INSTRUCTION MANUAL ‘SLIT LAMP AIA-11 3SL/5SL/ZoomL SLIT LAMP AIA-11 L. SLIT LAMP APPASAMY MODEL: AIA-11 L SERIES Lil ASSOCIATES Empowering visionTABLE OF CONTENTS / # Description Page ! A Table Of Content........-::-scssceeeesssesreeseesessneereees 03 | B Product Description & Intended Use . 04 | 14 Quality, Reliability and Safety ............. 05 | 12 Important Safety and Maintenance Instruction....... ae 05 | | 13 Areas of application of the device. sescesanes = Oe ; 14 Ambient Conditions.......... i . eects = 06 i; 15 Operation, Environment. oo a = ie 06 | 16 Light Toxicity. 06 17 Disinfection........++e--cee 07 | 2.0 Warranty and Limitation of Liability. 07 r 3.0 Symbols, 08 | ! 44 Unpacking Instruction. e : 7 : og | i. 4.2 Installation Instruction. .......-.0e-0s0000 secs . 10 | \ 5.0 Introduction. 13 ! 5.1 Part Description AIA-11 L... 13 | 5.2 Part Description AIA-11 35 L/ 5S L/ Zoom L. 15 : 5.3 Part Description AIA-11 Dynamic L. 17 | 5.4 Appliance Assembly / Installation 19 6.0 Operating 19 | 61 Preparing the Patient. 19 62 Operating the Instrument 19 63 Instrument Table. 20 | 64 Cross-Side (Base ‘Assembly).. 20 65 Microscope 2Step Magnification. 20 65 Microscope 5Step Magnification. 21 | 66 Illumination... 22 ! 67 Fixation Lamp 22 ! 6.8 Equipment Maintenance 1 General Cleaning instruction. 23 ! 7 Technical Specification AIA-11 L.. 25 Tal Technical Specification AIA-11 5S L / 3S L. 26 73 Technical Specification AIA-11 Zoom L 27 74 Technical Specification AIA-11 Dynamic L 28 84 Standard Accessories. .. 29 / 8.2 Optional Accessories... 29 1 83 Legal Regulations... 29 ! 84 Classification. 30 85 Standards. a 30 \ 8.7.2 Emitted Interference — EMC Emission Test and Results (Standard table — Re 31 : 8.7.2 Emitted Interference — EMC Immunity Test and Results (Standard table — 2 ) 31 | 88 Electrical Circuit Diagram. 32 } o1 Trouble Shooting. 33, | 92 Intensity Warning 34 } 93 Disposal 34 3 | | eee eee este cesta eee see see esse eee eee eet eee ee eee eee ee aaaINTRODUCTION Thank you for choosing a Appasamy Slit lamp AIA-11 L Series PRODUCT DESCRIPTION The Slit lamp is a special microscope that provides a magnified, three- dimensional view of the different parts of the eye. A slit lamp examination is done to look at the front parts of the eye, including the comea, lens, iris and the front section of the vitreous gel. Special lenses can be placed between the slit lamp and the cornea or directly on the cornea to view deeper structures of the eye, such as the optic nerve and the area where fluid drains out of the eye. A camera may be attached to the slit lamp to take photographs of different parts of the eye. INTENDED USE / INDICATION FOR USE ¥ The SLIT LAMP AIA-11 L Series is an AC-Powered SLIT LAMP bio microscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. Itis « used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment CONTRAINDICATIONS There are no absolute contraindications know for examinations with this device. Appropriate professional assessment and caution are necessary. WARNING! LAN Read the instruction manual carefully before commissioning this product. It contains | important information regarding the safety ofthe user and patient hon Federal law restricts this device to sale by or on the order of a physician or l practitioner. Models : AIA-11 L. AIA-11 3S L AIA-11 5S L AIA-11 Zoom L AIA-11 Dynamic L ae1.0. SAFETY 1.1 QUALITY, RELIABILITY AND SAFETY Appasamy Associates (P) Ltd., is responsible for the safety, reliability and performance of the equipment only if it is used in accordance with the instructions given in the Manual. The Instrument is designed to perform as per the deciared Intended for use with safer and reliable. > — Electrical installation of the room or building in which the equipment is to be used must comply with regulations specified by the country in which the equipment to be used as well the specified in the specification > The repair / service will be taken care by a qualified technical person of Appasamy Associates (P) Ltd. > — Read and follow the instructions, caution and warnings before installing the Instrument. > The applied part for this equipment is the chin rest and forehead rest. The part which may come in contract with the patient is the face frame, > To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 41.2. IMPORTANT SAFETY & MAINTENANCE INSTRUCTIONS Before using the Equipment, read instructions carefully. Handle the Equipment carefully. Use proper methods to clean optics and Equipment. Before switch off, turnoff regulator. Cover the Equipment when not in use. “1 Don't touch the LED immediately after switch off. 1 Don't touch the Mirror surface or exposed lenses, and keep them clean Don't rub the Gliding plate. Don't move Base on rails while locking knobs at on Don't spill liquid into the Equipment. Don't use any hazardous solvents to clean the optics and parts. Only use soft, dry cloth to clean the device. Unplug the Equipment and refer servicing to qualified service personnel under the following condition «Ifthe product isn’t able to use after done all the troubleshooting in this manual «Ifthe liquid has been spilled into the optics / Equipment. * Ifthe product has been exposed to rain or water.1.3 Areas of application of the device The device is intended for use in doctor's practices, hospitals and optometrists’ and opticians’ premises. 