Haag-Streit Slit lamp BQ 900 User manual

1
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
INSTRUCTIONS FOR USE
Slit Lamp
BQ 900®
18. Edition / 2016 – 02
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
INSTRUCTIONS FOR USE
Slit Lamp
BQ 900®
18. Edition / 2016 – 02
Introduction
Thank you for choosing a HAAG-STREIT device. Provided you comply carefully
with the regulations in this instructions for use, we can guarantee the reliable and
unproblematic use of our product.
Purpose of use
A
slit lamp biomicroscope is intended for use in eye examination. It is used to aid in
the diagnosis and documentation of diseases or trauma which affect the structural
properties of the eye.
Contraindication
There is no absolute contraindication for tests with this device.Appropriate profes-
sional judgement and caution are necessary.
WARNING!
Read the instruction manual carefully before commissioning this pro-
duct. It contains important information regarding the safety of the user
and patient.
NOTE!
Federal law restricts this device to sale by or on the order of a physician
or licensed practitioner.
WARNING!
This device is equipped with high intensity light emitting diodes. Exces-
sive exposure of patients in treatment with certain medication may lead
to phototoxic adverse reactions, due to higher photosensitivity.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
Contents
1. Safety....................................................................................4
1.1 Areas of application of the device...........................................................................4
1.2 Ambient conditions..................................................................................................4
1.3 Shipment and unpacking ........................................................................................4
1.4 Installation warnings ..............................................................................................4
1.5 Operation, environment ..........................................................................................4
1.6 Light toxicity............................................................................................................5
1.7 Disinfection.............................................................................................................5
1.8 Warranty and product liability..................................................................................5
1.9 Symbols..................................................................................................................5
2. Introduction..........................................................................5
2.1 Overview.................................................................................................................6
3. Appliance assembly / installation......................................6
3.1 Microscope and illumination....................................................................................6
3.2 Power supply ..........................................................................................................7
3.3 Instrument base with weight compensation facility.................................................7
3.4 Setting the weight compensation facility.................................................................7
3.5 Switching on the weight compensation facility........................................................7
3.6 Switching off the weight compensation facility........................................................7
3.7 Regulating the clearance of the slit width control....................................................7
4. Commissioning....................................................................7
4.1 Switching on the appliance.....................................................................................7
5. Operation..............................................................................7
5.1 Setting the eyepieces..............................................................................................7
5.2 Preparing the patient ..............................................................................................8
5.3 Operating the instrument ........................................................................................8
5.4 Settingthelters&diaphragms .............................................................................9
5.5 Fixation star ............................................................................................................9
5.6 Microscope and eyepiece.......................................................................................9
6. Decommissioning................................................................9
7 Technical data .....................................................................9
7.1 Slit illumination .......................................................................................................9
7.2 Stereo microscope ...............................................................................................10
7.3 Instrument base ...................................................................................................10
7.4 Net weight.............................................................................................................10
8. Maintenance.......................................................................10
8.1 Device inspection .................................................................................................10
8.2 Repair...................................................................................................................10
8.3 Cleaning................................................................................................................10
8.4 Replacing the illumination mirror...........................................................................10
8.5 Dust cover.............................................................................................................10
A. Appendix.............................................................................11
A.1. Accessories/spare parts........................................................................................11
B. Legal regulations ...............................................................11
C. Classication ....................................................................12
D. Disposal..............................................................................12
E. Standards...........................................................................12
F. Information and manufacturer's declaration
concerning electromagnetic compatibility
(EMC)..................................................................................13
F.1 General.................................................................................................................13
F.2 Emitted interference (standard table 1).................................................................13
F.3 Immunity (standard table 2)..................................................................................14
F.4 Immunity for non-life support devices (standard table 4)......................................15
F.5 Safe distances for non-life support devices (standard table 6).............................16
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
1. Safety
DANGER!
Failure to comply with these instructions may result in material damage
or pose a danger to patients or users.
WARNING!
These warnings must absolutely be complied with to guarantee
safe operation of the device and to avoid any danger to users and
to patients.
NOTE!
Important information: please read carefully.
1.1 Areas of application of the device
The device is intended for use in doctor's practices, hospitals and optometrists' and
opticians' premises.
