Bililed Maxi - Central Medical Supplies
Contents
1. 37 Standards and Directives 37 TECHNICAL CHARACTERISTICS 35 Environmental Requirements Operating Temperature 23 C to 28 C Humidity 5 99 RH non condensing Storage Temperature 20 C to 50 C Humidity 10 95 RH non condensing Noise Level 0 dBA Irradiation Specifications Spectral Irradiance 420 500 nm Light focus center gt mW cm 60 uW cm nm Average lamp usage 20 000 hours Measures and Control Parameters Total Time Adjustment 0 99999 hours Measurement accuracy 1 hour Therapy Time Adjustment range 0 99 hours Measurement accuracy 1 minute Electrical Specifications Voltage 220 V 9610 50 Hz Type BF Class 2 Fuse 3A SMPS 12V 6 67A Dimensions Width 650 mm Dept 180 mm Height Min 840 mm Height Max 1520 mm Height Head 85 mm Standards and Directives EN 60601 1 EN 60601 2 50 ISO 13485 2003 CE1984 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 36 Kazim Karabekir Cad Ba kent Merkezi No 91 67 skitler 06060 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 BILILED MAXI is registered tra2. novos medical sys Bililed Maxi Intensive LED Phototherapy Unit User s Manual Rev 4 12 09 2012 NOTICE 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 Tibbi Cihazlar San Tic Ith ve Ihr Ltd Sti Bililed 9 is registered trademark of NOVOS Tibbi Ciha
3. ALARMS Alarms and Info Messages Alarm amp Info Cause Proposal Call Service Led usage time is ended Contact technical service to replace the led module Lamp Timer Reset Lamp usage time is reset Low Skin Temperature Skin Temperature is below low skin temperature alarm limit Check Baby Low Skin Temperature Skin probe can be removed Re attach skin probe to baby s limit from baby s skin skin Skin Temperature is above High skin Temperature high skin temperature alarm Check Baby Skin Probe Fail Disconnect Skin Probe disconnected from the equipment or skin probe is faulty Connect Skin Probe to the equipment or replace the skin probe with a new one 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 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 canno
4. ME HMM 26 bahas Bigot ea eee 26 Terminating Therapy 26 Resetting Total Lamp Usage Time 27 Switching Equipment off sss 28 22 EQUIPMENT OPERATION Switching Equipment On Connect BILILED MAXI to proper line power Switch equipment on using the on 3 button placed to the side of the control panel Self test is performed automatically when the equipment is on and opening screen is displayed After the opening screen main operating screen is displayed Therapy Time 026 35 007 00 Set 01970 Lamp Time Intensity U NOVOS Bililed Maxi Ver 3 0 1 Skin Temp C 37 0 36 5 35 0 23 Preparation of Patient and Equipment BILILED MAXI should be positioned so that illuminated area mainly cover the thoracic abdominal area of the baby Detached BILILED MAXI head could be used directly putting onto the incubator canopy or BILILED MAXI 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 Height adjustable adjustable column or head movement joint Column NOTE BILILED MAXI head could be detached from the head movement joint lifting it up Red focus light may be helpful for positioning the equipm
5. BILILED MAXI by blanket or towel or any fabric It may 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 MAXI should be more than 30 cm WARNING Use caution when moving the BILILED MAXI 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 MAXI 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 MAXI Power supply of operating unit may
6. Therapy ending Intensity adjustment Focus Targeting Light Therapy Time Skin Alarms Adjustment Decrease Button Increase Button 17 NOVOS Bililed Maxi Ver 3 0 1 Turn On Screen Therapy Time 026 35 Skin Temp Set 007 00 37 0 Lamp Time 01970 36 5 Intensity 35 0 Main Screen Therapy Started Screen Therapy Time 026 35 Skin Temp C Set 007 00 37 0 LampTime 01970 36 5 Intensity TherapyStarted Therapy Time 026 35 Skin Temp C Set 007 00 LampTime 01970 Pause Screen Intensity 7 TherapyPaused press Start 111 Call Service Service Screen 18 Alarm Screen Therapy Terminated Screen Therapy Time 026 35 Skin Temp C Set 007 00 37 0 LampTime 01970 36 5 T Intensity Low Skin Temperature Therapy Time 026 35 Skin Temp C Set 007 00 37 0 LampTime 01970 36 5 Intensity Therapy Terminated 19 CHECKING READINESS FOR OPERATION 20 CHECKING READINESS FOR OPERATION Check below situations before using the phototherapy unit 21 EQUIPMENT OPERATION Switching Equipment On 23 Preparation of Patient and 24 Adjusting Parameter Set 25 Adjusting Skin Temperature Alarm Limits 25 Starting Therapy cnet cial RR ted dau gles ODER ERR 25
7. WARNING In order to avoid eye damage of patient 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 If a 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 MAXI 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 MAXI phototherapy Only use original NOVOS accessories and parts with BILILED MAXI phototherapy WARNING Do not use the BILILED MAXI in the presence of flammable anesthetics combustible gases or cleaning substances that may cause combustion CAUTION Do not push buttons with sharp
8. boring material or fingernail 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 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 MAXI 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 therefore endanger the patient WARNING Do not cover air circulation ports of
9. de mark of NOVOS Ltd Sti NOVOS T BB C HAZLAR SAN TIC ITH VE IHR LTD T 2009 37
10. ed service center no later than two 2 weeks following 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 MAXI 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 MAXI 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 5 mW cm2 The internationally acceptable level for proper treatment is 3 5 mW cm2 minimum value according to Mims
