Topcon IS-100 User manual

OPHTHALMIC UNIT
IS-100
USER
MANUAL
Rev. 6
November 2019

OPHTHALMIC UNIT
IS-100
Rev. 6 - November 2019Rev. 6 - November 2019
2USER MANUAL

OPHTHALMIC UNIT
IS-100
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Rev. 6 - November 2019
USER MANUAL USER MANUAL
1. INTRODUCTION 1-1
1.1. USE OF THE MANUAL 1-1
1.1.1. Symbols used in the manual 1-1
1.1.1.1. Warnings throughout the manual 1-1
1.2. PLATES AND LABELS 1-2
1.3. GLOSSARY 1-4
1.4. GENERAL CONSIDERATIONS 1-5
1.4.1. Intended use of the unit 1-5
1.4.2. Foreseeable misuse of the unit 1-6
1.5. INTELLECTUAL PROPERTY 1-6
1.6. WARRANTY 1-7
1.7. SPARES 1-9
2. GENERAL 2-1
2.1. SAFETY 2-1
2.2. MECHANICS 2-2
2.3. ELECTRICS 2-3
2.3.1. Electromagnetic Interference EMC 2-3
2.4. GASES 2-4
2.5. ENVIRONMENTAL MANAGEMENT 2-5
3. DESCRIPTION OF THE UNIT 3-1
3.1. CHARACTERISTICS 3-2
3.1.1. Unit IS-100 3-2
3.1.2. Ophthalmology chair OC-8 3-3
3.1.3. Unit dimensions 3-4
3.2. DESCRIPTION OF THE COMPONENTS 3-5
3.2.1. Ophthalmic unit 3-5
3.3. OPHTHALMOLOGY CHAIR 3-6
3.4. LENS DRAWER (OPTIONAL) 3-7

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4. HANDLING OF THE UNIT 4-1
4.1. NORMAL OPERATIONS 4-1
4.1.1. Switching on the unit 4-1
4.1.2. Switchingtheunito 4-1
4.1.3. Switchingotheunitforlongperiods 4-1
4.2. OPERATING ITEMS 4-1
4.2.1. Keypad 4-2
4.2.2. Phoropter arm (Optional) 4-3
4.2.3. Tabletop 4-5
5. TRANSPORT, INSTALLATION AND
STORAGE 5-1
6. MAINTENANCE 6-1
6.1. INTRODUCTION 6-1
6.2. CLEANING 6-3
6.3. CORRECTIVE MAINTENANCE 6-3
6.3.1. Thermalrepairofsupercialscratchesonthetabletop 6-3
6.3.2. Lifting motor of the chair not operational 6-4
7. ACCESSORIES 7-1
8. ANEXOS 8-1

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1. INTRODUCTION
This User Manual contains important and essential information for the correct
handling of the ophthalmic unit IS-100, manufactured by ANCAR and proper
maintenance of the same.
It also contains safety instructions that must be faithfully followed to avoid
accidents to people and to the unit.
1.1. USE OF THE MANUAL
1.1.1. Symbols used in the manual
Throughout the manual there are various symbols and warnings that alert and
notify the degree of importance of certain texts. The ones used are presented
and explained below.
1.1.1.1. Warnings throughout the manual
DANGER CALLS ARE A MEANS OF ATTRACTING ATTENTION TO
ESSENTIAL OR CRITICAL INFORMATION.
WARNINGS INCLUDE INFORMATION ON CONDITIONS,
PRACTICES OR PROCEDURES THAT MUST BE OBSERVED TO
PREVENT:
yPERSONAL INJURY.
yDISABLING OF THE DEVICE.
Calls for caution are used to describe the conditions, practices or
procedures that must be followed to avoid:
yDamaging equipment.
yDestroying equipment.
yEndangering health in the long-term.

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Notes are used to highlight information of particular importance or
interest that:
yMust be remembered.
yFacilitates a correct decision.
yOtherwiseitishardtond.
These are descriptions of both procedures and characteristics in
which it is advisable to consider the possible repercussions in the
environment of certain actions or choices, mainly of products to be
used.
1.2. PLATES AND LABELS
The following labels are put on the unit:
Figure 1-1. Ophthalmic Unit plate IS-100.

