Primedic HeartSave 6 Operating Instructions Manual
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Primedic HeartSave 6 Operating Instructions Manual

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Operating Instructions
21230 / GB / F02

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  • Page 1 Operating Instructions 21230 / GB / F02...
  • Page 2 Tel.: + 49 (0)741 257-0 Fax.: + 49 (0)741 257-235 info@primedic.com www.primedic.com  by METRAX GmbH 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.

  • Page 3: Table Of Contents

    PRIMEDIC™ AkuPak ....................26 Charging the AkuPak with the PRIMEDIC ClipCharger ..........28 Charging the AkuPak in the optional PRIMEDIC™ Charger Basis / Charger Comfort . 29 Connecting up the PRIMEDIC PowerLine (optional accessory) ....... 29 Periodic device self-test ..................... 30 6.9.1 Self-test after switching the HeartSave on ............
  • Page 4 20 Safety checks 21 Using the equipment on ships 21.1 Use of PRIMEDIC™ HeartSave units together with a PRIMEDIC™ battery on ships in the merchant navy: ......................73 21.2 Use of PRIMEDIC™ HeartSave units together with a PRIMEDIC™ AkuPak on ships in the merchant navy: ......................
  • Page 5 Table of contents Contact details...

  • Page 6: Introduction

    Introduction Foreword Dear User, You are faced with 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 7: Disclaimers

    It is imperative that you pay attention to these texts. This symbol indicates text which contains important advice / comments or Note tips. This point identifies the description of tasks that you need to perform. HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 8: Pictograms On The Device

    Do not dispose of device in domestic refuse. Dangerous electric voltage (high voltage) CF defibrillation-proof degree of protection, in connection with ECG patient cable Type certification GERMANISCHER LLOYD in accordance with Certificate No. 75 449-09 HH Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 9: Pictograms On Savepads

    Introduction Pictograms on SavePads Not to be reused Expiry date Batch ID Only for adults Order number Storage temperature information in Celsius and Fahrenheit HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 10: Intended Use

    Improper use of the defibrillator can lead to ventricular fibrillation, asystolia or other dangerous dysrhythmia. The operator of the HeartSave must ensure that the HeartSave is only used by authorised specialist personnel. Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 11: Indications

    (CPR) 2005. The PRIMEDIC™ HeartSave may only be used as described and under the conditions detailed in these operating instructions. Indications The PRIMEDIC™ HeartSave 6/6S may only be used for defibrillation if the patient  is unconscious and ...

  • Page 12: Safety Advice

     of burns from incorrectly applied electrodes. Apart from that, the device can be damaged or destroyed through improper use. Refer to the advice and rules in the appendix when using the PRIMEDIC™ HeartSave 6/6S. Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 13: General Safety Advice

    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). HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 14: Safety Advice For Protection Of The Patient

    (e.g. measuring equipment that is sensitive to magnetic fields) or strong sources of interference which could affect the way the PRIMEDIC™ HeartSave 6 / 6S works. Keep an adequate distance from other therapeutic and diagnostic energy sources (e.g. diathermy, high frequency surgery, magnetic resonance tomography).

  • Page 15: Safety Advice For The Protection Of Third Parties

    Safety advice for the protection of the device CAUTION Repairs, changes, extensions and installation of the PRIMEDIC™ HeartSave 6/6S may only be carried out by personnel authorised and trained by METRAX The PRIMEDIC™ HeartSave 6/6S does not have any parts that can be repaired by the user.

  • Page 16: Description Of Device

    The PRIMEDIC™ HeartSave 6/6S is an automatic external defibrillator, with an integrated 6-channel ECG and manual defibrillation mode. The ECG can be recorded either using the PRIMEDIC™ SavePads or the three-pin patient cable. In automatic mode (Auto Mode), the ECG is analysed with the implemented algorithm.

