User's Manual

Page 2 of 38
Table of Contents
1. INTRODUCTION ........................................................................................................................ 5
1.1. Product Intended Use and Indications for Use .................................................................... 5
1.2. Terms and Abbreviations ..................................................................................................... 5
1.3. Document Conventions ........................................................................................................ 6
1.4. Safety and Compliance Information ..................................................................................... 6
1.4.1 Symbols and Labeling .............................................................................................................................6
1.4.2 Compliance and Classification ................................................................................................................9
1.4.3 FCC and IC Information for EMC and Radio Frequency ....................................................................... 10
1.4.4 Biocompatibility ................................................................................................................................... 12
1.4.5 Degree of Protection against Ingress of Water and Dust .................................................................... 12
1.5. Warnings and Safety Precautions ......................................................................................12
1.5.1 General Warnings Precautions ............................................................................................................ 12
1.5.1.1 Waste Disposal ................................................................................................................................ 13
1.5.1.2 Explosion Hazard ............................................................................................................................. 14
1.5.1.3 Electromagnetic Compatibility ........................................................................................................ 14
2. WEARABLE INFUSION PUMP OVERVIEW ...............................................................................16
2.1. Top View .............................................................................................................................16
2.2. Side View ............................................................................................................................16
2.3. Pre-filled Medication Cartridge ..........................................................................................17
2.4. Single Unit Pack ..................................................................................................................17
3. INSTRUCTIONS FOR USE .........................................................................................................18
The patient is an intended operator of the Wearable Infusion Pump. ..........................................18
3.1. Step 1 - Prepare ..................................................................................................................18
3.2. Step 2 - Inject ......................................................................................................................21
3.3. Step 3 - Finish .....................................................................................................................24
4 ALARMS ..................................................................................................................................28
4.1 Alarm Information ..............................................................................................................28