SL-250 Operators Manual Sept 2006

BEFORE USE OR MAINTENANCE, READ THIS MANUAL. This Operator’s Manual contains the operating procedure, safety precautions, and specifications of NIDEK SLIT LAMP Model SL-250. IEC standards are applied in this manual. For correct use, it is necessary that this manual, in particular the safety precautions and operating procedures sections, be thoroughly understood before using this device. Keep the manual handy to verify use. There are no user-serviceable parts inside the device except bulbs and fuses. Therefore, if you find any problems or have questions about the device during operation, please contact your authorized distributor.

Table of Contents

§1 INTRODUCTION ... 1-1 1.1 Outline of Device ... 1-1 1.2 Indications for Use ... 1-1 1.3 Classifications ... 1-1 1.4 Symbol Information ... 1-2

§2 SAFETY ... 2-1 2.1 Operation ... 2-1 2.2 Storage ... 2-2 2.3 Placement ... 2-2 2.4 Installation ... 2-3 2.5 Wiring ... 2-4 2.6 After Use ... 2-5 2.7 Maintenance and Checks ... 2-5 2.8 Disposal ... 2-5 2.9 Labels ... 2-6

§3 CONFIGURATIONS ... 3-1 §4 OPERATING PROCEDURES ... 4-1 §5 MAINTENANCE ... 5-1 5.1 Replacement of Illumination Bulb ... 5-1 5.2 Replacement of Fixation Bulb ... 5-2 5.3 Replacement of Illumination Mirror ... 5-2 5.4 Replacement of Fuses ... 5-3 5.5 Setting of Voltage Selector ... 5-4 5.6 Cleaning the Exterior ... 5-5 5.7 List of Parts for Replacement ... 5-5

§6 SPECIFICATIONS ... 6-1 §7 ACCESSORIES ... 7-1 7.1 Standard Accessories ... 7-1 7.2 Optional Accessories ... 7-1

§8 UNPACKING AND MOUNTING ... 8-1 §9 EMC (ELECTROMAGNETIC COMPATIBILITY) ... 9-1 I

§1 INTRODUCTION 1.1 Outline of Device The operation of the joystick makes focusing and positioning of the SL-250 for forth and back, right and left and up and down easy and smooth. The SL-250 is easy to handle as it is designed functionally. Light weight mechanism and improvement of stability is acquired. Equipped chinrest has enough clearance. The built-in microscope has the high resolving power and gives the sharp stereo image. Installing of the optional accessories makes the usage of the device wide.

1.2 Indications for Use The Slit Lamp SL-250 is 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 disease or trauma which affect the structural properties of the anterior eye segment. Supplementary optics such as hruby lens and contact lens permit observation of the posterior segments and iridocorneal angle.

1.3 Classifications [Classification under the provision of 93/42/EEC(MDD)] Class I The SL-250 is classified into class I device. [Form of protection against electric shock] Class I The SL-250 is classified as a class I device. The class I device is a device in which the protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution that provides for a connection of accessible conductive parts to the protective (earth) conductor in the fixed wiring of the installation. Therefore, accessible conductive parts cannot become activated in the event of failure in the basic insulation. [Degree of protection against electric shock] Type B applied part The SL-250 is provided with a Type B applied part. The Type B Applied Part provides an adequate degree of protection against electrical shock, particularly regarding the following: - allowable leakage currents - reliability of the protective earth ground connection (If applicable). [Degree of protection against liquid entry] IP20 The SL-250 is classified as a ordinary device, which is provided with an enclosure not completely water proof. Avoid water splash on the device.

1-2 [Method(s) of sterilization or disinfection recommended by the manufacturer] The SL-250 does not have any part to be sterilized or be disinfected. [Degree of protection against flammability] The SL-250 is classified as a device not suitable to be used in a potentially flammable environment. Do not use near flammable materials. [Mode of operation] Continuous operation

1.4 Symbol Information This symbol on the device indicates the cautions. This symbol indicates that the degree of protection against electrical shock of the applied part is classified as a Type B applied part. This symbol on the main switch indicates that the power is ON. This symbol on the main switch indicates that the power is OFF. This symbol indicates a fuse. This symbol indicates alternating current. This symbol indicates output. This symbol indicates protective earth. This symbol indicates brightness control. This symbol under the filter control indicates open. This symbol under the filter control indicates heat absorb filter. This symbol under the filter control indicates 13% ND filter. This symbol under the filter control indicates red free filter. (Green)

This symbol under the filter control indicates blue filter. This symbol indicates that this product shall be disposed of in a separate collection of electrical and electronic equipment in EU.

§2 SAFETY In this manual, a Signal Word is used to designate a degree or level of safety alerting, whose definitions are as follows. CAUTION:

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury or property damage.

