HAAG-STREIT

BI 900 Instructions for Use 3 Edition

Instructions for Use

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INSTRUCTIONS FOR USE Slit lamp

BI 900® 3. edition / 2018 – 04

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DOC. No. 1500 1500.1400209.04000

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INSTRUCTIONS FOR USE Slit lamp

BI 900® 3. edition / 2018 – 04

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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.

Safety... 4

1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9

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

Introduction... 6

2.1 2.2 2.3 2.4 2.5

Overview...6 Overview LED illumination...6 LED illumination LI02...7 Blue filter...7 Periphery or background illumination ...7

Device assembly / installation... 7

3.1 3.2 3.3 3.4 3.5 3.6

Placement of adhesive label for the automatic left/right detection...7 Camera assembly...7 Cabling of the RM02 (diagram)...8 Microscope and illumination...8 Regulating the clearance of the slit width control...8 Step-by-step cabling...9

Startup... 10

Operation... 10

4.1 5.1 5.2 5.3 5.3.1 5.3.2 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 5.12

Switching on the device...10 Setting the eyepieces...10 Field of view ...10 White balance ...10 Slit lamp preparation ...10 Conducting a white balance...10 Software / Help menu / Error messages...11 Preparing the patient ...11 Operating the instrument...12 Setting the filters & diaphragms ...12 Fixation star...13 Microscope and eyepiece ...13 Reduced operation...13 LED display Illumination head...13 LED display power supply...13

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5.13 5.14 5.15 5.16 5.17 5.18

LED display release module RM02...13 LED display camera...14 Error messages (illumination head)...14 Error messages release module RM02...14 Error messages camera...15 Software / Help menu / Error messages...15

6. 7.

Decommissioning... 15 Technical data ... 15

7.1 7.2 7.3 7.4 7.5 7.6 7.7

Slit illumination ...15 Power supply ...15 Stereo microscope ...15 Instrument base ...16 Dimensions...16 Camera...16 Minimum PC requirements ...16

Maintenance... 16

8.1 8.2 8.3 8.4 8.5

Device inspection...16 Repair...17 Cleaning and disinfection...17 Replacing the illumination mirror...17 Dust cover...17

Appendix... 17

B. C. D. E. F.

Statutory requirements ... 18 Classification ... 18 Disposal... 18 Observed standards... 18 Information and manufacturer's declaration concerning electromagnetic compatibility (EMC)... 19

A.1.

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

Accessories/spare parts...17

General...19 Emitted interference (standard table 1)...19 Immunity (standard table 2)...20 Immunity for non-life support devices (standard table 4)...21 Safe distances for non-life support devices (standard table 6)...22

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Safety

Use:

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. If unexpected disturbances are observed which manifest themselves as communication problems between Imaging Module and EyeSuite software, the cause could be a cell phone or RF telephone in the immediate vicinity to the slit lamp or power supply. Increase the distance to the unit until the interference disappears. The communication between imaging module and PC may also be disturbed or interrupted, if the device is exposed to a mains power supply delivering excessively transient disturbances or short voltage interruptions. If this happens, the USB connector needs to be disconnected for a short time or the PC needs to be restarted.

1.2 Ambient conditions Transport: Storage:

Use:

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

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Storage: PORTUGUÊS

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%

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

from 500 hPa to 1060 hPa from 10% to 95% from −10°C to +55°C fromSVENSKA 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 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 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 HS replacement parts may be used. • The device must not be stacked or placed in close proximity to other electronic devices.

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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.

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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.

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

• Continued use of a product damaged by incorrect handling may lead to personal

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".

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

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 143 seconds exceeds the guideline value for a risk.

1.7 Disinfection

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

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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. 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 Follow instruction for use

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

Test symbol of CSA with approval for USA

On (Power)

Plug socket USB 3.0 micro B on RM02 for computer

Plug socket USB 3.0 on RM02 for camera

Strong permanent magnets

Slit lamp illumination

Background illumination

Plug socket on RM 01 for power supply 5

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ETL Listed Mark with approval for USA and Canada

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Introduction

1. 2. 3. 4.

