SL-D7 and SL-D8Z Instruction Manual ver Feb 2010

INTRODUCTION Thank you for purchasing the Slit Lamp SL-D7, SL-D8Z.

This slit lamp is used for the enlargement observation of eyeballs and the parts. This instrument has the following features: • • • •

Various accessories to extend the system Ergonomic cable layout Clear fluorescent cornea observation and photography of cornea Clear eyeground observation and photography by color conversion filter

This Instruction Manual covers an overview of the basic operation, troubleshooting, checking, maintenance and cleaning of the Slit Lamp SL-D7, SL-D8Z. To get the best usage from the instrument, please read “Displays for Safe Use” and “Safety Cautions”. Keep this Instruction Manual with the instrument for future reference. (Without package)

PRECAUTIONS [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.



CAUTION : Federal laws restrics 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.

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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 to 40°C Humidity : 30% to 90% (without dew condensation) Air pressure : 700hPa to 1060hPa

STORAGE CONDITIONS 1. Environmental conditions (without package) *Temperature : 10°C to 40°C Humidity : 10% to 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 to +50°C Humidity : 10% to 95%

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

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 CAUTION Icons

Prevention item

Page

To prevent falling during use and movement, secure each unit.

17

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

31

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

31

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

32

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

32

To avoid electric shocks, do not attempt overhauling, rebuilding or repairs. Ask your dealer for repair.

38

When replacing the lamp, switch off the power supply and remove the power cable to avoid electric shocks.

53

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

53

When replacing fuses, first switch off the power supply and remove the power cable to avoid electric shocks.

55

Before carrying out daily care, remove the power cable (to avoid electric shocks) and wait until the lamp house has cooled (to avoid burns). Do not touch parts inside the lamp house cover during operation and immediately after switching off the power supply: this could cause burns. The base contains strong springs. Do not attempt to disassemble or burn the base, as the springs could cause injury by shooting out of it. To prevent falling during use and movement, secure optional accessories.

56 56 57 58

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CAUTION Icons

6

Prevention item

Page

This instrument has been tested (with 100/120/230V) and found to comply with IEC60601-1-2 Ed.3.0: 2007as class B(classified according to CISPR11). But if the electronic flash device FD-21 of optional accessories is connected, whole device including accessories is classified as class A(according to CISPR11).According to IEC60601-1-2 Ed.3.0:2007,this instrument is more suitable to connect with exclusive power supply system in establishment such as hospital,etc than it connects with the domestic electricity power supplies. 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 plug it into a different outlet. Please consult your authorized dealer if you have any additional questions.

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MAINTENANCE 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 description of this manual. REPLACING THE ILLUMINATION LAMP The illumination lamp can be replaced if necessary. For specific instructions, see page 53. REPLACING THE FIXATION TARGET BULB (FOR BULB TYPE FIXATION TARGET ONLY) The fixation target bulb can be replaced if necessary, see page 54. REPLACING THE FUSE Fuses on the primary side can be replaced, if necessary. For specific instructions, see page 55.

ESCAPE CLAUSE • 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 cable 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.

CAUTION 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 cable 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.

* The illustration depicts the SL-D7 type.

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CONTENTS INTRODUCTION ...1 CAUTIONS FOR USE ...2 ENVIRONMENTAL CONDITIONS FOR USE ...2 STORAGE CONDITIONS...2 ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE ...3 ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTATION 3 CHECKPOINTS FOR MAINTENANCE ...3 DISPLAYS FOR SAFE USE...4 SAFETY CAUTIONS ...5 MAINTENANCE...7 USER MAINTENANCE...7 ESCAPE CLAUSE...7 WARNING INDICATIONS AND POSITIONS ...8

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

COMPONENTS COMPONENTS ...15

ASSEMBLY PROCEDURE SECURING THE INSTRUMENT TYPE TABLE TOP...17 SECURING THE UNIT TYPE TABLE TOP ...18 SECURING THE PATIENT GRIP PG-1(OPTIONAL ACCESSORY) ...18 SECURING THE CHINREST BASE PLATE ...19 SECURING THE BASE UNIT AND RAIL COVER ...19 SECURING THE BINOCULAR TUBES...20 SECURING THE ILLUMINATION UNIT ...20 REMOVING THE ILLUMINATION UNIT PAD ...21 CONNECTING AND SECURING OF CABLES...22 FITTING THE CHINREST TISSUE ...23 FITTING THE CAP ...23 SECURING THE TONOMETER MOUNT SO-TM1 (OPTIONAL ACCESSORY)..23 COUNTER BALANCING THE VERTICAL MOVEMENT...25

