instruction manual slit lamp sl-1e - acme revival · 2020. 5. 20. · this instruction manual...

INSTRUCTION MANUALSLIT LAMP

SL-1E

INTRODUCTION

Thank you for purchasing the TOPCON SL-1E Slit Lamp.

This instrument is used for the magnified observation of the anterior segment of theeye and its parts.

This SL-1E has the following features:• Smooth mechanical movements• Bright and clear observation of the eye with natural color rendition• Apochromatic optical system to enhance natural color and resolution• Robust construction for performance and durability

This Instruction Manual covers an overview of the basic operation, troubleshooting,checking, maintenance and cleaning of the SL-1E Slit Lamp.To get the best results from this instrument, read "Displays for Safe Use" and "SafetyCautions".Keep this Instruction Manual close at hand for future reference.

PRECAUTIONS

The patient who undergoes an examination by this instrument must maintain concen-tration for a few minutes and keep to the following instructions:To fix the face to the chinrest, forehead rest, etc.To keep the eye open.To understand and follow instructions when undergoing an examination.

WARNINGTo avoid injury to the patient’s eye and nose, pay particular attentionwhile operating the instrument body.(The patient may be injured.)

CAUTIONThis instrument must not be used for the following patients:

• Patients who are hypersensitive to light• Patients who recently underwent photodynamic therapy (PDT)• Patients taking medication that causes photosensitivity.

This symbol is applicable for EU member countries only.To avoid potential negative consequences for the environment and possibly humanhealth, this instrument should be disposed of (i) for EU member countries - inaccordance with WEEE (Directive on Waste Electrical and Electronic Equipment),or (ii) for all other countries, in accordance with local disposal and recycling laws.

WARNING : Handling the cord on this product or cords associated withaccessories sold with this product, will expose you to lead, a chemical knownto the State of California to cause birth detects or other reproductive harm.Wash hands after handling.

CAUTION : Federal laws restricts this device to the sale by or on the order of a physician.

1INTRODUCTION

CAUTIONS FOR USE

Use this instrument carefully on the following patients:• Patients who have epidemic corneitis, conjunctivitis or any other infectious disease• Patients who are taking medications that cause light hypersensitivity.Be careful not to let the patient touch this instrument. The patient's hand may be pinched by themovable part.To avoid injury or fire caused by electric shock, turn off the power switch and unplug the powercord. Then, replace the fuse with the rated one.To avoid injury caused by electric shock, turn off the power switch when replacing the lamp.To avoid burns caused by heat, do not replace the lamp with a new one immediately after itgoes off.When operating the base unit, please note the following:• Beware of catching fingers in the moving parts.• Avoid hitting the patient's eyes or nose.To avoid injury to the patient's head, incline the illumination unit slowly while holding the baseunit.

Disposal

When disposing the instrument and/or parts, follow the local regulations for disposal and recy-cling.

STORAGE PLACE, USAGE PERIOD

1. When storing the instrument, ensure that the following conditions are met:(1) The instrument should not be splashed with water.(2) Store the instrument where environmental conditions are appropriate.(3) Do not store or transport the instrument on a slope or uneven surface or in an area

where it is subject to vibrations or instability.(4) Do not store the instrument where chemicals are stored or gas is generated.

2. Usage period8 years from delivery providing regular maintenance is performed (according to the self-cer-tification [TOPCON data])

USER MAINTENANCE

1. Regularly maintain and check the instrument and its parts.2. When using the instrument after a prolonged period of inactivity, confirm normal and safe

operation beforehand.3. Keep the objective lens free from finger prints and dust.4.When not in use, protect the instrument with the dust cover.5.If the objective lens is stained, clean it following the "Cleaning" instructions listed in this

Instruction Manual.

2INTRODUCTION

DISPLAYS FOR SAFE USE

In order to ensure the safe use of the product and to prevent harm to the operator and others, ordamage to property, a number of important warnings are placed on the product and inserted in theinstruction manual.It is recommended that all users understand the meaning of the following displays and iconsbefore reading the "Safety Cautions" text.

DISPLAYS

ICONS

DISPLAY MEANING

WARNING Ignoring or disregarding this display may lead to death or seri-ous injury.

CAUTION Ignoring or disregarding this display may lead to personal injuryor physical damage.

Injury refers to cuts, bruises, sprains, fractures, burns, electric shocks, etc. Physical damage refers to damage to buildings, equipment or furniture.

ICON MEANING

This indicates Prohibition.Specific content is expressed with words or an icon either insertedin the icon itself or located next to the icon.

This indicates Mandatory Action.Specific content is expressed with words or an icon either insertedin the icon itself or located next to the icon.

This icon indicates Hazard Alerting (Warning).Specific content is expressed with words or an icon either insertedin the icon itself or located next to the icon.

3DISPLAYS FOR SAFE USE

SAFETY CAUTIONS

WARNING

Icon Prevention item Page

To avoid fire and electric shock in case of leakage, be sure to usea grounded outlet. Do not connect to outlets that are not grounded.

15

To avoid electric shock, unplug the power cord from the groundedoutlet before removing the fuse cover. Do not connect the powercord to the grounded outlet with the fuse cover not correctlyattached.

30

To avoid fire in the event of an instrument malfunction, immedi-ately turn OFF the power switch ( ) and disconnect the powercord from the instrument if you see smoke coming from the instru-ment, etc.Don't install the instrument where it is difficult to disconnect thepower cord from the instrument. Ask your dealer for service.

