Bililed Mini - Central Medical Supplies
Contents
1. UA E cu Em Standards and Directives 35 TECHNICAL CHARACTER ST CS Environmental Requirements Operating Storage Noise Level Temperature Humidity Temperature Humidity Max 50 dBA Irradiation Specifications Spectral Irradiance Light focus center Average lamp usage 420 500 nm 23 C to 27 5 99 condensing 20 to 50 10 95 RH condensing gt 3 mW cm 60 uW cm nm 20 000 hours Measures and Control Parameters Total Time Adjustment Measurement accuracy Therapy Time Adjustment range Measurement accuracy Electrical Specifications Voltage Fuse SMPS Dimensions Width Dept Height Up Down Height Head 0 99999 hours 1 hour 0 99 hours 1 minute 220 V 10 50 Hz Type B Class 1 3A 9V 6A 2 5 mm 120 mm 1010 16350 mm 65 mm 36 Standards and Directives EN 60601 1 EN 60601 2 50 ISO 13485 2003 Council Directive 93 42 EEC of 14 June 1993 concerning medical devices OJ No L 169 1 of 1993 07 12 MANUFACTURER NOVOS TIBB C HAZLAR SAN T C TH VE HR LTD T Uzay Cag Cad Ay k Is Merkezi No 82 B5 Ostim 06374 ANKARA T RK YE Tel 490 312 384 15 88 Faks 90 312 384 15 98 E mail info NOVOS com tr WEB www NOVOS com tr Note NOVOS reserves the right to make changes without notice in design specifications and models BILILED2. NOVOS technical service for a detailed control of the equipment in case of interrupted LED module operation LEDS Efficiency Control System For the next switch on the equipment Call Service message is shown on the screen if the total lamp usage time is higher than 20 000 hours Therapy cannot be started in case of Call Service message and equipment usage is prevented with the inefficient leds Led module should be replaced and total lamp usage time should be reset for using the equipment again 20 ROUTINE CLEANING amp MAINTENANCE Cleaning and Disinfection Preventive Maintenance 31 Cleaning of Cooling Duct 32 Intensity Control Replacement of Led Module 30 ROUTINE CLEANING amp MAINTANENCE Cleaning and Disinfection BILILED MINI must be thoroughly cleaned and disinfected periodically according to approved hospital protocols WARNING Always disconnect power supply before cleaning and disinfection e Remove visible soiling with a disposable cloth and detergent e Wipe disinfect the surfaces e After allowing disinfectant to take effect see manufacturer s directions for prescribed exposure times wipe surfaces with a clean damp disposable cloth then rub dry WARNING Do not allow any moisture disinfectant and liquid detergent enter the unit control panel and lens Do not disinfect control panel by i
3. 4 Return to the main screen Pressing the reset button after the minute value adjustment returns to the main screen Any time pressing the reset button for a few seconds returns to the main screen WARNING While setting time date parameters intensity level may change Therefore after setting date time parameters and turning to the main screen it may be necessary to adjust intensity level Switching Equipment Off Device is switched off when the switch position is 0 FUSE rower EVDE 27 On Off buton SAFETY SYSTEMS amp ALARMS Alarms Info Messages 29 Automate LEDS Shut OT mai inni 29 Control System for Inspection of LEDS efficiency 29 28 SAFETY SYSTEMS amp ALARMS Alarms and Info Messages Alarm amp Info Cause Proposal E Contact technical service to Call Service Led usage time is ended replace the led module Lamp Timer Reset Led usage time is reset Automatic LEDS Shut Off Leds are automatically shut off and therapy is paused if the temperature of the LED module increases above 60 C because of any technical problem and or high ambient temperature Leds are automatically illuminated again when the temperature of led module decreases to 40 C WARNING LED module illuminates uninterrupted under normal operation conditions Contact a certified
4. Bililed Mini Led Phototherapy Unit User Manual Rev 1 NOT CE Proprietary Information This document contains information in which NOVOS claimed proprietary rights The information may not be reproduced in whole or in part except as authorized in writing by NOVOS This information is the property of NOVOS it is provided solely for use intended Repairs Modifications Repairs on this device shall be performed only by NOVOS or Factory Authorized Service Centers Information about repairs can be obtained from NOVOS or Authorized Dealers NOVOS will not be responsible for injury to persons or damage to property arising directly or indirectly out of unauthorized repairs or modifications to this device Furthermore any unauthorized repairs or modifications void any warranty extended by NOVOS This document is provided for your information only It will not be exchanged or updated without request Definitions WARNING Warnings are directions which if they are not followed can cause fatal or serious injuries to a user engineer patient or any other person or can lead to a mistreatment CAUTION Cautions are directions which if they are not followed can cause damage to the system described in this manual Trademarks NOVOS name and logo are registered trademarks of NOVOS T bbi Cihazlar San Tic Ith ve Ihr Ltd Sti Bililed is registered trademark of NOVOS T bbi Cihazlar San Tic Ith ve Ihr Ltd Sti Table of Co
