Haag-Streit BX 900 User manual

1
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220449.04070 – 2018 – 04
INSTRUCTION FOR USE
Photo slit lamp
BX 900®
7. Edition / 2018 – 04
01-IFU_BX900-7220449-04070_eng.indd 1 03.05.2018 09:47:11

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220449.04070 – 2018 – 04
INSTRUCTION FOR USE
Photo slit lamp
BX 900®
7. Edition / 2018 – 04
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.
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 Description of symbols...............................................................................................5
2. Introduction............................................................................ 6
2.1 Overview....................................................................................................................6
2.2 Photo components.....................................................................................................6
2.3 Lens barrel.................................................................................................................8
2.4 Camera housing ........................................................................................................8
2.5 Flash unit FU 01 ........................................................................................................8
2.6 LED illumination.........................................................................................................8
2.7 Overview of the LED illumination unit upper part.......................................................8
2.8 Bluelter....................................................................................................................8
2.9 Shutter ......................................................................................................................8
2.10 Periphery or background illumination.........................................................................8
2.11 Power supply .............................................................................................................8
3. Device assembly / installation.............................................. 9
3.1 Instrument base with weight compensation facility....................................................9
3.2 Setting the weight compensation facility....................................................................9
3.3 Switching on the compensation facility ......................................................................9
3.4 Switching off the compensation facility ......................................................................9
3.5 Regulating the clearance of the slit width control.......................................................9
3.6 Attaching/removing a camera ....................................................................................9
4. Commissioning.................................................................... 10
4.1 Switching on the device ...........................................................................................10
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220449.04070 – 2018 – 04
5 Operation.............................................................................. 10
5.1 Setting the eyepieces ..............................................................................................10
5.2 Preparing the patient ..............................................................................................10
5.3 Operating the instrument .........................................................................................10
5.4 Peripheryorbackgroundillumination(ash)............................................................11
5.5 Photo diaphragm pre-selection................................................................................11
5.6 Settingthelters&diaphragms..............................................................................11
5.7 Fixation star .............................................................................................................11
5.8 Microscope and eyepiece .......................................................................................12
5.9 Operating the Flash unit FU 01................................................................................12
5.9.1 ErrormessagesforashunitFU01 ........................................................................12
6 Decommissioning................................................................ 12
7 Technical data ..................................................................... 12
7.1 Slit illumination ........................................................................................................12
7.2 Stereo microscope ..................................................................................................13
7.3 Instrument base ......................................................................................................13
7.4 Dimensions ..............................................................................................................13
7.5 Flash illumination Flash unit FU 01..........................................................................13
7.6 Mirror and diaphragm component............................................................................13
7.7 Lens barrel...............................................................................................................14
7.8 Camera ....................................................................................................................14
8 Maintenance......................................................................... 14
8.1 Device Check...........................................................................................................14
8.1.1 Testingtheashunit ................................................................................................14
8.2 Changingtheashtube...........................................................................................14
8.3 Servicing ..................................................................................................................15
8.4 Replacing the fuses .................................................................................................15
8.4.1 Mains fuses:.............................................................................................................15
8.4.2 Flash unit fuse: ........................................................................................................15
8.5 Cleaning and disinfection.........................................................................................15
8.6 Replacing the illumination mirror..............................................................................15
8.7 Dust cover................................................................................................................15
A. Appendix .............................................................................. 15
A.1 Accessories / spare parts ........................................................................................15
B. Legal regulations ................................................................ 16
C. Classication ...................................................................... 16
D. Disposal ............................................................................... 16
E. Observed standards............................................................ 16
F. Information and manufacturer's declaration
concerning electromagnetic compatibility (EMC) ............ 17
F.1 General ....................................................................................................................17
F.2 Emittedinterference(standardtable1)....................................................................17
F.3 Immunity(standardtable2) .....................................................................................18
F.4 Immunityfornon-lifesupportdevices(standardtable4).........................................19
F.5 Safedistancesfornon-lifesupportdevices(standardtable6)................................20
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PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220449.04070 – 2018 – 04
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 magnet-
ic 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.