  • Page 17: Description Of Device Details

    Fig. 1: PRIMEDIC™ HeartSave 6/6S front view 1 Carry handle 2 Flap for removing the device cover 3 Device cover Fig. 2: PRIMEDIC™ HeartSave 6/6S rear view 1 Mounting slot for wall bracket 2 Name plate HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 18 5 Key for scrolling downwards in the menu or for reducing parameters 6 Loudspeaker 7 Socket for electrode cable 8 Energy loading button (charging button in manual mode) 9 Socket for SpO sensor (on HeartSave 6S) 10 Shock button Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 19 7 Indicator ECG-channels (max.2 ) 8 Energy stages (only in manual mode) 9 SpO curve (only HeartSave 6S), instructions, information (only HeartSave 6) Fig. 6: PRIMEDIC™ HeartSave 6/6S status display 1 Status display HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 20 Description of device Fig. 7: PRIMEDIC™ HeartSave 6/6S device cover with kit holder 1 Device cover 2 Kit holder with quick start guide, face shield and razor 3 SavePads 4 Rubber gloves Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 21: Icons In The Status Display

    Carry out large self-test by replacing the battery / AkuPak or  Device may be defective by switching the equipment on again  Have device repaired by authorised dealer.  Device defective HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 22: Capacity Display

    Description of device Capacity display With the PRIMEDIC™ HeartSave 6/6S, the battery charge of the battery/battery pack appears on the display. The different images that may be displayed have the following meaning: 100% charged 60% charged 20% charged 0% (device runs on until charge is exhausted)

  • Page 23: Data Management

    "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). HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 24: Description Of The Accessories

    Two-pin patient cable for ECG recording (optional accessory) Fig. 9: Two-pin patient cable for ECG recording (optional accessory) 1 2-pin electrode cable with plug 2 Electrode clips (red, green) 3 ECG electrodes (Ag/AgCl) Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 25: Three-Pin Patient Cable For Ecg Recording

    3 Plug for connection to the adapter cable 4 Socket with locking device 5 Plug for connection to the HeartSave 6 Adapter cable Additional accessories can be found on our home page "www.primedic.com" under "Online-Shop" HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 26: Preparatory Measures Before (Initial) Start-Up

    Satisfy yourself that the scope of delivery is complete in accordance with the enclosed delivery note. Inserting / Replacing the SaveCard Fig. 12: PRIMEDIC™ HeartSave 6/6S SaveCard 1 SaveCard removal button 2 Slot with SaveCard inserted Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 27: Inserting The 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. Inserting / replacing the energy module The PRIMEDIC™ HeartSave 6/6S can be operated with three different power modules:  Rechargeable battery pack AkuPak ...

  • Page 28: Inserting The Power Module

    If this is not possible, a second charged battery pack must be available, to ensure that the device is ready for use. 6.3.1 Inserting the power module Fig. 13: PRIMEDIC™ HeartSave 6/6S inserting the power module 1 Power module slot 2 Power module 3 Limit stop...

  • Page 29: Removing The Power Module From The Device

    6.3.2 Removing the power module from the device Fig. 14: PRIMEDIC™ HeartSave 6/6S removing the power module 1 Release button 2 Power module tongue 3 Power module...

  • Page 30: Primedic™ Battery (Optional)

    If the battery charge is too low, both a visual and an acoustic signal are issued. In case an AkuPak is stored outside the equipment, its charge status can be checked by pressing button (2). Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 31 Trouble-free functioning of the equipment can not be assured. Charging the AkuPak is interrupted at temperatures of more than 45°C. HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 32: Charging The Akupak With 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. Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 33: Charging The Akupak In The Optional Primedic™ Charger Basis / Charger Comfort

    The HeartSave carries out a self-test and is then ready for use. METRAX GmbH recommends that you keep the HeartSave unit, with the PowerLine Note inserted, continuously connected to the mains, so that the equipment self-tests are carried out automatically. HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 34: Periodic Device Self-Test

    Periodic device self-test 6.9.1 Self-test after switching the HeartSave on The device self-test is run through automatically by switching on the PRIMEDIC HeartSave or by inserting the power module in the device to check all important functions and signal setups.

  • Page 35: Using The Device

    An electrical shock is not generated if the device does not detect a rhythm requiring defibrillation. In this case, the device recommends cardio pulmonary resuscitation (reanimation). HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 36: Manual Mode (Auto Sync)

    In manual mode, synchronous defibrillation (cardioversion) can be performed in addition to standard asynchronous defibrillation. 7.2.3 Changing the operating mode When switched on, the Primedic HeartSave is always in automatic mode (Auto Mode). To switch to manual mode, follow the steps below: ...

