novos Bililed Mini+ User manual

NVS.S9.KK14/Rev.05/12.02.2021
Bililed Mini+
User Manual

NVS.S9.KK14/Rev.05/12.02.2021
WARNING
Registered Information:
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.
Repair/Modifications:
Repairs on this device shall only be carried out by NOVOS or Factory Authorized Service Centers.
Information on repairs can be obtained from NOVOS or Authorized Resellers. 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 unauthorized
repair or modification shall void any warranty provided by NOVOS. This document is provided for
information purposes only. It cannot be changed or updated at will.
Definitions:
ATTENTION!
These are the guidances that may damage the system as described in this manual, if the
attention notes are not followed.
WARNING!
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.

NVS.S9.KK14/Rev.05/12.02.2021
Table of Contents
1. 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. About This Manual .............................................................................................................................................................. 10
2.1.1. Scope 10
2.1.2. Target Users ................................................................................................................................................................. 10
2.2. Applications ......................................................................................................................................................................... 10
2.2.1. Usage Purpose.............................................................................................................................................................. 10
2.2.2. Patient Population........................................................................................................................................................ 10
2.2.3. Life Cycle....................................................................................................................................................................... 10
2.3. Usage Restrictions ............................................................................................................................................................... 11
2.3.1. Operating...................................................................................................................................................................... 11
2.3.2. Power Supply................................................................................................................................................................ 11
2.3.3. Servicing ....................................................................................................................................................................... 11
2.3.4. Cleaning and Maintenance........................................................................................................................................... 11
2.3.5. Warnings Regarding Indications, Contraindications, Possible Physiological Effects .................................................... 11
2.3.6. Warnings for the Use of the Device ............................................................................................................................. 12
2.3.8. Restrictions of the Environment in which the Device will be Used.............................................................................. 13
2.3.9. Electrical Safety Restrictions ........................................................................................................................................ 13
2.3.10. Transportation Restrictions ............................................................................................................................. 14
3. Parts and Controls.................................................................................................................................................................. 15
3.1. Isometric View..................................................................................................................................................................... 15
3.2. Front View ........................................................................................................................................................................... 16
3.3. Bottom View........................................................................................................................................................................ 17
4. Preparation............................................................................................................................................................................. 18
4.1. Unpacking and Installation .................................................................................................................................................. 18
4.2. Electronic Operation Control............................................................................................................................................... 21
5. Use of Device.......................................................................................................................................................................... 21
5.1. Positioning Bililed Mini+ ...................................................................................................................................................... 21
5.2. Starting Bililed Mini+ ........................................................................................................................................................... 22

NVS.S9.KK14/Rev.05/12.02.2021
5.3. Starting Therapy .................................................................................................................................................................. 23
5.4. End of Therapy..................................................................................................................................................................... 27
5.5. Use of Examination Lamps .................................................................................................................................................. 28
5.6. Alarms and Warnings........................................................................................................................................................... 30
6. Routine Cleaning and Maintenance ....................................................................................................................................... 31
6.1. General Cleaning ................................................................................................................................................................. 31
6.2. Maintenance........................................................................................................................................................................ 32
6.2.1. Light Intensity Control .................................................................................................................................................. 32
6.2.2. LED Module Replacement ............................................................................................................................................ 32
6.2.3. Cleaning of Air Channels............................................................................................................................................... 33
7. Troubleshooting ..................................................................................................................................................................... 34
7.1. Fast Troubleshooting Guide ................................................................................................................................................ 34
8. Annexes.................................................................................................................................................................................. 35
8.1. Technical Specifications....................................................................................................................................................... 35
8.1.1. Mechanical Properties.................................................................................................................................................. 35
8.1.2. Electrical Properties...................................................................................................................................................... 35
8.1.3. Environmental Conditions............................................................................................................................................ 35
8.1.4. Radiation Properties..................................................................................................................................................... 35
8.1.5. Miscellaneous Properties ............................................................................................................................................. 36
8.2. Compatibility ....................................................................................................................................................................... 36
8.2.1. Compliance Directive: .................................................................................................................................................. 36
8.2.2. Guidance and Manufacturer's Declaration of Electromagnetic Compatibility............................................................. 37
8.3. Trademark Registrations ..................................................................................................................................................... 42
8.4. Manufacturer ...................................................................................................................................................................... 42

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NVS.S9.KK14/Rev.05/12.02.2021
1.Safety Information
1.1. Symbols
I
Device is ON.
O
Device is OFF.
IP20
Protected against solid objects larger than 12.5 mm.
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.
ATTENTION
These are the guidances that may damage the system as described in this manual, if
the attention notes are not followed.
NOTE:
NOTE is used where additional information on the subject is given.
ID
Product ID.
Manufacturer.
Date of Manufacture.
Electrical and electronic equipment waste should not be disposed of in general
municipal waste, but should be collected separately.
SN
Serial number.

NOVOS Bililed Mini+ User Manual
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NVS.S9. KK14/Rev.05/12.02.2021
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.
This sign on the label indicates that the package must be protected from moisture and
rain.
Specifies the lower and upper temperature / humidity limits for storage.
Specifies the lower and upper temperature / humidity limits for operation.

