BA 904 Slit Lamp Instruction Manual Issue 7 March 2015

Symbol Explanations Consult ‘Instructions for Use’ Caution, consult accompanying Documents Battery input charger

On/Off - Brightness Control Type B Equipment

Class II Equipment

2011

Year of Manufacture

This product complies with the essential requirements of the medical devices directive (93/42/EEC).

Do not dispose of with household refuse Storage

Transport 10/20

Continuous use recommendations, 10 minutes running / 20 minutes off.

Contents

1. General Layout - Suitcase... 1.1 General Layout - Briefcase

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3. 3.1 3.2 3.3 3.4

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2. 2.1 2.2 2.3

4.

5.

General Description... The Slit Lamp/Microscope The Joystick Platform The Complete Power Supply

Preparing the BA 904 Slit Lamp For Use... For Normal Use For Hand Held Use Mounting on to Parking Unit Transport/Packing for the Parking Unit Mains and Battery Operations...

Using the BA 904 Slit Lamp...

6. Routine Care and Maintenance... 6.1 Optics 6.2 Service and Maintenance 6.3 Inspection 6.4 Calibration 6.5 Technical Manual 6.6 Electrics 6.7 Replacement of the Lamp 6.8 Joystick Platform 6.9 EMC ( Electro Magnetic Compatibility ) Declaration 6.10 Transportation and Storage 6.11 End of Life and Disposal 6.12 Notes on Usage

7. 7.1 7.2 7.3 7.4 7.5

Technical Data... Optics Mechanical Electrical Spare and Replaceable Parts Technical Specifications Summary

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1. General Layout - Suitcase

Fig.1.

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1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30.

Bio-microscope Slit Lamp Projection Unit Brightness Control Rotating Prism Boxes Interchangeable Eyepieces Lamp Cover Mirror Forehead Rest Filter Control Aperture Control Slit Control Joystick Platform Chin-rest Chin-rest Locking Knob Joystick Rise and Fall Control Slit Lamp Mounting Retaining Bracket Locking Tubes Eye Level Indicator Battery Charger Mains Power Supply Energy Pack Alternative Plugs Spacer Disc Focusing Rod Bulb Extractor Spanner Spare Bulb Spare Energy Pack

General Layout - Suitcase

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Figure 1

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1.1 General Layout - Briefcase

Fig.2.

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1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21.

Bio-microscope Slit Lamp Projection Unit Brightness Control Rotating Prism Boxes Interchangeable Eyepieces Lamp Cover Mirror Filter Control Aperture Control Slit Control Forehead Rest Parking Unit Battery Charger Mains Power Supply Energy Pack Alternative Plugs Disc Focusing Rod Bulb Extractor Spanner Spare Bulb Spare Energy Pack

General Layout - Briefcase

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Figure 2

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2. General Description

The BA 904 Slit Lamp may be used as a table-mounted joystick controlled model, or in a hand held mode. A general arrangement of the two systems is shown in Figure 1 and 2. The BA 904 Slit Lamp consists of three basic components: Suitcase: Briefcase: • The Slit Lamp • The Slit Lamp Bio-microscope Bio-microscope • The Joystick Platform • Parking Unit • Removable battery • Removable battery and mains power supply and mains power supply

2.1 The Slit Lamp/Microscope (Refer to Fig 1)

The BA Slit Lamp bio-microscope consists of a conventional compound stereoscopic microscope (1) mounted on a light-alloy frame to which is attached the Slit Lamp Projection Unit (2) so that it rotates around the focal plane of the microscope.

The microscope consists of 1x objectives and 10x Kellner achromatic eyepieces (5). The objective lenses are fixed and the eyepieces are adjustable between at least -8 and +5 dioptres for optical correction of the user. All the microscope lenses are multi-layer anti-reflection coated.

The interpupillary distance is adjustable between at least 54mm and 94mm by rotating the prism boxes (4). The total magnification of the microscope is 10x using the 10x eyepieces, or 16x using the 16x eyepieces (supplied as an optional accessory). The stereoscopic angle of the microscope is 13°.

