Primedic DefiMonitor XD Operating Instructions Manual
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Primedic DefiMonitor XD Operating Instructions Manual

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DefiMonitor XD
Operating instructions
MGA21324 / GB / K05

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Summary of Contents for Primedic DefiMonitor XD

  • Page 1 DefiMonitor XD Operating instructions MGA21324 / GB / K05...
  • Page 2 Masthead Publisher METRAX GmbH Phone: 0741/257-0 Email: info@primedic.com Web: www.primedic.com Address: Rheinwaldstr. 22 D-78628 Rottweil Germany Release date: 11.04.2012 Proprietary note METRAX GmbH reserves all rights to these operating instructions. Without approval from METRAX GmbH, these operating instructions may not be duplicated or made accessible to third parties.

  • Page 3: Table Of Contents

    5.3 Power supply 5.3.1 Inserting PRIMEDIC™ AkuPak 5.3.2 Removing PRIMEDIC™ AkuPak 5.4 Loading the PRIMEDIC™ AkuPak 5.4.1 Charging the AkuPak in the optional PRIMEDIC™ Charger Basis / Charger Comfort 5.5 Connecting the mains cable 5.6 Inserting paper in the printer 6 Device self-test 6.1 Self-test when the PRIMEDIC™...
  • Page 4 Table of contents 7.1 Switching on / off 7.1.1 Switching the PRIMEDIC™ DefiMonitor XD on 7.1.2 Switching the PRIMEDIC™ DefiMonitor XD off 7.2 Selecting the operating mode 7.2.1 Operating modes 7.2.2 Auto mode (AED mode) 7.2.3 Manual mode (MAN Mode) 7.3 Changing the configuration/setup...
  • Page 5 20 Rhythm detection system in AED mode 21 General information on the use of pulse oximeters 22 Guidelines and manufacturer's declaration – Electromagnetic emissions 23 General instructions and rules for using PRIMEDIC™ AkuPaks 24 Safety checks 25 Index of diagrams...

  • Page 6: Introduction

    1 Introduction 1.1 Foreword Dear User, You are faced with the task of using the PRIMEDIC™ DefiMonitor XD in a medical emergency on human beings. To ensure that you can react quickly and correctly in this special situation and can optimally...

  • Page 7: Disclaimers

    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. • METRAX GmbH DefiMonitor XD 21324 / GB / K05 7 / 116...

  • Page 8: Symbols Used In These Operating Instructions

    < ... > The text in pointed brackets are acoustic instructions / arrangements of the equipment which are simultaneously shown on the monitor, depending on the equipment variant. 8 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...

  • Page 9: Pictograms On The Device

    100µA patient leakage current (SFC – defibrillation outputs) according to IEC60601-1 and IEC60601-2-4 Fig. 1: Brief instructions on use of devices Fig. 2: Brief instructions on use of devices with AED mode without AED mode METRAX GmbH DefiMonitor XD 21324 / GB / K05 9 / 116...

  • Page 10: Pictograms On Savepads

    Order number Storage temperature in Celsius and Fahrenheit 1.8 Image mark on the encompassing packaging Sticker on the encompassing packaging for the PRIMEDIC™ AkuPak LITE for airfreight despatch Sticker on the encompassing packaging for the PRIMEDIC™ AkuPak LITE for road/rail/marine despatch...

  • Page 11: Intended Use

    It is designed to be able to accompany the patient from the site of an accident or emergency to the hospital without changing the electrodes. METRAX GmbH DefiMonitor XD 21324 / GB / K05 11 / 116...
  • Page 12 Any use above or beyond this is not considered as intended use and can lead to personal injury or damage to property. The PRIMEDIC™ DefiMonitor XD may only be used as described and under the conditions detailed in these operating instructions.

  • Page 13: Indication/Contraindication For Defibrillation

    Intended use 2.1 Indication/Contraindication for Defibrillation WARNING The defibrillator unit of the PRIMEDIC™ DefiMonitor XD may only be used when dysrhythmia, such as ventricular fibrillation/flutter or certain types of arterial and ventricular tachycardia occur, accompanied by the following symptoms (indication): patient is unconscious •...

  • Page 14: Users

    Intended use 2.3 Users In manual mode, the PRIMEDIC™ DefiMonitor XD is to be used exclusively by specially trained medical personnel. In automatic mode, the PRIMEDIC™ DefiMonitor XD can be used by trained medical personnel. Use of the equipment must be ordered by a doctor.