1.2 Ambient conditions
Transport: Temperature
Air pressure
Relative humidity
from
from
from
−40°C
500 hPa
10%
to
to
to
+70°C
1060 hPa
95%
Storage:
Temperature
Air pressure
Relative humidity
from
from
from
−10°C
700 hPa
10%
to
to
to
+55°C
1060 hPa
95%
Use:
Temperature
Air pressure
Relative humidity
from
from
from
+10°C
800 hPa
30%
to
to
to
+35°C
1060 hPa
90%
1.3 Shipment and unpacking
• Before you unpack the appliance, check whether the packaging shows traces of
incorrect handling or damage. If this is the case, notify the transport company that
has delivered the goods to you. Unpack the equipment together with a represen-
tative of the transport company. Make a report of any damaged parts. This report
must be signed by you and by the representative of the transport company.
• Leave the device in the packaging for a few hours before unpacking it (conden-
sation).
• Check the appliance for damage after it is unpacked. Return defective appliances
in the appropriate packaging.
• Store packaging material carefully so that it can be used for potential returns or
when moving.
• 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 HS replacement parts may be used.
The device must not be stacked or placed in close proximity to other
electronic devices.
•
•
•
1.5 Operation, environment
DANGER!
Never use the device in potentially explosive environments where vola-
tile solvents (alcohol, petrol, etc.) and flammable anaesthetics are in
use.
WARNING!
The device must be switched off after every use. Otherwise there is a
risk of overheating when a protective dust cover is used.
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220449.04070 – 2018 – 04
NOTE!
This equipment 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!
• The light from this instrument may be dangerous. The risk of eye
damage increases with the radiation period and number of pulses.
Exposure at maximum output of longer than 90 seconds with the LED
illuminationand90pulseswiththeashsourcewillexceedthehaz-
ard guideline value.
• Using a 90 D lens reduces the exposure time to 9 seconds and the
number of pulses to 10.
NOTE!
• The radiation times and number of total pulses of all light sources are
cumulative.
• If the intensity of any of the light sources is reduced to 50% of the
maximum intensity, the illumination time or number of pulses to reach
the guideline value for radiation for the light source in question is dou-
bled. This linear relationship can be used to determine the illumina-
tion time to reach the guideline value for radiation for the combination
of slight sources at various brightness settings.
• The guideline value for the evaluated irradiation of the retina is 10 J/
cm2.
• Nevertheless, we recommend keeping the intensity of the light reach-
ing the patient's retina to the minimum possible for the respective di-
agnosis. 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.
• Whentheashilluminationisused,theemissionexceedstheGroup
2 limit of parameter “weighted retinal visible and infrared thermal ra-
diance, LVIR-R“asspeciedbyENISO15004-2:2007butdoesnot
exceedthelimit“retinalthermal”asspeciedbyICNIRP2013.Since
this retinal exposure limit is not exceeded in case of normal operation,
the device can be regarded as safe for the patient’s eye when operat-
edwithinthelimitsspeciedbyHaag-Streit.
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
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220449.04070 – 2018 – 04
HS reference number
European certificate of
conformity
ETL Listed Mark with approval
for USA and Canada
Testsymbol of TÜV Rheinland
with approval for INMETRO
Brasil
Test symbol of CSA with
approval for USA Warning: dangerous voltage
On (Power) Off (Power)
Alternating currentFlash Test
Fuse
AfterturningofftheFU01ash
unit, wait at least 15 seconds
before the slide is opened
AfterturningofftheFU01ash
unit, wait at least 15 seconds
beforetheashcableisre-
moved.
2. Introduction
The slit lamp comprises an illumination part and a binocular microscope. The entire
device 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.
