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.

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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

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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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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.

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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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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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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.

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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.

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Conclusion:
The mentioned failures or breakdowns partially limit the life of the device. However, with the intervention of the
authorized technical service, the device can be used functionally for an average of 10 years without being
scrapped.
2.3. Usage Restrictions
Before using this device, it is important to know, understand and correctly apply the safety measures to be
applied. The precautions mentioned below are intended to prevent a possible risk of injury to the patient or the
device operator who will receive phototherapy with Bililed Mini+, and to guarantee efficient use of the device.
2.3.1. Operating
•Read the entire user manual thoroughly before using the device.
•As with all other medical devices, interventions without understanding how to operate this
product can cause injury to the patient or the user.
•This device should only be used by healthcare professionals trained in the operation of such
devices.
•Before starting the device, make sure that all checks have been made successfully.
NOTE: If it is determined that any function cannot be performed during the inspections performed,
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 disconnected
the from the socket. Supply power to the device only where you need to operate the device within the
scope of service and maintenance procedures.
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.
•Use only original spare parts and accessories of NOVOS. The use of unauthorized parts may harm patient health and
the device.
.
2.3.4.Cleaning and Maintenance
•All necessary additional measures are mentioned in the cleaning and maintenance unit of this document.
2.3.5.Warnings Regarding Indications, Contraindications, Possible Physiological Effects
2.3.5.1. Indications:
- Hyperbilirubinaemia treatment
- Kernicterus prevention
- Patients with light sensitivity disorders (e.g. congenital erythropoietic porphyria)
2.3.5.2. Counterindications:
- Bronze baby syndrome
- Dehydration
- Hyperthermia
- Temporary skin redness

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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.
The amount of bilirubin in the patient's blood should be measured continuously at regular intervals.
The use of reflectors is not suitable! Because it can cause the patient's body temperature to increase to
dangerous levels.
.
As with all phototherapy treatments applied to babies, sufficient fluid should be given to the patient in
phototherapy treatment with Bililed Mini+ and a protective path should be worn on the eyes throughout the
therapy. In addition, the patient's condition should be checked routinely by nurses and medical assistants.
During therapy, the toxic effect of bilirubin can be seen.
The hydraulic balance of the patient may vary depending on the phototherapy application.
Bilirubin photoisomers can cause toxic effect during therapy.
Drugs, serum and liquid infusions should not be stored or kept in the radiation field.
In newborns with jaundice on their skin, whiteness may occur in the illuminated area within a few hours
after treatment with the Bililed Mini+ 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.Warnings for the Use of the Device
Fixing the Device
During the use of the device, the wheels of the device must be fixed in order for the treatment to continue
correctly.
Patient Monitoring.
• Do not leave the patient unattended while using the device.
• Blue light can prevent observation of the skin discoloration such as cyanosis (bruising)! The patient
should be observed very carefully.
• Thermotherapy devices (warmed cradles, incubators, radiant warmers, etc.) When used with
Bililed Mini+, they may cause the patient's body temperature to reach dangerous limits. For this
reason, the temperature of the baby should be continuously monitored with the help of a stand-
alone thermometer throughout the use of the device from distant areas such as armpits or ears.
Do not cover the phototherapy unit or the device it is used with, with materials such as cloth or towel. This
may cause an increase in temperature and / or prevent light emission. This can pose a danger to the patient
and device.
Accompanied Devices
• All devices to be used with Bililed Mini+ must comply with the IEC 60601 standard.
• Hospital guidelines and medical protocol must be followed when using the Bililed Mini+ with other
devices.
• 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 Mini+. See the relevant document and the use of
attached devices before using the medical device.
• All devices and accessories to be used with Bililed Mini+ are under the responsibility of the operator.

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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.
The device should not be used in environments with substances that support combustion (oxygen,
anesthetic agents, etc.). Otherwise there is a danger of explosion.
It is recommended that the distance of the Bililed Mini+ phototherapy device to the baby is
approximately 30 cm.
2.3.7.EMC Restrictions
ATTENTION
•This device must be operated in accordance with the EMC information provided in this manual.
•Cell phones should not be used within 20 m2 of this device. Cell phones may impair the functions of
the electromedical device and thus patient safety may be compromised
•When using this device alongside other devices, it is important to verify normal operation in the
configuration in which it is used.
2.3.8.Restrictions of the Environment in which the Device will be Used
The device should be used in ideal environmental conditions between 20 °C and 30 °C. Unsuitable
ambient temperature, low or high ambient temperature may disrupt the patient's thermal balance.
It should not be used in front of windows that receive direct sunlight etc.
NOTE:
This is a mobile device that can be operated 24 hours a day.
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" 200V AC-240V AC ve 50 Hz). To
maintain ground integrity, connect only to a "hospital grade" plug socket.
The power cord plug must be fixed to the power input in the wall or 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 hospital patient
rooms (e.g. IEC / EN 60601-1, “Safety of Medical Equipment”, UL 544). Always observe the total leakage
current and current consumption limits when using the integrated power strip to connect auxiliary devices!
Auxiliary power socket for any type of device can lead to reduced safety in the system.

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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.

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3.Parts and Controls
3.1. Isometric View
1
Bililed Mini+ Light Source
4
Trolley
2
Safety Lock
5
Wheels with Brakes
3
Height Adjustment Screw
1
2
3
4
5

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3.2. Front View
1
Focus Button
6
Air Ducts
2
2x16 LCD Display
7
Status Indicator LED
3
Up Arrow Button
8
Examination Lamp Button
4
Confirm Button
9
Down Arrow Button
5
Power Switch
10
Therapy Start / Pause / Stop Button
1
2
3
4
5 6 7
8
9
10

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3.3. Bottom View
1
Blue Phototherapy LED (4 pieces in total)
4
White Phototherapy LED (2 pieces in total)
2
Plastic Screw Head
5
Focusing LED
3
Ventouse
6
Air Ducts
1
2
3
5
6
4

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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.
After you receive the package, complete the installation by following the steps below.
• Unpack and set the trolley parts aside.
• Fix the trolley's right
and left feet to the
baseplate.

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• 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.

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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).
2
1