  • Page 15: Safety Information

    3.1 General information Both in conjunction with its accessories and the optional accessories, and also individually, the PRIMEDIC™ DefiMonitor XD fulfils the currently applicable safety standards and complies with the provisions of the medical products regulations 93/42/EC. The device and its accessories are safe when used as intended and taking into account the descriptions and information detailed in these operating instructions.

  • Page 16: General Safety Instructions

    Observe the information and rules in the appendix on using the PRIMEDIC™ DefiMonitor XD. When carrying the DefiMonitor XD in a vehicle, the paddles must be secured in the attachment provided and the device must be secured stored in a wall bracket.

  • Page 17: Safety Notes For You, The User

    • or traction devices) which present unintended paths for the defibrillation current! Although the DefiMonitor XD and its original accessories are defibrillation-protected, we recommend that you do not touch them while defibrillation is being carried out with another device. 3.4 Safety notes for protection of the patient...
  • Page 18 Only connect the self-adhesive electrodes with the PRIMEDIC™ DefiMonitor XD. 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.

  • Page 19: Safety Notes For The Protection Of Third Parties

    3.6 Safety notes for protection of the device CAUTION Damage to property Repairs, changes, extensions and installations of the • PRIMEDIC™ DefiMonitor XD may only be carried out by personnel authorised and trained by METRAX The PRIMEDIC™ DefiMonitor XD does not have any •...

  • Page 20: Description Of Device

    4.1 General description The PRIMEDIC™ DefiMonitor XD is an external defibrillator with integrated 6-channel ECG. The ECG can be recorded either via the PRIMEDIC™ SavePads, the defibrillation paddles or the three-pin patient cable with self-adhesive ECG electrodes. The PRIMEDIC™ DefiMonitor XD is available in various configurations.
  • Page 21 Description of device The PRIMEDIC™ DefiMonitor XD - Generation has been designed to be safe and quick to use in an emergency. All functional units are operating elements subject to the following principles: Clear organisation of functional units • Reduction of functions to what is necessary •...

  • Page 22: Description Of Device Details

    Description of device 4.2 Description of device details A. completely manual defibrillators: Fig. 3: PRIMEDIC™ DefiMonitor XD 1 / 3 – Front view Carrying handle Paddle Paddle cable, detachable Operating membrane Monitor Microphone Status display 22 / 116 DefiMonitor XD 21324 / GB / K05...
  • Page 23 Description of device Fig. 4: PRIMEDIC™ DefiMonitor XD 10 / 30 – Front view Carrying handle Paddle Paddle cable, detachable Operating membrane Monitor Microphone Status display METRAX GmbH DefiMonitor XD 21324 / GB / K05 23 / 116...
  • Page 24 Description of device B. Manual defibrillators with AED mode: Fig. 5: PRIMEDIC™ DefiMonitor XD 100 / 300 – Front view Carrying handle Paddle Paddle cable, detachable Operating membrane Monitor Microphone Status display 24 / 116 DefiMonitor XD 21324 / GB / K05...
  • Page 25 Description of device Fig. 6: PRIMEDIC™ DefiMonitor XD 110 / 330 – Front view Carrying handle Paddle Paddle cable, detachable Operating membrane Monitor Microphone Status display METRAX GmbH DefiMonitor XD 21324 / GB / K05 25 / 116...
  • Page 26 Fig. 7: PRIMEDIC™ DefiMonitor XD – rear view Opening for hook of the one-hand quick release. Specification plate Quality seal Fig. 8: PRIMEDIC™ DefiMonitor XD – view from below SaveCard cover Release button (to remove the power module) 26 / 116...
  • Page 27 Description of device Power module Fig. 9: PRIMEDIC™ DefiMonitor XD – side view Loudspeaker Jack for electrode connectors Jack for SpO sensor (optional) Jack for paddle cable METRAX GmbH DefiMonitor XD 21324 / GB / K05 27 / 116...
  • Page 28 Description of device Fig. 10: PRIMEDIC™ DefiMonitor XD – side view Unlocking lever for printer cover Printer cover Mains connection jack Attachment device for bag (optional) Fig. 11: PRIMEDIC™ DefiMonitor XD – status display 28 / 116 DefiMonitor XD 21324 / GB / K05...
  • Page 29 Battery fully discharged Charge battery Carry out extensive self-test Device defective by reinserting PRIMEDIC™ AkuPak or switching the device on again Have device repaired by authorised dealer METRAX GmbH DefiMonitor XD 21324 / GB / K05 29 / 116...
  • Page 30 Description of device Fig. 12: Panel foil PRIMEDIC™ DefiMonitor XD 1/10/3/30 (completely manual defibrillators) Fig. 13: Panel foil PRIMEDIC™ DefiMonitor XD 100 / 110 / 300 / 330 30 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...
  • Page 31 Alarm acknowledgement button, heart rate Alarm acknowledgement button SpO Pacer XD On / Off button Pacer mode changeover button DEMAND/FIX/OVERDRIVE Stimulation rate +/- Stimulation intensity +/- Stimulation Start/Stop button with LED METRAX GmbH DefiMonitor XD 21324 / GB / K05 31 / 116...
  • Page 32 CF card capacity, printer status, paper status Indicator ECG-channels (max.2 ) SpO2 curve, messages, information Calibration peak, height corresponds to 1mV (display size depends upon the sensitivity of the ECG) 32 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...

