Haag-Streit BI 900 User manual

1
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04010 – 2015 – 08 DOC. No. 1500 1500.1400209.04000
INSTRUCTIONS FOR USE
Slit lamp
BI 900®
1. edition / 2015 – 08
01-IFU_BI900-7220505-04010_eng.indd 1 12.08.2015 14:37:46

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04010 – 2015 – 08
INSTRUCTIONS FOR USE
Slit lamp
BI 900®
1. edition / 2015 – 08
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 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.
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. 1500.7220505-04010 – 2015 – 08
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
1.5 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
2.2 Overview LED illumination......................................................................................6
2.3 LED illumination LI02..............................................................................................7
2.4 Bluelter.................................................................................................................7
2.5 Periphery or background illumination .....................................................................7
3. Appliance assembly / installation......................................7
3.1 Placement of adhesive label for the automatic
left/right detection....................................................................................................7
3.2 Camera assembly...................................................................................................7
3.3 Cabling of the RM02 (diagram)...............................................................................8
3.4 Microscope and illumination....................................................................................8
3.5 Regulating the clearance of the slit width control....................................................8
3.6 Step-by-step cabling...............................................................................................9
4. Startup................................................................................10
4.1 Switching on the device........................................................................................10
5. Operation............................................................................10
5.1 Setting the eyepieces............................................................................................10
5.2 Field of view .........................................................................................................10
5.3 White balance ......................................................................................................10
5.3.1 Slit lamp preparation ............................................................................................10
5.3.2 Conducting a white balance..................................................................................10
5.4 Software / Help menu / Error messages...............................................................11
5.5 Preparing the patient ............................................................................................11
5.6 Operating the instrument ......................................................................................12
5.7 Settingthelters&diaphragms ...........................................................................13
5.8 Fixation star ..........................................................................................................13
5.9 Microscope and eyepiece ....................................................................................13
5.10 Reduced operation................................................................................................13
5.11 LED display Illumination head...............................................................................13
5.12 LED display power supply.....................................................................................13
5.13 LED display release module RM02.......................................................................14
5.14 LED display camera..............................................................................................14
5.15 Error messages (illumination head)......................................................................14
5.16 Error messages release module RM02.................................................................14
5.17 Error messages camera........................................................................................15
5.18 Software / Help menu / Error messages...............................................................15
6. Decommissioning..............................................................15
7 Technical data ................................................................... 15
7.1 Slit illumination .....................................................................................................15
7.2 Power supply .......................................................................................................15
7.3 Stereo microscope ...............................................................................................15
7.4 Instrument base ...................................................................................................16
7.5 Dimensions...........................................................................................................16
7.6 Camera.................................................................................................................16
7.7 Minimum PC requirements ..................................................................................16
8. Maintenance.......................................................................16
8.1 Device inspection..................................................................................................16
8.2 Servicing...............................................................................................................16
8.3 Cleaning................................................................................................................17
8.4 Replacing the illumination mirror...........................................................................17
8.5 Dust cover.............................................................................................................17
A. Appendix............................................................................17
A.1 Accessories / spare parts......................................................................................17
B. Statutory requirements .................................................... 17
C. Classication ....................................................................17
D. Disposal..............................................................................18
E. Observed standards..........................................................18
F. Information and manufacturer's declaration
concerning electromagnetic compatibility
(EMC)..................................................................................19
F.1 General.................................................................................................................19
F.2 Emitted interference (standard table 1).................................................................19
F.3 Interference immunity (standard table 2)..............................................................20
F.4 Interference immunity for non-life-supporting devices (standard table 4).............21
F.5 Safe distances for non-life-supporting devices (standard table 6)........................22
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04010 – 2015 – 08
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 device, check whether the packaging shows traces of in-
correct handling or damage. If this is the case, notify the transport company that
has delivered the goods to you. Unpack the device together with a representative
of the transport company. Prepare a report for any possibly 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 device for damage after it is unpacked. Return defective devices in the
appropriate packaging.
• Store packaging material carefully, so that it can be used for possible returns or
when moving.
• Theslitlampandheadrestmustbeinstalledonanelectricallyinsulated,re-re-
sistant table top.
• The rail covers (a) prevent the slit lamp from tilting.
• Check:Are the connection parts of the accessories in the correct position
(screwed 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.
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.
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04010 – 2015 – 08
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".
1.5 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. The illumination of this slit lamp emits a radiation in the
range between 400 and 750nm. Detailed information on the radiation
can be provided on request. 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 radia-
tion hazard has been detected in slit lamps. Nevertheless, we recom-
mend 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 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 ap-
plies,inparticular,iftheretinahasbeenphotographedwithaashbulb
in advance.
The light from this instrument may be dangerous. The risk of eye dam-
age increases with the exposure time.An exposure time with this in-
strument 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 require disinfection. 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 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
Strong permanent magnets Plug socket USB 3.0 micro
B on RM 02 for computer
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04010 – 2015 – 08
Plug socket on RM 02 for
power supply Slit lamp illumination
Background illumination
2. Introduction
The BI 900 slit lamp comprises an illumination unit and a binocular microscope. The
entire device can be moved in front of the eyes using the instrument base. The il-
lumination 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.