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CAUTION

Icon Prevention item Page

To avoid electric shock, do not touch the external connection ter-minal and the patient at the same time.

31,34

This instrument has been tested (with 100/120/230V) and foundto comply with IEC60601-1-2: Ed.3.0 : 2007 as class A (classifiedaccording to CISPR11).According to IEC60601-1-2, this instrument is more suitable toconnect with exclusive power supply system in establishmentsuch as hospital, etc than it connects with the domestic electricitypower supplies.This instrument radiates radio frequency energy within standardand may affect other devices in the vicinity.If you have discovered that turning on / off the instrument affectsother devices, we recommend you change its position, keep aproper distance from other devices, or plug it into a different out-let. Please consult your authorized dealer if you have any addi-tional questions.

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4SAFETY CAUTIONS

MAINTENANCE

USER MAINTENANCE

To maintain the safety and performance of the instrument, never attempt to do mainte-nance of items other than those specified here unless done by an authorized service engi-neer. For details about maintenance, read the chapter entitled "Maintenance" in thismanual.

REPLACING THE ILLUMINATION LAMP

The illumination lamp can be replaced if necessary. For specific instructions, see page 31.

REPLACING THE FUSES

Fuses on the primary side can be replaced if necessary. For specific instructions, seepage 30.

DISCLAIMERS TOPCON is not responsible for damage due to fire, earthquakes, actions or inactions

of third persons or other accidents, or damage due to negligence and misuse by theuser and any use under unusual conditions.

TOPCON is not responsible for damage derived from inability to properly use thisequipment, such as loss of business profits and suspension of business.

TOPCON is not responsible for damage caused by operations other than thosedescribed in this Instruction Manual.

The device does not provide a diagnose of any condition or lack thereof or any recom-mendations for appropriate treatment. The relevant healthcare provider is fully respon-sible for all diagnose and treatment decisions and recommendations.

5MAINTENANCE

WARNING INDICATIONS AND POSITIONS

To ensure safety, warning labels are placed on the instrument body.Use the instrument according to these warning instructions. If any of the following labels are miss-ing, contact your dealer or TOPCON (see the back cover for contact information).

CAUTIONWhen operating the base unit, notethe following:Pendant la manipulation de la basede l'instrument, veillez prendre lesprécautions suivantes; To prevent fingers from being

caught in between, be aware ofmoving parts.Prenez garde aux pièces mobilesafin d'éviter be coincer les doigts.

Keep a safe distance from thepatient's face to prevent injuries tothe nose and eyes.Gardez une distance de travailappropriée afin d'éviter le contactavec les yeux et le nez du patient.

CAUTION To prevent electric shock, switch off the power supply and remove

the power cable before replacing the lamp.Afin d'éviter tout choc électrique, coupez le contact et débranchezle câble d'alimentation avant de remplacer l'ampoule.

To avoid burns, do not touch the lamp immediately after switchingthe instrument off.Afin d'éviter toute brûlure, prenez garde à la température élevée del'ampoule lorsque le remplacement de celle-ci se fait immédiate-ment après avoir coupé l'alimentation électrique.

Degree of protection against electric shock:TYPE B APPLIED PART

[Refer to instruction manual]

[Refer to instruction manual]

6WARNING INDICATIONS AND POSITIONS

CONTENTSINTRODUCTION ...............................................................................................................1DISPLAYS FOR SAFE USE ..............................................................................................3SAFETY CAUTIONS .........................................................................................................4MAINTENANCE .................................................................................................................5DISCLAIMERS ...................................................................................................................5WARNING INDICATIONS AND POSITIONS ....................................................................6

CONFIGURATION .................................................................................................................9

NAMES OF MAIN BODY COMPONENTS ........................................................................9CONFIGURATION OF PARTS IN CONTACT WITH PATIENT ........................................9STANDARD ACCESSORIES ..........................................................................................10

COMPONENTS ....................................................................................................................11

COMPONENTS ...............................................................................................................11

ASSEMBLY PROCEDURE ...............................................................................................12

ASSEMBLY PROCEDURE ..............................................................................................12CHECKING PROCEDURE ..............................................................................................15

OPERATION PROCEDURES ..........................................................................................16

PREPARATION-DIOPTER COMPENSATION AND INTERPUPILLARY DISTANCE ADJUSTMENT ..............................................................................................16PATIENT POSITION ........................................................................................................17BASE OPERATION .........................................................................................................17OPERATION OF THE ILLUMINATION UNIT ..................................................................18

TROUBLESHOOTING ........................................................................................................19

TROUBLESHOOTING GUIDE ........................................................................................19

SPECIFICATIONS ...............................................................................................................20

ENVIRONMENTAL CONDITIONS ..................................................................................22ELECTROMAGNETIC COMPATIBILITY .........................................................................23OPTICAL RADIATION HAZARD .....................................................................................27SYSTEM CLASSIFICATION ............................................................................................28PURPOSE OF USE .........................................................................................................28OPERATION PRINCIPLE ................................................................................................28SHAPE OF PLUG ............................................................................................................29SYMBOL ..........................................................................................................................29

MAINTENANCE ....................................................................................................................30

DAILY CARE ....................................................................................................................30REPLACING THE FUSE .................................................................................................30REPLACING THE CHINREST PAPER ...........................................................................30REPLACING THE ILLUMINATION LAMP .......................................................................31CLEANING .......................................................................................................................32ORDERING SUPPLIES ...................................................................................................33USER MAINTENANCE ITEMS ........................................................................................33

