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Summary of Contents for getemed CardioMem CM 100 XT
- Page 1 Instructions for Use CardioMem CM 100 XT ® ECG Loop Recorder Revision 05 EN Cardiac Diagnostics Vital Signs Monitoring Telemonitoring...
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Page 3: Table Of Contents
Contents Information about this Manual ..........5 Intended use ................6 Indications and contraindications .......... 7 Indications ..............7 Contraindications ............7 Regulatory information ............8 MDR compliance ............8 Radio frequency compliance ......... 8 Classifications ..............8 Labelling ................9 Safety information .............. - Page 4 13.1 Required hardware and software ........ 35 13.2 Installation ..............36 13.3 Checking the system time ..........37 13.4 Connecting the USB download cable to recorder and PC ................. 38 13.5 Turning on the recorder ..........39 13.6 Starting the CM 100 Configurator software ....40 The “Information”...
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Page 5: Information About This Manual
Google LLC. The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc., and any use of such marks by GETEMED is under license. CardioMem, CardioDay and PhysioGate are trademarks owned by GETEMED. Other company and product names mentioned herein are trade- marks of their respective companies. -
Page 6: Intended Use
2 Intended use 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 on patients whose symptoms oc- cur infrequently; Document the impact of an initiating drug therapy for ar- rhythmias;... -
Page 7: Indications And Contraindications
3 Indications and contraindications 3.1 Indications CardioMem CM 100 XT is intended for adult and pediatric pa- tients (weight >10 kg) who require monitoring of the following car- diac arrhythmias: Tachycardia, bradycardia, atrial fibrillation, and pause. 3.2 Contraindications Contraindications include the use on patients ... -
Page 8: Regulatory Information
4 Regulatory information 4.1 MDR compliance The CE Mark and Notified Body Registration Number signifies the device including accessories meets all general safety and perfor- mance requirements of the Medical Device Regulation (EU) 2017/745 (MDR). 4.2 Radio frequency compliance The CE Mark signifies the device including accessories meets all essential requirements of the Radio Equipment Directive 2014/53/EU (RED). -
Page 9: Labelling
5 Labelling The following symbols are used on the recorder and / or on the packaging: CardioMem CM 100 XT Device type (CardioMem CM 100), model (XT) The name and address of the manufac- turer are specified to the right of this sym- bol.The date of manufacture is specified... - Page 10 This symbol refers to the obligation to dis- pose of the recorder in accordance with the relevant environmental regulations. For further information, refer to the “Dis- posal of device, batteries and accessories” section on page 62. Observe the Instructions for Use. Before starting work with the recorder, make sure that you have read and under- stood the Instructions for Use.
- Page 11 Keep away from heat Indicates that the recorder must be kept away from heat sources Keep dry Indicates that the recorder must be kept away from rain and other sources of mois- ture Fragile Indicates that the contents are fragile and should be handled with care Maximum stacking height: 10 boxes The packaging is recyclable.
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Page 12: Safety Information
WARNING NO MONITORING DEVICE The recorder is not intended for monitoring of the clinical condition of a person. Do not use CardioMem CM 100 XT as a monitor- ing device. WARNING MIXING UP RECORDINGS The patient's life or health can be put at risk if the... - Page 13 Always disconnect the recorder form the patient before using an electrosurgical device. WARNING EXPLOSION HAZARD Electrical sparks can cause explosions in the presence of certain gases. Do not use the recorder in an oxygen-enriched environment or in the vicinity of flammable or ex- plosive gases.
- Page 14 If so, observe the following standard procedures for handling contaminated objects and the follow- ing safety notes: Always use protective gloves when touching the equipment. Isolate the material by using appropriate packaging and labelling. Contact the addressee and label the packaging accordingly before shipping the equipment.