  • Page 33: Capacity Display

    Description of device 4.3 Capacity display The charging status of the PRIMEDIC™ DefiMonitor XD is shown on the display. The different possible images displayed have the following meaning: Image on display Meaning 100 % charged 50 % discharged partly discharged or with reduced capacity 0 % (device runs on until charge is exhausted) PRIMEDIC™...

  • Page 34: Data Management

    The saved data can be viewed with the help of a PC / laptop and the PRIMEDIC Viewer software, but must not be used for diagnosis or therapy of the patient! This data is only intended for administrative or legal purposes.

  • Page 35: Description Of The Accessories

    The accessories need to be secured appropriately before being transported. 4.5.1 Paddles The PRIMEDIC™ DefiMonitor XD features ergonomically shaped defibrillation paddles with integrated child paddles for the defibrillation of children. To access the child paddles, unscrew the large electrodes on both paddles by turning them anticlockwise.

  • Page 36: Tm Savepads Connect Cable

    SavePads Connect cable Fig. 16: PRIMEDIC™ SavePadsConnect cable, 2-pin Connector Connecting clips for SavePads Connect 4.5.3 PRIMEDIC SavePads Fig. 17: PRIMEDIC SavePads Connect Defibrillation electrodes with protective film 36 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...

  • Page 37: Ecg Patient Cable, 3-Pin

    Description of device 4.5.4 ECG patient cable, 3-pin Fig. 18: ECG patient cable, 3-pin 3-pin ECG electrode cable with connector Electrode clips (red, green, yellow) ECG electrodes (Ag/AgCl) METRAX GmbH DefiMonitor XD 21324 / GB / K05 37 / 116...

  • Page 38: Spo -Sensor (Only For Primedic™ Defimonitor Xd3/Xd30/Xd300/Xd330)

    Reusable SpO sensor Plug (for connecting the sensor cable to the adapter cable) Jack (with locking device) Plug (for connecting the adapter cable to the device) Adapter cable 38 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...

  • Page 39: Preparatory Measures Before (Initial) Start-Up

    Endangering health cannot be ruled out. Satisfy yourself that the scope of delivery is complete in accordance with the enclosed delivery note. 5.2 Inserting / Changing the SaveCard Fig. 20: PRIMEDIC™ DefiMonitor XD – SaveCard SaveCard slot SaveCard removal button Cover...

  • Page 40: Power Supply

    • Note If you operate the PRIMEDIC™ DefiMonitor XD exclusively via power from the mains, then you must ensure that the PRIMEDIC™ AkuPak is inserted in the power module slot. Without this, the PRIMEDIC™ DefiMonitor XD is not operational. WARNING Whenever the device has been used, check the power level.

  • Page 41: Inserting Primedic™ Akupak

    It should not fall out when the device is moved. If it does, it is not securely engaged. Note The device switches on automatically when the PRIMEDIC™ AkuPaks battery is inserted and performs an automatic self-test. Monitor the Status Display. If the display is showing "OK", the device is ready to use.

