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
36
Version C
Clinician Instructions for Use – Device and Mobile Application
C
1)
Once the device is securely adhered to the body, move into the first position (Position One) specified by the
clinical care team during the baseline measurement. Press the large blue button on the CPM Device until a
small beep is heard, about 2 seconds.
2)
The device will start by checking to see if the patient is in the right position and for electrode contact quality
for a maximum of 1 minute. The measurement will then proceed for 1 minute. The LED bar will blink purple
and a tone will sound every 5 seconds throughout this time.
If there are measurement errors with positioning or contact, the LED will blink yellow (tilt) or orange
(contact) and chimes will sound. See the section on lights and sounds for how to resolve these errors.
3)
There will be an audible alert and the LED bar will flash pink when the first position is complete.
4)
Move to the second position (Position Two) specified during the clinic visit. When in position, press the button
for about 2 seconds, the same as in the first position. After 30 seconds, the device will automatically proceed
with the measurement even if the button was not pressed.
5)
After checking for contact and tilt errors in this position, the measurement will proceed for one minute more,
with the LED bar blinking purple and a chime sounding every 5 seconds throughout this time.
6)
After the second position is complete, the device will chime and the LED light will flash green, indicating the
measurement is finished.
7)
At this point, the device can be gently removed and placed back in the Base Station to charge. The data will
automatically upload to the cloud if there is cellular connectivity.
IMPORTANT
If the patient is having undue trouble with the device (e.g. excessive beeping, cannot place the device,
thinks there is something wrong with the device), they should contact the support team for help.