Kowa VX-20 User Manual

RETINAL CAMERA
Kowa
INSTRUCTION MANUAL
KOWA VX-20
US

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

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.
I
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.
II
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
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
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.
IV

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”.
V

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
VI
Caution
Federal law restricts this device to sale by or on the order of a Physician or Practitioner.
For US market
● 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-
1
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
2
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
3
3b Item A in PATIENT ENVIRONMENT and item B in non-medi­cally used room
A
IEC
60601
A
IEC
60601
A
IEC 60601
IEC XXXXX
A
IEC
60601
A
IEC
60601
A
IEC
60601
A
IEC
60601
B
IEC
60601
B
IEC
XXXXX
B
Protective earth
B
IEC
60601
B
IEC
XXXXX
Common protective earth
B IEC 60601 or IEC XXXXX
B IEC 60601 or IEC XXXXX
Protective earth with potential difference
For B:Additional protective earth or separating transform­er
For B:Additional protective earth or separating transform­er
For B:See 19.201 and its rationale
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

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

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.
6.
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.
9.
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.
IX

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
X
Chin rest paper retaining pins:2
Blower:1 Dust cover:1
Compact ash
memory card: 1
Hex wrenches: 3 Head bands: 2 Fuses:2

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
XI

MENU

Introduction ............................................................................................. I
Operational considerations for safety ....................................................................................I
Meanings of symbols ............................................................................ V
Operating precautions .........................................................................VI
Precautions: use of medical electrical system ................................VIII
Operational considerations for hospital grade electrical instrument
(safety and accident prevention) ........................................................IX
Components and supplies ....................................................................X
Main unit ...............................................................................................................................X
Accessories ..........................................................................................................................X
Optional accessories ...........................................................................................................XI
MENU .................................................................................................... XII
1 System description .................................................................................. 1
1.1 Indication for use .......................................................................................................1
1.2 System overview........................................................................................................1
1.3 Features.....................................................................................................................1
1.4 Name and function of each component .....................................................................2
1.5 LCD monitor indications ............................................................................................6
2 Preparation ............................................................................................... 8
2.1 Assembly and installation ..........................................................................................8
2.2 Inserting/ removing compact ash memory card ....................................................... 8
2.3 System connection conguration ............................................................................... 9
2.4 Turning ON the power .............................................................................................10
2.5 Turning OFF the power ............................................................................................10
2.6 Retinal camera preparation ..................................................................................... 11
2.7 Preparatory procedure of the examined eye ........................................................... 11
3 Basic operation ...................................................................................... 12
3.1 How to use the control lever ....................................................................................12
3.2 Non-mydriatic photography/ autouorescence photography procedures ................13
3.3 Mydriatic color/ Red Free photography procedures ................................................16
XII
3.4 Mydriatic Fluorescein angiography procedures ....................................................... 19
3.5 Viewer mode functions and procedures ..................................................................23
4 Advanced operation .............................................................................. 30
4.1 Tilt and panning ....................................................................................................... 30
4.2 Small pupil photography ..........................................................................................31
4.3 LCD Monitoring ........................................................................................................ 33
4.4 Switching xation target ........................................................................................... 34
4.5 Additional adjustment of the ash intensity(+5 or more,
4.6 Blue/Brown button ................................................................................................... 37
4.7 Customize button .................................................................................................... 37
4.8 Power saving function ............................................................................................38
4.9 Recalling and printing images .................................................................................38
-
5 or less) ........................37
5 Setting ..................................................................................................... 39
5.1 Main .........................................................................................................................39
5.2 Capture ....................................................................................................................41
5.3 Viewer .....................................................................................................................42
5.4 Advanced functions ................................................................................................. 43
5.5 Maintenance ............................................................................................................46
6 Troubleshooting ..................................................................................... 48
7 Maintenance and inspection ................................................................. 52
7.1 Daily maintenance ...................................................................................................52
7.2 Daily inspection .......................................................................................................53
7.3 Daily cleaning .......................................................................................................... 54
7.4 Replacement of consumables ................................................................................. 55
7.5 Regular inspection ...................................................................................................59
8 Specications ........................................................................................ 60
9 Technical information ............................................................................ 61
9.1 Folder structure and data format of the compact ash memory card ......................61
9.2 Number of photographs taken using the supplied memory card .............................63
9.3 File format and name of the les generated in the Network connection setting ......63
10 Light Hazard (ISO 15004-2) ................................................................... 64
11 Electromagnetic compatibility (IEC60601-1-2) .................................... 68
XIII
XIV

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
1
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.
2
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
3
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.
4
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.
5
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
1
2 4
3 5
6
7 8
9 0
-
^
\
Timer
1
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.
q
w
e
r
t
Photography mode
2
This indicates the photography mode currently selected.
LCD monitoring mode
3
Used for the LCD monitoring mode.
Field angle
4
This indicates the current eld angle.
Left or right eye
5
This indicates which eye will be photographed.
Diopter compensation
6
This indicates the state of the diopter compensation lens.
Fixation target information
7
This indicates the information of the xation target currently selected.
Filter
8
It indicates whether the lter for uorescent is inserted.
Aperture
9
This indicates that a large value is selected in the aperture.
Flash intensity
0
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.
ID
\
The current patient's is indicated. Do not appear in VK con­nection mode.
VIEWER button
q
It is a button to go to the V iewer mode from the Capture mode.
Fixation target selection button
w
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
e
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
r
It is a user-dened button in the setting.
Blue/Brown button
t
Used to adjust the intensity which is suitable for blue eyes.
6
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
y
CENTRAL button
u
DISC button
i
MACULA button
o
1.5.2 Viewer mode screen
y
u
i
o
p
CENTRAL
DISC
MACULA
PERI
PHERAL
VIEWER
EXT
FIXTION
When you press the “PERIPHERAL button”, par ticular bottons below appear.
RERI
PHERAL
NEXTBACK
@ [
PERIPHERAL button
p
BACK button
@
NEXT button
[
a
Setting button
a
It is a button to set various settings.
CAPTURE button
s
Used for changing to the Capture mode.
Input ID button
d
It is a button to input IDs.
VIEW button
g
Used to display a next image of the currently played image.
MULT button
h
Used to display an image of the same ID in four sections.
PRINT button
j
Used to print out the currently displayed image.
s
d
f
g
h
j
k
REVIEW button
f
Used to display a previous image of the currently played im­age.
TRASH button
k
Used to delete the currently displayed image from the com­pact ash memory card.
7

2 Preparation

Notice

2.1 Assembly and installation

Following the assembly manual provided separately, assemble the power supply unit and the optical
1
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).
2
As needed, adjust the adjuster so that the retinal camera will be level.
3
Make sure that the power switch is in the OFF position, and connect
4
the power supply cable plug to a 120VAC power outlet.
If you want to attach the objective lens cap holder, attach it directly on
5
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.
8
2.2.2 Removing a compact ash memory card
Notice
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.
9
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.
1
It takes approximately 40 seconds for the instrument to be fully ready for operation. Wait until the start-up
2
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
1
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
2
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
3
turns orange, switch the power switch to the OFF position.
10
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,
1
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.
2
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.
11
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