Kowa VX-20 User Manual

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Page 1

RETINAL CAMERA

Kowa

INSTRUCTION MANUAL

KOWA VX-20

Page 2

Page 3

Introduction

Accept our congratulations on your purchase of KOWA VX-20. KOWA VX-20 is a retinal camera which is capable of mydriatic and non-mydriatic photography. This manual provides a description of the operation procedures of KOWA VX-20 and important precautions to be observed during its use. Please read this manual carefully to assure that the instrument can demonstrate its full capabilities and work safely. After you have nished reading, keep this manual in an easily accessible location near the instrument for future reference.

Operational considerations for safety

This manual describes important precautions to be observed when you use this system to assure that the system is used safely without causing any damage to the human body or property of the purchaser and other persons. The designations and pictorial symbols used in this manual have the following meanings. These should be fully comprehended before reading the text of this manual.

Meanings of designations

Warning

Caution

*1 A bodily injury means an injury, burn, electrical shock and so forth that will not necessitate

hospitalization or long-term outpatient treatment.

*2 Damage to property means an extensive damage to a house and/or household goods as well as a

domestic animal and pet.

Meanings of symbols

If the instrument should be operated wrongly, there may incur a risk of causing death or serious injury.

If the instrument should be operated wrongly, there may result in a bodily injury*1 or damage to property*2.

Graphical indication of any danger (including warning and caution). What is warned is explicitly and pictorially indicated by a picture or its associated message on or near a pictorial symbol.

Graphical indication of prohibited operation (prohibitive item). What is prohibited is explicitly and pictorially indicated by a picture or its associated message on or near a pictorial symbol.

Graphical indication of any mandatory action (obligatory item). What must always be done is explicitly and pictorially indicated by a picture or its associated message on or near a pictorial symbol.

Disclaimer

Kowa is not responsible for:

• Any damage caused by re, earthquake, third party’s action, any other accident or user’s intentional or unintentional error, abuse or use under abnormal conditions.

• Any damage resulting from use of the product or its malfunction (e.g. operating loss, shutdown, change/ loss of stored data and so forth).

• Any damage resulting from disobedience of what is described in this manual.

• Any damage resulting from, for instance, malfunctioning of instrument caused by a combination of connected devices.

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Unplug

Obligatory

Warning

If any abnormal smell, sound, overheating or smoke should be detected, be sure to turn OFF the main power immediately and then unplug the instrument from the power outlet. Continued use of the instrument may cause the instrument to malfunction or cause a re. Contact Kowa or your Kowa dealer for inspection immediately.

When replacing the ash lamp and observation lamp, make sure the instrument is turned OFF and then unplugged from the power outlet. Wait for more than 5 minutes, or more than 30 minutes if immediately after use, before replacing. Otherwise, there may occur electrical

Warning

High-Voltage

Be sure to plug into the power outlet completely and securely. Otherwise, there may cause a re or electrical shock.

Use a designated fuse only. Otherwise, the instrument may malfunction or a re may break out.

Make sure that the instrument is properly grounded to protect from bodily injury. Connect the plug into the three-wire grounding type outlet with ground wire. Otherwise, there may occur electrical shock.

shock.

When replacing the fuse, make sure the instrument is turned OFF and unplugged from the power outlet. If the fuse holder cover is removed with the instrument unplugged, there may occur electrical shock.

Prohibitory

Disassembly prohibited

Do not place a container or cup containing liquid near the instrument. Spilled liquid entering into the instrument may cause electrical shock. If liquid should be spilled into the instrument, turn OFF the main power and then unplugged from the power outlet. Contact Kowa or your Kowa dealer for inspection.

Do not load the power outlet or cable with excess of its rated capacity. If the main power cable should share a power outlet with other devices and the rated capacity is exceeded, there may cause a re or electrical shock.

Do not insert any metal object into an air vent or opening of the instrument. It may cause an instrument malfunctioning, re or electrical shock.

Do not disassemble, modify or repair the instrument yourself. It may cause a re, electrical shock, instrument malfunctioning or bodily injury. Refer all servicing to Kowa or your Kowa dealer. The product assembled by yourself will not be covered under warranty nor any other service.

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Caution

The power supply must be provided for the sole use of this instrument. Sharing a same power supply with other devices may cause malfunctioning.

When operating the instrument, take good care so that the patient’s eye, nose or face does not come in contact with the instrument.

Obligatory

When moving up or down the chin rest to adjust the height of the patient’s eyes, carefully manipulate the instrument while checking the position of the patients’ head. A patient with the smaller head may get his or her head caught between the components.

Handle the ash lamps and halogen lamps and fuses made of glass with good care.

Do not pull the power supply cable when unplugging. Doing so may damage the cable and cause a re or electrical shock. Be sure to hold the plug when unplugging.

Do not plug or unplug the power supply cable with wet hand. Otherwise, there may occur electrical shock.

Do not install the instrument at unstable location such as on a shaky base or a tilting surface. Doing so may cause the instrument to drop or fall over and result in a bodily injury.

Do not replace the flash lamp and halogen lamp immediately after turning the OFF the main power.

Caution

High-temperature

Do not touch the ash lamp bulb and halogen lamp bulb with your bare hand. Otherwise, the lamp may reduce the light intensity and longevity.

You could be burned by the lamp heated to a high temperature. Wait for more than 30 minutes to cool the lamp down before replacing.

Prohibitory

Do not increase the observation illumination light intensity more than required. Otherwise, the eye may be injured.

Do not increase the photography light intensity more than required. Otherwise, the patient may experience pain and his or her eye may be injured.

The air vent must not be obstructed. Obstructing the air vent may increase the internal temperature resulting in malfunctioning of the instrument or a re.

Do not insert any metal object into an air vent or opening of the instrument. It may cause electrical shock and malfunctioning of the instrument.

When operating this instrument, keep your ngers off the gap between the optical head base and panning arm or the tilting arm and tilting component, or the gap of the panning arm. Otherwise, the ngers may be pinched and injured. Instruct the patient not to place his or her ngers on the instrument.

Do not wipe the outer surface of the instrument with solvents such as benzene, organic solvent, ether. Doing so may cause discoloration or degradation.

Instruct the patient not to place his or her ngers on the instrument except for the grips (optional accessory). Otherwise, the ngers may be pinched and injured.

Do not use a sharp object to perform touch operation on the LCD monitor . It may cause malfunctioning of the instrument.

Do not apply excess force when performing touch operation on the LCD monitor. The optical component may move unexpectedly, resulting in an injury.

III

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Caution for ngers location

Keep your ngers off the location shown with the arrows in the illus-

Caution

tration when operating this instrument. Otherwise, the ngers may be pinched and injured. Instruct the patient not to place his or her ngers on the instrument.

Caution for contact

Caution for air vent

Caution

The air vent shown with the arrows in the illustration must not be obstructed. Obstructing the air vent may increase the instrument temperature and resulting in malfunction of the instrument or a re. Do not insert any metal object into an air vent or opening of the instrument, also. It may cause electrical shock and malfunctioning of the instrument.

Take good care so that the patient’s eye, nose or face does not come in contact with the locations shown with an arrow in the illustration when operating the instrument.

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Meanings of symbols

Symbol for “Power ON”.

Symbol for “Power OFF”.

Symbol for “Type B applied part”.

Symbol for “Caution”.

Symbol for “Warning High-voltage”.

Symbol for “Caution High-temperature”.

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Operating precautions

1. Operating environment

1) Instrument should be operated only by qualied and trained personnel.

2) Handle the instrument with care, and do not apply strong shock to the instrument.

3) Avoid high temperature and humidity, direct sunlight, and dust when installing and storing the instrument. Strictly observe the following environmental conditions.

Operating Transporting and storing

Environmental temperature 10 to 35 °C

Relative humidity 30 to 90 % 10 to 95 %

4) Avoid condensation when using, transporting or storing the instrument.

5) Do not connect a digital camera other than that supplied with this instrument. Using other camera may adversely affect the safety or performance of this instrument.

6) Install the instrument in a room where the lighting is 5 lux or less which you may barely manage to read a newspaper.

2. Precautions on electric system

1) When the instrument has not been used for a long period of time, inspect the items below.

Inspect if the objective lens is free from soils. Inspect if intensity of the lamps appropriately adjustable.

2) Install the system in a location where there is little risk of the plug being pulled out while operating. If the plug should be pulled out accidentally, be sure to turn OFF the main power before plugging the system back in.

3) Kowa is not liable for malfunctions and/or damages resulting from maintenance and/or repairs performed by the third party other than an agent authorized by Kowa.

4) Kowa is not liable for malfunctions and/or damages resulting from maintenance and/or repairs using parts other than repair parts specied by Kowa.

5) The input voltage should always be maintained within ± 10% of the rated voltage.

6) Do not turn on the ash lamp and adjust photography light intensity at the same time.

7) Wait for approx. 1 minute until the instrument has safely started up.

8) Do not turn the main power ON and OFF in succession. Allow an interval of at least 10 seconds before turning the main power ON and OFF.

9) Be sure to turn OFF the main power before connecting an external device.

10) Do not touch the patient and connectors at the same time as it may adversely affect the safety.

11) Disinfect using alcohol the parts accessible by the patient.

12) The power supply must be provided for the sole use of this instrument.

3. Precautions when using this instrument

1) Carefully handle the objective lens as soiled or scratched part of the objective lens may be imaged as white spots.

2) Always cover this instrument when not in use in order to protect them.

3) Do not apply strong shock or force to the objective lens.

4) Set a dial or knob with clicking positions to its designated position.

5) Do not press sharp instruments or tools against the LCD monitor or add excessive force to the monitor.

6) Never disassemble or adjust this instrument by yourself as it uses precision parts which requires special tool for doing so.

4. Disposal precautions

When disposing this instrument, applicable federal, state, and local regulations must be observed. Ensure that disposal is handled by a licensed industrial waste disposal contractor in accordance with the applicable regulations and ordinances.

5. Replacement of the Aluminum Electrolytic Capacitor

The aluminum electrolytic capacitor for the ash lamp, which is used in the power supply section of this instrument, is a component requiring regular replacements. The useful life of this type of components may be signicantly reduced depending the frequency and conditions in which this instrument is used. If the capacitor is used beyond its useful life, its electrolytic solution may leak or drain, which can result in abnormal odor, smoke, bursting sound, and other failures.

The design life of the capacitor is 50,000 flashes when used in an ambient temperature of 25°C. This is, however, only a guideline, and the capacitor may need to be replaced earlier depending on the usage environment. In order to ensure safe and stable operation of this instrument, early replacement of the aluminum electrolytic capacitor is recommended. Replacement of components requiring regular replacement, such as aluminum electrolytic capacitor, is supported as a paid service. For more information about replacement of such components, please contact Kowa or your Kowa dealer.

6. Prescription device caution:

15 to +55 °C

─

Caution

Federal law restricts this device to sale by or on the order of a Physician or Practitioner.

For US market

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● Combination of medical electrical equipment and non-medical electrical equipment

IEC 60601-1-1 “Safety requirements for medical electrical systems” describes the components combination grouped into various clinical settings. The brief overview of IEC 60601-1-1 is shown below.

Medically used room

Feasible solution

(See clause 19 in all

situations)

Situation No.

Inside

the PATIENT

ENVIRONMENT

Outside

the PATIENT

ENVIRONMENT

Non-medically

used room

1a Items A and B in PATIENT ENVIRONMENT

1b Items A and B in PATIENT ENVIRON-

MENT

1c Item A powerd from specied power supply in item B in PATIENT ENVIRONMENT

2a Item A in PATIENT ENVIRONMENT and item B in medically used room

2b Item A in PATIENT ENVIRONMENT and item B in medically used room

3a Item A in PATIENT ENVIRONMENT and item B in non-medically used room

3b Item A in PATIENT ENVIRONMENT and item B in non-medically used room

IEC

60601

IEC

60601

IEC 60601

IEC XXXXX

IEC

60601

IEC

60601

IEC

60601

IEC

60601

IEC

60601

IEC

XXXXX

Protective earth

IEC

60601

IEC

XXXXX

Common protective earth

B IEC 60601 or IEC XXXXX

Protective earth with potential difference

For B:Additional protective earth or separating transformer

For B:See 19.201 and its rationale

For B:Additional protective earth or SEPARATION DEVICE

KEY TO TABLE

• Additional protective earth : If necessary, provide additional protective earthing , which is permanently

connected(See also 58.201).

NOTE Equipment modication may be required.

• Separating transformer : If necessary, limit the ENCLOSURE LEAKAGE CURRENT, by using an ad-

ditional separating transformer according to annex EEE.

NOTE1 No equipment modication is required. NOTE2 A separating transformer is a transformer with one or more input winding(s) separated from the

output winding(s) by at least basic insulation [IEC 60989].

• SEPARATION DEVICE : If necessary, apply SEPARATION DEVICE.

• IEC 60601 : MEDICAL ELECTRICAL EQUIPMENT in compliance with IEC 60601.

• IEC XXXXX : Non medical equipment in compliance with relevant IEC safety standards.

VII

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Precautions: use of medical electrical system

1. Precautions on use of medical electrical system

1) All components of this medical electrical system may be installed within a limited patient environment (a radius of 1.5 m around a patient) when all components are installed in accordance with the installation instructions using “Multi-tap with Isolation Transformer”, which is one of the system components.

2) As prerequisite for installing to this system, other components (a PC, printer, video capture printer, video monitor, or other devices) which do not comply with IEC60601-1 must be powered from Multi-tap with Isolation Transformer. The electric power to these components supplied from an electric source other than Multi-tap with Isolation Transformer (e.g., wall outlets) may cause increased enclosure leakage current or potential difference between protective grounds resulting in the injury to the patient or operator. Use Multi-tap with Isolation Transformer only for supplying the power to the components other than the system components.

3) Any medical electrical equipment that connected to this system to compose a medical system must comply with IEC60601-1.

4) Any non-medical electrical equipment that is connected to this system to compose a medical system must comply with safety standards of IEC or ISO provisions applicable to such a non-medical electrical equipment.

5) Do not use any additional multi-tap or extension power cable other than those Kowa specied to this system.

6) Power supply to this system or “Multi-tap with Isolation Transformer” must be provided individually. (Do not route the power supply through other multi-tap to the system or “Multi-tap with Isolation Transformer”.)

7) The power cable for an electrical equipment that compose a medical system must have durability that meets IEC60245/IEC60227 or higher standards.

8) Assure that the power supply is turned OFF when connecting other device to the system.

9) Do not turn ON the power supply until all devices are completely connected.

