Binocular Indirect Ophthalmoscope

IO-α LED (Battery-powered Type)

User’s Manual

Thank you for purchasing the NEITZ Binocular Ophthalmoscope IO-α LED (Battery-powered
Type). This 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-BPⅡ which can be
attached to the Headband or a belt or the like
Please read this User’s Manual carefully before use to avoid unexpected accidents and store it in
a safe place for future reference.

TD11-12610004E-3
 Table of Contents
1 Important Information ................................................................................................................ 2
1.1 Intended Use...................................................................................................................... 2
1.2 Symbols ............................................................................................................................. 2
1.3 Safety Information .............................................................................................................. 3
1.4 Labeling on Package ......................................................................................................... 5
2 Checking Package Contents..................................................................................................... 6
2.1 Composition ....................................................................................................................... 6
2.2 Nomenclature..................................................................................................................... 7
2.2.1 IO-α Main Unit ............................................................................................................ 7
2.2.2 IO-BPⅡ ...................................................................................................................... 9
3 Operation................................................................................................................................. 10
3.1 Preparation ...................................................................................................................... 10
3.1.1 Charging the IO-BPⅡ............................................................................................... 10
3.1.2 Attaching the IO-BPⅡ .............................................................................................. 10
3.1.3 Connecting the IO-BPⅡto the Scope Unit ................................................................11
3.2 Operation ......................................................................................................................... 12
3.2.1 Wearing the IO-α ...................................................................................................... 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 Teaching Mirror......................................................................................... 15
3.2.7 Turning Illumination Off............................................................................................. 15
4 Maintenance ............................................................................................................................ 16
4.1 Cleaning ........................................................................................................................... 16
4.1.1 Cleaning the Optics .................................................................................................. 16
4.1.2 Cleaning the Headpad .............................................................................................. 16
4.1.3 Cleaning Other Exterior Parts .................................................................................. 16
4.2 Replacing the LED Bulb................................................................................................... 16
4.3 Replacing the IO-BPⅡ .................................................................................................... 17
4.4 Disposal ........................................................................................................................... 17
5 Troubleshooting....................................................................................................................... 18
6 Specifications .......................................................................................................................... 19
7 Contact Information ................................................................................................................. 20
ANNEX A ........................................................................................................................................ 21
ANNEX B ........................................................................................................................................ 22

i
1 Important Information
For the U.S. Market;
CAUTION: Federal law restricts this device to sale by or on the order of a physician.

1.1 Intended Use

The NEITZ Binocular Indirect Ophthalmoscope IO-α LED (Battery-powered Type)
(hereinafter referred to as “IO-α”) is a battery powered medical device containing an LED
bulb for illumination and viewing optics intended to examine the media (cornea, aqueous,
lens and vitreous) and retina of the eye.
Do not use this device for any purpose other than its intended use.

1.2 Symbols
The following symbols are used on this manual and/or package to assist you in proper
handling and use of the IO-α, and to warn 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 avoided may result in minor
or moderate injury or property damage

Prohibited actions (must not be performed)

Prohibited

Required actions (must be performed)

Instruction

Consult User’s Manual for information on proper use

Temperature limits (°C) for storage and transport

Relative humidity limits (%) for storage and transport

Atmospheric pressure limits (hPa) for storage and transport

Fragile. Handle with care

Keep dry

Meets Japanese Product Safety, Electrical Appliance and Materials Law

requirements

“UL certified” product

Product complies with the European requirements for safety, health,

environment and customer protection. (not applicable to the IO-α)

1 / 25
 Product must not be disposed of with general household waste under
the WEEE directive

Manufacturer’s name and address

Federal Communications Commission approved product

Class II equipment

Alternating Current, AC

Direct Current, DC

Polarity of DC plug (center pin is positive)

For indoor use only

Nickel-metal hydride rechargeable battery (must be recycled)

Ni-MH

Potentially hazardous levels of non-ionizing radiation or RF transmitters

(not applicable to the IO-α)

Barcode for traceability purposes

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

accessories supplied by the manufacturer. Doing so may result in electric
Prohibited shock or device failure.
Do not illuminate the patient’s eye for more than 1 minute per eye and be
Prohibited sure to keep illumination at minimal intensity needed to view the fundus.

