Faro MAIA User manual

USER’S MANUAL

MAIA USER’S MANUAL - EN
COD. 988300 Edition 2.22023-01 Pag. 2 di 8
Dear Customer,
FARO hopes you enjoy your work with the new high quality light. For safe work and to take full
advantage of the performance of the product, read carefully this manual before using the device.
In particular, follow all the warnings and the notes described into the Safety Recommendations included
in the Packaging.
Warranty Conditions:
FARO offers the final customer a 12 month warranty starting from the date of installation until a maximum of 18
months from the manufacturing date.
Repairs under warranty must be performed by FARO or its approved Service partner.
Warranty is considered valid only when:
•the user sent the Certificate of Warranty duly filled out at the following email: [email protected]t
•the user registered the warranty throughout the Faro website;
The warranty covers manufacturing and engineering defects; in case of valid claims, the warranty covers free parts
replacement only. Manhour work is not included in the warranty.
The warranty is not considered valid, at the sole discretion of FARO, if the fault is due to tampering, damage,
unauthorized changes to the product, incorrect use, improper maintenance and normal wear and tear.
This product have a Service Life of: 10 Years.
The Product is covered by the WEEE Directive 2012/19/EU. When scrapping and disposing of materials, follow the
regulations in force in your country, using recognised and authorised companies.
At the end of the life cycle, sort the materials according to their type (ferrous, rubber, plastic).
Any serious incident occurring in relation to the device should be reported to the Manufacturer and the competent
authority of the Member State in which the user and/or patient is established.
Table of contents
1SYMBOLS USED .................................................................................................................................................................................3
1.1 SYMBOLS USED IN THIS MANUAL ......................................................................................................................................3
1.2 SYMBOLS USED IN THE LABELLING AND ON THE PACKAGING...........................................................................3
2INTENDED USE .................................................................................................................................................................................3
2.1 USER’S MINIMUM REQUIREMENTS..................................................................................................................................3
3DESCRIPTION OF THE PRODUCT ...........................................................................................................................................4
4INSTRUCTION FOR USE ...............................................................................................................................................................4
4.1 DESCRIPTION OF COMMON USER’S INTERFACE .......................................................................................................4
4.2 SWITCHING ON/ OFF ...............................................................................................................................................................5
4.3 ADJUSTING THE LIGHT INSTENSITY ................................................................................................................................5
4.4 VIDEO RECORDING MODE.....................................................................................................................................................5
4.4.1 Video recording mode ON (or OFF) ..........................................................................................................................5
4.4.2 Adjusting Light intensity in Video Mode .................................................................................................................5
4.5 REMOTE CABLE...........................................................................................................................................................................5
4.6 AUTO-ON MODE .........................................................................................................................................................................5
4.7 USING THE POLIBLOCK FILTER ..........................................................................................................................................5
5CLEANING, DISINFECTION AND STERILIZATION............................................................................................................6
5.1 CLEANING OF THE MIRRORS...............................................................................................................................................6
5.2 CLEANING AND DISINFECTION OF THE HEAD ............................................................................................................6
5.3 CLEANING AND DISINFECTION OF ARMS......................................................................................................................6
5.4 DECONTAMINATION AND STERILIZATION OF PARTS ............................................................................................6
5.4.1 Decontamination And Disinfection Of The Handles ...........................................................................................6
5.4.2 Sterilization Of The Handles.......................................................................................................................................6
5.4.3 Decontamination And Disinfection Of Poliblock ..................................................................................................6
5.4.4 Sterilization Of Poliblock .............................................................................................................................................6
6PREVENTIVE MAINTENANCE AND ROUTINE CHECKS.................................................................................................7
7TROUBLESHHOTING .....................................................................................................................................................................7
8TECHCNICAL SPECIFICATION..................................................................................................................................................8

MAIA USER’S MANUAL - EN
COD. 988300 Edition 2.22023-01 Pag. 3 di 8
1SYMBOLS USED
1.1 SYMBOLS USED IN THIS MANUAL
WARNING
FORBIDDEN
The paragraphs marked with this symbol contain instructions that must be carefully followed
to avoid damaging the device, harming the operator or the patient.
