GE BiliSoft LED Phototherapy System Operation and Maintenance Manual Rev E

© 2021 by General Electric Company All rights reserved. General Electric Company (GE) reserves the right to make changes in 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. Trademarks The GE logo, BiliSoft, BiliBlanket, and Giraffe are registered 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 under the warranties set forth in the following paragraphs. Such warranties are extended only with respect to the purchase of this Product directly from GE Healthcare or GE Healthcare’s Authorized Dealers as new merchandise and are extended to the Buyer thereof, other than for the purpose of resale. For a period of twelve (12) months for the light box and the pad from the date of original delivery to Buyer or to Buyer’s order, but in no event for a period of more than two years from the date of original delivery by GE Healthcare to an GE Healthcare Authorized Dealer, this Product, other than its expendable parts, is warranted to be free from functional defects in materials and workmanship and to conform to the description of the Product contained in the operation manual and accompanying labels and/or inserts, provided that the same is properly operated under the conditions of normal use, that regular periodic maintenance and service is performed and that replacements and repairs are made in accordance with the instructions provided. This same warranty is made for a period of thirty (30) days with respect to expendable parts. The foregoing warranties shall not apply if the Product has been repaired other than by GE Healthcare or in accordance with written instructions provided by GE Healthcare, or altered by anyone other than GE Healthcare, or if the Product has been subject to abuse, misuse, negligence, or accident. GE Healthcare’s sole and exclusive obligation and Buyer’s sole and exclusive remedy under the above warranties is limited to repairing or replacing, free of charge, at GE Healthcare’s option, a Product, which is telephonically reported to the nearest GE Healthcare Regional Service Office and which, if so advised by GE Healthcare, is thereafter returned with a statement of the observed deficiency, not later than seven (7) days after the expiration date of the applicable warranty, to the designated GE Healthcare Service Center during normal business hours, transportation charges prepaid, and which, upon GE Healthcare’s examination, is found not to conform with above warranties. GE Healthcare shall not be otherwise liable for any damages including but not limited to incidental damages, consequential damages, or special damages. There are no express or implied warranties that extend beyond the warranties hereinabove set forth. GE Healthcare makes no warranty of merchantability or fitness for a particular purpose with respect to the product or parts thereof.

Table of Contents

About this Manual...v Conventions... v Repair Policy ... v

Important Safety Information...vii Warnings... vii Service Language Disclaimer... vii Cautions...xv Symbol Definitions...xvi

Chapter 1: Functional Description... 1 Chapter 2: Components and User Controls... 3 BiliSoft Light Box...3 BiliSoft Fiberoptic Light Pad Assembly...4 Soft Cover Options (Disposables)...5

Chapter 3: Troubleshooting... 7 Troubleshooting Guide...7

Chapter 4: Replacement/Checkout Procedures... 11 Fuse Replacement... 11 LED Module Replacement... 12 Air Filter Cleaning/Replacement... 13 Accessing/Replacing Other Internal Components... 14 Checkout Procedures... 14 Electrical Safety Checkout Procedure... 15 Light Intensity Checkout Procedure... 15 Labels Checkout Procedure... 16

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Table of Contents

Chapter 5: Spare Parts... 17 NOTE 1: Service Kit Package for Control PCA... 21 NOTE 2: Replacement strategy for the failed parts... 22 Hardware Kits (Sold in Packs of 10)... 23

Chapter 6: Accessories ... 25 Chapter 7: Specifications... 29 Electrical Specifications... 29 Environmental Operating Conditions... 29 Storage Requirements... 29 Performance Specifications... 30 Physical Specifications... 30 Regulatory Standards... 31

Chapter 8: Technical Reference ... 33 Appendix: Additional Safety Information... 34 Statements... 34

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About this Manual

Conventions Various types of pictures or icons are used in this service manual wherever 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. SENSITIVE TO ELECTROSTATIC DISCHARGE CAUTION An Electrostatic Discharge (ESD) Susceptibility symbol is displayed to alert service personnel that the part(s) are sensitive to electrostatic discharge and that static control procedures must be used to prevent damage to the equipment. NOTE: A note provides additional information to clarify a point in the text. IMPORTANT: An Important statement is similar to a note, but is used for greater emphasis.