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Figure 1-2. Ophthalmology chair plate OC-8.
Figure 1-3. Warning in the entrance area at 110-240 V.
Figure 1-4. Please refer to the user manual.

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Figure 1-5. Type B electrical classication.
Figure 1-6. Foot entrapment hazard.
1.3. GLOSSARY
Table 1-1. Glossary.
TERM DEFINITION
ANCAR Acronym of the company ANTONI CARLES, S.A.
EM Electromagnetic
EMC Electromagnetic compatibility.
Ophthalmic Related to the eyes.

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1.4. GENERAL CONSIDERATIONS
THIS USER MANUAL SHOULD BE CONSIDERED AN INTEGRAL
PART OF THE UNIT AND MUST STAY WITH IT THROUGHOUT ITS
LIFE CYCLE.
THE PEOPLE IN CHARGE OF THE UNIT MUST READ AND
UNDERSTAND THE MANUAL IMPERATIVELY BEFORE ITS
COMMISSIONING AND USE.
The user is in charge of keeping the unit in perfect operating
conditions, cleaning.
The ophthalmic unit, manufactured and designed by ANCAR, is a
class I device, according to Directive 93/42/EEC (as amended in
accordance with 2007/47/EEC). See EC Declaration in the Annex.
TOPCONreservestherighttomakeimprovementsormodications
to the unit without prior notice.
1.4.1. Intended use of the unit
The IS-100 unit is foreseen to facilitate support and positioning of ophthalmic
instruments used during examination and diagnosis of patients. To do this, it has
electronically regulated power contacts and patient seating using an electric
lifting group.

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1.4.2. Foreseeable misuse of the unit
TOPCON/ANCARisnotliableformaterialdamagessueredbythe
unit or personal injury that may be caused by the misuse of the same.
Below are a number of uses for which the unit is not designed:
yTo support or hold furniture or other materials.
yFor interventions in operating theatres.
yTo access elements at heights.
yLean or sit on the junction box or the tabletop.
yHang from the lamp.
1.5. INTELLECTUAL PROPERTY
This user manual, including drawings, operating diagrams and annexes, are the
intellectual property of ANCAR, which reserves the right to modify its content
without having to update the preceding manuals.
They will not be accessible to third parties without its express authorisation.
They are only available to users of the units.
It is not allowed to copy, publish and disseminate, in whole or in part, documents,
or make them available to others, in particular, of competing companies and
without the prior authorisation of ANCAR.

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1.6. WARRANTY
yTOPCON/ANCARshallnotbeliablefordamagesduetore,naturaldisas-
ters, actions undertaken by third parties or other accidents (caused by the
negligence or misuse of the operator) or due to the use of the unit under
unusual conditions.
yTOPCON/ANCAR shall not be liable for damage derived from inappropriate
useofthedevice,suchaslossofbusinessorlossofprots.
yTOPCON/ANCAR shall not be liable for the results of diagnoses made by a
doctor when using this device.
Devices manufactured by ANCAR are warranted for a period of 2 years, from
the date of installation correctly recorded on the form in the website. During this
period, ANCAR, assumes the repair or supply free of charge, of those parts of the
devicethat,onceveried,arerecognisedasdefective.Itshallnotbeliablefor
defects and their consequences, produced by:
yNatural wear.
yInadequate cleaning or maintenance.
yAccidental knocks.
The right to compensation for damages and replacement of the entire device
are also excluded.

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TOPCON/ANCAR's liability ceases, automatically cancelling the warranty, in the
following cases:
1. If within 30 days from the date of installation, registration is not formalised
on the website.
2. If interventions on the device are not made by technicians certied by
TOPCON/ANCAR.
3. If incorrect maintenance operations are made on the device, or non-original
spare parts are used.
4. If the electrical installation required for the operation of the device is carried
out not observing the indications in the maintenance or the provisions of
the current standards of the country of use are not observed.
5. Ifnon-authorisedmodicationsaremadeonthedevice,orothermedical
devices and/or accessories not foreseen by TOPCON/ANCAR are
connected.
6. In the case of a complaint about the conditions of the device delivered, the
buyer may not delay or suspend payments.
Breach at the time of sale as a new product, of points 4 and 5, exempts TOPCON/
ANCAR of liability relating to the CE mark, which shall be transferred to the seller,
which should be considered for all purposes as assimilated to the manufacturer
of the device.
The warranty for the integrated elements of other brands, will be that granted by
each of the respective manufacturers, with TOPCON/ANCAR not assuming any
liability or obligation in regard to this warranty.
Parts under warranty to be repaired or replaced must be sent to the warehouses
of TOPCON/ANCAR with postage paid, indicating the device number they
belong to.

