Ophthalmoscope
BXα-13/BXα-13A
User’s Manual
Thank you for purchasing t he NEITZ Ophthalmoscope BXα-13 and/or BXα-13A. This is a hand-
held ophthalmic device (direct ophthalmoscope) using dry-cell batteries to power a halogen
lightbulb for examination o f the int ernal areas and fundus of the eye.
This device is available in 2 models, depending on the size of the bat t er ie s used:
Ophthalmoscope BXα-13 ( her einafter referred to as “BXα-13”) using 2 C-size batteries.
Ophthalmoscope BXα-13A (hereina ft er r eferred to as “BXα-13A”) using 2 AA-size batteries.
Please read this User’s Manual carefully before use t o avoid unexpected accidents and st or e it in
a safe place for future refe r ence.
TD11-10750002E-2
Table of Contents
1 Important Information ................................................................................................................ 1
1.1 Intended Use ...................................................................................................................... 1
1.2 Symbols ............................................................................................................................. 1
1.3 Labeling on Package ......................................................................................................... 2
1.3 Safety Information .............................................................................................................. 2
2 Package Contents and Nome nclature ...................................................................................... 4
3 Operation ................................................................................................................................... 5
3.1 Turn ing Illumination ON/OF F ............................................................................................. 5
3.2 Correction Lens and Filter s ................................................................................................ 5
3.2.1 Rekoss Lens ............................................................................................................... 5
3.2.2 4000 K and Polarizing Filters ..................................................................................... 5
3.2.3 Observation Polarizing Filter ...................................................................................... 6
3.2.4 Illumination Dial .......................................................................................................... 6
3.3 Viewing the Fundus ........................................................................................................... 6
4 Maintenance .............................................................................................................................. 8
4.1 Cleaning ............................................................................................................................. 8
4.2 Replacing Batteries ............................................................................................................ 8
4.3 Replacing the Lightbulb ..................................................................................................... 8
4.4 Disposal ............................................................................................................................. 8
5 Troubleshooting ......................................................................................................................... 9
6 Specifications .......................................................................................................................... 10
7 Contact Information .................................................................................................................. 11
ANNEX ........................................................................................................................................... 12
i
Potentially hazardous sit uation which, if not avoided, could result in
death or serious injury
Potentially hazardous sit uation which, if not avoided may r esult i n m inor
or moderate injury or proper t y damage
Prohibited
Instruction
1 Important Information
For the U.S. Market;
CAUTION: Federal law restricts this devic e to sale by or on the order of a phys ici an.
1.1 Intended Use
The NEITZ Ophthalmoscope BXα-13 or BXα-13A is a hand-held, battery-powered medical
device containing a halogen bulb for illumination and viewing optics for examination of the
media (cornea, aqueous, l ens and vitreous) and retina of the eye.
Do not use this device for any pur pose ot her than its intended use.
1.2 Symbols
The following symbols are us ed on t his manual and/or package to as sist you in proper
handling and use of the BXα-13 or BXα-13A, and t o warn and caution you of potenti al
hazards to yourself and other s.
Prohibited actions (must not be per f ormed)
Required actions (must be performed)
Consult User’s Manual for information on pr oper use
Temperature limits (°C) for storage and transpor t
Relative humidity limits (%) for storage and transport
Atmospheric pressure limits (hPa) for storage and transport
Fragile. Handle with care
Keep dry
Product complies with the European requirements fo r s afety, health,
environment and custo me r pr ot ection.
Product must not be disposed of with general household w ast e under
the WEEE directive
Manufacturer’s name and addr ess
1 / 13
Do not use in oxygen rich environments, in the presence of prop ane,
gasoline or other combust ibl e gasses, or near dust and debris. Doi ng so may
cause explosion.
Do not leave the illumination o n for prolonged periods or cover the device
temperatures, resulting i n fire, burns or device failure.
Never touch liquid which may have leaked from the batteries. In case of
including loss of eyesight.
Prohibited
Prohibited
Prohibited
Prohibited
Prohibited
Prohibited
Environmental conditions for
transport and storage
Barcode for traceability pur poses
Serial number
Authorized representative in Europe
1.3 Labeling on Pa c kage
The following label has been adhered to the Outer Package o f t he BXα-13 or BXα-13A to
assist you in the proper transport and storage of the device.
