Transcript
SVENSKA
NEDERLANDS
ESPAÑOL
ITALIANO
FRANÇAIS
SLLA224 ENGLISH
DEUTSCH
INSTRUCTIONS FOR USE Slit Lamp
BQ 900® 14. Edition / 2011 – 11
© HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7001000-04140 – 2011 – 11
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DOK. no. 1500 1500.1400209.04000
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ENGLISH
DEUTSCH
FRANÇAIS
INSTRUCTIONS FOR USE Slit Lamp
BQ 900® 14th Edition / 2011 – 11
ITALIANO
ESPAÑOL
NEDERLANDS
SVENSKA
SLLA224
Preface
We would like to thank you for your decision to purchase this HAAG-STREIT product. If the instructions in this manual are carefully followed, we are confident that this product will give you reliable and trouble-free usage.
Purpose of use
The BQ 900 is an AC-powered slit lamp biomicroscope intended for the use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment. Caution: Federal law restricts this device to sale by or on the order of a physician or practitioner.
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Contents
Additional information
1
A
Equipment maintenance routines ........................12
B
Mounting of the equipment ..................................14
C
Equipment maintenance........................................16
D
Halogen / Tungsten illumination (not for LI 900) ...........17
E
Accessories............................................................19
F
EMC Supplement....................................................24
1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8
Safety ........................................................................4
Ambient conditions ................................................................................. 4 Transport and unpacking ....................................................................... 4 Installation warning notices .................................................................... 4 Operation, environment ......................................................................... 5 Light toxicity ........................................................................................... 5 Cleaning and disinfection ....................................................................... 5 Warranty and third-party product liability ................................................ 5 Pictographs and type plates ................................................................... 6
2 Overview ...................................................................6 3 Operation ..................................................................8 3.1 3.2 3.3 3.4
Adjusting the eyepieces ......................................................................... 8 Prepare the patient ................................................................................ 8 Operating the instrument ....................................................................... 9 Set filters and apertures ....................................................................... 10
4
Technical specifications .......................................10
4.1 Slit illumination ..................................................................................... 10 4.2 Slit illumination tungsten ...................................................................... 11 4.3 Spectrum tungsten illumination ............................................................ 11 4.4 Slit illumination halogen ....................................................................... 11 4.5 Spectrum halogen illumination ............................................................. 11 4.6 Stereo-microscope ............................................................................... 11 4.7 Instrument base ................................................................................... 11 4.8 Net weight ............................................................................................ 11
5 Statutory Regulations ........................................... 11 6 Classification .........................................................12 7 Environment ...........................................................12
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A.1 A.2 A.3 A.4
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Replacement of the bulb (not for LI 900) ............................................. 12 Microscope and ocular.......................................................................... 12 Attaching an accessory in the beam path ............................................ 13 Fixation lamp ........................................................................................ 13
B.1 Microscope and illumination Unit ......................................................... 14 B.2 Power supply ....................................................................................... 15 B.3 Instrument base with load compensation ............................................. 15 B.3.1 Compensating the weight of added components.................................. 15 B.3.2 Engaging............................................................................................... 15 B.3.3 Disengaging.......................................................................................... 15 B.4 Slit illumination and Diffusor ................................................................. 15
C.1 C.2 C.3 C.4 C.5 C.6
D.1 D.2 D.3
F.1 F.2 F.3 F.4 F.5 F.6 F.7 F.8
Replacement of the mirror ................................................................... 16 Cleaning of the optical parts ................................................................ 16 Adjustment of friction of the slit width control ....................................... 16 Cleaning of the gliding plate and the rails ............................................ 16 Cleaning of the axle ............................................................................. 16 Plastic dust cover ................................................................................. 16
Replacement of the bulb ...................................................................... 17 Check electrical contacts of bulb and lamp housing ............................ 17 Use of the contact medium................................................................... 18
General................................................................................................. 24 System components............................................................................. 24 Connecting cables................................................................................ 24 Basic performance factors.................................................................... 24 Table 1: Emitted interference................................................................ 24 Table 2: Interference immunity.............................................................. 25 Table 3: Immunity (not life-support equipment)..................................... 26 Table 4: Recommended safe distances (not life-support equipment)... 27
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1 Safety
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Symbols correspond to EN 980 and ISO 15223-1. Other symbols that are used in these instructions: FORBIDDEN! Not observing these notes will lead to material damage and the endangering of patients.
•
WARNING! These signs must be adhered strictly to ensure safe operation of the instrument and to avoid endangering users and patients.
•
NOTE! Important notes! Please read carefully.