Do not connect the power cable to an outlet with too many other devices.
Prohibited Doing so may cause injury or fire.

Do not use damaged cables or cords. Doing so may cause electric shock,
Prohibited fire or device failure.

2 / 25
 Do not use in oxygen rich environments, in the presence of propane,
gasoline or other combustible gasses, or near dust and debris. Doing so may
Prohibited cause explosion.
Do not leave the illumination of for prolonged periods or cover the device
during illumination. Doing so may cause the device to reach high
Prohibited temperatures.
Never touch liquid which may have leaked from the Battery Pack. In case of
contact with the eye(s), flush with clean water without rubbing, and consult a
physician immediately. If leaked liquid gets on skin or clothing, wash with
Prohibited clean water immediately. Failure to do so may result in serious injury,
including loss of eyesight.
Do not short-circuit connectors or touch them with bare hands. Doing so may
Prohibited cause electric shock or device failure.

Do not attempt to disassemble or modify the device. Doing so may result in

Prohibited electric shock, fire or device failure.
Never remove the cover of the battery pack. Attempting to charge
commercial batteries so may cause leakage of liquids, heat generation or
Prohibited rupturing during charging.
Do not touch the device with wet hands. Doing so may result in electric
Prohibited shock.
In the event of ingress of water or other liquids, unplug from the power outlet
immediately. Failure to do so may result in electric shock, fire or device
Instruction failure.
Unplug the power cable from the power outlet prior to cleaning. Failure to do
Instruction so may result in electric shock

Take care to only touch insulated parts when inserting the power plug into
Instruction the power outlet. Failure to do so may cause electric shock or fire.

Do not sterilize the device. Doing so may cause device deformation or

Prohibited failure.
Do not install the device in places where it may be difficult to plug in/out
to/from the power outlet or to switch power since the plug-out from the outlet
Prohibited is one of the separation methods between the device and the power supply
Do not use in excessively humid or saline environments, or places where the
device may be sprayed with water. Doing so may result in electric shock or
Prohibited device failure.
Do not expose the device to direct sunlight or harmful radiation. Doing so
Prohibited may lead to unexpected heating and result in device failure.
Do not attempt to charge the device in temperatures exceeding 35 °C
(95 °F). Doing so may prevent the device from charging or result in device
Prohibited failure.
Do not attempt to charge the device when wet. Doing so may cause
Prohibited excessive heating, fire or rupture.
Do not place heavy objects on, apply excessive tension to, or fold cables,
cords and connectors. Doing so may result in damage and electric shock or
Prohibited fire.
Do not use paint thinners, cleaning agents or boiling water to clean the
Prohibited device. Doing so may cause deformation or device failure.

3 / 25
 Do not immerse in cleaning detergents or rinse with water. Doing so may
Prohibited cause device failure.

Unplug from the power outlet during long periods of disuse. Not doing so
Instruction may cause fire or device failure.

Allow the device to return to room temperature before unpacking. Not doing
Instruction so may cause condensation and lead to device failure.
Make sure the illumination is turned off during transport or storage and only
use the specified casing. Failure to do so may result in deformation, device
Instruction failure or fire.

When disconnecting cables, be sure to hold the plug. Never pull the cable.
Instruction

1.4 Labeling on Package

The following label has been adhered to the package of the IO-α LED.

Environmental conditions for

transport and storage

Product Name
and Model
Manufacturer’s WEEE directive
Name & Address

Consult User’s
Manual

Serial Number of:

Scope Unit Headband
Battery Pack Teaching Mirror

4 / 25
2 Checking Package Contents
2.1 Composition
Make sure to match all items in the package with the components shown below and inspect
each item for damage. Should any items be missing or damaged, do not use the IO-α and
contact your local dealer immediately.
Set Type Set 4 Set 3 Set 2
Item
IO-α Main Unit See 2.2.1 1 1 1
IO-BPⅡ See 2.2.2 1 1 1
(example)
AC Adapter 1 1 1