2.2 Photo components
29. Flashcable(withtubeandashtube
connection)
30. Optical light guide for periphery or
background illumination
31. Pivoting mirror
32. Rotating knob for diaphragm pre-se-
lection
33. Rotating knob for diaphragm preview
actuation
34. Rotating knob for aperture preview
35. Flash unit FU 01
36. Flash tube housing
37. Flash tube
38. Lens barrel
39. Camera housing
40. Camera cable
41. Ocular with double cross hairs
42. Mirror and diaphragm component
43. Cable trigger key for mirror/
diaphragm component
44. Trigger key with cable
2.1 Overview
1. LED illumination unit upper part
2. Leverforgreylterandredremov-
allter
3. Scale for angled position of the slit
image(5°increments)
4. Illumination mirror
5. Magnicationchanger
6. Mounting screw for the stereo mi-
croscope
7. LED periphery or background illumi-
nation with swivel bracket
8. Illumination unit / microscope an-
gle scale
9. Illumination arm locking screw
10. Microscope arm locking screw
11. Slit width setting screw
12. Weight compensation screws
13. Trade mark BX 900
14. Slit length / diaphragm scale
15. Slitlength,slitrotation,bluelterand
xationstarcontrol,knobforrotat-
ing the slit
16. Cover screw for accessories pin
17. Bayonet connector for accessories
18. Stereo microscope with eyepieces
19. Breath shield
20. Fastening pin for breath shield
21. Threadforxingthetonometer
22. Centering screw
23. Inclination angle latch 0°-20°
24. Joy stick base locking screw
25. Axle
26. Rail cover
27. Control lever
28. Slide plate
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13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
1
2
3
4
5
6
7
8
9
10
11
12
Diffusor
1007432
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
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2.3 Lens barrel
Lensbarrelfor35mmphotography(38).Imagetakenbytherightbeampathofthe
microscope.Objectimagesize:seeTableb,Chapter7.8,pg17.
2.4 Camera housing
Noteverycamerahousing(39)canbeconnected.HAAG-STREITselectssuitable
camera models and makes the necessary adjustments. The photo slit lamp is only
guaranteed to function properly if cameras recommended by HAAG-STREIT are
used. Please consult your local partner for information on the supported cameras.
2.5 Flash unit FU 01
WARNING!
Thisdevicemustonlybeoperatedbyqualiedandtrainedpersonnel.
Face plate
45. Flash intensity high with LED
46. Symbols with LED (See chapter “Er-
rormessagesashunit”)
47. Flashtest(Inordertotesttheash,
pressthereleasebutton(44)orthe
testbutton(47).)
48. Flash intensity
49. Flash intensity normal
50. MainswitchON(lightsup)/OFF
45
46
47
48
49
50
2.6 LED illumination
• The LED illumination head is made up of an LED illumination unit, a power sup-
ply, an optical light guide set for periphery or background lighting and an illumina-
tion control.
• The two-core connection cable between the power supply and illumination head
transmits both the supply current for the LED as well as signals for communica-
tion between the power supply and illumination.
• The light intensity of the slit and periphery/background illumination can be regulat-
edcontinuously(withoutincrements)usingtheilluminationcontrollers.Thesecan
be connected using a longer connection cable on the PS-LED power supply.
2.7 Overview of the LED illumination unit upper part
51. LED illumination LI 01-plus with periphery or background lighting
52. Flash tube connection
53. Flash tube
54. Filterwheelforconstantillumination(LED)bluelter
55. Optical light guide connection for slit and periphery/background illumination
56. Filter/diaphragmwheelforperiphery/backgroundillumination(ash)Thiswheel
isusedtocontroltheintensityoftheashperiphery/backgroundillumination
andbluelter;see5.4
51
52
53
54
55
56
57
2.8 Bluelter
Therotatingwheel(54)isusedtopivotthebluelter.Markingpointsatthesame
height=bluelterison.
2.9 Shutter
57. The shutter cable must be connected to the illumination head. This ensures that
ashuttercloseswhentheashistriggered,inordertoprotecttheLEDfromthe
intenseradiationoftheash.
2.10 Periphery or background illumination
58. Periphery/backgroundillumination(swiveling) 58
2.11 Power supply
NOTE!
• Observe the respective HAAG-STREIT instructions for use. (For fur-
therinformation,pleasecontactyourHAAG-STREITdealer).
• This device may only be operated with PS-LED and PS-LED HSM
901 power supplies from HAAG-STREIT.
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3. Device assembly / installation
59
66
61
67
72
74
62 63 64 65
7168 69 70
73
75 76
60
77
59. Medically approved isolating trans-
former
60. Power grid
61. Instrument table
62. Camera power supply
63. Printer
64. Screen
65. Personal computer
66. Illumination control IC 01
67. PS-LED or PS-LED HSM 901
68. Flash unit FU 01
69. Optional power input (also possible
withbatteryoperation)
70. Optional camera port (saving to a
cardisalsopossible)
71. Galvanicisolation(EN60601-1)
72. Headrest
73. Release key
74. LED illumination
75. Mirror and diaphragm component
76. Camera
77. Local network
WARNING!
