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Related Manuals for Primedic HeartSave AED
Summary of Contents for Primedic HeartSave AED
- Page 1 HeartSave AED / AED-M Operating Instructions 21212 / GB / E02...
- Page 2 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.
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Page 3: Table Of Contents
5.6.2 Periodic self-tests ................... 27 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 Simple change of configuration – example: Time ............29 Changing the PIN ...................... - Page 4 15 Safety checks 16 Using the equipment on ships 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: ....................
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Page 5: Introduction
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. -
Page 6: Disclaimers
It is imperative that you pay attention to these texts. This symbol indicates text which contains important advice / comments or Note Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02... -
Page 7: Pictograms On The Device
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... -
Page 8: Pictograms On Primedic
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 Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02... - Page 9 HeartSave AED-M The PRIMEDIC 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.
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Page 10: Indications
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. -
Page 11: General Safety Instructions
Safety information The PRIMEDIC™ HeartSave AED / AED-M may only be used by trained and Note authorised personnel. Reading the operating instructions does not replace training. The PRIMEDIC™ HeartSave AED / AED-M is not licensed for use in explosive areas. -
Page 12: Safety Notes For The User
(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... -
Page 13: Safety Notes For The Protection Of Third Parties
3.5 Safety notes for the protection of third parties DANGER Warn people in the vicinity loudly and clearly before the defibrillation so that they step back from the patient and are no longer in contact with him. HeartSave AED / AED-M, 21212 / GB / E02... -
Page 14: Safety Notes For Protecting The Device
HeartSave AED Basic Model with Monitor PRIMEDIC HeartSave AED-M 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 ... -
Page 15: Description Of Device Details
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. - Page 16 Electrode symbol with LEDs Membrane keyboard "Do not touch patient" symbol (lights up during analysis) Jack for electrode connectors Loudspeaker Trigger button for defibrillation, shock button Language selection button Status display Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02...
- Page 17 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...
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Page 18: Symbols In The Status Display
Device may be defective Carry out large self-test by replacing the battery / AkuPak or by switching the equipment on again. Device defective Have device repaired by authorised dealer. Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02... -
Page 19: Capacity Display On The Monitor
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: 100 % charged... -
Page 20: 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. -
Page 21: Description Of The Accessories
SavePads AED Fig. 8: PRIMEDIC SavePads defibrillation electrodes (in the unpacked condition) Plug Defibrillation electrodes with protective film 4.6.2 PRIMEDIC battery Lithium battery, 15V / 2.8 Ah 6 years standby time HeartSave AED / AED-M, 21212 / GB / E02... -
Page 22: Aed-M)
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: <... -
Page 23: Preparatory Measures Before (Initial) Start-Up
5.2 Inserting / Changing the PRIMEDIC SaveCard Fig. 10: PRIMEDIC HeartSave AED without power module SaveCard removal knob SaveCard slot Contacts for power module Guarantee seal Release button HeartSave AED / AED-M, 21212 / GB / E02... -
Page 24: Inserting The Primedic Tm Savecard
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... -
Page 25: Inserting The Power Module
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. -
Page 26: Removing The Power Module From The Device
Fig. 12: Removing the power module Release button Power module tongue 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... -
Page 27: Primedic Tm Battery
Charger Basic / Comfort Charger (optional) 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. HeartSave AED / AED-M, 21212 / GB / E02... - Page 28 41% - 60% charged 1% - 20% charged When charging using the Charger Basis / Charger Comfort, the PRIMEDIC™ Note AkuPak is automatically charged up again fully if the level falls below 80% of the charge capacity.
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Page 29: Charging The Primedic
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 Note exchanged at the latest after 2.5 years depending on the frequency of use. HeartSave AED / AED-M, 21212 / GB / E02... -
Page 30: Loading The Primedic
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. METRAX GmbH recommends that you keep the HeartSave unit, with the PRIMEDIC Note PowerLine inserted, continuously connected to the mains, so that the equipment self- tests are carried out automatically. -
Page 31: Periodic Self-Tests
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™... - Page 32 (Check sum 4-digits), Date MSP SW x.xx(Version number) xxxx (Check sum 4-digits), Date Check sum 8-digit Serial No. XXXX Page 6 BQ SW Version: BQ serial number: Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02...
