DENTIS LUVIS L200 User manual

Please read this USER’S MANUAL before operating this equipment.
Global TOP 10 in Healthcare
LUVIS L200 USER’S MANUAL
(V2.2) Mar/12/2018
Major Surgical Luminaire
DENTIS CO., LTD.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
Tel. [phone] FAX. [phone] www.dentis.co.kr / www.luvis.co.kr

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CONTENTS
1. Standard ..................................................................................................................................................................................... 4
2. Warning ...................................................................................................................................................................................... 5
3. Symbol......................................................................................................................................................................................... 7
4. Introduction .............................................................................................................................................................................. 9
4.1 Intended use ....................................................................................................................................................................... 9
4.2 General description ........................................................................................................................................................ 10
4.3 Environmental requirement ......................................................................................................................................... 11
4.4 Safety information .......................................................................................................................................................... 11
4.5 Warranty regulation ....................................................................................................................................................... 12
4.6 Electromagnetic Compatibility .................................................................................................................................... 12
5. LIGHTHEAD specification ................................................................................................................................................. 16
5.1 Technical specification (In accordance with IEC 60601-2-41) .............................................................................. 16
5.2 Electrical specification (In accordance with IEC 60601-1) .................................................................................... 17
5.3 Mechanical specification .............................................................................................................................................. 17
5.4 Internal Camera(optional) specification ................................................................................................................... 18
6. USE ............................................................................................................................................................................................. 19
6.1 ARM CONTROLLER.......................................................................................................................................................... 19
6.2 HANDLE TOUCH CONTROLLER..................................................................................................................................... 20
6.3 WALL CONTROL BOX(optional) .................................................................................................................................... 21
6.4 Controlling the INTERNAL CAMERA(optional) ......................................................................................................... 22
6.5 Positioning ........................................................................................................................................................................ 23

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6.6 MAIN HANDLE ................................................................................................................................................................. 24
6.7 Mobile Type...................................................................................................................................................................... 25
6.8 BATTERY PACK .................................................................................................................................................................. 26
7. Performance characteristic .............................................................................................................................................. 26
7.1 L200 LIGHTHEAD on the SPRING ARM(STD) ............................................................................................................ 27
7.2 OperOperating range of HEAD ARM .......................................................................................................................... 27
8. Sterilization and Cleaning ............................................................................................................................................... 28
8.1 Sterilization....................................................................................................................................................................... 28
8.2 Cleaning............................................................................................................................................................................. 28
9. Maintenance .......................................................................................................................................................................... 29
10. Troubleshooting................................................................................................................................................................. 30
11. Disposal ................................................................................................................................................................................. 32
12. Model designation ........................................................................................................................................................... 33
13. List of component ............................................................................................................................................................ 35
14. Manufacturer and Factory ............................................................................................................................................ 37
15. Europe Representative.................................................................................................................................................... 38
“WARNING: Modification of this equipment is not allowed”

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1. Standard
Ÿ Certification of DENTIS
• ISO 9001:2008
• EN ISO 13485:2012
• Relevant EC Directives: 93/42/EEC Medical Device Directive as amended by
2007/47/EC, Annex I and Annex VII.
Ÿ Applied Standards:
• EN ISO 15223-1:2012, Medical devices – Symbols to be used with medical device
labels, labelling and information to be supplied
• EN 1041:2008, Information supplied by the manufacturer with medical devices
• EN ISO 13485:2012, Medical devices – Quality management systems – Requirements
for regulatory purpose
• EN ISO 14971:2012, Medical devices – Application of risk management to medical
devices
• IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General
requirements for safety
• EN 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements
for safety - Collateral standard: Electromagnetic compatibility – Requirements and
tests
• EN 60601-1-6:2010, Medical electrical equipment-Part 1-6: General requirements for
safety – Collateral Standard: Usability
• EN ISO 7010:2012, Graphical symbols – Safety colors and safety signs-Registered
safety signs
• EN 62471:2008, Photo biological safety of lamps and lamps systems
• EN 62366:2008, Medical devices – Application of usability engineering to medical
devices
• IEC 60601-2-41:2009, Medical electrical equipment – Part 2-41: Particular
requirements for the basic safety and essential performance of surgical luminaires
and luminaires for diagnosis
• IEC 62133:2012, Secondary cells and batteries containing alkaline or other non-acid
electrolytes – Safety requirements for portable sealed secondary cells, and for
batteries made from them, for use in portable applications
• IEC 62304:2006, Medical device software, Software life-cycle processes

