getemed CardioMem CM 100 XT User Manual
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getemed CardioMem CM 100 XT User Manual

Ecg-recorder
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User Manual
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CardioMem
CM 100 XT
ECG-Recorder
Revision 01
Cardiac Diagnostics
Vital Signs Monitoring
Telemonitoring

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Summary of Contents for getemed CardioMem CM 100 XT

  • Page 1 User Manual ® CardioMem CM 100 XT ECG-Recorder Revision 01 Cardiac Diagnostics Vital Signs Monitoring Telemonitoring...

  • Page 3: Table Of Contents

    Contents Information about this Manual ..........6 Intended Operator ..............6 Intended Use ................. 7 Indications ................8 Definitions ................8 Regulatory Information ............9 Medical Device Compliance .......... 9 Radio Frequency Compliance ........9 Medical Device Classification ........9 Labeling ................
  • Page 4 12.2 Instructing the Patient ..........22 12.3 Preparing the Patient’s Skin ........23 12.4 Connecting the Electrodes........... 23 12.5 Placing the Device ............24 12.6 Switching on the Device ..........25 12.7 Check the Lead Quality ..........25 Starting the Recording ............. 25 Recording an Event ............
  • Page 5 17.3 Detection of Atrial Fibrillation (AFib) ......45 17.4 Pause Detection ............45 Disposing of the Device, Batteries and Accessories ..46 Troubleshooting .............. 47 Notifications (LED and Speaker) ........48 Accessories, Ordering Information ........49 Specifications ..............50 22.1 General ................

  • Page 6: Information About This Manual

    1 Information about this Manual This manual is owned by GETEMED Medizin- und Informationstechnik AG Oderstr. 77, 14513 Teltow, Germany. Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries. Adobe, Acrobat, and Reader are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.

  • Page 7: Intended Use

    3 Intended Use The CardioMem CM 100 XT is intended to continuously analyse and periodically record ECG data for later evaluation by a medical professional in order:  to document arrhythmias in individuals whose symptoms occur infrequently  to document the impact of initiating drug therapy for an arrhythmia ...

  • Page 8: Indications

    4 Indications The CardioMem CM 100 XT is indicated for those adult and pediatric (weight > 10kg) patients who require monitoring for the detection of the following non-lethal cardiac arrhythmias: tachycardia, bradycardia, atrial fibrillation, and pause. Contraindications:  Patients with known allergies or hypersensitivities to adhesives or hydrogel.

  • Page 9: Regulatory Information

    6 Regulatory Information 6.1 Medical Device Compliance The CE Mark and Notified Body registration number signifies that this equipment is in compliance with the essential requirements of the EU Regulation 93/42/EEC (MDD) by declaration of the manufacturer. 6.2 Radio Frequency Compliance The CE Mark signifies that this equipment is in compliance with the essential requirements and other relevant provisions of the EU Regulation 2014/53/EU (RED) by declaration of the...

  • Page 10: Labeling

    7 Labeling 7.1 Symbols The following symbols appear on the device and / or on the packaging: CardioMem CM 100 XT Device Type (CardioMem CM 100) and model (XT), Name and address of the manufacturer. Below the solid factory symbol is the date on which the device was manufactured.
  • Page 11 The symbol indicates that the device is powered by a replaceable, non- rechargeable battery. This symbol indicates that you must dispose of the device properly. Further information is provided in the section “Disposing of the Device, Batteries or Accessories“. Follow the Instructions for Use. Read and understand the operator's manual before using the device or product.
  • Page 12 Atmospheric pressure Limits 700hPa ... 1060hPa. Indicates the upper and lower atmospheric pressure limits allowed for the device’s storage and shipping. Keep away from heat Indicates that you need to keep the container away from sources of heat. Keep dry Indicates that you need to keep the container away from rain and other sources of moisture.

  • Page 13: Type Label

    7.2 Type Label The type label is located on the back of the device (Figure 1). Figure 1 – Type label 7.3 Packaging Label The packaging label is located on the side of the cardbox (Figure Figure 2 – Packaging label ®...

  • Page 14: Safety Information

    8 Safety Information 8.1 General Warnings 1. RISK OF CONTAMINATION OR INFECTION - Device and accessories may be contaminated with bacteria or viruses after use. If any contamination of the device or accessories has occurred, observe the standard procedures for handling contaminated objects and the following precautions: ...

