Kowa fm600 User Manual

Quantitative measurement equipment

600

for flare in the anterior chamber

Laser Flare Meter

KOWA FM-

INTRODUCTION

Accept our congratulations on your purchase of Laser Flare Meter KOWA FM-600 (referred to as FM-600 in this manual). This manual provides a description of the operation procedures of FM-600 along with important precautions to be observed during its use. Please read this entire manual carefully to assure that the instrument can demonstrate its full capabilities and be used effectively. After you have finished reading it, please keep it in an easily accessible location near the instrument for future reference.

INTENDED USE

FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber.

Operational Considerations for Safety

This manual describes important precautions to be observed during its use to assure that the instrument can be used safely without causing any damage to the human body and property of its purchaser and other persons. The designations and their pictorial symbols have the following meanings. These should be fully comprehended before reading the text of this manual.

■ Meanings of Designations

WarningWarning

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

CautionCaution

If the instrument should be operated wrongly, there may result in a bodily injury (not so serious as to cause death) damage to property

✽ 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 the house and household goods as well as the domestic animal

and pet.

■ Meanings of Symbols

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 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.

✽ 2

✽ 1

■ 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 the instruction manual.

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

Unplug

Obligatory

Warning

Prohibitory

Disassembly

prohibited

WarningWarning

If any abnormal smell or sound, or 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 fire. Contact your Kowa dealer where you have purchased the instrument or your nearest repair shop for inspection.

When replacing the fuse, be sure to turn OFF the main power and unplug the instrument from the power outlet.

Warning

/ High-Voltage

Removing the fuse holder cover without unplugging the instrument may cause electrical shock.

Be sure to plug into the power outlet completely and securely. Doing otherwise may cause a fire or electrical shock.

Use only a specified fuse. Doing otherwise may cause a device failure or fire.

Be sure to ground the instrument properly and securely in order to avoid bodily injury. Be sure to connect the plug in the three-wire grounding type socket. Doing otherwise may cause electrical shock.

Be sure that the tips of instrument are not in contact with the eye and the nose of the patient when in operation. (The patient may be injured.)

Do not place a cup or a glass containing liquid or the like on or near the instrument. Spilling liquid into the instrument may cause electrical shock. If liquid should be spilled into the instrument, turn OFF the main power, and unplug the instrument from the power outlet. Contact your Kowa dealer where you have purchased the instrument or your nearest repair shop for inspection.

Do not disassemble, modify or repair the instrument yourself. Doing so may cause a fire, electrical shock, instrument malfunctioning or bodily injury. Contact your Kowa dealer where you purchased the instrument for repair. The product assembled by yourself will not be covered under warranty nor any other service.

Prohibitory

Obligatory

Prohibitory

Do not load the socket or plug board with excess of its rated capacity. If the main power cord should share a power outlet with other devices and the rated capacity is exceeded, there may cause a fire or electrical shock.

CautionCaution

The power supply must be provided for the sole use of this instrument. Sharing one and the same power supply with other devices may cause FM-600 to malfunction.

Do not pull the electrical cord when unplugging. Doing so may damage the cord and cause a fire or electrical shock. Be sure to hold the plug when unplugging the instrument.

Do not plug or unplug the power cord with wet hand. Doing so may cause electrical shock.

Do not install the power unit 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 wipe the exterior of the instrument with solvent such as benzene, alcohol, thinner and ether. Doing so may cause discoloration or degradation.

If the instrument is not to be in use for a long period of time, unplug the power cable.

Unplug

Leaving the power cable plugged may cause a fire.

Location of Cautionary Marking

Description of Labels and Symbols

Before replacing fuse, be sure to turn OFF the main power and unplug the instrument. Removing the fuse holder cover without unplugging the instrument may cause electrical shock.

Do not touch directly the connector pins that are labeled with the symbols shown in the left. ❇ For details, please refer to p.36 [About electromagnetic compatibility (EMC)].

Type B applied parts (degree of protection of applied part against electric shock).

Alternative Current

OFF

CLASS 1 LASER PRODUCT

Laser Class based on IEC60825-1:2001

Precautions Concerning Use

• Handle the instrument with care, and do not apply strong shock to it. Also, do not leave any objects on the instrument.

• Always cover the system when not in use in order to protect its components.

• Avoid high temperature and humidity, direct sunlight, and dust when shipping, installing, and storing the instrument. Strictly observe the following environmental conditions. When in use, in storage or in transit, environmental conditions described below must be observed strictly in order to protect the instrument from condensation.

