GE Bilisoft 2.0 Service and Maintenance Manual Rev F

© 2020 by Lumitex Inc. All rights reserved. Lumitex Inc. and General Electric Company reserve 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. Lumitex is a registered trademark of Lumitex, Inc. BiliSoft is a registered trademark 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 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 this 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.

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Table of Contents About this Manual ... v About this Product... vi Important Safety Information ... vii Service Language Disclaimer ... vii Safety Information ... xv Symbol Definitions... xv Chapter 1 Functional Description ...1-1 Modes of operation... 1-4 Chapter 2 Components and User Controls ...2-1 BiliSoft 2.0 Light Box... 2-1 BiliSoft 2.0 Fiberoptic Light Pad Assembly ... 2-4 Soft Cover Options (Disposables)... 2-5 Chapter 3 Troubleshooting ...3-1 Troubleshooting Guide ... 3-1 Chapter 4 Service Maintenance / Checkout Procedures ...4-1 Procedures Schedule ... 4-2 Environmental Requirements... 4-2 Tool Requirements ... 4-3 Maintenance and Checkout Procedures ... 4-3 Visual Inspection ... 4-3 Functional Checks ... 4-4 Light Intensity Check ... 4-5 Light Pad Output ... 4-5 Electrical Safety Tests ... 4-6 Leakage Current Checks... 4-7 Chapter 5 Replacement/Procedures ...5-1 Electrical Safety Checkout Procedure ... 5-1 Light Intensity Checkout Procedure ... 5-1 Air filter Cleaning/Replacement ... 5-1 LED Module Replacement... 5-2 Fan Replacement... 5-6 Accessing/Replacing Other Internal Components ... 5-7 iii

Chapter 6 Illustrated Replacement Parts ...6-1 Illustrated Parts... 6-2 Cover ... 6-3 LED Module ... 6-6 Base & Power Supply ... 6-7 Wire Harnesses... 6-8 Air Filter ... 6-9 Power Cords ... 10 Chapter 7 Optional Equipment and Replacement Parts...7-1 Chapter 8 Specifications...8-1 Chapter 9 Technical Reference...9-1 Spectral Irradiance Light Output... 9-1 Effective Pad Area for Irradiance Output ... 9-2 Pad Output Measurement Points ... 9-2 Chapter 10 EMC Guidance ... 10-1 Degraded Performance Characteristics... 10-1 Manufacturer’s Guidance and Declaration Regarding Electromagnetic Emissions ... 10-2 Manufacturer’s Guidance and Declaration Regarding Electromagnetic Immunity ... 10-2 Manufacturer’s Guidance and Declaration Regarding Electromagnetic Immunity to RF Wireless Communication Devices... 10-4 EMC Service Life... 10-5

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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. SENSITIVE TO ELECTROSTATIC DISCHARGE CAUTION An Electrostatic Discharge (ESD) Susceptibility symbol is displayed to alert service personnel that the parts 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.

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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). This manual describes how to use, maintain and repair the BiliSoft 2.0 Phototherapy System. The BiliSoft 2.0 should only be serviced by qualified personnel.

Description The BiliSoft LED 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 an optional large (25cm x 30cm).

Repair Policy WARNING: No modification or alteration of this device is allowed. 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 by Lumitex and 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 a number on the back of the manual PRIOR to performing any repairs on the unit.

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Important Safety Information WARNING: Electrical shock hazard: Before servicing, always unplug the unit from wall power. WARNING: Side Effects: Looking at the blue light for a long time may experience headache, nausea, or mild vertigo. WARNING: Flammable Solutions: Never use flammable solutions to clean the BiliSoft 2.0 Phototherapy System or any of its parts. WARNING: Dispose of all waste as required by federal, state, and local waste regulations. Improper disposal could result in personal injury or harm the environment. WARNING: To avoid patient injury, do not mount the system using a dove tail rail or service the unit while a patient occupies the bed or is receiving treatment.

Note: Isolation of the unit from the supply mains is achieved by unplugging the device.

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

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If a customer’s service provider requires a language other than English, it is the customer’s responsibility to provide translation services.

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Do not attempt to service the equipment unless this service manual has been consulted and is understood.

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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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Safety Information Symbol Definitions Symbol

Description Electrical shock hazard possible. WARNING statements are used when the possibility of injury exists. CAUTION statements are used when there is a possibility to damage the equipment.

NOTE:

NOTE statements are used to provide additional information, or clarify a point.

~

Indicates alternating current (AC).

Type BF applied part.

