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

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24050 | GB | I
www.primedic.com
DefiMonitor XD
Operating instructions
English
10/2021

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  • Page 1 DefiMonitor XD Operating instructions English 24050 | GB | I 10/2021 www.primedic.com...

  • Page 2: Masthead

    Rheinwaldstr. 22 D-78628 Rottweil Germany Phone: +49 741 257-0 Fax: +49 741 257-235 www.primedic.com info@primedic.com Revision: I Date of issue: 10/2021 Proprietary note Metrax GmbH reserves all rights to these instructions for use. These instructions for use may not be duplicated or made accessible to third parties without the approval of Metrax GmbH.

  • Page 3: Table Of Contents

    Separation from the supply network Using the DefiMonitor XD Switching on / off 7.1.1 Switching on 7.1.2 Switching off Device self-test 7.2.1 Self-test after switching on 7.2.2 Automatic, periodic self-tests DefiMonitor XD | 24050 | GB | I 3 / 108...
  • Page 4 Defibrillation during pacing / Defibrillation via multifunction electrodes 7.13 AED-Mode (AED) 7.13.1 Voice messages 7.13.2 Carrying out ECG analysis in AED-Mode 7.13.3 Defibrillation required 7.13.4 Defibrillation not required 7.14 Keeping the defibrillator ready for use 4 / 108 DefiMonitor XD | 24050 | GB | I...
  • Page 5 Functional versus Fractional Saturation 12.2.3 Performance Considerations Nellcor™ Pulse Oximetry Sensors 12.2.4 12.2.5 Functional Testers and Patient Simulators 12.3 Rhythm detection system in AED-Mode 12.4 Electromagnetic compatibility 12.5 Optional accessories DefiMonitor XD | 24050 | GB | I 5 / 108...
  • Page 6 Table of contents 6 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 7: Glossary

    Foreword Dear User, You are faced with the task of using the DefiMonitor XD on human beings in a medical emergency! To ensure that you can react quickly and correctly in this special situation and can optimally use the options given with the device, it is necessary for you to read through these operating instructions in your own time beforehand to familiarise yourself with the device, its functions and the areas of applica- tion.

  • Page 8: Validity

    Refer to the start dialogue of your DefiMonitor XD to determine which model you have. The DefiMonitor XD is run using an AkuPak LITE XD. This item will also be referred to as an energy module in this document.

  • Page 9: Pictograms

    Manufacturer and production date if necessary YYYY-MM-DD Follow the instructions for use "General warning” safety symbol – the individual meanings are explained in the operating instructions Dangerous electrical voltage (high voltage) DefiMonitor XD | 24050 | GB | I 9 / 108...
  • Page 10 Recycling code for low-density polyethylene Do not reuse non sterile Can be used a maximum of 24 hours after opening Observe the instructions for use Not made from natural latex 10 / 108 DefiMonitor XD | 24050 | GB | I...
  • Page 11 3. Pull off protective foil 4. Attach SavePads and smooth out Prescription only Silver / Silver Chloride Remove chest hair Dry skin Connect the ECG cable to the ECG electrodes DefiMonitor XD | 24050 | GB | I 11 / 108...

  • Page 12: Purpose

    Purpose Functionality The DefiMonitor XD is a portable defibrillator / monitor that is intended for use of trained medical per- sonnel in indoor and out-of-doors emergency care setting with environmental condition specified in the technical data. DefiMonitor XD is designed to be used during ground transportation. DefiMonitor XD is battery powered and can be powered by mains.
  • Page 13 The high-intensity current pulse is called defibrillation. DefiMonitor XD will apply high-intensity current pulse in biphasic waveform. In adult mode, DefiMonitor XD will apply up to 360J, in pediatric mode up to 100J. DefiMonitor XD DefiMonitor XD provides asynchronous manual defibrillation using multifunction elec- trodes or paddles.