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Page 15: General Precautions
For example, pets can cause damage from biting or exude fluids over the recorder and its accesso- ries. Vermin can also cause damage impairing the functioning of the device. Make sure that no pets or vermin come into con- tact with the device or its accessories. 6.3 General precautions CAUTION CONDUCTIVITY... - Page 16 CAUTION DAMAGE TO THE DEVICE ARISING FROM LEAKING BATTERIES Batteries may leak if not used for longer. Always remove the battery from the recorder if you intended not to use the recorder for longer than a week. CAUTION INSUFFICIENT RECORDING QUALITY Damaged recorders or accessories can lead to in- sufficient ECG quality.
- Page 17 CAUTION SAFETY AND RELIABILITY ONLY WITH PROPER MAINTENANCE Proper maintenance is vital for long-term safety and reliability. Observe the information provided in this Manual to ensure proper maintenance. CAUTION DAMAGE TO DEVICE AND ACCESSORIES Unauthorised personnel do not have the proper training required to repair the recorder.
- Page 18 recording. For further information, see Section “Instructing the patient”. CAUTION ELECTROMAGNETIC EMISSIONS The use of accessories other than those specified or provided by the manufacturer could result in in- creased electromagnetic emissions or decreased electromagnetic immunity of the recorder, result- ing in improper operation.
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Page 19: Incident Reporting
CAUTION REPAIR AND MAINTENANCE Repair by inadequately trained personnel could result in hazards, e.g. due to excessive tempera- tures or high voltages. Only the electrodes and battery may be replaced by the patient. Repairs must only be performed by persons who are authorised by the manufacturer to do so. -
Page 20: Warranty And Service Information
Please add a detailed error description. If you determine an unexpected operational condition or unex- pected occurrences or if you need technical support, contact the manufacturer under the following address: GETEMED Medizin- und Informationstechnik AG Oderstr. 77, 14513 Teltow, Germany www.getemed.de ® CardioMem... -
Page 21: Cleaning And Disinfection
Disinfect the device at regular intervals, prior to first use and be- fore passing it on to another person. GETEMED recommends to use a 70% alcohol solution for disin- fection. Please note the application time of the disinfectant (10 minutes for 70% alcohol solution). -
Page 22: Operating Elements
9 Operating elements The recorder possesses a pushbutton (1), a LED status indicator (2) and a buzzer (Fig. 1). The following symbol can be found on the pushbutton: Fig. 1 – Operating elements 9.1 Pushbutton The pushbutton is used to perform the following functions: Function Operator action Switching on the device... -
Page 23: Visual And Acoustic Signals
9.2 Visual and acoustic signals The recorder states are indicated by way of a multi-colour LED status indicator and acoustic signals: Recorder status LED status indicator Buzzer Device is starting Flashing green, red and Single beep blue Pushbutton pressed Single beep Recording in progress Flashing green Open lead... -
Page 24: Lead Scheme
9.3 Lead scheme The device can record acquire two channels (Fig. 2): A = Channel 1 B = Channel 2 Fig. 2 – Lead scheme ® CardioMem CM 100 XT 78812021-EN... -
Page 25: Preparing The Recording
10 Preparing the recording You may set the limit values of automatic heart rate detection for each patient individually, as explained in the “The “Setup” win- dow” section on page 43. To prepare the recording, in addition, perform the following steps: ... - Page 26 CAUTION Do not apply too much force. The recorder could be dam- aged. CAUTION Always use a ballpoint pen. Do not use sharp or pointed objects. They could cause injuries. Remove the cover of the battery compartment. Insert a new CR2477N 3V lithium battery. Observe the polarity. Push the battery under the battery clip until it snaps into place (Fig.
