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. 1500.7220505‑04060 – 2021 – 08
INSTRUCTIONS FOR USE
Slit lamp
BI 900¨
6. Edition / 2021 – 08

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220505‑04060 – 2021 – 08
INSTRUCTIONS FOR USE
Slit Lamp
BI 900¨
6. Edition / 2021 – 08
Preface
Thank you for choosing a Haag-Streit device. Provided you comply carefully with the
regulations in these instructions for use, we can guarantee reliable and trouble-free
use of our product.
WARNING!
Read the instruction manual carefully before commissioning this product.
It contains important information regarding the safety of the user and
patient.
NOTE!
For USA only: 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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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220505‑04060 – 2021 – 08
Contents
¥ 1 Safety...................................................................................................................................................4
◦ 1.1 Comments on these instructions for use........................................................................................4
◦ 1.2 Ambient conditions.........................................................................................................................4
◦ 1.3 Shipment and unpacking ...............................................................................................................4
◦ 1.4 Installation warnings ......................................................................................................................4
◦ 1.5 Operation, environment .................................................................................................................5
◦ 1.6 Light toxicity ...................................................................................................................................5
◦ 1.7 Disinfection ....................................................................................................................................6
◦ 1.8 Warranty and product liability ........................................................................................................6
◦ 1.9 Reporting obligation.......................................................................................................................6
◦ 1.10 Description of symbols.................................................................................................................6
¥ 2 Intended purpose / intended use .......................................................................................7
◦ 2.1 Device description..........................................................................................................................7
▪ 2.1.1 Intended users....................................................................................................................7
◦ 2.2 Medical purpose.............................................................................................................................7
▪ 2.2.1 Indications...........................................................................................................................7
▪ 2.2.2 Part of the body ..................................................................................................................7
▪ 2.2.3 Patient population...............................................................................................................7
▪ 2.2.4 Contraindications................................................................................................................7
◦ 2.3 Principles of operation ...................................................................................................................7
▪ 2.3.1 Operating environment .......................................................................................................8
◦ 2.4 Clinical benefit................................................................................................................................8
¥ 3 Introduction .....................................................................................................................................8
◦ 3.1 Overview........................................................................................................................................8
◦ 3.2 Overview LED illumination.............................................................................................................9
◦ 3.3 LED illumination LI02 plus .............................................................................................................9
▪ 3.3.1 Blue filter.............................................................................................................................9
▪ 3.3.2 Background illumination......................................................................................................9
¥ 4 Device assembly / installation ...........................................................................................10
◦ 4.1 Placement of adhesive label for the automatic left/right detection...............................................10
◦ 4.2 Camera assembly........................................................................................................................10
◦ 4.3 Cabling of the RM02 (diagram)....................................................................................................10
◦ 4.4 Microscope and illumination.........................................................................................................11
◦ 4.5 Step-by-step cabling ....................................................................................................................11
¥ 5 Commissioning ...........................................................................................................................13
◦ 5.1 Switching on the device ...............................................................................................................13
¥ 6 Operation.........................................................................................................................................13
◦ 6.1 Setting the eyepieces...................................................................................................................13
◦ 6.2 Field of view.................................................................................................................................13
◦ 6.3 White balance ..............................................................................................................................13
▪ 6.3.1 Slit lamp preparation.........................................................................................................13
▪ 6.3.2 Conducting a white balance..............................................................................................14
◦ 6.4 Software / Help menu / Error messages...................................................................................... 14
◦ 6.5 Preparing the patient ...................................................................................................................14
◦ 6.6 Operating the device ...................................................................................................................14
◦ 6.7 Setting the filters & diaphragms................................................................................................... 16
◦ 6.8 Fixation star................................................................................................................................. 16
◦ 6.9 Microscope and eyepiece............................................................................................................ 16
◦ 6.10 Reduced operation ....................................................................................................................16
◦ 6.11 LED indicator illumination head................................................................................................. 17
◦ 6.12 LED indicator power supply....................................................................................................... 17
◦ 6.13 LED indicator release module RM02......................................................................................... 17
◦ 6.14 LED indicator camera................................................................................................................ 17
◦ 6.15 Error messages (illumination head)........................................................................................... 18
◦ 6.16 Error messages release module RM02..................................................................................... 18
◦ 6.17 Error messages camera ............................................................................................................18
◦ 6.18 Software / Help menu / Error messages.................................................................................... 19
¥ 7 Decommissioning ..................................................................................................................... 19
¥ 8 Technical data ............................................................................................................................. 19
◦ 8.1 Slit illumination............................................................................................................................. 19
◦ 8.2 Power supply............................................................................................................................... 19
◦ 8.3 Stereo microscope....................................................................................................................... 20
◦ 8.4 Instrument base........................................................................................................................... 20
◦ 8.5 Dimensions.................................................................................................................................. 20
◦ 8.6 Camera........................................................................................................................................ 20
◦ 8.7 Minimum PC requirements.......................................................................................................... 20
¥ 9 Maintenance.................................................................................................................................. 21
◦ 9.1 Device inspection ........................................................................................................................21
◦ 9.2 Service......................................................................................................................................... 21
◦ 9.3 Cleaning and disinfection ............................................................................................................ 21
◦ 9.4 Replacing the illumination mirror .................................................................................................21
◦ 9.5 Dust cover ...................................................................................................................................22
¥ 10 Appendix ...................................................................................................................................... 22
◦ 10.1 Accessories / functionals parts / detachable parts / consumables ............................................22
◦ 10.2 Legal regulations .......................................................................................................................22
◦ 10.3 Classification ............................................................................................................................. 22
◦ 10.4 Disposal..................................................................................................................................... 23
◦ 10.5 Observed standards ..................................................................................................................23
◦ 10.6 Information and manufacturer's declaration concerning electromagnetic compatibility (EMC) .23
▪ 10.6.1 General........................................................................................................................... 23
▪ 10.6.2 Emitted interference .......................................................................................................24
▪ 10.6.3 Electromagnetic immunity environment tested (part 1).................................................. 25
▪ 10.6.4 Electromagnetic immunity environment tested (part 2).................................................. 26
▪ 10.6.5 Recommended separation distances between portable and mobile RF communications
equipment and this product....................................................................................................... 28

