HAAG-STREIT BD 900 slit lamp INSTRUCTIONS FOR USE
إعلان
إعلان
SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7200631.04080 – 8. Edition – 2014 – 10
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INSTRUCTIONS FOR USE
Slit lamp
BD 900
®
8. Edition / 2014 – 10
DOC. no. 1500 1500.1400209.04000
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ENGLISH DEUTSCH FRANÇAIS
INSTRUCTIONS FOR USE
Slit lamp
BD 900
®
8. Edition / 2014 – 10
ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA
Introduction
Thank you for deciding on a HAAG-STREIT product. By complying carefully with the instructions in these instructions for use, you will protect your HAAG-STREIT product.
Purpose of use
An AC-powered slitlamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
Contraindications
There are no absolute contraindications known for examinations with this device.
Appropriate professional assessment and caution are necessary.
WARNING!
Read the instruction manual carefully before commissioning this product. It contains important information regarding the safety of the user and patient.
NOTE!
Federal law restricts this device to sale by or on the order of a physician or licensed practitioner.
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ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA SVENSKA NEDERLANDS PORTUGUÊS
Contents
1.1
1.2
1.3
1.4
Areas of application of the device ...........................................................................4
Ambient conditions ..................................................................................................4
Shipment and unpacking ........................................................................................4
Installation warnings ..............................................................................................4
1.5
1.5
1.7 Disinfection .............................................................................................................5
1.8
1.9
Operation, environment ..........................................................................................4
Light toxicity ............................................................................................................5
Warranty and product liability ..................................................................................5
Symbols ..................................................................................................................5
2 Introduction .......................................................................... 6
2.1 Overview .................................................................................................................6
3. Appliance assembly / installation ...................................... 7
3.1
3.2
Microscope and illumination ....................................................................................7
Power supply (Type designation: LC-SLT) ..............................................................7
3.2.1 Possible causes of errors ........................................................................................7
3.2.2 Replacing the primary fuse .....................................................................................7
3.2.3 Replacing the secondary fuse .................................................................................7
4. Commissioning .................................................................... 7
4.1 Switching on the appliance .....................................................................................7
5. Operation .............................................................................. 8
5.1
5.2
5.3
5.4
5.5
5.6
Setting the eyepieces ..............................................................................................8
Preparing the patient ...............................................................................................8
Operating the instrument ........................................................................................8
Setting the filters & diaphragms ..............................................................................9
Camera equipment (option) ..................................................................................10
Microscope and eyepiece .....................................................................................10
6. Decommissioning .............................................................. 10
7. Technical data ................................................................... 10
7.1
7.2
7.3
7.4
7.6
7.7
7.8
Slit illumination .....................................................................................................10
Slit lamp illumination with halogen lamps .............................................................11
Spectrum of halogen illumination ..........................................................................11
Stereo microscope ................................................................................................11
Instrument base ....................................................................................................11
Net weight ............................................................................................................11
Power supply LC-SLT ...........................................................................................11
ESPAÑOL ITALIANO FRANÇAIS DEUTSCH
8. Maintenance ........................................................................11
8.1 Repairs ..................................................................................................................11
8.2 Cleaning ................................................................................................................12
8.3
8.4
Replacing the illumination mirror ...........................................................................12
Dust cover .............................................................................................................12
A. Appendix ............................................................................ 12
A.1 Accessories / spare parts ......................................................................................12
B. Legal regulations ............................................................... 12
C. Classification .................................................................... 13
D. Disposal .............................................................................. 13
E. Standards ........................................................................... 13
F. Information and manufacturer's declaration concerning electromagnetic compatibility
(EMC) .................................................................................. 14
F.1 General .................................................................................................................14
F.2
F.3
F.4
F.5
Emitted interference (standard table 1) .................................................................14
Immunity (standard table 2) ..................................................................................15
Interference immunity on non-life-supporting devices (standard table 4) .............16
Safe distances for non-life-supporting devices (standard table 6) ........................17
ENGLISH
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7200631.04080 – 8. Edition – 2014 – 10
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1. Safety
DANGER!
