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
16
Version C
Clinician Instructions for Use – Device and Mobile Application
C
NOT DETECTED –
Pre-Ventricular
Contraction (PVC)
Diastolic Heart Sound Energy
Diastolic heart sounds represent the energy of heart sounds during diastole as measured by the CPM System’s
acoustic sensor. In healthy subjects, this value should be stable across days, while increasing values can indicate an
increase in diastolic sounds. These values are not displayed in standard units and may vary among individuals
and depending on sensor placement. Values should be used to track day-to-day changes and should never
be compared between subjects.
Skin Temperature
Provided in °F and °C by the CPM System, this measurement offers a way to detect changes across multiple days in
skin temperature. When other trended CPM system parameters show a certain behavior, skin temperature trends can
provide additional information to determine whether such changes are associated with a change in temperature. For
example, if a patient’s heart rate is showing an increasing trend, the clinical team can determine whether th is trend is
associated with a change in skin temperature and take the steps they deem necessary to validate these observations.
4.4 Parameter Thresholds
The CPM System allows clinicians to manage "thresholds” related to many of the parameters captured by the CPM
Device. These thresholds can be manipulated either by using the mobile app or the web software and allow a way for
clinicians working with the web software to easily visualize whether physiological parameters are out of range from
what would be considered normal or expected – in other words, alerts for any values that are outside of threshold
values (“breached” thresholds) will be flagged and displayed.
There are two types of thresholds – “absolute” and “relative”. Absolute thresholds refer to parameters where individual
values are well understood and could be compared from patient to patient. Minimum and maximum thresholds can be
set. Heart rate, respiration rate, QTc interval, and QRS width are the CPM System’s absolute thresholds. Relative
thresholds refer to parameters that are meant to look for changes only within a single patient and do not translate to a
population. These thresholds are set not according to absolute number but relative to the Baseline measurement (a
percentage increase or decrease from Baseline). Thoracic impedance, relative changes in tidal volume, and diastolic
heart sound energy are relative thresholds for the CPM System.
WARNING
This is NOT a final diagnosis of Atrial Fibrillation or any other cardiac abnormality. A clinician
should always confirm the CPM System’s analysis with other relevant clinical information,
including a clinical 12-lead ECG if deemed necessary.
CAUTION
Skin temperature provided by the CPM Device is not intended to be used to assess core
temperature and should be confirmed through other means before diagnosing a patient with a fever.