Use Instructions
Table Of Contents
- GLOSSARY & ACRONYMS
- PART 1. GENERAL SYSTEM INFORMATION
- 2. INDICATIONS AND CONTRAINDICATIONS FOR USE
- 3. WARNINGS AND PRECAUTIONS
- CAUTION
- 6. BASELINE MEASUREMENT PREPARATION AND DEVICE SETUP
- 8. THE ALIGNMENT TOOL
- PART 3. AT-HOME CPM SYSTEM USE
- PART 4. LIGHTS, SOUNDS, AND TROUBLESHOOTING
- 12. CPM DEVICE LIGHTS AND SOUNDS
- 13. BASE STATION INDICATIONS
- 14. BUTTON PRESSES
- 15. GENERAL TROUBLESHOOTING / FAQS
- 15.1 Physician Q&As
- Q: No data from my patient is appearing on the server, but after getting in touch with the patient, they say that they have been taking measurements consistently with no issue and their device is connected to a plugged- in Base Station.
- Q: No size of the CPM Device fits my patient.
- Q: I initiated a patient mode measurement while trying to put the device into Bluetooth pairing mode and now I can’t pair the CPM Device to the Mobile App.
- Q: How do patients get more adhesives when they run out?
- Q: Can the CPM System be used near other electronic or medical equipment such as telephones, televisions, computers, etc.?
- Q: Is data secure when transmitting from the CPM Device to the Mobile App, the Device to the Base Station, or the Base Station to the Cloud platform?
- 15.2 Patient Q&As
- Q: The CPM Device is not lighting up when plugged into the Base Station to charge.
- Q: Nothing happens when I am trying to start a measurement and/or the button is pressed on the CPM Device.
- Q: The device visually does not stick well to my body or is obviously peeling up.
- Q: I lost the clear protective liners for covering the adhesive.
- Q: I pressed the button accidentally/too early and a measurement started before the device was on my body. How do I get the device to stop beeping?
- Q: The CPM Device continues to beep, indicating there are errors, during a measurement.
- Q: Can I shower with the CPM Device or get it wet?
- Q: Can I travel with the CPM System?
- Q: A piece or part broke off the device, base station, or alignment tool.
- Q: What do I do if I think I am having a medical emergency or decompensation event?
- 15.1 Physician Q&As
- PART 5. CLEANING AND MAINTENANCE
- PART 6. SYSTEM SPECIFICATIONS
- PART 7. SYMBOLS GLOSSARY
53
Version C
Clinician Instructions for Use – Device and Mobile Application
Adhesive Storage Conditions
Temperature:
10 – 27 °C
Relative Humidity:
40 - 60 %
Pressure:
500 -1060 hPa
Shipping and Transport Conditions
Temperature:
-30 – 60 °C
Relative Humidity:
5 - 93 %
Pressure:
700 -1060 hPa
Other Specifications
Wearable Shelf Life:
6 months
Base Station Shelf Life:
6 months
Adhesive Shelf Life:
6 months
CPM System Operating Life:
1 year
Wearable Battery Life Expectancy:
> 80% after 500 charge-discharge cycles
Wearable Battery Operation Time:
1.5 days
Adhesive Reuse:
5 uses
Data Storage Capacity:
256 MB
20.
STANDARDS AND TESTING COMPLIANCE
IEC 60601-1-2
Medical Electrical Equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic
disturbances – Requirements and tests
IEC 60601-1-11
Medical Electrical Equipment – Part 1-11: General requirements for basic
safety and essential performance -- Collateral Standard: Requirements
for medical electrical equipment and medical electrical equipment and
medical electrical systems used in the home healthcare environment
IEC 60601-2-27
Medical electrical equipment – Part 2-27: Particular requirements for the
basic safety and essential performance of electrocardiographic
monitoring equipment