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The Slit Lamp Projection Unit (2) consists of a halogen light source, located behind the lamp cover (6). The unit rotates about a central pivot which coincides with the focal plane of the microscope. This pivot has a central hole which accommodates the focusing rod (see Fig. 3) for checking the optics of the instrument when in the hand held mode.

2.1 The Slit Lamp/Microscope continued

Figure 3 The slit image is formed by a precision graticule operated by a slit control (11), which is projected onto the eye via a threeelement projection lens and a mirror (7). Colour filters (blue for fluorescein examination, and yellow for elimination of blue light hazard) are built into the unit and are selected using the filter control (9).

The aperture height is controlled by the aperture control (10). The slit image has three widths at the eye: (0.12mm, 0.25mm and 0.5mm), allowing for fine and coarse slit examination. An aperture is also provided in the slit control (11), [setting 0] to allow different sized patches to be projected onto the eye. The slit has four heights available: 3, 5, 8 and 14 mm.

The light source is accessed through the lamp cover, but before removing this cover refer to Section 6 - Routine Care and Maintenance.

The BA Slit Lamp has a spring loaded shaft to which is fixed a forehead rest for stabilisation when used in the hand held mode (see Fig. 3).

2.2 The Joystick Platform

The joystick platform consists of a forehead rest and chin-rest (13), and a slit lamp platform with precise three dimensional positioning mechanism consisting of a joystick (15) and rise 7 and fall control (16).

2.2 The Joystick Platform continued

The chin-rest has two positions so that either eye may be positioned centrally over the platform. The chin-rest height is adjustable by releasing and locking the two chin-rest locking knobs (14). Horizontal movement of the platform (forwards and backwards, and from side to side) is performed conventionally using the joystick (15). Vertical movement of the platform is achieved by rotating the rise and fall control (16).

Before mounting the slit lamp bio-microscope onto the platform ensure that the platform is assembled as in Section 3 - Preparing the BA 904 Slit Lamp for use.

The BA Slit Lamp is assembled onto the platform using the spigot which is inserted into the slit lamp mounting (17). The slit lamp arm may be located in the retaining bracket (18) which will prevent the slit lamp arm from rotating. Or using the spacer, the slit lamp arm may be raised so that the slit lamp body clears the retaining bracket and is allowed to rotate freely (see Fig. 4).

Figure 4

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Note 1 Care should be taken when using the spacer as the stability of the BA 904 may be affected when the Slit Lamp is swung over to one side or the other.

2.2 The Joystick Platform continued

Note 2 Rated load for the chin rest & components

Rated load is 5.9kg with a Tensile strength safety factor of 4 Head rest general assembly drawing 5606393

Part Nos Aluminium base - Aluminium Alloy 6082 Tensile strength 260 MPa

Upright assembly Stainless Steel AISI 302 - Tensile strength 860 MPa

Chinrest Assembly - Aluminium Alloy 2014-T6 Tensile strength 483 MPa

Headrest Support Assembly - Mild Steel 1090 16 SWG Tensile strength 841 MPa Tensile strengths greater than 23.6kg (4x5.9kg)

The Joystick is of robust construction. The user should always mount the platform on a suitable and stable surface before operation.

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2.3 The Complete Power Supply

The Mains Power Supply (Fig 5) is used to power the BA Slit Lamp from the mains.

The BA Slit Lamp can be operated using the Energy Pack (Fig 6), once fully charged (see page 13), for portable use. When fully charged the battery will last for 45 minutes with continuous use, however it is not recommended to keep the Slit Lamp on for longer than 10 minutes, allowing 20mins before switching on again. The Battery Charger ( Fig 6), supplied with alternative plugs, is used to charge the Energy Pack.

Fig 5 - Mains Power Supply Note

Fig 6 - Energy Pack and Battery Charger

The power supply has a 2 year warranty, the green LED illuminated when the power supply is plugged into the mains, indicating operation functions normally. The mains power supply should be unplugged from the power socket when not in use.

