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
11
Version C
Clinician Instructions for Use – Device and Mobile Application
Adhesive Disposables
The adhesive disposables attach to the CPM Device with gentle hook and loop material like that found on an infant
diaper. The skin-side adhesive is a low-tack medical silicone. Hydrogel material is embedded in the adhesive stack,
and these hydrogel areas overlay the metal electrodes on the device to create a robust electrode-skin contact. Finally,
there is a double-sided silicone adhesive that aligns with the acoustic sensor.
The adhesive stack consists of two tear-apart adhesive islands, one for each side of the device, which align with the
shape of the CPM Device. The adhesive stack includes a liner material that protects the skin-side adhesive and
hydrogel when not in use.
The adhesives are disposable items for single person use only and can be disposed of in the trash after use. They are
meant to be used in conjunction with the CPM Device for up to a week at a time. Adhesive refills will be provided to
patients throughout their prescriptions as needed.
Figure 2 a-b. a) Adhesive packs. b) Rendering of the CPM Adhesive Disposable.
Alignment Tool
The CPM System features an alignment tool accessory intended to repeatably fit the device onto the patient’s body.
The alignment tool positions the device relative to the clavicular notch and ensures consistent device placement.
The placement guide comes in two pieces (the “Alignment Strap” and the “Housing Attachment Mechanism”) and its
length is configurable by the clinical team during the initial set-up visit of the CPM System. The tool snaps onto the
electronics housing of the CPM Device and is held using the index finger at the clavicular notch to help keep the
device in place reliably. The guide is removed after the device is positioned.
Figure 3. The CPM Alignment Tool.