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
31
Version C
Clinician Instructions for Use – Device and Mobile Application
3)
Close the lid of the Base Station when the CPM Device is not in use to prevent dust build-up.
Before shifting
the Base Station, ensure that the magnetic clasp on the front of the Base Station is securely fastened.
Figure 19 a-c. a) Plugging in the Base Station b) The CPM Device charging with LEDs illuminated c) Base Station clasp..
8.
THE ALIGNMENT TOOL
It is recommended that the alignment tool be given to the patient to help consistently locate the CPM Device at home
until they are comfortable using the device. The alignment tool should be assembled and fit to the patient during
the baseline visit, before the CPM Device is removed. This can either occur before or after the baseline reading.
8.1 Assembly and fitting
IMPORTANT
Always connect the CPM Device in the Base Station to charge when not in use.
1)
Once the device is placed on the patient and skin contact is strong
under all device sensors, remove the two pieces of the alignment
tool (strap and snap-on mechanism) from the packaging.
2)
Snap the plastic piece onto the CPM Device electronics housing,
aligning the two nubs with the indents on the device. Make sure that
the blue quick release slider is in the “up” position and the silver pin
is in place.