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The power supply is part of the ME system.

3. Preparing the BA 904 Slit Lamp for Use

The BA 904 Slit Lamp may be supplied with or without the joystick platform. The Suitcase includes the Joystick Platform. The Briefcase includes the Parking Unit.(The parking unit is used for supporting the Slit Lamp when not in use.) Operation of the Slit Lamp bio-microscope without the platform (i.e., in the hand held mode) is identical to its operation on the joystick platform with the inclusion of the forehead rest shaft (see Fig. 8).

3.1 For Normal Use

For operation with the joystick platform, remove the BA Slit Lamp and the joystick platform from the carrying case. Assemble the joystick platform by pivoting up the head and chin-rest (see fig.7). Lock the uprights in position by screwing down the locking tubes. Take the spigot and insert it into the slit lamp mounting hole. Now take the BA Slit Lamp microscope and mount it over the mounting spigot and locate the body of the BA Slit Lamp into the retaining bracket. Spigot

Figure 7 The microscope has conventional focusing eyepieces and rotating prism boxes to suit variations in the users’ IPD and refractive correction. It is important that the microscope focus 11 coincides with the slit image focus.

3.1 For Normal Use continued

Best optical performance will be achieved if the eyes are relaxed (i.e., accommodated at infinity), but providing any accommodation is constant, this is not important.

It is convenient to remember your own personal eyepiece settings in order to avoid having to set them up each time. Once the individual eyepieces are set, the interpupillary distance is adjusted (if not already done) to achieve a crisp stereoscopic binocular view. The BA 904 is ready for use. Note The microscope is factory set to allow a small amount of convergence through the microscope in order to achieve optimum stereopsis, in some users this convergence can induce a small amount of accommodation.

Important: Switch off between uses. Do not use the Slit Lamp continuously for longer than 10 minutes. 3.2 For Hand Held Use

Set up the microscope eyepieces and IPD as previously described. Screw the forehead rest into the forehead rest shaft, (see Fig.8). This shaft is spring loaded and helps reduce shake and wander while the BA Slit Lamp is in use.

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When using the BA 904 Slit Lamp in the hand held mode, the forehead rest is placed on the patient’s forehead and the lock released by turning the lock anti-clockwise. This will steady the instrument when it is moved towards or away from the eye for focusing. The forehead rest may be locked at any time, by turning the forehead rest lock clockwise.

3.2 For Hand Held Use continued

Connect the Energy Pack to the BA Slit Lamp as shown in fig 9. (when fitting for the first time you may need to push it down with some force to align the connectors). Switch on the power using the brightness control knob and the BA 904 is ready for use. When detaching the Energy Pack, press the small knob, at the base, back and up to release Pack from unit, (see fig 10).

Figure 8

Figure 9

Figure 10

Figure 11

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3.3 Mounting on to Parking Unit

Pivot hole/nut

Location pin

Mounting the Slit Lamp to Parking unit :-

Parking unit

Locate the pivot hole/nut over the location pin on the parking unit

3.4 Transport/Packing for the Parking unit

1. Lift the Slit Lamp slightly to disconnect it from the parking unit

2. Place the Parking unit inside the brief case (above the 3 battery packs) with the location pin inserted into the cut out slot

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4.

Mains and Battery Operations

Mains Operation

1. Attach Mains Adaptor to the BA Slit Lamp. 2. Plug the Mains Power Supply into the mains socket. 3. Switch on and use as normal.

