Ancar Sd-175 User manual

Sd-175
USER MANUAL
July 2014, QS4 591 v.2

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
[email protected]
www.ancar-online.com
EC Declaration of Conformity (Directive 93/42/EEC)
Manufacturer's Name
ANTONI CARLES, S.A.
With medical device manufacturing and assembly license number 2509-PS granted by the Health
Authorities of Spain
Name of device Type or Model:
Dental Unit
Code GMDNS: 34991 Sd-175
Device Class According to the intended use and the criteria of Annex IX of the Directive:
Class IIa (rule 11).
Scope of Application: All (including pieces and accessories)
Power Supply: 220-240 V ~ / 50-60 Hz
Electrical Classification Type B
This Declaration is based on Certificates issued by DNV:
# 78388-2010-CE-IBE-NA according to annex V, DIR 93/42/EEC,
No. 109037-2012-AQ-IBE-ENAC, according to ISO 9001:2008, and
No. 112630-2012-AQ-IBE-NA, according to ISO 13485:2003.
Notified Body:
0434 DNV (Det Norske Veritas) – Region Norge As.
We, the undersigned, under our sole responsibility, hereby certify and declare that the medical
devices specified above are in conformity with the essential requirements applicable to them, of RD
1591/09, transposition to the Spanish law of the directive 93/42/CEE 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 products for dentistry. Equipment
EN ISO 7494-1:2011 Dental units. Part 1. General requirements and testing methods
EN ISO 7494-2:2003 Dental units. Part 2. Air and water supply
EN 60601-1:2006
+ AC:2010
Medical electrical equipment. General requirements for safety.
EN 60601-1-2:2007
+ AC:2010
Medical electrical equipment. General requirements 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 31 July 2014
Regulatory & Safety Officer General Manager
ANTONI CARLES, S.A.
Pol. Ind. “Els Garrofers”
C/Volta dels Garrofers, 41-42.
08340 VILASSAR DE MAR
BARCELONA-SPAIN
ANTONI CARLES BOSCH
ISO 9001
109037 AQ-IBE
ISO 13485
112630 AQ-IBE

USER MANUAL DENTAL UNIT - QS4-591-02 / SD 175
1
PAGE
1.- GENERALITIES 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.- DENTAL UNIT DESCRIPTION 7
8.1.- Circuit box 8
8.2.- Pneumatic pedal 9
8.3.- Instrument tray 10
8.4.- Main keypad 12
8.5.- Water Cabinet 13
8.6.- Cannula support 15
8.7.- Auxiliary keypad 16
8.8.- Headrest 17
8.9.- Optional armrest 17
9.- SAFETY MOVEMENTS 18
10.- CLEANING AND STERILISING 18
11.- TECHNICAL DATA 19
ANNEX 1. CLEANING & DISINFECTING OF CATTANI GLASS, CANNULAS AND BASIN 20
ANNEX 2. SPITTOON BASIN CUT-OFF VALVE AND ASPIRATION UNIT (CATTANI) 21
ANNEX 3. VSA300: SUCTION SYSTEM (DÜRR DENTAL) 22
ANNEX 4. ASPIRATION SYSTEM TYP1 (METASYS) 23
ANNEX 5. ECO ASPIRATION SYSTEM (METASYS) 24
ANNEX 6. IGN - CALBENIUM DECONTAMINATION SYSTEM (AIREL) 25
ANNEX 7. SELF WATER SYSTEM KIT 26
ANNEX 8. COMBI-SEPARATOR CAS 1 (DÜRR DENTAL) 27
ANNEX 9. COMBI-SEPAMATIC CS 1 (DÜRR DENTAL) 27
ANNEX 10. WATER DECONTAMINATION SYSTEM: WEK (METASYS) 28
ANNEX 11. HYGIENE SYSTEM H1 (METASYS) 29
ANNEX 12. SELECTIVE CANNULA SYSTEM S1 (METASYS) 30
ANNEX 13. MINILIGHT SYRINGE (LUZZANI) 31
ANNEX 14. OPTIONAL ITEMS 33
ANNEX 15. CLEANING AND DISINFECTING OTHER PARTS OF THE UNIT 34
ANNEX 16. SAFETY NOTES 35
TABLE OF CONTENTS