Repair Policy CAUTION: The procedures described in this service manual should be performed by trained and authorized personnel only. Maintenance should only be undertaken by competent individuals who have a general knowledge of and experience with devices of this nature. No repairs should ever be undertaken or attempted by anyone not having such qualifications. Genuine replacement parts manufactured or sold by GE Healthcare must be used for all repairs. Read completely through each step in every procedure before starting the procedure; any exceptions may result in a failure to properly and safely complete the attempted procedure. After repair, test the equipment to ascertain that it complies with the published specifications. Do not use malfunctioning equipment. If the unit is under warranty, contact GE technical support at the number on the back of the manual PRIOR to performing any repairs on the unit.

v

About this Manual

vi

Important Safety Information

Warnings WARNING: Side Effects: Looking at light emitted by any phototherapy device for prolonged periods may cause side effects, such as headache, nausea, or mild vertigo. WARNING: Flammable Solutions: Never use flammable solutions to clean the BiliSoft Phototherapy System or any of its parts. WARNING: To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. WARNING: The user or service staff should dispose all the waste properly as per federal, state, and local waste disposal regulations. Improper disposal could result in personal injury and environmental impact. WARNING: Electrical shock hazard: Before servicing, always unplug the unit from wall power.

Service Language Disclaimer WARNING: This service manual is available in English only. (EN)

• • •

If a customer’s service provider requires a language other than English, it is the customer’s responsibility to provide translation services. Do not attempt to service the equipment unless this service manual has been consulted and is understood. Failure to heed this warning may result in injury to the service provider, operator, or patient from electric shock, mechanical hazards, or other hazards.

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Important Safety Information

Symbol Definitions This section identifies the symbols that are displayed on the BiliSoft unit: Symbol

~

Description Indicates alternating current.

Indicates IEC Type B equipment.

T

This letter appearing before a fuselink value indicates a time delay fuselink. Cover patient’s eyes during phototherapy. On/Off Standby Switch Unit overheated indicator Hour meter LED failure indicator Do not spray cleaner directly onto the fiberoptic lenses. The fiberoptic lenses require special cleaning methods. See cleaning section of this manual for complete details.

Consult accompanying documents. Manufacturer

Serial Number

Ground/Earthing

xvi

Important Safety Information

Symbol

Description Do not place items in radiant heat path. 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 decommissioning of your equipment.

UDI

Unique Device Identifier. The UDI is a unique marking for identification of the medical device.

Beginning in September 2016, some medical devices sold in the USA must be labeled with a Unique Device Identifier (UDI). The UDI label will be located on or adjacent to the serial number label on the device. Example of UDI label format.

xvii

Important Safety Information

xviii

Chapter 1: Functional Description

AC 110 - 240V

EMI Filter 2 Fuses

J1

Power Supply Output DC J2 12V 5A

Chassis Ground J3

Stand By Switch 12V Lamp

3 LED Current Drivers 750mA 1.5A

J4

Enable

Control PCB

Fan 12v

J2

J2

6 LED PCB T-Stat

J1

Fan 12V

LED Current Sencer Over Temp Sencer

J5

Pad Shutter Switch

J1

J1

Front PCB Hour Meter LED Indicators

AC power is fused and filtered by the EMI Filter before it is converted to 12V DC by the Power Supply and delivered to the Control PCB. The Control PCB consists of three identical buck regulator circuits that are configured as constant voltage/constant current sources with the ability to adjust the constant current source output to the LEDs. The Control PCB drives three pairs of LEDs on the LED PCB and the 12V fan. The LED PCB is only enabled when power is supplied, the Standby Switch is “On”, the Pad Shutter Switch is closed and the solid-state thermostat on the LED PCB is not tripped. When the solid-state thermostat on the LED PCB is tripped, the fan still gets 12V to help cool the box. The Control PCB also delivers 12V to the Standby Switch lamp. When the LED current sensor on the Control PCB detects that at least one pair of LEDs is not working properly, the LED module failure indicator on the Front PCB blinks. When the thermostat on the LED PCB is tripped, the unit overheated indicator on the Front PCB lights. Whenever power to the LED PCB is “enabled”, the hour meter gets the signal to count hours. See the schematic on the following page for more detail.

