GE BiliSoft LED Phototherapy System Operation and Maintenance Manual Rev D

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Table of Contents User Responsibility... v Care of the Skin ... vii Chapter 1 Product Description ... 1-1 Intended Use ... 1-1 Description ... 1-1 Chapter 2 Safety Information ... 2-1 Symbol Definitions ... 2-1 General Safety Information... 2-3 Chapter 3 Home Use ... 3-1 Homecare provider ... 3-1 Parents or Guardians ... 3-1 Recording Daily Activities ... 3-2 Taking Temperatures ... 3-2 Urine/Stools ... 3-2 Feeding ... 3-2 Treatment Time... 3-2 Bathing ... 3-2 Daily Record Sheet ... 3-3 Chapter 4 Components and User Controls... 4-1 BiliSoft Light Box ... 4-1 BiliSoft Fiberoptic Light Pad Assembly... 4-3 Soft Cover Options (Disposables)... 4-4 Chapter 5 Operating Instructions ... 5-1 Checking the Unit ... 5-1 Positioning the Unit ... 5-3 Attaching the Mounting Bracket ... 5-4 Using the Unit ... 5-5 Chapter 6 Troubleshooting... 6-1 Alarm/Troubleshooting Guide... 6-1 Chapter 7 Routine Cleaning and Maintenance... 7-1 Maintenance Schedule... 7-1 Cleaning and Disinfecting ... 7-2 BiliSoft Light Box ... 7-2 BiliSoft Fiberoptic Light Pad and Cable ... 7-3 BiliSoft Cable Connector and Fiberoptic Lenses ... 7-4 Air Filter ... 7-5 Chapter 8 Options ... 8-1 Chapter 9 Specifications ... 9-1 Chapter 10 Technical Reference... 10-1 EMC Guidance IEC 60601-1-2 - 4th edition ... 10-2 Appendix - Additional Safety Information………………………………………………………………….……………………A-1 Warranty

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User Responsibility This Product will perform in conformity with the description thereof contained in this operating manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, GE Healthcare recommends that a telephone or written request for service advice be made to the nearest GE Healthcare Regional Service Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by GE Healthcare and by GE Healthcare trained personnel. The Product must not be altered without GE Healthcare’s prior written approval. The user of this Product shall have the sole responsibility for any malfunction that results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than GE Healthcare. CAUTION: US Federal law restricts this device to sale by or on the order of a licensed medical practitioner.

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.

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Care of the Skin Important clinical information – please read carefully before using this device. The skin serves as a protective barrier against chemical, mechanical, and biological insults. The skin is also important in the regulation of body temperature and serves as a route of water excretion, especially in premature infants. The introduction of new intensive-care techniques has been associated with the increased survival of very small, premature infants. The immaturity of the skin of the very low weight infants, coupled with excessive instrumentation and handling, 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 with all infants. 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 for prophylactic treatment, particularly of premature infants, is not recommended. These infants have extremely fragile skin3 and various clinical studies have produced inconsistent conclusions concerning the effectiveness of prophylactic phototherapy 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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Chapter 1 Product Description Intended Use The BiliSoft LED Phototherapy System provides light therapy for the treatment of indirect hyperbilirubinemia, commonly known as neonatal jaundice, in a hospital or home setting.

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 440-460 nanometer). Units are available with two fiberoptic pad sizes: large (25cm x 30cm) and small (15cm x 30cm). The large pad’s nominal spectral irradiance is 35 µW•cm-2•nm-1 through a typical BiliSoft Pad Cover or BiliSoft Nest. The small pad’s nominal spectral irradiance is 50 µW•cm-2•nm-1 through a typical BiliSoft Pad Cover or BiliSoft Nest.

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Chapter 2 Safety Information Symbol Definitions Symbol

Description A WARNING statement is used when the possibility of injury exists. A CAUTION statement is used when the possibility of damage to the equipment exists.

NOTE:

~

A NOTE provides additional information to clarify a point in the text. 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

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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.

See the Operation Manual for more information.

Manufacturer

ETL symbol

WEEE symbol

Ground/Earthing

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General Safety Information WARNING: Eye Protection: Direct exposure of the eyes to any phototherapy light may cause eye damage. Always protect the baby’s eyes with eye patches or an equivalent appropriate eye protection product. Periodically and/or per your hospital protocol or healthcare provider’s instructions, verify that the patient’s eyes are protected and free of infection. Care should also be taken to protect the eyes of patients adjacent to the treatment area, when necessary. WARNING: Home Users: During phototherapy treatment always follow your healthcare professional’s care instructions. WARNING: Caregiver Side Effects: Looking at light emitted by any phototherapy device for prolonged periods may cause side effects, such as headache, nausea, or mild vertigo, in some caregivers or visitors. WARNING: Bilirubin Levels: The bilirubin levels of patients receiving phototherapy should be regularly measured. WARNING: Possible Risks: All phototherapy methods have possible risks including, but not limited to apnea, bronze baby syndrome, diarrhea, hyperpigmentation-reddening, patent ductus arteriosus, riboflavincalcium and other deficiencies, skin blistering, skin irritation and thrombocytopenia. Monitor the patient closely for signs of these conditions during phototherapy. WARNING: Porphyrins/Photoisomers: Bilirubin photoisomers may cause toxic effects. Porphyrins are the by-products of the photochemical break down of the bilirubin molecule. In some cases, exposure of porphyrins to phototherapy may result in a localized reddening of the patient’s skin. Therefore, skin assessment is recommended with all types of phototherapy. WARNING: Photosensitive Drugs: The light generated by phototherapy devices can degrade photosensitive medications. Do not place or store any drugs near or in the illuminated area.

