Ancar 3200 User manual

ANCAR 3200
USER MANUAL

ISO 9001 ISO 13485
109037-AQ-IBE 112630-AQ-IBE
EC Declaration of Conformity (Directive 93/42/EEC)
Manufacturer’s Name
ANTONI CARLES, S.A.
With manufacturing and putting together of medical devices license number 2509-PS granted by
the Health Authorities of Spain.
Name of device: Type or Model:
Dental Unit
GMDNS Code:34991
Ancar 3200
Device Class according to the intended use and the criteria of Annex IX of the Directive:
Class I (rule 12)
Scope of Application: All (including parts and accessories)
Power Supply: 220-240 V ~ / 50-60 Hz
This Declaration is based on Certificates issued by DNV:
#109037-2012-AQ-IBE-ENAC according to ISO 9001:2008.
#112630-2012-AQ-IBE-NA according to ISO 13485:2003.
We, the undersigned, under our sole responsibility, certify and declare that the medical devices specified
above are in conformity with the essential requirements, which are applicable to them, of RD 1591/09,
transposition to the Spanish law of the directive 93/42/EC as amended by the directive 2007/47/EC. We also
declare that we comply with the design and construction requirements of the following standards:
EN 1640 :2009
Dentistry. Medical devices for dentistry. Equipment.
EN ISO 7494-1:2011
Dentistry. Dental Units. Part 1. General requirements and test methods.
EN ISO 7494-2:2003
Dentistry. Dental Units. Part 2. Water and air supply.
EN 60601-1:2006
+ AC :2010
Medical Electrical Equipment. General requirement for safety.
EN 60601-1-2:2007
+ AC :2010
Medical Electrical Equipment. General requirement for safety.
Electromagnetic Compatibility – Requirements and tests.
EN ISO 14971 :2012
Medical Devices. Application of Risk Management to Medical Devices.
Authorized Signatory Stamp, Date
Josep Álvarez Antoni Carles Bosch November 27, 2013
Regulatory & Safety Officer General Manager
Antoni Carles, S.A.
Volta dels Garrofers, 41-42
Pol. Ind. Els Garrofers
08340-Vilassar de Mar
(Barcelona-SPAIN)
T. (34) 93 754 07 97
F. (34) 93 759 26 04
[e-mail]
www.ancar-dental.com
ANTONI CARLES, S.A.
Pol. Ind. “Els Garrofers
C/Volta dels Garrofers, 41-42.
08340 VILASSAR DE MAR
BARCELONA-SPAIN

USER MANUAL DENTAL UNIT - QS4-472-01 / ANCAR 3200
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DESCRIPTION PAGE
1.- WARNINGS 2
2.- GUARANTEE 2
3.- IDENTIFICATION 3
4.- PRECAUTIONS 3
5.- CLAUSES 4
6.- TECHNICAL FEATURES 5
6.1.- Chair 5
6.2.- Dental unit 5
7.- DIMENSIONS AND TRANSPORTATION 6
8.- COMPOSITION 7
8.1.- Circuit box 8
8.2.- Instrument control pedal (pneumatic) 9
8.3.- Instrument tray 10
8.4.- Control panel 11
8.5.- Headrest 12
8.6.- Optional armrest 12
9.- SAFETY MOVEMENTS 13
10- CLEANING AND STERILISING 13
11.- TECHNICAL DATA 14
APPENDIX 1. CLEANING AND DISINFECTING OTHER PARTS OF THE UNIT 15
APPENDIX 2. MINILIGHT SYRINGE (LUZZANI) 16
APPENDIX 3. SAFETY OBSERVATIONS 18
INDEX

