Use Instructions

2
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