1.4 Ambient conditions * Transportation Temperature 40°C to. -++70°C Air Pressure 500hPa to 1060 hPa Relative humidity 10% to 95% * Storage Temperature 10°C to -+55°C Air Pressure 700hPa to 1060hPa Relative humidity 10% to 95% © Working Temperature +10°C to +40°C Air Pressure 800hPa to 1080 hPa Relative humidity 30% to 90% 1.5 Operation, Environment FORBIDDEN! | Never use the device in potentially explosive environments where volatile solvents (Alcohol, Benzene, etc) and combustible anaesthetics are in use. To avoid the risk of an electric shock, this device must be connected up to Av the mains with a ground connection when using power supplies assigned to protection class 1. WARNING! | The device must be switched off after every use. Otherwise there is a risk of || | overheating when a protective dust cover is employed, This appliance must only be operated by qualified and trained personnel The owner is responsible for their training. 1.6 Light Toxicity Because prolonged intense light exposure can damage 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. This device should be used with filters that eliminate UV radiation (<400 nm) and, whenever possible filters that eliminate short-wavelength blue light (<420 nm), The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. If the value of the 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 slit lamps, 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 with 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.1.7 Disinfection Before placing the chin of the patient on the chinrest part, place the chinrest papers on the chinrest. For this purpose two chinrest pins are available on the chinrest part. Insert the chinrest pins into the chinrest paper's holes and insert the pins into the holes available on chinrest. Change chinrest paper for every patient. It helps to protect the patient from the spreading of infection from one patient to others, | ZXwaintain tissue paper below the chin and change for the every patient 2.0 Warranty and Limitation of Liability APPASAMY ASSOCIATES (P) Ltd. Warrants that our equipment Slit Lamp is free from manufacturing defects in material or workmanship for a period of ONE YEAR from the date of installation. In case of any defect during the warranty period, the concerned person / Hospital / Institution, shall immediately contact Appasamy Associates (P) Ltd., Chennai or nearby our regional service center given below. Appasamy Associates (P) Ltd. will rectify the problem and replace any parts if necessary. Please read and follow the safety and maintenance instruction given in this User guide. The following terms and conditions apply during the warranty period. Terms and Conditions:- a. The failure of electrical and components LED, Switch etc., are not covered by this warranty. b. Warranty becomes void in the follo ig cases, {f the equipment's is modified and or serviced by persons not authorized by Appasamy Associates (P) Ltd., Chennai, w If the equipment's is handled / used by persons other than qualified ophthalmologist or technicians. @ Incase damages occurred due to accident, negligence and power fluctuations. = In case of improper handling and improper maintenance of equipment's.3.0 Symbols Safety pointers for the manual and the device are explained. In order to ensure you gain the maximum benefits we suggest that you read this instruction manual carefully before assembly or use. Please be sure to check all warning or rating labels on your Slit Lamp. The following code categories describe the degree of danger or damage likely to be incurred in the event of user error made in ignorance of these codes. Read the instruction for use attentively Caution, refer to accompanying documents Warning Alternating Current a Shock Production Type ‘8’ Manufacturer Year of Production LE»? PEO oN Om European certificate of conformity For Disposal instructions, please consult the ‘Disposal’ section [>t SN Number following this symbol indicate the serial number of the Equipment REF Character following the symbol indicate the Model number of the Equipment Standard EN 60601-1Slit lamp AIA-11 L Series acc. To protection Class II 5 Clssincaton SE ReqUaton, SOMZIEEC Clase RoHS Regulation 2011/65/EU Covered the Category-8 for Medical Device4.1 Unpacking Instruction The Packing box consists of three layers, which are placed horizontally (Fig.1) Fig.1 The top layer consists of instruction manual, dust cover and face frame (chinrest assemble). The spare accessories are kept in a separate box and placed in this layer (Fig. 2). Fig.2 The middle layer consists of the cross slide assembly, illumination array and microscope assembly. Spare bulb & mirror are kept separately. Handle the assembly carefully (Fig.3). The Bottom layer consists of the Tabletop assembly. Accessory drawer, Face frame bottom plate, Rack and Nylon Sheet are fitted in the tabletop (Fig.4)4.2 Installation Instruction Step-1: Place the table top on the manual stand or motorized stands and fit it tightly. Step-3: Fix the face frame bottom on the Table Top plate and check its mounting and tightness after fitting While fixing make sure the face frame is perpendicular to Table Top Step-5: Put the chinrest paper on the chinrest and position with the chinrest pin. Er ‘Step-2: Remove the screws in the face frame bottom plate fee ‘Step-4: Fix the face frame handle on the bush fitted on the face frame rod on each side Step-6: Place the Slit Lamp on the Table Top. The toothed roller should be evenly fixed with the toothed rack on the table. Check the base XY movement on rails. Check the up & down movement of the base. It should be smooth. 