Lamp cable LED illumination LI 900 Filter lever Optical light guide for periphery or background illumination (option) 5. Slit length, slit rotation, blue filter and fixation star control, knob for rotating the slit 6. Scale for angled position of the slit image (5° increments) 7. Periphery or background illumination FI01f (option) 8. Illumination mirror 9. Diffusing lens 10. Headrest (see separate instructions) 11. Protective cover 12. Illumination unit / microscope angle scale 13. Illumination arm locking screw 14. Microscope arm locking screw 15. Camera cable (option) 16. Release module RM02 6

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Testsymbol of TÜV Rheinland with approval for INMETRO Brasil

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. NOTE! The BI 900 slit lamp can be optionally equipped with the imaging set (HS art. no. 7220535).

2.1 Overview

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17. Sticker left/right identification 18. Axle 19. Rail cover 20. Cover cap for the accessories base 21. Stereo microscope 22. Eyepieces 23. Mounting screw for breath shield (option) 24. Breath shield (option) 25. Centering screw for illumination 26. Camera operational control LED (option) 27. Inclination angle latch 0° − 20° 28. Slit width controls 29. Roller rail 30. Control lever 31. Camera (option) 32. Slide plate 33. EyeSuite Imaging software (option) 34. Power supply 35. Electric power supply lead (countrydependent)

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

20 21 22 23 24 25 26 27 28 29 30 32 33

2.2 Overview LED illumination

36. LED illumination LI02 plus with periphery or background lighting 37. Plug connection 38. Filter wheel for blue filter 39. Connection periphery or background illumination 40. Cover

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• Position the sticker against the right roller rail (45) and the gliding plate (46). Press firmly on the white/black surface, press away any air bubbles.

• Carefully tear off the remainder of the adhesive label (44) along the perforation. • Reassemble the slit lamp and rail cover.

37 38 36

39 40

2.3 LED illumination LI02 2.4 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.

2.5 Periphery or background illumination

This periphery or background illumination may only be used in conjunction with an LI02 plus LED illumination. 42. Periphery or background illumination, fixed 43. Periphery or background illumination, swiveling (option)

Device 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 HS replacement parts may be used.

3.1 Placement of adhesive label for the automatic left/right detection

44. Rest of the sticker 45. Roller rail 46. Gliding plate • Remove rail cover (19) and place slit lamp aside. Clean surface of table. • Remove protective film from the back of the adhesive label. Carefully start at the corner opposite the black surface. © HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04030 – 2018 – 04

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3.2 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 the position is correct; reaffix the camera. Through the software, the image can be displayed horizontally or vertically. • Mount the camera casing (50) and fix in place with screws (49) 47. Retaining screws 48. Camera 49. Fastening screws 47 50. Camera casing 48 49 50

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3.3 Cabling of the RM02 (diagram)

WARNING! • Only use the supplied USB 3.0 cable (3m long, HS art. no. 1022373) for the connection to the PC. • With lengths of over 3m, the cable with active signal amplification (HS art. no. 1022441) must be used. • Only use medically approved PCs or operate via a medically approved isolating transformer. • Auxiliary units on the PC (e.g. printer, monitor) must be operated through an isolating transformer. • Ethernet may only be used through a galvanic isolation in accordance with EN 60601-1. • The power supply unit's mains connector must be accessible in order to allow for disconnection from the electric mains at any time!

51. Power grid 59. Galvanic isolation (EN 60601-1) 52. Med. approved isolating transformer 60. Headrest 53. Instrument table 61. Cable headrest / LED illumination / 54. Med. approved power supply RM02 55. Printer 62. Release module RM02 56. Screen 63. LED illumination 57. Personal computer 64. Camera 58. Local network 52

55 60

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NOTE! To ensure that the system works correctly, HAAG‑STREIT recommends not using laptops and using a high-quality desktop computer instead. 65. Fastening screw 66. Two-pole connection plug

180°

If the middle LED lights up red dur66 ing operation, the two-pole connection 1 plug (66) is connected incorrectly. • Disconnect the device from the power grid • Remove the cover on the upper part of the illumination facility by loosening the fastening screw (65). • Turn the two-pole connection plug (66) 180°. • Fix the cover on the upper part of the illumination facility with the fastening screw (65). • Connect the device to the power grid 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.

