Ancar TOPCON ATE-800 User manual

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INSTRUCTION MANUAL
OPHTHALMIC TABLE
ATE-800
(MARCH - 2009)

Antoni Carles, S.A.
Volta dels Garrofers, 41-42
Pol. Ind. Els Garrofers
08340-Vilassar de Mar
(Barcelona-SPAIN)
ISO 9001 ISO13485
DCA-0274-AQ-99 DCA-0274-NA-99
T. (34) 93 754 07 97
F. (34) 93 759 26 04
[e-mail]
www.ancar-online.com/
EC Declaration of Conformity (Directive 93/42/EEC)
Manufacturer’s Name
ANTONI CARLES, S.A.
With manufacturing and putting together of medical device license number 2509-PS granted by the Health
authorities of Spain
GMDN Code and Term Type or Model:
36255 - Examination / Treatment
Ophthalmic Table Line-powered ATE-800
Device Class according to the intended use and the criteria of Annex IX of the Directive 93/42/EEC:
Class I
Scope of Application: All
Power Supply: 220-240 V ~ / 50-60 Hz
Electrical Categorization: Type B
Each kind of medical device complies with the applicable provisions of the essential principles and the
classification rules before being supplied.
This Declaration is based on Certificates of Conformity issued by DNV Spain:
#0274-1999-AQ-BAR-ENAC according to ISO 9001:2000.
#0274-1999-NA-BAR-ENAC 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 414/96,
transposition to the Spanish law of the directive 93/42/EEC. We also declare that we comply with the design
and construction requirements of the following standards:
Standards Applied:
UNE-EN 60601-1:1993 Medical electrical equipment. General requirements for safety
UNE-EN 60601-1-2:2002 Medical electrical equipment. General requirements for safety.
Electromagnetic Compatibility – Requirements and tests.
ISO 14971:2007 Medical Devices. Application of Risk Management to Medical Devices.
Authorized Signatory: Stamp, Date
ANTONI CARLES, S.A.
Pol. Ind. “Els Garrofers
C/Volta dels Garrofers, 41-42.
E-08340 VILASSAR DE MAR
BARCELONA-SPAIN
Josep Álvarez Antoni Carles Bosch
Regulatory & Safety Officer General Manager March 23, 2009
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INTRODUCTION
Thank you for purchasing the TOPCON elevation table ATE-800.
This instruction manual covers an overview of the TOPCON line-powered elevation table,
basic operations, troubleshooting, maintenance and cleaning.
To ensure the efficient, safe use, carefully read through “Safety Precautions” and use the
instrument correctly accordingly operating procedures.
Keep this instruction manual within reach for future reference
This symbol is applicable for EU member countries only.
To avoid potential negative consequences for the environment and possibly
human health, this instrument should be disposed of (i) for EU member
countries – in accordance with WEEE (Directive on Waste Electrical and
Electronic Equipment), of (ii) for all other countries, in accordance with local
disposal and recycling laws.
Chap. DESCRIPTION Page
1 EC Declaration of Conformity 2
2 Introduction 3
3 Safety Precautions 4
4 Usage and Maintenance 5
5 Description 5
6 Dimensions 6
7 Installation 7
8 Keyboard 9
9 Auxiliary Outputs 9
10 Labeling 9
11 Maintenance 10
12 Specifications 10
13 Electrical Diagram 11
14 Addresses 12
Escape Clause
 TOPCON / ANTONI CARLES, S.A. accepts no liability for damage due to fire, natural
disasters, actions by third persons or other accidents, or the negligence and misuse of the
user or if the device is used under unusual conditions.
 TOPCON / ANTONI CARLES, S.A. accepts no liability for damage deriving from the use
or inability to use this unit, such as a loss of business profits and / or suspension of
business.
 TOPCON / ANTONI CARLES, S.A. accepts no liability for the result of diagnosis using this
equipment. A doctor must take full responsibility for the medical treatment.
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 TOPCON / ANTONI CARLES, S.A. accepts no liability for damage caused by usage other
than that described in this User’s Manual.

3.- SAFETY PRECAUTIONS
Warnings
- To ensure that the product is used correctly and to avoid risk of accident to the operator
and third parties or damage to property, warnings and information have been placed on the
table and are described in the User Manual.