  • Page 15: General Cautions

    Otherwise, degradation of the performance of this equipment could result. 7. ELECTROMAGNETIC RADIATION - Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches). Otherwise, degradation of the performance of the device could result.
  • Page 16 7. Protect the device against mechanical damage by shocks, pressure and scratches. Otherwise, the correct functioning of the device can no longer be guaranteed. 8. Malfunction or damage of the device – Changes in temperature and humidity can cause condensation inside the device. Wait at least two hours after the externally visible dampness of the device has disappeared before reusing it.
  • Page 17 18. Repair by inadequately trained personnel could result in a hazard, e. g. excessive temperatures or high voltages. Replacement of the electrodes and of the battery can be done by the patient. 19. Malicious software –Software delivered is scanned for viruses but can, nevertheless, be intruded by malicious software.

  • Page 18: Warranty And Service Information

    Disinfect the device at regular intervals, prior to first use, and before passing it on to another person. GETEMED recommends disinfecting the device with a 70 % alcohol solution. ®...

  • Page 19: Operating Elements

    11 Operating Elements The device features a push-button (1), a LED (2) and a speaker (Figure 3). The push-button is marked with the following symbol: Figure 3 – Operating elements 11.1 Event Button The push-button is used to perform the following functions: Function User Action Switch on the device Press and hold for more than a second until a...

  • Page 20: Led

    11.2 LED This multi-color LED indicates the device status: Device status Status indicator Ready for recording Shining green Recording in progress Flashing green Open lead Flashing yellow Contains recording Shining yellow Low battery Flashing red USB connected Shining cyan Error Flashing green, red, blue and flashing red afterwards For a detailed description of all notifications refer to section...

  • Page 21: Preparing The Recording

    12 Preparing the Recording 12.1 Inserting a Battery Push the latch with the thumb nail to unlock the battery compartment door (Figure 4). Figure 4 – Unlock the battery compartment Remove the battery compartment door. Take a new 3V Lithium CR2477N battery and place it in the battery compartment.

  • Page 22: Instructing The Patient

    Figure 6 – Close the battery compartment door 12.2 Instructing the Patient It is the responsibility of the medical professional to provide the patient with the following information required for a safe use of the device. CAUTION: Notify the doctor if skin problems develop. In rare cases allergic reactions may occur.

  • Page 23: Preparing The Patient's Skin

    Marking an event Instruct the patient to press the Event Button briefly during a recording to mark an event. A short beep informs the patient that the event has been marked. Recording Diary We also recommend having the patient maintain a diary to record activities, symptoms and the corresponding times during the ECG recording.

  • Page 24: Placing The Device

    Figure 7 – Connecting the electrodes CAUTION: Only use disposable electrodes that are clearly marked as ECG electrodes. Otherwise allergic skin reactions could occur. CAUTION: Do not reuse disposable ECG electrodes that have been used in an other patient. Infections could be the consequence.

  • Page 25: Switching On The Device

    Place the device on (a) the sternum or (b) the upper left chest and press gentle (Figure 9). Figure 9 – Placing the device Make sure that all electrodes adhere properly on the skin. 12.6 Switching on the Device Press the push-button until a beep sounds. The LED shows a color sequence when the device starts.
  • Page 26 Figure 10 – Starting the recording NOTE: If a previous recording is still stored on the device, the LED will shine yellow and the recording will not start. You will need to download or erase the recording before continuing. ® CardioMem CM 100 XT 78812021-EN...

  • Page 27: Recording An Event

    14 Recording an Event 14.1 Recording Modes The device features two recording modes:  Manual recording of an event, activated by pressing the push-button.  Automatic recording of an event, activated by algorithms for automatic arrhythmia detection (Auto-Trigger) or activated by a timer. The recording duration depends on the preset parameters (refer to section "Setup").

  • Page 28: End Of Recording

    rhythm detection is not functioning properly in patients with cardiac pacemakers. Time triggered Recording The device can start the ECG recording automatically based on a preset timer. The possible timer interval is 1h ... 24h. 15 End of Recording Disconnect the device carefully from the electrodes and remove the battery to stop the recording.

  • Page 29: Use Of The Cm 100 Configurator Software

    Software The software CM 100 Configurator is intended to be used as an accessory for the device CardioMem CM 100 XT .The software is intended to be used by trained medical professionals (user) in medical facilities.The software is running on a personal computer equipped with the Microsoft Windows operating system.

