CEFLA VENUS PLUS User manual

VENUS PLUS
97055152
rev.1
2021-04
Cefla s.c. Via Selice Provinciale 23/A - 40026 IMOLA (BO) - ITALY
PLANT: Via Bicocca 14/C - 40026 IMOLA (BO) - ITALY
EN

3EN
OPERATOR’S MANUAL
TABLE OF CONTENTS
1. GENERAL WARNINGS ................................................................................................................... 4
1.1. SYMBOLS........................................................................................................................................ 4
1.2. INTENDED USE.............................................................................................................................. 5
1.2.1. CLASSIFICATION........................................................................................................................... 5
1.2.2. ENVIRONMENTAL CONDITIONS................................................................................................. 5
1.2.3. WARRANTY .................................................................................................................................... 5
1.3. SAFETY WARNINGS ..................................................................................................................... 6
1.4. DISPOSAL AT THE END OF LIFE................................................................................................. 6
1.5. APPLIED PARTS ............................................................................................................................ 7
2. EQUIPMENT DESCRIPTION ........................................................................................................... 7
2.1. IDENTIFICATION PLATE............................................................................................................... 8
3. OPERATION ..................................................................................................................................... 9
3.1. SWITCH-ON / SWITCH-OFF ......................................................................................................... 9
3.2. BRIGHTNESS ADJUSTMENT....................................................................................................... 10
3.3. CHANGING OPERATING MODE AND COLOUR TEMPERATURE........................................... 11
3.4. REMOVING THE HANDLES........................................................................................................ 12
4. CLEANING AND DISINFECTION .................................................................................................. 13
4.1. CLEANING AND DISINFECTION INSTRUCTIONS...................................................................................... 13
5. MAINTENANCE ............................................................................................................................. 14
5.1 REMOVING THE TRANSPARENT SCREEN............................................................................................... 14
5.2. REPLACING THE BULB .............................................................................................................. 15
6. DATA SPECIFICATIONS ............................................................................................................... 16
6.1. TECHNICAL SPECIFICATIONS.................................................................................................. 16
6.2. DIMENSIONAL FEATURES......................................................................................................... 18
7. TROUBLESHOOTING ................................................................................................................... 21
8. TECHNICAL SERVICE .................................................................................................................. 22

4
1
2
4
5
6
3
135°C
10
11
12
9
13
7
14
15
8
OPERATOR’S MANUAL
EN
1. GENERAL WARNINGS
• These instructions explain how to correctly use the following operating lights:
VENUS PLUS (code 96601020, 96601072)
VENUS PLUS L version (code 96601060, 96601071)
VENUS PLUS MCT version (code 96601069, 96601070)
VENUS PLUS E version (code 96601090)
VENUS PLUS CL version (code 96601024)
VENUS PLUS CL -L version (code 96601063)
VENUS PLUS CL MCT version (code 96601080)
Read this manual thoroughly before using the device.
• The devices described in this manual are manufactured by CEFLA s.c. - via Selice Provinciale 23/A - 40026
Imola (BO) Italy, a manufacturer complying with the European Directive on medical devices.
• All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted
in any form or by any means, electronic, mechanical, photocopying, recording, translation, or otherwise,
without the prior written permission of the manufacturer.
• Themanufacturerhasacompanypolicyofcontinualdevelopment.Althougheverye󰀨ortismadetokeep
technicaldocumentationup-to-dateatalltimessomeoftheinstructions,specicationsandguresgivenin
thismanualmayslightlydi󰀨erfromthepurchasedproduct.Themanufacturerreservestherighttomake
changes without prior notice.
• The original text is in Italian; translation from the original in Italian.
• For operators in Europe: it is necessary to report any serious incident that occurred in relation to the equipment
toCeas.c.andtothecompetentauthorityoftheMemberStatewheretheuserand/orpatientislocated.
1.1. SYMBOLS
Note the meaning of the following symbols and
expressions:
1) Degree of protection against direct and indirect
contact with the applied part: Type B.
2) Type of protection against direct and indirect
contact: CLASS II.
3) WARNING!
It indicates a condition in which the failure to
observe the instructions may result in equipment
damage or injury to the user and/or patient.
4) NOTE:
Identiesinformationthatisespeciallyimportant
for the user and/or the assistant.
5) Alternating current.
6) Part that can be sterilized in an autoclave up to
135°C.
7)
8)
ON / OFF control.
Equipment compliant with Regulation (EU)
2017/745 on Medical Devices.
9) Disposal symbol in accordance with Directive
2012/19/EU.
10) Manufacturer.
11) Equipment date of manufacture.
12) Product/equipmentidenticationcode.
13) "Refer to the instruction manual"
Means that for reasons of safety you need to
consult the instruction manual before using the
equipment.
14) Medical device.
15) The operator’s manual is provided in electronic
format.

