommendation for additional shocks is given. After the second shock, all additional shocks are applied

HeartSave AED

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Intended use

with the maximum available energy so that with a patient resistance of 70 Ohm up to 100 Ohm, around 360J can be applied. The device supports the user in the reanimation process depending on the factory-setting in accordance with the current guidelines from the European Resuscitation Council (ERC) from 2005 or the American Heart Association (AHA) from 2005 for immediate lifesaving measures to be taken when using an automatic defibrillator.

PRIMEDIC

The PRIMEDICTM HeartSave AED-M is intended for use by suitably qualified first-aiders, trained paramedics and doctors in daily routine, both in clinics and in the preclinical area of emergency medicine. The device can be powered either by a rechargeable removable power source (battery) or from the mains. The compact and light construction allows you to take the PRIMEDIC transporting a patient. The display shows the paramedic or the doctor the 1-Channel ECG (corresponds to the Einthoven Derivation II) from the adhesive defibrillation electrodes. This allows monitoring via the defibrillation electrodes.

Notes for PRIMEDIC™ HeartSave AED and AED-M:

HeartSave AED-M

HeartSave with you when

Note

WARNING

The PRIMEDIC™ HeartSave devices may only be used as described and under the conditions detailed in these operating instructions!

Any use above or beyond this is not considered as intended use and can lead to personal injury or damage to property.

The guidelines governing the application of emergency treatment in the event of cardiac arrest may change. The device currently at issue works in accordance with the International Guidelines 2005 Resuscitation (2005) of the European Resuscitation Council or according to the American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) 2005.

Improper use of the defibrillator can lead to ventricular fibrillation, asystolia or other dangerous dysrhythmia.

The operator of the PRIMEDIC™ HeartSave has to make sure that the PRIMEDIC™ HeartSave is only used by authorised specialist personnel.

HeartSave AED / AED-M, 21212 / GB / E02

Safety information

2.1 Indications

The PRIMEDIC™ HeartSave AED-(M) may only be used for defibrillation if the patient

 is unconscious and  no normal breathing can be ascertained; and  after talking to the patient, no other signs of life can be perceived.

2.2 Contraindications

The PRIMEDIC™ HeartSave AED-(M) may not be used for defibrillation if the patient

 is conscious; or  breathing; or  shows other signs of life  is a child under the age of 8 or weighs less than 25 kg respectively.

Treatment should not be delayed to ascertain the precise age or weight of the patient.

3 Safety information

3.1 General information

Both in conjunction with its accessories and the optional accessories, and also individually, the PRIMEDIC™ HeartSave defibrillator fulfils the currently applicable safety standards and complies with the provisions of medical products regulations. The device and its accessories are safe when used as intended and when following the descriptions and information detailed in these operating instructions. Despite this, if used incorrectly, the device and its accessories can be dangerous to you, the patient or third parties!

For this reason, we emphatically advise that before using for the first time, all those who are supposed to use this device or want to use it

 must be instructed in a training session about the

medical background of defibrillation and the indications or contraindications and thus need to be authorised.

 need to read and take note of these operating

instructions and in particular, the safety tips and warnings detailed in them.

DANGER

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Safety information

Note

The PRIMEDIC™ HeartSave AED / AED-M may only be used by trained and authorised personnel. Reading the operating instructions does not replace training. The PRIMEDIC™ HeartSave AED / AED-M is not licensed for use in explosive areas.

DANGER

Not using the device as intended or using it improperly, exposes you (the user), the patient or third parties to danger

 of an electric shock from the high voltage generated by

the device,

 of influencing active implants,  of burns from incorrectly applied electrodes.

Apart from that, the device can be damaged or destroyed through improper use.

DANGER

Observe the information and rules in the appendix on using

Applicable for Europe:

The device complies with the Medical Device Directive (MDD). The respective national guidelines for operating medical products are applicable.

For Germany, the following is also applicable:

The device is subject to the German Medical Products Act (MPG). Thus the German Medical Products User Regulations (MPBetreibV) also apply. The German Medical Products User Regulations is not applicable for medica l products which serve neither commercial nor business purposes and where no employees are working in the hazardous area around them.

the PRIMEDIC™ HeartSave!

3.2 General safety instructions:

Do not use the device in the vicinity of flammable materials (e.g. cleaning solvent or similar) or in an atmosphere enriched

HeartSave AED / AED-M, 21212 / GB / E02

with oxygen or with flammable gases / vapours!

DANGER

Safety information

3.3 Safety notes for the user

Only use the device on a patient if:  You have been authorised to do so as a result of

training!

 You have ensured its operational safety before using it

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

temperature range. This applies for example, if the defibrillator is stored in a rescue vehicle.

Do not use the device if it is defective (e. g. if the defibrillation cable is damaged).

DANGER

3.4 Safety notes for protection of the patient

DANGER

Only use the device on a patient if:

 You have been authorised to do so as a result of training!  You have ensured its operational safety before using it and

that it is in good condition.

 Before using the device, ensure that the device is within

the operating temperature range. This is important, for example, when the device is stored in an emergency services vehicle in winter. Do not use the device if it is defective (e. g. if the defibrillation cable is damaged).

 Only use the device with accessories, wearing parts and

disposable items which have proven to be completely safe to use by being tested by a testing authority licensed to test the device when equipped ready for use. These conditions are fulfilled by all original PRIMEDIC™ accessories and wearing parts.

 Use new, undamaged defibrillation electrodes before their

expiry date for every patient to avoid any possible burns to the skin!

 Only connect the adhesive electrodes to the PRIMEDIC™

HeartSave. Use of the electrode system with other devices can lead to dangerous impedance currents for the patient!

 Do not use the device in the immediate vicinity of other

sensitive equipment (e.g. measuring equipment that is sensitive to magnetic fields) or strong sources of interference which could affect the way the PRIMEDIC™ HeartSave works. Keep a sufficient distance away from

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Safety information

other therapeutic and diagnostic energy sources (e.g. diathermy, high frequency surgery, magnetic resonance tomography). These devices can affect the PRIMEDIC™ HeartSave and disrupt the way it operates. For this reason, disconnect the patient from any interfering devices.

 During defibrillation, disconnect the patient from all other

medically used devices which do not have a defibrillation resistant application part.

 Keep the defibrillation electrodes away from other

electrodes and from metallic parts which are in contact with the patient.

DANGER

 Do not use the device on children under the age of 8 or on

children with an estimated body weight of less than 25 kg.

 Position the electrodes precisely according to the

description.

 Dry the chest and carefully remove any large amount of

hair on the patient before applying the defibrillation electrodes.

 Do not place the defibrillation electrodes directly over an

implanted pacemaker to avoid a possible misinterpretation by the device and to avoid any damage to the pacemaker from the defibrillation impulse.

 Do not touch the patient during the ECG analysis and

avoid any vibrations.

 If the ECG analysis is being carried out in a vehicle, the

vehicle has to stop and switch off the engine to guarantee correct analysis.

 Stop any reanimation while the PRIMEDIC™ HeartSave is

analysing the ECG.

 Do not touch the patient during defibrillation. Avoid any

contact between o parts of the patient's body (such as bare skin on head

or legs), as well as

o conductible liquids (such as gels, blood or salt

solutions) and

o metallic objects in the vicinity of the patient (such as

bed frame or stretching device), which represent unintentional paths for the defibrillation current!

3.5 Safety notes for the protection of third parties

DANGER

Warn people in the vicinity loudly and clearly before the defibrillation so that they step back from the patient and are

HeartSave AED / AED-M, 21212 / GB / E02

no longer in contact with him.

Description of device

3.6 Safety notes for protecting the device

DANGER

Repairs, changes, extensions and installations of the PRIMEDIC™ HeartSave may only be carried out by personnel authorised and trained by METRAX! The PRIMEDIC™ HeartSave does not have any parts that can be repaired by the user! The device may only be equipped and operated with original accessories from PRIMEDIC™. Only clean the device when it is switched off and the electrodes have been removed and only clean it in the prescribed manner.

4 Description of device

4.1 General description

The PRIMEDIC™ HeartSave is an automatic external defibrillator (AED) with an integrated Single Channel ECG. The ECG is recorded using the PRIMEDIC™ SavePads. The algorithm implemented recognises potentially fatal heart arrhythmia. The defibrillator generates the electric shock necessary to reanimate a patient with a shockable ECG rhythm. This method is the generally recognised therapy. The family of devices is set up on a modular basis. These operating instructions cover the models:

PRIMEDIC

The PRIMEDIC™ HeartSave generation has been designed for rapid and safe use in emergency situations. All functional units and operating elements are subject to the following principles:

 Clear organisation of functional units  Reduction of functions to those necessary  Intuitive and logical operator guidance  Clear, self-explanatory operating elements  Ergonomic layout.