OPTIONAL ACCESSORIES .............................................................................................34

FIXATION TARGET .........................................................................................................34

7CONTENTS

HRUBY LENS ..................................................................................................................3510×MEASURING EYEPIECE ..........................................................................................3616×EYEPIECE .................................................................................................................36ACCESSORY DRAWER .................................................................................................37APPLANATION TONOMETER ........................................................................................37AUTOMATIC INSTRUMENT TABLE AIT-15 ...................................................................37

8CONTENTS

CONFIGURATION

NAMES OF MAIN BODY COMPONENTS

CONFIGURATION OF PARTS IN CONTACT WITH PATIENT

Forehead rest : Polyamide resinChinrest : Polyamide resin

JoystickBase locking knob

Rail cover

Base

TableBrightness control switch

Power switch

Pilot lamp

Click stop

Lamphouse coverclamping screw

Lamphouse cover

Filter selection lever

Aperture and slit lengthcontrol wheel

Slit width control knob

Slit rotation control ring

Magnification changer lever

Microscope arm locking screw

Illumination arm locking screw

Chinrest adjuster

Chinrest *1

Canthus marker

Forehead rest *1

Fixation target mounting holes

Chinrest jack

Cap

10 Eyepiece

*1 : Contacting part (class B)

9CONFIGURATION

STANDARD ACCESSORIES

Make sure that all the following standard accessories are included.Figures in parentheses are the quantities.Some accessories are not included as standard depends on the model.

Chinrest paper (1) Focusing test rod (1)

Spare illumination lamp (1) Spare chinrest paper pin (2)

Spare fuse (1) Brush (1)

Dust cover (1) Instruction manual (1)

Accessory box (1) Phillips screwdriver (1)

Wrench (not supplied with unit model slit lamp) (1)

10CONFIGURATION

COMPONENTS

COMPONENTS

(1) Main unit (2) Instrument type table (w/power supply)

(2)’ Unit type table (w/power supply) (3) Rail cover

(4) Chinrest unit (5) Power cable

Article name Q'ty

(1) Main unit 1

(2) Instrument type table (w/power supply) 1

(2)' Unit type table (w/power supply) 1

(3) Rail cover 2

(4) Chinrest unit 1

(5) Power cable 1

11COMPONENTS

ASSEMBLY PROCEDURE

ASSEMBLY PROCEDURE

(1) Selecting Voltage and Fuse

* Check the setting on the voltage selector, which is located on the bottom of the power supply.* If the selector does not match the outlet voltage, turn the selector to the proper setting with a

screwdriver.* Turn the center of the fuse holder with the Phillips screwdriver, remove the fuse and check it's

rating. Insure that the fuse is the correct rating for the supplied voltage:

(except for U.S.A. and Canada) (for U.S.A. and Canada)F1, F2: T1AL 250V(100, 120V) F1, F2: T1AL 250V(120V)

T500mAL 250V(220, 240V) T500mAL 250V(220V)F3: F4AL 125V F3: F4AL 125V

(2) Mounting the Table

(a) To attach the table on the instrument table AIT-15, use the four 8×24mm bolts with lockingwashers.

* Raise the table to allow the bolts to pass through the mounting flange.* Place the table on the mounting flange of the table and screw the bolts into the mounting

bracket. The controls of the power supply should face the practitioner. Tighten the boltssecurely with the included wrench.

Display window Voltage selector

Fuse holder[except for U.S.A. and Canada]

Voltage selector

Fuse holder[for U.S.A. and Canada]

Bolt

12ASSEMBLY PROCEDURE

(b) To secure the unit model table to the ophthalmic unit.

* Peel off the tape which secures the plastic washer to the mounting bracket's shaft.* Insert the shaft of the mounting bracket into the hole of the arm on the ophthalmic unit. The

plastic washer should be between the mounting bracket and the arm.Note: The power supply is attached to the left side of the unit top (practitioner's view). If the

ophthalmic stand is located to the left of the ophthalmic chair, the power supply mustbe relocated to the right side of the unit top to prevent interference with the arm. In thisinstance, remove the four wood screws which attach the power supply to the unit top,re-position the power supply in a similar position to the right side of the unit top, and re-attach the power supply with the four screws.

(3) Mounting the Chinrest

* Remove the four screws which are attached to the chinrest mounting plate with the Phillipsscrewdriver.

* Place the chinrest cord in the gap between the chinrest mounting plate and the chinrestassembly. While making sure that the cord is not being pinched by the mounting plate, re-tighten the previously removed screws.

Washer

Chinrest cord

Chinrest mounting plate

Screw


(4) Mounting the Main Unit

* Place the wheels of the base assembly evenly on the table rails.* After checking to see that the main unit moves smoothly on the rails, insert the rail covers in

the space between the rail and table.* Remove the protective tape from the illumination unit and the hole cap while being careful to

avoid touching the lens surface.

(5) Connecting Cables

* Connect the chinrest cable, main body cable and power cable to the power supply.* Remove the cable clips from the bottom of the table top, slip them over the chinrest and

power cables and re-attach them to the table.

Tape

Wheel

Rail

Cable clip


(6) Installing the Chinrest Paper

* Remove the two pins from the chinrest.* Place the pins through the holes in the chinrest paper. Remove the wrapping from the chin-

rest paper.* Align the pins with the holes in the chinrest and secure the paper to the assembly.

