Haag-Streit Clement Clarke Ophthalmic BA 904 User manual

BA 904 PORTABLE SLIT LAMP
Instructions for use
© HAAG-STREIT UK 2021
1902546/ISSUE 9/MAY 2021

Introduction
Thank you for choosing the BA 904 portable slit lamp device. Provided you comply
carefully with the instructions for use, we guarantee the reliable and unproblematic use
of the product.
Intended purpose
A slit lamp bio-microscope is intended for use in eye examinations. A light source is
projected towards the eye, this is then viewed using binocular magnication. It is used
to aid the diagnosis and documentation of diseases or trauma that affect the structural
properties of the eye.
Contraindications
There are no known contraindications for tests with this device. Appropriate
professional judgement and caution are necessary.
Manufacture
The BA 904 portable slit lamp is manufactured in the UK by Haag-Streit UK (HS-UK).
Clement Clarke Ophthalmic is a brand of HS-UK, collectively representing the company’s
own range of manufactured ophthalmic diagnostic devices and products. Information on
the Clement Clarke Ophthalmic product range can be found on the HS- UK website at
https://hsuk.co/CCO.
Servicing & maintenance
For information on the servicing or repair of the BA 904 portable slit lamp, users will need
to contact the HS-UK Service Division, at [email protected]. Information on the
HS-UK Service Division can be found on the HS-UK website at
www.haagstreituk.com/service.
Please read this instructions for use manual carefully before commissioning this
product. It contains important information regarding the safety of the user and
patient.
Federal law restricts this device to sale by or on the order of a physician
or licensed practitioner.
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Contents
1. Safety
2. Introduction & general description
3. Appliance assembly/installation
4. Operation
5. Decommissioning
6. Technical data
7. Maintenance
Appendix A: Accessories, consumables. spare parts & upgrades
Appendix B: Legal
Appendix C: Classication
Appendix D: Disposal
Appendix E: Standards
Appendix F: EMC declaration
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1 Safety
1.1 Areas of application of the device
The device is intended for use in professional healthcare facility environments, including
but not limited to; doctor’s practices, hospitals, optometrists and opticians premises.
Some portable radio frequency equipment, like mobile phones or RF telephone
equipment, including antennas, may cause interference with medical devices.
Such equipment has to be kept at a distance of more than 30cm (12 inches)
from any part of the instrument. Failure to observe this precaution may result in
the device malfunctioning.
1.2 Ambient conditions
1.3 Shipment & unpacking
Check the appliance for damage after it is unpacked. Do not use damaged
equipment. Return defective appliances in the appropriate packaging.
Failure to comply with these instructions for use may result in material damage
and/or pose a danger to patients or users.
These warnings must absolutely be complied with to guarantee safe operation
of the product and to avoid any danger to users and patients.
Transport Temperature -10°C to 55°C
Atmospheric pressure 10% to 95%
Relative humidity 500 hPa to 1060 hPa
Storage Temperature +5°C to +45°C
Atmospheric pressure 10% to 95%
Relative humidity 500 hPa to 1060 hPa
Use Temperature +10°C to +40°C
Atmospheric pressure 30% to 75%
Relative humidity 700 hPa to 1060 hPa
4
Any serious incident in relation to this device must be reported to the
manufacturer and the regulatory authority of the country where the event
occured.

Store packaging material carefully so that it can be used if the device needs to
be moved or returned for servicing.
The slit lamp and head rest must be assembled on an electrically insulated,
reproof table top.
1.4 Installation warnings
Only original manufacturer-supplied replacement parts and materials may be
used.
Repairs may only be performed by fully-trained Haag-Streit UK accredited
engineers.
The device must not be stacked or placed in close proximity to other electronic
devices.
Any third-party device must be connected in compliance with the EN 60601-1
standard.
1.5 Operation environment
Never use the device in a potentially explosive environment where
volatile solvents (alcohol, petrol etc) and ammable anaesthetics are in use.
This equipment must only be operated by qualied personnel. The owner is
responsible for any training on the device. The BA 904 may only be used in
accordance with the intended purpose.
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The slit lamp is not designed to have direct contact with the patient. For more
information please refer to section 7.4, ‘Cleaning & disinfection’.
Clement Clarke Ophthalmic products must be used only for the purposes and in the
manner described in the documents distributed with the product.
Improper handling can damage the product. This would void all warranty claims.
Continued use of a product damaged by incorrect handling may lead to personal injury.
In such a case, the manufacturer will not accept any liability.
1.7 Disinfection
1.8 Warranty & product liability