10Step-7: Insert the rack guards under the toothed rack. And check its tight fitting ‘Step-8: Loosen the locking screw and insert the microscope arm fitted with microscope on the pillar of the base. Check for the smooth the rotation of the arm and locking of the arm Step-9: Insert the Aluminium ring in tothe __‘SteP-10: Loosen the locking screw and then insert the Center Pin, So that the slot to be aligned with illumination column in the pillar of the base. Check for the Tonometer Stopper Plate. the smooth rotation of the column rotation and its locking Step-11: Fix the test rod on the hole provided step-12: Fix the breath shield to the microscope arm in the pillar on the base "1Step-13: Connect the single pin right angle connector with its female connector firmly. Step-15: Connect the 4pin / 6pin right angle connector with its male connector on face frame bottom. Step-14: Connect the 4pin / 6pin right angle connector with its male connector on base Step-16: Connect the power supply adopter with female connector on face frame bottom. 125.0 INTRODUCTION The Slit lamp comprises an illumination and a Binocular Microscope. The entire device can be moved in front of the eye using the instrument base. The illumination offers a range of setting possibilities for | making the practically invisible areas of the eye visible. There is also a range of accessories available for the slit lamp to allow special diagnosis possibilities in addition to the general examinations. 5.1 PART DESCRIPTION (SLIT LAMP AIA-11 L) 13 |PART DESCRIPTION (AIA-11 L) 1. _ | Gliding plate for cross slide (Base) movements - 2. | Base Assembly : 3. Joystick Handle for horizontal, vertical and fine adjustment 4. | Rack guards 5. Power Input Pit 6. _| Latch for the angle of inclination (Ratchet Stopper) z Slit width Control Knob (Cam Knob) 8. 5° to 20° stops (Ratchet). . 9. | Centering Adjust Knob : 10. | Focusing Rod (Test Rod) 11, | Interchangeable illumination mirror : 12. | Aperture changing knob o 43. | Filter Changing Knob - 14. | LED housing Cap 15. Main Illumination Connector - 16. | LED Flexible Tube — . Fixation Lamp: . 18. | Face Frame Assembly | 19. | Head rest 20. | Eye Level marking Ring 21. | Interchangeable eyepieces 22. | Lever for changing the Objectives 23. | Breathing Shield = 24. | Microscope Arm Locking Screw | 25. | Positioning rod for setting the angle between Microscope and Illumination 26. Face Frame Handle : 27. Link Connector 28._| Fixing screw for horizontal movement of cross slide 29. | Intensity Control Knob 30. | Table Top Plate 31. | Table Top. : 32. | Accessory drawer 145.2 PART DESCRIPTION (SLIT LAMP AIA-11 3S L/ 5S L/ ZOOM LL)PART DESCRIPTION (SLIT LAMP AIA-11 3S L/ 5S L/ ZOOM L) 1. | Gliding plate for cross slide (Base) movements Base Assembly Joystick Handle for horizontal, vertical and fine adjustment Rack guards Latch for the angle of inclination (Ratchet Stopper) Slit width Control Knob (Cam Knob) 5° to 20° stops (Ratchet). 2 3. 4 5. | Power Input Pin 6. 7. 8. 9. Centering Adjust Knob 10. | Focusing Rod (Test Rod) 11. | Interchangeable illumination mirror 12. | Aperture changing knob 13. | Filter Changing Knob 14. | LED housing Cap 15. | Main Illumination Connector 16. | LED Flexible Tube 17. | Fixation Lamp 18. | Face Frame Assembly 19. | Head rest 20. | Eye Level marking Ring 21. | Interchangeable eyepieces 22. | Magnification Changing Knob 23. | Breathing Shield 24, | Microscope Arm Locking Screw 25. | Positioning rod for setting the angle between Microscope and Illumination 26. | Face Frame Handle 27. | Link Connector 28. | Fixing screw for horizontal movement of cross slide 29. | Intensity Control Knob 30. | Table Top Plate 31. | Table Top 32. | Accessory drawer 165.3 PART DESCRIPTION (SLIT LAMP AIA-11 Dynamic L)PART DESCRIPTION (SLIT LAMP AIA-11 Dynamic L) 1.__| Gliding plate for cross slide (Base) movements 2 | Base Assembly 3 _| Joystick Handle for horizontal, vertical and fine adjustment Rack guards 4 7 _| Slit width Control Knob (Cam Knob) 10 | Focusing Rod (Test Rod) 11 Interchangeable illumination mirror 12. Aperture changing knob 13 | Filter Changing Knob 14 | LED housing Cap 15 | Main Illumination Connector 16 | LED Flexible Tube 17 | Fixation Lamp 18 | Face Frame Assembly 19 | Head rest 20 | Eye Level marking Ring 21 | Interchangeable Eyepieces 22. | Lever for changing the Objectives 24 | Microscope Arm Locking Screw 25 _| Positioning rod for setting the angle between Microscope and Illumination 26 | Face Frame Handle 27 | Link Connector 28 | Fixing screw for horizontal movement of cross slide 29. | Intensity Control Knob 30 | Table Top Plate 31 ‘| Table Top 32 | Accessory drawer 186.0 5.4 APPLIANCE ASSEMBLY / INSTALLATION WARNING! This device must not be modified without the manufacturer's approval. © Installation and repairs may only be performed by trained specialists. * Contact your Appasamy Associates representative for the installation, repair and modification of the system. You can find the contact information at www.appasamy.com OPERATING 6.1 Preparing the Patient 1 | 10. In order to attain a solid basis for the forehead and chin to rest on, the table height should be selected such that the patient sits bent over forward. To ensure that only the part of the eye being examined is illuminated, the slit height should be accordingly. Parts which come into contact with the patient should be cleaned with a dry cloth prior to every use. The lamp must be switched off after every examination. 