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Page 27: Instructing The Patient
10.2 Instructing the patient It is the responsibility of the doctor to provide the patient with the following information required for safe use of the recorder. CAUTION If you have any skin problems, inform the doctor. In rare cases, allergic reactions can also occur with biocompati- ble electrodes. -
Page 28: Recording Diary
10.2.2 Recording diary We recommend having the patient maintain a diary to record ac- tivities, symptoms and the corresponding times during the ECG recording. The header of the diary should include data required to identify the patient and recording and for the medication taken during the recording. -
Page 29: Connecting The Electrodes To The Recorder
10.4 Connecting the electrodes to the recorder Place the recorder with the front side down to a level surface (ta- ble). Take three new disposable ECG electrodes. Do not yet remove the protective film from the contact sides of the electrodes. Snap the studs of the electrodes into the adapters on the rear of the recorder (Fig. -
Page 30: Attaching The Device To The Patient
10.5 Attaching the device to the patient Carefully remove the protective film from the electrodes (Fig. 7). Fig. 7 – Removing the protective film Place the recorder on the sternum (a), the upper left chest (b) or, turned by 180°, on the sternum (c) and gently press (Fig. 8). Fig. -
Page 31: Turning On The Recorder
10.6 Turning on the recorder Press the pushbutton until a beep sounds. A colour sequence is displayed on the LED to indicate that the recorder is starting (Fig. Fig. 9 – Turning on the recorder 10.7 Checking the signal quality If the signal quality is good and the recorder is not in an open lead condition, the LED flashes green to indicate that the recorder is ready to operate. -
Page 32: Recording An Event
11 Recording an event The device records events either when the patient presses the pushbutton, automatically when settable limit values are ex- ceeded or specified target values are not reached, or at settable time intervals. You can set the pre- and post-event times as explained in the “The “Setup”... -
Page 33: Time-Triggered Recording
For more information, refer to the “The “Setup” window” section on page 43 and the “Description of automatic rhythm detection” section on page 60. NOTICE Even though the algorithms have been clinically vali- dated, 100% detection and classification of arrhythmias cannot be guaranteed. -
Page 34: End Of Recording
12 End of recording Carefully disconnect the recorder form the electrodes and remove the battery to stop recording. The recording automatically stops in the following situations: Full memory Low battery 12.1 Removing the electrodes Slowly peel off the electrodes, starting at their outer edges. Dis- pose of the used electrodes in the household waste. -
Page 35: Using The Cm 100 Configurator Software
13 Using the CM 100 Configurator software The CM 100 Configurator software is an accessory for Cardi- oMem CM 100 XT. It is intended for use by trained medical pro- fessionals (users) in medical institutions. The software runs on PCs on which the Microsoft Windows operating system is in- stalled. -
Page 36: Installation
It installs all program files and the USB driver required for com- munication with the device CardioMem CM 100 XT. Copy the installation file to a local folder on your PC. Double-click on the installation file to start the installation process. -
Page 37: Checking The System Time
Fig. 11 – Download path You will be asked whether you wish to create a program icon on your desktop. Then you can start the installation with the specified settings. NOTICE It is recommended to uninstall an existing installation of the CM 100 Configurator software and to make a backup of all stored ECG data before installing a new version of the soft- ware. -
Page 38: Connecting The Usb Download Cable To Recorder And Pc
13.4 Connecting the USB download cable to recorder and PC WARNING RISK OF ELECTRIC SHOCK – Only use the USB down- load cable supplied by GETEMED to connect the re- corder to a PC. CAUTION Make sure that the PC complies with the latest version of the IEC 60950 standard for safety of IT equipment. -
Page 39: Turning On The Recorder
Open the battery compartment of the recorder (1) and remove the battery (2). Insert the device connector of the download cable into the socket (see illustration) of the recorder (3) as shown in (Fig. 12). Fig. 12 – Connecting the device connector of the download cable to the recorder 13.5 Turning on the recorder Press the pushbutton to turn on the recorder (Fig. -
Page 40: Starting The Cm 100 Configurator Software
13.6 Starting the CM 100 Configurator software Double-click on the appropriate icon on the desktop to start the application. The starting window that then appears displays the software version and manufacturer information. Click on the button “Connect to recorder” to establish the commu- nication (Fig. -
Page 41: The "Information" Screen
13.7 The “Information” screen The “Information” screen is displayed after the communication has been established between the recorder and the “Configura- tor” software. Fig. 15 – The “Information” screen Buttons for opening further windows are displayed on the left- hand side of the “Information” screen. Furthermore, the serial number of the connected recorder, the number of the ECG data stored on the device and further infor- mation for unambiguous identification of the appropriate recorder... -
Page 42: The "Download" Window; Downloading A Recording
13.8 The “Download” window; downloading a recording WARNING The patient's life or health can be put at risk if the patient is assigned an examination of a different patient, resulting in an incorrectly assigned diagnosis. Click on the “Download” button in the “Information” window. The “Download”... -
Page 43: Deleting Data On The Recorder
13.8.2 Deleting data on the recorder Click first on the “Delete” button and then on “Delete recordings” to delete all data in the memory of the recorder (Fig. 17). The number of stored ECG files is displayed in the upper left cor- ner of the “Download”... - Page 44 The individual trigger limits The heart rate limit values for automatic recording of tachycardia or bradycardia and the limit value in seconds from which a “pause” is detected and recorded. ON/OFF of automatic atrial fibrillation detection (AFib) TIR trigger (time interval recording) The time interval for automatic time-triggered ECG re- cording...