Transport: Temperature Atmospheric pressure Relative humidity
−40°C to +70°C 500 hPa to 1060 hPa 10% to 95%
Storage: Temperature Atmospheric pressure Relative humidity
−10°C to +55°C 700 hPa to 1060 hPa 10% to 95%
Operating: Temperature Atmospheric pressure Relative humidity
+10°C to +35°C 800 hPa to 1060 hPa 30% to 75%
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1.2 Transport and unpacking • Before you unpack the instrument, check whether the packing shows traces
Symbols
1.1 Ambient conditions
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• • •
of improper handling or damage. If this is the case, inform the haulier which has delivered the product to you. Unpack the instrument together with a representative of the haulier. Prepare a protocol describing parts that are possibly damaged. This must be signed by you and by the representative of the haulier. Leave instrument in the packing for several hours before unpacking (condensation). After unpacking, check if the instrument has been damaged. Return the defective equipment in an appropriate packaging. Always mount the slit lamp and the headrest on an electric insulated and fire resistant table top. The rail covers (a) prevent from a tip over of the slit lamp. Check if the connection pieces of the accessories fit tightly (like screwed connections and quick fit).
(a)
1.3 Installation warning notices WARNING! Only a hospital grade 3-conductor electrical power supply cable must be used. For USA and Canada: Detachable power supply cord set, UL listed, type SJE, SJT or SJO, 3-conductor, not smaller than 18 AWG. Plug, cable and ground lead connection of the socket have to be in perfect condition.
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1.4 Operation, environment
FORBIDDEN! Never use the ocular to look at the sun. Never operate the instrument in the same room with combustible gases, volatile solvents (alcohol, benzol) or flammable anaesthetic agents.
1.5 Light toxicity WARNING! Because prolonged intense light exposure can damage the retina, the use of the device for ocular examination should not be unnecessarily prolonged, and the brightness setting should not exceed what is needed to provide clear visualization of the target structures. This device is fitted with protective filters, which limit the spectrum from 400 to 750 nm, see 4.2. The retinal exposure dose for a photochemical hazard is aproduct of the radiance and the exposure time. If the value of radiance were reduced in half, twice the time would be needed to reach the maximum exposure limit. While no acute optical radiation hazards have been identified for slit lamps, it is recommended that the intensity of light directed into the patient’s eye be limited to the minimum level which is necessary for diagnosis. Infants, aphakes and persons with diseased eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply particularly if the eye has been exposed to retinal photography. © HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7001000-04140 – 2011 – 11
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WARNING! The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. The maximum exposure time with this instrument set to the maximum intensity is related to the chosen type of illumination (Halogen / Tungsten illumination). The maximum values are specified in chapter 4.2, respectively 4.4..
NOTE! Only qualified and trained personnel should operate the equipment, the training is at the owner’s responsibility. Use only HAAG-STREIT accessories. WARNING! Shut down after every use. In case the dust cover is used: risk of overheating.
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1.6 Cleaning and disinfection • Clean the slit lamp housing only with a slightly water dampened cloth. • No liquids, no alcohol or corrosive agents. • Clean only the exterior surfaces of the optical parts. • Use chin paper and clean the forehead band with a cotton pad soaked in alcohol. 1.7 Warranty and third-party product liability • The instrument should be operated in accordance with the chapter 'Safety'. • Incorrect operation can damage the instrument. Thus no warranty claims can • •
be accepted. Continued use of an instrument that has been damaged by incorrect operation can lead to personal injury. The manufacturer cannot accept liability in this case. Repairs and alterations on this equipment should only be carried out by HAAGSTREIT service technicians or by authorized persons.
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a) Read very carefully (in the instruction for use)! b) Warning for hot surfaces! c) Disconnect the electrical supply plug! d) Manufacturer e) Serial number f) Date of manufacture g) Application part Type B h) HS reference number
Product: Type:
(c)
(f)
(g)
(h)
Slit Lamp BQ 900
Input: 4.5-8VDC, 40W use only Power Supply from H-S HAAG-STREIT AG Gartenstadtstrasse 10 3098 Koeniz, Switzerland
Made in Switzerland
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XXXX SN XXXXX
1123 1002113 01100
(e)
1. 2. 3. 4.
