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22

DEUTSCH

ENGLISH 

FRANÇAIS

ITALIANO

ESPAÑOL

NEDERLANDS

PORTUGUÊS

SVENSKA

© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220449‑04090 – 2021 – 08

Applanation Tonometer

Please refer to the instructions for use 'Applanation

tonometer 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 standard must be observed when using different medical and/

or non-medical electrical devices in combination.

• Compliance of the device with the Medical Device Regulation 2017/745 is

confirmed by the CE-designation.

• The device satisfies the electromagnetic compatibility requirements of EN

60601-1-2. The device has been designed to maintain the emissions of

electromagnetic interference at a level which does not exceed the statutory

guidelines and which does not affect other devices in its vicinity.

• The device also has the immunity stipulated by the standard.

• You can request a copy of the declaration of conformity for this device from

Haag-Streit at any time.

• Statutory accident regulations are to be observed.

10.3 Classification

Standard EN 60601-1

Protection class I

Operating mode

Continuous operation

CE Medical Device Regulation

2017/745

Class I

FDA

Class II

10.4 Disposal

Electrical and electronic devices must be disposed of separately from

household waste! This device was made available for sale after the

13th August 2005. For correct disposal, please contact your Haag-

Streit representative. This will guarantee that no hazardous

substances enter the environment and that valuable raw materials are

recycled.

10.5 Observed standards

EN 60601-1
EN 60601-1-2
EN ISO 10939
EN ISO 15004-2 *

*

When the flash illumination is used, the emission exceeds the Group 2 limit of parameter 'weighted

retinal visible and infrared thermal radiance, LVIR-R' as specified by EN ISO 15004-2:2007 but does
not exceed the limit 'retinal thermal' as specified by ICNIRP 2013. Since this retinal exposure limit is
not exceeded in case of normal operation, the device can be regarded as safe for the patient’s eye
when operated within the limits specified by Haag-Streit.

Summary of Contents for BX 900

Page 1: ...UTSCH ENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS PORTUGUÊS SVENSKA HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220449 04090 2021 08 INSTRUCTIONS FOR USE Photo slit lamp BX 900 9 Edition 2021 08 ...

Page 2: ...an 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 emitti...

Page 3: ...e compensation facility 13 4 4 Switching off the compensation facility 13 4 5 Regulating the clearance of the slit width controls 13 4 6 Attaching removing a camera 13 5 Commissioning 13 5 1 Switching on the device 13 6 Operation 14 6 1 Setting the eyepieces 14 6 2 Preparing the patient 14 6 3 Operating the device 14 6 4 Background illumination flash 15 6 5 Photo diaphragm pre selection 15 6 6 Set...

Page 4: ...ir 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...

Page 5: ...here 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...

Page 6: ...ed 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 us...

Page 7: ...e 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 th...

Page 8: ...ncide 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 s...

Page 9: ...and red removal filter 3 Scale for angled position of the slit image 5 increments 4 Illumination mirror 5 Magnification changer 6 Mounting screw for the stereo microscope 7 LED background illumination with swivel bracket 8 Illumination unit microscope angle scale 9 Illumination arm locking screw 10 Microscope arm locking screw 11 Slit width controls 12 Weight compensation screws 13 Diffusor 14 Sli...

Page 10: ...ht guide for background illumination 31 Pivoting mirror 32 Rotating knob for diaphragm pre selection 33 Rotating knob for diaphragm preview actuation 34 Rotating knob for aperture preview 35 Flash unit FU 01 36 Flash tube housing 37 Flash tube 38 Lens barrel 39 Camera housing 40 Camera cable 41 Ocular with double cross hairs 42 Mirror and diaphragm component 43 Cable trigger key for mirror diaphra...

Page 11: ...t a power supply an optical light guide set for background illumination and an illumination control The two core connection cable between the power supply and illumination head transmits both the supply current for the LED as well as signals for communication between the power supply and illumination The light intensity of the slit and background illumination can be regulated continuously without ...