6.2 Operating the Instrument Adjust the chin rest by means of the control knob so that the patient's eyes are approximately level with the black marker on the side of the headrest. Focus the eyepieces (21) to suit your refraction by turning the rings and then set to your inter- pupillary distance. (For lever type Microscope). ‘Switch on the lamp and then regulate the regulator at required illumination. ‘Adjust the slit lamp by means of the Joystick handle (3), to until the pencil of light is level with the patient's eyes, Holding the Joystick handle (3), inclined towards you, displace the slit lamp by moving the cross-slide until the slit appears to be approximately in focus on the cornea. This coarse setting is achieved with the naked eye. Fine adjustment is subsequently carried out by tilting the control lever, lightly held at its upper end, whilst observing the slit image through the microscope. The slit width is varied by rotating either the left hand or right hand cam control knob (7). To vary the angle between illumination and microscope use one or other of these same controls as handles. The slit image is made vertical, horizontal, or given any desired inclination by means of the aperture knob (12) (notches at 45°, 90°, 135°; stops at 0%and 180°) By tripping the latch (6) and tilting the illumination, the light can be introduced from as much as 20° below the horizontal. (a) The magnification of the microscope can be changed by rotating the lever (22), which alters the objectives, or by exchanging the eyepieces. (For 2 - Step Microscope). (b) The magnification of the microscope can be changed by rotating the drum (22), which alters the objectives. (For 5 — Step Microscope). For observation by retro-illumination or proximal illumination the centering screw (9) is loosened, so that the slit image can be moved away from the center of the field of observation. 19 aS. rr—”——.U—™C—“ENEEEENB'' '—>?''—EE EXCZL EEE I | The image is centered again by tightening the screw. 11. For the examination of the fundus, Hruby lens (Optional) is employed. The Hruby lens is introduced into the holder on the slide underneath the chin rest and guided independently. SUMMARY 6.3 INSTRUMENT TABLE The height of the instrument table and of the examiners chair is adjusted so that the surgeon can operate the instrument conveniently. The height of the patient’s chair is adjusted to suit is stature. The patients should rest their chin and forehead firmly against the headrest (19). Move the chinrest by turning the control knob until the eyes are level with the black marker (20) at the side of the headrest. The Gliding plate on the table must always be kept clean, to ensure free movement of the slit lamp. The accessory drawer (32) is provided to keep the second pair of eyepieces, preset lenses, one insert mirror, spare bulb and Test rod. 6.4 CROSS-SLIDE (BASE ASSEMBLY) The Joystick handle (3) enables the entire slit lamp to be moved easily in all directions in a { horizontal plane. The cross ~ slide moves parallel to itself during the adjustments. Displace the slit lamp, with the Joystick lever held firmly and slightly inclined towards the examiner, until the 1age of the slit appears sharply on the cornea The accuracy of this rough adjustment is checked by the naked eye. The fine adjustment is Now carried out while observing the slit through the microscope. Tilt the contro! lever, which is now lightly held at its upper end, until the slit appears sharply at the depth of the eye, which is to be observed. The horizontal motion of the cross-slide can be locked by tightening the screw (28). Rotate the Joystick to adjust the height of the light to the level of the eye. The microscope can be locked on the pivoting axis by means of screw, while the illumination unit can be freely rotated about the common axis. The illumination and the microscope can be moved together with any fixed angle between them, if one of the knobs is tightened and the screw is loosened. If you wish to move the instrument with or without the table, it is advisable to lock all movable parts by tightening screws (24) The index ring and the scale ring are suited on the microscope arm and the lamp arm respectively. The longer central mark on the index ring shows the angle between the axis of the microscope and the illumination unit; the shorter marks, which are 6.5° to the left and to the right of it, show the angle between the left and right microscopes and the illumination unit. The positioning rod (25) is notched in position when the illumination unit is in its central position (0°) or (15°) to the right or to the left of it. a 206.5 MICROSCOPE > a. 2 Step Magnification