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Chapter 1: Functional Description

2

Chapter 2: Components and User Controls

BiliSoft Light Box The light box contains the LED module, a power supply, a cooling system, and an overheating protection. The universal power supply allows the unit to be supplied via any standard AC main power source at either 50 or 60 Hertz that has voltages in the range of 90 to 264 V~. The LED module produces a very narrow bandwidth of light with no appreciable amount of ultraviolet or infrared light. The light box is cooled by a fan, and a thermal cutout switch located on the LED module protects the light box from overheating. The LED module in the light box is activated only when the fiber optic cable is plugged into the system. Component/Control

Function 1. Standby Switch – Turns the unit on/off. The green light on the switch indicates that the standby switch is turned on and the unit is powered. 2. Hour Meter – The non-resettable hour meter runs whenever the fiberoptic light pad is illuminated. If the fiberoptic cable is not fully inserted into the light box, the LEDs are automatically shut off and the hour meter does not run. 3. Unit Overheated Indicator – When the red indicator light is on, the unit has overheated. See Troubleshooting Guide for more details. 4. LED Module Failure Indicator – When the red indicator light flashes, at least one of the three LED pairs has failed. See the Troubleshooting Guide for more details. 5. Fiberoptic Light Pad Assembly Port - Where the fiberoptic light pad assembly connects to the main unit. An LED shutoff switch inside the port automatically shuts off the LED module whenever the fiberoptic light pad assembly is disconnected. 6. Air Vents – For proper cooling it is important to keep the air vents clear of obstruction. 3

Chapter 2: Components and User Controls

Component/Control

Function 7. Air Filter – For proper cooling it is important to keep the air filter clear of obstruction. See the maintenance section of this manual for more details. 8. Power Cord Receptacle 9. Fuse Cover - Houses two power inlet fuses. 10. Mounting Bracket Holes – Four holes on the bottom of the main unit are used to attach the optional mounting bracket. The mounting bracket can be positioned on the left or right side of the light box.

BiliSoft Fiberoptic Light Pad Assembly The fiberoptic light pad comes in two sizes, large and small. The LED light source in the BiliSoft light box is focused on the fiberoptic lenses at the end of the fiberoptic cable connector. The fiberoptic cable contains plastic fibers that transmit light from the light box to the light pad. The light pad is constructed of these plastic fibers woven into a mat. This patented process produces a light pad that emits light over its entire surface. Average light intensity depends on the size of the light pad. See Specifications section for more details. Component/Control 1. Fiberoptic light pad 2. Fiberoptic cable connector 3. Fiberoptic lenses 4. Fiberoptic cable

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Chapter 2: Components and User Controls

WARNING: Never place a baby directly on the bare fiberoptic light pad. The fiberoptic light pad should always be covered with a BiliSoft Pad Cover or BiliSoft Nest when used with the patient.

Soft Cover Options (Disposables) The BiliSoft Pad Cover and BiliSoft Nest are designed for use with both premature and full-term infants. The BiliSoft Pad Cover and BiliSoft Nest are available in small and large sizes to accommodate whichever fiberoptic light pad is used. BiliSoft Pad Cover

BiliSoft Nest

A flat cushioned cover with straps

A cushioned cover with developmental positioning foot roll and straps

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Chapter 2: Components and User Controls

6

Chapter 3: Troubleshooting

WARNING: Whenever the unit is plugged in, AC power is present. Use caution when cover is removed. CAUTION Insulation on electrical wiring can deteriorate with age. Check for brittle or deteriorated insulation on the power cord before each use and all other electrical wiring while performing troubleshooting or replacement of internal components. NOTE: Potentiometers on the boards are set at the factory and are not to be adjusted in the field.

Troubleshooting Guide Symptom

Troubleshooting Steps

A Unit Overheated Indicator light is on.

1. Check that the air filter in the back of the unit and the air vents on either side of the unit are unobstructed.

red

2. Inspect the air filter. Clean or replace, if clogged. 3. Check that the environment that the unit is being operated in does not have ambient temperature above 35°C (95°F). 4. Turn off the power and allow the unit to cool. NOTE: It can take up to 10 minutes for the thermostat to reset. 5. Check that the fan is running with the power switch on (fan operates at low noise level- listen carefully). If the fan is not running, do the following: remove LED module, check connections J1 and J2, then check for 12V at pins 19 and 20 on J2 of the ribbon cable. If 12V present, replace the fan. 6. Slide unit out of housing and check the Control PCB connections. If properly connected, replace the Control PCB. 7. If the problem persists, replace the LED module.