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Page 45: Pre- And Post-Event Times
13.9.1 Pre- and post-event times The following settings are possible: Pre/post (s) 25 / 15 45 / 15 * 30 / 30 60 / 30 60 / 60 Length of ECG record- ing (s) (*) = default setting The “Length of ECG recording” results from the settings for pre- and post-event times. -
Page 46: The "Default Settings" Window
The “Default settings” window 13.10 To restore the factory settings, click the “Default settings” button in the “Information” window. The “Default settings” window is opened (Fig. 19). Fig. 19 – Default settings NOTICE This action cannot be undone! All saved data and settings are deleted, and the setup of the recorder is reset to the factory settings. -
Page 47: Disconnecting The Recorder
Fig. 20 – Factory settings restored 13.11 Disconnecting the recorder Click on the “Disconnect recorder” button to disconnect the USB connection. Remove the device connector of the download cable from the device. 13.12 Licence information The CM 100 Configurator software uses software components that have been published under an Open Source license. -
Page 48: Displaying The Ecg Report
14 Displaying the ECG report WARNING To evaluate ECG reports, use the software “Adobe Reader”, version 10 or higher. If you use a different PDF viewer software, accurate display cannot be guaranteed. The ECG reports can be found in the selected download direc- tory. - Page 49 Fig. 22 – ECG report, header area The following information is displayed in the header of the ECG report (Fig. 22): (1) – Device ID / serial number, device type, recording and trans- mission time, event code (see table below). The event code is displayed as a four-digit number: Event Value...
- Page 50 (3) – Heart rate information, minimum, maximum and mean heart rates, number of detected QRS complexes The data area of the ECG report displays the ECG characteristic with a recording speed of 25 mm/s and an amplitude of 10 mm/mV. The number of pages depends on the length of the ECG record- ing.
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Page 51: Description Of The "Tele Ecg" Mode
To this end, the PhysioGate App must be installed on the smartphone. Upon the customer's request, CardioMem CM 100 XT is delivered with a smartphone with the PhysioGate App preinstalled. It is not possible to use smartphones not provided by GETEMED. - Page 52 Fig. 23 – Tele ECG ECG recordings that have been successfully transmitted via Blue- tooth are deleted in the memory of the recorder. Failed transmis- sions are repeated automatically after 15 minutes, 1 hour and 24 hours. New ECG recordings will reset the timer. If the Bluetooth transmission fails permanently, it is also possible to download the ECG recordings via the USB connection by way of the CM 100 Configurator software.