Microscope The eye — pieces (21) must be set to suit your refractive error before the examination commences. For this purpose a focusing rod is supplied. The flat black surface of focusing rod (10) is set perpendicular to the microscope. Set the illumination unit at 0° to the microscope. Adjust each eyepiece separately, by turning the knurled rings, until the projected slit is seen in focus. This must be done separately for the 10x and 15x eye pieces, and the appropriate positions on the sale of the eye — piece holder should be noted, in order that the setting does not have to be repeated. The figures close to the scale indicate the corrections in diopters for the 10x eyepieces, the figures above them for the 15x eye pieces. The magnification of the microscope is readily altered by changing the objectives in the revolving holder. To do this, itis only necessary to rotate the lever (22) from 1x to 1.6x and the objectives snap automatically into their correct position, as soon as they have been moved over the dead center. Examination is not interrupted whilst this is done, and a resetting of the microscope is unnecessary. The change cover alters the total Magnification from 10x to 16x for the low power eye pieces, and from 16x to 24x for the high power ones. Having focused the eye- pieces, adjust them to suit your inter pupillary distance. The ability to focus each eyepiece separately not only enables the examiner's refraction to be corrected, but also compensates for any asymmetrical course of the two microscope pencils in the examined eye, especially during fundus observation. A satisfactory binocular and stereoscopic examination of the slit image on the fundus is usually possible only when an accurate setting of each eye — piece is made. a, 58/38 Magnification Microscope A-5-step magnification microscope with achromatic optics gives sharp and grips images. The five primary magnifications 0.4x, 0.6x, 1.0x, 1.6%, 2.5x / 0.6x, 1.0x, 1.6x gives total magnification of 6x, 10x, 16x, 25x, 40x 1 10x, 16x, 25x respectively. The magnification is changing by rotating the Drum. The eye pieces (21) must be set to suit your refractive error before the examination commences. For this purpose a focusing rod is supplied. The flat black surface of focusing rod (10) is set perpendicular to the microscope. Set the illumination unit at 0° to the microscope. Adjust each ‘eyepiece separately, by turing the rings, until the projected slit is seen in focus. A satisfactory binocular and stereoscopic examination of the slit image on the fundus is usually possible only when an accurate setting of each eyepiece is made. Also, The microscope having the provision to adopt Beam splitter, C-Mount and Camera attachment for video imaging and mono tube for assistance viewing etc 21EN 6.6 ILLUMINATION The light from a vertically suspended LED lamp passes through the condenser, slit mechanism and objective, and is reflected by an inclined mirror into the patient's eye. a._ Incandescent lamp: To fit a new lamp, loosen the knurled screw and lift off the lid of the housing. Remove the bulb and replace. The lamp housing is then replaced and pushed firmly into position before the screw is tightened b. Slit. Filter and Diaphragm: The slit width is varied by means of the controls which are also used as handles for altering the angle between microscope and illumination unit. By turning the knob, the slit image can be rotated form the vertical through any oblique angle to the horizontal. Moreover, the slit image can be inclined, thus Producing a horizontal optical section, particularly valuable in gonioscopy and fundus examination, ; ‘This inclination is achieved by depressing latch and titing the whole illumination unit Two discs lie in the path of the illumination. One of these contains 3 filters: a heat absorption filter, Green filter, and cobalt blue. This blue filters used for Applanation Tonometry. An UV filter also fitted. 4 The other disc manipulated by rotating knob (12) contains 7 apertures producing areas of 14,10,6,4,3,1 and 0.2 mm diameters. Thus slit lengths of these dimensions are obtainable. c. Filter Indicating Sticker 1 2 3 4 5 1. Open 2. Green Filter 3. Blue Filter 4, Heat Absorbing 5. Empty space for accommodating and add filter d. Illumination mirror The front surface of mirror (11) is reasonably scratchproof. The mirror is easily removed for cleaning or replacement. Retro- illumination, indirect illumination, scleral scatter etc., is obtainable by displacing the slit image away from the center of the field of vision. This is achieved by loosening screw (9) and rotating the illumination unit about its vertical axis. The slit image is centered again by tightening the screw, 6.7 Fixation Lamp The fixation target can be set to the patient's distant vision in order to eliminate accommodation and convergence connected with it and to enable the patient's eye to remain steady. 