  • Page 42: Removing Primedic™ Akupak

    Preparatory measures before (initial) start-up 5.3.2 Removing PRIMEDIC™ AkuPak Fig. 22: PRIMEDIC™ DefiMonitor XD – Removing the power module Note Only change the power module when the device is switched off and electrode plug is disconnected. Procedure: Lay the device on its back and press the release button in the direction shown by the arrow (1.) until the tongue on the power module is released and the power module...

  • Page 43: Loading The Primedic™ Akupak

    1 % - 20 % charged  Note Of the two charging possibilities mentioned above, PRIMEDIC™ AkuPak, will be automatically recharged in case the charge should fall below 80 % of its charging capacity. This 80 %-limit can temporarily be made inoperative by pressing 3 seconds on push button (2), i.e., the PRIMEDIC™AkuPak can be recharged even before reaching...

  • Page 44: Charging The Akupak In The Optional Primedic™ Charger Basis / Charger Comfort

    It resumes once the temperature is within the valid range. This prevents harmful overcharging of the PRIMEDIC™ AkuPaks battery. If the PRIMEDIC™ AkuPak battery is not charged, the PRIMEDIC™ DefiMonitor XD can be operated using the integrated mains power pack. The PRIMEDIC™ AkuPaks are charged automatically during operation of the PRIMEDIC™...

  • Page 45: Inserting Paper In The Printer

    Insert the roll of paper into the printer so that the side with the check pattern faces upwards. Close the cover. Note The cover is designed to spring out of its position without damage if great pressure is exerted from the outside. METRAX GmbH DefiMonitor XD 21324 / GB / K05 45 / 116...

  • Page 46: Device Self-Test

    The device carries out automatic self-tests to ensure that it is always ready for operation. Self- testing is only possible if the PRIMEDIC™ DefiMonitor XD is either connected to the mains or if a charged PRIMEDIC™ AkuPak has been inserted.

  • Page 47: Operating The Primedic™ Defimonitor Xd

    If the self-test is successful, the device is immediately ready for operation in the corresponding mode (manual for the DefiMonitor XD1, XD3, XD10, XD30 or automatic for the PRIMEDIC™ DefiMonitor XD100, XD110, XD300, XD330).

  • Page 48: Manual Mode (Man Mode)

    Operating the PRIMEDIC™ DefiMonitor XD 7.2.3 Manual mode (MAN Mode) Pressing the MAN/AUTO button switches the PRIMEDIC™ DefiMonitor XD to manual operating mode. Manual mode is now activated. Illuminated LED is the identification of this state. For further information, see chapter 10.

  • Page 49: Parameter List Menu

    Version number – Check sum Date (e.g. Jul. 11 2005) MSP SW: Version number - check sum Date (e.g. Jul. 11 2005) ULF: Check sum 8-digit Serial No.: xxxxxxx METRAX GmbH DefiMonitor XD 21324 / GB / K05 49 / 116...
  • Page 50 BQ SW Version: BQ serial number: xxxxxxx Ext. MSP SW: Version number - check sum Ext. MSP HW: Version number Version: xxxx Pacer Version SW: xxxx Pacer Version HW: xxxx 50 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...

  • Page 51: Changing The Configuration - Example: Time

    Accordingly the equipment ECG, VF Alarm and SPO Alarm differ. The alarms are always activated when the PRIMEDIC™ DefiMonitor XD is switched on. The alarm limits can be specifically configured by the user in the Setup menu and are retained after the monitor has been switched off.

  • Page 52: Ecg Alarm

    Note: If the equipment is operated with PRIMEDIC™ SavePads Connect-Electrodes on the patient, in auto mode the bell symbol for the ECG Alarm is always crossed out, in order to indicate that in this condition no ECG Alarm occurs.

  • Page 53: Event Button

    Note The printing format for the Memo print is always 3-channel print. The signal graphs displayed on the monitor at the time of the event are printed out. METRAX GmbH DefiMonitor XD 21324 / GB / K05 53 / 116...

  • Page 54: Operating The Printer

    The printer can only be operated or used in manual mode. 7.7.1 Log of the ECG signal The PRIMEDIC™ DefiMonitor XD is equipped with a high-resolution printer. ECG printout of 3 to 6 channels simultaneously is possible. Printing speeds of 25 and 50 mm/s can be selected.