Do not modify this equipment without authorization of the manufacturer.
Installation and repairs may only be performed by trained specialists.
Contact your HAAG-STREIT representative for installation, repairs and
modification work on the system. The contact details are available at
www.haag-streit.com.
Only original HS replacement parts may be used.
•
•
Theinitialinstallationofthedeviceisconductedbyanauthorizedservicetechni-
cian. The following adjustments can be conducted by the end user:
• Regulating the clearance of the slit width control
• Attaching/removing a camera
• Adjusting the weight compensation
3.1 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.
3.2 Setting the weight compensation facility
Turnthecontrollever(27)toitslowestpositionandthenslackenitslightlybya
quarter turn. Swivel the microscope and illumination to the side. Apply 1-3 springs
depending on the accessory.
3.3 Switching on the compensation facility
Turnanticlockwiseuntilthescrews(12)arecompletelyreleased.
3.4 Switching off the compensation facility
Turnthescrews(12)clockwiseuntilyoumeetresistance.Verifywhetherthemicro-
scope arm springs back downwards if you push it upwards with your hand. This will
only happen 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.
3.5 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 Attaching/removing a camera
78. Lens barrel
79. Mirror and diaphragm component
80. Camera
81. Eyepiece
78
79
80
81
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Remove the camera cover, attach the spacer ring to the camera and place the cam-
era on the lens barrel. If the camera is removed, the connection to the lens barrel
should be closed off with the cap intended for this purpose.
NOTE!
Consult your Haag-Streit representative for information on the support-
ed cameras and their connection rings.
4. Commissioning
ConnectthePS-LEDpowersupplyandFU01ashunittothemains.
4.1 Switching on the device
• Throw the rocker switch on the PS-LED power supply and the main switch on the
FU01ashunit01I=’ON’.Thegreenlightsontherockerswitcheswilllightup
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(82)inplaceoftheprotectivecover(83)andturnitsblack
projection surface at a right angle to the microscope axis. Return the
illuminationandmicroscopetothecentralposition(0°).
Insert the 12.5x eyepiece with double crosshair into the right eyepiece mounting in
the binocular tube. The depth of the double crosshair on the reticle corresponds to
thelm/chiplevel.Thesettingisperformedfromthe(+)sidetothe(-)sideatlow
magnicationuntilthedoublecrosshaircomesintosharpfocus.
82. Test rod
83. Protective cover
84. Sliding occluders
82
83
84
• 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(+)sidetothe(-)sideatlowmagnication
• Theslidingoccluders(84)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.
• Parts which come into contact with the patient should be cleaned with a dry cloth
prior to every use.
• To ensure that only the part of the eye being examined is illuminated, the slit
height should be set accordingly in order to avoid objectionable radiation.
• The lamp must be switched off 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.
• The slit lamp BX 900 may only be operated with the HS Flash Unit
FU 01
• Theslitilluminationmayonlybeoperatedwiththeashtubeinserted.
• The images should only be used for documentation purposes. Only
the image in the eyepiece may be used for diagnosis.
• Use the turn screw to set the chin rest in such a way that the patient’s eyes are at
the same height as the black mark on the sides of the head rest.
• Adjusttheeyepieces(41)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.
• Adjusttheheightoftheslitlampbyturningthecontrollever(27)untilthelumi-
nous aigrette is at eye level.
• Themagnicationofthestereomicroscopeischangedusingtherotaryknobon
themagnicationchanger(5).
• Therigidlyheldcontrollever(27)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(18).
• Theslitwidthissetleftorrightwiththerotatingknob(11),asistheanglebetween
the stereo microscope and illumination.
• Theslitimagecanbesetvertically,horizontallyorasdiagonalasrequiredby
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turningtheilluminationfacilityonthehandle(15)(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 is used, the illumination turned 90°
usingthelockingscrew(15)andtiltedin5°stepsusingthelatch(23),andtheillu-
mination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upstreamcreatesdiffusedillumination(14).Thisallows
monitoring of the overview and can be used to capture the overview.
