INSTRUCTIONS FOR USE Slit lamp BD 900

Transcription

1 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH INSTRUCTIONS FOR USE Slit lamp BD Edition / DOC. no IFU_BD _eng.indd :17:45

2 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA INSTRUCTIONS FOR USE Slit lamp BD Edition / Introduction Thank you for deciding on a HAAG-STREIT product. By complying carefully with the instructions in these instructions for use, you will protect your HAAG-STREIT product. Purpose of use An AC-powered slitlamp biomicroscope is intended for 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. Contraindications There are no absolute contraindications known for examinations with this device. Appropriate professional assessment and caution are necessary. 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 IFU_BD _eng.indd :17:46

3 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH Contents 1. Safety Areas of application of the device Ambient conditions Shipment and unpacking Installation warnings Operation, environment Light toxicity Disinfection Warranty and product liability Symbols Introduction Overview Appliance assembly / installation Microscope and illumination Power supply (Type designation: LC-SLT) Possible causes of errors Replacing the primary fuse Replacing the secondary fuse Commissioning Switching on the appliance Operation Setting the eyepieces Preparing the patient Operating the instrument Setting the filters & diaphragms Camera equipment (option) Microscope and eyepiece Decommissioning Technical data Slit illumination Slit lamp illumination with halogen lamps Spectrum of halogen illumination Stereo microscope Instrument base Net weight Power supply LC-SLT Maintenance Repairs Cleaning Replacing the illumination mirror Dust cover...12 A. Appendix A.1 Accessories / spare parts...12 B. Legal regulations C. Classification D. Disposal E. Standards F. Information and manufacturer's declaration concerning electromagnetic compatibility (EMC) F.1 General...14 F.2 Emitted interference (standard table 1)...14 F.3 Immunity (standard table 2)...15 F.4 Interference immunity on non-life-supporting devices (standard table 4)...16 F.5 Safe distances for non-life-supporting devices (standard table 6) IFU_BD _eng.indd :17:46

4 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA 1. Safety DANGER! Failure to comply with these instructions may result in material damage or pose a danger to patients or users. These warnings must absolutely be complied with to guarantee safe operation of the device and to avoid any danger to users and to patients. NOTE! Important information: please read carefully. 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 possible 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. Check: Are the connection parts of the accessories in the correct position (screw connections, quick-release fasteners)? (a) 1.1 Areas of application of the device The device is intended for use in doctor's practices, hospitals and optometrists' and opticians' premises. 1.2 Ambient conditions Transport: Storage: Use: Temperature Air pressure Relative humidity Temperature Air pressure Relative humidity Temperature Air pressure Relative humidity from from from from from from from from from 40 C 500 hpa 10% 10 C 700 hpa 10% +10 C 800 hpa 30% to to to to to to to to to +70 C 1060 hpa 95% +55 C 1060 hpa 95% +35 C 1060 hpa 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). 1.4 Installation warnings This device must not be modified without the manufacturer's approval. Installation and repairs may only be performed by trained specialists. Any third-party device must be connected in compliance with the EN standard. 1.5 Operation, environment DANGER! Never use the device in potentially explosive environments where volatile solvents (alcohol, benzine, etc.) and combustible anaesthetics are in use. To avoid the risk of an electric shock when using protection class I power supplies, they must be connected to the public power grid with a ground connection. The device must be switched off after every use. There is a risk of overheating when using a dust cover IFU_BD _eng.indd :17:46

5 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH NOTE! This appliance must only be operated by qualified and trained personnel. The owner is responsible for their training. 1.5 Light toxicity As extended, intensive illumination can damage the retina, the use of the instrument in the examination of the eye should not be prolonged unnecessarily. This slit lamp is equipped with protective filters which limit the light spectrum to nm, see 7.2. 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, aphakes 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 instrument with a visible light source within 24 hours. This specially applies if the retina has been photographed with a flashbulb in advance. The light from this device may be dangerous. The risk of eye damage increases with the irradiation period. The exposure time with this device at maximum intensity is linked to the selected type of illumination. An exposure time with this instrument at maximum intensity of longer than 2.8 minutes exceeds the risk guideline value (as per EN ISO ). 1.8 Warranty and product liability Haag-Streit products must be used only for the purposes and in the manner described in the documents distributed with the product. The product must be treated as described in the Safety chapter. Improper handling can damage the product. This would void all guarantee claims. Continued 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 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 Symbols Read the instructions for use attentively Warning hot surfaces! European certificate of conformity Notes on disposal, see the 'Disposal' chapter On (Power) General warning: Read the accompanying documentation Disconnect the plug before opening the device Test symbol of CSA with approval for USA This appliance fulfills the European Directive 2001/65/EU (RoHS) Off (Power) 1.7 Disinfection NOTE! The device does not need to be disinfected. For more information on cleaning, please refer to the 'Maintenance' section. Manufacturer Alternating current HS reference number Year of production Direct current Serial number 5 01-IFU_BD _eng.indd :17:49