Cover the patient’s eyes during phototherapy. On/Off Standby Switch Unit overheated indicator Hour meter

LED failure indicator

Double Insulated

See the Operation Manual for more information. Do not spray cleaner directly onto the fiberoptic lens. The fiberoptic lens require special cleaning methods. See cleaning section of the Operation Manual for complete details. xv

Symbol

Description European Union Representative

Manufacturer

ETL approval symbol

Do not place items in path of radiant heater

Rx Only

US Federal law restricts this device to sale by or on the order of a licensed medical practitioner. (Applicable only in the USA)

Waste Electrical and Electronic Equipment Directive symbol CE mark - Lumitex declares that product displaying the CE mark conforms to the Medical Devices Directive [93/42/EEC] and [2007/47/EC]. Do Not Reuse

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IP21

Protection levels for solid objects and water ingress: 2 - Fingers or similar objects < 12.5mm diameter 1 - Dripping water (vertically falling drops)

IPX4

Protection levels for water ingress: 4 - Water splashing against the enclosure from any direction shall have no harmful effect.

SN

Serial Number

REF

Part Number

UDI

Unique Device Identifier. The UDI is a unique identifier for medical device.

Symbol

Description Beginning in September 2016, some medical devices sold in the USA must be labeled with a Unique Device Identifier (UDI).

SMALL PAD

LARGE PAD

The baby outline defines the side of the pad upon which to place the baby. Place the baby on this side of the pad.

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Chapter 1 Functional Description

1-1

Component

Therapeutic LED assembly

LED driver PCB

Control PCB

1-2

Description The therapeutic LED is mounted directly to a fan-cooled heat sink and also has a built-in thermistor output which is used to produce the temperature fault indications. The thermistor signal is routed through the LED driver board and then to the control board. The LED assembly contains a reflector which serves to narrow and direct the output LED light into the fiberoptic lens at the end of the fiberoptic cable connector. A 12VDC fan is mounted to the baffle and secured to the heat sink. The fan is positioned to pull air from the cool zone (one side of baffle) and blow it into the hot zone (other side of baffle). The baffle ensures that the heat sink exhaust heat is directed to the exhaust vents to prevent recirculation. Backward installation of the fan causes reverse air flow from hot zone to cool zone and negatively impacts the heat sink cooling. During overtemperature/under-temperature conditions, the fan keeps running to bring the LED assembly temperature to the ambient temperature. This PCB powers the therapeutic LED, cooling fan, and also generates a 5VDC supply for powering the control PCB. The LED driver PCB is set at the factory so that sufficient drive current for the therapeutic LED is provided. The current to the therapeutic LED is factory-sealed and non-adjustable in the field. Therefore, the LED driver PCB and the therapeutic LED assembly shall always be replaced as a pair with a new factory-set pair. (Mixing and matching is not allowed.) The control PCB is mounted to the inside of the unit cover and provides the system controls, indicator LEDs, hour meter display, standby/on switch, and user interface. The control PCB sends the commands to the LED driver PCB to operate the therapeutic LED and the fan. It also controls when to cut power to the therapeutic LED in the event of an over or under temperature fault. The control board includes the hour meter display which shows the total accumulated run time that the therapeutic LED has been illuminated since it was used for the first time. The hour meter is not resettable, therefore, new product units ship with readings other than zero from the factory because of production tests. The hour meter counts only when the therapeutic LED is illuminated.

Component

User interface indicators

Description Colored indicators on the front face of the light box provide information as to the status of the device. The standby indicator is housed inside of the standby/on switch, and it illuminates green whenever it is turned on with AC power applied to the unit. The standby indicator will not illuminate if there is either a problem with the light itself, or the internal power supply. When there is a pad plugged into the light box, the standby/ on switch will control the therapeutic LED. Pressing the standby/ on switch with a pad plugged into the system will elicit the two red indicator lights to flash, indicating that they operate properly. The system-overheating indicator light will illuminate solid red whenever the LED temperature goes beyond a factory-preset limit. In this state, the phototherapy light will be disabled, and the system-cooling fan will remain enabled while the system attempts to bring the LED temperature back to ambient temperature. When the over-temperature fault is removed, the red indicator light will turn off, and the therapeutic LED will illuminate. In the event the user attempts to run the device when the temperature is below freezing, the standby/ on indicator will illuminate and the red indicator lights will also illuminate upon initial power up, however, the therapeutic LED will be disabled and no red indicator lights will be enabled. The cooling fan will continue to run to attempt to bring the unit back up to ambient temperature. When the under-temperature fault is removed, the therapeutic LED will illuminate. The system also monitors the status of the therapeutic LED. When there is a problem with it, a red LED-Fault indicator light will flash repeatedly.

Power supply

The system includes a universal medical grade switching power supply that can accept AC input voltages in the range of 100-240VAC at 50/60Hz to generate a 12VDC output that powers the system.

Appliance Coupler

The power cord connects to the appliance coupler located on the bottom of the device. This appliance coupler also provides EMI filtering.

1-3

Modes of operation Operational State Standby

Normal Operation/ Phototherapy On

Under-temp Standby

Over-temp Standby

Therapy LED Failure

1-4

Identified As 1. 2. 3. 4.

Unit is plugged into the wall. Green standby/ on switch is turned on and illuminated. Pad is not plugged in. Hour meter display is off.

1. 2. 3. 4. 5. 6.

