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
7
Version C
Clinician Instructions for Use – Device and Mobile Application
3.
WARNINGS AND PRECAUTIONS
3.1 General
WARNING
The CPM System is NOT intended to be used as a diagnostic tool. Rather, CPM
System outputs are intended to provide insight into how patients are trending.
The Clinical Care Team should confirm any CPM System information with other
relevant clinical information and analyses.
This device is NOT intended to be used as an apnea monitor. Do not rely on the
respiration monitoring function of the device for detection of the cessation of breathing.
Do NOT use if the patient has allergies or skin sensitivities to silicone-based adhesive.
Do NOT use if the patient has skin breakdown and/or open wounds in the area that the
device is placed as determined by the care team.
•
The CPM System is
NOT
compatible for use with MRI machines.
Keep out of the reach of children, those who may be mentally compromised or
unstable, and pets. Use with caution if the patient has a history of ingesting small
objects. Smaller parts of the system such as the adhesive disposable and liners may
be choking hazards and harmful if swallowed.
Avoid getting any of the CPM System components wet, including the Device, Base
Station and charger. The device is NOT meant to withstand water ingress. Do NOT
shower or bathe with the device.
Use
ONLY
the charging cords, adaptors, and accessories provided with the system in
the original packaging. Any other adaptors or cords may damage the device, cause the
device to malfunction, and have electrical hazards or affect EMC performance.