Extension Cord (1 m) 1 1 1

Belt Hook 1 1 1

Wiring Ring 1 1 1

Teaching Mirror 1 - -

Detachment Chart 1 - -

User’s Manual 1 1 1

Carrying Case 1 1 -

Aspheric Lens Optional

Replacement Bulb Optional

Headpad (replacement) Optional

IO Stand Optional

5 / 25
2.2 Nomenclature
2.2.1 IO-α Main Unit

Label

19 16 15 E 1 4 A 6
18

5 7

C B
14
D
17
13 8
12
11 10 9 2 3

A Manufacturer’s Logo

B Model Logo

C Uses an LED bulb

D SN ********* Serial number of the Main Unit

E SN ********* Serial number of the Headband

1 Lamphouse Holds the LED bulb

2 Front Window Outputs illumination
3 Teaching Mirror Slot To insert the Teaching Mirror
Switches between “UV filter (white)”, “Red-free filter (green)”
4 Filter Selection Lever
and “Cobalt Blue Filter (blue)”

5 Filter Selection Marker

Aperture Selection
6 Switches the area of the illumination field
Lever

7 Aperture Selection Marker

8 Eyepiece A +2 D (diopters) lens is included

Adjusts the pupil distance (PD). The scale (54 mm to 74 mm)
9 PD Adjuster
is indicated above the Eyepiece
Illumination Angle Adjusts the illumination angle. Levers located on both sides of
10
Adjustment Lever the Scope Unit are coupled and move in conjunction.
Observation Angle Adjusts the observation angle. Levers located on both sides of
11
Adjustment Lever the Scope Unit are coupled and move in conjunction.

12 Graphic display of the approximate subject pupil size.

13 Lamp Plug Connects to the Lamp Jack of the IO-BPⅡ

6 / 25
 Scope Unit
14 Loosen to position the Scope Unit
Fixation Knob
15 Headpad Applied to the forehead to keep the Scope Unit in Place
16 Overband Holds the Scope Unit. Can be flipped up.
Overband Loosen to flip up the Overband. Tighten to keep the Overband
17
Fixation Knob in place
Covers the adjustment mechanics of the Headband. For your
18 Headband Cover(s)
safety, do not remove.
Headband Size Turn clockwise to tighten the Headband. Turn counter-
19
Adjustment Knob(s) clockwise to loosen the Headband.

7 / 25
 2.2.2 IO-BPⅡ

A Manufacturer’s Logo

B Model Logo

C SN ********* Serial Number of the IO-BPⅡ

1 CHARGE Jack Connects to the AC Adapter for charging

Charge Lamp: Lights orange during charging and changes to
2
green when fully charged

Illumination Switch: Turns illumination On/Off and allows for

3
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 Jack

8 Lamp Jack Connects to the Lamp Plug on the Scope Unit
9 Headband Hook Attaches the IO-BPⅡ to the Headband Size Adjustment Knob
Hook Fixation Fixates either the Headband Hook or the Belt Hook.
10
Screw(s) The device is shipped with the Headband Hook attached.

8 / 25
3 Operation
3.1 Preparation
3.1.1 Charging the IO-BPⅡ

Do not use battery packs or AC adaptors other than the standard accessories
supplied by the manufacturer. Doing so may result in electric shock or device
WARNING failure.
Never remove the cover of the battery pack. Attempting to charge commercial
batteries may cause leakage of liquids, heat generation or explosion during
WARNING charging.

(1) Insert the DC Plug of the AC Adapter into the CHARGE Jack (see Fig. 3.1)
(2) Connect the power plug to the power outlet to start charging. The CHARGE Lamp will
light orange.
(3) Charging time is approximately 2.5 hours from a fully discharged state.
*Note: The IO-α cannot be illuminated while the DC Plug is connected.
(4) Once fully charged, the CHARGE Lamp will light green.
(5) Unplug the power plug from the power outlet and the DC Plug from the CHARGE
Jack.
DC Plug

Fig. 3.1

3.1.2 Attaching the IO-BPⅡ

The IO-BPⅡ can be attached to either the Headband using the Headband Hook or a belt
or the like using the Belt Hook.
<Attaching using the Headband Hook>
Using the Headband Hook, affix the IO-BPⅡ to either Headband Size Adjustment Knob
as shown in Fig. 3.2. Be sure to insert the insert the Knob into the Hook Firmly.

