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(5)  Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

 

The IO-

α 

is intended for use in the electromagnetic environment specified below. The customer 

or the user of the IO-

α 

should assure that it is used in such an environment. 

Immunity Test 

IEC 60601 Test 

Level 

Compliance 

Level 

Electromagnetic Environment – 

Guidance 

Electrostatic 
discharge (ESD) 

IEC 61000-4-2 

± 6 kV contact 

± 8 kV air 

± 6 kV contact 

± 8 kV air 

Floors should be wood, concrete 
or ceramic tile. If floors are 
covered with synthetic material, 
the relative humidity should be at 
least 30 %. 

Electric fast 
transient/burst 

IEC 61000-4-4 

± 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. 

Surge 

IEC 61000-4-5 

± 1 kV line(s) to 
line(s) 

± 1 kV line(s) to 
line(s) 

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 % 

U

(>95 % dip in 

U

T

for 0.5 cycle 

40 % 

U

T

 

(60 % dip in 

U

T

for 5 cycles 

70 % 

U

T

 

(30 % dip in 

U

T

for 25 cycles 

<5 % 

U

(>95 % dip in 

U

T

for 5 s 

<5 % 

U

(>95 % dip in 

U

T

for 0.5 cycle 

40 % 

U

T

 

(60 % dip in 

U

T

for 5 cycles 

70 % 

U

T

 

(30 % dip in 

U

T

for 25 cycles 

<5 % 

U

(>95 % dip in 

U

T

for 5 s 

Mains power quality should be 
that of a typical commercial or 
hospital environment. If the user 
of the IO-

α 

requires continued 

operation during power mains 
interruptions, it is recommended 
that the IO-

α 

be powered from an 

uninterruptible power supply or a 
battery. 

Power frequency 
(50/60 Hz) 
magnetic field 

IEC 61000-4-8 

3 A/m 

3 A/m 

Power frequency magnetic fields 
should be at levels characteristic 
of a typical location in a typical 
commercial or hospital 
environment. 

NOTE 

U

T

 is the AC mains voltage prior to application of the test level. 

 

 

 

 

Содержание IO-A LED

Страница 1: ...is is a battery powered device to examine the inside and fundus of the eyes by illuminating with an LED bulb The device is powered by the Battery Pack IO BP which can be attached to the Headband or a...

Страница 2: ...ng the IO BP to the Scope Unit 11 3 2 Operation 12 3 2 1 Wearing the IO 12 3 2 2 Positioning the Scope Unit 12 3 2 3 PD Adjustment 12 3 2 4 Illumination 12 3 2 5 Examination 13 3 2 6 Using the Teachin...

Страница 3: ...and caution you of potential hazards to yourself and others Potentially hazardous situation which if not avoided could result in death or serious injury Potentially hazardous situation which if not av...

Страница 4: ...ses Catalog number product code Serial number 1 3 Safety Information For your safety please comply with the following precautions Do not use battery packs or AC adaptors other than the standard access...

Страница 5: ...ing Failure to do so may result in electric shock Take care to only touch insulated parts when inserting the power plug into the power outlet Failure to do so may cause electric shock or fire Do not s...

Страница 6: ...ned off during transport or storage and only use the specified casing Failure to do so may result in deformation device failure or fire When disconnecting cables be sure to hold the plug Never pull th...

Страница 7: ...do not use the IO and contact your local dealer immediately Set Type Item Set 4 Set 3 Set 2 IO Main Unit See 2 2 1 1 1 1 IO BP See 2 2 2 1 1 1 AC Adapter example 1 1 1 Extension Cord 1 m 1 1 1 Belt Ho...

Страница 8: ...nation field 7 Aperture Selection Marker 8 Eyepiece A 2 D diopters lens is included 9 PD Adjuster Adjusts the pupil distance PD The scale 54 mm to 74 mm is indicated above the Eyepiece 10 Illumination...

Страница 9: ...ds the Scope Unit Can be flipped up 17 Overband Fixation Knob Loosen to flip up the Overband Tighten to keep the Overband in place 18 Headband Cover s Covers the adjustment mechanics of the Headband F...

Страница 10: ...ff and allows for continuous intensity adjustment 4 Illumination Off Mark 5 Illumination Intensity Mark 6 Battery Lamp Indicates the remaining battery capacity 7 Indicates power output from the Lamp J...

Страница 11: ...ange 3 Charging time is approximately 2 5 hours from a fully discharged state Note The IO cannot be illuminated while the DC Plug is connected 4 Once fully charged the CHARGE Lamp will light green 5 U...

Страница 12: ...th a click see Fig 3 4 Note The plug and jack interlock at a single configuration Rotate the plug as needed to connect smoothly 2 When using the Belt Hook the Lamp Cord attached to the Scope Unit is n...

Страница 13: ...n the Scope Unit Fixation Knob to fix in the position with the best view when observed through the eyepieces see Fig 3 7 3 2 3 PD Adjustment 1 Turn the Observation Angle Adjustment Lever upward to ful...

Страница 14: ...lens in one hand direct the illumination into the patient eye It is recommended to place the unoccupied fingers of the hand holding the aspherical lens on the patient s face for stability 2 Bring the...

Страница 15: ...observation axes remain apart see Fig 3 9c Examining Vertically Elliptical Pupils When examining the fundus through vertically elliptical pupils raise the Illumination Angle Adjustment Lever and lowe...

Страница 16: ...detaching the Teaching Mirror from the Scope Unit depress the mark on both the upper and lower faces of the Teaching Mirror and pull gently Note Do not attempt to detach the Teaching Mirror forcefull...

Страница 17: ...pe the surface using a dry lint free cloth or cloth moistened with diluted neutral detergent and then wipe dry Use a cloth moistened with alcohol to disinfect 4 2 Replacing the LED Bulb As LED bulbs h...

Страница 18: ...operate If such events should occur contact your local dealer to purchase a new Battery Pack 4 4 Disposal Dispose of the IO and its accessories excluding the IO BP in accordance with your local regula...

Страница 19: ...oned Move the lever s until you feel a click Observation image blurry Foreign matter is adhered to the eyepiece or observation system Clean in accordance with 4 1 1 Foreign matter is adhered to the as...

Страница 20: ...tion Degree of protection against electric shock Internally powered ME equipment Applied parts No applied parts Degree of protection against harmful ingress of water or particulate matter IPX0 Method...

Страница 21: ...ort contact your local dealer or Neitz located at the following address LOCAL DEALER Neitz Instruments Co Ltd 4F Ichibancho Court 15 21 Ichibancho Chiyoda ku Tokyo 102 0082 Japan Phone 81 3 3237 0552...

Страница 22: ...Ophthalmic instruments Fundamental requirements and test methods Part 2 Light hazard protection indicates that the IO is classified to be Group 2 and ophthalmic instrument for which a potential light...

Страница 23: ...O is intended for use in the electromagnetic environment specified below The customer or the user of the IO should assure that it is used in such an environment Emissions Test Compliance Electromagnet...

Страница 24: ...000 4 5 1 kV line s to line s 1 kV line s to line s Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power...

Страница 25: ...d 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 t...

Страница 26: ...cy of transmitter m 150 kHz to 80 MHz 1 2 80 MHz to 800 MHz 1 2 800 MHz to 2 5 GHz 2 3 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 maxi...

Страница 27: ...25 25 Notes...

Страница 28: ...Japan Phone 81 3 3237 0552 FAX 81 3 3237 0554 E mail int neitz co jp URL http www neitz ophthalmic com Distributed by As part of our policy of continued product improvement we reserve the right to alt...

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