getemed CardioMem CM 100 XT Instructions For Use Manual Download

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78812021-EN

CardioMem

CM 100 XT

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



With known allergies or hypersensibilities to adhesives or
hydrogels;



With potentially life-threatening arrhythmias, or



Who require inpatient / hospital monitoring.

Summary of Contents for 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...

Page 2: ......

Page 3: ...2 9 2 Visual and acoustic signals 23 9 3 Lead scheme 24 10 Preparing the recording 25 10 1 Inserting the battery 25 10 2 Instructing the patient 27 10 2 1 Saving an event manually 27 10 2 2 Recording...

Page 4: ...3 12 Licence information 47 13 13 Importing recordings with CardioDay 47 14 Displaying the ECG report 48 14 1 Information contained in the ECG report 48 15 Description of the Tele ECG mode 51 15 1 Gen...

Page 5: ...marks of Adobe Systems Incorporated in the United States and or other countries Android is a brand of Google LLC The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG Inc...

Page 6: ...triggered either manually by the patient or automatically by a programmed timer or by way of an algorithm that can detect the following arrhythmias Tachycardia Bradycardia Atrial fibrillation Pause T...

Page 7: ...ight 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 With k...

Page 8: ...vice 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 4...

Page 9: ...l number SN 21 and the or der number REF 241 Barcode with kit order number REF CE mark followed by the registration num ber notified body of the manufacturer This symbol informs medical experts that t...

Page 10: ...or Use General warning sign Observe the information in the Instructions for Use for proper use of the device Serial number REF catalogue number for identification and ordering of the product Pushbutto...

Page 11: ...mois ture Fragile Indicates that the contents are fragile and should be handled with care Maximum stacking height 10 boxes The packaging is recyclable RCM Regulatory Compliance Mark Australia New Zeal...

Page 12: ...oduct or property NOTICE indicates application notes or other useful information to ensure that you get the most from the product 6 2 General warning notes WARNING NO MONITORING DEVICE The recorder is...

Page 13: ...malfunction can occur if the electrodes come into contact with electrically con ductive materials Always keep the contacts of the electrodes away from other conductive parts including earth Make sure...

Page 14: ...G HAZARD OF SUFFOCATION Small parts and packaging material represent a suffocation hazard Make sure that small parts are always out of the reach of children WARNING ELECTRIC SHOCK Before starting clea...

Page 15: ...not use the recorder if the cover of the battery compartment is missing Fit the cover before using the recorder CAUTION RISK OF INFECTION AND CONTAMINATION Reusing consumables that came into contact w...

Page 16: ...ALFUNCTION OR DAMAGE OF THE RE CORDER Any changes in temperature or humidity can cause formation of condensate inside the re corder Allow the recorder to become dry and wait an other two hours before...

Page 17: ...or defects send the recorder to an authorised work shop for checking Please enclose a detailed de scription of the noticed malfunction CAUTION ADVERSE ENVIRONMENTAL IMPACTS Electrical devices and acc...

Page 18: ...manufacturer CAUTION ELECTROMAGNETIC EMISSIONS Any other electromedical equipment in the vicinity of the recorder can impair the performance of the recorder Make sure that there is always is distance...

Page 19: ...d anti virus software and regularly updating it Install appropriate procedures to prevent infected software from reaching your computer For exam ple check the source of any software you use and use on...

Page 20: ...ed life time It is the operator s responsibility to report the need for repair to the manufacturer or one of his authorised representatives If you determine or suppose any malfunction send the recorde...

Page 21: ...time of the disinfectant 10 minutes for 70 alcohol solution Subsequently use a lint free cloth slightly moistened to remove remainders of the disinfectant The device withstands up to 700 cleaning disi...

Page 22: ...hbutton 9 1 Pushbutton The pushbutton is used to perform the following functions Function Operator action Switching on the device Press and hold down for more than a second until a beep sounds NOTICE...

Page 23: ...Flashing green red and blue Single beep Pushbutton pressed Single beep Recording in progress Flashing green Open lead Flashing orange Three beeps Memory occupied Is lit orange Bluetooth pairing acti v...