Fig. 3.2

As this configuration adds additional weight to your head, be sure to choose the
configuration which feels best balanced.

9 / 25
 <Attaching using the Belt Hook>
The IO-BPⅡmay also be attached to a belt or the like by replacing the Headband Hook
with the Belt Hook.
Remove the Headband Hook from the IO-BPⅡby unscrewing the 2 Hook Fixing Screws.
Then, affix the Belt Hook to the IO-BPⅡby screwing the 2 Hook Fixing Screws into the
respective outer holes (see Fig. 3.3).

Belt Hook

Note: Use the outer holes to

affix the Belt Hook.
Fig. 3.3

3.1.3 Connecting the IO-BPⅡto the Scope Unit

(1) Holding the black rubber portion, insert the Lamp Plug into the Lamp Jack. Make
sure metal rings on the plug and jack interlock with a click (see Fig. 3.4).
*Note: The plug and jack interlock at a single configuration. Rotate the plug as
needed to connect smoothly.

Black Rubber
Portion

Fig. 3.4

(2) When using the Belt Hook, the Lamp Cord

attached to the Scope Unit is not long enough to
connect to the IO-BPⅡ. In this case, connect the
Extension Cord provided to the Lamp Cord to
accommodate. The Wiring Ring can be used to
keep the wiring from getting in your way (see Fig. Wiring Ring
3.5). Lamp plug
(3) Gently pull the metal ring on the Lamp Plug to
disconnect from the IO-BPⅡ. Extension Cord Plug
*Note: The cord will not disconnect by turning the Extension Cord
metal ring.
Battery Pack
Fig. 3.5

10 / 25
3.2 Operation
3.2.1 Wearing the IO-α

(1) Loosen the Headband by turning the Headband ②

Size Adjustment Knobs located at the top and
rear of the Headband counter-clockwise and
position the Headband so that it comes into
contact with the forehead.
(2) Turn the rear Headband Size Adjustment Knob
(①) clockwise to tighten and keep the Headband
in place. It is advised to lower the rear portion of
the headband to increase stability (see Fig. 3.6) . ①
(3) Turn the top Headband Size Adjustment Knob Fig. 3.6
(②) clockwise to adjust the height.

3.2.2 Positioning the Scope Unit ③

(1) Loosen the Scope Unit Fixation Knob (③) by

turning counter-clockwise. Be sure to keep hold
of the Scope Unit (④) while loosening, as the
Scope Unit may suddenly tilt.
(2) Move the Scope Unit and tighten the Scope Unit ④
Fixation Knob to fix in the position with the best
view when observed through the eyepieces (see
Fig. 3.7)
Fig. 3.7
3.2.3 PD Adjustment PD Scale
(1) Turn the Observation Angle Adjustment ⑤
Lever (⑤) upward to fully spread the angle
of observation (see Fig. 3.8).
(2) Focusing on an object (such as a thumb)
approximately 400 mm from the Scope
Unit, move each Eyepiece one at a time by
sliding the PD Adjuster (⑥) so that the ⑥
object is centered in the field of view. Fig. 3.8

3.2.4 Illumination

(1) Turn the Illumination Switch clockwise from the OFF position ( ) to turn the
illumination on. Illumination intensity will increase as the switch is turned (a marking
to indicate the intensity is shown as )
A clicking sensation indicates the median.
(2) Choose the desired field of illumination using the Aperture Selection Lever. The
following diameters can be selected.

Marker Aperture Diameter at 500 mm distance

Large 80 mm
Medium 50 mm
Small 19 mm

11 / 25
 (3) Rotate the Filter Selection Lever to choose between the 3 available filters below:

Marker Filter Use

White UV Normal use. Filter will not alter the color tone
Blood will appear dark, facilitating recognition of blood
Green Red-free
vessels or hemorrhages.
Blue Cobalt Blue Used in conjunction with fluorescein

The color of the Battery Lamp will change according to the amount of battery power
remaining. The Battery Lamp will turn orange to indicate that there is less than 20 minutes
remaining (at maximum illumination level).