6 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA 2 Introduction 2.1 Overview 1. Lamp cable 2. Head rest 3. Headband 4. Height mark on head rest (patient eye) 5. Adjustable fixation lamp 6. Chin rest 7. Height adjustment of chin rest 8. Lamp cover 9. Lever for grey and red removal filters 10. Lever for slit length, blue filter 11. Scale for angled position of the slit image 12. Illumination mirror 13. Diffusor 14. Camera connection (C-mount) 15. Protective cover 16. Illumination unit / microscope angle scale 17. Slit width setting screw 18. Brightness setting 19. Power supply connection 20. Registered trademark BD Scale for slit length and blue filter 22. Lever for switching on the yellow filter 23. Cap for accessories base 24. Stereo microscope with eyepieces 25. Eyepiece fixing screw 26. Lens-changing lever 27. Knurled screw for fixation of breath shield 28. Breath shield 29. Joy stick base locking screw 30. Rail cover 31. Control lever 32. Slide plate 33. Prism housing 34. Eyepiece mounting 35. Index (white point) 36. Knurled ring with dioptre scale for setting the refraction of the examiner (± 6 D) 37. Sliding occluder Diffusor Eyepiece with prism housing IFU_BD _eng.indd :17:50

7 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH 3. Appliance assembly / installation This device must not be modified without the manufacturer's approval. Installation and repairs may only be performed by trained specialists. Contact your HAAG-STREIT representative for the installation, repair and modification of your system. The contact data are available at Microscope and illumination The slit lamp is packaged and shipped fully assembled. The transport safety measures must be removed before commissioning. Fix the breath shield (28) in place by fastening the knurled screw (27) on the inside of the bearer arm. 3.2 Power supply (Type designation: LC-SLT) 38. Voltage selector switch 39. Secondary fuse (1 x F 3.15 AL, 250 V HS part number ) 40. Primary fuse (2 x T 800 mal, 250 V HS part number ) 41. Main switch (rocker switch) Use only with the HS power supply LC-SLT. This is equipped with a voltage selector switch (38) 115 V / 230 V. The range must be set to the local power supply prior to initial commissioning Possible causes of errors Error The main switch is switched on but not illuminated The main switch is illuminated but the slit illumination is not Replacing the primary fuse Cause The primary fuses are defective The secondary fuse or halogen lamp is defective Only the fuses described in the corresponding table in the "Technical data" section should be used. Unplug the power cable. Open the fuse socket (40) with a screwdriver. Replace the fuses. Screw the fuse socket (40) back in. Connect the electric power supply cable Replacing the secondary fuse Unplug the power cable. Turn the slit on the fuse holder (39) to the left with a screwdriver. Replace the fuse. Turn the fuse holder (39) to the right with a screwdriver. 4. Commissioning 4.1 Switching on the appliance The main switch (rocker switch) is found on the front of the power supply, under the table top. Connect the power supply up to the power and set the rocker switch ( / ) to ON ( ). The device is now ready for use. When it is switched on, the green light in the main switch (41) illuminates. To prevent the lamp cover from getting too hot, the slit lamp should not be switched on for longer than 5 minutes. The slit lamp can be used again after 5 minutes of being switched off IFU_BD _eng.indd :17:50