1.3 Safety Information
For your safety, please comply with the following precautions.
during illumination. Doing s o m ay cause the device to reach high
contact with the eye(s), flush with clean water withou t rubbing, and consult a
physician immediately. If leaked liquid gets on skin or clothing, wash with
clean water immediately. Failure to do so may result in serious injury,
Do not attempt to disasse mb le or modify the device. Doing so may r esult in
electric shock, fire or devi ce failure.
Do not touch the device with wet hands. Doing so may result in elect r ic
shock.
Do not touch the Lightbulb immediately after turning the illu m ination off, as
the bulb may be extremely hot . Doing so may result in burns.
2 / 13
Use of accessories other than t hose specified or provided by t he
result in improper operatio n.
Do not use in excessively hu mid or sal ine environments, or places wher e t he
device failure.
Do not use the BXα-13 or BXα-13A adjacent to or st acked with other
BXα-13 or BXα-13A operates nor mally prior to use.
Portable RF communicat ions equipment (including peripherals such as
the performance of this equip m ent c ould result.
Make sure the illumination is tur ned off during transpor t or storage and only
failure or fire.
Prohibited
Prohibited
Prohibited
Prohibited
Prohibited
Prohibited
Prohibited
Prohibited
Prohibited
Prohibited
Instruction
Instruction
Instruction
Instruction
Instruction
Instruction
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.
manufacturer of this equip me nt c ould result in increased electr omagnetic
emissions or decreased elec t r omagnetic immunity of this equipment and
Do not apply strong force t o t he device or handle it roughly. Doing so may
result in injury or device fa ilure.
device may be sprayed wit h w at er. Doing so may result in electric shock or
Do not expose the device to direct sunlight or harmful radiati on. Do ing so
may lead to unexpected heat ing and result in device failure.
Do not sterilize.
Do not use paint thinners, cleani ng agents or boiling water to clean t he
device. Doing so may cause deformation or device failure.
Do not immerse in cleaning det ergents or rinse with water. Doing so may
cause device failure.
equipment. In cases where adjacent or stacked use is necessary, verify the
antenna cables and external antennas) should be used no c loser than 30 cm
(12 inches) to any part of the BXα-13 or BXα-13A. O t her wise, degradation of
Be sure the head and handle are at t ached firmly before use.
Use only alkaline dry-cell batt eries.
When replacing batteries, replace both cells at the same time using identical
batteries.
Remove batteries from the device during prolonged per iod s of d isuse.
Allow the device to return to r oom temperature before unpac king. N ot doing
so may cause condensation and lead to device failure.
use the specified casing. Failure to do so may result in defor mati on, device
3 / 13
2 Package Contents and Nomenclature
Make sure to match all items in t he package with the components shown below and inspect
each item for damage. Should any items be missing or damaged, do not use the BXα-13 or
BXα-13A and immediately contact your local dealer.
1) Head Part of BXα (hereinafter referred to as “Head”)
① Viewing Window
② Rubber Stabilizer
③ Aperture Shutter
④ Rekoss Disc
⑤ Auxiliary Lens Selector
⑥ Diopter Indicator
⑦ Illumination Dial
⑧ Filter Lever
⑨ Observation Polarizing Filter
⑩ Lightbulb
⑪ Manufacturer’s Logo
⑫ Model Logo
⑬ Country of Origin
⑭ CE Mark
⑮ Serial Number of Head Unit
2) Battery Handle (hereinafter referred to as “Handle”)
⑯ C-size Battery Handle (BXα-13)
⑰ AA-size Battery Handle (BXα-13A)
⑱ Switch Button
⑲ Switch Ring
⑳ Bottom Cap
㉑ CE Mark
㉒ Serial Number of Handle
3) Dry Cell Batteries (Prea s sem ble d wit h the Head a nd Handl e prior to ship pi ng)
BXα-13: C-size batterie s ( 2 pcs. )
BXα-13A: AA-size bat t er ies (2 pcs.)
4) Spare Bulb
Ty pe L-30 (1 pc.)
5) Carrying Case
6) Outer Package
7) User’s Manual
4 / 13
-5 D
+
+3 D
+
-2 D
=
-4 D
Examiner’s My opi a
Patient’s Hyperopia
Accommodation
Power
Position
Range
-
-36 D to -13 D
-12 D to +11 D
+
+12 D to +35 D
Fig. 3.1
Switch Button
Switch Ring
3 Operation
3.1 Turning Illumination ON/OFF
While pressing the Switch But t on on t he Handle,
rotate the Switch Ring to the left (towards O N) t o
turn the illumination on ( see Fi g. 3.1).
