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 10

EN

KEELER K-LED II

Immunity test IEC 55015 Test 

level

Compliance 

level

Electromagnetic 

environment – guidance

Voltage dips, short 

interruptions and 

voltage variations 

on power supply 

input lines.
IEC 61000-4-11

<5% 

U

T

 

(> 95% dip in 

U

T

) for 

0.5 cycles
40% 

U

T

 

(60% dip in 

U

T

) for 

10 cycles
70% 

U

T

 

(30% dip in 

U

T

) for 

25 cycles

<5% 

U

T

 

(> 95% dip in 

U

T

) for 

0.5 cycles
40% 

U

T

 

(60% dip in 

U

T

) for 

10 cycles
70% 

U

T

 

(30% dip in 

U

T

) for 

25 cycles

Mains power quality should be 

that of a typical commercial or 

hospital environment.
If the user of the Keeler Spectra 

Iris/K-LED requires continued 

operation during power mains 

interruptions, it is recommended 

that the charger be powered from 

an uninterruptible power supply.

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

Charger only

Portable and mobile RF communications equipment 

should be used no closer to any part of the Keeler 

Spectra Iris/K-LED, including cables, than the 

recommended separation distances calculated from the 

equation applicable to the frequency of the transmitter.

Recommended separation distance

d = 1.2 √ p
d = 1.2 √ p 80MHz to 800MHz 
d = 2.3 √ p 800MHz to 2.7GHz
Where p is the maximum output power rating of the 

transmitter in watts(W) according to the transmitter 

manufacturer and d is the recommended separation 

distance in metres(m).
Field strengths from fixed RF transmitters, as 

determined by an electromagnetic site survey¹, 

should be less than the compliance level in each 

frequency range².

Interference may occur in the vicinity of 

equipment marked with the this symbol.

Conducted 

RF IEC 

61000-4-6

3 Vrms
150 kHz to 

230 MHz

3 V

Spectra/K-LED only

Radiated 

RF IEC 

61000-4-3

10V/m
80MHz to 

2.7GHz

10 V/m

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 and 

reflection from structures, objects and people.

1

 Field strengths from fixed transmitters, such as base stations (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 fixed RF transmitters, an electromagnetic site survey 

should be considered. If the measured field strength in the location in which the Keeler Spectra Iris/K-LED is used 

exceeds the applicable RF compliance level above, the Keeler Spectra Iris/K-LED 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 Spectra Iris/K-LED.

2

 Over the frequency range 150kHz to 230 MHz, field strengths should be less than 3 V/m.

Summary of Contents for 2004-P-1012

Page 1: ...Keeler K LED II Headlamp INSTRUCTIONS FOR USE A world without vision loss ...

Page 2: ......

Page 3: ... YOUR LOUPE FRAME 6 6 K LED II CHARGER POWER SUPPLY ASSEMBLY 7 6 1 SET PLUG 7 7 K LED II CHARGER AND STORAGE UNITS 7 8 K LED II BATTERY PACK CHARGING CYCLE 7 8 1 CHARGING CYCLE 8 9 SPECIFICATIONS AND ELECTRICAL RATINGS 8 9 1 ELECTROMAGNETIC EMISSIONS 8 9 2 ELECTROMAGNETIC IMMUNITY 9 9 3 RECOMMENDED SAFE DISTANCES 11 9 4 TECHNICAL SPECIFICATIONS 11 10 SPARE PARTS AND ACCESSORIES 12 11 WARRANTY 13 1...

Page 4: ...nity Humidity limitation Use by date Serial number Catalogue number Medical device Translation The Keeler K LED II is 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 manufact...

Page 5: ...ver use the product if visibly damaged and periodically inspect it for signs of damage or misuse Do not shine directly into a person s eye Do not stare into the light when in use May be harmful to eyes Do not hold magnifying glasses or any other optical system in front of the light Do not use in the presence of flammable gases liquids or in an oxygen rich environment This product should not be imm...

Page 6: ...d periods Do not charge battery in any environment 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 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...

Page 7: ...IPA by volume Avoid optical surfaces 2 Ensure that excess solution does not enter the instrument Use caution to ensure cloth is not saturated with solution 3 Surfaces must be carefully hand dried using a clean non shedding cloth 4 Safely dispose of used cleaning materials 5 Do not operate LED until thoroughly dry 4 K LED II HEADLAMP AND CHARGING UNITS 4 1 DESCRIPTION OF THE PRODUCT A Power supply ...

Page 8: ...d held securely in position 3 Re attach the loupes and LED light to the frame hinge by holding the loupe bar as before Locate the hinge pins into the loupe bar holes and push the loupes onto the hinge 4 If the LED light is to be used without loupes attach the light to the adaptor PD bar Attach the cable to the frame using the strap provided 5 Connect the LED light lead into the connector port on t...

Page 9: ... 3 A yellow LED indicates the battery pack s charge state 8 K LED II BATTERY PACK CHARGING CYCLE The battery pack can be used at any time during the charging cycle and will automatically resume charging when replaced in the charging well The battery pack can be left in the charger storage unit when it is not being used The charger will automatically stop charging the battery pack when fully charge...

Page 10: ...lectromagnetic compatibility EMC This Section describes its 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 Keeler Spectra Iris and K LED are d...

Page 11: ...The Keeler Spectra Iris K LED is intended for use in the electromagnetic environment specified below The customer or user should ensure that it is used in such an environment Immunity test IEC 55015 Test level Compliance level Electromagnetic environment guidance K LED Spectra Only Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood concret...

Page 12: ...ording to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths 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 this symbol Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 230 MHz 3 V Spectra K L...

Page 13: ...cy of transmitter m 150 kHz to 230MHz d 1 2 p 80MHz to 800MHz d 1 2 p 800MHz to 2 7GHz d 2 3 p 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to the frequency of the transmitter where p is the maximum o...

Page 14: ...60 hPa 700 hPa TRANSPORT CONDITIONS 70 C 40 C 95 10 1060 hPa 500 hPa Vibration sinusoidal 10 Hz to 500 Hz 0 5g Shock 30 g duration 6 ms Bump 10 g duration 6 ms 10 SPARE PARTS AND ACCESSORIES Item Part Number Power supply EP29 32777 Yellow filter cap EP39 57298 Battery pack 1919 P 5215 Twin charger 1941 P 5350 Single charger 1941 P 5385 Adaptor PD Bar 2001 P 7027 ...

Page 15: ... PACKAGING AND DISPOSAL INFORMATION Disposal of old electrical and electronic equipment This symbol on the product or on its packaging and instructions indicates 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 product end of life that this eq...

Page 16: ...ice 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 Halma China Group 名称 沃迈 上海 机电有限公司 地址 上海市闵行区金都路1165弄 123号23幢一号厂房三层B座 电话 021 6151 9025 Visiometrics S L ...

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