  • Page 55: Automatic Printout After Each Shock (Autoprint)

    7.8 Automatic printout after each shock (Autoprint) The PRIMEDIC™ DefiMonitor XD allows you to record the event automatically each time defibrillation or cardioversion is performed. Data from 5 seconds before and 5 seconds after the shock was administered are recorded.

  • Page 56: Printing Out The Event Memory

    Operating the PRIMEDIC™ DefiMonitor XD 7.9 Printing out the Event Memory The PRIMEDIC™ DefiMonitor XD automatically stores the last 30 defibrillations / cardioversions / events in an Event Memory. It stores the ECG (5 seconds before and 5 seconds after each shock) and the pulse graph (only on XD 3, XD30, XD300 or XD330 if SpO active) as well as all relevant parameters.

  • Page 57: Applying The Electrodes

    Medicinal plasters must be removed before attaching the defibrillation electrodes. Note The PRIMEDIC™ DefiMonitor XD carries out automatic impedance measurement. Defibrillation can only be carried out if the patient is within the permissible impedance range. See Chapter "Technical Data“. Ensure that the electrodes have good contact.

  • Page 58: Positioning The Ecg Self-Adhesive Electrodes

    (roughly V position) Posterior Red (R) ( + ) back left of chest, between tip of shoulder blade and spine 58 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...
  • Page 59 Snap the upper part of the clip back in place to fix the connection. Observe the colour marking showing the polarity of the electrode chips when attaching them to the respective electrodes Connect the cable with the PRIMEDIC™ DefiMonitor XD. Note If it should become necessary during pacing to defibrillate the patient, defibrillation can be carried out via the self-adhesive electrodes.

  • Page 60: Removing Hair Growth From Chest

    Fig. 26: Removing the protective film from the electrodes Protective film Electrode coated with electrolyte gel In automatic mode, the PRIMEDIC™ DefiMonitor XD gives voice commands instructing you to attach the defibrillation electrodes to the patient. Please proceed as follows: Open the SavePads packaging by tearing open the protective cover along the tear strip.

  • Page 61: Checking The Electrodes

    Electrode plugs not plugged in • Remedy the cause of the fault. Note With the model SpO , message < check electrodes > is supressed in the display. METRAX GmbH DefiMonitor XD 21324 / GB / K05 61 / 116...

  • Page 62: Changeover Of Ecg Source

    8.7 Changeover of ECG source The ECG can be recorded via the defibrillation paddles or via the self-adhesive electrodes. Press the ECG source changeover button to switch to paddles or self-adhesive electrodes. 62 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...

  • Page 63: Auto Mode (Aed Mode)

    Note In automatic mode, defibrillation is exclusively enabled by the PRIMEDIC™ DefiMonitor XD after it has detected ventricular fibrillation (VF). The paddles, energy level selection buttons, source selection buttons, pacer buttons, the printer and charging buttons are disabled in AUTO mode. An acoustic warning signal is sounded if these buttons are pressed while the device is in automatic mode.

  • Page 64: Carrying Out Ecg Analysis In Auto Mode

    < Shock advised > < Device is charging > < Do not touch the patient > < Device is charging > < Do not touch the patient > 64 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...
  • Page 65 (e. g. parts of the stretcher)! After defibrillation, the device once again undertakes cardio pulmonary resuscitation (CPR) cycle, before carrying out renewed analysis. The CPR time is shown on the PRIMEDIC™ DefiMonitor in the form of a display bar.

  • Page 66: Defibrillation Not Required

    After a reanimation, clean the device, replace the SavePads, check and if necessary replace the power supply unit to ensure that the device is ready for operation again as quickly as possible. Charge the PRIMEDIC™ AkuPak to ensure that sufficient energy is available for the device to be used again.

  • Page 67: Manual Mode (Man Mode)

    Manual mode (MAN Mode) 10 Manual mode (MAN Mode) All variants of PRIMEDIC™ DefiMonitor XD have manual mode. The manual mode presupposes medical knowledge is therefore not suitable for lay helpers. Only doctors and trained medical personnel should operate the defibrillator in manual mode.

  • Page 68: Charging

    If the charge is loaded via the charge button on the device, the shock can only be administered via the SavePads Connect. If the charge is loaded via the paddle buttons, the shock can only be administered via the paddles. 68 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...