Even the cases mentioned in CAUTION may result in serious injury under a certain situation. Be sure to observe the instructions of CAUTION. When using this system, be sure to follow all the instructions below in order to avoid damage to the personnel and the system.

2.1 Operation CAUTION • Never disassemble or touch the inside of the device. This may result in an electric shock or device malfunction. • Do not touch the lamp house since it is hot while a lamp is illuminated. Especially, pay attention not to touch the knobs on both sides of the lamp house since they will get extremely hot. If not, you may get burned. • Never yank the power cord to disconnect from wall outlet but hold the plug while disconnecting. This can weaken the metal core of the cord and may result in a short circuit or an electric shock. • Do not place the device on the power cord. The sheath of the cord becomes ragged and may cause an electric shock or a short circuit. • If the metal core of the power cord is exposed, power turns on and off by shaking the cord, or cord/plug gets so heated that one cannot hold it, it means that the cord is damaged. Immediately replace the cord. This may cause an electric shock or a fire. • Do not use the device for other than the intended purpose. NIDEK will not be responsible for accidents or malfunction caused by carelessness. • In the event of a malfunction, do not touch the inside of the device, but remove the power cord and contact your authorized distributor.

2-2

CAUTION • In advance of an observation of each patient, wipe the foreheadrest and chinrest with a clean cloth. Moreover, remove one chinrest paper for each patient if a bunch of the chinrest papers is fixed on the chinrest. If necessary, wipe the foreheadrest and chinrest using a cloth dampened with rubbing alcohol. • Set a light intensity as low as possible. The light intensity depends on the slit lamp settings such as voltage of illumination lamp, slit width, slit length, slit angle, selection of the filters and illumination time. High light intensity may cause thermal and photochemical damages (blue light hazard) onto the patient’s retina.

2.2 Storage CAUTION • Do not store the device in a place where it may get wet or where poisonous gas or liquid is stored. • Avoid storing the device in an area with excessive heat, humidity, or dust. To preserve the appearance or internal parts of the device, avoid direct exposure to sunlight.

2.3 Placement CAUTION • Before transferring the device, tighten each locking knob to fix the main body, microscope arm and illumination arm. Accidental move of the base unit, microscope arm, illumination arm may result in injury and failure of the device. • Before transferring the device, disconnect the power cord from the power connector of the device. Stepping on the cord or catching it on any objects may fall the device or break the cord. • When transferring the device, hold the table unit to move. Holding the microscope arm, illumination arm, chinrest or fixation lamp will deform the holding part or will result in malfunction of the device.

2-3

2.4 Installation CAUTION • Perform assembling work on a level floor with enough space. Collision between the arm or microscope and a personnel will result in injury or failure of the device. • Do not install the device near water. If water gets into the internal structure, there is the possibility of electrical shock or device malfunction. • Install the device in a stable and level place where vibration or shock does not occur. The device may not perform observation correctly or may malfunction. Also, if the device is tripped over because of any accidental shock, it may result in possible injury. • Install the device in the following conditions. A low dust environment A low light interference environment A vibration and shock free environment • Install the device in the environment whose condition can be set to the following. Use the device under the following temperature and humidity. Use environment Temperature : +10 to +40ºC (+50 to +104ºF) Humidity : 30 to 75% (non-condensing) • This device has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2: 2001, and Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This device generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this device does cause harmful interference to other devices, which can be determined by turning the device off and on, the user is encouraged to try to correct the interference by one or more of the following measures: - Reorient or relocate the receiving device - Increase the separation between the devices. - Connect the device into an outlet on a circuit different from that to which the other device (s) are connected. - Consult the manufacturer or field service technician for help.

2-4

CAUTION • In installation and operation of the device, observe the following instructions about EMC (electromagnetic compatibility): - Do not use the device simultaneously with other electronic equipment to avoid electromagnetic interference with the operation of the device. - Do not use the device near, on, or under other electronic equipment to avoid electromagnetic interference with the operation of the device. - Do not use the device in the same room with other equipment such as life-support equipment, other equipment that has major affects on the life of the patient and results of treatment, or other measurement or treatment equipment that involves small electric current. - Do not use the device simultaneously with portable and mobile radio frequency communication systems because it may have an adverse effect on operation of the device. - Do not use cables and accessories that are not specified for the device because that may increase the emission of electromagnetic waves from the device or the system and decrease the immunity of the device to electromagnetic disturbance. • The Electromagnetic Compatibility Directive sets the essential requirements for electrical and electronic equipment that may disturb, or be disturbed by, other equipment. The SL250 complies with these requirements as tabled on pages 9-1 to 9-3. Follow the guidance in the tables for use of the device in an electromagnetic environment.