(7) Accessory Box

* An accessory box is supplied to store the accessories.

CHECKING PROCEDURE

(1) Power Plug

* Make sure that the instrument is always properly grounded.

(2) Illumination and Instrument Functions

* Turn the power supply on and observe that the illumination is passing through the opened slitcontrols.

* Check to see that the slit width and length controls, filter lever and magnification changerlever operate smoothly and properly.

(3) After the installation is completed, turn the power supply off and cover the instrumentwith the dust cover.

WARNING To avoid fire and electric shock in case of leakage, be sure to use agrounded outlet. Do not connect to outlets that are not grounded.

Pin


OPERATION PROCEDURES

PREPARATION-DIOPTER COMPENSATION AND INTERPUPILLARY DIS-TANCE ADJUSTMENT

Before using the instrument, always carry out the diopter compensation and interpupillary dis-tance adjustments.

(1) Use of the focusing test rod

The focusing test rod which is a standard accessory, is used to establish the proper micro-scope settings for each use.Insert test rod in the hole in chinrest with the flat surface at the top of test rod facing the micro-scope.

(2) Preparation of illumination unit

* Turn the power switch ON. Set the brightness control switch at the '0.1' position.* Turn aperture and slit length control wheel until slit diameter becomes 14mm, then turn slit

width control knob to set slit width to maximum.* Use joystick gross control to move base so that illumination is provided on the test rod.* Then use joystick fine control to move base so that a 1 to 2mm width slit image focuses

sharply on test rod when seen naturally by eye.

(3) Diopter compensation

Independently set the diopter setting for each eyepiece as follows.* First, turn the eyepiece ring in a counterclockwise direction until it stops.* Now, turn the ring clockwise until a sharp image is seen through the microscope on the

focusing test rod.

Test rod

Chinrest

Prism boxRing

16OPERATION PROCEDURES

(4) Interpupillary distance adjustment

While looking through the eyepieces at the image on the focusing test rod, adjust the converg-ing binocular's prism box, so that the image is fused and a stereo-scopic image results. Foroperator comfort, since each eyepiece can be moved independently, insure that both eye-pieces are at the same height.

PATIENT POSITION

Positioning patient's head

Have the patient place his chin on the chinrest and forehead against the forehead rest. Adjust thechinrest adjuster so that the patient's outer canthus is at the approximate height of the canthusmarker.

BASE OPERATION

(1) Horizontal gross adjustment

To adjust the microscope's position horizontally, move the base while keeping the joystick inthe vertical position.

(2) Horizontal fine adjustment

For fine adjustment, such as alignment or focusing, tilt the joystick to the left or the right.

(3) Vertical fine adjustment

For fine vertical adjustment, turn the joystick clockwise to raise the microscope and counter-clockwise to lower it.

Prism box

At the same height

Canthus marker

Chinrest adjuster


(4) Locking the base

To lock the base, tighten the base locking knob.

(5) Focusing

* Gross adjustment for alignment or focusing is done by the operation described in (1)* Fine adjustment for alignment or focusing should be done by the operations described in (2)

and (3) above while looking through the microscope.

OPERATION OF THE ILLUMINATION UNIT

(1) Change of slit size

By operating the slit width control knob or turning the aperture and slit length control wheel,ideal slit width, slit length and spot size can be achieved.

(2) Change of slit position

By turning the illumination unit or operating slit rotation control ring, the desired positioning ofthe slit image can be obtained.

(3) Change of filter

A cobalt-blue filter or red-free filter can be set in the light path.White mark -- No filterBlue mark -- Blue filterGreen mark -- Red-free filter


19TROUBLESHOOTING

TROUBLESHOOTING

TROUBLESHOOTING GUIDE

If any problem should occur, first consult the following trouble shooting table, and follow thesuggested instructions. Then, if the trouble is not corrected, contact your nearest TOPCONdealer.

Trouble Possible Cause Remedy Refer to

No illumination Power cable is not properly con-nected to the power outlet.

Connect cable to the outlet. P. 14

Power switch is still OFF. Turn power switch ON. ----

The lamp socket is damaged fromthe heat.

Replace the socket. P. 31

The lamp has burned out. Replace the lamp. P. 31

Fuse has blown. Replace the fuse. P. 30

Slit light is too dim The lamp is not correctly inserted. Insert lamp correctly. P. 31

Voltage selector setting is incorrect.(except for USA and Canada)

Check voltage selector andset it to the correct position. P. 12

Fuse has blown Voltage selector setting is incorrect.(except for USA and Canada)

Check voltage selector andset it to the correct position. P. 12

Type of fuse used is incorrect. Replace with the correcttype as specified. P. 30

SPECIFICATIONS

MICROSCOPE

Type Binocular stereoscopic microscope with erect image.

Magnification changerRevolver type objective changing system provides two magnifi-cation changes.

