INSTRUCTION MANUAL SLIT 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 the eye 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 "Safety Cautions". Keep this Instruction Manual close at hand for future reference. PRECAUTIONS The patient who undergoes an examination by this instrument must maintain concentration 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. 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 negative consequences for 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. 1 INTRODUCTION 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 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 When disposing the instrument and/or parts, follow the local regulations for disposal and recycling. 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 period 8 years from delivery providing regular maintenance is performed (according to the self-certification [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. 2 INTRODUCTION DISPLAYS FOR SAFE USE In order to ensure the safe use of the product and to prevent harm to the operator and others, or damage to property, a number of important warnings are placed on the product and inserted in the instruction manual. It is recommended that all users understand the meaning of the following displays and icons before reading the "Safety Cautions" text. DISPLAYS DISPLAY MEANING WARNING Ignoring or disregarding this display may 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. 3 DISPLAYS FOR SAFE USE SAFETY CAUTIONS WARNING 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. 15 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. 30 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. ----- CAUTION Icon 4 SAFETY CAUTIONS Prevention item Page To avoid electric shock, do not touch the external connection terminal and the patient at the same time. 31,34 This instrument has been tested (with 100/120/230V) and found to comply with IEC60601-1-2: Ed.3.0 : 2007 as class A (classified according to CISPR11). According to IEC60601-1-2, 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. ----- MAINTENANCE USER MAINTENANCE To maintain the safety and performance of the instrument, never attempt to do maintenance of items other than those specified here unless done by an authorized service engineer. For details about maintenance, read the chapter entitled "Maintenance" in this manual. 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, see page 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 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 Instruction Manual. The device does not provide a diagnose of any condition or lack thereof or any recommendations for appropriate treatment. The relevant healthcare provider is fully responsible for all diagnose and treatment decisions and recommendations. 5 MAINTENANCE 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 missing, contact your dealer or TOPCON (see the back cover for contact information). 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 débranchez le câble d'alimentation avant de remplacer l'ampoule. To avoid burns, do not touch the lamp immediately after switching the instrument off. 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. [Refer to instruction manual] CAUTION When operating the base unit, note the following: Pendant la manipulation de la base de l'instrument, veillez prendre les précautions suivantes; To prevent fingers from being caught in between, be aware of moving parts. Prenez garde aux pièces mobiles afin d'éviter be coincer les doigts. Keep a safe distance from the patient's face to prevent injuries to the nose and eyes. Gardez une distance de travail appropriée afin d'éviter le contact avec les yeux et le nez du patient. [Refer to instruction manual] Degree of protection against electric shock: TYPE B APPLIED PART 6 WARNING INDICATIONS AND POSITIONS CONTENTS INTRODUCTION ...............................................................................................................1 DISPLAYS FOR SAFE USE ..............................................................................................3 SAFETY CAUTIONS .........................................................................................................4 MAINTENANCE .................................................................................................................5 DISCLAIMERS ...................................................................................................................5 WARNING INDICATIONS AND POSITIONS ....................................................................6 CONFIGURATION .................................................................................................................9 NAMES OF MAIN BODY COMPONENTS ........................................................................9 CONFIGURATION OF PARTS IN CONTACT WITH PATIENT ........................................9 STANDARD ACCESSORIES ..........................................................................................10 COMPONENTS .................................................................................................................... 