In operation Ambient Temperature Relative Humidity

Precautions Concerning Use of Electrical System

• If the instrument is not to be in use for a long period of time, turn OFF the main power and unplug the instrument.

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

• The manufacturer is not liable for malfunctions and/or damages resulting from maintenance and/or repairs performed by persons other than the specified repair service.

10 - 40 °C -15 - +50 °C

30 - 60 % 10 - 95 %

Transportation, storage

• The manufacturer is not liable for malfunctions and/or damages resulting from maintenance and/or repairs using parts other than specified repair parts.

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

• Do not turn the main power on and off in succession. Allow an interval of at least 5 seconds before turning the main power on and off.

• Be sure to turn OFF the main power before plugging or unplugging the system.

Precautions Concerning Disposal of the Instrument

• The liquid crystal display of this instrument contains mercury. When disposing of this instrument, comply with the regulations of countries or areas in which the instrument is used.

Other Precautions

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

• It is recommended that this instrument be used where ambient illumination is evenly distributed at 100 lx or less (400 lx or less when using an optional light shielding cover).

• Take the history of the patient’s medical history; once it is confirmed that there will not be a problem with using mydriatic agent, administer mydriatic drops to him/her regardless of the level of ambient illumination.

◆ Precautions during Operation

• Use special caution when operating the instrument to avoid hands being caught in the areas indicated with arrows in the illustration below.

• There is an air vent on the bottom surface of the instrument. When installing the instrument, do not obstruct the vent.

Air vent

Precautions (Safety Precautions and Hazard prevention) Concerning Use of Medical Electrical Instrument

1. Instrument should be operated only by qualified personnel.

2. The following precautions must be observed when installing the instrument:

(1) Install at a location free of moisture. (2) Install at a location where there is no risk of detrimental effects caused by atmospheric pressure, temperature,

humidity, ventilation, sunlight, dust, salt, or air containing sulfur and so forth. (3) Install the instrument in a stable manner, avoiding inclines, vibrations and shock (including those during transport). (4) Do not install in locations where chemicals or pharmaceuticals are stored or where there is generation of gas. (5) Use the proper power supply, frequency, voltage and allowable current values (or power). (6) Check the status of battery-operated power supplies (degree of discharge, polarity, etc.). (7) Be sure that the instrument is properly grounded.

3. The following precautions must be observed before using the instrument:

(1) The instrument must be inspected for switch contact, polarity, dial settings and meter readings to confirm its proper

operation. (2) Be sure that the instrument is properly grounded. (3) Be sure that all cords are connected properly and securely. (4) Avoid combined use of instruments since this can lead to inaccurate diagnosis and hazards. (5) Re-inspect any external circuits that come in direct contact with patients. (6) Check all battery-operated power supplies if applicable.

4. The following precautions must be observed while using the instrument:

(1) Do not exceed the time and quantity required for diagnosis and treatment. (2) Continuously monitor the instrument for any abnormalities as well as the condition of the patient. (3) When an abnormality is noticed in the instrument or the patient, take appropriate measures, such as to terminating

operation of the instrument while ensuring the safety of the patient. (4) Do not allow the patient to touch the instrument.

5. The following precautions must be observed following use of the instrument:

(1) Follow the specified procedures to return all operating switches, dials and other components to their positions prior

to use; then turn OFF the main power. (2) When disconnecting cords, hold the plug body firmly so as not to apply excessive force to the cord itself. (3) The following items must be observed with respect to the location where the instrument is stored.

(a) Store in a location free from moisture.

(b) Store in a location where there is no risk of detrimental effects caused by atmospheric pressure, temperature,

humidity, ventilation, sunlight, dust, salt, or air containing sulfur and so forth.

port).

(d) Do not store in locations where chemicals or pharmaceuticals are stored or where there is generation of gas. (4) Store all accessories, cords, leads and other components in an organized manner after cleaning. (5) Be sure to clean the instrument so that it functions properly the next time it is used.

6. If the instrument should malfunction, the operator should not attempt to correct the problem. Appropriately indicate that the instrument is not operating properly and await repairs by qualified personnel.

7. Never attempt to disassemble or modify the instrument.

8. Maintenance and inspection

(1) All instrument and components should be inspected regularly. (2) When resuming use of instrument that has not been used for a long period of time, always confirm that the instru-

ment operates properly and safely before use.

9. Beware that strong electromagnetic waves may cause the instrument to operate incorrectly.

This instrument has been tested based on JIS T0601-1-2:2002 and IEC60601-1-2:2001. The purpose of these standards is to maintain safety against the dangerous obstacle in typical medical facilities. However, the instrument may affect or be affected by certain equipment such as cellular phones and pace makers. In case this instrument is influenced by other equipment, or it affects other equipment, or there is such fear, relocate and/or increase the distance between FM-600 and affecting equipment. Should there be any further questions and/or unknown points, please consult your Kowa sales representative or dealership beforehand.