5EN
OPERATOR’S MANUAL
1.2. INTENDED USE
• The operating light is part of a dental surgery equipment and is used to illuminate the operating area.
• The operating light is designed for continuous operation.
• DEVICE FOR PROFESSIONAL USE: the use of the device is strictly reserved to qualied dental
professionals. Under no circumstances it can be used or handled by unskilled and/or unauthorised
persons.
1.2.1. CLASSIFICATION
• MEDICALDEVICESclassication
EquipmentclassicationaccordingtotherulessetoutinAnnex VIII of Reg. (EU) 2017/745: Class I.
• ELECTRICALMEDICALEQUIPMENTclassication.
 ClassicationofthedentalunitinaccordancewithstandardIEC60601-1onsafetyofmedicalequipment:
- VENUS PLUS / VENUS PLUS -L version / VENUS PLUS MCT version / VENUS PLUS E version:
Class II - Type B.
- VENUS PLUS CL version / VENUS PLUS CL -L version / VENUS PLUS CL MTC version:
Class I - Type B.
• PHOTOBIOLOGICALSAFETYclassication.
 • ClassicationoftheequipmentinaccordancewithstandardsEN62471:2008andIEC62471:2006:
- VENUS PLUS -L version / VENUS PLUS CL -L version / VENUS PLUS CL MCT version / VENUS PLUS
Eversion:Riskgroup1.
1.2.2. ENVIRONMENTAL CONDITIONS
The equipment is to be installed in rooms that satisfy the following requirements:
• temperature: +5 to +40° C;
• relative humidity from 25 to 75% (non-condensing);
• atmospheric pressure ranging from 700 to 1060 hPa;
• the electric system in the room in which the equipment is installed must conform to IEC 60364-7-710 V2
(standards for electric systems in medical and dental surgeries) or equivalent standards in force in the
country where the equipment is installed.
1.2.3. WARRANTY
The manufacturer stands behind its products warranting safety, reliability and performance.
The warranty is valid only under the following terms:
• Conditionsgivenonthewarrantycerticateareobserved.
• Yearly scheduled maintenance is performed.
• The equipment is only to be used as instructed in this manual.
• Equipment installation, expansion and technical support must be performed exclusively by personnel
authorised by the manufacturer to carry out these operations.
• The equipment must be installed only in rooms that follow the requirements specied in paragraph
“Environmental conditions”.

