NVS.S9.KK13/Rev06/19.03.2021
Bililed Maxi+
User Manual
Page 1: ...NVS S9 KK13 Rev06 19 03 2021 Bililed Maxi User Manual...
Page 2: ...llers NOVOS shall not assume any responsibility for any injury to persons or damage to property arising directly or indirectly from unauthorized repair or modification of this device In addition any u...
Page 3: ...Power Supply 7 2 3 3 Servicing 7 2 3 4 Cleaning and Maintenance 7 2 3 5 Warnings Regarding Indications Contraindications Possible Physiological Effects 7 2 3 5 1 Indications 7 2 3 5 2 Counter Indicati...
Page 4: ...7 Troubleshooting 30 7 1 Fast Troubleshooting Guide 30 8 Annexes 31 8 1 Technical Specifications 31 8 1 1 Mechanical Properties 31 8 1 2 Electrical Properties 31 8 1 3 Environmental Conditions 31 8 1...
Page 5: ...that if not followed could result in fatal or serious injury to a user engineer patient or other person or could result in improper treatment ATTENTION These are the guidance that may damage the syste...
Page 6: ...l indicates that the package should stand upright This sign on the label indicates that the contents of the package are fragile and should be handled with care This sign on the label indicates that th...
Page 7: ...NOVOS Bililed Maxi User Manual 3 NVS S9 KK13 Rev06 19 03 2021 1 2 Label Information Product Identity Technical Service Warning Outer Box Label...
Page 8: ...result from the combination of this product with other products from NOVOS or other manufacturers unless such combination is approved by NOVOS 1 4 Patient Monitoring Operators of this phototherapy sy...
Page 9: ...ts 6 As for the warranty claim for the recovery of damage during transportation a The package case should always be checked for any signs of damage b If any traces of damage are found necessary record...
Page 10: ...e Bililed Maxi is routinely used in the treatment of neonatal hyperbilirubinemia where concentrated radiation of the blue spectrum of visible light is applied for a period to be decided by the physici...
Page 11: ...med take the device out of service and call the authorized Novos service for repair 2 3 2 Power Supply Before any service maintenance and cleaning procedures make sure that the power plug is disconnec...
Page 12: ...area within a few hours after treatment with the Bililed Maxi device and this area may become brighter This is due to the intense effect of light on the bilirubin pigment deposited on the skin 2 3 6 W...
Page 13: ...s that support combustion oxygen anesthetic agents etc Otherwise there is a danger of explosion It is recommended that the distance of the Bililed Maxi phototherapy device to the baby is approximately...
Page 14: ...bank as required by rules of low voltage directive An extension cord or multiple sockets should never be used Use only auxiliary electro medical device that complies with national safety standards for...
Page 15: ...NOVOS Bililed Maxi User Manual 11 NVS S9 KK13 Rev06 19 03 2021 3 Parts and Controls 3 1 Isometric View 1 Bililed Maxi Light Source 4 Trolley 2 Safety Lock 5 Wheels 3 Height Adjustment Screw 1 2 3 4 5...
Page 16: ...splay 7 Air Ducts 3 Up Arrow Button 8 Examination Lamp Button 4 Confirm Button 9 Down Arrow Button 5 Power Switch 10 Therapy Start Pause Stop Button 3 3 Bottom View 1 Blue Phototherapy LED 16 in total...
Page 17: ...ley thereof are included in one package This package contains Bililed Maxi Light Source Power Adapter 24V 1 1A Trolley Eye protection masks in 3 different sizes After you receive the package complete...
Page 18: ...3 2021 Unpack the Bililed Maxi light source After locking the wheels of the trolley secure the light source to the trolley you will hear a locking sound when the light source is fixed to the mounting...
Page 19: ...19 03 2021 While the light source is attached to the trolley the position of the safety lock is as shown in the figure below To detach the light source from the trolley pull the safety lock towards y...
Page 20: ...therapy hour digit using the Up and Down arrow buttons 11 Press the Confirm button 12 Set the target therapy minute digit using the Up and Down arrow buttons 13 Set the target therapy time by pressin...