Objective 1× and 1.6×

Eyepieces 10× and (16× option)

Magnification & field of view

Objectives × Eyepieces = Magnification Field of view

Pupillary adjustments 55mm to 75mm

Diopter adjustments -5D to +3D

SLIT ILLUMINATION

Slit projection 1.23×

Slit width Continuously variable from 0 to 14mm

Slit length 14mm, 10mm, 8mm, 5mm, 3mm, 2mm, 1mm

Aperture diameters 14mm, 10mm, 8mm, 5mm, 3mm, 2mm, 1mm

Slit angle Continuously rotatable from vertical to horizontal

Filters Blue, Red-free

Lamp 6V 20W halogen

BASE

Longitudinal movement 80mm

Lateral movement 100mm

Fine cross-slide adjustments 12mm

Vertical movement 30mm

CHINREST

Vertical movement 80mm

POWER

Source voltage120V/220V AC (USA and Canada)100/120/220/240V AC (except for USA and Canada)

Frequency 50-60Hz

Power input 30VA

DIMENSION & WEIGHTS

DimensionsW/TableW/Unit TableW/O TableW/O Table and Chinrest

550mm(W) × 398mm(D) × 552mm(H)440mm(W) × 378mm(D) × 552mm(H)329mm(W) × 276mm(D) × 405~435mm(H)329mm(W) × 276mm(D) × 405~435mm(H)

1× 10× 10× 18mm diameter

1.6× 10× 16× 11.25mm diameter

1× 16× 16× 14.25mm diameter

1.6× 16× 25.6× 9mm diameter

20SPECIFICATIONS

Subject to change in design and/or specifications without advance notice.

Agency ComplianceThe SL-1E is designed to comply with the following agency standards:

• IEC60601-1:2005 Ed3.0• EN60601-1:2006/AC:2010• IEC60601-1-2 Ed3.0:2007/EN60601-1-2:2007/AC:2010• UL 60601-1: 2003• ISO 10939: 1998• ISO 15004-1: 2006• ISO 15004-2: 2007• EC Medical Device Directive 93/42/EEC

WeightW/TableW/Unit TableW/O TableW/O Table and Chinrest

19kg18kg12kg10kg

Table size 550mm × 370mm

Unit Table size 440mm × 350mm

The following statement is the "Essential performance" provided for by IEC60601-1.1) The halogen lamp isn't to be turned off.2) There are no component failures.

21SPECIFICATIONS

ENVIRONMENTAL CONDITIONS

ENVIRONMENTAL CONDITIONS FOR USE

Temperature : 10°C - 40°CHumidity : 30% - 90% (without dew condensation)Air pressure : 700hPa - 1060hPa

STORAGE CONDITIONS

Environmental conditions (without package) Temperature : 10°C - 40°CHumidity : 10% - 95% (without dew condensation)Air pressure : 700hPa - 1060hPa THIS INSTRUMENT DOES NOT MEET THE TEMPERATURE REQUIREMENTS OF ISO

15004-1 FOR STORAGE. DO NOT STORE THIS INSTRUMENT IN CONDITIONS WHERETHE TEMPERATURE MAY RISE ABOVE 40°C OR FALL BELOW 10°C.

ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE

Temperature : -20°C - 50°CHumidity : 10% - 95%

ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTATION

Temperature : -40°C - 70°CHumidity : 10% - 95%

22SPECIFICATIONS

ELECTROMAGNETIC COMPATIBILITY

This product conforms to the EMC Standard (IEC60601-1-2 Ed.3.0: 2007).

a) MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC andneeds to be installed and put into service according to the EMC information provided in theACCOMPANYING DOCUMENTS.

b) Portable and mobile RF communications equipment can affect MEDICAL ELECTRICALEQUIPMENT.

c) The use of ACCESSORIES, transducers and cables other than those specified, with theexception of transducers and cables sold by the manufacturer of the EQUIPMENT or SYS-TEM as replacement parts for internal components, may result in increased EMISSIONS ordecreased IMMUNITY of the EQUIPMENT or SYSTEM.

d) The EQUIPMENT or SYSTEM should not be used adjacent to or stacked with other equip-ment. IF adjacent or stacked use is necessary, the EQUIPMENT or SYSTEM should beobserved to verify normal operation in the configuration in which it will be used.

Guidance and manufacturer's declaration - electromagnetic emissions

The SL-1E is intended for use in the electromagnetic environment specified below.The customer or the user of the SL-1E should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissionsCISPR 11

Group 1

The SL-1E uses RF energy only for its internal func-tion. Therefore, its RF emissions are very low andare not likely to cause any interference in nearbyelectronic equipment.

RF emissionsCISPR 11

Class A

The SL-1E is suitable for use in all establishmentsother than domestic and those directly connected tothe public low-voltage power supply network thatsupplies buildings used for domestic purposes.

Harmonic emissionsIEC61000-3-2

Class A

Voltage fluctuations/flicker emissionsIEC61000-3-3

Complies

23SPECIFICATIONS

Guidance and manufacturer's declaration - electromagnetic immunity


Immunity testIEC 60601test level

Compliance level

Electromagnetic environment - guidance

Electrostaticdischarge (ESD)IEC 61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Floors should be wood, con-crete or ceramic tile. If floorsare covered with syntheticmaterial, the relative humidityshould be at least 30%.

Electrical fasttransient/burstIEC 61000-4-4

± 2 kV for powersupply lines

± 1 kV forinput/output lines

± 2 kV for powersupply lines

± 1 kV forinput/outputlines

Mains power quality should bethat of a typical commercial orhospital environment.

SurgeIEC 61000-4-5

± 1 kVline(s) to line(s)

± 2 kVline(s) to earth

± 1 kVline(s) to line(s)

± 2 kVline(s) to earth

Mains power quality should bethat of a typical commercial orhospital environment.

