Haag-Streit BI 900 User manual

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

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04010 – 2015 – 08
INSTRUCTIONS FOR USE
Slit lamp
BI 900®
1. edition / 2015 – 08
Introduction
Thank you for choosing a HAAG-STREIT device. Provided you comply carefully
with the regulations in this instructions for use, we can guarantee the reliable and
unproblematic use of our product.
Purpose of use
A
slit lamp biomicroscope is intended for use in eye examination. It is used to aid in
the diagnosis and documentation of diseases or trauma which affect the structural
properties of the eye.
Contraindication
There are no absolute contraindications known for examinations with this device.
Appropriate professional assessment and caution are necessary.
WARNING!
Read the instruction manual carefully before commissioning this pro-
duct. It contains important information regarding the safety of the user
and patient.
NOTE!
Federal law restricts this device to sale by or on the order of a physician
or licensed practitioner.
WARNING!
This device is equipped with high intensity light emitting diodes. Exces-
sive exposure of patients in treatment with certain medication may lead
to phototoxic adverse reactions, due to higher photosensitivity.
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04010 – 2015 – 08
Contents
1. Safety ...................................................................................4
1.1 Areas of application of the device...........................................................................4
1.2 Ambient conditions..................................................................................................4
1.3 Shipment and unpacking ........................................................................................4
1.4 Installation warnings ..............................................................................................4
1.5 Operation, environment ..........................................................................................4
1.5 Light toxicity............................................................................................................5
1.7 Disinfection.............................................................................................................5
1.8 Warranty and product liability..................................................................................5
1.9 Symbols..................................................................................................................5
2. Introduction..........................................................................6
2.1 Overview.................................................................................................................6
2.2 Overview LED illumination......................................................................................6
2.3 LED illumination LI02..............................................................................................7
2.4 Bluelter.................................................................................................................7
2.5 Periphery or background illumination .....................................................................7
3. Appliance assembly / installation......................................7
3.1 Placement of adhesive label for the automatic
left/right detection....................................................................................................7
3.2 Camera assembly...................................................................................................7
3.3 Cabling of the RM02 (diagram)...............................................................................8
3.4 Microscope and illumination....................................................................................8
3.5 Regulating the clearance of the slit width control....................................................8
3.6 Step-by-step cabling...............................................................................................9
4. Startup................................................................................10
4.1 Switching on the device........................................................................................10
5. Operation............................................................................10
5.1 Setting the eyepieces............................................................................................10
5.2 Field of view .........................................................................................................10
5.3 White balance ......................................................................................................10
5.3.1 Slit lamp preparation ............................................................................................10
5.3.2 Conducting a white balance..................................................................................10
5.4 Software / Help menu / Error messages...............................................................11
5.5 Preparing the patient ............................................................................................11
5.6 Operating the instrument ......................................................................................12
5.7 Settingthelters&diaphragms ...........................................................................13
5.8 Fixation star ..........................................................................................................13
5.9 Microscope and eyepiece ....................................................................................13
5.10 Reduced operation................................................................................................13
5.11 LED display Illumination head...............................................................................13
5.12 LED display power supply.....................................................................................13
5.13 LED display release module RM02.......................................................................14
5.14 LED display camera..............................................................................................14
5.15 Error messages (illumination head)......................................................................14
5.16 Error messages release module RM02.................................................................14
5.17 Error messages camera........................................................................................15
5.18 Software / Help menu / Error messages...............................................................15
6. Decommissioning..............................................................15
7 Technical data ................................................................... 15
7.1 Slit illumination .....................................................................................................15
7.2 Power supply .......................................................................................................15
7.3 Stereo microscope ...............................................................................................15
7.4 Instrument base ...................................................................................................16
7.5 Dimensions...........................................................................................................16
7.6 Camera.................................................................................................................16
7.7 Minimum PC requirements ..................................................................................16
8. Maintenance.......................................................................16
8.1 Device inspection..................................................................................................16
8.2 Servicing...............................................................................................................16
8.3 Cleaning................................................................................................................17
8.4 Replacing the illumination mirror...........................................................................17
8.5 Dust cover.............................................................................................................17
A. Appendix............................................................................17
A.1 Accessories / spare parts......................................................................................17
B. Statutory requirements .................................................... 17
C. Classication ....................................................................17
D. Disposal..............................................................................18
E. Observed standards..........................................................18
F. Information and manufacturer's declaration
concerning electromagnetic compatibility
(EMC)..................................................................................19
F.1 General.................................................................................................................19
F.2 Emitted interference (standard table 1).................................................................19
F.3 Interference immunity (standard table 2)..............................................................20
F.4 Interference immunity for non-life-supporting devices (standard table 4).............21
F.5 Safe distances for non-life-supporting devices (standard table 6)........................22
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04010 – 2015 – 08
1. Safety
DANGER!
Failure to comply with these instructions may result in material damage
or pose a danger to patients or users.
WARNING!