PREPARATIONS POWERING ON ...27 ADJUSTING THE DIOPTER AND PUPILLARY DISTANCE (PD) ...27

OPERATION PROCEDURE FIXING THE PATIENT’S FACE AND FIXATION ...29 OPERATING THE MICROSCOPE UNIT ...30 OPERATING THE BASE AND FOCUSING ...31 OPERATING THE ILLUMINATION UNIT...32 ENDING PROCEDURE...37

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TROUBLESHOOTING TROUBLESHOOTING GUIDE ...38

SPECIFICATIONS AND PERFORMANCE SPECIFICATIONS AND PERFORMANCE ...39 ELECTROMAGNETIC COMPATIBILITY ...41 INFORMATION ABOUT THE OPICAL RADIATION HAZARD FOR THE USER..46 ELECTRIC RATING ...47 SYSTEM CLASSIFICATION ...47 PURPOSES OF USE ...47 OPERATION PRINCIPLES ...47 SYSTEM CLASSIFICATION ...48 PURPOSES OF USE ...48 OPERATION PRINCIPLES ...48 SYSTEM CONFIGURATION...49 SHAPE OF PLUG...50 SYMBOL...50

MAINTENANCE AND CHECKUPS MAINTAINING THE PRECISION ...51 PERIODIC MAINTENANCE ...52 DAILY CARE ...52 PLACING AN ORDER FOR CONSUMABLES...53 REPLACING ILLUMINATION LAMPS...53 REPLACEING THE FIXATION TARGET BULB...54 REPLACING FUSES ...55 RESTOCKING CHINREST TISSUE...55 DAILY CARE ...56 CLEANING APPLIED PARTS ...56 CLEANING LENSES AND MIRRORS...56 CLEANING THE SLIDING PLATE, RAIL AND WHEEL SHAFT ...57 DISPOSAL OF THE PRODUCT...57

OPTIONAL ACCESSORIES DIGITAL CAMERA UNIT DC-1...58 DIGITAL CAMERA UNIT DC-3...58 ELECTRONIC FLASH DEVICE FD-21...59 BEAM SPLITTER ...60 TV RELAY LENS ...60 TV RELAY LENS TL-54/55 (BUILT-IN BEAM SPLITTER TYPE) ...61 TV ATTACHMENT TL-56 ...61 TV ATTACHMENT TL-57 ...62 BACKGROUND ILLUMINATION BG-4 ...62 BACKGROUND ILLUMINATION WITH INFRARED FILTER BG-4M ...62 BACKGROUND ILLUMINATION BG-2GN ...62 OBSERVATION TUBE ...63 YELLOW FILTER UNIT ...63 IRIS DIAPHRAGM SO-DF01...63 12.5X MEASURING EYEPIECE...63 20X EYEPIECE ...63

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APPLANATION TONOMETER...63 HRUBY LENS...64 PARALLEL BINOCULAR TUBE PB-2 ...64 AUXILIARY SPRING SO-AS 1,2,3 ...64 PATIENT HANDLE PG-1...64 ADAPT COVER SO-AC1, 2, 3, 4, 5...64

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CONFIGURATION NAMES OF MAIN BODY COMPONENTS Forehead rest Chinrest

Plug

Objective lens

Lamp house cover

Magnification selector handle

Illumination Unit

SL-D7 Microscope Unit

Aperture/slit length display window *1 Exciter filter Color conversion filter selector lever Filter selector lever

*2 Barrier filter selector lever Diopter adjusting ring

Aperture/slit-length control knob

12.5× eyepiece Binocular tubes Magnification index mark

Chinrest Unit Canthus marker Mirror Centering knob

Chinrest adjuster Microscope arm Cap Illumination arm Illumination arm locking knob

Inclination lever Slit-width control knob Photo switch Control lever Base Unit

Microscope arm locking knob Power Supply Power switch

Table Unit

Base locking knob Brightness adjustment knob Base

*3 Table

Base relay cable *1,2) A model without exciter filter for slit lamp/barrier filter for slit lamp is also available. *3) A model without table unit is also available.

