SD-D701 SLIT LAMP User Manual July 2014

INTRODUCTION Thank you for purchasing the SLIT LAMP SL-D701.

INTENDED USE / INDICATIONS FOR USE The Slit Lamp SL-D701 is an AC-powered slitlamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

FEATURES 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

PURPOSE OF THIS MANUAL To get the best usage from the instrument, please read "DISPLAYS FOR SAFE USE" and "GENERAL SAFETY INFORMATION". Keep this Manual with the instrument for future reference.

CAUTION : Federal law restricts this device to sale by or on the order of a Physician or Practitioner(CFR 801.109(b)(1)).

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1. No part of this manual may be copied or reprinted, in whole or in part, without prior written permission. 2. The contents of this manual are subject to change without prior notice and without legal obligation. 3. The contents of this manual are correct to the best of our knowledge. Please inform us of any ambiguous or erroneous descriptions, missing information, etc. 4. Original Instructions This instruction manual was originally written in English. ©2014 TOPCON CORPORATION ALL RIGHTS RESERVED

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CONTENTS INTRODUCTION ... 1 GENERAL SAFETY INFORMATION ... 5 HOW TO USE THIS MANUAL ... 7 GENERAL MAINTENANCE INFORMATION ... 7 DISCLAIMERS ... 7 DISPLAYS AND SYMBOLS FOR SAFE USE ... 8 POSITIONS OF WARNING AND CAUTION INDICATIONS ... 9 SYSTEM DIAGRAM ... 10 COMPONENT NAMES ... 10 COMPOSITION OF PARTS THAT COME IN CONTACT WITH THE PATIENT ... 10 STANDARD ACCESSORIES ... 11

COMPONENTS ... 12 COMPONENTS ... 12

ASSEMBLY PROCEDURE ... 14 SECURING THE INSTRUMENT TYPE TABLE TOP ... 14 SECURING THE UNIT TYPE TABLE TOP ... 14 SECURING THE PATIENT GRIP PG-1(OPTIONAL ACCESSORY) ... 15 SECURING THE CHINREST BASE PLATE ... 15 SECURING THE BASE UNIT AND RAIL COVER ... 15 SECURING THE BINOCULAR TUBES ... 16 SECURING THE ILLUMINATION UNIT ... 16 REMOVING THE ILLUMINATION UNIT PAD ... 17 CONNECTING AND SECURING OF CABLES ... 17 FITTING THE CHINREST TISSUE ... 18 FITTING THE CAP ... 18 SECURING THE TONOMETER MOUNT SO-TM1 (OPTIONAL ACCESSORY) ... 19 COUNTER BALANCING THE VERTICAL MOVEMENT ... 20

PREPARATIONS ... 22 POWERING ON ... 22 HOW TO RECOVER FROM THE POWER SAVING STATE ... 22 ADJUSTING THE DIOPTER AND PUPILLARY DISTANCE (PD) ... 22

OPERATION PROCEDURE ... 24 FIXING THE PATIENT'S FACE AND FIXATION ... 24 OPERATING THE MICROSCOPE UNIT ... 25 OPERATING THE BASE AND FOCUSING ... 26 OPERATING THE ILLUMINATION UNIT ... 27 ENDING PROCEDURE ... 32

MAINTENANCE AND CHECKUPS ... 33 MAINTAINING THE PRECISION ... 33 PERIODIC MAINTENANCE ... 33 DAILY CARE ... 34 PLACING AN ORDER FOR CONSUMABLES ... 34 USER MAINTENANCE ITEMS ... 34 RESTOCKING CHINREST TISSUE ... 34 CLEANING ... 35 CLEANING/DISINFECTING PATIENT-CONTACTING PARTS ... 35

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CLEANING LENSES AND MIRRORS ... 35 CLEANING THE SLIDING PLATE, RAIL AND WHEEL SHAFT ... 35 TROUBLESHOOTING ... 36 TROUBLESHOOTING GUIDE ... 36 SPECIFICATIONS AND PERFORMANCE ... 37