Page 12: ... original Haag Streit spare parts may be used 59 Medically approved isolating transformer 60 Mains 61 Instrument table 62 Camera power supply 63 Printer 64 Screen 65 Personal computer 66 Illumination control IC 01 67 PS LED or PS LED HSM 901 68 Flash unit FU 01 69 Optional power input also possible with battery operation 70 Optional camera port saving to a card is also possible 71 Galvanic isolati...

Page 13: ...he counterbalance springs 4 5 Regulating the clearance of the slit width controls The small screw in the centre of the right control knob A 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 4 6 Attaching r...

Page 14: ...g 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 d...

Page 15: ...ng The latch 23 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 6 4 Background illumination flash When the flash is triggered the light is transferred to the background illumination by a light guide 100 open 50 open 25...

Page 16: ...al filter 6 8 Microscope and eyepiece 87 Front lens 88 Rotary knob displaying the set magnification 89 5 level magnification changer Galilei system 90 Knurled ring for bayonet connector 91 Binocular tube with convergent view pupil distance can be set from 52 to 78 mm 92 Eyepiece 12 5 field of vision ø 16 mm 93 Index white point 94 Knurled ring with dioptre scale for setting the refraction of the e...

Page 17: ...defect GENERAL ALARM Contact your Haag Streit representative 7 Decommissioning Throw the rocker switch on the PS LED power supply and the main switch on the FU 01 flash unit 01 I OFF The green lamps in the rocker switches stop lightning when the device is switched off NOTE Disconnect the power supply from the mains if you do not intend to use it for an extended period of time 8 Technical data 8 1 ...

Page 18: ...e slit flash illumination 400 to 750nm Spectral range background flash illumination 400 to 750nm NOTE Detailed information regarding the radiation can be provided on request Flash capacitor capacity normal 200 Ws high 400 Ws Flash frequency See chapter Operating the Flash unit FU 01 Mains connection a 115 V 60 Hz b 230 V 50 Hz Mains fuses a 2 T10AH 250V b 2 T6 3AH 250V Flash unit fuse 1 T5AL 250V ...

Page 19: ...nstallation 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 The LED illumination can be operated maintenance free for its entire service life 9 1 Device inspection In order to correctly check the slit lamp proceed as follows Insert the test rod into the radial movement bearing whilst at the same ...

Page 20: ...ee 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 4 Replacing the fuses WARNING The mains cable must be disconnected from the mains before the cover is screwed on Only fuses of the type indicated in the technical data may be used Remove th...

Page 21: ...ure time Clean optical surfaces after disinfection with a very soft cloth NOTE IP code IPX0 device is not protected against liquids 9 6 Replacing the illumination mirror The mirror can be most easily accessed if the microscope is turned away from the illumination and the illumination inclined two points WARNING Only use mirrors with a LOT number 9 7 Dust cover We recommend protecting the slit lamp...

Page 22: ...immunity stipulated by the standard You can request a copy of the declaration of conformity for this device from Haag Streit at any time Statutory accident regulations are to be observed 10 3 Classification Standard EN 60601 1 Protection class I Operating mode Continuous operation CE Medical Device Regulation 2017 745 Class I FDA Class II 10 4 Disposal Electrical and electronic devices must be dis...

Page 23: ... those specified or provided by Haag Streit could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation Third party devices may only be connected in compliance with the IEC 60601 1 standard 10 6 2 Emitted interference This product is intended for use in the electromagnetic environment specified below The customer or the ...

Page 24: ...ot 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 cy...

Page 25: ...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...

Page 26: ...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...

Page 27: ... kHz 80 MHz outside ISM and radio amateur bands d 1 2 P 150 kHz 80 MHz in ISM and radio amateur bands d 2 0 P 800 MHz 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 determine...

Page 28: ...ALIANO ESPAÑOL NEDERLANDS PORTUGUÊS SVENSKA HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220449 04090 2021 08 Should you have any further questions please contact your Haag Streit representative at Wiki Revision ID 114023 ...

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