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 20

EN

ALL PUPIL II by KEELER

Immunity test IEC 60601 Test

level

Compliance 

level

Electromagnetic 

environment – guidance

Electrical fast 

transient/burst. 
IEC 61000-4-4

± 2 kV for power 

supply lines
± 1 kV for power  

supply lines

± 2 kV for power 

supply lines
N/A

Mains power quality should be 

that of a typical professional 

healthcare facility environment.

Surge.
IEC 61000-4-5

± 1 kV line(s) to 

line(s)
± 2 kV line(s) for 

input/output line(s)

± 1 kV line(s) to 

line(s)
N/A

Mains power quality should be 

that of a typical professional 

healthcare facility environment.

Voltage dips, short 

interruptions and 

voltage variations 

on power supply 

input lines.
IEC 61000-4-11

U

T

 = 0% 0.5 cycle

(0, 45, 90, 135, 180,
225, 270, 315°)

U

T

 = 0%; 1 cycle

U

T

 = 70%;

25/30 cycles (@ 0°)

U

T

 = 0%;

250/300 cycle

U

T

 = 0% 0.5 cycle

(0, 45, 90, 135, 180,
225, 270, 315°)

U

T

 = 0%; 1 cycle

U

T

 = 70%;

25/30 cycles (@ 0°)

U

T

 = 0%;

250/300 cycle

Mains power quality should be 

that of a typical

 

professional 

healthcare facility environment. 

If the user of the Keeler All Pupil 

II requires continued operation 

during power mains interruptions, 

it is recommended that the 

charger be powered from an 

uninterruptible power supply.

Power frequency 

(50/60 Hz)
Magnetic field. IEC 

61000-4-8

30 A/m

30 A/m

Power frequency magnetic fields 

should be at a level characteristic 

of a typical location in a typical 

professional healthcare facility 

environment. 

Note: 

U

T

 is the a. c. mains voltage prior to application of the test level.

Immunity 

test

IEC 60601
Test level

Compliance 

level

Electromagnetic environment 

– guidance

Portable and mobile RF communications equipment 

should be used no closer to any part of the Keeler 

All Pupil II, including cables, than the recommended 

separation distances calculated from the equation 

applicable to the frequency of the transmitter.

Recommended  separation distance

Conducted 

RF IEC 

61000-4-6

6 Vrms 

150 kHz to 80 

MHz

6 V

d = 1.2 √ p

Radiated 

RF IEC 

61000-4-3

10 V/m 80MHz 

to 2.7GHz

10 V/m

d = 1.2 √ p 80MHz to 800 MHz 
d = 2.3 √ p 800MHz to 2.7GHz

Содержание All Pupil 2

Страница 1: ...All Pupil II Indirect Ophthalmoscope INSTRUCTIONS FOR USE A world without vision loss ...

Страница 2: ......

Страница 3: ...ARD SLIMLINE LITHIUM ION 11 5 4 CHARGING 11 5 5 CHARGING CYCLE 13 6 WIRELESS CHARGERS WALL MOUNTING 13 7 SMARTPACK AND WALLPACK 14 7 1 PARTS LIST 14 7 2 POWER CONVERSION 15 7 3 FIXING THE WALL MOUNT 15 8 BULB LED REPLACEMENT 17 8 1 ALL PUPIL II LED 17 9 TEACHING MIRROR 18 9 1 EYEPIECE CAPS 18 9 2 PLANO LENSES 19 10 SPECIFICATIONS AND ELECTRICAL RATINGS 19 10 1 ELECTROMAGNETIC EMISSIONS 19 10 2 ELE...

Страница 4: ...unity Humidity limitation Catalogue number Serial number Translation Medical device The Keeler All Pupil II Instruments are designed and built in conformity with Directive 93 42 EEC Regulation EU 2017 745 and ISO 13485 Medical Devices Quality Management Systems Classification CE Class I FDA Class II The information contained within this manual must not be reproduced in whole or part without the ma...

