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. 1500.7220505‑04050 – 2020 – 10
DOC. No. 1500 1500.1400209.04000
INSTRUCTIONS FOR USE
Slit lamp
BI 900®
5. edition / 2020 – 10
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
INSTRUCTIONS FOR USE
Slit lamp
BI 900®
5. edition / 2020 – 10
Introduction
Thank you for choosing a Haag-Streit device. Provided you comply carefully
with the regulations in this instructions for use, we can guarantee the reliable and
unproblematic use of our product.
Purpose of use
A
slit lamp biomicroscope is intended for use in eye examination. It is used to aid in
the diagnosis and documentation of diseases or trauma which affect the structural
properties of the eye.
Contraindication
There is no absolute contraindication for tests with this device. Appropriate profes-
sional judgement and caution are necessary.
WARNING!
Read the instruction manual carefully before commissioning this pro-
duct. It contains important information regarding the safety of the user
and patient.
NOTE!
Federal law restricts this device to sale by or on the order of a physician
or licensed practitioner.
WARNING!
This device is equipped with high intensity light emitting diodes. Exces-
sive exposure of patients in treatment with certain medication may lead
to phototoxic adverse reactions, due to higher photosensitivity.
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
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 ..........................................................................................5
1.6 Light toxicity ............................................................................................................5
1.7 Disinfection .............................................................................................................5
1.8 Warranty and product liability..................................................................................5
1.9 Description of 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. Device 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 ...............................................................................................8
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 ......................................................................................11
5.7 Settingthelters&diaphragms ...........................................................................12
5.8 Fixation star ..........................................................................................................12
5.9 Microscope and eyepiece ....................................................................................12
5.10 Reduced operation................................................................................................12
5.11 LED display Illumination head...............................................................................13
5.12 LED display power supply.....................................................................................13
5.13 LED display release module RM02.......................................................................13
5.14 LED display camera..............................................................................................13
5.15 Error messages (illumination head) ......................................................................14
5.16 Error messages release module RM02.................................................................14
5.17 Error messages camera........................................................................................14
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 ...................................................................................................15
7.5 Dimensions ...........................................................................................................16
7.6 Camera .................................................................................................................16
7.7 Minimum PC requirements ..................................................................................16
8. Maintenance....................................................................... 16
8.1 Device inspection..................................................................................................16
8.2 Repair ...................................................................................................................16
8.3 Cleaning and disinfection......................................................................................16
8.4 Replacing the illumination mirror...........................................................................17
8.5 Dust cover.............................................................................................................17
A. Appendix ............................................................................ 17
A.1. Accessories / consumables / spare parts / upgrade .............................................17
B. Statutory requirements .................................................... 18
C. Classication .................................................................... 18
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..............................................................................................19
F.3 Electromagnetic immunity environment tested (part 1).........................................20
F.4 Electromagnetic immunity environment tested (part 2).........................................21
F.5 Recommended separation distances between portable and mobile
RF communications equipment and this product..................................................23
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PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
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 product 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 to use in professional health care facility environment, like
doctor's practices, hospitals and optometrists and opticians premises, except near
of HF surgical equipment and in RF shielded rooms of ME-systems for magnetic
resonance imaging. Some portable radio frequency equipment, like cell phones
or RF telephone equipment including antennas may interference medical devices.
Such equipment has to be kept in a distance of more than 30 cm (12 inches) from
any part of the instrument. Inobservance of this precaution may lower the correct
function of the instrument. If unexpected disturbances are observed which manifest
themselves as communication problems between Imaging Module and EyeSuite
software, the cause could be a cell phone or RF telephone in the immediate vicinity
to the slit lamp or power supply. Increase the distance to the unit until the interfer-
ence disappears.
The communication between imaging module and PC may also be disturbed or in-
terrupted, if the device is exposed to a mains power supply delivering excessively
transient disturbances or short voltage interruptions. If this happens, the USB con-
nector needs to be disconnected for a short time or the PC needs to be restarted.