1.2 Ambient conditions
Transport: Temperature
Air pressure
Relative humidity
from
from
from
−40°C
500 hPa
10%
to
to
to
+70°C
1060 hPa
95%
Storage:
Temperature
Air pressure
Relative humidity
from
from
from
−10°C
700 hPa
10%
to
to
to
+55°C
1060 hPa
95%
Use:
Temperature
Air pressure
Relative humidity
from
from
from
+10°C
800 hPa
30%
to
to
to
+35°C
1060 hPa
90%
1.3 Shipment and unpacking
• Before you unpack the appliance, check whether the packaging shows traces of
incorrect handling or damage. If this is the case, notify the transport company that
has delivered the goods to you. Unpack the equipment together with a represen-
tative of the transport company. Make a report of any damaged parts. This report
must be signed by you and by the representative of the transport company.
• Leave the device in the packaging for a few hours before unpacking it (conden-
sation).
• Check the appliance for damage after it is unpacked. Return defective appliances
in the appropriate packaging.
• Store packaging material carefully so that it can be used for potential returns or
when moving.
• Theslitlampandheadrestmustbeinstalledonanelectricallyinsulated,reproof
table top.
• The rail covers (a) prevent the slit lamp from tilting.
• Are the connection parts of the accessories in the correct position (screw connec-
tions, quick-release fasteners)?
(a)
1.4 Installation warnings
WARNING!
• Do not modify this equipment without authorization of the manufacturer
.
Installation and repairs may only be performed by trained specialists.
Any third-party device must be connected in compliance with the
EN 60601-1 standard.
Only original HS replacement parts may be used.
The device must not be stacked or placed in close proximity to other
electronic devices.
•
•
•
1.5 Operation, environment
DANGER!
Never use the device in potentially explosive environments where vola-
tile solvents (alcohol, petrol, etc.) and flammable anaesthetics are in
use.
WARNING!
The device must be switched off after every use. Otherwise there is a
risk of overheating when a protective dust cover is used.
NOTE!
This equipment must only be operated by qualified and trained person-
nel. The owner is responsible for their training. This device may only be
used in accordance with the instructions in "Purpose of use".
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
1.6 Light toxicity
WARNING!
As extended, intensive illumination can damage the retina, the use of the de-
vice in the examination of the eye should not be prolonged unnecessarily. The
illumination of this slit lamp emits a radiation in the range between 400 and
750nm. The retinal dose for a photochemical risk is composed of the product
of the radiance and the exposure time. If the radiance is halved, the time until
the exposure time limit value is reached will double accordingly. To date, no
acute, optical radiation hazard has been detected in slit lamps. Nevertheless,
we recommend keeping the intensity of the light reaching the patient's retina
to the minimum possible for the respective diagnosis. Children, people with
aphakia and people suffering from eye conditions are most at risk. An increas-
ed risk may also occur if the retina is exposed to the same or a similar device
with a visible light source within 24 hours. This applies, in particular, if the
retina has been photographed with a flashbulb in advance.
The light from this instrument may be dangerous. The risk of eye damage
increases with the exposure time. An exposure time with this instrument at
maximum intensity of longer than 143 seconds exceeds the guideline value
for a risk in accordance with EN ISO 15004-2.
1.7 Disinfection
NOTE!
The device does not need to be disinfected. For more information on
cleaning, please refer to the 'Maintenance' section.
1.8 Warranty and product liability
Haag-Streit products must be used only for the purposes and in the manner des-
cribed in the documents distributed with the product.
The product must be treated as described in the ‘Safety’ chapter. Improper hand-
ling can damage the product. This would void all guarantee 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.
Haag-Streit does not grant any warranties, either expressed or implied, including
implied warranties of merchantability or fitness for a particular use.
Haag-Streit expressly disclaims liability for incidental or consequential damage
resulting from the use of the product.
This product is covered by a limited warranty granted by your seller.
This product is covered by a limited warranty, which may be reviewed at
www.haag-streit-usa.com.
•
•
•
•
•
•
For USA only:
•
Haag-Streit products must be used only for the purposes and in the manner des-
cribed in the documents distributed with the product.
The product must be treated as described in the ‘Safety’ chapter. Improper hand-
ling can damage the product. This would void all guarantee 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.
Haag-Streit does not grant any warranties, either expressed or implied, including
implied warranties of merchantability or fitness for a particular use.
Haag-Streit expressly disclaims liability for incidental or consequential damage
resulting from the use of the product.
This product is covered by a limited warranty granted by your seller.
This product is covered by a limited warranty, which may be reviewed at
www.haag-streit-usa.com.