USER MANUAL
DENTAL UNIT - QS4-591-02 / SD 175
2
1.- GENERALITIES
Thank you for purchasing the SD-175 dental unit.
This instruction manual contains information on the dental unit, including its configuration and
maintenance.
0434
This symbol means the unit is certified under Directive 93/42/EEC by
the DNV
Notes
This symbol means CAUTION, PRECAUTION
Before starting the unit you must read and fully understand 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.
This dental equipment is for the exclusive use of a professional who must have the appropriate
training and be a member of a dental association to practise as a dentist.
This equipment may only be installed and serviced by authorised technicians.
The unit must be installed in an environment with 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 use instructions.
Under Directive 93/42/EEC, the dental unit and dental 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, you must also return the installation form.

USER MANUAL DENTAL UNIT - QS4-591-02 / SD 175
3
3.- IDENTIFICATION
The identification tag, containing technical information required for connection, is duplicated.
One can be seen on the back of the seat, and the other can be found on the electronic card
protection cover. It 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 (Doctor, user) must ensure there is no one (patient,
guests, children) within the projection and movement area of the equipment. Ensure that no
one is under the chair, around the backrest area, and also pay attention around the 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, disconnect it from the mains supply and
close the main air and water inlet taps.
Make sure the general power switch (fig. 4, “J”) is turned off if the equipment is to be left without
staff supervision. This prevents the water pipes from having to sustain 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.
The use of mobile telephones is not recommended in the proximity of the working unit.
This equipment is not designed to work in operating theatres.
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USER MANUAL
DENTAL UNIT - QS4-591-02 / SD 175
4
ENVIRONMENTAL PROTECTION
All packaging materials are produced with 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 2011/65/
EC and 2012/19/EC.
This symbol is only applicable for member countries of the European Union.
In order to avoid potential negative consequences for the environment or
human health, this equipment should be disposed of (i) in EU member countries
– in accordance with the WEEE (Waste Electrical and Electronic Equipment)
Directive, and (ii) for all other countries, in accordance with local provisions and
recycling laws.
EMC
The Sd-175 dental unit conforms to the basic requirements of Directive 93/42/EEC 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 margin from -20˚C to +50˚C.
b) a relative humidity range of 10% to 100%, including condensation.
c) an atmospheric pressure range of 500 hPa to 1060 hPa (from 500 mbar to 1060 mbar).
-Functioning conditions:
d) ambient temperature range from +10˚C to +40˚C.
e) a relative humidity range of 30% to 75%, including condensation.
f) an atmospheric pressure range of 700 hPa to 1060 hPa (from 700 mbar to 1060 mbar).
5.- CLAUSES
Antoni Carles, S.A. will not assume responsibility for damages 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 damages 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 - QS4-591-02 / SD 175
5
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-to-zero movement (configurable height).
- automatic chair-to-spittoon movement (configurable height).
- 3 programmable chair settings (configurable seat height and backrest).
High quality, hygienic anatomic upholstery
Safe movement of the backrest and seat, chair is raised upwards until jamming is released.
Height-adjustable, folding headrest.
Includes Trendelenburg position.
6.2.- Dental Unit
Easy-maintenance finish.
Instrument tray with space to hold 5 instruments and a 14-function control panel. Includes
syringe.
Optional: adjustable electric micromotor. Reversible rotation.
Available connection for instruments with light fitting (micromotor, turbine, ultrasound).
70° rotational water unit, spittoon with automatic cup filler and basin washer system. Optional
fitting of different suction systems and amalgam systems.
Pneumatically braked arm movements with auxiliary instrument tray.
Cannula and circuit boxes located in the front of the chair.
Control panel on instrument tray and cannula support.
The unit is designed to hide all tubes or cables out of sight, except for those on the
instrument tray.
The unit conforms to the basic requirements applied by Directive 93/42/EEC on medical devices,
to 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 to ISO standard 14971, a Risk Management analysis.