The device is equipped wit h a bui lt -in illumination
adjustment function. The further left the ring is
rotated, the brighter the illumination.
To turn the illumination off, rotate the Swit ch R ing
to the right until the Switch Butt on r et ur ns t o t he
OFF position.
3.2 Correction Le ns and Fi lters
3.2.1 Rekoss Lens
The Rekoss Lens is used to adjust the diopter between the examiner and patient to bring
the fundus image into focus. Use t he “+” lens to correct hyperopia a nd “-" lens to correct
myopia.
[Example]
For an examiner with myopia a nd a patient with hyperopia:
In the above example, it would be necessary to set the Rekoss D isc t o -4 D.
However, in practice, the Rekoss Disc is rotated while observing the fundus to find the
appropriate diopter.
In cases of extreme myopi a or hyperopia, where the image cannot be focused by using
only the Rekoss Disc, it is also p ossible to insert an auxiliary lens for accommodation. The
following ranges may be covered depending on the position o f the Auxiliary Lens Selector:
・
3.2.2 4000 K and Polarizing Filters
It is possible to insert the following filters in the illumination sys t em us in g the Filter Lever:
Position Filter Function
O Open No filter is inserted in the center position
F 4000 K
P Polarizing
A 4000 K filter is inserted into the illum ination system. Use
for observation with light r esembling natural light (day light).
A polar izing filter is inserted into the i ll umination system.
Use in combination with th e Observation Polarizing Filt er.
5 / 13
WARNING
When observing the fundus , use only illumination with the least int ensity
illuminate the patient eye for more than
one minute per eye.
Fig. 3.2
3.2.3 Observation Polarizing Filter
The Observation Polarizing Filter is used when light reflected from the cornea interferes
with examination.
Rotate the disc to insert a polariz ing filter into the observation system. When the white
mark on the disc faces up, the Observation Polarizing Fi lter is aligned perpendicular to the
Polarizing Filter mention ed in 3.2.2, for minimum reflection.
Rotating the disc further will rotate the polarizing axis t o allow for a brighter image. Adjust
the disc to obtain the optimum i ma ge.
The disc will stop with a click to indic ate that the Observation Polarizing Filter has been
disengaged.
3.2.4 Illumination Dial
The Illumination Dial ca n be used to adjust the illuminati on entering the patient’s eye as
follows:
Position Aperture/Filter Function
○
RF
|
Normal Aperture Used for typical fundus exam in ations
Used when examining small pupils. In particular, when
Small Aperture
Red-Free Filter
Concentric Scale
Slit
examining through co nstricted pupils such as during
examination of the macula.
Red tissue such as blood v es sels a ppear black,
facilitating detection of minut e fu ndal hemorrhages.
While observing the patient’s fundus, instruct the
patient to fixate on the center of the concentric scale. It
is possible the determine the pr esence of eccentric
fixation from the re lation between the center of the
concentric scale and the pat ient ’s foveola.
Using a slit illumination fa cil itates recognition of
roughness on the surface of the f undus.
3.3 Viewing the Fundus
necessary for visualization, and do not
(1) Open the Aperture Shutter until it click s and turn on the
illumination.
(2) To examine the patient’s ri ght eye, hold the
ophthalmoscope in your ri ght hand and observe using
your right eye. To examine the left eye, use your left
hand and eye.
(3) Place your index finger on t he edge of the Rekoss Disc
and grip the Handle with the r emaining 4 fingers. Use
your index finger to rotate the Rekoss Disc as needed.
(4) Place the upper part of the ophthalmoscope against
the side of your nose and position it so that you have a
clear view when looking through the Viewing Window
(see Fig. 3.2).
(5) While looking at a distant t ar get , r ot at e the Rekoss
Disc to correct your refract ive error.
6 / 13
Fig. 3.3
(6) Sit the patient down away from a mb ient light and
instruct the patient to focus on a distant target.
(7) To examine the right eye, stand to the right of the
patient. Placing the ophth al mo scope firmly against
your face, direct the light int o t he patient’s pupil from
a distance of about 15 cm to c heck for the presence
of a red reflex.