3.4 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 (24) in place by fastening the mounting screw (23) on the in3.5 Regulating the clearance of the slit width control

62 54

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side of the bearer arm.

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The small screw in the center 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.

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3.6 Step-by-step cabling • Place the release module RM02 (73) over the slit lamp's cross slide. Four magnets are used for fixing. NOTE! No external USB devices may be connected to USB ports (85) and (87).

• Insert the camera cable's connector plug (76) into the socket (85). • Press the cable into the recess on the microscope arm (75). • Feed computer cable USB 3.0 (73), power supply cable (72), and cable headrest / LED illumination / RM02 (71) through the braided sleeving (70).

• Insert the connector plug of the power supply cable (72) into the socket (86). • Insert the connector plug of the computer cable USB 3.0 (73) into the (87). • Pull on the braided sleeving until taut and mount a cable tie (69) on each end. • Mount a cable cover (91) on the threaded bolts (88) or mount the USB connector screws.

• Connect the headrest cable (68) with its counterpart (67) on the headrest. • 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 (14) to the power supply (13). • Connect the power supply connector plug to the power grid. • Plug the headrest cable (1) into the lamp head. 73 67 68 69 70 71 72 73

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76 78 79 73 72 71

80 81 82 83 84 81 82

74 75 76 77

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67. Connection plug headrest 79. On/Off key 68. Connector plug headrest / LED illumi- 80. Rotating knob, periphery or backnation / RM02 ground illumination 69. Cable tie 81. Rotating knob, slit illumination 70. Braided sleeving 82. Selector key A 71. Cable headrest / LED illumination / 83. Selector key B RM02 84. Release key RM02 72. Power supply cable 85. Socket camera cable 73. Computer cable USB 3.0 (3m long) 86. Socket for power supply connec74. Camera (not shown) tor plug 87. Socket computer cable USB 3.0 75. Recess on the microscope arm 76. Connector plug camera cable micro B 88. Threaded bolt 77. Release module RM02 78. RM02 operational control LED 89. Pin assignment without imaging set 90. Pin assignment with imaging set 91. Cable cover

85 86 87 71

88 89 34

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69 90

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Startup

4.1 Switching on the device • Connect the power supply to the power grid and press the On/Off key (75) on the release module RM03. The green operational control LED (74) illuminates when the device is switched on. The camera has no On/Off key and switches on automatically when the PC is switched on. • Turn the rotating knob on the slit illumination (77) to a position between '1' and '10'.

PORTUGUÊS

1x 1.6 x

5.1 Setting the eyepieces

93 94

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

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 (86) 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 Field of view WARNING! The images and videos should only be used for documentation purposes. Only the image in the eyepiece may be used for diagnosis. 10

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10 x

6.3 x 5.4

ø 18 ø 11.25

21.4 x 18.3 14 x 11.8

5.3 White balance

The image quality is dependent on the correct calibration of the color tones to the respective slit lamp illumination. We recommend performing a white balance in order to improve the image quality and achieve a realistic color reproduction.

92. Adjusting pin 93. Protective cover 94. Sliding occluders

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Field of view of the object, see table Circle: The field of view of the object observed through the microscope's eyepiece. Rectangle: Surface area of the sensor: Object image section in the Object image section in the eyepiece (mm) camera with active sensor area (mm)

Operation

NOTE! The eyepieces must be individually set prior to the first examination in accordance with the refraction of the examiner. Insert the adjusting pin (84) provided in place of the protective cover (85) and turn its black projection surface at a right angle to the microscope axis. Return the illumination and microscope to the central position (0°).

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5.3.1 Slit lamp preparation 1. 2. 3. 4. 5. 6.