This icon highlights what you should not do to avoid
damaging the device.
CAUTION
NOTES
These instructions warns you that you must pay attention to avoid situations that could
damage the device.
This icon supplies information that allows you to use
the device more efficiently.
1.2 SYMBOLS USED IN THE LABELLING AND ON THE PACKAGING
The data plate is fixed:
•for the complete light or arms: on the rear arm
•for the head: under the switch cover
Serial Number description
•For dental light YYLDNNNNNN
•For head of dental light YYTENNNNNN
Where
•YY: last two digit of the year of manufacturing
•NNNNNN: progressive counter of the year
e.g.: 21LD000001 I the first product manufactured in 2021.
Following symbols are present also:
Symbol
Description
Symbol
Description
Symbol
Description
Mark for Conformitè Europe
Can be sterilized with heat at 134°C
Fragile
Medical Device according to
Regulation (EU) 2017/745 on
medical devices,
Use the device at a temperature
between 10°C and 40°C
Protect the packaging from
rain and high humidity
Read the instructions use.
Supplied by Electronic means.
Use the device at pressure between
800 mbar and 1060 mbar
Do not Roll
Manufacturer symbol according
to Regulation (EU) 2017/745
Use the device at relative humidity
between 30 RH and 75RH
Do not use hooks
The instructions for use include
safety warnings
Serial Number
Maximum stackable weight
WEEE equipment according to
the Directive 2012/19/EC.
Symbol to adjust light intensity
Storage and Trasportation
temperatures
Double insulation. Class 2 device
against electrical risk
Symbol to switch on/off the
light
Storage and Trasportation
Relative Humidity
Recyclable cardboard
High
Swiss Authorized
Rapresentative for Medical
Device Regulation
(MedDo)
Storage and Trasportation
Atmospheric Pressure
2INTENDED USE
The device is used in dental cabinets and is intended for illuminating the oral cavity and oral structures of patients in dentistry.
In the normal use, the device is positioned distance of 700mm from the operative area, the distance for which the lighting features were designed.
Patients can be of all ages with typical dental pathologies.
2.1 USER’S MINIMUM REQUIREMENTS
The user with the following characteristics does not require any special training
Intended User
Professional qualification:
Minimum skills
Experience
Possible user handicaps
The intended users are
Dentists (all specializations)
or Dental Nurse, Hygienists
and Assistants
Degree in Medicine with
Dentistry Specialization
Degree in Dentistry
Degree in dental nursery
Those planned for the
professional qualification
Understanding of language:
Those acquired for the
professional qualification
Those outlined to
conduct the profession
For the use it is necessary at
least one upper limb;
Visual faculty compatible
with the profession;

MAIA USER’S MANUAL - EN
COD. 988300 Edition 2.22023-01 Pag. 4 di 8
3DESCRIPTION OF THE PRODUCT
1 –Post for connection to unit or ceiling
2a –Fixed arm unit mount
2b –Fixed Arm Ceiling Mount
3 –Joint of the fixed arm
4 –Rear Joint of swivel arm
5 –Swivel arm
6 –Joint of the Head
7 –Joke of the Head
7a –Joke of the head with 3rd axis
8 –Head light
Fig 1 –Maia Dental Light 3 axis unit mount
These main variants can be supplied with:
-Full dental light or Dental Light Head
-Command Interface: Mechanical Switch or Proximity Sensor
-Different Mounting (ceiling or dental unit)
-Different arm length combination
-Remote cable for bring the command to the Dental Unit’s
-Auto-on setting;
-Power supply (with or without integrated transformer)
Fig 2 –Maia Dental Light ceiling mount
All variants can be ordered by dedicated product codes as reported in the table below:
32X YWZ 3NN - 42X YWZ 3NN - 32X YWZ 0NN - 42X YWZ 0NN:
