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9-2

Manufacturer’s Guidance and Declaration Regarding
Electromagnetic Emissions

The BiliSoft 2.0 is intended for use in the electromagnetic environment specified below. The customer
or the user of the BiliSoft 2.0 should assure that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic Environment Guidance

RF emissions CISPR 11

Class B

The BiliSoft 2.0 uses RF energy only for its internal function. Its
RF emissions are very low and are not likely to cause any
interference in nearby equipment.

Harmonic emissions IEC
61000-3-2

Class A

The BiliSoft 2.0 is suitable for use in all hospitals and domestic
residences directly connected to a public low voltage power
utility.

Voltage fluctuations/flicker
emissions IEC 61000-3-3

Complies

Manufacturer’s Guidance and Declaration Regarding
Electromagnetic Immunity

The BiliSoft 2.0 is intended for use in the electromagnetic environment specified below. The customer
or the user of the BiliSoft 2.0 should assure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic
Environment
Guidance

Electrostatic discharge
(ESD) IEC 61000-4-2

+/- 8kV contact

+/- 15kV air

+/- 8kV contact

+/- 15kV air

Floors should be wood,
concrete or tile. If
floors are carpeted, the
relative humidity
should be at least 30%.

Electrical fast
transient/burst IEC 61000-
4-4

+/- 2kV for power supply
line.

100 kHz Repetition Rate

+/- 2kV for power supply
line.

100 kHz Repetition Rate

Electric power supplied
should be that of a
typical public low
voltage power utility.

Surge IEC 61000-4-5

+/- 1kV line to line

+/- 1kV line to line

Electric power supplied
should be that of a
typical public low
voltage power utility.

Voltage dips, shorts
interruptions and voltage
variations on power supply
input lines IEC 61000-4-11

<5 % Ut (>95 % dip in Ut)
for 0.5 cycle

At phase angles of :

<5 % Ut (>95 % dip in Ut)
for 0.5 cycle

At phase angles of :

Electric power supplied
should be that of a
typical public low
voltage power utility

1

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Содержание BiliSoft 2.0

Страница 1: ...BiliSoft 2 0 Phototherapy System Lighting by LumitexTM Operation Manual ...

Страница 2: ...emarks 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 with a GE depot repair warranty that covers labor and parts under the terms and conditions set forth in the GE Healthcare Warranty Statement presented to the customer at the point of sale The light pad ligh...

Страница 3: ...infecting 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 R...

Страница 4: ...aps 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 ...

Страница 5: ...ht 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 CAUTI...

Страница 6: ...optic 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 ...

Страница 7: ...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 ...

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Страница 9: ... 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...

Страница 10: ... 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 ...

Страница 11: ... 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 fami...

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Страница 13: ...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 Pre...

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Страница 15: ... 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 ...

Страница 16: ...s 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 Regulation EU 2017 745 Do Not Reuse 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 lig...

Страница 17: ... 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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Страница 19: ...e 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 over...

Страница 20: ...ck 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 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 ...

Страница 21: ...aintenance section of this manual for more details 8 AC Power Cord Receptacle Is where the AC power cord plugs in 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 7 8 9 9 9 9 ...

Страница 22: ... 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 7 and 8 for detailed specifications Component Control 1 Light pad 2 Pad connector 3 Fiberoptic lens 4 Fiberoptic cable Warning Do n...

Страница 23: ...cts 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 Disposable Pad Cover Flat BiliSoft Disposable Pad Cover Nest A flat cushioned cover with straps A cushioned co...

Страница 24: ...1 6 This page intentionally left blank ...

Страница 25: ...hen to an appropriate power source 5 Turn the BiliSoft 2 0 Phototherapy System on using the Standby Switch on the front of the unit the Over Temperature and LED Failure Indicators will briefly illuminate 6 Confirm that the fan is operating by placing your hand close to the exhaust vent when the device is operating to feel for air flow coming out of the device See the Trouble Shooting Section if th...

Страница 26: ...ing chapter of this manual If troubleshooting does not improve the average reading the LED should be replaced Once the check is completed the unit is ready for use Factory Rated Outputs Settings Replacement Center Row Output2 bare fiberoptic light pad µW cm 2 nm 1 Full Output2 bare light pad µW cm 2 nm 1 Output2 Requiring LED Replacement1 bare light pad µW cm 2 nm 1 Large Pad D E F 3 40 0 A B C D ...

