SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH

INSTRUCTIONS FOR USE

Slit Lamp

BQ 900®
18. Edition / 2016 – 02

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INSTRUCTIONS FOR USE Introduction

Slit Lamp 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

BQ 900®
unproblematic use of our product.

Purpose of use
18. Edition / 2016 – 02 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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Contents

1. Safety .................................................................................... 4 6. Decommissioning ................................................................ 9

1.1 Areas of application of the device ...........................................................................4
1.2 Ambient conditions..................................................................................................4 7 Technical data ..................................................................... 9
1.3 Shipment and unpacking ........................................................................................4 7.1 Slit illumination .......................................................................................................9
1.4 Installation warnings ..............................................................................................4 7.2 Stereo microscope ...............................................................................................10
1.5 Operation, environment ..........................................................................................4 7.3 Instrument base ...................................................................................................10
1.6 Light toxicity ............................................................................................................5 7.4 Net weight .............................................................................................................10
1.7 Disinfection .............................................................................................................5
8. Maintenance ....................................................................... 10
1.8 Warranty and product liability ..................................................................................5
8.1 Device inspection .................................................................................................10
1.9 Symbols ..................................................................................................................5
8.2 Repair ...................................................................................................................10
2. Introduction .......................................................................... 5 8.3 Cleaning ................................................................................................................10
2.1 Overview .................................................................................................................6 8.4 Replacing the illumination mirror ...........................................................................10
8.5 Dust cover .............................................................................................................10
3. Appliance assembly / installation ...................................... 6
3.1 Microscope and illumination....................................................................................6 A. Appendix .............................................................................11
3.2 Power supply ..........................................................................................................7 A.1. Accessories/spare parts........................................................................................11
3.3 Instrument base with weight compensation facility .................................................7
B. Legal regulations ...............................................................11
3.4 Setting the weight compensation facility .................................................................7
3.5 Switching on the weight compensation facility ........................................................7 C. Classification .................................................................... 12
3.6 Switching off the weight compensation facility ........................................................7
3.7 Regulating the clearance of the slit width control ....................................................7 D. Disposal.............................................................................. 12
4. Commissioning .................................................................... 7 E. Standards ........................................................................... 12
4.1 Switching on the appliance .....................................................................................7
F. Information and manufacturer's declaration
5. Operation .............................................................................. 7 concerning electromagnetic compatibility
5.1 Setting the eyepieces..............................................................................................7
(EMC) .................................................................................. 13
5.2 Preparing the patient ..............................................................................................8
F.1 General .................................................................................................................13
5.3 Operating the instrument ........................................................................................8
F.2 Emitted interference (standard table 1).................................................................13
5.4 Setting the filters & diaphragms .............................................................................9
F.3 Immunity (standard table 2) ..................................................................................14
5.5 Fixation star ............................................................................................................9
F.4 Immunity for non-life support devices (standard table 4) ......................................15
5.6 Microscope and eyepiece .......................................................................................9
F.5 Safe distances for non-life support devices (standard table 6) .............................16

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1. Safety • Store packaging material carefully so that it can be used for potential returns or
when moving.
DANGER! • The slit lamp and head rest must be installed on an electrically insulated, fireproof
Failure to comply with these instructions may result in material damage table top.
or pose a danger to patients or users. • The rail covers (a) prevent the slit lamp from tilting.
WARNING! • Are the connection parts of the accessories in the correct position (screw connec-
These warnings must absolutely be complied with to guarantee tions, quick-release fasteners)?
safe operation of the device and to avoid any danger to users and
to patients.
NOTE! (a)
Important information: please read carefully.

