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
30
Version C
Clinician Instructions for Use – Device and Mobile Application
C
10)
Review and Confirm your Patient’s details and medical
information. These will appear on the Web Application if/when
completed. When finished, select “Confirm and Save”.
11)
The baseline reading is now complete. Return the CPM
Device to the Base Station to upload the Baseline reading to
the cloud.
7.2 Removing the CPM Device from the body
Gently and slowly peel the CPM Device from your patient’s chest using the tabs on the device. Avoid touching the
sticky parts of the adhesive, replacing the device back on top of the clear liners in the Base Station immediately.
Ensure that the hydrogel and acoustic discs remain intact and on the device during removal.
For those with loose skin, it may help to hold down the skin near the device as you are peeling off the CPM device
adhesive to lower the chances of bruising or skin tears.
7.3 Charging the CPM Device
1)
While in the Base Station, connect the magnetic charging adapter to the device, snapping it into the bottom of
the CPM Device electronics housing. Make sure that the Base Station is plugged into a wall outlet.
2)
Ensure that the device is charging by verifying that the Base Station’s top and bottom LEDs as well as the
CPM Device’s light bar are illuminated.
CAUTION
Thresholds changed in the mobile app will only apply to this specific patient and should ONLY be
selected by a licensed medical professional.
CAUTION
Carefully examine your patient’s chest for adverse effect (e.g. bruising, skin irritation) after
removing the CPM Device. Be especially observant of skin changes during the use of the
device if your patient is on blood thinners and/or steroids.