KOWA

FM-700 Instruction Manual Ver 1E

Instruction Manual

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File Name: KOWA - FM-700 Instruction Manual Ver 1E.pdf

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Page 1

Laser Flare Meter Quantitative measurement equipment for flare in the anterior chamber

Kowa INSTRUCTION MANUAL

KOWA FM-700

Introduction

Accept our congratulations on your purchase of KOWA FM-700. KOWA FM-700 is an instrument to measure the protein level contained in the aqueous humor of the anterior chamber of the human eye. This manual provides a description of the operation procedures of KOWA FM-700 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 finished 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 the instrument to assure that the instrument 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

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

Caution

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

*1 Bodily injury means vision loss, an injury, high- or low-temperature burn, electrical shock, fracture, or poisoning that causes a subsequent complication or requires 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 Graphical indication of any 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 fire, 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.

Warning When cleaning the instrument, make sure to turn OFF the power switch and then unplug the instrument from the power outlet. Cleaning the instrument without unplugging it may cause electrical shock or burn. Unplug

If any abnormal smell, sound, overheating or smoke should be detected, make sure to turn OFF the power switch immediately and then unplug the instrument from the power outlet. Continued use of the instrument may cause a fire or instrument malfunction. Contact Kowa or your Kowa dealer for inspection immediately. Only use a power supply cable supplied with the instrument. Otherwise, it may cause a fire or instrument malfunction. Make sure to insert the power plug into the power outlet completely and securely. A loosely connected electrical plug may cause a fire or electrical shock.

Obligatory

Regularly remove dust on the power plug. Dust accumulated on the power plug may absorb moisture, which may result in isolation failure and cause a fire. Make sure that the instrument is properly grounded to prevent bodily injuries. Connect the power plug into the three-wire grounding type outlet with ground wire. Failing to properly ground the instrument may cause electrical shock. Use a designated fuse only. Using an undesignated fuse may cause a fire or instrument malfunction. 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 power switch immediately, unplug the instrument from the power outlet, and then contact Kowa or your Kowa dealer for inspection. Do not touch the power plug with a wet hand when plugging or unplugging the instrument. Otherwise, it may cause electrical shock. Do not load the power outlet or cable with excess of its rated capacity. If the main power supply cable should share a power outlet with other devices and the rated capacity is exceeded, it may cause a fire or electrical shock. Do not install the instrument in a place where it is difficult or impossible to unplug its power supply cable. Otherwise, it may cause a fire or electrical shock.

Prohibitory

Disassembly prohibited

The air vent shown with the arrows in the illustration must not be obstructed. Obstructing the air vent may increase the internal temperature, causing a fire, instrument damage, or instrument malfunction Do not insert any metal object into an air vent or opening of the instrument. Otherwise, it may cause a fire, electrical shock, or instrument malfunction. Do not disassemble, modify or repair the instrument by yourself. Otherwise, it may cause a fire, electrical shock, bodily injury, or instrument malfunction. Refer all servicing to Kowa or your Kowa dealer. The instrument disassembled; modified or repaired by anyone other than a Kowa designated repair facility will void the warranty.

Caution

Unplug

Electrical Hazard

When replacing the lamp, make sure to turn OFF the power switch and then unplug the instrument from the power outlet. Wait for more than five minutes, or more than 30 minutes if immediately after use, before replacing. Replacing the lamp without unplugging the instrument or waiting for more than five minutes may cause electrical shock or burn.

If it will not be used for a long period, unplug the instrument from the power outlet. Otherwise, it may cause a fire. The power supply must be provided for the sole use of this instrument. Sharing the same power supply with other external devices may cause instrument malfunction. Obligatory

When moving up or down the chin rest to adjust the height of the examined eye, carefully manipulate the instrument while checking the position of the patient’s head. A patient with the smaller head may have his or her head caught between the components. Handle the lamp and fuses with care. Otherwise, glass components may be damaged, causing a bodily injury. Do not pull the power supply cable when unplugging the instrument from the power outlet. Doing so may damage the cable and cause a fire or electrical shock. Make sure to hold the power plug when unplugging the instrument. Do not install the instrument at unstable location such as on a shaky base or a tilting surface. Otherwise, the instrument may drop or fall over, causing a bodily injury. This instrument is a stationary device not intended to be used as a portable device. After installing the instrument, do not raise the instrument. This instrument may be shaky and fall over, causing a bodily injury.