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It is necessary to complete a form provided by TOPCON, specifying
the returned material.
The warranty is only valid if the appliance has been used correctly
and installed by authorised technical personnel.
If within the warranty period a fault were to arise the cause of which is uncertain
and may lead to the use of the warranty by the customer, the latter must promptly
notify this to the TOPCON dealer.
TOPCON/ANCAR shall investigate the cause and chargeability of the damage
and, in the meantime, it must keep the unit in the conditions it ended up in as a
result of the fault.
TOPCON/ANCAR shall not be liable for defects caused by improper handling of
the unit or non-compliance with the instructions contained in this manual.
The user of the ophthalmic unit is not authorised to make any repairs
or replace any components. If assistance is needed, contact the
TOPCON dealer.
1.7. SPARES
If spare parts are needed of any of the components of the unit, contact the dealer
of the ophthalmic unit.

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2. GENERAL
2.1. SAFETY
For the correct and safe use of the unit, it is necessary to identify the hazards
theunitmighthave,aswellasobservethesafetymeasuresdenedbytheuser:
yInstallation and handling of the products of TOPCON/ANCAR should be
carried out by authorised personnel. In particular, electrical connections
mustbecarriedoutonlybyqualiedspecialists.
yIt is forbidden to perform any replacement or remove protective caps.
yDo not attempt to repair any material after a fault or damage and put it back
into operation again. In these cases, it is essential to contact TOPCON’s
ocialdealer.
yNo liability can be accepted for damage caused as a result of a misuse.
yStore or install the unit in a controlled environment the conditions of which
conformtothespecicationbelow:
Temperature: 10 ºC - 40 ºC
Moisture: 30% - 75%
Atmospheric pressure: 700 hPa - 1060 hPa
Free from condensation and dust.
Not exposed to direct sunlight.
yIn the event of an anomalous situation, disconnect the unit immediately and
consult the technical support team.
yThe unit must be installed in a place where it can be easily disconnected.
yPlace the instruments centred on the tabletop, and if possible, fastened to
it. Do not use them to move the tabletop.

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yDonotleavethepatientwithoutdirectsupervisionofsta.Ifnecessary,dis-
connect the unit with the main switch.
yBoth of the patient’s feet must be on the footrest before operating the auto-
matic lowering of the chair, in order to avoid potential entrapments.
yThe parts touching the patient are the chair and the tabletop. Pay special
attention to keeping these parts away from the live parts under normal con-
ditions. Make sure there is no conductive connection to any metal parts that
are not grounded.
yDonotremovecoversoraccesstheinternalparts.Onlythetechnicalsta
has the know-how to carry out installation or maintenance work, in particu-
lar repairs on the electronic control elements and the elevation of the chair.
yDo not place objects on the cover or the drawer (optional) underneath the
tabletop, as when it is returned to its resting position the latter may become
trapped.
yToavoidtheinstalledinstrumentsfromsueringadverseeects,useofmo-
bile phones and other devices that emit waves in the surroundings of the
device while it is being used is discouraged.
yBefore moving the tabletop in any way, make sure that no one is underneath,
especially children.
yDo not place the patient on the footrest. Place him or her on the chair with
the footrest in its vertical position.
2.2. MECHANICS
yDo not overload the tabletop. Observing the maximum weight to be borne
by the tabletop prolongs the useful life of the components.
yDo not use the tabletop or the keyboard desk for sitting, to prevent damage
to the unit and possible falls.