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%
Transport: Temperature
Air pressure
Relative humidity
from
from
from
−40°C
500 hPa
10%
to
to
to
+70°C
1060 hPa
95%
Storage: Temperature
Air pressure
Relative humidity
from
from
from
−10°C
700 hPa
10%
to
to
to
+55°C
1060 hPa
95%
Use: Temperature
Air pressure
Relative humidity
from
from
from
+10°C
800 hPa
30%
to
to
to
+35°C
1060 hPa
90%
1.3 Shipment and unpacking
• Before you unpack the appliance, check whether the packaging shows traces of
incorrect handling or damage. If this is the case, notify the transport company that
has delivered the goods to you. Unpack the equipment together with a represen-
tative of the transport company. Make a report of any damaged parts. This report
must be signed by you and by the representative of the transport company.
• Leave the device in the packaging for a few hours before unpacking it (conden-
sation).
• Check the appliance for damage after it is unpacked. Return defective appliances
in the appropriate packaging.
• Store packaging material carefully so that it can be used for potential returns or
when moving.
• Theslitlampandheadrestmustbeinstalledonanelectricallyinsulated,reproof
table top.
• The rail covers (a) prevent the slit lamp from tilting.
• Are the connection parts of the accessories in the correct position (screw connec-
tions, quick-release fasteners)?
(a)
1.4 Installation warnings
WARNING!
• Do not modify this equipment without authorization of the manufacturer
.
Installation and repairs may only be performed by trained specialists.
Any third-party device must be connected in compliance with the
EN 60601-1 standard.
Only original Haag-Streit (HS) replacement parts may be used.
The device must not be stacked or placed in close proximity to other
electronic devices.
Grounding reliability can only be achieved when unit is connected to
a hospital grade receptacle. (Not valid for EU countries).
•
•
•
•
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
1.5 Operation, environment
DANGER!
Never use the device in potentially explosive environments where vola-
tile solvents (alcohol, petrol, etc.) and flammable anaesthetics are in
use.
WARNING!
The device must be switched off after every use. Otherwise there is a
risk of overheating when a protective dust cover is used.
NOTE!
This device must only be operated by qualified personnel. 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 unneces-
sarily. The illumination of this slit lamp emits a radiation in the range be-
tween 400 and 750nm. The retinal dose for a photochemical risk is com-
posed of the product of the radiance and the exposure time. If the radi-
ance 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 intensi-
ty 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 applies, 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 damage increases with the exposure
time. An exposure time with this instrument at maximum intensity of lon-
ger than 131 seconds exceeds the guideline value for a risk.
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 US
A only:
•
1.9 Description of symbols
Follow instruction for use
Read the instructions for use
attentively
Notes on disposal, see the
'Disposal' chapter Date of manufacture
Manufacturer Serial number
HS reference number
European certificate of
conformity
MET Listed Mark with approval
for USA and Canada On (Power)
Plug socket USB 3.0 micro
B on RM02 for computer
Plug socket USB 3.0 on RM02
for camera
Strong permanent magnets Slit lamp illumination
Background illumination
Plug socket on RM02 for
power supply
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PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
2.1 Overview
1. Lamp cable
2. LED illumination LI 900
3. Filter lever
4. Optical light guide for periphery or
background illumination (option)
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 (option)
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
14. Microscope arm locking screw
15. Camera cable (option)
16. Release module RM02
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
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
(option)
27. Inclination angle latch 0 – 20°
28. Slit width controls
29. Roller rail
30. Control lever
31. Camera (option)
32. Slide plate
33. EyeSuite Imaging software (option)
34. Power supply
35. Electric power supply lead (country-
dependent)
ETL Listed Mark with approval
for USA and Canada
Testsymbol of TÜV Rheinland
with approval for INMETRO
Brasil
2. Introduction
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.
NOTE!