USER MANUAL
DENTAL UNIT - QS4-591-02 / SD 175
6
7.- DIMENSIONS AND TRANSPORTATION
The dental unit is suitably packaged and protected.
The package includes the dental unit secured to a pallet, with a further two cases containing the
water unit and colibri forceps system (Fig. 2).
It is essential that none of the boxes collide when in transit, and under no circumstances must
they fall to the floor. Great care should be taken when moving the equipment; we recommend
for the equipment to be transported by technicians authorised by Antoni Carles, S.A.
Before assembling the unit, together with a technician and the authorised member of staff on-
site you should determine its best location with regard to comfort and ergonomics.
If it is necessary to move a pre-assembled unit, fit the chair first with the seat
at its lowest position and the back raised, making sure the water unit and the
instrument tray are fully retracted over the chair at all times, keeping the unit as
solid as possible.
Once in position, remember to secure the chair to the floor.
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USER MANUAL DENTAL UNIT - QS4-591-02 / SD 175
7
8.- DENTAL UNIT DESCRIPTION
(A) Fig. 4 Circuit box Page 8
(B) Fig. 5 Pneumatic pedal Page 9
(F) Fig. 6-7 Instrument tray + Main control panel Pages 11, 12
(E) Fig. 8-13 Water Cabinet Pages 13, 14
(D) Fig. 14-17 Cannula support + Auxiliary control panel Page 15, 16
(C) Fig. 18-19 Chair Page 17
D
C
A
F
E
B
Fig. 3

USER MANUAL
DENTAL UNIT - QS4-591-02 / SD 175
8
8.1.- Circuit box
The circuit box contains all points for connecting the dental unit to the clinic’s power supply,
as well as controls for adjusting the air and water supply. The directional movement regulator
conforms to Standard UNE 20128.
As indicated in the diagram, the front part of the chair base contains: (Fig. 4)
A. Movement panel connection cover.
B. Connection panel and transformer cover.
C. Water inlet pressure control. Fitted with a solid particle filter. Check around once per
month. Clean using pressurized water. To modify water regulation pull (“1”) and turn (“2”).
D. Air inlet pressure control. Fitted with a solid particle filter. Check around once per month.
Clean using pressurized water. To modify air regulation pull (“1”) and turn (“2”).
Inlet water must be solid particle-free and thoroughly purified.
The compressor should be correctly installed to avoid the build-up of humidity in the air
circuit.
Note: when activating the general power switch, the connection panel will
perform a function test producing an audible beeping sound. If you do not hear
this sound, switch off the unit and contact your technical service provider.
By the circuit box, at its right side you will find:
General power switch (J). Up, on; down, off. Pilot light.
General power fuse (H), rating T6.3A/L/250V, type 5x20mm.
Fuses should be replaced (G) by an authorised technician.
General power switch must be turned off if
the unit is left unsupervised. Deactivating
this switch prevents water pipes from being
subjected to constant pressure through the
intake.
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B
C
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USER MANUAL DENTAL UNIT - QS4-591-02 / SD 175
9
8.2.- Pneumatic pedal:
INSTALLATION AND USE
Pedal for adjusting each of the optional instruments on the instrument tray: Micromotor, turbine.
Ultrasound on/off switch (fig 5).
Control the electric micromotor rotation speed, turbine power and pneumatic micromotor by
activating the trigger (B); select air only or air and water, using lever-operated spray function
(A). The pedal-controlled electric micromotor has a speed control potentiometer, as it allows
very sensitive and progressive movement.
Lever-operated chip blower function (A) when the lever (B) is in the rest position.
This pedal does not control cannula support instruments; it supports only those on the
instrument tray.
Optional instrument hygiene: turbines and micromotors, expelling every drop
of water using an automatic air blower, thanks to chip valve are delayed when
releasing the control pedal.
Safe movement of all optional instrument tray items: by adjusting the control
lever the chair is locked in place, or it can be secured in any position.
PEDAL FUNCTIONS
A. Chip blower control button/lever. Short-burst air blower.
B. Control trigger to activate and adjust the selected instrument while still on the tray.
Pressing the trigger (B): air only, no water.
Pressing the trigger (B) and lever (A): water and air, spray function.
C. Backrest returns via manual movement.
D. Descends chair via manual movement.
E. Backrest reclines via manual movement.
F. Raises chair via manual movement.
Safety:
To block any button-activated memory, press the control pedal.
When activating the control pedal, all chair movements are blocked.
This pedal does not allow any automatic memory to be saved nor does it accept
it in order to prevent any unexpected movements, except for return-to-zero. By
default, it is not incorporated.
B
D
E
A
F
C
Fig. 5