High-Temperature

Do not replace the lamp immediately after use. The lamp is heated to high temperature, and it may cause a burn. Wait for more than 30 minutes to cool down the lamp before replacing.

Do not touch the light bulb of the lamp with your bare hand. Otherwise, it may reduce the light intensity or operating life of the lamp. Do not increase the light intensity of the slit light more than required. Otherwise, the patient may experience pain and his or her eye may be injured. Do not look directly into the laser beam for purposes other than diagnosis. Doing so may cause an eye injury. Prohibitory

Keep your fingers off the location shown with the arrows when operating the instrument. Otherwise, your fingers may be pinched and injured. Instruct the patient not to place his or her fingers on the instrument.

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

III

Meanings of symbols

HighTemperature

Electrical Hazard

Symbol for “Power ON”

Symbol for “Caution Electrical Hazard”

Symbol for “Power OFF”

Symbol for “Caution High-Temperature”

Symbol for “Type B applied part”

Symbol for “Authorised Representative in the European Community”

Symbol for “Follow instruction for use”

Symbol for “Manufacturer”

Operating precautions

1. Operating environment 1) Avoid high temperature and humidity, direct sunlight and dust when transporting,installing and storing the instrument. Strictly observe the following environmental conditions. Environmental temperature Relative humidity

Operational

Transport and storage

10 to 35 ℃

-15 to +50 ℃

Slit lamp Flare meter

30 to 90 % 30 to 55 %

10 to 95 %

2) Avoid condensation when using, transporting or storing the instrument. 3) Install the instrument in a room where its lighting can darken to 10 lux or less at which you may barely read a newspaper. Intense outside light will hinder the accuracy of the measurement data. 2. Precautions for electric system 1) Install the instrument in a location where there is little risk of the power plug being pulled out while operating. If the power plug should be pulled out accidentally, make sure to turn OFF the power switch before plugging the system back in. 2) Connect the instrument to a specified power supply (AC100-230V, 50/60Hz). 3) The input voltage should always be maintained within ± 10% of the rated voltage. 4) Do not turn the power switch ON and OFF in succession. Allow an interval of at least ten seconds before turning the power switch ON and OFF. 5) Make sure to turn OFF the power switch before connecting an external device. 6) Do not touch the patient and connectors at the same time as it may adversely affect the safety. 7) Kowa is not liable for malfunctions and/or damages resulting from maintenance and/or repairs performed by a third party other than an agent authorized by Kowa. 8) Kowa is not liable for malfunctions and/or damages resulting from maintenance and/or repairs using parts other than repair parts specified by Kowa. 3. Precautions when using this instrument 1) Disinfect using alcohol the parts accessible by the patient. 2) Always cover this instrument with dust cover when not in use in order to protect. 3) When the instrument has not been used for a long period of time, inspect the items below. • The projection lens and the objective lens are free from dust, dirt or other soils. • Intensity of the lamps appropriately adjustable. • Calibration 4) 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 of 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.

Precautions: use of medical electrical system

1. Electrical devices which constitute KOWA FM-700 system This instrument constitutes medical electric system by connecting with products. - Personal computer It is used when acquiring the measurement results obtained by KOWA FM-700 in personal computer(PC) through a RS-232C cable. When you install a PC in patient environment (within a radius of 1.5m around a patient), please use the belowmentioned “Multi-tap with Isolation Transformer”. Do not touch the connector part of the instrument in KOWA FM700 system and the patient simultaneously.