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Page 33: Simple Change Of Configuration - Example: Time
On the right next to the cursor the entry < OK > should appear. This means your new PIN is active. When the device is first delivered, the PIN is always set in the factory to Note 0000. HeartSave AED / AED-M, 21212 / GB / E02... -
Page 34: Calling Up/Activating A Profile
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". Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02... -
Page 35: Operating The Device And Sequence Of Reanimation
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 Note menu. 6.1 Switching the PRIMEDIC™ HeartSave on / off 6.1.1 Switching the PRIMEDIC™... -
Page 36: Voice Prompts From Device / Preliminary Examination Of Patient According To Standards
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... -
Page 37: Determining The Position Of The Electrodes
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... -
Page 38: Removing Protective Film From Primedic™ Savepads
Figure 17: Removing protective film from PRIMEDIC™ SavePads. Protective film 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 >... -
Page 39: Plug In Electrode Plug
To be able to unplug the electrode plug, you have to push firmly on the top Note part of the locking pin while at the same time pulling the plug up. HeartSave AED / AED-M, 21212 / GB / E02... -
Page 40: Checking The Electrodes
The rhythm identification detector continuously analyses the ECG, even after a rhythm in need of defibrillation has been identified. Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02... -
Page 41: Defibrillation Required
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. -
Page 42: Defibrillation Not Required
< 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... -
Page 43: Keeping The Defibrillator Ready For Use
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. -
Page 44: Cleaning, Maintenance And Dispatch
Never pour liquids over the device and do not immerse it in any liquids! Clean the PRIMEDIC™ HeartSave and all its accessories, such as the wall bracket, with commercially available household cleaners. ... -
Page 45: Dispatching The Primedic Tm Heartsave
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. HeartSave AED / AED-M, 21212 / GB / E02... -
Page 46: Technical Data
Positive phase 11.25 ms, negative phase 3.75 ms Impulse length: Discharges: 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. - Page 47 Standards (for licensing in the EU, the corresponding harmonised European Standards applied 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...
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Page 48: Warranty Conditions
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... -
Page 49: Depiction Of The Current Time Functions
Time / ms First shock Second shock Third shock First shock Second shock Third shock First shock Second shock Third shock First shock Second shock Third shock First shock Second shock Third shock HeartSave AED / AED-M, 21212 / GB / E02... - Page 50 Depiction of the current time functions First shock Second shock Third shock First shock Second shock Third shock Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02...
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Page 51: Rhythm Detection System
Rhythm detection system 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 ... - Page 52 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...
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Page 53: Guidelines And Manufacturer's Declaration - Electromagnetic Emissions
Total number of ECGs where the device recommends VF shock therapy Guidelines and manufacturer's declaration – Electromagnetic emissions for PRIMEDIC HeartSave AED/AED-M (in the following referred to as PRIMEDIC HeartSave) The PRIMEDIC HeartSave is designed for use in an environment as described below. The customer or user of the PRIMEDIC HeartSave should ensure that the device is only used in an environment of this kind. - Page 54 (50/60 Hz) according found in a commercial or hospital to IEC 61000-4-8 environment. Note: U is the a.c. supply voltage before applying the test level. Operating Instructions HeartSave AED / AED-M, 21212 / GB / E02...
- Page 55 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.
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Page 56: General Information And Rules For Use Of The Optional Primedic
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. - Page 57 PRIMEDIC Charger Comfort available as an option. This optional accessory (it can 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: ...
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Page 58: Safety Checks
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... -
Page 59: Using The Equipment On Ships
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. - Page 60 Manufacturer / company location: developing state-of-the-art devices standards. With the brand METRAX GmbH for emergency medicine. Established PRIMEDIC™, Metrax offers a Rheinwaldstr. 22 in 1973 in Rottweil, today Metrax is reliable programme for emergency D-78628 Rottweil Germany...
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