Color Condition of Battery Pack and Necessary Actions

Green Battery operational. Continue use
Orange Little battery power remaining. Charge immediately
Unlit Battery fully discharged. Charge immediately

3.2.5 Examination

Do not illuminate the patient’s eye for more than 1 minute per eye and be sure
to keep illumination at minimal intensity needed to view the fundus.
WARNING

(1) Holding an aspherical 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 aspherical lens close to the patient eye and gradually move away from the
eye until a clear image of the fundus is obtained.
*Note: The distance between the patient eye and aspherical lens is dependent on
the optical power (diopter, 1 D = 1 / focal distance in meters) of the aspherical
lens.

Optical Power Description of Image

14 D to 16 D High magnification, bright image, narrow field of view
20 D Typically used in standard examinations
28 D to 30 D Low magnification, dim image, wide field of view

The illumination system and observation system can be configurated as follows to

optimize examination
Illumination
<Examining Large Pupils> Light

When examining the fundus through large pupils,

raise both the Illumination Angle Adjustment Lever
and Observation Angle Adjustment Lever. The
illumination axis and observation axes are
distanced, allowing for better stereoscopic vision
with reduced glare (see Fig. 3.9a).
Observation
Light

Fig. 3.9a
12 / 25
 Illumination
<Examining Small Pupils> Light

When examining the fundus through small pupils,

lower both the Illumination Angle Adjustment Lever
and Observation Angle Adjustment Lever. The
illumination axis and observation axes come closer,
allowing for easier concentration of light into the pupil
(see Fig. 3.9b).
Observation
Light

Fig. 3.9b

Illumination
<Examining Horizontally Elliptical Pupils> Light

When examining the fundus through horizontally

elliptical pupils, lower the Illumination Angle
Adjustment Lever and raise the Observation Angle
Adjustment Lever. The illumination axis will come
closer the observation axes while the observation
axes remain apart (see Fig. 3.9c). Observation
Light

Fig. 3.9c

<Examining Vertically Elliptical Pupils> Illumination

Light
When examining the fundus through vertically
elliptical pupils, raise the Illumination Angle
Adjustment Lever and lower the Observation Angle
Adjustment Lever. The illumination axis will remain
apart while the observation axes come closer (see
Fig. 3.9d).
Observation
Light
Fig. 3.9d

(3) Reflection off the cornea or front or back side of the aspherical lens may interfere
during examination. In such cases, tilt the lens slightly to offset the reflection for
better observation of the fundus.
(4) Use a scleral depressor to depress the eye for examination of the peripheral retina.

13 / 25
3.2.6 Using the Teaching Mirror Marks on
Both Faces
It is also possible to view the fundus image from
the side by inserting the Teaching Mirror into the
Teaching Mirror Slot on the Scope Unit (see Fig.
3.10).
The Teaching Mirror may be attached to face either
the left or right of the examiner.
When detaching the Teaching Mirror from the
Scope Unit, depress the ● mark on both the
upper and lower faces of the Teaching Mirror and
Fig. 3.10
pull gently.
*Note: Do not attempt to detach the Teaching Mirror forcefully as the Teaching Mirror may
break.

3.2.7 Turning Illumination Off

Thurn the Illumination Switch counter-clockwise to the OFF position ( ) to turn the
illumination off. Make sure to confirm the device is turned off by checking that the Battery
Lamp is unlit.

14 / 25
4 Maintenance
Unplug the power cable from the power outlet prior to cleaning. Failure to do
so may result in electric shock
WARNING

Do not short-circuit connectors or touch them with bare hands. Doing so may
cause electric shock or device failure.
WARNING

4.1 Cleaning
4.1.1 Cleaning the Optics

If dust or other foreign matter should adhere to the optical glass, remove with an air
blower or the like. If the foreign matter cannot be removed with an air blower, wipe gently
using diluted neutral detergent and then wipe dry.

4.1.2 Cleaning the Headpad

When the Headpad becomes dirty, wipe using a soft cloth moistened with diluted neutral
detergent and then wipe dry.

4.1.3 Cleaning Other Exterior Parts

Wipe 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 have a long lifetime, replacement is generally not necessary. However,
should the need arise, follow the directions below to replace the LED bulb (see Fig 3.11).