Axis of
rotation
X
Mounting -
Control
Y
Voltage input -
Control
W
Arm lenght
(mm)
Z
arm
shape
Type of
device
NN
Custom
32
standard
0
Unit std
0
24 Vac –MS (*)
1
750x550
0
Curved
3
Dental Light
00
Std FARO
42
3 axis
2
Unit Auto on
1
24 Vac –PS (*)
2
900x550
9
Straight
0
Head (*)
XX (**)
Custom
4
Unit Remote Cable
4
230Vac –MS
9
750x855
5
Ceiling std
5
230 Vac - PS
(*) MAIA can be supplied also with Direct Current 22 –35 Vdc
(**) Custom codes
MS: Mechanical Switch PS: Proximity Sensor
6
Ceiling Auto On
6
120 Vac - MS
1
Only Head std
7
120 Vac - PS
8
240Vac - MS
9
240Vac - PS
For the North American market (United States and Canada) the following variants are available: 32X YWZ 4NN - 42X YWZ 4NN:
Axis of
rotation
X
Mounting -
Control
Y
Voltage input -
Control
W
Arm lenght
(mm)
Z
arm
shape
Type of device
NN
Custom
32
standard
0
Unit std (**)
0
24 Vac –MS (*)
1
750x550
0
Curved
4
Dental Light
00
Std FARO
42
3 axis
2
Unit Auto on(**)
1
24 Vac –PS (*)
2
900x550
9
Straight
XX (**)
Custom
5
Ceiling std(**)
9
750x855
6
Ceiling Auto On
(**)
(*) MS: Mechanical Switch PS: Proximity Sensor
(**) Fixed equipments class I with earth protection connection
4INSTRUCTION FOR USE
4.1 DESCRIPTION OF COMMON USER’S INTERFACE
1 Mechanical Switch
2 Sterilisable Handle
3 Knob of the handle
4 Proximity Sensor
5 Mirrors
6 LED group
The device must be cleaned before use (see Device Cleaning paragraph).
WARNING AGAINST HAZARD OF EXPLOSION AND ELECTROMAGNETIC MALFUNCTIONING
Do not use the device in flammable or explosive environments
Simultaneous use of the light with electro-surgical devices can cause malfunctioning (flickering, no command, etc)
NOTE FOR POLYMERISATION OF RESTORATIVE COMPOSITES
MAIA is not equipped with anti-polymerisation function. To minimise the risk of polymerisation:
−Use the lamp at a light intensity close to the minimum; or
−Use the FARO Poliblock filter
FORBIDDEN
The joystick must be handled with care to avoid breakages.
Never move the light using the switch or parts other than the handles
WARNING OF PHOTOBIOLOGICAL HAZARD AND GLARE
Do not stare or aim the light beam directly into the patient's eyes, especially for patients at higher risk of eye injury (e.g. children or patient
with eye diseases). In this case, always use appropriate protection and precautions.
The lamp is classified as photobiological risk 1, without labelling according to IEC/EN 62471, at a distance of 200 mm.
However, it cannot be excluded that particularly photosensitive individuals, or those who have taken photosensitising substances, may
experience rashes or allergic reactions to light. In this case, discontinue treatment and use very low illuminance levels.
WARNING AGAINST THE DANGER OF SUSPENDED MASSES
Do not use the device if any parts or enclosure are damaged or if there is play or breaks between:
- Head joint / Head joke
- Fixed arm joint / Rear Joint of swivel arm
The device is equipped with limit switches on each rotating element. Do not move the lamp by hitting the limit switches.

MAIA USER’S MANUAL - EN
COD. 988300 Edition 2.22023-01 Pag. 5 di 8
4.2 SWITCHING ON/ OFF
Mechanical Switch
Proximity
Push right or left and release
Acoustic signal: 1 beep
Bring the hand towards the sensor up to 2 cm and move the
hand down
Acoustic signal: 1 beep
Each time the lamp is
switched on, the light
intensity will set
automatically on the
memorized at the
switch-off.
4.3 ADJUSTING THE LIGHT INSTENSITY
Switch –Increase Light Intensity
Switch - Decrease light intensity
Proximity
Push left and keep pushed until desired
intensity is reached. Then release
Acoustic signal: 1 beep at command
Maximum intensity reached: 2 beeps
Push right and keep pushed until desired
intensity is reached, then release.