The PRIMEDIC™ AED-M has a high resolution graphics display which offers high image contrast, even in difficult lighting conditions. The ECG monitor can be seen clearly in all positions, e.g. lying down when used outdoors and standing upright in low mounting positions in the ambulance.

The defibrillator unit has been optimised to be safe and very quickly ready to use. The loading time for a defibrillation is approx. 12 seconds with a battery capacity of

HeartSave AED Basic Model without Monitor

HeartSave AED-M Basic Model with Monitor

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Description of device

approx. 90 % of the rated value. The power supply PRIMEDIC™ HeartSave is provided either from disposable lithium batteries or rechargeable removable batteries with nickel cadmium cells or from a mains supply. The charging electronics incorporate state-of-the-art technology, ensuring maximum service life of the batteries used. The PRIMEDIC™ HeartSave can be stored on a wall bracket which can be affixed to a wall or in the ambulance. It is easy and quick to remove the PRIMEDIC™ HeartSave when you need it, using the one-hand quick release. The PRIMEDIC charger serves as a power supply for charging the batteries.

A wide range of accessories are available. The wall bracket and accessories are described in separate operating instructions.

4.2 Description of device details

(TM)

Basic / Comfort

Fig. 1: Front view with cover

1 Carry handle 2 Strap for pulling the lid off the device, replacement date adhesive electrodes 3 Cover of device 4 Status display

Fig. 2: Rear View

1 Receptacle opening for hook of the wall bracket 2 Specification plate

HeartSave AED / AED-M, 21212 / GB / E02

Description of device

Fig. 3: View from below

1 Release button 2 Power module

Fig. 4: PRIMEDIC

HeartSave AED front view

1 On / Off button 2 Electrode symbol with LEDs 3 M e mbrane keyboard 4 "Do not touch patient" symbol (lights up during analysis) 5 Jac k for elec trode connectors 6 Loudspeaker 7 Trigger button for defibrillation, shock button 8 Language selection button 9 Status display

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Description of device

Fig. 5: PRIMEDIC

HeartSave AED-M front view

1 On / Off button 2 Membrane keyboard with monitor 3 Menu button to navigate upwards or to increase parameters 4 Select/ confirm button 5 Menu button to navigate down or to decrease parameters 6 Loudspeaker 7 Jack for electrode connectors 8 Trigger button for defibrillation, shock button 9 Status display

Fig. 6: Monitor representation (onlyPRIMEDICTM HeartSave AED-M)

1 Display of switch-on duration / time sequence HLW cycle 2 Number of detected VFs 3 Number of defibrillations 4 Heart frequency 5 Status line to show CF card capacity, patient impedance, time of day, microphone, battery

capacity

HeartSave AED / AED-M, 21212 / GB / E02

Description of device

6 ECG display 7 Instructions

Fig. 7: PRIMEDICTM SavePads AED

1 Cover of device 2 Utensils carrier with brief instructions 3 SavePads (defibrillation electrodes) 4 Disposable gloves (not sterile) 5 Disposable razor and respiration cloth

4.3 Symbols in the status display

Display Meaning Action to be taken

Passed device self-test Device ready to use Battery/battery pack capacity is sufficient Battery/battery pack is discharged Equipment can be used, it may be necessary to Passed device self-test

charge or replace the battery / AkuPak.

Symbol also appears if no power module has been inserted!

Symbol also appears if the use by date of the power module has been exceeded.

Device may be defective Carry out large self-test by replacing the

Device defective Have device repaired by authorised dealer.

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Insert battery / AkuPak.

Check use by date, if necessary replace with new ones.

battery / AkuPak or by switching the equipment on again.

Description of device

Battery/battery pack is discharged Equipment can be used, it may be necessary to

Device may be defective Carry out large self-test by replacing the

Device defective Have device repaired by authorised dealer.

4.4 Capacity display on the monitor

With the HeartSave AED-M, the battery charge of the battery / AkuPak appears on the display. The different images that may be displayed have the following meaning:

charge or replace the battery / AkuPak. Carry out large self-test by replacing the

battery / AkuPak or by switching the equipment on again.

100 % charged

80 % charged

60 % charged

40 % charged

20 % charged

0% (device runs on until charge is exhausted)

Fault in the device or service life of the power module has expired

The battery and the optional AkuPak are monitored by means of electronic charge measurement to ensure the most accurate capacity display possible. In addition to this display, all HeartSave units issue a warning if the battery is about to be exhausted.

Audible warning Display on monitor AkuPak < Charging status battery low.

Please recharge >

Battery < Battery low, please replace

battery >

Charge status battery low. Please recharge

< Battery low, please replace battery >

If the device is being used, the corresponding voice prompt will be repeated regularly in the selected language.

The battery symbol in the status display is activated.

HeartSave AED / AED-M, 21212 / GB / E02

Description of device

4.5 Data management

The HeartSave AED automatically records all ECG data and all spoken communication/environmental sounds using a microphone. In the as-delivered condition, the microphone on the HeartSave AED / AED-M is always switched on. The saved data can be displayed with the aid of a PC / Laptop and the software ECG Viewer. The dat is evaluated purely for administrative or legal purposes and can not be used for diagnosis or treatment of the patient. In the Software there is a deployment protocol in which additional patient data can be entered.

Note

The SaveCard supplied with the device is already formatted and can be used straight away. If you have problems with the existing SaveCard or with a new CF card, you must format these using the FAT16 file system for use in HeartSave. When formatting, please ensure that you do not accidentally format on a Windows XP system according to FAT32.

To attain the highest possible degree of safety here, please proceed as follows:

Windows 2000, Windows XP, Windows Vista

Start a command line window using "Start->Run" and in the entry field, enter "cmd.exe". The command line window will then open. There you enter the following: format f: /U /FS:FAT /X /V: (where f: stands for the drive letter which you may have to change).

For Windows 98/ME and older

You can call up the details of the command "format" by entering "format /?".

The data saved on the SaveCard should be archived externally after every deployment if possible.

The SaveCard should then be re-formatted if possible (instead of the usual deletion process).

Once the storage capacity of the SaveCard is exhausted, no further data will be saved. The HeartSave remains ready for operation even if the memory is exhausted and even without a SaveCard.

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Description of device

4.6 Description of the accessories

4.6.1 PRIMEDICTM SavePads AED

Fig. 8: PRIMEDICTM SavePads defibrillation electrodes (in the unpacked condition)

1 Plug 2 Defibrillation electrodes with protective film

4.6.2 PRIMEDICTM battery

Lithium battery, 15V / 2.8 Ah 6 years standby time

HeartSave AED / AED-M, 21212 / GB / E02

Description of device

4.6.3 PRIMEDIC™ ECG-patient cable, 2-core (Optional accessory for PRIMEDICTM AED-M)

Fig. 9: ECG patient cable

1 2-pin ECG electrode cable with connector 2 Electrode clips, red/green

This cable is only used for ECG monitoring of a patient. This cable can not be used for defibrillation. If the automatic background analysis carried out by the HeartSave AED / AED-M detects a heart rhythm that is in need of defibrillation, the following verbal message is issued:

< Analysis Recommended. Use SavePads >

In order to be able to carry out defibrillation, the ECG cable must be removed and replaced by the SavePads.

Additional accessories can be found on our home page "www.primedic.com" under "Online-Shop“

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Preparatory measures before (initial) start-up

5 Preparatory measures before (initial) start-up

5.1 Unpacking

After delivery, first of all check the packaging and the device for transport damage. If you notice any damage to the device, immediately contact your transport company, dealer or directly contact technical services at METRAX GmbH, stating the serial number and describing the damage to the device.

DANGER

Definitely do not use the device if you know of any damage. A health hazard can not be ruled out.

Satisfy yourself that the scope of delivery is complete in accordance with the enclosed delivery note.

5.2 Inserting / Changing the PRIMEDICTM SaveCard

Fig. 10: PRIMEDIC

1 SaveCard removal knob 2 SaveCard slot 3 Contacts for power module 4 Guarantee seal 5 Release button

HeartSave AED without power module

HeartSave AED / AED-M, 21212 / GB / E02

Preparatory measures before (initial) start-up

5.2.1 Inserting the PRIMEDICTM SaveCard

Before switching the device on for the first time, insert the SaveCard into the specially designed slot (2). Gently press the SaveCard in until the button (1) projects slightly out of the device. Now insert the power module into the device.

Note

The device will now start automatically and will perform a self-test. The data saved on the SaveCard should be archived externally after every deployment if possible. Once the storage capacity of the SaveCard is exhausted, no further data will be saved. The device remains ready for operation even if the memory is exhausted and even without a SaveCard.

