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
14
Version C
Clinician Instructions for Use – Device and Mobile Application
C
Figure 8. Raw and derived measurements from the CPM Analytics Engine.
Thoracic Impedance (TI)
Thoracic Impedance, measured in ohms (Ω), has been demonstrated
1
to be a surrogate measurement for the fluid
content in the thoracic cavity and lungs, with lower values indicating a greater hydration or fluid level and higher
values meaning a patient is dryer. It is important to note that the differences in TI between different individuals can be
caused by a variety of factors (i.e. body type, fat content, placement of CPM Device electrodes, etc.) The day-to-day
change of TI values in an individual rather than the values themselves should be used as the clinically
relevant parameter.
Change in thoracic impedance (∆Z)
∆Z, measured in ohms (Ω), is a calculation of the difference in average thoracic impedance from one measurement
position to the other. Literature has shown that this measurement can provide insight into short-term fluid settling
behavior in the thoracic cavity
2
. Healthy patients should have ∆Z values close to 0.
Relative changes in tidal volume (rTV)
rTV acts as an analogue for the standard clinical tidal volume measurement. Increasing values can mean an increase
in lung tidal volume, while decreasing values can mean a decrease in lung tidal volume. Please note that rTV values
are not displayed in liters (L) or other standard units – it is meant to be used to track day-to-day changes in
lung capacity rather than tidal volume value itself. Values should never be compared between subjects.
1
Weyer, S., et al., Bioelectrical impedance spectroscopy as a fluid management system in heart failure. Physiol
Meas, 2014. 35(6): p. 917-30.
2
S. Dovancescu et al., "Sensitivity of a wearable bioimpedance monitor to changes in the thoracic fluid content of
heart failure patients," Computing in Cardiology 2013, Zaragoza, 2013, pp. 927-930.
CAUTION
The CPM System is not intended to directly measure thoracic fluid content.