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M1110147 Rev. 

5

   © 2007 Datex-Ohmeda.  All rights reserved  

1-1

 

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.   

Содержание BiliSoft

Страница 1: ... Healthcare BiliSoft LED Phototherapy System Operation and Maintenance Manual BiliSoft LED Phototherapy System Operation and Maintenance Manual English M1110147 Rev 5 2007 Datex Ohmeda All rights reserved ...

Страница 2: ...ii M1110147 Rev 5 2007 Datex Ohmeda All rights reserved This page intentionally left blank ...

Страница 3: ...mponents 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 ...

Страница 4: ...iv M1110147 Rev 5 2007 Datex Ohmeda All rights reserved This page intentionally left blank ...

Страница 5: ...hcare 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 p...

Страница 6: ...vi M1110147 Rev 5 2007 Datex Ohmeda All rights reserved This page intentionally left blank ...

Страница 7: ...s 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 pa...

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Страница 9: ...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 ...

Страница 10: ...1 2 M1110147 Rev 5 2007 Datex Ohmeda All rights reserved This page intentionally left blank ...

Страница 11: ... in the operation manual WARNING A WARNING statement is used when the possibility of injury exists CAUTION 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 fus...

Страница 12: ...beroptic lenses require special cleaning methods See cleaning section of this manual for complete details See the Operation Manual for more information European Union Representative Manufacturer ETL symbol CE mark WEEE symbol Ground Earthing 2 2 M1110147 Rev 5 2007 Datex Ohmeda All rights reserved ...

Страница 13: ...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 riboflavin calcium and other deficiencies skin blistering skin irritation and thrombocytopenia Monitor the patient closely for signs ...

Страница 14: ...NG 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...

Страница 15: ...n 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...

Страница 16: ...cky 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 ...

Страница 17: ...manual Reproduce this form if desired Daily Record Sheet Name Date Birth Date Bilirubin Level Method of Temperature Taking M1110147 Rev 5 2007 Datex Ohmeda All rights reserved 3 3 Time Temperature Number of Diapers indicate wet and or stool with description Amount Fed Times when baby is put on and taken off phototherapy treatment On Off On Off On Off Comments ...

Страница 18: ...3 4 M1110147 Rev 5 2007 Datex Ohmeda All rights reserved This page intentionally left blank ...

Страница 19: ...he 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 n...

Страница 20: ...onnected 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 att...

Страница 21: ...stic 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 Chapter 9 for detailed specifications Component Control 1 Fiberoptic light pad 2 Fiberoptic cable connector 3 Fiberoptic lenses 4 Fiberoptic cable Warning Never place a baby directly on the bare fiberoptic light pad The fi...

Страница 22: ...nts 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 4 4 M1110147 Rev 5 2007 Datex Ohmeda All rights reserved ...

Страница 23: ...t box 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 4 Connect the power cord to the back of the unit then to an appropriately grounded power source 5 Turn the BiliSoft LE...

Страница 24: ... Measure the irradiance level at each point using the template printed on the fiberoptic light pad Calculate the average of the irradiance measurements Use the second column of the chart below to determine if the average irradiance is within specification If the average irradiance is outside of the acceptable range see the troubleshooting section of this manual Center Row Irradiance bare fiberopti...

Страница 25: ...sold separately On the Ohmeda Medical Mobile Stand or Giraffe Spot PT Lite Roll Stand mounting brackets and stands sold separately The BiliSoft mounting bracket sold separately allows the BiliSoft LED Phototherapy System to be mounted to an Ohmeda dovetail rail Ohmeda mobile stand or Giraffe Spot PT Lite roll stand Attach the male mounting bracket accessory to the four holes at the bottom of the m...

Страница 26: ...da All rights reserved Attaching the Mounting Bracket Mounting bracket male for dovetail rail and mobile stand Mounting bracket female for dovetail rail and Giraffe Spot PT Lite roll stand Mounting bracket female for Ohmeda mobile stand ...

Страница 27: ...atch touch or soil the fiberoptic lenses at the end of the fiberoptic cable WARNING The light box is not waterproof Locate the unit where it will not be exposed to liquids Liquids that enter the unit can damage it and create an electric shock hazard WARNING Never place the light box inside the infant compartment of an incubator warmer or bassinet these conditions expose the patient to possible inj...

Страница 28: ...on of the pad remains in direct contact with the skin If a baby cannot be swaddled positioning aids may be placed under the light pad to bring more light to the sides of a baby s body for greater skin surface area exposure to the light 4 Protect the baby s eyes with eye patches or an equivalent appropriate eye protection product WARNING Direct exposure of the eyes to any phototherapy light may cau...

Страница 29: ...e patient use only The BiliSoft Pad Cover or BiliSoft Nest must be changed between patients and whenever it is soiled Follow all local and national regulations for disposing of this type of product WARNING The light is intended to shine through the padded surface of the BiliSoft Pad Cover or BiliSoft Nest If the BiliSoft Pad Cover or BiliSoft Nest is installed incorrectly and light shines through ...

Страница 30: ......

Страница 31: ...seek assistance from service personnel 3 Plug the power cord into an outlet Make sure a fiberoptic light pad is attached Turn the standby switch on 4 Verify that the fan is on and allow the unit to run with the fiberoptic light pad attached 5 If the fan is not running while the unit is turned on or if the Unit Overheated indicator light turns on again remove the unit from service and seek assistan...