11 COMPONENTS ...............................................................................................................11 ASSEMBLY PROCEDURE ...............................................................................................12 ASSEMBLY PROCEDURE ..............................................................................................12 CHECKING PROCEDURE ..............................................................................................15 OPERATION PROCEDURES ..........................................................................................16 PREPARATION-DIOPTER COMPENSATION AND INTERPUPILLARY DISTANCE ADJUSTMENT ..............................................................................................16 PATIENT POSITION ........................................................................................................17 BASE OPERATION .........................................................................................................17 OPERATION OF THE ILLUMINATION UNIT ..................................................................18 TROUBLESHOOTING ........................................................................................................19 TROUBLESHOOTING GUIDE ........................................................................................19 SPECIFICATIONS ...............................................................................................................20 ENVIRONMENTAL CONDITIONS ..................................................................................22 ELECTROMAGNETIC COMPATIBILITY .........................................................................23 OPTICAL RADIATION HAZARD .....................................................................................27 SYSTEM CLASSIFICATION ............................................................................................28 PURPOSE OF USE .........................................................................................................28 OPERATION PRINCIPLE ................................................................................................28 SHAPE OF PLUG ............................................................................................................29 SYMBOL ..........................................................................................................................29 MAINTENANCE .................................................................................................................... 30 DAILY CARE ....................................................................................................................30 REPLACING THE FUSE ................................................................................................. 30 REPLACING THE CHINREST PAPER ...........................................................................30 REPLACING THE ILLUMINATION LAMP ....................................................................... 31 CLEANING .......................................................................................................................32 ORDERING SUPPLIES ...................................................................................................33 USER MAINTENANCE ITEMS ........................................................................................33 OPTIONAL ACCESSORIES .............................................................................................34 FIXATION TARGET .........................................................................................................34 7 CONTENTS HRUBY LENS ..................................................................................................................35 10×MEASURING EYEPIECE ..........................................................................................36 16×EYEPIECE ................................................................................................................. 36 ACCESSORY DRAWER ................................................................................................. 37 APPLANATION TONOMETER ........................................................................................37 AUTOMATIC INSTRUMENT TABLE AIT-15 ...................................................................37 8 CONTENTS CONFIGURATION NAMES OF MAIN BODY COMPONENTS Chinrest jack 10 Fixation target mounting holes Eyepiece Forehead rest *1 Canthus marker Magnification changer lever Slit rotation control ring Slit width control knob Chinrest *1 Aperture and slit length control wheel Chinrest adjuster Filter selection lever Cap Lamphouse cover Illumination arm locking screw Lamphouse cover clamping screw Click stop Microscope arm locking screw Joystick Base locking knob Rail cover Pilot lamp Base Power switch Brightness control switch Table *1 : Contacting part (class B) CONFIGURATION OF PARTS IN CONTACT WITH PATIENT Forehead rest : Polyamide resin Chinrest : Polyamide resin 9 CONFIGURATION 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) 10 CONFIGURATION 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 11 COMPONENTS ASSEMBLY PROCEDURE ASSEMBLY PROCEDURE (1) Selecting Voltage and Fuse Display window Voltage selector Fuse holder [except for U.S.A. and Canada] Voltage selector Fuse holder [for U.S.A. and Canada] * 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 locking washers. Bolt * 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 bolts securely with the included wrench. 