  • Page 30: Installation

    16.2 Installation The installer is an executable file that can be downloaded from http://www.getemed.net/downloads/CM100/CM1 00Configurator_Setup.exe It installs all program files and the USB driver that is necessary for the communication with the CardioMem CM 100 device.
  • Page 31 Figure 11 - Installation ® 78812021-EN CardioMem CM 100 XT...

  • Page 32: Check The System Time

    16.4 Connect the USB Download Cable WARNING: Risk of electric shock - Only use the USB Download Cable that is provided by GETEMED to connect the device to a personal computer (PC). CAUTION: The PC used must comply with the most recent version of the international standard IEC 60950 for safety of IT equipment.

  • Page 33: Switch On The Device

    Connect the download cable to a free USB port of the PC. Open the battery compartment door of the recorder (1) and remove the battery (2). Connect the device plug of the download cable to the socket (Figure 12) of the device (3). Figure 12 –...

  • Page 34: Start The Cm 100 Configurator Software

    16.6 Start the CM 100 Configurator Software The application can be started by double-clicking the desktop icon. The startup screen shows version and manufacturer information. Click the button "Connect to recorder" to establish the communication link (Figure 14). Figure 14 – Start the CM 100 Configurator software 16.7 Downloading Recordings The download feature is available in the information screen which is displayed once a connection to the recorder has been...
  • Page 35 Figure 15 – Downloading recordings Select Folder The storage path for the ECG data has been pre-selected during the installation. You can change the path before starting the download. Click the button "Start Download" to copy the ECG data to the selected folder (Figure 16).
  • Page 36 Figure 16 – Select folder Delete Data on Device WARNING: To ensure that a recording is not assigned to the wrong patient, always make sure that the device memory has been deleted before the device is used in the next patient. Click the button "Delete Recordings"...
  • Page 37 Figure 17 – Delete data ECG Report WARNING: For the review of ECG reports the software Adobe Reader Version 10 or above must be used.If a different PDF viewer software is used the accuracy of the presentation cannot be guaranteed. The ECG reports are located in the selected download folder.
  • Page 38 Figure 18 - ECG report Information in the ECG Report The ECG report comprises a header part and a data part. The header of the ECG report () shows the following information:(1) - Device ID / serial number, device type, recording and transmission time, event code (see the table below).
  • Page 39 Event Value Auto-triggered Pause / Asystole 0040 Auto-triggered Atrial fibrillation (AFib) start 0080 Auto-triggered Atrial fibrillation (AFib) end 0081 Auto-triggered Bradycardia during ongoing AFib 0090 Auto-triggered Tachycardia during ongoing AFib 00A0 Auto-triggered Pause / Asystole during ongoing AFib 00C0 Time interval record 1000 Time interval record during ongoing AFib 1080...

  • Page 40: Setup

    16.8 Setup The setup feature is available in the information screen which is displayed once a connection to the recorder has been established. The setup feature is not active if there are ECG data stored on the device. Download the ECG data first and delete the device memory before changing the setup.
  • Page 41 Auto-Trigger The following trigger parameters can be adjusted: Trigger Possible values Default Bradycardia OFF, 30 bpm, 40 bpm, 50 bpm, 60 Tachycardia OFF, 100 bpm, 110 bpm, 120 bpm, 130 bpm, 140 bpm, 150 bpm, 160 bpm, 170 bpm, 180 bpm, 190 bpm, 200 bpm, 210 bpm, 220 bpm, 230 bpm, 240 bpm Pause...
  • Page 42 Figure 21 - Restore default settings NOTE: This action cannot be reverted. All data on the device will be deleted and the setup will be changed to factory settings. Click "Reset Recorder" to restore factory settings. You will be redirected to the information screen and the factory settings are displayed as current setup (Figure 22).

  • Page 43: Disconnect The Device

    Figure 22 – Default settings restored 16.9 Disconnect the Device Click the button "Disconnect recorder" to unlink the USB connection. Disconnect the device plug of the Download Cable from the device. ® 78812021-EN CardioMem CM 100 XT...

  • Page 44: Description Of Automatic Rhythm Detection

    17 Description of automatic Rhythm Detection 17.1 Heart Rate Detection The heart rate is continuously calculated in beats per minute [bpm] from the time that elapses between two consecutive beats. The heart rate detection is an essential performance characteristic of the device. It works from 30 bpm to 240 bpm with a tolerance of max.