  • Page 69: Sync And Async Mode

    It is vital to ensure that the energy is applied using the same method used to record the ECG. After synchronised energy transfer (cardioversion), the equipment switches back to asynchronous mode. METRAX GmbH DefiMonitor XD 21324 / GB / K05 69 / 116...
  • Page 70 In this case, the device should be disconnected from the mains, i.e. the mains plug should be pulled out of the socket and the device operated via the integrated PRIMEDIC™ AkuPak battery.

  • Page 71: Keeping The Defibrillator Ready For Use

    After a reanimation, clean the device, replace the SavePads, check and if necessary replace the power supply unit to ensure that the device is ready for operation again as quickly as possible. Charge the PRIMEDIC™ AkuPak to ensure that sufficient energy is available for the device to be used again.

  • Page 72: Attaching The Spo Sensor

    Note To disconnect from the device, first lift the sleeve with the arrow slightly and then pull the connector out of the jack. 72 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...

  • Page 73: Operating The Pacer

    12.1 General information on operating the Pacer XD The following operating sequence must be observed when using the PRIMEDIC™ Pacer XD: Switch the PRIMEDIC™ DefiMonitor XD on. The pacer can only be used in manual mode. Set the mode accordingly.

  • Page 74: Setting The Pacer Operating Modes

    If this is not done, there may be danger to the patient as a result of the device failing. Note If more than 3 minutes elapse without the PRIMEDIC™ Pacer being operated, it switches off automatically. 12.2 Setting the Pacer operating modes...

  • Page 75: Setting The Stimulation Rate

    The stimulation rate should only be changed if this is absolutely necessary. WARNING The ECG should be monitored closely when the stimulation rate is changed to observe possible reactions of the patient to the new stimulation parameters. METRAX GmbH DefiMonitor XD 21324 / GB / K05 75 / 116...

  • Page 76: Setting The Stimulation Intensity

    If one of these buttons is pressed, the 15 seconds are counted again. Stimulation can be stopped before the 15 seconds have elapsed by pressing the Stimulation Start/Stop button. 76 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...
  • Page 77 The patient must not be left unattended during pacing. The actual active patient current is monitored. If it falls below 70 % of the set current, the pulse emission is stopped and a fault message issued. METRAX GmbH DefiMonitor XD 21324 / GB / K05 77 / 116...

  • Page 78: Defibrillation During Pacing / Defibrillation Via Self-Adhesive Electrodes

    Defibrillation can also be carried out via the paddles, even though the adhesive electrodes are attached. Load the selected energy charge by briefly pressing one of the paddle trigger buttons and trigger defibrillation by pressing the buttons simultaneously. 78 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...

  • Page 79: Cleaning, Maintenance And Dispatch

    13.2 Servicing Independently of the use of the device, we recommend regular visual inspection / servicing of the PRIMEDIC™ DefiMonitor XD and the accessories by the user / service technician at least once a year. Make sure that the housing, cable, SavePads and all the other accessories are undamaged.

  • Page 80: Dispatching The Primedic™ Defimonitor Xd

    If the equipment is to be sent out for upgrading or servicing, in that case the power module must always be removed from the device and must be sent in with the device, but packaged separately. Where possible, use the original box. 80 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...

  • Page 81: List Of Error Codes

    - return the device for servicing HV, Disarm cannot be Error during the internal performed discharge, impossible to - return the device for servicing METRAX GmbH DefiMonitor XD 21324 / GB / K05 81 / 116...
  • Page 82 Error in the voltage supply, power module possibly due to an empty - if the error persists: Return the PRWIN fail > 100 ms accumulator/battery device for servicing 82 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...
  • Page 83 Error in the voltage supply, - charge and/or replace the possibly due to an empty power module 5V drop accumulator/battery - if the error persists: Return the METRAX GmbH DefiMonitor XD 21324 / GB / K05 83 / 116...
  • Page 84 - if the error persists: Return the need full test detected during auto-diagnosis device for servicing Program code area corrupt Error in the program memory - return the device for servicing 84 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...
  • Page 85 - if the error persists: Return the XtBoard err - runtime error board runtime check device for servicing Impedance measurement Error during the impedance - return the device for servicing METRAX GmbH DefiMonitor XD 21324 / GB / K05 85 / 116...
  • Page 86 List of error codes error measurement Error during the hardware XtBoard err - platform detection - return the device for servicing 86 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...