Indirect illumination:
• Forobservationinregredientlight(indirectillumination),thecenteringscrew(22)
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.
Tilting the slit:
• Thelatch(23)canbeusedtotilttheilluminationin5°steps.Inthisway,adiago-
nalrayoflightfrombelowisgeneratedwhentheslitisorientedhorizontally.The
slitorientationallowsareection-freeexaminationwithcontactglasses(fundus
andgonioscopy)andmagnifyingglasses.
5.4 Peripheryorbackgroundillumination(ash)
Whentheashistriggered,thelightistransferredtothebackgroundilluminationby
a light guide.
100% open
50% open
25% open
10% open
5% open
0% open
Bluelter
5.5 Photo diaphragm pre-selection
85. Rotating knob for diaphragm
pre-selection
You may select between levels 1 through 5,
each with an increasingly smaller aperture. The
sizeoftheintervalisequivalenttoonef-stop.
Level 1 = largest aperture
  (smallestdepthofeld)
Level 5 = smallest aperture
  (largestofeld)
85
86
86. Rotating knob for diaphragm actuation
Turning one of the two knobs on the right and left allows you to close the dia-
phragms to the preset aperture during observation in order to get a preview of the
expecteddepthofeld.
5.6 Settingthelters&diaphragms
a. Open
b. Greylter(10%)
c. Redremovallter
d. Reserveopeningforlteroptionallyø15mm(0/–0.2),thickness2.5mm
e. Fixation star
f. Aperturesof8,5,3,2,1and0.2mmø
g. Display of slit length in mm
h. Bluelter
(a)
(e) (f) (g) (h)
(b) (c) (d)
5.7 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.
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5.8 Microscope and eyepiece
87. Front lens
88. Rotaryknobdisplayingthesetmagnication
89. 5-levelmagnicationchanger(Galileisystem)
90. Knurled ring for bayonet connector
91. Binocular tube with convergent view, pupil dis-
tance can be set from 52 to 78 mm
92. Eyepiece12.5x/eldofvisionø16mm
93. Index(whitepoint)
94. Knurled ring with dioptre scale for setting the
refractionoftheexaminer(±7D)
95. Slidingoccluder(forpeoplewhowearglasses)
87 88 89 90 91 92 93 94 95
5.9 Operating the Flash unit FU 01
Capture frequency ‘normal’
Captures 1 to 10 in a 1-second cycle
Captures 11 to 20 in a 2-second cycle
Captures 21 to 30 in a 3-second cycle
NOTE!
A pause of 210 seconds will follow.
Capture frequency ‘high’
Captures 1 to 10 in a 1-second cycle
Captures 11 to 15 in a 2-second cycle
Captures 16 to 20 in a 3-second cycle
Captures 21 to 30 in a 5-second cycle
WARNING!
AfterturningofftheFU01ashunit,waitatleast2minutesbefore
turning it back on!
NOTE!
A pause of 210 seconds will follow.
5.9.1 ErrormessagesforashunitFU01
Symbols LED Sound
Wait
• Lettheashtubecooloff
–
Folding mirror inoperative
• Connect cable
• Make sure that the plug is seated properly
Red Long
beep
Camera not ready
• Switch on camera
• Empty image memory
• Take camera out of sleep mode
• Connect cable
• Make sure that the plug is seated properly
Red Long
beep
Flash inoperative
• Closeashslider
• Changeashtube
• Connect cable
Red Long
beep
NOTE!
Oncetheerrorinquestionhasbeenrectied,thevisualwarningsignal
is deleted by pressing the release button. The device will then be back
in operation.
NOTE!
AllredLEDsareashing(electronicdefect)
• Contact your HAAG-STREIT representative!
6 Decommissioning
Throw the rocker switch on the PS-LED power supply and the main switch on the
FU01ashunit01I=’OFF’.Thegreenlightsontherockerswitcheswillstopillu-
minating when the device is switched off.
NOTE, GENERAL ALARM!
Disconnect the power supply from the mains if you do not intend to use
it for an extended period of time.
7 Technical data
7.1 Slit illumination
NOTE!
Detailed information regarding the radiation can be provided
on request.
