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Dräger BiliLux, Инструкция по эксплуатации

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Instructions for use BiliLux

15

Safety-related information

The device is designed to comply with electromagnetic compatibility requirements. 
However, potential electromagnetic or other interference may exist. If interference 
is observed:

►

Move the equipment or identify the source of interference, and take appropriate 
action.

2.6.2

EMC precautions

The use of accessory equipment not complying with the equivalent safety 
requirements of this equipment may lead to a reduced level of safety of the resulting 
system.

►

All medical accessory equipment in the patient vicinity must comply with the 
safety requirements of IEC 60601-1 and must have the relevant safety 
certifications.

►

Use of accessories other than what is listed and approved for use in this product 
as original or replacement items may result in increased electromagnetic 
emissions or decreased electromagnetic immunity.

►

Devices connecting to the serial port must be compliant with IEC60601-1-2, the 
EMC requirement for Medical Devices.

►

Medical electrical equipment needs special precautions regarding EMC and 
must be installed and put into service according to the EMC information 
provided in this manual.

►

In addition, portable and mobile RF communications equipment can affect 
medical electrical equipment.

2.7

Explosion and fire protection

Use of the device in areas of explosion and fire hazard can lead to patient injury or 
device failure.

►

Do not use the device in areas where combustible gases are present (e.g., 
oxygen, nitrous oxide, anesthetic agents). The medical device is not approved 
for use in areas where combustible or explosive gas mixtures are likely to occur.

►

Textiles, oils, and other combustibles are easily ignited and burn with great 
intensity in air enriched with oxygen. Keep matches, and all other sources of 
ignition, out of the room in which the device is located.

►

Ensure adequate ventilation to avoid accumulation of oxygen around the device.

►

Do not place auxiliary equipment that produces sparks near the device.

►

Ensure that no oxygen sources are in use during maintenance or cleaning.

2.8

Drug storage precautions

Photo effects of radiation can degrade the efficacy of drugs.

►

Do not store infusion liquids or other drugs in the radiation area.

Содержание BiliLux

Страница 1: ...Instructions for use BiliLux WARNING To properly use this medical device read and comply with these instructions for use LED phototherapy light Software 1 n ...

Страница 2: ...2 Instructions for use BiliLux This page has been left blank intentionally ...

Страница 3: ...lure 16 3 Application 17 3 1 Intended use 17 3 2 Environment of use 17 3 3 Indications contraindications 17 4 Overview 19 4 1 BiliLux phototherapy light 19 4 2 BiliLux with optional spring arm 20 4 3 BiliLux with optional trolley 21 4 4 Radiometer optional 22 4 5 Description 22 4 6 Abbreviations 23 4 7 Definitions 24 4 8 Symbols 24 5 Operating concept 27 5 1 Control panel 27 5 2 Displaying BiliLux...

Страница 4: ...age 56 10 Troubleshooting 57 11 Reprocessing 59 11 1 Disassembly 59 11 2 Information on reprocessing 59 11 3 Classifications for reprocessing 60 11 4 Reprocessing list 61 11 5 Reprocessing procedures 61 11 6 After reprocessing 63 11 7 Preparations before reuse 63 12 Service 65 12 1 Safety information 65 12 2 Overview 66 12 3 Definition of service terminology 66 12 4 Inspection 66 12 5 Maintenance ...

Страница 5: ...or use BiliLux 5 Contents 14 8 Radiometer option requirements 75 14 9 Device combinations 76 14 10 EMC Declaration 76 15 List of accessories 83 15 1 Device 83 15 2 Accessories 83 15 3 Optional components 83 Index 85 ...

Страница 6: ...6 Instructions for use BiliLux This page has been left blank intentionally ...

Страница 7: ...t points indicate individual actions or different options for action Dashes indicate the listing of data options or objects A Letters in parentheses refer to elements in the related illustration A Letters in illustrations denote elements referred to in the text Preventive measures in a safety message Result of a step Final result of a sequence of steps Indicates information that makes it easier to...

Страница 8: ...8 Instructions for use BiliLux This page has been left blank intentionally ...

Страница 9: ...ed to perform the task The target group has read and understood the chapters required to perform the task 2 1 2 Description of target groups The target groups may only perform the following tasks if they meet the corresponding requirements 2 1 2 1 User 2 1 2 2 Reprocessing personnel 2 1 2 3 Service personnel Task Requirement Use of the product in accordance with the intended use Specialist medical...

