Haag-Streit BP 900 User manual

1
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220322.04040 – 2014 – 12 DOC. no. 1500 1500.1400209.04000
INSTRUCTIONS FOR USE
Slit lamp
BP 900®
4. Edition / 2014 – 12
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220322.04040 – 2014 – 12
INSTRUCTIONS FOR USE
Slit lamp
BP 900®
4. Edition / 2014 – 12
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
AnAC-powered slitlamp biomicroscope is intended for use in eye examination of
the anterior eye segment, from the cornea epithelium to the posterior capsule. It is
used to aid in the diagnosis of diseases or trauma which affect the structural proper-
ties of the anterior eye segment.
Contraindications
There are no absolute contraindications known for examinations with this device.
Appropriate professional assessment 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.
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220322.04040 – 2014 – 12
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..........................................................................6
2.1 Overview.................................................................................................................6
3. Appliance assembly / installation......................................7
3.1 Microscope and illumination....................................................................................7
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 compensation facility...................................................................7
3.6 Switching off the compensation facility...................................................................7
3.7 Regulating the clearance of the slit width control....................................................7
4. Commissioning....................................................................7
4.1 Switching on the device..........................................................................................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.....................................................................................10
6. Decommissioning..............................................................10
7 Technical data ...................................................................10
7.1 Slit illumination .....................................................................................................10
7.2 Stereo microscope ...............................................................................................10
7.3 Instrument base ...................................................................................................10
7.4 Net weight.............................................................................................................10
8. Maintenance.......................................................................10
8.1 Cleaning the slide plate and the rack rails............................................................10
8.2 Cleaning the axle..................................................................................................11
8.3 Replacing the illumination mirror...........................................................................11
8.4 Repairs..................................................................................................................11
8.5 Cleaning................................................................................................................11
8.6 Replacing the illumination mirror...........................................................................11
8.7 Dust cover.............................................................................................................11
A. Appendix.............................................................................11
A.1 Accessories / spare parts......................................................................................11
B. Legal regulations ..............................................................12
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 Interference immunity on non-life-supporting devices (standard table 4).............15
F.5 Safe distances for non-life-supporting devices (standard table 6)........................16
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220322.04040 – 2014 – 12
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 possible returns or
when moving.
• Theslitlampandheadrestmustbeinstalledonanelectricallyinsulated,re-
proof table top.
• The rail covers (a) prevent the slit lamp from tilting.
• Check:Are the connection parts of the accessories in the correct position (screw
connections, 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.
•
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!
• To avoid the risk of an electric shock, this device must be connected
up to the mains with a ground connection when using power supplies
assigned to protection class I.
• The device must be switched off after every use. Otherwise there is a
risk of overheating when a protective dust cover is employed.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220322.04040 – 2014 – 12
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".
1.6 Light toxicity
WARNING!
As extended, intensive illumination can damage the retina, the use of
the device in the examination of the eye should not be prolonged un-
necessarily.Thisslitlampisequippedwithprotectivelterswhichlimit
the light spectrum to 400-750 nm. 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, aphakes and
people suffering from eye conditions are most at risk.An increased 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 specially applies if the
retinahasbeenphotographedwithaashbulbinadvance.Thelight
from this device may be dangerous. The risk of eye damage increases
with the irradiation period. The exposure time with this device at maxi-
mum intensity is linked to the selected type of illumination.An exposure
time with this instrument at maximum intensity of longer than 2.45 min-
utes exceeds the guideline value for a risk (as per 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
Disconnect the plug before
opening the device
Notes on disposal, see the
'Disposal' chapter
Test symbol of CSA with ap-
proval for USA
European certificate of
conformity
This appliance fulfills the Euro-
pean Directive 2011/65/EU (RoHS)
Trademark of the manufacturer
HAAG-STREIT AG
Year of production Manufacturer
Alternating currentAlternating current
Direct current Earth (ground)
HS reference number Serial number
Not protected from foreign
bodies
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220322.04040 – 2014 – 12
2. Introduction
2.1 Overview
The slit lamp comprises an illumination and a binocular microscope. The entire de-
vice can be moved in front of the eyes using the instrument base. The illumination
offers a range of setting possibilities for making the practically invisible areas of the
eye visible. There is also a range of accessories available for the slit lamp to allow
special diagnosis possibilities in addition to the general examinations.
