Use Instructions

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TABLE OF CONTENTS
1. OVERVIEW OF THE CANARY TIBIAL EXTENSION WITH CHIRP SYSTEM.................... 5
2. ADDITIONAL REFERENCED DOCUMENTS ................................................................. 6
3. TERMS AND ACRONYMS .......................................................................................... 7
4. DEVICE SYSTEM DESCRIPTION ................................................................................. 9
4.1. The Canary Tibial Extension (CTE).......................................................................... 10
4.2. CTE Template ......................................................................................................... 12
4.3. CTE with CHIRP System Surgical Instrumentation ................................................. 12
4.3.1. Impaction Sleeve ............................................................................................ 12
4.3.2. Canary Tibia Cut Guide (5 Degree – L/R) ........................................................ 13
4.3.3. Canary Drill Bit ................................................................................................ 13
4.3.4. CTE Provisional ............................................................................................... 14
4.4. Base Station Systems ............................................................................................. 14
4.4.1. OR Base Station System .................................................................................. 15
4.4.2. Home Base Station System ............................................................................. 16
4.4.3. The Canary Medical Cloud Data Management Platform (Cloud) ................... 17
4.5. Physician Portal ...................................................................................................... 17
4.6. Patient Dashboard ................................................................................................. 20
5. INTENDED USE ....................................................................................................... 22
5.1. Intended Use .......................................................................................................... 22
5.2. Indications for Use ................................................................................................. 22
5.3. Users and Component Interfaces .......................................................................... 22
Physician Instructions for Use
DRAFT