5. NOVOS original parts and accessories Serious harm to the patient and device may result from the use of unauthorized parts or accessories CAUTION Maintenance Repair The equipment must be inspected and serviced at regular 1 year intervals A record must be kept on this preventive maintenance We recommend obtaining a service contract with NOVOS through your vendor For repairs of BILILED MINITM we recommend that you contact NOVOS WARNING Never cover phototherapy unit with cloths blanket aluminum foil or other materials with the intention to boost the phototherapeutic effect It may cause to temperature rising and or obstruct to irradiance of light WARNING Normally the original NOVOS lamps life expectance is about 20 000 hours however it is recommended to follow up the irradiance constantly with a radiometer in accordance with the usual maintenance procedures to assure a better evaluation of the actual efficacy of the leds The irradiance source should be replaced always when it reaches a loss of 25 of the total irradiance for bilirubin Ebi CAUTION Before delivery the equipment must be switched OFF WARNING Mobile telephones must not be used within 10 meters 33 feet of the phototherapy unit Mobile phones can interfere with the function of electro medical equipment and therefore endanger the patient WARNING Do not cover air circulation ports of BILILED MINI by blanket or towel or any fabric It may
6. expiration of this warranty The above is the sole warranty provided by NOVOS No other warranty expressed or implied is intended Representatives of NOVOS are not authorized to modify the terms of this warranty WARNINGS WARNING This User Manual contains extremely important information to insure the safety and the physical integrity of the patient of the user and of the equipment Therefore read it CAREFULLY Warnings for Using the Equipment WARNING Operating the device without a complete and thorough understanding of its attributes is unsafe and may cause harm to the patient BILILED MINI should only be used by properly trained personnel under the Supervision of qualified medical personnel familiar with the currently known risks and benefits of using a phototherapy device WARNING Power cable plug shall be connected to mains connection permanently fixed in wall or bench as per rule for low power electrical instillations Never use extension cord WARNING NOVOS BILILED MNI phototherapy should be used in accordance with the ideal environmental comfort standards for a nursery that is between 23 27 C WARNING We recommend the use of Radiation Monitor to confirm a proper lamp radiation condition to ensure a minimum radiation of 3 0 mW cm2 The internationally acceptable level for proper treatment is 3 0 mW cm2 minimum value according to Mims WARNING In order to avoid eye damage of patient
7. MINI is registered trade mark of NOVOS Ltd Sti NOVOS TIBB C HAZLAR SAN T C TH VE HR LTD T 2009 37
8. atient Safety Attention Operating the device without a complete and thorough understanding of its attributes is unsafe and may cause harm to the patient It is important that this part of manual be read and understood in its entirety before operating the device PLEASE READ IT CAREFULLY This equipment should be used for the purpose specified under Intended Use Observe all warnings and cautions rendered throughout this manual and labels on the equipment The design of this equipment the accompanying literature and the labeling on the equipment take into consideration that the purchase and use of this equipment are restricted to trained professionals and that certain inherent characteristics of the equipment are known by trained operator Instructions warnings and caution statements are limited therefore largely to the specifics of the NOVOS design This publication excludes references to various hazards which are obvious to a medical professional and operator of this equipment to the consequences of product misuse and to potentially adverse effects in patients with abnormal conditions Product modification or misuse can be dangerous NOVOS disclaims all liability for the consequences of product alterations or modifications as well as for the consequences which might result from the combination of this product with other products whether supplied by NOVOS or by other manufacturers if such a combination is not endor