  • Page 37: Setup Menu

    40 to 120 Page 5 Guideline ERC/AHA Language depending on language packages installed Date in format DD/MM/YYYY Time 00:00 in 24-hour format Network filter [50Hz/60Hz/Off] Display [0 degrees / 180 degrees] HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 38: Simple Change To Configuration - Example: Time

     Setup and confirm this with the key If no key is pressed for one minute, the device automatically leaves the setup Note menu and goes back to standby. Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 39: Changing The Pin

    Select your required profile using the keys   and confirm it with the key The selected profile is active Please note that your profile selection is only active until the device is Note switched off. The devices always starts with the profile "Basic" HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 40: Saving Menu Parameters In A Single Profile

    Alarm ECG: Alarm SpO Network filter The following settings are always active after the device is started: Alarm ECG: On Alarm SpO : On Mains filter: Off Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 41: Alarms

    Using the device Alarms The PRIMEDIC™ HeartSave 6/6S, depending on the version, monitors the heart rate from the ECG signal and the oxygen saturation level of the patient from the data of the SPO sensor. If the SPO sensor only is connected to the patient, the heart rate displayed is that determined from the SPO signal.

  • Page 42: Spo Alarm

    There is no acoustic warnings if the alarms are turned off in case one of the monitored parameters is beyond the permissible range. Hence, regularly check the patients and the equipment indicators so as to react rapidly to changes. Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 43: Positioning The Electrodes

     On the left side of the chest, above the apex of the heart on the axillary line (2). CAUTION Positioning the electrodes incorrectly may result in misinterpretations by the device. HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 44: Checking The Skin

    Positioning the electrodes incorrectly or using electrodes that are of poor quality or too dry may result in device misinterpretations. You should therefore only used ECG adhesive electrodes that have been approved by Metrax. Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 45: Connecting The Electrodes

    Fig. 20: Removing the protective film 1 Protective film 2 Defibrillation electrode with gel layer The PRIMEDIC™ HeartSave 6 will give you a voice and text prompt to apply the defibrillation electrodes to the patient. To do so, follow the steps below: First, remove the protective film (1) from one electrode (2) and them immediately place the electrode on the position you had ascertained previously.

  • Page 46: Plug In Electrode Plugs

     Hair growth on patient not removed.  Air pockets between skin and defibrillation electrodes cause a bad contact.  Dried out electrodes. Remedy the cause of the fault. Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 47: Operation In Automatic Mode

    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. HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 48: Defibrillation Required

    Before and during the energy discharge, all those participating in the reanimation must stand clear and all contact with the patient or conductive parts (e.g. a stretcher) must be avoided. Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 49: 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. HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 50: Keeping The Defibrillator Ready For Use

    You decide whether defibrillation is required and when it should be initiated. Fig. 22: Primedic HeartSave 6/6S, trigger button 1 Energy loading button 2 Trigger button for shock Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 51 CAUTION When the first message "Charge battery" appears, you still have at least 3 energy discharges at max. energy. If this message appears, you should replace the power module. HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 52: Auto-Sync

    ECG signal appears on the monitor. 10.2 AUTO-SYNC Unlike conventional defibrillators, the HeartSave 6/6S has synchronisation (AUTO- SYNC) that is automatically activated, i.e., the synchronous markers are set for the QRS complexes as soon as the ECG clearly identifies an R-wave.

  • Page 53: Keeping The Defibrillator Ready For Use

    Since skin tolerance at the measurement site varies according to different skin types, you may need to switch the measurement site more often for some patients. HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 54: Connecting The Spo2 Sensor

    To disconnect the plug connection, first raise the sleeve with the arrow (2) slightly and then pull the plug connector from the socket. Fig. 24: Inserting SpO plug Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 55: Cleaning, Maintenance And Dispatch

    12.2 Servicing Regardless of device usage, we recommend that visual inspection of the PRIMEDIC™ HeartSave 6/6S and the accessories be carried out by the user/service technician at regular intervals (at least once a year). Make sure that the housing, cable, SavePads and all the other accessories are undamaged.