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Page 53: Starting The Physiogate App
The Bluetooth transmission works within a range of approx. 5 metres. The patient should always carry the smartphone with the PhysioGate App with him. 15.2 Starting the PhysioGate App The PhysioGate App starts automatically when the smartphone is turned on. It runs as a background service. To open the Physio- Gate App, tap on the app icon (Fig. -
Page 54: Operating The Physiogate App
15.3 Operating the PhysioGate App The PhysioGate App provides three screens which are called by tapping on the appropriate title in the menu bar. The HOME screen (Fig. 25) is dis- played when the app is opened. It dis- plays the data of the paired device: ... -
Page 55: Bluetooth Pairing
Press the pushbutton to turn on the re- corder. Press and hold down the pushbutton (>5 s) to activate Bluetooth on CardioMem CM 100 XT until a tune sounds and the LED flashes blue (Fig. 28). Fig. 28 – Activating Bluetooth ®... - Page 56 Open the PhysioGate App on your smartphone. Open the PAIRING screen. Tap on SEARCH DEVICES (Fig. 29). Fig. 29 – Searching for de- vices Available devices are displayed in a list. Tap on the entry of a device in the list you wish to pair with the recorder (Fig.
- Page 57 Click on YES to confirm the attempt of pairing (Fig. 31). Fig. 31 – Confirmation of the pairing attempt Confirm the pairing request (Fig. 32). A tune indicates that the pairing was successful. Fig. 32 – Request confirmation ® 78812021-EN CardioMem CM 100 XT...
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Page 58: Checking The Transmission
15.5 Checking the transmission Prepare the recorder, switch on and attach to the patient as de- scribed above. Switch on the smartphone on which the PhysioGate App is in- stalled. Open the PhysioGate App, select the INFO screen and check that the connectivity status (WWW) is “OK” (Fig. 33 and Fig. -
Page 59: Licence Information
The assign- ment of ECG recordings to a certain patient lies in the responsibil- ity of the doctor. NOTICE Inform GETEMED immediately if your smartphone on which the PhysioGate App has been installed is lost or was stolen. ® 78812021-EN... -
Page 60: Description Of Automatic Rhythm Detection
16 Description of automatic rhythm detection 16.1 Heart rate detection The heart rate in beats per minute [bpm] is continuously calcu- lated from the interval of two consecutive R waves. Heart rate de- tection is an essential feature of the recorder. Heart rates in the range between 30 bpm and 240 bpm are detected with a toler- ance of max. -
Page 61: Detection Of Atrial Fibrillation (Afib)
The automatic recording of events is suppressed if Open leads are detected by the recorder; Signal noise is detected or The calculated heart rate is not valid. 16.3 Detection of atrial fibrillation (AFib) The onset of AFib is detected once three arrhythmic changes of two consecutive RR' intervals have been determined within the last 16 QRS complexes. -
Page 62: Disposal Of Device, Batteries And Accessories
17 Disposal of device, batteries and accessories Electrical devices contain metal and plastic parts. To avoid envi- ronmental damage, the recorder and its accessories must only be disposed of in accordance with the relevant disposal directives at the end of their service life. If you have any questions regarding the disposal of the product, do not hesitate to contact the manufacturer or its representatives. -
Page 63: Troubleshooting
18 Troubleshooting Symptom Cause Remedy CM100 XT: Low battery or no Insert new battery. battery inserted Device cannot be turned on (LED is not lit). CM 100 XT: Memory full recorder Connect the to the PC and the CM 100 Configu- Recording can- rator software and switch it not be started... - Page 64 Symptom Cause Remedy CM 100 XT: General device er- Remove and reinsert the bat- tery. Device does not switch to normal If the problem persists, con- mode tact your dealer or the service representative of the manu- (LED is flashing facturer.
- Page 65 Symptom Cause Remedy Bluetooth is disa- Enable Bluetooth, see manual bled on your of your smartphone. smartphone. “Mobile Data” or Turn on “Mobile Data” and “Data Roaming” is “Data Roaming”. turned off on your See manual of your smartphone. smartphone. Airplane mode is Deactivate the airplane turned on on your...
- Page 66 Symptom Cause Remedy CM 100 Either the USB Connect the USB download Configurator: download cable is cable to the PC. not connected to Error in the USB Turn on the recorder (the LED the PC or the CM connection is lit orange after the starting 100 XT is turned sequence) and click on the off.