The BI 900 slit lamp can be optionally equipped with the imaging set
(REF 7220535).
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
36
37
38
39
40
41
2.3 LED illumination LI02
2.4 Bluelter
41. Therotatingwheelisusedtopivotthebluelterforthebackgroundillumination.
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. Device assembly / installation
WARNING!
Do not modify this equipment without authorization of the manufacturer.
Installation and repairs may only be performed by trained specialists.
Contact your Haag-Streit representative for installation, repairs and
modification work on the system. The contact details are available at
www.haag-streit.com.
Only original Haag-Streit replacement parts may be used.
•
•
3.1 Placement of adhesive label for the automatic
left/right detection
• Remove rail cover (19) and place slit lamp aside. Clean surface of table.
• Removeprotectivelmfromthebackoftheadhesivelabel.Carefullystartatthe
corner opposite the black surface.
• Position the sticker against the right roller rail (45) and the gliding plate (46).
Pressrmlyonthewhite/blacksurface,pressawayanyairbubbles.
• Carefully tear off the remainder of the adhesive label (44) along the perforation.
• Reassemble the slit lamp and rail cover.
44. Rest of the sticker
45. Roller rail
46. Gliding plate
46
19
45
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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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.
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.
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
3.6 Step-by-step cabling
• Place the release module RM02 (73) over the slit lamp's cross slide. Four mag-
netsareusedforxing.
3.3 Cabling of the RM02 (diagram)
WARNING!
• Only use the supplied USB 3.0 cable (REF 1022373) for the connec-
tion to the PC.
• 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
NOTE!
To ensure that the system works correctly, Haag-Streit recommends
not using laptops and using a high-quality desktop computer instead.
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NOTE!
No external USB devices may be connected to USB ports (85) and
(87).
• Insert the camera cable's connector plug (76) into the socket (85).
• Press the cable into the recess on the microscope arm (75).
• Feed computer cable USB 3.0 (73), power supply cable (72), and cable headrest /
LED illumination / RM02 (71) through the braided sleeving (70).
• Insert the connector plug of the power supply cable (72) into the socket (86).
• Insert the connector plug of the computer cable USB 3.0 (73) into the (87).
• Pull on the braided sleeving until taut 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 headrest cable (68) with its counterpart (67) on the headrest.
• Mount the table board and place the slit lamp on the table.
• Connect the computer cable USB 3.0 (73) to the PC.
• Connect the electric power supply lead (14) to the power supply (13).
• Connect the power supply connector plug to the power grid.
• Plug the headrest cable (1) into the lamp 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
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 key A
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
83
82
8785 86
71
61
62
42
91
34
35
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
4. Startup
4.1 Switching on the device
• Connect the power supply to the power grid and press the On/Off key (79) on the
release module RM02. The green operational control LED (78) 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 (81) 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 (92) provided in place of the protective cover (93) 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 (94) 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 ×
1.6 ×
ø 18
ø 11.25
24 × 32
15 × 20
Object image section in the
eyepiece (mm)
Object image section in the
camera (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16×
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 focusing
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
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
NOTE!
To achieve an optimal result during the white balance, the image must
be homogeneously illuminated.
White balance greycard
REF 1021485
Image is blurry or overexposed Structure is discernible
5.4 Software / Help menu / Error messages
The software is described in the EyeSuite Imaging instruction for use.
WARNING!
The software must be installed by trained personnel in accordance with
separate installation instructions.
5.5 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 light
height should be set accordingly in order to avoid objectionable irradiation.
• After each examination, the LED illumination must be switched off via the release
module. See sec. "Decommissioning".
5.6 Operating the instrument
WARNING!
• Before every examination, check that the automatic left to right de-
tection works correctly from the release module!
• 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 (A) to set the chin rest (B) so that the patient’s eyes are at the
same height as the black mark (C) on the sides of the head rest.
• Set the eyepieces (26) in accordance with the examiner’s refraction by turning the
knurled rings and set the eye distance.
