Streak Retinoscope RX-RC Instruction Manual

Thank you for purchasing the NEITZ Streak Retinoscope RX-RC. This is a battery-powered retinoscope. For charging battery an optional Dual Desk Charger RC-II is exclusively used. Please read this instruction manual carefully before use to avoid unexpected accidents, and store it in a safe place for future reference. Please also read the instruction manual of the Dual Desk Charger RC-II carefully when the charge for battery is required. For more detailed information for operating please refer to a technical book for retinoscopy.

TD11-10890031E-2

Table of Contents 1. Important Information ................................................................................................................ 1

1-1 Intended Use ...................................................................................................................... 1 1-2 Symbols ............................................................................................................................. 1 1-3 Labeling on Package ......................................................................................................... 2 1-4 Safety Information .............................................................................................................. 3

2. Checking Package Contents and Nomenclature ...................................................................... 5 3. Operation ................................................................................................................................... 7

3-1 Charging RX-RC ................................................................................................................ 7 3-2 Turning Illumination ON/OFF ............................................................................................. 8 3-3 Varying and Rotating Streak .............................................................................................. 8 3-4 Screening ........................................................................................................................... 8 3-5 Astigmatic Axis Examination ............................................................................................ 10 3-6 Determining Refraction .................................................................................................... 10 3-7 Accessories ...................................................................................................................... 10

4. Troubleshooting ........................................................................................................................ 11 5. Maintenance ............................................................................................................................ 12

5-1 Cleaning ........................................................................................................................... 12 5-2 Replacing Battery............................................................................................................. 12 5-3 Replacing Bulb ................................................................................................................. 13 5-4 Disposal ........................................................................................................................... 13

6. Specifications .......................................................................................................................... 14 7. Contact Information ................................................................................................................. 20

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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 Streak Retinoscope RX-RC (hereinafter, called as “RX-RC”) is a battery-powered retinoscope intended to measure the refraction of the eye by illuminating the retina and noting the direction of movement of the light on the retinal surface and of the refraction by the eye of the emergent rays.

1-2 Symbols

The following symbols are used on this manual and/or package to assist you in proper handling and using this device, and to warn and caution you of potential hazards to yourself and others.

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Used with the safety alert symbol, indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices that may cause property damage.

Prohibited action (must not be performed).

Required actions (that must be performed) based on the instructions.

Serial number. This symbol should be accompanied by the serial number of the device.

Manufacturer. This symbol should be accompanied by the name and address of the manufacturer.

This symbol shows that this device may not be disposed of together with general household waste and can be recycled separately from other household waste under the WEEE directive.

Symbol of Nickel-Hydrogen Secondary Battery to be recycled.

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This symbol instructs to consult the instructions of the device for information on how to properly use it.

This symbol shows the lower and upper temperature limits (°C) for storage and transport.

This symbol shows the lower and upper humidity limits for storage and transport.

This symbol shows the lower and upper atmospheric pressure limits for storage and transport.

Fragile. Handle with care.

Keep dry.

Nickel-cadmium rechargeable battery.

Potentially hazardous levels of non-ionizing radiation or RF transmitters (not applicable to the RX-RC)

Barcode for traceability purposes.

1-3 Labeling on Package

The following label has been adhered to the Outer Package of the RX-RC to assist you in the proper transport and storage of the device

Ni-Cd

Environmental conditions for transport and storage

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1-4 Safety Information

For your safety please strictly comply with the following precautions. Failure to comply may cause safety problem or device failure.

Do not illuminate the light more than required to observe the fundus of patient’s eye. It may damage the patient’s eye.

Do not use together with parts other than standard accessories including in this package. Problems or damage may occur.

Do not apply a strongly impact. It may cause injury or device failure.

Do not turn the illumination on when covered with the plastic bag and the like. It may cause the inside high temperature and result in injury, device failure or fire.

Do not touch the bulb with bare hands immediately after turned off since it is still hot. It may result in injury.

Do not impact to the device during the bulb is lighted or immediately after turning the bulb off. It may cause breakage of bulb filament.

Do not operate in direct sunlight or harmful light. Doing so may create high heat or damage of the device.

Do not use in extremely humid place or come in contact with salt water, or allow water to come in contact with the device. It may cause device failure.

Do not sterilize the device. It may cause deformation or device failure.

Do not use thinner, cleaning agents, or boiled water to clean the device. It may cause deformation or device failure.

Do not insert any foreign materials into the gaps of device. It may cause device failure.

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Be sure to use original Carrying case during movement or transportation. Doing so may protect against deformation or device failure.