8 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA 5. Operation 5.1 Setting the eyepieces 42. Adjusting pin 43. Protective cover 44. Sliding occluder NOTE! The eyepieces must be individually set prior to the first examination in accordance with the refraction of the examiner. Insert the provided check rod (a) in place of the protective cover (b) and turn its black projection surface at a right angle to the microscope axis. Return the illumination and microscope to the central position (0 ) Each eyepiece should be set individually by turning the knurled ocular refraction 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 pupil distance should then be set on the microscope. The sliding occluder (44) is used to set the correct working distance of the examiner from the eyepiece. Examiners who do not wear glasses: Pull the occluder out as far as it will go. Examiners who do wear glasses: Push the occluder in as far as it will go Operating the instrument Use the turn screw (7) to adjust the chin rest (6) until the patient s eyes are at the same height as the black marks (4) on the sides of the head rest. Tighten the eyepiece fixing screw (25). Focus the eyepieces in accordance with the examiner s refraction by turning the knurled rings and set the eye distance. Switch on the illumination by pressing the green main switch on the power supply. The brightness can be continuously adjusted with the potentiometer (18). Adjust the height of the slit lamp by turning the control lever (31) until the luminous aigrette is at eye level. The rigid control lever (31) gently inclined towards the examiner can be used to push the entire instrument 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, easily controllable at the top end, while observing via the stereo microscope (24). The slit width is set left or right with the rotating knob (17), as is the angle between the stereo microscope and illumination. The slit image can be set vertically, horizontally or as diagonally as required by turning the illumination device (8) (locking point at 90 ; stops at 0 and 180 ). The angle can be read off the scale (11). On the slit lamp BD 900, the magnification of the stereo microscope is adjusted by changing the lenses with the lever (26) or by exchanging the eyepieces (option). The diffusor (13) is connected upstream for monitoring the overview. The camera output (14) can be used for documentation. The yellow filter (22) can be engaged to obtain the fluo-image display. 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 in order to avoid objectionable irradiation. The lamp brightness should be reduced to the minimum after every examination. Parts which come into contact with the patient should be cleaned with a dry cloth prior to every use IFU_BD _eng.indd :17:51

9 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH 13 Brightness regulation for camera images The brightness of peripheral or background illumination (option) can be altered on the cold light source housing by using the knob for infinite brightness regulation. For more detailed information, please consult the respective operating instructions. 8 Focussing for camera images Focussing of an object level during the examination should usually be done by moving the microscope towards the object until the level of interest is in focus. If it is brought even further towards the object, the same object level can still be observed by means of accommodation, but with loss of connection with the image level of the camera Illumination facility The halogen lamp is centred in the factory in order to ensure optimal illumination. The light emitted from the pre-centred halogen lamp bulb travels through the condenser, slit diaphragm and lens and is directed into the patient s eye via the 45 mirror Setting the filters & diaphragms (a) (b) (c) Brightness regulation The brightness of the slit illumination can be adjusted with the knob (18) on the instrument base for the slit illumination intensity or by using the 10% grey filter on the upper part of the illumination unit on the slit lamp. Filter in window (a) Operation via lever (b) 45. Open 46. Red removal filter 47. Grey filter (10%) NOTE! UV and thermal-protection filters are installed as per the EN ISO standard. Diaphragm in window (a) Operation via lever (c) 48. Aperture of diameter 14 mm 49. Wedge-shaped diaphragm for continuous slit length adjustment 50. Blue filter 9 01-IFU_BD _eng.indd :17:52

10 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA 5.5 Camera equipment (option) Dimension of object field Size of the camera sensor Microscope magnification 1/3" 1/2" 1x 16 x x x 10 x x 10 The camera equipment is composed of the following components: Either camera with C-mount Maximum camera size (a) Height 110 mm Width 50 mm Length 55 mm or lipstick camera requires an adapter (b) from the respective camera manufacturer and can then be connected to the C-mount interface on the BD 900. Cable guide composed of Cable clamp for camera cable Cable guide for optical fibre Cable guide on the rail cover HAAG STREIT recommends: Camera module CM 900 Peripheral or background illumination with cold light source, composed of Cold light source Optical fibre 5.6 Microscope and eyepiece 56. Two objective-lens pairs 57. Lever for yellow filter 58. Cap for accessories base 59. Serial number of microscope 60. Eyepiece 10x or 25x 61. Connection for camera (C-mount) 62. Lens-changing lever 63. Eyepiece fixing screw Lens 1x 1.6x 1x 1.6x Eyepiece 10x 10x 25x 25x Total magnification 10x 16x 25x 40x Object field diameter 18 mm 11.3 mm 8 mm 5 mm 6. Decommissioning The main switch (rocker switch) is found on the front of the power supply, under the table top. Set the rocker switch ( / ) to OFF. The device is now switched off. When the device is switched off, the main switch (41) is not illuminated. NOTE! Disconnect the power supply from the mains if you do not intend to use it for an extended period of time Technical data 7.1 Slit illumination Slit image width 0 14 mm continuous Slit image length 1-14 mm continuous Max. diaphragm diameter 14 mm Slit image rotatability 0-90 Rotation of slit illumination to microscope Horizontal ±90 axis Filters Blue, grey (10%) and red removal. UV and thermal-protection filters are installed. 01-IFU_BD _eng.indd :17:52