9. ating screen alternately with an interval of 10 Thrp Time 00 00 seconds 16 12 10 15 58 m 23 Preparation of Patient and Equipment BILILED MINI should be positioned so that illuminated area mainly covers the thoracic abdominal area of the baby Detached BILILED MINI head could be used directly putting onto the incubator canopy or BILILED MINI with mobile stand could be used onto the incubator canopy or close to a radiant warmer positioning the illuminated area over the baby using the height adjustable column or head movement joint NOTE BILILED MINI head could be detached from the head movement joint rotating 180 and pulling it off Red focus light may be helpful for positioning the equipment for the optimum adjustment of the illuminated area on the thoracic abdominal area NOTE Press the focus button for the focus light Brakes of casters should be closed to avoid any movement of equipment during the treatment in case of using BILILED MINI with mobile stand Use eye protector for infant in order to avoid risk of eye damage WA P NS 2 WARNING During the therapy eyes of baby must be protected by using eye protector WARNING Height adjustable column Before starting therapy inspect all LEDS whether they are working properly or not Improper LEDS working may cause decrease irradiance efficacy and therapy efficiency 24 Starting Therapy Start Function
10. be replaced and led Mini total lamp usage time should be reset after a period of 20 000 hours usage e Call Service Total lamp usage time counter is checked by the microprocessor automatically on each switching the equipment on Call Service message is shown on the screen to warn user when the lamp usage time counter is e Hier 20 000 hours In this case it is not possible sj Zproed to use the device without replacing the LED X module and resetting total lamp usage timer For resetting total lamp usage timer 26 1 Switch off the equipment 2 Switch the equipment on while pressing the focus and intensity level adjustment buttons at the same time 3 Lamp Timer Reset message is shown on the screen and device turns to main operating screen automatically WARNING Contact an authorized technical service for the replacement of the LED module in case of Call Service message is seen on the screen WARNING Resetting total lamp usage time function is only to be used after the replacement of LED module Date and Time Setting 1 Switch on the equipment Press focus and intensity level buttons to get the date time setting Screen 2 n this screen flashing parameter is adjusted by using the intensity level and focus buttons Intensity level button is used for increasing and focus button is used for decreasing the flashing parameter value 3 Reset button is used to select next parameter
11. cause to temperature rising and it may affect patient skin temperature WARNING Verify that power cord is connected properly to the device and all necessary measurements are supplied against disconnection WARNING Only use NOVOS original LEDS Using unauthorized LEDS may affect intensity and temperature levels defined for device WARNING We recommend that the distance between patient and BILILED MINI should be more than 30 cm WARNING Use caution when moving the BILILED MINI over uneven surfaces e g rough pavement outside the hospital or into elevator as castors may become damaged or dislodged WARNING In order to avoid risk of electric shock always disconnect power supply before starting any maintenance procedures WARNING Inspect the parts of equipment and ensure it has not physical damage Never operate BILILED MINI if it has damaged part or does not seem to operate properly Contact authorized technical service of NOVOS WARNING Always disconnect power supply before cleaning and disinfecting WARNING To avoid any risk of infection clean and disinfect device and accessories before any maintenance according to established hospital procedures this applies also when returning units or parts for repair WARNING If any part of power supply is directly in contact with the baby s body do not use BILILED MINI Power supply of operating unit may heat up and this overheating may cause burn of patient ski