1.1 Areas of application of the device 1.4 Installation warnings

The device is intended for use in doctor's practices, hospitals and optometrists' and WARNING!
opticians' premises. • Do not modify this equipment without authorization of the manufacturer.
Installation and repairs may only be performed by trained specialists.
1.2 Ambient conditions • Any third-party device must be connected in compliance with the
Transport: Temperature from −40°C to +70°C
EN 60601-1 standard.
Air pressure from 500 hPa to 1060 hPa
• Only original HS replacement parts may be used.
Relative humidity from 10% to 95%
• The device must not be stacked or placed in close proximity to other
Storage: Temperature from −10°C to +55°C electronic devices.
Air pressure from 700 hPa to 1060 hPa
Relative humidity from 10% to 95% 1.5 Operation, environment
Use: Temperature from +10°C to +35°C DANGER!
Air pressure from 800 hPa to 1060 hPa Never use the device in potentially explosive environments where vola-
Relative humidity from 30% to 90% tile solvents (alcohol, petrol, etc.) and flammable anaesthetics are in
use.
1.3 Shipment and unpacking
• Before you unpack the appliance, check whether the packaging shows traces of WARNING!
incorrect handling or damage. If this is the case, notify the transport company that The device must be switched off after every use. Otherwise there is a
has delivered the goods to you. Unpack the equipment together with a represen- risk of overheating when a protective dust cover is used.
tative of the transport company. Make a report of any damaged parts. This report NOTE!
must be signed by you and by the representative of the transport company. This equipment must only be operated by qualified and trained person-
• Leave the device in the packaging for a few hours before unpacking it (conden- nel. The owner is responsible for their training. This device may only be
sation). used in accordance with the instructions in "Purpose of use".
• Check the appliance for damage after it is unpacked. Return defective appliances
in the appropriate packaging.
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 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.
SVENSKA NEDERLANDS PORTUGUÊS • Haag-Streit
ESPAÑOLdoes not grant
ITALIANO FRANÇAIS
any warranties, DEUTSCH
either expressed or implied, including ENGLISH
implied warranties of merchantability or fitness for a particular use.
1.6 Light toxicity • Haag-Streit expressly disclaims liability for incidental or consequential damage
WARNING! resulting from the use of the product.
As extended, intensive illumination can damage the retina, the use of the de- • This product is covered by a limited warranty granted by your seller.
vice in the examination of the eye should not be prolonged unnecessarily. The For USA only:
illumination of this slit lamp emits a radiation in the range between 400 and • This product is covered by a limited warranty, which may be reviewed at
www.haag-streit-usa.com.
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
1.9 Symbols
acute, optical radiation hazard has been detected in slit lamps. Nevertheless, Read the instructions for use General warning: Read the ac-
we recommend keeping the intensity of the light reaching the patient's retina attentively companying documentation
to the minimum possible for the respective diagnosis. Children, people with This appliance fulfills the Euro-
aphakia and people suffering from eye conditions are most at risk. An increas- Notes on disposal, see the
pean Directive 2011/65/EU
ed risk may also occur if the retina is exposed to the same or a similar device 'Disposal' chapter
(RoHS)
with a visible light source within 24 hours. This applies, in particular, if the
retina has been photographed with a flashbulb in advance. Year of production Manufacturer
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
European certificate of
maximum intensity of longer than 143 seconds exceeds the guideline value Earth (ground)
conformity
for a risk in accordance with EN ISO 15004-2.
Not protected from foreign
1.7 Disinfection Direct current
bodies
NOTE!
The device does not need to be disinfected. For more information on Serial number HS reference number
cleaning, please refer to the 'Maintenance' section.
Plug socket on RM 02 for
Slit lamp illumination
1.8 Warranty and product liability power supply
• Haag-Streit products must be used only for the purposes and in the manner des- Test symbol of CSA with ap-
cribed in the documents distributed with the product. Background illumination
proval for USA
• The product must be treated as described in the ‘Safety’ chapter. Improper hand-
ling can damage the product. This would void all guarantee claims. 2. Introduction
• Continued use of a product damaged by incorrect handling may lead to personal The slit lamp consists of an illumination and a binocular microscope. The instrument
injury. In such a case, the manufacturer will not accept any liability. base can be used to move the entire device in front of the eyes. The illumination of-
• Haag-Streit does not grant any warranties, either expressed or implied, including fers a large number of setting options to make the practically invisible areas in the
implied warranties of merchantability or fitness for a particular use. eye visible. A wide range of accessories is available for the slit lamp to open up spe-