•
•
•
•
•
•
For US
A only:
•
1.9 Symbols
Read the instructions for use
attentively
General warning: Read the ac-
companying documentation
Notes on disposal, see the
'Disposal' chapter
This appliance fulfills the Euro-
pean Directive 2011/65/EU
(RoHS)
Year of production Manufacturer
European certificate of
conformity Earth (ground)
Direct current
Not protected from foreign
bodies
Serial number HS reference number
Plug socket on RM 02 for
power supply Slit lamp illumination
Background illumination
Test symbol of CSA with ap-
proval for USA
2. Introduction
The slit lamp consists of an illumination and a binocular microscope. The instrument
base can be used to move the entire device in front of the eyes. The illumination of-
fers a large number of setting options to make the practically invisible areas in the
eye visible.A wide range of accessories is available for the slit lamp to open up spe-
cial diagnosis options in addition to the general tests.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
2.1 Overview
1. Lamp cable
2. Head rest
3. Headband
4. Height mark on head rest (patient eye)
5. Adjustablexationlamp
6. Chin rest
7. Height adjustment of chin rest
8. LED illumination LI 900, see separate
manual
9. Leverforlters
10. Scale for angled position of the slit im-
age (5° increments)
11. Illumination mirror
12. Diffusor
13. Magnicationchanger
14. Mounting screw for the stereo micro-
scope
15. Protective cover
16. Illumination unit/microscope angle
scale
17. Illumination arm locking screw
18. Microscope arm locking screw
19. Slit width setting screw
20. Weight compensation screws
21. Slit length/diaphragm scale
22. Setting screw for adjusting the slit
length,bluelterandxationstar,han-
dle for turning the slit
23. Cover screw for accessories pin
24. Quick-release fastener for accessories
25. Stereo microscope with eyepieces
26. Eyepieces
27. Breath shield
28. Mounting screw for breath shield
29. Threadforxing(right-handside)
the tonometerAT 900 model BQ or
AT 900 D model BQ
30. Centering screw
31. Inclinationanglelatch0°−20°
32. Joy stick base locking screw
33. Axle
34. Rail cover
35. Control lever
36. Slide plate
1
2
3
4
5
6
7
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
9
8
10
12
12
13
14
15
16
17
18
19
20
11
3. Appliance assembly / installation
WARNING!
Do not modify this equipment without authorization of the manufacturer.
Installation and repairs may only be performed by trained specialists.
Contact your HAAG-STREIT representative for installation, repairs and
modification work on the system. The contact details are available at
www.haag-streit.com.
Only original HS replacement parts may be used.
•
•
3.1 Microscope and illumination
• The slit lamp is packaged and delivered fully assembled. The transport lock must
be removed prior to commissioning.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
• Fix the breath shield (27) in place by fastening the knurled screw (28) on the in-
side of the bearer arm.
3.2 Power supply
NOTE!
Observe the respective HAAG-STREIT instructions for use. (For further
information, please contact your HAAG-STREIT dealer).
Dieses Gerät darf nur mit HS Gerätenetzteilen PS-LED, PS-LED HSM901
und dem Release Modul RM02 betrieben werden.
3.3 Instrument base with weight compensation facility
The weight of additional accessories mounted on the microscope can be compen-
sated using counterbalance springs. This keeps the height adjustment of the slit
lamp easy.
3.4 Setting the weight compensation facility
Turn the control lever (35) to its lowest position and then loosen it slightly a quarter
turn.Turnthemicroscopeandilluminationtotheside.Apply1−3springsdepend-
ing on the accessory.
3.5 Switching on the weight compensation facility
Turn anticlockwise until the screws (20) are completely released.
3.6 Switching off the weight compensation facility
Turn clockwise until you meet resistance. Verify whether the microscope arm
springs back downwards if you push it upwards with your hand. This will only hap-
pen if the load is already at maximum. Generally, as many counterbalance springs
should be deactivated as necessary until this spring action occurs. The weight
compensation facility is set correctly once the illumination and microscope with the
mounted accessories weigh slightly more than the counterbalance springs.
3.7 Regulating the clearance of the slit width control
The small screw in the center of the right control knob (A)
allows you to regulate the friction of the turning movement
of these adjusting knobs. Turning it slightly to the right (in)
makes it harder, turning it left (out) makes it easier. It should
at least be set so hard that the slit cannot close on its own.A A
4. Commissioning
The device can be switched on and off with a mains isolator on the power supply.
The green lamp in the rocker switch lights up when the device is switched on.