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7.5 Flash illumination Flash unit FU 01
Spectralrangeslitashillumination 400 to 750nm
Spectralrangebackgroundashillumination 400 to 750nm
NOTE!
Detailed information regarding the radiation can be provided
on request.
Flash capacitor capacity 'normal' 200 Ws
'high' 400 Ws
Flash frequency See Chapter 5.9 'Flash Unit FU 01'
Mains connection a) 115V,60Hz
b) 230V,50Hz
Mains fuses a) 2xT10AH,250V
b) 2xT6,3AH,250V
Flash unit fuse 1 x T5AL, 250V
Power consumption 25 VA, peak 2.6 kVA
7.6 Mirror and diaphragm component
Pre-set diaphragms 5 different diaphragms
Max. depth of focus on object seeTable(a)
Depth of focus in air
Thisdependsonthediaphragmandmagnicationsettings.Inthetransparentme-
dia of the eye, the values increase by approx. 35% (refractive index of the eye me-
dia).
(Table a)
Fieldofdepthofeld(+/-inmm)withdiaphragm
1 2 3 5 6
6.3x 1.3 1.8 2.6 3.6 5.2
10x 0.5 0.7 1 1.4 2
16x 0.2 0.3 0.4 0.5 0.8
25x 0.1 0.1 0.15 0.2 0.3
40x 0.05 0.05 0.05 0.1 0.15
Spectral range slit illumination 400 to 750 nm
Spectral range background
illumination
400 to 750 nm
Slit image width 0 – 8 mm continuous
Slit image length 1 – 8 mm continuous
Illuminationeldcircle ø8/5/3/2/1/0.2mm
Test mark Withxationstar
Slit image rotatability ± 90°
Swiveling of the slit illumination to
the microscope axis
Horizontal±90°,vertical0–20°
Filters Blue,redremoval(green),gray(10%).
NOTE!
(Further information available in the LED illumination LI 900 instruc-
tionsforuse)
7.2 Stereo microscope
Stereo angle: 13°
Magnicationchanger: 6.3x / 10x / 16x / 25x / 40x
Ocularmagnication: 12.5x
Range of adjusting eye-pieces: +7to−7diopters
Pupil distance: 52 – 78 mm
Totalmagnication: 6.3x / 10x / 16x / 25x / 40x
Objecteldøinmm: 32.0 / 20.0 / 12.7 / 8.0 / 5.1
7.3 Instrument base
Operation: Single-handed operation of control lever in 3 dimensions
Adjustment of instru-
ment base:
100mm(length)
100mm(side)
30mm(height)
7.4 Dimensions
Weight: 14.8kg(withoutpowersupply,headrestandoptions)
Dimensions L x W x H: 370 x 332 x 800 mm
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(Table b)
Magnicationatchiplevel
Object size with chip size
15 x 22.4 mm
6.3 x 0.63 x 23.2 x 34.6 mm
10 x 1 x 14.6 x 21.9 mm
16 x 1.6 x 9.3 x 13.8 mm
25 x 2.5 x 5.8 x 8.7 mm
40 x 4 x 3.7 x 5.5 mm
Field of view of the object
Circle: Theeldofviewoftheobjectobservedthroughthemicroscope's
eyepiece.
Rectangle: Area of photograph.
7.7 Lens barrel
Focal length: f 170 mm
7.8 Camera
NOTE!
The camera is to be set to a shutter time of 1/60 s in MANUAL operat-
ing mode. The instruction for use for the camera must be followed for
this purpose.
8 Maintenance
WARNING!
Do not modify this equipment without authorization of the manufacturer.
Installation and repairs may only be performed by trained specialists.
Contact your HAAG-STREIT representative for installation, repairs and
modification work on the system. The contact details are available at
www.haag-streit.com.
Only original HS replacement parts may be used.
•
•
The LED illumination can be operated maintenance-free for its entire service life.
8.1 Device Check
In order to correctly check the slit lamp, proceed as follows:
•
Insert test rod into the radial movement bearing, whilst at the same time aligning
the surface to the microscope at a right angle
•
Set slit length to 8 mm
•
Set llumination strength to 50%
•
Set magnification to max. in the microscope.
•
Set the eyepieces in such a way that the test rod is in sharp focus. Turn the
eyepiece from the (+) to the (-) side.
