Haag-Streit Slit lamp BQ 900 User manual
1
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© 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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© 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 Settingthelters&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. Classication ....................................................................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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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.
• Theslitlampandheadrestmustbeinstalledonanelectricallyinsulated,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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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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2.1 Overview
1. Lamp cable
2. Head rest
3. Headband
4. Height mark on head rest (patient eye)
5. Adjustablexationlamp
6. Chin rest
7. Height adjustment of chin rest
8. LED illumination LI 900, see separate
manual
9. Leverforlters
10. Scale for angled position of the slit im-
age (5° increments)
11. Illumination mirror
12. Diffusor
13. Magnicationchanger
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,bluelterandxationstar,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. Threadforxing(right-handside)
the tonometerAT 900 model BQ or
AT 900 D model BQ
30. Centering screw
31. Inclinationanglelatch0°−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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• 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.Turnthemicroscopeandilluminationtotheside.Apply1−3springsdepend-
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!
Theeyepiecesmustbeindividuallysetpriortotherstexaminationin
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-
tingisperformedfromthe(+)tothe(-)sideatlowmagnication.
• 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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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.
• Themagnicationofthestereomicroscopeischangedusingthemagnication
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.
Thisinitialsettingisveriedwiththenakedeye.Finetuningisperformedbytilting
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)
isloosenedinordertomovetheslitimageoutofthecenterofthevisualeld.
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-
gledlightbeamduringhorizontalslitorientation.Tiltingtheslitenablesreex-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 Settingthelters&diaphragms
a. Open
b. Greylter(10%)
c. Redremovallter
d. Reserveopeningforlterofchoiceø15mm(0/-0.2),thickness2.5mm
e. Fixationstar(predominantlyusedforxationexaminationofcross-eyedchildren
with amblyopia)
f. Aperturesof8,5,3,2,1and0.2mmø
g. Display of slit length adjustment from 1 to 14 mm
h. Bluelter
(a)
(e) (f) (g) (h)
(b) (c) (d)
5.5 Fixation star
• Turningthediaphragmdisctotheleftstopswitchesonthexationstar
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.
• Atypicaluseofthexationstarisclosetothemaculaduringlasertre-
atment.Theprojectionofthexationstarcanalsobeusedtoidentify
microstrabismus.Thexationstarisusuallyusedwithupstreamredre-
movallter.
5.6 Microscope and eyepiece
40. Front lens
41. Rotaryknobdisplayingthesetmagnication
42. 5-levelmagnicationchanger(Galileisystem)
43. Knurled ring bayonet joint
44. Binocular tube with convergent insight, pupil di-
stance adjustable 52 – 78 mm
45. Eyepiece12.5x/eldofvisionø16mm
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
Illuminationeldcircle ø8/5/3/2/1/0.2mm
Test mark Withxationstar
Slit image rotatability ± 90°
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Swiveling of the slit illumination to
the microscope axis Horizontal ± 90°, vertical 0 – 20°
Filters Blue,redremoval(green),gray(10%).
UVandthermal-protectionltersareinstalledxed
NOTE!
(Further information available in the LED illumination LI 900 instruc-
tions for use)
7.2 Stereo microscope
Stereo angle: 13°
Magnicationchanger: 6.3x / 10x / 16x / 25x / 40x
Ocularmagnication: 12.5x
Range of adjusting eye-pieces: +7to−7diopters
Pupil distance: 52 – 78 mm
Totalmagnication: 6.3x / 10x / 16x / 25x / 40x
Objecteldøinmm: 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
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A. Appendix
A.1. Accessories/spare parts
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.
•
•
NOTE!
An asterisk (*) shows that you should contact your HAAG-STREIT
dealer for further information. Two asterisks (**) indicate that you
should consult the separate instructions for use.
Component HS art. no.