12. g of its attributes 1 unsafe and may cause harm to the patient It is important that this part of manual be read and understood in its entirety before operating the device PLEASE READ IT CAREFULLY The following are exceptions of this warranty 1 The defect shall be a result of workmanship or material Defects caused by misuse mishandling tampering or by modifications not authorized by NOVOS or its representatives are not covered 2 Rubber and plastic components and materials are warranted to be free of defects at time of delivery Any product which proves to be defective in workmanship or material will be replaced credited or repaired with NOVOS holding the option NOVOS is not responsible for deterioration wear or abuse In any case NOVOS will not be liable beyond the original selling price Application of this warranty is subject to the following conditions 1 NOVOS or its authorized representative must be promptly notified in writing upon detection of the defective material or equipment 2 Defective material or equipment must be returned shipping prepaid to NOVOS or its factory authorized service center 3 Examination by NOVOS or its factory authorized service center must confirm that the defect is covered by the terms of this warranty 4 Notification in writing of defective material or equipment must be received by NOVOS or its factory authorized service center no later than two 2 weeks following
13. i 5 o jer nos 1Mini Call Service 16 12 10 15 58 K 19 CHECKING READINESS FOR OPERATION 20 CHECKING READINESS FOR OPERATION Check below situations before using the phototherapy unit EQUIPMENT OPERATION Switching Equipment On 23 Preparation of Patient Equipment 24 Staino MA 2 a mila a B II 25 PAUSING game aa itti ai 25 Terminating Therapy 26 ResettinglotaLampUsagelime 26 Adjustment of Date and Time Parameters 27 Switching Equipment off sss 27 27 EQUIPMENT OPERATION Switching Equipment On Connect BILILED MINITM to proper line power owitch equipment on using the on off 1 button placed to the back side of the control panel FT Y LEM ori iri mii TI m Self test is performed automatically when the equipment is on and opening screen is displayed EE Lamp usage time screen is displayed for a few Lamp Time 5h i E M Please wait seconds following the opening screen Time unit is in hours Intensity 5 Main operating screen is displayed following the lamp usage time screen Intensity and Date Time informations are shown on the main ledMini novOs oper
14. interrupted period therapy timer will start again counting the therapy time following the starting of the therapy by pressing the start button The conditions below during the ongoing therapy are the equivalent of pause function Switching the equipment off using the on off button During the ongoing therapy therapy time will be maintained in case of a switch off the equipment using the on off button Therapy timer counts starting from the previous time value on switching the equipment on and pressing the start button Interruption of voltage supply During the ongoing therapy therapy time will be maintained in case of a power supply interruption Therapy timer counts starting from the previous time value following the power supplied to the equipment and start button depressed Terminating Therapy Reset Function Press Reset button to terminate the ongoing therapy Then leds will go off and therapy time led Mini counter will be reset 00 00 for a new C Thrp Time 00 00 patient Equipment may be switched off or Eu Intensity 5 therapy can be started again pressing the start Em button for a new patient WARNING If therapy time counter shows the previous therapy time before pressing the start button and starting a new therapy for a new patient it is necessary to reset therapy timer using the reset function Resetting Total Lamp Usage Time Average led module usage time is 20 000 hours Led module should