(1) Confirm the illumination is turned OFF and disconnect the Battery Pack.
(2) Using a thins stick such as the tip of a pencil, press the indented tabs located on each
side of the lamphouse to remove the lamphouse cover.
(3) Remove the old LED bulb and replace with a new one. When inserting the LED bulb,
be sure to align the protrusion on the side of the bulb with either groove on the socket.
(4) Shut the cover of the Lamphouse until it shuts with a click
(5) Turn the illumination on for confirmation.
Lamphouse

New Bulb

Indents Grooves
on Lamp
House

Fig. 3.11

15 / 25
4.3 Replacing the IO-BPⅡ
Never remove the cover of the battery pack. Attempting to charge commercial
batteries so may cause leakage of liquids, heat generation or rupturing during
WARNING charging.

Rechargeable batteries degrade through repeated charging and discharging cycles.

Degraded batteries experience shortened illumination times and eventually will cease to
operate. If such events should occur, contact your local dealer to purchase a new Battery
Pack.

4.4 Disposal
Dispose of the IO-α and its accessories (excluding the IO-BPⅡ) in accordance with your
local regulations and/or environmental guidelines

The IO-BPⅡincorporates rechargeable batteries which contain precious

resources that can be reused. Recycle used rechargeable batteries in
accordance with your local rules, regulations and guidelines.
The symbol shown to the right means “This product can be recycled”
with text to indicate the material used, nickel-metal hydride Ni -MH

16 / 25
5 Troubleshooting
If you experience any problems using the IO-α, refer to the chart below for possible solutions.
If the problem cannot be solved, stop using and immediately contact your local dealer or
Neitz directly.
Problem Possible Cause Solution
Incorrect cable connection Correct connection
Battery empty Charge battery
Illumination does not
DC Plug is inserted Remove DC Plug
light
Replace with a new bulb in
LED bulb degraded
accordance with 4.2
Improper Illumination Switch
Adjust Illumination Switch
position
Illumination dark Insufficient charging Charge Battery Pack
Replace with a new bulb in
LED bulb degraded
accordance with 4.2
Illumination flickers Insufficient battery power Charge Battery Pack
Foreign matter is adhered to the Clean in accordance with
Front Window 4.1.1
Nonuniform illumination Aperture Selection Lever or
Move the lever(s) until you
Filter Selection Lever is
feel a click
mispositioned
Foreign matter is adhered to the Clean in accordance with
Observation image eyepiece or observation system 4.1.1
blurry Foreign matter is adhered to the
Clean aspherical lens
aspherical lens
DC plug not fully plugged in Plug in all the way
Cannot charge Replace Battery Pack in
Battery Pack degraded
accordance with 4.3
Cannot charge despite Ambient temperature too high
Charge under the conditions
AC adapter properly (a sensor is incorporated to
specified in Section 6
connected detect high temperature)
Reduced illumination Replace Battery Pack in
Battery Pack degraded
time when fully charged accordance with 4.3
Heat occurring during charging is normal. The temperature of
Battery Pack becomes
the Battery Pack may rise to temperatures which may feel
hot during charging
slightly hot to the touch.
Wear of the Headband Size Tighten the screw in the
Headband size loosens
Adjustment Knob center of the knob.
Headband size fixation If the Headband Size Adjustment Knob feels loose, tighten the
is loose screw in the center of the knob.

17 / 25
6 Specifications
Product Specifications
Illumination Source Warm White LED
Filters UV, Red-free, Cobalt Blue
Illumination Field Diameter*1 19 mm / 50 mm / 80 mm
Maximum Illuminance*1 Approximately 600 lx (using the UV filter)
PD Adjustment Range 54 mm to 74 mm
Minimum Pupil Diameter 2 mm
Continuous Illumination Time*2 Approximately 5 hours at maximum intensity
Two (2) AA type Nickel-metal hydride batteries
Incorporated Rechargeable Battery
(2.4 V)
Charging Time Approximately 2.5 hours
161 mm x 111.5 mm x 58 mm
Scope Unit*3
Approximately 480 g
Headband
Dimensions Approximately 530 mm to 630 mm
Circumference
72.5 mm x 65 mm x 20 mm
Battery Pack*4
Approximately 140 g
*1: measured at 500 mm distance
*2: for new batteries
*3: excluding Headband
*4: excluding protrusions