Locating pin 3000332
LED illumination, black without background illumination** 1020884
LED illumination with background illumination light gray RAL7035** 1021178
LED illumination, background illumination ready black RAL9005** 1020885
Illumination control double slit and background 'in table'** 1021022
Illumination control double slit and background 'on table'** 1020883
Illumination control single 'in table'** 1021024
Illumination control single 'on table'** 1021020
Split image eyepiece 12.5x 1400300
Cover T-0 for table opening** 1021085
Plug-in mirror short 1001591
Plug-in mirror long 1001590
Photo adapter DC 01 for digital cameras 1004665
Power supply for LED illumination on third-party tables** 1020882
Power supply for LED illumination HSM 901** 1020881
Imaging Module IM 900 complete (Camera Module CM03 + Release
Module RM02 + Software) 7220550
Instrument table HSM 901 *
Instrument table HSM 901 Imaging *
Instrument table HSM 901 Workstation *
Cablechannelwithouttabletoptablechannelø12mm 7200086
Cablechannelwithouttabletoptablechannelø20mm 1001575
Contrastenhancerlter(yellow) 1400306
Measuring eyepiece 12.5x 1400302
Observer tube, short (without eyepiece) 1400301
Observer tube, long (without eyepiece) 1400034
Eyepiece 12.5x with diopter ring 1400303
Eyepiece 12.5x with McIntyre reticle 1400304
Eyepiece with double cross hair 12.5x 3000470
Check rod 1001051
Dust cover, large (for several instruments) 1001434
Dust cover, small (for slit lamp) 1001395
Stereo variator 7200109
Beam splitter 50/50 1400308
Beam splitter 70/30 1001600
Diffusor 1007085
Backgroundilluminationxed** 1020886
Background illumination with swivel holder** 1020887
USB illumination cable 2000 mm** 1020940
USB illumination cable 5000 mm** 1020956
Video adapter with lens tube f56 1/3 (C-Mount) 1007780
Video adapter with lens tube f60 (3-chip, ½ inch) 1400321
Video adapter with lens tube f60 (mini camera) 1400320
Video adapter with lens tube f75 (C-mount) 1400319
Prescription glass, moving, -58.6 diopters, according to Hruby 1400223
Prescription glass carriage with rail (with guide plate) 1001219
Zoom module for slit lamp BQ 900 1400013
Connecting piece for angled view 20° 1400305
B. Legal regulations
• The BQ 900 slit lamp was developed and designed in observance of the stan-
dards EN 60601-1, EN ISO 10939 and EN ISO 15004-2. Production, testing, set-
up, maintenance and repairs are performed in observance of international stan-
dards.
• The EN 60601-1 standard must be observed when using different medical and/or
non-medical electrical appliances in combination.
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• TheCEmarkingconrmsthattheBQ900slitlampisincompliancewithDirective
93/42/EEC.
• TheslitlampBQ900fulllstheelectromagneticcompatibilityrequirementsofEN
60601-1-2. The device was designed to maintain the emission of electromagnetic
interference at a certain level which does not exceed the statutory directives and
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.
C. Classication
Standard EN 60601-1 BQ 900 slit lamp as per protection class I
Operating mode: Continuous operation
CE Directive 93/42/EEC Class I
FDA Class II
D. Disposal
Electrical and electronic devices must be disposed of separately from
household waste!
This appliance was made available for sale after the
13th
August 2005. For correct disposal, please contact your
HAAG-STREIT
representative. This will guarantee that no hazardous
substances enter the environment and that valuable raw materials are
recycled.
E. Standards
EN 60601-1 EN 60601-1-2
EN ISO 15004-1 EN ISO 15004-2
EN ISO 10939
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F. Information and manufacturer's declaration
concerning electromagnetic compatibility
(EMC)
F.1 General
TheBQ900slitlampsystemfulllstherequirementsonelectromagneticcompati-
bility 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 in their use in accordance with the regulations and so that the in-
strument itself is suitably immune to electromagnetic interference.
WARNING!
• Electrical medical devices and systems are subject to special EMC
measures and must be installed in accordance with the EMC instruc-
tions contained in this accompanying document.
Portable and mobile HF communication systems may interfere with
electrical medical devices.
The operation of other lines or equipment than those listed may lead
to higher emissions or may reduce the device's resistance to interfe-
rence.
Third-party devices may only be connected in compliance with the
EN 60601-1 standard.
•
•
•
F.2 Emitted interference (standard table 1)
Guidance and manufacturer's declaration – electromagnetic emissions
This 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 envi-
ronment
RF emissions CISPR 11 Group 1 This product uses RF energy only for its internal function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class B This product is suitable for use in all establishments, including domestic establishments and those
directly connected to the public low-voltage power supply network that supplies buildings used for
domestic purposes.
Emission of harmonics according to
EN 61000-3-2 Class A
Voltage fluctuations / flicker emissions
according to EN 61000-3-3 Fulfilled
Emission test Compliance Electromagnetic environment - guidance
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F.3 Immunity (standard table 2)
Guidance and manufacturer's declaration – electromagnetic immunity
This product is intended for use in the electromagnetic environment specifi ed below.The customer or the user of this product should assure that it is used in such an envi-
ronment.
Immunity test standard EN 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge (ESD)
EN 61000-4-2 ± 6 kV contact
± 8 kV air ± 6 kV contact
± 8 kV air Floors should be wood, concrete or ceramic tile. If floors are
covered withs ynthetic material, the relative humidity should
be at least 30%.