Failure to comply with these instructions may result in material damage or pose a danger to patients or users.
WARNING!
These warnings must absolutely be complied with to guarantee safe operation of the device and to avoid any danger to users and to patients.
NOTE!
Important information: please read carefully.
PORTUGUÊS NEDERLANDS SVENSKA
• Check the appliance for damage after it is unpacked. Return defective appliances in the appropriate packaging.
• Store packaging material carefully, so that it can be used for possible returns or when moving.
• The slit lamp and head rest must be installed on an electrically insulated, fireproof table top.
•
The rail covers (a) prevent the slit lamp from tilting.
• Check: Are the connection parts of the accessories in the correct position (screw connections, quick-release fasteners)?
(a)
4
1.1 Areas of application of the device
The device is intended for use in doctor's practices, hospitals and optometrists' and opticians' premises.
1.2 Ambient conditions
Transport:
Storage:
Use:
Temperature
Air pressure
Relative humidity
Temperature
Air pressure
Relative humidity
Temperature
Air pressure
Relative humidity from from from from from from from from from
−40°C
500 hPa
10%
−10°C
700 hPa
10%
+10°C
800 hPa
30% to to to to to to to to to
+70°C
1060 hPa
95%
+55°C
1060 hPa
95%
+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 representative 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 (condensation).
1.4 Installation warnings
WARNING!
• This device must not be modified without the manufacturer's approval.
• Installation and repairs may only be performed by trained specialists.
• Any third-party device must be connected in compliance with the
EN 60601-1 standard.
1.5 Operation, environment
DANGER!
• Never use the device in potentially explosive environments where volatile solvents (alcohol, benzine, etc.) and combustible anaesthetics are in use.
WARNING!
•
To avoid the risk of an electric shock when using protection class I power supplies, they must be connected to the public power grid with a ground connection.
• The device must be switched off after every use. There is a risk of overheating when using a dust cover.
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7200631.04080 – 8. Edition – 2014 – 10
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NOTE!
This appliance must only be operated by qualified and trained personnel. The owner is responsible for their training.
1.5 Light toxicity
WARNING!
As extended, intensive illumination can damage the retina, the use of the instrument in the examination of the eye should not be prolonged unnecessarily. This slit lamp is equipped with protective filters which limit the light spectrum to 380-750 nm, see 7.2. The retinal dose for a photochemical risk is composed of the product of the radiance and the exposure time. If the radiance is halved, the time until the exposure time limit value is reached will double accordingly. To-date, no acute, optical radiation hazard has been detected in slit lamps. Nevertheless, we recommend keeping the intensity of the light reaching the patient's retina to the minimum possible for the respective diagnosis. Children, aphakes and people suffering from eye conditions are most at risk. An increased risk may also occur if the retina is exposed to the same or a similar instrument with a visible light source within 24 hours. This specially applies if the retina has been photographed with a flashbulb in advance.
WARNING!
The light from this device may be dangerous. The risk of eye damage increases with the irradiation period. The exposure time with this device at maximum intensity is linked to the selected type of illumination.
An exposure time with this instrument at maximum intensity of longer than 2.8 minutes exceeds the risk guideline value (as per EN ISO
15004-2).
1.7 Disinfection
NOTE!
The device does not need to be disinfected.
ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH
•
1.8 Warranty and product liability
•
•
•
•
•
•
Haag-Streit products must be used only for the purposes and in the manner described in the documents distributed with the product.
The product must be treated as described in the ‘Safety’ chapter. Improper handling 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.
For USA only:
This product is covered by a limited warranty, which may be reviewed at www.haag-streit-usa.com.
1.9 Symbols
Read the instructions for use attentively
Warning – hot surfaces!