10) Do not place or install the devices and the system components on the unstable or inclined table.

2. Precautions for use of “Multi-tap with Isolation Transformer”

1) Do not place “Multi-tap with Isolation Transformer” directly on the floor. Water droplets during room cleaning may enter the multi-tap resulting in the component failure.

2) The power supply cable to “Multi-tap with Isolation Transformer” must be connected to a power receptacle with a protective ground terminal equipotential to the protective ground of this instrument.

3) When using a multi-tap power receptacle with a protective ground terminal, read the instruction for use attached to the receptacle to familiarize yourself with the correct use before use.

3. Daily maintenance and cleaning

1) System components

• Wipe the soiled outer surface with rmly squeezed dampened soft cloth. Use mild detergent to remove excessive soils. Do not use chemicals or solvents such as thinner and benzene. (As the LCD monitor screen cover easily gets scratched, lightly wipe it with soft cloth such as gauze.)

• Refer to the instruction for use provided with each device for details of device maintenance and cleaning.

2) Power cables, connecting cables, and connectors

• Visually inspect that all cables have no aw or damage.

• Visually verify that earth leads of all components and protective ground terminals are securely connected.

• Disconnect the power cables from the power supply receptacles when you do not use the system for a long period of time.

3) Others

• When you add a PC to the system for a ling purpose, captured images are stored in the HDD of the PC. Back up the data stored in the HDD regularly since HDDs may have a mechanical or electrical failure.

VIII

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Operational considerations for hospital grade electrical instrument (safety and accident prevention)

1. Only qualied personnel should operate this instrument.

2. The following items shall be considered when installing the instrument.

1) Install at a location away from water or accidental splashing.

2) Install at a location which will not be adversely affected by atmospheric pressure, temperature, humidity, ventilation, sunlight, dust, air containing salt, sulfur and other substances, and the like.

3) Take care to guard against tilt, vibration and strong impacts, for instance, during transportation.

4) Instrument must not be installed at locations where chemicals are stored or gasses are generated.

5) Be careful with the radio frequencies, voltages and allowable amperes (power consumption) of the power supply.

6) Properly connect ground wires.

3. The following items shall be considered before using the instrument.

1) Make sure that instrument activates properly after checking switch contact, polarity, dial setting and meters and so forth.

2) Make sure that the instrument is properly grounded.

3) Make sure that all cords are properly connected and secured.

4) Use of other instruments and appliances on the same power circuit is liable to cause errors and incorrect ash output resulting in incorrect diagnosis or hazards.

5) External circuits and connectors that may come in direct contact with the patient must be checked frequently for signs of wear.

4. The following items shall be considered when using the instrument.

1) Be sure to minimize the time and quantity required for diagnosis and treatment.

2) Always assure that the instrument and patient are in good condition.

3) When an abnormality is found on the instrument, take proper measures, for instance, to stop the operation of the instrument while assuring the patient’s safety.

4) Do not allow the patient to touch any of the instrument controls.

5. The following items shall be considered after using the instrument.

1) Turn OFF the instrument after setting control switches, dials and so forth to their initial status following with a specied procedure.

2) Do not pull cords for removal because an excessive force is exerted on them.

3) The following shall be considered regarding storage location.

• Store the instrument at locations free from splashes of water.

• Store at a location which will not be adversely affected by atmospheric pressure, temperature, humid-

ity, ventilation, sunlight, dust, air containing salt, sulfur and other substances, and the like.

• Take care to guard against tilt, vibration and strong impacts, for instance, during transportation.

• Instrument must not be stored at locations where chemicals are stored or gasses are generated.

4) Clean and rearrange accessories, cords, and the like.

5) The instrument must be cleaned prior to use so that there will be no problem when using it again.

In case of a problem or malfunction, stop the operation and contact Kowa or your Kowa dealer for repair.

7. Instrument shall not be modied.

8. Maintenance

1) Periodically check the instrument and its components for any abnormality.

2) When using the instrument that has not been used for a while, it must be checked beforehand to assure that it is in normal condition and operates safely.

Be careful of the possibility that incorrect operation may be caused by strong electromagnetic waves.

This instrument is examined based on IEC 60601-1-2. The purpose of this standard is to keep safety against the dangerous obstacle in typical medical facilities. When this instrument is inuenced by other instrument, or when it affects other instrument or when there is such fear, please devise to move this instrument and other apparatus or to make the distance between those instrument. Moreover, if there is an unknown point, please consult our company, or an agency beforehand.

Page 12

Components and supplies

Main unit

Optical Component

Accessories

USB cable 1(A─mini-B type×2):1(2.3m)

Objective lens cap holder: 1 Illumination lamp: 1

Power supply

Instruction manual: 1

Setup manual: 1

Chin rest

paper:1

Chin rest paper retaining pins:2

Blower:1 Dust cover:1

Compact ash

memory card: 1

Hex wrenches: 3 Head bands: 2 Fuses:2

Page 13

Optional accessories

Internal xation target: 1

K9L-PE56

Exciter & Barrier lter set for FAF: 1

K9L-IF56K

LAN cable(cross):1(5m)

K9L-SC56B

Grips: 2

K9L-GR56

Bar code reader: 1(1.6m)

VK-CB2H

USB cable 2(A-B type):1(5m)

K9L-SC56C

Forehead rest: 1

K9L-HR56

Card reader: 1(1.2m)

VK-CB2G

Page 14

1 System description

1.1 Indication for use

The KOWA VX-20 is intended for taking picture of retinal images with mydriatic or without mydriatic.

1.2 System overview

This instrument is a retinal camera, capable of capturing both non-mydriatic and mydriatic, has two photography eld angles of 50º and 30º (45º and 27º for non-mydriatic), with ability to perform various photography such as Red Free photography and Fluorescence angiography and FAF photography (optionally available).

1.3 Features

• Provides lmless photography with full computerization

• Large screen touch the LCD monitor

• Signicantly lowered eye level; as much as 75mm compared with the previous model

• Equipped with simplied ling function

• Finer ash compensation

• Gathering operations to close at hand

• Offers wide range of photography modes

Page 18

1 System description

1.4 Name and function of each component

Main unit

External xation target

It freely moves patient’s xation.

Eye level mark indicating lamp

Located on the both sides.

Optical viewnder (eyepiece)

This is an optical viewfinder (eyepie ce) capable of using in mydriatic color photography, Red Free ph ot og ra ph y, and Fluo re sc ence angiogr aphy. It is equippe d with the diopter adjust func tion to use for observing retinal images with unaided eye.

Panning arm

It helps to move the optical hea d leftward/rightward. There is a lock lever on the left.

Instrument label

Air vent

Wind generated by the internal cooling fan blows out.

LCD monitor

It d is pla ys a n alig nm ent ima ge used for aligning the anterior segme nt or re ti na l, an d f oc us in g in black-and-white live image. Also, it displays simplied ling or photography information. For selecting the methods for patient’s fi xation, and changing the position of the internal xation target, select the buttons on the LCD monitor with the touch panel.

Shutter button

It is a button to fire the flash light for photography.

Control lever

It is a st ic k to move the op tical head lengthwise or crosswise. By rotating the stick, the optical head is moved upward/downward.

Operation panel

(See the next page for details)

Adjusters

They can adjust the retinal camera to be level. There are four of them.

Page 19

1 System description

Field angle selection button

It is a button to switch the eld angles between 50º/30º in mydriatic, and bet ween 45º/27º in nonmydriatic.

Photography mode switching buttons

Observation light intensity control knob

It is a knob to adjust the intensity of the illumination during observation.

Flash intensity compensation knob

It is a knob to adjust the intensity of the illumination when photographing.

FA button

It is a button to switch the photography mode to FA.

RF/FAF button

It is a button to switch the photography mode to Red Free or FAF.

Mydriatic color button

It is a but ton to switch the ph otography mode to mydriatic color.

Non-mydriatic color button

It is a button to switch the photography mode to non-mydriatic color.

Lock lever

Lock the optical head base by operating the lever.

Chin rest buttons

They are buttons used for raising or lowering the chin rest.

Timer button

It is a button to starts counting the timer in FA.

Diopter compensation buttons

They are but tons to inse rt a len s to correct the diopter of the patient’s eye.

LCD monitoring button

It is a button to observe on the LCD monitor in mydriatic colo r phot ograp hy, Red Free photography, Fluorescence angiography (mydriatic fluorescence), and autouorescence photography (FAF [optionally available]) modes.

S.P. button

By using this button when the mydriatic state is insufficient, brighter photography images can be captured.

Barrier lter button

Page 20

1 System description

W.D. switch

It turns on/off the illuminating dots for detecting the alignment position of the retinal camera. It can be used for mydriatic color photography, Red Free photography, Fluorescence angiography, and autouorescence photography (FAF).

Lamp cover

Air vent

Wi nd g en erate d by the inter na l cooling fan blows out.

Forehead rest

Us ed f or res ti ng t he patient’s forehead against it.

F.D. switch

It turns on/off the luminous bar for detecting the focus. It can be used for mydriatic color photography, Red Free photo graphy, Fluorescence angiography, and autofluorescence photography (FAF).

Internal xation target socket

Focusing knobs

Knobs located on both sides of the optical head base, used for focusing.

Tilting handle

This is a handle to tilt the optical head. There is a lock mechanism.

Tilting arm

It helps to move the optical hea d upward/downward.

Power supply unit

(See the next page for details)

Head band mounts

Mount to at tach the head band. Located on the both sides.

Objective lens

Chin rest

Used for sustaining the patient’s chin position.

Grip socket

Located on the both sides.

Page 21

I/O port

Power supply unit

1 System description

Power switch

It is a switch to turn on/off the power of this instrument. I: ON, : OFF

Cable clamps

Us ed fo r hol ding cab le s to keep them from being disconnected

Fuse holder

Ethernet connector

Used for connecting an external PC in the Network connection mode.

Compact ash memory card insert slot

Accepts a compact ash memory card [supplied].

Ejector button

Wh en pressed, the co mpac t fl as h memory card comes off.

Image output terminal Photography condition output terminal

Used in the VK connection mode.

Data output terminal

Used to connect an external PC with a USB cable in the Network connection mode.

USB connector

Used for connecting a numerical keypad, ID card reader, printer to the instrument.

Page 22

1 System description

1.5 LCD monitor indications

In this section, the information and buttons displayed on the LCD monitor are described.

1.5.1 Capture mode screen

2 4

3 5

7 8

9 0

Timer

By pressing the timer button in the Fluorescence angiography mode, it will be displayed on the LCD monitor and start counting. It counts up to 59:59 in Minute:Second display.

Flash intensity compensation buttons

It appears when the flash intensit y compensation knob on the panel is at the position of +5 or ─5. It enables a wider

range of light intensity compensation.

Photography mode

This indicates the photography mode currently selected.

LCD monitoring mode

Used for the LCD monitoring mode.

Field angle

This indicates the current eld angle.

Left or right eye

This indicates which eye will be photographed.

Diopter compensation

This indicates the state of the diopter compensation lens.

Fixation target information

This indicates the information of the xation target currently selected.

Filter

It indicates whether the lter for uorescent is inserted.

Aperture

This indicates that a large value is selected in the aperture.

Flash intensity

The intensity of light emitting from the photography flash lamp is indicated.

EXIT button

It is a button to terminate this instrument. Press it to terminate the instrument before turning off the power switch.

The current patient's is indicated. Do not appear in VK connection mode.

VIEWER button

It is a button to go to the V iewer mode from the Capture mode.

Fixation target selection button

It is a button to select the xation target. When this button is pressed, each xation target is displayed in a button, and becomes selectable.

STILL/VIEW selection button

It is a button to hide or display an image immediately af ter it is photographed. It is not displayed when VK connection is selected.

Customize button

It is a user-dened button in the setting.

Blue/Brown button

Used to adjust the intensity which is suitable for blue eyes.

Page 23

VIEWER

1 System description

When you press the “Fixation target selection button”, particular bottons appear shown below.

FIXATION

USER1

USER2

STILLVIEW

USER3

BLUE

BROWN

EXT button

CENTRAL button

DISC button

MACULA button

1.5.2 Viewer mode screen

CENTRAL

DISC

MACULA

PERI

PHERAL

VIEWER

EXT

FIXTION

When you press the “PERIPHERAL button”, par ticular bottons below appear.

RERI

PHERAL

NEXTBACK

@ [

PERIPHERAL button

BACK button

NEXT button

[

Setting button

It is a button to set various settings.

CAPTURE button

Used for changing to the Capture mode.

Input ID button

It is a button to input IDs.

VIEW button

Used to display a next image of the currently played image.

MULT button

Used to display an image of the same ID in four sections.

PRINT button

Used to print out the currently displayed image.

REVIEW button

Used to display a previous image of the currently played image.

TRASH button

Used to delete the currently displayed image from the compact ash memory card.

Page 24

2 Preparation

Notice

2.1 Assembly and installation

Following the assembly manual provided separately, assemble the power supply unit and the optical

component. Assembly must be done by qualied personnel who have received assembly training provided by Kowa or a Kowa dealer.

Place the retinal camera on a stable surface, such as a powered optical table (optional device).

As needed, adjust the adjuster so that the retinal camera will be level.

Make sure that the power switch is in the OFF position, and connect

the power supply cable plug to a 120VAC power outlet.

If you want to attach the objective lens cap holder, attach it directly on

or near the instrument.

Recommended location

2.2 Inserting/ removing compact ash memory card

When using the instrument in the Stand-alone setting (see “2.3.1 Stand-alone”) , make sure that the compact ash memory card is inserted. To transfer data from compact ash memory card to a computer, follow the procedures and notice below to remove the card.

2.2.1 Inserting a compact ash memory card

Slowly insert the supplied compact flash memory card, Kowa logo facing up, in the compact ash memory card insert slot as far as it goes. Check that the ejector button comes out.

¿Do not use a compact ash memory card other than the one supplied with the instrument.

¿Do not use any compact ash memory card other than the one supplied with this instrument or

designated by Kowa.

Page 25

2.2.2 Removing a compact ash memory card

Notice

Slowly press the ejector button to eject the compact flash memory card. Then, hold and slowly pull out the card.

¿Do not attempt to remove the compact ash memory card without using the ejector button.

¿Do not remove the compact ash memory card immediately after an image is photographed.

2.3 System connection conguration

2 Preparation

This instrument may be used in 3 connection congurations.

• Stand-alone: Images taken by the instrument are acquired by the instrument itself as a stand-alone system.

• VK connection: Images taken by the instrument are acquired directly by Kowa ling system.

• Network connection: Images taken by the instrument are acquired by a computer via a network.

