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
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Version C
Clinician Instructions for Use – Device and Mobile Application
4.5 Device Use and Duration
The ADI CPM System is intended for long term (up to one year) once-or-twice daily monitoring. The device is not
meant to be worn between measurements and should be removed and returned to the Base Station directly following
data collection. Measurements should be initiated in the morning as soon as the patient wakes up, and/or in the
evening just before the patient goes to sleep. The care team will instruct the patient how often and for how long to use
the CPM System depending on the device prescription. Each measurement takes less than 5 minutes, with half of the
measurement in Position 1 (usually an upright seated position) and half of the measurement in Position 2 (usually a
reclined Supine position). Measurements are initiated by the patient with the large button on the CPM device
electronics housing.
The two measurement positions are determined by the clinical care team during the baseline reading; these must be
repeated for all measurements to ensure accurate data collection.
4.6 Device Placement and Location
The CPM Device is placed on the upper left chest area. The device spans the left lung, with the larger side of the
device (the side with the electronics housing, the “medial island”) on the sternum and the smaller (“lateral”) island near
the left mid-axillary line. The CPM alignment tool can be used to aid in this placement of the device.
CAUTION
Thresholds should only be set and/or changed by licensed medical professionals to suit the clinical
needs of their patients. Threshold changes apply only to individual patients.
IMPORTANT
The CPM System can be used for up to one year after the date of prescription.
IMPORTANT
As prescribed by the care team, patients should take measurements
•
First thing in the morning;
AND/OR
•
Right before bed
IMPORTANT
Accurate and consistent placement is key to acquiring good signals from the device.
Patients should try to place the device consistently to within 2 cm of baseline placement.