• Haag-Streit expressly disclaims liability for incidental or consequential damage cial diagnosis options in addition to the general tests.
resulting from the use of the product.
• This product is covered by a limited warranty granted by your seller.
For USA only:
• This product is covered by a limited warranty, which may be reviewed at
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02 5
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2.1 Overview
1. Lamp cable 29. Thread for fixing (right-hand side)
2. Head rest the tonometer AT 900 model BQ or 1
3. Headband AT 900 D model BQ
2
4. Height mark on head rest (patient eye) 30. Centering screw
5. Adjustable fixation lamp 21
31. Inclination angle latch 0° − 20° 8
6. Chin rest 32. Joy stick base locking screw 9 22
7. Height adjustment of chin rest 23
33. Axle 10
8. LED illumination LI 900, see separate 3 24
34. Rail cover 4 11 25
manual 35. Control lever 12 26
5 13
9. Lever for filters 36. Slide plate
10. Scale for angled position of the slit im- 14
6 27
age (5° increments) 15 28
11. Illumination mirror 16
29
12. Diffusor 7 30
13. Magnification changer 17 31
14. Mounting screw for the stereo micro- 18
12
scope 19 32
15. Protective cover 20 33
34
16. Illumination unit/microscope angle
scale 35
17. Illumination arm locking screw 36
18. Microscope arm locking screw
19. Slit width setting screw
20. Weight compensation screws
21. Slit length/diaphragm scale 3. Appliance assembly / installation
22. Setting screw for adjusting the slit
WARNING!
length, blue filter and fixation star, han- • Do not modify this equipment without authorization of the manufacturer.
dle for turning the slit Installation and repairs may only be performed by trained specialists.
23. Cover screw for accessories pin Contact your HAAG-STREIT representative for installation, repairs and
24. Quick-release fastener for accessories modification work on the system. The contact details are available at
25. Stereo microscope with eyepieces www.haag-streit.com.
26. Eyepieces • Only original HS replacement parts may be used.
27. Breath shield
28. Mounting screw for breath shield 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- 4. Commissioning
side of the bearer arm. The device can be switched on and off with a mains isolator on the power supply.
3.2 Power supply The green lamp in the rocker switch lights up when the device is switched on.
NOTE! 4.1 Switching on the appliance
Observe the respective HAAG-STREIT instructions for use. (For further • Connect the power supply to the mains and press the rocker switch. The green
information, please contact your HAAG-STREIT dealer). lamp in the rocker switch lights up when the appliance is switched on.
Dieses Gerät darf nur mit HS Gerätenetzteilen PS-LED, PS-LED HSM901 • Set the knob on the illumination control to a position between '1' and '10'.
und dem Release Modul RM02 betrieben werden.
5. Operation
3.3 Instrument base with weight compensation facility 5.1 Setting the eyepieces
The weight of additional accessories mounted on the microscope can be compen-
NOTE!
sated using counterbalance springs. This keeps the height adjustment of the slit
lamp easy. The eyepieces must be individually set prior to the first examination in
accordance with the refraction of the examiner. Insert the provided fo-
3.4 Setting the weight compensation facility cus test rod (37) in place of the protective cover (38) and turn its black
Turn the control lever (35) to its lowest position and then loosen it slightly a quarter projection surface at a right angle to the microscope axis. Return the
turn. Turn the microscope and illumination to the side. Apply 1 − 3 springs depend- illumination and microscope to the central position (0°).
ing on the accessory.
3.5 Switching on the weight compensation facility 377
Turn anticlockwise until the screws (20) are completely released.
37. Test rod
3.6 Switching off the weight compensation facility 38. Protective cover 38
Turn clockwise until you meet resistance. Verify whether the microscope arm
39. Sliding occluder
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 39
should be deactivated as necessary until this spring action occurs. The weight
compensation facility is set correctly once the illumination and microscope with the • Each eyepiece should be set individually by turning the knurled ocular refraction
mounted accessories weigh slightly more than the counterbalance springs. ring with diopter scale such that the projected slit can be seen in focus. The set-
3.7 Regulating the clearance of the slit width control ting is performed from the (+) to the (-) side at low magnification.
The small screw in the center of the right control knob (A)
• The sliding occluders (39) are used to set the correct working distance for the ex-
aminer from the eyepiece.
allows you to regulate the friction of the turning movement
of these adjusting knobs. Turning it slightly to the right (in)
• Examiners who do not wear glasses: Pull the occluders out as far as they will go.
makes it harder, turning it left (out) makes it easier. It should
• Examiners who do wear glasses: Push the occluders in as far as they will go.
at least be set so hard that the slit cannot close on its own. A A