Voltage dips, shortinterruptions andVoltage variationson power supplyinput linesIEC 61000-4-11

<5% Ut(>95% dip in Ut)for 0.5 cycle40% Ut(60% dip in Ut)for 5 cycles70% Ut(30% dip in Ut)for 25 cycles<5% Ut(>95% dip in Ut)for 5 sec

<5% Ut(>95% dip in Ut)for 0.5 cycle40% Ut(60% dip in Ut)for 5 cycles70% Ut(30% dip in Ut)for 25 cycles<5% Ut(>95% dip in Ut)for 5 sec

Mains power quality should bethat of a typical commercial orhospital environment. If the useror the SL-1E requires continuedoperation during power mainsinterruptions, it is recommendedthat the SL-1E be powered froman uninterruptible power supplyor battery.

Power frequency(50/60 Hz)magnetic fieldIEC 61000-4-8

3 A/m 3 A/m

Power frequency magnetic fieldsshould be at levels characteristicof a typical location in a typicalcommercial or hospital environ-ment.

NOTE Ut is the a.c. mains voltage prior to application of the test level.

24SPECIFICATIONS

Guidance and manufacturer's declaration - electromagnetic immunity


Immunity test IEC 60601test level

Compliance level

Electromagnetic environment - guidance

Conducted RFIEC 61000-4-6

Radiated RFIEC 61000-4-3

3 Vrms150kHz to 80MHz

3 V/m80MHz to 2.5GHz

3 V

3 V/m

Portable and mobile RF communica-tions equipment should be used nocloser to any part of the SL-1E, includ-ing cables, than the recommendedseparation distance calculated from theequation applicable to the frequency ofthe transmitter.

Recommended separation distance

d = 1.2

d = 1.2 80MHz to 800MHzd = 2.3 800MHz to 2.5GHz

where P is the maximum output powerrating of the transmitter in watts (W)according to the transmitter manufac-turer and d is the recommended sepa-ration distance in meters (m).

Field strengths from fixed RF transmit-ters, as determined by an electromag-netic site survey, a should be less thanthe compliance level in each frequencyrange. b

Interference may occur in the vicinity ofequipment marked with the followingsymbol:

NOTE 1NOTE 2

At 80 MHz and 800 MHz, the higher frequency range applies.These guidelines may not apply in all situations. Electromagnetic propagation isaffected by absorption and reflection from structures, objects and people.

a

b

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TVbroadcast cannot be predicted theoretically with accuracy. To assess the electromagneticenvironment due to fixed RF transmitters, an electromagnetic site survey should be con-sidered. If the measured field strength in the location in which the SL-1E is used exceedsthe applicable RF compliance level above, the SL-1E should be observed to verify normaloperation. If abnormal performance is observed, additional measures may be necessary,such as reorienting or relocating the SL-1E.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

P

PP

25SPECIFICATIONS

Recommended separation distance betweenportable and mobile RF communications equipment and the SL-1E

The SL-1E is intended for use in an electromagnetic environment in which radiated RF dis-turbances are controlled. The customer or the user of the SL-1E can help prevent electro-magnetic interference by maintaining a minimum distance between portable and mobile RFcommunications equipment (transmitters) and the SL-1E as recommended below, accordingto the maximum output power of the communications equipment.

Rated maximum output power of transmitter

W

Separation distance according to frequency of transmitterm

150kHz to 80MHzd = 1.2

80MHz to 800MHzd = 1.2

800MHz to 2.5GHzd = 2.3

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended sepa-ration distance d in meters (m) can be estimated using the equation applicable to the fre-quency of the transmitter, where P is the maximum output power rating of the transmitter inwatts (W) according to the transmitter manufacturer.

NOTE 1

NOTE 2

At 80 MHz and 800 MHz, the separation distance for the higher frequency rangeapplies.These guidelines may not apply in all situations. Electromagnetic propagation isaffected by absorption and reflection from structures, objects and people.

P P P

26SPECIFICATIONS

OPTICAL RADIATION HAZARD

THE RELATIVE SPECTRAL OUTPUT

PHOTOCHEMICAL LIGHT SOURCE RADIANCES OF THIS INSTRUMENT

LA (without crystalline lens) : 352 mW/ (cm2·sr)LB (with crystalline lens) : 338 mW/ (cm2·sr)

MEANING OF LB AND LA

Spectrally-weighted photochemical radiance LB and LA give a measure of the potential hazard thatexists for a beam of light to cause photochemical damage to the retina. LB gives the measure foreyes in which the crystalline lens is in place. LA gives this measure for aphakes in which the lenshas not been replaced by a UV blocking intraocular lens or for the eyes of very young children.The value stated for an SL-1E gives a measure of hazard potential when the instrument is oper-ated at maximum intensity and maximum aperture. Values of LB or LA over 80 mW/(cm2·sr) areconsidered high for beams which wholly fill a dilated pupil.The retinal exposure dose for a photochemical hazard is a product of the radiance and the expo-sure time. For instance, at a radiance level of 80 mW/ (cm2·sr), 3 min irradiation of the dilated (8mm diameter) pupil would cause the retinal exposure dose level to attain the recommended expo-sure limit. If the value of radiance were reduced to 40 mW/ (cm2·sr), twice that time (i.e. 6 min)would be needed to reach the recommended limit. The recommended exposure is based on cal-culations arising from the American Conference of Governmental Industrial Hygienists (ACGIH)Threshold Limit Values for Chemical Substances and Physical Agents (1995-1996 edition).Because prolonged intense light exposure can damage the retina, the use of the device for ocularexamination should not be unnecessarily prolonged, and the brightness setting should not exceedwhat is needed to provide clear visualization of the target structures.While no acute optical radiation hazards have been identified for SL- 1E it is recommended thatthe intensity of light directed into the patient's eye be limited to the minimum level which is neces-sary for diagnosis. Infants, aphakes and persons with diseased eyes will be at a greater risk. Therisk may also be increased if the person being examined has had an exposure with the sameinstrument or any other ophthalmic instrument using a visible light source during the previous 24h. this will apply particularly if the eye has been exposed to retinal photography.