11. ent 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 MAXI with mobile stand Use eye protector for infant in order to avoid risk of eye damage WARNING During the therapy eyes of baby must be protected by using eye protector WARNING Head movement joint Before starting therapy inspect all LEDS whether they are working properly or not Improper LEDS working may cause decrease irradiance efficacy and therapy efficiency Adjusting Parameter Set 24 The parameter Set means desired therapy time adjusted by caregiver Desired therapy time can be adjusted in terms of hour and minute Adjusting format is as hhh mm On the main screen when you press Set button field for hhh mm starts to flashing Adjust hour value for therapy time by pressing 1 or buttons Then press Set button The minute value field will start to flash Adjust minute value for therapy time by pressing 1 or buttons Then press Set button The default value of Set is 10 hours If you would like to start therapy with default value just press Set button twice When you adjust parameter Set as 000 00 and then start therapy the equipment will operate continuously without stopping unless caregiver terminates the therapy War
12. er manufacturers if such a combination is not endorsed 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 t
13. he 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 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 authoriz
14. heat up and this overheating may cause burn of patient skin Warnings Related with Possible Physiological Effects WARNING While being transitory some collateral effects may be observed as a result from phototherapy Among them vve 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 Patient s serum levels of bilirubin should be regularly measured WARNING Newborns submitted to NOVOS BILILED MAXI 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 Warnings Related with Ambient Conditions 10 INTENDED USE 11 INTENDED USE BILILED MAXI 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 accommoda
15. nger 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 3l 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 MAXI 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 Intensity Control Expected life of led module is 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 Fo
16. ning When the therapy is started with set value as 000 00 Therapy can only be terminated manually by pressing Pause and then Reset buttons In case of selection of unlimited therapy time 000 00 we recommend to use alternative time counter to check applied therapy time Exceeded therapy may be harmful to the patient Adjusting Skin Temperature Alarm Limits On the main screen when you press set button twice skin temperature upper alarm limit field starts flashing Adjust skin temperature upper alarm limit value by pressing 1 or buttons Then press Set button Then the skin temperature lower alarm limit field will start to flash Adjust skin temperature lower alarm limit value by pressing 1 or buttons Then press Set button After adjusting skin temperature alarm limits you return to main screen automatically Starting Therapy Start Function Therapy starts by pressing Start button on the main screen Lamps illuminate and therapy time starts counting the therapy period Light intensity level is adjusted to level 5 automatically for each switching on the equipment Intensity can be adjusted by care giver before starting the therapy or during the therapy at any time NOTE NOTE Therapy is paused by pressing Pause NOVOS recommends using intensity at level 5 button and is ended by pressing Reset Intensity values at different levels button Otherwise therapy will continue unless terminated Level Light inte
17. nsity mW cm2 35 cm WARNING Information messages or warnings related with infant and or equipment during the therapy are explained in Safety Systems section Alarms High Low skin temperature alarm 29 Bililed Maxi warns caregiver with an audible alarm and a message on the screen if the measured skin temperature of the infant exceeds the adjusted skin temperature alarm limits To silence audible alarm for 15 minutes press Reset button After 15 minutes if the alarm situation continues audible alarm will be active again Skin Probe Fail alarm If the skin probe is disconnected from the main unit Skin Probe Fail message will be seen on the screen with an audible alarm To silence this alarm press Reset button When you silence Skin Prob Fail alarm Skin Prob Fail message can be seen on screen but the alarm sound will not be heard again otherwise you switch on and off equipment Pausing Therapy Pause Function Therapy can be interrupted by pressing the Pause button at any time Led lights will go off Pause Screen will be seen and equipment will be in stand by pause condition 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 interrupted period therapy timer will start again counting the the
