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11. Annex I – EMC statement and guidelines

The Keeler All Pupil II Indirect Ophthalmosope is a medical electrical
instrument. The instrument requires special care concerning
electromagnetic compatibility (EMC). This section describes the
suitability in terms of electromagnetic compatibility of this instrument.
When installing or using this instrument, please read carefully and
observe what is described here.

Portable or mobile-type radio frequency communication units may have
an adverse effect on this instrument, resulting in malfunctioning.

Note: The API II LED is considered to be inherently EMC benign

(1)

,

however when used as intended in conjunction with the All Pupil II
Indirect Ophthalmoscope, the EMC requirements for the API II apply,
and must be adhered to.

(1)

Refer to section 1.1.4 of the guide for the EMC Directive 2004/108/EC, published 21st May 2007.

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Содержание All Pupil II LED

Страница 1: ...Next Next All Pupil II Indirect Ophthalmoscope Instructions for use ...

Страница 2: ... lithium ion 16 Charging and charging cycle 17 Wall mounting 20 7 SmartPack and WallPack 22 Parts list Power conversion 23 Wall mounting charging 24 LED displays 25 8 LED bulb replacement 26 9 Cleaning instructions 27 10 Specifications and electrical ratings 28 Electrical specifications Transport storage and operation 11 Annex I EMC statement and guidelines 29 12 Spare parts and accessories 34 API...

Страница 3: ...ufacturer s prior written approval As part of our policy for continued product development we reserve the right to make changes to specifications and other information contained in this document without prior notice All Pupil II and All Pupil II LED are registered trademarks of Keeler Ltd 2012 Copyright Keeler Limited 2012 Published in the UK 2012 ...

Страница 4: ...e in the design development and manufacture of this product to ensure that you get many years of trouble free service However it is important that you read the descriptions installation and operating instructions carefully prior to installing or using your new indirect ophthalmoscope Please read and follow these instructions carefully ...

Страница 5: ...Manufacturer s name and address This Symbol on the product or on its packaging and instructions indicates that it was put on the market place after August 2005 and that this product shall not be treated as Household Waste Type B protections against shock Mandatory action sign Follow instructions for use High voltage Trip hazard Optical radiation hazard Hot surface Non ionizing radiation This way u...

Страница 6: ...duct should not be immersed in fluids Do not disassemble or modify the battery There are no serviceable parts inside Do not dispose of battery in fire puncture or short circuit Do not use a battery that is deformed leaking corroded or visually damaged Handle a damaged or leaking battery with care If you come into contact with electrolyte wash exposed area with soap and water If it contacts the eye...

Страница 7: ... where the temperature may exceed 40 C or fall below 0 C There are no user serviceable parts inside Contact authorised service representative for further information Ensure battery orientation is correct or personal injury damage to equipment may occur Care should be taken when handling halogen bulbs Halogen bulbs can shatter if scratched or damaged Ensure device is securely held in docking statio...

Страница 8: ...to use bright light clearly visualize ocular structure during delicate ophthalmic surgical procedure While no visible retinal lesions have been identified for ophthalmic instruments it is recommended that illumination levels be set to the minimum level necessary to perform the diagnostic function Young children and persons with diseased eyes may be at a higher risk The risk may also be increased i...

Страница 9: ... B Headband Height Adjuster C Cushioned Padded Liners D Aperture Control Lever E Headband Dimmer Switch F Brow Bar Adjuster G Front Window H Binocular Block A B D E F F G H J K K L M C C I Brow Bar J Interpupillary Distance Setting Control K Mirror Angle Control L Optics Hinge Adjuster M Filter Selector Bar I ...

Страница 10: ...halmoscope Angle Alignment Position the Brow Bar I such that the Binocular Block H is set on the optical axis The Brow Bar I may be correctly positioned by loosening the Brow Bar Adjusters F When in the correct position secure by tightening F as shown in fig 3 Position the All Pupil II as close to the eyes as possible for maximum field as shown in fig 4 by using the Optics Hinge Adjuster L fig 1 f...

