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Operating Manual
20439 / 03.04 / 03 / engl.
by METRAX GmbH
This operating manual or any part thereof shall not be reproduced, transmitted, saved
on electronic media or translated into any human or computer language without our
approval. Any violations of this restriction not only infringe our copyright, but also
limit our ability to provide accurate and up-to-date information to the user and the
operator of this device.
Right to make changes to this operating manual are reserved.
METRAX GmbH
Rheinwaldstrasse 22
D-78628 Rottweil
Tel.: + 49 (0)741 257-0
Fax.: + 49 (0)741 257-235
www.metrax.de
Printed in Germany
HeartSave AED / AED-M
I
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Related Manuals for Primedic HeartSave AED
Summary of Contents for Primedic HeartSave AED
- Page 1 Operating Manual HeartSave AED / AED-M by METRAX GmbH This operating manual or any part thereof shall not be reproduced, transmitted, saved on electronic media or translated into any human or computer language without our approval. Any violations of this restriction not only infringe our copyright, but also limit our ability to provide accurate and up-to-date information to the user and the operator of this device.
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Page 2: Table Of Contents
HeartSave AED / AED-M Operating Manual Contents Chapter Topic Page Introduction Foreword Scope Intended Use Guarantee Liability Exemptions Indications Contraindications Symbols In This Operating Manual Symbols On The Device 1.10 Symbols On The SavePads Safety Instructions General Instructions General Safety Instructions... - Page 3 HeartSave AED / AED-M 4.7.2 Periodical self test Configuration Of PRIMEDIC™ HeartSave AED 4.8.1 Configuration Of PRIMEDIC™ HeartSave AED (Without Monitor) 4.8.2 Configuration Of PRIMEDIC™ HeartSave AED-M (With Monitor) Operation Of The Device And Resuscitation Switching PRIMEDIC™ HeartSave AED On And Off.
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Page 5: Introduction
Introduction Foreword Dear User, You have the task of using PRIMEDIC™ HeartSave AED to help a patient in a medical emergency! In such a situation, you have to react quickly and correctly and use the functions of- fered by this device optimally. Therefore, it is important that you read this operating manual fully and thoroughly so that you are familiar with the device, its functions and its various applications. -
Page 6: Liability Exemptions
– Deficient monitoring of parts subject to wear and tear. – Treatment of patients without any prior indications. Indications The PRIMEDIC™ HeartSave AED-(M) shall ony be used, if the patient is – Unconscious and – is not breathing and – has no pulse. -
Page 7: Symbols In This Operating Manual
Numbers in brackets refer to items in illustrations. < ... > Texts put in angle brackets are voice prompts / instructions from the device. In case of the HeartSave AED-M model, the instructions are simultaneously displayed on the monitor. 20439 / 03.04 / 03 / engl. -
Page 8: Symbols On The Device
HeartSave AED / AED-M Operating Manual Symbols On The Device Safety Class II (only valid in connection with PRIMEDIC PowerLine) Jet-proof IP55 Please follow the instructions in the operating manual! Safety level BF, opening is protected against defibrillation Dangerous electric voltage (high voltage) Safety level CF in conjunction with an ECG patient cable 1.10... -
Page 9: Safety Instructions
HeartSave AED / AED-M Safety Instructions General Instructions The PRIMEDIC™ HeartSave AED defibrillator and its standard as well as optional ac- cessories fulfil all safety norms currently valid and meet all the criteria of the guide- lines for medical devices. -
Page 10: General Safety Instructions
To avoid possible skin burns, use new and undamaged defibrillation electrodes falling within the expiry date for each patient! Connect the adhesive electrodes only to PRIMEDIC™ HeartSave AED. The use of electrode systems with other devices can cause harmful leakage current to emit on to the patient. -
Page 11: Safety Instructions For A Third Person
Safety Instructions For The Device Any repairs, modifications, enhancements and installations of PRIMEDIC™ – HeartSave AED must only be carried out by persons authorised and trained by METRAX! No parts of PRIMEDIC™ HeartSave AED can be repaired by the user! –... -
Page 12: Device Description
When not in use, the HeartSave AED can be kept in a wall unit that can fixed to a wall or in an ambulance. When required, it can be removed quickly and easily with the help of an (optional) one-hand release. -
Page 13: Detailed Description
Handle Flap to take off the device cover with the SavePads Device cover Status display Illustration 1 PRIMEDIC™ HeartSave AED – Front View 1 Microphone opening 2 Retainer opening for the fixation hooks 3 Type plate 4 Infrared window Illustration 2 PRIMEDIC™... - Page 14 1 Key pad without monitor 4 Lower latch 2 SavePads 5 Groove for the lower latch 3 Upper latch 6 Groove for the upper latch Illustration 4 PRIMEDIC™ HeartSave AED without Monitor, with the cover off 20439 / 03.04 / 03 / engl.