Страница 10: ...ibed in each safety instruction 2 2 2 Precautionary statements Precautionary statements relate to process steps and warn of risks that may arise when executing the process steps Precautionary statements precede the process steps The following warning signs and signal words indicate precautionary statements and differentiate the possible consequences of noncompliance Task Requirement Basic and comp...

Страница 11: ... use in healthcare facilities only and exclusively by persons with specific training and experience in its use 2 3 3 Service If service is not performed regularly malfunctions may occur which can result in personal injury and property damage Observe chapter Service The medical device must be inspected and serviced regularly by service personnel Repair and complex maintenance carried out on the med...

Страница 12: ... improper use of the medical device Potentially negative effects on patients with different underlying diseases Medical device modification or misuse can be dangerous Risk of patient injury Do not make therapeutic decisions based solely on individual measured values and monitoring parameters Assess the patient frequently to observe any change in condition To make therapeutic decisions also use med...

Страница 13: ...eration in such a configuration can be achieved If other devices are used with the BiliLux refer to their manufacturer s instructions for use 2 5 Safety instructions for accessories 2 5 1 Accessories The use of incompatible accessories may adversely affect the functional integrity of the product Personal injury and property damage may occur as a consequence Dräger has tested the compatibility only...

Страница 14: ...ompatibility Observe the EMC information during installation and initial operation For further information see the following section EMC Declaration on page 76 Portable and mobile high frequency communication equipment can affect medical electrical equipment Malfunctions that endanger the patient may occur if no protective measures against electrostatic discharge are employed in the following situ...

Страница 15: ...ical equipment needs special precautions regarding EMC and must be installed and put into service according to the EMC information provided in this manual In addition portable and mobile RF communications equipment can affect medical electrical equipment 2 7 Explosion and fire protection Use of the device in areas of explosion and fire hazard can lead to patient injury or device failure Do not use...

Страница 16: ... To prevent injuries and damage to the device when moving the trolley prepare the trolley as follows Remove or secure all loose system components Fold the spring arm down to a compact position Lower the trolley pole to its lowest position Push or pull the trolley in a straight line along the length of the trolley Lateral or angular movement across the width can result in inadvertent tip over if th...

Страница 17: ...artments that provide neonatal and infant care including nurseries and Neonatal Intensive Care Unit NICU levels I IV 3 3 Indications contraindications The BiliLux phototherapy light is indicated for the reduction of hyperbilirubinemia in newborn infants up to 3 months of age who weigh less than 10 kg 22 lb The BiliLux phototherapy light is not indicated for home use or for use inside an incubator ...

Страница 18: ...18 Instructions for use BiliLux This page has been left blank intentionally ...

Страница 19: ...view 4 1 BiliLux phototherapy light 4 1 1 Top view A Control panel B Quick connect plug for connection to optional spring arm 4 1 2 Bottom view A Blue phototherapy LED lights B White observation LED lights C Rating plate 001 BiliLux A B 002 C A B B ...

Страница 20: ...ication port E Receptacle for radiometer cable F USB port 4 2 BiliLux with optional spring arm A Quick connect for phototherapy light B Release knob for phototherapy light C Spring arm D Cable clips E Plug to connect to trolley pole or rail clamp F Rail clamp for phototherapy light to connect to 38 mm pole and DIN Fairfield and GCX rails 003 A B C D E F 004 A C D D E B F ...

Страница 21: ...use BiliLux 21 Overview 4 3 BiliLux with optional trolley A Spring arm B Tightening knob for spring arm C Trolley pole D Height adjustment knob E Cable holder optional F Trolley base with locking castors 005 A B D E F C ...

Страница 22: ...phototherapy light can be placed directly on an incubator hood It has slip resistant feet on the bottom that help to hold it in place The phototherapy light houses the 20 blue lights that provide therapy as well as 2 white lights used for observation The front panel has a display screen and keys to control functions and change settings The BiliLux phototherapy light also has the capability to prod...

Страница 23: ...radiant warmer crib or bassinet The trolley has 4 locking castors and a height adjustable pole These features together with the adjustable spring arm allow the BiliLux to be moved rotated and positioned for optimum effectiveness The phototherapy light can be easily attached and released from the spring arm by using the quick connect mechanism 4 6 Abbreviations The following abbreviations appear on...