Accessories

Power cable (1) Fuse (2) Dust cover (1)

Chin-rest paper (1)

Instruction Manual (1)

Chin-rest’s pin

(2) Printer paper (2)

Table of Contents

Introduction ................................................................................................................................ 1

Precautions Concerning Use .................................................................................................... 4

Precautions (Safety Precautions and Hazard Prevention)

Concerning Use of Medical Electrical Instrument .................................................................. 5

Accessories ................................................................................................................................ 6

Table of Contents ....................................................................................................................... 7

1. Principle of operation ......................................................................................................... 9

2. Names and functions of components ............................................................................. 10

2-1 Names and functions of components ......................................................................................................... 10

2-2 Screen display details ................................................................................................................................ 13

3. Setting up .......................................................................................................................... 15

3-1 Installation .................................................................................................................................................. 15

3-2 Printer paper installation ............................................................................................................................ 15

4. Basic aligning procedure ................................................................................................. 16

4-1 Coarse lengthwise / crosswise adjustment ................................................................................................ 16

4-2 Fine lengthwise / crosswise adjustment ..................................................................................................... 16

4-3 Measurement switch .................................................................................................................................. 16

4-4 Frontal view switch ..................................................................................................................................... 16

5. Calibration ......................................................................................................................... 17

5-1 Calibration .................................................................................................................................................. 17

5-2 Light shielding cover .................................................................................................................................. 18

6. Procedure for measurements .......................................................................................... 19

6-1 Procedure for measurements: Overview .................................................................................................... 19

6-2 Ocular height adjustment ........................................................................................................................... 19

6-3 Frontal view alignment ............................................................................................................................... 19

6-4 Diagonal view alignment ............................................................................................................................ 20

6-5 BG check ................................................................................................................................................... 21

6-6 Measurement ............................................................................................................................................. 21

6-7 Displaying measurement results ................................................................................................................ 22

6-8 Viewing and editing acquired data ............................................................................................................. 23

Table of Contents

7. Tips for measurements .................................................................................................... 24

7-1 How to block laser beams .......................................................................................................................... 24

7-2 Warning beep during BG check ................................................................................................................. 24

7-3 Recommended procedure when BG check obtains no correct alignment ................................................. 24

7-4 Recommended procedures when BG check obtains no good result ......................................................... 24

7-5 Recommended procedures when measured waveforms are offset to left or right ..................................... 25

8. Configuration and settings .............................................................................................. 26

9. Miscellaneous ................................................................................................................... 28

9-1 ID input ....................................................................................................................................................... 28

9-2 Connecting external devices ...................................................................................................................... 28

9-3 Display messages ...................................................................................................................................... 30

9-4 Function switches ...................................................................................................................................... 31

9-5 Relocation .................................................................................................................................................. 31

10. Troubleshooting ................................................................................................................ 32

10-1 Phenomena and validation ........................................................................................................................ 32

10-2 Error messages.......................................................................................................................................... 32

11. Maintenance/Inspection ................................................................................................... 33

11-1 Daily maintenance ..................................................................................................................................... 33

11-2 Daily inspection (by the user)..................................................................................................................... 33

11-3 Fuse replacement ...................................................................................................................................... 34

11-4 Chin-rest paper installation ........................................................................................................................ 34

11-5 Sterilization of Forehead stopper and Chin-rest ........................................................................................ 34

11-6 Refilling and replacing consumables ......................................................................................................... 34

11-7 Regular inspection (by the device supplier) ............................................................................................... 34

11-8 Repairing.................................................................................................................................................... 34

12. Specifications ................................................................................................................... 35

12-1 Specifications ............................................................................................................................................. 35

12-2 Applicable safety standards and Classification .......................................................................................... 35

13. Electromagnetic Compatibility ........................................................................................ 36

14. Photochemical Hazard (ISO 15004:1997)........................................................................ 39

1. Principle of operation

Weak scattered light induced by laser beam entered into the anterior chamber is detected and used for measurements. It is known that intensity of the scattered light is proportional to the protein level contained in aqueous humor of the anterior chamber. However, intensity of the scattered light may vary if there is a difference in the protein composition between aqueous humor samples at the same protein concentration. We refer to this scattered light intensity as “flare value" and indicates the value using photon count per millisecond in this device.

