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
C
device is charging. If it is red, it is NOT yet ready to take a measurement, and you should continue to charge the
device until the LED bar is yellow or green.
Q: The device visually does not stick well to my body or is obviously peeling up.
A: For men: The CPM Device is not intended to be used on patients with a large amount of chest hair – men that do
have chest hair may need to trim in the area of the device. Ensure that this is done before the initial placement of the
CPM Device and as hair grows back throughout the prescription duration of the CPM System.
A: The adhesive disposables may have been used too many times or may be dirty. Replace the adhesive disposables
and try again if this is the case by following the instructions in this document.
Q: I lost the clear protective liners for covering the adhesive.
A:
Replace the current set of adhesives on the device so that they can be covered when not in use.
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?
A: Plugging the device into a Base Station will quiet it and stop the measurement.
Q: The CPM Device continues to beep, indicating there are errors, during a measurement.
A: The most common cause of beeping during measurements are electrode contact errors. See the Lights and
Sounds Indications section of this document for more information about how this is communicated by the device. If
you are experiencing an electrode contact error:
Press down around all the sensors to ensure that the entire adhesive surface of the device is contacting your
skin.
Ensure that the adhesive disposable is placed correctly on the device, checking that you can see all the round
metal electrodes (5) under the clear hydrogel and that there is no air gap between the metal and the hydrogel.
In rare cases, patients may have extremely dry skin and need to slightly dampen the skin under the device
adhesives in order to achieve good electrode contact. This can be done using a baby or wet wipe.
The hydrogels may be dried out, preventing good measurement data. Remove the CPM Device, replace the
adhesive disposables using the instructions in this document, and try again.
A:
Tilt errors may also be causing continuous beeping while trying to take measurements. These errors always
appear first and will automatically go away after 20 seconds.
Patients should contact their healthcare provider or
clinical care team immediately if they are no longer able to achieve the two positions outlined in the initial
baseline office visit.
A: Note that after a period of time, about 1 minute, all errors will be disregarded, and the measurement will continue.
However, these measurements may give poor data quality.
Q: Can I shower with the CPM Device or get it wet?