Страница 24: ...cal obstruction to bile flow within the liver or in the extrahepatic bile duct system as with hepatitis or biliary obstruction Cyanosis Bluish discoloration of the skin due to poor circulation or insufficient oxygenation of the blood Hyperbilirubinemia Abnormally high level of bilirubin in the blood and in the subcutaneous layers Irradiance Radiant power emitted by the phototherapy light Symbol Me...

Страница 25: ...bel Weight limit Do not discard with regular waste Total mass including safe working load Key to switch white light on off Calibration due date Menu key Key used to start pause therapy Therapy on Key to increase irradiance Therapy paused Key to decrease irradiance Follow operating instruc tions Earth ground Functional earth Protective earth ground Store button Symbol Meaning Symbol Meaning ...

Страница 26: ...26 Instructions for use BiliLux This page has been left blank intentionally ...

Страница 27: ...ators above the key illuminate in succession each time the key is pressed The available settings are 20 40 60 80 and 100 D On off key for observation light The observation light operates independently of the phototherapy light E Menu key used to select among various operational and service screens Buttons variable function F Buttons whose functions are defined on the currently selected screen LED ...

Страница 28: ... Function Phototherapy screen default Shows the elapsed duration of therapy in hours and minutes as well as therapy status on off paused Radiometer screen Allows the user to view and store irradiance readings measured by the radiometer Phototherapy report screen Allows export of the phototherapy report to a USB flash drive Configuration screen Allows the user to adjust date time and language Devic...

Страница 29: ...ection A as needed to bring the BiliLux closer or further from the warming therapy device 2 Move the top arm up or down B as needed 3 Adjust the phototherapy light to a position that will provide the optimum light coverage to the patient The phototherapy light can be moved up or down C side to side D or swiveled 360 E 035 360 A B C D E ...

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Страница 31: ...rrectly or parts are not reinstalled after cleaning or service the essential performance and or basic safety of the device may be compromised Perform a functional check of the device to verify proper assembly WARNING Risk of injury or device damage If the total load limits of device components and accessories are exceeded the essential performance and or basic safety of the device may be compromis...

Страница 32: ... have slip resistant feet on the bottom that help to keep the light in place 6 4 Installing the BiliLux with optional spring arm The BiliLux with spring arm consists of the phototherapy light the spring arm and mounting adapters for a 38 mm pole or for GCX DIN and Fairfield rails 6 4 1 Attaching the BiliLux to a 38 mm pole 1 Attach the compact rail A or the clamp B to the 38 mm pole 2 Attach the r...

Страница 33: ...ototherapy light B to the pivot rail 3 Insert the post C on the bottom of the spring arm into the rail clamp B Ensure that the arm is seated properly and then tighten the adjustment screw D on the rail clamp to secure the arm 4 Insert the quick connect plug E on the phototherapy light into the arm socket F until it audibly clicks into place 013 A B C D E F G 011 A B C D E F ...

Страница 34: ... light into the arm socket E until it audibly clicks into place 6 5 Installing the BiliLux with optional trolley The BiliLux with trolley consists of the phototherapy light a spring arm and a trolley 1 Remove the screw and two washers attached to the bottom of the trolley pole 2 From underneath the trolley base install the cup spring washer A and screw B in the hole in the trolley base 3 Install t...

Страница 35: ...arm 6 Insert the quick connect plug G on the phototherapy light into the arm socket H until it audibly clicks into place 6 6 Installing the optional radiometer Plug the radiometer cable into the receptacle A on the rear of the phototherapy light Keep the radiometer in a convenient place until needed On trolley versions you may attach the radiometer to the trolley metal pole via the magnets on the ...

Страница 36: ...36 Instructions for use BiliLux This page has been left blank intentionally ...

Страница 37: ...the startup screen which contains the BiliLux firmware version and the current date and time The screen then proceeds to the therapy screen The device is ready for use immediately after startup At system startup if the next inspection date is due within 30 days the screen may display a message informing the user of the due date for 15 seconds before proceeding to the therapy screen The screen will...

Страница 38: ...trol panel to turn off the observation light and confirm that the observation light turns off 4 Press the key on the control panel to turn on the phototherapy light 5 Press the irradiance key on the control panel several times Confirm that the irradiance increases and that the LED indicators on the control panel illuminate in succession each time the key is pressed 6 Press the irradiance key on th...

