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
10
Version C
Clinician Instructions for Use – Device and Mobile Application
C
4.
DETAILED DESCRIPTION OF THE SYSTEM
The ADI CPM System consists of the following components:
■
The
measurement hardware
that is used by the patient to collect data daily, including
▪
the CPM Device wearable;
▪
the cloud-connected CPM Base Station used to charge and store the device;
▪
Disposable Adhesives
which attach the device to the body
;
▪
and an Alignment Tool used to repeatably locate the device on the body.
■
A
mobile app
used by the Clinical Care Team to guide initial device setup and collect patient calibration
information.
■ Cloud Software for the Clinical Care Team that is used to view measurement data and trends.
4.1 System Components
CPM Device
The CPM Device (also known as the “wearable” or “patch”) contains several sensors: five electrodes, a round
acoustic sensor (electronic stethoscope), an accelerometer to measure tilt, and a temperature sensor. The device
works with the supplied adhesives to stick to the body and acquire measurements. The device has an adjustable
length to accommodate differences in chest circumference and breast size, configured by clinicians during an initial
baseline and fitting visit.
The CPM Device is intended to be used for a less than 5-minute period in the morning and/or at night (up to two
measurements per day) while the patient is stationary and is not intended to be worn between uses.
The CPM Device is NOT disposable and is intended to be used for up to one-year.
This device is battery powered and is plugged in to charge via a magnetic charging cable. A multicolored LED bar and
large button on the electronics housing communicate the status of the system and initiate measurements with the
device, respectively.
Figure 1 a-b. Renderings of the CPM Device a) front side (left) and b) back/sensor side (right)