Cortrium C3+, Instructions For Use And Technical Documentation

Page 1: ...Instructions for use and technical documentation ...

Page 2: ...Cortrium C3 Holter Monitor Instruction for use and technical documentation Ver 1 0 Rev 02 EN Issue date 2019 10 14 ...

Page 3: ...ftware 6 2 Safety information 7 2 1 Notes on proper C3 use 7 2 2 Warnings 7 3 Device description 9 3 1 Included components 9 3 2 Accessories 9 3 3 Device layout and light 9 3 4 Interfaces 11 3 5 Button presses 11 3 6 LED light notifications 12 3 7 Package and device symbols 13 ...

Page 4: ...fter use 20 4 4 Charging 21 4 5 Cleaning 21 4 6 Frequently asked questions 22 5 Maintenance storage and disposal 23 5 1 Maintenance 23 5 2 Storage 23 5 3 Warranty 23 5 4 Disposal 23 6 Technical and regulatory information 24 6 1 Technical specification 24 6 2 Regulatory information 26 6 3 Declaration of conformity 27 ...

Page 5: ...nternal memory Additionally the C3 has a built in Bluetooth module for streaming live data to a mobile app in order for the healthcare personnel to visually verify signal quality of the ECG Data recorded by the device can be analyzed by other processing software to provide reports This software can be either third party or designed maintained and or owned by Cortrium The C3 hardware has no capacit...

Page 6: ...ool software tool found at www cortrium com Cortrium Data Transfer Tool is required to prepare the C3 for use on patients and for extracting recordings after use Instructions for Cortrium Data Transfer Tool can be found at www cortrium com Further the C3 is compatible with the CE marked 3rd party software CUBE by Cardioline and CE marked software Cardiomatics Additionally it is possible to export ...

Page 7: ...althcare professional The patient should always be walked through all required instructions before wearing the device The data recorded by the C3 can only be used to diagnose heart related diseases such as atrial fibrillation and arrhythmias when reviewed by a properly trained healthcare professional e g a cardiologist ECG electrodes not supplied by Cortrium may cause a patient s skin to react wit...

Page 8: ... fields Do not leave C3 on top of or next to other electrical equipment Do not use C3 with cables different than the one provided by Cortrium Do not submerge the C3 in liquid Do not clean the C3 with agents other than those listed in the cleaning instructions in this manual Do not damage the C3 through drops violent shaking or crushing Do not use the C3 on patients with highly sensitive skin or kn...

Page 9: ...l 3 2 Accessories The C3 requires the following to function as intended Three third party ECG electrodes per patient use not supplied with device The Cortrium Data Transfer Tool software found on www cortrium com 3 3 Device layout and light The C3 has three connectors for ECG electrodes a single button at the center as well as an LED indicator A USB port can be found on the back of the device The ...

Page 10: ...trode connectors C3 recordings are stored in an internal memory Recordings can be transferred and removed from the device via the device s micro USB port when interfaced with the Cortrium Data Transfer Tool software The C3 contains a non replaceable rechargeable Lithium battery The C3 is recharged via the device s micro USB port ...

Page 11: ...a PC using the accompanying USB cable and iOS mobile devices using Bluetooth 3 5 Button presses Press pattern Meaning Single press Turn on Mark event Double press Activate Bluetooth Long press 3 seconds Turn off Note Device must not have connection to body ...

Page 12: ... progress Turning ON Event button pressed Fully charged Blue Slow Fast Streaming Bluetooth Pairing with Bluetooth Yellow Slow Fast Constant Memory full Low battery Turning off Charging White Fast Constant Lead OFF detected C3 does not have proper contact to body Error Contact Cortrium or supplier ...

Page 13: ...13 3 7 Package and device symbols The following symbols are found on the C3 package and device label Device label example ...

Page 14: ...ufacturer Year of manufacture Temperature limitation temperature range 5 40 degrees Celsius while operating 25 70 degrees Celsius while stored Pressure limitation 700 1060 mBar Humidity limitation 10 95 Serial number Device ID ...

Page 15: ...neral warning sign Refer to warning section Protected against solid foreign objects degree 5 dust protected Protected against ingress of water degree 4 protected against splashing water from any direction Type BF applied part Recycle Electronic equipment ...

Page 16: ...16 CE mark with notified body identification number Company logo with name ...

Page 17: ...trium Data Transfer Tool from www cortrium com When the C3 is connected to a PC the device will appear as a Mass Storage Device that can be opened by Cortrium Data Transfer Tool 4 2 How to start a recording Before starting a new recording make sure that the C3 is sufficiently charged as described in section 4 5 and it has been setup for the intended recording using Cortrium Data Transfer Tool ...

Page 18: ...have all hair in the area where the electrodes will be placed Clean and abrade the skin with a cotton swab and appropriate alcohol denat 80 2 Attach electrodes to each electrode connector 3 Remove plastic from electrodes ...

Page 19: ...atient Make sure the adhesive sticks properly to skin Make sure there is no air left between adhesive and skin Make sure that there is no hair underneath the electrode The dashed outline shows alternative placement of the C3 ...

Page 20: ...When recording has ended remove the device from the patient patient may have done this already 2 Detach ECG electrodes and dispose of them 3 Connect the C3 to a PC via USB cable 4 Extract recordings using Cortrium Data Transfer Tool 5 Clean and store the C3 according to instructions in section 4 5 and 5 2 ...