SL-1E:Illumination spectral distribution

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

300 400 500 600 700 800 900 1000 1100Wavelength (nm)

Rer

ativ

e in

tens

ity

27SPECIFICATIONS

SYSTEM CLASSIFICATION

Degree of protection against electric shocks: Type B applied partType B applied part is the applied part complying with the specified requirements of theStandard IEC 60601-1 to provide protection against electric shock, particularly regardingallowable LEAKAGE CURRENT.

Type of protection against electric shocks: Class I equipmentClass I equipment does not depend on basic insulation only for protection against electricshocks. It can also be earthed; therefore, the metal parts with which one comes into contactdo not become conductive if the basic insulation fails.

The mode of operation: continuous operation equipment Degree of protection against ingress of water: IP×0

SL-1E is the ordinary instrument (enclosed instrument without protection against ingressof water)

Methods of sterilization or disinfection recommended by the manufacture: SL-1E do not haveany part to be sterilized or disinfected.

Not AP or APG equipment

PURPOSE OF USE

This instrument is used for the enlargement observation of eyeballs and the parts.

OPERATION PRINCIPLE

Illuminates the observed part by the illumination light emitted from the illumination optical sys-tem and allows enlargement observation by binocular stereoscopic microscope.

28SPECIFICATIONS

SHAPE OF PLUG

SYMBOL

Country Voltage/frequency Shape of plug

Mexico 110V/50Hz Type C&E

Argentina 220V/60Hz Type A

Peru 220V/60Hz Type A

Venezuela 110V/50Hz Type C&E

Bolivia & Paraguay 220V/60Hz Type A (Most common)Type H (Infrequently)

Chile 220V/60Hz Type A

Colombia 110V/50Hz Type C

Brazil 220V/60Hz127V/60Hz

Type AType C

Ecuador 110V/50Hz Type C&E

USA 120V/60Hz Type A (Hospital Grade)

Canada 120V/60Hz Type A (Hospital Grade)

Symbol IEC/ISO Publication Description Description (French)

IEC 60417-5032 Alternating Current Courant alternatif

IEC 60417-5008Off (power: disconnectionfrom the main power supply)

Éteint (courant: coupureavec le secteur)

IEC 60417-5007On (power: connection tothe main power supply)

Allumé (courant: raccorde-ment sur le secteur)

IEC 60878-02-02 Type B applied part Partie appliquée du Type B

ISO 7010-W001 General warning signSymbole d'avertissementgénéral

ISO 7010-M002Refer to instruction manual/booklet

Voir le manuel/la brochure

29SPECIFICATIONS

MAINTENANCE

DAILY CARE

* Remove dust from the instrument except the lenses and prisms, using a dry soft cloth at reg-ular intervals.

* This instrument may be adversely affected by dust. Use the dust cover when not in use.

REPLACING THE FUSE

* First, turn the power switch OFF, and remove the power cable from the outlet.* With a Phillips screwdriver, turn the center of the fuse holder at the back of the power unit.

The fuse will come out.* Replace it with a new fuse and then tighten the center of the fuse holder.* Always use the same type of fuse as indicated in the holder:

F1, F2: T1AL 250V (100,120V)T500mAL 250V (220,240V)

F3: F4AL 125V

REPLACING THE CHINREST PAPER

If the chinrest paper supply is depleted, remove the pins on the chinrest, place the new pack-age of paper over the chinrest and replace the two locating pins.

WARNINGTo avoid electric shock, unplug the power cord from the grounded out-let before removing the fuse cover. Do not connect the power cord tothe grounded outlet with the fuse cover not correctly attached.

Pin

30MAINTENANCE

REPLACING THE ILLUMINATION LAMP

When replacing the lamp, use care as the metal components inside the housing can becomeextremely hot. The suggested procedure is as follows:* After turning the power switch OFF, loosen the lamphouse cover clamping screw to remove

the lamphouse cover.* Hold the connector as illustrated below, turn the clamping lever in the direction of the arrow,

and remove the socket and lamp assembly.* Insert the new lamp into the socket.* Place the assembly into the housing by aligning the guide with the groove in the lamp flange.

Note:If the lamp and/or socket is incorrectly attached, uneven or partially obscured illumination mayoccur. (i.e., edge of the 14mm circle may be partially occluded)* Re-assemble the illumination housing following in the reverse order of the above procedures.* Turn the power switch ON and check to see that the new lamp is properly illuminated.

CAUTION To avoid electric shock, do not touch the external connection terminaland the patient at the same time.

Connector Clamping leverSocket

Illumination lamp Guide

31MAINTENANCE

CLEANING

(1) Cleaning the lens and mirror

If any dust settles on the lens or mirror, remove it as follows:Use the cleaning brush, which is included in the standard accessories, to remove the dust. Incase any dust still remains, wipe it off using a soft cotton cloth moistened with a little alcohol.Never use your finger or any hard object for cleaning.