Important

◇ When you use a peripheral device and/or other device connected to the peripheral device, it must

meet all applicable EN(IEC) standards.

◇ Data processing device must meet IEC60601-1 or IEC60950.

The system that combines such data processing device must meet IEC60601-1-1. The system admin-

istrator who builds such system bears all responsibility to have the system comply with requirement of IEC60601-1-1. Should you have any question, contact Kowa or your Kowa dealership.

2.3.1 Stand-alone (factory default)

Following the procedure described in Section 2.2.1, insert the compact ash memory card. As needed, connect a USB-enabled printer to “USB connector” port.

¿The maximum power that may be supplied through a USB port is

500 mA.

¿In the Stand-alone setting, photographed images are saved in the compact ash memory card in-

serted to this instrument. Photography function is disabled when the compact ash memory card becomes full. Damage to the compact ash memory card may result in an inability to access to the data saved in the card. Transfer data in the card to a computer on a regular basis.

Page 26

2 Preparation

2.3.2 VK connection

In order to use this instrument in the VK connection setting, Kowa VK series (optional device) and the USB cable 1 are required. For information on the installation and use of the VK series, refer to the installation and the user manuals supplied with the VK series.

Use the USB cable 1 to connect “Image output terminal” and “photography condition output terminal” of this instrument and USB ports of the VK series. Use a designated USB port to connect if you are instructed to do so. After starting up this instrument, change the connection conguration to “VK connection” following the procedure described in Section 5.1.5. After the instrument is started up, a message “No compact ash memory card” appears as you switch to the viewer mode; press “OK” and continue.

When the instrument is connected to the VK series and the correct settings are made on both the instrument and the VK series, be sure to photograph images as a trial and check that images and photographing conditions are correctly acquired.

USB cable 1

2.3.3 Network connection

In order to use this instrument in the Network connection setting, a computer (optional device) with image acquisition software installed is required along with K9L-SC56B (optional accessory) or K9L-SC56C (optional accessory). To use the instrument in this setting, you must establish a network containing this instrument and other external devices. The network must be established by Kowa or a Kowa dealer representative and qualied personnel knowledgeable in network conguration; therefore, please contact Kowa or a Kowa dealer in advance.

K9L-SC56C

K9L-SC56B

2.4 Turning ON the power

Turn ON power switch.

It takes approximately 40 seconds for the instrument to be fully ready for operation. Wait until the start-up

logo disappears and photography information is displayed on the LCD monitor.

2.5 Turning OFF the power

Make sure that the the instrument is in the capture mode. If it is in the viewer mode, press “CAPTURE

button” to go to the capture mode.

Press “EXIT button”. A message appears asking whether you want to end the operation; if there is no

problem, press “OK” to turn off the optical head.

The LCD monitor goes dark and all panel lamps except for the Power lamp go off. When the Power lamp

turns orange, switch the power switch to the OFF position.

Page 27

2 Preparation

Notice

¿Turning OFF the instrument without following the above procedures may result in a loss of data or

damage to the instrument. With an exception of emergency situations, follow the above procedures to turn OFF the instrument.

¿The power switch does not go OFF automatically. Do not forget to turn OFF the power switch.

2.6 Retinal camera preparation

Following the daily inspection list in “7.2 Daily inspection”, prepare the retinal camera for operation.

2.7 Preparatory procedure of the examined eye

In case of mydriatic photography, apply mydriatic eye drops to the examined eye. After it dilates fully,

guide the patient to the retinal camera. In case of non-mydriatic photography, take the patient to a dark room and let the examined eye dilate spontaneously.

Make sure that the pupil is sufciently open.

Sufcient diameter of the pupil is 5.5 mm or more in mydriatic mode, 4.0 mm or more in small pupil mode

and 4.0 mm or more in non-mydriatic mode.

My driatic p hotogra phy is enabled if 5.5 mm or more in diameter.

3) Fixing the patient

1. Instruct the patient whose eyes are dilated sufciently, to be seat-

ed in front of the retinal camera.

2. Adjust the height of a powered optical table to let the chin on the

chin rest and the forehead on the forehead rest in a natural posture.

3. The height of chin rest can be adjusted with the chin rest buttons.

4. Set the examined eye at the eye level mark indicating lamp. (See

illustration on the right.)

Important

◇ When using mydriatic eye drops, be sure to follow the instruction of the eye drops.

Small pupil or non-mydriatic photography is enabled if 4.0 mm in diameter.

Page 28

3 Basic operation

3.1 How to use the control lever

The control lever is used to move the optical component of the retinal camera lengthwise or crosswise, and upward/downward. When roughly divided, there are three ways to use it:

• Coarse motion: moves the optical component lengthwise or crosswise broadly.

• Fine motion: moves the optical component lengthwise or crosswise nely.

• Upward/downward motion: moves the optical component upward/downward.

For coarse motion control

Grab the control lever completely in a hand.

While holding the control lever in upright position, move it lengthwise

or crosswise so that the entire panel will move.

For ne motion control

Hold the control lever with your nger tips.

Tilt the control lever lengthwise or crosswise.

The optical component is moved to the direction where the control le-

ver is tilted.

For upward/downward motion control

Hold the control lever with your nger tips.

Rotate the control lever, the optical component is moved upward/

downward.

Rotate clockwise: the optical component is moved upward. Rotate counterclockwise: the optical component is moved downward.

Downward

Upward

Page 29

3 Basic usage

3.2

This section describes the basic operation procedures for non-mydriatic and autouorescence photography. The operation of buttons explained in the procedures is based on the factory default. If the settings have been changed, operate the buttons according to the modied settings. In order to photograph images with natural dilation, dim the illumination of the room so that you may barely manage to read a newspaper (approx. 5 lx.)

According to the system connection conguration, enter, switch, or check the patient’s ID. In the Stand-alone setting, the patient’s ID may be entered or switched. Refer to 3.5.1 to enter an ID or

In the VK connection setting, IDs are managed through the VK series connected to this instrument.

In the Network connection setting, the function depends on the external device connected to the instru-

With the “photography mode switching buttons” on the right side panel, press the “Non-mydriatic button”

Non-mydriatic photography/ autouorescence photography procedures

Enter, switch, or check the ID.

switch between IDs.

Please read the user manual supplied with the VK series for operational procedures.

ment. Follow the user manual of the external device for the details on available functions and operational procedures.

Select a photography mode.

once for non-mydriatic photography; press the “RF/FAF button” twice for autouorescence photography.

Adjust the ash intensity.

The ash intensity is automatically set according to the photography

mode. If it is necessary to adjust ash intensity, you may do so with the ash intensity compensation knob.

Select a eld angle.

Press the “eld angle selection button” to select a eld angle.

Page 30

3 Basic usage

Notice

Select a xation target.

Press the “xation target selection button” on the LCD monitor to select a xation target and the position

of the patient's eye xation.

Compensate the diopter.

As needed, press the “diopter compensation buttons” on the right side

panel and use the diopter compensation lens.

The diopter range of each button is shown below.

+ : +10 to +35D

─

12 to +13D

0 :

─

: ─32 to ─10D

Pull the main unit towards you as far as it goes, and move the optical

head base horizontally and/or the optical component vertically so that the patient's eye is displayed in the center of the LCD monitor.

Adjust the working length.

Slowly move the optical head base forward until the working dot is shown on the retinal image. (Coarse

motion)

Adjust the position of the main unit so that the working dot shown on the retinal image becomes the

brightest on the working dot aid. (Fine motion)

NO N- MY D

ࠋ

Cen tra l

VIEWER

NO N- MY D

ࠋ

USER1

USER2

USER3

FIXATION

Cen tra l

VIEWER

FIXATION

USER1

USER2

USER3

12.5W

EX IT

ID: 123

12.5W

EX IT

ID: 123

¿Maintain a sufcient distance to avoid hitting the patient while moving the instrument in a coarse mo-

tion.

Page 31

3 Basic usage

Notice

Adjust the focus.

Turn the “focusing knob” to adjust the focus. When you turn the focusing knob, the focus dots on the

LCD monitor move left and right. Turn the focusing knob so that the upper and lower focus dots come to form a straight line.

¿The focus dots are not displayed when using the diopter compensation lens. Adjust the focus as you

view the retinal image on the LCD monitor.

Photograph the image.

Press the “shutter button” to activate the ash and photograph the im-

age.

When the connection conguration in “Stand-alone” or “Network con-

nection”, images are displayed in the preview window immediately after they are photographed

Page 32

3 Basic usage

Notice

3.3 Mydriatic color/ Red Free photography procedures

This section describes the basic operation procedures for mydriatic color photography and Red Free photography.

¿In some cases, the use of mydriatics may aggravate patient's medical conditions or cause some pa-

tients to go into shock. Be sure to read the instruction for use carefully before using mydriatics, and follow the instruction.

¿After photography using mydriatics, patient's pupils are dilated; therefore, patients may experience

glaring or blurred vision. Instruct patient to be careful when they walk or move around and refrain from driving.

Enter, switch, or check the ID.

switch between IDs.

In the VK connection setting, IDs are managed through the VK series connected to this instrument.

Please read the user manual supplied with the VK series for operational procedures.

In the Network connection setting, the function depends on the external device connected to the instru-

ment. Follow the user manual of the external device for the details on available functions and operational procedures.

Select a photography mode.

With the “photography mode switching buttons” on the right side panel, press the “Mydriatic color button”

for mydriatic photography; press the “RF/FAF button” for Red Free photography.

Compensate the diopter of the optical viewnder. (eyepiece)

Clear of all objects within the distance of 3m from the objective lens. Look through the optical viewnder (eyepiece) and rotate the diopter

adjuster ring until the double lines become clear.

Page 33

Adjust the ash intensity.

Notice

The ash intensity is automatically set according to the photography

mode. If it is necessary to adjust ash intensity, you may do so with the ash intensity compensation knob.

Select a eld angle.

Press the “eld angle selection button” to select a eld angle.

3 Basic usage

Compensate the diopter.

As needed, press the “diopter compensation buttons” on the right side

panel and use the diopter compensation lens.

The diopter range of each button is shown below.

+ : +10 to +35D

─

12 to +13D

0 :

─

: ─32 to ─10D

Pull the main unit towards you as far as it goes, and move the optical

head base horizontally and/or the optical component vertically so that the patient's eye is displayed in the center of the LCD monitor.

Adjust the working length.

Move the optical head base forward until the patient's pupil and the

ring illumination coincide. (Coarse motion)

Adjust the position of the main unit so that the working dot shown on

the retinal image becomes the brightest over the working dot aid. (Fine motion)

¿Maintain a sufcient distance to avoid hitting the patient while moving the instrument in a coarse mo-

tion.

Page 34

3 Basic usage

Notice

Guide the patient's xation.

Use the external xation target to guide the patient's xation position

until the part you want to photograph becomes visible through the optical viewnder (eyepiece).

¿ Position the external xation target where the patient can x the vi-

sion with the eye not examined.

¿If the patient's xation cannot be achieved with the eye not pho-

tographed, press the “LCD monitoring button”; then, select an internal xation target using the “xation target selection button”, or use the internal xation target (optional accessory) to guide the patient's xation.

Adjust the focus.

Turn the “focusing knob” to adjust the focus. When you turn the fo-

cusing knob, the focus dots on the LCD monitor move left and right. Turn focusing knob so that the upper and lower focus dots come to form a straight line.

¿ The focus dots are not displayed when using the diopter compensation lens. Adjust the focus as you

view the retinal image on the LCD monitor.

Photograph the image.

Press the “shutter button” to activate the ash and photograph the im-

age.

When the connection conguration is in “Stand-alone” or the “Network

connection”, images are displayed in the preview window.

Page 35

3 Basic usage

Notice

3.4

This section describes the basic operation procedures for mydriatic Fluorescein angiography.

In the VK connection setting, IDs are managed through the VK series connected to this instrument.

In the Network connection setting, the function depends on the external device connected to the instru-

Mydriatic Fluorescein angiography procedures

¿In some cases, the use of mydriatics may aggravate patient's medical conditions or cause some pa-

tients to go into shock. Be sure to read the instruction for use carefully before using mydriatics, and follow the instruction.

¿After photography using mydriatics, patient's pupils are dilated; therefore, patients may experience

glaring or blurred vision. Instruct patient to be careful when they walk or move around and refrain from driving.

¿In some cases, the use of uorescent agent may aggravate patient's medical conditions or cause

some patients to go into shock . Monitor the patient closely during photography and make sure that there are no abnormal changes in the patient. Be sure to read the instruction for use carefully before using uorescent agent, and follow the instruction.

Enter, switch, or check the ID.

switch between IDs.

Please read the user manual supplied with the VK series for operational procedures.

ment. Follow the user manual of the external device for the details on available functions and operational procedures.

Select a photography mode.

With the “photography mode switching buttons” on the right side pan-

el, press the “FA button”.

Compensate the diopter of the optical viewnder (eyepiece)

Clear of all objects within the distance of 3m from the objective lens. Look through the optical viewnder (eyepiece) and rotate the diopter

adjuster ring until the double lines becomes clear.

Page 36

3 Basic usage

Notice

Adjust the ash intensity.

The ash intensity is automatically set according to the photography

mode. If it is necessary to adjust ash intensity, you may do so with the ash intensity compensation knob.

Select a eld angle.

Press the “eld angle selection button” to select a eld angle.

Compensate diopter.

As needed, press the “diopter compensation buttons” on the right side

panel and use the diopter compensation lens.

The diopter range of each button is shown below.

+ : +10 to +35D

─

12 to +13D

0 :

─

: ─32 to ─10D

Pull the main unit towards you as far as it goes, and move the optical

head base horizontally and/or the optical component vertically so that the patient's eye is displayed in the center of the LCD monitor.

Adjust the working length.

Move the optical head base forward until the patient's pupil and the

ring illumination coincide. (Coarse motion)

Adjust the position of the main unit so that the working dot shown on

the retinal image becomes the brightest over the working dot aid. (Fine motion)

¿Maintain a sufcient distance to avoid hitting the patient while moving the instrument in a coarse mo-

tion.

Page 37

Guide the patient's xation.

Notice

Use the external xation target to guide the patient's visual xation

until the part you want to photograph becomes visible through the optical viewnder (eyepiece).

¿Position the external xation target where the patient can x the vi-

sion with the eye not examined.

¿ If the patient's xation cannot be achieved with the eye not pho-

Adjust the focus.

Turn the “focusing knob” to adjust the focus. When you turn the focus-

ing knob, the focus dots on the LCD monitor move left and right. Turn focusing knob so that the upper and lower focus dots come to form a straight line.