12 ASSEMBLY PROCEDURE (b) To secure the unit model table to the ophthalmic unit. Washer * 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 must be relocated to the right side of the unit top to prevent interference with the arm. In this instance, 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 reattach the power supply with the four screws. (3) Mounting the Chinrest Chinrest cord Chinrest mounting plate * Remove the four screws which are attached to the chinrest mounting plate with the Phillips screwdriver. Screw * Place the chinrest cord in the gap between the chinrest mounting plate and the chinrest assembly. While making sure that the cord is not being pinched by the mounting plate, retighten the previously removed screws. 13 ASSEMBLY PROCEDURE (4) Mounting the Main Unit Tape Wheel Rail * 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 Cable clip * 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. 14 ASSEMBLY PROCEDURE (6) Installing the Chinrest Paper Pin * Remove the two pins from the chinrest. * Place the pins through the holes in the chinrest paper. Remove the wrapping from the chinrest 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 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. (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 slit controls. * Check to see that the slit width and length controls, filter lever and magnification changer lever operate smoothly and properly. (3) After the installation is completed, turn the power supply off and cover the instrument with the dust cover. 15 ASSEMBLY PROCEDURE OPERATION PROCEDURES PREPARATION-DIOPTER COMPENSATION AND INTERPUPILLARY DISTANCE ADJUSTMENT Before using the instrument, always carry out the diopter compensation and interpupillary distance adjustments. (1) Use of the focusing test rod The focusing test rod which is a standard accessory, is used to establish the proper microscope settings for each use. Insert test rod in the hole in chinrest with the flat surface at the top of test rod facing the microscope. Test rod Chinrest (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. Ring 16 OPERATION PROCEDURES Prism box (4) Interpupillary distance adjustment While looking through the eyepieces at the image on the focusing test rod, adjust the converging binocular's prism box, so that the image is fused and a stereo-scopic image results. For operator comfort, since each eyepiece can be moved independently, insure that both eyepieces are at the same height. Prism box 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 the chinrest adjuster so that the patient's outer canthus is at the approximate height of the canthus marker. Canthus marker Chinrest adjuster BASE OPERATION (1) Horizontal gross adjustment To adjust the microscope's position horizontally, move the base while keeping the joystick in the 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 counterclockwise to lower it. 17 OPERATION PROCEDURES (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 of the 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 filter Blue mark -- Blue filter Green mark -- Red-free filter 18 OPERATION PROCEDURES TROUBLESHOOTING TROUBLESHOOTING GUIDE If any problem should occur, first consult the following trouble shooting table, and follow the suggested instructions. Then, if the trouble is not corrected, contact your nearest TOPCON dealer. Trouble No illumination Possible Cause Refer to Power cable is not properly con- Connect cable to the outlet. nected to the power outlet. Power switch is still OFF. Turn power switch ON. P. 14 ---- The lamp socket is damaged from Replace the socket. the heat. P. 31 The lamp has burned out. Replace the lamp. P. 31 Fuse has blown. Replace the fuse. P. 30 Insert lamp correctly. P. 31 Slit light is too dim The lamp is not correctly inserted. Fuse has blown Remedy Voltage selector setting is incorrect. Check voltage selector and (except for USA and Canada) set it to the correct position. P. 12 Voltage selector setting is incorrect. Check voltage selector and (except for USA and Canada) set it to the correct position. P. 12 Type of fuse used is incorrect. Replace with the correct type as specified. P. 30 19 TROUBLESHOOTING SPECIFICATIONS MICROSCOPE Type Binocular stereoscopic microscope with erect image. Magnification changer Revolver type objective changing system provides two magnification changes. Objective 1× and 1.6× Eyepieces 10× and (16× option) Objectives × Eyepieces = Magnification Field of view Magnification & field of view 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 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 voltage 120V/220V AC (USA and Canada) 100/120/220/240V AC (except for USA and Canada) Frequency 50-60Hz Power input 30VA DIMENSION & WEIGHTS Dimensions W/Table W/Unit Table W/O Table W/O Table and Chinrest 20 SPECIFICATIONS 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) Weight W/Table W/Unit Table W/O Table W/O Table and Chinrest 19kg 18kg 12kg 10kg Table size 550mm × 370mm Unit Table size 440mm × 350mm Subject to change in design and/or specifications without advance notice. Agency Compliance The 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 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. 21 SPECIFICATIONS ENVIRONMENTAL CONDITIONS ENVIRONMENTAL CONDITIONS FOR USE Temperature Humidity Air pressure : 10°C - 40°C : 30% - 90% (without dew condensation) : 700hPa - 1060hPa STORAGE CONDITIONS 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. ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE Temperature Humidity : -20°C - 50°C : 10% - 95% ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTATION Temperature Humidity 22 SPECIFICATIONS : -40°C - 70°C : 10% - 95% 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 and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS. b) Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT. c) The use of ACCESSORIES, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the EQUIPMENT or SYSTEM as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the EQUIPMENT or SYSTEM. d) The EQUIPMENT or SYSTEM should not be used adjacent to or stacked with other equipment. IF adjacent or stacked use is necessary, the EQUIPMENT or SYSTEM should be observed 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 emissions CISPR 11 Group 1 RF emissions CISPR 11 Class A Harmonic emissions IEC61000-3-2 Class A Voltage fluctuations/ flicker emissions IEC61000-3-3 Complies The SL-1E uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The SL-1E is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 23 SPECIFICATIONS Guidance and manufacturer's declaration - electromagnetic immunity 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. Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and Voltage variations on power supply input lines IEC 61000-4-11 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 IEC 60601 test level Compliance level ± 6 kV contact ± 6 kV contact ± 8 kV air ± 8 kV air ± 2 kV for power supply lines ± 2 kV for power supply lines ± 1 kV for input/output lines ± 1 kV for input/output lines ± 1 kV line(s) to line(s) ± 1 kV line(s) to line(s) ± 2 kV line(s) to earth ± 2 kV line(s) to earth <5% Ut (>95% dip in Ut) for 0.5 cycle 40% Ut (60% dip in Ut) for 5 cycles 70% 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 cycle 40% Ut (60% dip in Ut) for 5 cycles 70% Ut (30% dip in Ut) for 25 cycles <5% Ut (>95% dip in Ut) for 5 sec 3 A/m 3 A/m Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user or the SL-1E requires continued operation during power mains interruptions, it is recommended that the SL-1E be powered from an uninterruptible power supply or battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE Ut is the a.c. mains voltage prior to application of the test level. 24 SPECIFICATIONS Guidance and manufacturer's declaration - electromagnetic immunity 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. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the SL-1E, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 3 Vrms 150kHz to 80MHz 3V Radiated RF IEC 61000-4-3 3 V/m 80MHz to 2.5GHz 3 V/m d = 1.2 P d = 1.2 d = 2.3 P P 80MHz to 800MHz 800MHz to 2.5GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 NOTE 2 a At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 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 TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SL-1E is used exceeds the applicable RF compliance level above, the SL-1E should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SL-1E. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 25 SPECIFICATIONS Recommended separation distance between portable and mobile RF communications equipment and the SL-1E The SL-1E is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SL-1E can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SL-1E as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter Rated maximum output power of transmitter W m 150kHz to 80MHz d = 1.2 P 80MHz to 800MHz d = 1.2 P 800MHz to 2.5GHz d = 2.3 P 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 separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 NOTE 2 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 26 SPECIFICATIONS OPTICAL RADIATION HAZARD THE RELATIVE SPECTRAL OUTPUT SL-1E:Illumination spectral distribution 1 0.9 Rerative intensity 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0 300 400 500 600 700 800 Wavelength (nm) 900 1000 1100 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 that exists for a beam of light to cause photochemical damage to the retina. LB gives the measure for eyes in which the crystalline lens is in place. LA gives this measure for aphakes in which the lens has 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 operated at maximum intensity and maximum aperture. Values of LB or LA over 80 mW/(cm2·sr) are considered 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 exposure time. For instance, at a radiance level of 80 mW/ (cm2·sr), 3 min irradiation of the dilated (8 mm diameter) pupil would cause the retinal exposure dose level to attain the recommended exposure 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 calculations 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 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. While no acute optical radiation hazards have been identified for SL- 1E 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 a greater risk. The risk may also be increased if the person being examined has had an exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 h. this will apply particularly if the eye has been exposed to retinal photography. 