Be sure to use genuine battery without fail. Not doing so may cause device failure.

Remove the battery when the device will not be used for long periods of time to prevent from electrolyte leakage.

Do not attempt to disassemble or modify the device. Doing so may result in electrical shock, fire or device failure.

Do not touch the device with wet hands. Doing so may cause device failure.

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2. Checking Package Contents and Nomenclature

Make sure to match all items in the package with the components shown below. Inspect each item for damage. If any items are missing or damaged, do not use the device and immediately contact your local dealer. (The RX-RC consists of a retinoscope head RX, a handle and a rechargeable battery.) Before using the RX-RC for the first time, clean it according to the instructions given in this manual.

(1) Retinoscope Head RX (Hereinafter, called as “Head”) …….. 1 unit

(1) Headrest Mount (2) Viewing Window (3) Viewing Window Rim (4) Illumination Opening (5) Reference Line (6) Streak Varying Lever (7) Head Rotation Ring (8) Streak Rotation Ring (9) Head Joint (10) Logo of Manufacturer (11) Logo of Model Name of

Head (12) Serial Number of Head

(2) Battery Handle (hereinafter, called as “Handle”) …….. 1 unit (13) Switch Button (14) Switch Ring (15) Bottom Cap (16) Serial Number of Handle (3) Headrest…… 1 piece

①

③ ②

④

⑤

⑥ ⑦

⑧ ⑨

⑩ ⑪

⑫

⑬

⑭

⑮ ⑯

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(4) Presbyopic Lens ……. 1 piece (5) Rechargeable Battery …… 1 piece Type: 1000RS Output Voltage 3.6V (6) Spare Bulb …….. 1piece (7) Carrying Case ……. 1 piece Type: L-27 (8) Instruction Manual ……. 1 set (9) Outer Package …… 1 piece

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3. Operation 3-1 Charging RX-RC Charge the RX-RC with the optional Dual Desk Charger RC-II (hereinafter, called as

“RC-II”) sold separately.

RX-RC It is available to charge 2 sets of the RX-RC

simultaneously

ME System

Charging Ports

RC-II (Non-medical device)

Insert the Handle of RX-RC into the charging port of RC-II, which is exactly connected

to the AC power through the AC adaptor, until it stops as shown in the above figure. Be sure to turn the RX-RC off during charging.

Full charging of battery is completed after approx. 15 hours from an uncharged condition.

When fully charged the RX-RC can be illuminated for approximately 80 minutes at the maximum amount of light.

Read the instruction manual for RC-II

Be sure to charge the RX-RC after turning it off. If still ON, it may create high heat felt hot in touch as well as charging is unable.

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3-2 Turning Illumination ON/OFF While pressing the Switch button on the Handle,

rotate the Switch ring to the left (towards ON) to turn the power and light on. (Fig. 3-1)

Since the light adjustment function is built in the RX-RC, the further the Switch ring is rotated to the left (towards ON), the brighter the light becomes.

To turn the light off, rotate the Switch button to the right until it completely returns to the OFF position.

3-3 Varying and Rotating Streak

By shifting the Streak varying lever upward and downward based on the reference line, it is available to vary the streak as follows. The reference point on the Streak varying lever is the top of it.

(1) Upper position than the reference line: Convergent ray (Fig. 3-2a) (2) On the reference line: Parallel ray (Fig.3-2b) (3) Lower position than the reference line: Divergent ray (Fig. 3-2c)

In addition, the streak can be rotated 360 degrees with no limit by turning the Streak

rotation ring (see Fig. 3-3).

3-4 Screening

(1) Turn the RX-RC on and shift the Streak varying lever fully downward to observe the divergent ray.

When the divergent ray is used, follow the procedure below.

Fig. 3-1 Illumination OFF Illumination ON

Fig. 3-2a Fig. 3-2b Fig. 3-2c Fig. 3-3

Reference Line

Streak Varying Lever

Streak

Streak Rotation Ring

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(2) While the gazing point of the examined eye is set to far point that is no regulated power, illuminate the light to the examined eye from the distance of 50cm.

(3) Approach to the Viewing window of RX-RC as much as possible to look in. (4) Observe the movement of reflex against the projection direction by scanning the

projected light on fundus of eye slowly and horizontally. On this occasion, scan it in the direction of perpendicular to the lengthwise direction of linear streak.

(5) The relation between the motion of reflex and the refraction in condition of naked eye (in case the trial lens is not used in front of examined eye) is as follows (Fig. 3-4).