REF XXXXXXX
(d)
(b)
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2 Overview
1.8 Pictographs and type plate
(a)
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Lamp cable Headrest Forehead band Headrest height marker (patient's eye) 5. Fixation lamp 6. Chin rest 7. Chin rest height adjustment 8. Lamp cover tungsten and halogen (LED LI 900 see separate instructions for use) 9. Lever for grey and red free filter 10. Scale for angled position of the slit image (steps of 5°) 11. Illumination mirror 12. Diffusor 13. Magnification changer 14. Mounting screw for the stereo microscope 15. Protective cover 16. Illumination unit / microscope angle scale 17. Illumination arm locking screw
SLLA224 18. Microscope arm locking screw 19. Slit width controls 20. Screws for weight compensation 21. Registered trade mark BQ 900 22. Slit / diaphragm scale 23. Slit length, slit rotation, blue filter and fixation star control 24. Cap screw for accessories pin 25. Quick fit connector accessory 26. Stereo microscope 27. Eyepieces 28. Breath shield 29. Mounting screw for breath shield 30. Mounting hole for tonometer (right side) for Tonometer AT 900 model BQ or AT 900 D model BQ 31. Centering screw 32. 0° to 20° tilting angle latch 33. Screw to block horizontal movement 34. Axle 35. Rail covers 36. Joystick 37. Gliding plate
Caution: Federal law restricts this device to sale by or on the order of a Physician or Practitioner
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59
* LI 900 1
8
60
21 2 22 9 3 4 5 6
10 11 12 13 14 15 16
7
17
23 24 25 26 27
12. Diffusor 1007085 61
28 29 30 31 32
18 19 20
33 34 35 36 37
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3 Operation 3.1 Adjusting the eyepieces NOTE! Before the first examination, the eyepieces should be adjusted singly to correspond with the refraction divergence of the examiner. Insert the provided focusing rod (a) in place of the protective cover (b) with the flat projection surface facing the microscope. Line up the illumination unit and the microscope in the central position (0°).
• • • • •
Adjust each eyepiece separately, by turning the knurled ring with the diopter scale separately, until the projected slit is seen in focus. Adjust from (+) to (-) at low magnification. Younger examiners are recommended to make an additional correction on both eyepieces of −1 to −2 diopters each, to compensate for the accommodation that occurs as a result of convergence when conducting binocular examinations. The requisite pupil distance on the microscope can then be adjusted. The adjustable eyecup (c) serves to set up the correct working distance of the examiner to the eyepiece. For examiners without spectacles: pull out the eyecup fully to the extended position. For examiners wearing spectacles: push in the eyecup fully to the retracted position.
3.2 Prepare the patient • The height of the table must be selected to enable the patient to obtain a firm • • •
a)
b)
c)
rest for the forehead and chin. In order to ensure that only that part of the eye to be examined is illuminated and to avoid disturbing glare, the height of the light beam should be appropriately adjusted. Those parts of the equipment coming into contact with patients should be cleaned with a dry cloth before each examination. Turn off the illumination of the lamp after each examination.
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3.3 Operating the instrument • Move the chin rest (6) up or down with the adjustment screw (7) until the • • • • • •
• • •
• • •
eyes of the patient are level with the black mark on the headrest column (4). Focus the eyepieces (27) to suit your refraction by turning the knurled rings and then set to your interpupillary distance. Switch on the illumination unit by turning the power supply switch. Control level of slit illumination / knob on the power supply / 10% grey filter (see chap. 3.4). LI 900 see separate instructions for use. Rotate the joystick (36) until the light beam is at eye level. Microscope magnification is changed by rotating the magnification changer (13). Holding the joystick (36), inclined towards you, move the instrument base until the slit appears to be approximately in focus on the cornea. This coarse setting is achieved with the naked eye. Fine adjustments are obtained by rotating and tilting the lever while observing the image through the microscope (27). The slit width is adjusted to the left or right by means of the knob (19), which also adjusts the angle between the microscope and the illumination unit. The slit image is made vertical, horizontal, or given any desired angle by means of control knob (23) (notches at 45°, 90° and 135°; stops at 0° and 180°, scale in 5° steps). In order to ensure the possibility of conducting a binocular fundus examination in optical cross section without difficulty from side angles between 3 and 10°, the shorter mirror (11) should be installed, the illumination unit is rotated through 90° with the knurled control knob (23) and with the latch (32) in stages of 5°, the illumination unit and the microscope are turned to the centre position (0°). Loosening the centering screw (31) will allow the slit image to be moved off centre for scleral illumination. Tightening the screw will re-centre the slit image in the visual field of the microscope. Set the diffusor (12) in place for general observations. For examination of the posterior of the eye, preset lenses or diagnostic contact lenses have to be used.
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* LI 900 1
8 21
2 22 9 3 4 5 6
10 11 12 13 14 15 16
7
17
23 24 25 26 27 28 29 30 31 32
18 19 20
33 34 35 36 37
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3.4 Set filters and apertures a) b) c) d) e) f) g) h)
Open aperture Grey filter (10%) Red free filter Empty space for accommodating an add filter Fixation star (particularly suitable for examining the fixation in amblyopia) Apertures of 8, 5, 3, 2, 1 and 0.2 mm ø Indication of continuous slit length adjustment in mm Blue filter NOTE! The UV filter and the heat absorption filter are permanently mounted according to the ISO 10939 norm.
