Haag-Streit BM 900 Manual de usuario
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7200492-04180 – 18. Edition / 2021 – 08
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DOC. no. 1500 1500.1400209.04000
INSTRUCTIONS FOR USE
Slit lamp
BM 900¨
18. Edition / 2021 – 08
2© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7200492-04180 – 18. Edition / 2021 – 08
DEUTSCHENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS
PORTUGUÊS SVENSKA
INSTRUCTIONS FOR USE
Slit lamp
BM 900¨
18. 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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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7200492-04180 – 18. Edition / 2021 – 08
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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 ....................................................................................................................................5
◦ 1.8 Warranty and product liability ........................................................................................................6
◦ 1.9 Reporting obligation.......................................................................................................................6
◦ 1.10 Description of symbols.................................................................................................................6
¥ 2 Intended purpose / intended use .......................................................................................6
◦ 2.1 Device description..........................................................................................................................6
▪ 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 .......................................................................................................7
◦ 2.4 Clinical benefit................................................................................................................................7
¥ 3 Introduction .....................................................................................................................................8
◦ 3.1 Overview........................................................................................................................................8
¥ 4 Device assembly / installation .............................................................................................9
◦ 4.1 Microscope and illumination...........................................................................................................9
◦ 4.2 Power supply .................................................................................................................................9
◦ 4.3 Regulating the clearance of the slit width controls.........................................................................9
¥ 5 Commissioning .............................................................................................................................9
◦ 5.1 Switching on the device .................................................................................................................9
¥ 6 Operation...........................................................................................................................................9
◦ 6.1 Setting the eyepieces.....................................................................................................................9
◦ 6.2 Preparing the patient....................................................................................................................10
◦ 6.3 Operating the device....................................................................................................................10
◦ 6.4 Setting the filters & diaphragms...................................................................................................11
◦ 6.5 Fixation star .................................................................................................................................11
◦ 6.6 Microscope and eyepiece ............................................................................................................12
¥ 7 Decommissioning......................................................................................................................12
¥ 8 Technical data..............................................................................................................................12
◦ 8.1 Slit illumination.............................................................................................................................12
◦ 8.2 Stereo microscope....................................................................................................................... 12
◦ 8.3 Instrument base........................................................................................................................... 13
◦ 8.4 Dimensions.................................................................................................................................. 13
¥ 9 Maintenance.................................................................................................................................. 13
◦ 9.1 Device inspection ........................................................................................................................ 13
◦ 9.2 Servicing...................................................................................................................................... 13
◦ 9.3 Cleaning and disinfection ............................................................................................................13
◦ 9.4 Replacing the illumination mirror .................................................................................................14
◦ 9.5 Dust cover ................................................................................................................................... 14
¥ 10 Appendix ...................................................................................................................................... 14
◦ 10.1 Accessories / functionals parts / detachable parts / consumables ............................................14
◦ 10.2 Legal regulations .......................................................................................................................15
◦ 10.3 Classification ............................................................................................................................. 15
◦ 10.4 Disposal..................................................................................................................................... 15
◦ 10.5 Observed standards ..................................................................................................................15
◦ 10.6 Information and manufacturer's declaration concerning electromagnetic compatibility (EMC) .15
▪ 10.6.1 General........................................................................................................................... 15
▪ 10.6.2 Emitted interference .......................................................................................................16
▪ 10.6.3 Electromagnetic immunity environment tested (part 1).................................................. 17
▪ 10.6.4 Electromagnetic immunity environment tested (part 2).................................................. 18
▪ 10.6.5 Recommended separation distances between portable and mobile RF communications
equipment and this product....................................................................................................... 20
4© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7200492-04180 – 18. Edition / 2021 – 08
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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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• 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.
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 152 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
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.
6© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7200492-04180 – 18. Edition / 2021 – 08
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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.
• The optional T-Cone must be stored in its original dust cover and protected from
direct sunlight.
• 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
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.
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© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7200492-04180 – 18. Edition / 2021 – 08
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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.
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.
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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.