• Adjust the height of the slit lamp by turning the control lever until the light beam is
at eye level.
• Switch on the illumination by turning the switch on the power supply.
• Themagnicationofthestereomicroscopeischangedusingthemagnication
changer (100, chapter 5.9).
• The rigid control lever (30) 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 (21).
• The slit width is set left or right with the rotating knob (28), as is the angle be-
tween the stereo microscope and illumination. The slit image can be set vertical-
ly, horizontally or diagonally as required by turning the illumination facility on the
handle (5) (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 (9)) is used, the illumination turned
90° using the locking screw (5) and tilted in 5° steps using the latch (27), and the
illumination and microscope turned to the central position (0°).
• Front-lens glasses and contact glasses are used to examine the ocular fundus.
Diffuse illumination:
• A diffuse illumination is achieved by positioning the diffusor (9) upstream. This en-
ables overview monitoring and can be used for taking overview images with the
Imaging Module.
Indirect illumination:
• For observation in regredient light (indirect illumination), the centering screw (25)
isloosenedinordertomovetheslitimageoutofthecenterofthevisualeld.
Tightening the screw centers the slit image again.
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
Slit tilting:
• The latch (27) can be used to tilt the illumination in 5° steps. This creates an
angledlightbeamduringhorizontalslitorientation.Tiltingtheslitenablesreex-
free examination with contact glasses (fundus and gonioscopy) and magnifying
glasses.
5
C
9
A
22
25
27
28
30
9
8
B
5.7 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
f. Aperturesof8,5,3,2,1and0.2mminø
g. Display of slit length adjustment from 1 to 14 mm
h. Bluelter
(a)
(e) (f) (g) (h)
(b) (c) (d)
8 5 3 2 1 0.2
5.8 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 center 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.
5.9 Microscope and eyepiece
95. Two objective-lens pairs
96. Leverforyellowlter
97. Cover cap for the accessories base
98. Serial number microscope
99. 10×or25×eyepiece
100. Lens-changing lever
101. Eyepiece retaining screw
95 96 97 98 99
100 101
5.10 Reduced operation
In order to ensure that the light sources will have a long lifespan, the power of the
periphery or background illumination is reduced somewhat once the maximum op-
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
erating temperature has been reached. Full power can be used again after a short
period of time for it to cool down. This operating state is only reached if both light
sourcesareswitchedontogetherforalongperiodoftimeoutsidethespeciedtem-
perature range.
5.11 LED display
Illumination head
a) b) c)
Periphery or back- ground illumination Polarity Slit lamp illumination
a) b) c)
Operating status
Standby mode
Green, short
ashes × Green,shortash-
es
Normal operation
Slit and periphery or background illumi-
nation on
Green ×Green
Only slit illumination on
Green, short
ashes × Green
Only periphery or background illumina-
tion on
Green ×
Green, short
ashes
Reduced periphery of background il-
lumination operation
High LED temperature, thus reducing
periphery or background illumination
operation
Green,ashing ×Green,ashing
5.12 LED display power supply
Normal operation Green
5.13 LED display release module RM02
Normal operation Green
LED illumination switched off Green, pulsing
Establishing connection Orange
5.14 LED display camera
Normal operation Green
Establishing connection Orange
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
5.15 Error messages (illumination head)
ERROR
a) b) c)
a) b) c)
Periphery or back- ground illumination Polarity Slit lamp illumination
Error messages Measures
E1 Incorrect supply polarisation Contact your Haag-Streit representative. × Red ×
E2 Illumination control not recognized Connect illumination control or replace, if necessary. Red × Red
E3 Temperature is too high The light sources’ power will be reduced. Normal operation is ensured once the
permissible temperature has been reached.
