Kowa fm600 manuel d'utilisation

EU Quantitative measurement equipment for flare in the anterior chamber Laser Flar e Meter KO W A K O WA FM- 600[...]

1 War ning War ning Caution Caution INTRODUCTION 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 (not so serious as to cause death) ✽ 1 or damage to property ✽ 2 . INTRODUCTION Accept our congratulations on [...]

2 War ning War ning 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[...]

3 Description of Labels and Symbols Location of Cautionary Marking 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. Type B applied parts (degree of protection of applied part against electric shock). Alternative Current O[...]

4 • Handle the instrument with care, and do not ap- ply strong shock to it. Also, do not leave any objects on the instru- ment. • Always cover the system when not in use in or- der to protect its components. • Avoid high temperature and humidity, direct sunlight, and dust when shipping, installing, and storing the instrument. Strictly observe[...]

5 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[...]

6 Accessories Power cable (1) Fuse (2) Dust cover (1) Chin-rest paper (1) Chin-rest’s pin (2) Printer paper (2) Instruction Manual (1)[...]

7 Table of Contents Introduction ................................................................................................................... ............. 1 Precautions Concerning Use .................................................................................................... 4 Precautions (Safety Precautions and Hazar d Prevention)[...]

8 7. Tips for measurements .................................................................................................... 24 7-1 How to b lock laser beams .................................................................................................... ...................... 24 7-2 W arning beep dur ing BG check ...........................[...]

9 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 co[...]

10 2. Names and functions of components ■ 2-1 Names and functions of components 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[...]

11 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 [...]

12 G Self-locking screw Tightening this screw lock the Main unit. H Measurement switch Pushing this switch proceeds with Frontal view alignment screen ➔ Diagonal align- ment 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 asc[...]

13 FLARE: 9. 5 WA: C N: 5 ID:1234567890 L FLARE: 9. 5 WA: C N: 5 ID:1234567890 L List List Stop ■ 2-2 Screen display details Detail of each screen display ■ Frontal view alignment screen ■ ■ Diagonal alignment screen ■ Function switch display area Previous data Flare value Additional information Number of data saved Corneal reflection lum[...]

14 Del Scale BG N:3 S/N CELL FLARE : 9 SIG:20 BG2:10 (9%) BG1:12 B S FLARE W/A NB G (%) 1 1.3 7 5.3 2 1.0 1 6.1 3 1.2 0 5.7 4 0.7 2 4.7 5 0.7 2 4.3 AV. :5.2 SD. :0.8 Cont. Edit Stat End List ■ Measurements graph screen ■ Background Signal 1 Background Signal 2 Flare Signal Flare V alue = SIG - ( BG1 + BG2 ) /2 To save no data T o change vertica[...]

15 ■ 3-1 Installation Place the device on a motorized table (optional accessory). Make sure that POWER Switch shown in Fig. 1 is at OFF position (O). Connect the power cable to the power supply inlet and connect the other end of the cable to a nearby wall outlet. ■ 3-2 Printer paper installation The printer lid opens when the round dimple “Pr[...]

16 ■ 4-4 Frontal view switch Use this switch to c h ange from fine adjustment (Diagonal alignment screen) to coarse adjustment (Frontal view alignment screen) or return to fine adjustment (Diagonal alignment screen) from post-measurement (Measurements graph screen) (Fig. 4). ■ 4-3 Measurement switch Use this switch to change from coarse adjustm[...]

17 Stained lens may affect measurements. It is recommended to calibrate regularly in order to obtain accurate measurements. A message will appear during device start-up if the device had no calibration done for more than a month. Calibrate the device as soon as possible when the message appears. 5. Calibration Follow the calibration procedure descr[...]

18 Close the light shade as shown in Fig. 9 for calibration, BG check, and measurement. 5 Fig. 5 is displayed when calibration is completed. 6 Slide the protective cap back into the original position, and turn Calibrator counterclockwise to MEASUREMENT position (Fig. 6). 5. Calibration ■ 5-2 Light shade Remove the white cap using a paper crip or [...]