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2. Warning
WARNING
The instructions given in this document must be followed when handling the
product. Failure to do so may endanger the safety of the installers or users.
As well as specific information on operating the entire product and conducting
preventive maintenance, are provided in the USER’S MANUAL. For further
information, please contact our sales network or our local network.
WARNING
The electrical connections must be performed by a qualified technician only.
The Lithium Battery replacement must be performed by a qualified technician only.
The electrical installation must be planned, performed and inspected by electrical
engineers.
WARNING
The LIGHTHEAD is designed to operate using a AC 100-240V, 50/60Hz. Higher or
lower voltages may affect the light intensity and operating life of the LEDs.
WARNING
Damaged wire insulation may result in the risk of electric shock.
To protect against the risk of electrocution, connect the power cables carefully.
WARNING
Major Surgical Luminaire(LUVIS L200) is class I equipment. In order to avoid the risk
of an electric shock, the equipment must be connected to a mains supply with
PE(protective earth).
WARNING
A main control switch must be installed for turning the system power-off.
WARNING
The power supplies may be installed and connected only by an electrician or a
DENTIS authorized service agent.
WARNING
This product may only be repaired and special assembly work may only be carried
out by DENTIS or a company that has been authorized by DENTIS.
WARNING
Check the polarity of all electrical connections before turning on the power.

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WARNING
Electromagnetic waves discharged from MRI can cause malfunction of this product.
Please keep away any device that can influence this product.
WARNING
The LIGHTHEAD must be connected to a backup power supply(BATTERY PACK or
UPS).
Always should be checked Battery capacity level before use by pressing the BATTERY
CHECK BUTTON. A backup lifetime of a BATTERY PACK or UPS should be greater than
3 hours on power cut condition
WARNING
DENTIS is not responsible for the customer’s backup power supply.(BATTERY PACK
or UPS)
WARNING
Take care when handling the circuit boards: these boards are supplied in an
electrostatic envelope and must be handled with great care.
WARNING
Do not look directly into light source(LED).
WARNING
The LIGHTHEAD brakes are adjusted during installation. Like all mechanical parts,
the brakes are subject to wear.
Read just the brakes if the LIGHTHEAD no longer remains steady in any position.
Check the condition of the mounting surface.
WARNING
The operation and safety of the device may be affected by the removal of certain
components during servicing operations.
WARNING
All the information in this manual has been checked out carefully and discerned as
accurate one at the time of publication.
However, DENTIS takes no responsibilities of the results caused by default, omission,
or misuse of it.
WARNING
DENTIS has rights to modify the product itself or specifications of the product
without any prior notice, as well as rights not to renew that modification on this
manual.

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3. Symbol
Ÿ The following symbols are used in the equipment and/or in this manual.
Symbol
Meaning
CE label
The device bears the CE mark and complies with the requirements of
European Directive 93/42/EEC Medical Device Directive as amended by
2007/47/EC, Annex I and Annex VII.
Medical general medical equipment as to electrical shock, fire and mechanical
hazards only in accordance with ANSI/AAMI ES60601-1 & CAN/CSA-C22.2 NO.
60601-1] <E473884>
☞
Recommendation sign
Protective earth (ground)
Alternating current
Off (power: disconnect to the mains)
On (power: connection to the mains)
Do not throw away with general household waste
Warning sign
Risk of electric shock
Instruction for user manual
Operating instructions
General mandatory action sign
General prohibition sign
Keep dry symbol
DO NOT Hand Hooks symbol