Red,ashing × Red,ashing
E4 No communication between
power supply and illumination Contact your Haag-Streit representative. Red,ashing2× × Red,ashing2×
E6 General error Send RM02 to the appropriate service branch. Red,ashing4× × Red,ashing4×
5.16 Error messages release module RM02
ERROR Error messages Measures
Operational con-
trol LED (78)
E14 No communication with LED illumination LI02 plus Contact your Haag-Streit representative. Red,ashing2×
E16 General error Send device to the appropriate service branch. Red,ashing4×
5.17 Error messages camera
ERROR Error messages Measures
Operational control
LED (26)
E18 No communication with LED illumination LI02 plus Contact your Haag-Streit representative. Red
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
5.18 Software / Help menu / Error messages
The software's Help section contains instructions and guidance for performing an
examination as well as descriptions of the error messages. Help can be opened by
pressing the F1 key or by going to the [?] - [Help] menu.
WARNING!
The software must be installed by trained personnel in accordance with
separate installation instructions.
6. Decommissioning
PresstheOn/Offkey(79)onthereleasemoduleRM02brieytoswitchofftheLED
illumination after the examination. This does not switch off the camera. This is sig-
naledwithpulsinggreenashing.Pressingthekeyforapprox.3sec.switchesoff
the release module completely and the operational control LED (78) goes out. The
camera has no separate On/Off switch. It switches off automatically when the PC is
switched off.
NOTE!
The On/Off key on the release module RM02 does not disconnect the
device from the electric mains. Disconnect the power supply from the
power grid by unplugging the mains connector if you do not intend to
use it for an extended period of time.
7. Technical data
7.1 Slit illumination
NOTE!
Detailed information regarding the radiation can be provided
on request.
Spectral range slit illumination 400 to 750nm
Spectral range periphery or back-
ground illumination
400 to 750nm
Slit image width (continuous) 0 – 14 mm
Slitimagelength(xeddiaphragms) 1 – 14 mm
Illuminationeldcircle 8/5/3/2/1/0.2mminø
Test mark withxationstar
Slit image radial range ±90°
Radial (swiveling) movement of the
slit illumination to microscope axis
Horizontal ± 90°, vertical 0 – 20°
Filters Blue,redremoval(green),grey(10%).
7.2 Power supply
Type ICCN EXERGY, ELPAC POWER SYSTEMS,
Model MWA030018B REF 1022106
Mains voltage 100−240V
Current consumption 0.8 A
Operating frequency 50−60Hz
7.3 Stereo microscope
Stereo angle 13°
Magnicationchanger 1×and1.6×
Eyepiecemagnication 10×(standard)
Magnicationchanger 10×/16×,witheyepiece25×:25×/40×
Range of adjusting eyepieces +6 to -6 dioptres
Pupil distance 54−94mm
Filters Contrast enhancing (yellow)
Lens 1× 1.6× 1× 1.6×
Eyepiece 10× 10× 25× 25×
Totalmagnication 10× 16× 25× 40×
Objectelddiameter 18 mm 11.3 mm 8 mm 5 mm
7.4 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)
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
7.5 Dimensions
Weight: 12 kg (without power supply, headrest and options)
DimensionsL×W×H: 310×332×700mm
PackagingL×W×H: 420×510×780mm
7.6 Camera
Camera beam Beam path left (from the point of view of the doctor)
Sensor type CMOS
Interface USB 3.0
Frame rate 30 fps (frames per second)
Power consumption 5V / 600 mA
7.7 Minimum PC requirements
Processor type Intel i5, 5th gen or higher with 4 cores.
Note: 6th gen is not recommended.
2 cores with hyperthreading are not
recommended.
RAM 8 GB RAM if PC is exclusively used to operate the imag-
ing module.
16 GB RAM if third-party applications such as patient ad-
ministration software are to be used alongside EyeSuite.
Use 2 RAM module.
Hard disk At least 500 GB (NTFS data system).
Graphics Graphics card with at least 2 GB memory (Nvidia or AMD
chip set recommended).
OpenGL 2.0
Monitor Atleast19",1920×1080pixelresolution.
