SL-3G Instruction Manual ver Sept 2008

INTRODUCTION Thank you for purchasing the TOPCON SL-3G Slit Lamp.

This instrument is used for the magnified observation of the eye and its various structures. This SL-3G has the following features: • Smooth mechanical movements • Bright and clear observation of the eye with natural color rendition • Optical system to enhance natural color and resolution

This Instruction Manual covers an overview of the basic operation, troubleshooting, checking, maintenance and cleaning of the SL-3G Slit Lamp. To get the best results from this instrument, read "Displays for Safe Use" and "Safety Cautions". Keep this Instruction Manual close at hand for future reference.

[Warning] To avoid injury to the patient’s eye and nose, pay particular attention while operating the instrument body. (The patient may be injured.) [Caution] This 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 damage to 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), or (ii) for all other countries, in accordance with local disposal and recycling laws.

CAUTION : Federal laws restricts this device to the sale by or on the order of a physician. WARNING : Handling the cord on this product or cords associated with accessories sold with this product, will expose you to lead, a chemical known to the State of California to cause birth detects or other reproductive harm. Wash hands after handling.

CLASS

IEC60601-1

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CAUTIONS FOR USE Important cautions 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.

Basic cautions Be careful not to let the patient touch this instrument. The patient's hand may be pinched by the movable part. To avoid injury or fire caused by electric shock, turn off the power switch and unplug the power cord. 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 it goes 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 base unit.

Disposal Dispose of the instrument according to local disposal and recycling laws.

ENVIRONMENTAL CONDITIONS FOR USE Temperature : 10°C - 40°C Humidity : 30% - 90% (without dew condensation) Air pressure : 700hPa - 1060hPa

STORAGE CONDITIONS 1. Environmental conditions (without package) ∗Temperature : 10°C - 40°C Humidity : 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 WHERE THE TEMPERATURE MAY RISE ABOVE 40°C OR FALL BELOW 10°C. 2. 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. 3. Usage period 8 years from delivery providing regular maintenance is performed (according to the self-certification [TOPCON data])

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ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE Temperature : -20°C - 50°C Humidity : 10% - 95%

ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTATION Temperature : -40°C - 70°C Humidity : 10% - 95%

CHECKPOINTS FOR 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, eyepiece and mirror free from finger prints and dust. 4. When not in use, protect the instrument with the dust cover. 5. If the objective lens, eyepiece or mirror is stained, clean it following "Cleaning lenses and mirrors" in this Instruction Manual.

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DISPLAYS FOR SAFE USE In order to ensure the safe use of the product and to prevent danger to the operator and others, or damage to property, important warnings are placed on the product and inserted in the instruction manual. It is recommended for all users to take note of the meaning of the following displays and icons before reading the "Safety Cautions" and text.

DISPLAYS DISPLAY

MEANING

WARNING

Ignoring or disregarding this notice could lead to death or serious injury.

CAUTION

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

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

ICONS ICON

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

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SAFETY CAUTIONS WARNINGS Icon

Prevention item

Page

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

16

To avoid injury to the eye and nose while moving the base unit, make sure that you have a clear view of the slit lamp and the patient's face.

20

To avoid electric shock, do not attempt disassembling, rebuilding and/or repairs on your own. Ask your dealer for repairs.

26

Do not remove the covers from the main unit, chinrest unit or power supply unit except for the lamp house cover. You may receive an electric shock.

26

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

36

To avoid fire in the event of an instrument malfunction, use only fuses that are listed on the marked label at the side of the fuse holder.

36

To avoid fire and electric shock, install the instrument in a dry place free of water and other liquids.

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To avoid fire and electric shock, do not put cups or other containers with liquids near the instrument.

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To avoid electric shock, do not insert metal objects into any vents and/or slots.

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To avoid fire in the event of an instrument malfunction, immediately turn OFF the power switch " " and unplug the cable if you see smoke coming from the instrument, etc. Ask your dealer for service.

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CAUTIONS Icon

6

Prevention item

Page

To prevent damage and injuries, install the instrument on a level surface.

16

To avoid electric shock, do not handle the plugs with wet fingers.

16

For the safety of the operator and the patient, do not place fingers between moving parts.

20

To avoid injury to the patient’s head, incline the illumination unit slowly while holding the base unit.