6
OPERATOR’S MANUAL
EN
1.3. SAFETY WARNINGS
WARNING!
• Equipment installation, expansion and technical support must be performed EXCLUSIVELY by personnel
authorised by the manufacturer to carry out these operations.
• Thedentallightmustbeinstalledonaspeciccontrolandpowersupplydevice,suchasadentalunit,orwith
an electric system that complies with the standard IEC 60364-7-710;V2 (i.e. the regulations concerning the
electric systems to be used in surgeries) or equivalent standards in force in the country where the equipment
is installed.
The contacts of the double pole power switch must be at a distance from each other of at least 3mm (as
required by standard I.E.C. 60601-1). The switch must comply with standards I.E.C. 61058-1, 60447 or other
standards in force at the place of installation.
 Werecommendtheuseofathermal-magnetic/di󰀨erentialcircuitbreakerwiththefollowingcharacteristics:
 -di󰀨erentialsensitivity=0.03A;
- distance between contacts of at least 3 mm;
- contact capacity: 250V 6A (curve c).
• Toavoidtheelectricshockrisk,theceilinglightsmustbeconnectedonlytoapowersupplynetworkwith
protective earthing system.
• Theequipmentmustonlybeusedbyauthorisedandadequatelytrainedsta󰀨 (dentists and paramedics).
• Carry out only the operations described in this manual; contact the Technical Service in any other case.
• Do not apply any weight on any point of the equipment and act on it only with the force necessary to move
it.
• Thisequipmentmustbestoredproperlysothatitiskeptintopworkingorderatalltimes.
The manufacturer shall not be held responsible (under civil and criminal law) for misuse, carelessness or
improper use of the equipment.
• An operator must always be present when the light is on, in particular, it should not be left unattended in the
presence of minors/incapacitated subjects or in general persons not authorised for use.
• Do not carry out any maintenance operation on the equipment when the power is on. Cut the power before
carrying out any operation on the light.
• The dental unit is not protected against liquid penetration (IPX0).
• Theequipmentisnotsuitableforuseinthepresenceofamixtureofammableanaestheticgaswithoxygen
or nitrous oxide.
• Thecleaningoperationsmustbecarriedoutwiththelighto󰀨andatroomtemperature.
• Do not spray detergent liquid directly onto parts of the optical unit.
• Do not leave small parts of the equipment unattended or within reach of exposed people (children) as they
are potential sources of danger.
• Do not apply protections, not even transparent ones, on the optical unit, as they may obstruct the fan air
intakesandoutletsatthetransparentscreen.
• Do not remove the transparent screen while the light is in operation.
• Donotforgettoturno󰀨themainswitchontheequipmentbeforeleavingthesurgery.
• The device is supplied NON-sterile.
• Do not point the light beam in the direction of the eyes.
• Thedevicecangenerateasmallelectromagneticeld,therefore,itisadvisabletopayattentionwhenusing
itinproximityoflifesupportequipment(e.g.pacemakersorheartstimulators)accordingtothespecications
included in the user manual of such equipment.
• It is forbidden to tamper with the device, even in the event of a malfunction.
1.4. DISPOSAL AT THE END OF LIFE
In compliance with Directives 2011/65/EU and 2012/19/EU regarding restriction of the use of certain hazardous
substances in electrical and electronic equipment as well as waste electrical and electronic equipment, it is
forbidden to dispose of this equipment in the municipal waste stream as unsorted municipal waste.
When purchasing a new device of an equivalent type, one for one, the device that has come to the end of
its lifetime should be returned to the dealer for disposal.
As regards reuse, recycling and other forms of recovery of waste electrical and electronic equipment, the
manufacturercarriesoutthefunctionsdenedbycurrentlocallaws.
Appropriatedi󰀨erentiatedwastecollectionforsubsequentrecyclingtreatmentandenvironmentallyfriendly
disposalcontributestopreventingpossiblenegativee󰀨ectsontheenvironmentandhealthandencourages
recycling of the materials of which the device is made up.
The symbol indicating separate collection for electrical and electronic equipment consists of the crossed out
binmarkedontheequipment.
NOTE: Disinfect the device before disposal because of the risk of cross-contamination.
WARNING!
Underlocallegislation,nescanbeimposediftheequipmentisdisposedinanillegalmanner.

7
e
d
a
b
c
c
e
b
fd
a
e
d
a
c
k
c
a
d
k
EN
OPERATOR’S MANUAL
1.5. APPLIED PARTS
The parts of the equipment which may come into
contact with the patient during operation are the front
panels of the light.
2. EQUIPMENT DESCRIPTION
Equipment description.
VENUS PLUS, VENUS PLUS CL version light
body:
a) Optical unit.
b) Transparent screen.
c) Removable handles suitable for cold sterilization.
d) ON switch.
e) Brightnessadjustmentknob.
VENUS PLUS -L version, VENUS PLUS CL -L
version light body:
a) Light source consisting of 2 multichip LEDs.
c) Removable handles sterilizable inside autoclave.
d) ON switch.
e) Brightnessadjustmentknob.
k) NOTOUCHsensorforturningonandbrightness
adjustment.
VENUS PLUS MCT version, VENUS PLUS CL
MCT version light body:
a) Light source consisting of 6 LEDs.
b) Removable handles sterilizable inside
autoclave.
c) Brightnessadjustmentknob.
d) NO TOUCH sensor for turning on and
brightness adjustment.
e) Buttons for selecting standard/curing safe
mode and colour temperature in standard
mode.
f) Colour bar to display the selected colour
temperature.
VENUS PLUS E version light body:
a) Light source consisting of 6 LEDs.
c) Removable handles suitable for cold sterilization.
d) ON switch.
k) NO TOUCH sensor for turning on and
brightness adjustment.