1.9 Description of symbols
REF
SN
Waste Electrical & Electronic
Equipment (WEEE)
Reference number
Keep dry
Fragile
Manufacturer This way up
Recycle
Electrocution
Direct current/alternating current
Authorised Representative
Date of manufacture
European mark of conformity
Follow instructions for use
Serial number
Caution/warning
Class II equipment
Transport temperature
Storage temperature
LOT
Quantity
55 ˚
-10 ˚
45 ˚
5 ˚
Transport
Storage
55 ˚
-10 ˚
45 ˚
5 ˚
Transport Storage
LOT
QTY
6
REP
EC

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2 Introduction & general description
General description
The BA 904 slit lamp consists of the illumination of a binocular microscope which can be
moved, in front of the eyes, either in hand-held operation or with an optional instrument
base. The illumination offers a range of setting possibilities for making the practically
invisible areas of the eye visible.
The BA 904 slit lamp is available in 2 models; Set A and Set C. The device can be
operated as a table-mounted joystick controlled model, or in a hand-held mode. A
general arrangement of the two systems, accompanied by accessories, is shown in
Figures 1 and 2; Figure 1 shows Set A and Figure 2 shows Set C.
2.1 Overview

1. Stereoscopic bio-microscope
2. Illumination projection unit
3. Illumination control dial
4. Interchangeable eyepieces
5. Bulb cover
6. Illumination mirror
7. Removable forehead rest
8. Filter control
9. Aperture control
10. Slit width control
11. Joystick platform
12. Chin rest
13. Chin rest retaining dial
14. Joystick
15. Rise and fall control
16. Slit lamp mounting
17. Retaining bracket
18. Locking tubes
19. Eye level indicator
20. Battery charger
21. Mains power supply
22. Rechargable battery pack
23. Alternative plugs
24. Focusing rod
25. Bulb extractor tool
26. Spanner
27. Spare bulb
28. Spacer
27 23
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Figure 1 - BA 904 Set A
8
11
14
26
25
7
24
21
17
18
5
12
4
22
1
19
20
16
28
15
13
10
9
3
6
2
8

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1. Stereoscopic bio-microscope
2. Slit lamp projection unit
3. Brightness control
4. Eyepieces
5. Lamp cover
6. Illumination mirror
7. Filter control
8. Aperture control
9. Slit control
10. Forehead rest
11. Parking unit
12. Battery charger
13. Mains power supply
14. Energy pack
15. Alternative plugs
16. Disc focusing rod #26
17. Bulb extractor
18. Spanner
19. Spare bulb
20. Spare energy pack
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Figure 2 - BA 904 Set C
110 6
8
9
7
3
17 18 19
11 15
12
4
5
14
13
16
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3 Appliance assembly/installation
BA 904 Set A
Figure 3
3.1 Set-up
•Remove the BA 904 slit lamp and the joystick platform from the suitcase (see gure 3)
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SUITCASE
•Assemble the combined head rest, chin rest and joystick platform by pivoting the
head and chin rest up (see gure 4)

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BA 904 Set C
•Remove the BA 904 slit lamp from the briefcase (see gure 5)
•To mount the slit lamp on the parking unit locate the pivot hole over the location pin
on the parking unit (see gure 6).
•Screw the forehead rest into the forehead rest shaft. This shaft is spring-loaded and
helps reduce shake and wander while the BA 904 slit lamp is in use. When using the
slit lamp in hand-held mode, the forehead rest is placed on the patient’s forehead and
the lock is released by turning it anti-clockwise.
•Lock the headrest posts in position by screwing the locking tubes
•Insert the location pin into the slit lamp mounting hole
•Mount the BA 904 slit lamp over the location pin and locate the body of the slit lamp
into the retaining bracket.
Figure 4
PIVOTING HEAD & CHIN REST