✽ Photon count is the number of pulses output from photomultiplier when scattered light is detected. This value may be converted

into an albumin level. Bovine albumin solution at 100mg/dl equals to 13 Photon counts per millisecond.

CautionCaution

Note that some factors including circadian rhythm, age, mydriasis, and drug may affect flare values. Measurement must be taken carefully taking any of these factor in account. The accuracy of the reading may be affected by disorders shown below:

✽ Intensive lens clouding, corneal edema, corneal opacity, the anterior chamber with an artificial lens implanted, shallow anterior

chamber, and achromatic eye.

■ Details ■

Measurements

Optical system is composed of a laser beam emitter and a photoreceiver positioned at a orthogonal to the axis of the beam. The scanning laser beam emitted through a condensing lens is focused at the anterior chamber or target point. Scattered light from the anterior chamber goes through a photoreceiver lens and comes into a focus at a photoreceiver mask. The photoreceiver mask has an important role to create a reading window within aqueous humor of the anterior chamber. Scattered light coming through the mask reach to a photoreceiver element (or a photomultiplier tube) where it undergoes a photo-electro conversion process. Then, the collected data is analyzed at the analyzer unit to determine a flare value. Results are shown in the display.

Anterior chamber

Photoreceiver element

Photoreceiver mask

Photoreceiver lens

Measurement window

Condensing lens

Scanning laser

Details of flare reading

An area including the Measurement window is scanned with laser beam. As a result, a waveform shown in Fig. 1-2 is obtained. Background Signal 1 (BG1) obtained when laser beam is located below the a Measurement window and Background Signal 2 (BG2) obtained when laser beam is located above the a Measurement window are scattered 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 concentration in aqueous humor of the anterior chamber is calculated using the formula: SIG - (BG1 + BG2)/2. A result obtained using this formula is called “flare value” and represented as photon count per millisecond.

Figure 1-1

BG2

SIG

BG1

Figure 1-2

Measurement window

Laser scanning light

2. Names and functions of components

■

2-1 Names and functions of components

Measurement unit

Main unit

Operating unit

Power supply unit

1 Power switch

: OFF : ON

2 Power supply inlet

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

3 External device I/O terminal (for a communication cable)

Used for connecting a PC to which measurement data outputs are transmitted.

4 External device I/O terminal (for a ten key pad)

Used for connecting a ten key pad.

5 Chin-rest illumination

Used for illuminating indirectly the patient’s eyes from a lower level than the eyes (used in dark room).

6 Chin-rest

Used for holding patient's chin on it. A sheet of chin-rest paper may be attached.

7 Forehead rest

Used for holding patient's forehead. The screw holes on the top are used for installing a light shade (optional accessory) .

12 34 5

2. Names and functions of components

89 0 A

8 Photoreceiver lens

The lens that mainly receives scattered light.

9 Front camera and Eye fixation lamp window

Used for monitoring a patient’s eye. The patient may see the eye fixation lamp inside.

0 Light emitting lens

Used for emitting laser beam and alignment light.

A Calibrator

Used for calibrating the device. This may be used as a laser beam attenuator when located in between a measuring position and a calibrating position.

B Printer

Used for printing the results obtained.

C Printer lid button

The printer lid opens when the round dimple is pushed. Used for replacing printer paper.

D Joy stick (rubber ring)

Hold and move this joy stick to move the Main unit lengthwise or crosswise for a longer distance. Tilt this joy stick to move the Main unit lengthwise or crosswise for a shorter distance. Turn the rubber ring to ascend or descend the Measurement unit.

E Display

Used for displaying Images for monitoring and obtained measurement results. Also used for displaying each function.

F Eye level mark

This mark is a suitable position of the patient’s eye on measurement.

2. Names and functions of components

GHI

G Self-locking screw

Tightening this screw lock the Main unit.

H Measurement switch

Pushing this switch proceeds with Frontal view alignment screen ➔ Diagonal alignment screen ( BG check ) ➔ Start measurement.

I Print switch

Pushing this switch allows contents in the display to be printed or output (only when light is lit).

J Chin-rest ascending/descending switch

Used for ascending and descending Chin-rest.

K Function switches

✽

Operates as they are assigned in accordance with each screen.

L Switches for frontal view

Pushing this switch switches the current display screen to Frontal view alignment screen (only when the light is ).

✽

Function switches

Functions assigned to the [Function Switch Display Area] (refer to Page 13) may vary depending on the screen you have chosen. Each of functions shown in each screen is selected and executed by pushing the corresponding function switch. In this manual, “select [xxx]” means pushing the corresponding function switch.

Display Function switch display area

Operating segment function swiches

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