(2) Cleaning the gliding plate, base rail and shaft

If the gliding plate or cross-slide rail and shaft are dirty, an unsmooth vertical or horizontalmovement of the cross-slide results. Clean them by using a dry cloth.

(3) Cleaning the plastic parts

To clean the plastic parts, such as chinrest and forehead rest, use only a cloth moistened witha solution of neutral detergent and water to wipe off the accumulated dust. Avoid using othertypes of cleansers.

(4) Cleaning applied parts

Wipe the forehead rest and chinrest with a cloth moistened with a tepid solution of neutraldetergent for kitchenware

Shaft

Rail

Gliding plate

32MAINTENANCE

ORDERING SUPPLIES

To order the following replacement parts, be sure to specify the product name, part numberand quantity required.

USER MAINTENANCE ITEMS

Product name Part number Appearance

Illumination lamp 40340 20700

Socket 44615 20100

Chinrest paper 40310 40820

FuseF1, F2: T1AL 250V (100, 120V)

T500mAL 250V (220, 240V)F3: F4AL 125V

44635 6003044635 6004044620 67710

Item Inspection time Contentss

Inspection Before using • Adjusting the diopter and pupillary distance• Focus of slit image• The base unit must move smoothly.• The components must be fitted in place correctly.• The chinrest unit must be fitted to the table unit correctly.• The cables and plugs must be connected correctly.• The objective lens, eyepiece and mirror must not be

stained or damaged.

Cleaning When the part is stained

• Objective lens• Eyepiece• Mirror• Sliding plate, rail and wheel shaft unit• Forehead rest and chinrest unit

Adjustment As required • Slit width control knob torque

Replacement As required • Illumination lamp• Fixation target lamp• Socket• Fuse

Supply As required Chinrest tissue

33MAINTENANCE

OPTIONAL ACCESSORIES

FIXATION TARGET

Target for the fixation of patient's eyes.* The fixation device can be installed on either side of the chinrest.* Insert the fixation target into either of the two mounting holes and then remove the cap to

insert the fixation target plug into the chinrest jack.

SpecificationsAnnular Fixation TargetRed-LEDDC 2V

CAUTION To avoid electric shock, do not touch the external connection terminaland the patient at the same time.

Fixation target

Plug

Hole

34OPTIONAL ACCESSORIES

HRUBY LENS

Used for observation of the fundus and posterior segment of the vitreous body.In routine applications, only the anterior segment of the vitreous body can be examinedbecause of the refraction effects of the cornea and crystalline lens. However, with the HrubyLens, examination of the fundus and the posterior segment of the vitreous body is possible.

Operation procedure(1) The pupil should be well dilated by administering a mydriatic approximately 20 minutes

before the examination.(2) Remove the hole cap to insert Hruby lens guide plate in the hole of carrier arm so that the

groove of guide plate fits with guide pin on the microscope arm.(3) Insert the lower end of the Hruby Lens shaft in the groove on the guide plate.(4) Center the illumination and microscope arms so that they face the patient's eye.(5) Align lever, shown in the illustration below, with the center of the microscope's field of view.

Then move the lever backward and forward to position close to the patient's eye.(6) Use the joystick to focus on the fundus.

The slit width and length will have to be adjusted to reduce the undesirable reflectionsseen in the field of view.

(7) To view a different segment, either turn the microscope and illumination arms or have thepatient alter fixation by manipulating the fixation target.

SpecificationsHruby Lens: -58.7 diopters

Hruby lens

Lever

Guide plate


10×MEASURING EYEPIECE

Use this accessory eyepiece in place of the normal eyepiece for measurements of both thesize and angle. The measuring eyepiece is extremely helpful when fitting toric contact lenses:

SpecificationsScalesLinear Scale: 16mm; minimum 0.5mm, increments to be used at 10×magnificationAngle Scale: 360°; minimum 5°readingsDiopter compensation: -5D to +3D

16×EYEPIECE

Increases the total magnification of the slit lamp.

SpecificationsTotal magnification: 16×, 25.6×Field of view: 11.25mm dia, 9mm dia Diopter compensation: -5D to +3D


ACCESSORY DRAWER

For storing the focusing test rod and other accessories.

APPLANATION TONOMETER

Haag-Streit AG Model R900 can be used.

AUTOMATIC INSTRUMENT TABLE AIT-15

Specifications• Dimensions ......................510(W)×450(D)mm• Table height......................600~820mm• Table size .........................490×500mm• Weight ..............................approx. 23kg• Power consumption..........270VA• Source voltage .................120V AC, 50/60Hz (USA and Canada)

100-120V, 220-240V AC, 50/60Hz (except for USA and Canada)


When contacting us, please have the following information at hand reyour unit: Machine type: SL-1E Manufacturing No. (Displayed on the rating plate on the left of the

base.) Period of Usage (i. e. the purchase date). Description of Problem (as detailed as possible).

SLIT LAMP SL-1E

INSTRUCTION MANUAL

The 2011 version (2011.06-100TH )Date of issue: 3, June 2011

Published by TOPCON CORPORATION

75-1 Hasunuma-cho, Itabashi-ku, Tokyo, 174-8580 Japan.

©2011 TOPCON CORPORATION ALL RIGHTS RESERVED

7

SLIT LAMP

SL-1E

44615 95997Printed in Japan 1106-100TH 7

instruction manual slit lamp sl-1e - acme revival · 2020. 5. 20. · this instruction manual...

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