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NVS.S9. KK14/Rev.05/12.02.2021
NOVOS Bililed Mini+ User Manual
1.2. Label Information
Product Identity
Technical Service
Warning
Outer Box Label

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NOVOS Bililed Mini+ User Manual
1.3. User Obligations for Patient Safety
The design of this equipment takes into account the relevant literature and labeling on the equipment, the
purchase and use of this equipment is restricted to trained professionals and the specific features of the device
are known to the trained operator. Therefore, instructions, warnings and cautions are mainly limited to the
features of the NOVOS design. This document does not contain references to various hazards open to the
consequences of misuse of the product by a medical professional and the operator of this device, and to potential
side effects that may occur in patients with abnormal conditions. Modification or misuse of the product can be
dangerous. 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.
1.4. Patient Monitoring
Operators of this phototherapy system should recognize their responsibilities in selecting appropriate safety
monitoring that provides adequate information on equipment performance and patient condition. Patient safety
can be achieved through a wide range of different tools, from electronic monitoring of equipment performance
and patient status to simple and direct observation of clinical findings. The responsibility for selecting the best
patient monitoring level rests solely with the operator of the equipment.
1.5. Limitation of Liabilities
NOVOS has liabilities in the production, sale (activities), installation, promotion, use, application and product
production guarantee of goods etc. These liabilities are subject to and are limited to the specific terms described
in this manual. Circumstances that void the warranty, negligence that may occur independently of NOVOS,
product violation, etc. limit the liability of NOVOS regardless of whether it was the fault of NOVOS and regardless
of the manner in which the fault occurred. NOVOS shall not assume any liability for compensation for damages
arising from or related to the products and for the buyer's liabilities to third parties; the buyer shall not have any
right to claim compensation for these damages.
WARNING!
Strictly follow this guide. Any use of the product requires thorough understanding and strict observation of all
sections of these instructions. This equipment should only be used for the purpose specified in article "Intended
Use". Follow all WARNING and ATTENTION notes stated in this manual and on the label on the device.

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NVS.S9. KK14/Rev.05/12.02.2021
NOVOS Bililed Mini+ User Manual
1.6. Warranty
All NOVOS products are warranted against manufacturing, workmanship and assembly defects for 12 months from the date of
invoice. The conditions for this warranty are listed below;
1. Tax and import expenses of the shipped product are not covered by the warranty.
2. Repair, modification and changes made within the warranty period cannot be used to extend the specified warranty
period.
3. The defect must have been caused by workmanship or material.
4. Only for problems caused by workmanship or materials, the parts replacement, reimbursement or repair of the
product by NOVOS Tıbbi Cihazla are possible. NOVOS Tıbbi Cihazla reserves the right to apply one of the methods
specified above, that is deemed appropriate based on the warranty claim.
5. NOVOS Tıbbi Cihazla cannot be held responsible for the following conditions;
a. Deterioration, wear or abuse of any component of the product
b. Alteration, misuse, damage in transit, or modifications not approved by NOVOS Tıbbi Cihazlar or an
authorized representative.
c. Malfunctions arising from force majeure circumstances and other circumstances for which the manufacturer
is not responsible.
d. Malfunctions caused by voltage fluctuation.
e. Malfunctions caused by inadequate or, if necessary, never provided customer service and maintenance.
.
f. Normal wear and tear of working parts.
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 records should be kept for proof of the damage.
c. The carrier should be warned and the damaged product warranty claim form should be filled.
7. In any case, NOVOS Tıbbi Cihazlar is not liable for more than the original selling price.
8. The buyer guarantees that all services and maintenance are carried out in a timely manner by qualified personnel
according to NOVOS service guidelines.
.
If these liabilities are not fulfilled, all warranty liabilities will expire. Warranty applications
depend on the following:
1. If any malfunction occurs in the device or its parts, NOVOS or its authorized representative must be notified in
writing immediately.
2. Defective devices and parts must be returned to NOVOS or an authorized factory center in accordance with the
instructions of NOVOS service personnel.
.
3. As a result of evaluations, NOVOS or the authorized factory center must confirm that the warranty conditions cover
this defect.
4. Written notification of the failure of the device or any part thereof must be received by NOVOS or authorized factory
center no later than 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.
Dealers and representatives of NOVOS are not authorized to change these warranty conditions.
NOVOS Tıbbi Cihazlar.

NOVOS Bililed Mini+ User Manual
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NVS.S9. KK14/Rev.05/12.02.2021
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
•Installation
•Usage
•Maintenance
of the Bililed Mini+ phototherapy device. All features and technical information of the device are listed
considering the user benefit in order to facilitate the efficient use of the device.
2.1.2.Target Users
This device should only be used by medical personnel trained in the operation of the device who are aware of
all the risks and benefits of the operation of such devices. The intended users of this guide are end users of
the device, healthcare providers in delivery rooms and neonatal intensive care units, and hospitals’
biomedical and clinical engineering services. The product is intended for professional use.
2.2. Applications
2.2.1.Usage Purpose
Bililed Mini+ 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 physician based on
the patient's condition. During jaundice treatment, the patient is placed in a heated baby bed or incubator
depending on its clinical condition. Bililed Mini+ is designed for jaundice treatment in hospitals.
2.2.2.Patient Population
Bililed Mini+ is used in the treatment of babies between 0-28 days postnatal and for preterm babies whose
adjusted age is 52 weeks.
2.2.3.Life Cycle
Factors affecting the life cycle are listed below;
•The silicon structure of semiconductor materials (integrated, diode, etc.) on electronic cards may
deteriorate over time and cause the semiconductor material to become partially or completely
dysfunctional.
•Connectors of sensor-like parts on the device may oxidize over time or plastic parts may deform.
•Deformation or deterioration may occur in the body and silicon seals of the device over time as a
result of cleaning these parts with disinfectant.
•The buttons on the device may lose their functionality over time.