Acoustic signal: 1 beep at command
Minimum intensity reached: 1 beep
Bring the hand towards the sensor up to 2 cm and keep this
distance until the desired light intensity is reached
Acoustic signal: 1 beep at command
Maximum intensity reached: 2 beeps
Minimum intensity reached: 1 beep
4.4 VIDEO RECORDING MODE
Maia is equipped with a function that allows it to be used during camera video recordings and/or the use of diagnostic instruments (e.g. Diagnodent and
laser) without the risk of interference that could affect the result.
The function is only present in Mechanical Switch (MS) version and can be activated or deactivated by the user.
4.4.1 Video recording mode ON (or OFF)
1. Switch on the dental lamp
2 Act on the control to reach the minimum light intensity (1 beep at minimum ).
3 Without release the MS, keep pushed for at least 4 seconds.
4. A confirmation beep is heard, the light intensity rises to the maximum level and the Video-
Diagnostics function is ON (or OFF).
If the procedure does not work, repeat it from point 1.
4.4.2 Adjusting Light intensity in Video Mode
In Video-Diagnostics Mode, the light intensity adjustment changes from continuous to stepwise.
Two intermediate levels of light intensity can be selected between maximum and minimum.
Procedure:
1. Switch on the Maia dental lamp using the MS (beep at the control socket).
2. Release the MS.
3. Push the MS again to reduce the light intensity and release the control at the desired intensity
level.
When the minimum intensity is
reached, a beep sounds.
When it is switched on again, the
dental lamp will return to full
brightness (beep at the control
socket).
4.5 REMOTE CABLE
Make reference to the Dental Unit’s instruction for use the Dental Light from the Dental
Unit’s control panel.
In case remote cable is managed in installation, ask the Installator.
Commands from remote cable are managed by a Push Button,
Function
Button
Command
On –Off
A
Press and Release
Adjustment
A
Press and keep pushed
4.6 AUTO-ON MODE
When the Auto On mode is on, the lamps switch on automatically (without a specific command from the user) when there is power from the dental unit.
To change the Auto On setting, contact a Service Engineer.
4.7 USING THE POLIBLOCK FILTER
The anti-polymerisation filter "POLIBLOCK" modifies the light spectrum,
avoiding the activation of the composite up to 520 nm wavelength. The device
can be applied to MAIA directly by the end user during dentistry procedures.
Insert the POLIBLOCK filter, checking that it well secured to the LED group.
The light emitted by the lamp with the "POLIBLOCK" turns to a red colour,
cutting the blue frequencies.
Use the POLIBLOCK only for the time necessary to the composite to be
modelled to the final shape.

MAIA USER’S MANUAL - EN
COD. 988300 Edition 2.22023-01 Pag. 6 di 8
5CLEANING, DISINFECTION AND STERILIZATION
Warning against danger of wear and corrosion and falling suspended mass
For all metal or plastic parts it is strictly forbidden to
use substances that are
-abrasive,
-corrosive,
-acids,
-substances containing chlorine or chloride
ions, phosphorous or phosphorous ions,
-detergents with Trilene base, petrol, white
spirit, chlorine or similar.
It is forbidden to directly spray any chemical substance
on the device.
Do not use detergents-disinfectants containing the following
substances to clean plastic parts:
-Ammonium Hydroxide
-Sodium Hydroxide
-Hydrogen peroxide
-Ammonium Chloride
-Methylene chloride
-Methyl alcohol
-Acids and corrosive substances of all kinds.
It is forbidden the use of wet wipes without rinsing.
Faro tested and suggests the use of the following disinfectants, for plastic parts and metal parts:
-Durr FD366 Sensitive
-Water-alcohol based disinfectants with 70% isopropyl alcohol or ethanol are suitable.
5.1 CLEANING OF THE MIRRORS
Cleaning must be carried out using a soft cloth in cotton or absorbent cotton with ethyl alcohol.
Water-alcohol based disinfectants are suitable with 70% isopropyl alcohol or ethanol.
Caution - potential damage or wear on the mirrors
Never spray detergent directly on the mirrors.