(a)
(e)
(b)
(c)
(f)
(d)
(g)
(h)
4 Technical data
(LED illumination LI 900, see separate instructions for use)
4.1 Slit illumination
Slit image width 0 – 8 mm continuous Slit image length 1– 8 mm continuous Illumination fields Circle ø: 8 / 5 / 3 / 2 / 1 / 0.2 mm Test mark with fixation star Slit image radial range ± 90° Radial movement of the slit Horizontal ± 90°, vertical 0 – 20° illumination relative to the microscope axis. Filters Blue, red free (green), grey (10%) The UV filter and the heat absorption filter are permanently mounted. Light source Tungsten / Halogen-bulb 5 V, 7.5 A / max. 38 W Slit illumination intensity 0 V 0 Lux at Position 0 5 V ~150 000 Lux at Position 1/2 6 V ~300 000 Lux at Position 1 7.5 V ~600 000 Lux at Position 2 10
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LED illumination LI 900, see separate instructions for use © HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7001000-04140 – 2011 – 11
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4.2 Tungsten illumination
WARNING! The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum output will exceed the safety guideline after 3.2 minutes with slit illumination or 2.5 minutes with both slit and peripheral illumination.
4.3 Spectrum tungsten illumination 100% 60% 40% 20% 0% 300
IR
UV
Y
X= Wavelength [nm] Y= Rel. intensity
X 400
500
600
700
800
900
1000
Stereo angle: Magnification changer: Ocular magnification: Range of adjusting eyepieces: Inter pupillary distance:
4.7 Instrument base
1100
WARNING! The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum output will exceed the safety guideline after 3.2 minutes with slit illumination or 2.5 minutes with both slit and peripheral illumination.
4.5 Spectrum halogen illumination 100%
40%
Y
IR
UV
20%
X
13° 6.3x / 10x / 16x / 25x / 40x 12.5x + 8 to - 8 diopters 52 - 78 mm
4.8 Weight
12.7 kg (without power supply, headrest and options)
5 • • • • • •
Statutory requirements
The slit lamp BQ 900 has been designed and constructed to conform to the IEC / EN 60 601-1 and EN ISO 15004-2 standards. Manufacturing procedures, testing, commissioning, maintenance and repair are conducted under the observance of Swiss and international regulations. When combining different medical and/or nonmedical electrical equipment standard IEC / EN 60601-1-1 applies. The 'CE' marking confirms compliance of the slit lamp BQ 900 with the directive 93/42/EEC. The slit lamp BQ 900 meets the electromagnetic compatibility requirements of IEC / EN 60601-1-2. The appliance is designed to keep emissions of electromagnetic interference at a level that does not exceed the legal guidelines, or bothers other devices in its vicinity. The device itself has the immunity required by the standard. All statutory accident prevention regulations are to be observed.
X= Wavelength [nm] Y= Rel. intensity
0% 300 400 500 600 700 800 1000 1100 900 © HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7001000-04140 – 2011 – 11
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Single handed 3-dimensional operation of the joystick 80 mm (length) 30 mm (height) 100 mm (side)
Maximum examination times according to ISO 15004-2 and ISO 10939
60%
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Operation: Adjustment of the instrument base
4.4 Halogen illumination
80%
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4.6 Stereo-microscope
Maximum examination times according to ISO 15004-2 and ISO 10939
80%
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Classification
IEC / EN Standard 60 601-1: Application part: Operation mode: CE-Regulation 93/42 EEC FDA
7 Environment • • • •
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Slit Lamp BQ 900 equipment safety class I. Type B continuous operation Class I Class II
Electric and electronic equipment must be separated from house waste! This equipment has been introduced into the market after the 13th of August 2005. Disposal via your local collecting point or your HAAG-STREIT representative. Please take the old batteries to a professional disposal. Thus it is ensured, that no harmful materials get into the environment and that valuable raw materials can be used again.
