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
9
Version C
Clinician Instructions for Use – Device and Mobile Application
3.2 Implant Information
3.3 Blood Thinner and Steroid Precautions
WARNING
Do NOT place the electrodes of the CPM Device directly on top of implanted devices
such as pacemakers, defibrillators, or loop monitors.
Do
NOT
wear the device while externally communicating with implanted devices or
external defibrillators.
Use with caution if the patient or you have an implant such as a pacemaker or an ICD.
Maintain a distance of at least 8 inches or 20 centimeters away from the CPM Base
Station when plugged in. Failure to do so could result in an unintended shock to you or
the patient.
If a mobile device and CPM Device are both in close proximity (within 6in) to the chest
of a patient with an implantable and the Mobile App is actively communicating over BLE
with the CPM device, there may be a low likelihood that the combination of both RF
sources in such close proximity may interfere with the implantable.
CAUTION
If the patient is currently taking a blood thinner or steroid, they may be at greater risk for
bruising. If bruising is seen after use, clinicians should be consulted immediately. Use special
care in observing skin changes such as bruising or bleeding when prescribing this device to
patients on blood thinners or steroids.