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
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Version C
Clinician Instructions for Use – Device and Mobile Application
A: The CPM System is designed to be surface-cleanable using an alcohol wipe or damp cloth. This device is NOT
meant to be used in the shower or any other very wet environment.
Q: Can I travel with the CPM System?
A:
Traveling with the CPM System is encouraged, especially if you are travelling for a longer period of time. There is a
leather strap on the CPM Base Station to allow patients to easily carry the Device inside the Base Station. Please
note that the CPM System contains lithium ion batteries, which may need to be declared before traveling by plane.
Make sure that the CPM Device and Base Station are plugged in to charge immediately as soon as they have arrived
at the destination. Also note that the hydrogels on the device adhesives are only meant to withstand the temperature
range given in the Specifications Table in this document and may lose their efficacy or tack if left in hot or cold
environments for a sustained period of time.
If you are travelling to an area where your Base Station does not have cellular coverage, the CPM system will still
record data up to approximately a month’s worth of measurements. This data will be available to your clinical team
once the CPM system is back in a coverage zone.
Q: A piece or part broke off the device, base station, or alignment tool.
A:
Contact the support team for a replacement part if the device is not working or electronics and/or sharp edges are
exposed.
Q: What do I do if I think I am having a medical emergency or decompensation event?
A: If you think this is a life-threatening emergency, call 911 immediately. Otherwise, call your primary care physician,
cardiologist, or pulmonologist immediately. This device is NOT meant to warn clinicians of medical emergencies
or diagnose decompensation events. Patients should use their own best judgement while using this device
and should not wait for the clinical care team to call with results from the CPM System. Care regimens for
patients with cardiopulmonary conditions should be continued as they would be with or without the CPM
System.