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. LI01-plus lamp cover with back-
ground illumination
9. Backgroundillumination(xed)
10. Leverforlters
11. Scale for angled position of the slit
image (5° increments)
12. Background illumination with swiv-
el bracket
13. Illumination mirror
14. Diffusor
15. Magnicationchanger
16. Mounting screw for the stereo mi-
croscope
17. Slot for accessories (test rod, back-
ground illumination, etc.)
18. Centring screw
19. Illumination unit / microscope an-
gle scale
20. Illumination arm locking screw
21. Slit width setting screw
22. Microscope arm locking screw
23. Cross slides
24. Rail cover
25. Illumination control 'on table'
26. Illumination control 'in table'
27. Slit length / diaphragm scale
28. Slitlength,slitrotation,bluelter
andxationstarcontrol
29. Cover screw for accessories pin
30. Quick-release fastener for acces-
sories
31. Stereo microscope
32. Eyepieces
33. ThreadforxingthetonometerAT
900 mod. BP or tonometerAT900
D mod. BP
34. Mounting screw for breath shield
35. Breath shield
36. Inclination angle latch 5°-20°
37. Joy stick base locking screw
38. Axle
39. Control lever
40. Slide plate
1
8
27
40
37
38
39
33
34
35
36
29
30
31
9
11
10
23
24
25
26
12
19
20
21
22
13
14
14
15
16
17
18
2
3
4
5
6
7
28
32
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220322.04040 – 2014 – 12
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.
3.1 Microscope and illumination
• The slit lamp is packaged and shipped fully assembled. The transport safety de-
vices must be removed before commissioning.
• Fix the breath shield (35) in place by fastening the knurled screw (34) 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 consult your HAAG-STREIT representative.
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 (60) to its lowest position and then loosen it slightly a quar-
ter turn.
Turn the microscope and illumination to the side.
Apply 1-3 springs depending on the accessory.
3.5 Switching on the compensation facility
Turn anticlockwise until the screws (59) are completely released.
3.6 Switching off the 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 centre of the right control knob
(83) allows you to regulate the friction of the turning
movement of these adjusting knobs. Turning it slight-
ly 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. 83
4. Commissioning
The device can be switched on and off using the mains power switch on the device
power supply. The green light on the rocker switch illuminates when the device is
switched on.
4.1 Switching on the device
• Connect the power supply up to the mains and press the rocker switch. The green
light on the rocker switch illuminates when the device is switched on.
• Turn the rotating 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 (41) in place of the protective cover (42) and turn its black
projection surface at a right angle to the microscope axis. Return the
illumination and microscope to the central position (0°).
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41. Test rod
42. Protective cover
43. Sliding occluders
41
42
43
• Each eyepiece should be set individually by turning the knurled ocular refraction
ring with dioptre 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 required pupil distance should then be set on the microscope.
• The sliding occluders (43) 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.
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 selected such 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.
• Parts which come into contact with the patient should be cleaned with a dry cloth
prior to every use.
• The slit lamp must be switched off in accordance with the 'Decommissioning' sec-
tion after every examination.
5.3 Operating the instrument
WARNING!
• The device must be switched off after every use. Otherwise there is a
risk of overheating when a protective dust cover is employed.
• Use the turn screw (7) to set the chin rest (6) in such a way that the patient’s eyes
are at the same height as the black mark (4) on the sides of the head rest.
• Adjust the eyepieces (32) in accordance with the examiner’s refraction by turning
the knurled rings and set the eye distance.
• Switch on the illumination by pressing the switch on the power supply.
• Regulating the brightness of the slit illumination / multi-level mains switch on pow-
ersupply/10%greylter(Sect.3.4).LEDilluminationseeseparateinstructions
for use.
• Adjust the height of the slit lamp by turning the control lever (39) until the lumi-
nous aigrette is at eye level.
• Themagnicationofthestereomicroscopeischangedusingthemagnication
changer (15).
• The rigid control lever (40) 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 (31).
• The slit width is set left or right with the rotating knob (21), as is the angle be-
tween the stereo microscope and illumination.
• The slit image can be set vertically, horizontally or as diagonal as required by
turning the illumination facility on the handle (28) (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 (13) is used, the illumination turned
90° using the locking screw (21) and tilted in 5° steps using the latch (36), and
the illumination and microscope turned to the central position (0°).
• Front-lens glasses and contact glasses are used to examine the ocular fundus.