5.2.2 Changing the PRIMEDICTM SaveCard

Before you can remove or replace the SaveCard, you must first remove the power module.

Procedure:

Press the button (1) in fully - this pushes the SaveCard (2) slightly out of its

holder.

Remove the SaveCard and insert a new one into the equipment with the plug end

going in first. Gently press the card in until the button (1) projects slightly out of the device. Finally insert the power module into the device again. The HeartSave AED will be ready for operation again after it carries out a

subsequent self-test

5.3 Inserting / replacing the energy module

The PRIMEDIC™ HeartSave AED can be operated using 3 different power modules:

 A disposable LiMnO  A rechargeable AkuPak (optional)  PowerLine (optional)

Before using the PRIMEDIC™ HeartSave for the first time, the power module has to be inserted in the appropriate slot.

battery,

CAUTION

Whenever the device has been used, check the power level. If necessary, replace the battery or recharge the battery pack.

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

If this is not possible make sure you always have a second, fully charged battery to hand to ensure that the device is always ready for use!

Preparatory measures before (initial) start-up

5.3.1 Inserting the power module

Fig. 11: Inserting the power module

1 Release button 2 Power module tongue 3 Power module

The HeartSave is always supplied with a power module. All three different types of power module are inserted the same way.

Procedure:

Lay the device on its back. Push the power module (3) into the device in the direction shown by the arrow

(A) until it reaches the back as shown in the diagram.

Then press the front of the power module into the slot in the direction shown by

the arrow (B) until you hear a "click" as the release button (1) engages securely with the tongue on the power module (2).

The power module should now be flush with the front housing of the device. If the power module has been inserted correctly, then the device will start

automatically and will carry out a self-test. If applicable, follow the acoustic/visual instructions from the device and then switch it off. The HeartSave AED is now ready for use.

HeartSave AED / AED-M, 21212 / GB / E02

Preparatory measures before (initial) start-up

CAUTION

Monitor the Status Display. If the display is showing "OK", the device is ready to use. (If applicable), switch it off using

5.3.2 Removing the power module from the device

the on / off button or put the device cover back on. If the display does not read "OK" or if a fault message appears on the monitor, remedy the cause or contact your nearest service station.

Fig. 12: Removing the power module

1 Release button 2 Power module tongue 3 Power module

CAUTION

Only change the power module when the device is switched off and electrode plug is disconnected.

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Preparatory measures before (initial) start-up

Procedure:

Lay the device on its back and press the release button (1) in the direction shown

by the arrow (D) until the tongue on the power module (2) is released and the power module (3) protrudes from the slot.

Twist the power module slightly in the direction of the arrow (C) and then pull it

in the direction of the arrow (D) out of the device.

5.4 PRIMEDICTM battery

The battery is a disposable lithium battery. It is fully charged when delivered. This type of battery is state-of-the-art and was selected due to its extremely long service life and energy storage.

Figure see chapter 4.6.2

Note

Use the battery before its use-by date expires. After the equipment has been used, the battery should, if necessary, be replaced by a new one (so that the full period of operation will be available for the next deployment).

In any event, heed the instruction leaflet enclosed with the battery and store it safely with these operating instructions. If the device has to be sent away to technical services, remove the battery before sending it and put some adhesive insulation tape over its contacts. When sending the battery, observe the separate shipping regulations.

On no account try to charge the battery. There would be risk of an explosion!

5.5 PRIMEDIC™ AkuPak (optional)

You can charge the AkuPak in two different ways:

 with the PRIMEDICTM ClipCharger (optional)  with the PRIMEDIC

The integrated detection of charge endpoint detection protects the bettery from harmful deep discharge. If the battery charge is too low, both a visual and an acoustic signal are issued.

Charger Basic / Comfort Charger (optional)

DANGER

HeartSave AED / AED-M, 21212 / GB / E02

Preparatory measures before (initial) start-up

In case an AkuPak is stored outside the equipment, its charge status can be checked by presing button (2).

Note

Fig. 13: PRIMEDIC™ AkuPak Battery charge indicator

1 Battery charge indicator 2 push button to activate battery charge indicator

Battery charge indicator (1) means:

    

  

81% - 100% charged 41% - 60% charged



1% - 20% charged

When charging using the Charger Basis / Charger Comfort, the PRIMEDIC™ AkuPak is automatically charged up again fully if the level falls below 80% of the charge capacity.

This 80%-limit can temporarily be made inoperative by pressing on push button (2), i.e., the PRIMEDIC™AkuPak can be recharged even before reaching this limit. This, for example, is practical if you wish to fully recharge PRIMEDIC™AkuPak prior to next use, independant of its current charge status. After recharging, the programmed 80%-limit is operative for the next automatic full recharge.

Charging the PRIMEDIC

AkuPaks outside the stipulated operating

temperature can cause damage to the rechargeable battery.

A completely discharged battery must be charged for at least 2 hours. If the charging time is too short, incorrect interpretation of the rechargeable battery charge status may occur.Trouble-free functioning of the equipment can not be assured. Charging the PRIMEDIC

battery pack is interrupted at temperatures of more than 45°C.

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Preparatory measures before (initial) start-up

5.5.1 Charging the PRIMEDICTM AkuPak with the PRIMEDICTM ClipCharger

Note

Fig. 14: PRIMEDICTM AkuPak with PRIMEDICTM ClipCharger

1 AkuPak 2 ClipCharger 3 Mains plug 4 green LED (Power) 5 yellow LED (Charge)

Procedure:

Removing the PRIMEDIC™ AkuPak from the device. Position the ClipCharger on the AkuPak in accordance with Fig. 14.

Now plug the mains plug into a plug socket. The green LED (Power) and the

yellow LED (Charge) light up and signal "Power Available". Charging is started if it becomes necessary because of the remaining residual

energy. The yellow Charge LED on the ClipCharger indicates charging. Charging time is approx. 2 1/2 hours. The yellow LED goes out when charging is complete.

Pull the mains plug out of the plug socket and release the ClipCharger from the

AkuPak.

Nickel Cadmium batteries are subject to natural wear and should be exchanged at the latest after 2.5 years depending on the frequency of use.

HeartSave AED / AED-M, 21212 / GB / E02

Preparatory measures before (initial) start-up

5.5.2 Loading the PRIMEDIC TM battery pack in the optional charger Basic / Comfort.

Please refer to the separate operating instructions for the charger Basic / Comfort.

5.5.3 Connecting up the PRIMEDIC TM PowerLine (optional accessory)

Fig. 15: PRIMEDIC TM PowerLine

Procedure:

Insert the PRIMEDIC TM PowerLine following the instructions in chapter 5.3. Then plug the mains plug of the mains cable into a socket in the vicinity of the

patient.

The HeartSave carries out a self-test and is then ready for use.

Note

METRAX GmbH recommends that you keep the HeartSave unit, with the PRIMEDIC PowerLine inserted, continuously connected to the mains, so that the equipment selftests are carried out automatically.

5.6 Periodic device self-test

5.6.1 Self-test after switching on the PRIMEDICTM HeartSave devices

The device self-test is run automatically by switching the HeartSave on, or by inserting the power module in the device to check all important functions and signal setups.

If the power module is replaced and the unit has first registered a fault, the large selftest (FULL) is carried out automatically. Please proceed to follow the device instructions.

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Preparatory measures before (initial) start-up

5.6.2 Periodic self-tests

The HeartSave carries out a periodic self-test as detailed below.

Frequency Effect of test SHORT Daily

MEDIUM First day of the month

LONG

FULL

On the 1st. July and on the 1st. January every year

After identifying an internal error

Software, operating membrane, ECG calibration, clock, internal voltage supply and HV part at 0 V

Software, operating membrane, ECG calibration, clock, internal voltage supply and HV part at 300 V

Software, operating membrane, ECG calibration, clock, internal voltage supply and HV part at 1600 V

Software, operating membrane, ECG calibration, clock, internal voltage supply and HV part at 1600 V, microphone test, key query

5.7 Configuration of the PRIMEDIC™ HeartSave

5.7.1 Configuration of the PRIMEDIC™ HeartSave AED (without monitor)

The PRIMEDIC™ HeartSave AED has been configured in the factory. It is not possible to change these settings.

5.7.2 Configuration of the PRIMEDIC™ HeartSave AED-M (with monitor)

The PRIMEDIC™ HeartSave AED-M has been configured in the factory. In the setup menu (displayed on the monitor) you can change certain parameters. You can save different configurations in a total of four profiles for different user groups. To activate a profile, see chapter 5.10. The device always starts in the profile „Basic“, independently of which changes have been made to the configuration before switching off or removing the power module.

