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DEUTSCH

ENGLISH

FRANÇAIS

ITALIANO

ESPAÑOL

NEDERLANDS

PORTUGUÊS

SVENSKA

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 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.

Содержание BI 900

Страница 1: ... DEUTSCH ENGLISH 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 ...

Страница 2: ...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 ...

Страница 3: ...p 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 indicat...

Страница 4: ...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 d...

Страница 5: ...th 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 ...

Страница 6: ... 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 ...

Страница 7: ...onitoring 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 a...

Страница 8: ... 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 illumin...

Страница 9: ...ilter 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 Backgroun...

Страница 10: ... 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 t...

Страница 11: ...ction plug 66 180 Fix the cover on the upper part of the illumination facility with the fastening screw 65 Connect the device to the mains again WARNING Keep magnet sensitive storage media e g credit cards away from the magnets on the release module RM02 Only external medical power supplies approved by Haag Streit that fulfill EN 60601 1 may be used 4 4 Microscope and illumination The slit lamp is...

Страница 12: ...drest Mount the table board and place the slit lamp on the table Connect the computer cable USB 3 0 73 to the PC Connect the electric power supply lead 35 to the power supply 34 Connect the power supply connector plug to the mains Plug the headrest cable 1 into the lamp head 67 Connection plug headrest 68 Connector plug headrest LED illumination RM02 69 Cable tie 70 Braided sleeving 71 Cable headr...

Страница 13: ...ring with dioptre scale until the projected slit can be seen in focus The setting is performed from the to the side at low magnification The sliding occluders 94 are used to set the correct working distance for the examiner from the eyepiece Examiners who do not wear glasses Pull the occluders out as far as they will go Examiners who do wear glasses Push the occluders in as far as they will go 6 2...

Страница 14: ...e 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 After each examination the LED illumination must be switched off via the release module See chapter Decommis...

Страница 15: ...d 10 a short mirror 8 is used the illumination turned 90 using the setting screw 5 and tilted in 5 steps using the latch 27 and the illumination and microscope turned to the central position 0 Front lenses and contact lenses are used to examine the ocular fundus Diffuse illumination Connecting the diffusor 9 upstream creates diffused illumination This allows monitoring of the overview and can be u...

Страница 16: ...entre hole of the star This allows the examiner to see where the patient s vision is most focused A typical use of the fixation star is close to the macula during laser treatment Similarly it is also possible to identify microstrabismus with the projection of the fixation star The fixation star is usually used with an upstream red removal filter 6 9 Microscope and eyepiece 95 Two objective lens pa...

Страница 17: ...ound illumination on Green x Green Only slit illumination on Green pulsing x Green Only background illumination on Green x Green pulsing Reduced background illumination operation High LED temperature thus reducing background illumination operation Green flashing x Green flashing 6 12 LED indicator power supply Normal operation Green 6 13 LED indicator release module RM02 Normal operation Green LED...

Страница 18: ...d once the permissible temperature has been reached Red flashing x Red flashing E4 No communication between power supply and illumination Contact your Haag Streit representative Red flashing 2 x Red flashing 2 E6 General error Send RM02 to the appropriate service branch Red flashing 4 x Red flashing 4 6 16 Error messages release module RM02 ERROR Error messages Measures Operational control LED 78 ...

Страница 19: ... goes out The camera has no separate On Off switch It switches off automatically when the PC is switched off NOTE The On Off key on the release module RM02 does not disconnect the device from the electric mains Disconnect the power supply from the mains by unplugging the mains connector if you do not intend to use it for an extended period of time 8 Technical data 8 1 Slit illumination NOTE Detail...

Страница 20: ...adrest and options Dimensions L W H 310 332 700 mm Packaging L W H 420 510 780 mm 8 6 Camera Camera beam Beam path left from the point of view of the doctor Sensor type CMOS Interface USB 3 0 Frame rate 30 fps frames per second Power consumption 5 V 600 mA 8 7 Minimum PC requirements Processor type Intel i5 5th gen or higher with 4 cores NOTE 6th gen is not recommended 2 cores with hyperthreading ...

Страница 21: ...t rod by 45 the sharp area must be in the centre of the test rod 9 2 Service To guarantee a long service life the device must be cleaned weekly as described and protected with the dust cover when not in use We recommend having the device inspected once a year by an authorized service technician 9 3 Cleaning and disinfection The Haag Streit slit lamps and their accessories can if required be carefu...

Страница 22: ...er to the instructions for use Contact lenses Goldmann Diagnostics Laser Applanation Tonometer Please refer to the instructions for use AT 900 AT 870 and Applanation tonometer AT 900 D Headrest Please refer to the instructions for use Headrest 10 2 Legal regulations This device was developed and designed taking the EN 60601 1 EN ISO 10939 and EN ISO 15004 2 standards into account The EN 60601 1 st...

Страница 23: ...evice fulfills the requirements on electromagnetic compatibility according to IEC 60601 1 2 2014 4th Edition The device is built so that the generation and emission of electromagnetic interference is limited to the extent that other devices are not disturbed in their use in accordance with the regulations and so that the device itself is suitably immune to electromagnetic interference WARNING Elec...

Страница 24: ...etic environment guidance RF emissions CISPR 11 Group 1 This product uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B Harmonics emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable This product is suitab...

Страница 25: ...Not applicable for DC and I O if cable 3 m Surge IEC 61000 4 5 0 5 1 kV line s to line s 0 5 1 2 kV line s to earth 1 kV line s to line s 0 5 1 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Not applicable for DC and I O if cable 3 m Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT 0 5 c...

Страница 26: ...o amateur band 6 Vrms 150 kHz 80 MHz in ISM bands and radio amateur band 3 Vrms 150 kHz 80 MHz outside ISM bands and radio amateur band 6 Vrms 150 kHz 80 MHz in ISM bands and radio amateur band Radiated RF IEC 61000 4 3 3 V m 80 MHz 2 7 GHz 80 AM 1 kHz 3 V m 80 MHz 6 GHz 80 AM 1 kHz Proximity field from RF wireless communication equipment IEC 61000 4 3 27 V m 380 390 MHz 50 PM 18 Hz 28 V m 430 470...

Страница 27: ...AN 802 11 a n max 0 2 W Interference may occur in the vicinity of equipment marked with the following symbol The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 6 795 MHz 13 553 13 567 MHz 26 957 27 283 MHz 40 66 40 7 MHz The amateur radio bands between 0 15 MHz and 80 MHz are 1 8 MHz 2 MHz 3 5 4 0 MHz 5 3 5 4 MHz 7 7 3 MHz 10 1 10 15 MHz 14 14 2 MHz 18 07 18 17 MH...

Страница 28: ...z Ð 80 MHz outside ISM and radio amateur bands d 1 2 P 150 kHz Ð 80 MHz in ISM and radio amateur bands d 2 0 P 800 MHz Ð 2 7 GHz for define RF Wireless transmitters see table before d 2 0 P 0 01 0 12 0 20 0 20 0 1 0 38 0 63 0 63 1 1 2 2 0 2 0 10 3 8 6 3 6 3 100 12 20 20 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determ...

Страница 29: ...ALIANO ESPAÑOL NEDERLANDS PORTUGUÊS SVENSKA HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220505 04060 2021 08 Should you have any further questions please contact your Haag Streit representative at Wiki Revision ID 113676 ...

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