Neitz RX-RC User manual

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

1
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 measurethe 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 s
hows 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.

2
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.
T
his symbol shows the lower and upper humidity limits for storage
and transport.
T
his 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

3
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 orcome 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.

4
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.

5
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

6
(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

7
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 theAC power through theAC 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.

8
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 anddownward 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

9
(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

10
3-5 Astigmatic Axis Examination
When the angles of scanning the examined eye and the motion of reflex arenot 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 coveron 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

11
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.

12
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
ofthedevice.Useablowerandtheliketo removedustor dirtoutof theViewingwindow.
5-2 Replacing Battery
Be sure to use genuine battery without fail. Not doing so may
cause device failure.
As the batteryis deteriorated by repeated charges, the battery powerand the operating
time decrease little by little. It is strongly recommended to replace with a new battery
for use ofapproximately 2 years as a guide.The battery is replacedin 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

13
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

14
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

15
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

16
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.

17
(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 % U
T
(>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 % U
T
(>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 UTis the AC mains voltage prior to application of the test level.

18
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
= 1.2√
150 kHz to 80 MHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
= 1.2√
80 MHz to 800 MHz
= 2.3√
800 MHz to 2.5 GHz
where is the maximum output
power rating of the transmitter in watts
(W) according to the transmitter
manufacturer and is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters as determined by an
electromagnetic site survey,ashould
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.
aField 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.