Cleaning operations must be carried out wearing gloves, to avoid leaving fingerprints on the surfaces.
Never use detergents containing surfactants or water-repellents that depositing can leave streaks. Slight streaking will not
prejudice the quality of the light.
Products differing from those suggested could damage the mirrors.
If in doubt, contact FARO customer care.
5.2 CLEANING AND DISINFECTION OF THE HEAD
Cleaning must be carried out using a soft cloth in cotton wetted with disinfectant solution.
Always squeeze the cloth to remove all the liquid in excess.
5.3 CLEANING AND DISINFECTION OF ARMS
Always use a cloth soaked in disinfectant approved to disinfect the surfaces and pass it over.
Always squeeze the cloth to remove all the liquid in excess.
5.4 DECONTAMINATION AND STERILIZATION OF PARTS
Handles and PolIblock can be sterilized according to the requirements described below.
WARNING –CROSS CONTAMINATION
The handles and Poliblock are not supplied sterile, they must therefore be sterilised before use.
The handles and Poliblock must be sterilised before each patient.
5.4.1 Decontamination And Disinfection Of The Handles
To remove the handle, unscrew knob “A” and remove it from the support.
To disinfect, Faro has tested the following products for disinfection:
•Durr FD366 Sensitive
WARNING - danger of plastic breaking
The handles cannot be disinfected by thermo-disinfection.
5.4.2 Sterilization Of The Handles
The handles must be packaged in compliance with EN 868-5.
The handles can be sterilised with standard cycles 121°/134° C up to two hundred (200) cycles or however up to loss of the mechanical performance.
The parameters of the sterilisation cycle are as follows:
Cycle EN 13060
Temperature
Pressure
Holding Time Minimum
B
121°C
207 kPa
15 min
B
134°C
308 kPa
3 min
Number of cycles validated for maintaining mechanical integrity: 200
5.4.3 Decontamination And Disinfection Of Poliblock
Before sterilisation, the Polyblock must be cleaned and decontaminated.
Faro has tested the following products for disinfection:
•Durr FD366 Sensitive
Follow the instructions of the manufacturer of the disinfectant for the correct procedure.
5.4.4 Sterilization Of Poliblock
WARNING –DANGER OF FALL OF SUSPENDED MASSES
Poliblock cannot be sterilized at 134°C.
Do not Exceed the number of steriliation cycles
Poliblock must be packaged in compliance with EN 868-5.
Poliblock can be sterilised with standard cycles 121° C up to forty (40) cycles or however up to loss of the mechanical performance.
The parameters of the sterilisation cycle are as follows:
Cycle EN 13060
Temperature
Pressure
Holding Time Minimum
B
121°C
207 KPa
15 min
Number of cycles validated for maintaining mechanical integrity: 40
WARNING –DANGER OF FALL OF
SUSPENDED MASSES
Poliblock cannot be disinfected by
thermo-disinfectors.

MAIA USER’S MANUAL - EN
COD. 988300 Edition 2.22023-01 Pag. 7 di 8
6PREVENTIVE MAINTENANCE AND ROUTINE CHECKS
Only Service Engineer are allowed to perform corrective Maintenance and replacement of any part of the device, according to Manufacturer’s
Service Manual.
Check
Freq
Procedure
Resp.
No plays or space gaps between the
junction points (points 1, 2, 3, 4)
Yearly
Service
Engineer
Screws of connection points must
be tightened and integer:
•screws 1
•Screw 2 (both sides)
Yearly
Service
Engineer
The nuts of connection points
under carter 1, 2 must be well
secured and safety screws intact.
The screws under carter 3 must be
well secured.
Yearly
Carter 1 Carter 2 3 axis joint
Service
Engineer
Check the absence
of any oxidation into joints, arms or
plastic parts.
Yearly
Visual inspection
Service
Engineer
Check the main plate can be read
Yearly
Visual inspection
Service
Engineer
Check of damages on enclosure and
plastic joints integrity.
