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
8
Version C
Clinician Instructions for Use – Device and Mobile Application
C
CAUTION
The device is
NOT
meant to be worn between readings. It should be removed
immediately following each measurement and returned to the base station.
•
The CPM System is for prescription use only. Federal law restricts this device
to sale by or on the order of licensed practitioners.
•
Each device is configured for a specific patient. Do NOT exchange devices or
otherwise use a device on an individual not assigned to the specific device.
Clinicians should always refer to and use EMR data as the primary source of patient
information. If there is a mismatch between CPM System data and the EMR, the EMR
data should be used.
Use caution when using the device on patients with sensitive skin in the left chest/sternal
area where the device is placed.
Remove the device if any pain or discomfort occurs. A topical skin cream may be applied
(in consultation with a healthcare provider) if discomfort, redness, itching, or rash persists
after the device is removed. Patients should consult their healthcare provider and stop
using the device for future measurements if these symptoms occur.
•
Do NOT change, modify, or disassemble any parts of the ADI CPM System – the system
contains no user-serviceable components. Any changes, modifications, updates, or
servicing of the system will ONLY be performed by the manufacturer. Do not use if the
CPM System has been modified in any way.
If the system shows signs of damage, discontinue using it and contact CPM System
Support.
The CPM System has not been validated in a pediatric population.
This device may not fit or function as intended on patients who meet the medical definition
of obese or morbidly obese.