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220505‑04060 – 2021 – 08
1Safety
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 Comments on these instructions for use
NOTE!
In these instructions for use the point is used as decimal separator.
1.2 Ambient conditions
Temperature −40 °C ... +70 °C
Air pressure 500 hPa ... 1060 hPa
Transport
Relative humidity 10 % ... 95 %
Temperature −10 °C ... +55 °C
Air pressure 700 hPa ... 1060 hPa
Storage
Relative humidity 10 % ... 95 %
Temperature +10 °C ... +35 °C
Air pressure 800 hPa ... 1060 hPa
Use
Relative humidity 30 % ... 90 %
1.3 Shipment and unpacking
• Before unpacking the device, check whether the packaging shows traces of
improper handling or damage. If this is the case, notify the transport company
that delivered the goods to you.
• Unpack the device 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).
•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 potential returns or
when moving.
• The slit lamp and headrest must be installed on an electrically insulated,
fireproof table top.
• The rail covers (a) prevent the slit lamp from tilting.
•Check that the connection parts of the accessories are in the correct position
(screw connections, quick-release fasteners).
1.4 Installation warnings
WARNING!
• Do not modify this device without authorization of the manufacturer.
Installation and repairs may only be performed by trained
specialists.
• Any third-party device must be connected in compliance with the EN
60601-1 standard.
• Only original Haag-Streit spare parts may be used.

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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220505‑04060 – 2021 – 08
• Use of this device adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If
such use is necessary, this device and the other equipment should
be observed to verify that they are operating normally.
• Grounding reliability can only be achieved when unit is connected to
a hospital grade receptacle. (Not valid for EU countries).
• The device should be set up in such a way that the plug is always
easily accessible and the device can easily be disconnected from
the mains.
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.
• This device must not be operated near of high frequency surgical
equipment and the radio frequency shielded room of a medical
electrical system for magnetic resonance imaging, where the
intensity of electromagnetic disturbances is high.
• Portable radio frequency communications equipment (including
peripherals such as antenna cables and external antennas) should
be used no closer than 30 cm (12 inches) to any part of the device,
including cables specified by Haag-Streit. Otherwise, degradation of
the performance of this device could result.
NOTE!
• This device must only be operated by qualified personnel. The
owner is responsible for their training.
• This device may only be used in accordance with the instructions in
the 'Intended purpose / intended use' chapter.
• If unexpected disturbances are observed which manifest themselves
as communication problems between the imaging module and the
EyeSuite software, the cause could be a cell phone or a radio
frequency telephone in the immediate vicinity to the slit lamp or
power supply. Increase the distance to the unit until the interference
disappears.
•The communication between imaging module and PC may also be
disturbed or interrupted, if the device is exposed to a mains power
supply delivering excessively transient disturbances or short voltage
interruptions. If this happens, the USB connector needs to be
disconnected for a short time or the PC needs to be restarted.
1.6 Light toxicity
WARNING!
• The light from this device may be dangerous. The risk of eye
damage increases with the exposure time. An exposure time with
this device at maximum intensity of longer than 131 seconds
exceeds the guideline value for a risk.
• As extended, intensive illumination can damage the retina, the use
of the device 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 750 nm. 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 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