Страница 11: ...f the opposite hand slide the Interpupillary Distance Setting Control J of the open eye located directly under each eyepiece so that your object moves into the centre of the field keeping the object in the centre of the light patch Repeat for the other eye Obtaining a Fused Image Ensure that a singular fused image is obtained as follows Mirror Angle Control K The light is positioned vertically int...

Страница 12: ...ls Intermediate The intermediate patch is designed to reduce reflections when entering a partially or poorly dilated pupil 3mm It is also ideal for closer inspection of particular fundal areas Small This light patch is ideal for small undilated pupils Select either the large intermediate or small aperture by The intermediate patch is designed to reduce reflections when entering a partially or poor...

Страница 13: ...elaxed technique during more challenging fundus examinations Beginners may also find this aperture particularly helpful since in order to achieve a full lens image the alignment between the headset the condensing lens and the pupil is not as critical as with the conventional beam The instrument provides protection from UV IR which direction to slide it for each filter more relaxed technique during...

Страница 14: ...Back 14 IEC 60320 TYPE 7 connector 6 Wireless chargers power supply assembly Set Plug Replace the blanking plate with the appropriate mains plug adaptor if required or use IEC 60320 TYPE 7 connector not supplied ...

Страница 15: ...button 6 Wireless chargers Standard Lithium Inserting replacing the Battery Pack 1 Release battery by pressing release button as shown and lift battery pack from cradle 2 To insert new battery pack place in cradle until fully engaged 2 ...

Страница 16: ...s chargers Slimline Lithium ion Inserting replacing the Battery Pack 1 Release battery by pressing release button as shown and lift battery pack from cradle 2 To insert new battery pack place in cradle until fully engaged 1 2 1 2 ...

Страница 17: ...release button and push up Power supply inlet Spare battery Spare battery 6 Wireless chargers Charging 1 Replace the blanking plate with the appropriate mains plug adapter and connect plug on cable to power input socket on charger Switch on your Lithium Charger by plugging it into a mains outlet 2 Place your spare battery pack or headset into your Lithium Charger as shown 1 2 2 Next Home Back ...

Страница 18: ... charging Charging Station No indicator Battery is fully charged Flashing indicator Top up Charge Solid indicator Rapid Charge The battery pack can be used at any time during the charging cycle and will automatically resume charging when battery pack is placed back in the charger Direction arrow on charger indicates which battery is being charged Slimline Lithium ion Standard Lithium Next Home Bac...

Страница 19: ...o fully charge The battery will last approximately 2 hours on full power The spare battery will take 4 hours to charge Charging Cycle Slimline Lithium ion The battery attached to the indirect will take approximately 1 hours to fully charge The battery will last approximately 1 hour on full power The spare battery will take 1 hours to charge ...

Страница 20: ...Next Home Back 20 6 Wireless chargers wall mounting Use template document provided to mark position of charger and drill holes ...

Страница 21: ...Next Home Back 21 6 Wireless chargers wall mounting 1 2 3 4 Caution ...

Страница 22: ...ck Parts List A Hex Key B Screws C Screws D Wall Plugs E Base Cap F Wall Mount G Adhesive Pads H Rechargeable battery Part No EP39 22079 I Body J Power Supply K Australian Plug L UK Plug M Euro Plug N USA Plug B B A C D E F G H I I J K L M N ...

Страница 23: ...3 7 SmartPack and WallPack Set Plug Assemble the power supply as per the instructions in section 6 Power Conversion Convert to either WallPack or SmartPack by following the illustration below IEC 60320 TYPE 7 connector ...

Страница 24: ...connecting ensure that both the dimmer control and mains outlet are switched off 30 mm Ø 6 x 50 mm 7 SmartPack and WallPack Charge Time Charge the battery for 12 14 hours before initial use Note The unit becomes warm when charging this is normal Recharging may take place while indirect is in use Normal battery life is 1 5 to 5 hours depending on setting with a recharge time of two hours or on cont...

Страница 25: ... Off Charging In use Trickle Charging Battery low Power Supply Battery Insert or remove the indirect plug or switch the indirect off on Power Supply Mains Switch the indirect ON OFF Insert or remove the mains plug Place on or off the cradle switch Green LED illuminates when indirect is on ...

