novos Bililed Maxi+ User manual

NVS.S9.KK13/Rev06/19.03.2021
Bililed Maxi+
User Manual

NVS.S9.KK13/Rev06/19.03.2021
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. This 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:
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.
ATTENTION!
These are the guidance that may damage the system as described in this manual if the attention
notes are not followed.

NVS.S9.KK13/Rev06/19.03.2021
Table of Contents
1. 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. About This Manual ................................................................................................................................................................ 6
2.1.1. Scope 6
2.1.2. Target Users ................................................................................................................................................................... 6
2.2. Applications........................................................................................................................................................................... 6
2.2.1. Usage Purpose................................................................................................................................................................ 6
2.2.2. Patient Population.......................................................................................................................................................... 6
2.2.3. Life Cycle......................................................................................................................................................................... 6
2.3. Usage Restrictions ................................................................................................................................................................. 7
2.3.1. Operating........................................................................................................................................................................ 7
2.3.2. 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 Indications: .......................................................................................................................................... 7
2.3.5.3. Warnings on Possible Physiological Effects ....................................................................................................... 8
2.3.6. Warnings for the Use of the Device ............................................................................................................................... 8
2.3.8. Restrictions of the Environment in which the Device will be Used................................................................................ 9
2.3.9. Electrical Safety Restrictions ........................................................................................................................................ 10
2.3.10. Transportation Restrictions ............................................................................................................................. 10
3. Parts and Controls.................................................................................................................................................................. 11
3.1. Isometric View..................................................................................................................................................................... 11
3.2. Front View ........................................................................................................................................................................... 12
3.3. Bottom View........................................................................................................................................................................ 12
4. Preparation............................................................................................................................................................................. 13
4.1. Unpacking and Installation.................................................................................................................................................. 13
4.2. Electronic Operation Control............................................................................................................................................... 16
5. Use of Device.......................................................................................................................................................................... 17

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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
6. Routine Cleaning and Maintenance ....................................................................................................................................... 27
6.1. General Cleaning ................................................................................................................................................................. 27
6.2. Maintenance........................................................................................................................................................................ 28
6.2.1. Light Intensity Control.................................................................................................................................................. 28
6.2.2. LED Module Replacement ............................................................................................................................................ 28
6.2.3. Cleaning of Air Channels............................................................................................................................................... 29
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
8.1.4. Radiation Properties..................................................................................................................................................... 31
8.1.5. Miscellaneous Properties ............................................................................................................................................. 31
8.2. Compatibility ....................................................................................................................................................................... 32
8.2.1. Compliance Directive: .................................................................................................................................................. 32
8.2.2. Guidance and Manufacturer's Declaration of Electromagnetic Compatibility............................................................. 33
8.2.2.1. Electromagnetic Environment ......................................................................................................................... 33
8.2.2.2. Electromagnetic Immunity .............................................................................................................................. 34
8.2.2.3. Recommended Separation Distance................................................................................................................ 36
8.3 Trademark Registrations ..................................................................................................................................................... 37
8.4 Manufacturer ...................................................................................................................................................................... 37

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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.
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 guidance 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.
Power
SN
Serial number

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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.
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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1.2. Label Information
Product Identity
Technical Service
Warning
Outer Box Label

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1.3. User Obligations for Patient Safety
ATTENTI
ON
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.
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.

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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 Cihazlar are possible. NOVOS Tıbbi Cihazlar reserves the right to apply one
of the methods specified above, that is deemed appropriate based on the warranty claim.
5. NOVOS Tıbbi Cihazlar 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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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
•Installation
•Usage
•Maintenance
of the Bililed Maxi+ 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 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 physician according to the
patient's condition.
During jaundice treatment, the patient is placed in a heated baby bed or incubator depending on its clinical
condition. Bililed Maxi+ is designed for jaundice treatment in hospitals.
2.2.2.Patient Population
Bililed Maxi+ 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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NOVOS Bililed Maxi+ User Manual
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 Maxi+, 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:
-Hyperbilirubinemia treatment
-Kernicterus prevention
-Patients with light sensitivity disorders (e.g., congenital erythropoietic porphyria)
2.3.5.2. Counter Indications:
-Bronze baby syndrome
-Dehydration
-Hyperthermia
-Temporary skin redness

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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.
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 Maxi+ 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 photo isomers 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 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.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 (heated cradles, incubators, radiant heaters etc.) can cause the
patient's body temperature to reach dangerous limits when used with the Bililed Maxi+.
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 Maxi+ must comply with the IEC 60601 standard.
•Hospital guidelines and medical protocol must be followed when using the Bililed
Maxi+ with other devices.

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•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.
•All devices and accessories to be used with Bililed Maxi+ are under the
responsibility of the operator.
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 Maxi+ 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.

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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" 200VAC-
240VAC and 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.
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 Maxi+ Light Source
4
Trolley
2
Safety Lock
5
Wheels
3
Height Adjustment Screw
1
2
3
4
5

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3.2. Front View
1
Focus Button
6
Status Indicator LED
2
2x16 LCD Display
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)
4
White Phototherapy LED (4 in total)
2
Plastic Screw Head
5
Focusing LED
3
Ventouse
6
Air Ducts
6
5
1
2
3 4
5 6
7
8
9
10
1
2
3
4

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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.
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 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 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 and then simultaneously
pull the device out.
2
1

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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:
•Make sure the power adapter is connected to the device and to a suitable outlet.
The following steps should be followed to verify the electronic operation of the Bililed Maxi+™.
1. Observe if the Status Indicator LED is flashing red.
2. Press the “Power” switch located on the right side of the device.
3. Wait for the device to boot until the home screen appears.
4. Observe if the Status Indicator LED is flashing green.
5. Switch between the therapy light intensity levels with the "Down" and "Up" arrow buttons.
6. Press the "Focus" button and observe that the red focus LED lights up.
7. Enter the menu by pressing the "Confirm" button.
8. Go to "Therapy Time" option by pressing the "Down" arrow button once.
9. Enter the "Therapy Time Setting" mode by pressing the "Confirm" button.
10. Set the target 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 pressing the "Confirm" button.
14. Go to "Lamp Intensity" option by pressing the "Down" arrow button once.
15. Enter the "Lamp Intensity Setting" mode by pressing the "Confirm" button.
16. Activate the examination lamp by pressing the "Examination Lamp" button.
17. Adjust the examination lamp brightness using the "Up" and "Down" arrow buttons.
18. Save the set inspection lamp intensity by pressing the "Confirm" button.
19. Go to "Exit" option by pressing the "Down" arrow button once.
20. Return to the main screen by pressing the "Confirm" button.
21. Start therapy by pressing the "Therapy Start/Pause/Stop" button.
22. Observe if the Status Indicator LED is flashing blue.
23. Wait for a minute and confirm that the countdown timer is working properly.
24. Pause therapy by pressing the "Therapy Start/Pause/Stop" button.
25. Observe if the Status Indicator LED is flashing green.
26. Resume therapy by pressing the "Therapy Start/Pause/Stop" button again.
27. Observe if the Status Indicator LED is flashing blue.
28. Stop therapy by holding down the "Therapy Start/Pause/Stop".
29. Observe if the Status Indicator LED is flashing green.