Figure 5
Figure 6 - Mounting the slit lamp
Parking unit
Pivot hole/nut
Location pin
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BRIEFCASE

13
Figure 9 Figure 10
This device must only be operated with the provided mains power supply lead
and rechargeable battery power supplies.
3.2 Power supply
Connect the energy pack to the BA 904 slit lamp as shown in gure 7. When tting for the
rst 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 the pack from the unit (see gure 8).
Figure 7 Figure 8
CONNECTING THE ENERGY PACK DETACHING THE ENERGY PACK
MAINS POWER SUPPLY ENERGY PACK & BATTERY CHARGER

Mains operation
The mains power supply (gure 9) is used to power the BA 904 slit lamp from the mains.
•Attach the appropriate mains plug to the power supply
•Connect the power supply to the BA 904 slit lamp by pushing it down, to align the
connectors.
Battery operation
The rechargeable battery (gure 10) may be used to power the BA 904 slit lamp. When
used for the rst time, the rechargeable battery pack will need to be charged for ve
hours.
1. Attach the appropriate mains plug adapter to the recharger
2. Plug the recharger into the rechargeable battery pack
3. Plug in and switch on at the mains. The LED display will be green before the fast
charge commences. It then changes to orange. The rechargeable battery pack is
fully-charged when the LED turns green, with a short intermittent yellow ash
4. Connect the rechargeable battery pack to the BA 904 slit lamp by pushing it down,
to align the connectors
5. Maximum duration of illumination, using one fully-charged battery pack, is 45
minutes.
The green LED illuminates when the power supply is plugged into the mains. This
indicates the device is functioning normally.
The mains power supply should be unplugged from the power socket when not
in use.
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The energy pack can be recharged at any time before the batteries are exhausted and
recharging will take between 4 and 5 hours.
The device can be turned on by rotating the illumination control dial clockwise.
3.3 Commissioning - switching on the device

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4 Operation
4.1 Setting the eyepieces
The BA 904 slit lamp is factory set to allow a small amount of convergence through the
device, in order to achieve optimum stereopsis. In some users this convergence
may induce a small amount of accommodation. The eyepieces must be individually set
prior to the rst examination in accordance with the refraction of the examiner. Insert the
provided focusing rod (see gure 1, item 24) in place of the central pivot hole (see gure
13) and turn its black projection surface at a right angle to the microscope axis. Return
the illumination and microscope to the central position (0°).
• Each eyepiece can be set individually by turning the knurled ocular refraction ring
(see gure 11) so that the projected slit can be seen in focus
• The pupil distance can then be set on the binocular microscope. Adjust the
interpupillary distance by gently rotating the stereo microscope until a full binocular
image is attained.
Greater magnication from the microscope can be achieved using the 16x eyepieces
(available as an optional accessory). The microscope needs no re-adjustment if the
eyepieces have been changed.
Figure 11
4.2 Preparing the patient
• In order to attain a solid basis for the forehead and chin to rest on, any supplementary
table height should be selected, so that the patient sits leaning slightly forwards
•To ensure that only the part of the eye being examined is illuminated, the slit height
should be set accordingly to prevent over exposure to the light source
OCULAR REFRACTION RING

16
The joystick can be used to position the entire device forwards, backwards, left and right
until the slit appears approximately focused on the eye. Fine tuning can be achieved
whilst looking through the stereo microscope. The slit width is selected using the
diaphragm. To achieve various perspective sections of the eye, the angle between the
microscope and the illumination can be manually adjusted by rotating the illumination
arm, to project from the left or right. The magnification of the stereo microscope can be
changed on the BA 904 slit lamp by exchanging the eyepieces (10x or 16x).
Figure 12
• Head and chin rest components that come into contact with the patient should be
cleaned prior to every use to prevent cross-infection.
The lamp must be switched off after every examination to preserve the life of the
battery and bulb, and to minimise operating temperatures.
4.3 Operating the instrument
• Use the chin rest retaining dial to set the chin rest, ensuring the patients eyes are at
the same height as the level on the side of the head rest
• Adjust the eyepieces in accordance with the examiners refraction, by turning the
eyepieces and setting the inter-pupillary distance
• Switch the illumination on by rotating the illumination control dial clockwise
• Adjust the height of the slit lamp by rotating the rise and fall control until the
illumination is at the patient’s eye level.
4.3.1 Headrest conguration (gure 12)
HEADREST CONFIGURATION