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2.3. ELECTRICS
yWhen disconnecting the power outlet, do so carefully. Never pull the cable
because this can cause cracks in the internal wires, resulting in a short cir-
cuit,electricshockorre.
yThevoltagesocketmustcorrespondtopowerspecications.Variationsin
themainvoltagecanaecttheoperationoftheinstrument.
yBefore using the unit, connect all power cables properly and make sure they
are in good condition.
yDo not handle the power socket with wet hands.
yTo avoid the risk of electrocution, only connect the unit to supplies with a
ground connection.
2.3.1. Electromagnetic Interference EMC
The ophthalmic unit is in conformity with the essential requirements, applicable
to it, of the Medical Device Directive MDD 93/42/EEC, complying with the
requirements of design and construction contained in the standards EN60601-
1 and EN60601-1-2 regarding the Safety of Medical Electrical Equipment and
Electromagnetic Compatibility, thus not causing electromagnetic disturbances,
and complying with immunity standards. To avoid this, the unit requires special
attention to the following requirements of the EMC regulation:
yItmustbeinstalledandconguredinaccordancewiththeEMCguidelines
included in the applicable documentation.
yMobileRFcommunicationdevices(e.g.cellphones)mayaectthemedical
instrument.
yTheuseofaccessories,transducersorcablesotherthanthosespecied
or supplied by the manufacturer may lead to an increase in emissions or a
reduction in the protection of the unit from them.
yThe unit should not be used near other equipment. Where this proximity is
necessary,theentiresystemmustbecheckedtoensurethenalcongu-
ration is working properly.

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yA minimum distance of 30 cm should be kept between cellphones and the
unit.
yIt is possible to avoid EMC interference by keeping a minimum distance
away from the transmitting device, depending on the intensity of its signal.
yThe unit is designed to operate in an electromagnetic environment, provid-
ed interferences are kept under control.
yAny of the described situations that does not meet the precautions men-
tionedmighthaveanegativeaectontheusefullifeoftheproduct.
yDirect simultaneous contact between the user, the patient, and non-EM
equipment is not foreseen.
2.4. GASES
Theunitisclassiedasadevicenotdesignedtoworkinapotentiallyammable
environment. Therefore, it must not be located in operating theatres, in the
presenceofammableanaestheticgaswithoxygenornitrousoxide.

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2.5. ENVIRONMENTAL MANAGEMENT
The user, as a producer of waste caused during the use of the device,
is responsible for the proper management of the same according to
the legislation in force.
All the materials used for packaging respect the environment and are recyclable:
woodenpallet,cardboard,polyethylenebagandbubblelm.Collectionofthe
materials used favours the reduction of waste material.
TOPCON/ANCAR are committed to achieving the objectives of Directives
2011/65/EC and 2012/19/EC.
The symbol of the Figure 2-1 is only applicable for member states of the European
Union. In order to avoid potential negative consequences for the environment
and possibly for human health, this device has to be removed:
yIn the member countries of the EU: according to WEEE (Waste Electrical
and Electronic Equipment Directive).
yFor the rest of the countries: according to local regulations and laws.
Figure 2-1. Environmental management

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3. DESCRIPTION OF THE UNIT
The unit is designed to facilitate support and positioning of ophthalmic
instruments used during examination and diagnosis of patients. To do this, it has
electronically regulated power contacts and patient seating using an electric
lifting group.
The Figure 3-1 shows the components of the unit.
1Ophthalmic unit.
See Section 3.2.1.
2Ophthalmology chair.
See Section 3.3.
3Phoropter arm (optional).
4Lens drawer (optional).
See Section 3.4.
5Support CV5000 PS (optional).
6Near vision lamp (optional).
3
1
2
4
6
4
5
Figure 3-1. Components of the unit.

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3.1. CHARACTERISTICS
3.1.1. Unit IS-100
CHARACTERISTIC VALUE
Power supply 110-240 VAC / 50-60 Hz
Consumption 850 VA
Electricalclassication Class I / Type B
Maximumpowerofthersttabletop
instrument 160 VA
Maximum power of the second tabletop
instrument 150 VA
Slow start system (bulb protection) Yes
Unit lamp output 24 VDC - 9 W
General protection (junction box)
220 V: 2 x F4A/L/250 V
Ø5 x 20 mm
110 V: 2 x F8A/L/250 V
Ø5 x 20 mm
Net weight 120 kg
Gross weight 140 kg
Maximum load on the tabletop 35 kg
Maximum acceptable load for support 3
(phoropter) 10.3 kg
Maximum acceptable load for support 3 (light,
screen, etc.) 6 kg