-Install, use and store the ophthalmic table under controlled conditions, including the
temperature range (+10ºC a +40ºC), humidity (30-80%), and atmospheric pressure (700 to
1060 hPa), dust and condensation free, and away from direct sunlight as well as salty /
sulfurous air environments.
-Do not store this equipment where chemicals are stored or gas is generated.
-To ensure that the table works correctly, place it on a horizontal, shock- and vibration-free
surface. Maintain these conditions during storage and transportation.
-The table must be installed in a well-lit area, away from areas with a lot of movement and
must be suitably conditioned for fitting the instruments and for facilitating the accommodation
of the patient and the operator.
-Before carrying out any movement of the tabletop, the operator (Doctor, user) must ensure
that no one (mainly children in between 3 and 6) within the range of height between 609 to
959 mm, is situated under the tabletops, to prevent them coming in contact with them.
-While using the unit do not leave the patient alone. Should this be necessary, switch off
auxiliary outlets by turning off the unit at the mains switch.
-Never dismount or touch the interior part of the table by removing the casing. Only
authorized technicians should carry out installation or maintenance works.
-Check that the power cable is appropriate for the voltage supplied. If the supplied voltage is
higher or lower that specified, the instrument may not work correctly and may pose a fire
hazard.
-Ensure that the sockets are duly earthed to prevent electric shock or fire in case of power
failure. For a correct installation, External Earth Connection is mandatory.
-Before using the table, connect all power cords correctly and ensure that they are in good
condition. Do not handle the power plug with wet hands.
-If any faults arise when using the ophthalmic equipment, disconnect it immediately by the
instruments switch. Consult with the technical support service.
-After using the table, disconnect all the instruments and the unit itself. Turn off the table at
the end of the working day. If the equipment will not be in use for a long period of time,
please disconnect the equipment from the mains supply by removing the power lead.
-Always unplug the lead carefully. Never tug on it. This could cause the wires inside to break
and result in a short-circuit, an electric shock or a fire.
-If care is taken not to overload the table, this will prolong the life of elevation group
components.
-The use of cell phones in the vicinity of the equipment and instruments while working should
be actively discouraged.
-Continuous or systematic use of the table may cause operator fatigue because of the height
maladjustment. The use of an adjustable-height chair is recommended to compensate for
this.
-Place the instruments on the tabletop maintaining stability, and, if possible, fixed to it. Do not
hold on to the instrument or tabletops to move the unit. If required, move the table itself by
the base and feet.
-Don’t incline the device by more than 10º when it is on the table, as it may tip over.
-The owner is responsible for keeping and maintaining the table clean and in perfect working
order.
-Do not use alcohol, abrasive or aggressive chemical products to clean the unit.
-This equipment is not designed to work in operating theatres. ATE-800 table is classified as
equipment unsuitable for use in a potentially flammable environment. Do not use when
mixtures of flammable anesthetic gas with oxygen or nitrogen monoxide are present.
-To avoid injury by falling, do not install the instrument on a thin or weak wall.
-When unit is not used over a long period of time, remove the plug from the outlet.
-Package made of corrugated paper. Re-usable and recycled material.
-Manufacturer declines any responsibility if above requirements are not followed!
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4.- USAGE AND MAINTENANCE
This elevation table is an electric instrument and it must be used in accordance with its
Instruction Manual.
User Maintenance
To maintain the safety and performance of the equipment, never attempt to repair or perform
maintenance. An authorized service representative should perform these tasks.
Repairs to the elevation group and electronic controls should be only carried out at the
manufacturer’s facilities.
Maintenance tasks that can be performed by the user are specified at the manual’s
instructions. For details, refer to the corresponding chapter.
5.- DESCRIPTION
Table intended for the ophthalmic instrument support: Slit Lamp, Ophthalmometer,
Retinographs, etc., providing auxiliary contacts for the professional working.
The equipment loaded can be moved up and down smoothly according to the height of the
patient’s eyes.
For height instrument adjustment, it disposes of an electric vertical raising group and a
displacement system made by a spindle. Equipped with silent end of runs in the raising
column (up and down) by means of two magnetic field detectors (Hall effect).
Maneuver buttons conveniently placed on tabletop for easy up and down movements.
Horizontal displacement available. Casters provided, 2 of them with locks.
This table has four auxiliary outlets CEI320 type for tabletop instrument providing a total power
seized up to 230V / 50Hz / 850 VA, available while operating simultaneously the elevation
group. They have associated a switch placed underneath tabletop.