Turn on the slit lamp Filter position ‹open› (no filter) Set magnification to 16x Completely open the slit diaphragm Connect the diffuser upstream Position the HAAG-STREIT greycard in front of the slit lamp and use it for focusing 7. The brightness of the slit lamp's illumination should be set in such a way that the greycard's structure is clearly discernible.

5.3.2 Conducting a white balance 1. 2. 3. 4.

Start the ‹EyeSuite Imaging› software Activate the intensity auto mode Open the ‹White balance› application Start the ‹White balance› by activating the ‹Calibration› function © HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04030 – 2018 – 04

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NOTE! To achieve an optimal result during the white balance, the image must be homogeneously illuminated.

White balance greycard HS No.: 1021483

Image is blurry or overexposed

Structure is discernible

5.4 Software / Help menu / Error messages

The software is described in the relevant IFU for EyeSuite Imaging. WARNING! The software must be installed by trained personnel in accordance with separate installation instructions.

5.5 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 light height should be set accordingly in order to avoid objectionable irradiation.

• After each examination, the LED illumination must be switched off via the release module. See sec. "Decommissioning".

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5.6 Operating the instrument

WARNING! • Before every examination, check that the automatic left to right detection works correctly from the release module! • 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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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 reflexfree examination with contact glasses (fundus and gonioscopy) and magnifying glasses.

• Use the turn screw (A) to set the chin rest (B) so that the patient’s eyes are at the same height as the black mark (C) on the sides of the head rest.

• Set the eyepieces (26) in accordance with the examiner’s refraction by turning the

knurled rings and set the eye distance. • Adjust the height of the slit lamp by turning the control lever until the light beam is at eye level. • Switch on the illumination by turning the switch on the power supply. • The magnification of the stereo microscope is changed using the magnification changer (100, chapter 5.9). • 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 while observing via the stereo microscope (21). • The slit width is set left or right with the rotating knob (28), as is the angle between the stereo microscope and illumination. The slit image can be set vertically, horizontally or diagonally as required by turning the illumination facility on the handle (5) (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 (9)) is used, the illumination turned 90° using the locking screw (5) and tilted in 5° steps using the latch (27), and the illumination and microscope turned to the central position (0°). • Front-lens glasses and contact glasses are used to examine the ocular fundus. Diffuse illumination: • A diffuse illumination is achieved by positioning the diffusor (9) upstream. This enables overview monitoring and can be used for taking overview images with the Imaging Module. Indirect illumination: • For observation in regredient light (indirect illumination), the centering screw (25) is loosened in order to move the slit image out of the center of the visual field. Tightening the screw centers the slit image again. 12

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C 9

B 25

27 28 30

5.7 Setting the filters & diaphragms a. b. c. d.

Open Grey filter (10%) Red removal filter Reserve opening for filter of choice ø15 mm (0 / –0.2), thickness 2.5 mm © HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04030 – 2018 – 04

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5.11 LED display Illumination head (c)

(d) a) b) c)

(e)

0.2

(f)

(g)

(h)

Standby mode

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 center 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. 95. Two objective-lens pairs 96. Lever for yellow filter 97. Cover cap for the accessories base 98. Serial number microscope 99. 10x or 25x eyepiece 100. Lens-changing lever 101. Eyepiece retaining screw

95 96

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Green, short flashes

Normal operation Slit and periphery or background illumination on Only slit illumination on

Green Green, short flashes

Only periphery or background illumination on

Green

Reduced periphery of background illumination operation High LED temperature, thus reducing periphery or background illumination operation

Green, flashing

X X X

Green, short flashes Green Green Green, short flashes

Green, flashing

5.12 LED display power supply Normal operation 100

101

5.10 Reduced operation

In order to ensure that the light sources will have a long lifespan, the power of the periphery or background illumination is reduced somewhat once the maximum operating temperature has been reached. Full power can be used again after a short period of time for it to cool down. This operating state is only reached if both light © HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04030 – 2018 – 04

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DEUTSCH

Operating status

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

5.9 Microscope and eyepiece

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Slit lamp illumination

(b)

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sources are switched on together for a long period of time outside the specified temperature range.