NOTE!
The BI 900 slit lamp can be optionally equipped with the imaging set
(HS art. no. 7220535).
2.1 Overview
1. Lamp cable with special connection
plug for LI02 plus
2. LED illumination LI 900
3. Filter lever
4. Optical light guide for periphery or
background illumination
5. Slitlength,slitrotation,bluelterand
xationstarcontrol,knobforrotat-
ing the slit
6. Scale for angled position of the slit
image (5° increments)
7. Periphery or background illumination
FI01f (standard)
8. Illumination mirror
9. Diffusing lens
10. Headrest (see separate instructions)
11. Protective cover
12. Illumination unit / microscope an-
gle scale
13. Illumination arm locking screw
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
32
33
34
9
8
35
31
2.2 Overview LED illumination
36. LED illumination LI02 plus with periphery or background lighting
37. Plug connection
38. Filterwheelforbluelter
39. Connection periphery or background illumination
40. Cover
14. Microscope arm locking screw
15. Camera cable
16. Release module RM02
17. Stickerleft/rightidentication
18. Axle
19. Rail cover
20. Cover cap for the accessories base
21. Stereo microscope
22. Eyepieces
23. Mounting screw for breath shield
(option)
24. Breath shield (option)
25. Centering screw for illumination
26. Camera operational control LED
27. Inclinationanglelatch0°−20°
28. Slit width controls
29. Roller rail
30. Control lever
31. Camera
32. Slide plate
33. EyeSuite Imaging software
34. Power supply
35. Electric power supply lead (country-
dependent)
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04010 – 2015 – 08
36
37
38
39
40
41
41
2.3 LED illumination LI02
2.4 Bluelter
41. Therotatingwheelisusedtopivotthebluelter.Markingpointsatthesame
height=bluelterison.
2.5 Periphery or background
illumination
This periphery or background illumination may only be
used in conjunction with an LI02 plus LED illumination.
42. Peripheryorbackgroundillumination,xed
43. Periphery or background illumination, swiveling (op-
tion)
42 43
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 Placement of adhesive label for the automatic
left/right detection
44. Protectivelm
45. Rest of the sticker
46. Table edge
• Remove rail cover (19) and place slit lamp aside. Clean surface of table.
• Removeprotectivelm(44)fromthebackoftheadhesivelabel.Carefullystartat
the corner opposite the black surface.
• Position the sticker against the right roller rail (29) and the edge of the table (46).
Pressrmlyonthewhite/blacksurface,pressawayanyairbubbles.
• Carefully tear off the remainder of the adhesive label (45) (the 'positioning tool')
along the perforation.
• Reassemble the slit lamp and rail cover.
45
29
46
19
44
3.2 Camera assembly
• Remove the cover caps from the camera and adapter.
• Screw the camera (48) onto the adapter.
• Position the image upright setting on the monitor: slightly loosen the 3 retaining
screws (47), turn the camera around its vertical axis until the position is correct;
reafxthecamera.Throughthesoftware,theimagecanbedisplayedhorizontally
or vertically.
• Mountthecameracasing(50)andxinplacewithscrews(49)
47. Retaining screws
48. Camera
49. Fastening screws
50. Camera casing 47
48
49
50
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04010 – 2015 – 08
NOTE!
To ensure that the system works correctly, HAAG-STREITrecom-
mends not using laptops and using a high-quality desktop computer
instead.
65. Fastening screw
66. Two-pole connection plug
If the middle LED lights up red dur-
ing operation, the two-pole connection
plug (66) is connected incorrectly.
• Disconnect the device from the
power grid
• Remove the cover on the upper part
of the illumination facility by loosen-
ing the fastening screw (65).
180°
65
66 1
• Turn the two-pole connection plug (66) 180°.
• Fix the cover on the upper part of the illumination facility with the fastening screw
(65).
• Connect the device to the power grid again.
3.4 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 (24) in place by fastening the mounting screw (23) on the in-
side of the bearer arm.
3.5 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
3.3 Cabling of the RM02 (diagram)
WARNING!
• Only use the supplied USB 3.0 cable (3m long, HS art. no. 1022373)
for the connection to the PC.
• Withlengthsofover3m,thecablewithactivesignalamplication
(HS art. no. 1022441) must be used.
• Only use medically approved PCs or operate via a medically ap-
proved isolating transformer.
• Auxiliary units on the PC (e.g. printer, monitor) must be operated
through an isolating transformer.
• Ethernet may only be used through a galvanic isolation in accor-
dance with EN 60601-1.
• The power supply unit's mains connector must be accessible in order
to allow for disconnection from the electric mains at any time!