226.8 EQUIPMENT MAINTENANCE / GENERAL CLEANING INSTRUCTION = & 4. Replacement of the main LED. The Main lamp is a LED lamp, which operates for long periods. When it is eventually necessary to replace the LED, it can be done easily by following the instructions below: Loosen the top LED Cap screw and remove the cap b. Unscrew the screws on heat shrink (3 No’s) and remove the heat shrink from the condenser lens assembly. c. Remove the LED from Heat shrink by unscrewing the screws (2 No's) and remove the LED from wire. d. Place the new LED with wire in a right way (ie. +ve & -ve pole should be match with +ve &-ve of the wire). Then fit the LED in the heat sink. e. Assemble the heat shrink with LED assembly on the condenser assembly and screw it. f. Then fix the LED housing and screw it. | A to cool before touch / replace the ] lamp and housing 2. Replacement of the Mirror Tilt the illumination system by releasing the latch and then grasp the narrow shank of the long mirror and pull upwards. Then replace the new mirror. (shown Fig.6) 3. Mirror Cleaning. Remove dust accumulation with a camel's hair brush. After brushing, finger marks can be removed, if necessary clean with isopropyl alcohol and a cotton swab. Dry with a facial tissue While changing the Mirror, be sure no finger marks on the surface of Mirror. It reduces the intensity. 4. Eyepiece lens cleaning. Finger marks can be removed by the same method used for the mirror. Use Cleaning solvent Isopropyl alcoho! 70% gently rub using cotton swab from centre to centre periphery 2 times slowly. 235. Cleaning of the optical parts To remove dust from the exposed optical surface, use the camel's hair brush. Always return the brush to its case after use, in order to keep it clean. Occasionally the upper surface of the condenser lens should be dusted. Remove the lid of the lamp housing and the bulb. Unscrew the four small knurled nuts undemeath and lift off the body of the housing. The condenser surface is now visible and can be brushed. Surfaces, which have become really dirty should first be dusted, then wiped carefully with a soft clean cloth, washed linen, chamois leather, which will not scratch the surface. 6. Adjustment of friction of the slit width control ‘Adjusting the small screws in the cam knobs can regulate the friction of the slit width controls. The screw should be at least tight enough to ensure that the slit does not close spontaneously. 7. Cleaning of the toothed bars (Rack). From time to time these bars should be cleaned with a brush 8. Cleani 1g of the gliding-plate on the instrument table If the gliding-plate (1) is dirty and the slit lamp becomes difficult to move, rub the plate vigorously with oil soaked cloth to restore normal movement. 9. Exterior Surface general cleaning Clear the Exterior Surfaces, especially the joystick glide plate, by wiping with a soft, dry cloth. Do not use commercial or household cleaners WARNING A Intake of silica gel is dangerous. For external use only Always place silica gel, which packed in a packet, near to optics e. etc. It reduces the moisture contamination and fungus of optics. ATTENTION ZX Toavoid heating of power supply And for safe, replace fuses with correct size and rating, . between IPD adjustment cups 10. Frequently used Function intensity control This equipments is used only 2 mints for eye examination. And interval time is 5 mints for next patients. Per day using 50 (approx) patients for eye examination 247.0 Technical Specifics 7.4 SLIT LAMP (AIA-11 L) Microscope Galilean Magnification Change | 2 Position Lever Eye Piece 10x or 15x Magnification Ratio 10x, 16x or 15x, 24x Real field of view in mm 20, 12.5 or 14, 9 Pupillary Distance 52-90 mm Adjustable Diopter Adjustment 4/-8D Working Distance 100 mm ‘Slit Width 0-14 mm Continually Slit Length 0-14mm Continually Slit Apertures 0.2, 1, 3, 4, 6, 10, 14mm | iit Angles | or - 180" | Slit inclination 5°, 10°, 18°, 20° Input Voltage 100-240v AC~ ,0.3A, 47-63Hz LED (Lamp) 3.4V, 700mA ] LED (Background) 3.4V, 350mA [rae ite ome Power Consumption 31 VA (Max) Movement Range Longitudinal Inout | 99 mm : Lateral (Left/Right) | 118 mm Vertical (Up/Do 30mm | Chin Rest Range i | | Dimension (mm) '530(L) x 380(W) x 780(H) Gross Weight 17.150 Kg. Net Weight (Packed) | 26.000 Kg; 7.2 SLIT LAMP (AIA-11 5SL/3S L) Microscope Galilean Magnification Change 5 Step Drum Rotation Eye Piece Magnification Ratio 12.5x 6x, 10x, 16x, 25x, 40x for 5Step 10x, 16x, 25x for 3Step | Real field of view in mm 43, 27, 16, 11, 7.0mm, for 5Step 27, 16, 114mm for 3Step Pupillary Distance 50 ~ 78 mm Adjustable Diopter Adjustment +-8D Working Distance 100 mm Slit Width 0-14 mm Continually Slit Length 0-14 mm Continually [Slt Apertures |0.2,1,3,4,6, 10, 14mm Slit Angles 0° - 180° | Sil Inclination 5°, 10°, 15°, 20° Input Voltage 100-240v AC~ ,0.3A, 47-63Hz LED (Lamp) 3.4V, 700mA LED (Background) | 3.4v, 350mA Heat absorbing, Green & Cobalt Filters Power Consumption | 31 VA (Max) Movement Range : Longitudinal injOut | 99 mm Lateral (Left/Right) [118mm : Vertical (Up/Down) | 30 mm [Chin RestRange | 120mm Dimension (mm) | 530(L) x 380(W) x 780(H) Gross Weight 17.700 Kg Net Weight (Packed) | 28.000 Kg. 26 |7.3 SLIT LAMP (AIA-11 ZOOM L) Microscope | ‘\cien | Magnification Change _ | Continues Zoom by manual | Eye Piece | 12.5x a Magnification Ratio. | Continues from 6x to 40x | Real field of view inmm | Continues from 7 to 43 7] Pupillary Distance | 527mm Adjustable Diopter Adjustment | +/-8D Working Distance 400 mm = ‘Slit Width a o-14 mm Continually sitLength 0-14mmContinualy Slit Apertures = 0.2, 1, 3,4,6, 10,14 mm | slit Angles | 0° - 180° a [stitinctination __| 5°, 40", 15°, 20° | Input Voltage 100-240v AC~ ,0.3A, 47-63Hz ‘LED (Lamp) . 