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
35
Version C
Clinician Instructions for Use – Device and Mobile Application
Figure 23. Adhesive storage compartment in the Base Station.
10.
PATIENT MODE MEASUREMENTS
10.1 Measurement preparation
1)
Ensure that the room is quiet (e.g. no talking, no loud machines in the background such as air
conditioners, fans, radios, TVs, etc.).
2)
The patient should
remove their shirt and/or bra
to expose the chest. For men: trim chest hair if needed.
3)
Remove the CPM Device from the Base Station, checking that the device charge LEDs on the device and
Base Station are green or yellow. Replace the adhesives if needed (instructions on page 37).
4)
Peel off the two clear liners to expose the skin adhesive and then place them back into the Base Station,
aligning their shapes to the appropriate wells.
5)
Place the device as designated by the clinician (guidelines given on page 17), pressing down around all the
sensors. Use the alignment tool (use is described on page 33) and/or Base Station mirror to help, if needed.
10.2 Patient mode workflow
IMPORTANT
For best results, take measurements at the same time each day (recommended at morning wake-up).
IMPORTANT
For best results, apply the device as consistently as possible during each use, in the location used to take
the baseline reading.
IMPORTANT
Stay stationary and do not speak for the duration of the measurement.