Unit is plugged into the wall. Pad is plugged into the unit. Green standby/ on switch is on and illuminated. Both Red indicator lights flashed briefly upon initial power up. Light Pad is emitting blue light. Hour meter display is on and counting.

1. 2. 3. 4. 5. 6. 7. 8.

Unit is plugged in to the wall. Green standby/ on switch is on and illuminated. Pad is plugged in. Both Red indicator lights flashed briefly upon initial power up. Light Pad is NOT emitting blue light. Hour meter display is on, but not counting. Internal fan is running. (There will not be any red indicators illuminated during an undertemp lockout state). 9. Once the unit warms sufficiently the unit will transition to the Normal Operation/Phototherapy On state. 1. 2. 3. 4. 5. 6. 7. 8. 9.

Unit is plugged in to the wall. Green standby/ on switch is on and illuminated. Pad is plugged in. Both Red indicator lights flashed briefly upon initial power up. Light Pad is NOT emitting blue light. Hour meter display is on, but not counting. Internal fan is running. Red Over-temp indicator is on. Once the unit cools sufficiently the unit will transition to the Normal Operation/Phototherapy On state.

1. 2. 3. 4. 5. 6. 7. 8.

Unit is plugged in to the wall. Green standby/ on switch is on and illuminated. Pad is plugged in. Both Red indicator lights flashed briefly upon initial power up. Light Pad is NOT emitting blue light. Hour meter display is on, but not counting. Internal fan is running. Red LED Fault indicator is flashing.

Chapter 2 Components and User Controls BiliSoft 2.0 Light Box The Light Box contains the output LED module, a power supply, a cooling fan and temperature protection. The power supply is universal. The device can be supplied by most all standard AC main power sources. The rated input voltage is 100-240VAC at 50/60 Hz. The rated input current is 0.25-0.75 Amps. The LED module produces a very narrow band of blue light with no appreciable amount of ultraviolet or infrared. The LED module can only be activated when the Light Pad connector is plugged into the system. The light box is cooled by a fan. A thermal sensor located on the LED module protects the device from overheating. It also prevents operation if the temperature is below freezing. .

Component/Control

Function 1. Standby Switch – Turns the unit ON/OFF. The green light in the switch indicates that the standby switch is turned on and the unit has power.

1

2

3 4 5 6

2. Hour Meter –The non-resettable hour meter shows the number of hours a light pad has been active during the life of the light box. If the Light Pad connector is not fully inserted into the light box, the LED is automatically shut off and the hour meter does not run. Note: The hour meter is provided to track LED life and is not intended to be used to measure therapy durations.

2-1

Component/Control

Function 3. Unit Overheated Indicator – When this red indicator light is ON, the unit has overheated. See Troubleshooting Guide for more details.

1

2

3 4 5 6

4. LED Module Failure Indicator - When this red indicator light FLASHES, the LED module has failed. See the Troubleshooting Guide for more details. 5. Light Pad Connector Port – Where the light pad assembly connects to the main unit. A shutoff switch inside the port automatically turns off the LED module whenever the fiberoptic light pad assembly is removed. 6. Exhaust Air Vents – For proper cooling it is important to keep the air vents clear of obstructions.

7. Air Filter & Air Intake Vents – For proper cooling it is important to keep the air filter clean and clear of obstructions. See the Replacement/Procedures chapter of this manual for more details. 7 8

2-2

8. AC Power Cord Receptacle – IEC 60320 C18 appliance coupler, accepts C17 power cord connector. Ensure good connection by firmly pushing in power cord.

Component/Control

Function

9

9

9

9

9. Mounting Bracket Holes – Four M4 threaded 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.

2-3

BiliSoft 2.0 Fiberoptic Light Pad Assembly The fiberoptic light pad comes in two sizes, small and large. The small pad surface is 8x10 inches. The large pad surface is 10x12 inches. The LED light source in the BiliSoft 2.0 light box is focused on the fiberoptic lens at the end of the Light Pad 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. The average light intensity depends on the size of the light pad. See Chapters 8 and 9 for detailed specifications.

Component/Control 4

3

1. Light pad 2. Pad connector 3. Fiberoptic lens

2 1

4. Fiberoptic cable

Warning: Do not place a baby directly on the bare fiberoptic light pad. The fiberoptic light pad should always be covered with a BiliSoft Pad Cover or Nest when used.

2-4

Soft Cover Options (Disposables) The BiliSoft Pad Covers and Nests are designed for use with both premature and full-term infants. They are available in small and large sizes to match the size of the Light Pad.

Warning: The soft covers are single-use products. They are not to be reused on a different patient. Reuse may cause a risk of cross-contamination or, affect the system performance. Repeated use on the same patient, is acceptable. The user must ensure that the product is not damaged or contaminated between uses on the same patient. BiliSoft Pad Covers cannot be washed.

BiliSoft Pad Cover, Flat

A flat cushioned cover with straps.

BiliSoft Pad Cover, Nest

A cushioned cover with developmental positioning foot roll and straps.

2-5