Page 21: ...rotating it around the horizontal axis Once positioned the device will stay in this position until you change it 360o rotation angle Loosen the height adjustment screw while holding the horizontal pr...
Page 22: ...1 1A to the wall socket and device Turn on the device by pressing the Power button Flashing green LEDs indicate that the device has started During booting the device model software version and immedia...
Page 23: ...re are 5 therapy light intensity levels in total Adjust the light intensity of the blue therapy LEDs using the Up and Down arrow buttons The target therapy time can be set between 00 00 and 99 59 Ente...
Page 24: ...e target therapy hour digit using the Up and Down arrow buttons Press the Confirm button Set the target therapy minute digit using the Up and Down arrow buttons Return to the menu by pressing the Conf...
Page 25: ...ill light up The therapy time counter will flash The therapy started icon will be displayed in the upper right corner of the screen The elapsed therapy time set therapy time appears on the bottom line...
Page 26: ...s a safety precaution when the temperature inside the device is higher than 60 o C the therapy is paused and the High temperature inside the device warning is displayed on the screen and a warning sou...
Page 27: ...ambient temperature is within 20 C 30 C When the temperature inside the device drops below 60 C the therapy continues from where it left off however if the ambient temperature is not low enough the hi...
Page 28: ...Examination Lamps Bililed Maxi has 4 white examination LEDs Press Examination lamp button Enter the menu by pressing the Confirm button Go to Lamp Intensity option by pressing the Down arrow button t...
Page 29: ...examination lamp s light intensity Adjust the light intensity of the white therapy LEDs using the Up and Down arrow buttons Return to the menu by pressing the Confirm button Go to Exit option by pres...
Page 30: ...eeds 60 C it means that the ambient temperature is high The therapy will be terminated When the temperature inside the device drops below 60 C the therapy continues from where it left off however if t...
Page 31: ...a clean damp disposable cloth then dry dry all surfaces with a dry cloth Avoid humidity disinfectant and liquid detergent from entering into the light source Do not disinfect any part of the device b...
Page 32: ...nly original NOVOS spare parts 6 2 1 Light Intensity Control The LEDs used have an average lifespan of 50 000 hours In order to accurately detect and evaluate the glow intensity of the LEDs it is reco...
Page 33: ...ing of Air Channels Air channels should be protected from dust for effective use of the device and long lasting operation of the LED module Clogged cooling channels cause the internal temperature of t...
Page 34: ...ter to a suitable outlet Defective fuse Contact an authorized NOVOS Technical Service Internal electrical problem Power Failure message received during the boot Incorrect power adapter connection Conn...
Page 35: ...Frequency 50Hz 60Hz Maximum Power Consumption 80VA AC 25W DC Noise Level 50dbA 8 1 3 Environmental Conditions Operating Temperature Between 20 C and 30 C Operating Humidity 5 95 RH uncondensed Storage...
Page 36: ...characteristics experiments and guidance for warning systems in electrical medical equipment and electrical medical systems TSE 6 5 2012 TS EN 60601 2 50 Electrical medical equipment Part 2 50 Specifi...
Page 37: ...netic Environment Bililed Maxi is intended for use in the electromagnetic environment specified below The customer or user of the Bililed Maxi must guarantee that the device will be used in such an en...
Page 38: ...hospital environment 8 2 2 2 Electromagnetic Immunity Bililed Maxi is intended for use in the electromagnetic environment specified below The customer or user of the Bililed Maxi must guarantee that...
Page 39: ...lection from buildings people and objects a Fixed transmitted field strengths such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcas...
Page 40: ...100 12 m 12 m 23 m For the rated transmitter at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequenc...
Page 41: ...zlar Sanayi ve Ticaret thalat ve hracat Limited irketi 8 4 Manufacturer Novos T bbi Cihazlar Sanayi ve Ticaret thalat ve hracat Limited irketi Address vedikosb Mahallesi 1518 Cad Matbaac lar Sitesi Si...