(a) Movement (The reflex moves in the same direction as the projected light): Myopic eye, emmetropic eye, or hyperopic eye of -2D or under (b) Neutrality (The movement of reflex stops.): Myopic eye of -2D (c) Against Movement (The reflex moves in the opposite direction to the projected

light.) Myopic eye of -2D or over * The abovementioned principle is applied only to the situation used the divergent

ray, and the motion of reflex is the reverse direction when the convergent ray is used.

* The value of “-2D” depends on the distance of examination, and it is determined by calculating -1 divided by examination distance [m].

Projected light

Reflex

Shadow Scanning Direction

[Movement]

[Neutrality]

[Against Movement]

Fig. 3-4

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3-5 Astigmatic Axis Examination When the angles of scanning the examined eye and the motion of reflex are not related

with the movement or against movement but are the same, this meridian of eye is a main meridian. If they are not the same, the angle of movement of reflex is a main meridian, and the meridian which is apart 90 degrees from the main meridian becomes the other meridian. Either of their meridians is astigmatic axis.

3-6 Determining Refraction

(1) Scan the naked eye and wear in 12mm front of patient’s eye the (+) lens in case of movement or the (-) lens in case of against movement (or by using retinoscopy rank), and find the neutrality point by increasing 0.5 to 1.0D.

* Since against movement is hard to observe comparing with movement, if against movement exists, more high accuracy neutrality can be obtained by adding the (-) lenses until movement can be observed and increasing the (-) lenses step by step.

(2) The relation between the lens power required for neutralization and the refraction is shown below.

Refraction = Lens power required for neutralization – (1/examination distance[m])

(3) After confirming the refraction of the main meridian, find the neutrality point of the other main meridian in the same procedures.

3-7 Accessories

(1) Headrest When performing the examination with

glasses on, remove the cover on the Headrest mount to insert the accessory Headrest into there (see Fig. 3-5). It is hard to scratch the glasses by operating the RX-RC while putting the Headrest on your forehead.

(2) Presbyopic Lens When using the presbyopic lens, loosen and

turn the Viewing window rim to be removed, and then put the presbyopic lens on it.

* +2D of presbyopic lens is provided as the stanadard accessory.

Fig. 3-5

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4. Troubleshooting If the RX-RC does not function properly, some problems may be solved by referring to the following chart. If the problem cannot be resolved, stop using and contact your local dealer or Neitz immediately.

The following table shows the possible causes and troubleshooting solutions.

Problem Possible Cause Solution

Light does not turn on.

Battery is not installed. Install the battery.

Battery is discharged. Charge the battery.

Bulb has burned out. Replace with a new bulb if burned out.

The shape of streak is curved.

The filament of bulb is curved by external impact. Replace it with a new bulb.

Bulb comes loose. Install the bulb exactly without any looseness.

The RX-RC becomes hot when

the light is on.

It is not abnormal for heat to be generated when the light is on. The temperature on RX-RC may increase to the level that it may feel warm or hot to the touch.

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5. Maintenance 5-1 Cleaning

Do not use thinner, cleaning agents, or boiled water to clean the device. It may cause deformation or device failure.

Do not sterilize the device. It may cause deformation or device failure.

If the device becomes dirty, wipe the surface with dry lint-free cloth or lint-free soft cloth slightly moistened with diluted neutral detergent, and then dry all surfaces completely.

Disinfection by using alcohol may be carried out at the minimum to clean the surface of the device. Use a blower and the like to remove dust or dirt out of the Viewing window.

5-2 Replacing Battery

Be sure to use genuine battery without fail. Not doing so may cause device failure.

As the battery is deteriorated by repeated charges, the battery power and the operating time decrease little by little. It is strongly recommended to replace with a new battery for use of approximately 2 years as a guide. The battery is replaced in accordance with the following procedure. (1) Rotate the Bottom cap counterclockwise to

detach it and remove the current battery. (2) Insert a new battery in the direction in which

the metal terminal portion is on the Bottom cap side as shown in Fig. 5-1.

(3) Screw the Bottom cap clockwise on the Handle.

Metal terminal portion

Fig. 5-1

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5-3 Replacing Bulb

Do not touch the bulb with bare hands immediately after turned off since it is still hot. It may result in injury.

When the illumination is not turned on, the bulb may have burned out. In accordance with the following procedure, confirm the condition of the bulb and replace it with a new one if burned out.

(1) As shown in Fig. 5-2, hold the Head and the Handle

with both hands. Holding the Head, twist the Handle counterclockwise to detach it from the Head.

(2) The bulb appears in the top of the detached Handle. Check the filament of bulb. If the filament is broken, replace it with a new one.

