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
C
Contents
Glossary & Acronyms ................................................................................................................................................................ 4
Part 1. General System Information ................................................................................................................................. 6
1.
Introduction ........................................................................................................................................................................ 6
2.
Indications and Contraindications for Use ............................................................................................................... 6
3.
Warnings and Precautions ................................................................................................................................................ 7
3.1 General ...............................................................................................................................................................7
3.2 Implant Information ...........................................................................................................................................9
3.3 Blood Thinner and Steroid Precautions ..............................................................................................................9
4.
Detailed Description of the System ................................................................................................................................. 10
4.1 System Components ......................................................................................................................................... 10
CPM Device ............................................................................................................................................................. 10
Adhesive Disposables .............................................................................................................................................. 11
Alignment Tool ........................................................................................................................................................ 11
Base Station ............................................................................................................................................................. 12
Mobile Application .................................................................................................................................................. 12
Cloud Software ........................................................................................................................................................ 13
4.2 How the System Works ..................................................................................................................................... 13
4.3 Measurement Parameters ................................................................................................................................ 13
4.4 Parameter Thresholds ...................................................................................................................................... 16
4.5 Device Use and Duration .................................................................................................................................. 17
4.6 Device Placement and Location ........................................................................................................................ 17
Guidance for Correct Clinician Placement............................................................................................................... 18
Incorrect CPM Device Placements .......................................................................................................................... 20
Part 2. In-Clinic Instructions For Use .............................................................................................................................. 22
5.
Getting Started ........................................................................................................................................................ 22
6.
Baseline Measurement Preparation and Device Setup ................................................................................................... 22
6.1 Before meeting your patient for the baseline reading ..................................................................................... 22
6.2 Preparing the skin ............................................................................................................................................. 23
6.3 Fitting and sizing the CPM Device ..................................................................................................................... 23
6.4 Pairing the CPM Device to the Mobile App ...................................................................................................... 25
7.
In-Clinic Setup and Baseline ................................................................................................................................... 26
7.1 Taking a Baseline Reading using the CPM Mobile App ..................................................................................... 27