GE BiliSoft 2.0, Operation Manual

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iii
Table of Contents
Indications for Use ............................................................................................................................. v
About this Manual ............................................................................................................................. v
About this Product ............................................................................................................................ vi
User Responsibility .......................................................................................................................... vii
Important Safety Information ........................................................................................................... ix
Contraindications ..................................................................................................................................... xi
Care of the Patient’s Skin ................................................................................................................ xiii
Safety Information ........................................................................................................................... xv
Symbol Definitions .................................................................................................................................. xv
Chapter 1 Components and User Controls ....................................................................................... 1-1
BiliSoft 2.0 Light Box .............................................................................................................................. 1-1
BiliSoft 2.0 Light Pad Assembly ............................................................................................................. 1-4
Soft Cover Options (Disposables) .......................................................................................................... 1-5
Chapter 2 Operating Instructions ..................................................................................................... 2-1
Pre-use Checkout Procedure ................................................................................................................. 2-1
Light Pad Output ................................................................................................................................... 2-2
Positioning the Unit ............................................................................................................................... 2-3
Attaching the Mounting Bracket ........................................................................................................... 2-4
Using the Unit ........................................................................................................................................ 2-5
Installing Pad Covers ............................................................................................................................. 2-6
Chapter 3 Troubleshooting .............................................................................................................. 3-1
Indicator Lights/Troubleshooting Guide ............................................................................................... 3-1
Chapter 4 Routine Cleaning and Maintenance ................................................................................. 4-1
Cleaning and Disinfecting ...................................................................................................................... 4-1
Approved Cleaning Solutions ............................................................................................................. 4-1
Point of Use Cleaning ......................................................................................................................... 4-2
Cleaning the Light Box between Patients .......................................................................................... 4-2
Cleaning the Light Pad and Cable between Patients ......................................................................... 4-3
Cleaning the Light Pad Connector, Fiberoptic Lens and Connector Port Between Patients ............. 4-4
Air Filter Cleaning/Replacement........................................................................................................ 4-5
Factors that affect product life .......................................................................................................... 4-5
Product storage ................................................................................................................................. 4-6
Chapter 5 ........................................................................................................................................ 5-1
Chapter 6 Optional Equipment and Replacement Parts .................................................................... 6-1
Chapter 7 Specifications .................................................................................................................. 7-1
Chapter 8 Technical Reference ........................................................................................................ 8-1
Spectral Irradiance Light Output ........................................................................................................... 8-1
Effective Pad Area for Irradiance Output .............................................................................................. 8-2
Pad Output Measurement Points ......................................................................................................... 8-2
Chapter 9 EMC Guidance ................................................................................................................. 9-1
Degraded Performance Characteristics ................................................................................................ 9-1
EMC Service Life .................................................................................................................................... 9-5
Appendix A1 - Additional Safety Information ................................................................................ A1-1
Statements .......................................................................................................................................... A1-1
Appendix A2 - Home Use .............................................................................................................. A2-1
Homecare Providers ............................................................................................................................ A2-1
Parents or Guardians ........................................................................................................................... A2-1
Before You Begin Treatment ........................................................................................................... A2-1
The BiliSoft 2.0 Phototherapy System Components ........................................................................... A2-2