Страница 27: ...interfere with the performance of other equipment Use care when moving beds or roll stands using a Dovetail Rail with a BiliSoft 2 0 attached Protect the unit from impacting door jambs or any other obstacles Follow these guidelines to prevent damage to the Light Pad coverings and optical fibers Failure to do so could decrease light intensity at the light pad Do not allow the fiberoptic cable to be...

Страница 28: ...n Ohmeda Medical Dovetail Rail Optional mounting brackets and stands sold separately The BiliSoft mounting bracket to allow use with an Ohmeda Medical Dovetail Rail is sold separately The bracket is attached to the Light Box using screws provided with the bracket The Light Box has four matching inserts on the bottom of the unit The bracket can be positioned on the left or right side of the unit Wh...

Страница 29: ...s Either could result in strangulation or choking CAUTIONS The light from the Light Pad is intended to shine through the padded side of the BiliSoft Cover and Nest Handle the Light Pad Connector with caution The fiberoptic lens can be damaged or scratched if struck The eyes of babies can be damaged from direct exposure to any phototherapy light Always protect the baby s eyes with eye patches or eq...

Страница 30: ...ptic light pad The light pad should be covered with the BiliSoft Flat Pad Cover or Nest Installing Pad Nest Covers Onto Pad 2 After the Pre Use Checkout gently insert the fiberoptic pad into a Nest cover shown below The back of pad should face the strap side of the cover as shown For patient comfort and hygiene never place a baby directly on the bare fiberoptic light pad The light pad should be co...

Страница 31: ...tment as long as their skin remains exposed the pad light Positioning aids may be placed under the light pad edges to bring more light to the sides of a baby s body This will allow expose more patient skin to the light 4 Protect the baby s eyes with eye patches or an equivalent appropriate eye protection product 5 Insert the fiberoptic cable in the box 6 Turn the Light Box on 7 During treatment a ...

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Страница 33: ...ached 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 assistance from service personnel LED failure indicator light is blinking The LED is not operating 1 The LED module needs t...

Страница 34: ...et Meter II to take the light output readings 6 Perform the comprehensive 6 point small pad or 9 point large pad check 7 If the light output is still 25 below minimum rated value remove the unit from service and seek assistance from service personnel Main unit cover handle or base plate is cracked or damaged Unit was dropped or damage by impact with another object 1 Remove the unit from service an...

Страница 35: ... confirm that the unit is plugged into an active outlet 4 If the connector is fully inserted and the standby switch is illuminated green and there is still no light to the fiberoptic light pad remove the unit from service and seek assistance from trained service personnel Fiberoptic light pad connector fails to stay inserted Loss of magnetic latch 1 The Light Pad connector is designed to be retain...

Страница 36: ...3 4 This page intentionally left blank ...

Страница 37: ...s in infants CAUTIONS Do not autoclave or gas sterilize the any part of the BiliSoft 2 0 DO NOT use any of the following cleaners They will damage the device Isopropyl Alcohol in concentrations greater than 15 Solvents such as acetone Wescodyne Approved Cleaning Solutions For continued long life of the Light Box or Light Pad use only the following solutions and disinfectants Generic Formulation Ma...

Страница 38: ... changing the pad cover it is noticed that these materials leeched onto the pad the user should wipe the surface to remove the debris before applying a new cover The pad can be wiped down using a cloth moistened with the cleaning solutions listed above except for bleach solution or with a mild hand soap or with a standard baby wipe Never submerge any portion of the pad during the course of cleanin...

Страница 39: ...n soft cloth to avoid scratches 4 Once all visible contaminants and blood are removed from the device surfaces apply one of the recommended cleaning solutions per the manufacturer s instructions to perform disinfection 5 Always dry the parts with a clean damp soft cloth to avoid scratches Cleaning the Light Pad and Cable between Patients CAUTIONS The light pad connector requires special cleaning m...

Страница 40: ...id Do not use iodine strong acid strong alkali or bleach solutions to clean any part of the Light Pad Connector lens or the Connector Port in the Light Box Iodine and other cleaning solutions that discolor the light pad will reduce the pad s light output Never use an abrasive cleaner on the light pad connector fiberoptic lens or the connector port 1 Direct cleaning of the Fiberoptic Lens and the C...

