Haag-Streit Slit lamp BQ 900 Instructions For Use Manual
1
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
INSTRUCTIONS FOR USE
Slit Lamp
BQ 900
®
18. Edition / 2016 – 02
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
INSTRUCTIONS FOR USE
Slit Lamp
BQ 900®
18. Edition / 2016 – 02
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 professional judgement 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.
WARNING!
This device is equipped with high intensity light emitting diodes. Excessive exposure of patients in treatment with certain medication may lead
to phototoxic adverse reactions, due to higher photosensitivity.
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PORTUGUÊS
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
Contents
1. Safety ....................................................................................4
1.1 Areas of application of the device ...........................................................................4
1.2 Ambient conditions ..................................................................................................4
1.3 Shipment and unpacking ........................................................................................4
1.4 Installation warnings ..............................................................................................4
1.5 Operation, environment ..........................................................................................4
1.6 Light toxicity ............................................................................................................5
1.7 Disinfection .............................................................................................................5
1.8 Warranty and product liability ..................................................................................5
1.9 Symbols ..................................................................................................................5
2. Introduction ..........................................................................5
2.1 Overview .................................................................................................................6
3. Appliance assembly / installation ...................................... 6
3.1 Microscope and illumination ....................................................................................6
3.2 Power supply ..........................................................................................................7
3.3 Instrument base with weight compensation facility .................................................7
3.4 Setting the weight compensation facility .................................................................7
3.5 Switching on the weight compensation facility ........................................................7
3.6 Switching off the weight compensation facility ........................................................7
3.7 Regulating the clearance of the slit width control ....................................................7
4. Commissioning ....................................................................7
4.1 Switching on the appliance .....................................................................................7
5. Operation ..............................................................................7
5.1 Setting the eyepieces ..............................................................................................7
5.2 Preparing the patient ..............................................................................................8
5.3 Operating the instrument ........................................................................................8
5.4 Settingthelters&diaphragms .............................................................................9
5.5 Fixation star ............................................................................................................9
5.6 Microscope and eyepiece .......................................................................................9
6. Decommissioning ................................................................9
7 Technical data .....................................................................9
7.1 Slit illumination .......................................................................................................9
7.2 Stereo microscope ...............................................................................................10
7.3 Instrument base ...................................................................................................10
7.4 Net weight .............................................................................................................10
8. Maintenance .......................................................................10
8.1 Device inspection .................................................................................................10
8.2 Repair ...................................................................................................................10
8.3 Cleaning ................................................................................................................10
8.4 Replacing the illumination mirror ...........................................................................10
8.5 Dust cover .............................................................................................................10
A. Appendix .............................................................................11
A.1. Accessories/spare parts ........................................................................................11
B. Legal regulations ...............................................................11
C. Classication .................................................................... 12
D. Disposal ..............................................................................12
E. Standards ........................................................................... 12
F. Information and manufacturer's declaration
concerning electromagnetic compatibility
(EMC) ..................................................................................13
F.1 General .................................................................................................................13
F.2 Emitted interference (standard table 1) .................................................................13
F.3 Immunity (standard table 2) ..................................................................................14
F.4 Immunity for non-life support devices (standard table 4) ......................................15
F.5 Safe distances for non-life support devices (standard table 6) .............................16
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
1. Safety
DANGER!
Failure to comply with these instructions may result in material damage
or pose a danger to patients or users.
WARNING!
These warnings must absolutely be complied with to guarantee
safe operation of the device and to avoid any danger to users and
to patients.
NOTE!
Important information: please read carefully.
1.1 Areas of application of the device
The device is intended for use in doctor's practices, hospitals and optometrists' and
opticians' premises.
1.2 Ambient conditions
Transport: Temperature
Air pressure
Relative humidity
from
from
from
−40°C
500 hPa
10%
to
to
to
+70°C
1060 hPa
95%
Storage:
Temperature
Air pressure
Relative humidity
from
from
from
−10°C
700 hPa
10%
to
to
to
+55°C
1060 hPa
95%
Use:
Temperature
Air pressure
Relative humidity
from
from
from
+10°C
800 hPa
30%
to
to
to
+35°C
1060 hPa
90%
1.3 Shipment and unpacking
• Before you unpack the appliance, check whether the packaging shows traces of
incorrect handling or damage. If this is the case, notify the transport company that
has delivered the goods to you. Unpack the equipment together with a 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 (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.
• Theslitlampandheadrestmustbeinstalledonanelectricallyinsulated,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 volatile solvents (alcohol, petrol, etc.) and flammable anaesthetics are in
use.