Страница 39: ...eck the spring arm adjustment Pull up and push down on the spring arm Confirm that it moves smoothly and maintains set position Move the spring arm from side to side Confirm that it moves smoothly and maintains set position 2 Check the phototherapy light adjustment Rotate the phototherapy light clockwise and counterclockwise Confirm that it moves smoothly and maintains set position Move the photot...

Страница 40: ...started 7 2 7 Fastener check Inspect the device for loosened fasteners if equipped and tighten if necessary Quick connect plug to spring arm Height adjustment knob on trolley Tightening knob for spring arm on trolley Cable clips on spring arm ...

Страница 41: ...steps to monitor and maintain positive water balance in the patient Water balance may be disturbed in patients receiving phototherapy Monitor patient s skin closely Blue light can interfere with clinical observation by masking skin color changes such as cyanosis Always use eye shields to protect the patient from phototherapy equipment radiation WARNING Risk of patient injury Accessories or other o...

Страница 42: ...ming therapy device Adjust the air temperature in incubators or the heat output of radiant warmers as needed according to patient temperature WARNING Risk to other patients or to the operator Phototherapy radiation may affect other patients or the operator if proper precautions are not taken Follow established hospital protocol Protect nearby patients by using screens and protective eye shields Th...

Страница 43: ...ains power supply WARNING Risk of patient injury Improper distance between the patient and the phototherapy light can result in incorrect therapy Position the phototherapy light at least 30 cm 12 in from the patient at a distance that provides the prescribed therapy 8 1 1 Positioning the BiliLux phototherapy light Position the phototherapy light on the incubator hood with the long side of the ligh...

Страница 44: ...rolley CAUTION Risk of injury Cables or attached accessories may be inadvertently disconnected or otherwise compromised when adjusting the spring arm Take care not to compromise cables or accessories when adjusting the spring arm to the desired position 4 Adjust the spring arm to the desired height and position CAUTION Risk of injury The LED panel on the phototherapy light may be hot to the touch ...

Страница 45: ...knob If equipped with spring arm without trolley proceed to step 4 2 Roll the trolley under the radiant warmer Keep the distance between the trolley and the radiant warmer to a minimum 3 Lock the castors to prevent movement of the trolley CAUTION Risk of injury Cables or attached accessories may be inadvertently disconnected or otherwise compromised when adjusting the spring arm Take care not to c...

Страница 46: ...t s skin as possible is covered with phototherapy light Fig 1 Proper positioning of phototherapy light with radiant heater switched ON Fig 2 Proper positioning of phototherapy light with BiliLux light shield curtain and radiant heater switched OFF 037 053 30 cm 12 in 30 cm 12 in 0 1 OK Dräger 30 mm 12 in ...

Страница 47: ...increase irradiance lower the phototherapy light The minimum distance between the light and the patient is 30 cm 12 in The graph below shows irradiance levels at distances of 30 cm 40 cm and 50 cm within a wavelength range of 460 nm to 490 nm with the phototherapy light positioned horizontally above the mattress For effective therapy position the light over the patient so that it covers as much bo...

Страница 48: ...nsity keys on the control panel The phototherapy screen shows the elapsed therapy time in hours and minutes A The colon in the therapy time B blinks on and off to indicate that therapy is in progress Therapy will continue until one of the following occurs Therapy is paused or ended by the user The device is turned off via the on off switch The device loses power Distance between patient and photo ...

Страница 49: ...e readings can be impacted by ambient light 8 4 1 Measuring irradiance 1 Ensure that the optional radiometer is connected to the receptacle on the rear of the phototherapy light 2 Press the key until the Radiometer screen is displayed 3 To obtain the irradiance measurement position the radiometer sensor close to the patient s skin without touching the patient The Radiometer screen displays the cur...

Страница 50: ...erapy report Press the Cancel button to retain stored values after successful export of the phototherapy report 6 When the export process is complete the message Successful is displayed on the screen If export is attempted when a USB flash drive is not connected or if export to the USB flash drive was not successful the message USB error is displayed on the screen and the export does not complete ...

Страница 51: ...stored assuming the stored values were not deleted during an earlier export 8 6 Checking device status The Device Status screen allows to user to check the total LED light usage in hours firmware version date of last device inspection and date of next device inspection 1 Press the key repeatedly until the Device Status screen is displayed The screen shows the total LED light usage in hours A firmw...