European certificate of conformity
Notes on disposal, see the
'Disposal' chapter
General warning: Read the accompanying documentation
Disconnect the plug before opening the device
Test symbol of CSA with approval for USA
This appliance fulfills the European Directive 2001/65/EU (RoHS)
On (Power) Off (Power)
Manufacturer
Alternating current
Year of production
Direct current
For more information on cleaning, please refer to the 'Maintenance' section.
HS reference number Serial number
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2 Introduction
2.1 Overview
1. Lamp cable
2. Head rest
3. Headband
4. Height mark on head rest (patient eye)
5. Adjustable fixation lamp
6. Chin rest
7. Height adjustment of chin rest
8. Lamp cover
9. Lever for grey and red removal filters
10. Lever for slit length, blue filter
11. Scale for angled position of the slit image
12. Illumination mirror
13. Diffusor
14. Camera connection (C-mount)
15. Protective cover
16. Illumination unit / microscope angle scale
17. Slit width setting screw
18. Brightness setting
19. Power supply connection
20. Registered trademark
BD 900
21. Scale for slit length and blue filter
22. Lever for switching on the yellow filter
23. Cap for accessories base
24. Stereo microscope with eyepieces
25. Eyepiece fixing screw
26. Lens-changing lever
ITALIANO ESPAÑOL
27. Knurled screw for fixation of breath shield
28. Breath shield
29. Joy stick base locking screw
30. Rail cover
31. Control lever
32. Slide plate
33. Prism housing
34. Eyepiece mounting
35. Index (white point)
36. Knurled ring with dioptre scale for setting the refraction of the examiner (± 6 D)
37. Sliding occluder
PORTUGUÊS
1
2
5
6
7
NEDERLANDS
33 34
25
35 36 37
SVENSKA
8
16
17
9
10
11
12
13
Diffusor
1004744
13
Eyepiece with prism housing
6
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22
28
29
30
31
32
25
26
27
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7200631.04080 – 8. Edition – 2014 – 10
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ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA SVENSKA NEDERLANDS PORTUGUÊS
3. Appliance assembly / installation
WARNING!
This device must not be modified without the manufacturer's approval.
Installation and repairs may only be performed by trained specialists.
Contact your HAAG-STREIT representative for the installation, repair and modification of your system. The contact data are available at www.haag-streit.com.
3.1 Microscope and illumination
• The slit lamp is packaged and shipped fully assembled. The transport safety measures must be removed before commissioning.
• Fix the breath shield (28) in place by fastening the knurled screw (27) on the inside of the bearer arm.
3.2 Power supply
(Type designation: LC-SLT)
38. Voltage selector switch
39. Secondary fuse (1 x F 3.15 AL, 250 V HS part number 1001331)
40. Primary fuse (2 x T 800 mAL, 250 V HS part number 1001330)
41. Main switch (rocker switch)
ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH
3.2.1 Possible causes of errors
Error
The main switch is switched on but not illuminated
The main switch is illuminated but the slit illumination is not
Cause
The primary fuses are defective
The secondary fuse or halogen lamp is defective
3.2.2 Replacing the primary fuse
WARNING!
Only the fuses described in the corresponding table in the "Technical data" section should be used.
• Unplug the power cable.
•
Open the fuse socket (40) with a screwdriver.
• Replace the fuses.
• Screw the fuse socket (40) back in.
• Connect the electric power supply cable.
3.2.3 Replacing the secondary fuse
• Unplug the power cable.
•
Turn the slit on the fuse holder (39) to the left with a screwdriver.
• Replace the fuse.
• Turn the fuse holder (39) to the right with a screwdriver.
4. Commissioning
4.1 Switching on the appliance
The main switch (rocker switch) is found on the front of the power supply, under the table top. Connect the power supply up to the power and set the rocker switch (
38 39 40 41
WARNING!
Use only with the HS power supply LC-SLT. This is equipped with a voltage selector switch (38) 115 V / 230 V. The range must be set to the local power supply prior to initial commissioning.
WARNING!
