BP 900 Instructions For Use 8 Edition

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INSTRUCTIONS FOR USE Slit lamp

BP 900® 8. Edition / 2019 – 06

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Introduction

Thank you for choosing a Haag-Streit device. Provided you comply carefully with the regulations in this instructions for use, we can guarantee the reliable and unproblematic use of our product.

Purpose of 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.

Contraindication

There is no absolute contraindication for tests with this device. Appropriate professional judgement and caution are necessary. WARNING! Read the instruction manual carefully before commissioning this product. It contains important information regarding the safety of the user and patient. NOTE! 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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Contents 1.

1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9

2.

2.1

3.

3.1 3.2 3.3 3.4 3.5 3.6 3.7

Safety... 4

Areas of application of the device...4 Ambient conditions...4 Shipment and unpacking...4 Installation warnings ...4 Operation, environment...4 Light toxicity...5 Disinfection...5 Warranty and product liability...5 Description of symbols...5

Introduction... 5

Overview...6

Appliance assembly / installation... 7

Microscope and illumination...7 Power supply...7 Instrument base with weight compensation facility...7 Setting the weight compensation facility...7 Switching on the compensation facility...7 Switching off the compensation facility...7 Regulating the clearance of the slit width controls...7

4.

Commissioning... 7

5.

Operation... 7

6.

Decommissioning... 10

7.

Technical data ... 10

4.1 5.1 5.2 5.3 5.4 5.5 5.6

7.1 7.2 7.3 7.4

Switching on the device...7

8.

Maintenance... 10

A.

Appendix...11

B.

Legal regulations ... 12

8.1 8.2 8.3 8.4 8.5 A.1.

Device inspection ...11 Repair...11 Cleaning and disinfection...11 Replacing the illumination mirror...11 Dust cover...11 Accessories / consumables / spare parts / upgrade...11

C.

Classification ... 12

D.

Disposal ... 12

E.

Standards... 12

F.

Information and manufacturer's declaration concerning electromagnetic compatibility (EMC)... 12

F.1 F.2 F.3 F.4 F.5

General...13 Emitted interference (standard table 1)...13 Immunity (standard table 2)...14 Immunity for non-life support devices (standard table 4)...15 Safe distances for non-life support devices (standard table 6)...16

Setting the eyepieces...7 Preparing the patient...8 Operating the instrument...8 Setting the filters & diaphragms ...9 Fixation star...9 Microscope and eyepiece...10

Slit illumination ...10 Stereo microscope ...10 Instrument base ...10 Dimensions...10

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1.

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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 Areas of application of the device

The device is intended to use in professional health care facility environment, like doctor's practices, hospitals and optometrists and opticians premises, except near of HF surgical equipment and in RF shielded rooms of ME-systems for magnetic resonance imaging. Some portable radio frequency equipment, like cell phones or RF telephone equipment including antennas may interference medical devices. Such equipment has to be kept in a distance of more than 30 cm (12 inches) from any part of the instrument. Inobservance of this precaution may lower the correct function of the instrument.

1.2 Ambient conditions Transport: Storage: Use:

Temperature Air pressure Relative humidity Temperature Air pressure Relative humidity Temperature Air pressure Relative humidity

from −40°C to +70°C from 500 hPa to 1060 hPa from 10% to 95% from −10°C to +55°C from 700 hPa to 1060 hPa from 10% to 95% from +10°C to +35°C from 800 hPa to 1060 hPa from 30% to 90%

1.3 Shipment and unpacking • Before you unpack the appliance, check whether the packaging shows traces of

incorrect handling or damage. If this is the case, notify the transport company that has delivered the goods to you. Unpack the equipment together with a represen-

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tative 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 appliance for damage after it is unpacked. Return defective appliances in the appropriate packaging. • Store packaging material carefully so that it can be used for potential returns or when moving. • The slit lamp and head rest must be installed on an electrically insulated, fireproof table top. • The rail covers (a) prevent the slit lamp from tilting. • Are the connection parts of the accessories in the correct position (screw connections, quick-release fasteners)? (a)

1.4 Installation warnings WARNING! • Do not modify this equipment 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 (HS) replacement parts may be used. • The device must not be stacked or placed in close proximity to other electronic devices. • Grounding reliability can only be achieved when unit is connected to a hospital grade receptacle. (Not valid for EU countries).