Energy Pack Operation

For the first time, the Energy Pack will need to be fully charged - charge for 5 hours:-

1. Plug the Battery Charger into the mains wall supply. 2. Plug the Battery Charger (jack plug) into the Energy Pack. 3. Switch on at the mains. The LED will be green before the fast charge starts, it then changes to orange. The Energy Pack is fully charged when the LED turns green, with a short intermittent yellow flash. (please refer to the charger on IFU for more infomation) 4. Subsequent charging will take approximately 4 to 5 hours. 5. Disconnect the Energy Pack from the Battery Charger. 6. Plug the Energy Pack onto the BA Slit Lamp. 7. The Energy Pack can be recharged at any time before the batteries are exhausted. Figure 12

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5. Using the BA 904 Slit Lamp

The BA 904 uses optics of the highest quality found only in the world’s leading Slit Lamp. No compromise is made to image quality either through the microscope or slit projection system, thus the compact design delivers performance unsurpassed in any major Slit Lamp.

With the BA 904 Slit Lamp set up as previously described (Section 3 - Preparing the BA 904 Slit Lamp for use), position the patient’s head on the chin-rest so that the eye to be examined is located centrally. Use the chin-rest locking knobs on the side of the chin-rest to raise or lower the patient’s head so that the eyes are level with the eye level indicators on the uprights.

Switch on the illumination and with a slit image in position, focus this image sharply onto the sclera of the eye. (This is easiest done by not using the microscope at this stage, but by manipulating the joystick platform and using the naked eye.) Once a sharp image is formed on the sclera, use the microscope and joystick to obtain fine focus. Once this is achieved it is simple to transport the slit image across onto the cornea and into the optical media of the eye.

Note

It is assumed that the operator is generally familiar with Slit Lamp microscopy

The angle between the Slit Lamp and bio-microscope axis may be varied to achieve various perspective sections of the anterior chamber (or any other medium being viewed) by manually adjusting the angle, i.e., rotating the slit lamp arm manually.

The tension between the slit lamp arm and microscope arm is factory set at an optimum value to prevent the slit lamp arm rotating under its own weight (when used in the hand held 16 mode this could be inconvenient).

5. Using the BA 904 Slit Lamp continued

Once a satisfactory slit view is obtained, it may be desirable to decrease the slit width for finer sections. The BA 904 Slit Lamp has three slit widths operated by the knob on the lowest of three discs. The slit widths are 0.12, 0.25, and 0.5 mm. The selection position for each control is in the centre line of the Slit Lamp. The quality of the BA 904’s optics allow viewing fine detail, using the narrowest slit under normal lighting conditions. As for all Slit Lamps, however, the best results are obtained in darkened surroundings, but complete darkness is not necessary, and may have the disadvantage of making the patient uneasy.

The slit control also has a clear aperture for general field illumination. This clear aperture will illuminate a circle of approximately 14 mm diameter at the eye when used with the slit height setting of 14 mm in the aperture control immediately above the slit control.

The slit may be varied in height using the aperture control (see Fig. 1) immediately above the slit control. The available slit heights are 3, 5, 8 and 14 mm. When used with the clear aperture in the slit control, patches of these diameters are illuminated at the eye.

The filter control (above the aperture control) carries two filters - a blue light hazard filter, and a deep blue filter for use with fluorescein. There is also a clear aperture which allows the full white radiation to be transmitted.

Note

There is some concern over the possible damage caused by exposure of the eye, particularly the retina, to short wave-length (violet and blue) light and ultra-violet. For this reason it is safer to have the blue light hazard filter in place when examining the eye.

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Note continued

This produces a yellow light which may not be satisfactory for some examinations, where a white light is preferred. However, it is strongly recommended that when possible the blue light hazard safety filter is used, particularly when this light may impinge on the retina. At all times the intensity of the light should be at the lowest level possible for satisfactory examination results.

If an oblique view is required from the microscope, the BA Slit Lamp must be raised (use the spacer, as described on page 8) so that the microscope arm may be rotated. Complete rotation of the microscope arm should be avoided to eliminate the possibility of instability. Greater magnification from the microscope can be achieved using the 16x eyepieces (available as an optional accessory). The microscope needs no re-adjustment on changing eyepieces.

Important

The Slit Lamp illumination should be switched off when the BA 904 Slit Lamp is not in use.

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