3.1 Overview
1. Lamp cable
2. Headrest
3. Headband
4. Height mark on headrest (patient
eye)
5. Adjustable fixation lamp
6. Chin rest
7. Height adjustment of chin rest
8. Diffusor
9. Illumination head LED LI 900 (see
separate instructions)
10. Lever to change filter
11. Scale for angled position of the slit
image (5° increments)
12. Illumination mirror
13. Breath shield (option)
14. Protective cover
15. Illumination unit / microscope
angle scale
16. Illumination arm locking screw
17. Microscope arm locking screw
18. Slit width controls
19. Slit length / diaphragm scale
20. Slit length, slit rotation, blue filter
and fixation star control
21. Cover screw for accessories pin
22. Stereo microscope with eyepieces
23. Eyepieces
24. Lens-changing lever
25. Mounting screw for the stereo
microscope
26. Centring screw
27. Inclination angle latch 0 − 20°
28. Joy stick base locking screw
29. Rail cover
30. Control lever
31. Slide plate
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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 Microscope and illumination
• The slit lamp is packaged and delivered fully assembled. The transport safety
devices must be removed prior to commissioning.
4.2 Power supply
NOTE!
• Observe the respective Haag-Streit instructions for use. For further
information, please contact your Haag-Streit representative.
•This device must only be operated with PS-LED and PS-LED HSM
901 Haag-Streit power supplies and the RM02 release module.
4.3 Regulating the clearance of the slit width controls
The small screw in the centre of the right control knob
(18) allows you to regulate the friction of the turning
movement of these adjusting knobs. Turning it slightly
to the right (in) makes it harder, turning it left (out)
makes it easier. It should at least be set so hard that
the slit cannot close on its own.
5 Commissioning
The device can be switched on and off using the mains power switch on the power
supply. The green lamp in the rocker switch lights up when the device is switched
on.
5.1 Switching on the device
• Connect the power supply to the mains and press the rocker switch. The green
lamp in the rocker switch lights up when the device is switched on.
• Turn the rotating knob on the illumination control to a position between '1' and
'10'.
6Operation
6.1 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 focus
test rod (32) in place of the protective cover (14) and turn its black
projection surface at a right angle to the microscope axis. Return the
illumination and microscope to the central position (0°).
14. Protective cover
32. Test rod
33. Knurled ocular refraction ring with
dioptre scale
• Each eyepiece should be set individually by turning the knurled ocular refraction
ring with dioptre scale (33) 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.
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6.2 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 distracting streaking of light.
• Applied parts which come into contact with the patient (headrest) should be
disinfected prior to every use (see instructions for use 'Headrest').
• The slit lamp must be switched off after every examination in accordance with
the 'Decommissioning' chapter.
6.3 Operating the device
WARNING!
The device must be switched off after every use. Otherwise there is a
risk of overheating when a protective dust cover is employed.
• Use the turn screw (7) to set the chin rest (6) in such a way that the patient’s
eyes are at the same height as the black mark (4) on the sides of the headrest.
• Adjust the eyepieces (23) in accordance with the examiner’s refraction by
turning the knurled rings and set the eye distance.
• Switch on the illumination by turning the switch on the power supply.
• Adjust the height of the slit lamp by turning the control lever (30) until the light
beam and microscope axis are at eye level.
• The rigid control lever (30) gently inclined towards the examiner can be used to
push the entire device until the slit appears approximately focused on the
cornea. This initial setting is verified with the naked eye. Fine tuning is
performed by tilting the control lever, which is easily controlled at the top end,
while observing via the stereo microscope (22).
• 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 facility on the control knob (20) (locking points at 45°,
90° and 135°; stops at 0° and 180°; scale in 5° increments).
• To ensure that unimpeded binocular fundus examination in the optical section is
also possible at lateral angles of between 3° and 10°, a short mirror (12) is
used, the illumination turned 90° using the locking screw (20) and tilted in 5°
steps using the latch (27), and the illumination and microscope turned to the
central position (0°).
• The magnification of the stereo microscope can be changed on the slit lamp BM
900 by changing the lenses using the lever (24) or exchanging the eyepieces.
• Front lenses and contact lenses are used to examine the ocular fundus.
Diffuse illumination:
Connecting the diffusor (8) upstream creates diffused illumination. This allows
monitoring of the overview and can be used to capture the overview with an imaging
module.
Indirect illumination:
For observation in regredient light (indirect illumination), the centring screw (26) is
loosened in order to move the slit image out of the centre of the visual field.
Tightening the screw centres the slit image again.
Slit tilting:
The latch (27) can be used to tilt the illumination in 5° steps. This creates an angled
light beam during horizontal slit orientation. Tilting the slit enables reflex-free
examination with contact lenses (fundus and gonioscopy) and magnifying lenses.
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3
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