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.

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• 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 handSVENSKA

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NOTE! This equipment 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 "Purpose of use".

1.6 Light toxicity

WARNING! 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 750nm. 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. The light from this instrument may be dangerous. The risk of eye damage increases with the exposure time. An exposure time with this instrument at maximum intensity of longer than 131 seconds exceeds the guideline value for a risk.

ling can damage the product. This would void all guarantee claims.

ESPAÑOL ITALIANO DEUTSCH use of a product damaged by FRANÇAIS incorrect handling may lead to personalENGLISH • Continued 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 Description of symbols

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.

Read the instructions for use attentively

Notes on disposal, see the 'Disposal' chapter

Date of manufacture

Manufacturer

Serial number

HS reference number

European certificate of conformity

ETL Listed Mark with approval for USA and Canada

Testsymbol of TÜV Rheinland with approval for INMETRO Brasil

MET Listed Mark with approval for USA and Canada

1.7 Disinfection

NOTE! The device does not need to be disinfected. For more information on cleaning, please refer to the 'Maintenance' section.

Follow instruction for use

2.

Introduction

The slit lamp comprises an illumination and a binocular microscope. The entire device can be moved in front of the eyes using the instrument base. The illumination offers a range of setting possibilities for making the practically invisible areas of 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.

• 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

© HAAG-STREIT AG, 3098of Koeniz, Switzerland - HS-Doc. No. 1500.7220590.04080 – 2019 – 06 implied warranties merchantability or fitness for a particular use.

• Haag-Streit expressly disclaims liability for incidental or consequential damage

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resulting from the use of the product.

• This product is covered by a limited warranty granted by your seller.

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2.1 Overview 1. 2. 3. 4.

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Lamp cable Head rest Headband Height mark on head rest (patient eye) 5. Adjustable fixation lamp 6. Chin rest 7. Height adjustment of chin rest 8. LED illumination LI 900, see separate manual 9. Background illumination (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

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20. Illumination arm locking screw 21. Slit width controls 22. Microscope arm locking screw 23. Cross slides 24. Rail cover 25. Illumination control 'on table' 26. Illumination control 'in table' 27. Slit length / diaphragm scale 28. Slit length, slit rotation, blue filter and fixation star control 29. Cover screw for accessories pin 30. Quick-release fastener for accessories 31. Stereo microscope 32. Eyepieces 33. Thread for fixing the tonometer AT 900 mod. BP or tonometer AT 900 D mod. BP 34. Mounting screw for breath shield 35. Breath shield 36. Inclination angle latch 5 – 20° 37. Joy stick base locking screw 38. Axle 39. Control lever 40. Slide plate

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Appliance assembly / installation WARNING!

• Do not modify this equipment 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 replacement parts may be used.

3.1 Microscope and illumination • The slit lamp is packaged and shipped fully assembled. The transport safety devices must be removed before commissioning. • Fix the breath shield (35) in place by fastening the knurled screw (34) on the inside of the bearer arm.

3.2 Power supply NOTE! • Observe the respective Haag-Streit instructions for use. (For further information, please contact your Haag-Streit dealer). • This device must only be operated with PS-LED and PS-LED HSM 901 HS power supplies and the RM02 release module.

3.3 Instrument base with weight compensation facility

The weight of additional accessories mounted on the microscope can be compensated using counterbalance springs. This keeps the height adjustment of the slit lamp easy.

3.4 Setting the weight compensation facility

Turn the control lever (60) to its lowest 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.

3.5 Switching on the compensation facility

Turn anticlockwise until the screws (59) are completely released.