15. led Mini Thrp Time 00 00 Therapy starts pressing the Start button on the main screen Lamps illuminate and therapy Started time starts counting the therapy period Turis Light intensity level is adjusted to level 5 automatically for each switching on the equipment Intensity can be adjusted by care gt giver before starting the therapy or during the Thrp Time 00 00 therapy at any time N ame ledMini WARNING Information messages or warnings related with infant and or equipment during the therapy are explained in Safety Systems section NOTE NOVOS recommends using intensity at level 5 Intensity values at different levels Level Light intensity mW cm2 30 cm at the beginning of turning on 4 20 3 70 3 10 2 50 1 90 NOTE Therapy is paused by pressing Pause button and is ended by pressing Reset button Otherwise therapy will continue unless terminated Pausing Therapy Pause Function Therapy can be interrupted by pressing the Pause button at any time Led lights will go ate led Mini off Pause Screen will be seen and equipment will be in stand by pause condition Treatment Paused Pres Start Press Start button to continue therapy again Pause function is used for maintaining the therapy time during the feeding of the baby or for any clinical reason MRI imaging etc that tharapy needs to be interrupted At the end of the
16. mmersion or spraying WARNING Do not disinfect unit control panel and any parts of unit by immersion WARNING Led module including the lenses should be cleaned with a soft damp cloth WARNING Do not touch lens by finger The dirt body oil perfume or such ingredients available on finger may damage the optical property WARNING Do not use organic solvents sometimes used for cleaning and disinfecting e g alcohols phenols halogen releasing compounds oxygen releasing compounds strong organic acids etc Exposure to such substances may cause damage of equipment and parts CAUTION We recommend using Ammonia Quaternary WARNING Do not allow any moisture disinfectant and liquid enter the unit 3 Preventive Maintenance This equipment must be inspected and serviced at regular 1 year intervals A record must be kept on this preventive maintenance We recommend obtaining a service contract with NOVOS Service through your vendor For repairs of BILILED MINI phototherapy we recommend that you contact NOVOS Service Cleaning of Cooling Duct For effective operation of the device and long lasting use of LED module cooling duct must be free of dust Blocked cooling channels because of dust may cause inside temperature increase and shut off the leds Therefore each three months two cooling channels on head should be cleaned by using brush or low pressurized air Intensity Control Expected life of led module i
17. n Warnings Related with Possible Physiological Effects WARNING While being transitory some collateral effects may be observed as a result from phototherapy Among them we would emphasize the increase in peripheral blood flow with consequent vessel dilatation erythema and an increase in insensible water loss eyes injury an alternation in the intestinal transit WARNING The operator doctor or nurses eyes may be affected in case of long stay around the patients WARNING Patients serum levels of bilirubin should be regularly measured WARNING Newborns submitted to NOVOS BILILED MINI as to any other type of phototherapy will require an adequate hydric supply and eyes protection during treatment in addition to the routine nursing and medical assistance WARNING During the treatment the photo isomers of bilirubin may cause toxic effects WARNING Liquid infusions and drugs should not be stored or kept within the radiation area WARNING The use of reflector sheet is not adequate because it may cause dangerous temperatures to the patient body WARNING The water balance of the patient may be altered due to the use of phototherapy WARNING In newborn patients with very jaundiced skin it is common to observe after a few hours of treatment with BILILED MINI M that the area submitted to light appears paler and whitish This is due to the intense action of the light on the bilirubin pigment depo
18. ng light WARNING BILILED MINI should only be used by properly trained personnel under the supervision of qualified medical personnel familiar with the currently known risks and benefits of using a phototherapy device WARNING Only use NOVOS original parts and accessories Serious harm to the patient and device may result from the use of unauthorized parts or accessories WARNING Intensive phototherapy BILILED MINI does not replace an incubator or and any other heated systems WARNING BILILED MINI is ready for operation only when all checks have been carried out successfully WARNING DANGER Risk of explosion if used in the presence of flammable anesthetics This device is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely WARNING This device is to be used only in rooms with line power installations complying with national safety standards for hospital patient rooms e g IEC EN 601 1 Safety of Medical Equipment 110V or 220 V 10 and 50 60Hz 100W To maintain grounding integrity connect only to a hospital grade receptacle WARNING The use of this device requires continuous supervision of the infant by trained nursing personnel in order to avoid immediate corrective action in situations with a risk of patient injury WARNING NOVOS medical equipment conforms to the interference immunity requirements laid down in product specific standa