Classification
Degree of protection against electric
Internally powered ME equipment
shock
Applied parts No applied parts
Degree of protection against harmful
IPX0
ingress of water or particulate matter
Method(s) of sterilization Do not sterilize
Suitability for use in an oxygen rich
Do not use in oxygen rich environments
environment
Mode of operation Continuous operation
Input AC 100-240 V, 50-60 Hz, 0.3 A
AC Adapter (APS315-0525)
Output DC 5 V, 2.5 A

Safety Standards
Electric Safety IEC 60601-1:2005+AMD1:2012
Electromagnetic Disturbances IEC 60601-1-2:2007
Ophthalmic Instruments ISO 15004-1:2006
Light Hazard ISO 15004-2:2007
Indirect Ophthalmoscopes ISO 10943:2011

Environmental Conditions
Use Storage Transport
+10 °C to +35 °C -10 °C to +55 °C -10 °C to +55 °C
Temperature
(50 °F to 90 °F) (14 °F to 131 °F) (14 °F to 131 °F)
30 % to 90 % 10 % to 95 % 10 % to 95 %
Relative Humidity (no condensation) (no condensation) (no condensation)
Atmospheric
800 hPa to 1060 hPa 500 hPa to 1060 hPa 500 hPa to 1060 hPa
Pressure

18 / 25
7 Contact Information
If you have any questions or need technical support, 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 Fax: +81-3-3237-0554
e-mail: [email protected]
URL: http://www.neitz-ophthalmic.com/

19 / 25
 ANNEX A
Protection from Optical Hazards

The light emitted from this instrument is potentially hazardous. The

longer the duration of exposure, the greater the risk of ocular damage.
Exposure to light from this instrument when operated at maximum
intensity will exceed the safety guideline after 7 minutes.

The figure below shows the relative optical output when the device is operated at maximum light
intensity at the largest aperture. The figure represents wavelengths from 360 nm to 780 nm, as
the LED light source does not emit radiation in the infrared or ultraviolet range.

*The results of evaluation according to ISO 15004-2 “Ophthalmic instruments – Fundamental

requirements and test methods – Part 2: Light hazard protection” indicates that the IO-α is
classified to be Group 2 (and ophthalmic instrument for which a potential light hazard exists).
Therefore, an indicator that shows that latent optical hazards could arise in relation to the
ophthalmic instruments used by the operator is shown. However, this does not determine usage
threshold values.
*The above-mentioned optical exposure time means the cumulative time over one day for one
eye and this is inversely proportionate to the light intensity applied to the eye. Accordingly, if, for
example, half of the maximum light intensity is used, the exposure time to reach latent optical
hazard level is twice (approximately 14 minutes) that of when maximum intensity is used.
Relative Light Intensity [a.u.]

Wavelength [nm]

20 / 25
 ANNEX B
EMC Guidance

The IO-α is a medical device and requires special precautions regarding EMC. Refer to the
following EMC information for appropriate installation and putting into service.
Take care when using portable and mobile RF communications equipment in proximity of the IO-
α, as they can affect performance.

(1) Designated Cable

N/A
(2) Using accessories, transducers or cables other than those provided by Neitz may result in
increased emissions or decreased immunity of the IO-α.
(3) Do not use the IO-α adjacent to or stacked with other equipment.
In cases where adjacent or stacked use is necessary, verify the IO-α operates normally prior
to use.
(4) Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

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.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions The IO-α uses RF energy only for its internal
function. Therefore, its RF emissions are very low
CISPR 11 Group 1
and are not likely to cause any interference in
nearby electronic equipment.
RF emissions The IO-α is suitable for use in all establishments,
including domestic establishments and those
CISPR 11 Class B directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
Harmonic emissions
Not Applicable
IEC 61000-3-2

Voltage fluctuations/ The IO-α is suitable for use in all establishments,

flicker emissions including domestic establishments and those
Complies directly connected to the public low-voltage power
IEC 61000-3-3 supply network that supplies buildings used for
domestic purposes.