Page 21: ...the C3 to a charger or PC with the USB cable Never do this while user or patient is in contact with the electrode connectors 3 Maintain USB connection to the charger or PC until the light indicator turns continuously green 4 5 Cleaning In order to protect patients against risk of cross contamination the C3 should be cleaned and disinfected in preparation for a new patient sterilisation is not requ...

Page 22: ... the PC when preparing for a new patient If the time is incorrect just setup the device for a new patient and the device will automatically set the clock to the same time as the PC 1 3 Do I need software for downloading measurement data from the C3 Yes as a minimum you need Cortrium Data Transfer Tool which can be downloaded from www cortrium com 1 4 My C3 does not start what might cause this prob...

Page 23: ...ocations in which the device would be exposed to Temperatures lower than 25 or higher than 70 Celsius Air humidity outside 10 95 Heavy contamination from dirt or other foreign agents Running water Strong electromagnetic forces 5 3 Warranty The C3 has a warranty of 2 years from the date of purchase 5 4 Disposal The C3 should be decommissioned when it reaches the end of its service life The C3 shoul...

Page 24: ...ar Time Up to 7 days Recording Format Continuous Power Requirement Lithium Polymer 3 7V 520 mAh Dimensions 85 x 80 x 15 mm Weight 32 grams Sampling Rate 256 Hz Input Impedance 10 Mohm Resolution 24 bit Performance Standard Design verification IEC 60601 2 47 Safety Safety Standard IEC 60601 1 Basic Safety Essential Perfor mance IEC 60601 2 47 ...

Page 25: ...days continued contact Mucosal membrane contact N A Sterile or non sterile Non sterile Biological compatibility ISO 10993 5 ISO 10993 10 Clinical Medical purpose Ambulatory ECG Single use reusable Reusable Rechargeable Monitor Recording standard Holter Recording format Continuous Intended placement Midsternal line Recording period Up to 7 days on a single charge ...

Page 26: ...al Usability DS EN 60601 1 11 Home Healthcare Environment DS EN 60601 2 47 Particular requirements for the basic safety and essential performan ce of ambulatory electrocardiographic systems DS EN 62366 1 Application of usability engineering to medical devices DS EN ISO 10993 1 Biological evaluation of medical devices DS EN ISO 15223 1 Symbols to be used with medical devices labels labeling and inf...

Page 27: ...lity EMC standard for radio equipment and services Part 17 EN 300 328 V2 1 1 Wideband transmission systems Data transmission equipment operating in the 2 4 GHz ISM band 6 3 Declaration of conformity The C3 is in conformity with the essential requirements and provisions of the EU Medical Device Directive MDD 2 2 COUNCIL DIRECTIVE 93 42 EEC of 14 June 1993 concerning medical devices ...

Page 28: ...Cortrium ApS Erik Husfeldts Vej 7 DK 2630 Taastrup Denmark Email info cortrium com Website www cortrium com Ver 1 0 Rev 02 EN Issue date 2019 10 14 ...

Page 29: ...Appendix A Cortrium Data Transfer Tool Instructions for Use Cortrium Cortrium Data Transfer Tool Instructions for Use ...

Page 30: ... Cortrium Data Transfer Tool please follow the instructions below 1 On a computer running Windows 7 or 10 use an internet browser to visit the Cortrium website www cortrium com and download the Cortrium Data Transfer Tool 2 When the download is complete locate the downloaded file on the computer It will be a zipped compressed folder Unzip uncompress the folder by right clicking the folder and sele...

Page 31: ...er Cortrium Data Transfer Tool will open a window listing connected C3 devices 1 2 Prepare C3 for a new patient If the C3 has been used to make recordings from a patient please refer to the section titled Transfer recordings from C3 before following the steps in this section 1 Make sure the C3 is fully charged 2 Turn on the computer that the Cortrium Data Transfer Tool was installed on 3 Connect t...

Page 32: ... Data Transfer Tool will appear when a C3 is connected via USB 5 Click on the C3 identifier in the list of devices to select the C3 6 Click on the pop up menu called Prepare for new patient and choose the desired recording length ...

Page 33: ...rdings on the C3 will be deleted and ask if you want to proceed 8 If you choose to proceed to prepare for a new patient Cortrium Data Transfer Tool will open a dialog box where you can specify patient information Please fill in any applicable information and proceed by clicking OK ...

Page 34: ...is section Important this procedure can only be completed if the third party software is already installed or you have an online account for the chosen software 1 Make sure the C3 is fully charged 2 Turn on the computer that the Cortrium Data Transfer Tool was installed on 3 Connect the C3 to the computer via the included USB cable 4 Cortrium Data Transfer Tool will open and show a list of connect...

Page 35: ... transferred over the internet for analysis or stored locally depending on your choice in step 7 10 To transfer and convert additional recordings please repeat steps 6 9 11 When you have completed transfer and conversion of recordings proceed to prepare the C3 for a new patient please see the section titled Prepare C3 for a new patient Alternatively safely eject the C3 by clicking the Eject button...

Page 36: ...Appendix B iOS App Instructions for Use Cortrium C3 iOS app Instructions for Use ...

Page 37: ...ize the data on you iPad please note This app does not possess the ability to analyze and should not be used to make direct diagnostic evaluations It is currently only for visualization of signal quality Please use the data stored on the C3 for interpretation and analysis You can find the Cortrium C3 iOS app in the app store Comment Screen shots Press the Cortrium C3 app icon to open the app The m...

Page 38: ...Choose from the listed C3 devices Or cancel pairing The ECG will appear on the screen To disconnect press disconnect ...