GE BiliSoft 2.0 Bedienungsanleitung

BiliSoft™ 2.0

Phototherapy System

Lighting by LumitexTM

Operation Manual

specifications and features shown herein, or discontinue the product described at any time without

notice or obligation. Contact your GE Representative for the most current information. Lumitex is a

owned by Datex-Ohmeda, Inc. GE and GE Monogram are trademarks of General Electric Company.

All other company and product names mentioned may be trademarks of the companies with which

they are associated.

Warranty

This product is sold by GE Healthcare with a GE depot repair warranty that covers labor and parts

under the terms and conditions set forth in the GE Healthcare Warranty Statement presented to the

customer at the point of sale. The light pad, light box chassis and cooling fan carry a 12-month

warranty. The electronics carry a 24-month warranty. The phototherapy LED carries a 36-month

warranty.

The product warranty is only offered through GE service depot. Field service is not covered

under warranty for this product.

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

How it works........................................................................................................................................A2-2

Installing Pad Covers ........................................................................................................................... A2-3

Soiled Pad Covers ............................................................................................................................ A2-4

Prepare the Baby –Remove Clothing .................................................................................................A2-5

Positioning the Baby............................................................................................................................A2-5

Using the Pad Straps to Swaddle the Baby .........................................................................................A2-6

Use of Additional Blankets...............................................................................................................A2-7

Eye Protection for the Baby ................................................................................................................ A2-7

Ready the Unit for Operation.............................................................................................................. A2-8

Placement of Light Box ....................................................................................................................A2-8

Frequently Asked Questions .............................................................................................................A2-10

Feeding Time .................................................................................................................................A2-10

Bathing...........................................................................................................................................A2-10

Taking Temperatures..................................................................................................................... A2-10

Urine/Stools................................................................................................................................... A2-10

Treatment Time .............................................................................................................................A2-10

Recording Daily Treatment............................................................................................................ A2-11

Homecare Use - Quick Reference .....................................................................................................A2-12

Indications for Use

The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of

hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the

hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light

considered to be the most effective in the treatment of hyperbilirubinemia.

About this Manual

Conventions

Various types of pictures or icons are used in this manual or on the product. They reinforce the

printed message to alert you to potential safety hazards in one of the following ways:

WARNING:

A WARNING statement is used when the possibility of injury to the patient or

the operator exists.

CAUTION:

A CAUTION statement is used when the possibility of damage to the equipment

exists.

About this Product

Scope and Intended Users

This manual describes how to use and maintain the BiliSoft 2.0 Phototherapy System (also referred

to as BiliSoft 2.0).

The device is intended to be used in hospital and home settings. Intended user groups are trained

caregivers/ parents, hospital staff, and biomedical technicians/ biomed service personnel.

BiliSoft 2.0 should be used by direction of qualified medical personnel. Medical personnel should be

familiar with currently known risks and benefits of infant phototherapy.

Description

BiliSoft 2.0 Phototherapy System consists of a light box and a detachable fiberoptic light pad with a

long, flexible fiberoptic cable. The fiberoptic cable delivers light from a high intensity LED module in

the light box to the fiberoptic light pad. The flexible fiberoptic light pad is placed in a soft BiliSoft Pad

Cover or BiliSoft Nest that is then brought into contact with the patient’s skin. The patient is exposed

to light in the wavelength of 430-490 nanometer range (peak 445-470 nanometer).

Units are available with two fiberoptic pad sizes: small (20cm x 25cm) and large (25cm x 30cm).

Carton Contents

The BiliSoft 2.0 Phototherapy System is shipped with the following contents:

Light Source Box with language specific warning labels

Light Pad (Small 8x10 inch or Large 10x12 inch)

Country / Region specific AC Power cord

Operation Manual (Language specific)

Service Manual (English Language Only)

Disposable Pad Cover, Flat

Disposable Pad Cover, Nest

Note: A Home Healthcare model sold to equipment providers will substitute (15) flat pad covers for

the standard disposables.

Note: Replacement disposable pad covers (Flat and Nest) can be purchased from GE Healthcare, see

Chapter 6 for part numbers.

vii

User Responsibility

This product will perform properly, when used and cared for as described in the instructions

provided.

