novos Bilisphere 360 LED User manual

NVS.S9.KK07/Rev.07/26.10.2020
Bilisphere 360 LED
User Manual

NVS.S9.KK07/Rev.07/26.10.2020
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.
ATTENTION!
These are the guidance 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.KK07/Rev.07/26.10.2020
Table of Contents
1. Safety Information .......................................................................................................................................... 2
1.1. Symbols ........................................................................................................................................................ 2
1.2. Label Information......................................................................................................................................... 4
1.3. User Obligations for Patient Safety.............................................................................................................. 6
1.4. Patient Monitoring....................................................................................................................................... 6
1.5 Limitation of Liabilities................................................................................................................................. 6
1.6 Warranty...................................................................................................................................................... 7
2. Usage Purpose................................................................................................................................................. 8
2.1. Applications.................................................................................................................................................. 8
2.2. Target Users ................................................................................................................................................. 8
2.3. Patient Population........................................................................................................................................ 8
2.4. Usage limitations.......................................................................................................................................... 9
2.4.1. Warnings Regarding Indications, Contraindications, Possible Physiological Effects........................... 10
3. Parts and Controls......................................................................................................................................... 11
3.1. Isometric View............................................................................................................................................ 11
3.2. Front View.................................................................................................................................................. 12
3.3. Side View.................................................................................................................................................... 13
3.4. Control Panel.............................................................................................................................................. 14
3.4.1. Main Display........................................................................................................................................ 14
3.5. Temperature Sensors................................................................................................................................. 14
4. Preparation ................................................................................................................................................... 15
4.1. Unpacking and Installation......................................................................................................................... 15
4.2. Electronic Operation Control ..................................................................................................................... 18
5. Use of Device................................................................................................................................................. 26
5.1. Turning On Bilisphere 360 LED................................................................................................................... 26
5.2. Use of Control Panel................................................................................................................................... 28
5.2.1. Main Display........................................................................................................................................ 28
5.2.2. Alarms and Warnings .......................................................................................................................... 29
5.2.2.1. Alerts ...................................................................................................................................... 31
5.2.2.2. Audible Alarms Activation / Deactivation............................................................................... 32
5.2.3. Settings Menu ..................................................................................................................................... 33
5.2.3.1. Changing Display Language .................................................................................................... 33
5.2.3.2. Total Lamp Usage Time .......................................................................................................... 34
5.2.3.3. Changing the Temperature Unit............................................................................................. 34
5.2.3.4. Touch Screen Calibration........................................................................................................ 35
5.2.3.5. DEMO Mode........................................................................................................................... 37
5.3. Starting Therapy......................................................................................................................................... 39

NVS.S9.KK07/Rev.07/26.10.2020
5.4. Temperature Sensors................................................................................................................................. 45
5.4.1. Placing/Removing the Skin Probe ....................................................................................................... 46
5.5. Baby Bed .................................................................................................................................................... 47
5.5.1. Baby Cotwith Drainage........................................................................................................................ 47
5.5.2. Hammock ............................................................................................................................................ 48
5.5.2.1. Hammock Replacement ......................................................................................................... 48
5.6. Thermo-Elevation....................................................................................................................................... 49
5.6.1. Operation Principle ............................................................................................................................. 49
5.7. Manual Height Adjustment for the Upper Part.......................................................................................... 52
6. Routine Cleaning and Maintenance.............................................................................................................. 53
6.1. General Cleaning ........................................................................................................................................ 53
6.2. Cleaning Skin Probe.................................................................................................................................... 53
6.3. Maintenance .............................................................................................................................................. 54
6.3.1. Lamp Replacement.............................................................................................................................. 54
6.3.2. Hammock Replacement ...................................................................................................................... 54
7. Troubleshooting ............................................................................................................................................ 56
7.1. Fast Troubleshooting Guide ....................................................................................................................... 56
8. Annexes......................................................................................................................................................... 57
8.1. Technical Specifications ............................................................................................................................. 57
8.1.1. Environmental Conditions................................................................................................................... 57
8.1.2. Mechanical Properties ........................................................................................................................ 57
8.1.3. Electrical Properties ............................................................................................................................ 57
8.1.4. Radiation Properties............................................................................................................................ 57
8.1.5. Other Properties.................................................................................................................................. 58
8.2. Compatibility .............................................................................................................................................. 58
8.2.1. Compliance Directive: ......................................................................................................................... 59
8.2.2. Guidance and Manufacturer's declaration - Electromagnetic Emissions............................................ 59
8.2.2.1. Electromagnetic Environment................................................................................................ 59
8.2.2.2. Electromagnetic Immunity ..................................................................................................... 60
8.2.2.3. Recommended Separation Distance ...................................................................................... 63
8.3. Trademark Registrations ............................................................................................................................ 63
8.1. Manufacturer ............................................................................................................................................. 63

2
NVS.S9.KK07/Rev.07/26.10.2020
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 BF 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.
Do not place hand here!
Attention: There is a risk of electric shock
Wear eye patch!
ID
Product ID.
Manufacturer.

NOVOS Bilisphere 360 LED User Manual
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NVS.S9.KK07/Rev.07/26.10.2020
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.
Fuse Box
Grounding
CE mark Authorized body
See User Manual
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.

NOVOS Bilisphere 360 LED User Manual
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NVS.S9.KK07/Rev.07/26.10.2020
1.2. Label Information
Product
Identity
Technical
Service
Warning

NOVOS Bilisphere 360 LED User Manual
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NVS.S9.KK07/Rev.07/26.10.2020
Outer Box
Label
Reusable
Skin Probe
Label

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NVS.S9.KK07/Rev.07/26.10.2020
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.

NOVOS Bilisphere 360 LED User Manual
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NVS.S9.KK07/Rev.07/26.10.2020
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 Medical Devices are possible. NOVOS
Medical Devices reserves the right to apply one of the methods specified above, that is
deemed appropriate based on the warranty claim.
5. NOVOS Medical Devices 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 notice of the failure of the device or part must be received by NOVOS or authorized
factory center 2 weeks before the end of the warranty period.
The above provisions belong to the sole warranty which is applicable and providedby 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