Страница 41: ...lean by rinsing in water or replace if necessary 4 Pat dry the filter 5 Once the filter is dry place filter on back of unit and re install Filter Plate 6 Insert tab in upper slot while flexing the plate and inserting the lower tab into the lower slot Factors that affect product life Factor Description Thermal stress Operating without the cooling fan running or operating with clogged filters will r...

Страница 42: ...let light can cause premature breakdown of the plastic material Do not leave the light pad in direct sunlight It is recommended to disconnect the Light Pad and hang straight or lay flat during storage between uses The light box should be stored upright with the power cord provided Both the Light Box and the Light Pad should be protected from excessive dust and dirt ...

Страница 43: ...5 1 Chapter 5 This chapter has been intentionally left blank ...

Страница 44: ...5 2 This page intentionally left blank ...

Страница 45: ... Stand mounting brackets must be ordered separately 6700 0025 800 Giraffe Spot PT Lite Roll Stand mounting brackets must be ordered separately 6600 0894 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 s...

Страница 46: ...6 2 This page intentionally left blank ...

Страница 47: ...t condition Environmental Operating Conditions Temperature 5 C to 35 C 41 F to 95 F Humidity 15 to 90 RH non condensing but not requiring a water vapor partial pressure 5 kPa Atmospheric pressure 70 kPa to 106 kPa 10 000 ft to 1 250 ft Light Box IP21 Light Pad IPX4 Transportation Conditions Storage Conditions while sealed in shipping carton Temperature 25 C to 5 C 13 F to 41 F without humidity con...

Страница 48: ...al Specifications Light box W x H x L 16 5 x 21 x 17 5 cm Light box weight excluding fiberoptic pad 1 7 kg Light Pad weight 5 kg large or small Light Pad size small 20 x 25 cm light emitting area Light pad large 25 x 30 cm light emitting area Light Pad cable length 137 5 cm Product Life Span Service Life The Light Box is designed to meet a life span of 7 years The Light Pad is designed for a life ...

Страница 49: ...Reference Spectral Irradiance Light Output Average Total Irradiance for Bilirubin 8 9 mW cm2 bare fiberoptic pad small 6 1 mW cm2 bare fiberoptic pad large Note measured with a spectroradiometer between 400 550 nm BiliSoft 2 0 ...

Страница 50: ...8 2 Effective Pad Area for Irradiance Output Pad Output Measurement Points Small Pad Measurement Grid Large Pad Measurement Grid ...

Страница 51: ...oft 2 0 is intended to be used in a hospital and home setting Use of the BiliSoft 2 0 in other settings may result in disruption of nearby devices or the BiliSoft 2 0 itself Hospital personnel or caregivers trained in the use of the BiliSoft 2 0 are the intended users Degraded Performance Characteristics High levels of electromagnetic disturbance near the BiliSoft 2 0 can cause Jumbled Hour Meter ...

Страница 52: ...lectromagnetic environment specified below The customer or the user of the BiliSoft 2 0 should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 8kV contact 15kV air 8kV contact 15kV air Floors should be wood concrete or tile If floors are carpeted the relative humidity sh...

Страница 53: ...4 3 10 V m over 80 MHz 2 7 GHz Modulation 80 AM at 1 kHz 10 V m over 80 MHz 2 7 GHz Modulation 80 AM at 1 kHz Radio devices such as cell phones and walkie talkies should not be used within 30 cm 12 inches of the BiliSoft 2 0 Light Box or power cord2 Conducted disturbances induced by RF electromagnetic fields IEC 61000 4 6 3 V rms over 150 kHz 80 GHz 6 V rms in ISM and amateur radio bands between 1...

Страница 54: ...vel V m 385 380 390 TETRA 400 Pulse Modulation 18 Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse Modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse Modulation 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse Modulation 217 Hz 2...

Страница 55: ...the Expected Service Life of the product defined in Chapter 7 by Following the recommended service and maintenance schedule found in the Service and Maintenance manual Using only recommended service parts as found in Chapter 8 or within the Service manual ...

Страница 56: ...9 6 This page intentionally left blank ...

Страница 57: ...by those trained in the use of the BiliSoft 2 0 The 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 No additional tasks are required to turn off the unit after completing the therapy session Clean the unit in preparation for storage or the next patient Isolation of the unit f...

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Страница 59: ...protect the baby s eyes with eye patches or equivalent eye protection products Periodically confirm that the baby s eyes are protected Perform this check more frequently if required by healthcare provider s instructions Care should be taken to protect the eyes of other infants nearby Before You Begin Treatment Ask your healthcare provider for information on how to care for your baby during the tre...