  • Page 14: Intended Use

    SpO2 SpO2 monitoring included in DefiMonitor XD is a portable pulse oximeter intended as a continuous non-invasive monitor of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neo- natal patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

  • Page 15: Medical Contraindications

    Patients older than one year where pacemaker therapy is indicated. SpO2 Nellcor OxiMax™ technology allows the use of different types of SpO2 sensors. The intended patient group is specified in the instruction for use if the SpO2 sensor. DefiMonitor XD | 24050 | GB | I 15 / 108...

  • Page 16: Probable Body Part

    The applied part is defined in the instructions for use of the sensor itself. 3.3.5 Intended use environment The DefiMonitor XD will be used on scene of emergency. The DefiMonitor XD can be used in road am- bulances as well. The limitations for temperature, humidity and air pressure are specified in chapter 11.7.

  • Page 17: Description Of Device

    Description of device General description The DefiMonitor XD is an external defibrillator with integrated 6-channel ECG. The ECG can be rec- orded either via the SavePads, the defibrillation paddles or the four-pin patient cable with self-adhe- sive ECG electrodes. The DefiMonitor XD is available in various models. The respective model will be shown on the monitor when the defibrillator is turned on.

  • Page 18: Scope Of Delivery

    SPO2 option: Nellcor SpO2 finger sensor FLEXMAX 97802 reusable, patient weight >20 kg Nellcor SPO2 interface cable DOC10 97221 Cable length 3 m Subject to change without notice. 18 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 19: Description Of Device Details

    Paddle cable, detachable Membrane keypad (option-dependent, here: DefiMonitor XD AED, PACER, SPO2) Monitor Status display Fig. 2 DefiMonitor XD – rear view (similar to illustration) Opening for single-hand release hook Identification plate Quality seal DefiMonitor XD | 24050 | GB | I...

  • Page 20: Fig. 3 Defimonitor Xd - Bottom View

    Fig. 3 DefiMonitor XD – bottom view SaveCard cover Release button (to remove the energy module) Energy module AkuPak LITE XD Fig. 4 DefiMonitor XD – left-hand side view Slot for paddle Loudspeaker Socket for electrode connector Socket for paddle connector...

  • Page 21: Fig. 5 Defimonitor Xd - Right-Hand Side View

    Description of device Fig. 5 DefiMonitor XD – right-hand side view Slot for paddle Release lever for printer cover Printer cover Power supply socket Attachment point for bag Fig. 6 Paddle set STERNUM paddle button APEX paddle button Paddle connector...

  • Page 22: Controls

    Energy level in joules Event button Paper feed Printer button Shock button for use with the multifunction electrodes (SavePads) LED display - battery charging LED display - connected to mains 22 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 23: Monitor Display

    Status bar for displaying SaveCard storage capacity, patient contact status, time, pediatric mode, pacer status, printer status, paper status, battery capacity Calibration peak, height corresponds to 1 mV ECG channels display (max. 2) SpO2 curve, notes, information (SpO2 option) DefiMonitor XD | 24050 | GB | I 23 / 108...

  • Page 24: Monitor Symbols

    Information area 5 Status bar 5.3.3 Monitor symbols Symbol Meaning Pacer passed self-test Pacer failed self-test No paper Printer error Paddle Heart rate Alarm limits / Alarm activated Alarm deactivated 24 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 25: Preparatory Measures Before (Initial) Start-Up

    Daily testing of the DefiMonitor XD Note We recommend carrying out visual inspection of the DefiMonitor XD, its accessories and the MMI test daily. Conduct the daily testing of the DefiMonitor XD according to the following checklist. Check expiration dates • Check the expiration date ➢...

  • Page 26: Power Supply

    ➢ Do not inhale any fumes which arise. ➢ Do not inhale any gas which is emitted. ➢ Keep the energy module away from sources of ignition. The DefiMonitor XD has two power supply options: ■ Energy module AkuPak LITE XD energy module (see attached operating instructions) ■...