* 1 piece of bulb is provided as an accessory. (3) Turn the bulb counterclockwise to remove it. (4) Replace a new bulb to the original position in the

reverse procedure of removal (Fig. 5-3). Attach the Head to the Handle.

Do not directly touch the glass part of the bulb with your hands and be sure it remains clean.

5-4 Disposal

Safely dispose of the RX-RC and accessories, except rechargeable batteries, in accordance with local regulations and/or environmental guidelines.

The rechargeable battery that contain precious resources can be reused. Do not discard but recycle used rechargeable battery in accordance with your local rules, regulations and/or guidelines.

Fig. 5-2

Head

Fig. 5-3

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6. Specifications

Bulb Rating 4V, 2.6W

Battery used Ni-Cd rechargeable battery, 1000RS

Continuous Light Hours

Approximately 80 minutes

Streak Divergent ray, Parallel ray, Convergent ray

Streak Rotation 360 degrees with no limit

Headrest To protect the glasses from contacting to the RX-RC

Presbyopia Lens +2D

Dimensions and Weight (including battery)

34(W) x 32(D) x 269 (H)mm, Approx. 380g

Safety Standards

(1) Safety: IEC 60601-1:2005 Ed.3.1:2012 ISO 15004-1:2006

(2) EMC: IEC 60601-1-2 Ed. 3.0:2007 (3) Form of protection against electrical shocks: Internal power supply equipment (4) Class of the level of electrical shock protection: Type B equipment (5) Level of protection against entry of water and particles: IPX0 (6) Method of sterilization:

Do not sterilize (7) Suitability for use in an oxygen rich environment:

Do not use in oxygen rich environments (8) Mode of operation

Continuous operation

Options

(1) Dual Desk Charger RC-II (2) Rechargeable Battery 1000RS (3) Bulb L-27 (4) Presbyopic Lens (+1D) (5) Presbyopic Lens (+2D) (6) Presbyopic Lens (+3D) (7) Headrest

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

Pressure 800 hPa to 1060 hPa 500 hPa to 1060 hPa 500 hPa to 1060 hPa

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ANNEX EMC Guidance

The RX-RC is a medical device and requires special precautions regarding EC. 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 RX-RC, as they can affect performance. (1) Designated Cable

Power cord for AC adapter (2) Using accessories, transducers or cables other than those provided by Neitz may

result in increased emissions or decreased immunity of the RX-RC. (3) Do not use the RX-RC adjacent to or stacked with other equipment.

In cases where adjacent or stacked use is necessary, verify the RX-RC operates normally prior to use.

(4) Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The RX-RC is intended for use in the electromagnetic environment specified below. The customer or the user of the RX-RC should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

RF emissions

CISPR 11 Group 1 The RX-RC 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

The RX-RC 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.

Harmonic emissions

IEC 61000-3-2 Not Applicable

Voltage fluctuations/ flicker emissions

IEC 61000-3-3 Complies

The RX-RC 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.

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

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The RX-RC is intended for use in the electromagnetic environment specified below. The customer or the user of the RX-RC 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 % UT (>95 % dip in UT) for 0.5 cycle

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 0.5 cycle

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

Mains power quality should be that of a typical commercial or hospital environment. If the user of the RX-RC requires continued operation during power mains interruptions, it is recommended that the RX-RC 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 UT is the AC mains voltage prior to application of the test level.

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

The RX-RC is intended for use in the electromagnetic environment specified below. The customer or the user of the RX-RC should assure that it is used in such an environment.

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 RX-RC, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms 𝑑𝑑 = 1.2√𝑃𝑃 150 kHz to 80 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m 𝑑𝑑 = 1.2√𝑃𝑃 80 MHz to 800 MHz 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 RX-RC is used exceeds the applicable RF compliance level above, the RX-RC should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the RX-RC.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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(6) Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the RX-RC

Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the RX-RC The RX-RC is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the RX-RC can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the RX-RC as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

W

Separation distance according to frequency of transmitter

m

150 kHz to 80 MHz

𝑑𝑑 = 1.2√𝑃𝑃

80 MHz to 800 MHz

𝑑𝑑 = 1.2√𝑃𝑃

800 MHz to 2.5 GHz

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 RX-RC

No. Essential Performance Operation Mode

1 Uninterrupted charging Charging Mode

2 Continuous steady illumination Illumination Mode

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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: int@neitz.co.jp URL: http://neitz-ophthalmic.com/

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FOR YOUR NOTE:

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: int@neitz.co.jp URL: http://neitz-ophthalmic.com/

Distributed by

TD11-10890031E-2 201901

Printed in Japan

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.