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5.2 Preparing the patient Diffuse illumination:

• In order to attain a solid basis for the forehead and chin to rest on, the table height • A diffuse illumination is achieved by positioning the diffusor (12) upstream. This
should be set so that the patient sits bent over forward. enables overview monitoring and can be used for taking overview images with the
• To ensure that only the part of the eye being examined is illuminated, the slit Imaging Module.
height should be set accordingly in order to avoid distracting streaking of light. Indirect illumination:
• Parts which come into contact with the patient should be cleaned with a dry cloth • For observation in regredient light (indirect illumination), the centering screw (30)
prior to every use. is loosened in order to move the slit image out of the center of the visual field.
• The lamp must be switched off after every examination. Tightening the screw centers the slit image again.
Slit tilting:
5.3 Operating the instrument • The latch (31) can be used to tilt the illumination in 5° steps. This creates an an-
WARNING! gled light beam during horizontal slit orientation. Tilting the slit enables reflex-free
The device must be switched off after each use. The risk of overheat- examination with contact glasses (fundus and gonioscopy) and magnifying glass-
ing increases if a dust cover is used. es.
• 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.
1
• Set the eyepieces (26) in accordance with the examiner’s refraction by turning the
knurled rings and set the eye distance. 2
• Adjust the height of the slit lamp by turning the control lever until the light beam is
21
at eye level. 8
22
• Switch on the illumination by turning the switch on the power supply. 9
23
• The magnification of the stereo microscope is changed using the magnification 3
10
24
changer (13). 4 11 25
12
• The rigid control lever (35) gently inclined towards the examiner can be used to 5 13
26
push the entire device until the slit appears approximately focused on the cornea.
14
This initial setting is verified with the naked eye. Fine tuning is performed by tilting 6 27
15 28
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- 16
29
tween the stereo microscope and illumination. The slit image can be set vertical- 7 30
17 31
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 18
12
5° increments). 19 32
20 33
• To ensure that unimpeded binocular fundus examination is also possible at lateral 34
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 35
36
the illumination and microscope turned to the central position (0°).
• Front-lens glasses and contact glasses are used to examine the ocular fundus.

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5.4 Setting the filters & diaphragms 5.6 Microscope and eyepiece 40 41 42 43 44 45 46 47 48
a. Open 40. Front lens
b. Grey filter (10%) 41. Rotary knob displaying the set magnification
c. Red removal filter 42. 5-level magnification changer (Galilei system)
d. Reserve opening for filter of choice ø15 mm (0 / -0.2), thickness 2.5 mm 43. Knurled ring bayonet joint
e. Fixation star (predominantly used for fixation examination of cross-eyed children 44. Binocular tube with convergent insight, pupil di-
with amblyopia) stance adjustable 52 – 78 mm
f. Apertures of 8, 5, 3, 2, 1 and 0.2 mm ø 45. Eyepiece 12.5x / field of vision ø 16 mm
g. Display of slit length adjustment from 1 to 14 mm 46. Index (white point)
h. Blue filter 47. Knurled ring with diopter scale for setting the
refraction of the examiner (± 7 D)
48. Sliding occluder (for people who wear glasses)

(a) (b) (c) (d)

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.
(e) (f) (g) (h) 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.
5.5 Fixation star NOTE!
• Turning the diaphragm disc to the left stop switches on the fixation star Disconnect the power supply from the mains if you do not intend to use
and the 'S' symbol appears in the viewing window. In some examina- it for an extended period of time.
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 7 Technical data
the star. This shows the examiner the point where the patient's vision is
most focused. 7.1 Slit illumination
• A typical use of the fixation star is close to the macula during laser tre- NOTE!
atment. The projection of the fixation star can also be used to identify Detailed information regarding the radiation can be provided
microstrabismus. The fixation star is usually used with upstream red re- on request.
moval filter. Slit image width 0 – 14 mm continuous
Slit image length 1 – 14 mm continuous
Illumination field circle ø 8 / 5 / 3 / 2 / 1 / 0.2 mm
Test mark With fixation star
Slit image rotatability ± 90°