  • Page 45: Detection Of Atrial Fibrillation (Afib)

    17.3 Detection of Atrial Fibrillation (AFib) The onset of AFib will be detected once three arrhythmic changes of two consecutive RR' distances have been found within the last 16 QRS complexes. AFib continues if AFib onset has been previously detected and at least one arrhythmic change of two consecutive RR' distances was found within the last 16 QRS complexes.

  • Page 46: Disposing Of The Device, Batteries And Accessories

    18 Disposing of the Device, Batteries and Accessories Electrical devices and accessories contain metal and plastic parts. To avoid any adverse environmental impact, dispose of the device and its accessories in accordance with applicable waste regulations after the product’s lifetime has expired. If you have questions concerning the disposal of this product, contact the manufacturer or its representatives.

  • Page 47: Troubleshooting

    19 Troubleshooting Symptom Cause Recommendation Device cannot be Battery Insert a new battery switched on (LED is exhausted or no not shining) battery inserted Recording cannot be Memory Connect the device to a PC started (LED is occupied with the software CM 100 shining yellow) Configurator and switch it Start the software CM 100...

  • Page 48: Notifications (Led And Speaker)

    20 Notifications (LED and Speaker) Device Buzzer Condition / Error Green Blue Yellow Cyan Beep Device switched 1x 0,25s 0,25s 0,25s Recording in flashing, progress pause 5s Open lead flashing, 3 x 3, pause pause 1s (repeated after 15min, 60min, 24h) Battery exhausted flashing,...

  • Page 49: Accessories, Ordering Information

    21 Accessories, Ordering Information Product REF Number Protective Bag 78451002 Instructions for Use / Operator Manual 78812011 Battery Renata CR2477N Q001 12477 Single use ECG electrodes * 90131 Download Cable * 78412001 USB Cable * 78412002 CM 100 Configurator Software * 78313011 *) Not included in the delivery - order separately.

  • Page 50: Specifications

    22 Specifications 22.1 General Classification: IIa according to 93/42/EEC (MDD) Applied part type: BF (Body Floating), non- defibrillation-proof applied part. Operating time (typical): 7 ... 14 days Dimensions (W x L x H): 76 mm x 89 mm x 14 mm Weight: approx.

  • Page 51: Operating Conditions

    22.2 Operating Conditions Temperature: 5 °C to 45 °C Relative humidity: 0 % to 93 %, non-condensing Ambient pressure: 1060 hPa ... 700 hPa (-380 m ... 3000 m) 22.3 Transport and Storage Conditions Temperature: 5 °C to 45 °C Relative humidity: 0 % to 93 %, non-condensing Ambient pressure:...

  • Page 52: Electromagnetic Compatibility

    22.5 Electromagnetic Compatibility Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to EMC information provided in this document. Guidance and manufacturer’s declaration - electromagnetic emissions This device is intended for use in the electromagnetic environment specified below.
  • Page 53 Guidance and manufacturer’s declaration - electromagnetic immunity (line-bound disturbances) This device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that the device is used in such an environment. Immunity test IEC60601-1-2 Compliance...
  • Page 54 Guidance and manufacturer’s declaration - electromagnetic immunity (Conducted and radiated RF disturbances) This device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that the device is used in such an environment.
  • Page 55 **) EN 60601-1-2: 2015, table 9: Test Band a) Service a) Modulation b) Maximum Distance Immunity test frequency power level (MHz) (MHz) (V/m) 380 –390 TETRA 400 Pulse modulation 18 Hz 430 – 470 GMRS 460, FM c) FRS 460 ±...
  • Page 56 WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

  • Page 57: List Of Figures

    23 List of Figures Figure 1 – Type label ..............13 Figure 2 – Packaging label ............13 Figure 3 – Operating elements ............ 19 Figure 4 – Unlock the battery compartment ........ 21 Figure 5 – Insert a battery ............21 Figure 6 –...
  • Page 58 ® CardioMem CM 100 XT 78812021-EN...
  • Page 60 Distributor: Manufacturer: 78812021 GETEMED Medizin- und Informationstechnik AG Oderstr. 77 / 14513 Teltow / Deutschland Telephone: 03328 / 3942-0 Fax: 03328 / 3942-99 Revision 01 / 2017-11-10 info@getemed.de / www.getemed.de...

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