Yearly
Visual inspection
Service
Engineer
Electrical Safety according EN
62353
1. Dielectric strength
2. Current Leakage
24
months
Use the parameters defined into IEC 60601-1
Service
Engineer
Light checks
24
months
With a spectroradiometer check the values for:
Max Luminance: >30000 lux
CRI > 85
Radial power on blue light: <100 W/m2
Service
Engineer
7TROUBLESHHOTING
Effect
Cause
Azione (Service Engineer - SE)
Resp
The ioght does not switch on
Power supply not connected correctly
Check that power supply mains in connected and the dental
uniti s switched on
User
EM interference with electro surgical
scalpels or high energy tools
Switch off the electro surgical scalpels
User
Wrong command to the switch or
proximity
See dedicated chapter
User
Flickering of the light
EM interference with electro surgical
scalpels or high energy tools
Switch off the electro surgical scalpels.
User
Adjustment of the intensity
not possible
Wrong command to the switch or
proximity
See dedicated chapter for the correct use of commands
User
EM interference with electro surgical
scalpels or high energy tools
Switch off the electro surgical scalpels.
User
Light intensity low
Mirrors are dirty
Clean mirror and optical group
User
Wrong command to the switch or
proximity
See dedicated chapter for the correct use of commands
User
Presence of stains or halos on
the mirrors.
Lack of reflecting treatment
on the surface of the mirrors
Use of non approved product or wrong
procedure
See dedicated part of the manual on cleaning.
User
The light does not mantain the
position of equilibrium
Overload due to the presence of other
devices on the light (external mirrors,
camera’s etc.)
Remove the excessive load
User

MAIA USER’S MANUAL - EN
COD. 988300 Edition 2.22023-01 Pag. 8 di 8
8TECHCNICAL SPECIFICATION
Dental Light
Dental Light Head
Power Supply (without Transformer):
17÷24Vac ±10% 50/ 60Hz;
17÷24Vac ±10% - 50/ 60Hz;
22 –35 Vdc
Power supply (with transformer):
230 Vac 50/60 Hz / 240 Vac 50/60 Hz / 120 Vac 50/60 Hz
N/A
Max Power :
9 VA max
Fuses (Version with transformer):
2 x T 250mA1 250V
N/A
Reccomended fuses for installation without
transformer
17÷24Vac: T600mAL
17÷24Vac: T600mAL
22 –35 Vdc: T600mAL
Protection against electrical hazad
Class II
(final classification of the Protection Class of the Medical System is demanded to the installator or to the
manufacturer)
Only for the US Market: Class I for fixed or permanent installations (ceiling, unit, wall of floor
installations)
Classification against IEC 62471
Class 1- labelling exempt
Actinic UV: EXEMPT Near UV: EXEMPT Blu Retinal: Low Risk
Exposure limit for Blue : 1536 seconds
Max illuminance (*)
From 3000 to 30.000 lux (with Poliblock > 10.000). Continuous adjustment
Typical colour Temperature(*)
5.000 K (with Poliblock 1500 K)
Size of light spot (*)
175 mm x 100 mm
Hard Shadow
horizontal dimension: 5 mm / vertical dimension: 10 mm
Camphorquinone weighted irradiance
Poliblock: 0,047 W/m^2
Nature of the radiation
Non ionizing radiation
Type of radiation
Visible spectrum only
Typical distribution of illuminance(*)
(*)Typical optical values subjected to
tolerances
Measurement performed at 700 mm
distance. Contact Faro for the correct
procedure for the measurement.
Take care to leave sufficient space around the
lamp to avoid any interference with fixed
obstacles.
The free space can be determined from the
dimensions shown below
A
B
C
D
mm
550
830
170
605
mm
550
980
170
605
mm
855
830
360
835
mm
855
980
360
835
Storage and transportation conditions
The appliance in the original packaging can be transported or kept in a warehouse for a period of 15
weeks if the following environmental conditions are met:
• Environmental temperature from -20°C to + 70°C
• Relative humidity from 10% to 90%
• Atmospheric pressure from 50 kPa to 106 kPa
Use environmental conditions
The appliance must be used in the following environmental conditions:
• Temperature from 10° to 40°C
• Max altitude: 2000 m
• Relative humidity from 30% to 75%