To prevent the lamp cover from getting too hot, the slit lamp should not be switched on for longer than 5 minutes. The slit lamp can be used again after 5 minutes of being switched off.
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5. Operation
5.1 Setting the eyepieces
NOTE!
The eyepieces must be individually set prior to the first examination in accordance with the refraction of the examiner. Insert the provided check rod (a) in place of the protective cover (b) and turn its black projection surface at a right angle to the microscope axis. Return the illumination and microscope to the central position (0°).
42. Adjusting pin
43. Protective cover
44. Sliding occluder
FRANÇAIS
42
43
ITALIANO ESPAÑOL
44
• Each eyepiece should be set individually by turning the knurled ocular refraction ring with dioptre scale such that the projected slit can be seen in focus. The setting is performed from the (+) to the (-) side at low magnification.
• The pupil distance should then be set on the microscope.
• The sliding occluder (44) is used to set the correct working distance of the examiner from the eyepiece.
•
Examiners who do not wear glasses: Pull the occluder out as far as it will go.
•
Examiners who do wear glasses: Push the occluder in as far as it will go.
5.2 Preparing the patient
• In order to attain a solid basis for the forehead and chin to rest on, the table height should be selected such that the patient sits bent over forward.
• To ensure that only the part of the eye being examined is illuminated, the slit height should be set accordingly in order to avoid objectionable irradiation.
• The lamp brightness should be reduced to the minimum after every examination.
• Parts which come into contact with the patient should be cleaned with a dry cloth prior to every use.
PORTUGUÊS NEDERLANDS SVENSKA
5.3 Operating the instrument
• Use the turn screw (7) to adjust the chin rest (6) until the patient’s eyes are at the same height as the black marks (4) on the sides of the head rest.
• Tighten the eyepiece fixing screw (25). Focus the eyepieces in accordance with the examiner’s refraction by turning the knurled rings and set the eye distance.
• Switch on the illumination by pressing the green main switch on the power supply.
• The brightness can be continuously adjusted with the potentiometer (18).
• Adjust the height of the slit lamp by turning the control lever (31) until the luminous aigrette is at eye level.
• The rigid control lever (31) gently inclined towards the examiner can be used to push the entire instrument until the slit appears approximately focused on the cornea. This initial setting is verified with the naked eye. Fine tuning is performed by tilting the control lever, easily controllable at the top end, while observing via the stereo microscope (24).
• The slit width is set left or right with the rotating knob (17), as is the angle between the stereo microscope and illumination.
• The slit image can be set vertically, horizontally or as diagonally as required by turning the illumination device (8) (locking point at 90°; stops at 0° and 180°). The angle can be read off the scale (11).
• On the slit lamp BD 900, the magnification of the stereo microscope is adjusted by changing the lenses with the lever (26) or by exchanging the eyepieces (option).
• The diffusor (13) is connected upstream for monitoring the overview.
• The camera output (14) can be used for documentation.
• The yellow filter (22) can be engaged to obtain the fluo-image display.
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ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH
4
6
8
9
10
13
11
22
Brightness regulation for camera images
The brightness of peripheral or background illumination (option) can be altered on the cold light source housing by using the knob for infinite brightness regulation.
For more detailed information, please consult the respective operating instructions.
Focussing for camera images
Focussing of an object level during the examination should usually be done by moving the microscope towards the object until the level of interest is in focus. If it is brought even further towards the object, the same object level can still be observed by means of accommodation, but with loss of connection with the image level of the camera.
Illumination facility
The halogen lamp is centred in the factory in order to ensure optimal illumination.
The light emitted from the pre-centred halogen lamp bulb travels through the condenser, slit diaphragm and lens and is directed into the patient’s eye via the 45° mirror.
5.4 Setting the filters & diaphragms
24
7
26
14
25
(a)
(b)
(c)
45 46 47
17
18
31
Brightness regulation
• The brightness of the slit illumination can be adjusted with the knob (18) on the instrument base for the slit illumination intensity or by using the 10% grey filter on the upper part of the illumination unit on the slit lamp.