Page 24: ...24 CardioMem CM 100 XT 78812021 EN 9 3 Lead scheme The device can record acquire two channels Fig 2 A Channel 1 B Channel 2 Fig 2 Lead scheme...

Page 25: ...patient Preparing the skin of the patient Connecting the electrodes to the recorder Attaching the device to the patient Turning on the recorder Checking the signal quality 10 1 Inserting the battery...

Page 26: ...bjects 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 pl...

Page 27: ...of the recorder must always be in the range between 5 C and 45 C CAUTION Do not expose the recorder to sudden temperature or hu midity changes Do not bring the recorder in the vicinity of heat source...

Page 28: ...ce is not intended to detect life threatening events In struct the patient to call a doctor or emergency services immedi ately if he she feels unwell in the state of his her health 10 3 Preparing the...

Page 29: ...ds of the electrodes into the adapters on the rear of the recorder Fig 6 CAUTION Only use ECG electrodes that are clearly marked as such for single use Otherwise allergic skin reactions can oc cur CAU...

Page 30: ...e 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 a b c Fig 8 Attaching the device Check that all electrodes are in good contac...

Page 31: ...king 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 If the signal quality is...

Page 32: ...ccur or at regular intervals specified by the doctor An acoustic signal beep sounds to indicate that the recording was started 11 2 Automatic recording Automatic recording is always started either whe...

Page 33: ...ms have been clinically vali dated 100 detection and classification of arrhythmias cannot be guaranteed Automatic arrhythmia detection does not function properly on patients with cardiac pacemakers 11...

Page 34: ...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 t...

Page 35: ...hermore the software can be used to adapt the setting pa rameters of the recorder to the requirements of the appropriate patient 13 1 Required hardware and software To be able to run the CM 100 Config...

Page 36: ...emed net downloads CM100 CM100Configurator_Setup exe 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 lo...

Page 37: ...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: ...third par ties The responsible organisation must identify analyse evaluate and control these risks Changes to the IT network such as Changes in the configuration of the network data coupling configura...

Page 39: ...e 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 t...

Page 40: ...ck 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 recor...

Page 41: ...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 unambigu...

Page 42: ...utton in the Information window The Download window is opened Fig 16 If no data are stored in the device the download function has been deactivated Fig 16 Downloading recordings selecting the path 13...

Page 43: ...ess is completed Fig 17 The Delete window 13 9 The Setup window To change the recorder settings for a patient click on the Setup button in the Information window The Setup window is opened If no ECG d...

Page 44: ...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 ON OFF o...

Page 45: ...m the settings for pre and post event times 13 9 2 Settings for automatic detection of events The following limit values and parameters can be set Parameter Settable values Default Brady trigger bpm O...

Page 46: ...fault 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 setting...

Page 47: ...from the device 13 12 Licence information The CM 100 Configurator software uses software components that have been published under an Open Source license The li cense information can be found in the...

Page 48: ...viewer software accurate display cannot be guaranteed The ECG reports can be found in the selected download direc tory Double clicking on a file opens the ECG report in Adobe Reader Fig 21 Fig 21 ECG...

Page 49: ...systole recorded automatically 0040 Atrial fibrillation AFib start recorded automatically 0080 Atrial fibrillation end recorded automatically 0081 Bradycardia recorded automatically during ongoing AFi...

Page 50: ...racteristic 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 The time of detection of an event is highlighted by way of a...

Page 51: ...G recordings can be sent from the recorder automatically via Bluetooth short range communication to a compatible smartphone with Android operating system The recordings can then be forwarded via the I...

Page 52: ...e The operation of the smartphone is described in the correspond ing manual CAUTION Do not use the smartphone with the PhysioGate App other than as described in these Instructions Otherwise the receip...

Page 53: ...turned on It runs as a background service To open the Physio Gate App tap on the app icon Fig 24 Fig 24 Starting the PhysioGate App NOTES Always switch off the smartphone or activate the airplane mode...

Page 54: ...played when the app is opened It dis plays the data of the paired device Serial number Firmware version Number of unsent ECG re cordings stored in the device Last contact between the re corder and the...