21 / 25
(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.
IEC 60601 Test Compliance Electromagnetic Environment –
Immunity Test
Level Level Guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete
discharge (ESD) or ceramic tile. If floors are
± 8 kV air ± 8 kV air covered with synthetic material,
IEC 61000-4-2 the relative humidity should be at
least 30 %.

Electric fast ± 2 kV for power ± 2 kV for power Mains power quality should be
transient/burst supply lines supply lines that of a typical commercial or
hospital environment.
IEC 61000-4-4

Surge ± 1 kV line(s) to ± 1 kV line(s) to Mains power quality should be

line(s) line(s) that of a typical commercial or
IEC 61000-4-5 hospital environment.

Voltage dips, short <5 % UT <5 % UT Mains power quality should be

interruptions and (>95 % dip in UT) (>95 % dip in UT) that of a typical commercial or
voltage variations for 0.5 cycle for 0.5 cycle hospital environment. If the user
on power supply of the IO-α requires continued
input lines 40 % UT 40 % UT operation during power mains
(60 % dip in UT) (60 % dip in UT) interruptions, it is recommended
IEC 61000-4-11 for 5 cycles for 5 cycles that the IO-α be powered from an
uninterruptible power supply or a
70 % UT 70 % UT
battery.
(30 % dip in UT) (30 % dip in UT)
for 25 cycles for 25 cycles
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 s for 5 s

Power frequency 3 A/m 3 A/m Power frequency magnetic fields

(50/60 Hz) should be at levels characteristic
magnetic field of a typical location in a typical
commercial or hospital
IEC 61000-4-8 environment.
NOTE UT is the AC mains voltage prior to application of the test level.

22 / 25
 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (continued)
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.
IEC 60601 Test Compliance Electromagnetic Environment –
Immunity Test
Level Level Guidance
Portable and mobile RF
communications equipment should be
used no closer to any part of the IO-α,
including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance

Conducted RF 3 Vrms 3 Vrms 𝑑𝑑 = 1.2√𝑃𝑃 150 kHz to 80 MHz

IEC 61000-4-6 150 kHz to 80 MHz

Radiated RF 3 V/m 3 V/m 𝑑𝑑 = 1.2√𝑃𝑃 80 MHz to 800 MHz

IEC 61000-4-3 80 MHz to 2.5 GHz 𝑑𝑑 = 2.3√𝑃𝑃 800 MHz to 2.5 GHz

where 𝑃𝑃 is the maximum output

power rating of the transmitter in watts
(W) according to the transmitter
manufacturer and 𝑑𝑑 is the
recommended separation distance in
meters (m).
Field strengths from fixed 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 range 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 fixed 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 fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the IO-α is used exceeds the applicable RF compliance level above, the IO-α should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the IO-α.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

23 / 25
(6) Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and the IO-α
Recommended Separation Distances Between Portable and
Mobile RF Communications Equipment and the IO-α
The IO-α is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the IO-α can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the IO-α as recommended below, according
to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum
output power of m
transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W
𝑑𝑑 = 1.2√𝑃𝑃 𝑑𝑑 = 1.2√𝑃𝑃 𝑑𝑑 = 2.3√𝑃𝑃
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 𝑑𝑑 in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where 𝑃𝑃 is the maximum output rating of the transmitter in watts
(W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

(7) Essential Performance of the IO-α

No. Essential Performance Operation Mode
1 Uninterrupted charging Charging Mode
2 Continuous steady illumination Illumination Mode

24 / 25
Notes:

25 / 25
 Manufactured by
NEITZ INSTRUMENTS CO., LTD.
4F Ichibancho Court, 15-21, Ichibancho, Chiyoda-ku,
Tokyo 102-0082, Japan
Phone: +81-3-3237-0552 FAX: +81-3-3237-0554
E-mail: [email protected]
URL: http://www.neitz-ophthalmic.com

Distributed by

As part of our policy of continued product improvement, we reserve the right

to alter and/or amend specifications at any time without prior notice.

TD11-12610004E-3
201901
Printed in Japan