Use Instructions

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6. LIMITATIONS .......................................................................................................... 26
7. CONTRAINDICATIONS ............................................................................................ 26
8. MRI Compatibility .................................................................................................. 27
9. GENERAL WARNINGS AND PRECAUTIONS............................................................. 27
9.1. CTE ......................................................................................................................... 27
9.2. Surgical and Home Base Stations and Accessories (including Bar Code Scanners,
Laptops, and cables) ...................................................................................................... 27
10. PRINCIPLES OF OPERATION ................................................................................... 28
10.1. Collection, Storage, and Transmission of the CTE Data .................................. 28
10.2. Canary Medical Gait Parameters Data Characteristics ................................... 29
11. DIRECTIONS FOR USE ............................................................................................. 30
11.1. Surgeon’s Office Patient Account Setup ......................................................... 31
11.1.1. Orthopedic Surgeon .................................................................................... 31
11.1.2. Surgeon’s Office Staff .................................................................................. 31
11.2. Patient Registration and Account Setup ......................................................... 33
11.2.1. Patient ......................................................................................................... 33
11.3. Home Base Station System Setup................................................................... 33
11.3.1. Patient ......................................................................................................... 33
11.4. Day of Surgery ................................................................................................ 34
11.4.1. Preoperative: CTE Implant Self-Test and Sensor Check ............................. 34
11.4.2. Intraoperative: Tibia Resection, Preparation, and Trialing ........................ 36
11.4.3. Intraoperative: Activate the CTE implant .................................................. 37
Physician Instructions for Use
DRAFT