Страница 52: ...ment systems or computers via an RS 232 communication port Devices connected to the RS 232 communication port must comply with the specifications listed on page 73 Note the following communication protocols before transmitting any data MEDIBUS X Rules and Standards for Implementation 9052607 MEDIBUS X Profile Definition for Data Communication V1 n 9052608 WARNING Risk of patient injury All data ex...

Страница 53: ... the phototherapy light 3 Secure the device for safe storage Disconnect the radiometer if equipped and store in a safe location With a BiliLux phototherapy light placed directly on an incubator hood secure the power cable and remove the device from the incubator hood With a BiliLux with optional spring arm secure the power cable and fold the spring arm to a compact position With a BiliLux with opt...

Страница 54: ...54 Instructions for use BiliLux This page has been left blank intentionally ...

Страница 55: ...tion screen The day field in the date is highlighted E Press the Increase button F to adjust the day to the desired setting Press the Next button G to confirm the setting and move to the next field 3 Repeat the process for each field in the date and time The year can be adjusted until it reaches 2099 It then reverts to 2000 4 When all changes are complete press the key to save the settings and to ...

Страница 56: ...ed see Table 1 below Press the Next button G to confirm the setting and move to the next field 4 Press the key to save the setting and to exit the configuration screen 025 029 Table 1 Language options English default Hrvatski Croatian 日本語 Japanese Srpski Serbian 中文 Chinese Čeština Czech Deutsch German Magyar Hungarian Français French Norsk Norwegian Español Spanish Slovenčina Slovak Italiano Itali...

Страница 57: ...y reading The message USB error is displayed on the phototherapy report screen An export of a phototherapy report was attempted with no USB flash drive connected Connect a USB flash drive to the phototherapy light and attempt the export again The message No export during running therapy is displayed on the phototherapy report screen An export of a phototherapy report was attempted during active th...

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Страница 59: ...nformation on reprocessing Instructions for reprocessing are based on internationally accepted guidelines e g standard ISO 17664 11 2 1 Safety information WARNING Risk due to inappropriately reprocessed products Reusable products must be reprocessed otherwise there is an increased risk of infection Observe the hygiene regulations and reprocessing regulations of the healthcare facility Observe nati...

Страница 60: ...t Do not use harsh cleansers detergents such as scouring pads or heavy duty solvents Do not use alcohol to clean the device because crazing could occur Take care not to scratch or otherwise damage surfaces during reprocessing procedures CAUTION Risk due to faulty products Signs of wear e g cracks deformation discoloration or peeling may occur with reprocessed products Check the products for signs ...

Страница 61: ...al compatibility They can be used in addition to the surface disinfectants listed in the section Validated reprocessing procedures The manufacturers of the surface disinfectants have verified at least the following spectra of activity Bactericidal Yeasticidal Virucidal or virucidal against enveloped viruses Observe the specifications of the surface disinfectant manufacturers Other surface disinfec...

Страница 62: ...c shock device malfunctions Ensure that no liquid penetrates the device Class of active ingredi ent Surface disinfectant Manufacturer Chlorine releasing agents Actichlor plus Ecolab BruTab 6S Brulin Clorox Professional Disin fecting Bleach Cleaner Clorox Dispatch Hospital Cleaner Disinfectant Towels with Bleach Klorsept 17 Medentech Oxygen releasing agents Descogen Liquid Antiseptica Descogen Liqu...

Страница 63: ...duct for visible damage and replace if necessary 11 6 After reprocessing 11 6 1 Assembling the components CAUTION Risk of injury or damage to the device If the device is assembled incorrectly or parts assemblies are not reinstalled after cleaning or maintenance the essential performance and or basic safety of the device may be compromised Assemble the device according to the instructions for use I...

Страница 64: ...64 Instructions for use BiliLux This page has been left blank intentionally ...

Страница 65: ...ce must be performed by those target groups that are assigned to the particular measure WARNING Risk if service is not performed properly If the device is connected to the power supply during service there is a risk of personal injury and property damage Before performing service disconnect the device from the power supply WARNING Risk when the housing is being opened Under the housing there are l...

Страница 66: ...des the preventive replacement of wearing parts as specified by the manufacturer 12 4 2 1 Performing the safety checks 1 Check that the respective instructions for use are present 2 Perform a functional test of the following functions according to the instructions for use Device startup Electrical and control panel functional check Trolley and spring arm functional check if equipped 3 Check that t...