21

To avoid causing discomfort to the patient or any damage to the patient's eye, keep the illumination at its minimum during adjustment.

21

When replacing the lamp, switch off the power supply and remove the power cord to avoid electric shock.

35

Beware of high temperatures when replacing the lamp immediately after switching it off: these could cause burns.

35

Before carrying out daily care, remove the power cord (to avoid electric shock) and wait until the main unit has cooled (to avoid burns).

38

Do not touch parts inside the lamp house cover during operation and immediately after switching off the power supply: this could cause burns.

38

To prevent falling during use and movement, secure optional accessories.

40

To prevent the movable parts from hitting anyone's body, tighten and fix the illumination arm locking knob, microscope arm locking knob and base locking knob before moving the instrument.

25

CAUTIONS Icon

Prevention item

Page

The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum intensity will exceed the safety guideline after 65 sec.

44

This instrument has been tested (with 100V/120V/230V) and found to comply with IEC60601-1-2 Ed.2.1:2004. This instrument radiates radio frequency energy within standard and may affect other devices in the vicinity. If you have discovered that turning on/off the instrument affects other devices, we recommend you change its position, keep a proper distance from other devices, or change the outlet. Please consult the dealer from whom you purchased the equipment for any questions.

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USAGE AND MAINTENANCE Usage: • The Slit Lamp is an electric equipment for medical use. When using this instrument, follow the instructions of a well-trained and experienced doctor.

USER MAINTENANCE To maintain the safety and performance of the instrument, unless done by an authorized service engineer, never attempt to do maintenance of items other than those specified here in. For details about maintenance, read the descriptions in this manual.

Replacing the illumination lamp The illumination lamp can be replaced if necessary. For specific instructions, see page 35.

Replacing the fuse Fuses on the primary and secondary sides can be replaced, if necessary. For specific instructions, see page 36.

Replacing the fixation target bulb The fixation target bulb can be replaced if necessary. For specific instructions, see "REPLACING THE FIXATION TARGET BULB" on page 38.

ESCAPE CLAUSES • TOPCON shall take no responsibility for damage due to fire, earthquakes, actions by a third party or other accidents, or the negligence and misuse of the user and use under unusual conditions. • TOPCON shall take no responsibility for damage derived from the inability to use this equipment, such as a loss of business profit and suspension of business. • TOPCON shall take no responsibility for damage caused by operations other than those described in this Instruction Manual. • Diagnoses made are the responsibility of qualified doctors and TOPCON shall take no responsibility for the results of such diagnoses.

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WARNING INDICATIONS AND POSITIONS To ensure safety, warning labels are provided on the instrument body. Use the instrument following these warning instructions. If any of the following labels are missing, contact your dealer or TOPCON (see the back cover). CAUTION • To prevent electric shocks, switch off the power supply and remove the power cord before replacing the lamp. Afin d’éviter tout choc électrique, coupez le contact et débranchez le câble d’alimentation avant de remplacer l’ampoule. • Do not replace the lamp immediately after switching it off: the high temperatures could cause burns. Afin d’éviter toute brûlure, prenez garde à la température élevée de l’ampoule lorsque le remplacement de celle-ci se fait immédiatement après avoir coupé l’alimentation électrique.

CAUTION To avoid injury to the patient’s head, incline the illumination unit slowly while holding the base unit. Afin d’éviter toute blessure à la tête du patient, inclinez l’unité d’illumination lentement tout en maintenant la base de l’instrument.

WARNING When operating the base unit, please note the following: Pendant la manipulation de la base de l’instrument, veuillez prendre les précautions suivantes; • Beware of catching fingers in the moving parts. Prenez garde aux pièces mobiles afin d’éviter de coincer les doigts. • Avoid hitting the patient’s eyes or nose. Gardez une distance de travail appropriée afin d’éviter le contact avec les yeux et le nez du patient.

CAUTION • To prevent electric shocks, turn off the power switch and remove the power cord before replacing fuses. Afin d’éviter tout choc électrique, coupez le contact et débranchez le câble d’alimentation avant de remplacer les fusibles. • Use the specified fuse. Utilisez des fusibles de même type et de même valeur.

