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
13
Version C
Clinician Instructions for Use – Device and Mobile Application
Cloud Software
The Clinical Care Team can view patient reports, compliance, notifications, trends, and derived measurement data via
the CPM Cloud Software, accessed via URL link or through your organization’s EMR (depending on system
implementation). The Software does not modify the data or control functions of the CPM measurement hardware.
Further information regarding the Cloud Software and Web Application can be found in the separate Web Application
User Guide.
Figure 6. Log-in page of the CPM Web Application.
4.2 How the System Works
Figure 7. System Architecture Diagram of the CPM System.
After a patient is enrolled into the CPM System, a clinician will fit the device in the clinic for the patient by securing the
CPM Device at the appropriate length, and then will take a baseline measurement using the CPM Mobile Application.
The alignment tool will also be fitted appropriately if needed.
At home, after the device is placed correctly and a measurement is initiated, the device acquires raw measurement
data for under 5 minutes. Once the device is charging in the Base Station, data are automatically transmitted from the
CPM Device to the Base Station, and then forwarded to the CPM Cloud Services platform via wireless network. These
data are then processed to generate derived measurements from the raw measurement data, and data will then be
visible on the Web Application. This system is designed for use in outpatient clinic and home environments.
4.3 Measurement Parameters
The CPM Analytics Engine derives the measurements listed below from raw measurement data acquired from the
CPM Device’s sensors and electrodes. The derived measurements, along with trending information about these
measurements, are then displayed on the CPM Web Application for viewing by the clinical care team. The clinical
relevance of selected parameters is described in the following section.
WARNING
The information presented to the clinical care team as part of the CPM Web App is NOT
intended to be used to take immediate action but rather to inform clinical decisions for the
monitored patient.