  • Page 27: Removing The Energy Module

    6.1.2 . 6.1.1 Removing the energy module Note When the DefiMonitor XD is delivered, there is a film between the energy module con- tacts and the device contacts. This film must be removed before use. Note Only change the power module when the device is switched off and the mains plug has been disconnected.

  • Page 28: Inserting The Energy Module

    Press the energy module (2) into the energy module slot until it audibly clicks into place and it is flush with the device housing. ➢ The DefiMonitor XD switches on automatically when the AkuPak LITE XD is inserted and per- forms an automatic self-test.

  • Page 29: Battery Capacity Display On The Monitor

    6.1.5 Battery capacity display on the monitor On the DefiMonitor XD the charge status of the energy module is displayed as a bar chart in the status bar on the monitor. Examples of what might be displayed are explained below:...

  • Page 30: Separation From The Supply Network

    Separate the power cable connector from the power supply socket, Fig. 5 (4) at the device. • Separate the mains plug from the socket. ✓ The LED, Fig. 7 (19) goes out. This signals that the DefiMonitor XD has been separated from the supply network. Using the DefiMonitor XD...
  • Page 31 30 cm to the defibrillator or accessories connected to the defibrillator. WARNING Injury due to incorrectly secured defibrillator Injuries to patients, users or third parties ➢ Secure the DefiMonitor XD to the wall bracket during transport. ➢ Secure the accessories before transport. WARNING DefiMonitor XD can not be turned on No use of the DefiMonitor XD is possible ➢...

  • Page 32: Switching On / Off

    ➢ Do not use disposable accessories when they have dried out. ➢ Use disposable accessories only once. Select your position to the DefiMonitor XD so that you can see the monitor at all times and operated the device. Switching on / off 7.1.1 Switching on...

  • Page 33: Self-Test After Switching On

    7.2.1 Self-test after switching on The self-test is activated by turning the DefiMonitor XD on or by inserting the AkuPak LITE XD into the device. The self-test checks all important functions and signalling devices. If an error is detected, an extended self-test (LONG) is automatically carried out. If the error is not re- solved, all subsequent self-tests will be extended (LONG).

  • Page 34: Fig. 13 Status Display

    XD Not test by reinserting the between ready for energy module or by DefiMonitor switching the device XD and the on again energy Charge or replace the module energy module 34 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 35: Internal Error

    If the DefiMonitor XD detects an internal error, voice message Internal error will be played. The error code will be displayed on the monitor while the voice message is playing. The DefiMonitor XD will shut itself down independently immediately afterwards.

  • Page 36: Basic Settings

    ✓ The device is now ready for operation again. 7.3.2 Basic settings The following table shows the settings of a fully-equipped DefiMonitor XD with AED, PACER and SPO2 options. With the other device variants only entries corresponding to existing options are dis- played.

  • Page 37: Positioning The Electrodes On The Patient

    Note Use the electrodes on intact (uninjured) skin. Note The electrodes may cause redness in the area to which they are applied. DefiMonitor XD | 24050 | GB | I 37 / 108...

  • Page 38: Undressing The Patient

    SavePads are self-adhesive multifunction electrodes which can be used for defibrillation, stimulation, monitoring and cardioversion. SavePads are available in various models, see chapter 12.5. The DefiMonitor XD is delivered with SavePads Connect as standard. The SavePads Connect are connected to the DefiMonitor XD using the SavePads Connect cable.

  • Page 39: Paddles

    Using the DefiMonitor XD 7.4.4.1 SavePads Mini / Pediatric mode When the DefiMonitor XD detects that SavePads Mini are connected, the energy is limited to max. 100 joules. The DefiMonitor XD is in Pediatric Mode. This applies for asynchronous and synchronous de- fibrillation.