(8) Paying attention not to los e sight of this red reflex,
slowly move closer, with the ophthalmoscope, to the
patient’s face. The fundus image should become
visible at a distance of about 2 cm to 3 cm (see Fig.
3.3).
(9) Rotate the Rekoss Disc as necessary t o br ing the
fundus image into focus.
(10) To examine other regions of the fundus, move both t he opht halmoscope and your fac e
in unison. Move in an arc with t he patient’s pupil as the center o f rot ation so as to keep
directing illumination into the pupil.
(11) Turn of f the illumination and close the Aperture Shutter once you are finished with t he
examination.
7 / 13
WARNING
the Lightbulb immediately after turning the illumination off, as the
Fig. 4.1
Handle
Direction of Batteries
Fig. 4.2
Fig. 4.3
Protrusion
4 Maintenance
4.1 Cleaning
If the device becomes dirty, wipe clean with a dry, lint-free cloth.
Should dirt remain, moisten with diluted neutral det ergent and wipe clean. Then, wipe dry.
To disinfect the device, only wipe with alcohol, and DO NOT STERILIZE.
Use an air blower or the like to r em ove dust and debris from the Viewing Window.
4.2 Replacing Batteries
As the batteries become depleted, the illumination will become dark, or will not light at all.
In such cases, follow the directions below to replace the bat t er ies.
(1) Remove the Bottom Cap fr om the
Handle by turning counter-clockwise.
(2) Remove both batteries.
(3) Insert two (2) new batter ies wit h t he plu s
terminal going in first (see Fig. 4. 1) .
(4) Screw the Bottom Cap shut by turning
clockwise.
4.3 Replacing the Lightbulb
Do not touch
bulb may be extremely hot . Doing s o m ay result in burns.
If the BXα-13 or BXα-13A does not light, the Lightb ulb may have blown out. Follow the
directions below to check if the Lightbulb has blown out, and i f so, to replace the Lightbulb.
(1) Holding the Head in one hand an d t he Handle in
the other, turn the Handle counter-clockwise to
detach from the Head (se e Fig. 4. 2).
(2) Remove the Lightbulb from the Head by pulling the
tip which can be found at the bottom o f the Head.
(3) Check the Lightbulb, and if the filament has blown
out, replace with a new bulb.
(4) Insert the new Lightbulb until it comes to a stop.
When inserting the bulb, align the protrusion on the
bulb with either of the groov es located at the
bottom of the Head (see Fig. 4.3) . Pay close
attention so as not to touch t he gla s s par t of the
bulb.
(5) Attach the Head and Handle by s cr ew ing the
Handle clockwise.
Bottom Cap
4.4 Disposal
Dispose of the BXα-13 or the BXα-13A and its accessories in accordance with your local
regulations and/or environmental guidelines.
8 / 13
5 Troubleshooting
If you experience any problem s using the BXα-13 or BXα-13A, refer to the table below for
possible solutions. If the p r oblem persists, st op using the device and imm edi ately contact
your local dealer or Neitz directly.
Problem Possible Cause Solution
Batteries not inserted. Insert batteries.
Light does not turn on
(Diopter Indicator
is dark)
Illumination blocked
(Diopter Indicator
lights up)
Poor illumination
Narrow field of view
Head becomes hot
Batteries not oriented correctly.
Batteries depleted. Replace with new batterie s.
Lightbulb blown out. Replace with new Lightbulb.
Illumination Dia l mispositioned.
Filter Lever mispositioned.
Aperture Shutter shut.
Batteries low. Replace with new batterie s.
Unintentional use of filters. Disengage filters.
Aperture Shutter partial ly shut.
Rekoss Disc mispositioned.
It is normal for heat to be generated during illumination.
The Head may reach temper at ur es w here it feels warm or hot to
the touch.
Re-insert batteries in the
correct orientation.
Rotate the Illumination Dial
until it stops with a click.
Swing the Filter Lever until it
stops with a click.
Open the Aperture Shutter
until it stops with a click.
Open the Aperture Shutter
until it stops with a click.
Rotate the Rekoss Disc u nt il it
stops with a click.
9 / 13
Product Specifications
*1: Values when stored in case.