3 Basic usage

¿ The focus dots are not displayed when using the diopter compensation lens. Adjust the focus as you

view the retinal image on the LCD monitor.

Start the timer.

Press the “Timer button” on the right side panel at the same time that

uorescein is intravenously injected to the patient.

Elapsed time is indicated on the LCD monitor. The elapsed time at the

time of photography is also recorded in the photographed image.

Insert the barrier lter.

Press the “Barrier lter button” on the right side panel and insert the

barrier lter into the light path.

Page 38

3 Basic usage

Photograph the image.

Press the “Shutter button” to activate the ash and photograph the

image.

When the connection conguration in “Stand-alone” or “Network con-

nection”, images are displayed in the preview window immediately after they are photographed.

¿Holding down the shutter button allows you to con-

secutively take one photograph per second. This function is useful during the initial period of the uorescence angiography.

¿Preview cannot be displayed quickly enough when

consecutively taking a photograph each second. If you want to use this function frequently, it is recommended to set the connection conguration to “VK connection.”

¿With the ash intensity of 300W, you may take up

to 20 consecutive photographs at a speed of one image per second. After taking 20 photographs consecutively, allow approx. 1 minute without using the photography ash lamp. Otherwise the instrument may be damaged.

Page 39

3 Basic usage

3.5 Viewer mode functions and procedures

This section describes various functions of the viewer mode. You may go to the viewer mode by pressing the “VIEWER button” on the LCD monitor while in the capture mode. You cannot take photograph in the viewer mode. Also, all buttons on the panel become disabled in this mode. If you go to the viewer mode during Fluorescence angiography, the timer indication disappears; however, the timer continues and the timer indication resumes at the actual elapsed time when you return to the capture mode.

Page 40

3 Basic usage

Notice

3.5.1 Entering an ID and switching between IDs

─

Entering an ID

This function is enabled while the connection conguration is in “Stand-alone” or “Network connection.” Enter a new ID. Numbers 0 through 9 and the hyphen (“─”) may be used for ID. You may enter an ID directly with the keypad on the screen or read it through a designated card reader (optional accessory) or bar code reader (optional accessory).

─

Procedure 1: Directly entering an ID

Press the “Input ID button”.

The current ID appears in the ID eld. Check that all digits in the eld are highlighted or delete the

current ID using the BS/Del key; then, use the keypad and enter a new ID. Check that the new ID is displayed in the ID eld and press “OK button”.

Procedure 2: Reading the ID through a card reader/ bar code reader

Press the “Input ID button”.

Read the ID through a card reader/ bar code reader.

Check the new ID is displayed in the ID eld and press “OK button”.

¿The last ID entered will be the Save/ View ID of the instrument. If you want to save or view images

under a different ID, follow the procedures in “Switching to another ID” and switch to the ID you want to use.

¿Connect a card reader or bar code reader to the instrument before pressing the “Input ID button”.

¿A card reader or bar code reader must be congured according to its usage environment. If you

are to use a card reader or bar code reader, contact Kowa or your Kowa dealer in advance.

Page 41

3 Basic usage

─

Switching to another ID

─

This function is enabled while the connection conguration is “Stand-alone.” You may switch from the current ID to an existing ID under which you want to save or view.

Procedure

Press the “Input ID button” to go to the ID screen.

Select an ID from the ID list shown in the ** section of the screen. The selected ID becomes high-

lighted.

Press “OK button”.

When more than 10 IDs are registered, use the list switching buttons to change IDs to view.

ID :

N0 ID

LastVisited

Today

7 8 9 4 5 6

1 2 3

BS Del

CANCEL

3.5.2 Single image display

This function is enabled while the connection conguration is “Stand-alone.” You may view the images saved under an ID one at a time. This function is enabled immediately after you go to the viewer mode. The most recent image saved under the selected ID is displayed. Use the arrows on the LCD monitor to switch images; “VIEW button” for the next image and “REVIEW button” for the previous image.

When you press “VIEW button” while the most current image is displayed, the oldest image appears. When you press “REVIEW button” while the oldest image is displayed, the most current image appears.

The total number of images saved under the ID and the photography sequence number of the image displayed are indicated on the upper left of the image.

Page 42

3 Basic usage

3.5.3 Multiple image display

This function is enabled while the connection conguration is “Stand-alone.” You may view the images saved under an ID, up to four images at a time.

─

Four-image display

Press the “MULT button” on the LCD monitor while on the single image display to show the four most current images saved under the same ID.

─

CAPTURE

IN ID/LIST

REVIEW

VIEW

MULT

No ID

TRASHSETTING

When you press “VIEW button” while on the four-image display, the four oldest images appear in one window. When you press “REVIEW button”, the next four images, including the one immediately older to the four previously on display, appear. The total number of pages and the current page number, both of which are based on four-image display, are indicated on the upper left of the four-image display window.

When you press the “MULT button”, four images indicated “A” in the illustration appear in a window. Press “VIEW button” while the images A are displayed: Four images “B” appear in the window. Press “REVIEW button” while the images A are displayed: Four images “D” appear in the window. Press “VIEW button” while the images B are displayed: Four images “C” appear in the window. Press “REVIEW button” while the images B are displayed: Four images “A” appear in the window.

When the total number of images saved is not the multiples of 4, one to three most current images appear when you press the “MULT button.”

Page 43

3 Basic usage

─

Selected image display

While on the four-image display, press any of the images to view. “Select ” is indicated on the corner of the selected images ( is a number of your selection). After making your selection, press the “MULT button” again to view only the selected images.

Example: When 7, 3, 11, and 14 are selected in this order

─

The selected images are displayed as shown above.

Example: When two images, 7 and 3, are selected in this order

The selected images are displayed as shown above.

─

Switching back to the single image display

While on the four-image display, tap on an image twice, to go to the single image display of the selected image. If you press the “MULT button, while on the four-image display but there are no selected images, the most current image of the four is shown.

¿You may select up to four images.

─

Page 44

3 Basic usage

Notice

3.5.4 Deleting photographed images

This function is enabled while the connection conguration is “Stand-alone.” You may delete images while viewing them.

─

While on the single image display

When you press the “TRASH button” while the image you want to delete is displayed, an alarm message appears. If you are certain that you want to delete the image, press “Yes”. If not, press “No.”

─

While on the four-image display

Press the images you want to delete. “Select ” is indicated on the corner of the selected images ( is a number of your selection). When you press the “TRASH button”, an alarm message appears. If you are certain that you want to delete the images, press “Yes”. If not, press “No.”

─

¿Deleted images may not be recovered.

Page 45

3 Basic usage

Notice

3.5.5 Printing photographed images

This function is enabled while the connection conguration is “Stand-alone.” You may print photographed images that are saved.

CAPTURE

IN ID/LIST

REVIEW

VIEW

MULT

No ID

While on the single-image or multiple-image display, press the “PRINT button” to print the images that are shown. If on the multiple image display, the photographed images are printed as shown in the LCD monitor.

TRASHSETTING

¿A designated printer (optional device) is required to print photographed images.

3.5.6 Switching to the capture mode

You may switch from the viewer mode to the capture mode. While in the viewer mode, press the “CAPTURE button” on the LCD monitor to go to the capture mode.

No ID

CAPTURE

IN ID/LIST

REVIEW

VIEW

MULT

TRASHSETTING

Page 46

4 Advanced operation

Point

4.1 Tilt and panning

This instrument has the tilt and panning mechanism, which is used to photograph more surrounding eld in mydriatic color photography and uorescence angiography.

4.1.1 Tilt

Rotate the tilt lock knob to the left as you face directly to the tilt lock knob to release the lock.

Turning the tilting handle to the right (as you face directly to the tilting handle) allows you to tilt the op-

tical component in an angle of depression.

Turning the tilting handle to the left (as you face directly to the tilting handle) allows you to tilt the opti-

cal component in an angle of elevation.

The tilting mechanism has a level position, where you feel a

;

“click” when moving the instrument. When you have finished photographing the surrounding eld and return to the standard photography, return the instrument to this position.

When the tilting angle of elevation is insufficient in order to

;

photograph a surrounding eld, you may use a higher forehead rest K9L-HR56 (optional accessory), which moves back the patient's forehead and increase the angle of elevation,

Tilting handle

Tilt lock knob

4.1.2 Panning

Rotate the panning lock lever to the left as you face directly to the panning lock lever to release the

lock.

Hold the area under the focusing knobs and slowly panning it to right or left.

;

The panning mechanism has a reference position, where you feel a “click” when moving the instrument. When you have nished photographing the surrounding eld and return to the standard pho-

tography, return the instrument to this position.

Page 47

4 Other functions

4.2 Small pupil photography

This section describes how to photograph patients with a small pupil diameter. While this method allows you to photograph patients with a small pupil diameter, there are such disadvantages as smaller eld angles or easier occurrence of a are.

Press the “S.P. button” on the right side panel to change the pupil diameter that can be photographed. The pupil diameter that can be photographed under each photography mode is shown below.

Photography mode Standard S.P. S.S.P

Mydriatic color Φ5.5 mm Φ4.0 mm Φ3.5 mm

Red Free Φ4.0 mm × ×

FA Φ5.5 mm Φ4.0 mm Φ3.5 mm

Non-mydriatic color Φ4.0 mm Φ3.5 mm ×

FAF (Non-mydriatic monitoring) Φ4.0 mm Φ3.5 mm ×

FAF (Mydriatic monitoring) Φ5.5 mm Φ4.0 mm Φ3.5 mm

¿pupil of the diameter shown in the table or larger may be photographed.

Two levels of the S.P. mode is available for mydriatic color photography, uorescence angiography, and mydriatic monitoring in FAF.

The S.P. button on the right side panel is indicated as shown below: Normal pupil diameter : Off S.P. : Lit S.S.P. : Flashing

Page 48

4 Other functions

The LCD monitor shows the approximate pupil diameter that may be photographed. The outer circle of the double circles shown in the illustrations below is the approximate pupil diameter that may be sufciently photographed in the current diameter setting. The inner circle is the pupil diameter that may barely be photographed in the current diameter setting. Use these circles as reference to select the suitable pupil diameter for photography.

When you select Φ3.5mm as the pupil diameter to be photographed, a green line appears outside the outer circle. This circle shows an area where a are may occur during photography. Align the pupil so that the part to be photographed is within the green line.

Page 49

4 Other functions

Point

4.3 LCD Monitoring

This section describes how to perform alignment on the LCD monitor without using the optical viewnder (eyepiece) during mydriatic color photography, Red Free photography, uorescence angiography, and mydriatic monitoring in FAF. This function eliminates the need of diopter adjustment of the optical viewnder (eyepiece). Also, this mode uses infrared rays instead of visible light to observe patients; therefore, patients are relieved of glaring, which facilitate smooth photography.

Pressing the “LCD monitoring button” on the right side panel switches to the LCD monitoring mode. Pressing the “LCD monitoring button” once again switches back to the viewnder monitoring mode.

When the patient's pupil in natural dialation is 5.5 mm or more in diameter, mydriatic color observation

;

allows you to photograph with eld angle of 50 degrees without using mydriatics . The eld angle for the standard non-mydriatic color photography is 47 degrees.

Important

◇ Images on the LCD monitor are not as clear as the ones in the viewnder monitoring mode; therefore,

it becomes more difcult to remove a are or adjust focus.

◇ Notice that when performing LCD monitoring in the FA mode, not only a uorescence image but also

an actual captured image with infrared rays; therefore, the photographed uorescence image differs from the image seen while performing alignment.

The LCD monitor angle may be changed. Adjust the angle if the LCD monitor is hard to see during the

;

viewnder observation or while the optical head is tilted.

Page 50

4 Other functions

4.4 Switching xation target

This instrument automatically switches to an appropriate xation target and the position of patient’s eye xation when the photography modes are changed. Please note that xation targets are automatically switched according to the photography mode, not according to the state of the patient or the part required to be photographed. This section describes how to change the xation target and the position of the patient’s eye xation.

Procedure

Press the “FIXATION button” on the LCD monitor.

Select a button from “EXT”, “CENTRAL”, “DISC”, “MACULA”, and “PERIPHERAL” buttons, which ap-

pear on the LCD monitor.

VIEWER

FIXATION

NO N- MY D

ࠋ

50 D+ Cen tra l

SP4.0

Blue 50W

FLASHDOWN FLASH UP

EX IT

NO N- MY D

ࠋ

50 D+ Cen tra l

SP4.0

Blue 50W

FLASHDOWN FLASH UP

EX IT

USER1

USER2

USER3

RID: No ID

1 2

The function and main intended use of each button are shown below.

Button Fixation target and its position Common use

When you are observing under

EXT External xation target

CENTRAL

DISC

MACULA

Internal xation target: center of posterior

Internal xation target: center of optic disc

Internal xation target: center of macula

visible light or want to guide the patient's fixation to a part to be photographed.

When you want to guide the patient's xation under infrared ray observation. The position of the xation target is internally xed in the instrument; therefore, stability is increased when photographing repeatedly.

VIEWER

EXT

FIXTION

CENTRAL

DISC

MACULA

PERI

PHERAL

RID: No ID

When you want to perform mosaic mode photography with macula in the center under non-mydriatic observation. You may congure the settings to specify an area and sequence of

PERIPHERAL

Internal xation target: center of macula, and one of eight peripheral points (according to the setting)

photography.

For all of the above xation targets, a red and a green lamp alternatively turns on.

Important

◇ The internal xation target is unavailable for mydriatic color photography, Red Free photography, or

uorescence angiography (observation with visible light). To use the internal xation target in these photography mode, switch to the “LCD monitoring” mode.

Page 51

4 Other functions

Point

─

About “Peripheral” photography

─

This section describes how to switch the light position of the xation target and how to guide the patient's xation when “Peripheral” photography is selected.

Go to [Settings\Internal Fixation Target] to specify a photography sequence for a part to be photographed. When “Peripheral” is selected, the xation targets turn on to guide you through the specied sequence.

The xation target applicable for the rst part to be photographed is lit immediately after selecting “Peripheral”. The screen shows the guiding direction for the patient's xation; guide the patient in the direction exactly as indicated.

Example:

1) To photograph the part No.1, “Center” is indicated on the LCD monitor. You would say to the patient, “Please look at the luminous dot in the center.”

2) To photograph the part No.2, “Up” is indicated on the LCD monitor. You would say to the patient, “Please look at the luminous dot above the center.”

3) To photograph the part No.3, “Left up” is indicated on the LCD monitor. You would say to the patient, “Please look at the luminous dot on upper left.”