Страница 67: ... only LED lights recommended by Dräger Contact DrägerService for further information 12 6 Maintenance instructions Following any maintenance procedure perform the functional checkout procedure on page 38 12 6 1 Exchanging the clock battery 1 Remove the back cover from the phototherapy light 2 Remove the old clock battery 3 Install the new clock battery CR2032 4 Reinstall the back cover on the phot...

Страница 68: ... Tighten the hex nut B in each joint using a 13 mm socket wrench so that the device stays securely in the horizontal position Do not overtighten 4 Verify that the spring arm moves freely and remains in any position 5 Reattach the covers on the spring arm joints 12 7 Repair Dräger recommends that all repairs are performed by DrägerService and that only authentic Dräger repair parts are used 039 A A...

Страница 69: ...ith its registration according to this directive this device may not be disposed of at municipal collection points for waste electrical and electronic equipment Dräger has authorized a company to collect and dispose of this device To initiate collection or for further information visit Dräger on the Internet at www draeger com Use the Search function with the keyword WEEE to find the relevant info...

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Страница 71: ... connect plug 19 cm 7 5 in with quick connect plug Height 8 cm 3 1 in Weight without options accessories 1 2 kg 2 7 lb BiliLux spring arm Length spring arm fully folded 61 cm 24 in Length spring arm fully extended 106 cm 41 7 in Weight without options accessories 1 5 kg 3 3 lb BiliLux trolley with spring arm Height trolley at lowest position and spring arm fully folded 132 cm 52 in Height trolley ...

Страница 72: ... 2 1 Spring arm dimensions 14 2 2 Trolley dimensions 040 110 120 155 10 20 155 360 6 1 cm 2 4 in 45 2 cm 17 8 in 45 2 cm 17 8 in 115 115 Ø22 041 126 cm 49 6 in MAX 84 cm 33 1 in MIN 48 4 cm 19 1 in 49 5 cm 19 49 in 35 1 cm 13 82 in 12 0 cm 4 7 in MAX ...

Страница 73: ...60 Hz 0 42 0 22 A Earth leakage current 500 µA Noise level during normal operation 20 dB A RS 232 communication port output only Only connect devices that fulfill the requirements of the standard IEC 60950 1 on unearthed SELV circuits or the requirements of the standard IEC 60601 1 on accessible secondary circuits with max 60 V DC nominal voltage Type 9 pin Sub D female Configuration MEDIBUS X Drä...

Страница 74: ... values below are at the 100 irradiance setting Values are typical 14 7 1 Spectral irradiance distribution graph Pin assignment Pin 2 RXD Pin 3 TXD Pin 5 GND 30 cm 40 cm 50 cm Ebi mW cm2 400 550 nm 3 42 2 01 1 34 Eλmean µW cm2 nm 460 490 nm 85 5 50 1 33 4 Relative irradiance Wavelength nm 0 0 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0 9 1 1 1 400 410 420 430 440 450 460 470 480 490 500 510 520 530 540 550 ...

Страница 75: ...ation graph The radiometer is calibrated for measurement of light with the relative spectrum shown in the graph 2 07 2 11 2 19 2 15 2 07 10 cm Ebi mW cm2 400 550 nm 1 88 1 92 2 01 1 96 1 94 10 cm 2 07 2 21 2 31 2 24 2 22 10 cm 10 cm 10 cm 10 cm 10 cm 10 cm Category Value Accuracy 3 15 Measurement output Average spectral irradiance 460 nm to 490 nm Relative irradiance Wavelength nm 0 0 1 0 2 0 3 0 ...

Страница 76: ...mpliance of the product has been evaluated with the external cables transducers and accessories specified in the list of accessories Other accessories which do not affect EMC compliance may be used if no other reasons forbid their use see other sections of the instructions for use The use of noncompliant accessories can result in increased emissions or decreased immunity of the medical device The ...

Страница 77: ...pping spread spectrum limited to 2 5 mW 14 10 3 Electromagnetic environment The medical device is intended for use in an electromagnetic environment as specified below The user must ensure that the medical device is used in such an environment Emissions Compliance according to Electromagnetic envi ronment Radio frequency RF emissions CISPR 11 Group 1 The medical device uses radio frequency energy ...