Operating system Windows 7, Windows 8.1, Windows 10.
64-bit system only.
PCI slot PCI-Express 3.0
PCI Express card Chip set by Renesas / NEC.
8. Maintenance
WARNING!
Do not modify this equipment without authorization of the manufacturer.
Installation and repairs may only be performed by trained specialists.
Contact your Haag-Streit representative for installation, repairs and
modification work on the system. The contact details are available at
www.haag-streit.com.
Only original Haag-Streit replacement parts may be used.
•
•
The LED illumination can be operated without any maintenance throughout its en-
tire duration of life.
8.1 Device inspection
The following procedure should be used to check that the slit lamp is working cor-
rectly:
• Insert the test rod in the radial movement bearing, while aligning the surface at a
right-angle to the microscope
• Set the slit light length to 8 or 14mm
• Illuminationintensityto50%
• Setthemagnicationinthemicroscopetomax.
• Set the eyepieces so that the structure on the test rod is shown in focus. Turn the
eyepiece from the (+) to the (-) side.
• Forallmagnications,thestructureofthetestrodmustbeshowninfocus.
• Close the slit edges to approx. 0.5mm. The edges must be shown in focus.
• Open the slit edges completely and turn the test rod 45°, the area in focus must
be in the center of the test rod.
8.2 Repair
To guarantee a long service life, the device must be cleaned weekly as described
and protected with the dust cover when not in use. We recommend having the de-
vice inspected once a year by an authorized service technician.
In order to guarantee optimal operational integrity, the device must undergo periodic
maintenance. The length of the maintenance interval depends on use, but may not
exceed 3 years.
8.3 Cleaning and disinfection
The Haag-Streit slit lamps and their accessories can, if required, be carefully wiped
downwithready-for-usedisposable70%ethanoldisinfectantwipes.Surface-friend-
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
ly disinfectants (containing aldehyde or aldehyde-free) are also permitted, such as
Kohrsolin FF.
WARNING!
• The preparation instructions provided do not apply to tonometer mea-
suring prisms!
• Tonometer measuring prisms must be prepared in accordance with a
different manual
• Do not use sprays
• Observe the manufacturer's safety instructions
• Do not use any cloths that drip.
• Wring out any soaked cloths before use when necessary
• Ensure that no liquid penetrates the device
• Comply with the stipulated exposure time
• Clean optical surfaces after disinfection with a very soft cloth
NOTE!
IP code: IPX0 (device is not protected against liquids)
8.4 Replacing the illumination mirror
The mirror can be most easily accessed if the microscope is turned away from the
illumination and the illumination inclined two points.
WARNING!
Only use mirrors with a LOT number.
8.5 Dust cover
We recommend protecting the slit lamp with a dust cover
when not in use.
A. Appendix
A.1. Accessories / consumables / spare parts / upgrade
WARNING!
Do not modify this equipment without authorization of the manufacturer.
Installation and repairs may only be performed by trained specialists.
Contact your Haag-Streit representative for installation, repairs and
modification work on the system. The contact details are available at
www.haag-streit.com.
Only original Haag-Streit replacement parts may be used.
•
•
NOTE!
An asterisk (*) indicates that you should contact your Haag-Streit re-
presentative for further information. Two asterisks (**) indicate a need
to refer to the separate instructions for use.
