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
Q: No size of the CPM Device fits my patient.
A:
Your patient may be outside the range of body types that the CPM Device was designed for. This device was
designed to accommodate about 95% of the population, but very large or very small people, or those with large
breasts, may not be able to wear the device.
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.
A:
Plug the CPM Device into the Base Station to charge to stop the measurement. Then unplug and attempt to pair
the device again.
Q: How do patients get more adhesives when they run out?
A: Adhesives are provided on a prescription basis in boxes of 15. Patients will receive replacement adhesives for the
duration of the device prescription length. Patients should contact the support team if they are running low on
adhesive disposables.
Q: Can the CPM System be used near other electronic or medical equipment such as telephones, televisions,
computers, etc.?
A: Yes, although some sources of Electromagnetic Interference (EMI) can temporarily disrupt data transmission or
cause the CPM System to transmit more slowly.
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?
A:
Yes, many measures have been taken to comply with data privacy and cybersecurity guidelines. The data is
transmitted securely with no identifying information and stored privately and securely.
15.2 Patient Q&As
Q: The CPM Device is not lighting up when plugged into the Base Station to charge.
A: The Base Station might not be plugged in. Ensure that the charging adaptor is connected to both a wall outlet and
the Base Station and the power LED is lit up on the Base Station. If power to the Base Station is confirmed, try re-
plugging in the magnetic charging adaptor to the CPM Device. If still nothing happens, the device might be out of
battery. Wait a few minutes to see if the device boots up. If not, contact the support team.
Q: Nothing happens when I am trying to start a measurement and/or the button is pressed on the CPM
Device.
A: First, make sure that the CPM Device is not connected to the Base Station when trying to start a measurement.
Also ensure that the battery of the CPM Device has been charged to over 20% by looking at the LED color while the