11 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH Light source Halogen lamp 12 V / 2.5 A Illumination intensity 0 V / ~ 0 lux at position 0 7 V / ~75,000 lux at position 1/4 9 V / ~150,000 lux at position 1/ V / ~300,000 lux at position Slit lamp illumination with halogen lamps Maximum examination times according to EN ISO and EN ISO The light from this instrument may be dangerous. The risk of eye damage increases with the irradiation period. An exposure time with this instrument at maximum intensity of longer than 2.8 minutes with the slit illumination or longer than 2.3 minutes with slit and peripheral or background illumination exceeds the risk guideline value. 7.3 Spectrum of halogen illumination X 400 UV IR Y [nm] Stereo microscope Stereo angle 13 Magnification changer 1x and 1.6x 7.5 Magnification with eyepiece 10x (standard) with eyepiece 25x Range of adjusting eye-pieces Pupil distance Camera connection x and 16x 25x and 40x +6 to 6 dioptres mm C-mount X = Rel. intensity (%) Y = Wavelength (nm) Instrument base Operation Adjustment of instrument base 7.7 Net weight 8.1 kg (without power supply, head rest and options) 7.8 Power supply LC-SLT Single-handed operation of control lever in 3 dimensions 100 mm (length) 100 mm (side) 30 mm (height) Only use the LC-SLT power supply from HAAG STREIT with 4-12 V / 30 W Input (voltage selector switch) 115 V~ / 60 Hz / 60 VA or 230 V~ / 50 Hz / 60 VA Operating frequency 50 / 60 Hz Output V / 3 A Output 2 5 V / 300 ma Primary fuse 2 x T 800 mal, 250 V HS part number Secondary fuse 1 x F 3.15 AL, 250 V HS part number Maintenance This device must not be modified without the manufacturer's approval. Installation and repairs may only be performed by trained specialists. 8.1 Repairs To ensure a long service life, the device should be cleaned weekly as described and covered with a dust cover when not in use. We recommend having the device inspected by an authorised service technician annually IFU_BD _eng.indd :17:53

12 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA 8.2 Cleaning Only clean the housing with a dry cloth. No liquids, no aggressive agents, no alcohol. The exposed glass surfaces can be dusted with a dusting brush. Lens brush HAAG-STREIT number Replacing the illumination mirror Do not touch the mirroring surface. Only use mirrors with a LOT number. The mirror (49) dont need to be removed for cleaning. It should only be replaced if mechanically damaged. Dismantling: Depress the mirror in the direction of the arrow, taking care to ensure that it does not jam. Assembly Depress the spring retaining plate downwards Slide the mirror half way in with the other hand Release the retaining plate Continue to slide the mirror into position until it engages 8.4 Dust cover We recommend protecting the slit lamp with a dust cover (50) when not in use. Dust cover, small (for slit lamp) HS art. number Dust cover, large (for several devices) HS art. number A. Appendix A.1 Accessories / spare parts This device must not be modified without the manufacturer's approval. Installation and repairs may only be performed by trained specialists. Connecting third-party systems to the same mains socket can compromise the system's safety Component NOTE! An asterisk (*) shows that you should contact your HAAG-STREIT representative for further information. HS art. no. Cover Adapter for lipstick to C-mount * Applanation tonometer AT 900 D model R for BC / BD Applanation tonometer AT 900 model R for BC / BD Pivot with screw AT 900 type R Illumination mirror BC Block of papers for chin rest Camera module CM 900 (C-mount) * Spacer screw Guide plate ( ) Power supply * Halogen lamp BC V 2.5 A Instrument table HSM 801 * Instrument table HSM 901 * Instrument table HSM 901 "Imaging" * Instrument table HSM 901 "Workstation" * Cold light source * Head rest with fixation lamp * Eyepiece 10x Eyepiece 10x with double crosshairs Eyepiece 25x Check rod Pin for chin rest mm Allen key Diffusor BC Peripheral or background illumination for optical fibre holder * Movable front-lens glass, dioptres, as per Hruby Carriage for preset lenses with rail (guide plate included) B. Legal regulations The BD 900 slit lamp was developed and designed taking the EN and EN ISO standards into account. Production, testing, set-up, maintenance and repairs are performed taking international standards into account IFU_BD _eng.indd :17:53

13 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH The EN standard must be observed when using different medical and/or non-medical electrical appliances in combination. Compliance of the BD 900 slit lamp with the Directive 93/42/EEC is confirmed by the CE marking. The BD 900 slit lamp satisfies the electromagnetic compatibility requirements of EN The device has been designed to generate and maintain emissions of electromagnetic interference at a level which does not affect the standard operation of other components. The device has also been developed to offer a certain amount of resistance to electromagnetic interference from other devices. The statutory accident regulations must be observed. C. Classification Standard EN Operating mode: CE Directive 93/42/EEC FDA BD 900 split lamp acc. to protection class I Intermittent, 5 minutes ON and 5 minutes OFF 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 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 EN ISO EN EN EN ISO IFU_BD _eng.indd :17:53