48 49
Filter in window (a) Operation via lever (b)
45. Open
46. Red removal filter
47. Grey filter (10%)
NOTE!
UV and thermal-protection filters are installed as per the
EN ISO 10939 standard.
Diaphragm in window (a) Operation via lever (c)
48. Aperture of diameter 14 mm
49. Wedge-shaped diaphragm for continuous slit length adjustment
50. Blue filter
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7200631.04080 – 8. Edition – 2014 – 10
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5.5 Camera equipment
(option)
Dimension of object field Size of the camera sensor
Microscope magnification
1x
1/3"
16 x 12
1/2"
21.3 x 16
1.6x
10 x 7.5
The camera equipment is composed of the following components:
Either camera with C-mount
Maximum camera size (a)
Height 110 mm
Width 50 mm
Length 55 mm
13.3 x 10 or lipstick camera requires an adapter (b) from the respective camera manufacturer and can then be connected to the C-mount interface on the BD 900.
Cable guide composed of
•
Cable clamp for camera cable
• Cable guide for optical fibre
• Cable guide on the rail cover
HAAG-STREIT recommends:
• Camera module CM 900
•
Peripheral or background illumination with cold light source, composed of
• Cold light source
• Optical fibre
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PORTUGUÊS NEDERLANDS SVENSKA
5.6 Microscope and eyepiece
56. Two objective-lens pairs
57. Lever for yellow filter
58. Cap for accessories base
59. Serial number of microscope
60. Eyepiece 10x or 25x
61. Connection for camera (C-mount)
62. Lens-changing lever
63. Eyepiece fixing screw
56 57
Lens
Eyepiece
Total magnification
Object field diameter
61
58 59
1x
10x
10x
1.6x
10x
16x
18 mm 11.3 mm
62 63
1x
25x
25x
8 mm
60
1.6x
25x
40x
5 mm
6. Decommissioning
The main switch (rocker switch) is found on the front of the power supply, under the table top. Set the rocker switch ( / ) to OFF . The device is now switched off.
When the device is switched off, the main switch (41) is not illuminated.
NOTE!
Disconnect the power supply from the mains if you do not intend to use it for an extended period of time.
7. Technical data
7.1 Slit illumination
Slit image width
Slit image length
Max. diaphragm diameter
Slit image rotatability
0–14 mm continuous
1-14 mm continuous
14 mm
0-90°
Horizontal ±90° Rotation of slit illumination to microscope axis
Filters Blue, grey (10%) and red removal.
UV and thermal-protection filters are installed.
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ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA
Light source
Illumination intensity
7.4 Stereo microscope
Stereo angle
Magnification changer
7.5 Magnification
with eyepiece 10x (standard) with eyepiece 25x
Range of adjusting eye-pieces
Pupil distance
Camera connection
SVENSKA NEDERLANDS PORTUGUÊS
Halogen lamp 12 V / 2.5 A
0 V / ~ 0 lux at position 0
7 V / ~75,000 lux at position 1/4
9 V / ~150,000 lux at position 1/2
11.5 V / ~300,000 lux at position 1
ESPAÑOL ITALIANO
7.6 Instrument base
Operation
Adjustment of instrument base
7.2 Slit lamp illumination with halogen lamps
Maximum examination times according to EN ISO 15004-2 and EN ISO 10939
WARNING!
The light from this instrument may be dangerous. The risk of eye damage increases with the irradiation period. An exposure time with this instrument at maximum intensity of longer than 2.8 minutes with the slit illumination or longer than 2.3 minutes with slit and peripheral or background illumination exceeds the risk guideline value.
7.3 Spectrum of halogen illumination
100
80
60
40
20
0
X
UV IR
Y [nm]
X = Rel. intensity (%)
Y = Wavelength (nm)
13°
1x and 1.6x
10x and 16x
25x and 40x
+6 to –6 dioptres
54-94 mm
C-mount
FRANÇAIS
Single-handed operation of control lever in 3 dimensions
100 mm (length)
100 mm (side)
30 mm (height)
7.7 Net weight
8.1 kg (without power supply, head rest and options)
DEUTSCH ENGLISH
7.8 Power supply LC-SLT
WARNING!