USER MANUALDENTAL UNIT - QS4-472-01 / ANCAR 3200
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Thank you for purchasing the dentistry equipment ANCAR-3200.
This instruction manual contains information about the dental equipment, its configuration and
maintenance.
This symbol means the unit is certified under Directive 93/42/EEC
(modified in accordance with 2007/47/EC)
Notes
This symbol means CAUTION, PRECAUTION
Before starting-up the unit you must have read and fully understood the user
manual.
Keep this manual in a safe place for future reference, for as long as you use
the equipment.
Follow all safety standards.
It is the user’s responsibility to keep the unit clean, disinfected and in perfect
working order.
1.- WARNINGS
This dental equipment is for the exclusive use of a professional, who should have the appropriate
training and be a member of a dental association to practise as a dentist.
This equipment may only be moved by authorised technicians.
The unit must be installed in an environment under controlled conditions, including temperature
(+10˚C to +40˚C), humidity (30-75 %) and atmospheric pressure (700 a 1060 hPa), free from
dust and condensation and protected from direct sunlight.
The electrical circuit at the premises where the unit is to be installed must satisfy the provisions
in standard IEC 601.1 regarding protection against electric shock for class I equipment.
Antoni Carles, S.A. reserves the right to make any improvements or modifications to the dental
unit without prior warning.
The unit must be used in accordance with the instructions of use.
Under Directive 93/42/EEC (modified in accordance with 2007/47/EC), the dental unit and
orthodontic chair manufactured by Antoni Carles, S.A. are class IIa equipment. It is absolutely
prohibited to install any class IIb or III dental instrument, e.g. surgical lasers, electronic scalpels,
X-rays or electric cauterizers. Only class I or IIa equipment may be installed, in compliance
with the provisions in the aforementioned Directive and standardised regulations EN60601-1,
EN60601-1-2.
2.- GUARANTEE
The device comes with a Certificate of Guarantee. If you do not receive this, ask your dealer
directly. The Certificate of Guarantee must be completed and returned to the manufacturer
(Antoni Carles, S.A.) within 8 days of delivery of the device.
The guarantee is only valid if the device has been used correctly and installed by an authorised
technician.
Moreover, to comply with Health Equipment traceability in accordance with Directive 93/42/EEC
(modified in accordance with 2007/47/EC), you must also return the installation form.

USER MANUAL DENTAL UNIT - QS4-472-01 / ANCAR 3200
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3.- IDENTIFICATION
The identification tag, containing technical information required for connection, can be found
close to the base on the front of the chair, and is visible when the outer cover is removed (Fig. 1)
4.- PRECAUTIONS
The unit should be installed in a bright place away from corridors or passageways, and should
have adequate room to accommodate both the patient and the user.
The dental chair should be fixed to the floor to guarantee stability.
Before moving the chair, the operator (dentist, user) must ensure that there is no-one (patient,
guests, children) in the vicinity. Be aware of people around the backrest area and around the
auxiliary instrument tray.
After using the unit, switch off all instruments as well as the unit itself, which should remain
switched off at the end of each working day. If the unit is to be out of use for a long period of
time, also disconnect it from the mains supply and close the main air and water inlet taps.
Make sure the general power switch underneath the instrument tray is turned off if the equipment
is to be left without staff supervision. It will disconnect the electro valves and prevent the water
entry channelling conducts from having to withstand a constant pressure.
The air and water inlets must not exceed a pressure of 10.3 Bar, nor should the pipes be
exposed to temperatures exceeding 46˚C, to avoid system faults and damage to property.
To prolong the working life of the lifting unit components, take care not to overload the chair.
It is advisable not to use mobile telephones in the proximity of the working unit.
This equipment is not designed to work in operating theatres.