- Page 15 5 Groove for the lower latch 3 Upper latch 6 Groove for the upper latch Illustration 5 PRIMEDIC™ HeartSave AED with Monitor, with the cover off 1 On-off button Speaker grill 2 Key pad with the patient symbol Electrodes’ connector socket...
- Page 16 4 Selection and Confirmation Button 5 Button to scroll down in the monitor menu and /or to reduce parameters Illustration 7 PRIMEDIC™ HeartSave AED with Monitor Device cover Tools holder with manual, artificial respiration cloth and shaver Defibrillation electrodes Rubber hand gloves (unsterilised) Illustration 8 PRIMEDIC™...
- Page 17 Operating Manual HeartSave AED / AED-M Tools holder with manual, artificial respiration cloth and shaver Illustration 9 PRIMEDIC™ HeartSave AED – SavePads Language selection button Status display Illustration 10 20439 / 03.04 / 03 / engl.
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Page 18: Capacity Display
/ Metrax – Device ready for – Device can be used operation Capacity Display The charge level is shown in the display of HeartSave AED-M. The six possible display levels mean the following: ••••• > 80% ... 100% ••••... -
Page 19: Data Management
If possible, data stored on the SaveCard should be archived on external media after each use. If the storage capacity of the SaveCard is exhausted, no further data will be stored. PRIMEDIC™ HeartSave can be used even if there is no space to store data and even without the SaveCard. -
Page 20: Preparatory Measures Before (First) Operation
HeartSave AED / AED-M Operating Manual Preparatory Measures Before (First) Operation Unpacking After delivery, check the packing and the device for any damage during transport. In case you determine any damage to the device, contact your shipper, dealer or even the technical service of METRAX GmbH immediately. Give your serial num- ber and describe the damage to the device. -
Page 21: Changing The Savecard
After each use, the data stored on the SaveCard should be archived on external me- dia as soon as possible. No further data can be stored if there is no space left on the SaveCard. PRIMEDIC™ HeartSave can be used even if there is no space to store data and even without the SaveCard. -
Page 22: Inserting The Power Module
Inserting The Power Module Illustration 13 PRIMEDIC™ HeartSave AED – Inserting the Power Module The HeartSave is always supplied with a power module. The method of inserting the power module is the same in case of all the three vari- ants. -
Page 23: Removing The Power Module From The Device
Does the display not show "OK", resp. an error message appears on the Monitor, remove the cause or call your next service partner. The device switches off itself. 4.3.2 Removing The Power Module From The Device Illustration 14 PRIMEDIC™ HeartSave AED – Removing the Power Module 20439 / 03.04 / 03 / engl. -
Page 24: Battery
HeartSave AED / AED-M Operating Manual Change the power module only when the device is switched off and the connec- tor of the defibrillation electrodes is removed. Place the device on its rear side and press the release button (1) in the direction of the arrow (1.) until the tab of the power module (2) is released and a part of the... -
Page 25: Charging The Akupak With The Plug-In Power Pack
Operating Manual HeartSave AED / AED-M 4.5.1 Charging The AkuPak With The Plug-In Power Pack 1 Power plug 2 plug 3 socket at AkuPak 4 AkuPak 5 Marking“red dot“ 6 plug Illustration 15 The AkuPak must be put into the device. -
Page 26: Device Self Test
HeartSave AED / AED-M Operating Manual Device Self Test 4.7.1 Self Test After Switch On Of HeartSave The self test will either be activated when switching on the HeartSave or inserting the energy module into the device and passes immediately the device self test to check all important functions and signal settings. -
Page 27: Configuration Of Primedic™ Heartsave Aed
HeartSave AED / AED-M Configuration Of PRIMEDIC™ HeartSave AED 4.8.1 Configuration Of PRIMEDIC™ HeartSave AED (Without Monitor) PRIMEDIC™ HeartSave AED is configured by the factory. Changes to this setting are not possible. 4.8.2 Configuration Of PRIMEDIC™ HeartSave AED-M (With Monitor) PRIMEDIC™... - Page 28 Now carry out any other changes (if required) in the same manner. To exit the Setup Menu, move the selection with the button to the menu item END and confirm this with the button. PRIMEDIC™ HeartSave AED is then ready for operation again. 20439 / 03.04 / 03 / engl.