Страница 5: ...er 35 minutes Testing was completed with a 20D 55mm diameter Volk lens While no acute optical radiation hazards have been identified for Indirect Ophthalmoscopes we recommend keeping the intensity of the light reaching the patient s retina to the minimum possible for the respective diagnosis Children people with aphakia and people suffering from eye conditions are most at risk An increased risk ma...

Страница 6: ...ing 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 seek medical attention immediately No modification to this equipment is allowed The mains plug is the means of isolating the device from the mains supply Ensure both the power switch and mains plug are always accessibl...

Страница 7: ...logen bulbs Halogen bulbs can shatter if scratched or damaged Ensure device is securely held in docking station to minimise risk of injury or damage to equipment Follow guidance on cleaning routine maintenance to prevent personal injury damage to equipment Note Lithium Ion contain no toxic heavy metals such as mercury cadmium or lead After removal of the battery do not touch the battery contacts a...

Страница 8: ... useable depressor should not be re used if visibly contaminated with fluids or blood The cleaning and sterilization of reusable depressor can be accomplished as follows 1 Manually clean all surfaces of the units using a suitable brush and de ionised water detergent solution 2 detergent by volume Ensure all crevices are accessed and cleaned Solution can be heated to no more than 35 C 2 Carefully ex...

Страница 9: ...B F J K L M F A Headband Size Adjuster 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 I Brow Bar J Interpupillary Distance Setting Control K Mirror Angle Control L Optics Hinge Adjuster M Filter Selector Bar ...

Страница 10: ...es as possible for maximum field as shown in fig 4 by using the Optics Hinge Adjuster L Interpupillary Distance Setting Control J Because the eyes are dissociated particular care must be taken to ensure the optics eyepieces are set properly in front of each eye Always set the Aperture Control Lever D to the large light patch for this exercise Place an object approximately 40cm from the face and ce...

Страница 11: ...er D The Aperture Control Lever D changes the aperture size to view through large medium and small pupils Select either the large intermediate or small aperture by adjusting lever from left to right small intermediate large Large The large round homogenous patch is suitable for routine examinations through fully dilated pupils Intermediate The intermediate patch is designed to reduce reflections w...

Страница 12: ... dye for the detection and examination of corneal scars and abrasions Diffuser This extra wide beam of diffused light permits a more relaxed technique during more challenging fundus examinations The instrument provides protection from UV IR 5 WIRELESS CHARGERS 5 1 POWER SUPPLY ASSEMBLY Set Plug Replace the blanking plate with the appropriate mains plug adaptor if required or use IEC 60320 TYPE 7 c...

Страница 13: ... new Battery Pack place in the cradle until fully engaged 5 4 CHARGING 1 Replace the Bblanking Plate with the appropriate mains plug adapter and connect the plug on cable to power input socket on charger Switch on your Lithium Charger by plugging it into a mains outlet 1 1 2 2 Connect to Charging Docking Station Power Supply Remove the blanking plate Replace with appropriate mains plug adapter ...

Страница 14: ... 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 Spare Battery Charging Docking Station 2 Spare Battery Press release button and push up Charging Docking Station Power Supply Inlet 2 Slimline Lithium Ion Charging spare battery Charging ba...

Страница 15: ... 1 hour on full power The Spare Battery will take 2 hours to charge Standard Lithium Ion The Battery attached to the Indirect will take approximately 2 hours to fully charge The Battery will last approximately 2 hours on full power The Spare Battery will take 4 hours to charge 6 WIRELESS CHARGERS WALL MOUNTING Use template document provided to mark position of charger and drill holes 1 2 ...

Страница 16: ...L II by KEELER 7 SMARTPACK AND WALLPACK 7 1 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 A B C D F E H I I G 3 4 Caution ...