Страница 78: ...lity should be that of a typical commercial or hospital environ ment Power frequency 50 60 Hz Magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environ ment Voltage Dips Drop out IEC 61000 4 11 100 dip for 0 5 cycle at 0 45 90 135 180 225 270 and 315 100 dip for 1 cycle at 0 60 dip...

Страница 79: ...table and mobile RF commu nications equip ment should be used no closer to any part of the Bili Lux including cables than the recommended sep aration distance calculated from the equation applica ble to the frequency of the transmitter Recommended separation dis tance Immunity test IEC 60601 test level Compliance level Electromagnetic environment D 1 2 P ...

Страница 80: ...tters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted the oretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an elec tromagnetic site survey should be considered If the measured field strength in the location in which the device is used excee...

Страница 81: ...rtable and mobile RF communications equipment and the BiliLux as recommended according to the maximum output power of the communications equipment Maximum out put power Watts Separation m 150 kHz to 80 MHz Separation m 80 MHz to 800 MHz Separation m 800 MHz to 2 5 GHz 0 01 0 1167 m 0 3829 ft 0 12 m 0 39 ft 0 23 m 0 76 ft 0 1 0 369 m 1 211 ft 0 38 m 1 25 ft 0 73 m 2 4 ft 1 1 167 m 3 829 ft 1 2 m 3 ...

Страница 82: ... represent actual modulation it would be worst case 2 0 3 28 710 704 to 787 LTE Band 13 17 Pulse modulation2 217 Hz 0 2 0 3 9 745 780 810 800 to 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation2 18 Hz 2 0 3 28 870 930 1720 1700 to 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation2 217 Hz 2 0 3 28 1845 1970 2450 2400 to 2570 Bluetooth WLAN 802 11 b...

Страница 83: ...system MU20100 Description Part number Phototherapy mask Eyemax 2 disposable micro 20 MP03770 Phototherapy mask Eyemax 2 disposable preemie 20 MP03771 Phototherapy mask Eyemax 2 disposable regular 20 MP03772 Description Part number BiliLux radiometer MU26079 USB flash drive 8416347 BiliLux trolley MU26076 Cable holder for trolley pole G13171 BiliLux spring arm MU26077 BiliLux light shield curtain ...

Страница 84: ...84 Instructions for use BiliLux This page has been left blank intentionally ...

Страница 85: ...iguration screen 55 control panel 19 coverage area 47 D date and time adjusting 55 definitions safety 10 device combinations 13 76 device status screen 51 disassembly 59 disinfectants 61 disinfection 62 disposal 69 E EMC declaration 76 emissions 77 ending phototherapy 52 environment of use 17 eye shields 41 42 F functional check procedure 38 H height adjustment knob trolley 21 humidity 73 hyperbil...

Страница 86: ...22 LED lights phototherapy 19 22 M maintenance intervals 67 MEDIBUS 52 73 N Notice 10 O observation light 22 27 On off switch 20 operation 41 P patient monitoring 12 patient safety 12 phototherapy light 19 22 29 44 45 47 phototherapy report 50 phototherapy report screen 50 phototherapy screen 48 positioning on incubator hood 32 43 positioning with incubator 44 positioning with radiant warmer 45 po...

Страница 87: ...S safety 10 safety checks 66 safety instructions 10 screens 28 Separation distance 81 service 11 65 shut down 53 spring arm 20 21 23 spring arm adjustment 29 spring arm installing 32 starting therapy 48 start up 37 Store button 22 25 symbols 24 T technical data 71 temperature operating 73 storage 73 trolley 21 23 trolley installing 34 trolley moving 16 troubleshooting 57 typographical conventions ...

Страница 88: ...88 Instructions for use BiliLux This page has been left blank intentionally ...

Страница 89: ...Instructions for use BiliLux 89 This page has been left blank intentionally ...

Страница 90: ...0 800 4DRAGER 800 437 2437 FAX 215 723 5935 http www draeger com Draeger Inc 3135 Quarry Road Telford PA 18969 1042 USA 215 721 5400 800 4DRAGER 800 437 2437 FAX 215 723 5935 http www draeger com In Europe Middle East Africa Latin America Asia Pacific distributed by Distributed in Canada by Drägerwerk AG Co KGaA Moislinger Allee 53 55 D 23542 Lübeck Germany 49 451 8 82 0 FAX 49 451 8 82 20 80 http...

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