Page 55: ...e must be paired before data transfer via Bluetooth is possible Pairing is usually performed by the manu facturer or an authorised service partner of the manufacturer If the pairing must be repeated e...

Page 56: ...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 t...

Page 57: ...CM 100 XT 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...

Page 58: ...order 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 conne...

Page 59: ...35 and Fig 36 Fig 35 Tap to display Fig 36 Licence information 15 7 Data privacy information The PhysioGate App does not collect store or transmit infor mation allowing identifications or tracking of...

Page 60: ...dycardia and tachycardia A bradycardia event is recorded once the specified pre event time has elapsed and the heart rate has fallen below the specified limit value for more than three consecutive bea...

Page 61: ...t one arrhythmic change of two consecutive RR intervals was determined during the last 16 QRS complexes AFib ends if no arrhythmic change of two consecutive RR inter vals have been found in the last 1...

Page 62: ...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...

Page 63: ...and switch it on Start CM 100 Configurator and check the recorder sta tus Download the ECG data and delete the memory of the re corder CM 100 XT Recording can not be started LED is flashing orange 3x...

Page 64: ...ossible Device not found Bluetooth on CM 100 XT is deac tivated Press and hold down the pushbutton on the CM 100 XT until a tune sounds and the LED flashes blue Repeat the Bluetooth pairing CM 100 XT...

Page 65: ...rned off or the battery is low Turn on your smartphone and recharge the battery if neces sary CardioMem CM 100 XT is not con figured for the Tele ECG mode Connect the recorder to the PC and the CM 100...

Page 66: ...and then on Connect to recorder to reset the USB connection If this does not function Exit the CM 100 Configu rator software Remove the USB down load cable the device is turned off Reconnect the USB...

Page 67: ...onnect re corder and then on Con nect to recorder to reset the USB connection If this does not function Exit the CM 100 Configu rator software Remove the USB down load cable the device is turned off R...

Page 68: ...off Reconnect the USB down load cable and restart the recorder Start the CM 100 Configu rator software Click on Connect to re corder and make the set tings anew CM 100 Configurator The Tele ECG mode...

Page 69: ...ide 78821021 Battery Renata CR2477N Q001 12477 Disposable ECG electrodes 90131 Download cable 78412001 CM 100 Download Cable Kit for the use with CardioDay Download cable Bluetooth dongle and Short in...

Page 70: ...prox 39 g incl battery Battery type 3 V lithium Renata CR2477N Operating mode Continuous mode for 14 days Battery life typical 14 days Material PC PET plastic housing Degree of protection IP64 Service...

Page 71: ...Relative humidity 0 93 non condensing Ambient pressure 1 060 hPa 700 hPa 380 m 3 000 m Wireless capabilities The recorder receives and sends electromagnetic energy so as to meet its intended purpose...

Page 72: ...ion tests Compliance Electromagnetic environment standards RF emissions acc to CISPR 11 Group 1 The device uses RF energy exclu sively to perform its internal func tions Its RF emissions are very low...

Page 73: ...is charge Floors should be made of wood concrete or ceramic tiles If the floor is covered with synthetic material the relative humidity must be at least 30 Fast electrical transients bursts acc to IEC...

Page 74: ...le RF devices is not less than 30 cm to the recorder and the leads 6V RMS in ISM bands in the range between 0 15 MHz and 80 MHz 6V RMS in bands as per Table 5 Note N Tests on the site have shown that...

Page 75: ...kHz sine 2 0 3 28 710 745 780 704 787 LTE bands 13 17 Pulse modu lation b 217 Hz 0 2 0 3 9 9 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE band 5 Pulse modu lation b 18 Hz 2 0 3 28 1720 1845 197...

Page 76: ...ARNING Do not use the device in the vicinity of or stacked with other devices since this could lead to improper operation If such a use is inevitable check this and the other de vices for normal funct...

Page 77: ...he recorder 39 Fig 14 Starting the CM 100 Configurator software 40 Fig 15 The Information screen 41 Fig 16 Downloading recordings selecting the path 42 Fig 17 The Delete window 43 Fig 18 Setup 44 Fig...

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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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