4.1 Switching on the appliance
• Connect the power supply to the mains and press the rocker switch. The green
lamp in the rocker switch lights up when the appliance is switched on.
• Set the knob on the illumination control to a position between '1' and '10'.
5. Operation
5.1 Setting the eyepieces
NOTE!
Theeyepiecesmustbeindividuallysetpriortotherstexaminationin
accordance with the refraction of the examiner. Insert the provided fo-
cus test rod (37) in place of the protective cover (38) and turn its black
projection surface at a right angle to the microscope axis. Return the
illumination and microscope to the central position (0°).
37. Test rod
38. Protective cover
39. Sliding occluder
37
7
38
39
• Each eyepiece should be set individually by turning the knurled ocular refraction
ring with diopter scale such that the projected slit can be seen in focus. The set-
tingisperformedfromthe(+)tothe(-)sideatlowmagnication.
• The sliding occluders (39) are used to set the correct working distance for the ex-
aminer from the eyepiece.
• Examiners who do not wear glasses: Pull the occluders out as far as they will go.
• Examiners who do wear glasses: Push the occluders in as far as they will go.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
5.2 Preparing the patient
• In order to attain a solid basis for the forehead and chin to rest on, the table height
should be set so 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 set accordingly in order to avoid distracting streaking of light.
• 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.
5.3 Operating the instrument
WARNING!
The device must be switched off after each use. The risk of overheat-
ing increases if a dust cover is used.
• Use the turn screw (7) to set the chin rest (6) so that the patient’s eyes are at the
same height as the black mark (4) on the sides of the head rest.
• Set the eyepieces (26) in accordance with the examiner’s refraction by turning the
knurled rings and set the eye distance.
• Adjust the height of the slit lamp by turning the control lever until the light beam is
at eye level.
• Switch on the illumination by turning the switch on the power supply.
• Themagnicationofthestereomicroscopeischangedusingthemagnication
changer (13).
• The rigid control lever (35) gently inclined towards the examiner can be used to
push the entire device until the slit appears approximately focused on the cornea.
Thisinitialsettingisveriedwiththenakedeye.Finetuningisperformedbytilting
the control lever while observing via the stereo microscope (25).
• The slit width is set left or right with the rotating knob (19), as is the angle be-
tween the stereo microscope and illumination. The slit image can be set vertical-
ly, horizontally or diagonally as required by turning the illumination facility on the
handle (23) (locking points at 45°, 90° and 135°; stops at 0° and 180°; scale in
5° increments).
• To ensure that unimpeded binocular fundus examination is also possible at lateral
angles of between 3° and 10°, a short mirror (11) is used, the illumination turned
90° using the locking screw (23) and tilted in 5° steps using the latch (31), and
the illumination and microscope turned to the central position (0°).
• Front-lens glasses and contact glasses are used to examine the ocular fundus.
Diffuse illumination:
• Adiffuse illumination is achieved by positioning the diffusor (12) upstream. This
enables overview monitoring and can be used for taking overview images with the
Imaging Module.
Indirect illumination:
• For observation in regredient light (indirect illumination), the centering screw (30)
isloosenedinordertomovetheslitimageoutofthecenterofthevisualeld.
Tightening the screw centers the slit image again.
Slit tilting:
• The latch (31) can be used to tilt the illumination in 5° steps. This creates an an-
gledlightbeamduringhorizontalslitorientation.Tiltingtheslitenablesreex-free
examination with contact glasses (fundus and gonioscopy) and magnifying glass-
es.
1
2
3
4
5
6
7
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
9
8
10
12
12
13
14
15
16
17
18
19
20
11
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5.4 Settingthelters&diaphragms
a. Open
b. Greylter(10%)
c. Redremovallter
d. Reserveopeningforlterofchoiceø15mm(0/-0.2),thickness2.5mm
e. Fixationstar(predominantlyusedforxationexaminationofcross-eyedchildren
with amblyopia)
f. Aperturesof8,5,3,2,1and0.2mmø
g. Display of slit length adjustment from 1 to 14 mm
h. Bluelter
(a)
(e) (f) (g) (h)
(b) (c) (d)
5.5 Fixation star
• Turningthediaphragmdisctotheleftstopswitchesonthexationstar
and the 'S' symbol appears in the viewing window. In some examina-
tions of the fundus, this star is projected onto the ocular fundus and is
also visible to the patient, who is asked to focus on the center hole of
the star. This shows the examiner the point where the patient's vision is
most focused.