2.5 Wiring CAUTION • Be sure to use the wall outlet which meets the requirements of power specification. If the line voltage is too high or too low, the device may not give full performance. Malfunction or a fire also may occur. • Be sure to use a power outlet equipped with a grounding terminal. Otherwise, this may cause electric shock when it breaks or power leaks. • Be sure to securely plug in the power cord. Insecure connections may cause a fire. • Do not use the power cord other than supplied. Also do not connect the supplied cord to any other instrument. Malfunction or fire may result.

2-5

2.6 After Use CAUTION • If the device is not be used for a long time, disconnect the power cord from the wall outlet. This may cause a fire. • If the device will not be used during an extended period of time, turn off the main switch and put the dust cover over the device. If not, settled dusts may impair visibility through the microscope.

2.7 Maintenance and Checks CAUTION • As the illumination bulb can get quite hot, replace it when it is cool. Otherwise, it may cause an injury. • Disassembling for service is not permitted except at NIDEK or authorized distributor. • Be careful not to leave fingerprints or dust on the lenses and mirrors. This may impair visibility through the microscope. • Never use an organic solvent such as paint thinner to wipe the exterior. This may ruin the surface. • When the device is sent back to NIDEK for repair or maintenance, wipe the surface (especially, the area where the patient’s skin contacts) of the device with a clean cloth immersed in ethyl alcohol for disinfection.

2.8 Disposal CAUTION • Follow local governing ordinances and recycling plans regarding disposal or recycling of device components. • When disposing packing materials, sort them by the materials and follow local governing ordinances and recycling plans.

2-6

2.9 Labels Cautionary labels are provided on the SL-250. If labels are curling up or characters fading and becoming barely legible, contact NIDEK or your authorized distributor. [Standard Type]

(For Europe)

2-7 [Without table unit Type]

(For Europe)

(For Europe)

§3 CONFIGURATIONS Lamp house

Filter control

Diaphragm diameter control Slit angle control Scale of slit angle

Illumination Mirror Slit width control

Binocular tubes Visual power control Eyepieces

Centering knob Scale for angle between Illumination and Microscope arms Illumination arm locking knob

Magnification change lever

Microscope arm locking knob

Main body locking screw

Joystick

3-2 Magnification change lever Changes over the magnification of objective lens between 1 × or l.6 ×. Scale of slit angle There are click stops at the 45º , 90º and 135º. Slit angle control Changes the slit angle to any angle from vertical to horizontal by moving this laterally. Diaphragm diameter control Selects diaphragm diameter among 0.2, 1, 2, 3, 5 and 8 mm by sliding this. Filter control Selects the following filters by sliding this. Open, Heat absorb, 13%ND, Red free, Blue Slit width control Changes the slit width from 0 to 8 mm by turning this. Centering knob Turn the upper part of the illumination arm with loosening this, the slit image can be shifted within 3.5º to right and left from the center. To tighten this makes the slit image be at the center automatically. Scale for angle between Illumination and Microscope arms Indicates the angle between the illumination arm and the microscope arm. There are click stops at 0º and 10º to right and left. Illumination arm locking knob Locks the illumination arm. Microscope arm locking knob Locks the microscope arm.

Main body locking screw Locks the main body.

Joystick Controls the main body back and forth or right and left. Tilting the joy stick makes the fine movement of the main body and turning its handle makes the up-and-down movement of the main body except the base.

3-3

Forehead rest

Chinrest

Eye level marker

Chinrest elevation control

Fixation lamp

Pilot lamp Wheel covers

Main switch

Sliding plate Power supply box Accessories box Illumination control

Power connector Fuse holder

3-4 Chinrest elevation control Moves the chinrest up and down.

Eye level marker Alignment marker to adjust the patient’s eye to this level.

Fixation lamp Keep the patient’s eye in one direction by instructing him/her to gaze at this.

Sliding plate Bottom part of the joystick slides on this plate to move the main body. Always keep this plate clean.

Illumination control Choose the proper light intensity by changing the Voltage of the illumination lamp among 4 V, 5 V, 6 V and 7.5 V. Keeping the illumination lamp illuminating on condition that 7.5 V is applied to it (the knob is tuned fully clockwise) will shorten a life span of the illumination bulb. Turn the knob to 7.5 V only when increasing the brightness.

Pilot lamp Lights when the power is ON.

Fuse holder The fuses are set and this fuse holder has a function of the voltage selector.

5V 4V

6V

7.5 V

§4 OPERATING PROCEDURES 1. Turn the main switch ON. The illumination lamp and pilot lamp light. 2. Adjust the visibility of the eyepieces. 1) Set a focusing rod on the center of the arms connection then face its flat side to the microscope. 2) Project the slit image on the focusing rod. 3) Turn the visual power control fully counterclockwise (+ side) at first, and look at the slit image through the eyepieces. 4) Turn the visual power control clockwise (– side) slowly until you get the sharp image. The scale in front of the visual power control is graduated in diopter. The scales of –8 to +8 is for the eyepieces with a magnification of 10×. The scales of –10 to +10 is for the eyepieces with a magnification of 16×. Taking record of each adjusted diopter value makes adjustment of eyepieces easier and prompter from next time.