  • Page 87: Disposal

    He will have further information on this for you. Information for disposal in countries outside the European Union This symbol is only applicable within the European Union. METRAX GmbH DefiMonitor XD 21324 / GB / K05 87 / 116...

  • Page 88: Technical Data

    34 J 100 J ± 15 % 83 J 75 J 68 J 200 J ± 15 % 300 J ± 15 % 360 J ± 15 % 88 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...
  • Page 89 > 5 MOhm @ 10 Hz CMRR: > 85 dB Input d.c. voltage: ± 0.5 V Bandwidth: 0.5 – 40 Hz (- 3 dB) SR = 101 samples/s METRAX GmbH DefiMonitor XD 21324 / GB / K05 89 / 116...
  • Page 90 1h pacing, operation at 120 pulses/min at 140 mA Connect 8h pacing, operation at 60 pulses/min at 70 mA 10 minutes, operation OverDrive pacing at 200 pulses/min at 180 mA 90 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...
  • Page 91 European standards EN were used instead of the IEC standards): IEC 60601-1:1988 + A1:1991 + A2:1995 IEC 60601-1-2:2001 IEC 60601-1-4:1996 + A1:1999 IEC 60601-2-4:2002 CEN EN ISO 9919:2005 (only for XD3,XD30,XD300,XD330) EN1789:2003 Subject to change without notice. METRAX GmbH DefiMonitor XD 21324 / GB / K05 91 / 116...

  • Page 92: Accessories

    Accessories 17 Accessories The PRIMEDIC™ DefiMonitor XD is supplied with the following accessories fitted at the factory: Paddle set • PRIMEDIC™ SavePads Connect • Power module: PRIMEDIC™ AkuPak • For details of further accessories, see separate list of accessories / price list.

  • Page 93: Warranty Conditions

    (e.g. consumables such as PRIMEDIC™ AkuPak) or damages caused after transfer of risk as a result of incorrect or negligent handling, excessive wear or caused by special external influences which are not provided for according to the contract.

  • Page 94: Depiction Of The Current Time Function

    5 Joule @ 175 Ohm 10 Joule @ 25 Ohm 10 Joule @ 50 Ohm 10 Joule @ 75 Ohm 10 Joule @ 100 Ohm 10 Joule @ 125 Ohm 94 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...
  • Page 95 30 Joule @ 25 Ohm 30 Joule @ 50 Ohm 30 Joule @ 75 Ohm 30 Joule @ 100Ohm 30 Joule @ 125 Ohm 30 Joule @ 150 Ohm METRAX GmbH DefiMonitor XD 21324 / GB / K05 95 / 116...
  • Page 96 100 Joule @ 50 Ohm 100 Joule @ 75 Ohm 100 Joule @ 100 Ohm 100 Joule @ 125 Ohm 100 Joule @ 150 Ohm 100 Joule @ 175 Ohm 96 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...
  • Page 97 300 Joule @ 75 Ohm 300 Joule @ 100 Ohm 300 Joule @ 125 Ohm 300 Joule @ 150 Ohm 300 Joule @ 175 Ohm 360 Joule @ 25 Ohm METRAX GmbH DefiMonitor XD 21324 / GB / K05 97 / 116...
  • Page 98 360 Joule @ 50 Ohm 360 Joule @ 75 Ohm 360 Joule @ 100 Ohm 360 Joule @ 125 Ohm 360 Joule @ 150 Ohm 360 Joule @ 175 Ohm 98 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...
  • Page 99 2. Shock 3. Shock 1. Shock 2. Shock 3. Shock 1. Shock 2. Shock 3. Shock 1. Shock 2. Shock 3. Shock 1. Shock 2. Shock 3. Shock METRAX GmbH DefiMonitor XD 21324 / GB / K05 99 / 116...
  • Page 100 Depiction of the current time function 1. Shock 2. Shock 3. Shock 1. Shock 2. Shock 3. Shock 100 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...

  • Page 101: Rhythm Detection System In Aed Mode

    Rhythm detection system in AED mode 20 Rhythm detection system in AED mode The rhythm detection system of the PRIMEDIC™ DefiMonitor XD analyses the patient's ECG and recommends procedure based on whether the device detects a shockable rhythm or not.
  • Page 102 False positive rate 0.04 % Real predictive value 97,93 % The databases used have a total length of about 10,000 minutes. The calculation was made in accordance with IEC60601-2-4-2003. 102 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...
  • Page 103 Total number of ECGs where shock is not clinically recommended Positive predictive value shockable = Number of "correct " algorithm decisions Total number of ECGs in which administering an impulse is recommended by the device METRAX GmbH DefiMonitor XD 21324 / GB / K05 103 / 116...