2. Precautions for use of medical electrical system 1) The system which consists of this instrument and other electrical devices (hereinafter referred to as “this system”) may be installed and used all within a limited patient environment when all components are correctly 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 IEC 60601-1 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., power outlets) may cause increased touch current or potential difference between protective grounds resulting in the injury to the patient or operator. Use “Multi-tap with Isolation Transformer” for supplying the power to all the components other than this instrument. And do not use “Multi-tap with Isolation Transformer” in this system for supplying the power to any components other than this system. 3) Any medical electrical equipment that is connected to this system to compose a medical system must comply with IEC 60601-1. 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 non-medical electrical equipment. 5) Do not use any additional multi-tap or extension power supply cable other than those Kowa specified 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 supply cable for an electrical equipment that compose a medical system must have durability that meets IEC 60245/IEC 60227 or higher standards. 8) Make sure that the instrument is turned OFF when connecting other device to the system. 9) Do not turn ON the power switch until all devices are completely connected. 10) Do not place or install the devices and the system components on the unstable or inclined table. 3. Precautions for use of “Multi-tap with Isolation Transformer” 1) “Multi-tap with Isolation Transformer” should use the one equipped with the rated output more than power consumption of equipment to connect. 2) 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. 3) 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. 4) When using a “Multi-tap with Isolation Transformer”, read the instruction for use attached to it to familiarize yourself with the correct use before use. 4. Daily maintenance and cleaning 1) System components • Wipe the soiled outer surface with firmly squeezed dampened soft cloth. Use mild detergent to remove excessive soils. Do not use chemicals or solvents such as thinner or benzene. (As the 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 supply cables, connecting cables and connectors • Visually inspect that all cables have no flaw or damage. • Visually verify that earth leads of all components and protective ground terminals are securely connected. • Disconnect the power supply cables from the power outlet when you do not use the system for a long period of time. 3) Others • When you change the components of this system, and connection after installing the system, you must build secure system according to notes currently written here. • When the instrument is connected to a PC, measurement results 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. VI

Precautions: use use of of medical medical electrical electrical system system Precautions: ● Combinations of medical electrical equipment and non-medical electrical equipment

IEC 60601-1 Annex Ⅰ“ME system aspects” describe the summary of situations that could occer when different combinations of equipment are used in barious medical enbironments. The brief oberview of IEC 60601-1 Annex Ⅰ is shown below. Medically used room Situation No.

1a Items A and B are ME EQUIPMENT

1b Items A and B are ME EQUIPMENT powered via a MULTIPLE SOCKETOUTLET

Inside the PATIENT ENVIRONMENT

Mains Plug A IEC 60601

Mains Plug B IEC 60601

A IEC 60601

B IEC 60601

Examples of possible Outside the Non-medically causes for exceeding used room LEAKAGE PATIENT CURRENT limits ENVIRONMENT

MULTIPLE SOCKET-OUTLET

1d Item A is ME EQUIPMENT and B is non- ME EQUIPMENT powered via a MULTIPLE SOCKETOUTLET

2a Items A and B are ME EQUIPMENT

2b Items A and item B are ME EQUIPMENT powered via a MULTIPLE SOCKETOUTLET 2c Item A is ME EQUIPMENT and item B is non- ME EQUIPMENT 2d Item A is ME EQUIPMENT and item B is non- ME EQUIPMENT powered via a MULTIPLE SOCKETOUTLET

Mains Plug A IEC 60601

Mains Plug B IEC xxxxx

A IEC 60601

B IEC xxxxx

MULTIPLE SOCKET-OUTLET

Mains Plug A IEC 60601

Mains Plug B IEC 60601

A IEC 60601

B IEC 60601

MULTIPLE SOCKET-OUTLET

Mains Plug A IEC 60601

Mains Plug B IEC xxxxx

A IEC 60601

B IEC XXXXX

MULTIPLE SOCKET-OUTLET

Apply 16.5 in all situations

Multiplied APPLIED PARTS of the same type can cause the total PATIENT LEAKAGE CURRENT to exceed limits See Note 1.

– Verify total PATIENT LEAKAGE CURRENT

Earth conductor of the MULTIPLE SOCKET-OUTLET is broken See also 1a.

– Additional PROTECTIVE EARTH CONNECTION (for A or B) or, – Separating transformer

Due to high TOUCH CURRENT of B

– Additional PROTECTIVE EARTH ONNECTION (for B) or, – Separating transformer (for B)

The earth conductor of the MULTIPLE SOCKET-OUTLET is broken or, Due to high TOUCH CURRENT of B

– Additional PROTECTIVE EARTH CONNECTION (for A or B) or, – Separating transformer

No causes of exceeding LEAKAGE CURRENT

– No further measures are necessary

Earth conductor of the MULTIPLE SOCKET-OUTLET is broken

– Additional PROTECTIVE EARTH CONNECTION (for A or B) or, – Separating transformer

Due to high TOUCH CURRENT of B See rationale for 16.5.