Components REF
Dust cover, small (for slit lamp) 1001395
Dust cover, large (for several instruments) 1001434
Long mirror 1001590
Short mirror 1001591
Eyepiece10×forestimatinglengthBI/BD900 7220514
Eyepiece10×withcrosshairreticuleBI/BD900 7220515
Eyepiece10×BI/BD900 7220517
Eyepiece25×BI/BD900 7220520
Imaging set BI 900 7220535
Release Module RM02 with power supply 7220546
Power supply for LED illumination on third-party tables** 7220741
Power supply for LED illumination, HSM 901** 7220742
Illumination control, double slit and background 'on table'** 7220743
Background illumination FI 01f 7220744
Illumination control box slit on table (1 Pot.) 7220745
Illumination control, double slit and background 'in table'** 7220746
Illumination control box slit in table (1 Pot.) 7220747
Pad of chin rest papers 7220756
Background illumination swivelling 7220765
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18
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
Diagnostic contact lenses Please refer to the instructions for use Contact lenses,
Goldmann/Diagnostics/Laser
Applanation Tonometer Please refer to the instructions for use AT 900 / AT 870
Please refer to the instructions for use AT 900 D
Headrest Please refer to the instructions for use Headrest
B. Statutory requirements
• The BI 900 slit lamp was developed and designed taking the EN 60601-1, EN ISO
10939 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 devices in combination.
• ComplianceoftheBI900slitlampwiththeDirective93/42/EECisconrmedby
the CE-designation.
• TheBI900slitlampsatisestheelectromagneticcompatibilityrequirementsof
EN 60601-1-3. 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 device also has the immunity stipulated by the standard.
• Statutory accident regulations are to be observed.
C. Classication
Standard EN 60601-1 Slit lamp BI 900 acc. to protection class II
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
13
th 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. Observed standards
EN 60601-1 EN 60601-1-2
EN ISO 10939 EN ISO 15004-2
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
F.2 Emitted interference
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 environment.
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
Harmonics emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Not applicable
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.
F. Information and manufacturer's declaration
concerning electromagnetic compatibility
(EMC)
F.1 General
TheBI900slitlampsystemfulllstherequirementsonelectromagneticcompat-
ibility according to IEC 60601-1-2:2014 (4th Edition). The product is built so that the
generation and emission of electromagnetic interference is limited to the extent that
other devices are not disturbed in their use in accordance with the regulations and
so that the product itself is suitably immune to electromagnetic interference.
WARNING!
Avoid damages due to high electrostatic discharges (ESD). Electrosta-
ticdischargeswithvoltagesexceeding6kVtosomepartsoftheslit
lamplikejoystickormetallicpartsontheinstrumentbasemayinuen-
ce the product.
• The communication between Imaging Module and PC could be inter-
rupted, which would require a restart of the EyeSuite software.
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.
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
IEC 60601-1 standard.
•
•
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS Doc. no. 1500.7220505‑04050 – 2020 – 10
F.3 Electromagnetic immunity environment tested (part 1)
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 environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment Ð guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30%.
Electrical fast transient/burst
IEC 61000-4-4
± 2 kV, 100kHz for power supply lines *
± 1 kV, 100 kHz for input/output lines *
± 2 kV, 100kHz for power supply lines *
± 0.5, ± 1 kV, 100 kHz for input/output
lines *
Mains power quality should be that of a typical
commercial or hospital environment.
* Not applicable for DC and I/O if cable < 3 m.
Surge
IEC 61000-4-5
± 0.5, ± 1 kV line(s) to line(s) *
± 0.5, ± 1, ± 2 kV line(s) to earth *
± 1 kV line(s) to line(s) *
± 0.5, ± 1, ± 2 kV line(s) to earth *
Mains power quality should be that of a typical
commercial or hospital environment.
* Not applicable for DC and I/O if cable < 3 m.
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
0% UT: 0.5 cycle at 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315°
0% UT: 1 cycle at 0°
0% UT: 250/300 cycles at 0°
70% UT: 25/30 cycles at 0°
0% UT: 0.5 cycle at 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315°
0% UT: 1 cycle at 0°
0% UT: 250/300 cycles at 0°
70% UT: 25/30 cycles at 0°
Mains power quality should be that of a typical
commercial or hospital environment.
If the user of this product requires continued operation
during power mains interruptions, it is recommended
that this product be powered from an uninterruptible
power supply or battery.
UTis the a.c. mains voltage (100 – 240 V) prior to
application of the test level.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
50/60 Hz
30 A/m
50/60 Hz
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
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