27 SPECIFICATIONS SYSTEM CLASSIFICATION Degree of protection against electric shocks: Type B applied part Type B applied part is the applied part complying with the specified requirements of the Standard IEC 60601-1 to provide protection against electric shock, particularly regarding allowable LEAKAGE CURRENT. Type of protection against electric shocks: Class I equipment Class I equipment does not depend on basic insulation only for protection against electric shocks. It can also be earthed; therefore, the metal parts with which one comes into contact do 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 ingress of water) Methods of sterilization or disinfection recommended by the manufacture: SL-1E do not have any 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 system and allows enlargement observation by binocular stereoscopic microscope. 28 SPECIFICATIONS SHAPE OF PLUG 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/60Hz 127V/60Hz Type A Type C Ecuador 110V/50Hz Type C&E USA 120V/60Hz Type A (Hospital Grade) Canada 120V/60Hz Type A (Hospital Grade) SYMBOL Symbol IEC/ISO Publication Description Description (French) IEC 60417-5032 Alternating Current Courant alternatif IEC 60417-5008 Off (power: disconnection Éteint (courant: from the main power supply) avec le secteur) IEC 60417-5007 On (power: connection to Allumé (courant: raccordethe main power supply) ment sur le secteur) IEC 60878-02-02 Type B applied part Partie appliquée du Type B ISO 7010-W001 General warning sign Symbole général ISO 7010-M002 Refer to instruction manual/ Voir le manuel/la brochure booklet coupure d'avertissement 29 SPECIFICATIONS MAINTENANCE DAILY CARE * Remove dust from the instrument except the lenses and prisms, using a dry soft cloth at regular intervals. * This instrument may be adversely affected by dust. Use the dust cover when not in use. REPLACING THE FUSE WARNING 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. * 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 package of paper over the chinrest and replace the two locating pins. Pin 30 MAINTENANCE REPLACING THE ILLUMINATION LAMP CAUTION To avoid electric shock, do not touch the external connection terminal and the patient at the same time. When replacing the lamp, use care as the metal components inside the housing can become extremely 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. Connector Socket Illumination lamp Clamping lever Guide Note: If the lamp and/or socket is incorrectly attached, uneven or partially obscured illumination may occur. (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. 31 MAINTENANCE 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. In case 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 horizontal movement 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 with a solution of neutral detergent and water to wipe off the accumulated dust. Avoid using other types of cleansers. Shaft Rail Gliding plate (4) Cleaning applied parts Wipe the forehead rest and chinrest with a cloth moistened with a tepid solution of neutral detergent for kitchenware 32 MAINTENANCE ORDERING SUPPLIES To order the following replacement parts, be sure to specify the product name, part number and quantity required. Product name Part number Illumination lamp 40340 20700 Socket 44615 20100 Chinrest paper 40310 40820 Fuse F1, F2: T1AL 250V (100, 120V) T500mAL 250V (220, 240V) F3: F4AL 125V 44635 60030 44635 60040 44620 67710 Appearance USER MAINTENANCE ITEMS Item Inspection Cleaning Adjustment Replacement Supply Inspection time Contentss 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. When the part • Objective lens is stained • Eyepiece • Mirror • Sliding plate, rail and wheel shaft unit • Forehead rest and chinrest unit As required • Slit width control knob torque As required • Illumination lamp • Fixation target lamp • Socket • Fuse As required Chinrest tissue 33 MAINTENANCE OPTIONAL ACCESSORIES To avoid electric shock, do not touch the external connection terminal and the patient at the same time. CAUTION 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. Specifications Annular Fixation Target Red-LED DC 2V Fixation target Hole Plug 34 OPTIONAL 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 examined because of the refraction effects of the cornea and crystalline lens. However, with the Hruby Lens, 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 reflections seen in the field of view. (7) To view a different segment, either turn the microscope and illumination arms or have the patient alter fixation by manipulating the fixation target. Specifications Hruby Lens: -58.7 diopters Hruby lens Lever Guide plate 35 OPTIONAL ACCESSORIES 10×MEASURING EYEPIECE Use this accessory eyepiece in place of the normal eyepiece for measurements of both the size and angle. The measuring eyepiece is extremely helpful when fitting toric contact lenses: Specifications Scales Linear Scale: 16mm; minimum 0.5mm, increments to be used at 10×magnification Angle Scale: 360°; minimum 5°readings Diopter compensation: -5D to +3D 16×EYEPIECE Increases the total magnification of the slit lamp. Specifications Total magnification: 16×, 25.6× Field of view: 11.25mm dia, 9mm dia Diopter compensation: -5D to +3D 36 OPTIONAL ACCESSORIES 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) 37 OPTIONAL ACCESSORIES When contacting us, please have the following information at hand re your 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 7 ) 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 SLIT LAMP SL-1E 44615 95997 Printed in Japan 1106-100TH 7