Страница 60: ...w it works Many newborn infants are born with jaundice Jaundice occurs because your baby s liver has not fully developed and the body has more bilirubin than it can get rid of Bilirubin is a yellow substance that s made when the body breaks down old red blood cells It leaves the body through urine and stool The blue light provided by the device passes through your baby s skin and breaks down the B...

Страница 61: ... have the blue light side with baby symbol directed toward the baby Installing Flat Pad Covers Onto Pad 1 Gently insert the BiliSoft 2 0 fiberoptic pad into a BiliSoft flat pad cover shown below The back of pad should face the strap side of the cover as shown For baby s comfort and hygiene never place a baby directly on the bare fiberoptic light pad The light pad should be covered with the BiliSof...

Страница 62: ...ay from the foot roll as shown For baby s comfort and hygiene never place a baby directly on the bare fiberoptic light pad The light pad should be covered with the BiliSoft Flat Pad Cover or Nest Soiled Pad Covers Remove soiled disposable cover replace with a fresh disposable cover Wipe clean the fiberoptic pad with baby wipes NEST COVER FIBEROPTIC PAD FOOT ROLL ...

Страница 63: ... prevent the light from reaching the baby skin Positioning the Baby Regularly check that the patient is in the treatment area of the device PLACING BABY ON FLAT PAD COVER 1 Place the baby on the padded side of the flat cover The straps are on the bottom Fiberoptic cable is at the baby s feet IMPORTANT Be sure to position the baby to expose the most amount of their skin to the pad light Baby should...

Страница 64: ...PORTANT Be sure to position the baby to expose the most amount of their skin to the pad light Baby should wear diaper only Using the Pad Straps to Swaddle the Baby SWADDLE BABY WITH STRAPS NEST FLAT COVER When not in use tie cloth straps together and place under the pad Loose straps can cause strangulation or a choking hazard FIBEROPTIC CABLE FIBEROPTIC CABLE FIBEROPTIC CABLE FIBEROPTIC CABLE ...

Страница 65: ...t Eye Protection for the Baby PROTECT and COVER BABY S EYES The eyes of babies can be damaged from direct exposure to any phototherapy light Always protect the baby s eyes with eye patches or equivalent eye protection products Periodically confirm that the baby s eyes are protected Perform this check more frequently if required by healthcare provider s instructions Care should be taken to protect ...

Страница 66: ... children or pets Position the power cord and pad so that you do not trip over them Never place the light box inside of an incubator warmer or bassinet with the patient This could cause possible injury to the patient Never position the unit in the path of or next to sources of heat For example near a fireplace or in the path of radiant heaters To avoid damage to the equipment or injury to users an...

Страница 67: ... the air vents on the sides and the back of the unit are not obstructed or covered 6 Turn the Light Box on 7 Confirm that the fan is operating by placing your hand close to the exhaust vent when the device is operating to feel for air flow coming out of the device 8 During treatment a Periodically monitor the baby for its position on the light pad b Monitor the baby for items found in the Importan...

Страница 68: ...from water Taking Temperatures It is important to track your baby s temperature during phototherapy sessions Your doctor will tell you the range of acceptable temperatures for your baby The doctor may also suggest a method for taking temperatures It is important to 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 st...

Страница 69: ...y record of your baby s activities and condition Use the example template of a simple record form shown here This will provide your doctor with an accurate account of your baby s activities and allow them to better assess the progress being made ...

Страница 70: ...A2 12 Homecare Use Quick Reference 1 Cover Pad 2 Undress Baby 3 Position Baby 4 Swaddle With Straps 5 Optional Blanket 6 Cover Baby s Eyes 7 Plug in Cord 8 Plug in Pad 9 Turn on Unit ...

Страница 71: ...A2 13 This page intentionally left blank ...

Страница 72: ...ista 37 13º andar CEP 01311 902 Cerqueira César São Paulo SP Brasil Tel 55 11 3053 2500 Fax 55 11 3053 2573 Russia Only OOO GE Healthcare 123112 Russia Moscow Presnenskaya naberezhnaya 10 Tel Service 8 800 333 6967 Tel Office 7 495 739 6931 Fax 7 495 739 6932 Russia Only ООО ДжиИ Хэлскеа 123112 Российская Федерация Москва Пресненская набережная д 10 Тел сервисной службы 8 800 333 6967 Тел офиса 7 ...

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