This product must be periodically checked. A defective product should not be used. Broken, missing,

plainly worn, distorted or contaminated parts should be replaced immediately.

Should repair or replacement become necessary, Lumitex recommends that a request for service be

made to the nearest GE Healthcare Regional Service Center listed on the back cover. This Product, or

any of its parts, should only be repaired by trained GE Healthcare technicians.

WARNING:

No modification or alteration of this device is allowed.

WARNING:

US Federal law restricts this device to sale by or on the order of a licensed

medical practitioner.

If repairs are made by anyone other than GE Healthcare trained personnel, the user shall be solely

responsible for any malfunction due to:

Improper use

Inadequate maintenance

Improper repair, damage or alteration

To ensure that the BiliSoft 2.0 Phototherapy System provides effective phototherapy treatment:

Read this manual

Pay special attention to WARNINGs and CAUTIONs that appear in this manual

Use the product according to your healthcare provider’s instructions

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as

unsorted municipal waste and must be collected separately. Please contact an authorized

representative of the manufacturer for information concerning the proper disposal of your

equipment.

viii

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Important Safety Information

WARNINGS:

Eye Protection:

Long exposure to any phototherapy light may cause eye damage. Never look

directly at the light. Infants should wear eye protection during therapy. Take

care to protect the eyes of nearby infants.

Home Users:

Always follow your healthcare professional’s instructions.

Caregiver Side Effects:

Caregivers looking at the blue light for a long time may experience headache,

nausea, or mild vertigo.

Bilirubin Levels:

Measure the bilirubin levels during treatment. Follow hospital policies and

procedures.

Possible Risks:

All phototherapy has possible risks including, but not limited to:

Apnea

Bronze baby syndrome

Diarrhea

Hyperpigmentation-reddening

Patent ductus arteriosus

Riboflavin-calcium and other deficiencies

Skin blistering

Skin irritation and thrombocytopenia

Watch closely for signs of these conditions during treatment.

Porphyrins/Photoisomers:

Bilirubin photoisomers may cause toxic effects. Porphyrins are the result of the

breakdown of the bilirubin molecule. Exposure of porphyrins to phototherapy

may result in a localized reddening of the patient’s skin. Monitoring of the skin is

recommended.

Photosensitive Drugs:

The phototherapy light can harm drugs and other infusion liquids. Shield any IV

tubing with an appropriate material. Do not store drugs or infusion liquids near

the phototherapy light.

Power Cord:

Do not block the power cord plug. It can be disconnected for emergency power

shutoff.

Hospital Policy & Procedures:

Follow hospital policies and procedures for assessing

Bilirubin

Temperature

Skin

Eyes

Disposal:

Dispose of all waste as required by federal, state, and local waste regulations.

Improper disposal could result in personal injury or harm the environment.

Skin Color:

The blue light can mask skin color changes such as cyanosis.

Patient Positioning:

Regularly check that the patient is in the treatment area of the device.

Product Mounting and Service:

Do not mount the system to a Dove Rail, or service the unit, while a patient is in

the bed, or is receiving treatment.

Patient Water Loss:

Phototherapy treatment can increase a patient’s insensible water loss. Maintain

the patient’s fluid balance while administering phototherapy.

Patient Skin Temperature:

Phototherapy used with warming devices may raise the patient’s body

temperature. Incubator or warming beds should use skin controlled (servo)

mode for warming during treatment. Always monitor the patient’s temperature

to avoid temperature fluctuations during treatment.

Reflective Foils:

Do not use foils or reflective materials with the treatment. Hazardous patient

body temperatures may result.

Combustible Gases:

Do not use the BiliSoft 2.0 in the presence of flammable anesthetics (e.g. ether)

mixtures with air or with oxygen or nitrous oxide. These mixtures can support

combustion. A possible explosion hazard exists under these conditions.

Flammable Solutions:

Never use flammable solutions to clean the BiliSoft 2.0 Phototherapy System or

any of its parts.

Oxygen:

Oxygen rich air greatly reduces the temperature at which materials burn.

Remove all opaque materials from the immediate light path when using the light

while administering oxygen.

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