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Swiveling of the slit illumination to Horizontal ± 90°, vertical 0 – 20° 8.1 Device inspection
the microscope axis In order to correctly check the slit lamp, proceed as follows:
Filters Blue, red removal (green), gray (10%). • Insert test rod into the radial movement bearing, whilst at the same time aligning
UV and thermal-protection filters are installed fixed the surface to the microscope at a right angle.
• Set slit length to 8 or 14 mm.
NOTE! • Set llumination strength to 50%.
(Further information available in the LED illumination LI 900 instruc- • Set magnification to max. in the microscope.
tions for use) • Set the eyepieces in such a way that the test rod is in sharp focus. Turn the
eyepiece from the (+) to the (-) side.
7.2 Stereo microscope • The structure of the test rod must be in sharp focus in all magnifications.
Stereo angle: 13° • Close slit edges to approx. 0.5 mm. The borders must be in sharp focus here.
Magnification changer: 6.3x / 10x / 16x / 25x / 40x • Completely open slit edges and turn the test rod by 45°, the sharp area must
Ocular magnification: 12.5x be in the centre of the test rod.
Range of adjusting eye-pieces: +7 to −7 diopters 8.2 Repair
Pupil distance: 52 – 78 mm To guarantee a long service life, the device must be cleaned weekly as described
Total magnification: 6.3x / 10x / 16x / 25x / 40x 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.
Object field ø in mm: 32.0 / 20.0 / 12.7 / 8.0 / 5.1
7.3 Instrument base 8.3 Cleaning
• Only clean the housing with a dry cloth.
Operation: Single-handed operation of control lever in 3 dimensions • Do not use any liquids, alcohol or corrosive substances.
Adjustment of instru- 100 mm (length) • The exposed glass surfaces can be dusted with a dusting brush.
ment base: 100 mm (side) Lens brush HAAG-STREIT number 1001398
30 mm (height)
8.4 Replacing the illumination mirror
7.4 Net weight The mirror can be most easily accessed if the microscope is turned away from the
12.7 kg (without power supply, head rest and options) illumination and the illumination inclined two points.
8. Maintenance WARNING!
Only use mirrors with a LOT number.
WARNING!
• Do not modify this equipment without authorization of the manufacturer.
Installation and repairs may only be performed by trained specialists. 8.5 Dust cover
Contact your HAAG-STREIT representative for installation, repairs and We recommend protecting the slit lamp with a dust cover
modification work on the system. The contact details are available at (49) when not in use. 49
www.haag-streit.com. Dust cover, small (for slit lamp) HS no. 1001395
• Only original HS replacement parts may be used. Dust cover, large (for several instruments) HS no. 1001434
The LED illumination can be operated maintenance-free for its entire service life.
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A. Appendix Cable channel without table top table channel ø 12 mm 7200086

A.1. Accessories/spare parts Cable channel without table top table channel ø 20 mm 1001575
Contrast enhancer filter (yellow) 1400306
WARNING! Measuring eyepiece 12.5x 1400302
• Do not modify this equipment without authorization of the manufacturer. Observer tube, short (without eyepiece) 1400301
Installation and repairs may only be performed by trained specialists.
Observer tube, long (without eyepiece) 1400034
Contact your HAAG-STREIT representative for installation, repairs and
modification work on the system. The contact details are available at Eyepiece 12.5x with diopter ring 1400303
www.haag-streit.com. Eyepiece 12.5x with McIntyre reticle 1400304
• Only original HS replacement parts may be used. Eyepiece with double cross hair 12.5x 3000470
Check rod 1001051
NOTE! Dust cover, large (for several instruments) 1001434
An asterisk (*) shows that you should contact your HAAG-STREIT Dust cover, small (for slit lamp) 1001395
dealer for further information. Two asterisks (**) indicate that you Stereo variator 7200109
should consult the separate instructions for use.
Beam splitter 50/50 1400308
Component HS art. no. Beam splitter 70/30 1001600
Locating pin 3000332 Diffusor 1007085
LED illumination, black without background illumination** 1020884 Background illumination fixed** 1020886
LED illumination with background illumination light gray RAL7035** 1021178 Background illumination with swivel holder** 1020887
LED illumination, background illumination ready black RAL9005** 1020885 USB illumination cable 2000 mm** 1020940
Illumination control double slit and background 'in table'** 1021022 USB illumination cable 5000 mm** 1020956
Illumination control double slit and background 'on table'** 1020883 Video adapter with lens tube f56 1/3 (C-Mount) 1007780
Illumination control single 'in table'** 1021024 Video adapter with lens tube f60 (3-chip, ½ inch) 1400321
Illumination control single 'on table'** 1021020 Video adapter with lens tube f60 (mini camera) 1400320
Split image eyepiece 12.5x 1400300 Video adapter with lens tube f75 (C-mount) 1400319
Cover T-0 for table opening** 1021085 Prescription glass, moving, -58.6 diopters, according to Hruby 1400223
Plug-in mirror short 1001591 Prescription glass carriage with rail (with guide plate) 1001219
Plug-in mirror long 1001590 Zoom module for slit lamp BQ 900 1400013
Photo adapter DC 01 for digital cameras 1004665 Connecting piece for angled view 20° 1400305
Power supply for LED illumination on third-party tables** 1020882
Power supply for LED illumination HSM 901** 1020881 B. Legal regulations
Imaging Module IM 900 complete (Camera Module CM03 + Release 7220550 • The BQ 900 slit lamp was developed and designed in observance of the stan-
Module RM02 + Software) dards EN 60601-1, EN ISO 10939 and EN ISO 15004-2. Production, testing, set-
Instrument table HSM 901 * up, maintenance and repairs are performed in observance of international stan-
Instrument table HSM 901 Imaging * dards.
Instrument table HSM 901 Workstation * • The EN 60601-1 standard must be observed when using different medical and/or
non-medical electrical appliances in combination.
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• The CE marking confirms that the BQ 900 slit lamp is in compliance with Directive
93/42/EEC.
• The slit lamp BQ 900 fulfills the electromagnetic compatibility requirements of EN
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. Classification
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 WARNING!