  • Page 104: General Information On The Use Of Pulse Oximeters

    It is also not suitable for use on patients who move around, a lot as the mechanism of the casing cannot prevent the sensor slipping off the finger. 104 / 116 DefiMonitor XD 21324 / GB / K05 METRAX GmbH...
  • Page 105 However, if it is used correctly, if the sensor-specific warnings and information provided are observed and the clinical symptoms taken into consideration, SpO measurement is an important instrument in the evaluation of a patient's condition. METRAX GmbH DefiMonitor XD 21324 / GB / K05 105 / 116...

  • Page 106: Guidelines And Manufacturer's Declaration - Electromagnetic Emissions

    22 Guidelines and manufacturer's declaration – Electromagnetic emissions The PRIMEDIC DefiMonitor XD is intended for operation in an environment as described below. The customer or user of the PRIMEDIC DefiMonitor XD -Family should ensure that it is only operated in a suitable environment.
  • Page 107 Guidelines and manufacturer's declaration – Electromagnetic emissions The PRIMEDIC™ DefiMonitor XD is designed for operation in the electromagnetic environment described below. The customer or user of the PRIMEDIC DefiMonitor XD - Family should ensure that it is only operated in a suitable environment.
  • Page 108 Guidelines and manufacturer's declaration – Electromagnetic emissions The PRIMEDIC™ DefiMonitor XD is designed for operation in the electromagnetic environment described below. The customer or user of the PRIMEDIC DefiMonitor XD - Family should ensure that it is only operated in a suitable environment.
  • Page 109 If the field strength measured at the location in which the PRIMEDIC™ DefiMonitor XD is operated exceeds the conformance levels for HF listed above, the PRIMEDIC™...
  • Page 110 PRIMEDIC DefiMonitor XD product family The PRIMEDIC DefiMonitor XD family is designed for use in an electromagnetic environment in which the HF interference is controlled. The customer or user of the PRIMEDIC DefiMonitor XD can help avoid electromagnetic interference by maintaining the...

  • Page 111: General Instructions And Rules For Using Primedic™ Akupaks

    PRIMEDIC™ AkuPak battery automatically begins a recharging cycle every 2 weeks, thus automatically compensating for the loss of charge. If you are using several PRIMEDIC™ AkuPak batteries, use the reserve batteries in rotation to replace the battery in the device in order to avoid long storage times.
  • Page 112 For this reason, the PRIMEDIC™ AkuPak the date of manufacture stored. After 2.5 years, the device issues the voice message < Charging status battery low, please recharge >. At the same time, the battery symbol appears on the status display. If necessary, PRIMEDIC™ AkuPak should be replaced.

  • Page 113: Safety Checks

    Metrax. The test protocols necessary for the checks can be provided by Metrax. Only authorised persons can operate the device. Please consider also the national directives in your country about safety technical checks. METRAX GmbH DefiMonitor XD 21324 / GB / K05 113 / 116...

  • Page 114: Index Of Diagrams

    Fig. 12: Panel foil PRIMEDIC™ DefiMonitor XD 1/10/3/30 (completely manual defibrillators) ..........................30 Fig. 13: Panel foil PRIMEDIC™ DefiMonitor XD 100 / 110 / 300 / 330 ......30 Fig. 14: Monitor display ....................32 Fig. 15: Locking the adult paddles in place over the electrodes for children ....35 Fig.

  • Page 115: Contact Details

    Index of diagrams Contact details METRAX GmbH Rheinwaldstr. 22 D-78628 Rottweil Tel.: 0741/257-0 info@primedic.com www.primedic.com METRAX GmbH DefiMonitor XD 21324 / GB / K05 115 / 116...
  • Page 116 With the brand PRIMEDIC™, Metrax offers a info@primedic.com reliable programme for emergency medicine: Professional defibrillators and mobile ultrasound scanners. Emergency rescue services around the world are familiar with PRIMEDIC™ as a Repräsentanzen: guarantor for the highest quality and innovative medical technology. METRAX GmbH METRAX GmbH Shanghai Rep.

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