Once an image is photographed, the fixation target changes according to the next part to be photographed. Continue to guide the patient's xation and photograph images.

PHERAL

VIEWER

FIXATION

RERI

NEXTBACK

NO N- MY D

ࠋ

50 D+ Ext

SP4.0

50W

FLASHDOWN FLASH UP

EX IT

RID: No ID

If the currently set photography sequence includes parts unnecessary to be photographed or if you want to recapture an already-photographed part, you may use the arrow buttons (“NEXT button” and “BACK button”) on the LCD monitor to change the sequence. Press “NEXT button” to switch to the xation target for the part to be photographed next. Press “BACK button” to switch to the xation target for the part previously photographed.

The internal xation target may not be visible to the patient immediately after switching the position.

;

First, guide the patient's xation to the general area indicated on your monitor; then, instruct the patient to look at the luminous dot as it becomes visible during the alignment process.

Page 52

4 Other functions

Notice

─

About the internal xation target (optional accessory)

Use the internal xation target (optional accessory) if you want to record the patient's xation position in the photographed images.

─

Attaching the internal xation target

1) Remove the cover of the internal xation target socket on the optical component.

2) Remove the protective tube of the internal xation target.

3) Screw the internal xation target into the socket on the optical component.

¿When removing the cover from the internal xation target, be careful not to bend the body of the

xation target.

Page 53

4 Other functions

4.5

Additional adjustment of the ash intensity(+5 or more,

You may use this function to compensate the flash intensity beyond the compensation range allowed with the ash intensity compensation knob. When the ash intensity compensation knob is turned to +5, a "FLASH UP button” appears on the LCD monitor that allows adjustment to higher ash intensity. Pressing the button once increases the ash intensity by one level. Similarly, when the ash intensity compensation knob is turned to ─5, a “FLASH DOWN button” appears on the LCD monitor that allows adjustment to lower ash intensity.

These buttons allow adjustment to the maximum ash intensity of 300W and the minimum ash intensity of 0.6W. If you change the setting on the ash intensity compensation knob while making an additional adjustment to ash intensity, the adjustment made with the ash intensity compensation knob precedes.

5 or less)

4.6 Blue/Brown button

The Blue/Brown button allows you to set the ash intensity suitable for the iris pigment. The standard setting at the factory default is “Brown”. When you press the Blue/Brown button, “Blue” appear on the screen and the ash intensity reduces by approximately 2.5 EV. The new setting is enabled until you press the button again.

4.7 Customize button

“Customize buttons” allow you to easily switch to preset camera sensitivity, aperture size, and ash intensity magnication. Three customize buttons are available. For the methods for changing the defaults, effects and targets, and setting values, refer to 5.4.2 Customize button.

“Customize buttons” are enabled at any time during the capture mode. Some photography modes, however, may not allow certain settings.

NO N- MY D

。

50 D+ Cen tra l

SP4.0

Blue 50W

FLASHDOWN

FLASH UP

EX IT

VIEWER

FIXATION

USER1

USER2

USER3

RID: No ID

Page 54

4 Other functions

Notice

4.8 Power saving function

When the buttons on the operation panel and LCD monitor are not operated for a certain period of time (approximately 10 minutes), the instrument goes into the power saving mode. During the power saving mode, the Power lamp is lit in green while all other lamps, such as LED lamps, observation lamps, photography lamps, and LCD monitor backlight, are turned off. All internal functions, except for the ones required at minimum, are also turned off during this time. The instrument recovers from the power saving mode when you press a panel button or touch the LCD monitor.

4.9 Recalling and printing images

This function is enabled while the connection conguration is “Stand-alone.”

─

Recalling an image ─

When you want to examine an image closely after preview is complete, you may recall the previewed image by pressing the “STILL/VIEW button” on the LCD monitor. The recalled image remains on the LCD monitor until the “STILL/VIEW button” is pressed again.

VIEWER

FIXATION

USER1

USER2

USER3

─

Printing an image ─

A recalled image may be printed through a printer

connected to the instrument. Press the “PRINT button” that appears in the recalled image to print.

¿Deleted images may not be recovered.

EX IT

No ID

Page 55

5 Setting

5.1 Main

5.1.1 Monitor brightness

In this tab, you may adjust the brightness of the LCD monitor,from level 1 through 10 with an increment of one.

Main

Capture

LCD Bright

Adiust the moniter brightness.

Viewer Extension Maintenance

Date Power Saving Sound System

5.1.2 Date

In this tab, you may set the date format and delimiter as well as adjust the date and time.

Main

Capture

LCD Bright

Set the display format and delimiter.

Display Format

YYYYMMDD

DDMMYYYY

Viewer Extension Maintenance

Date Power Saving Sound System

Delimiter

/ (Slash)

(Hyphen)MMDDYYYY

test

datetime setting

APPLY

CANCEL

Main

Capture

LCD Bright

Set the display format and delimiter.

Display Format

YYYYMMDD

DDMMYYYY

Viewer Extension Maintenance

Date Power Saving Sound System

Date 2011 5 27

Time

/ /

Delimiter

11 4 28: :

/ (Slash)

(Hyphen)MMDDYYYY

datetime setting

test

APPLY

CANCEL

APPLY

CANCEL

APPLY

CANCEL

Select “YY(Year)MM(Month)DD(Day)” as the format. You may select a slash or a hyphen as the delimiter to separate year, month, and day. When you press “Date button”, the setting dialog box appears. When you press the “Change the setting button”, control buttons appear next to each eld. Use the control buttons to set the date and time.

5.1.3. Power saving mode

In this tab, you may configure the settings for the power saving mode. ON: When this instrument is not operated for approximately 10 minutes, it will resume the power saving mode (LCD backlight is turned off; halogen lamp, panel LED, and other lamps are turned off, and charging function is suspended). OFF: The instrument will not resume the power saving mode.

Main

Capture

LCD Bright

Set the display format and delimiter.

Display Format

YYYYMMDD

DDMMYYYY

Main

Capture

LCD Bright

Set power saving mode.

Viewer Extension Maintenance

Date Power Saving Sound System

Date 2011 5 27

Time

/ /

Delimiter

11 4 28: :

/ (Slash)

Set

(Hyphen)MMDDYYYY

Viewer Extension Maintenance

Date Power Saving Sound System

OFF

※The Setting is applied when you pushed Apply or OK button.

APPLY

test

datetime setting

CANCEL

APPLY

CANCEL

APPLY

CANCEL

Page 56

5 Setting

Notice

5.1.4 Operation sound

In this tab, you may enable or disable the operation sound used in functions such as timer and alarm.

Main

Capture

LCD Bright

Timer

Warning

Viewer Extension Maintenance

Date Power Saving Sound System

OFF

5.1.5 System connection conguration

In this tab, you may set the system connection conguration of this instrument. Stand-alone: The instrument is used in stand-alone. VK connection: The instrument is connected to Kowa VX series. Network connection: The instrument is connected to external equipment.

Select a button that suits the use of the instrument.

Main Capture

Viewer Extension Maintenance

Date Power Saving Sound System

※The system logoff and logon, when you changed the system constitution.

Stand Alone

VK Connection

Network Connection

Reset the communication at VK Connection

D:\VX-20\Image

※Kowa serviceman set a directory of the network and the setting of the TCP/IP.

APPLY

CANCEL

APPLY

CANCEL

¿When using the instrument in Stand-alone, be sure to insert a compact ash memory card.

¿When using the instrument in VK connection, use USB cable 1(A─mini-B type)(K9L-SC56A) to

connect this instrument and a VK series model.

¿When using the instrument in Network connection, make sure a network path is specied. If a net-

work path is not specied, please contact Kowa or Kowa dealer representative.

Page 57

5 Setting

5.2 Capture

5.2.1 Flash intensity

Increments of ash intensity: You may set 0.3EV or 0.5EV to calibrate the increment of increase/decrease of the ash intensity compensation knob.

Flash intensity indication: The ash intensity may be displayed on the LCD monitor as the position of the ash intensity compensation knob (in ±) or as a value in watt.

Reference ash intensity: You may set the reference flash intensity of each photography mode, which is the ash intensity at the zero (0) position of the ash intensity compensation knob, at ±4 levels.

5.2.2 Start-up mode

Main Capture

Flash Intensity

Default Value

STEP

Select the compensation step value for Flash Intensity.

0.3EV

0.5EV

Viewer Extension Maintenance

Start up

Image Quarity

APPLY

CANCEL

In this tab, you may set the “photography mode settings button” operation regarding the photography mode at the time of start-up.

Start-up photography mode: T h e i n strume n t i s in

either mydriatic or nonmydriatic photography mode at start-up.

RF/FAF button: The instrument is in either Red Free

or FAF photography mode when the “RF/FAF switching button” is pressed for the rst time after start-up.

Main Capture

Flash Intensity

Select the detault capture mode whea the system starts up.

Non-MYD

MYD Color

Viewer Extension Maintenance

Start up

Image Quarity

Select priority capture mode when you pushed caputure mode button after the system starts up for the first time.

FAF/RF

FAF

APPLY

CANCEL

Page 58

5 Setting

5.2.3 Image quality/color

This function is enabled while the connection conguration is in “Stand-alone” or “Network connection.”

¿ In “VK connection”, the image quality and color settings for the photographed images are congured

in the VK series, which allows more detailed settings. To achieve images that are close to what you want, using the instrument in VK connection is recommended.

Image quality/color: You may adjust the quality and color of the photographed images in color

(mydriatic color and non-mydriatic color) photography.

Size and compression rate: You may set the size and compression rate of the photographed images. A common size and compression rate settings are used for color photogra-

phy, Red Free photography, and FAF photography.

A separate set of settings are available for Fluorescence angiography.

5.3 Viewer

5.3.1 Preview

You may set the length of time during which preview

is displayed on the LCD monitor immediately after photographing when the instrument is in Stand-alone or Network connection. A set of settings for color, Red Free, and FAF photography and another set for Fluorescence angiography are available.

Main Capture

Flash Intensity

Color/RF/FAF

Size

S Basic

M Normal

S Basic : 310KB S Basic : 90KB

Main Capture

Preview

Set the image preview time.

Available Range: 0,0.5,1〜10 second

Color/RF/FAF 5

Viewer Extension Maintenance

Start up

Compression

Fine

Image Quarity

Hue(Color)

-3

Viewer Extension Maintenance

Size

Compression

S Basic

M Normal

Fine

APPLY

CANCEL

APPLY

CANCEL

5.3.2 Print

When Stand-alone is selected for the connection conguration, you may print photographed images using a printer connected to this instrument. You may set whether photographing conditions are printed in the margin.

Items that may be set: number of images (Image No.

within an ID/total number of images within an ID), ash intensity (W), eld angle, right or left eye, ID, photographed date and time, internal xation target

Main Capture

Preview

Select the items to be printed on the image.

Flash intensity

Camera Sensitivity

Angle

L / R

Viewer Extension Maintenance

Count

Date . Time

Fixation

APPLY

CANCEL

Page 59

5 Setting

5.4 Advanced functions

5.4.1 Internal xation target

In this tab, you may congure the internal xation target settings regarding “Peripheral”. You may set the lighting sequence of the xation targets to be lit and whether the sequence for the right eye should be mirrored for the left eye.

─

Setting the photographing sequence ─

The lighting sequence is specied by setting the parts

to be photographed in the right eye.

A: Current sequence in the right eye B: Current sequence in the left eye C: Numerical pad for entering a new sequence D: Mirror button

The numbers shown in “C: Numerical pad for entering a new sequence” signifies the parts to be pho-

Main Capture

Custom FA Filter FAF ObserveBlue/BrownInt Fix

Present order(Right eye)

Viewer Extension Maintenance

(Left eye)

Select the order for the right(R).

* * *

SetOFF

ResetMirror Setting

APPLY

CANCEL

tographed. Press the numbers in the sequence you want to register a new photographing sequence. You may enter any number of digits up to nine. When you

A D CB

have entered the sequence, press “OK”. The new sequences will be reected in A and B.

─

Setting the mirror function

─

When the “mirror button (D)” is pressed, the sequence entered for the left eye will be mirrored for the right eye photography. When the “mirror button (D)” is not pressed, exactly the same sequence entered for the left eye will be copied for the right eye photography.

5.4.2 Customize button

“Customize buttons” allow you to easily switch to a preset combination of camera sensitivity, aperture size, and reference ash intensity.

In this menu, you may specify a separate set of settings for each customize button. Press a button number for which you want to set and press the items you want to specify. If the button looks “pressed down”, it is selected. Press “APPLY button” or “OK button” to store the settings in memory.

Main Capture

Custom

Custom1 Custom2 Custom3

Sensitivity

x1 x1

x2 x1/2

x4 x1/4

※‘Large’ setting is enable when the capture mode is FA and FAF. ※”Large” setting is thatthe optical system become the brightness of half

apperture (about 1.5 times).

Viewer Extension Maintenance

FA Filter FAF ObserveBlue/BrownInt Fix

Flash Intensity Iris

Standard

Large

APPLY

CANCEL

Page 60

5 Setting

Items to set

Camera sensitivity : photography sensitivity of the camera. X1: Standard, X2: two fold, X4: four fold As the setting is changed from X1 to X4, photography with low ash intensity be-

comes possible, but the image quality is compromised.

Aperture size : the size of the camera aperture. Standard : When the customize buttons is pressed, the aperture remains the standard size. Large : When the customize buttons is pressed, the aperture is switched to a size larger

than the standard aperture. When the photography mode is in non-mydriatic, mydriatic color, or Red Free, however, the aperture size remains in the standard size.

Flash intensity : Reference ash intensity. X1 : Remains in the standard setting. X1/2 : 1/2 of the standard setting. X1/4 : 1/4 of the standard setting.

Examples of customize buttons (target use of the factory default settings)

Settings of each button and its effects and target use are shown below.

Button

Custom 1 ×2 Standard ×1

Custom 2 ×4

Custom 3 ×4 Standard ×1/4

Camera

sensitivity

Aperture

Lar ge a per ture

Flash

intensity

×1

5.4.3 FA lter

With the standard setting, when FA photography mode is selected, the exciter lter is inserted in the light path; when the lter button is pressed, the barrier lter is inserted. The setting is “After” as the factory default.

If you want to insert the barrier lter rst and then exciter lter as the FA button is pressed, select “Before” to change the setting.

Effect and target use

Relatively bright-color images are achieved without increasing glaring for patients. The image quality is not overly compromised.

Ver y brigh t-color imag es are achie ve d wit ho ut increasing the glaring for patients, but the image quality is compromised and a are increases. This setting is effective when the ash intensity is insufcient during uorescence photography.