•
The structure of the test rod must be in sharp focus in all magnifications.
•
Close slit edges to approx. 0.5 mm. The borders must be in sharp focus here.
•
Completely open slit edges and turn the test rod by 45°, the sharp area must
be in the centre of the test rod.
8.1.1 Testingtheashunit
Inordertotesttheash,pressthereleasebutton(44)orthetestbutton(47).
8.2 Changingtheashtube
WARNING!
• AfterturningofftheFU01ash
unit, wait at least 15 seconds be-
fore opening the slide!
• Do not touch the glass body of the
ashtube.
96. Coupling slide
97. Protective plug
98. Flash tube
• Slide the coupling slide upwards.
• If the split lamp is new, remove the protective
plugfromtheashtubehousing.
• Removethedefectiveashtube.
• Insert the tube without touching the glass.
• Slide the coupling slide back downward until it
stops in place.
96
97
98
96
97
98
NOTE!
OnlyoriginalHSashtubesmaybeused.
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8.3 Servicing
To ensure a long service life, the device should be cleaned weekly as described in
the 'Cleaning' chapter and covered with a dust cover when not in use. We recom-
mendhavingthedeviceinspectedbyanauthorizedservicetechnicianannually.
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.
8.4 Replacing the fuses
WARNING
• The mains cable must be disconnected from the mains before the co-
ver is screwed on.
• Only fuses of the type indicated in the technical data may be used.
• Removethecover(99)bylooseningthetwoscrews(100).
8.4.1 Mains fuses:
• Removethemainsplug(102),removethefuseholder(103)andreplacethefus-
es(fusetypeaccordingtothetechnicaldata).
• Insertfuseholder(103)andattachmainsplug(102).
8.4.2 Flash unit fuse:
• Removethemainsplug(102),removethefuseholder(101)andreplacethefus-
es(fusetypeaccordingtothetechnicaldata).
• Insertfuseholder(101)andattachmainsplug(102).
100
99
101
102
103
• Closethecover(99)byapplyingthetwoscrews(100)andplugthemainscable
into the mains.
8.5 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-
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)
8.6 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
when not in use.
A. Appendix
A.1 Accessories / spare parts
WARNING!
Do not modify this equipment without authorization of the manufacturer.
Installation and repairs may only be performed by trained specialists.
Contact your HAAG-STREIT representative for installation, repairs and
modification work on the system. The contact details are available at
www.haag-streit.com.
Only original HS replacement parts may be used.
•
•
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PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220449.04070 – 2018 – 04
B. Legal regulations
• The BX 900 photo 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BX900slitlampwiththeDirective93/42/EECisconrmedby
the CE-designation.
• TheBX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 device also has the immunity stipulated by the standard.
• Statutory accident regulations are to be observed.
C. Classication
Standard EN 60601-1 Photo slit lamp BX 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. Observed standards
EN 60601-1 EN 60601-1-2
EN ISO 10939 EN ISO 15004-2 *
*Whentheashilluminationisused,theemissionexceedstheGroup2limitofpa-
rameter“weightedretinalvisibleandinfraredthermalradiance,LVIR-R“asspecied
byENISO15004-2:2007butdoesnotexceedthelimit“retinalthermal”asspecied
by ICNIRP 2013. Since this retinal exposure limit is not exceeded in case of normal
operation, the device can be regarded as safe for the patient’s eye when operated
withinthelimitsspeciedbyHaag-Streit.
NOTE!
Anasterisk(*)indicatesthatyoushouldcontactyourHAAG-STREIT
representative for further information.
Twoasterisks(**)indicateaneedtorefertotheseparateinstructions
for use.
Components HS item no.
