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Summary of Contents for novos Bililed Mini+
- Page 1 Bililed Mini+ User Manual NVS.S9.KK14/Rev.05/12.02.2021...
- 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. These 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 ................................... 5 1.1. Symbols ....................................5 1.2. Label Information .................................. 7 1.3. User Obligations for Patient Safety ............................8 1.4. Patient Monitoring ................................8 1.5. Limitation of Liabilities ................................8 1.6. Warranty ....................................9 2. Product Description ..................................10 2.1. - Page 4 5.3. Starting Therapy .................................. 23 5.4. End of Therapy..................................27 5.5. Use of Examination Lamps ..............................28 5.6. Alarms and Warnings................................30 Routine Cleaning and Maintenance ............................31 6.1. General Cleaning ................................. 31 6.2. Maintenance ..................................32 6.2.1. Light Intensity Control ..............................32 6.2.2.
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Page 5: Safety Information
1. Safety Information 1.1. Symbols Device is ON. Device is OFF. Protected against solid objects larger than 12.5 mm. IP20 Use eye protection band! 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. Warnings are instructions 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. - Page 6 NOVOS Bililed Mini+ User Manual Fuse Box CE mark Authorized body See User Manual Class II Device. Alternative Current Power 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 Mini+ User Manual 1.2. Label Information Product Identity Technical Service Warning Outer Box Label NVS.S9. KK14/Rev.05/12.02.2021... -
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 Mini+ 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 Mini+ 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. • Information on extensive repair operations has been included in the service manual for service officers trained by Novos to provide accurate information to users and to demonstrate the equipment and the test equipment. -
Page 12: Warnings For The Use Of The Device
NOVOS Bililed Mini+ 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 Mini+ User Manual In order to guarantee the minimum luminous value of 3.5 mW/cm2, the light intensity of the lamp should be measured at regular intervals using a light intensity measurement monitor or similar radiometers. The eyes of other babies lying close to the phototherapy device should be protected by taking precautions such as protective glasses and light barrier. -
Page 14: Transportation Restrictions
NOVOS Bililed Mini+ User Manual 2.3.10. Transportation Restrictions Be careful when moving the device on its wheels on uneven surfaces, pavement descents/exits, while entering/exiting the elevator, as the wheels may be damaged or dislodged. Make sure that the wheels of the device are not locked during transportation. -
Page 15: Parts And Controls
NOVOS Bililed Mini+ User Manual 3. Parts and Controls 3.1. Isometric View Bililed Mini+ Light Source Trolley Safety Lock Wheels with Brakes Height Adjustment Screw NVS.S9. KK14/Rev.05/12.02.2021... -
Page 16: Front View
NOVOS Bililed Mini+ User Manual 3.2. Front View 5 6 7 Focus Button Air Ducts 2x16 LCD Display Status Indicator LED Up Arrow Button Examination Lamp Button Confirm Button Down Arrow Button Power Switch Therapy Start / Pause / Stop Button... -
Page 17: Bottom View
NOVOS Bililed Mini+ User Manual 3.3. Bottom View Blue Phototherapy LED (4 pieces in total) White Phototherapy LED (2 pieces in total) Plastic Screw Head Focusing LED Ventouse Air Ducts NVS.S9. KK14/Rev.05/12.02.2021... -
Page 18: Preparation
NOVOS Bililed Mini+ User Manual 4. Preparation 4.1. Unpacking and Installation Bililed Mini+ and transport trolley thereof are included in one package. This package contains: • Bililed Mini+ Light Source • Power Adapter (12V, 0.7A) • Trolley • Eye protection masks in 3 different sizes. - Page 19 NOVOS Bililed Mini+ User Manual • Unpack the Bililed Mini+ light source. • Secure the light source to the trolley (you will hear a locking sound when the light source is fixed to the mounting kit) and make sure the device is locked into the trolley.
- Page 20 NOVOS Bililed Mini+ 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 (Step 1) and then simultaneously pull the device out (Step 2).
