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CardioMem

CM 100 XT

78812021-EN

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).

4.3 Classifications

(EU) 2017/745 (MDR) classification

Class IIa

Protection against electric shock

Type BF, non-defibrillation-
proof applied part

Mode of operation

Continuous

Method(s) of sterilisation recom-
mended by the manufacturer

Not applicable

Содержание CardioMem CM 100 XT

Страница 1: ...Instructions for Use CardioMem CM 100 XT ECG Loop Recorder Revision 05 EN Cardiac Diagnostics Vital Signs Monitoring Telemonitoring...

Страница 2: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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Страница 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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