USER MANUAL
DENTAL UNIT - QS4-591-02 / SD 175
10
8.3.- Instrument tray
The instrument tray (Fig. 6), ergonomically designed to facilitate the work by the user, is also
fitted with an auxiliary instrument tray (A), a slight inclination of the main keypad (B) to provide
easy viewing, and a comfortable positioning handle (C). Use the button located on the front (D)
to release the pneumatic brake and to adjust the height position.
Should you need scroll tray, move it by means of the handle.
Do not pull instrument hoses!
The instrument layout (P) has up to five (1,2,3,4,5) positions which can be pre-configured upon
request.
Any later modifications must be carried out by an authorised technician.
The turbine and both pneumatic and electric micromotors can be situated in any of work
positions, from 1
st
to 4th.
Once their positions are set, the turbine and pneumatic micromotor are interchangeable.
- Top of tray (E) enabled as work surface. It is a supplement to auxiliary instrument tray
(A). Protection mat supplied to both surfaces, which is easily removable for autoclave
sterilisation.
- The smooth, non-porous, rounded-edge tray allows easy access for rapid cleaning and
disinfecting.
- Arm levelling (authorised technician only)
- Arm brake adjustment (authorised technician only)
- Turbine lamp with pedal-free operation.
- Instrument tray: vertical movement, 39 cm; horizontal, 75°, left, 50° right.
LOWER PART OF TRAY:
R (1, 2, 3, 4) Water controllers are aligned with each optional instrument, installed upon request
(micromotor, light micromotor, turbine, light turbine or ultrasound, respectively).
F Ultrasound power setting.
G Micromotor directional selector.
Should the turbine or micromotor spray function not work, or if there is no water
in the ultrasound, check that these regulators are fully opened by turning them
counterclockwise.
J Electric micromotor work mode selector: normal or reduced mode. This allows the user to
work at low speeds within the range of approx. 0 to 3,000 rpm. Applies to NSK M40 instrument.
K Removable tank for the micromotor and turbine lubrication oil return filter. Check
periodically.

USER MANUAL DENTAL UNIT - QS4-591-02 / SD 175
11
The tray is attached to the unit by means of a pantographic arm, with a pneumatic brake for
comfortable, effortless front positioning (handle side).
P2
P5
C
P4 DP1
A
B
E
P3
R4
G
F
K
R1R2R3 J
Fig. 6

USER MANUAL
DENTAL UNIT - QS4-591-02 / SD 175
12
8.4.- Main keypad
A. Dental light switch (ON/OFF)
B. Water cup and spittoon taps. Timed, 2-12 seconds. If spittoon and cup tap have been set-up
to work simultaneously, both are operated. It may be set up independently (then only cup).
CPress continuously: Raises backrest via manual movement.
Press once: Automatic movement to memory #2 position.
D. Press continuously: Backrest reclines via manual movement.
Press once: Automatic movement to memory #3 position
E. Spittoon return position. Pressing once moves the backrest up to the spittoon.
Pressing it a second time returns the backrest to the original position.
F. Auxiliary switch activation (non-powered contact).
Can be configured as a switch or button.
G. Spittoon water. Timed, max. 3 min. Can be switched off using the same button.
H. Yellow LED indicating electric micromotor directional change.
J. Press continuously: Raises chair via manual movement.
Press once: Automatic movement to memory #1 position
K. Chair movement positional memory storage button (settings 1, 2 and 3). First press reset.
Set the chair to the desired position using the manual function keys. Hold “Enter” key
(“K”) and press any of the three positions (1, 2 or 3); wait for the “beep” to confirm setting.
Release “Enter” key (“K”).
L. Press continuously: Descends chair via manual movement.
Press once: Automatic reset movement.
C
D
A
B
E
F
G
H
J
L
K
Fig. 7

