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ESPAÑOL

NEDERLANDS

PORTUGUÊS

SVENSKA

10.6 Information and manufacturer's declaration concerning

electromagnetic compatibility (EMC)
10.6.1 General

This device 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!

• Electrical medical devices and systems are subject to special EMC

measures and must be installed in accordance with the EMC

instructions contained in this accompanying document.

• Use of accessories, transducers and cables other than 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 user of this product should assure that it is used in such an

environment.

Emission test

Compliance

Electromagnetic 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 suitable for use in all establishments, including domestic establishments and those

directly connected to the public low-voltage power supply network that supplies buildings used for

domestic purposes.

Содержание BP 900

Страница 1: ... DEUTSCH ENGLISH FRANÇAIS ITALIANO ESPAÑOL NEDERLANDS PORTUGUÊS SVENSKA HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220590 04090 2021 08 INSTRUCTIONS FOR USE Slit lamp BP 900 9 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: ...on facility 9 4 6 Switching off the compensation facility 9 4 7 Regulating the clearance of the slit width controls 9 5 Commissioning 9 5 1 Switching on the device 9 6 Operation 10 6 1 Setting the eyepieces 10 6 2 Preparing the patient 10 6 3 Operating the device 10 6 4 Setting the filters diaphragms 12 6 5 Fixation star 12 6 6 Microscope and eyepiece 12 7 Decommissioning 12 8 Technical data 13 8 ...

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: ...ance 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 th...

Страница 6: ...d 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...

Страница 7: ...n 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...

Страница 8: ...mination fixed 10 Lever for filters 11 Scale for angled position of the slit image 5 increments 12 Background illumination with swivel bracket 13 Illumination mirror 14 Diffusor 15 Magnification changer 16 Mounting screw for the stereo microscope 17 Slot for accessories test rod background illumination etc 18 Centring screw 19 Illumination unit microscope angle scale 20 Illumination arm locking sc...

Страница 9: ...west position and then loosen it slightly a quarter turn Turn the microscope and illumination to the side Apply 1 3 springs depending on the accessory 4 5 Switching on the compensation facility Turn anticlockwise until the screws 59 are completely released 4 6 Switching off the compensation facility Turn clockwise until you meet resistance Verify whether the microscope arm springs back downwards i...

Страница 10: ...p 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 th...

Страница 11: ...ew with an imaging module Indirect illumination For observation in regredient light indirect illumination the centring screw 18 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 36 can be used to tilt the illumination in 5 steps This creates an angled light beam during horizontal slit orientati...

Страница 12: ... laser treatments close to the macula 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 6 Microscope and eyepiece 44 Frontal objective f 103 mm 45 Rotary knob displaying the set magnification 46 3 level magnification changer Galilei system 47 Quick release fastener for knurled r...

Страница 13: ... changer 10 16 25 Ocular magnification 12 5 Range of adjusting eye pieces 6 to 6 dioptres Pupil distance 53 78 mm Total magnification 10 16 25 Object field ø in mm 20 0 12 7 8 0 8 3 Instrument base Operation Single handed operation of control lever in three dimensions Adjustment of instrument base 100 mm length 100 mm side 30 mm height 8 4 Dimensions Weight 12 3 kg without power supply headrest an...

Страница 14: ...disinfectants containing aldehyde or aldehyde free are also permitted such as Kohrsolin FF WARNING The preparation instructions provided do not apply to tonometer measuring prisms Tonometer measuring prisms must be prepared in accordance with a different manual Too strong or aggressive disinfectants or cleaning liquids e g hydrogen peroxide will damage the finish and coating of the device Do not u...

Страница 15: ...SO 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 mainta...

Страница 16: ... 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 user o...

Страница 17: ...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 18: ...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 19: ...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 20: ...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 21: ...ALIANO ESPAÑOL NEDERLANDS PORTUGUÊS SVENSKA HAAG STREIT AG 3098 Koeniz Switzerland HS Doc no 1500 7220590 04090 2021 08 Should you have any further questions please contact your Haag Streit representative at Wiki Revision ID 108517 ...

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