Diffused illumination:
• Connecting the diffusor (14) upstream creates diffused illumination.This allows
monitoring of the overview and can be used to capture the overview with an im-
aging module.
Indirect illumination:
• For observation in regredient light (indirect illumination), the centring screw (18) is
loosenedinordertomovetheslitimageoutofthecentreofthevisualeld.Tight-
ening the screw centres the slit image again.
Tilting the slit:
The latch (36) can be used to tilt the illumination in 5° steps. In this
way, a diagonal ray of light from below is generated when the slit is ori-
entedhorizontally.Theslitorientationallowsareection-freeexamina-
tion with contact glasses (fundus and gonioscopy) and magnifying glasses.
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1
8
2 7
4 0
37
38
39
33
34
35
36
2 9
30
31
9
1 1
1 0
2 3
2 4
2 5
2 6
1 2
1 9
2 0
2 1
2 2
1 3
1 4
1 4
1 5
1 6
1 7
1 8
2
3
45
6
7
2 8
32
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 wedge-shaped diaphragm for continuous slit length adjustment in mm
h) Bluelter
( a )
( e ) ( f ) ( g ) ( h )
( b ) ( c ) ( d )
NOTE!
UVandthermal-protectionltersareinstalledasperthe
ISO 10939 standard
5.5 Fixation star
• Turning the diaphragm disc as far as it will go to the left switches on
thexationstarandthesymbol"S"appearsinthewindow.Thisstaris
projected onto the fundus at the back of the eye in certain examinations
and is visible to the patient at the same time, who is asked to focus on
the hole in the centre of the star. This allows the examiner to see where
the patient's vision is most focused.
• Atypicalapplicationofthexationstarisduringlasertreatmentsclose
to the macula. Similarly, it is also possible to identify microstrabismus
withtheprojectionofthexationstar.Thexationstarisusuallyused
witharedremovallter.
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220322.04040 – 2014 – 12
5.6 Microscope and eyepiece
44. Frontal objective f 103 mm
45. Rotaryknobdisplayingthesetmagnication
46. 3-levelmagnicationchanger(Galileisystem)
47. Quick-release fastener for knurled ring
48. Binocular tube f 130 mm with convergent in-
sight, pupil distance can be set from 53-78 mm
49. Eyepiece12.5x/eldofvisionø16mm
50. Index (white point)
51. Knurled ring with dioptre scale for setting the
refraction of the examiner (± 8 D)
52. Sliding occluder (for people who wear glasses)
4 4 4 5 4 6 4 7 4 8 4 9 5 0 5 25 1
6. Decommissioning
The LED illumination can be switched off with the illumination control. The device
power supply remains switched on and the switch illuminates green. To switch the
system off completely, the rocker switch must be set to the 0 = 'OFF' position. This
results in double-poles disconnection 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
Slit image width 0–8 mm continuous
Slit image length 1–8 mm continuous
Illuminationeldcircle 8/5/3/2/1/0.2mminø
Test mark withxationstar
Slit image rotatability ±90°
Inclination of slit illumination to mi-
croscope axis Horizontal ± 90°, vertical 0-20°
Filters Blue, red removal (green), grey (10%).
UVandthermal-protectionltersareinstalled.
NOTE!
Further information is available in the LED illumination LI 900 instruc-
tions for use.
7.2 Stereo microscope
Stereo angle: 13°
Magnicationchanger: 10x / 16x / 25x
Ocularmagnication: 12.5x
Range of adjusting eye-pieces: +7to−7diopters
Pupil distance: 52 – 78 mm
Totalmagnication: 10x / 16x / 25x
Objecteldøinmm: 20.0 / 12.7 / 8.0
7.3 Instrument base
Operation: Single-handed operation of control lever in three dimen-
sions
Adjustment of instru-
ment base: 100 mm (length) 100 mm (side)
30 mm (height)
7.4 Net weight
12.3 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.
The LED illumination can be operated maintenance-free for its entire service life.
8.1 Cleaning the slide plate and the rack rails
• If the slide plate (56) is dirty and the general
movement of the slit lamp is impaired, rubbing
theplatewithalightlyoiledclothisusuallysuf-
cient remedy.
• After removing the rail covers (55) the rack rails
(54) should be dusted from time to time with a
brush.
5 3
5 4
5 5 5 6
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8.2 Cleaning the axle
The axle (53) should only be cleaned with a clean, lint-free cloth.
8.3 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 LOT number.