3.6 Switching off the compensation facility

Turn clockwise until you meet resistance. Verify whether the microscope arm springs back downwards if you push it upwards with your hand. This will only happen if the load is already at maximum. Generally, as many counterbalance springs © HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220590.04080 – 2019 – 06

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should be deactivated as necessary until this spring action occurs. The weight compensation facility is set correctly once the illumination and microscope with the mounted accessories weigh slightly more than the counterbalance springs.

3.7 Regulating the clearance of the slit width controls

The small screw in the centre of the right control knob (83) 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.

83

Commissioning

The device can be switched on and off using the mains power switch on the device power supply. The green light on the rocker switch illuminates when the device is switched on.

4.1 Switching on the device • Connect the power supply up to the mains and press the rocker switch. The green light on the rocker switch illuminates when the device is switched on.

• Turn the rotating knob on the illumination control to a position between '1' and '10'.

5.

Operation

5.1 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 (41) in place of the protective cover (42) and turn its black projection surface at a right angle to the microscope axis. Return the illumination and microscope to the central position (0°). 41

41. Test rod 42. Protective cover 43. Sliding occluders

42

43

• Each eyepiece should be set individually by turning the knurled ocular refraction

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ring with dioptre scale such that the projected slit can be seen in focus. The setting is performed from the (+) to the (-) side at low magnification. • The required pupil distance should then be set on the microscope. • The sliding occluders (43) 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.

5.2 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.

• Parts which come into contact with the patient should be cleaned with a dry cloth prior to every use.

• The slit lamp must be switched off in accordance with the 'Decommissioning' section after every examination.

5.3 Operating the instrument

WARNING! • The device must be switched off after every use. Otherwise there is a risk of overheating when a protective dust cover is employed.

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• The slit image can be set vertically, horizontally or as diagonal as required by

turning the illumination facility on the handle (28) (locking points at 45°, 90° and 135°; stops at 0° and 180°; scale in 5° increments). • To ensure that unimpeded binocular fundus examination is also possible at lateral angles of between 3° and 10°, a short mirror (13) is used, the illumination turned 90° using the locking screw (21) and tilted in 5° steps using the latch (36), and the illumination and microscope turned to the central position (0°). • Front-lens glasses and contact glasses are used to examine the ocular fundus. Diffused illumination: • Connecting the diffusor (14) 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 (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. Tilting the slit: • The latch (36) can be used to tilt the illumination in 5° steps. In this way, a diagonal ray of light from below is generated when the slit is oriented horizontally. The slit orientation allows a reflection-free examination with contact glasses (fundus and gonioscopy) and magnifying glasses.

• 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 head rest.

• Adjust the eyepieces (32) 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 (39) until the luminous aigrette is at eye level.

• The magnification of the stereo microscope is changed using the magnification changer (15).

• The rigid control lever (40) 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 while observing via the stereo microscope (31). • The slit width is set left or right with the rotating knob (21), as is the angle between the stereo microscope and illumination. 8

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5.4 Setting the filters & diaphragms 14

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a) Open b) Grey filter (10%) c) Red removal filter d) Reserve opening for filter of choice ø15 mm (0 / -0.2), thickness 2.5 mm e) Fixation star (predominantly used for fixation examination of cross-eyed children with amblyopia) f) Apertures of 8, 5, 3, 2, 1 and 0.2 mm ø g) Display of slit length adjustment from 1 to 14 mm h) Blue filter

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5.5 Fixation star • Turning the diaphragm disc as far as it will go to the left switches on

the fixation star and the symbol "S" appears in the window. This star is projected onto the fundus at the back of the eye in certain examinations and is visible to the patient at the same time, who is asked to focus on the hole in the centre of the star. This allows the examiner to see where the patient's vision is most focused. • A typical application of the fixation star is during 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 a red removal filter.