Imag e s as b right a s th e s tanda r d mo d e ar e achieved while reducing glaring for patients. The image quality is compromised. This setting is effective when you want to separately photograph images in the low ash intensity.

Main Capture

Custom FA Filter FAF ObserveBlue/BrownInt Fix

Select the timing to insert the Barrier Filter (First or Next).

First

Viewer Extension Maintenance

APPLY

CANCEL

Page 61

5.4.4 Blue/Brown

5 Setting

You may select whether “Blue” or “Brown” is enabled

at the time of start-up.

5.4.5 FAF observation

The FAF observation mode, which is usually used for

the LCD monitoring of non-mydriatic state, also allows observation of mydriatic state through the optical viewnder (eyepiece).

This function may be set when you purchase and apply the FAF options.

Main Capture

Viewer Extension Maintenance

Custom FA Filter FAF ObserveBlue/BrownInt Fix

Set the initial setting (Blue or Brown).

Brown

Blue

Main Capture

Viewer Extension Maintenance

Custom FA Filter FAF ObserveBlue/BrownInt Fix

Select Observation method.

Finder

Monitor

APPLY

CANCEL

APPLY

CANCEL

Page 62

5 Setting

Notice

5.5 Maintenance

5.5.1 Making a backup copy of compact ash memory card

You may make a backup copy of the data saved in

the compact ash memory card.

Main Capture

Backup at CF card

※Connect the USB memory for backup. If you connected more then two, copy it the first connected USBmemory.

Viewer Extension Maintenance

Format Version PasswordBackUp

¿When more than two backup media are connected, the one connected to the instrument rst pre-

cedes the other.

¿This function is enabled while the connection conguration is in “Stand-alone” or “Network connec-

tion.”

5.5.2 Formatting a compact ash memory card

In this tab, you may format a compact ash memory card connected to the instrument.

¿This function is enabled while the connection con-

guration is in “Stand-alone” or “Network connection.”

Main Capture

Format Version PasswordBackUp

Format at CF card

Viewer Extension Maintenance

APPLY

CANCEL

If a password is set according to “5.5.4 Setting a password”, you will be asked to enter the password

5.5.3 Version information

This tab shows the instrument's serial number and the versions of applications installed.

APPLY

CANCEL

Page 63

5.5.4 Setting a password

You may set so that a password is required when making a backup copy or formatting a compact ash memory card.

Select “Password” tab.5.5.4_1 Press “Set a password” button.

The window shown in 5.5.4_2 appears.

Enter a password in the “New Password” field and press “OK” next to it. Enter the same password for conrmation in the “New Password (Again)” eld and press “OK” next to it. If the conrmation password is entered correctly, the new password is set.

5 Setting

5.5.4_1

Once the passwor d is set, the window shown in

5.5.4_3 appears whenever the “Backup tab” or the “Format” tab is pressed. The backup and formatting functions are enabled only when the correct password is entered.

5.5.4_2

5.5.4_3

Page 64

6 Troubleshooting

This section describes troubleshooting procedures to solve problems you may encounter. Look for the applicable symptom from those shown in the following list and apply the applicable remedy. When the described remedy did not eliminate the symptom or you encountered a symptom that is not listed, please contact Kowa or your Kowa dealer.

Abnormal performance of the instrument

Symptom What to check · State of equipment Remedy

Non- mydriatic mode is enabled. Change to mydriatic mode.

LCD monitoring mode is enabled. Change to viewnder observation.

Th e ob servatio n il luminati on lamp does not illuminate.

The shutter button cannot be pressed.

The pho tog raphy fl ash lam p does not illuminate.

Observation light intensity control knob is in the minimum position.

It is in the power saving mode.

Is the illumination lamp properly attached?

The illumination lamp is burned out.

Compact flash memory card is not inserted (in stand- alone).

The cable is pulled out (inVK connection).

Viewer mode is enabled. Enable capture mode.

Is the ash lamp properly attached?

The ash lamp is white and cloudy. Replace the ash lamp. See 7.4.2.

Is mydriatic color mode/ RF mode/ FA mode/ finder observation mode for FAF enabled?

Turn the observation light intensity control knob to the 10 o'clock position.

Press any button on the operation panel.

Review if the illumination lamp is attached properly.

Replace the illumination lamp. See

7.4.1.

Insert the compact flash memory card.

Connect the cable.

Review the attachment of the ash lamp.

Enable non- myd riatic mode or LCD monitoring mode.

The observation image is not displayed on the LCD monitor.

Not hing i s displ a yed o n the LCD monitor.

Operation from the LCD monitor is disabled.

Is observation light intensity control knob at the minimum position?

Is it soon after the power is turned on?

It is in power saving mode.

The error message EPC02 was displayed.

Is it in the power saving mode? Press a button on the panel.

The s y stem con f igura t ion is not “Stand-alone”.

The error message EPC09 is displayed.

Turn the observation light intensity control knob to the 10 o'clock position.

Wait until boot-up completes. (It takes about 40 seconds from turning on the power.)

Press the button on the operation panel.

Turn off the power and stop using.

Many functions in Viewer mode is disabled during “VK connection” and “Network connection”.

Turn off the power and stop using.

Page 65

Symptom What to check · State of equipment Remedy

The button different from the pressed button reacts during LCD monitor operation.

6 Troubleshooting

Abnormal performance of the instrument

It is out of calibration. Calibration must be performed.

You see nothing when you look into the viewnder.

The focus dot and the working dot are not displayed.

The e x terna l fixati on t arget does not illuminate.

Non-mydriatic mode is enabled.

LCD monitoring mode is enabled.

Alignment of the retinal camera is not correctly adjusted.

The ON/OFF switch is off.

The diopter compensation button is turned to “+” or “

Is illumination light for monitoring too bright?

Is internal xation target enabled?

It is in the power saving mode.

”.

You cannot observe from the viewnder in non-mydriatic mode.

Press the LCD monitoring button to change to the viewnder monitoring mode.

Align the retinal camera correctly.

Turn on the focus dot switch or the working dot switch.

Focus dots and working dots are not dis played when the diopter compensation lens is inserted.

When the retinal image is bright, focus dots and working dots may be lost. Decrease the amount of illumination light for monitoring.

The external fixation target and the internal fixation target do not illuminate at the same time. Select the external fixation target at the xation target selection button.

Press a button on the operation panel to cancel the power saving mode.

The alarm does not sound.

All LED on the operation panel turn on and off.

Is alarm sound of the timer turned off?

EHD07 or EHD08 is displayed. Turn off the power and stop using.

Turn on the alarm sound of the timer in the setting. See 5.1.4.

Page 66

6 Troubleshooting

Abnormality in captured images

Images show white shadow spots at the same places.

Image’s peripheral area becomes darkened.

Image’s peripheral area becomes whitened.

Is the r e dust on the o b jecti v e lens?

Is the objective lens contaminated by tears etc.?

Are the eyelashes of the patient in front of the eye?

Is the digital camera located too far from the patient’s eye?

Cle a n the obje ctive lens. S ee

7.3.1.

Cle a n the obje ctive lens. S ee

7.3.1.

Make sure that the eyelashes do not come in front of the pupil.

Align the retinal camera correctly.

Image is locally too dark.

Images show black shadow spots at the same places.

Is the digital camera located too close to the patient’s eye?

Is the pupil of the patient’s eye sufciently dilated?

Align the retinal camera correctly.

Try small pupil mode. If it is less than the pupil diameter guideline, the center of the images becomes dark.

It is necessary to clean the inside of the camera. Contact Kowa or your Kowa dealer.

Page 67

6 Troubleshooting

Error message

Error code Description Remedy

EPC01 Failure of the camera for image capturing Turn off the power and stop using.

EPC02 Failure of the camera for observation Turn off the power and stop using.

EPC03 Failure of the CF memory card Replace the CF memory card.

EPC04 The CF memory card is not inserted. Insert the CF memory card.

EPC05

EPC06 Failure of the CF memory card Replace the CF memory card.

EPC07

EPC08 Abnormality of the internal circuit (battery) Turn off the power and stop using.

EPC09 Abnormality of the touch panel Turn off the power and stop using.

EPR01 The printer is not connected. Connect the specied printer.

EPR02 Out of paper

EPR03 Out of ink

EPE01

EPE02 Insufcient capacity of backup memory Replace the backup memory.

EHW01 Failure of an optical unit (ring slit) Turn off the power and stop using.

EHD07 Abnormality of the internal circuit Turn off the power and stop using.

EHD08 Abnormality of the internal circuit

Insufficient capacity of the CF memory card

Abnormality of the internal circuit (communication)

Connection of any uncertain peripheral equipment

Replace or format the CF memory card.

Turn off the power and stop using.

Replenish the printer paper. (Replenish according to the manual of the printer.)

Replenish the printer ink. (Replenish according to the manual of the printer.)

Do not connect equipment which is not specied by Kowa.

Turn off the power and provide the power supply for the sole use of this instrument. If this error occurs after restart, stop using.

EHD09

Abnormality in communication with outside PC

Reconrm the connection of the system.

Page 68

7 Maintenance and inspection

The retinal camera is a precision instrument and daily maintenance and inspection may affect the imaging results. Please read this section carefully in order to use this instrument correctly and safely.

7.1 Daily maintenance

1) Close the application of the main unit when the photographing is nished, and make sure to turn off the power switch. Place the lens cap on the objective lens, set the panning lock and the optical head base lock, and place the dust cover over the instrument.

2) Check that no dust, debris, nger print, or body uid is found on the objective lens. Conrm that the objective lens is clean before you use the instrument. Conrmation of dirt is easier in mydriatic color mode with observation light intensity adjusted to visible light.

3) Clean the dirt of this instrument according to routine cleaning method.

4) If it is not used for a long period, unplug the power code for safety. When the instrument has not been used for a long period of time, conrm if any errors are in each setting of this instrument.

Important

◇ If the retinal camera in a cool room is suddenly moved to a warmer room, or if the room in which the

instrument is located is heated rapidly, the objective lens and/or internal lens may be fogged. Wait for a while until the lens is clearly defogged before starting photographing. Or, images may be out of focus.

◇ When condensation occurs repeatedly, lenses may get moldy. When such a case has occurred to

you, contact Kowa or your Kowa dealer.

Page 69

7 Maintenance and inspection

7.2 Daily inspection

Inspect this instrument in accordance with “KOWA VX-20 daily inspection table” below.

KOWA VX-20 daily inspection table

Inspection items Procedure Acceptability criteria

Visually verify that plates and la-

Plates and labels

bels are readily readable and not contaminated.

Plates and labels are readable

Exterior

Power supply cable

Cable between Power supply unit and optical component

Cable between the panel and the panning arm

Cable between the panning arm and optical component

Cable between the panning arm and LCD

USB cable 1 (only during operation)

K9L-SC56B (only during operation)

Visually verify that exterior components have no flaw, crack, deformation or rust.

Visually verify that there is no aw or damage.

Visually verify that the connector is not unplugged.

Visually verify that there is no aw or damage.

Visually verify that the connector is not unplugged.

There is no aw, crack, deformation or rust.

There is no aw or damage.

The connector is plugged.

There is no aw or damage.

The connector is plugged.

K9L-SC56C (only during operation)

Power supply connection

Observation illumination lamp

Visually verify that there is no aw or damage.

Visually verify that the connector is not unplugged.

Visually verify that the power supply cable is individually connected to commercial power supply.

Start this instrument. Sel e ct mydr iatic m ode for t he photography mode, and turn the Observation light intensity control knob to 10 o'clock position. Conrm that the objective lens cap is removed. Place a hand in front of the objective lens and visually verify that the observation light illuminates the hand.

There is no aw or damage.

The connector is plugged.

The power supply cable is individually connected to commercial power supply.

Observation light illuminates.

Page 70

7 Maintenance and inspection

Point

(Perform the following after inspecting the observation illumination lamp.) Turn the observation light intensity

Objective lens

Internal circuit

control k nob to m axi mum , and visually verify the objective lens from oblique angle. Return the observation light intensity control knob to the 10 o'clock position after the conrmation.

(Perform the following after inspecting the objective lens.) Make th e ins tru men t rea dy f or photography according to the system conguration. Place a hand in front of the objective lens, and push the shutter button to verify that the ash light is emitted and the image is saved.

No dust, debris, teardrop must be found.

Flash light is emitted. The image is saved.

7.3 Daily cleaning

7.3.1 Cleaning the objective lens

Images may show white shadow spots at the same places if the objective lens is contaminated with ngerprints, etc. Clean the objective lens according to the procedure below.

1) Turn on the power.

2) Set the photography mode to “mydriatic color” after the instrument has started up.

3) Set the observation illumination light intensity to maximum.

4) Blow off debris or dust using the attached blower.

5) When it is not cleaned by the procedure 4), moisten soft cloth or cleaning paper with cleaning solution

made from ethyl alcohol and ether (1:1) and lightly wipe the lens starting from its center in a circular motion. Repeat this step several times.

6) If any soil is left out after cleaning according to the step 5), gently wipe off the soiled area with a cot-

ton swab soaked with a little amount of water. If you have done this procedure, repeat the step 4).

7) Should you have any soil that cannot be removed by the steps above, contact Kowa or your Kowa

dealer.

Change the cleaning paper or the soft cloth to new one every time you wipe.

;

Important

◇ Cleaning the lens without removing dusts and debris when wiping may scratch the lens surface. ◇ Do not use chamois leather, silicon cloth etc. ◇ Carefully store and handle the ammable and combustible cleaning solution.

Page 71

7 Maintenance and inspection

7.3.2 Cleaning and disinfection of the parts where patients contact the instrument (the

forehead base, the chin rest, and the grip (optional accessory))

Wipe the forehead rest (including K9L-HR56 (optional accessory)), head bands, the chin rest (in case not using the chin paper), and the grip (K9L-GR56 (optional accessory)) with rubbing alcohol as soon as a patient completes the examination.

7.3.3 Cleaning the exterior and the LCD monitor

When exterior of this instrument other than described above is dirty, follow the steps below to clean it.

1) Wipe the surface with rmly squeezed dampened soft cloth.

2) Wipe off the obstinate dirt with soft cloth, after dampening it in water or lukewarm water with diluted

small amount of neutral detergent and rmly squeezing it.

¿Do not use solvents such as thinner and benzene for cleaning the exterior.

When the LCD monitor is dirty, clean according to the following steps.

1) Wipe the LCD monitor with soft cloth, after dampening in water and rmly squeezing it

2) Lightly wipe the LCD monitor with dry and soft cloth before the surface becomes completely dry.