General navigation:

Press the selection / confirmation key during operation to open the setup menu. Press the button  (up) or the button  (down) to navigate in the menu and to

increase or respectively decrease a selected parameter

Press the button  to select a parameter and to confirm the changed value.

HeartSave AED / AED-M, 21212 / GB / E02

Preparatory measures before (initial) start-up

Parameters Selection options

Page 1

Basic List of available profiles. Profile 1 The profile that is currently active is marked as "active" by the entry Profile 2 identified by the entry "active". Profile 3 By selecting it, the respective profile can be activated.

Page 2

Microphone: [On/Off] BLS information: [On / Off] CPR sounds [0% / 25% / 50% / 75% / 100%] CPR cycles 1-5 Contrast: from 40 to 120 Systole sound: [0% / 25% / 50% / 75% / 100%] Volume: [0% / 25% / 50% / 75% / 100%]

Page 3

Guideline ERC/AHA Language depending on language packages installed

Date in format DD/MM/YYYY Time 00:00 in 24 h format Network filter [50Hz/60Hz/Off] Display [0 degrees / 180 degrees]

Page 4 New PIN 0000-9999

PIN Repeat 0000-9999 Change PIN Confirmation for “Change PIN“ Save to profile This is used the save the parameters in the selected profile PIN Input field for current PIN Profile selection Basic, Profile 1, Profile 2, Profile 3

Page 5

ARM SW x.xx(Version number) xxxxxxxx (check sum 8 digits), Date DSP SW x.xx(Version number) xxxx (Check sum 4-digits), Date MSP SW x.xx(Version number) xxxx (Check sum 4-digits), Date ULF Check sum 8-digit Serial No. XXXX

Page 6

BQ SW Version: x.x BQ serial number: x

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Preparatory measures before (initial) start-up

5.8 Simple change of configuration – example: Time

To change the time, proceed as follows:

Navigate the cursor by pressing the key  down several times to the menu item

< To page 2 > Press this several times to get to page 3. Move the cursor by pressing the key  to the menu item Time. Select the

key. The hour is then highlighted.



Note

highlighted menu item Time by pressing the Change the hour by pressing the  or  key.

Confirm the correct value with the  key. The minute is now highlighted. Then

change this as described under 3 and then press the key  To exit the setup menu, move the marking with the key  to the menu item End

Setup and confirm this with the key  .

If no key is pressed for one minute, the device automatically leaves the setup menu and goes back to standby.

5.9 Changing the PIN

The PIN is used to save profiles. Entering a PIN is absolutely necessary. If you want to change the PIN you will always need to know the old PIN. proceed as follows:

Use the key  to change into the setup menu Change to page 4 of the menu Navigate with the key  to the entry < PIN > and confirm your selection with the

key



Enter the current PIN as follows: Using the keys   you can increase or

decrease a digit. With the key

fourth digit, it jumps back to the menu item Navigate to the entry < New PIN > and enter your new PIN as described above. Navigate to the entry < Repeat PIN > and enter your PIN again. Select the menu parameter < Change PIN > and confirm your new PIN with the

key  . On the right next to the cursor the entry < OK > should appear. This means your

new PIN is active.

Note

When the device is first delivered, the PIN is always set in the factory to

0000.

you can change to the next digit. After the



HeartSave AED / AED-M, 21212 / GB / E02

Preparatory measures before (initial) start-up

5.10 Calling up/activating a profile

Certain parameter settings for the menu can be summarised into profiles. Saved profiles can be called up as follows:

Use the key  to change into the setup menu Select your required profile using the keys   and confirm it with the key 

Note

The selected profile is active

Please note that your profile selection is only active until the device is switched off. The devices always starts with the profile „Basic“

5.11 Saving menu parameters in a profile

Certain parameter settings for the menu can be saved as profiles. The profiles Basic, Profile 1, Profile 2, and Profile 3 are available. If you want to save parameters in a profile or want to change a profile, proceed as follows:

Use the key  to change into the setup menu Change the required parameters from the various pages of the menu to suit your

needs. Change to page 4 of the menu. Use the key  to navigate to the entry < Profile selection > and confirm your

selection with the key Use the keys   to select the required profile which is to be used to save the

menu parameters previously selected. Confirm this with the key Navigate with the key  to the entry < PIN > and confirm your selection with the

key



Enter the current PIN as follows: Using the keys   you can increase or

decrease a digit. With the key

fourth digit, it jumps back to the menu Change to the menu entry < Save to profile > and confirm your selection with the

key



On the right next to the cursor the entry < OK > should appear. This means the

profile is saved. Now leave the menu by using the key  to navigate to the menu item < End

Setup > and confirm this with the key

If you want to change the configuration that your device starts up with when it is switched on, you have to save your changed menu parameters in the profile "Basic".



you can change to the next digit. After the



Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Operating the device and sequence of reanimation

Note

The parameter "Network filter" can only be changed temporarily while operating the device. After starting the device, the network filter is always switched off initially.

6 Operating the device and sequence of

reanimation

The sequence of the reanimation is realised in the device according to the recommended guidelines of the European Resuscitation Council (ERC): Resuscitation 2005, 67S1, S7—S23, or the American Heart Association (AHA), 2005: American Heart Association (Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (CPR) 2005). Make sure that before using the device you have completed suitable training.

Note

On the HeartSave AED, the guideline for the sequence of operation is preconfigured in the factory. A software update is necessary for changing the guidelines. If necessary, contact Metrax Service or your local dealer. After the software update, the identification on the device must match the software programmed.

On the HeartSave AED-M you can select the guideline used in the setup menu.

6.1 Switching the PRIMEDIC™ HeartSave on / off

6.1.1 Switching the PRIMEDIC™ HeartSave on

The device is automatically activated by removing its cover. If the device does not switch on automatically, switch it on by pressing the on / off button. After this, all buttons are unlocked, apart from the trigger button. Triggering defibrillation is only activated once ventricular fibrillation (VF) has been ascertained.

Directly after switching it on, an internal self-test is carried out to check important functions and signal devices. Standby is confirmed by a beep. It is important to ensure that the loudspeaker is working.

6.1.2 Switching off the PRIMEDIC™ HeartSave

The PRIMEDIC™ HeartSave can be switched off in different ways:

 By pressing the on/off button for approx. 3 seconds. A warning beep will sound

simultaneously.

 By closing the cover of the device.  If the device does not recognise a signal for 10 minutes and if no button is

pressed, it switches off automatically.

HeartSave AED / AED-M, 21212 / GB / E02

Operating the device and sequence of reanimation

Note

If the device detects a fault, it will automatically switch off to avoid possible injuries.

6.2 Voice prompts from device / Preliminary examination of patient according to standards

During the course of the voice output, you will be asked to examine the patient.

Note

After the device has successfully carried out the self-test, the following Basic Life Support (BLS) instructions (the basic measures of cardio pulmonary resuscitation) are issued. Here on the basis of ERC 2005

For your own protection, please take the rubber gloves out or the lid of the device first and put them on.

< Talk to patient > < Call emergency services >

< Open up airways, carefully hyperextend head >

< Check breathing > < If not breathing, 30 times cardiac massage > < 2x artificial respiration >

< Position electrodes >

< Plug in electrode plugs >

6.3 Undressing the patient

If during your preliminary examination, you have ascertained that the patient may need defibrillation, undress the upper body to be able to position the electrodes.

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Operating the device and sequence of reanimation

6.4 Determining the position of the electrodes

Fig. 16: Position the electrodes on the patient

The positions of the electrodes are:

 On the right side of the chest, below the collar bone (1)  On the left side of the chest, above the apex of the heart on the axillary line (2).

6.5 Opening PRIMEDIC™ SavePads

On the utensils carrier you will find 1 pair of electrodes, 1 razor, 1 artificial respiration cloth and 1 pair of disposable gloves. Open the defibrillation electrodes bag by tearing open the protective cover along the tear strip.

6.6 Removing hair growth from chest

If the patient has hair growing where the electrodes need to be positioned, you must remove it. Use the enclosed razor to remove the hair from the electrode positions.

HeartSave AED / AED-M, 21212 / GB / E02

Operating the device and sequence of reanimation

6.7 Removing protective film from PRIMEDIC™ SavePads.

Figure 17: Removing protective film from PRIMEDIC™ SavePads.

1 Protective film 2 Electrode

The PRIMEDIC™ HeartSave AED will give a voice prompt for you to apply the defibrillation electrodes to the patient.

When the device asks you to:

< Position electrodes >

proceed as follows:

First, remove the protective film (1) from one electrode (2) and them immediately

place the electrode on the position you had ascertained previously. Refer to label stuck on the back of the electrodes.