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5.6 Microscope and eyepiece

44. Frontal objective f 103 mm 44 45 46 45. Rotary knob displaying the set magnification 46. 3-level magnification changer (Galilei system) 47. Quick-release fastener for knurled ring 48. Binocular tube f 130 mm with convergent insight, pupil distance can be set from 52 − 78 mm 49. Eyepiece 12.5× / field of vision ø 16 mm 50. Index (white point) 51. Knurled ring with dioptre scale for setting the refraction of the examiner (± 6 D) 52. Sliding occluder (for people who wear glasses)

6.

47 48 49 50 51 52

Decommissioning

The LED illumination can be switched off with the illumination control. The device power supply remains switched on and the switch illuminates green. To switch the system off completely, the rocker switch must be set to the 0 = 'OFF' position. This results in double-poles disconnection from the mains. NOTE! Disconnect the power supply from the mains if you do not intend to use it for an extended period of time.

7.

Technical data NOTE! Detailed information regarding the radiation can be provided on request.

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Swiveling of the slit illumination to the microscope axis Filters

SVENSKA Horizontal ± 90°, vertical 0 – 20° Blue, red removal (green), gray (10%).

NOTE! (Further information available in the LED illumination LI 900 instructions for use)

7.2 Stereo microscope Stereo angle: Magnification changer: Ocular magnification: Range of adjusting eye-pieces: Pupil distance: Total magnification: Object field ø in mm:

13° 10× / 16× / 25× 12.5× +6 to −6 diopters 53 – 78 mm 10× / 16× / 25× 20.0 / 12.7 / 8.0

7.3 Instrument base Operation:

Adjustment of instrument base:

Single-handed operation of control lever in three dimensions 100 mm (length) 100 mm (side) 30 mm (height)

7.4 Dimensions

7.1 Slit illumination

Spectral range slit illumination Spectral range background illumination Slit image width Slit image length Illumination field circle Test mark Slit image rotatability

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400 to 750 nm 400 to 750 nm 0 – 14 mm continuous 1 – 14 mm continuous ø 8 / 5 / 3 / 2 / 1 / 0.2 mm With fixation star ± 90°

Weight: 12.3 kg (without power supply, head rest and options) Dimensions L × W × H: 305 × 332 × 700 mm Packaging L × W × H: 420 × 510 × 780 mm

8.

Maintenance WARNING!

• Do not modify this equipment 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 replacement parts may be used.

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The LED illumination can be operated maintenance-free for its entire service life.

8.1 Device inspection

In order to correctly check the slit lamp, proceed as follows: • Insert test rod into the radial movement bearing, whilst at the same time aligning the surface to the microscope at a right angle. • Set slit length to 8 or 14 mm. • Set llumination strength to 50%. • Set magnification to max. in the microscope. • Set the eyepieces in such a way that the test rod is in sharp focus. Turn the eyepiece from the (+) to the (-) side. • The structure of the test rod must be in sharp focus in all magnifications. • Close slit edges to approx. 0.5 mm. The borders must be in sharp focus here. • Completely open slit edges and turn the test rod by 45°, the sharp area must be in the centre of the test rod.

8.2 Repair

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. In order to guarantee optimal operational integrity, the device must undergo periodic maintenance. The length of the maintenance interval depends on use, but may not exceed 3 years.

8.3 Cleaning and disinfection

The Haag-Streit slit lamps and their accessories can, if required, be carefully wiped down with ready-for-use disposable 70% ethanol disinfectant wipes. Surface-friendly 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 • Do not use sprays • Observe the manufacturer's safety instructions • Do not use any cloths that drip. • Wring out any soaked cloths before use when necessary © HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. No. 1500.7220590.04080 – 2019 – 06

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• Ensure that no liquid penetrates the device • Comply with the stipulated exposure time • Clean optical surfaces after disinfection with a very soft cloth NOTE! IP code: IPX0 (device is not protected against liquids)

8.4 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.

8.5 Dust cover

We recommend protecting the slit lamp with a dust cover when not in use.

A. Appendix

A.1. Accessories / consumables / spare parts / upgrade WARNING!

• Do not modify this equipment 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 replacement parts may be used.