¿ Do not wipe all the surface at a time, and nish area by area

Water drops leave spots when they are dried.

¿ Do not use any liquid other than water or rubbing alcohol for cleaning the LCD monitor..

7.4 Replacement of consumables

7.4.1 Replacement of observation illumination lamps

1) Turn off the power switch and unplug the power plug from the electrical outlet. Wait for about 30 minutes and cool the lamp unit.

2) Loosen the lamp cover screws with a at-head screwdriver, and

remove the lamp cover.

Hold a hand toward the internal black lamp cover, and touch it if

you do not feel the heat to conrm it is cool enough.

3) Loosen the inside lamp cover screws with a at-head screwdriver.

Loosen the 3 screws bit by bit, and remove the lamp cover when all screws are loosened. The observation illumination lamp comes out with the cover from the lamp house.

4) Hold a hand toward the illumination lamp, and lightly touch it if you do not feel the heat to conrm it is

cool enough.

Page 72

7 Maintenance and inspection

5) Hold the shade of the illumination lamp, pull the at spring which

xes the lamp cover, and remove the lamp with the lamp socket from the lamp cover.

6) Hold the shade of the illumination lamp and pull it straight and

slowly from the lamp socket

7) Attach a new illumination lamp to the lamp socket. Push tightly until the bottom of the lamp and the

socket surface adheres.

8) Fix the lamp to the cover so that the hollow of the illumination lamp pedestal and the projection of the

lamp and the shade are not misaligned.

9) Pay attention not to place the socket cable forward of the lamp shade when attaching the cover. Fix

the cover by fastening the 3 screws successively with a at-head screwdriver. Make sure there is no gap between the lamp house and the cover.

10) Insert the light source cover to the exterior of the optical head, and x it with screws.

Important

◇ Do not turn the illumination lamp. ◇ Push the illumination lamp to the end of the socket. ◇ When attaching the lamp cover, handle it so that the cable of the socket is not get caught or

stressed. ◇ If the pedestal and the shade and the projection are misaligned, the lamp may be damaged. ◇ If you touch the lamp in the shade directly, it may shorten the life of the lamp. ◇ Pay attention not to drop the lamp or bump against the optical head.

When replacing with new flash lamp and observation

Warning

Unplug

Warning

High-voltage

lamp, be sure to turn OFF the power switch before unplugging from the power outlet. Otherwise, there is a fear of electrical shock.

Caution

Prohibitory

Warning

High-temperature

Do not replace the ash lamp tube or observation light bulb immediately after use. When replacing the ash tube or observation light bulb, be sure to turn OFF the main power switch and unplug it from the power outlet, and wait for 30 minutes or more. Do not touch the ash lamp tube with your bare hands. Otherwise, the lamp may have a lower quantity of light and a shorter useful life.

Page 73

7 Maintenance and inspection

7.4.2 Replacement of the lamp for photography

1) Turn off the power switch and unplug the power plug from the electrical outlet. Wait for about 30 minutes and cool the lamp unit.

2) Remove the internal black lamp cover when replacing the illumination lamp.

3) Insert the pulling tool attached to the replacement lamp for photography into the grooves at the top and the bottom of the lamp for photography in the lamp house.

4) With the pulling tool inserted at the socket of the lamp for photography, pull it straight and slowly.

5) Hold the replacement lamp for photography with the pulling tool, and insert it into the lamp house straightly.

6) Take out the pulling tool from the lamp house.

7) Push the peripheral part of the lamp socket using the pulling tool or the protection cover of the replacement lamp for photography until the bottom of the lamp socket and the lamp house adhere to each other.

8) Attach the inside lamp cover and the light source cover as you replaced the illumination lamp.

Important

◇ Do not turn the lamp for photography. ◇ Do not replace the lamp for photography directly holding it with hands. It may cause electrical

shock or damage.

◇ Pay attention not to drop the lamp or bump against the optical head.

Warning

Unplug

Warning

High-voltage

When replacing with new flash lamp and observation lamp, be sure to turn OFF the power switch before unplugging from the power outlet. Otherwise, there is a fear of electrical shock.

Page 74

7 Maintenance and inspection

Do not replace the ash lamp tube or observation light bulb immediately after use. When replacing the ash tube or observation light bulb,

Caution

Prohibitory

Warning

High-temperature

7.4.3 Fuse replacement

1) Turn off the power switch and unplug the power plug from the electrical outlet.

2) Turn the fuse holder at the power supply counterclockwise with a at-head screwdriver.

3) When the head of the old fuse comes out, hold it with a hand to pull it out.

4) Replace the fuse and place it in the fuse holder.

5) Press down the fuse holder with a at-head screwdriver and turn the screwdriver clockwise.

Warning

Unplug

Warning

High-voltage

be sure to turn OFF the main power switch and unplug it from the power outlet, and wait for 30 minutes or more. Do not touch the ash lamp tube with your bare hands. Otherwise, the lamp may have a lower quantity of light and a shorter useful life.

When replacing with new fuses, turn OFF the power switch and unplug from the power outlet. Otherwise, there is a fear of electrical shock. Use accessory or designated fuses. If other than designated ones should be used, there may occur failure or a re on the equipment.

Warning

Obligatory

The fuse differs according to the voltage which is used. Make sure to use a correct fuse when replacing one.

7.4.4 List of consumables

Following is the list of consumables used on this instrument. Please contact Kowa or your Kowa dealer for purchase or any inquiry. It is recommended that you always stock the illumination lamp and the fuse for replacement.

Part name Purchase order number

Flash lamp K9L56 FU3A

Illumination lamp K9L52 A26

Fuse 0218010.MXP

Page 75

7 Maintenance and inspection

7.5 Regular inspection

In order to use this instrument safely over its useful life, we recommend you to have it inspected annually.

1. Records of each setting

2. External components and their installation

3. Optical components

4. Operations and functions of the components

5. Switching operations of photography mode

6. Observation image using Standard Model Eye (OD)

7. Photography using Standard Model Eye (OD)

8. Photography light intensity

9. Electrical safety test

Contact Kowa or your Kowa dealer for specic detail and cost of inspections.

Page 76

8 Specications

Field angle

Working distance

Diopter compensation range of patient’s eye

Focusing Split luminous bars coincidence (with ON/OFF function)

Working distance adjustment Luminous dots indication (with ON/OFF function)

Optical viewnder (eyepiece) diopter compensation range

Observation illumination light Halogen lamp

Photography ash lamp Xenon ash lamp

Horizontal optical head base moving distance

Vertical optical head base moving distance 30mm

Mydriatic: 50º/30º

Non- mydriatic: 45º/27º

39mm (between the patient’s eye and the front of the objective lens)

0 ─12D - +13D

─ ─10D - ─32D

+ +10D - +35D

─8D - +5D

Lengthwise (coarse motion) --- 90mm (ne motion) --- approximately 17.5mm

Crosswise (coarse motion) --- 140mm (ne motion) --- approximately 17.5mm

Tilting operation range Elevation --- 11º, depression --- 15º

Rotating arm operation range 30° each for left and right

Power supply voltage AC120V

Power supply frequency 50/60Hz

Power supply input Normal: 250VA, Maximum: 1500VA

Dimensions 394mm (W) x 562mm(D) x 724mm(H)

Weight 39kg

Compliance standard

• IEC 60601-1:1988+A1:1991+A2:1995

• IEC 60601-1-2:2007

Safety standard and classication

• According to the type of protection against electric shock (Class I device)

• According to the degree of protection against electric shock (Type B applied part)

• According to the type of protection against ingress of water as detailed in the current edition of IEC60529. (IPX0)

• According to the degree of safety of application in the presence of a ammable anaesthetic mixture with air or with oxygen or nitrous oxide.

(Equipment not suitable for use in the presence of a ammable anesthetic mixture with air or with

oxygen or nitrous oxide)

• According to the mode of operation.

(continuous operation)

Page 77

9 Technical information

9.1 Folder structure and data format of the compact ash memory card

Image les (JPEG) and photography condition les (XML) are generated and saved in each of ID folders.

File name

[ID]_[YYMMDD]_[HHMMSS]_KOWA_[Photography type]_[Photographed eye]_[Timer elapsed time].Jpg [ID]_[YYMMDD]_[HHMMSS]_KOWA_ [Timer elapsed time].XML

ID: Patient's ID YYMMDD: Date of photograph taken HHMMSS: Time of photograph taken Photography type: COLOR: Color photography REDFREE: Red free photography FA: Fluorescent photography AF: Autoorescent photography Photographed eye: Right eye: R Left eye: L Timer elapsed time: Elapsed time on the timer at the time of FA photography 00MMSSmmm 01 or 02 is indicated if photography other than FA was performed.

Page 78

9 Technical information

The structure of the photography condition les is as shown below.

<?xml version=“1.0” encoding=“UTF-8”?> <?xml-stylesheet type=“text/xsl” href=“Fundus_Stylesheet.xsl”?>

<nsCommon:Common> <nsCommon:Company>KOWA</nsCommon:Company> <nsCommon:ModelName>VX-20</nsCommon:ModelName> <nsCommon:MachineNo> [11-digit serial number] </nsCommon:MachineNo> <nsCommon:ROMVersion></nsCommon:ROMVersion> <nsCommon:Version>1.0</nsCommon:Version> <nsCommon:Date>YYYY-MM-DD</nsCommon:Date> <nsCommon:Time>HH:MM:SS</nsCommon:Time> <nsCommon:Patient> <nsCommon:No.> [4-digit test number] </nsCommon:No.> <nsCommon:ID> [Patient’s ID] </nsCommon:ID> <nsCommon:FirstName> </nsCommon:FirstName> <nsCommon:MiddleName></nsCommon:MiddleName> <nsCommon:LastName></nsCommon:LastName> <nsCommon:Sex></nsCommon:Sex> <nsCommon:Age></nsCommon:Age> <nsCommon:DOB></nsCommon:DOB> <nsCommon:NameJ1></nsCommon:NameJ1> <nsCommon:NameJ2></nsCommon:NameJ2> </nsCommon:Patient> <nsCommon:Operator> <nsCommon:No.></nsCommon:No.> <nsCommon:ID></nsCommon:ID> </nsCommon:Operator> <nsCommon:Parts> [2-digit maintenance code for Kowa] </nsCommon:Parts> </nsCommon:Common>

<nsFUNDUS:Measure type=“FUNDUS”> <nsFUNDUS:FUNDUS> <nsFUNDUS:List No=“1”> <nsFUNDUS:ImageType> [Photography type] </nsFUNDUS:ImageType> <nsFUNDUS:AcquisitionDate> YYYY-MM-DD </nsFUNDUS:AcquisitionDate> <nsFUNDUS:AcquisitionTime> HH:MM:SS </nsFUNDUS:AcquisitionTime> <nsFUNDUS:Timer> [Timer elapsed time 00MMSSmmm] </nsFUNDUS:Timer>

<nsFUNDUS:ImageLaterality> [Photographed eye] </nsFUNDUS:ImageLaterality> <nsFUNDUS:PixelSpacing unit=“mm”></nsFUNDUS:PixelSpacing> <nsFUNDUS:FileName> [Image le name] </nsFUNDUS:FileName> </nsFUNDUS:List> <nsFUNDUS:FUNDUS>

<nsStatus:Status> <nsStatus:ImageTypeEx>[Photography type extension]</nsStatus:ImageTypeEx> <nsStatus:FlashIntensity>[Flash intensity]</nsStatus:FlashIntensity> <nsStatus:ISOSensitivity>[Sensitivity]</nsStatus: ISOSensitivity > <nsStatus:Apperture>[Aperture size]</nsStatus:Apperture> <nsStatus:Fixation>[Fixation target position]</nsStatus:Fixation> <nsStatus:Diopter>[Diopter compensation]</nsStatus:Diopter> <nsStatus:Pupil>[Pupil diameter]</nsStatus:Pupil> <nsStatus:ImageSize>[Image size]</nsStatus:ImageSize> <nsStatus:ImageLevel>[Compression rate]</nsStatus:ImageLevel> </nsStatus:Status>

</nsFUNDUS:Measure>

</Ophthalmology>

<nsFUNDUS:HorizontalFieldOfView unit=“deg”> [Field angle] </nsFUNDUS:HorizontalFieldOfView>

Page 79

9 Technical information

9.2 Number of photographs taken using the supplied memory card

The number of photographs you may take using the supplied 2-GB memory card depends on the photography mode as well as size and compression rate that are set according to 5.2.3. Image quality/color. The table below shows approximate number of photographs that may be taken with each setting.

Size Compression rate

Basic 5800

Fine 1500

Basic 3400

Fine 800

Basic 2200

Fine 500

¿Based on the number of photographs taken with a model eye. The le sizes of actual photographs

vary. Please note the above numbers are only approximate numbers.

Number of photographs

Other than FA FA

18500Normal 2200

9300Normal 1150

5350Normal 700

9.3 File format and name of the les generated in the Network connection setting

In the Network connection setting, image les (JPEG) and photography condition les (XML) are generated and saved in a designated folder. The rules on assigning a le name and the le structure of photography condition les are the same as those of the compact ash memory card.

Page 80

10 Light Hazard (ISO 15004-2)

“Caution – 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 form this instrument when operated at maximum intensity will exceed the safety guideline after 1874 pulses for image capturing light, 206 min for illumination light, 30 min for working dots lights(visible), 7 hour for working dots light(IR), 43 hour for focus dots light(visible), 43 hour for focus dots light(IR), 7 hour for internal xation light(red), 7 hour for internal xation light(green), 440662 pulses for external xation light(red), 536139 pulses for external xation light(green).”

