Table Of Contents - Canary CanarE System Instructions For Use Manual

TABLE OF CONTENTS

1. Overview ........................................................................................................................... 4
2. References ........................................................................................................................ 7
3. Terms and Definitions ...................................................................................................... 8
4. Intended Use ....................................................................................................................10
5. Contraindications, Warnings, and Precautions ............................................................11
5.1. Contraindications ........................................................................................................11
5.2. Warnings ....................................................................................................................11
5.3. Precautions .................................................................................................................11
6. Packaging Content ..........................................................................................................12
7. Device Description ..........................................................................................................14
7.1. The CanarE and Straps ..............................................................................................14
7.2. The CanarE Charger ...................................................................................................14
7.3. The Clinic Cart ............................................................................................................14
8. Directions for Use ...........................................................................................................16
8.1. Getting Started: CanarE ..............................................................................................16
8.2. Attaching the CanarE to a Patient ...............................................................................17
8.3. Performing Data Collections with the CanarE .............................................................19
8.4. Using the Clinic Cart ...................................................................................................20
8.4.1. Clinic Laptop Placement and Power Supply .........................................................20
8.4.2. Clinic Base Station Placement and Power Supply ...............................................20
8.4.3. CanarE Placement and Power Supply .................................................................21
9. Data Security and Patient Privacy ..................................................................................22
10. Component Maintenance ................................................................................................23
10.1. Updating a CanarE .....................................................................................................23
10.2. CanarE, CanarE Charger, and Clinic Cart Cleaning ....................................................23
10.3. Clinic Cart Maintenance ..............................................................................................24
11. Service Life ......................................................................................................................25
12. Servicing ..........................................................................................................................26
13. Disposal ...........................................................................................................................27
14. Troubleshooting ..............................................................................................................28
15. Adverse Events ...............................................................................................................29
16. Electrical Safety and Standard .......................................................................................31
16.1. Guidance and Manufacturer's Declaration - Electromagnetic Immunity ......................31
16.2. Electromagnetic Immunity Specifications ....................................................................31
16.3. Electromagnetic Emissions .........................................................................................32
17. Warranty ..........................................................................................................................33
18. Patents and Trademarks .................................................................................................34
19. Symbols Glossary ...........................................................................................................35
Page | 3 Instructions for Use
Rev. 4
CanarE System