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Page 21: Electronic Operation Control
NOVOS Bililed Mini+ 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 22: Use Of Device
NOVOS Bililed Mini+ User Manual 5. Use of Device 5.1. Positioning Bililed Mini+ Bililed Mini+ can be rotated around the vertical and horizontal axis. rotation angle • After inserting the light source into the holder and making sure it is... -
Page 23: Starting Bililed Mini
NOVOS Bililed Mini+ User Manual 5.2. Starting Bililed Mini+ • Connect the power adapter (12V 0.7A) to Bililed Mini+ and plug it in. • Turn on the device by pressing the "Power" button. • Flashing green LEDs indicate that the device has started. -
Page 24: Starting Therapy
NOVOS Bililed Mini+ User Manual 5.3. Starting Therapy Bililed Mini+ must be properly positioned and operated before therapy is initiated. • There are 5 preset therapy light intensity levels in total. • Adjust the light intensity of the blue therapy LEDs using the "Up and Down"... - Page 25 NOVOS Bililed Mini+ 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 26 NOVOS Bililed Mini+ 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 the "Therapy Start/Pause/Stop”...
- Page 27 NOVOS Bililed Mini+ User Manual • A long beep will be heard. • Blue phototherapy and status LEDs will turn green. • The therapy started icon in the upper right corner of the screen will disappear. • The therapy time counter reverts to the target therapy time.
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Page 28: End Of Therapy
NOVOS Bililed Mini+ User Manual 5.4. End of Therapy When the targeted therapy time is reached, the message "Therapy Ended" will be displayed on the screen and this message will remain on the screen until any button is pressed. NVS.S9. KK14/Rev.05/12.02.2021... -
Page 29: Use Of Examination Lamps
NOVOS Bililed Mini+ User Manual 5.5. Use of Examination Lamps • Bililed Mini+ has 4 white examination LEDs. • Press “Examination lamp” button. • Enter the menu by pressing the "Confirm" button. • Go to "Lamp Intensity" option in the menu by pressing the "Down"... - Page 30 NOVOS Bililed Mini+ User Manual • There are 5 different preset levels for the examination lamp’s light intensity. • Set the appropriate light intensity level for the white inspection LEDs using the "Up and Down" arrow buttons. • Return to the menu by pressing the "Confirm"...
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Page 31: Alarms And Warnings
NOVOS Bililed Mini+ 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 that the device the ambient temperature is high. -
Page 32: Routine Cleaning And Maintenance
Such disinfectants can damage the phototherapy unit. WARNING! 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. NVS.S9. KK14/Rev.05/12.02.2021... -
Page 33: 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 Mini+ Phototherapy device. -
Page 34: Cleaning Of Air Channels
NOVOS Bililed Mini+ 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 due to dust cause the internal temperature of the device to increase, and this can lead to damage to electronic components. -
Page 35: Troubleshooting
NOVOS Bililed Mini+ User Manual 7. Troubleshooting 7.1. Fast Troubleshooting Guide Failure Case Cause Solution Recommendat Connect the power adapter to a suitable Power supply failure. outlet. Device does not start Defective fuse. Contact an authorized NOVOS Technical Service. Internal electrical problem. -
Page 36: Annexes
NOVOS Bililed Mini+ 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: 1098mm) Width 300 mm – (with Transport Trolley: 834mm) Depth 168 mm – (with Transport Trolley: 504mm) -
Page 37: Miscellaneous Properties
Screen Dimensions 2 x 16 LCD 8.2. Compatibility The NOVOS Bililed Mini+ phototherapy system has been designed to comply with the requirements of the following standards: IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and basic... -
Page 38: Guidance And Manufacturer's Declaration Of Electromagnetic Compatibility
NOVOS Bililed Mini+ 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 39 NOVOS Bililed Mini+ User Manual Immunity Test IEC 60601 test level Compatibility level Electromagnetic 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 40 NOVOS Bililed Mini+ User Manual 8.2.2.2. Electromagnetic Immunity Bililed Mini+ is intended for use in the electromagnetic environment specified below. The customer or user of the Bililed Mini+ must guarantee that the device will be used in such an environment.
- Page 41 NOVOS Bililed Mini+ User Manual Note 1: At 80 MHZ and 800 MHz, the higher frequency range applies. Note 2: This document may not be applicable in all cases. Electromagnetic propagation is affected by absorption and reflection from buildings, people and objects.
- Page 42 NOVOS Bililed Mini+ User Manual 8.2.2.3. Recommended Separation Distance Separation distance according to frequency of transmitter (m) Transmitter's highest rated output power (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz �� = ��. �� √ ��...
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Page 43: Trademark Registrations
NOVOS Bililed Mini+ User Manual 8.3. Trademark Registrations Bililed Mini+ 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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