Classification
Degree of protection against electric
shock
Applied parts
No applied parts
Degree of protection against harmful
ingress of water or particulate matter
Method(s) of sterilization
Do not sterilize
Suitability for use in an oxygen rich
environment
Mode of operation
Continuous operation
Safety Standards
Electric Safety
IEC 60601-1:2005+AMD1:2012
Electromagnetic Disturbances
IEC 60601-1-2:2014
Ophthalmic Instruments
ISO 15004-1:2006
Light Hazard
ISO 15004-2:2007
Direct Ophthalmoscopes
ISO 10942:2006
Environmental Conditi ons
Use
Storage
Transport
+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)
30 % to 90 %
10 % to 95 %
10 % to 95 %
(no condensation)
(no condensation)
(no condensation)
Atmospheric
Pressure
6 Specifications
Illumination Source L-30 Halogen Bulb (3 V, 2 W)
Correction Range -36 D to +35 D
Filter Lever (Illumination s ystem) Polarizing filter, 4000 K filter
Observation Polarizin g Filter ON/OFF
Illumination Dial
Normal Aperture, Small Aper t ur e, Sl it, Concentric
Scale, Red-Free filter
BXα-13 C-size batteries (2 pcs. )
Batteries
BXα-13A AA-size batteries (2 pcs.)
Illumination T ime Approximately 80 min.
85 mm x 245 mm x 45 mm
Approximately 550 g
85 mm x 245 mm x 45 mm
Approximately 450 g
Dimensions
*1
BXα-13
BXα-13A
Internally powered ME equipment
IPX0
Do not use in oxygen rich environments
Temperature
Relative Humidity
800 hPa to 1060 hPa 500 hPa to 1060 hPa 500 hPa to 1060 hPa
10 / 13
7 Contact Information
If you have any questions or need t echnical support, contact your local dealer or Neitz
located at the following addr ess .
[LOCAL DEALER]
Neitz Instruments Co., Ltd.
4F Ichibancho Court, 15-2 1, Ichibancho, Chiy oda-ku
Tokyo 102-0082, Japan
Phone: +81-3-3237-0552 Fax: +81-3-3237-0554
e-mail: int@neitz.co.jp
URL: http://www.neitz-ophthalmic.com/
Medical Device Safety S er vi ce G m bH
Schiffgraben 41, D-30 175 Han nover, Germany
11 / 13
Electromagnetic Emissions
Electromagnetic Immunity
ANNEX
EMC Guidance
The BXα-13 or BXα-13A is a medical device and requires specia l precautions regarding EMC.
Refer to the following EMC information for appropriate inst allation and putting into serv ice.
Take care when using portable and mobile RF co m munications equipment in pr oximity of the
BXα-13 or BXα-13A, as they can affect performance .
(1) Environments of intended use:
Professional healthcare facility environments and home healthcare environments
(2) Replaceable cables, transducers or accessories li kely to affect compliance of the BXα-13 or
BXα-13A with the applied EMC Standard:
N/A
(3) Applied EMC Standard:
IEC 60601-1-2:2014
(a) Connection to the public ma in s net work: None
(b) Applicable port(s): Encl osure Port
Phenomenon Applied Standard Emission Test Levels
Conducted and radiated RF
emissions
Phenomenon Applied Stan da rd Immunity Test Levels
Electrostatic discharge IEC 61000-4-2 ± 8 kV contact
Radiated RF EM fields /
Proximity fields from RF
wireless communications
equipment
Rated power frequency
magnetic fields
CISPR 11 Class B Group 1
± 2 kV, ± 4 kV, ± 8 kV , ± 15 kV air
IEC 61000-4-3 10 V/m
80 MHz – 2.7 GHz
80 % AM at 1 k Hz
385 MHz – 5785 MHz
IEC 61000-4-8 30 A/m
50 Hz or 60 Hz
(4) Effect of electro mag net ic disturbances on essential performance
Essential Performance Outcome if Essential Pe r f orm ance is Lost or Degraded
Continuous steady illumination Flickering illumination
12 / 13
Notes:
13 / 13
Manufactured by
NEITZ INSTRUMENTS CO., LTD.
4F Ichibancho Court, 15-21, Ichibancho, Chiy oda-ku,
Tokyo 102-0082, Japan
Phone: +81-3-3237-0552 FAX: +81-3-3237-0554
E-mail: int@neitz.co.jp
URL: http://www.neitz-ophthalmic.com
Distributed by
As part of our policy of continued product improvement, we reserve the right
to alter and/or amend specifications at any time without prior notice.
TD11-10750002E-2
Printed in Japan
201901
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