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Additional information A Equipment maintenance routines
A.1 Replacement of the bulb (not for LI 900) • The tungsten/halogen lamp bulb is centreed ex-works to obtain an optimal •
illumination. The 'H-S' marking on the centreing base-cap indicates a genuine HAAG-STREIT spare part. The light beam from the pre-centreed bulb passes through the condenser, the slit diaphragm and the illumination lens, before it is directed to the patient's eye by the oblique mirror. 'H-S'
A.2 Microscope and ocular
38. Front lens f 105 mm 39. Turning knob with display of selected magnification 40. Magnification changer 5 step (Galilean system) 41. Knurled ring for quick fit 42. Binocular tube f 130 for convergent viewing range of pupillary distance 53 – 78 mm 43. Eyepiece 12.5x Diameter of field 16 mm 44. Index (white spot) 45. Knurled ring with diopter scale for setting the refraction of the examiner (± 8 D) 46. Sliding eyecup (for spectacle wearers) Total magnification 6.3x 10x 16x 25x 40x Object image section ø in mm 32.0 20.0 12.7 8.0 5.1 12
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41
42
43
44 45
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A.4 Fixation lamp • • • •
The fixation lamp is lit as soon as the power supply switch is activated, then the fixation lamp (53) gets visible. The fixation target can be brought into any position by moving the bearer's arm (49). This permits uninterrupted observation through the microscope and simultaneous guidance of the patient's eye to any desired position. This is especially advantageous in examining the fundus. It's a condition, that the patient's eye is correctly positioned at the headrest's height marker (52). Ametropia of the patient from +10 D to −15 D (50) can be corrected (51). Steady fixation of the eye is maintained as accommodation and convergence are avoided. 48 49 50
A.3 Attaching an accessory in the beam path
Align the positioning points (47) on the upper side of the parts to be joined. Close Push together and tighten firmly the joint in direction of the arrow by turning it.
51
52 53
47
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B Mounting of the equipment B.1 Microscope and illumination unit • Place the stereo microscope on the saddle bearing of the microscope arm. • • •
Move it forward against the stop piece and secure with the screw (54) appearing from obliquely below (use the Allen key 5 mm). Secure the breath shield (56) by means of the knurled screw (55) on the bearer arm. Before attaching the illumination unit to the column of the instrument base, the set screw (54) in the hub of the bearer arm is to be sufficiently loosened so that its tip no longer protrudes into the screw hole. Grasp the illumination unit arm (57) as shown and place in position. Tighten the set screw (58) in the hub of the bearer arm with the small screwdriver.
Small screwdriver Allen key 5 mm
HAAG-STREIT part number 1001436 HAAG-STREIT part number 1001602
B.2 Power supply
54 55 56
57 58
NOTE! The corresponding HAAG-STREIT operating instructions should be observed! (Ask your HAAG-STREIT distributor for further information.)
B.3 Instrument base with load compensation
The weight of components or accessories added to the microscope can be compensated by relieving springs so that height adjustment of the slit lamp remains smooth, no matter what accessories remain permanently mounted.
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B.3.1 Compensating the weight of added components • Turn the joystick (60) down to its lowest stop, then loosen it by 1/4 turn. • Swing the microscope and illumination unit to one side. • Engage 1-3 springs depending on accessories. B.3.2 Engaging
Turn the screws (59) counter-clockwise until they are in the uppermost position.
B.3.3 Disengaging
Tighten the screws by turning them clockwise. • Lift the microscope arm with one hand. Release it and check whether it returns to the original position. This will not happen unless the maximum load has been added. • As a rule, it will be necessary to disengage as many relieving springs as required for ensuring that the arm and spring housing settle down in their original position. • The load is adequately counter-balanced when the weight of illumination unit and microscope with all permanently mounted components exceeds the compensating force of the springs by a small amount.
59
60
B.4 Slit illumination and Diffusor
It is possible to take images and video using the inbuilt illumination of the slit lamp and the diffusor. However, this excludes simultaneous slit projection. Montage • Insert the diffusor into the foreseen reception slots (61) where it will snap in to secure.
C Equipment maintenance C.1 Replacement of the mirror
61
Removal of the mirror (62) is easiest when the microscope and illumination unit are well separated and the latter inclined by two steps.
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C.2 Cleaning of the optical parts
A dust brush (63) is to be employed for dusting the exposed glass surfaces. HAAG-STREIT part number 1001398
62
C.3 Adjustment of friction of the slit width control
The friction of the slit width control (64) can be regulated by means of the small screw in the centre of the right hand control. The movement can be stiffened by turning the screw clockwise or loosened by turning it counter-clockwise. The screw should be at least tight enough to ensure that the slit does not close spontaneously.
64
C.4 Cleaning of the gliding plate and the rails
If it becomes difficult to move the slit lamp around on the gliding plate (68), the plate should be cleaned with a slightly oily rag. After removing the rail covers (67), the rails (66) should be cleaned with a stiff brush.
C.5 Cleaning of the axle (65) Clean only with dry, lint-free cloths!
65 66
C.7 Plastic dust cover
It is recommended to protect the slit lamp with a dust cover (69) in case it is not in use. Plastic dust cover, small (for slit lamp) HAAG-STREIT part number 1001395 Plastic dust cover, large (for several instruments) HAAG-STREIT part number 1001434
63
67
68
69
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D Halogen / Tungsten illumination NOTE! The slit lamp BQ 900 in combination with the illumination set LI 900 may be used without any maintenance during the entire life cycle without replacement of the bulb.