- Page 67 Symptom Cause Remedy (Error! No data saved!). CM 100 Program installa- Install the CM 100 Configura- Configurator: tion defective or tor anew. Repeat the down- damaged. load. The ECG report could not be cre- ated. (Error! No PDF file created!). Click on “Disconnect re- CM 100 Communication er-...
- Page 68 Symptom Cause Remedy (Error! Setup not Remove the USB down- transferred!). load cable (the device is turned off). Reconnect the USB down- load cable and restart the recorder. Start the CM 100 Configu- rator software. Click on “Connect to re- corder”...
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Page 69: Information Regarding Consumables And Accessories
19 Information regarding consumables and accessories Designation REF / order number Protective bag 78451002 Instructions for Use 78812021 Brief Guide 78821021 Battery Renata CR2477N Q001 12477 Disposable ECG electrodes * 90131 Download cable * 78412001 CM 100 Download Cable Kit for the use with 78412001-1 CardioDay * (Download cable, Bluetooth dongle and Short... -
Page 70: Specifications
20 Specifications 20.1 General Classification: IIa acc. to MDR (EU) 2017/745 Type of applied part: BF (body floating), non-defibrillation-proof applied part Application time (typical): 7 ... 14 days Dimensions (W x L x H): 76 mm x 89 mm x 14 mm Weight: Approx. - Page 71 Operating conditions Temperature range: 5 °C ... 45 °C Relative humidity: 0% ... 93%, non-condensing Ambient pressure: 1,060 hPa ... 700 hPa (-380 m ... 3,000 m) Transport and storage conditions Temperature range: -20 °C ... 60 °C Relative humidity: 0% ...
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Page 72: Electromagnetic Compatibility
20.2 Electromagnetic compatibility Medical electric devices require special precautions with regard to electromagnetic compatibility (EMC) and are to be installed and commissioned in accordance with the information provided in this document. Guidelines and manufacturer's declaration - Electromagnetic emissions The recorder is intended for operation in electromagnetic environ- ments as specified below. - Page 73 Guidelines and manufacturer's declaration - Electromagnetic interference immunity (conducted disturbances) The recorder is intended for operation in electromagnetic environ- ments as specified below. It is to be guaranteed by the customer or user of the device that it is only operated in such environments. Noise immunity IEC60601-1-2 Compli-...
- Page 74 Standards and manufacturer's declaration - Electromagnetic interference immunity (conducted and radiated RF disturb- ances) The recorder is intended for operation in electromagnetic environ- ments as specified below. It is to be guaranteed by the customer or user of the device that it is only operated in such environments. Interference im- IEC60601-1-2 Compliance...
- Page 75 **) EN 60601-1-2: 2015, Table 9: Test Band a) Service a) Modulation Maxi- Dis- Immunity fre- tance test level quency (MHz) power (V/m) (MHz) 380 ... TETRA 400 Pulse modu- lation b) 18 Hz 430 ... GMRS 460, FM c) FRS 460 ±...
- Page 76 NOTICE To achieve the required immunity test level, the distance be- tween the transmitting antenna and the ME device or ME sys- tem can be reduced to 1 m where necessary. The test dis- tance of 1 m is permitted in accordance with IEC 61000-4-3. a) For a few services, only the uplink frequencies are provided.
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Page 77: List Of Figures
21 List of figures Fig. 1 – Operating elements ............22 Fig. 2 – Lead scheme ..............24 Fig. 3 – Opening the battery compartment ........25 Fig. 4 – Inserting the battery ............26 Fig. 5 – Closing the battery compartment ........26 Fig. - Page 80 GETEMED Medizin- und Informationstechnik AG Oderstr. 77 / 14513 Teltow / Germany Telephone: 03328 / 3942-00 Telefax: 03328 / 3942-99 Revision 05 EN / 2021-10-25 info@getemed.de / www.getemed.de...
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