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.

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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

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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

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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.

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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.

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1.2. Label Information
Product
Identity
Technical
Service
Warning

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Outer Box
Label
Reusable
Skin Probe
Label

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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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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

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2.Usage Purpose
2.1. Applications
BİLİSPHERE 360 LED™ 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 needs a thermotherapy device and is placed in a heated baby
bed or incubator depending on its clinical condition. Considering these situations, NOVOS developed
the BİLİSPHERE 360 phototherapy. The aim is to provide maximum patient comfort and shorten the
treatment time during treatment.
BİLİSPHERE 360 LED is a versatile phototherapy, especially recommended for rapid decrease in serum
bilirubin level, thus reducing the need for blood exchange and treatment time.
The expected lifetime of the Bilisphere 360 LED™ device is 10 years.
2.2. 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.
2.3. Patient Population
Bilisphere 360 LED is used in the treatment of babies between 0-28 days postnatal and for preterm
babies whose adjusted age is 52 weeks.

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2.4. Usage limitations
WARNING!
BİLISPHERE 360 LED will be ready to work
only when all the controls are successfully
implemented.
WARNING!
This device is designed for use only in
rooms with line powered installations that
comply with national safety standards for
hospital patient rooms (eg IEC / EN 60601-
1, "Safety of Medical Devices"). To maintain
ground integrity, connect only to a
"hospital grade" plug socket.
WARNING!
Use of this device requires constant
supervision of the baby by trained nursing
personnel to provide immediate corrective
action in situations where there is a risk of
patient injury.
WARNING!
HAZARD! There is a risk of explosion if used
in the presence of flammable anesthetics.
This device has not been approved or
documented for use in areas where
flammable or explosive gas mixtures are
likely.
WARNING!
Cell phones should not be used at 10
meters near the incubator. Cell phones may
impair the functions of the electromedical
device and thus patient safety may be
compromised
WARNING!
NOVOS medical equipment conforms to the
requirements for interference immunity
specified in product specific standards or
EN 60601-1-2 (IEC 60601-1-2). However,
depending on the design and use of the
mobile phone, field strengths exceeding the
specified standard values may be generated
near the phone. Thus, it can cause
interference and malfunctions.
WARNING!
BİLİSPHERE 360 LED intensive
phototherapy does not replace an
incubator and / or any warmer.
WARNING!
NOVOS cannot guarantee or approve the
safety performance of third-party
accessories used with BİLİSPHERE 360 LED
phototherapy. Use only original NOVOS
accessories and parts with the BİLİSPHERE
360 LED™. Unauthorized use of parts and
accessories may result in serious harm to
the patient.
WARNING!
Side plexiglass protectors of Bilisphere 360
LED should always be installed in normal
operating condition. Otherwise, there is a
risk of injury for the patient during manual
height adjustment.

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2.4.1.Warnings Regarding Indications, Contraindications, Possible Physiological Effects
•Indications
Hyperbilirubinaemia treatment
Kernicterus prevention
Patients with light sensitivity disorders (e.g. congenital erythropoietic porphyria)
•Counterindications
Bronze baby syndrome
Dehydration
Hyperthermia
Temporary skin redness
•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 BS360 LED 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 BS 360 LED device, and this area may
become brighter. This is due to the intense effect of light on the bilirubin pigment
deposited on the skin.

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3.Parts and Controls
3.1. Isometric View
1
Control Panel
5
IV Pole (Optional)
2
Baby Bed Handle
6
Monitor Tray
3
Height Adjustment Membrane Switch
7
Side Handle
4
Wheels with brake
8
Power Input, Fuse Holder, On/Off Switch
5
6
7
8
1
2
3
4

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3.2. Front View

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3.3. Side View

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3.4. Control Panel
3.4.1.Main Display
Bilisphere 360 LED has a 5.1” single-color touch screen. On this screen;
•Air temperature
•Skin temperature
•Therapy Time
•Set Therapy Time
•Fan Conditions
•Upper and Lower Skin Temperature Limits
•Alarms can be seen simultaneously.
3.5. Temperature Sensors
Air and skin temperatures are measured with the corresponding sensors shown below.
1) Skin Temperature Probe
2) Air Temperature Probe

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4.Preparation
4.1. Unpacking and Installation
Bilisphere 360 LED is packaged in two main groups as main body and accessories. It includes
accessory box, hammock, monitor tray, power cord, IV pole (optional) and eye protection mask.
After you receive the package, complete the installation by following the steps below.
•Unpack and set the main body aside.
•Open the accessories box.
Set aside the following:
omonitor tray
opower cord
oIV Pole (Optional)
oeye protection
patches
•Align the monitor tray in place.

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•Install 4 pieces of M4x12 YHB
screws.
•Install the white screw caps.
•Slide and open the baby bed
drawer.

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•Place the hammock.
•Place the IV pole in place and tighten the plastic head screw to secure it in the desired position.