Proceed to remove the protective film from the second electrode and place it in its

position.

Smooth the electrodes onto the patient ensuring there are no air bubbles under

the electrodes!

DANGER

Do not touch the floor, objects, clothing or other body parts with the electrodes (once the protective film has been removed). The conductive layer of gel on the electrodes

Make sure that with the device variant without a monitor, the red electrode symbol LEDs on the membrane keyboard go out. With the device variant with a monitor, the sign on the display must disappear.

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

might be removed by this. A thinner layer of gel could reduce the success of defibrillation or lead to burns of the skin under the electrodes during defibrillation!

Operating the device and sequence of reanimation

Note

Refer to the summarised operating instructions on the packaging of the adhesive electrodes.

6.8 Plug in electrode plug

Note

Fig. 18: Plug in electrode cable

1 Electrode plug with interlocking jack 2 Jack

Action prompt:

< Plug in electrode plugs >

Before positioning the electrodes on the patient, carry out the BLS steps as

instructed!

Once the electrodes are connected to the patient and the electrode plug is

plugged in, the BLS instructions are automatically interrupted.

Insert the plug connector (1) of the electrode cable in the HeartSave socket (2).

Make sure that the locking pin (2) locks into place.

To be able to unplug the electrode plug, you have to push firmly on the top part of the locking pin while at the same time pulling the plug up.

HeartSave AED / AED-M, 21212 / GB / E02

Operating the device and sequence of reanimation

6.9 Checking the electrodes

If the device reports the fault <Check electrodes>, this can be for several reasons:

 Electrode plug not plugged in  There is contact between the defibrillation electrodes or a conductive gel

connection.

 Hair growth on patient not removed.  Air pockets between skin and defibrillation electrodes cause a bad contact.  Dried out electrodes.

It is very important to remedy the cause of the fault!

6.10 Carrying out the ECG analysis

If the defibrillation electrodes have been applied, the device will automatically start the analysis. Now the patient has to be put in an immobile position and may no longer be touched.

The device prompts:

< Do not touch patient, rhythm analysis >

The algorithm of the device program will now check the ECG for ventricular fibrillation. This process takes approx. 7 - 12 seconds. If the device identifies VF, it will recommend defibrillation.

Take care that during the analysis phase, the Auto switch is not continuously pressed as otherwise safety shutdown of

The rhythm identification detector continuously analyses the ECG, even after a rhythm in need of defibrillation has been identified.

the equipment is effected.

Observe the patient during the entire reanimation. It is possible at any time that the patient may regain consciousness and does not need to be defibrillated. If that is the case, do not carry out the defibrillation under any circumstances.

DANGER

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Operating the device and sequence of reanimation

6.11 Defibrillation required

If the device clearly identifies VF, then it will recommend defibrillation which is automatically prepared inside the device.

The device prompts:

< Shock advised >

< Device is charging >

< Do not touch the patient >

< Device is charging >

< Do not touch the patient >

If the condenser is charged internally, then the power for the defibrillation impulse is available for 15 seconds. This is signalled with the trigger button being lit up green.

The device prompts:

< Stand clear of patient. Deliver shock now >

Turn on green lit trigger key to give shock.

Note

Pressing the trigger key during power charging (before it turns green) does not result in release of shock, rather it leads to internal safety discharge.

DANGER

Before pressing the trigger button, disconnect all equipment which is not defibrillation-proof from the patient!

Once the defibrillation pulse has been given, a two minute phase follows for cardio pulmonary resuscitation (CPR). On the HeartSave AED-M you can freely select the cycles for the HLW between 1-5. The default is preset to 4.

Capacitor charging time for defibrillation depends on the available battery capacity. Charging may take longer if the power module is partly discharged. If an error should occur during charging, an intermittent warning beep will sound.

Before and during the energy discharge, all those participating in the reanimation have to step back and all contact with the patient or conductive parts (e.g. a stretcher) must be avoided.

HeartSave AED / AED-M, 21212 / GB / E02

Operating the device and sequence of reanimation

When the first message "Charge Battery” is issued, there are still at least 3 power discharges with max. energy available. The power module should be replaced when this message appears.

Note

If the device is switched on and for 10 minute no ECG is recorded or no key is pressed, then the device will automatically switch off. Approx. 30 seconds before the switch-off this is signalised by an interrupted warning tone. Pressing any button or any other activity will interrupt the switching off process.

In basic state of the device variant with a monitor, a dotted line appears on the display with the message "Check electrodes" if the electrodes are not connected up. As soon as a derivation via the electrodes occurs, the ECG signal appears on the monitor.

If you have not noticed the possibility of administering a shock, the device internally destroys the power charged and the heart rhythm is analysed again. If there is still a shockable rhythm present, the device will prompt:

< Do not touch the patient >

< Analysing rhythm >

< Shock advised >

< Device is charging >

< Do not touch the patient > ...

< Stand clear of patient. Deliver shock now >

Please make sure that you definitely use this chance of administering a shock!

If you do not deliver a shock again, then this process will be repeated several times.

WARNING

6.12 Defibrillation not required

If the device can not find a shockable rhythm, then it recommends cardiopulmonary resuscitation (CPR).

< No shock advised > < Cardiopulmonary resuscitation >

< 30 x cardiac massage>

< 2x artificial respiration >

Once the CPR time has expired, the device returns to ECG analysis.

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Operating the device and sequence of reanimation

6.13 Keeping the defibrillator ready for use

At the end of a reanimation, clean the device, replace the PRIMEDIC™ SavePads and check or, if necessary, replace the power supply unit so that the PRIMEDIC™ HeartSave device is ready to use again as soon as possible. Charge the PRIMEDIC™ battery pack to ensure that sufficient energy is available for the device to be used again.

Note

If any malfunctions or noticeable problems occur, please contact your nearest service station.

6.14 Monitoring the patient with the PRIMEDICTM AED-M

After successful defibrillation with the AED-M, the patient can be monitored by the monitoring function using the SavePads electrodes already used whilst they are being transferred to hospital. On the HeartSave AED-M you only have the lead II (Einthoven) available. If in this situation, ventricular fibrillation is detected again, renewed resuscitation can be carried out very quickly. For this purpose, the vehicle must be stopped and the engine switched off to ensure the analysis is correct.

If you need to monitor the ECG of a patient in other situations, please use the 2-core ECG patient cable.

HeartSave AED / AED-M, 21212 / GB / E02

Cleaning, maintenance and dispatch

7 Cleaning, maintenance and dispatch

7.1 Cleaning

WARNING

Only clean the device when it is switched off and with the electrodes unplugged. Before cleaning, remove the power module from the device or if there is an optional mains

 Clean the PRIMEDIC™ HeartSave and all its accessories, such as the wall bracket,

with commercially available household cleaners.

 Use a slightly damp, clean cloth.  Use ordinary wiping disinfectants to disinfect (e.g. Gigasept FF).

power supply, unplug it from the mains! Do not use any dripping wet cloths to clean it. Never pour liquids over the device and do not immerse it in any liquids!

7.2 Servicing

Independently of the use of the device, we recommend regular visual inspection / servicing of the PRIMEDIC™ HeartSave and its accessories by the user / service technician on a regular basis, at least once a year.

Make sure that the housing, cable, PRIMEDIC™ SavePads and all the other accessories are undamaged!

Servicing checklist:

 Check the expiry date of the PRIMEDIC™ SavePads.  Check the expiry date of the power module and if necessary, replace the parts

with original parts!

 Check that the status display is showing "OK".  Check whether you can switch on the device.  Check whether the device carries out a self-test automatically after being switched

on!

 Check whether the slot for the power supply is clean!  Check that the device is fully equipped!  Check that the device is labelled and that the label is legible.

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Disposal

DANGER

 If parts of the housing or insulation are damaged, they

must be repaired or exchanged immediately.

 If parts of the housing or insulation are damaged, do not

use the device or switch it off immediately.

 Have the device repaired as soon as possible by the

manufacturer.

7.3 Dispatching the PRIMEDICTM HeartSave

If the HeartSave has to be returned for servicing or to be upgraded, then the power module must always be removed from the device and must be sent in with the device, but packaged separately. Protect the contacts of the power module with insulating adhesive tape.

Where possible, use the original box.

8 Disposal

In accordance with the founding principles of the company Metrax GmbH, your product has been developed and made using high quality materials and components which are recyclable.

At the end of its serviceable life, recycle the device through disposal companies registered under public law (council recycling facilities). Proper disposal of this product helps with environmental protection.

Through the registration of Metrax GmbH with the responsible authorities we ensure that disposal and recycling of electrical devices introduced by us onto the market in accordance with the EU Directive on the disposal of waste electrical and electronic equipment (WEEE directive) is guaranteed.