Страница 26: ...the back of the instrument and insert the replacement ensuring that the bulb LED key is aligned with the aperture and securely pushed in After removal of the bulb LED do not touch the bulb LED contacts and the patient simultaneously All Pupil II LED All PupiI II bulbs can be replaced with an LED light source if required Follow fitting instructions as for bulbs and as shown below For further detail...

Страница 27: ...xternal surface with a clean absorbent non shedding cloth dampened with a water detergent solution 2 detergent by volume or water isopropyl alcohol solution 70 IPA by volume Avoid optical surfaces b Ensure that excess solution does not enter the instrument Use caution to ensure cloth is not saturated with solution c Surfaces must be carefully hand dried using a clean non shedding cloth d Safely di...

Страница 28: ...lass II equipment Type B protection against shock API II LED Voltage 6V DC Light output Minimum 1500 LUX 1 Optical radiation complies with BS EN ISO 15004 part 1 1997 Transport storage and operating conditions Transport Storage Operation Temperature range 40 C to 70 C 10 C to 55 C 10 C to 35 C Relative humidity 10 to 95 10 to 95 30 to 75 1 Measured at 440mm from front window ...

Страница 29: ...ing or using this instrument please read carefully and observe what is described here Portable or mobile type radio frequency communication units may have an adverse effect on this instrument resulting in malfunctioning Note The API II LED is considered to be inherently EMC benign 1 however when used as intended in conjunction with the All Pupil II Indirect Ophthalmoscope the EMC requirements for ...

Страница 30: ... 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s N A Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for ...

Страница 31: ... 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 The Keeler All Pupil II 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 ...

Страница 32: ...s from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80MHz and 800MHz the higher frequency range applies Note 2 These guide lines may not apply in all situations Electromagnetic propagation is affected by absorption ...

Страница 33: ...tions equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80MHz d 1 2 p 80MHz to 800MHz d 1 2 p 800MHz to 2 5GHz d 2 3 p 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be de...

Страница 34: ...90 84030 Screws qty 2 1201 P 6067 Large depressor 1201 P 6075 Small depressor 1201 P 7000 Chart pad pack of 50 1202 P 7117 API II teaching mirror 1299 P 7032 Coloured pencils pack of 12 1945 P 1001 SmartPack 2105 K 1159 20D lens 2199 P 7136 Lens Cloth 2415 P 7000 Instructions for Use CD 3412 P 5100 API II accessory case Part Number Description 1012 P 7003 API II bulbs qty 2 1205 P 5014 API II LED ...

Страница 35: ...Next Home Back 35 12 Spare parts and accessories API II LED The API II LED is a replacement light source for the All Pupil II Indirect Ophthalmoscope Follow the guidance in section 8 for fitting ...

Страница 36: ...he right of the pin and return to its case leaving mounting bar in position To make the teaching mirror Non Removable for security purposes proceed as follows Remove the screws as in step A Position the mounting bar and replace the screw on left side only Fit the teaching mirror as in step B Fold the Teaching Mirror down and slide it to the right to reveal fixing hole Then secure the mounting bar ...

Страница 37: ...e from the distributor These are included in certain API II kits For further details please refer to the accessory lists on page 34 ExpressiOn Clip on Covers A range of different colour front covers are available to fit over your Indirect To fit the cover simply push on until the small clips on the side and underneath engage with the slots in the main moulding as shown in diagram Please ensure the...

Страница 38: ...t is guaranteed for 3 years and will be replaced or repaired free of charge subject to the following Any fault due to faulty manufacture The instrument and accessories have been used in compliance with these instructions Proof of purchase accompanies any claim Please note The API II LED is guaranteed for 5 years Batteries are covered by this warranty statement for 1 year only ...

Страница 39: ...and other European Countries with separate Collection Systems This symbol on the product or on its packaging and instructions indicates that it was put on the market place after August 2005 and that this product shall not be treated as Household Waste To reduce the environmental impact of WEEE Waste Electrical Electronic Equipment and minimise the volume of WEEE entering landfills we encourage at ...

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