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220505‑04060 – 2021 – 08
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.
1.7 Disinfection
NOTE!
The device can, but does not need to be disinfected. For more
information, please refer to the 'Maintenance' chapter.
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 Reporting obligation
NOTE!
Any serious incident that has occurred in relation to the device must be
reported to Haag-Streit and the competent authority of the Member
State in your country.
1.10 Description of symbols
Follow instruction for use Read the instructions for use
attentively
General warning, read the
accompanying documentation
European certificate of
conformity
Date of manufacture Manufacturer
Haag-Streit reference number Serial number
Trademark of the manufacturer
Haag-Streit AG
Notes on disposal, see the
'Disposal' chapter
Listed European Authorized
Representative Medical Device
Testsymbol of TÜV Rheinland
with approval for INMETRO
Brasil
MET Listed Mark with approval
for USA and Canada
Plug socket USB 3.0 micro B
on RM02 for computer
Plug socket USB 3.0 on RM02
for camera
Strong permanent magnets Plug socket on RM02 for power
supply
Slit lamp illumination Background illumination
On (Power)

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DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
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DEUTSCHENGLISHFRANÇAISITALIANOESPAÑOLNEDERLANDS PORTUGUÊS SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220505‑04060 – 2021 – 08
2Intended purpose / intended 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.
2.1 Device description
The devices of the slit lamp are made up of:
• Stereo biomicroscope
• Slit illumination
• Instrument base
• Headrest and chin rest
The illumination system and a biomicroscope are mounted to an instrument base
operated by joystick. The single joystick allows horizontal and vertical displacement
of the slit lamp across the examination table. Both elements, the illumination system
and the biomicroscope, can be swiveled progressively across the pivot,
independently of one another.
A sturdy headrest is attached to the table. Both the table and the chin rest are
adjustable in height to provide a comfortable, yet sturdy examination position to the
patient, outside of the device's range of motion. As this device operates non-
invasively it only comes into contact with the patient at the chin rest and forehead
band.
2.1.1 Intended users
Users are qualified medical professionals such as ophthalmologists, optometrists,
opticians, nurses and researchers or other qualified specialists as permitted by local
legislation.
2.2 Medical purpose
This device has the following medical purpose:
• Diagnosis and monitoring of diseases of the anterior segment of the eye
• Diagnosis and monitoring of injuries of the anterior segment of the eye
• Investigation of the anatomy and physiological or pathological state of the
anterior segment of the eye
2.2.1 Indications
The use of the slit lamp is indicated for the following medical conditions:
• Local and systemic diseases affecting the eye
• Lesions and defects of the anterior segment
• Acute infections and inflammations
• Presence of intraocular foreign bodies
• Other traumata of the eye
2.2.2 Part of the body
The slit lamp is intended for the examination of the human eye, specifically the
anterior segment of the eye (i.e., lids, lashes, conjunctiva, cornea, anterior chamber,
iris, and lens).
2.2.3 Patient population
This device is intended for use on human patients with the physical ability to sit in
front of a slit lamp with their head resting against the headrest in a steady position
and the mental ability to follow instructions.
2.2.4 Contraindications
There are no known contraindications.
2.3 Principles of operation
• The slit lamp implements the principle of focal illumination: The focal point of the
microscope and the illumination coincide.
• The microscope arm and the illumination arm are mounted on an instrument
base: Both can be swivelled independently around the same vertical axis.
• The instrument base can be moved in all three axes.
• When illuminating transparent media with a narrow, sharp slit, an 'optical
section' can be magnified and viewed through the microscope.
• The patient's head is fixed to a height-adjustable headrest holder so that the
examination can be carried out quickly and as comfortably as possible for both
doctor and patient.