19 2 As shown in Fig. 4, move the luminous dot into “ ” mark and adjust the position of Main unit or Measurement unit to reduce the size of the luminous dot as small as possible. After all adjustments are completed, push “Measurement switch”. ■ 6-3 Frontal view alignment Perform the frontal view alignment while monitoring Frontal view ali[...]

20 Points for alignment 1. Measurement window must be between the left and right laser beams. 2. Measurement window must be located below the Spot light. 3. Measurement window and the right laser beam must be within the pupil. Points for operation It is recommended to tilt the joy stick lightly in diagonal directions while monitoring Diagonal view [...]

21 BG level indicator BG check finds out the uniformity of background lights by determining the back- ground lights around Measurement window. Level of the uniformity appears in Measurement window shown in the display. This is what we call “BG level indi- cator”. Details are shown in Figure 9. Level 5 is the highest level that indicates backgro[...]

22 ● Waveform evaluation Flare is compared with |BG1 - BG2 | per measurement. (SIG – BBG ✽ ) - |BG1 - BG2 | > 0 is acceptable and no message is displayed. (SIG – BBG ✽ ) - |BG1 - BG2 | 0 is unacceptable and the message “ Inappropriate Data Form. Delete? ” is displayed. Select “ Del ” to delete or “ Store ” to save. ✽ BBG [...]

23 N BG (%) FLARE W/A 1 9.8 17 20 BC 2 8.5 6 22 3 8.0 9 21 4 9.0 8 19 AV: 20.5 SD: 1.1 Cont Edit Stat End N BG % FLARE W/A 1 9.8 17 20 BC 2 8.5 6 22 3 8.0 9 21 4 9.0 8 19 AV: 20.5 SD: 1.1 Del Set N BG (%) FLARE W/A 1 0.7 7.4 82.9 2 0.9 23.0 77.6 B 3 0.9 55.6 81.8 B AV : 80.8 SD : 2.8 NAME: SEX: M / F ID: Eye: R YY / MM / DD HH:MM KOWA FM-600 Ver. 1[...]

24 ■ 7-4 Recommended procedures when BG check obtains no good result Reading on the eye. BG check may result in good without using the alignment mark (Fig. 4). Important point is to align the device so that no iris image or reflected glare comes into Measurement window (see ■ 6-4 Diagonal view alignment). ■ 7-3 Recommended procedures when BG [...]

25 ■ 7-5 Recommended procedures when measured waveforms are offset to left or right You may encounter waveform offset to the left as shown in Fig. 6 when attempting a measurement at an excessively lower part of the anterior chamber. You can not obtain a correct flare value in this condition. 1 Select “ON” for “Laser : Position” as describ[...]

26 8. Configuration and settings 1 Press and hold “ Print switch ” for more than 4 seconds to display the menu screen (Fig. 1). 2 Select “Setting” using “ ” or “ ” and select “Ent” to display Setting menu screen. Laser Flare Meter FM-600 Ver. 1.0 Setting Calibration End Ent Ent Setting Meas. Process Illumination Laser Output mod[...]

27 Data output settings Date/Time settings Setting menu Description Selection Date Form Selecting “yy/mm/dd ” , “ mm/dd/yy ” , or “ dd/mm/yy ” . YY / MM / DD Date Displaying the date when settings were made. Values may be changed using . — — — Time(24h) Displaying the time (24h) when settings were made. — — — Sleep time sett[...]

28 9. Miscellaneous ■ 9-1 ID input In order to input an ID number, “ID No. Input” must be “On” (refer to “8. Configuration and settings”). Use function keys, ten keys, or a barcode reader to input an ID number. 9-1-1 Inputting an ID number using function keys 1 Select “CLR” to clear the number shown if any 2 Use “ ” to move wi[...]