concerning electromagnetic compatibility • Electrical medical devices and systems are subject to special EMC
measures and must be installed in accordance with the EMC instruc-
(EMC) tions contained in this accompanying document.
F.1 General • Portable and mobile HF communication systems may interfere with
The BQ 900 slit lamp system fulfills the requirements on electromagnetic compati- electrical medical devices.
bility according to EN 60601-1-2. The instrument is built so that the generation and • The operation of other lines or equipment than those listed may lead
emission of electromagnetic interference is limited to the extent that other devices to higher emissions or may reduce the device's resistance to interfe-
are not disturbed in their use in accordance with the regulations and so that the in- rence.
strument itself is suitably immune to electromagnetic interference. • 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
Emission test Compliance Electromagnetic environment - guidance
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
Emission of harmonics according to Class A directly connected to the public low-voltage power supply network that supplies buildings used for
EN 61000-3-2 domestic purposes.
Voltage fluctuations / flicker emissions Fulfilled
according to EN 61000-3-3

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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 specified 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) ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or ceramic tile. If floors are
EN 61000-4-2 ± 8 kV air ± 8 kV air covered withs ynthetic material, the relative humidity should
be at least 30%.
Electrical fast transient / burst ± 2 kV for power supply lines ± 2 kV for power supply lines Mains power quality should be that of a typical commercial
EN 61000-4-4 or hospital environment.
Surge ± 1 kV for symmetrical voltages ± 1 kV for symmetrical voltages Mains power quality should be that of a typical commercial
EN 61000-4-5 ± 2 kV for asymmetrical voltages ± 2 kV for asymmetrical voltages or hospital environment.
Voltage dips, short interruptions < 5% UT (> 95% drop in UT) < 5% UT (> 95% drop in UT) Mains power quality should be that of a typical commercial
and voltage variations on power for ½ cycle for ½ cycle or hospital environment. If the user of this product requires
supply lines < 40% UT (> 60% drop in UT) < 40% UT (> 60% drop in UT) continued function even in the event of interruptions in the
EN 61000-4-11 for 5 cycles for 5 cycles energy supply, this product should be powered from an un-
< 70% UT (> 30% drop in UT) < 70% UT (> 30% drop in UT) interruptible power supply or a battery.
for 25 cycles for 25 cycles
< 5% UT (> 95% drop in UT) < 5% UT (> 95% drop in UT)
for 5 s for 5 s
Power frequency (50/60Hz) 3 A/m 100 A/m Power frequency magnetic fields should be at levels char-
magnetic field EN 61000-4-8 acteristic of a typical location in a typical commercial or hos-
pital environment.
NOTE: UT= the AC mains voltage prior to application of the test level.

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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 specified 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 Vrms 10 Vrms D = 1.2
150 kHz – 80 MHz
Radiated RF EN 61000-4-3 3 V/m 10 V/m D = 1.2 80 MHz – 800 MHz
80 MHz – 2.5 GHz 80 MHz – 2.7 GHz D = 2.3 800 MHz – 2.5 GHz

Where P is the maximum output power rating of thet ransmitter in watts (W) according to the transmitter manufacturer and D is the recommended separation
distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level
in each frequency range b 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. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
c. Possible shorter distances outside the ISM bands do not contribute to improved application in this table.

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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.
Safe distance according to transmission frequency (m)
150 kHz – 80 MHz 80 MHz – 800 MHz 800 MHz – 2.5 GHz
Nominal output of the transmitter (W) D = 1.2 D = 1.2 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 D can 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 10/3 was used to reduce the
probability of a mobile/portable communication device causing interference if inadvertently brought into the patient area.
NOTE 3: These guidelines may not apply in all situations. Electromagnetic wave propagation is influenced by absorption and reflection of buildings, objects and people.

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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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