User Manual

Appendix: Electrical Safety

Table of Contents

............................................................................................................................................. 1

Introduction and Components ............................................................................................... 9

Using this Manual ................................................................................................................. 9

System Components ........................................................................................................... 10

SmartPill Capsule Pack ................................................................................................... 10

Capsule Operational Specifications ............................................................................... 10

SmartBar ........................................................................................................................... 10

Data Receiver ................................................................................................................... 11

Docking Station ............................................................................................................... 12

Activation Fixture ........................................................................................................... 13

System Computer and MotiliGI Software ................................................................... 13

Accessories ....................................................................................................................... 14

Use and Care of the System .................................................................................................. 16

Acronyms, Use, and Symbols ............................................................................................ 16

Acronyms ......................................................................................................................... 16

Intended Use/Indications for Use ................................................................................... 16

Contraindications for Use .............................................................................................. 16

Restricted Use .................................................................................................................. 17

Storage .................................................................................................................................. 17

Power Requirements ....................................................................................................... 17

Recycling and Disposal Instructions ............................................................................. 18

Device Markings ................................................................................................................. 18

Data Receiver Display Messages ................................................................................... 19

Risks and Safety .................................................................................................................. 20

Non-Passage .................................................................................................................... 20

Patient-Contacting Materials .......................................................................................... 21

Care, Cleaning and Maintenance ....................................................................................... 21

Data Receiver ................................................................................................................... 21

Docking Station ............................................................................................................... 22

Troubleshooting and Support ........................................................................................... 22

Setting-Up the System ........................................................................................................... 23

Getting Started .................................................................................................................... 23