  • Page 40: Positioning The Savepads And/Or Paddles On Adults

    (1) • on the left side of the chest, above the apex of the heart on the axillary line (2) 40 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 41: Positioning The Savepads And/Or Paddles On Children

    (1), red SavePad • on the left side of the chest, above the apex of the heart on the axillary line (2) green SavePad DefiMonitor XD | 24050 | GB | I 41 / 108...

  • Page 42: Opening And Attaching Savepads

    If you are using the SavePads Mini , insert the electrode connector into the socket of the DefiMon- itor XD. • If you are using the SavePads Connect or SavePads Mini Connect, it is imperative that you fol- low the procedure described below. 42 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 43: Positioning The Ecg Adhesive Electrodes

    Monitor XD. Make sure that the markings match up. 7.4.9 Positioning the ECG adhesive electrodes Fig. 22 ECG patient cable, 4-pin IEC Connector Electrode clips (green, black, red, yellow) DefiMonitor XD | 24050 | GB | I 43 / 108...

  • Page 44: Removing The Electrodes From The Patient

    Dispose of the electrodes in the residual waste. Fitting an SpO2 sensor The approval of the DefiMonitor XD was carried out using the Nellcor™ SpO2 finger sensor FLEXMAX and the Nellcor™ interface cable DOC10. Nonetheless, the option exists to insert all Nellcor™ sensors with OxiMax™...

  • Page 45: Removing An Spo2 Sensor

    The patient’s critical state is not recognised. ➢ Select purposeful alarm thresholds. The DefiMonitor XD has an intelligent alarm system. High, medium and low priority alarms exist and also informative notifications and error notifications. If several alarms are triggered simultaneously, all the alarms are displayed on the monitor.

  • Page 46: Alarms With Medium Priority

    Check the SpO2 sensor’s connection to the patient. Correct it if necessary. 7.8.2 Alarms with medium priority The following table provides an overview of the alarms with medium priority. 46 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 47: Alarms With Low Priority

    Every 2 minutes PACE • Charge the AkuPak LITE XD as soon as possible. Connect the DefiMonitor XD to the mains if pos- sible. 7.8.3 Alarms with low priority The following table provides an overview of the alarms with low priority.
  • Page 48 Check the SpO2 sensor. • Check the SpO2 sensor’s connection to the patient • Ensure that the SpO2 sensor is safely connected to the DefiMonitor XD. SpO2 sensor not con- The SpO2 sensor is not Text notification Check ECG MON...
  • Page 49 Defi- Information signal Monitor XD was inter- rupted. The patient cannot be treated using PACE mode as the patient’s connection to the DefiMonitor XD was interrupted. • Check the connection between the patient and the DefiMonitor XD.
  • Page 50 XD turns itself off independently. • Switch the DefiMonitor XD back on. ✓ If the self-test is successful, the DefiMonitor XD can be used. If not, please contact the tech- nical services team. 50 / 108 DefiMonitor XD | 24050 | GB | I...
  • Page 51 Defi- electrodes the DefiMonitor XD Monitor XD has been in- Apply electrodes one SYNC terrupted. after the other to pa- PACE tient's bare chest DefiMonitor XD | 24050 | GB | I 51 / 108...
  • Page 52 SYNC PACE • Archive the data on the SaveCard externally. • Insert an empty SaveCard into the DefiMonitor XD. “NO CF” displayed in the Data recording not There is no SaveCard in ECG MON possible the DefiMonitor XD.

  • Page 53: Messages In Aed-Mode

    Using the DefiMonitor XD 7.8.5 Messages in AED-Mode The DefiMonitor XD issues voice messages. The corresponding text version of the message will be shown in the lower area of the monitor. For devices with SpO2 option, the plethysmogram will not be shown in AED mode.