Optional elements, can be put together accordingly user needs. Regarding tabletops there is
one choice to be made: there are two tabletops, one specific for Slit Lamp instruments, and a
second one, for general purposes (which is a little bit bigger).

6.- DIMENSIONS
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7.- INSTALLATION
Turn upside-down elevation group (3) and lean it on wood plug.
First remove covers (10, 11) from base frame (6).
To assemble it into lift column, pass wire through hole (5). Then screw on to fix elevation
group into base with the help of screws (8) and washers (3 of them standard ones, flat ones,
“9”, and one to assure electrical safety, earth continuity, a glover washer, “7”).
Accordingly to electrical diagram connect up column wire to earth grounded 3-wired electrical
connector (4).
Place back covers (10, 11) with the help of screws (12).
When turning the right way up, you should have to face accordingly next image: please notice
position of hole (2) so that it could match with tabletop support frame.
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Before placing tabletop support frame, remove wood plugs (in previous image, details “1” and
“2”). Frame is fixed on top of lift column with screws (3).
Please pay attention when passing cabling through hole (5).
Disassemble cover (8) to get access to the connection to be made in connector (7) and
proceed in order with electrical diagram.
Place covers with the help of screws (6).
Keyboard wires have also to be connected.
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8.- KEYBOARD
The table moves up and down by pressing the up & down
switch.
Detail about up (“1”) & down (“2”) maneuver control placed
on tabletop.
Both push buttons have light incorporated.
9.- AUXILIARY OUTPUTS
There are four available outlets placed under tabletop.
They have an on/off switch associated that can be located below frame.
You’ll find a mark helping to find its location at the vertical edge of the tabletop base.
When power supply is turn on it has incorporated also a light led lighting.
10.- LABEL
Labels placed by the outputs identifying the isolated one.
Identification level placed near entry of power supply.
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11.- MAINTENANCE
Surfaces of the table can be cleaned by a cotton piece dampened with water and neuter soap.
Dry up immediately. Do not splash with water or any other liquid. Do not blow spray cleaner
directly into the unit. It could travel through a clearance around the switches and cause
electrical problems. A fire or electric shock may occur as a result.
You must never clean with alcohol, abrasive or chemical products!
If table does not operate, may be that motor thermal had actuated (after continuous
operation), in that case wait for its reestablishment. Furthermore:
-Check supply voltage according to the table model: 230Vac (± 10%) 50/60Hz (±1 Hz).
-Check if power cord has come out of the outlet. Insert the power plug securely.
-Check main switch status. Turn it on.
-Check if fuses have blown out.
Before replacing or checking fuses, make sure power switch is turned off and power cord has
been removed from the outlet. If fuses have blown out, use the specified rated values.
If after a certain time any anomaly persists, call the technical service!
In the event of a smoke comes from the table, immediately turn off the power switch and
remove the power plug from the outlet.
Make sure fixation bolts are tightened securely. When a bolt becomes loose, tabletop may lay
off, causing the table to tip over or loaded equipment to fall off and caused an injury.
12.- SPECIFICATIONS
Technical Features
Concept
Total Power 220-230 Vac / 50-60 Hz
Maximum Consumption 1.300 VA
Electrical classification Class I, Type B
Electrical protection degree IP21
Maximum overload of instruments on tabletop 80 Kg.
Maximum overload on PC holder 15 Kg.
Maximum overload on Printer support 10 Kg.
Stroke 350 mm.
Horizontal displacement Casters.
Net weight / Gross weight 38.2 kg. / 47.5 kg.
Duty cycle (on/off) tabletop elevation motor 1/29 minutes
Fuses (consumable part) 2 x F6.3A / 250V
Electrical Safety
In order to use with a completely safety, the equipment disposes of the following protection
elements:
Concept
Protection against electric shock Earth connection, Class I Type B
Maneuver voltage 12Vdc (Very Low Safety Voltage)
Electrical classification Class I, Type B
Rigidity of transformer Separated winding isolation 3,9 Kv
Motor overload protection By thermal protector
Failure power supply Stationary equipment
Short circuit protection By fuses (see electric diagram)
Plug connection Previous earth connection
Auxiliary outlets 4 outlets up to 850 VA
Subject to change in performance and / or appearance without prior notice for future improvement.
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