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Fragile symbol
This side up
Handle with care symbol
Do not build up more than 5 boxes
Manufacture
Europe Representative
Manufacture Date
Temperature between 0˚C ~ 40˚C
Humidity between 0%RH ~ 80%RH

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4. Introduction
4.1 Intended use
Ÿ Major Surgical Luminaire (L200) is intended to be used to provide visible illumination
of the surgical area or the patient during surgical operations, diagnosis and
treatment.
Ÿ Classification under the provision of 93/42/EEC(MDD) : Class I
- Major Surgical Luminaire (L200) is classified as a Class I device.
Ÿ Classification under the provision of FDA (U.S. Food and Drug Administration) : Class II
- Major Surgical Luminaire (L200) is classified as a Class II(exempt) device.
Ÿ Form of protection against electric shock : Class I
- Major Surgical Luminaire (L200) is classified as Class I
Ÿ Degree of protection against flammability
- Major Surgical Luminaire (L200) is classified as a device not suitable to be used in a
potentially flammable environment.
- Do not use near flammable materials.
Ÿ Method(s) of sterilization or disinfection recommended by the manufacturer
- The SIDE HANDLE should be cleaned with cloths, and the MAIN HANDLE should be
sterilized with sterilizer regularly to prevent disinfection.
Ÿ Mode of operation
- Classification of Major Surgical Luminaire: continuous operation.

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4.2 General description
Ÿ The user must ensure that that the device works properly and is in a satisfactory
condition before each use.
Ÿ This DENTIS device is intended only for use in the field of medical. It is impermissible
to use the device for a purpose for which it was not intended.
Ÿ “Proper Use” includes following all the instructions for use and ensuring that all
inspections and service tasks are performed.
Ÿ Apply and meet the overarching guidelines and/or national laws, national regulations
and the rules of technology for medical devices applicable for startup and use of the
device for the intended purpose.
Ÿ The user must observe the following:
- Only use properly operating equipment.
- Protect himself or herself and third parties from danger.
- Avoid contamination from the device.
Ÿ During use, the following national regulations must be observed:
- The applicable health and safety regulations.
- The applicable accident prevention regulations.
Ÿ To ensure that device maintains their value and are always ready for use, they must
be serviced once a year as recommended.
Ÿ Before using the products, You must receive training by authorized person of the
DENTIS.
Ÿ The safety checks must be performed every year.
Ÿ Repair and service of the device is authorized only to those who meet the
requirements below:
- Technicians of authorized dealers specially trained by DENTIS.
- The trained technicians of DENTIS branches.

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4.3 Environmental requirement
Ÿ Conditions of the usage environment
ž Temperature : 0 ºC - 40 ºC
ž Humidity : R.H. 30 % - R.H. 90 %
ž Atmospheric pressure: 0 - 2,000 m (106 – 80 Kpa)
Ÿ Conditions of the transportation environment
ž Temperature : 0 ºC - 40 ºC
ž Humidity : R.H. 0 % - R.H. 80 %
4.4 Safety information
Ÿ Major Surgical Luminaire (L200) as a medical device complies with the safety
regulation IEC/EN 60601-1.
Ÿ Accessory equipment connected to the analog and digital interfaces must be
certified according to the respective IEC/EN standards (e.g. IEC/EN 60601-2-41 for
data processing equipment and IEC/EN 60601-1 for medical equipment).
Ÿ Furthermore all configurations shall comply with the system standard EN 60601-1-
2:2001. Everybody who connects additional equipment to the signal input part or
signal output part configures a medical system, and is therefore responsible that the
system complies with the requirements of the system standard EN 60601-1-1:2001.
Ÿ If in doubt, consult the technical service department or your local representative.
Ÿ For EU Countries
∙ The following mark, the name & address of the EU Representative shows compliance
of the instrument with Directive Council Directive 93/42/EEC of 14 June 1993 as
amended by Directive 2007/47/EC concerning medical devices.
∙ Europe Representative
CALMED INVEST Kft.
1191 Budapest, Attila utca 34.,
Budapest, Hungary
Ÿ Safety is everyone’s obligation and responsibility.
Ÿ The safe use of this product is related to everyone such as installer, user, operator