These warnings must absolutely be complied with to guarantee
safe operation of the device and to avoid any danger to users and
to patients.
NOTE!
Important information: please read carefully.
1.1 Areas of application of the device
The device is intended for use in doctor's practices, hospitals and optometrists' and
opticians' premises.
1.2 Ambient conditions
Transport: Temperature
Air pressure
Relative humidity
from
from
from
−40°C
500 hPa
10%
to
to
to
+70°C
1060 hPa
95%
Storage:
Temperature
Air pressure
Relative humidity
from
from
from
−10°C
700 hPa
10%
to
to
to
+55°C
1060 hPa
95%
Use:
Temperature
Air pressure
Relative humidity
from
from
from
+10°C
800 hPa
30%
to
to
to
+35°C
1060 hPa
90%
1.3 Shipment and unpacking
• Before you unpack the device, check whether the packaging shows traces of in-
correct handling or damage. If this is the case, notify the transport company that
has delivered the goods to you. Unpack the device together with a representative
of the transport company. Prepare a report for any possibly damaged parts. This
report must be signed by you and by the representative of the transport company.
• Leave the device in the packaging for a few hours before unpacking it (conden-
sation).
• Check the device for damage after it is unpacked. Return defective devices in the
appropriate packaging.
• Store packaging material carefully, so that it can be used for possible returns or
when moving.
• Theslitlampandheadrestmustbeinstalledonanelectricallyinsulated,re-re-
sistant table top.
• The rail covers (a) prevent the slit lamp from tilting.
• Check:Are the connection parts of the accessories in the correct position
(screwed connections, quick-release fasteners)?
(a)
1.4 Installation warnings
WARNING!
• Do not modify this equipment without authorization of the manufacturer
.
Installation and repairs may only be performed by trained specialists.
Any third-party device must be connected in compliance with the
EN 60601-1 standard.
The device must not be stacked or placed in close proximity to other
electronic devices.
•
•
1.5 Operation, environment
DANGER!
Never use the device in potentially explosive environments where vola-
tile solvents (alcohol, petrol, etc.) and flammable anaesthetics are in
use.
WARNING!
The device must be switched off after every use. Otherwise there is a
risk of overheating when a protective dust cover is used.
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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04010 – 2015 – 08
NOTE!
This equipment must only be operated by qualified and trained person-
nel. The owner is responsible for their training. This device may only be
used in accordance with the instructions in "Purpose of use".
1.5 Light toxicity
WARNING!
As extended, intensive illumination can damage the retina, the use of
the device in the examination of the eye should not be prolonged un-
necessarily. The illumination of this slit lamp emits a radiation in the
range between 400 and 750nm. Detailed information on the radiation
can be provided on request. The retinal dose for a photochemical risk
is composed of the product of the radiance and the exposure time.
If the radiance is halved, the time until the exposure time limit value
is reached will double accordingly. To date, no acute, optical radia-
tion hazard has been detected in slit lamps. Nevertheless, we recom-
mend keeping the intensity of the light reaching the patient's retina to
the minimum possible for the respective diagnosis. Children, people
with aphakia and people suffering from eye conditions are most at risk.
An increased risk may also occur if the retina is exposed to the same
or a similar device with a visible light source within 24 hours. This ap-
plies,inparticular,iftheretinahasbeenphotographedwithaashbulb
in advance.
The light from this instrument may be dangerous. The risk of eye dam-
age increases with the exposure time.An exposure time with this in-
strument at maximum intensity of longer than 143 seconds exceeds
the guideline value for a risk in accordance with EN ISO 15004-2.
1.7 Disinfection
NOTE!
The device does not require disinfection. For more information on
cleaning, please refer to the 'Maintenance' section.
1.8 Warranty and product liability
Haag-Streit products must be used only for the purposes and in the manner des-
cribed in the documents distributed with the product.
The product must be treated as described in the ‘Safety’ chapter. Improper hand-
ling can damage the product. This would void all guarantee claims.
Continued use of a product damaged by incorrect handling may lead to personal
injury. In such a case, the manufacturer will not accept any liability.
Haag-Streit does not grant any warranties, either expressed or implied, including
implied warranties of merchantability or fitness for a particular use.
Haag-Streit expressly disclaims liability for incidental or consequential damage
resulting from the use of the product.
This product is covered by a limited warranty granted by your seller.
This product is covered by a limited warranty, which may be reviewed at
www.haag-streit-usa.com.
•
•
•
•
•
•
For US
A only:
•
1.9 Symbols
Read the instructions for use
attentively
General warning: Read the ac-
companying documentation
Notes on disposal, see the
'Disposal' chapter
This appliance fulfills the Euro-
pean Directive 2011/65/EU
(RoHS)
Year of production Manufacturer
European certificate of
conformity Earth (ground)
Direct current
Not protected from foreign
bodies
Serial number HS reference number
Strong permanent magnets Plug socket USB 3.0 micro
B on RM 02 for computer
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