NOTE! An asterisk (*) indicates that you should contact your Haag‑Streit representative for further information. Two asterisks (**) indicate a need to refer to the separate instructions for use. Components Dust cover, small (for slit lamp) Dust cover, large (for several instruments)

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Long mirror 1001590 Short mirror 1001591 Eyepiece for estimating length 7020022 Eyepiece 10 × with reticule for estimating length and angle (BM900) 7020028 To be used in combination with 7220737 Eyepiece 12.5 × with crosshair-reticule 7220454 Eyepiece 12.5 × with McIntyre comparison grid 7220455 Eyepiece BP 900 12.5 × 7220516 Eyepiece 12.5 × with diopter adjustment 7220518 Imaging Module 600 BP 7220539 Release Module RM02 with power supply 7220546 Contrast enhancing filter 7220740 Power supply for LED illumination on third-party tables** 7220741 Power supply for LED illumination, HSM 901** 7220742 Illumination control, double slit and background 'on table'** 7220743 Background illumination FI 01f 7220744 Illumination control box slit 'on table' (1 Pot.) 7220745 Illumination control, double slit and background 'in table'** 7220746 Illumination control box slit 'in table' (1 Pot.) 7220747 Pad of chin rest papers 7220756 Background illumination swivelling 7220765 Diagnostic contact lenses Please refer to the instructions for use Contact lenses, Goldmann/Diagnostics/Laser Applanation Tonometer Please refer to the instructions for use AT 900 / AT 870 Please refer to the instructions for use AT 900 D Headrest Please refer to the instructions for use Headrest

B. Legal regulations

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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 instrument also boasts the immunity stipulated by the standard. • The statutory accident regulations must be observed.

C. Classification Standard EN 60601-1 Operating mode: CE Directive 93/42/EEC FDA

Slit lamp BP 900 acc. to protection class I Continuous operation Class I Class II

D. Disposal

Electrical and electronic devices must be disposed of separately from household waste! This appliance 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.

E.

Standards

F.

Information and manufacturer's declaration

EN ISO 10939 EN 60601-1-2

EN 60601-1 EN ISO 15004-2

• The BP 900 slit lamp was developed and designed taking the EN 60601-1 and

EN ISO 15004-2 standards into account. Production, testing, set-up, maintenance and repairs are performed taking international standards into account. • The EN 60601-1 standard must be observed when using different medical and/or non-medical electrical appliances in combination. • Compliance of the BP 900 slit lamp with the Directive 93/42/EEC is confirmed by the CE marking. • The BP 900 slit lamp satisfies the electromagnetic compatibility requirements of 12

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F.1

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concerning electromagnetic compatibility (EMC) General

The BP 900 slit lamp system fulfills the requirements on electromagnetic compatibility according to EN 60601-1-2:2007 (IEC 3. Edition) + EN 60601-1-2:2015 (IEC 4. Edition). The instrument 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 instrument itself is suitably immune to electromagnetic interference.

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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. • The operation of other lines or equipment than those listed may lead to higher emissions or may reduce the device's resistance to interference. • Third-party devices may only be connected in compliance with the EN 60601-1 standard.

Emitted interference (standard table 1)

The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rd edition) and EN 60601-1-2:2015 (IEC 4th edition). Guidance and manufacturer's declaration – electromagnetic emissions 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 RF emissions CISPR 11

Compliance Group 1

RF emissions CISPR 11

Class B Class A

Emission of harmonics according to EN 61000-3-2 Voltage fluctuations / flicker emissions according to EN 61000-3-3

Electromagnetic environment - guidance 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. 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.