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WARNING: Water Loss: The radiant energy from phototherapy lights can increase a patient’s insensible water loss. Take appropriate measures to maintain the patient’s fluid balance while administering phototherapy. WARNING: Skin Temperature: Phototherapy light can affect the temperature in thermoregulation devices (incubator, radiant warmers or heated mattresses) and may raise the patient’s body temperature. It is recommended to use the incubator or warmer in skin controlled (servo) mode. Always monitor the patient’s temperature to avoid temperature fluctuations during phototherapy. WARNING: Reflective Foils: Using reflective foils to increase the efficacy of phototherapy may cause hazardous patient body temperatures. WARNING: Combustible Gases: Do not use the BiliSoft LED Phototherapy System in the presence of gases that support combustion like oxygen, nitrous oxide or other flammable or combustible anesthetics. WARNING: Flammable Solutions: Never use flammable solutions to clean the BiliSoft LED Phototherapy System or any of its parts. CAUTION: Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the service manual. Portable and mobile RF communications equipment can affect Medical Electrical Equipment. The BiliSoft LED Phototherapy System should not be used adjacent to or be stacked on other equipment. If adjacent or stacked use is necessary, the BiliSoft LED Phototherapy System should be observed to verify normal operation in the configuration in which it will be used.

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Chapter 3 Home Use Homecare provider Ensure when you deliver BiliSoft LED Phototherapy System for use in the home that you provide adequate in-service training for parents or guardians. Be sure to provide this Operation Manual and eye covers.

Parents or Guardians Ask your healthcare provider for information about monitoring your baby during the phototherapy treatment. Follow your doctor’s recommendation for treatment duration. Before you begin treatment, place the following items close to the treatment area:   

Phone numbers of doctor, hospital and home healthcare provider Thermometer Extra BiliSoft Covers or BiliSoft Nests

To properly operate the unit, follow the steps described in "Using the Unit" in Chapter 5 of this manual. Position your baby according to your doctor’s recommendations. Ensure that as much of the baby’s skin as possible is in direct contact with the illuminated section of the covered light pad. The baby, along with the light pad, may be covered or wrapped in a thin blanket. It is possible to hold and feed the baby while continuing treatment. The baby will continue to receive effective phototherapy treatment as long as the covered, light emitting section of the pad remains in direct contact with the skin. You may swaddle the baby. Cover the baby’s eyes when using the BiliSoft LED Phototherapy System to shield them from light emitted by the BiliSoft fiberoptic light pad. WARNING: Direct exposure of the eyes to any phototherapy light may cause eye damage. Always protect the baby’s eyes with eye patches or an equivalent appropriate eye protection product. Periodically and/or per your hospital protocol or healthcare provider’s instructions, verify that the patient’s eyes are protected and free of infection. Care should also be taken to protect the eyes of patients adjacent to the treatment area, when necessary.

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Recording Daily Activities You should keep a daily record of your baby’s activities and condition. A sample of an easyto-use chart is provided on the following page. These records will provide your healthcare provider or physician with an accurate account of your baby's activities, enabling them to better assess the progress being made.

Taking Temperatures It is important to monitor your baby’s temperature during phototherapy sessions. Your doctor will tell you the range of acceptable temperatures for your infant and may suggest a method for taking temperatures. For charting purposes, it is important that you use the same method each time you take your baby's temperature.

Urine/Stools It is essential that you count and record the number of stools and wet diapers. You will also be asked to describe stools. Loose stools, black or dark green sticky stools are common during phototherapy. These observations will help your healthcare provider determine if your baby is getting enough fluids and will signify any significant changes in their condition. On your record sheet, note occurrences under the appropriate column and describe the stools.

Feeding Follow your baby’s regular feeding schedule. Your healthcare provider can help you determine this. Note feeding times and amount of formula taken, or length of time fed, on the record sheet.

Treatment Time Your healthcare provider or physician will tell you how long your baby needs to undergo treatment. Record the actual times at which your baby is put on and taken off the BiliSoft LED Phototherapy System during each 24-hour period. Apply phototherapy for as long as possible during each 24-hour period.

Bathing You may continue your baby's normal bathing routine. Discontinue phototherapy during bathing. WARNING: If you have questions or concerns, contact your healthcare provider immediately.

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Note: This form is provided as a reference only. To preserve the integrity of this manual, please do not write directly on this page or remove this page from the manual. Reproduce this form, if desired.

Daily Record Sheet Name:

Date:

Birth Date:

Bilirubin Level:

Method of Temperature Taking:

Time

Temperature

Number of Diapers

Amount Fed

(indicate wet and/or stool with description)

Times when baby is put on and taken off phototherapy treatment: On

Off

On

Off

On

Off

Comments:

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Chapter 4 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 nonresettable 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. 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 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.

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Component/Control

Function 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. 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.

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