Electrical fast transient / burst
EN 61000-4-4 ± 2 kV for power supply lines ± 2 kV for power supply lines Mains power quality should be that of a typical commercial
or hospital environment.
Surge
EN 61000-4-5 ± 1 kV for symmetrical voltages
± 2 kV for asymmetrical voltages ± 1 kV for symmetrical voltages
± 2 kV for asymmetrical voltages Mains power quality should be that of a typical commercial
or hospital environment.
Voltage dips, short interruptions
and voltage variations on power
supply lines
EN 61000-4-11
< 5% UT(> 95% drop in UT)
for ½ cycle
< 40% UT(> 60% drop in UT)
for 5 cycles
< 70% UT(> 30% drop in UT)
for 25 cycles
< 5% UT(> 95% drop in UT)
for 5 s
< 5% UT(> 95% drop in UT)
for ½ cycle
< 40% UT(> 60% drop in UT)
for 5 cycles
< 70% UT(> 30% drop in UT)
for 25 cycles
< 5% UT(> 95% drop in UT)
for 5 s
Mains power quality should be that of a typical commercial
or hospital environment. If the user of this product requires
continued function even in the event of interruptions in the
energy supply, this product should be powered from an un-
interruptible power supply or a battery.
Power frequency (50/60Hz)
magnetic field EN 61000-4-8 Power frequency magnetic fields should be at levels char-
acteristic of a typical location in a typical commercial or hos-
pital environment.
NOTE: U
T
= theAC mains voltage prior to application of the test level.
3 A/m 100 A/m
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F.4 Immunity for non-life support devices (standard table 4)
Guidance and manufacturer's declaration – electromagnetic immunity
This product is intended for use in the electromagnetic environment specifi ed below.The customer or the user of this product should assure that it is used in such an envi-
ronment.
Electromagnetic environment – guidance
Portable and mobile RF communications equipments hould be used no closer to any part of this product, including cables, than the recommended separation distance cal-
culated from the equation applicable to the frequency of the transmitter.
Immunity test standard EN 60601 test level Compliance level Recommended distance(c):
Conducted RF EN 61000-4-6 3 V
rms
150 kHz – 80 MHz 10 V
rms
D= 1.2
Radiated RF EN 61000-4-3 3 V/m
80 MHz – 2.5 GHz 10 V/m
80 MHz – 2.7 GHz D= 1.2 80 MHz – 800 MHz
D= 2.3 800 MHz – 2.5 GHz
Where Pis the maximum output power rating of thet ransmitter in watts (W) according to the transmitter manufacturer and Dis the recommended separation
distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level
in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz the higher frequency applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broad-
cast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which this product is used exceeds the applicable RF compliance level above, this
product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating
this product.
b.
c. Over the frequency range 150 kHz to 80 MHz,
Possible shorter distances outside the ISM bands do not contribute to improved application in this table.
field strengths should be less than 3 V/m.
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F.5 Safe distances for non-life support devices (standard table 6)
Recommended safe distances between portable and mobile HF communication devices and this device.
This product is designed to be operated in an electromagnetic environment in which radiated HF interference is controlled. The customer or user of this product can help to
prevent electromagnetic interference by maintaining minimum distances between portable and mobile HF communication systems (transmitters) and this product, as rec-
ommended below in accordance with the maximum output of the communication system.
Nominal output of the transmitter (W)
Safe distance according to transmission frequency (m)
150 kHz – 80 MHz
D = 1.2 80 MHz – 800 MHz
D = 1.2 800 MHz – 2.5 GHz
D = 2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters with a nominal output not listed in the table above, the distance Dcan be calculated in meters (m) using the equation for the respective column, in which P
is the nominal output of the transmitter in watts (W)
NOTE 1: At 80 MHz and 800 MHz the higher frequency applies.
NOTE 2: To calculate the recommended safe distance of transmitters in the frequency range of 80 MHz to 2.5 GHz an additional factor of 10/3was used to reduce the
probability of a mobile/portable communication device causing interference if inadvertently brought into the patient area.
These guidelines may not apply in all situations. Electromagnetic wave propagation is influenced by absorption and reflection of buildings, objects and people.NOTE 3:
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Should you have any further questions, please contact your HAAG-STREIT dealer at:
http://www.haag-streit.com/contact/contact-your-distributor.html
HAAG-STREIT AG
Gartenstadtstrasse 10
3098 Koeniz, Switzerland
Phone +41 31 978 01 11
Fax +41 31 978 02 82
eMail [email protected]
Internet www.haag-streit.com
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Table of contents
Other Haag-Streit Microscope manuals