Страница 32: ...e fiberoptic lenses to ensure that the fiberoptic lenses have not been damaged or discolored 3 Make sure that the irradiance measurement is taken with the fiberoptic light pad on a flat surface and that the pad is not covered with a BiliSoft Pad Cover or BiliSoft Nest when taking the measurement 4 Make sure that the light output is being measured with a properly calibrated Ohmeda Medical BiliBlank...

Страница 33: ...ully inserted in the light box If the fiberoptic cable is not fully inserted in the light box the LEDs are automatically shut off 2 If the front panel standby switch is in the on position and the small green LED on the switch is lit and there is still no light to the fiberoptic light pad remove the unit from service and seek assistance from trained service personnel 3 If the front panel standby sw...

Страница 34: ...6 4 M1110147 Rev 5 2007 Datex Ohmeda All rights reserved This page intentionally left blank ...

Страница 35: ... hygienic purposes never place a baby directly on the bare fiberoptic light pad The light pad must be covered with the BiliSoft Pad Cover or BiliSoft Nest as described in the Operating Instructions BiliSoft Pad Covers and BiliSoft Nests are for single patient use only The BiliSoft Pad Cover or BiliSoft Nest must be changed between patients and whenever it is soiled Follow all local and national re...

Страница 36: ...components CAUTION Do not autoclave or gas sterilize the Light Box 1 Unplug the power cord 2 Clean the outside of the light box using a mild detergent solution Aqueous solutions which are both hospital disinfectants and microbactericides may be used Do not allow liquids to seep into the housing Apply the cleaning solutions with a clean cloth or sponge Always dry the parts with a clean damp soft cl...

Страница 37: ...cause premature breakdown of the plastic material Cleaning solutions that discolor the fiberoptic light pad such as iodine solutions will reduce the pad s light output Do not place the fiberoptic light pad in direct sunlight Do not use iodine solutions strong acids strong alkali or bleach solutions to clean the pad Clean the fiberoptic light pad and cable using a mild detergent solution Never use ...

Страница 38: ... cleaner on the fiberoptic cable connector If disinfection is required aqueous solutions which are both hospital disinfectants and microbactericides may be used sparingly minimizing their exposure to the fiberoptic lenses Apply the cleaning solutions with a clean soft cloth Do not saturate Remove any cleaning residue from the fiberoptic lenses with a clean damp soft cloth soaked with water only Do...

Страница 39: ... light box should be visually checked and cleaned if needed to prevent air blockage that may cause overheating The filter may be cleaned by vacuuming it The filter can also be removed for cleaning If the filter needs to be removed take the unit out of service and seek assistance from service personnel ...

Страница 40: ...7 6 M1110147 Rev 5 2007 Datex Ohmeda All rights reserved This page intentionally left blank ...

Страница 41: ... 216 Bracket Ohmeda Mobile Stand female for mounting to the Ohmeda mobile stand order male bracket separately 6700 0014 800 Bracket Dovetail Rail female for mounting to an Ohmeda dovetail rail or Giraffe Spot PT Lite roll stand order male bracket separately 6600 0031 900 BiliSoft Mounting Bracket male mounts the BiliSoft to Ohmeda mobile stand Giraffe Spot PT Lite roll stand or Ohmeda dovetail rai...

Страница 42: ...8 2 M1110147 Rev 5 2007 Datex Ohmeda All rights reserved This page intentionally left blank ...

Страница 43: ...0V slo blo type qty 2 Leakage Current 300 µA 264 V Ground impedance 0 1 ohm from ground pin of the power inlet module to any exposed metal surface Environmental Operating Conditions Ambient temperature 10 C to 35 C 50 to 95 F Humidity 10 to 90 RH non condensing Atmospheric pressure 70 kPa to 106 kPa Storage Requirements Temperature 40 C to 70 C 40 to 158 F Humidity 0 to 100 RH non condensing Atmos...

Страница 44: ...1 meter X ray X ray compatible Physical Specifications Light box W x H x L 16 5 x 21 x 16 5 cm Light box weight excluding fiberoptic pad 2 5 kg Fiberoptic Pad weight 1 1 kg Fiberoptic light pad small 15 x 30 cm light emitting area Fiberoptic light pad large 25 x 30 cm light emitting area Fiberoptic cable length 137 5 cm Regulatory Standards IEC Type B equipment IEC Class 1 continuous operation FDA...

Страница 45: ...Ohmeda Medical BiliBlanket Light Meter Sensitivity Average Total Irradiance for Bilirubin measured with a spectroradiometer between 400 550 nm 10 5 mW cm 2 bare fiberoptic pad small 7 9 mW cm 2 bare fiberoptic pad large Large Fiberoptic Light Pad Effective Surface Area 15cm Small Fiberoptic Light Pad Effective Surface Area 30cm 25cm 30cm M1110147 Rev 5 2007 Datex Ohmeda All rights reserved 10 1 ...

Страница 46: ...10 2 M1110147 Rev 5 2007 Datex Ohmeda All rights reserved This page intentionally left blank ...

Страница 47: ... 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...

Страница 48: ...5 2700 Europe France Datex Ohmeda S A S 17 rue Jean Elysée Dupuy F 69410 Champagne Au Mont d Or France Tel 33 01 30 68 60 00 Fax 33 04 78 43 26 58 Germany Datex Ohmeda GmbH Dr Alfred Herrhausen Allee 24 D 47228 Duisburg Germany Tel 49 2065 691 0 Fax 49 2065 691 236 Italy Datex Ohmeda S p A Via Cassanese 100 20090 Segrate Milan Italy Tel 39 2 21693431 Fax 39 2 26926226 Netherlands Datex Ohmeda B V ...

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