USER MANUAL DENTAL UNIT - QS4-591-02 / SD 175
13
8.5.- Water Cabinet
The water unit has a rotation of approx. 70° towards the arm support, facilitating the ergonomics
of daily use. The upper part holds the cup holder (A) and spittoon (B), made of porcelain to offer
high standards of hygiene (fig. 8).
To avoid splashes and the passing of solids the spittoon is fitted with filter (E) and cover piece
(F) located in the drain of the spittoon (fig. 9).
Front panel (C) supports cannula filter, (D) is a lateral door towards Water Unit (fig. 8).
To get access to interior you must push gently inwards (“1”) at upper corner (K), it will open by
itself (“2”). Take in to consideration that the opening is only up to 90°.
B
C
A
D
70°
Fig. 8
FE
Fig. 9
K
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Fig. 10

USER MANUAL
DENTAL UNIT - QS4-591-02 / SD 175
14
You can easily dismount porcelain pieces of spittoon following the steps depicted in fig. 11 and
those of the tap in fig. 12.
Turn the spittoon (B) 180° (“1”), and lift it (“2”).
For the tap, first hold the glass faucet (G) upwards (“1”), then remove (“2”) the glass support
(H), so you can get access to the spittoon faucet (J), and detach it (“3”).
Inside it comes with two stopcocks to regulate the cup water (L) and spittoon water (M).
Fig. 14
M
L
Fig. 13
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G
H
J
Fig. 12
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Fig. 11

USER MANUAL DENTAL UNIT - QS4-591-02 / SD 175
15
8.6.- Cannula support (surgical suction, instruments, auxiliary keypad)
The surgical suction motor is activated by lifting any of the cannulas. The tube support
is mounted on an arm with a large capacity for movement to find the desired position. The
cannula support has an auxiliary keypad (A), medium and large capacity surgical suction (B
and C) and, as optional instruments, a 3F syringe (always placed at E), and Polymerized Lamp
or Intraoral Camera (position D).
The cannula support safety connected in sequence with the pedal, blocks any automatic or
manual movement following any slight tilt (F) of the support arm. This safety is particularly
useful following any inadvertent collisions with furniture, stools, etc.
A
B
135°
Fig. 15: The surgical air suction tubes
manifold (H) contains a changeable (G) filter,
which allows the use of foamless tablets.
The suction of a glass of clean water is
recommended after each use, cleaning the
filter at the end of each day. Always clean
using manufacturer-recommended products.
Fig. 16: Cannulas (A) and cannula-holders
(B) can be sterilised and are autoclave-safe.
If not fitted with a continuous suction system,
the separator system should be left for a short
emptying period.
SURGICAL SUCTION
Depending on the type of amalgam separator installed (Cattani, Metasys, Dürr), all manufacturers
recommend their own products and methods for disinfecting cannulas, attached to this manual.
The cannula and cannula-holder sterilisation process is the same for all systems.
Both cannula holders and tubes are safe for autoclave sterilisation. The use foamless disinfecting
tablets is recommended as these can be left to work overnight. Furthermore, the outer tubes and
tongues should be lubricated every 15 days with Lubri-Jet products, drying off any excess water.
3F SYRINGE (Optional)
The second instrument on the cannula support is the 3F syringe, with 3 functions: air, water and
spray. This instrument works independently from the control pedal. See appendix.
C D
A
B E
F
Fig. 14
Fig. 16
G
H
Fig. 15

USER MANUAL
DENTAL UNIT - QS4-591-02 / SD 175
16
8.7.- Auxiliary keypad.
The auxiliary keypad (or assistant’s keypad) is located at the cannula support (Fig. 14).
A. Cup tap and spittoon tap. Timed, 2s-12s.
It is possible to set up the spittoon and cup tap to work together or separately.
B. Pressed continuously: Raise chair. Manual chair return.
Pressed once: Automatic movement -> Memory position 1
C. Pressed continuously: Manually lowers chair.
Pressed once: Automatic movement: -> Reset.
D. Spittoon tap. Timed, 10s-180s. Can be turned off using the same button.
E. Pressed continuously: Manually raises backrest.
Pressed once: Automatic movement -> Memory position 2
F. Pressed continuously: Manually lowers backrest.
Pressed once: Automatic movement -> Memory position 3.
G. Spittoon return position. Pressing this once, moves backrest to the spittoon position.
Pressing twice, backrest returns to the original position.
A
F
D
C
B
E
G
Fig. 17