WARNING!
The device must be switched off after every use. Otherwise there is a
risk of overheating when a protective dust cover is used.
NOTE!
This equipment must only be operated by qualified and trained personnel. The owner is responsible for their training. This device may only be
used in accordance with the instructions in "Purpose of use".
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS
PORTUGUÊS
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
1.6 Light toxicity
WARNING!
As extended, intensive illumination can damage the retina, the use of the de-
vice in the examination of the eye should not be prolonged unnecessarily. The
illumination of this slit lamp emits a radiation in the range between 400 and
750nm. 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, people with
aphakia and people suffering from eye conditions are most at risk. An increased risk may also occur if the retina is exposed to the same or a similar device
with a visible light source within 24 hours. This applies, in particular, if the
retina has been photographed with a flashbulb in advance.
The light from this instrument may be dangerous. The risk of eye damage
increases with the exposure time. An exposure time with this instrument at
maximum intensity of longer than 143 seconds exceeds the guideline value
for a risk in accordance with EN ISO 15004-2.
1.7 Disinfection
NOTE!
The device does not 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 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 products must be used only for the purposes and in the manner des-
cribed in the documents distributed with the product.
The product must be treated as described in the ‘Safety’ chapter. Improper hand-
ling can damage the product. This would void all guarantee claims.
Continued use of a product damaged by incorrect handling may lead to personal
injury. In such a case, the manufacturer will not accept any liability.
Haag-Streit does not grant any warranties, either expressed or implied, including
implied warranties of merchantability or fitness for a particular use.
Haag-Streit expressly disclaims liability for incidental or consequential damage
resulting from the use of the product.
This product is covered by a limited warranty granted by your seller.
This product is covered by a limited warranty, which may be reviewed at
www.haag-streit-usa.com.
•
•
•
•
•
•
For US
A only:
•
1.9 Symbols
Read the instructions for use
attentively
General warning: Read the ac-
companying documentation
Notes on disposal, see the
'Disposal' chapter
This appliance fulfills the Euro-
pean Directive 2011/65/EU
(RoHS)
Year of production Manufacturer
European certificate of
conformity
Earth (ground)
Direct current
Not protected from foreign
bodies
Serial number
HS reference number
Plug socket on RM 02 for
power supply
Slit lamp illumination
Background illumination
Test symbol of CSA with ap-
proval for USA
2. Introduction
The slit lamp consists of an illumination and a binocular microscope. The instrument
base can be used to move the entire device in front of the eyes. The illumination offers a large number of setting options to make the practically invisible areas in the
eye visible. A wide range of accessories is available for the slit lamp to open up special diagnosis options in addition to the general tests.
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7220589-04170 – 2016 – 02
2.1 Overview
1. Lamp cable
2. Head rest
3. Headband
4. Height mark on head rest (patient eye)
5. Adjustablexationlamp
6. Chin rest
7. Height adjustment of chin rest
8. LED illumination LI 900, see separate
manual
9. Leverforlters
10. Scale for angled position of the slit image (5° increments)
11. Illumination mirror
12. Diffusor
13. Magnicationchanger
14. Mounting screw for the stereo microscope
15. Protective cover
16. Illumination unit/microscope angle
scale
17. Illumination arm locking screw
18. Microscope arm locking screw
19. Slit width setting screw
20. Weight compensation screws
21. Slit length/diaphragm scale
22. Setting screw for adjusting the slit
length,bluelterandxationstar,handle for turning the slit
23. Cover screw for accessories pin
24. Quick-release fastener for accessories
25. Stereo microscope with eyepieces
26. Eyepieces
27. Breath shield
28. Mounting screw for breath shield
29. Threadforxing(right-handside)
the tonometer AT 900 model BQ or
AT 900 D model BQ
30. Centering screw
31. Inclinationanglelatch0°−20°
32. Joy stick base locking screw
33. Axle
34. Rail cover
35. Control lever
36. Slide plate
1
2
3
4
5
6
7
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
9
8
10
12
12
13
14
15
16
17
18
19
20
11
3. Appliance assembly / installation
WARNING!
Do not modify this equipment without authorization of the manufacturer.
Installation and repairs may only be performed by trained specialists.
Contact your HAAG-STREIT representative for installation, repairs and
modification work on the system. The contact details are available at
www.haag-streit.com.
Only original HS replacement parts may be used.
•
•
3.1 Microscope and illumination
• The slit lamp is packaged and delivered fully assembled. The transport lock must
be removed prior to commissioning.
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