Only use the LC-SLT power supply from HAAG-STREIT with 4-12 V
/ 30 W
Input (voltage selector switch)
Operating frequency
Output 1
Output 2
Primary fuse
Secondary fuse
115 V~ / 60 Hz / 60 VA or
230 V~ / 50 Hz / 60 VA
50 / 60 Hz
4-12 V / 3 A
5 V / 300 mA
2 x T 800 mAL, 250 V HS part number 1001331
1 x F 3.15 AL, 250 V HS part number 1001331
8. Maintenance
WARNING!
This device must not be modified without the manufacturer's approval.
Installation and repairs may only be performed by trained specialists.
8.1 Repairs
To ensure a long service life, the device should be cleaned weekly as described and covered with a dust cover when not in use. We recommend having the device inspected by an authorised service technician annually.
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8.2 Cleaning
• Only clean the housing with a dry cloth.
•
No liquids, no aggressive agents, no alcohol.
• The exposed glass surfaces can be dusted with a dusting brush.
Lens brush HAAG-STREIT number 1001398
8.3 Replacing the illumination mirror
WARNING!
• Do not touch the mirroring surface.
• Only use mirrors with a LOT number.
The mirror (49) dont need to be removed for cleaning. It should only be replaced if mechanically damaged.
Dismantling: Depress the mirror in the direction of the arrow, taking care to ensure that it does not jam.
Assembly
• Depress the spring retaining plate downwards
• Slide the mirror half way in with the other hand
• Release the retaining plate
• Continue to slide the mirror into position until it engages
49
8.4 Dust cover
We recommend protecting the slit lamp with a dust cover
(50) when not in use.
Dust cover, small (for slit lamp) HS art. number 1001395
Dust cover, large (for several devices) HS art. number
1001434
50
A. Appendix
A.1 Accessories / spare parts
WARNING!
• This device must not be modified without the manufacturer's approval. Installation and repairs may only be performed by trained specialists.
• Connecting third-party systems to the same mains socket can compromise the system's safety.
12
PORTUGUÊS NEDERLANDS SVENSKA
NOTE!
An asterisk (*) shows that you should contact your HAAG-STREIT representative for further information.
Component HS art. no.
Cover
Adapter for lipstick to C-mount
Applanation tonometer AT 900 D model R for BC / BD
Applanation tonometer AT 900 model R for BC / BD
Pivot with screw AT 900 type R
Illumination mirror BC 900
Block of papers for chin rest
Camera module CM 900 (C-mount)
Spacer screw
Guide plate (900-415)
Power supply
Halogen lamp BC 900 12 V 2.5 A
Instrument table HSM 801
Instrument table HSM 901
Instrument table HSM 901 "Imaging"
Instrument table HSM 901 "Workstation"
Cold light source
Head rest with fixation lamp
Eyepiece 10x
Eyepiece 10x with double crosshairs
Eyepiece 25x
Check rod
Pin for chin rest
5 mm Allen key
Diffusor BC 900
Peripheral or background illumination for optical fibre holder
Movable front-lens glass, -58.6 dioptres, as per Hruby
Carriage for preset lenses with rail (guide plate included)
1002788
*
1200671
1003022
1200987
1001051
1200713
1001602
1004744
*
1400223
1400100
*
7220064
7200154
1003603
1200602
1001309
*
1008363
1001219
*
1200559
*
*
*
*
*
B. Legal regulations
• The BD 900 slit lamp was developed and designed taking the EN 60601-1 and
EN ISO 15004-2 standards into account. Production, testing, set-up, maintenance and repairs are performed taking international standards into account.