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and equipment’s manager.
Ÿ It must read and learn this user’s manual is compulsory before installation, using,
cleaning, fixing or operation of this product or its accessories. Pay particular
attention and be familiar with warning symbols about safety.
Ÿ If do not follow safety direction of this manual, you can get injured or accident when
you operate this product. After read carefully and understand this manual, use this
product.
Ÿ This manual is in keep a place where you can find easily.
4.5 Warranty regulation
Ÿ DENTIS warrants all products against defects in materials or workmanship for one
year from time of delivery.
Ÿ DENTIS’s sole obligation under the warranty is to provide parts for the repair, or at its
option, to provide the replacement product (excluding labor).
Ÿ The buyer shall have no other remedy. All special, incidental, and coincidental
damages are excluded.
Ÿ Written notice of breach must be given to DENTIS within the warranty period.
Ÿ The warranty does not cover damage resulting from improper installation or
maintenance, accident or misuse.
Ÿ The warranty does not cover damage resulting from the use of cleaning, disinfecting
or sterilization chemicals and processes.
Ÿ The Failure to follow instructions provided in the DENTIS Instructions for Use
(operation and maintenance instructions) may void the warranty.
Ÿ LED PCB is covered under 50,000 hours warranty.
4.6 Electromagnetic Compatibility
Ÿ Guidance and manufacturer’s declaration - Electromagnetic emissions
The L200 is intended for use in the electromagnetic environment specified below. The customer or
the user of the L200 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Complies
(Group 1,
Class A)
The L200 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.

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Harmonic
emissions
IEC 61000-3-2
Complies
The L200 is suitable for use in all establishments other than
domestic premises and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Ÿ Guidance and manufacturer’s declaration - Electromagnetic immunity
The L200 is intended for use in the electromagnetic environment specified below. The customer or
the user of the L200 should assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for
input/output
lines
± 2 kV for power
supply lines
N/A
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-
11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the L200 requires
continued operation during
power mains interruptions, it is
recommended that the L200
be powered from an
uninterruptible power supply or
a battery.
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial
or hospital environment.
NOTE UT is the AC mains voltage prior to application of the test level.

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Ÿ Guidance and manufacturer’s declaration - Electromagnetic immunity
The L200 is intended for use in the electromagnetic environment specified below. The customer or
the user of the L200 should assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the L200, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in
each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the L200 is used exceeds the applicable RF compliance level above,
the L200 should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the L200.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

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Ÿ Recommended separation distances between portable and mobile RF
communications equipment and the L200
The L200 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the L200 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the L200 as recommended below, according
to the maximum output power of the communications equipment.
Rated
maximum
output
power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
  
  
80 MHz to 800 MHz
  
  
800 MHz to 2,5 GHz
  
  
0,01
0,12
0,12
0,23
0,1
0,37
0,37
0,74
1
1,17
1,17
2,33
10
3,69
3,69
7,38
100
11,67
11,67
23,33
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

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5. LIGHTHEAD specification
5.1 Technical specification (In accordance with IEC 60601-2-41)
Ÿ STANDARD SPECIFICATION
Specifications
Unit
LUVIS L200
Remark
Normal Mode
Central illuminance Ec (@1m)
lx
160,000
Electronic adjustment range
%
25 ~ 100
Light field diameter d10
Cm
20 ~ 30
Light field diameter d50
Cm
12 ~ 18
Diameter d50/d10
N/A
> 0.55
Depth of illumination at 20%
Cm
150
Depth of illumination at 60%
Cm
85
Color temperature (3 levels)
K
3,800/4,300/4,800
Color rendering index Ra
N/A
95
Special color rendering index R9
N/A
90
Shadow dilution
With tube
%
98
With one mask
%
75
With two mask
%
60
With one mask, at base of tube
%
70
With two mask, at base of tube
%
56
Radiation energy
mW/㎡·lx
3.49
Illumination energy(Ee)
W/㎡
546.7
Endo Mode
Illumination
lx
8,000
Ec * 5%
* Optical values are measured with a tolerance of ±10%