Fixation star Apertures of 8, 5, 3, 2, 1 and 0.2 mm in ø Display of slit length adjustment from 1 to 14 mm Blue filter

(a)

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Polarity

e. f. g. h.

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Periphery or background illumination

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Green

5.13 LED display release module RM02 Normal operation LED illumination switched off Establishing connection

Green Green, pulsing Orange

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5.14 LED display camera Normal operation

Green

Establishing connection

Orange

Polarity

Slit lamp illumination

ERROR

a) b) c)

Periphery or background illumination

5.15 Error messages (illumination head)

Error messages

Measures

E1 E2

Incorrect supply polarisation

Contact your HAAG-STREIT representative.

Illumination control not recognized

Connect illumination control or replace, if necessary.

Red

Temperature is too high

Red, flashing

No communication between power supply and illumination

The light sources’ power will be reduced. Normal operation is ensured once the permissible temperature has been reached. Contact your HAAG-STREIT representative.

Red, flashing 2x

Send RM02 to the appropriate service branch.

Red, flashing 4x

General error

Red X X X X

X Red Red, flashing Red, flashing 2x Red, flashing 4x

ERROR

5.16 Error messages release module RM02 Error messages

Measures

E14

No communication with LED illumination LI02 plus

Contact your HAAG-STREIT representative.

Red, flashing 2x

E16

General error

Send device to the appropriate service branch.

Red, flashing 4x

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Operational control LED (74)

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ERROR

5.17 Error messages camera Error messages

Measures

E18

No communication with LED illumination LI02 plus

Contact your HAAG-STREIT representative.

5.18 Software / Help menu / Error messages

The software's Help section contains instructions and guidance for performing an examination as well as descriptions of the error messages. Help can be opened by pressing the F1 key or by going to the [?] - [Help] menu. WARNING! The software must be installed by trained personnel in accordance with separate installation instructions.

Decommissioning

Press the On/Off key (75) on the release module RM02 briefly to switch off the LED illumination after the examination. This does not switch off the camera. This is signaled with pulsing green flashing. Pressing the key for approx. 2 sec. switches off the release module completely and the operational control LED (74) 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 power grid by unplugging the mains connector if you do not intend to use it for an extended period of time.

NOTE! Detailed information regarding the radiation can be provided on request. 400 to 750nm

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Spectral range periphery or background illumination Slit image width (continuous) Slit image length (fixed diaphragms) Illumination field circle Test mark Slit image radial range Radial (swiveling) movement of the slit illumination to microscope axis Filters

Red

400 to 750nm 0 – 14 mm 1 – 14 mm 8 / 5 / 3 / 2 / 1 / 0.2 mm in ø with fixation star ±90° Horizontal ± 90°, vertical 0-20° Blue, red removal (green), grey (10%).

7.2 Power supply Type Model Mains voltage Current consumption Operating frequency

ICCN EXERGY, ELPAC POWER SYSTEMS, MWA030018B HS no.: 1022106 100 − 240 V 0.8 A 50 − 60 Hz

7.3 Stereo microscope

Technical data

7.1 Slit illumination

Spectral range slit illumination

Operational control LED (26)

Stereo angle Magnification changer Eyepiece magnification Magnification changer Range of adjusting eyepieces

13° 1x and 1.6x 10x (standard) 10x / 16x, with eyepiece 25x: 25x / 40x +6 to -6 dioptres 15

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Pupil distance Filters Lens Eyepiece Total magnification Object field diameter

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54 − 94 mm Contrast enhancing (yellow) 1x 1.6x 1x 10x 10x 25x 10x 16x 25x 18 mm 11.3 mm 8 mm

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RAM 1.6x 25x 40x 5 mm

Hard disk Graphics

7.4 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)

7.5 Dimensions Weight: 12 kg (without power supply, headrest and options) Dimensions L x W x H: 310 x 332 x 700 mm Packaging L x W x H: 420 x 510 x 780 mm

7.6 Camera Camera beam Sensor type Interface Frame rate Power consumption Sensor size

Beam path left (from the point of view of the doctor) CMOS USB 3.0 20 fps (frames per second) / 300 mA 5V 7.2 mm x 5.4 mm

7.7 Minimum PC requirements Processor type

Intel i5, 5th gen or higher with 4 cores. Note: 6th gen is not recommended. 2 cores with hyperthreading are not recommended.