For Germany, in accordance with the law on bringing electrical and electronic equipment onto the market, taking back and disposing of in an environmentally friendly manner

(Electrical and Electronic Equipment Act– ElektroG) Metrax is registered with EAR (register of old electronic equipment) under the number: 73450404.

For business customers in the European Union: Please contact your dealer or supplier if you want to dispose of electrical and electronic

equipment. Your dealer or supplier will have further information available for you.

CAUTION

Incorrect disposal of the device or its individual parts can lead to injury.

HeartSave AED / AED-M, 21212 / GB / E02

Technical Data

9 Technical Data

Defibrillation Operating modes: Patient impedance: 23 – 200 Ohm Impulse shape: Biphasic, current regulated (CCD)

Output power at:

Asynchronous, external

Patient impedance 1st. stage 2nd. stage 3rd. stage

25 Ohm 143 J 201 J 277 J 50 Ohm 281 J 350 J 360 J

75 Ohm 348 J 360 J 360 J 100 Ohm 344 J 343 J 343 J 125 Ohm 314 J 316 J 317 J 150 Ohm 290 J 293 J 293 J 175 Ohm 269 J 272 J 272 J

Accuracy: Impulse length:

Discharges:

All data is subject to a tolerance of +/- 15%

Positive phase 11.25 ms, negative phase 3.75 ms 200 discharges at 20 °C with a new PRIMEDIC™ battery 6 at any energy of 360 J.

70 discharges at 20 °C with a new fully charged PRIMEDIC™ AkuPakat any energy of 200 J. 50 discharges at 20 °C with a new fully charged PRIMEDIC™ AkuPakat any energy of 360 J.

Charge time: 12 +/-3 seconds with a battery at 90% of the rated capacity

ECG

Derivation: Einthoven II Heart frequency: Input: Input resistance: CMRR: Input d.c. voltage: Bandwidth:

Impedance measurement

Defibrillation: Measurement frequency:

30 – 300 min

Class BF, for 2-pin patient cable, defibrillation protected > 5 MOhm @ 10 Hz > 85 dB

± 0.5 V

0.5 – 40 Hz (- 3 dB) SR = 101 samples/s

23 ... 200 Ohm (accuracy +/- 20%)

30 kHz

-1

(Accuracy +/- 1/min, 1%)

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Technical Data

Analysis Analysis recognition:

Analysis duration: Monitor (at AED-M)

Type: Resolution:

Displays:

Presentation:

Power supply

Battery: Removable battery (battery PowerLine:

Data storage

Memory type:

Safety

Classification:

Ventricular fibrillation (VF) Approx. 7 s until VF is recognised

High resolution LCD monitor, 95x72mm (Diagonal 120mm, 4.7 inches) 320x240 Pixels (Pixel size: 0.36 x 0.36mm)

Heat frequency, number of defibrillations, number of VFs identified, resuscitation time, date, time, power capacity, ECG graph

X 25mm/sec, Y 10mm/mV

LiMnO2 15V, 2.8Ah (0° to 20°) service life in device is max. 6 years at 20°C

NiCd 12V / 1.4Ah, service life max. 2.5 years, depending on use 100…240 Volt, 50/60 Hz

CompactFlashCard 32 MB – 2 GB possible

Medical product in class IIb, Device with internal power supply, Type BF, Defiresistant,

0123

Identification:

The device is a medical product and complies with EC Directive 93 / 42 / EEC

Other

Operating conditions:

Storage conditions:

Dimensions: Weight:

Standards applied

0 ... 55 °C, 30 ... 95 % rel. humidity, but without condensation 700 hPa ... 1060 hPa continuous operation

- 20 ... 70 °C, 20 ... 95 % rel. humidity, but without condensation 500 hPa ... 1060 hPa

28 x 25 x 9 cm (W x H x D) approx. 2 kg (without power module)

Standards (for licensing in the EU, the corresponding harmonised European standards EN were used instead of the IEC standards):

IEC 60601-1:1988 + A1:1991 + A2:1995 IEC 60601-1-4:1996 IEC 60601-1-2:2001 IEC 60601-2-4:2002 EN1789:2003

HeartSave AED / AED-M, 21212 / GB / E02

Warranty conditions

IEC 60601-1-6:2004

Subject to change without notice

10 Warranty conditions

The warranty period is 24 months and starts on the day of purchase. Please keep the invoice as proof of purchase.

Within this time period, METRAX will remedy any defects in the device free of charge if they are based on material or manufacturing errors. The device can be reinstated to its original condition as selected by METRAX either by repair or replacement.

A claim under warranty does not extend the original warranty period. Warranty and also legally entitled warranty claims are not applicable if the usefulness

of the device is only negligibly affected, or in the case of normal wear and tear (e.g. consumables such as AkuPak) or damage caused after transfer of risk as a result of incorrect or negligent handling, excessive wear or are caused by special external influences which are not provided for according to the contract. The same applies if inappropriate changes or incorrect repair work is carried out by the buyer or by a third party.

All other claims against METRAX are excluded out unless such claims are based on intent or gross negligence or compulsory legal liability standards.

Warranty claims made by the buyer against the seller (dealer) are not affected by this guarantee.

In the case of a warranty claim, please return the device with proof of purchase (e.g. invoice) stating your name and address to your dealer or to METRAX.

METRAX After-Sales Service is glad to be at your disposal, even after the warranty period has expired.

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Depiction of the current time functions

11 Depiction of the current time functions

Depiction of the current controlled defibrillation impulse depending on the patient resistance and the current set.

I / A

25 Ohm

Time / ms Time / ms Time / ms

First shock Second shock Third shock

I / A

50 Ohm

First shock Second shock Third shock

I / A

75 Ohm

First shock Second shock Third shock

I / A

100 Ohm

First shock Second shock Third shock

I / A

125 Ohm

HeartSave AED / AED-M, 21212 / GB / E02

Depiction of the current time functions

First shock Second shock Third shock

I / A

150 Ohm

First shock Second shock Third shock

175 Ohm

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Rhythm detection system

12 Rhythm detection system

The rhythm detection system on the PRIMEDIC™ HeartSave analyses the patient's ECG and supports it if the unit detects a shockable or non-shockable rhythm.

Operator control of the defibrillation shock therapy:

 Ascertaining the electrode contact  Automatic evaluation of the ECG  Operator control of the defibrillation shock therapy

Ascertaining the electrode contact

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

Automatic Interpretation of the ECG

The rhythm detection system of the device is designed to recommend defibrillation when the system detects a shockable rhythm.

With all other ECG rhythms, including asystolia and normal sinus rhythms, the rhythm detection system in the device does not recommend defibrillation.

Operator control of the output of defibrillation shocks

The device's rhythm detection system triggers automatic charging of power if the device ascertains a shockable cardiac rhythm. Optical and acoustic messages are emitted to show you that the device recommends giving a defibrillation shock. If a defibrillation shock is recommended, you decide whether and when the shock is to be given.

The Algorithm:

 Observes the ECG rhythm across a continuous recording of 10 seconds, of which

7 seconds have been used for an initial diagnosis or to display the message "Shock recommended."

 Measures the symmetry of the ECG signal by several wave form factors and area

abive and below the moving average of the signal. Shockable ryhthms show greater symmetry than non-shockable rhythms.

 Measures the ratio of the signal energy content in a frequency band typical for

shockable rhythms and the total of the signal energy content. For shockable rhythms the signal energy concentrates in a specific frequency band and its fraction with respect to the total signal energy is higher.

 Derives from these two signal processing steps two parameters and compares

them to a threshold. If both parameters drop below their respective threshold for a specific amount of time, the device will rate the heart rhythm shockable. However, if one of the parameters exceeds its higher threshold value, this shocking recommendation is retracted.

 Filters and measures artefacts and interference. If a specific artefact level is

exceeded no reliable signal analysis is possible and the heart rhythm is rated nonshockable.

HeartSave AED / AED-M, 21212 / GB / E02

Rhythm detection system

 Detects pacemaker pulses and removes them from the ECG signal before rhythm

evaluation.

 Measures the heart rate. If it drops below a threshold, the heart rhythm is rated

non-shockable.

Cardiac rhythms used to test the rhythm detection system in the device

For validation the following databases have been used:

 AHA Database for Evaluation of Ventricular Arrhythmia Detectors (80

records with 35 min length each)

 MIT-BIH Arrhythmia Database (48 records with 30 min length each)  European ST-T Database (48 records with 120 min length each)

These databases contain ECG rhythms with ventricular fibrillation (VF) of varying amplitudes, ventricular tachycardia and sinus rhythms with – amongst others – supreventricular tacjycardias, atrial fibrillation/flutter, sinus rhythm with premature ventricular contractions (PVC), asystole and pacemaker pulses. All records are valid for evaluation of the VT-/VF-rhythm detector with respect to used electrode systems and ECG signal processing characteristics. For validation the ECG was converted to an analog signal and put out to the device under test. The detection result was than read back by the validation system and compared to the reference annotation.