70
D.1 Replacement of the bulb (not for LI 900)
The lamp cover can be removed by depressing both pressure buttons (70) to expose the bulb. WARNING! Before changing the bulb, turn off the switch on the power supply and disconnect the power cord! WARNING! Increased temperatures can occur on the upper surface of the lamp housing! Allow the light bulb to cool down before removing it or use protective gloves to remove. Use only original HS (71) lamp bulbs! When installing a new bulb, care should be taken to place the notch in the centreing base into the positioning catch. Replace the lamp cover and push it down until the two pressure buttons engage securely.
D.2 Check electrical contacts of bulb and lamp housing
With suspicion of bad electrical contacts (flickering or loss of light): • The contact surface in the lamp housing (74) must be clean and show no traces of oxidation. • Clean contact surface (with sandpaper, screwdriver etc.) of bulb (72), the contact springs in the lamp housing (74) and (75) and apply some contact medium. • If necessary bend slightly the contact surfaces in the lamp housing (74) and (75) in direction of the bulb • Bend slightly both of the retaining clips (73) outwards
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71 72 73
74 75
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D.3 Use of the contact medium
At each change of light bulb, lubricate the contact points (A) and (B) with enough contact medium. The contacts of the bulb and the lid of the lamp should not show any scorch marks. • Fit the lamp cover and remove it to check if there is enough contact medium on the points of contact (C) and (D). Reapply some medium if needed. • The product does not require labelling. (Perfluorocarbones, Polyether oil PTFE). WARNING! Avoid contact with skin and eyes!
A
B
C D
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E Accessories NOTE! HAAG-STREIT part numbers are written in italics. An asterisk (*) indicates that your HAAG-STREIT distributor will provide you with more information.
Tungsten Bulb 6V, 4.5A - SL with centering base 3000353
Halogen bulb BM/BQ 900, 7.5V 38W 1300068
Eyepiece 12.5x with dioptre adjustment 1400303 Identification color: Red - Measuring eyepiece 12.5x 1400302 Yellow - Eyepiece with double crosshair reticule 12.5x 3000470 Blue - Eyepiece 12.5x with McIntyre comparison grid 1400304
Power supplies* (not for LI 900)
Eyepiece for length and angle measurements 10x 1400265 BQ-Adapter sleeve for Eyepiece for length and angle measurements 1006584
Long mirror 1001590 Short mirror 1001591
Adjusting pin 1001051
Pin 3000332
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Applanation Tonometer AT 900 model BQ/BP 7200034
Applanation Tonometer AT 900 model T (guide plate included) 7200032 19
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Not for sale in the USA!
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Not for sale in the USA!
Depth measuring attachments I up to 1.2 mm 7200006 II up to 6 mm 7200007 I + II 7200008 Digital Applanation Tonometer AT 900 D model BQ RAL 7035 7220065
Movable Hruby preset lens, -58.6 dioptres 1400223
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Digital Applanation Tonometer AT 900 D model T (guide plate included) 7220061
Split image eyepiece for depth measuring attachments12.5x 1400300
Headrest with fixation lamp* Box with chin rest paper 1001309
Guide plate (900-415) 1001219 Pin for chin rest 900-1359 1200713
Carriage for preset lenses with rail (guide plate included) 1001219
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Diffuser 1007085 Allen key 5 mm 1001602
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Beam splitter 50/50 1400308 70/30 1001600
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Stereo-variator 7200109
Contrast enhancing filter (yellow) 1400306 Zoom-Module for Slit Lamp BQ 900 1400013
Second observer tube, short (without eyepiece) 1400301 Adapter for inclined eyepieces 20° 1400305
Second observer tube, long (without eyepiece) 1400034
Split image eyepiece 12.5x 1400300 © HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7001000-04140 – 2011 – 11
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Video Adapter with objective tube f60 (mini-camera) 1400320
Video Adapter with objective tube f75 (C-mount) 1400319
Video Adapter with objective tube f56 1/3 (C-Mount) 1007780
Video Adapter with objective tube f60 (3-chip, ½ inch) 1400321
SLLA224 Background Illumination pivoting mirror* (not for LI 900)
Cable guide without duct on table top ø 12 mm 7200086 ø 20 mm 1001575 Background Illumination light lead holder* (not for LI 900)
Imaging Module IM 900 complete (Camera Module CM 01 + Release Module RM 01 + Software) 7200744
Cold light source* (not for LI 900) Photo Adapter DC 01 for digital cameras 1004665
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LED illumination LI 900 - see sep. instruction for use
Illumination head LED black without background illumination 1020884 Power Supply for LED Illumination HSM 901 1020882
Power Supply for LED Illumination 1020881
Illumination head LED, background illumination ready
BQ BQ BP
Black Light grey Black
RAL9005 RAL7035 RAL9005
1020885 1021178 1021179
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Background Illumination fixed 1020886
Background Illumination pivoting 1020887
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Illumination control double slitand background 'in table' 1021022
Illumination control single slit only 'in table' 1021024
Illumination control double slitand background 'on table' 1020883
Illumination control single slit only 'on table' 1021020
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Instrument Table HSM 801*
Cover T-0 for recess in table 1021085 Instrument Table HSM 901*
Ilumination Control Cable USB 2000 mm 1020940 5000 mm 1020956 24
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F. EMC Supplement F.1 General
Instrument Table HSM 901* 'Workstation'
WARNING! Electrical medical appliances and systems are subject to special measures regarding EMC and should be installed in accordance with these accompanying instructions. Portable and mobile high frequency communications’ equipment can negatively influence electrical medical appliances.