㻵㼙㼍㼓㼑㻌㼏㼍㼜㼠㼡㼞㼕㼚㼓㻌㼘㼕㼓㼔㼠

㻝

㻜㻚㻥

㻜㻚㻤

㻜㻚㻣

㻜㻚㻢

㻜㻚㻡

㻜㻚㻠

㼞㼍㼐㼕㼍㼚㼠㻌㼑㼚㼑㼞㼓㼥㻔㼙㻶㻕

㻜㻚㻟

㻜㻚㻞

㻜㻚㻝

㻜

㻟㻜㻜㻠㻜㻜㻡㻜㻜㻢㻜㻜㻣㻜㻜㻤㻜㻜㻥㻜㻜㻝㻜㻜㻜㻝㻝㻜㻜

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㻟㻜㻜㻠㻜㻜㻡㻜㻜㻢㻜㻜㻣㻜㻜㻤㻜㻜㻥㻜㻜㻝㻜㻜㻜㻝㻝㻜㻜

㼣㼍㼢㼑㼘㼑㼚㼓㼠㼔㻔㼚㼙㻕

㻵㼘㼘㼡㼙㼕㼚㼍㼠㼕㼛㼚㻌㼘㼕㼓㼔㼠

㼣㼍㼢㼑㼘㼑㼚㼓㼠㼔㻔㼚㼙㻕

Page 81

㼃㼛㼞㼗㼕㼚㼓㻌㼐㼛㼠㼟㻌㼘㼕㼓㼔㼠㻔㼢㼕㼟㼕㼎㼘㼑㻕

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㻜㻚㻜㻜㻠

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10 Light Hazard (ISO 15004-2)

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㻟㻜㻜㻠㻜㻜㻡㻜㻜㻢㻜㻜㻣㻜㻜㻤㻜㻜㻥㻜㻜㻝㻜㻜㻜㻝㻝㻜㻜

㻜㻚㻜㻝㻠

㻜㻚㻜㻝㻞

㻜㻚㻜㻝

㼣㼍㼢㼑㼘㼑㼚㼓㼠㼔㻔㼚㼙㻕

㻲㼛㼏㼡㼟㻌㼐㼛㼠㼟㻌㼘㼕㼓㼔㼠㻔㼢㼕㼟㼕㼎㼘㼑㻕

㻜㻚㻜㻜㻤

㻜㻚㻜㻜㻢

㼞㼍㼐㼕㼍㼚㼠㻌㼒㼘㼡㼤㻔㼙㼃㻕

㻜㻚㻜㻜㻠

㻜㻚㻜㻜㻞

㻜

㻟㻜㻜㻠㻜㻜㻡㻜㻜㻢㻜㻜㻣㻜㻜㻤㻜㻜㻥㻜㻜㻝㻜㻜㻜㻝㻝㻜㻜

㼣㼍㼢㼑㼘㼑㼚㼓㼠㼔㻔㼚㼙㻕

Page 82

10 Light Hazard (ISO 15004-2)

㻲㼛㼏㼡㼟㻌㼐㼛㼠㼟㻌㼘㼕㼓㼔㼠㻔㻵㻾㻕

㻜㻚㻜㻜㻡

㻜㻚㻜㻜㻠㻡

㻜㻚㻜㻜㻠

㻜㻚㻜㻜㻟㻡

㻜㻚㻜㻜㻟

㻜㻚㻜㻜㻞㻡

㼞㼍㼐㼕㼍㼚㼠㻌㼒㼘㼡㼤㻔㼙㼃㻕

㻜㻚㻜㻜㻞

㻜㻚㻜㻜㻝㻡

㻜㻚㻜㻜㻝

㻜㻚㻜㻜㻜㻡

㻜

㻟㻜㻜㻠㻜㻜㻡㻜㻜㻢㻜㻜㻣㻜㻜㻤㻜㻜㻥㻜㻜㻝㻜㻜㻜㻝㻝㻜㻜

㼣㼍㼢㼑㼘㼑㼚㼓㼠㼔㻔㼚㼙㻕

㻵㼚㼠㼑㼞㼚㼍㼘㻌㼒㼕㼤㼍㼠㼕㼛㼚㻌㼘㼕㼓㼔㼠㻔㼞㼑㼐㻕

㻜㻚㻜㻟

㻜㻚㻜㻞㻡

㻜㻚㻜㻞

㻜㻚㻜㻝㻡

㼞㼍㼐㼕㼍㼚㼠㻌㼒㼘㼡㼤㻔㼙㼃㻕

㻜㻚㻜㻝

㻜㻚㻜㻜㻡

㻜

㻟㻜㻜㻠㻜㻜㻡㻜㻜㻢㻜㻜㻣㻜㻜㻤㻜㻜㻥㻜㻜㻝㻜㻜㻜㻝㻝㻜㻜

㻜㻚㻜㻜㻞

㻜㻚㻜㻜㻝㻤

㻜㻚㻜㻜㻝㻢

㻜㻚㻜㻜㻝㻠

㼣㼍㼢㼑㼘㼑㼚㼓㼠㼔㻔㼚㼙㻕

㻵㼚㼠㼑㼞㼚㼍㼘㻌㼒㼕㼤㼍㼠㼕㼛㼚㻌㼘㼕㼓㼔㼠㻔㼓㼞㼑㼑㼚㻕

㻜㻚㻜㻜㻝㻞

㻜㻚㻜㻜㻝

㼞㼍㼐㼕㼍㼚㼠㻌㼒㼘㼡㼤㻔㼙㼃㻕

㻜㻚㻜㻜㻜㻤

㻜㻚㻜㻜㻜㻢

㻜㻚㻜㻜㻜㻠

㻜㻚㻜㻜㻜㻞

㻜

㻟㻜㻜㻠㻜㻜㻡㻜㻜㻢㻜㻜㻣㻜㻜㻤㻜㻜㻥㻜㻜㻝㻜㻜㻜㻝㻝㻜㻜

㼣㼍㼢㼑㼘㼑㼚㼓㼠㼔㻔㼚㼙㻕

Page 83

㻱㼤㼠㼑㼞㼚㼍㼘㻌㼒㼕㼤㼍㼠㼕㼛㼚㻌㼘㼕㼓㼔㼠㻔㼞㼑㼐㻕

㻜㻚㻜㻞

㻜㻚㻜㻝㻤

㻜㻚㻜㻝㻢

㻜㻚㻜㻝㻠

㻜㻚㻜㻝㻞

㻜㻚㻜㻝

㼞㼍㼐㼕㼍㼚㼠㻌㼒㼘㼡㼤㻔㼙㼃㻕

㻜㻚㻜㻜㻤

㻜㻚㻜㻜㻢

㻜㻚㻜㻜㻠

㻜㻚㻜㻜㻞

㻜

㻟㻜㻜㻠㻜㻜㻡㻜㻜㻢㻜㻜㻣㻜㻜㻤㻜㻜㻥㻜㻜㻝㻜㻜㻜㻝㻝㻜㻜

㼣㼍㼢㼑㼘㼑㼚㼓㼠㼔㻔㼚㼙㻕

㻱㼤㼠㼑㼞㼚㼍㼘㻌㼒㼕㼤㼍㼠㼕㼛㼚㻌㼘㼕㼓㼔㼠㻔㼓㼞㼑㼑㼚㻕

10 Light Hazard (ISO 15004-2)

㻜㻚㻜㻞㻡

㻜㻚㻜㻞

㻜㻚㻜㻝㻡

㼞㼍㼐㼕㼍㼚㼠㻌㼒㼘㼡㼤㻔㼙㼃㻕

㻜㻚㻜㻝

㻜㻚㻜㻜㻡

㻜

㻟㻜㻜㻠㻜㻜㻡㻜㻜㻢㻜㻜㻣㻜㻜㻤㻜㻜㻥㻜㻜㻝㻜㻜㻜㻝㻝㻜㻜

㼣㼍㼢㼑㼘㼑㼚㼓㼠㼔㻔㼚㼙㻕

Page 84

This instrument is a medical electrical instrument. Medical electrical instruments are requireed special attention to the electromagnetic compatibility (EMC). The following section describes the EMC and precautions regarding this instrument. When installing or using this instrument, read the description carefully and follow the directions described. (The EMC of this instrument was tested based on IEC60601-1-2.)

1. Please note that portable- or mobile-type radio frequency communication devices (RF communications instrument) may adversely affect this instrument resulting in malfunctioning.

2. The electromagnetic compatibility (EMC) of this instrument was tested with the options and accessories shown below.

Since using an option or accessory other than those specified may cause malfunctioning of this

instrument due to interferences of other device or cause malfunctioning of other device, use only the options or accessories specied for this instrument.

● Power cable: 3 m maximum

● USB cable (Type A

● USB cable (TypeA

● LAN cable: 5 m maximum

● Coaxial cable: 5 m maximum

● Personal computer: CE Marking and VCCI approved PC

Electromagnetic compatibility (IEC60601-1-2)

─

B): 5 m maximum

─

Mini-B): 3 m maximum

─

Mini-B): 5 m maximum

3. This instrument is not designed such that it can be used adjacent to other instrument or placing one on top of another. Therefore, do not apply such use. Nevertheless, if such use is inevitable, it is necessary to monitor constantly if the instrument is functioning normally after such use has been adopted.

4. We specified the functions listed in the table blow as the basic performance of this instrument to determine EMC of this instrument.

Function Essential performance

Adjusting observation light intensity

Photography functions

Functions concerning operation of the instrument

LCD monitor display functions LCD monitor display

Adjusting photography light intensity

Emission of photography light

Chin rest vertical movement

Field angle selection

Switching of ring slit

Switching of diopter compensation

Switching of optical viewnder (eyepiece), switching of black and white camera

Captured image output

Touch panel input

Page 85

11 Electromagnetic compatibility (IEC60601-1-2)

[Compliance verication and guidance]

Guidance and manufacturer’s declaration - electromagnetic emissions

KOWA VX-20 is intended for use in the electromagnetic environment specied below. The customer or the user of KOWA VX-20 should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11 EN 55011

RF emissions CISPR 11 EN 55011

Harmonic emissions IEC 61000-3-2 EN 61000-3-2

Voltage uctuations/ icker emissions IEC 61000-3-3 EN 61000-3-3

Group 1

Class B

Class A

Complies

KOWA VX-20 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 instrument.

KOWA VX-20 is acceptable in all types of facilities without any limitation to the electrical supply network connected to KOWA VX-20.

Guidance and manufacturer’s declaration - electromagnetic immunity

KOWA VX-20 is intended for use in the electromagnetic environment specied below. The customer or the user of tKOWA VX-20 should assure that it is used in such an environment.

Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance

Electrostatic discharge(ESD) IEC 61000-4-2 EN 61000-4-2

Electrical fast transient/burst IEC 61000-4-4 EN 61000-4-4

Surge IEC 61000-4-5 EN 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11 EN 61000-4-11

±6kV contact

±8kV air

±2kV for power supply lines ±1kV for input/output lines

±1kV differential mode ±2kV common mode

<5% U (>95% dip in UT) for 0.5 cycle

40% U (60% dip in UT) for 5 cycles

70% U (30% dip in UT) for 25 cycles

<5% U (>95% dip in UT) for 5 sec

±6kV contact

±8kV air

±2kV for power supply lines ±1kV for input/output lines

±1kV differential mode ±2kV common mode

<5% U (>95% dip in UT) for 0.5 cycle

40% U (60% dip in UT) for 5 cycle

70% U (30% dip in UT) for 25 cycle

<5% U (>95% dip in UT) for 5 sec

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

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of KOWA VX-20 requires continued operation during power mains interruptions, it is recommended that KOWA VX-20 be powered from an uninterruptible power supply.

Power frequency (50/60Hz) magnetic eld IEC 61000-4-8

3 A/m 3 A/m

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

EN 61000-4-8

NOTE U

is the a.c. mains voltage prior to application of the test level.

Page 86

11 Electromagnetic compatibility (IEC60601-1-2)

Guidance and manufacturer’s declaration - electromagnetic immunity

KOWA VX-20 is intended for use in the electromagnetic environment specied below. The customer or the user of KOWA VX-20 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 communica tions instrument should be used no closer to any part of KOWA VX-20, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Conducted RF IEC 61000-4-6 EN 61000-4-6

Radiated RF IEC 61000-4-3 EN 61000-4-3

NOTE 1 At 80MHz and 800MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from

structures, objects and people.

a Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which KOWA VX-20 is used exceeds the applicable RF compliance level above, KOWA VX-20 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reconguring or relocating KOWA VX-20

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

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

3 Vrms

3 V/m

Recommended separation distance d=1.2 P

d=1.2 P 80 MHz to 800 MHz d=2.3 P 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.

Interference may occur in the vicinity of instrument marked with the following symbol:

Recommended separation distances between

portable and mobile RF communications instrument and KOWA VX-20

KOWA VX-20 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of KOWA VX-20 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications instrument (transmitters) and KOWA VX-20 as recommended below, according to the maximum output power of the communications instrument.

Rated maximum output

power of transmitter

150 kHz to 80 MHz

Separation distance according to frequency of transmitter

d=1.2

80 MHz to 800 MHz

d=1.2 P

800 MHz to 2.5 GHz

d=2.3 P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74 1 1.2 1.2 2.3

10 3.7 3.7 7.4

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 80MHz and 800MHz, 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 reection from structures, objects and people.

Page 87

Page 88

World Sales Headquarters

4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo 103-8433 Japan Phone : 81(3) 3279-7639 Facsimile : 81(3) 3279-7541 URL: http://www.kowa.co.jp/e-life/

Kowa Company, Ltd. Hamamatsu Factory

3-1, Shinmiyakoda 1-chome, Kita-ku, Hamamatsu city, Shizuoka Pref., 431-2103 Japan

Printed on recycled paper.

20001 So.Vermont Ave.Torrance, CA 90502, U.S.A. Phone: 1(310)327-1913 Facsimile: 1(310)327-4177 URL : http://www.kowa-usa.com/

K9L56 V1.0K 110629 MS

Printed in Japan

Kowa VX-20 User Manual

Introduction

Operational considerations for safety

Meanings of symbols

Operating precautions

Precautions: use of medical electrical system

Operational considerations for hospital grade electrical instrument (safety and accident prevention)

Components and supplies

Main unit

Accessories

Optional accessories

MENU

1 System description

1.1 Indication for use

1.2 System overview

1.3 Features

1.4 Name and function of each component

1.5 LCD monitor indications

2 Preparation

2.1 Assembly and installation

2.4 Turning ON the power

2.5 Turning OFF the power

2.6 Retinal camera preparation

2.7 Preparatory procedure of the examined eye

3 Basic operation

3.1 How to use the control lever

3.3 Mydriatic color/ Red Free photography procedures

Mydriatic Fluorescein angiography procedures

3.5 Viewer mode functions and procedures

4 Advanced operation

4.1 Tilt and panning

4.2 Small pupil photography

4.3 LCD Monitoring

4.6 Blue/Brown button

4.7 Customize button

4.8 Power saving function

4.9 Recalling and printing images

5 Setting

5.1 Main

5.2 Capture

5.3 Viewer

5.4 Advanced functions

5.5 Maintenance

6 Troubleshooting

7 Maintenance and inspection

7.1 Daily maintenance

7.2 Daily inspection

7.3 Daily cleaning

7.4 Replacement of consumables

7.5 Regular inspection

9 Technical information

9.2 Number of photographs taken using the supplied memory card

10 Light Hazard (ISO 15004-2)

Electromagnetic compatibility (IEC60601-1-2)