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
15
Version C
Clinician Instructions for Use – Device and Mobile Application
Respiration Rate/Tidal Volume (RR/TV)
This is a metric that computes the ratio of respiration rate and relative tidal volume. An upward trend can indicate an
increase in respiration rate and/or a decrease in tidal volume, suggesting a rapid shallow breathing pattern.
QRS Width
QRS width, measured in milliseconds (ms), represents ventricular depolarization. It is
calculated as the difference between QRS onset and offset, which is determined
based on a metric representing the QRS-like morphology in the single-lead ECG
waveform. The reported value is the mean value from the lowest-angle posture.
QT Interval and QTc
The QT interval is the time from the beginning of the QRS complex to the end of the T
wave resulting from ventricular repolarization. QTc is the corrected QT interval,
accounting for the effects of heart rate. It is calculated using the equation
QTc=QT/
√
. QT interval and QTc are both measured in milliseconds (ms) and are
calculated from the ECG waveform.
Potential cardiac abnormalities
The CPM System is intended to detect and flag ECG tracings demonstrating an irregularly irregular rhythm such as
that seen in an atrial fibrillation.
Other types of arrhythmias not exhibiting this characteristic are
NOT
intended to be detected and will not be flagged
by the CPM System. An example of an abnormal rhythm flag can be found below.
NOT DETECTED –
Normal Sinus
Rhythm
DETECTED –
“Abnormal Rhythm”
WARNING
This device is
NOT
intended to be used as an apnea monitor. Do not rely on the respiration
monitoring function of the device for detection of the cessation of breathing.