• Atypicaluseofthexationstarisclosetothemaculaduringlasertre-
atment.Theprojectionofthexationstarcanalsobeusedtoidentify
microstrabismus.Thexationstarisusuallyusedwithupstreamredre-
movallter.
5.6 Microscope and eyepiece
40. Front lens
41. Rotaryknobdisplayingthesetmagnication
42. 5-levelmagnicationchanger(Galileisystem)
43. Knurled ring bayonet joint
44. Binocular tube with convergent insight, pupil di-
stance adjustable 52 – 78 mm
45. Eyepiece12.5x/eldofvisionø16mm
46. Index (white point)
47. Knurled ring with diopter scale for setting the
refraction of the examiner (± 7 D)
48. Sliding occluder (for people who wear glasses)
40 41 42 43 44 45 46 47 48
6. Decommissioning
The LED illumination can be switched off with the illumination controls. The pow-
er supply remains switched on during this process and the switch lights up green.
To switch off the system completely, the rocker switch must be set to position 0 =
'OFF'. This creates a two-pole isolation from the mains.
NOTE!
Disconnect the power supply from the mains if you do not intend to use
it for an extended period of time.
7 Technical data
7.1 Slit illumination
NOTE!
Detailed information regarding the radiation can be provided
on request.
Slit image width 0 – 14 mm continuous
Slit image length 1 – 14 mm continuous
Illuminationeldcircle ø8/5/3/2/1/0.2mm
Test mark Withxationstar
Slit image rotatability ± 90°
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10
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
Swiveling of the slit illumination to
the microscope axis Horizontal ± 90°, vertical 0 – 20°
Filters Blue,redremoval(green),gray(10%).
UVandthermal-protectionltersareinstalledxed
NOTE!
(Further information available in the LED illumination LI 900 instruc-
tions for use)
7.2 Stereo microscope
Stereo angle: 13°
Magnicationchanger: 6.3x / 10x / 16x / 25x / 40x
Ocularmagnication: 12.5x
Range of adjusting eye-pieces: +7to−7diopters
Pupil distance: 52 – 78 mm
Totalmagnication: 6.3x / 10x / 16x / 25x / 40x
Objecteldøinmm: 32.0 / 20.0 / 12.7 / 8.0 / 5.1
7.3 Instrument base
Operation: Single-handed operation of control lever in 3 dimensions
Adjustment of instru-
ment base: 100 mm (length) 100 mm (side)
30 mm (height)
7.4 Net weight
12.7 kg (without power supply, head rest and options)
8. Maintenance
WARNING!
Do not modify this equipment without authorization of the manufacturer.
Installation and repairs may only be performed by trained specialists.
Contact your HAAG-STREIT representative for installation, repairs and
modification work on the system. The contact details are available at
www.haag-streit.com.
Only original HS replacement parts may be used.
•
•
The LED illumination can be operated maintenance-free for its entire service life.
8.1 Device inspection
In order to correctly check the slit lamp, proceed as follows:
•
Insert test rod into the radial movement bearing, whilst at the same time aligning
the surface to the microscope at a right angle.
•
Set slit length to 8 or 14 mm.
•
Set llumination strength to 50%.
•
Set magnification to max. in the microscope.
•
Set the eyepieces in such a way that the test rod is in sharp focus. Turn the
eyepiece from the (+) to the (-) side.
•
The structure of the test rod must be in sharp focus in all magnifications.
•
Close slit edges to approx. 0.5 mm. The borders must be in sharp focus here.
•
Completely open slit edges and turn the test rod by 45°, the sharp area must
be in the centre of the test rod.
8.2 Repair
To guarantee a long service life, the device must be cleaned weekly as described
and protected with the dust cover when not in use. We recommend having the de-
vice inspected once a year by an authorized service technician.
8.3 Cleaning
• Only clean the housing with a dry cloth.
• Do not use any liquids, alcohol or corrosive substances.
• The exposed glass surfaces can be dusted with a dusting brush.
Lens brush HAAG-STREIT number 1001398
8.4 Replacing the illumination mirror
The mirror can be most easily accessed if the microscope is turned away from the
illumination and the illumination inclined two points.
WARNING!
Only use mirrors with a LOT number.
8.5 Dust cover
We recommend protecting the slit lamp with a dust cover
(49) when not in use.
Dust cover, small (for slit lamp) HS no. 1001395
Dust cover, large (for several instruments) HS no. 1001434
49
01-IFU_BQ900-7220589-04180_eng.indd 10 20.01.2016 14:52:24