F.2 System components
The BQ 900 Slit Lamp System includes the following equipment: • BQ 900 Slit Lamp • HSM 901/E1 Instrument Table • CLS 01 Cold Light Source • PS-A Power Supply Unit
F.3 Connecting cables
The following connecting cables are required: • Power Supply Unit CH: part number 1001319, max. length = 2500mm • Power Supply Unit USA: part number 1001316, max. length = 3100mm
Instrument Table HSM 901* 'Imaging'
WARNING! Any connecting cables or accessories used to run the appliance other than those indicated can lead to enhanced emissions or to a reduced interference factor in the BQ 900 Slit Lamp System.
F.4 Basic performance factors
The BQ 900 is an AC-powered slit lamp biomicroscope intended for the use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment. *Power supply not for LI 900 © HAAG-STREIT AG, 3098 Koeniz, Switzerland - HS-Doc. no. 1500.7001000-04140 – 2011 – 11
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Table 1: Emitted interference
Guidelines and manufacturer's declaration – Electromagnetic emissions The BQ 900 Slit Lamp system is designed to be operated in an environment as described below. The customer or user of the BQ 900 Slit Lamp system should ensure that it is operated in such an environment. Emitted interference measurements Compliance
Electromagnetic environment / Guidelines
HF emissions pursuant to CISPR11
Group 1
The BQ 900 Slit Lamp system uses HF energy exclusively for its internal functioning. Therefore, its HF emission is very low, and interference with neighbouring equipment is unlikely.
HF emissions pursuant to CISPR11
Class B
Emission of harmonics pursuant to IEC61000-3-2
Class A
The BQ 900 Slit Lamp system is suitable for use in facilities other than the residential area and facilities such as those directly connected to a public grid which also supplies buildings used for residential purposes.
Emission of voltage fluctuations / flickers pursuant to IEC 61000-3-3
Not applicable
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Table 2: Interference immunity
Guidelines and manufacturer's declaration – electromagnetic immunity The BQ 900 Slit Lamp system is designed to be operated in an environment as described below. The customer or user of the BQ 900 Slit Lamp system should ensure that it is operated in such an environment. Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment / Guidelines
Electrostatic discharge (ESD) pursuant to IEC61000-4-2
±6 kV contact discharge ±8 kV air discharge
±6 kV contact discharge ±8 kV air discharge
Flooring should be made of wood or concrete, or be covered with ceramic tiles. If the floor is coveredwith synthetic material, the relative air humidity must be at least 30%.
Electrical fast transients / bursts pursuant to IEC61000-4-4
±2 kV for power lines
±2 kV for power lines
The quality of the supply voltage should conform to that of a typical business or hospital environment.
Surges pursuant to IEC 61000-4-5
±1 kV for symmetrical voltages ±2 kV for asymmetrical voltages
±1 kV for symmetrical voltages ±2 kV for asymmetrical voltages
The quality of the supply voltage should conform to that of a typical business or hospital environment.
Voltage drops, short interruptions and fluctuations in the supply voltage according to IEC61000-4-11
< 5% UT(> 95% drop in UT) for ½ period < 40% UT(> 60% drop in UT) for5 periods < 70% UT(> 30% drop in UT) for 25 periods < 5% UT(> 95% drop in UT) for 5 s
< 5% UT(> 95% drop in UT) for ½ period < 40% UT(> 60% drop in UT) for 5 periods < 70% UT(> 30% drop in UT) for 25 periods < 5% UT(> 95% drop in UT) for 5 s
The quality of the supply voltage should conform to that of a typical business or hospital environment If the user of the BQ 900 Slit Lamp system requires continued function even in the event of interruptions in the energy supply, the BQ 900 Slit Lamp system should be powered from an uninterruptible power supply or a battery.