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CONTENTS INTRODUCTION ...1 DISPLAYS FOR SAFE USE ... 4 SAFETY CAUTIONS ...5 USAGE AND MAINTENANCE ...8 ESCAPE CLAUSES ... 8 WARNING INDICATIONS AND POSITIONS ... 9

CONFIGURATION NAMES OF MAIN BODY COMPONENTS ... 12 CONFIGURATION OF PARTS IN CONTACT WITH THE PATIENT ... 12 STANDARD ACCESSORIES ... 13

BASIC OPERATIONS FLOW OF OPERATION ... 15

PREPARATIONS CONNECTING THE POWER CORD ... 16 TURNING ON THE POWER ... 16 ADJUSTING THE DIOPTER AND PUPILLARY DISTANCE (PD) ... 17

OPERATION PROCEDURE FIXING THE PATIENT’S FACE AND FIXATION ... 18 OPERATING THE MICROSCOPE UNIT ... 19 OPERATING THE BASE AND FOCUSING ... 20 OPERATING THE ILLUMINATION UNIT ... 21 ENDING PROCEDURE ... 24

CAUTION WHEN MOVING THE INSTRUMENT ... 25 TROUBLESHOOTING TROUBLESHOOTING GUIDE ... 26

SPECIFICATIONS & PERFORMANCE SPECIFICATIONS ... 27 ELECTROMAGNETIC COMPATIBILITY ... 28 ELECTRIC RATING ... 31 SYSTEM CLASSIFICATION ... 32 DIMENSIONS AND WEIGHT ... 32 PURPOSE OF USE ... 32 OPERATION PRINCIPLE ... 32

MAINTENANCE AND CHECKUPS MAINTAINING ACCURACY ... 33 PERIODIC MAINTENANCE ... 33 USER MAINTENANCE ITEMS ... 34 DAILY CARE ... 34 PLACING AN ORDER FOR CONSUMABLES ... 34 REPLACING ILLUMINATION LAMPS ... 35 REPLACING FUSES ... 36

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RESTOCKING CHINREST TISSUE ... 38 REPLACING THE FIXATION TARGET BULB ... 38 DAILY CARE ... 38

OPTIONAL ACCESSORIES SYSTEM CONFIGURATION ... 40 10× MEASURING EYEPIECE ... 41 HRUBY LENS ... 41

REFERENCE MATERIAL SHAPE OF PLUG ... 42 SYMBOL ... 42 ADJUSTABLE AUTOMATIC INSTRUMENT TABLE ... 42

RELATION BETWEEN SETTING OF ILLUMINATION LEVEL AND MAXIMUM RADIANCE ... 43 INFORMATION ABOUT THE OPTICAL RADIATION HAZARD TO THE USER ... 44

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CONFIGURATION NAMES OF MAIN BODY COMPONENTS

Illumination unit Plug Forehead rest

Chinrest unit

Lamphouse cover

Chinrest

Canthus marker

Aperture/slit length display window

Microscope unit

Filter selector lever

Objective lens

Aperture/slit length control knob

Diopter adjusting ring Eyepiece

Fixation target

Magnification changer lever Microscope attaching screw

Reflection mirror

Chinrest adjuster

Hruby lens holder (Option)

Hruby lens (Option)

Hruby lens guide plate

Slit centering knob

Illumination arm locking knob

Illumination inclination lever Slit width control knob

Stop roller

Base unit

Angle scale

Control lever

Microscope arm locking knob

Base locking knob Rail cover Base

Table

Pilot lamp

Table unit

Power switch Fixation target plug Brightness adjustment knob

Illumination lamp plug

Primary fuse holder

Power supply unit

AC connector

Secondary fuse holder

CONFIGURATION OF PARTS IN CONTACT WITH THE PATIENT Forehead rest Chinrest

12 CONFIGURATION

: Polyamide resin : Polyamide resin

STANDARD ACCESSORIES Make sure that all the following standard accessories are included. Figures in parentheses are the quantities. Chinrest tissue (1)

Dust cover (1)

Test rod (1)

Phillips screwdriver (1)

Spare illumination lamp (1)

Slotted screwdriver (large) (1)

Spare socket (1)

Slotted screwdriver (small) (1)

Luminous fixation target (1)

Hexagonal wrench M3/M4 (2)

Spare fixation target bulb (1)

Spanner (1) ∗

Cleaning brush (1)

Spare chinrest tissue pin (2)

13 CONFIGURATION

Spare fuse Primary side (4) Secondary side (1)

16× eyepiece (2)

Accessory case (1)

Square mirror (1)

Power cord (1)

"Instruction manual" and "Unpacking and assembly" (1 each)

SL

-3G

∗ The spanner is provided only when the table is used. For optional accessories, see "OPTIONAL ACCESSORIES" on page 40.