NOTE • Adjust the visibility of eyepieces individually at left and right. • If the visual power control is turned conversely or turned back, the eyepiece diopter may not be adjusted correctly. 3. Adjust the pupil distance. In order to make individual left and right images into one image, adjust the binocular tubes at the proper pupil distance. 4. Remove the focusing rod. 5. Clean the areas where the patient’s skin contacts. Wipe the forehead rest and chinrest with a clean gauze or absorbent cotton dampenedwith alcohol. * When using the chinrest paper, remove a piece of paper. 6. Place the patient’s eye at the height of the eye level marker. 1) Set the voltage of the illumination lamp to 4 V by turning the illumination control. 2) Instruct the patient to take off his/her spectacles or contact lenses and to take a seat. 3) Put the patient’s chin on the chinrest. Then, instruct him/her to touch the forehead to the forehead rest. Adjust the height of the chair or the table if the patient does not sit in a comfortable position.

4-2 4) Bring the patient’s eye at the height of the eye level marker of the headrest by turning the chinrest elevation control. 7. Adjust the focal point of the microscope. 1) Without looking through the microscope, align the height of the slit beam to the patient’s eye by turning the joystick. 2) Without looking through the microscope, make the coarse adjustment of the focal point on the patient’s cornea by moving the joystick. 3) Looking through the microscope, make the fine adjustment of the focal point by tilting the joystick. 8. Observe the patient’s eye. According to the situation, make the proper adjusting operation as follows.

CAUTION • Set a light intensity as low as possible. The light intensity depends on the slit lamp settings such as voltage of illumination lamp, slit width, slit length, slit angle, selection of the filters and illumination time. High light intensity may cause thermal and photochemical damages (blue light hazard) onto the patient’s retina. • The illumination control should be set to a minimum (4V) on completion of each observation. This will protect the patient against excessive brightness at the beginning of the observation. • Especially pay attention to the projection of the illumination to the maximum light when examining infants, aphakic patients and patients with eye disease.

A : Adjustment of brightness of the illumination lamp By turning illumination control, brightness of the illumination lamp can be changed. (4 V, 5 V, 6 V, 7.5 V)

5V 4V

6V

7.5 V

NOTE • Turn the illumination control to 7.5 V only when increasing the brightness. Keeping the illumination lamp illuminating on condition that 7.5 V is applied to it (the knob is tuned fully clockwise) will shorten a life span of the illumination bulb.

4-3 B : Adjustment of slit width Set the proper slit width from the variable range of 0 to 8 mm by turning the slit width control. C : Adjustment of slit length Select the proper diaphragm diameter by sliding the diaphragm diameter control. The diaphragm diameter can be chosen among 0.2, 1, 2, 3, 5 and 8 mm dia. D : Adjustment of the slit angle Set the proper slit angle from the vertical to the horizontal by moving the slit angle control. (There are click stops at 45º, 90º and 135º.) E : Selection of the filters The following 4 filters can be selected by sliding the filter control. Name of filters Uses Heat absorb Decrease heat and dazzle. 13%ND

Decrease light quantity.

Red free

Red free & fundus observation.

Blue

Fluorescence & Color reaction.

(Green)

F : Selection of the magnification of the microscope The magnification is selected by changing the eyepieces and the objective lenses. Select either 10× eyepieces or 16× eyepieces to change the magnification. Select the magnification of the objective lens from 1× and 1.6× by setting the magnification change lever. G : Fixing of the patient’s eye directions Set the fixation lamp at certain position to position and keep the patient’s eye in desired direction. Fix his/her unexamined eye on the fixation lamp securely. H : Observation of retroillumination and indirect illumination The slit image can be shifted from the center by moving the upper part of the illumination arm with holding the slit width control while loosening the centering knob. The slit image returns to the center automatically by tightening the centering knob. (The moving range of the illumination unit is ±3.5º.)

§5

MAINTENANCE

5.1 Replacement of Illumination Bulb CAUTION • As the illumination bulb can get quite hot, replace it when it is cool. Otherwise, it may cause an injury.

NOTE • Use only supplied spare bulb to ensure continued reliability of the device.

1. Turn OFF the main switch. 2. Unplug the power cord from the wall outlet.

Lamp house cover

3. Loosen the screws at the both side of the lamp house.

4. Remove the lamp house cover.

5. Replace the old bulb with the new one. Align the groove of the lamp flange to the guide at the lower lamp house.

Bulb

Screw

Groove

Guide

6. Set the lamp house cover as before and tighten the screws with pushing it lightly.