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5.2 Electrical specification (In accordance with IEC 60601-1)
Ÿ SMPS TECHNICAL DATA
Content
Single LIGHTHEAD
Dual LIGHTHEAD
Input
AC 100 – 240 V, 50/60 Hz
(1.8/0.8 A typical at AC 115/230 V
full load)
AC 100 – 240 V, 50/60 Hz
(1.8/0.8 A typical at AC 115/230 V
full load) x 2
Output
DC 28 V, 6.4 A
DC 28 V, 6.4 A x 2
Ÿ RATING
Content
Rating
Remark
L200
LIGHTHEAD
AC 100 – 240 V, 67 VA, 50/60 Hz
Single LIGHTHEAD, without camera
AC 100 – 240 V, 74 VA, 50/60 Hz
Single LIGHTHEAD, with camera
BATTERY PACK
DC 14.8 V, 26 Ah
Lithium-ion Battery
5.3 Mechanical specification
Specifications
Length(mm)
Weight(kg)
Remark
CEILING COVER
600
1.0
CEILING TUBE
Φ300/300
19.2
CENTRAL AXIS
2Fold (850/700)
25.3
1Fold (850)
14.8
SPRING ARM
860
6.5
AC2000 STD(3Axis)
860
5.3
AC2000 NRH(2Axis)
860
6.5
AC2000 Mobile(2Axis)
LIGHTHEAD L200
660 x 660
17.5 (18.5)
3Axis
(Internal Camera : 1kg)

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660 x 660
14.8
2Axis
MOBILE ARM
-
28.4
Except SPRING ARM
BATTERY PACK
L x W x H :
244 x 164 x 120
3.8
* SPRING ARM Type of Internal Camera : AC 2000(W/S)
5.4 Internal Camera(optional) specification
Content
Specifications
REMARK
Image Sensor
1/2.8 type Exmor CMOS
SONY BLOCK CAMERA
Zoom Ratio
10X Optical
Image Point
Approx. 2.38 Megapixels
Min. Object Distance
10mm to 800mm
Video System
1080p/30
Video Output Signal
3G HD-SDI SMPTE 424M,
HD-SDI 292M
75Ω BNC

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6. USE
6.1 ARM CONTROLLER
Ÿ The LIGHTHEAD can be controlled using the ARM CONTROLLER
FUNCTION
LUVIS L200
On/Off button
(Standby)
• Press to turn on, press and hold (2
Second) to turn off.
• The light turns on, at the last illumination
level stored in its memory.
• Factory set to 100% illumination.
Level adjustment for
the selected function
• Press repeatedly to change levels
• Touch panel & LED indicator
• Six illumination levels
• Six light field diameter levels
• Three color temperature levels
3,800K / 4,300K / 4,800K
Maximum mode
• Illumination : Level 6
• Light field diameter : Level 6
• Color temperature : 4,300K
ENDO mode
• Toggles from NORMAL mode to ENDO
mode or vice versa.
Sensor On/Off button
• 4-sensor operating mode
• Dilution effect up-grade
1 Mask(10%↑) / 2 Mask(20%↑)

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6.2 HANDLE TOUCH CONTROLLER
Ÿ The LIGHTHEAD can be controlled using the HANDLE TOUCH CONTROLLER
The control panel of the HANDLE TOUCH CONTROLLER
LUVIS L200
①
Light field diameter
level down button
Ÿ The light field diameter decreases.
②
Light field diameter
level up button
Ÿ The light field diameter increases.
③
Illumination level
button
Ÿ The illumination level can be changed
(Rotation)
1 → 2 → 3 → 4 → 5 → 6 → 1 → 2…