14 CONFIGURATION

BASIC OPERATIONS FLOW OF OPERATION Basic observation procedure Turning on the power (P.16)

Adjusting the diopter and pupillary distance (P.17)

Fixing the patient's face and fixation (P.18)

Operating the microscope unit (P.19)

Operating the base and focusing (P.20)

Operating the illumination unit (P.21)

Ending procedure (P.24)

Other types of observation • Observation by adjusting the slit width • Observation by changing the aperture and slit length • Observation by turning the slit • Observation by swinging the slit sideways • Observation by inclined illumination • Observation by ND filter • Observation by Red-Free filter • Observation by blue filter

15 BASIC OPERATIONS

PREPARATIONS CONNECTING THE POWER CORD WARNING

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

CAUTION

To prevent damage and injuries, install the instrument on a level surface.

CAUTION

To avoid electric shock, do not handle the plugs with wet fingers.

1 Make sure that the "POWER switch" is OFF ( ) on the power supply unit. 2 Connect the power cord to the AC connector on the power supply unit. 3 Make sure that the cables are connected to the illumination lamp plug and the fixation target plug on the rear surface of the power supply unit.

Illumination lamp plug Fixation target plug

4 Check if the plug is inserted into the lamp house cover securely. Plug Lamp house cover

5 Plug the power cord into the grounded outlet. TURNING ON THE POWER

1 Connect the power cord. 2 Turn ON ( ) the "POWER switch". 16 PREPARATIONS

ADJUSTING THE DIOPTER AND PUPILLARY DISTANCE (PD) NOTE

To ensure sharp observation of slit images, always carry out the diopter and PD adjustments.

1 Insert the "test rod" into the rotation shaft cavity, and set the black face square with the microscope. Test rod

2 Place the "brightness adjustment knob" in an intermediate position. 3 Adjust the illumination to φ10mm by adjusting the "slit width control knob" and "aperture/slit length control knob".

4 Turn the "diopter adjusting ring" of the "eyepiece" at one side fully counter-clockwise. 5 Turn the "diopter adjusting ring" clockwise and stop when the "test rod" can be clearly seen. The values -8 to +8 on the scale indicate the diopter (D) on "10× eyepiece". -10 to +10 indicate the diopter (D) on "16× eyepiece".

6 Adjust the diopter of another "eyepiece" in the same way as above. 7 After adjusting the diopter, turn the "slit width control knob" until the slit width is about 1mm, then check if the slit image projected on the "test rod" is properly in focus.

8 Holding the "prism box", look through the "eyepiece" with both eyes, and adjust the pupillary distance so that the image projected on the "test rod" can be seen without diplopia (double vision), and appear to be three dimensional. Diopter scale

Diopter adjusting ring

Prism box

10× eyepiece

17 PREPARATIONS

OPERATION PROCEDURE FIXING THE PATIENT’S FACE AND FIXATION

1 Place the patient's chin on the "chinrest" with his or her forehead against the "forehead rest".

2 By rotating the "chinrest adjuster", align the patient's eye with the "canthus marker" on the chinrest frame.

Forehead rest Canthus marker

Chinrest

Chinrest adjuster

3 Ask the patient to look at the fixation target with the eye that is not being examined. To change the patient's fixation point, hold the fixation target at the end opposite to the target and adjust accordingly.

Fixation target lever

Diopter adjusting ring

Fixation target with diopter adjustment

Luminous fixation target

When using the fixation target with diopter adjustment, slide the diopter adjusting ring so that the patient can see the following target ( ). The ring target can be adjusted within a range of -15D to +10D. The luminous fixation target is used for myopia of -15D or more. When replacing targets, remove the target by pulling gently while supporting the opposite end.

18 OPERATION PROCEDURE

OPERATING THE MICROSCOPE UNIT Turn the "magnification changer lever" to set a desired magnification value.

Magnification changer lever

For the overall magnification in conjunction with magnification marks of the "magnification changer lever" and "eyepiece", see page 27.

19 OPERATION PROCEDURE