  • Page 54: Alarm Volume

    To start the settings menu during operation, press the enter key , Fig. 7 (9). • Move the cursor upwards by pressing the ▲ key several times until the desired parameter is high- lighted. 54 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 55: Muting The Alarm

    ✓ The device is now ready for operation again. 7.8.8 Muting the alarm The alarms are always activated when the DefiMonitor XD is switched on. The alarm limits can be ad- justed in the settings menu. If an alarm occurs, it can be muted for 60s using the alarm acknowledgement button, Fig. 7 (7). The visual alarms will continue to be displayed during this time.

  • Page 56: Connecting The Ecg Electrodes

    7.9.2 Changeover of ECG source The ECG can be recorded via the paddles or via the adhesive electrodes. Pressing the ECG source button, Fig. 7 (5) alternates between the paddles and multifunction electrodes. 56 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 57: Switching The Leads On The Monitor

    Note If the settings view is active, you can switch to MAN mode directly by pressing one of the energy levels or the ECG source button. DefiMonitor XD | 24050 | GB | I 57 / 108...

  • Page 58: Energy Selection

    ➢ If SYNC mode was activated beforehand, the defibrillator switches to MAN mode from SYNC mode. • The energy can also be discharged internally by pressing the charge button (12) again. 58 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 59: Triggering Defibrillation

    Triggering defibrillation can temporarily disrupt the ECG and SpO2 measurement. 7.10.3.1 MAN (manual mode) After switching the device on and successfully carrying out the self-test, all DefiMonitor XD models will automatically go into manual mode (MAN). “MAN” mode will be shown in information area 2 of the monitor.

  • Page 60: Fig. 26 Manual Defibrillation Man

    Press the paddles on to the patient’s chest with at least 60 N (6 kg) of force. • Wait until the ECG is visible on the monitor. ➢ The DefiMonitor XD now highlights the R waves of the ECG. • Make sure that the ECG is free of artefacts.

  • Page 61: Fig. 27 Display For Synchronous Defibrillation (Sync) Via Paddles

    Keep both paddle buttons pressed until the defibrillation output at the next marked QRS complex is completed. ➢ Until defibrillation is triggered, a changed beep will sound. ✓ If the energy is delivered to the patient, the DefiMonitor XD displays this. Fig. 27 Display for synchronous defibrillation (SYNC) via paddles Shock method via SavePads: •...

  • Page 62: Spo2 Measurement

    When synchronous defibrillation is triggered, the monitor looks like this: Fig. 28 Display for synchronous defibrillation (SYNC) via SavePads Note The DefiMonitor XD automatically switches back to MAN mode following synchronous defibrillation. This is displayed on the monitor accordingly. Changing from SNYC mode into MAN mode: •...

  • Page 63: General Spo2 Safety Advice

    SpO2 measurement can be used to determine functional oxygen saturation. The sensor can also be used to determine the pulse rate. If the patient is not connected to the DefiMonitor XD with ECG elec- trodes or via SavePads, the pulse rate will be displayed on the monitor instead of the heart rate. As soon as the heart rate can be determined via the ECG signal (ECG electrodes or SavePads), the source automatically switches back to ECG.

  • Page 64: Shown On The Monitor

    Too great a deviation (± 30 %) from the selected intensity, treatment automatically stopped Selected treatment is stopped ➢ Check the multifunction electrodes being used ➢ If necessary, replace the multifunction electrodes 64 / 108 DefiMonitor XD | 24050 | GB | I...
  • Page 65 DefiMonitor XD switches to MAN mode. Pacer mode can only be activated when the DefiMonitor XD is in MAN mode and multifunction elec- trodes are connected. Positioning the multifunction electrodes is described in chapter 7.4 .

  • Page 66: Setting The Pacer Modes

    Various stimulation intensities (current strengths) are available depending on the pacer mode: DEMAND, FIX, OVERDRIVE 10 to 180 mA The following current strengths are preset when the respective modes are activated: 66 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 67: Starting And Stopping Stimulation In Pacer Mode (Pace)

    (3) are changed. If one of these keys is pressed, the 15 seconds are restarted. Stimulation can be stopped before the 15 seconds have elapsed by pressing the Start/Stop button (4). DefiMonitor XD | 24050 | GB | I 67 / 108...

