GE Bilisoft 2.0 Operation Manual Rev D

© 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 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 iii

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

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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.

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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). 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: 1

Light Source Box with language specific warning labels

1

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

1

Country / Region specific AC Power cord

1

Operation Manual (Language specific)

1

Service Manual (English Language Only)

2

Disposable Pad Cover, Flat

1

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.

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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.

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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.

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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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Trip Hazard: The power cord can be a trip hazard. Do not leave the cord unattended when located in traffic areas. Unit Damage: A damaged or defective unit or accessory should not be used.

Electric Shock Hazard : Do not attempt to insert objects into the intake or exhaust vents on the cover.

CAUTIONS: Electromagnetic Interference: The user needs to be aware of electromagnetic interference, or EMC. This device is to be installed and put into service according to the EMC information provided in Chapter 9. Roll Stand: If the system is mounted on a portable roll stand, lock the wheels to prevent movement during the therapy. Trip Hazard: The power cord can be a trip hazard. Do not leave the cord unattended when located in traffic areas. Unit Damage : Do not attempt to insert objects into the intake or exhaust vents on the cover.

Contraindications The following patient symptoms or conditions make phototherapy treatment inadvisable*. • Congenital porphyria or family history of porphyria. • Concomitant use of drugs or agents that are photosensitive. • Concurrent therapy with metalloporphyrin heme oxygenase inhibitors. Phototherapy effectiveness may be reduced in presence of cholestasis (direct hyperbilirubinemia).

* MacDonald & Ramasethu (2007). Atlas of Procedures in Neonatology, Lippincott Williams & Wilkins, Philadelphia, PA

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Care of the Patient’s Skin Important clinical information – please read carefully before using this device. The skin has a number of roles. It provides a protective barrier against chemical, mechanical, and biological injuries. It helps maintain body temperature. It also serves as a route for water excretion, especially in premature infants. The introduction of new intensive care techniques has increased survival of very small, premature infants. Very low weight infants do not have fully developed skin. Combined with more instrumentation and handling, this poses previously unrecognized problems for the nursing care of these infants.1 Please read, evaluate and implement the following recommendations as appropriate: 1. Please refer to the following standard of skin care recommendations as given in the literature2 when utilizing this device. Special attention should be given to sanitation and skin integrity. • • • •

Observe color, rashes, excoriation. Clean skin with warm water. Clean perineal area after stooling. Change infant’s position every 2 hours.

2. This device is intended only for the treatment of existing hyperbilirubinemia. Use of this device as preventative treatment is not recommended. Premature infants have extremely fragile skin3 and various clinical studies have produced different conclusions concerning the effectiveness of preventative treatment. 4, 5

1 NAACOG (1992), OGN Nursing Practice Resource, Neonatal Skin Care, NAACOG. 2 ibid 3 Rutter, N., The immature skin, British Medical Bulletin, Vol. 44, No. 4, 1988 4 Curtis-Cohen, M., et al, Randomized trial of prophylactic phototherapy in the infant with very low birth weight,

The Journal of Pediatrics, July, 1985

5 Brown, A., et al, Efficacy of Phototherapy in Prevention and Management of Neonatal Hyperbilirubinemia,

Pediatrics, February, 1988

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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.

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Symbol

Description Do not spray cleaner directly onto the fiberoptic lens. The fiberoptic lens require special cleaning methods. See cleaning section of this manual for complete details. European Authorized Representative

Manufacturer

ETL approval symbol

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) Do not place items in path of radiant heater

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 (light box): 2 - Fingers or similar objects < 12.5mm diameter 1 - Dripping water (vertically falling drops)

IPX4

Protection levels for water ingress (light pad): 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 a 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 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 circuitry. The power supply is universal. The device can be supplied by any standard AC main power source. The rated input voltage is 100-240VAC at 50/60 Hz. The rated input current is 0.25-0.75 Amps. The LED module emits a very narrow band of blue light with no appreciable amount of ultraviolet or infrared light. The LED module can only be activated when the 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.

1-1

Component/Control

1

Function

2

3 4

5 6

1

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. 2. Hour Meter –The nonresettable 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.

3. Unit Overheated Indicator – When this red indicator light is ON, the unit has overheated. See Troubleshooting Guide for more details. 2

3 4 5 6

4. LED Module Failure Indicator When the 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.

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