8
f
f
i
OPERATOR’S MANUAL
EN
VENUS PLUS, VENUS PLUS -L version, VENUS
PLUS MCT version, VENUS E version lights
for installation on dental unit:
f) Self-balancing arm.
VENUS PLUS CL version, VENUS PLUS CL
-L version, VENUS PLUS CL MCT version for
ceiling installation:
f) Self-balancing arm.
i) Flange for ceiling installation.
2.1. IDENTIFICATION PLATE
Data given on plate:
• Manufacturer’s name.
• Name of equipment.
• Rated voltage.
• Type of current.
• Rated frequency.
• Maximum power absorbed.
• Serial number.
• Month and year of manufacture.
Nameplate position.
Lights model:
VENUS PLUS,
VENUS PLUS -L version,
VENUS PLUS MCT version,
VENUS PLUS E version.
The nameplate is located behind the light support arms
Lights model:
VENUS PLUS CL version,
VENUS PLUS CL -L version,
VENUS PLUS CL MCT version.
The nameplate is located on the light support pole.

9
d
g
k
d
k
EN
OPERATOR’S MANUAL
3. OPERATION
3.1. SWITCH-ON / SWITCH-OFF
VENUS PLUS, VENUS PLUS CL version lights:
• To turn light on, move switch (d) up.
The LED (g) located at the rear of the optical unit
indicates whether the light is powered.
NOTE for CL version: the light is powered
by the main switch mounted at the time of installation.
• Toturnlighto󰀨,moveswitch(d) up again.
VENUS PLUS -L version, VENUS PLUS CL -L
version lights:
• To turn light on, move switch (d) up.
NOTE for CL -L version: the light is
powered by the main switch mounted at the time of
installation.
• Toturnlighto󰀨,moveswitch(d) up again.
Lights with NO TOUCH sensor.
You can also turn the light on and off by rapidly
sweeping your hand in the sensitivity eld (5cm) of
the sensor (k).
NOTE: if the light does not turn on or o when
sweeping your hand rapidly across the sensor, sweep
it across again more slowly.
VENUS PLUS MCT version, VENUS PLUS CL
MCT version lights:
•You can also turn the light on and o󰀨 by rapidly
sweepingyourhandinthesensitivityeld(5cm)of
the sensor (k).
NOTE: if the light does not turn on or o
when sweeping your hand rapidly across the sensor,
sweep it across again more slowly.
NOTE for CL MCT version: the light is
powered by the main switch mounted at the time of
installation.

10
ON / OFF
d
k
e
5 cm
k
OPERATOR’S MANUAL
EN
VENUS lights, E version:
• Toturnthelightonando󰀨,operatetheswitch(d) or
sweepinthesensitivityeld(5cm)ofthesensor
(k).
NOTE: if the light does not turn on or o
when sweeping your hand rapidly across the sensor,
sweep it across again more slowly.
3.2. BRIGHTNESS ADJUSTMENT
Turntheknob(e):
• Clockwise:increasesbrightness.
• Counter-clockwise:reducesbrightness.
NOTE: in dental units with light brightness
adjustment from the console, it is recommended to
make this operation only from the lamp or the console
to avoid possible "ickering" of the light.
Lights with NO TOUCH sensor.
Brightnesscanbeadjustedalsobykeepingyourhand
stillinthesensitivityeld(5cm)ofthesensor(k).
Upon adjustment start, lamp issues an acoustic signal:
• 1 short BEEP: brightness increase.
• 2 short BEEPS: brightness decrease.
Whenever maximum or minimum levels are reached,
lamp issues 2 long BEEPS and the adjustment function
is stopped.
NOTE: if the light is set to maximum level,
the adjustment function decreases brightness and
the decrease stops as soon as the minimum level is
reached or when hand is removed from sensor.
If lamp is not set to maximum level (any intermediate
level), the adjustment function always increases
brightness and the increase stops as soon as the
maximum level is reached or when hand is removed
from sensor.
VENUS E version lights.
Brightnesscanbeadjustedbykeepingyourhandstill
on the sensor (k) sensitivity range (5 cm).
Whenever maximum or minimum levels are reached,
the light issues 1 BEEP and the adjustment function
is stopped.
NOTE: if the light is set to the maximum level,
the adjustment function decreases brightness and
the decrease stops when you remove your hand from
the sensor; when the minimum brightness is reached,
the adjustment stops for approx. 3 seconds and then
restarts, increasing brightness.
If the light is set to any intermediate level, the
adjustment function continues to increase or reduce
brightness, restarting from the latest adjustment made;
the increase stops when hand is removed from sensor.
ON/OFF
5 cm