For calculation of performance values those segments in the ECG data records marked with the PhysioBank annotation codes ventricular flutter/fibrillation (“[“ start, “]” end; see also www.physionet.org) are selected as shockable, all others as not shockable. These segments also include ventricular tachycardias, but these are not annotated seperately. Hence, they could not be considered in calculation of performance values.

For evaluation, the test and reference annotations of segments with a length of 12 seconds were compared to each other. Segments containing a shift between shockable and non-shockable rhythms were not taken into account

Performance results (weighted average):

Sensitivity 97,68% (Requirement of IEC 60601-2-4:2003: >90%) Specificity 99,99% (Requirement of IEC 60601-2-4:2003: >95%) False positive rate 0,01 % Real predictive value 98,59 % The databases used have a total length of about 10,000 minutes. The calculation was

made in accordance with IEC60601-2-4-2003.

Sensitivity

= Number of "correct shockable" algorithm decisions Total number of ECGs in which a shock is clinically recommended

Specificity

= Number of "correct not shockable" algorithm decisions Total number of ECGs in which a shock is not clinically recommended

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Guidelines and manufacturer's declaration – Electromagnetic emissions

False positive rate = Number of "incorrect shockable" algorithm decisions Total number of ECGs in which a shock is not clinically recommended

Positive predictive value

= Number of "correct shockable" algorithm decisions Total number of ECGs where the device recommends VF shock therapy

13 Guidelines and manufacturer's declaration –

Electromagnetic emissions

for PRIMEDICTM HeartSave AED/AED-M (in the following referred to as PRIMEDICTM HeartSave)

The PRIMEDICTM HeartSave is designed for use in an environment as described below. The customer or user of the PRIMEDIC

Emitted interference measurements Conformance Electromagnetic environment - code of practice

HF emissions according to CISPR 11 Group 1

HF emissions according to CISPR 11 Group 2

HF emissions according to CISPR 11 Class B Emission of harmonics according to

IEC 61000-3-2

Transmission of voltage fluctuations / Flicker according to IEC 61000-3-3

HeartSave should ensure that the device is only used in an environment of this kind.

The PRIMEDIC

HeartSave only uses HF energy for its internal function. This means that its HF emission is very low and it is unlikely that electronic devices in the vicinity are disrupted.

The PRIMEDIC

HeartSave has to emit electromagnetic energy to warrant its intended function. Neighbouring electromagnetic devices could be influenced.

n/a for battery / PRIMEDIC

battery pack n/a for battery /

PRIMEDIC

The PRIMEDIC including those in residential areas and those which are in the immediate vicinity of a public supply network which also supplies buildings that are used for residential purposes.

HeartSave is suitable for use in all locations

battery pack

HeartSave AED / AED-M, 21212 / GB / E02

Guidelines and manufacturer's declaration – Electromagnetic emissions

The PRIMEDIC PRIMEDIC

Immunity to interference testing

Discharge of static electricity (ESD) according to IEC 61000-4-2

Rapid transient electrical disturbances/ bursts according to IEC 61000-4-5

Surges according to IEC 61000-4-5

Voltage dips, short breaks and fluctuations in the supply voltage according to IEC 61000-4-11

Magnetic field at the supply frequency (50/60 Hz) according to IEC 61000-4-8

Note: Ut is the a.c. supply voltage before applying the test level.

HeartSave is designed for use in an environment as described below. The customer or user of the

HeartSave should ensure that the device is only used in an environment of this kind.

IEC 60601 test level Level of

conformance

± 6 kV contact discharge ± 8 kV air discharge

± 6 kV

± 6 kV air

± 2 kV for AC power lines ± 1 kV for incoming and

outgoing lines

± 1 kV normal mode voltage

± 2 kV common mode

n/a for battery / PRIMEDIC pack

voltage < 5% Ut (> 95% dip in

Ut) for ½ period 40% Ut (60% dip in Ut )

n/a for battery / PRIMEDIC

pack for 5 periods 70% Ut (30% dip in Ut )

for 25 periods < 5% Ut (> 95% dip in

Ut) for 5s 3 A/m 3 A/m

battery

Electromagnetic environment - guidelines

Floor should be made of wood or concrete or be tiled with ceramic tiles. If the floor is covered with a synthetic material, the relative air humidity should be at least 30%.

The quality of the supply voltage should correspond to that of a typical commercial or hospital environment.

The quality of the supply voltage should correspond to that of a typical commercial or hospital environment. If the user of the PRIMEDIC

HeartSave requires continued functioning even when disruptions in the power supply occur, it is recommended that the PRIMEDIC

HeartSave is fed from a

power supply free of disruptions or a battery. Magnetic fields at the mains frequency

should correspond to the typical values found in a commercial or hospital environment.

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Guidelines and manufacturer's declaration – Electromagnetic emissions

The PRIMEDICTM HeartSave is designed for use in an environment as described below. The customer or user of the PRIMEDIC

Immunity to interference testing

Conducted HF interference according to IEC 61000-4-6

Radiated HF disturbances according to IEC 61000-4-3

HeartSave should ensure that it is used in an environment of this kind.

IEC 60601 test level

Level of conformance

Electromagnetic environment - guidelines

Portable and mobile radio transceivers should not be used

3 V

eff

150 kHz to 80 MHz outside the ISM bands a

3 V

eff

150 kHz to 80 MHz outside the ISM bands a

10 V/m 80 MHz to

2 GHz

Not applicable for battery

n.a.

10 V/m for battery

any closer to the PRIMEDIC than the recommended protective distance which is calculated according to the equation applicable for the transmission frequency.

Recommended protective distance:

5,3







 





 





 





 













for 80 MHz to 800 MHz







for 800 MHz to 2.5 GHz





With P as the maximum power rating of the transmitter in Watts (W) in accordance with information provided by the manufacturer of the transmitter and d as the recommended protective distance in metres (m).

The field strength of stationary transmitters in accordance with an investigation on locations should be lower that the level of conformance.

Interference is possible in the vicinity of devices which have the following pictogram.

HeartSave, including its cables,

Note 1: At 80 MHz and 800 MHz the higher frequency range applies. Note 2: These guidelines may not be applicable in all cases. The spread of electromagnetic factors is affected by absorption

and reflection from buildings, objects and people.

The ISM frequency ranges (for industrial, scientific and medical applications) between 150 kHz and 80 MHz are 6.765

MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66MHz to 40.70 MHz.

The conformance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency band from 80 MHz to 2.5 GHz are defined to reduce the probability that mobile/portable communication devices can cause interference, if they are unintentionally brought into the vicinity of the patient. For this reason the additional factor of 10/3 is applied when calculating the recommended safety distance in these frequency ranges.

The field strength of stationary transmitters, such as base stations of wireless telephones between 150 kHz and 80 MHz and mobile field radio transmitters, amateur radio stations, AM and FM radio and television transmitters can theoretically not be precisely determined in advance. To determine the electromagnetic environment with regards to the stationary transmitters, a study of the location should be considered. If the field strength measured at the location at which the PRIMEDIC™ HeartSave is being used exceeds the conformance levels for HF listed above, then the PRIMEDIC™ HeartSave should be observed to prove that it is functioning as intended. If unusual performance characteristics are observed, then it may be necessary to take additional measures, such as change the orientation or the location where the PRIMEDIC

HeartSave is being used.

HeartSave AED / AED-M, 21212 / GB / E02

General information and rules for use of the optional PRIMEDICTM battery pack

Recommended protective distances between portable and mobile HF telecommunication devices and the PRIMEDIC

HeartSave

The PRIMEDICTM HeartSave is designed for use in an electromagnetic environment in which the HF interference is controlled. The customer or user of the PRIMEDIC the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the PRIMEDIC

HeartSave can help avoid electromagnetic interference by maintaining

HeartSave – independently of the output power of the communication device, as shown below.

Power rating of transmitter

Protective distance depends on the transmission frequency

80 MHz to 800 MHz















800 MHz to 2.5 GHz















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 with a maximum power rating that is not given in the table above, the distance can be determined by using the equation that belongs to the respective column, whereby P is the maximum power rating of the transmitter in Watts (W) according to the manufacturer of the transmitter.