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7200631.04080 – 8. Edition – 2014 – 10
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SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH
ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA SVENSKA NEDERLANDS PORTUGUÊS
• The EN 60601-1 standard must be observed when using different medical and/or non-medical electrical appliances in combination.
• Compliance of the BD 900 slit lamp with the Directive 93/42/EEC is confirmed by the CE marking.
• The BD 900 slit lamp satisfies the electromagnetic compatibility requirements of
EN 60601-1-2. The device has been designed to generate and maintain emissions of electromagnetic interference at a level which does not affect the standard operation of other components. The device has also been developed to offer a certain amount of resistance to electromagnetic interference from other devices.
• The statutory accident regulations must be observed.
C. Classification
Standard EN 60601-1
Operating mode:
CE Directive 93/42/EEC
FDA
BD 900 split lamp acc. to protection class I
Intermittent, 5 minutes ON and 5 minutes OFF
Class I
Class II
D. Disposal
Electrical and electronic devices must be disposed of separately from household waste! This appliance was made available for sale after the
13th August 2005. For correct disposal, please contact your
HAAG-STREIT representative. This will guarantee that no hazardous substances enter the environment and that valuable raw materials are recycled.
E. Standards
EN ISO 10939
EN 60601-1-2
EN 60601-1
EN ISO 15004-2
ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7200631.04080 – 8. Edition – 2014 – 10
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ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL
F. Information and manufacturer's declaration concerning electromagnetic compatibility
(EMC)
F.1 General
The slit lamp system BD 900 fulfils the requirements on electromagnetic compatibility according to EN 60601-1-2. The instrument is built so that the generation and emission of electromagnetic interference is limited to the extent that other devices are not disturbed in their use in accordance with the regulations and so that it itself has appropriate immunity to electromagnetic interference.
PORTUGUÊS NEDERLANDS SVENSKA
WARNING!
• Electrical medical devices and systems are subject to special EMC measures and must be installed in accordance with the EMC instructions contained in this accompanying document.
• Portable and mobile HF communication systems may interfere with electrical medical devices.
WARNING!
Operation with other cables or equipment than that listed may lead to a higher emissions or to a lower interference resistance of the device.
F.2 Emitted interference (standard table 1)
Guidance and manufacturer's declaration – electromagnetic emissions
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an environment
Emission test
RF emissions CISPR 11
RF emissions CISPR 11
Emission of harmonics according to
EN 61000-3-2
Voltage fluctuations / flicker emissions according to EN 61000-3-3
Compliance
Group 1
Class B
Class B
Fulfilled
Electromagnetic environment - guidance
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.
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.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7200631.04080 – 8. Edition – 2014 – 10
03.10.2014 09:17:54
SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH
ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH
F.3 Immunity (standard table 2)
Guidance and manufacturer's declaration – electromagnetic immunity
This product is intended for use in the electromagnetic environment specifi ed below. The customer or the user of this product should assure that it is used in such an environment.
Immunity test standard
Electrostatic discharge (ESD)
EN 61000-4-2
Electrical fast transient / burst
EN 61000-4-4
Surge
EN 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply lines
EN 61000-4-11
Power frequency (50/60Hz) magnetic fi eld EN 61000-4-8
EN 60601 test level
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines
± 1 kV for symmetrical voltages
± 2 kV for asymmetrical voltages
< 5% U
T
(> 95% drop in U
T
) for ½ cycle
< 40% U
T
(> 60% drop in U
T
) for 5 cycles
< 70% U
T
(> 30% drop in U
T
) for 25 cycles
< 5% U for 5 s
T
(> 95% drop in U
T
)
3 A/m
Compliance level
± 6 kV contact
± 8 kV air
± 2 kV for power supply lines
± 1 kV for symmetrical voltages
± 2 kV for asymmetrical voltages
< 5% U
T
(> 95% drop in U
T
) for ½ cycle
< 40% U
T
(> 60% drop in U
T
) for 5 cycles
< 70% U
T
(> 30% drop in U
T
) for 25 cycles
< 5% U for 5 s
0.3 A/m
T
(> 95% drop in U
T
)
Electromagnetic environment – guidance
Floors should be wood, concrete or ceramic tile. If fl oors are covered withs ynthetic material, the relative humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
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 uninterruptible power supply or a battery.