GENERAL INFORMATION ON USAGE AND MAINTENANCE ... 39 INTENDED PATIENT POPULATION ... 39 INTENDED USER PROFILE ... 39 ENVIRONMENTAL CONDITIONS FOR USE ... 39 STORAGE, USAGE PERIOD ... 39 ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE ... 40 ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTAION ... 40 ELECTRIC RATING ... 40 DIMENSIONS AND WEIGHT ... 40 SYSTEM CLASSIFICATION ... 41 OPERATION PRINCIPLES ... 41 CHECKPOINTS FOR MAINTENANCE ... 41 DISPOSAL ... 42 PATIENT’S ENVIRONMENT ... 43 REQUIREMENTS FOR THE EXTERNAL DEVICE ... 43 ELECTROMAGNETIC COMPATIBILITY ... 44 OPTICAL RADIATION HAZARD ... 48 TYPE OF PLUG ... 49

OPTIONAL ACCESSORIES ... 50 SYSTEM CONFIGURATION ... 50 DIGITAL CAMERA UNIT DC-4 ... 51 BEAM SPLITTER ... 51 TV RELAY LENS ... 51 TV RELAY LENS TL-54/55 ... 52 TV ATTACHMENT TL-56 ... 52 TV ATTACHMENT TL-57 ... 52 BACKGROUND ILLUMINATION BG-5 ... 53 OBSERVATION TUBE ... 53 YELLOW FILTER UNIT ... 53 IRIS DIAPHRAGM SO-DF01 ... 53 12.5X EYEPIECE ... 53 20X EYEPIECE ... 53 TONOMETER MOUNT SO-TM1 ... 54 HRUBY LENS ... 54 PARALLEL BINOCULAR TUBE PB-2 ... 54 AUXILIARY SPRING SO-AS 1,2,3 ... 54 PATIENT HANDLE PG-1 ... 54

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GENERAL SAFETY INFORMATION CONTRAINDICATIONS 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.

WARNINGS Ensuring the Safety of Patients and Operators 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. To avoid injury to the patient’s eye and nose, pay particular attention while operating the instrument body. (The patient may be injured.) The Topcon SL-D701 is a medical device. The software and hardware has been designed in accordance with U.S., European and other international medical device design and manufacturing standards. Unauthorized modification of the Topcon SL-D701 software or hardware, or any addition or deletion of any application in any way can jeopardize the safety of operators and patients, the performance of the instrument, and the integrity of patient data. Because prolonged intense light exposure can damage the retina, the use of the device for ocular examination should not be unnecessarily prolonged, and the brightness setting should not exceed what is needed to provide clear visualization of the target structures. The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. If the value of radiance were reduced in half, twice the time would be needed to reach the maximum exposure limit. While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes, it is recommended that the intensity of light directed into the patient's eye be limited to the minimum level which is necessary for diagnosis. Infants, aphakes and persons with diseased eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure to the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply particularly if the eye has been exposed to retinal photography. Equipment is not suitable for use in the presence of a Flammable Anesthetic Mixture with Air, Oxygen, or Nitrous Oxide. The Topcon SL-D701 has no special protection against harmful ingress of water or other liquids (classified IPX0). To avoid damage to the instrument and cause a safety hazard, the cleaning solutions, including water, should not be directly applied to the device. Using a dampened cloth (without dripping), is a good method to clean the exterior surface of the enclosure. 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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Preventing Electric Shock and Fire. To avoid fire in the event of an instrument malfunction, immediately turn OFF the power switch ( ) and disconnect the power cord from the instrument if you see smoke coming from the instrument, etc. Don't install the instrument where it is difficult to disconnect the power cord from the instrument. Ask your dealer for service.

CAUTIONS Ensuring the Safety of Patients and Operators Be careful not to let the patient touch this instrument. The patient's hand may be pinched by a movable part. To avoid burns caused by heat, do not replace the lamp with a new one immediately after it goes off. To avoid injury to the patient's head, incline the illumination unit slowly while holding the base unit. 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. Preventing Electric Shock and Burn To avoid injury or fire caused by electric shock, turn off the power switch and unplug the power cord when not in use. To avoid injury caused by electric shock, turn off the power switch when replacing the lamp. Electromagnetic Compatibility (EMC) 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). 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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HOW TO USE THIS MANUAL • Read the instructions on pages 1 to 9 before using the machine. • If you would like an overview of the system, begin by reading "OPERATION PROCEDURE" (page 24).