– Do not use metal connector housing or, – SEPARATION DEVICE

The earth conductor of the MULTIPLE SOCKET-OUTLET is broken

– Additional PROTECTIVE EARTH CONNECTION (for A or B) or, – Separating transformer

1 1c Item A is ME EQUIPMENT and B is Non- ME EQUIPMENT

Practical means of compliance

VII

Precautions: use of medical electrical system

Medically used room Situation No.

3a Items A and B are ME EQUIPMENT

3b Item A is ME EQUIPMENT and item B is non- ME EQUIPMENT

Inside the PATIENT ENVIRONMENT

Outside the PATIENT ENVIRONMENT

Mains Plug A IEC 60601

Mains Plug B IEC 60601 Common protective earth

A IEC 60601

B IEC xxxxx Common protective earth

Mains Plug 3c Item A is ME EQUIPMENT and item B in is ME EQUIPMENT or non- ME EQUIPMENT

Examples of possible Non-medically causes for exceeding used room LEAKAGE CURRENT limits

A IEC 60601

Common protective earth

Mains Plug B IEC 60601 or IEC xxxxx Protective earth with potential difference

Practical means of compliance Apply 16.5 in all situations

No causes of exceeding LEAKAGE CURRENT

– No further measures are necessary

Due to high TOUCH CURRENT of B See rationale for 16.5.

– Do not use metal connector housing for SIGNAL INPUT/OUTPUT PART or, – SEPARATION DEVICE

a) Potential difference between PROTECTIVE EARTH CONNECTIONs of A and B b) Due to high TOUCH CURRENT of B See rationale for 16.5.

– Additional PROTECTIVE EARTH CONNECTION for (A), or – SEPARATION DEVICE, or – Do not use metal connector housing in the PATIENT ENVIRONMENT

NOTE 1 No causes of TOUCH CURRENT or EARTH LEAKAGE CURRENT exceeding limits. NOTE 2 IEC 60601: MEDICAL ELECTRICAL EQUIPMENT in compliance with IEC 60601. NOTE 3 IEC xxxxx: Non-medical equipment in compliance with relevant IEC safety standards. NOTE 4 Separating transformer: see 16.9.2.1. NOTE 5 If equipment “B” is outside the PATIENT ENVIRONMENT and if equipment “A” is a CLASS II equipment and has accessible conductive parts connected to the PROTECTIVE EARTH CONNECTION of equipment “B” then additional safety measures could be necessary, for example: additional protective earth for “B” or separating transformer or SEPARATION DEVICE.

VIII

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

1. Only qualified 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, and 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 frequencies, voltages and allowable amperes (power consumption) of the power supply. 6) Check the status of the batteries and power supply (electrical discharge, polarity, etc.). 7) Properly connect ground wires. 3. The following items shall be considered before using the instrument. 1) Make sure that the 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 the all cables are properly connected and secured. 4) Use of other instruments and appliances on the same power outlet is liable to cause errors and incorrect output resulting in incorrect diagnosis or hazards. 5) Before operations, make sure that the battery is sufficiently charged. 4. The following items shall be considered when using the instrument. 1) Make sure to minimize the time and quantity required for diagnosis. 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 part of the instrument except for the chin rest and the forehead rest. 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 specified procedure. 2) Do not pull cables for removal because an excessive force is exerted on them. 3) The following shall be considered regarding storage location. • Store at a location away from water or accidental splashing. • Store 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. • 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,cables, and the like. 5) The instrument must be cleaned after using so that there will be no problem when using it again. 6. In case of a problem or malfunction, do not attempt to repair the instrument by yourself. Appropriately label the instrument as “out of order” and contact a qualified technician for repair. 7. Instrument shall not be modified. 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. 9. Be careful of the possibility that incorrect operation may be caused by strong electromagnetic waves. This instrument is examined based on EN 60601-1-2. The purpose of this standard is to keep safety against the dangerous obstacle in typical medical facilities. In case this instrument is influenced by other instrument, or it affects other instrument or there is such fear, relocate this instrument and other apparatus or extend the distance between those instruments. If you have any questions, please consult Kowa or your Kowa dealer.