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Immunity (standard table 2)

The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rd edition). Guidance and manufacturer's declaration – electromagnetic immunity 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. Immunity test standard Electrostatic discharge (ESD) EN 61000-4-2

EN 60601 test level ± 6 kV contact ± 8 kV air

Compliance level ± 6 kV contact ± 8 kV air

Electrical fast transient / burst EN 61000-4-4 Surge EN 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply lines EN 61000-4-11

± 2 kV for power supply lines

± 2 kV for power supply lines

± 1 kV for symmetrical voltages ± 2 kV for asymmetrical voltages < 5% UT (> 95% drop in UT) for ½ cycle < 40% UT (> 60% drop in UT) for 5 cycles < 70% UT (> 30% drop in UT) for 25 cycles < 5% UT (> 95% drop in UT) for 5 s 3 A/m

± 1 kV for symmetrical voltages ± 2 kV for asymmetrical voltages < 5% UT (> 95% drop in UT) for ½ cycle < 40% UT (> 60% drop in UT) for 5 cycles < 70% UT (> 30% drop in UT) for 25 cycles < 5% UT (> 95% drop in UT) for 5 s 100 A/m

Power frequency (50/60Hz) magnetic field EN 61000-4-8

Electromagnetic environment – guidance Floors should be wood, concrete or ceramic tile. If floors are covered withs ynthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of this product requires continued function even in the event of interruptions in the energy supply, this product should be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT= the AC mains voltage prior to application of the test level.

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Immunity for non-life support devices (standard table 4)

The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rd edition). Guidance and manufacturer's declaration – electromagnetic immunity 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. Electromagnetic environment – guidance Portable and mobile RF communications equipments hould be used no closer to any part of this product, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Immunity test standard Conducted RF EN 61000-4-6 Radiated RF EN 61000-4-3

EN 60601 test level 3 Vrms 150 kHz – 80 MHz 3 V/m 80 MHz – 2.7 GHz

Compliance level 10 Vrms

Recommended distance(c): D = 0.35

5 V/m 80 MHz – 2.7 GHz

D = 0.7 D = 1.4

80 MHz – 800 MHz 800 MHz – 2.7 GHz

Where P is the maximum output power rating of thet ransmitter in watts (W) according to the transmitter manufacturer and D is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: At 80 MHz and 800 MHz the higher frequency applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which this product is used exceeds the applicable RF compliance level above, this product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating this product. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. c. Possible shorter distances outside the ISM bands do not contribute to improved application in this table.

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Safe distances for non-life support devices (standard table 6)

The information is based on the requirements of EN 60601-1-2:2007 (IEC 3rd edition).

Recommended safe distances between portable and mobile HF communication devices and this device. This product is designed to be operated in an electromagnetic environment in which radiated HF interference is controlled. The customer or user of this product can help to prevent electromagnetic interference by maintaining minimum distances between portable and mobile HF communication systems (transmitters) and this product, as recommended below in accordance with the maximum output of the communication system. Safe distance according to transmission frequency (m) 80 MHz – 800 MHz 800 MHz – 2.7 GHz 150 kHz – 80 MHz Nominal output of the transmitter (W) D = 0.7 D = 1.4 D = 0.35 0.01 0.035 0.07 0.14 0.1 0.1 0.2 0.44 1 0.35 0.7 1.4 10 1.1 2.2 4.4 100 3.5 7 14 For transmitters with a nominal output not listed in the table above, the distance D can be calculated in meters (m) using the equation for the respective column, in which P is the nominal output of the transmitter in watts (W) NOTE 1: At 80 MHz and 800 MHz the higher frequency applies. NOTE 2: To calculate the recommended safe distance of transmitters in the frequency range of 80 MHz to 2.7 GHz an additional factor of 10/3 was used to reduce the probability of a mobile/portable communication device causing interference if inadvertently brought into the patient area. NOTE 3: These guidelines may not apply in all situations. Electromagnetic wave propagation is influenced by absorption and reflection of buildings, objects and people.

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Should you have any further questions, please contact your Haag‑Streit representative at:

http://www.haag-streit.com/contact/contact-your-distributor.html

Phone Fax eMail Internet 18

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HAAG-STREIT AG Gartenstadtstrasse 10 3098 Koeniz, Switzerland +41 31 978 01 11 +41 31 978 02 82 [email protected] www.haag-streit.com

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