3. AV, 700mA = . [LED (ackground) (SAV,360mA Filters [estersen Green . 7 Power Consumption 131 VA (Max) “Movement Range 3 oe | Longitudinal In/Out | 99 mm - : Lateral (Left/Right) | 118mm a Veceiipten |\Men | Chin Rest Range 120 mm — —— ‘Dimension (mm) | 530(L) x 380(W) x 780(H) Gross Weight =| 17.800 Kg. : | Net Weight (Packed) | 28.000 Kg —7.4 SLIT LAMP (AIA-11 Dynamic L) Microscope Galilean Magnification Change _| 2 Position Lever Eye Piece 10x or 15x Magnification Ratio 10x, 16x or 15x, 24x Real field of view in mm. 20, 12.5 or 14,9 Pupillary Distance 52-90 mm Adjustable Diopter Adjustment +-8D | Working Distance 4100 mm Slit Width 0-14 mm Continually {Slit Length 0— 14 mm Continually | Slit Apertures 0.2, 1, 3,4, 6, 10, 14 mm Slit Angles 0° - 180° Input Voltage 100-240v AC~,0.3A, 47-63Hz LED (Lamp) 3.4V, 700mA LED (Backround) 3.4V, 350mA Heat absorbing, Green & | Fiters Cobalt Blue Power Consumption | 31 VA (Max) Movement Range Longitudinal In/Out 99 mm Lateral (Left/Right) | 118 mm Vertical (Up/Down) 30 mm Chin Rest Range 120 mm Dimension (mm) 530(L) x 380(W) x 780(H) Gross Weight 16.800 kg. Net Weight (Packed) | 25.00 kg. 28SS 8.0 APPENDIX 8.1 STANDARD ACCESSORIES Parts Description Quantity Parts Description 1, Dust Cover 1 8. Black Bush 2. User Guide di 9. Allen Key 3. Test Rod 1 10. Face frame Handle 4. Side Cover 2 11. 15x Eyepiece 5. Chinrest Paper with Box 1 12, Breathing Shield 6. Chinrest Pin 2 13. Link Cable / Power Supply Adopter 7. Mirror 1 8.2 OPTIONAL ACCESSORIES (Extra Cost) 8.3 Additional Accessories (Not applicable) ; ion | Model? | | | # | ITEM DESCRIPTION re QUANTITY 1) | LED LED ot 2) _| Hruby Lens Assembly od 29See eee eee eee eee EEE eee eee eee 8.4 Legal Regulations The AIA-11 L_ Series Slit Lamp was developed and designed taking the EN 60601-1 and EN ISO 15004-2 standard into account. Production, testing, set-up, maintenance and repairs are performed taking internal standards into account. The EN 60601-1-1 standard must be observed when using different medical and/or non- medical electrical appliances in combination. Compliance of the AIA-11 L_ Series Slit lamp with the Directive 93/42IEEC is confirmed by the CE marking. The AIA-11 L Series Slit Lamp satisfies the electromagnetic compatibility requirements of EN6060-1—2. The device has been designed to maintain the emissions of electromagnetic interference at a level which does not exceed the statutory guidelines and which does not affect other devices in its vicinity. The instrument also boasts the immunity stipulated by the standard. The statutory accident regulations must be observed, 8.5 Classification * Standard EN 60601-1 __ Sit lamp AIA-11 L_ Series aco. To protection Class Il © CE-Regulation 93/42/EEC Class | FDA classification Class Il 2 RoHS Regulation 201 1/65/EU Covered the Category-8 for Medical Device 8.6 Standards ‘Slit Lamp Microscope AIA-11 L Series complies with the requirements of listed FDA Recognized Consensus Standards, a. 180 10939: 1017, Ophthalmic instruments — Slit Lamp Microscope b, ISO 15004-2:2007, Ophthalmic instruments — Fundamental requirements and test methods Part 2: Light hazard protection ¢. IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Safety 4. IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements for Safety- Collateral Standard: Electromagnetic compatibility — Requirements and Tests e. IEC 60601-1-6:2006, Usability Engineering f. 180 14971:2012 Medical Device Application of Risk Management to Medical Devices 9. ISO 10993-5:2009(E), Biological Evaluation of Medical Devices - Part 5, Tests for In vitro Cytotoxicity, h. 180 15004-1:2009, Environment Test i. EN ISO 15223-1:2012 Symbols for use in the labelling of medical devices. 8.7 Information and Manufacturer's Declaration Concerning Electro Magnetic Compatibility (EMC) 8.7.1 General The Slit Lamp AIA-11 L Series system fulfils the requirements for electromagnetic compatibility according to EN 60601-1-2. The instrument is built so that the generation and emission of electromagnetic interference is limited to the extent that other devices are not disturbed inn their use in accordance with the regulations and so ' that it itself has appropriate immunity to electromagnetic interference. = WARNING! : j\ * Electrical medical devices and systems are subject, in terms of EMC, to special | Measures and must be installed in accordance with the EMC instructions contained in this accompanying document. * Portable and mobile HF communication systems may interfere with electrical medical devices. WARNING! ‘+ The use of other wiring or equipment than that listed may lead to a higher emission or to a lower interference resistance of the device. | 308.7.2 Emitted Interference (Standard table - 1) Guidance and manufacturer's declaration - Electromagnetic Emissions The product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an environment EMC EMISSION TEST AND RESULTS Name ofthe | Product | Basic | AC/DC/ ; Test__| Standards | Standards | Signal Part eee a 150 KE 500 Rie, 66-56 GBAV | 500 ite 5 Me, 56 sBuV Siitiz=30 MMs, 60 JBV RF for aes peak ec cise it | zs0vac within the Conducted 150 it “500 ke, 66-46 dBuV Conducted | Sogos-1.2 | Clase 8 | powerpon | 1s0.tHe S00 S65 Umit Baovac | power portS MHz - 30 MHz, 50 dB aa forverage = Radeteo [ec [asPRTT | nq 30-2902, 30 Bp within the Emission | 60601-1-2 | Class 8 230-1000 Mi, 37 BpVquasipesk | Limit ‘Harmonic . 