Components and supplies

Main unit and accessories Main unit: 1

Chin rest paper: 1set

Chin rest paper retaining pins: 2

Power supply cable: 1

Fuses: 2

Printer papers: 2

External fixation light: 1

Flare fixation light: 1

Calibration tool: 1

Dust cover: 1

Lamp: 1

Instruction manual: 1 Laser Flare Meter Quantitative measurement equipment

Kowa INSTRUCTION MANUAL

KOWA FM-700

Contents Introduction... I Operational considerations for safety...I

Meanings of symbols... IV

Operating precautions...V

Precautions: use of medical electrical system... VI

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

Components and supplies... X Main unit and accessories...X

Contents...XII

Instrument description... 1

XII

1.1

Intended use...1

1.2

Overview...1

1.3

Features...1

1.4

Name and function of each component...2

1.5

Monitor indications...5

Preparation... 7 2.1

Assembly and installation...7

2.2

Moving and transporting the instrument...7

2.3

Turning ON/OFF the power...8

2.4

Setting the printer paper...9

2.5

Connecting external devices using DATA PORT... 9

2.6

Attaching chin rest paper...9

2.7

Basic operations...10

Contents Precautions: use of medical electrical system

Measurement... 13 3.1

Procedure for measurements: Overview...13

3.2

Preparation for measurement...13

3.3

Measurement...14

Setting... 19 4.1

MEASUREMENT SETTING...19

4.2

SYSTEM SETTING...20

Maintenance and inspection... 23 5.1

Regular maintenance...23

5.2

Daily inspection...23

5.3

Cleaning...24

5.4

Replacement of consumables...25

5.5

Checking and maintaining the accuracy of the instrument... 27

5.6

Regular inspection...29

Troubleshooting... 31 6.1

Problem and remedy...31

6.2

Error code...32

Specifications... 33

Literature... 35

Light Hazard... 37

10 Electromagnetic compatibility ... 39

XIII

1 1.1

Instrument description Intended use

KOWA FM-700 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of the human eye. This instrument is used by an ophthalmologist and/or ophthalmic technician to test for inflammation in the anterior segment of the eye.

1.2

Overview

This instrument is equipped with the SLIT LAMP MODE and the FLARE METER MODE. In the SLIT LAMP MODE, slit light is emitted to an examined eye, and the reflected surface is magnified by a microscope. This function may be used as an observation system to achieve a favorable measurement target position in the FLARE METER MODE. In the FLARE METER MODE, laser beam emitted into the anterior chamber scans the examined eye at an orthogonal (right angle) direction. Scattered light from the anterior chamber is detected and used to measure the scattered light intensity (a flare value), which is proportional to the protein level contained in aqueous humor of the anterior chamber. Clinical observation and the scattered light intensity (flare value) acquired through a use of this instrument is beneficial information to diagnose common intraocular inflammations due to uveitis and other anterior eye diseases or during the IOL implantation postoperative course. IMPORTANT Note that some factors including circadian rhythm, age, mydriasis, and drugs may affect flare values. Measurement should be taken carefully taking any of these factors into account. The accuracy of the reading may be affected by disorders shown below: 2 Japanese Journal of Clinical Ophthalmology 43(3):356-358,1989 ・Intensive lens clouding ・Corneal edema ・Corneal opacity ・Shallow anterior chamber ・Achromatic eye

1.3

Features

D Measuring system D Optical system is composed of an illumination unit and a microscope unit positioned orthogonally (at right angles) to the axis of the beam. The scanning laser beam emitted through a projection lens is focused at the anterior chamber or target point. Scattered light from the anterior chamber goes through an objective lens and comes into a focus at an optical aperture. Scattered light passing through the optical aperture is detected by a detector (phtomultiplier tube [PMT]), where it is converted to electrical signals. Then, the electrical signal data is analyzed to determine a flare value. Results are shown on the monitor.

Objective lens Projection lens Anterior chamber

Optical scanner

Laser diode BG2 SIG BG1

0.3mm

The laser beam is scanned by the optical scanner with a 0.6mm-length including the measurement window. As a result, a waveform is obtained as shown in the Figure in the right .

