Cortrium C3+ Instructions For Use Manual
Holter monitor
Hide thumbs
Also See for C3+:
- Instructions for use and technical documentation (38 pages) ,
- Short manual (2 pages)
Subscribe to Our Youtube Channel
Related Manuals for Cortrium C3+
Summary of Contents for Cortrium C3+
-
Page 1: Instructions For Use And Technical Documentation
Instructions for Use and Technical Documentation C3+ IFU - 0723 01140 (70048) UK Page 1 of 18... -
Page 2: Table Of Contents
3.4 Interfaces 3.5 Button presses 3.6 LED light notifications 3.7 Package and device symbols 4. User instructions 4.1 Installation of C3+ Cortrium software 4.2 How to start a recording 4.3 After Use 4.4 Charging 4.5 Cleaning 4.6 Frequently asked questions 5. -
Page 3: Introduction
Data recorded by the device can be analysed 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 capacity for automatic ECG analysis and consequently no capacity for automatically generating alerts to potentially critical cardiac conditions. -
Page 4: Patient Target Group
1.2 Patient target group Cortrium C3+ is intended for adult and paediatric patients (above 10kg) who require ECG monitoring. The C3+ can be used on patients wearing an implanted pacemaker, but the C3+ does not detect pacemaker pulses (see Warnings section). -
Page 5: Warnings
Do not expose the device to strong sources of static electricity or electromagnetic 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. ●... -
Page 6: Device Description
Three third-party ECG electrodes per patient use (not supplied with device) ● The software tools 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. -
Page 7: Interfaces
The device has three electrode 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 software tools. The C3+ contains a non-replaceable, rechargeable Lithium battery. -
Page 8: Button Presses
Fast: Lead OFF detected, C3+ does not have proper contact to body. Constant: Error. Contact Cortrium or supplier White 3.7 Package and device symbols The following symbols are found on the C3+ package and device label. C3+ IFU - 0723 01140 (70048) UK... - Page 9 Device label example Symbol Description Manufacturer and Year of production Temperature limitation / temperature range - 40 degrees Celsius (while operating) ° ° - 70 degrees Celsius (while stored) ° ° Pressure limitation 700 - 1060 mBar Humidity limitation 10% - 95% Serial number (Device ID) Reference number C3+ IFU - 0723 01140 (70048) UK...
-
Page 10: User Instructions
Refer to instructions for use General 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 Medical Device Recycle: Electronic equipment CE mark with notified body identification number Company logo with name 4. -
Page 11: Installation Of C3+ Cortrium Software
4.1 Installation of C3+ Cortrium software Before using the C3+, download and install the software 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 the software. - Page 12 4. Attach device to patient 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+ 5.
-
Page 13: After Use
Press the button The green light will flash The C3+ is now recording 4.3 After Use When recording has ended, remove the device from the patient (patient may have done this already). Detach ECG electrodes, and dispose of them. Connect the C3+ to a PC via USB cable. Extract recordings using Cortriums’... -
Page 14: Frequently Asked Questions
5.1 Maintenance The C3+ device contains no user serviceable parts, cannot be opened, and does not require routine maintenance. If a problem with the C3+ is experienced, contact Cortrium or your local supplier. Cortrium service contact: Cortrium ApS - Erik Husfeldts Vej 7 - DK-2630 Taastrup - Denmark email: support@cortrium.com - Website: www.cortrium.com... -
Page 15: Warranty
● 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+ should be disposed of in accordance with the EU WEEE directive for electronic waste. -
Page 16: Regulatory Information
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 6.2 Regulatory information The C3+ is a class IIa medical device according to 93/42/EEC. The C3+ complies with the following product standards: DS/EN 60601-1-1 Safety Requirements for Medical Electrical Systems... -
Page 17: Serious Incidents
6.3 Serious Incidents In case of serious incidents in relation to the device, please contact your local competent authority as well as Cortrium support@cortrium.com without undue delay. 6.4 Declaration of conformity The C3+ is in conformity with the essential requirements and provisions of the EU Medical Device Regulation (MDR). - Page 18 Cortrium ApS Erik Husfeldts Vej 7 DK-2630 Taastrup Denmark • • • Email: info@cortrium.com Website: www.cortrium.com • Cortrium C3+ UDI 05745000379002 C3+ IFU - 0723 01140 (70048) UK Page 18 of 18...
Need help?
Do you have a question about the C3+ and is the answer not in the manual?
Questions and answers