51. Power grid
52. Med. approved isolating transformer
53. Instrument table
54. Med. approved power supply
55. Printer
56. Screen
57. Personal computer
58. Local network
59. Galvanic isolation (EN 60601-1)
60. Headrest
61. Cable headrest / LED illumination /
RM02
62. Release module RM02
63. LED illumination
64. Camera
51
52
53
55
56
57
60
61
62
63
64
58
59
54
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3.6 Step-by-step cabling
• Place the release module RM02 (73) over the slit lamp's cross slide. Four mag-
netsareusedforxing.
WARNING!
• Keep magnet-sensitive storage media (e.g. credit cards) away from
the magnets on the release module RM02!
• Only external medical power supplies approved by Haag-Streit that
fulllEN60601-1maybeused.
• Pull the cable headrest through the braided sleeving.
• Connect the cable headrest with the counterpart on the headrest (67).
• Mount the table top and place the slit lamp on the table.
• Insert the camera cable connector plug (76) in the socket (85) on the RM02. In-
sert the other end in the camera carefully from below. Lay the cable in the recess
on the microscope arm (75).
• Thread the computer cable USB 3.0 (73) and power supply cable (72) through the
braided sleeving (70) too.
• Insert the connector plug of the power supply cable (72) in the socket (86).
• Insert the connector plug of the computer cable USB 3.0 (73) in the socket (83).
• Pull on the braided sleeving taught and mount a cable tie (69) on each end.
• Mount a cable cover (91) on the threaded bolts (88) or mount the USB connec-
tor screws.
• Connect the mating connector of the computer cable USB 3.0 (73) on the PC.
• Connect the electric power supply lead (35) to the power supply (34).
• Connect the power supply connector plug to the power grid.
• Plug the lamp cable (1) into the illumination head.
67
68
69
70
71
72
73
73 74
75
76
77
67. Connection plug headrest
68. Connector plug headrest / LED illumi-
nation / RM02
69. Cable tie
70. Braided sleeving
71. Cable headrest / LED illumination /
RM02
72. Power supply cable
73. Computer cable USB 3.0 (3m long)
74. Camera (not shown)
75. Recess on the microscope arm
76. Connector plug camera cable
77. Release module RM02
78. RM02 operational control LED
79. On/Off key
80. Rotating knob, periphery or back-
ground illumination
81. Rotating knob, slit illumination
82. Selector keyA
83. Selector key B
84. Release key RM02
85. Socket camera cable
86. Socket for power supply connec-
tor plug
87. Socket computer cable USB 3.0
micro B
88. Threaded bolt
89. Pin assignment without imaging set
90. Pin assignment with imaging set
91. Cable cover
76
78
79
73
72
71
80
81
82
83
84
81
82
8785 86
71
89
88 69
90 91
69
34
35
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4. Startup
4.1 Switching on the device
• Connect the power supply to the power grid and press the On/Off key (75) on the
release module RM02. The green operational control LED (74) illuminates when
the device is switched on. The camera has no On/Off key and switches on auto-
matically when the PC is switched on.
• Turn the rotating knob on the slit illumination (77) 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 adjusting
pin (84) provided in place of the protective cover (85) and turn its black
projection surface at a right angle to the microscope axis. Return the il-
lumination and microscope to the central position (0°).
92. Adjusting pin
93. Protective cover
94. Sliding occluders 94
92
93
• Each eyepiece should be set individually by turning the knurled ocular refraction
ring with dioptre scale until the projected slit can be seen in focus. The setting is
performedfromthe(+)tothe(-)sideatlowmagnication.
• The sliding occluders (86) 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 Field of view
WARNING!
The images and videos should only be used for documentation purpo-
ses. Only the image in the eyepiece may be used for diagnosis.
Field of view of the object, see table
Circle:  Theeldofviewoftheobjectobservedthroughthemicroscope's
eyepiece.
Rectangle: Surface area of the sensor:
1 x
1.6 x ø 18 ø 11.25 21.4 x 18.3 13.4 x 11.4
10 x 6.3 x 5.4
Object image section in the
eyepiece (mm) Object image section in the camera with active sensor
area (mm)
5.3 White balance
The image quality is dependent on the correct calibration of the color tones to the
respective slit lamp illumination. We recommend performing a white balance in or-
der to improve the image quality and achieve a realistic color reproduction.
5.3.1 Slit lamp preparation
1. Turn on the slit lamp
2. Filterposition‹open›(nolter)
3. Setmagnicationto16x
4. Completely open the slit diaphragm
5. Connect the diffuser upstream
6. Position the HAAG-STREIT greycard in front of the slit lamp and use it for fo-
cusing
7. The brightness of the slit lamp's illumination should be set in such a way that
the greycard's structure is clearly discernible.
5.3.2 Conducting a white balance
1. Start the ‹EyeSuite Imaging› software
2. Activate the intensity auto mode
3. Open the ‹White balance› application
4. Start the ‹White balance› by activating the ‹Calibration› function
01-IFU_BI900-7220505-04010_eng.indd 10 12.08.2015 14:37:58