19. ntents ImportantSafetylnformation 3 ala e e L EN A RM NE 11 Parts Control Systems of Equipment 13 CheckingReadinessforOperatlon 20 EguipmentOperation 22 Safety Systems amp Alarms 28 RoutineCleaningandMaintenance 30 Troubleshooting Re T 33 Technical Characteristics 35 Important Safety Information Important Safety Information e e e e Operator s Responsibility for Patient Safety lLimitationofliability WY gg a Warnings uoc hee el e e Kn di med ier Warnings and Cautions for Using of Equipment Warnings Related with Possible Physiological Affects Warnings Related with Ambient Conditions IMPORTANT SAFETY INFORMATION Symbols Used Symbol Meaning Attention Check Manual Type B Equipment Attention Risk of Electric Shock Equipotantial Mandatory Grounding Attention Hot surface Patient Eye Protector Ne Lu WA eee ON Electric power being supplied 0 OFF No power being supplied For using please see auxiliary documents Operator s Responsibility for P
20. ovement Joint By using this joint you can position the head with an angle to the left or right side Connecting Disconnecting The Head Head of Bililed Mini can be disconnected from the mobile stand and positioned directly onto the incubator canopy Rotate head of Bililed Mini 180 so as to face the lenses upwards and detach from the left right movement joint pulling it off The order of disconnection process The order of connection process 15 Head View 8 9 Label of eye protector Control Panel Power Input On off button Fuse Manufacturer info label CE mark Cooling Fan Lens 10 Focusing light 11 Device info label Bililed Mini 5 16 Labels Manufacturer identification label Warning for eye protection Electrical specification CE symbol 9 10 11 Head Views NOVOS LTD STi Kazim Karabekir C No 91 67 Ankara TURKEY 90 312 3841588 www novos com tr ELEC SPEC 220V 50HZ TYPEB CLASS 1 SERIAL NR 17 Control Systems Main Control Panel Control Panel Therapy Start Pause Therapy ending Intensity adjustment Focus oy NOVOS WA Bililed Mini 1 0 Turn On Screen 5 18 Lamp Usage Time Screen Main Screen Main Screen 1 Main Screen 2 Date and Time Setting Screen Pause Screen Service Screen J Treatment Paused Pres Start novos r
21. rds or in EN 60601 1 2 IEC 60601 1 2 However depending the design of a mobile phone and the use situation field strengths exceeding the values generated in the immediate vicinity of mobile phones thereby causing interference and malfunctions WARNING BILILED MINI has not been established for using inside of incubators and it should not be exposed directly heat coming from radiant warmer Risk of burn Risk of explosion upon O2 12 PARTS AND CONTROL SYSTEMS Main Parts of the Equipment 14 EON VICW Mee TC 14 FIC AG WE WW e EN NON 16 WADE e EN 17 COnWOlSVSICMS seir 18 CONTOR anek 18 bd uideo Eg 18 SETER al bilenin kayla 19 Data and Hour Adjustment Screen 19 PAUSE OCIO Bini iei Beo ted 19 Service Screen 1 19 13 PARTS AND CONTROL SYSTEMS Main Parts of the Equipment Front View 1 Head 2 Mobile stand 3 Height adjustable column 4 Head left right movement joint 5 Height fixing arm View of the equipment 14 Height Adjustable Column Thanks to the height adjustable column it is possibble to use Bililed Mini phototherapy unit with different height of baby codes and incubators Height of Bililed Mini head can be adjusted approximately between 100 160 cm Head Left Right M
22. s about 20 000 hours However it is recommended to follow up the irradiance with a radiation monitor to assure a better evaluation of the actual efficacy of the leds Led module should be replaced when there is a loss of 25 of the irradiance Replacement of Led Module We recommend replacing led module when led usage time is 20 000 hours For replacement of led module contact NOVOS technical service or authorized local service in your region 22 TROUBLESHOOTING 33 TROUBLESHOOTING a Connect the power cord to Power cord disconnects adequate socket Contact a certified NOVOS Burnt fuse technical service to replace the fuse On off button is 0 position Position on off button to 1 Power adaptor failure Replace power adaptor with new one Contact a certified NOVOS Electrical problem with technical service equipment May not be pressed Start Press Start button button e Contact certified NOVOS Internal electrical problem technical service Do not use the equipment and Electrical failure contact a certified NOVOS technical service Led module some of the leds does not light up 34 TECHNICAL CHARACTER ST CS Environmental Reguiremenis Irradiance Specification Measures and Control Parameters Electrical Specification IMME SIONS ote o ples