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Chapter 3: Troubleshooting

Symptom

Troubleshooting Steps

B No light output.

1. C  heck power connections and that the standby switch is on. Check that the fiberoptic pad connector is fully inserted. 2. Check that the green power indicator on the standby switch is lit. If indicator is not lit, see C. 3. Check if the Unit Overheated indicator is lit. If it is on, see A. 4. Check if the LED failure indicator is blinking. If it is blinking, see D. 5. Check if the fan is running. If so, replace the Control PCB. If not, remove cover and check Control PCB connections.

C Standby switch is on, but green indicator does not light. green off

6. Disconnect J5 and check continuity through the fiberoptic pad connector switch (pins 1 and 2) with the fiberoptic pad connector inserted. If there is continuity, replace the Control PCB. If there is no continuity, replace the fiberoptic pad connector switch. 1. Check that the power cord is in good condition, and properly connected at both the light source and the line power source. 2. Check the fuses. Replace, if necessary. 3. Remove the cover and check the AC input to the Power Supply at connector J1. If there is no AC voltage present, replace the EMI filter or the AC harness as needed.

D LED failure indicator light is blinking.

blinking

8

4. Check the 12V DC output of the Power Supply at connector J3 (pins 1 and 4). If there is no output, replace the Power Supply. if there is output, replace the power supply harness or Control PCB as needed. 1. Remove cover and check the Control PCB and LED PCB connections. 2. Check the voltage (5V is typical, but varies with array current demand) at pin 1 on U2 on the Control PCB and ground on pin 4 on J2 on the Power Supply. Repeat on U8 and U11 on the main control board. If voltage is present at all 3 test points, replace the LED module. If not, replace the Control PCB.

Chapter 3: Troubleshooting

Symptom

Troubleshooting Steps

E Indicator lights not working.

1. Confirm failure condition.

off

2. Remove cover and check all connections. 3. Check voltage across affected indicator LED pins on Display PCB. If voltage is present, replace the Display PCB. If no voltage is present, replace the Control PCB.

F Light output measurement is out of specification.

1. Check if the LED failure indicator is blinking. If it is blinking, see D. 2. Check that the fiberoptic pad connector is fully inserted and that nothing is obstructing the port. 3. Check the LED lenses inside the fiberoptic pad connector port for discoloration or damage. NOTE: See Operation and Maintenance Manual for approved cleaning procedure. 4. Check the fiberoptic light pad and fiberoptic lenses on the connector for discoloration or damage. NOTE: See Operation and Maintenance Manual for approved cleaning procedure. 5. Make sure that the irradiance measurement follows the procedure detailed in the Operation and Maintenance Manual. 6. Replace the LED module. 7. If the problem persists, replace the fiberoptic light pad.

G Excessive fan noise

8. If the problem persists, replace the Control PCB. 1. Check the air filter for obstruction. 2. Check the fan for obstruction. 3. Replace the fan.

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Chapter 3: Troubleshooting

Symptom

Troubleshooting Steps

H Fiberoptic light pad, cable or connector is damaged.

1. Replace the fiberoptic light pad.

J Fiberoptic pad connector switch not working

NOTE: See Operation and Maintenance Manual for approved cleaning procedure. 1. Check that the fiberoptic pad connector is fully inserted, and the standby switch is in the on position and the green indicator light is on. If indicator light is not lit, see C. 2. Remove cover and check the Control PCB and fiberoptic pad connector switch connections.

K Hour meter is not working.

3. Check the continuity through the switch. If the switch is working, replace the Control PCB. If the switch is not working, replace the switch. 1. If there is no light output, see B. 2. Check the connections on the Display PCB and the Control PCB. 3. Check pin 3 on the Display PCB ribbon cable for voltage. if voltage is present, replace the Display PCB. if no voltage is present, replace the Control PCB.

WARNING: When handling the fiberoptic cable connector (during insertion, removal or positioning of the fiberoptic light pad) use caution to prevent the fiberoptic cable connector from dropping, which can damage the fiberoptic cable connector and/or injure the patient or caregiver.

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