Power frequency magnetic fi elds should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE: U
T
= the AC mains voltage prior to application of the test level.
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7200631.04080 – 8. Edition – 2014 – 10
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F.4 Interference immunity on non-life-supporting devices (standard table 4)
Guidance and manufacturer's declaration – electromagnetic immunity
This product is intended for use in the electromagnetic environment specifi ed below. The customer or the user of this product should assure that it is used in such an environment.
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 calculated from the equation applicable to the frequency of the transmitter.
Immunity test standard
Conducted RF EN 61000-4-6
Radiated RF EN 61000-4-3
EN 60601 test level
3 V rms
150 kHz – 80 MHz
3 V/m
80 MHz – 2.5 GHz
Compliance level
3 V rms
3 V/m
80 MHz – 800 MHz
Recommended distance (c) :
D = 1.2
D = 1.2 80 MHz – 800 MHz
D = 2.3 800 MHz – 2.5 GHz
Where P is the maximum output power rating of thet ransmitter in watts (W) according to the transmitter manufacturer and D is the recommended separation distance in metres (m). Field strengths from fi xed RF transmitters, as determined by an electromagnetic site survey in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol:
a , should be less than the compliance level
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 broadcast 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 b.
c. this product.
Over the frequency range 150 kHz to 80 MHz, fi eld strengths should be less than 10 V/m.
Possible shorter distances outside the ISM bands do not contribute to improved application in this table.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7200631.04080 – 8. Edition – 2014 – 10
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SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH
ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH
F.5 Safe distances for non-life-supporting devices (standard table 6)
Recommended safe distances between portable and mobile HF communication devices and this device.
This product is designed to be operated in an electromagnetic environment in which radiated HF interference is controlled. The customer or user of this product can help to prevent electromagnetic interference by maintaining minimum distances between portable and mobile HF communication systems (transmitters) and this product, as recommended below in accordance with the maximum output of the communication system.
Nominal output of the transmitter (W)
0.01
0.1
1
10
100
Safe distance according to transmission frequency (m)
150 kHz – 80 MHz
D = 1.2
0.12
80 MHz – 800 MHz
D = 1.2
0.12
0.38
1.2
3.8
12
0.38
1.2
3.8
12
800 MHz – 2.5 GHz
D = 2.3
0.23
0.73
2.3
7.3
23
For transmitters with a nominal output not listed in the table above, the distance D can be calculated in meters (m) using the equation for the respective column, in which P is the nominal output of the transmitter in watts (W)
NOTE 1: At 80 MHz and 800 MHz the higher frequency applies.
NOTE 2: To calculate the recommended safe distance of transmitters in the frequency range of 80 MHz to 2.5 GHz an additional factor of 10 probability of a mobile/portable communication device causing interference if inadvertently brought into the patient area.
/
3
was used to reduce the
NOTE 3: These guidelines may not apply in all situations. Electromagnetic wave propagation is influenced by absorption and reflection of buildings, objects and people.
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7200631.04080 – 8. Edition – 2014 – 10
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Should you have any further questions, please contact your HAAG-STREIT dealer at:
http://www.haag-streit.com/contact/contact-your-distributor.html
C US
PRODUCTS CERTIFIED FOR BOTH THE U.S
AND CANADIAN MARKETS, TO THE APPLI-
CABLE U.S. AND CANADIAN STANDARDS
1250
HAAG-STREIT AG
Gartenstadtstrasse 10
3098 Koeniz, Switzerland
Phone +41 31 978 01 11
Fax eMail
+41 31 978 02 82 [email protected]
Internet www.haag-streit.com
© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7200631.04080 – 8. Edition – 2014 – 10
03.10.2014 09:17:55
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