Magnetic field at the supply frequency (50/60Hz) according to IEC 61000-4-8
3A/m
3A/m
Magnetic fields at the mains frequency should conform to the typical values as they can be found in business and hospital environments.
NOTE: UT = grid AC voltage before application of the test levels.
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Table 3: Immunity (not life-support equipment)
Guidelines and manufacturer's declaration – Electromagnetic immunity The BQ 900 Slit Lamp system is designed to be operated in an environment as described below. The customer or user of the BQ 900 Slit Lamp system should ensure that it is operated in such an environment. Electromagnetic environment – Guidelines Portable and mobile radio equipment shall not be used any closer to the BQ 900 Slit Lamp system, including the cables, than the recommended safe distance calculated in accordance with the equation appropriate for transmission frequency. Immunity test
IEC 60601 test level
Compliance level
Recommended distance:
Conducted HF interference pursuant to IEC61000-4-6
3 Veff 150 kHz – 80 MHz
3 Veff
D = 1.2
P
Radiated HF interference pursuant to IEC61000-4-3
3 V/m 80 MHz – 2,5 GHz
3 V/m
D = 1.2 D = 2.3
P 80 MHz – 800 MHz P 800 MHz – 2,5 GHz
With P as the nominal output of the transmitter in watts (W) in accordance with the specifications of the transmitter manufacturer and D as the recommended safe distance in metres (m). According to an on-site investigation(a), the field strength of stationary radio transmitters is lower for all frequencies than the compliance level(b). Interference is possible in the environment of devices that bear the following symbol. NOTE 1: for 80 MHz and 800 MHz the higher value shall apply. NOTE 2: these guidelines may not apply in all situations. Electromagnetic wave propagation is influenced by the absorption and reflection of buildings, objects and people. a) The field strength of stationary transmitters, e.g. base stations of cordless telephones and land mobile services, amateur radio stations, AM and FM radio and television broadcasting stations, may not, in theory, be precisely predetermined. To determine the electromagnetic environment resulting from stationary HF transmitters, an on-site inspection is recommended. If the calculated field strength at the site of the BQ 900 Slit Lamp system exceeds the above-mentioned compliance level, the BQ 900 Slit Lamp system must be monitored with regard to its normal operation at each application site. If any unusual operating characteristics are observed, it may be necessary to take additional measures, e.g. reorientation or relocation of the BQ 900 Slit Lamp system. b) Above the frequency range of 150 kHz to 80 MHz the field strength is less than 3 V/m.
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Table 4: Recommended safe distances (not life-support equipment)
Recommended safe distances between portable and mobile HF communication devices and the BQ 900 Slit Lamp system. The BQ 900 Slit Lamp system is designed for operation in an electromagnetic environment in which radiated HF interference is controlled. The customer or user of the BQ 900 Slit Lamp system can help to prevent electromagnetic interference by maintaining minimum distances between portable and mobile HF communication systems (transmitters) and the BQ 900 Slit Lamp system, as recommended below in accordance with the maximum output of the communication system. Nominal output of the transmitter (W)
Safe distance according to transmission frequency (m) 150 kHz - 80 MHz D = 1.2 P
80 MHz - 800 Mhz D = 1.2 P
800 MHz - 25 GHz D = 2.3 P
0.12 0.01 0.12 0.23 0.38 0.1 0.38 0.73 1.2 1 1.2 2.3 3.8 10 3.8 7.3 12 100 12 23 For transmitters with a nominal output not listed in the above table the distance (m) D can be calculated using the equation that applies to the respective column, where P is the nominal output of the transmitter in watts (W) in accordance with the specifications of the transmitter manufacturer.
NOTE 1: to calculate the recommended safe distance of transmitters in the frequency range of 80 MHz to 2.5GHz an additional factor of 10/3 was used to reduce the probability of interference from a mobile/portable communication device inadvertently brought into the patient area. NOTE 2: 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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For further questions please contact your HAAG-STREIT distributor at:
http://www.haag-streit.com/contact/contact-your-distributor.html
C
US
1250
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PRODUCTS CERTIFIED FOR BOTH THE U.S AND CANADIAN MARKETS, TO THE APPLICABLE U.S. AND CANADIAN STANDARDS
HAAG-STREIT AG Gartenstadtstrasse 10 3098 Koeniz, Switzerland Phone +41 31 978 01 11 Fax +41 31 978 02 82 eMail
[email protected] Internet www.haag-streit.com
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