Optical aperture

0.6mm

D measurement of the protein level (flare measurement) D

Detector

Measurement window 0.5mm

Laser scanning light

1 Instrument description

1.4

Name and function of each component

External fixation light

Used for guiding the patient's eye.

Magnification knobs

Forehead rest

Used for holding patient’s forehead in place.

Changes the magnifications of the microscope.

Diopter adjustment rings Adjusts the diopter power.

Chin rest

Used for sustaining the patient’s chin position. A set of chin rest paper may be attached.

Eyepieces

Chin rest handle

Used for adjusting the height of the examined eye.

Measurement button

Starts flare measurement

Instrument base locking knob Secure the position of the instrument base.

Air vent Control lever

AC inlet

Where a power supply cable is connected. A fuse holder is provided.

Instrument base

Used to move the main unit lengthwise or crosswise. You may move the main unit up or down by rotating the lever.

Power switch I : ON ○ : OFF

1 Instrument description

The background light signal 1 (BG1) obtained when laser beam is located below the measurement window and the background light signal 2 (BG2) obtained when laser beam is located above the measurement window are background light noise from intraocular tissue, while flare signal (SIG) is a sum of scattered light from protein and scattered light noise from intraocular tissue. Therefore, intensity of the scattered light caused by the protein level in aqueous humor of the anterior chamber is calculated by: [SIG - (BG1 + BG2)/2]. A result obtained is called “flare value” and in the unit of “photon count per millisecond (photon count/ms)”.

1 Instrument description

Focusing plate

Used for checking or adjusting the laser beam, the slit light and/or the microscope.

Eye level mark

This mark is a suitable position of the patient's eye for measurement.

Slit width adjustment knobs Used to change the width of the slit light.

Flare fixation light

Used for guiding the patient's eye when measuring the flare value.

Illumination unit locking knob Slit length adjustment knobs Used to changes the length of the slit light.

Used to hold the position of the illumination unit.

Microscope unit locking knob Used to hold the position of the microscope unit.

Air vent

Lamp cover

This cover must be opened or closed when replacing the lamp.

DATA PORT

Used for connecting the instrument to a PC to which the output of the measurement data is transmmited.

1 Instrument description

Paper cover open button

BEAM ATTENUATOR

Opens the paper cover.

Blocks the laser beam.

Used for displaying obtained measurement results and the description of function buttons.

Printer

Used for printing the results obtained.

Printer status indicator Indicates the printer status.

Laser status indicator

Projection lens Objective lens

STORE button

Used for saving the results obtained.

Light intensity control knob Adjusts the brightness of the slit light.

Indicates the output status of the laser beam.

Function buttons

Allows the operator to configure settings and control devices by pressing the button according to the monitor display. Selecting a function button which corresponds to the function displayed on the monitor allows the operator to select and operate accordingly.

Paper feed button

Feeds the printer paper.

Paper cut button

Cuts the printer paper.

Instrument description

Monitor

1 Instrument description

1.5

Monitor indications

This section describes the information and buttons displayed on the monitor. Four buttons at the bottom of the screen indicate the function of each buttons.

2JQVQP%QWPV=OU?

1.5.1

Measurement graph screen

BG1

SIG

BG2

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6KOG=UGE?

Background light signal 2 Deviation between BGs ｜BG1-BG2｜＝―――――― ×100 BG1+BG2 Flare signal

(.#4'㧦‫ޓ‬

Flare value

$)%'..50 *+

Measurement status code

';'.GHV 5614' q %#.

Left:Left eye/Right:Right eye

Background light signal 1

5'66+0)

5%#.'

24+06

Jumps to the [MEASUREMENT SETTING] menu

Changes the vertical line scale of the graph

Prints the graph

＝SIG-(BG1+BG2)/2

(See next page)

(indicated when [L/R DETECTION] is [ON])

EYE

Number of data sets saved Instrument status icon

'0& Ends measurement and jumps to the summary data screen

D Instrument status icon D The icons below indicate the status of the instrument while in the FLARE METER MODE. A corresponding instrument status message is also printed on the printout. Icon

Description The angle between the microscope unit and the

㪐㪇㫦 illumination unit is not 90°.

㪚㪘㪣 5

Action Check that the angle between the microscope unit and the illumination unit is 90°. When this angle is not at 90°, the flare value may become unreliable.