  • Page 68: Defibrillation During Pacing / Defibrillation Via Multifunction Electrodes

    Separate the patient from other electrical medical devices which are not defibrillation- proof for the defibrillation. In AED-Mode, the ECG is analysed via an implemented algorithm. This is only possible when using the SavePads. 68 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 69: Voice Messages

    Note If the patient is connected to the DefiMonitor XD , an ECG analysis will be carried out immediately. In this case, the other voice messages will be skipped. In basic state, a dashed line appears on the display and the acoustic message Check electrodes is played if the electrodes are not connected.

  • Page 70: Defibrillation Required

    Options for leaving the status of readiness to shock If the DefiMonitor XD looses the connection to the patient in the status of readiness to shock, the en- ergy is discharged internally. The status of readiness to shock will remain for 15 seconds. If no shock delivery takes place within this period, the energy is discharged internally.

  • Page 71: Defibrillation Not Required

    If the shock is not triggered within 15s, ■ An internal safety discharge of the defibrillation energy takes place. ■ the DefiMonitor XD outputs the message No shock delivered ■ the DefiMonitor XD instructs for cardiopulmonary resuscitation. 7.13.4 Defibrillation not required If the device cannot find a rhythm requiring defibrillation, it will recommend cardiopulmonary resuscita- tion (CPR).

  • Page 72: Mmi Test (Man-Machine-Interaction)

    After each use, check the DefiMonitor XD and accessories for damage. • Clean the DefiMonitor XD and accessories after each use. • Disinfect the DefiMonitor XD and the accessories if there is a risk of infection, see chapter 9.1. • Replace disposable accessories. •...

  • Page 73: Operating The Printer

    Result of the test If the test was completed successfully, the test will be receive the grade PASS. If the test was not completely successfully, the DefiMonitor XD will turn itself off automatically. No printout will be possible. DefiMonitor XD | 24050 | GB | I...

  • Page 74: Fig. 32 Self-Test Printout (Similar To Illustration)

    Using the DefiMonitor XD Fig. 32 Self-test printout (similar to illustration) Fig. 33 Detailed self-test printout (similar to illustration) 74 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 75: Ecg Signal Log

    Using the DefiMonitor XD 7.16.3 ECG signal log The DefiMonitor XD has a printer. ECG printout of 1 to 6 channels simultaneously is possible. Feed speeds of 25 and 50 mm/s can be selected. Logging the ECG curve during monitoring: •...

  • Page 76: Automatic Printout After Each Shock

    To stop the printout, press the printer button (16). ✓ Printout is produced at 25 mm/s. The data remains in the event memory after printout and after switching off the DefiMonitor XD. It can be printed out as often as required.

  • Page 77: Inserting / Replacing The Savecard

    When starting the device for the first time after formatting a SaveCard, it will take considerably longer because the device performs various self-tests. The device then resumes normal operation again. Inserting / replacing the SaveCard Fig. 34 DefiMonitor XD – open bottom view Slot for SaveCard SaveCard eject button Cover 8.1.1 Inserting SaveCard...

  • Page 78: Changing Savecard

    Clean the device and all its accessories with soap and water solution. Use a slightly damp, clean cloth. Use isopropyl alcohol to disinfect it. For cleaning and disinfecting the SpO2 sensor, please observe the separate instructions for use for the sensor. 78 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 79: Servicing

    Observe the current valid dangerous goods guidelines for shipping lithium batteries. If you are shipping the DefiMonitor XD together with the energy module, break the contact between the energy module and the DefiMonitor XD for shipment. This prevents the device from switching on during transport.