Applanation tonometer AT 900 model BQ/BP 7200034
Block of paper slips for chin rest 1001309
Connectionring(camera-specic) *
Contrast-boostinglter(yellow) 1400306
Diffusor 1007432
Dustcover,large(forseveralinstruments) 1001434
Dustcover,small(forslitlamp) 1001395
Eyepiece 12.5x with dioptre ring 7220518
Eyepiece with double crosshair reticle 12.5x 7220454
Flash tube, complete 1021972
Flash unit FU 01 *
Illumination control, double slit and background 'in table'** 1021022
Illumination control, double slit and background 'on table'** 1020883
Instrument table HSM 901 Imaging *
Instrument table HSM 901 Workstation *
Lens barrel 1022493
Long mirror 1001590
Mirror and diaphragm component 1007302
Optical light guide for background lighting 1021960
Pin 3000332
Pin for chin rest 900-1359 1200713
Pivoting mirror for background lighting 1400215
Power supply for LED illumination on third-party tables** 1020881
Power supply for LED illumination, HSM 901** 1020882
Short mirror 1001591
Spacer for angled eyepiece 20° 1400305
Test rod 1021656
Trigger key with cable *
USB illumination cable 2000 mm 1020940
USB illumination cable 5000 mm 1020956
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220449.04070 – 2018 – 04
F. Information and manufacturer's declaration
concerning electromagnetic compatibility
(EMC)
F.1 General
TheBX900slitlampsystemfulllstherequirementsonelectromagneticcompati-
bilityaccordingtoEN60601-1-2:2007(IEC3.Edition)+EN60601-1-2:2015(IEC4.
Edition).Theinstrumentisbuiltsothatthegenerationandemissionofelectromag-
netic interference is limited to the extent that other devices are not disturbed in their
use in accordance with the regulations and so that the instrument itself is suitably
immune to electromagnetic interference.
WARNING!
• Electrical medical devices and systems are subject to special EMC
measures and must be installed in accordance with the EMC instruc-
tions contained in this accompanying document.
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)
TheinformationisbasedontherequirementsofEN60601-1-2:2007(IEC3rdedition)andEN60601-1-2:2015(IEC4thedition).
Guidance and manufacturer's declaration – electromagnetic emissions
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an envi-
ronment
RF emissions CISPR 11 Group 1 This product uses RF energy only for its internal function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class B This product is suitable for use in all establishments, including domestic establishments and those
directly connected to the public low-voltage power supply network that supplies buildings used for
domestic purposes.
Emission of harmonics according to
EN 61000-3-2
Class A
Voltage fluctuations / flicker emissions
according to EN 61000-3-3
Fulfilled
Emission test Compliance Electromagnetic environment - guidance
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220449.04070 – 2018 – 04
F.3 Immunity (standard table 2)
The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rdedition).
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
± 8 kV contact
± 15 kV air
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 fi eld EN 61000-4-8
Power frequency magnetic fi elds should be at levels char-
acteristic of a typical location in a typical commercial or hos-
pital environment.
NOTE: U
T
= the AC mains voltage prior to application of the test level.
3 A/m 30 A/m
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220449.04070 – 2018 – 04
F.4 Immunity for non-life support devices (standard table 4)
The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rdedition).
Guidance and manufacturer's declaration – electromagnetic immunity
This product is intended for use in the electromagnetic environment specifi ed below. The customer or the user of this product should assure that it is used in such an envi-
ronment.
Electromagnetic environment – guidance
Portable and mobile RF communications equipments hould be used no closer to any part of this product, including cables, than the recommended separation distance cal-
culated from the equation applicable to the frequency of the transmitter.
Immunity test standard EN 60601 test level Compliance level Recommended distance(c):
Conducted RF EN 61000-4-6 3 V
rms
150 kHz – 80 MHz
10 V
rms
D= 0.35
Radiated RF EN 61000-4-3 3 V/m
80 MHz – 2.7 GHz
5 V/m
80 MHz – 2.7 GHz
D= 0.7 80 MHz – 800 MHz
D= 1.4 800 MHz – 2.7 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 fi xed RF transmitters, as determined by an electromagnetic site survey a, 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 fi xed 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 fi xed RF transmitters, an electromagnetic
site survey should be considered. If the measured fi eld 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.
fi eld strengths should be less than 10 V/m.
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland – HS Doc. No. 1500.7220449.04070 – 2018 – 04
F.5 Safe distances for non-life support devices (standard table 6)
The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rdedition).
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 = 0.35
80 MHz – 800 MHz
D = 0.7
800 MHz – 2.7 GHz
D = 1.4
0.01
0.1
1
10
100
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 2.7 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:
0.035
0.1
0.35
1.1
3.5
0.07
0.2
0.7
2.2
7
0.14
0.44
1.4
4.4
14
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