An optical device (the reference light or the laser) has not reached a specified temperature.

The flare value may become unreliable if a measurement is performed in this state. Wait for some time; if the icon remains on the monitor, please contact Kowa or your Kowa dealer.

The lamp has burnt out.

Replace the lamp. (See “5.4.1 Replacement of lamp”.)

Calibration has not been performed over a month.

Perform calibration. (See “5.5.1 Calibration”.)

1 Instrument description 1.5.2

Summary data screen

L: Left eye/ R: Right eye

Measurement No. Deviation between BGs BG average Flare value Measurement status code

（indicated when [L/R EYE DETECTION] is [ON]）

Measurement data: white

DELETE data: gray

(not included in the calculation of the flare value average and standard deviation)

#8) Average of flare values deviation of flare 5& Standard values '&+6

$#%-

24+06

0':6

Switches to the measure- Returns to the measure- Prints the summary ment data edit screen ment graph screen data

Deletes the measurement data, and jumps to a screen to start a new measurement

D Measurement status code D The flare value may become unreliable under certain alignment or measurement conditions while in the FLARE METER MODE. Factors which may compromise the reliability of the measurement data are indicated on this instrument as shown below: Code

Printer output code

Description

Action Intense background light noises may be interfering with the measurement window. Change the target point and measure again.

The deviation between BG1 and BG2 is 15% or more.

CELL

Cell contamination was detected during flare measurement. The data may be unreliable. * The cell criteria is SIG (variance)>5×SIG (average).

Background light signal (BG) is larger than flare value. Or background light signal is extremely strong. This code is displayed when the flare values are clasified as shown below. Flare value Less than 10 10 or higher, less than 30 30 or higher, less than 100 100 or higher

BG ≧ 20 ≧ 30 ≧ 40 ≧ 50

Change the target point and measure again.

Change the target point and measure again. If necessary, darken the exam room.

S/N

HI LO

H L

Flare value is out of the measurement range. The flare value may be unreliable. See “7. Specifications” for the measurement range.

The measured flare value is for reference purpose only.

Indicated when the [PRINT ALIGN INFO] setting is ON (See “4.2.3 PRINT LAYOUT SETTING”) and the [ALIGNMENT MONITOR] function is in use.

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Instrument description

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Preparation

2.1

Assembly and installation

This instrument must be installed by a person who is knowledgeable about its use and operations. ① Check if the location where the instrument is to be installed meets the conditions below; 3 a level, flat, and stable surface 3 exposed to least amount of dust 3 in a darkroom, or a room where its lighting can be dimmed to a level equivalent to a darkroom (10 lux or less) 3 equipped with an independent power outlet with a circuit breaker for AC100-230V ② The instrument must be operated, stored, or transported under the conditions shown in the table below: Environmental temperature Relative humidity Atmospheric pressure

Operating

Storing and transporting

10 to 35℃

-15 to +50℃

Slit lamp Flare meter

30 to 90% 30 to 55%

800 to 1060 hPa

10 to 95% 700 to 1060 hPa

* Install the instrument so that its side surfaces are apart from the walls approximately 5cm.

Caution Do not install the instrument at unstable location such as on a shaky base or a tilting surface. Otherwise, the instrument may drop or fall over, causing a bodily injury. Prohibitory

2.2

This instrument is a stationary device not intended to be used as a portable device. After installing the instrument, do not raise the instrument. This instrument may be shaky and fall over, causing a bodily injury.

Moving and transporting the instrument

The instrument weighs approximately 25kg. To avoid bodily injuries and/or damages to the instrument, please consult with Kowa or your Kowa dealer when moving the instrument. In order to assure the safety of personnel, the instrument and other devices to the utmost extent, please observe the following precautions when moving or transporting the instrument. 3 Turn OFF the power switch of the instrument. 3 Unplug the instrument from the power outlet. 3 Disconnect the instrument from the cable connected to the DATA PORT. When bundling the power supply cable, do not pull with an excess force or bend it hard to prevent damages. 3 Tighten the illumination unit locking knob and the microscope unit locking knob and secure the instrument with both the illumination unit and the microscope unit closed. 3 Tighten the instrument base locking knob and secure the main unit.

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