8.4 Repairs
To ensure a long service life, the device should be cleaned weekly as described and
covered with a dust cover when not in use. We recommend having the device in-
spected by an authorised service technician annually.
8.5 Cleaning
• Only clean the housing using a dry cloth.
• Do not employ any liquids, aggressive agents or alcohol.
• The exposed glass surfaces can be dusted with a dusting brush.
Lens brush HAAG-STREIT number 1001398
8.6 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.
8.7 Dust cover
We recommend protecting the slit lamp with a dust cover
(57) when not in use.
Dust cover, small (for slit lamp) H-S art. no. 1001395
Dust cover, large (for several instruments) H-S art. no.
1001434
5 7
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.
NOTE!
An asterisk (*) shows that you should contact your HAAG-STREIT rep-
resentative for further information.
Two asterisks (**) indicate a need to refer to the separate instructions
for use.
Component HS art. no.
Adapter rings for digital camera *
Pin 3000332
Illumination head LED, background illumination prepared 1021179
Illumination control, double slit and background 'in table'** 1021022
Illumination control, double slit and background 'on table'** 1020883
Camera module CM 900 BD/BP 7220041
Cover T-0 for recess in table** 1021085
Short mirror 1001591
Long mirror 1001590
Guide plate (900-415) 1001219
Power supply for LED illumination, HSM 801 and tables from other
manufacturers** 1020881
Power supply for LED illumination, HSM 901** 1020882
Instrument table HSM 801 *
Instrument table HSM 901 *
Instrument table HSM 901 Imaging *
Instrument table HSM 901 Workstation *
Contrast-boostinglter(yellow) 1007839
Eyepiece 12.5x measuring eyepiece 1400302
Eyepiece 12.5x with McIntyre reticle 1400304
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220322.04040 – 2014 – 12
Eyepiece BP 900 12.5x 1007200
Eyepiece with double crosshair reticule 12.5x 3000470
Test rod 1001051
Dust cover, large (for several instruments) 1001434
Dust cover, small (for slit lamp) 1001395
Diffusor 1007085
Backgroundillumination,xed** 1020886
Background illumination with swivel bracket** 1020887
USB illumination cable 2000 mm** 1020940
USB illumination cable 5000 mm** 1020956
Video adapter 70/30 (C-mount) f60 1007150
Movable Hruby preset lens, -58.6 dioptres 1400223
Carriage for preset lenses with rail (guide plate included) 1001219
B. Legal regulations
• The BP 900 slit lamp was developed and designed taking the EN 60601-1 and EN
ISO 15004-2 standards into account.
• The EN 60601-1 standard must be observed when using different medical and/or
non-medical electrical appliances in combination.
• ComplianceoftheBP900slitlampwiththeDirective93/42/EECisconrmedby
the CE marking.
• TheBP900slitlampsatisestheelectromagneticcompatibilityrequirementsof
EN 60601-1-2. The device has been designed to maintain the emissions of elec-
tromagnetic interference at a level which does not exceed the statutory guidelines
and which 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. Classication
Standard EN 60601-1 Slit lamp BP 900 acc. to 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 ISO 10939 EN 60601-1
EN 60601-1-2 EN ISO 15004-2
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220322.04040 – 2014 – 12
F. Information and manufacturer's declaration
concerning electromagnetic compatibility
(EMC)
F.1 General
TheBP900slitlampsystemfullstherequirementsonelectromagneticcompati-
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 it itself
has appropriate immunity 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 specifi ed 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 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
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220322.04040 – 2014 – 12
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 fl oors 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 3A/m0.3A/m 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.
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F.4 Interference immunity on non-life-supporting 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 Vrms
150 kHz – 80 MHz 3 Vrms D= 1.2
Radiated RF EN 61000-4-3 3 V/m
80 MHz – 2.5 GHz 3 V/m 80 MHz – 800 MHz 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 10 V/m.
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F.5 Safe distances for non-life-supporting 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:
1250
http://www.haag-streit.com/contact/contact-your-distributor.html
C US
PRODUCTS CERTIFIED FORBOTH THE
U.S
AND CANADIAN MARKETS, TO THE APPLI-
CABLE U.S. AND CANADIAN STANDARDS
HAAG-STREIT AG
Gartenstadtstrasse 10
3098 Koeniz, Switzerland
Phone [phone]
Fax [phone]
eMail [email protected]
Internet www.haag-streit.com
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