GENERAL MAINTENANCE INFORMATION 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.

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 the user and any use under unusual conditions. •TOPCON is not responsible for damage derived from inability to properly use this equipment, such as loss of business profits and suspension of business. •TOPCON is not responsible for damage caused by operations other than those described in this user manual. •The device does not provide a diagnose of any condition or lack thereof or any recommendation for appropriate treatment. The relevant healthcare provider is fully responsible for all diagnose and treatment decisions and recommendations.

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DISPLAYS AND SYMBOLS FOR SAFE USE To encourage safe and proper use and to prevent injury to the operator and others or potential damage to property, important messages are put on the instrument body and inserted in the instruction manual. We suggest that everyone understand the meaning of the following displays, icons and text before reading the "GENERAL SAFETY INFORMATION" and observe all listed instructions.

DISPLAYS Display

Meaning

CONTRAINDICATIONS

Situations in which the device should not be used because the risk of use clearly outweighs any possible benefit.

WARNINGS

Incorrect handling by ignoring this display may lead to a risk of death or serious injury.

CAUTIONS

Incorrect handling by ignoring this display may lead to personal injury or physical damage.

NOTES

Useful functions to know. Paying attention to these will prevent the noted problems.

SYMBOLS Symbol

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IEC/ISO Publication

Description

Description (French)

IEC 60417-5032

Alternating Current

Courant alternatif

IEC 60417-5008

Off (power: disconnection from the main power supply)

Éteint (courant: coupure avec le secteur)

IEC 60417-5007

On (power: connection to the main power supply)

Allumé (courant: raccordement sur le secteur)

IEC 60878-02-02

Type B applied part

Partie appliquée du Type B

ISO 7010-W001

General warning sign

Symbole d'avertissement général

ISO 7010-M002

Refer to instruction manual/ booklet

Voir le manuel/la brochure

POSITIONS OF WARNING AND CAUTION INDICATIONS 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). 1

2

3 4

No.

1

2

3

4

Label

Meaning

Signification

CAUTION

PRÉCAUTION

・To prevent electric shocks, switch off the power supply and remove the power cable before replacing the lamp. ・Do not replace the lamp immediately after switching it off: the high temperatures could cause burns.

• Afin d’éviter les chocs électriques, coupez l’alimentation électrique et débranchez le câble d’alimentation avant de remplacer la lampe. • Ne pas remplacer la lampe immédiatement après l’avoir éteinte: la température élevée peut provoquer des brûlures.

CAUTION

PRÉCAUTION

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

Afin d’éviter de blesser le patient à la tête, inclinez lentement l’élément lumineux tout en maintenant la base de l’appareil.

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.

PRÉCAUTION

Degree of protection against electric shock : TYPE B APPLIED PART

Lorsque vous maniez la base de l’appareil, veuillez noter les points suivants: • Faites attention à ne pas vous coincer les doigts dans les parties en mouvement. • Évitez de heurter les yeux ou le nez du patient. Degré de protection contre les chocs électriques : TYPE B PARTIE D'APPLICATION

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SYSTEM DIAGRAM COMPONENT NAMES Forehead rest *4

Illumination Unit

Chinrest *4

Plug

Objective lens

Lamp house cover

Magnification selector handle

Aperture/slit length display window Exciter filter *1

Microscope Unit

Color conversion filter selector lever Filter selector lever

Barrier filter selector lever *2 Diopter adjusting ring

Aperture/slit-length selector knob

12.5× eyepiece

Chinrest Unit Canthus marker

Magnification index mark

Mirror Centering knob

Chinrest adjuster Microscope arm

Inclination lever Slit adjustment knob Photo switch Control lever

Illumination arm Illumination arm locking knob Microscope arm locking knob Base relay cable Power Supply Power switch

Base Unit

Table *3

Base locking knob Brightness adjustment knob Base

*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. *4 Contacting part (class B)

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

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SYSTEM DIAGRAM

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)

Screwdriver (1)

Spanner (1)

Spare chinrest tissue pin (2)

Square mirror (1)

Hexagon wrench (2)

Cap (1)

Cleaning brush (1)

User manual (1)

D701

For optional accessories, see “Optional Accessories” on page 50.