7 F s ec [tec za0vAc | Current class A Curent | s0601-1-2 | 61000-3-2 | power port PRSDESPSI=T, | Relative steady state voltage Shange (6) 3.9% Ficter [tec te zaovac waitin he | Emission | 60601-1-2 | 610003 | power por | Maximum relative votage change, | Lim Value of dit) ring voltage, | change -3.3% = | 8.7.2. Immunity (Standard Table - 2) Guidance and manufacturer's declaration — Electromagnetic Immunity The product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an environment [EMG IMMUNITY TEST AND RESULTS: Faromarce Name otine | Protuct | Bosc )AC/BGI a Tes Standards | Standards | Signal Par _ | SPotification char met by Radated EC |IEo, |endonue | tov oitrarA ptibility | 606 1 kHz, B0%AM Ee eo [eo Contact charge = kV ee 60601-1-2 | 61000-4-2 | Enclosure Air discharge + BkV | ‘Gtlieria-a. = ee ive ae 60601-1-2 | 61000-4-4 | power port oon Sent High Energy | IEC 1ec ‘230VAC_ Tics s ga WS se BEY TESov2 [eibonas | eintgon — [Usos2ey tan | citatk cr ec [ec Zaovac | 3Vims.0.15-80 Ne, ann CRrunty | Boaor--2 | 61000--6 | power port | tate eOWAM | Power es oe eee eee cece eee Fromerey |tec | tec | Frowenoy EC |S ag | Ereoaue | 3m rere rea an Tig srat wiemupion Base Votage Ops Stoeups orsoces eo fiec zs0vac ond foo as or25 es citeraa Tnereaeat | | ooo t= | G1000-e11_ | power pore 0% of AC mains voltage for 0.5 cycles8.8 Electrical circuit diagram A\warninc Refer to the rating plate for voltage and check that the Equipment voltage corresponds to the supply voltage. Important: Wire colour code defined as follows From Main Line to Input of Power Supply: Brown Wire’ = Line Blue Wire - Neutral Green Yellow Wire - Earth All other wires colour are indicated in the below Schematic diagram, ‘Schematic diagram vemmin 500 pm CT. Bees -——_>+— — ‘eur oe | ee 32STANDARD COMPLIANCE Appasamy Associates (P) Ltd., Slit lamps are complies with IEC 60601-1 and IEC 60601-1-2 for electrical safety and electromagnetic compatibility. Disclaimer The illustration shown in this manual may vary from the original equipments and depending upon the | ‘ongoing developments, 9.1 TROUBLE SHOOTING Problem Reported Bulb not glowing Bulb Flickering Low illumination Slit not closed No clear image Self closing Restriction in Base movement Possible Causes LED fused Loose Connection Power Supply output problem oot “ Input AC voltage fluctuation + Loose contact of electrical connections + Weak LED after long term usage + Dust deposit on Mirror / Loss of coating + Fungus or dust deposit on optics ‘ Low input AC voltage + Strucking of slit housing assembly or cam lifting assembly in the illumination column + Breaking up of “U" spring “> Shutters misalignment * * * Dust or fungus in optics in llumination part (or) Microscope part + Loosening of cam screws Worn out of cam knob side washers 4 Formation of dust on base rod Dust formation on the surface of the Gliding Plate + Worn out of base bottom Tefion button 33 Remedy * Change the bulb + Check LED Connection * Check the Power Supply Adopter » Use a Stabilizer or UPS ~ Check the entire electrical connections a Replace the LED = Clean / replace the Mirror Clean dust & fungus in all | Illumination Optics. = Check input voltage * Open the slit housing assembly & then adjust. » Replace "V" spring = Adjust or replace shutters | © Clean the dust or fungus on the optical parts using appropriate cleaning solution © Adjust and tight the cam knob screws © Add or change the cam knob side washers © Clean the base rod © Clean or change the Gliding plate Change the bottom Teflon buttoneae tection ce ec 9.2 Intensity Warning Because prolonged intense light exposure can damage 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. This device should be used with filters that eliminate UV radiation (<400 nm) and, whenever possible filters that eliminate short- wavelength blue light (<420 nm). The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. If the value of the 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 slit lamps, 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 with 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. [ Ec | REP Mis. Emergo Europe, Prinsessegracht 20, 2514 AP The Hague The Netherlands.Phone: (31) (0) 70 345-8570, Website: www.emergogroup.com 9.3 DISPOSAL: 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 (i) for all other countries, in accordance with local disposal and recycling laws, DISPOSE OF THE INSTRUMENT ACCORDING TO LOCAL DISPOSAL AND RECYCLING LAWS eaAIA 5S Manufacturer & Marketed by APPASAMY ASSOCIATES Empowering Vision* ‘Ala ZOOM Factory Registered Office APPASAMY ASSOCIATES (P)LTD. No.446, SIDCO Industrial Estate Ambattur, Chennai 600 098 Tell: (91-44) 30101484, 30101480 Fax: (91-44) 2363 0721, Email: info@appasamy.com. Website: www.appasamy.com APPASAMY ASSOCIATES (P)LTD. No. 20, SBI Officer's Colony, First Street, ‘Arumbakkam, Chennai - 600 108, INDIA Tell: (91-44) 30101401, 30101435 Fax:: (91-44) 2363 0721, Email: info@appasamy.com. Website: www.appasamy.com AX caution: Federal law restricts this device to sale by or on the order of a Physician or Practitioner RD-7.3-13-A2/Rev-02 Date: 16.06.2019 36