COMPOSITION OF PARTS THAT COME IN CONTACT WITH THE PATIENT Forehead rest : Polyamide resin Chinrest : Polyamide resin

12 CONFIGURATION

SL-D8Z Microscope Unit Objective lens Tonometer mount

Magnification index mark Magnification selector handle

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) (This is not always included with the standard specifications.)

Crosshead screwdriver (1)

Spare illumination lamp (1)

Screwdriver (1)

Spare socket (1)

Spare fuse (2) (Depending on specification, quantity may differ, or this item may not be included in stan-dard accessories.)

Spare fixation target bulb (1) (for bulb type fixation target only)

Spanner (1) (for instrument type table top only)

13 CONFIGURATION

Spare chinrest tissue pin (2)

Instruction Manual (1)

Cleaning brush (1)

Hexagon wrench (2)Attached document (1)

Square mirror (1)

Accessory case (1) (This is not always included with the standard specifications.)

Cap (1)

For optional accessories, see “Optional Accessories” on page 58.

14 CONFIGURATION

COMPONENTS COMPONENTS (1) Illumination unit

(2) Binocular tubes

(3) Base unit

* The photo shows the SL-D7 type.

(4) Instrument type table top (w/power supply)

(4)’ Unit type table top

(5) Rail cover

(6) Chinrest unit

(7) Power cable

(8) Auxiliary spring

(9) Setscrew

(10) Cable cover

(11) Cable cover fixing screw

(12) Rail cover fixing screw

(13) Cable clip

(14) Tonometer maunt SO-TM1

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Article name

Qty

Article name

Qty

(1) Illumination unit

1

(8) Auxiliary spring

2

(2) Eyepiece unit

1

(9) Setscrew

2

(3) Base unit

1

(10) Cable cover

1

(4) Instrument type table top (w/power supply)*

1

(11) Cable cover fixing screw

2

or (4)’ Unit type table top*

1

(12) Rail cover fixing screw

4

(5) Rail cover

2

(13) Cable clip

1

(6) Chinrest unit*

1

(14) Tonometer maunt SO-TM1*

1

(7) Power cable

1

* (4) or (4)’ table top is not included, depending on the specifications. * (6) Depending on chinrest and (14) Tonometer mount might not be included.

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ASSEMBLY PROCEDURE SECURING THE INSTRUMENT TYPE TABLE TOP

CAUTION

To prevent falling during use and movement, secure each unit.

FITTING TO AUTOMATIC INSTRUMENT TABLE AIT-20 (except for USA and Canada)/AIT-15 (all area)/AIT-16 (all area)

1 Remove the cover of the instrument table. Remove the 3 screws of the cover (AIT-20 only: For details, refer to the instruction manual of AIT-20.)

2 Place the tabletop on the instrument table, and secure it with the 4 bolts attached to the instrument table. To reverse the direction of the instrument table, remove the power supply from the bottom of the table top and secure it on the opposite side.

Connect the power cable to the table outlet and power supply of the instrument table. Place the excess cable inside the cover, and attach the cover.

17 ASSEMBLY PROCEDURE

SECURING THE UNIT TYPE TABLE TOP

1 Remove the plastic washer from the unit type table top, which is taped to the shaft assembly.

2 Insert the plastic washer, together with the shaft, into the cavity for the ophthalmic unit arm. Washer

In the unit type table top, the power supply is fitted to attach the ophthalmic unit on the right hand side. When attaching the ophthalmic unit on the left-hand side, remove the power supply and reattach it to the right hand side (with 4 screws).

SECURING THE PATIENT GRIP PG-1(OPTIONAL ACCESSORY)

1 Align the patient grip with a groove on the rear of the chinrest base. 2 Fix the patient grip with screws. Chinrest base Patient grip

18 ASSEMBLY PROCEDURE

SECURING THE CHINREST BASE PLATE

1 Secure the chinrest base plate to the unit type table top with 2 screws (9).

Chinrest base plate

SECURING THE BASE UNIT AND RAIL COVER

1 Align the wheel of the base unit with the rail of the chinrest base plate. 2 Secure the rail covers with 4 screws (12): (2 screws each on the right and left sides).

Rail cover

19 ASSEMBLY PROCEDURE