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
38
Version C
Clinician Instructions for Use – Device and Mobile Application
C
1)
Gently pull the non-adhesive tabs on the used adhesive on the two islands to separate them from the from the
device.
2)
Also remove the small disc-shaped adhesive from the acoustic sensor using the blue tab. Discard the
three pieces of used adhesive disposables in the trash. Remove and throw away the old clear liners (2) from
the Base Station as well, if they are still seated inside.
3)
Remove a new adhesive disposable from its pouch using the tear notch on the packaging. Remove the
hydrogel protector sheet. This sheet is labeled with a “1”, as shown. Discard the protector sheet.
4)
Tear along the perforation to separate the adhesives for each side of the device. The perforation is labeled
“Separate Here” with a “2”, as shown.
5)
Remove the acoustic protector sheet, labeled with a “3” as shown. Make sure to hold down the blue tab so
that the adhesive disc does not come up with the liner. Discard this protector sheet.
6)
Place both pieces of the separated adhesive sheet into the Base Station, aligning the shapes with the wells.
7)
Place the CPM Device on top of the adhesives in the Base Station. It may help to put the rigid plastic part of
the device into the wells first.
8)
Gently press down on both islands to secure the disposables on the device.
IMPORTANT
When removing the clear liners for the first time on newly replaced adhesives, peel them off
slowly and gently to ensure that the five hydrogel discs and round acoustic adhesive remain
on the device.