14 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA F. Information and manufacturer's declaration concerning electromagnetic compatibility (EMC) F.1 General The slit lamp system BD 900 fulfils the requirements on electromagnetic compatibility according to EN 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 it itself has appropriate immunity to electromagnetic interference. 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. Portable and mobile HF communication systems may interfere with electrical medical devices. Operation with other cables or equipment than that listed may lead to a higher emissions or to a lower interference resistance of the device. F.2 Emitted interference (standard table 1) 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 Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 This product uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B This product is suitable for use in all establishments, including domestic establishments and those Emission of harmonics according to Class B directly connected to the public low-voltage power supply network that supplies buildings used for EN domestic purposes. Voltage fluctuations / flicker emissions Fulfilled according to EN IFU_BD _eng.indd :17:54

15 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH F.3 Immunity (standard table 2) Guidance and manufacturer's declaration electromagnetic immunity This product is intended for use in the electromagnetic environment specifi ed below. The customer or the user of this product should assure that it is used in such an environment. Immunity test standard EN test level Compliance level Electromagnetic environment guidance Electrostatic discharge (ESD) EN Electrical fast transient / burst EN Surge EN Voltage dips, short interruptions and voltage variations on power supply lines EN Power frequency (50/60Hz) magnetic fi eld EN ± 6 kv contact ± 8 kv air ± 6 kv contact ± 8 kv air Floors should be wood, concrete or ceramic tile. If fl oors are covered withs ynthetic material, the relative humidity should be at least 30%. ± 2 kv for power supply lines ± 2 kv for power supply lines Mains power quality should be that of a typical commercial or hospital environment. ± 1 kv for symmetrical voltages ± 2 kv for asymmetrical voltages < 5% U T (> 95% drop in U T ) for ½ cycle < 40% U T (> 60% drop in U T ) for 5 cycles < 70% U T (> 30% drop in U T ) for 25 cycles < 5% U T (> 95% drop in U T ) for 5 s NOTE: U T = the AC mains voltage prior to application of the test level. ± 1 kv for symmetrical voltages ± 2 kv for asymmetrical voltages < 5% U T (> 95% drop in U T ) for ½ cycle < 40% U T (> 60% drop in U T ) for 5 cycles < 70% U T (> 30% drop in U T ) for 25 cycles < 5% U T (> 95% drop in U T ) for 5 s 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. 3 A/m 0.3 A/m Power frequency magnetic fi elds should be at levels characteristic of a typical location in a typical commercial or hospital environment IFU_BD _eng.indd :17:54

16 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA F.4 Interference immunity on non-life-supporting devices (standard table 4) Guidance and manufacturer's declaration electromagnetic immunity This product is intended for use in the electromagnetic environment specifi ed 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 EN test level Compliance level Recommended distance (c) : Conducted RF EN Vrms 3 Vrms D = khz 80 MHz Radiated RF EN V/m 80 MHz 2.5 GHz 3 V/m 80 MHz 800 MHz D = 1.2 D = MHz 800 MHz 800 MHz 2.5 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 fi xed 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 fi xed 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 fi xed RF transmitters, an electromagnetic site survey should be considered. If the measured fi eld 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. c. Over the frequency range 150 khz to 80 MHz, fi eld strengths should be less than 10 V/m. Possible shorter distances outside the ISM bands do not contribute to improved application in this table IFU_BD _eng.indd :17:54

17 SVENSKA NEDERLANDS PORTUGUÊS ESPAÑOL ITALIANO FRANÇAIS DEUTSCH ENGLISH F.5 Safe distances for non-life-supporting devices (standard table 6) 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) Nominal output of the transmitter (W) 150 khz 80 MHz D = MHz 800 MHz D = MHz 2.5 GHz D = 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 2.5 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 IFU_BD _eng.indd :17:54

18 ENGLISH DEUTSCH FRANÇAIS ITALIANO ESPAÑOL PORTUGUÊS NEDERLANDS SVENSKA Should you have any further questions, please contact your HAAG-STREIT dealer at: C US PRODUCTS CERTIFIED FOR BOTH THE U.S AND CANADIAN MARKETS, TO THE APPLI- CABLE U.S. AND CANADIAN STANDARDS 1250 HAAG-STREIT AG Gartenstadtstrasse Koeniz, Switzerland Phone Fax info@haag-streit.com Internet IFU_BD _eng.indd :17:55