29 2. Header Name or data Description Data type :LSS50 HEAD Fixed :LSS50 HEAD Fixed ID ID No. 10digits, numeric TempCorrect Temperature compensation ON/OFF 0/1 CaliCorrect Calibrator compensation ON/OFF 0/1 LD_TempCheck LDTemp check ON/OFF 0/1 LD_AlarmCheck LDAlarm check ON/OFF 0/1 asterisk Calibration execution request OFF/ON 0/1 0 Data type (grap[...]

30 ■ 9-3 Display messages This section explains the massages that appear in the screens. LD Temp Check Please wait Latest Calibration Data: (YY/MM/DD HH:mm) Calibrate Now? Laser Attenuating… If Measure / Calibrate Set the positions of Cali. Tool as follows. Measure : Measurement Calibrate : Calibration ALERT Can't hold both R&L eye dat[...]

31 9. Miscellaneous ■ 9-4 Function switches Details of function switches are described in this section. Function switch Description Ent Set End Yes No Stop Store Del Moves the cursor upwards. Moves the cursor downwards. Moves the cursor to the left or right. Confirms the selected setting or item. Confirms the setting. Terminates the current setti[...]

32 Error1 DARK Error2 PMT sens Error3 PMT Temp. Alarm Error4 LD Temp. Uncontrolled Error5 Printer Please Check Printer Paper Error6 – 11 DARK count exceeded the limit. Sensitivity of the photoreceiver ele- ment dropped below the limit. Temperature of the photoreceiver ele- ment exceeded the limit. Temperature of the laser source be- came uncontro[...]

33 11. Maintenance/Inspection This instrument is a controlled medical device, of which the measurements obtained using this instrument may be affected by daily maintenance and inspection. In order to use this instrument safely and correctly, carefully read the items listed in this section. ■ 11-1 Daily maintenance 1 Perform a calibration of this [...]

34 War ning War ning ■ 11-4 Chin-rest paper installation Place a sheet of Chin-rest paper on Chin-rest and hold the sheet with Chin-rest pins. Use a sheet of Chin-rest paper per patient and replace it with a new sheet for a next patient. When replacing a fuse, be sure to turn OFF the Power switch and unplug instrument from the power outlet. Doing[...]

35 Scanning laser source Photoreceiver element Measurement range Measurement accuracy Measurement area Measurement time Measurement distance Printer Monitor Energy saving function Interface Power supply Dimension/Weight Semiconductor laser, Wave length: 635nm, Intensity: 35 ± 15 µ W A photomultiplier tube 1 - 500 Photon count/ms ± 5%(under the c[...]

36 13. Electromagnetic Compatibility This device is a medical electrical instrument. The medical electrical instrument requires special care concerning electromagnetic compatibility (EMC). This section describes its suitability in terms of electromagnetic compatibility of this instrument. When installing or using this instrument, please read carefu[...]

37 [ Compliance verification and guidance ] Guidance and manufacturer's declaration - electromagnetic emissions The KOWA FM-600 is intended for use in the electromagnetic environment specified below. The customer or the user of the KOWA FM-600 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic envir[...]

38 Guidance and manufacturer's declaration - electromagnetic immunity The KOWA FM-600 is intended for use in the electromagnetic environment specified below. The customer or the user of the KOWA FM - 600 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guida[...]

39 • The relative spectral output of the instrument • The spectrally-weighted photochemical source radiance, both aphakic L B and aphakic L A L B = 0.0352 mW/(cm 2 • sr) 305nm to 700nm L A = 0.0352 mW/(cm 2 • sr) 305nm to 700nm (informative) Spectrally weighted photochemical radiances L B and L A give a measure of the potential that exists [...]

40 For EU market.[...]

41[...]

© 2006 Kowa Company, Ltd. All rights reserved. LSS50 V1.0 E 061208 MS Printed in Japan Printed on recycled paper. Immermannstrasse 43B 40210 Duesseldorf F.R. Germany Phone: 49(211) 1793540 Facsimile: 49(211) 161952 Hamamatsu Factory 3-1, Shinmiyakoda 1-chome, Hamamatsu city, Shizuoka Pref., 431-2103 Japan 4-14, Nihonbashi-honcho 3-chome, Chuo-ku, [...]