  • Page 80: Technical Data

    Class IIb (MDD Annex IX Rule 09) 11.4 Printer Model Thermal printer Number of channels 1 to 3 channels Type of paper Thermal paper Paper width 58 mm Printing speed 25 mm/s, 50 mm/s 80 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 81: Memory

    Number of shocks at 200J Number of shocks at 360J Operating time (monitoring) at least 5:00 h (for AkuPak LITE XD in a DefiMonitor XD after three initial shocks in AED mode, ECG/SpO2 moni- toring until device is switched off at 20°C ± 5°C)

  • Page 82: Environmental Conditions

    15 % to 95 % non-condensing Air pressure 620 hPa to 1060 hPa Transient operating conditions The DefiMonitor XD can be operated for at least 20 minutes with the conditions specified as follows. Temperature DefiMonitor XD -20 °C to +50 °C with energy mod- -4 °F to +122 °F...

  • Page 83: Sound Definitions

    The following values will be displayed after 20 seconds: play and behaviour in case of irregular A1, ventricular bigeminies: 80 bpm rhythms A2, slowly changing ventricular bigeminies: 60 bpm (IEC 60601-2-27:2011+Cor.:2012) DefiMonitor XD | 24050 | GB | I 83 / 108...
  • Page 84 ±10 mV and ±700 mV amplitude, with pulse widths between 0.1 ms and 2 ms and overshooting from 0 to 10 Input Dynamic input range ± 5 mV AC, ± 300 mV DC 84 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 85: Spo2

    Because pulse oximeter equipment measurements are statistically distributed, about two-thirds of the measurements can be expected to fall in this accuracy (ARMS) range (refer to the Sensor Accuracy Grid for more details). DefiMonitor XD | 24050 | GB | I 85 / 108...

  • Page 86: Treatment Parameters

    ≤ 33 s when operated with an AkuPak LITE XD after dis- charge of energy for 15 shocks 11.10.1 Biphasic curve properties Pulse length Positive phase 11.25 ms, negative phase 3.75 ms Pulse shape Biphasic, current-regulated 86 / 108 DefiMonitor XD | 24050 | GB | I...
  • Page 87 224J 208J 192J 178J ± 15 % 300J 244J 300J 287J 268J 249J 230J 214J ± 15 % 360J 288J 360J 337J 315J 291J 269J 250J ± 15 % DefiMonitor XD | 24050 | GB | I 87 / 108...

  • Page 88: Manual Defibrillation (Asynchronous / Synchronous)

    ± 0.5 % Energy output via Multifunction electrodes 10 mA – 180 mA Stimulation intensity Stimulation intensity accuracy ± 10 % or + 3/-1 mA Pulse width 20 ms 88 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 89: Aed-Mode

    0.60 ± 0.10 mm Pieces / bag 1 set (2 pieces) Carrier material Adhesive PE foam Conductive material Adhesive hydrogel Separating film Siliconised PET film Packaging material PET, Al, PE Cable length DefiMonitor XD | 24050 | GB | I 89 / 108...
  • Page 90 Siliconised PET film Packaging material PET, Al, PE SavePads PreConnect cable length SavePads Mini Developed for patients with a maximum bodyweight of 25 kg and maximum age of 8 years. 90 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 91: Appendix

    12.1 Illustration of time-current curves The following diagrams show the graphs for the defibrillation pulse displayed depending on the load resistance: Maximum output Fig. 35 Defibrillation with a maximum output of 360 joules DefiMonitor XD | 24050 | GB | I 91 / 108...

  • Page 92: Fig. 36 First Defibrillation In Aed Adult Mode

    Appendix AED adult mode Fig. 36 First defibrillation in AED adult mode Fig. 37 Second defibrillation in AED adult mode 92 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 93: Fig. 38 Third And Subsequent Defibrillations In Aed Adult Mode

    Appendix Fig. 38 Third and subsequent defibrillations in AED adult mode AED pediatric mode Fig. 39 First defibrillation in AED pediatric mode DefiMonitor XD | 24050 | GB | I 93 / 108...