23. sed by NOVOS Patient monitoring The operators of this phototherapy system must recognize their responsibility for choosing appropriate safety monitoring that supplies adequate information on equipment performance and patient condition Patient safety may be achieved through a wide variety of different means ranging from electronic surveillance of equipment performance and patient condition to simple direct observation of clinical signs Responsibility for the selection of the best level of patient monitoring lies solely with the equipment operator Limitation of Liability NOVOS liability whether arising from or related to manufacture and sale of goods their installation demonstration sales representation use performance or otherwise including and liability based upon NOVOS s product warranty or any other cause of action whatsoever regardless of any fault attributable to NOVOS and regardless of the form of action including without limitation breach of warranty negligence strict liability or otherwise NOVOS shall not be liable for nor shall buyer be entitled to recover any special incidental or consequential damages or for any liability incurred by buyer to any third party in any way arising from or relating to the goods Warranty All NOVOS products are guaranteed to be free of defects for a period of one year from date of delivery Attention Operating the device without a complete and thorough understandin
24. sited in the skin Warnings Related with Ambient Conditions WARNING Ambient conditions such as air movement and airflow may affect the thermal balance of the patient WARNING Intensive phototherapy provides a rapid reduction in serum bilirubin levels thus reducing the need for blood transfusion and reducing treatment duration WARNING case of newborn patients with risk of developing high bilirubin serum levels and patients with continuously rising bilirubin concentration in spite of the application of phototherapy the use of BILILED MINI is recommended WARNING Eyes of the patient lie down near the phototherapy must be protected by using barrier or and eye protector etc WARNING Inappropriate ambient temperature may affect the thermal balance of the patient 10 INTENDED USE 11 INTENDED USE BILILED MINITM is routinely used in treatment of neonatal hyperbilirubinemia where the patient is submitted to an exposure of concentrated radiation in the blue spectrum of visible light during a time to be determined by the attending physician depending on the case During the jaundice treatment the patient is accommodated in a heated crip or incubator depending on his her clinical conditions BILILED MINI has been established for the purpose of jaundice treatment in hospitals Functions Hour and date info 5 levels adjustable intensity Therapy time info Lamp usage time info Focusi
25. use eye protector The newborn needs eye protection WARNING This device is to be used only in rooms with line power installations complying with national safety standards for hospital patient rooms e g IEC EN 601 1 Safety of Medical Equipment 110V or 220 V 10 and 50 60Hz 100VA To maintain grounding integrity connect only to a hospital grade receptacle WARNING proper grounding system is not available the equipment should not be used Do not use extension cord or multiple plugs WARNING Infant temperature must be monitored with particular care during phototherapy Absorption of light through the infant s skin will supply heat to the patient which may increase central temperature WARNING Thermotherapy sets Heated Cribs Heated Mattresses and Radiation Heaters coupled to BILILED MINI may rise the patient s body temperature to dangerous levels so the temperature should be constantly checked by using a clinical thermometer WARNING NOVOS cannot warrant or endorse the safe performance of third party accessories for use with BILILED MINI phototherapy Only use original NOVOS accessories and parts with BILILED MINITM phototherapy WARNING Do not use the BILILED MINI in the presence of flammable anesthetics combustible gases or cleaning substances that may cause combustion CAUTION Do not push buttons with sharp boring material or fingernail WARNING Only use
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