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SYSTEM DIAGRAM

COMPONENTS COMPONENTS (1) Illumination unit

(2) Binocular tubes

(3) Base unit

(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) Chinrest fixing screw

(10) Cable cover

(11) Cable cover fixing screw

* This component is unavailable in some regions. (12) Rail cover fixing screw

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COMPONENTS

(13) Cable clip

(14) Tonometer maunt SO-TM1

Article name

Qty

Article name

Qty

(1) Illumination unit

1

(8) Auxiliary spring

2

(2) Binocular tubes

1

(9) Chinrest fixing screw

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

3

(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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COMPONENTS

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-15/AIT-16

1 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.

NOTE

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.

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

NOTE

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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).

ASSEMBLY PROCEDURE

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

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 Insert the connection cable into the LAN output terminal of the instrument.

Rail cover

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ASSEMBLY PROCEDURE

SECURING THE BINOCULAR TUBES

1 Align the pin of the microscope unit with the groove on the binocular tubes, and fit the screw with a hexagon wrench. In the model without excitor/barrier filter, fit binocular tube with the fixing screw.

NOTES

Make sure you do not touch the lens surfaces.

Screw Microscope unit

SECURING THE ILLUMINATION UNIT Loosen the microscope arm locking-knob of the base unit, manually turn the shaft and tilt the guide rodshaft index 30-60°, then refasten the microscope-arm locking-knob. 30° - 60°

Indices

2 Loosen the fixing screw on the outside of the fitting cavity of the illumination unit with a screwdriver. Align indices and slowly lower the illumination unit onto the shaft of the base unit.

Indices

NOTES

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While assembling the illumination unit, take care not to get your fingers caught.

ASSEMBLY PROCEDURE

3 Firmly tighten the fixing screw with a screwdriver.

REMOVING THE ILLUMINATION UNIT PAD

1 Remove the rubber band and slowly withdraw the protection pad from the slit operation mechanism of the illumination unit.

Protection pad (for transportation)

CONNECTING AND SECURING OF CABLES

1 Remove the tape from the lamp house cover of the illumination unit. Plug the cable from the upper part of the chinrest into the illumination unit.

Plug

2 Connect the cable from the lower part of the chinrest unit and the power cable to the power supply.

Illumination cable

Power cable

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ASSEMBLY PROCEDURE

3 Pass the 8 pin connector from the metal plug connected to the power supply through the hole of the chinrest and connect to the base unit.

4 Fit the cable cover with 2 screws (11).

5 Pull the base unit toward the side of the operator, then lock. Attach the cables to the back of the table with the cable clip (13).

6 Move the base unit and illumination unit, and make sure there is enough cable to allow free movement of the base unit in all directions.

FITTING THE CHINREST TISSUE

1 Remove the chinrest tissue pins. 2 Take approximately one-fifth of the pad of chinrest tissues and secure this at each end with the pins.

FITTING THE CAP

1 Fit the cap to the shaft aligning the guide rod with the groove in the cap.

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ASSEMBLY PROCEDURE

SECURING THE TONOMETER MOUNT SO-TM1 (OPTIONAL ACCESSORY) Depending on specification, SO-TM1 may be included in standard accessories.

1 Align the locating pin of SO-TM1 into the holes of the microscope, and fasten the screw.

Screw Locating Pin The holes

2 Remove the fixing knob of the microscope, and secure the eyepieceunit, etc with the packaged screw. Fixing knob

Screw

3 Applanation tonometer R900 type, Photokeratoscope attachment, etc could be mounted on SOTM1.

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ASSEMBLY PROCEDURE