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Rotating the uppermost filter control disc allows for either a clear, a yellow (blue hazard)
or a cobalt blue filter to be introduced. Slit height can be adjusted by rotating the central
aperture control disc to 3mm, 5mm, 8mm or 14mm. Slit width can be adjusted by
rotating the lowest disc to clear 0.12mm, 0.25mm or 0.5mm.
4.4 Adjusting the lters & diaphragms
Figure 13
• Adjust the eyepieces in accordance with the examiners refraction, by turning the
eyepieces and set the inter-pupillary distance
• Switch the illumination on by rotating the illumination control dial clockwise
• Manually position the entire device up and down, forwards and backwards, left and
right until the slit appears approximately focused on the eye. Fine tuning can be
achieved whilst looking through the stereo microscope
• If an oblique viewing angle is required from the microscope, the BA 904 slit lamp must
be raised using the spacer so that the microscope arm may be rotated
• The slit width is selected using the diaphragm.
To achieve various perspective sections of the eye, the angle between the microscope
and the illumination can be manually adjusted by rotating the illumination arm to project
from the left or right. The magnification of the stereo microscope can be changed on the
BA 904 slit lamp by exchanging the eyepieces (10x or 16x).
4.3.2 Handheld conguration (gure 13)
HANDHELD CONFIGURATION

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5 Decommissioning
The illumination can be switched off by rotating the illumination control anticlockwise,
until the end of travel. Lift the slit lamp slightly to disconnect it from the parking unit or
retaining bracket.
To disconnect from either the mains power supply or the removable rechargeable
battery pack, press the small button (located at the base) back and up to release from
unit (see gure 14).
Set A:
When storing away the joystick platform in its carrying suitcase, always release the
head rest upright column locking tubes and chin rest retaining dial before folding down
the head and chin rest. Once the joystick platform is folded up, the chin rest retaining dial
may be tightened for transportation.
Set C:
When storing the parking unit inside the briefcase, the location pin should be inserted
into the cut out slot, above the battery packs.
To prevent damage, the slit lamp should always be stored in its carry case when
not in use.
Figure 14
The lamp must be switched off after every examination.
DETACHING THE ENERGY PACK

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6 Technical data
6.1 Slit illumination
Illumination source 6v 10w Halogen
Slit image width 0.12, 0.25, 0.5mm
Slit image length 3, 5, 8, 14mm
Illumination eld circle 14
Slit image rotatability ±90°
Filters Flat (Schott Bk7), Blue Hazard (yellow
Schott GG495), Blue (Schott OB12)
6.2 Stereo microscope
6.3 Electrical requirements
Stereo angle 13°
Magnication 10 x (standard) 16 x (optional)
Range of adjusting eye piece -8 to +5 Dioptres
Pupil distance 54mm - 94 mm
Object eld diameter 18 mm & 11.3 mm
Mains input voltage 110 – 240V AC 50 – 60 Hz
Battery charger input voltage 110 – 240V AC
Output voltage 6 V DC
Output current rating 2A

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6.4 The joy stick platform
Loading
Dimensions
Adjustment of optional instrument base 95mm (length), 50mm (side), 50mm
(height)
Rated load for chin rest 5.9kg
Set A Set C
Weight (packed) 10kg 7.5kg
Dimensions (packed) Set A - 61 x 50 x 17.5cm Set C - 50 x 49 x 14cm
Packaging Set A - 61 x 58 x 18 cm Set C - 50 x 49 x 15.5 cm