USER MANUALDENTAL UNIT - QS4-472-01 / ANCAR 3200
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ENVIRONMENTAL PROTECTION
All packaging materials are produced in respect for the environment and are fully recyclable:
wooden pallets, cardboard, plastic bags and, bubble-wrap. Collecting used materials helps
collection and recycling, and reduces waste material.
Antoni Carles, S.A., is obliged to satisfy the objectives set by Community Directives 2002/95/
EC and 2002/96/EC.
This symbol is only applicable for member countries of the European Union.
In order to avoid potential negative consequences on the environment and
possibly on human health, this instrument must be withdrawn (i) in member
countries of the EU – in accordance with WEEE (Electric and Electronic Material
Waste Directive), and (ii) for other countries in accordance with local provisions
and recycling laws.
EMC
The Sd-150 dental ANCAR-3200 conforms to the basic requirements of Directive 93/42/EEC
(modified in accordance with 2007/47/EC), concerning medical devices, and complies with the
design and construction requirements contained in Standard EN60601-1-2 regarding the safety
of Electromagnetic Compatibility and Electrical Medical Equipment, causing no electromagnetic
disturbances and complying with immunity standards.
ENVIRONMENTAL CONDITIONS
While it is in its packaging for transport and storage, the equipment can withstand being
exposed for no longer than 15 weeks to environmental conditions that do not exceed:
a) ambient temperature from -20ºC to +50ºC.
b) a relative humidity of 10% to 100%, including condensation.
c) an atmospheric pressure of 500hPa to 1060 hPa (from 500 mbar to 1060mbar).
- Functioning conditions:
d) ambient temperature from +10ºC to +40ºC.
e) a relative humidity of 30% to 75%, including condensation.
f) an atmospheric pressure of 700hPa to 1060 hPa (from 700 mbar to 1060mbar).
5.- CLAUSES
Antoni Carles, S.A. will not assume responsibility for damage caused by fire, natural disasters,
third party activities or other accidents caused by operator negligence or misuse, or from using
the equipment under unusual conditions.
Antoni Carles, S.A. will not assume responsibility for damage deriving from the improper use
of equipment, causing a loss of business or loss of earnings.
Antoni Carles, S.A. will not assume responsibility for results of diagnoses made by a doctor
using this equipment.

USER MANUAL DENTAL UNIT - QS4-472-01 / ANCAR 3200
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6.- TECHNICAL FEATURES
6.1.- Chair
Ergonomic design for the patient.
Dental chair with silent, automatic and highly reliable movement.
Microprocessor-controlled movements:
- Automatic chair return movement.
- 3 programmable chair settings.
High quality, hygienic anatomic upholstery
Safe movement of the base and backrest of the chair, which is raised upwards until locked in
place.
Height-adjustable, folding headrest.
Includes Trendelenburg position.
6.2.- Dental Unit
Electro pneumatic unit with support tray fitted on the rear of the chair giving access to the
patient from both the right and the left for the doctor to work.
Junction box built into the chair.
Instrument tray for up to 4 elements. Includes 3F syringe plus 2 instruments (electric micromotor
with/without light, and turbine with/without light) and suction.
Safety system to block the chair movements when it detects the activation for work with
the adjuster pedal with the instruments. Built-in as standard in the remaining safety device
activations:
- Instrument tray arm (rise and fall blocking).
- Lower contact articulation of instrument tray arm to chair.
- Chair base and back.
- Manual activation of the keyboard or pedal cancels automatic movement under way.
Lantern effect in the turbine with light on choosing the instrument, without using the pedal.
Cannula support with housing for small volume surgical suction.
Command on the instrument tray.
The unit conforms to the basic requirements applied by Directive 93/42/EEC on medical devices,
complies with the design and construction requirements contained in Standards EN60601-1
and EN60601-1-2 regarding the safety of Electromagnetic Compatibility and Electrical Medical
Equipment, and conforms to ISO standard 14971, Risk Management analysis.

USER MANUALDENTAL UNIT - QS4-472-01 / ANCAR 3200
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7.- DIMENSIONS AND TRANSPORTATION
The dental unit is suitably packaged and protected. (Fig. 2)
One box contains the palette-held dentistry chair, the pedal unit, upholstery and front cover. In
a second box, the instrument support arm unit.
It is essential that none of the boxes are knocked when in transit, and under no circumstances
must they fall to the floor. Great care should be taken when moving the equipment; we
recommend it be transported by technicians authorised by Antoni Carles, S.A.
Before assembling the unit, a technician, along with yourself and the authorised member of staff
on-site should determine its best location with regard to comfort and ergonomics.
If any assembled unit has to be moved, set the chair with its seat as low as
possible and the back raised, and make sure the instrument tray is retracted as
far as possible on the chair at all times.
Once in its new position, remember to secure the chair to the floor.
Fig. 2
575
960
Max: 2160
1540
MIN:
430
Max: 840
625
2045