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
12
Version C
Clinician Instructions for Use – Device and Mobile Application
C
Base Station
A Base Station is supplied with the CPM System. The Base Station provides a place to store the device and extra
adhesive disposables, charges the device, updates the device’s firmware, and uploads collected data to a secure
cloud platform. The data transfer first occurs between the CPM Device and CPM Base Station via USB and then
subsequently from the CPM Base Station to the cloud platform via cellular network where the CPM Analytics Engine
will process the raw measurement data. All data are anonymized, and no identifiable information is communicated by
or stored on either the CPM Device or CPM Base Station. Personal Identifiable Information (PII) and Protected Health
Information (PHI) are stored in an isolated partition in the Cloud, only accessible to authorized organizations as per
business associate agreements.
The Base Station includes a charging cord with a wall adapter and connects to the CPM Device via a magnetic
attachment head. The Base Station is also equipped with LEDs to indicate power supply, docking, and network
connectivity status. A mirror on the base station assists in placement of the device, and the device-shaped wells aid in
replacing and changing the adhesives.
Figure 4 a-b. The CPM Base Station in its a) open configuration with CPM Device stored inside and b) closed configuration.
Mobile Application
The clinical care team uses the CPM Mobile Application to set
up the CPM Device for patients. The app enables the clinical
care team to view physiological parameter information in real-
time to ensure the device is operating properly, verify the
placement of the device on the patient, perform the baseline
measurement, and input clinician’s observations such as blood
pressure or weight.
The clinical care team can use either default settings or
customize single-parameter threshold settings for trend analysis
performed by the CPM Analytics Engine. These analyses are
displayed on the CPM Web Services interface.
Figure 5. Log-in screen of the CPM Mobile Application.