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
41
Version C
Clinician Instructions for Use – Device and Mobile Application
12.3 Notifications and alerts during a measurement
Description
Active reading is taking place
CPM Device is currently
recording data. A tone will play
every 5 seconds.
Move to the next position
Error resolved /
measurement position
beginning / measurement
complete
Sounds
Single note every 5 seconds
3-note tone
2 tones
Actions
Remain still and quiet for the
duration of the measurement
and do not touch the sensors.
Move to the next position
specified by the Clinical Care
Team and press the blue button
on the electronics housing to
start the second half of the
measurement.
Description
Tilt Error – Lean forward
You are leaning too far back
and need to lean forward.
Tilt Error – Lean backward
You are leaning too far forward
and need to lay back further
Electrode Contact Error
The electrodes are not
contacting the skin well
Sounds
3 ascending notes
3 descending notes
4 flat notes
Actions
Lean forward until the LED
flashes green and the error
goes away; otherwise it will
resolve after 20 seconds.
Lean backward until the LED
flashes green and the error
goes away; otherwise it will
resolve after 20 seconds.
Press down on the parts of the
device with the electrodes until
LED flashes green and the error
resolves. You may also have to
replace the adhesives, dampen
skin, or remove and replace the
device.