18. r replacement of led module contact NOVOS technical service or authorized local service in your region 32 TROUBLESHOOTING 33 TROUBLESHOOTING Fault Cause Proposal The equipment does not turn on Power cord disconnect Connect the power cord to adequate socket Burnt fuse Contact a certified NOVOS technical service to replace the fuse On off button is on 0 position Position on off button to 1 Power adaptor failure Replace power adaptor with new one Electrical problem with equipment Contact a certified NOVOS technical service Therapy does not start May not be pressed Start button Press Start button Internal electrical problem Contact a certified NOVOS technical service Led module some of the leds does not light up Electrical failure Do not use the equipment and contact a certified NOVOS technical service Unable to display baby s skin temperature Skin Probe disconnected from the equipment or skin probe is faulty Connect Skin Probe to the equipment or replace the skin probe with a new one 34 TECHNICAL CHARACTERISTICS Environmental Requirements 37 Irradiance Specification 37 Measures and Control Parameters 37 Electrical Specification 37 Dimensions
19. rapy time following the starting of the therapy by pressing the start button The conditions below during the ongoing therapy is 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 a When the therapy time counter reaches adjusted set value At the end of the adjusted therapy time equipment terminates therapy automatically and warns caregiver with an audible alarm and a text message on screen b With Reset Function Press Reset button for 5 seconds to terminate the ongoing therapy Then leds will go off and therapy time counter will be reset 000 00 for a new patient Equipment may be switched off or therapy can be started again pressing the start 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 u
20. ront View 2 1 Head 2 Mobile Stand 3 Height Adjustable Column 4 Head rotation joint 5 Height Fixing Arm 3 Height Adjustable Column Thanks to the height adjustable column It is possible to use Bililed Maxi phototherapy unit with different height of baby codes and incubators Height of Bililed Maxi head can be adjusted approximately between100 150 cm Head Rotation Joint By using this joint you can position the head with an angle to side Connecting Disconnecting the Head 14 Head of Bililed Maxi can be disconnected from the mobile stand and positioned directly onto the incubator canopy Moving the head upwards it is possibble to detach from the movement joint Head View 1 Control pane 2 Label of eye protector 3 On Off Button 4 Fuse 5 Power input 6 Mounting Socket 7 Skin Temp Probe Socket 8 Led Module 9 Focus Light 10 Cooling channel 250 0 0 0 O O o 15 Labels Equipment manufacturer identification label Warning for eye protection NOVOS TIBB C HAZLAR SAN T C ITH ve IHR LTD T Adres K Karabekir Cad No 91 67 Ankara TURKIYE Tel 90 312 384 15 88 e mail infofanovos com tr C 1 Elektriksel zellik Voltaj G Tip BF Sinif O N KS 2 16 Conirol Systems Main Control System Set Control Panel Therapy Start Pause
21. ry documents Operator s Responsibility for Patient 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 oth
22. sing the reset function Resetting Total Lamp Usage Time Average led module usage time is 20 000 hours Led module should be replaced and total lamp usage time should be reset after a period of 20 000 hours usage 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 20 000 hours In this case it is not possible to use the device without replacing the LED module and resetting total lamp usage timer For resetting total lamp usage timer 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 Switching Equipment Off Device is switched off when the switch position is on 0 27 SAFETY SYSTEMS amp ALARMS Alarms and Info Messages Automatic LEDS Control System for Inspection of LEDS efficiency 28 SAFETY SYSTEMS amp
23. t 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 29 ROUTINE CLEANING amp MAINTENANCE Cleaning and Disinfection 32 Preventive Maintenance 33 Cleaning of Cooling Duct 33 Intensity Control 33 Replacement of Led Module 33 30 ROUTINE CLEANING amp MAINTENANCE Cleaning and Disinfection BILILED MAXI 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 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 immersion 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 fi
24. ted in a heated crip or incubator depending on his her clinical conditions BILILED MAXI has been established for the purpose of jaundice treatment in hospitals Functions 5 levels adjustable intensity Therapy time info Lamp usage time info Focusing light WARNING BILILED MAXI 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 MAXI does not replace an incubator or and any other heated systems WARNING BILILED MAXI 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 super
25. vision 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 standards or in EN 60601 1 2 IEC 60601 1 2 However depending on 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 MAXI 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 Front Pa Da eges eeu ex aa 14 Head View i i C EH eae Ea 15 Labels eroe 00 16 Control Systems 17 Main Control Panel 17 eii eR ME 18 Main Screen ret eb eh 18 Therapy Started 18 rede IA ERI 18 Service Dn eens 18 Alarm Sereen da a etd 19 Therapy Terminated Screen 19 13 PARTS AND CONTROL SYSTEMS Main Parts of The Equipment F
26. zlar San Tic Ith ve Ihr Ltd St Table of Contents Important Safety Information 3 Intended LAUR EST Ata 11 Parts and Control Systems of Equipment 13 Checking Readiness for Operation 20 Equipment Operation 22 Safety Systems amp Alarms 28 Routine Cleaning and Maintenance 30 Troubleshooting ve dae xke ae 33 Technical Characteristics 35 Important Safety Information Important Safety Information Symbols Operator s Responsibility for Patient Safety Limitation of Liability Warranty eet Warnings 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 x Type BF Equipment Attention Risk of Electric Shock Patient Eye Protector ON Electric power being supplied 0 OFF No power being supplied For using please see auxilia
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