Страница 17: ...Euro Plug N USA Plug 7 2 POWER CONVERSION Convert to either WallPack or SmartPack by following the illustration below 7 3 FIXING THE WALL MOUNT Use the wall plugs and screws to mount the WallPack unit attach the adhesive pads to the side of the case J K L N M 30mm ø 6 x 50mm ...

Страница 18: ...ng may take place while the 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 continuous trickle LED Displays Power Supply Battery Insert or remove the Indirect plug or switch the Indirect ON OFF Power Supply Mains Switch the Indirect ON OFF Insert or remove the mains plug Place on or off the cradle switch Green LED illuminates wh...

Страница 19: ...nnect the instrument from the electrical supply Remove the bulb LED from the back of the instrument and insert the replacement ensuring that the bulb LED key is aligned with the aperture and securely pushed in 8 1 ALL PUPIL II LED All PupiI II bulbs can be replaced with an LED light source if required Follow fitting instructions as for bulbs ...

Страница 20: ...movable for security purposes proceed as follows 3 Remove the screws as in step 1 Position the mounting bar and replace the screw on left side only Fit the Teaching Mirror as in step 2 4 Fold the Teaching Mirror down and slide it to the right to reveal fixing hole Then secure the mounting bar with the special washer and pan head screw provided 5 Return the Teaching Mirror to its central position T...

Страница 21: ...s CISPR 11 Group 1 The Keeler All Pupil II 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 Harmonic emissions IEC 61000 3 2 Class A The Keeler All Pupil II is suitable for use in all establishments including domestic establishments and those directly conne...

Страница 22: ... of a typical professional healthcare facility environment If the user of the Keeler All Pupil II requires continued operation during power mains interruptions it is recommended that the charger be powered from an uninterruptible power supply Power frequency 50 60 Hz Magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at a level characteristic of a typical location...

Страница 23: ...ion in which the Keeler All Pupil II is used exceeds the applicable RF compliance level above the Keeler All Pupil II should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orientating or relocating the Keeler All Pupil II 2 Over the frequency range 150kHz to 80 MHz field strengths should be less than 10 V m 10 3 RECOMMENDE...

Страница 24: ...uidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 10 4 TECHNICAL SPECIFICATIONS All Pupil II Input mains data 100 240V 50 60Hz Power supply rating 12V 2 5amps Operation Continuous Classification Class II equipment Type B applied part API II LED Voltage 6V DC Light output Minimum 1500 LUX1 Optical radiat...

Страница 25: ... 6067 Small depressor 1201 P 6075 AP II Teaching Mirror 1202 P 7117 AP II LED 1205 P 5014 Binocular Indirect Face Shield 1205 P 7034 Standard battery pack for wireless AP II 1919 P 1013 Slimline battery for wireless AP II 1919 P 5338 Wallpack for wired AP II 1945 P 1000 Smartpack for wired AP II 1945 P 1001 Slimline charger for wireless AP II 1945 P 5019 Standard charger for wireless AP II 1945 P ...

Страница 26: ...ent Any servicing or repairs should only be carried out by Keeler Ltd or by suitably trained and authorised distributors Service manuals will be available to authorised Keeler service centres and Keeler trained service personnel 13 PACKAGING AND DISPOSAL INFORMATION Disposal of old electrical and electronic equipment This symbol on the product or on its packaging and instructions indicates that th...

Страница 27: ......

Страница 28: ...sue F Date of Issue 12 05 2021 USA Sales Office Keeler USA 3222 Phoenixville Pike Building 50 Malvern PA 19355 USA Toll Free 1 800 523 5620 Tel 1 610 353 4350 Fax 1 610 353 7814 India Office Keeler India Halma India Pvt Ltd Plot No A0147 Road No 24 Wagle Industrial Estate Thane West 400604 Maharashtra INDIA Tel 91 22 4124 8001 China Office China Office Halma China Group 名称 沃迈 上海 机电有限公司 地址 上海市闵行区金都...

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