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Summary of Contents for novos Bililed Maxi+
- Page 1 Bililed Maxi+ User Manual NVS.S9.KK13/Rev06/19.03.2021...
- Page 2 This document contains information on which NOVOS assumes the property rights. The information may not be reproduced in whole or in part unless authorized in writing by NOVOS. This information are the property of NOVOS, for its intended use only.
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Page 3: Table Of Contents
Table of Contents Safety Information ................................... 1 1.1. Symbols ....................................1 1.2. Label Information .................................. 3 1.3. User Obligations for Patient Safety ............................4 1.4. Patient Monitoring ................................4 1.5. Limitation of Liabilities ................................4 1.6. Warranty....................................5 2. Product Description ..................................6 2.1. - Page 4 5.1. Positioning ................................... 17 5.2. Starting Bililed Maxi+ ................................18 5.3. Starting Therapy .................................. 19 5.4. End of Therapy ..................................23 5.5. Use of Examination Lamps ..............................24 5.6. Alarms and Warnings ................................26 Routine Cleaning and Maintenance ............................27 6.1.
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Page 5: Safety Information
NOVOS Bililed Maxi+ User Manual 1. Safety Information 1.1. Symbols Device is ON Device is OFF Protected against solid objects larger than 12.5 mm. IP20 This symbol means the device is in the B class. This symbol is used to warn the users of the device against possible risk or injury. - Page 6 NOVOS Bililed Maxi+ User Manual Fuse Box CE mark Authorized body See User Manual Class II Device Alternative Current Use eye protection band This sign on the label 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.
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Page 7: Label Information
NOVOS Bililed Maxi+ User Manual 1.2. Label Information Product Identity Technical Service Warning Outer Box Label NVS.S9.KK13/Rev06/19.03.2021... -
Page 8: User Obligations For Patient Safety
NOVOS Tıbbi Cihazlar disclaims any responsibility for the results of product changes or modifications, and the results that may result from the combination of this product with other products from NOVOS or other manufacturers, unless such combination is approved by NOVOS. -
Page 9: Warranty
2 weeks before the end of the warranty period. The above provisions belong to the sole warranty which is applicable and provided by NOVOS. It cannot be aimed to describe or explain the warranty status in any other way. -
Page 10: Product Description
NOVOS Bililed Maxi+ User Manual 2. Product Description 2.1. About This Manual 2.1.1. Scope This manual contains a detailed description of all sub-components, use and care details of the Bililed Maxi+ phototherapy device. This guide is a guide to •... -
Page 11: Usage Restrictions
2.3.3. Servicing • Servicing should only be carried out by persons who have been authorized by Novos to repair this device, in accordance with the procedures specified in the service manual. •... -
Page 12: Warnings On Possible Physiological Effects
NOVOS Bililed Maxi+ User Manual 2.3.5.3. Warnings on Possible Physiological Effects The eyes of the doctor and nurse, who stay with the patient for a long time, may be damaged by the radiation. Therefore, avoid looking directly at the LEDs. -
Page 13: Restrictions Of The Environment In Which The Device Will Be Used
NOVOS Bililed Maxi+ User Manual • Any device or combination of devices that do not comply with the conditions specified in this manual may adversely affect the functionality of the Bililed Maxi+. See the relevant document and the use of attached devices before using the medical device. -
Page 14: Electrical Safety Restrictions
NOVOS Bililed Maxi+ User Manual 2.3.9. Electrical Safety Restrictions The power cord plug must be connected to the power input on the wall or pendant in accordance with the rules of low voltage directive. This device is to be used only in rooms with line power installations that comply with national safety standards for hospital patient rooms (e.g., IEC / EN 60601-1 "Safety of Medical Devices"... -
Page 15: Parts And Controls
NOVOS Bililed Maxi+ User Manual 3. Parts and Controls 3.1. Isometric View Bililed Maxi+ Light Source Trolley Safety Lock Wheels Height Adjustment Screw NVS.S9.KK13/Rev06/19.03.2021... -
Page 16: Front View
NOVOS Bililed Maxi+ User Manual 3.2. Front View Focus Button Status Indicator LED 2x16 LCD Display Air Ducts Up Arrow Button Examination Lamp Button Confirm Button Down Arrow Button Power Switch Therapy Start / Pause / Stop Button 3.3. Bottom View... -
Page 17: Preparation
NOVOS Bililed Maxi+ User Manual 4. Preparation 4.1. Unpacking and Installation Bililed Maxi+ and transport trolley 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. - Page 18 NOVOS Bililed Maxi+ User Manual • 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...
- Page 19 NOVOS Bililed Maxi+ User Manual 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 you and then simultaneously pull the device out.
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Page 20: Electronic Operation Control
NOVOS Bililed Maxi+ User Manual 4.2. Electronic Operation Control Please apply the Electronic Operation Check after installation and notify the NOVOS Technical Service Department when you find that any of the following steps could not be implemented successfully. Before start: •... -
Page 21: Use Of Device
NOVOS Bililed Maxi+ User Manual 5. Use of Device 5.1. Positioning Bililed Maxi+ can be rotated around the vertical and horizontal axis. rotation angle • After inserting the light source into the holder and making sure it is locked, you can position it by rotating it around the horizontal axis. -
Page 22: Starting Bililed Maxi
NOVOS Bililed Maxi+ User Manual 5.2. Starting Bililed Maxi+ • Connect the power adapter (24V, 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. -
Page 23: Starting Therapy
NOVOS Bililed Maxi+ User Manual 5.3. Starting Therapy Bililed Maxi+ must be properly positioned and operated before therapy is initiated. • There are 5 therapy light intensity levels in total. • Adjust the light intensity of the blue therapy LEDs using the "Up and Down"... - Page 24 NOVOS Bililed Maxi+ User Manual • Set the 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 "Confirm"...