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Page 29: Operation Of The Device And Resuscitation
5.1.2 Switching PRIMEDIC™ HeartSave AED Off PRIMEDIC™ HeartSave AED can be switched off in many ways: – By pressing the On / Standby button for about three seconds. At the same time, there are three warning tones. This time is selected so that the device is not switched off by mistake. -
Page 30: Voice Prompts / Preliminary Examination Of The Patient
HeartSave AED / AED-M Operating Manual Voice Prompts / Preliminary Examination Of The Patient The voice prompts instruct you to examine the patient. For this, first put on the rubber gloves from the cover of the device. After the device has completed the self-test successfully, the following instructions are given: <... -
Page 31: Determining The Position Of Electrodes
Operating Manual HeartSave AED / AED-M Determining The Position Of Electrodes Illustration 16 Position of Electrodes on the Patient The electrodes are positioned – in the region of the right breast, below the collarbone (1) and – in the region of the left breast above the apex of the heart on the axillary line (2). -
Page 32: Removing The Savepads From The Electrodes And Connecting The Electrodes' Connector
HeartSave AED / AED-M Operating Manual Removing The SavePads From The Electrodes And Connecting The Electrodes’ Connector Illustration 17 Insert the electrode connector into the socket of HeartSave Remove the electrodes from the SavePads pack. Insert the connector (1) of the electrode cable in the socket (2) on HeartSave. -
Page 33: Check Electrodes
Operating Manual HeartSave AED / AED-M PRIMEDIC™ HeartSave AED instructs you to place the defibrillation electrodes on the patient through voice prompts. Proceed in the following manner: First pull off the protective sheet (1) from one electrode (2) and then place the electrode directly on the position determined earlier. -
Page 34: Carrying Out The Ecg Analysis
HeartSave AED / AED-M Operating Manual 5.10 Carrying Out The ECG Analysis The device starts the analysis automatically if the defibrillation electrodes are placed correctly. Now the patient must be kept still and not be touched. The device prompts < Do not touch the patient, rhythm analysis >... -
Page 35: Defibrillation Not Required
Clean the device after a resuscitation, replace the SavePads and check and / or change the power supply unit if required, so that PRIMEDIC™ HeartSave can be used as fast as possible on the next use. Charge the AkuPak for sufficient power on the next use. -
Page 36: Cleaning, Servicing And Despatching
Do not use a dripping wet cloth for cleaning. Do not pour any liquids on the device and / or do not dip it into any liquids! Clean PRIMEDIC™ HeartSave AED and all accessories such as the Wall Mount Rack with any commercially available household cleaner. -
Page 37: Despatching Primedic™ Heartsave Aed
Operator Ordinance (MPBetreibV) are available in the Appendix. Despatching PRIMEDIC™ HeartSave AED If PRIMEDIC™ HeartSave has to be sent for upgrades or servicing, then always re- move the power module from the device and send it with the device in a separate packing. -
Page 38: Technical Data
HeartSave AED / AED-M Operating Manual Technical Data Defibrillation Operating Modes: asynchronous, external in Auto Mode Pulse Form: biphasic, current-controlled (CCD) Output energy in case of: Patient impedance 1. Step 2. Step 3. Step 25 Ohm 143 J 201 J... - Page 39 Operating Manual HeartSave AED / AED-M Alarms System: ECG, defibrillator, power supply, data storage Physiological: Ventricular fibrillation (VF), pulseless ventricular tachycardia (VT) Duration of Analysis: max. 12 seconds till the detection of VF / VT with a fully charged accumulator or battery max.
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Page 40: Scope Of Delivery
– EN1789 – Germ. Lloyd Right to make changes reserved. Scope of Delivery Description Article No. – PRIMEDIC™ HeartSave AED consisting of: 96370 1 PRIMEDIC™ HeartSave AED 1 PRIMEDIC™ battery 1 SavePads AED 1 Patient cable, 2-pole 1 SaveCard 16 MB... -
Page 41: Warranty Conditions
Operating Manual HeartSave AED / AED-M Warranty Conditions As the manufacturer, METRAX offers a two-year guarantee on this device from the date of purchase. METRAX will repair or replace the device free of cost within two years of the purchase if it is found to be defective in material or manufacturing. Re- pairs or replacement will be at METRAX’s sole discretion. -
Page 42: Sudden Cardiac Arrest
Immediately inform the rescue service and start cardiopulmonary resuscitation (CPR). Use PRIMEDIC™ HeartSave AED only if you suspect VF and VT, and the above- mentioned indications are observed in the patient. The condition of the patient must be assessed after defibrillation and the ECG moni- tor must be observed. - Page 43 Operating Manual HeartSave AED / AED-M Contraindications Under Which PRIMEDIC™ HeartSave AED Must Not Be Used Do not use the AED under any circumstances if the patient is conscious, or – he is breathing, or – a pulse or any sign of normal blood circulation is detected.