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Monitor Operating system PCI slot PCI Express card

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8 GB RAM if PC is exclusively used to operate the imaging module. 16 GB RAM if third-party applications such as patient administration software are to be used alongside EyeSuite. Use 2 RAM module. At least 500 GB (NTFS data system). Graphics card with at least 2 GB memory (Nvidia or AMD chip set recommended). OpenGL 2.0 At least 19", 1920 x 1080 pixel resolution. Windows 7, Windows 8.1, Windows 10. 64-bit system only. PCI-Express 3.0 Chip set by Renesas / NEC.

Maintenance WARNING!

The LED illumination can be operated without any maintenance throughout its entire duration of life.

8.1 Device inspection

The following procedure should be used to check that the slit lamp is working correctly: • Insert the test rod in the radial movement bearing, while aligning the surface at a right-angle to the microscope • Set the slit light length to 8 or 14mm • Illumination intensity to 50% • Set the magnification in the microscope to max. • Set the eyepieces so that the structure on the test rod is shown in focus. Turn the © HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04030 – 2018 – 04

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eyepiece from the (+) to the (-) side.

• For all magnifications, the structure of the test rod must be shown in focus. • Close the slit edges to approx. 0.5mm. The edges must be shown in focus. • Open the slit edges completely and turn the test rod 45°, the area in focus must be in the center 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 • 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. © HAAG‑STREIT AG, 3098 Koeniz, Switzerland - HS Doc. no. 1500.7220505-04030 – 2018 – 04

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WARNING! Only use mirrors with a LOT number.

8.5 Dust cover

We recommend protecting the slit lamp with a dust cover (87) when not in use.

A. Appendix

A.1. Accessories/spare parts WARNING!

NOTE! An asterisk (*) shows that you should contact your HAAG-STREIT dealer for further information. (**) indicate that you should consult the separate instructions for use. Components

HS Art. No.

Breath shield (option) Camera cable Computer cable USB 3.0 (3m long) Cross hairs Diffusing lens Dust cover, large (for several instruments) Dust cover, small (for slit lamp) Eyepiece with linear scale Eyepieces 25x Imaging set Lens brush Mirror, short

1007129 1022309 1022373 7220515 7200660 1001434 1001395 7220514 7220520 7220535 1001398 1001591 17

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Periphery or background illumination (fix) Pivot Power supply RM02 Release module RM02 Test rod Tonometer AT 900 D model R** Tonometer AT 900 model R**

1020886 1022334 1022106 7220546 1021656 7220064 7200154

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Observed standards

EN 60601-1 EN ISO 10939

EN 60601-1-2 EN ISO 15004-2

B. Statutory requirements

• The BI 900 slit lamp 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 BI 900 slit lamp with the Directive 93/42/EEC is confirmed by the CE-designation.

• The BI 900 slit lamp satisfies the electromagnetic compatibility requirements of

EN 60601-1-3. 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. • Statutory accident regulations are to be observed.

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

Slit lamp BI 900 acc. to protection class II 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.

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F. F.1

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

The BI 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! Avoid damages due to high electrostatic discharges (ESD). Electrostatic discharges with voltages exceeding 6 kV to some parts of the slit lamp like joystick or metallic parts on the instrument base may influence the instrument. • The communication between Imaging Module and PC could be interrupted, which would require a restart of the EyeSuite software. 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 Emission of harmonics according to EN 61000-3-2

Class A Class A

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

± 1 kV for symmetrical 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

< 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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