- Page 25 NOVOS Bililed Maxi+ User Manual • Press the "confirm" button to exit the menu and return to the main screen. • Wear an appropriately sized eye mask so that the baby's eyes are completely covered. • Press “Therapy Start/Pause/Stop Button”...
- Page 26 NOVOS Bililed Maxi+ User Manual • Stop therapy by holding down the "Therapy Start/Pause/Stop” for 3 seconds. • A long beep will be heard. • Blue phototherapy LED and status LED will turn green. • The therapy started icon in the upper right corner of the screen will disappear.
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Page 27: End Of Therapy
NOVOS Bililed Maxi+ User Manual To return to the therapy screen • Press the confirmation button 3 times, waiting for transition times between menus. • Finally, the therapy screen will be displayed. If the temperature inside the device exceeds 60 °C, it means that the ambient temperature is high. -
Page 28: Use Of Examination Lamps
NOVOS Bililed Maxi+ User Manual 5.5. Use of 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"... - Page 29 NOVOS Bililed Maxi+ User Manual • There are 5 different levels for the 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"...
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Page 30: Alarms And Warnings
NOVOS Bililed Maxi+ User Manual 5.6. Alarms and Warnings Alarm settings can only be changed by authorized personnel! Alarm Message Alarm Priority Description High temperature inside High Priority If the temperature inside the device exceeds 60 °C, it means the device that the ambient temperature is high. -
Page 31: Routine Cleaning And Maintenance
Do not use caustic, corrosive substances or disinfectants containing sodium hypochloride or alcohol. Such disinfectants can damage the phototherapy unit. NOVOS recommends the use of Ammonia Quaternary components that do not have any harmful effects on the materials used in the device, that clean the surfaces and fight bacteria. -
Page 32: Maintenance
6.2. Maintenance This device should be maintained and serviced every 1 year. Records must be kept during these protective services. A technical services contract with NOVOS is recommended for a continuous service in line with the rules and standards. It is recommended to contact the NOVOS Technical Service Department for repair of the Bililed Maxi+ Phototherapy device. -
Page 33: Cleaning Of Air Channels
NOVOS Bililed Maxi+ User Manual 6.2.3. Cleaning 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 the device to increase, and this can lead to damage to electronic components. -
Page 34: Troubleshooting
NOVOS Bililed Maxi+ User Manual 7. Troubleshooting 7.1. Fast Troubleshooting Guide Failure Case Cause Solution Recommendation Power supply failure. Connect the power adapter to a suitable outlet. Device does not start Defective fuse. Contact an authorized NOVOS Technical Service. Internal electrical problem. -
Page 35: Annexes
NOVOS Bililed Maxi+ User Manual 8. Annexes 8.1. Technical Specifications 8.1.1. Mechanical Properties Protection against water and solid objects IP20 Height 82 mm – (with Transport Trolley: 1106 mm) Width 528.5 mm – (with Transport Trolley: 1064 mm) Depth 224 mm – (with Transport Trolley: 504 mm) -
Page 36: Compatibility
NOVOS Bililed Maxi+ User Manual 8.2. Compatibility Publishing Date Document Name / Title Body Acce 11-02-2009 TS EN 60601-1 / Electrical medical equipment-Part 1: General rules for ptanc basic safety and required performance 23-03-2016 TS EN 60601-1-2 / Electrical medical equipment-Part 1-2: General rules for basic... -
Page 37: Guidance And Manufacturer's Declaration Of Electromagnetic Compatibility
NOVOS Bililed Maxi+ User Manual 8.2.2. Guidance and Manufacturer's Declaration of Electromagnetic Compatibility This document is the Guideline and Manufacturer's Declaration prepared with reference to the Electromagnetic Compatibility requirements of the Electrical Medical Device according to EN 60601-1-2. EMC compatibility has been evaluated with original components. The use of incompatible components may result in increased emissions and decreased immunity. -
Page 38: Electromagnetic Immunity
NOVOS Bililed Maxi+ User Manual Electromagnetic Immunity Test IEC 60601 test level Compatibility level Environment 95% drop for 0.5 cycles, 40% drop for 5 cycles, 95% drop for 0.5 cycles, Voltage drops, short 30% drop for 25 cycles interruptions and... - Page 39 NOVOS Bililed Maxi+ User Manual IEC 60601 Immunity Test Compatibility level Electromagnetic Environment Experiment level 3Vrms outside ISM, Recommended Separation Conveyed RF IEC Distance 6Vmrs inside band 61000-4-6 D = 1,2√ 150kHz to 80MHz d = 1.2√P 800 MHz to 1000 MHz...
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Page 40: Recommended Separation Distance
NOVOS Bililed Maxi+ User Manual 8.2.2.3. Recommended Separation Distance Separation distance according to frequency of transmitter (m) Transmitter highest rated 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz output power (W) �� = ��. �� √ ��... -
Page 41: Trademark Registrations
NOVOS Bililed Maxi+ User Manual 8.3 Trademark Registrations Bililed Maxi+ model is a Novos branded commercial product of Novos Tıbbi Cihazlar Sanayi ve Ticaret İthalat ve İhracat Limited Şirketi. 8.4 Manufacturer Novos Tıbbi Cihazlar Sanayi ve Ticaret İthalat ve İhracat Limited Şirketi Address: İvedikosb Mahallesi 1518 Cad.
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