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Page 44: A2 Representation Of The Current-Time Function
HeartSave AED / AED-M Operating Manual Representation of the Current-Time Function The following diagrams show the defibrillation pulses in relation to the terminating resistance in wave form. 20439 / 03.04 / 03 / engl. - Page 45 Operating Manual HeartSave AED / AED-M 20439 / 03.04 / 03 / engl.
- Page 46 HeartSave AED / AED-M Operating Manual 20439 / 03.04 / 03 / engl.
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Page 47: A3 System Of Rhythm Detection
Operating Manual HeartSave AED / AED-M System of Rhythm Detection The rhythm detection system of HeartSave analyses the ECG of the patient and in- forms you if HeartSave has detected a shockable rhythm and vice versa. This system enables a person not trained in the analysis of ECG rhythms to use defi- brillation measures for victims of ventricular fibrillation, pulseless ventricular tachycar- dia. - Page 48 HeartSave AED / AED-M Operating Manual Operator Control to Deliver Defibrillation Shocks The rhythm detection system of HeartSave charges HeartSave automatically if Heart- Save detects a shockable rhythm. Optical and voice messages are generated to indi- cate that HeartSave is recommending a defibrillation shock. If a defibrillation shock is recommended, decide if the shock should be delivered and when it should be deliv- ered.
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Page 49: A4 Guidelines And Manufacturer's Statement - Electromagnetic Emissions -45
Guidelines And Manufacturer’s Statement – Electromagnetic Emissions – PRIMEDIC™ HeartSave is meant for operation in any of the environments given below: The customer or the user of PRIMEDIC™ HeartSave should ensure that it is operated in such an environment. Measurement of RFI Emis- Compliance... - Page 50 HeartSave AED / AED-M Operating Manual PRIMEDIC™ HeartSave is meant for operation in any of the environments given below: The customer or the user of PRIMEDIC™ HeartSave should ensure that it is operated in such an environment. Interference Resis- IEC 60601 Test...
- Page 51 Operating Manual HeartSave AED / AED-M PRIMEDIC™ HeartSave is meant for operation in any of the environments given below: The customer or the user of PRIMEDIC™ HeartSave should ensure that it is operated in such an environment. Interference Resistance IEC 60601 Test...
- Page 52 PRIMEDIC HeartSave is intended for use in an electromagnetic environment in which radiated RF dis- turbances are controlled. The customer ort he user of the PRIMEDIC HeartSave can help prevent elctro- magnetic interference by maintaining a minimum distance between portable or mobile RF communicationse-...
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Page 53: A5 General Instructions And Rules For Using The Optional Akupak
AkuPak A nickel cadmium accumulator (NiCd accumulator) has been selected for the opera- tion of PRIMEDIC™ HeartSave AED because in practice, this type of an accumulator has more advantages compared to other types. The NiCd accumulator has a higher energy density, that is, the PRIMEDIC™ accumu-... - Page 54 Generally, this effect needs to be considered, only if several accumulators were charged as ‘reserves’. PRIMEDIC™ AkuPak observes this self-discharge effect and balances it with a charge conservation circuit. Even with optimum care, after a period of 2 – 3 three years (depending on the fre- quency of use), an aging effect is seen in accumulators.
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Page 55: A6 Recommended Safety Checks
Operating Manual HeartSave AED / AED-M Recommended Safety Checks According to the Medical Devices Operator Ordinance (MPBetreibV) § 6 (Safety Checks), the user is required to undertake regular checks. By the Medical Devices Operator Ordinance (MPBetreibV) § 6, METRAX prescribes these checks every twelve months. - Page 56 HeartSave AED / AED-M Operating Manual 6. Function of the ECG monitor. – Are all the parameters displayed in the monitor? Feed an ECG signal with known frequency from an ECG simulator (Defi- Tester) through a service cable. – Is the heart rate displayed with a tolerance of ± 10 %?
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