  • Page 94: General Advice For Using Pulse Oximeters

    In contrast, hemoximeters such as the IL482 report fractional saturation where oxygenated hemoglobin is expressed as a per- centage of all measured hemoglobin, including measured dysfunctional hemoglobins. To compare 94 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 95: Performance Considerations

    Failure to cover the pulse oximetry sensor site with opaque material in high ambient light condi- tions ■ Excessive patient movement ■ Dark skin pigment ■ Intravascular dyes or externally applied coloring, such as nail polish or pigmented cream DefiMonitor XD | 24050 | GB | I 95 / 108...
  • Page 96 Instructions for Use accompanying the sensor. Clean and remove any substances such as nail polish from the application site. Periodically check to ensure that the sensor remains properly positioned on the patient. 96 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 97: Nellcor™ Pulse Oximetry Sensors

    (sterile, not reusable) Nellcor™ SpO2 sensor for newborn infants and <3 or >40 kg adults, two-part (sterile, not reusable) Nellcor™ SpO2 sensor for adults, two-part (ster- >30 kg ile, not reusable) DefiMonitor XD | 24050 | GB | I 97 / 108...
  • Page 98 ISO 10993-1 (Biological evaluation of medical devices, part 1: Evaluation and testing). The pulse oximetry sensors successfully passed the recommended biocompatibility tests and thus meet the re- quirements of ISO10993-1. 98 / 108 DefiMonitor XD | 24050 | GB | I...

  • Page 99: Functional Testers And Patient Simulators

    12.3 Rhythm detection system in AED-Mode The DefiMonitor XD rhythm detection system analyses the patient's ECG and supports it if the device detects a rhythm requiring defibrillation or not. The device’s rhythm detection system comprises: •...

  • Page 100: Electromagnetic Compatibility

    The DefiMonitor XD is designed for use in an environment like the one described below. The cus- tomer or user of the DefiMonitor XD should ensure that it is used in an environment of this kind. Electromagnetic environment – code of practice...
  • Page 101 Guidelines and manufacturer's declaration on resistance to electromagnetic interference The DefiMonitor XD is designed for operation in an electromagnetic environment like the one de- scribed below. The customer or user of the DefiMonitor XD should ensure that it is used in an envi- ronment of this kind.
  • Page 102 (50/60 Hz) as per IEC should correspond to 61000-4-8 the typical values found in a residential, commercial or hospital environment. NOTE: U is the a.c. supply voltage before applying the test level. 102 / 108 DefiMonitor XD | 24050 | GB | I...
  • Page 103 Appendix The DefiMonitor XD is designed for operation in an electromagnetic environment like the one de- scribed below. The customer or user of the DefiMonitor XD should ensure that it is used in an envi- ronment of this kind. Test for interference resistance...

  • Page 104: Optional Accessories

    96365 58 mm, 25 m, smudge-proof, with grid lines Conductive gel for defibrillation (15 96364 Tube 100 g pieces) Subject to change without notice. Additional accessories available on request. 104 / 108 DefiMonitor XD | 24050 | GB | I...
  • Page 105 Index of figures Index of figures Fig. 1 DefiMonitor XD – front view Fig. 2 DefiMonitor XD – rear view (similar to illustration) Fig. 3 DefiMonitor XD – bottom view Fig. 4 DefiMonitor XD – left-hand side view Fig. 5 DefiMonitor XD – right-hand side view Fig.
  • Page 106 Index of figures This page was intentionally left blank. 106 / 108 DefiMonitor XD | 24050 | GB | I...
  • Page 107 Index of figures This page was intentionally left blank. DefiMonitor XD | 24050 | GB | I 107 / 108...
  • Page 108 Head office / Product location Metrax GmbH Rheinwaldstr. 22 D-78628 Rottweil Germany Phone: +49 741 257-0 Fax: +49 741 257-235 www.primedic.com info@primedic.com www.primedic.com...

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