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GE BiliSoft 2.0 - User Manual

GE BiliSoft 2.0
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BiliSoft2.0
Phototherapy System
Lighting by Lumitex
TM
Operation Manual

Table of Contents

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GE BiliSoft 2.0 Specifications

General IconGeneral
Product TypePhototherapy System
BrandGE Healthcare
ModelBiliSoft 2.0
Intended UseTreatment of neonatal jaundice
Light SourceLED
Irradiance35 µW/cm²/nm
Power SourceAC Power
Irradiance LevelsAdjustable
Treatment SurfaceSoft, flexible pad
Safety FeaturesOverheat protection, automatic shut-off
Operating Temperature10-40°C
Storage Temperature-20°C to 60°C
Humidity30% to 75% non-condensing
Power Supply100-240 V AC

Summary

About this Manual

Indications for Use

Describes the intended medical uses of the BiliSoft 2.0 system for treating hyperbilirubinemia.

Conventions

Explains the meaning of symbols and icons used in the manual to convey safety information.

About this Product

Scope and Intended Users

Defines who should use the BiliSoft 2.0 and its intended hospital and home environments.

Description

Provides a technical overview of the BiliSoft 2.0 system's components, including the light box and pad.

Chapter 1 Components and User Controls

BiliSoft 2.0 Light Box

Details the components and features of the main light box unit, including controls and indicators.

BiliSoft 2.0 Light Pad Assembly

Describes the light pad, its sizes, and how it functions to deliver light therapy.

Chapter 2 Operating Instructions

Pre-use Checkout Procedure

Step-by-step guide for verifying the system's readiness and output before patient use.

Positioning the Unit

Guidelines and safety warnings for correctly placing the light box and pad during operation.

Installing Pad Covers

Instructions on how to properly fit disposable pad covers onto the light pad for patient comfort.

Chapter 3 Troubleshooting

Indicator Lights;Troubleshooting Guide

A guide to identifying common issues based on indicator lights and system symptoms.

Chapter 4 Routine Cleaning and Maintenance

Cleaning and Disinfecting

Procedures and approved solutions for cleaning the device to ensure hygiene and longevity.

Point of Use Cleaning

Cleaning procedures performed immediately after patient use to maintain cleanliness.

Air Filter Cleaning;Replacement

Procedures for cleaning or replacing the unit's air filter to prevent overheating.

Chapter 7 Specifications

Electrical Specifications

Technical details regarding the device's electrical properties, including voltage and current.

Performance Specifications

Details on light output, wavelength, LED module life, and sound level.

Chapter 8 Technical Reference

Spectral Irradiance Light Output

Graph and data showing the light output spectrum of the BiliSoft 2.0.

Pad Output Measurement Points

Grids indicating specific measurement points for verifying light output on the pad.

Chapter 9 EMC Guidance

Degraded Performance Characteristics

How electromagnetic disturbances can affect device function and performance.

Manufacturers Guidance and Declaration Regarding Electromagnetic Immunity

Immunity compliance and guidance for RF wireless communication devices.

Appendix A1 - Additional Safety Information

Statements

Additional safety warnings and statements regarding device use and disposal.

Appendix A2 - Home Use

Eye Protection for the Baby

Importance and method of protecting the baby's eyes from phototherapy light.

Positioning the Baby

Guidelines for correctly positioning the baby on the light pad for effective treatment.

Ready the Unit and Begin Treatment

Final steps to connect the unit, plug it in, and turn it on for treatment.

Frequently Asked Questions

Answers to common user questions regarding feeding, bathing, and temperature taking.

Homecare Use - Quick Reference

A summary of essential steps for using the BiliSoft 2.0 in a home setting.

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