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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220505‑04060 – 2021 – 08
2.3.1 Operating environment
The slit lamp is intended to be used in professional health care facilities such as
hospitals, physician's, optometrist's and optician's practices. For optimal use of the
slit lamp, the ambient lighting should be attenuated to improve image contrast. In
case of transillumination of the iris or for viewing details at great magnification at a
narrow slit, it may be necessary to completely darken the room.
2.4 Clinical benefit
The use of the slit lamp allows for the systematic examination of the eye under
magnification, thus permitting the diagnoses of pathologies that may have otherwise
remained unidentified and could have lead to blindness if left untreated.
The clinical benefits of the product outweigh the remaining residual risks to the
patient.
3Introduction
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. There is also a range of accessories available for the slit lamp to allow
special diagnosis possibilities in addition to the general examinations.
NOTE!
The BI 900 slit lamp can be optionally equipped with the imaging set
(REF 7220535).
3.1 Overview
1. Lamp cable
2. LED illumination LI 900
3. Filter lever
4. Optical light guide for background
illumination (option)
5. Slit length, slit rotation, blue filter
and fixation star control, knob for
rotating the slit
6. Scale for angled position of the slit
image (5° increments)
7. Background illumination FI01f
(option)
8. Illumination mirror
9. Diffusing lens
10. Headrest (see separate
instructions)
11. Protective cover
12. Illumination unit / microscope
angle scale
13. Illumination arm locking screw
14. Microscope arm locking screw
15. Camera cable (option)
16. Release module RM02
17. Sticker left/right identification
18. Axle
19. Rail cover
20. Cover cap for the accessories
base
21. Stereo microscope
22. Eyepieces
23. Mounting screw for breath shield
(option)
24. Breath shield (option)
25. Centring screw for illumination
26. Camera operational control LED
(option)
27. Inclination angle latch 0 – 20°
28. Slit width controls
29. Roller rail
30. Control lever
31. Camera (option)
32. Slide plate
33. EyeSuite Imaging software
(option)
34. Power supply
35. Electric power supply lead (country
dependent)

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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220505‑04060 – 2021 – 08
3.2 Overview LED illumination
36. LED illumination LI02 plus with background illumination
37. Plug connection
38. Filter wheel for blue filter
39. Connection background illumination
40. Cover
3.3 LED illumination LI02 plus
3.3.1 Blue filter
41. The rotating wheel is used to pivot the blue filter for the background
illumination. Marking points at the same height = blue filter is on.
3.3.2 Background illumination
The background illumination can only be used in conjunction with an LED
illumination LI02 plus.
42. Background illumination fixed
43. Background illumination pivoting (option)

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4 Device assembly / installation
WARNING!
• Do not modify this device without authorization of the manufacturer.
Installation and repairs may only be performed by trained
specialists.
•Contact your Haag-Streit representative for installation, repairs and
modification work on the system. The contact details are available at
www.haag-streit.com.
• Only original Haag-Streit spare parts may be used.
4.1 Placement of adhesive label for the automatic left/right
detection
• Remove rail cover (19) and place slit lamp aside. Clean surface of table.
• Remove protective film from the back of the adhesive label. Carefully start at the
corner opposite the black surface.
• Position the sticker against the right roller rail (45) and the gliding plate (46).
Press firmly on the white/black surface, press away any air bubbles.
•Carefully tear off the remainder of the adhesive label (44) along the perforation.
• Reassemble the slit lamp and rail cover.
44. Rest of the sticker
45. Roller rail
46. Gliding plate
4.2 Camera assembly
• Remove the cover caps from the camera and adapter.
• Screw the camera (48) onto the adapter.
• Position the image upright setting on the monitor: Slightly loosen the 3 retaining
screws (47), turn the camera around its vertical axis until the position is correct;
reaffix the camera. Through the software, the image can be displayed
horizontally or vertically.
• Mount the camera casing (50) and fix in place with screws (49)
47. Retaining screws
48. Camera
49. Fastening screws
50. Camera casing
4.3 Cabling of the RM02 (diagram)
WARNING!
• Only use the supplied USB 3.0 cable (REF 1022373) for the
connection to the PC.
•Only use medically approved PCs or operate via a medically
approved isolating transformer.
•Auxiliary units on the PC (e.g. printer, monitor) must be operated
through an isolating transformer.
• Ethernet may only be used through a galvanic isolation in
accordance with EN 60601-1.
• The power supply unit's mains connector must be accessible in
order to allow for disconnection from the electric mains at any time.