NOTE 1 At 80 MHz and 800 MHz the higher frequency range is applicable. NOTE 2 The ISM frequency ranges (for industrial, scientific and medical applications) between 150 kHz and 80 MHz are

6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66MHz to 40.70 M Hz . NOTE 3 The purpose of the concordance levels in the ISM frequency bands between 150 kHz and 80 MHz and 2.5 GHz

is to reduce the probability of mobile/portable communication devices causing interruptions if they are unintentionally brought into the vicinity of the patient. For this reason the additional factor of 10/3 is applied when calculating the recommended safety distance in these frequency ranges.

NOTE 4 These guidelines may not be applicable in all cases. The spread of electromagnetic factors is affected by absorption and reflections from buildings, objects and people.

14 General information and rules for use of the

optional PRIMEDICTM battery pack

A Nickel-Cadmium battery pack (NiCd battery) has been selected to operate the PRIMEDIC™ HeartSave, as this type of battery in practise has several advantages over other types of batteries.

The NiCd battery has a high power density, i.e. with the same physical size, the PRIMEDIC™ battery can provide much more defibrillation or has longer standby time than, for example, a comparable lead battery.

Handling the NiCd battery is unproblematic. With a modern, microprocessor controlled charge switch as used in the PRIMEDIC™ battery pack, it is possible to attain very short charging times while at the same time, conserving the battery pack.

If the NiCd battery is only slightly discharged and then recharged over a longer period of time, the typical "Memory" effect occurs. The practical consequence of this "Memory" effect is that the battery, although it has a large nominal charging capacity, behaves like a small battery with low capacity.

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

General information and rules for use of the optional PRIMEDICTM battery pack

An example to illustrate this

A battery has a capacity of e.g. 60 defibrillations. The power for 5 defibrillations is used and the battery is then recharged. If this is repeated over a long period of time, the "Memory" effect may occur, i. e. the capacity of the battery is reduced to 5 to 6 defibrillations, as the battery has been "trained" to perform 5 defibrillations.

It takes a great amount of effort to reverse the "Memory” effect, meaning that the battery can no longer be sensibly used once its "Residual capacity” falls below a practicable value.

Avoiding the "Memory" effect

To avoid the memory effect, the battery must be fully discharged from time to time so that it is possible to intermittently carry out a complete charge cycle. In practice this can be done in several ways:

If the battery has only been slightly discharged, do not recharge it immediately. There is usually still enough energy available that you can continue to work with the remaining energy at a later point in time. The PRIMEDIC™ ClipCharger does not always charge a rechargeable battery immediately. Only once it falls below a certain threshold, is the battery charged.

The optimum way to achieve this is with a fully automatic discharger / charger, which performs defined discharging before every charging process. For safety reasons, this charging technique is not used for batteries that are charged in the defibrillator directly. Otherwise the unfortunate case could occur that the defibrillator is needed just at the moment in time at which the battery is fully discharged.

The fully automatic discharge / charge device has been realised as a care function in the PRIMEDIC also be retrofitted) allows you to charge a second PRIMEDIC™ battery pack and the Care Function prevents the occurrence of the "Memory" effect.

Other effects of batteries

Batteries have two additional properties in daily practice:

 Self-discharge  Ageing after being used for a long time.

Self-discharge of a battery means that in practical use, that a battery that is still full, slowly but surely loses its charge. After around 4 weeks only around 90% of the capacity is still available. This effect normally only need to be taken into consideration if several batteries have been charged in "reserve".

Even with optimal care of a battery, after a time period of approx. 2 – 3 years (depending on the frequency of use) an ageing effect occurs. After around 500 – 1000 charge cycles (depending on the type) a battery is no longer able to transfer the electrical energy charged into the chemical reservoir. The battery is thus rendered useless and must be replaced with a new one.

Charger Comfort available as an option. This optional accessory (it can

HeartSave AED / AED-M, 21212 / GB / E02

Safety checks

15 Safety checks

(it is possible that other national regulations may be applicable)

In accordance with the German Medical Products User Regulations (MPBetreibV) § 6 (safety checks) the operator in the event of commercial and economic use undertakes to carry out regular checks or have them carried out. METRAX recommends carrying out safety checks in accordance with the MPBetreibV §6 every 24 months. The safety checks may only be carried out by or be assigned to the persons described in the MPBetreibV §6 (4).

The safety checks carried out are to be documented in accordance with MPBetreibV §7. In accordance with the German Medical Products User Regulations (MPBetreibV) § 6

(Safety checks) the operator is obliged to have regular checks carried out. In accordance with the German Medical Products User Regulations (MPBetreibV) § 6, METRAX stipulate these checks be carried out in a 24-month cycle.

The safety checks may only be assigned to people who, because of their training, their knowledge and their experience gained through practical activity, can carry the checks out properly and do not need instruction to do so.

If during the safety check, faulty are found which could be hazardous to patients, employees or third parties, then the operator must immediately inform the responsible authorities in accordance with German Medical Products User Regulations (MPBetreibV) § 3.

In the medical products log to be kept in accordance with the German Medical Products User Regulations (MPBetreibV) § 7, the following data is to entered:

 Time of carrying out the work  Name of person or company carrying out the work and  Measures taken.

The responsibility of METRAX GmbH only covers the information provided in the operating instructions. This applies in particular for readjustments, repairs and changes to the device.

Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02

Using the equipment on ships

16 Using the equipment on ships

16.1 Use of PRIMEDIC™ HeartSave units together with a PRIMEDIC™ battery on ships in the merchant navy:

The use of the following PRIMEDIC™ HeartSave (M250)-units: PRIMEDIC™ HeartSave PAD / AED / AED-M / HS6 / HS6-S with the energy supply module

PRIMEDIC™ Battery 15VDC 2.8Ah LiMnO4

fulfils the EMC requirements of "Zone for the bridge and the open deck" asper the "Guidelines for the Performance of Type Approvals" or "Test Requirements for Electrical / Electronic Equipment and Systems" of the "Rules for Classification and Construction", Book VI "Additional Rules and Guidelines" of "Germanischer Lloyd,"

2003.

16.2 Use of PRIMEDIC™ HeartSave units together with a PRIMEDIC™ AkuPak on ships in the merchant navy:

PRIMEDIC™ HeartSave units with a PRIMEDIC™ battery, have been EMC checked for compliance with "Test Requirements for Electrical / Electronic Equipment and Systems" of "Germanischer Lloyd," 2003.

Because the "PRIMEDIC™ AkuPak 12VDC 1.2Ah NiCd", whilst supplying the PRIMEDIC™ HeartSave (M250) units behave as the "PRIMEDIC™ battery", we can transpose the experience gained from all EMC test results to the combinations of the PRIMEDIC™ AkuPak with all PRIMEDIC™ HeartSave (M250) units.

These combinations fulfil, during supply mode, the requirements of "Zone for the bridge and the open deck".

Recharging the PRIMEDIC™ AkuPak requires a PRIMEDIC™ ClipCharger as the charger unit.

Recharging must be carried out in a dry room which is isolated by metallic screening from "Zone for the bridge and the open deck".

The equipment combination always fulfils, during charging, or in parallel charging mode, the EMC requirements of the "General Power Supply Zone".

HeartSave AED / AED-M, 21212 / GB / E02

About Us.

METRAX GmbH is specialised in developing state-of-the-art devices for emergency medicine. Established in 1973 in Rottweil, today Metrax is considered to be an outstanding example of the strengths in German development technology: Innovative vision, top quality and complete dedication in research and development have been the company's distinguishing features for the last 30 years. The result of this is high precision and extremely reliable high-tech devices which are

Your dealers

so user friendly that they set ne w standards. With the brand PRIMEDIC™, Metrax offers a reliable programme for emergency medicine: Professional defibrillators and mobile ultrasound scanners. Emergency rescue services around the world are familiar with PRIMEDIC

as a guarantor for the highest quality and innovative medical technology.

Manufacturer / company location:

METRAX GmbH Rheinwaldstr. 22 D-78628 Rottweil Germany Tel.: +49 741 257-0 Fax: +49 741 257-235 www.primedic.com info@primedic.com

Representatives:

METRAX GmbH Shanghai Rep. Office Unit B, 11/F First Trade Tower No. 985 Dongfang Road, Pudong New Area Shanghai 200122 P. R. China Tel.: +86 21 583199-80 Fax: +86 21 583177-79 www.primedic.cn info@metrax.cn

METRAX GmbH

Moscow Rep. Office Ul. Vavilowa 5, corpus 3 119334 Moscow Russia Tel.: +7 95 23170-61 Fax: +7 95 23170-62 www.primedic.ru info@metrax.ru

Gima PRIMEDIC HEART SAVE AED M, PRIMEDIC HEART SAVE AED User guide

Specifications and Main Features

Frequently Asked Questions

User Manual