  • Page 56: Dispatching The Primedic™ 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. Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 57: Technical Data

    15 shocks Derivation: 2 derivations from I, II, III, aVL, aVR, aVF 30 – 300 min (accuracy +/- 1/min or 1%) Heart frequency: CF class, for 2-pin patient cable, defibrillation-proof Input: HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 58 30 kHz Measurement frequency: Alarms , defibrillator, power supply. ECG, SpO System: schockable rhythm Physiological: Analysis duration: Approx. 7 secs. until VF is recognised Monitor High-resolution LCD monitor Monitor type: Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 59 Standards (for licensing in the EU, the corresponding harmonised Standards applied European standards EN were used instead of the IEC standards): IEC 60601-1:1988 + A1:1991 + A2:1995 IEC 60601-1-2:2001 IEC 60601-2-4:2002 EN1789:2003 Subject to technical changes without notice. HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 60: Warranty Conditions

    METRAX. METRAX After-Sales Service is glad to be at your disposal, even after the warranty period has expired. Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 61: Depiction Of The Current-Time Function

    Time / ms Time / ms 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 HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 62 Below you can see the graph shapes of the defibrillation impulse in manual mode depending on the load resistance. Time / ms Time / ms Time / ms 50 Joule @ 25 Ohm 50 Joule @ 50 Ohm 50 Joule @ 75 Ohm Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 63 100 Joule @ 125 Ohm 100 Joule @ 150 Ohm 100 Joule @ 175 Ohm 200 Joule @ 25 Ohm 200 Joule @ 50 Ohm 200 Joule @ 75 Ohm 200 Joule @ 100 Ohm HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 64 300 Joule @ 175 Ohm 360 Joule @ 25 Ohm 360 Joule @ 50 Ohm 360 Joule @ 75 Ohm 360 Joule @ 100 Ohm 360 Joule @ 125 Ohm Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 65: Rhythm Detection System

    360 Joule @ 150 Ohm 360 Joule @ 175 Ohm 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. The device's rhythm detection system includes: ...
  • Page 66 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): Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 67 Total number of ECGs where shock administration is not clinically recommended Positive predictive value = Number of "correct shockable" algorithm decisions Total number of ECGs in which administering an impulse is recommended by the device HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 68: General Advice For Using Pulse Oximeters

    Since it has no casing, the D-YS sensor can be used for a greater weight range; it offers more flexibility in terms of the attachment site and can be attached with adhesive tape (this reduces the operation speed however). Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 69 (e. g. ECG, blood pressure, breathing). When used correctly and with reference to the sensor-specific warnings and instructions and clinical symptoms, SpO measurement can be an important tool in evaluating patients. HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 70: Guidelines And Manufacturer's Declaration - Electromagnetic Emissions

    Transmission of voltage fluctuations Not applicable for residential purposes. / Flicker according to IEC 61000-3-3 battery Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 71 (5060 Hz) according to IEC 61000-4-8 Note: U is the a.c. supply voltage before applying the test level. HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 72 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.
  • Page 73 Guidelines and manufacturer's declaration – Electromagnetic emissions Recommended protective distances between portable and mobile HF telecommunication devices and the PRIMEDIC HeartSave The PRIMEDIC HeartSave is designed for use in an electromagnetic environment in which the HF interference is controlled. The...

  • Page 74: General Instructions And Rules For Using The Optional Akupak

    The fully automatic discharge / charge device has been realised as a care function in the 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. Operating...
  • Page 75 (depending on the type), a rechargeable battery will no longer be capable of giving up the electrical energy absorbed to chemical storage. The battery is thus rendered useless and must be replaced with a new one. HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 76: Safety Checks

    Name of person or company carrying out the work and  Measures taken. The responsibility of METRAX only covers the information provided in the operating instructions. This applies in particular for readjustments, repairs and changes to the device. Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...

  • Page 77: 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 78 Using the equipment on ships Contact details METRAX GmbH Rheinwaldstr. 22 D-78628 Rottweil Tel.: 0741/257-0 info@primedic.com www.primedic.com Operating Instructions HeartSave 6 / 6S, 21230 / GB / F02...
  • Page 80 With the brand METRAX GmbH for emergency medicine. Established PRIMEDIC™, Metrax offers a Rheinwaldstr. 22 D-78628 Rottweil in 1973 in Rottweil, today Metrax is reliable program for emergency Germany...

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