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8-6

Table 1

【

ENCLOSURE PORT

】

Test

Standard

Compliance

HOME HEALTHCARE ENVIRONMENT

Conducted Emissions

CISPR 11

Group 1 Class B

Radiated Emissions

CISPR 11

Group 1 Class B

Harmonic distortion

IEC 61000-3-2 Harmonic Class A

Voltage fluctuations and
flicker

IEC 61000-3-3 Complies

Test

Standard

IMMUNITY TEST LEVELS

HOME HEALTHCARE ENVIRONMENT

ELECTROSTATIC
DISCHARGE

IEC 61000-4-2

土

8 kV contact

土

2 kV

，

土

4 kV

，

土

8 kV,

土

15 kV air

Radiated RF EM
fields

IEC 61000-4-3 10 V/m

80MHz

–

2.7GHz

80% AM at 1kHz

Proximity fields from
RF wireless
communications
equipment

IEC 61000-4-3 See Table 2

RATED power
frequency magnetic
fields

IEC 61000-4-8 30 A / m

50Hz or 60Hz

Содержание MR-6000

Страница 1: ... safe operation Contact Tomey Corporation or our local distributor if you have any questions or you encounter any problems during operation Always follow the operation procedures described in this manual Keep this manual in a readily accessible place while operating this instrument Contact our local distributor if you lose this manual ...

Страница 2: ......

Страница 3: ...ROCEDURES Describes information required for installing and using the instrument 4 TECHNICAL INFORMATION Describes useful technical information about the instrument 5 INSPECTION AND MAINTENANCE Describes procedures for replacing consumable parts etc that the user of the instrument should normally conduct 6 TROUBLESHOOTING Describes how to solve problems 7 CONSUMABLES AND OPTIONAL EQUIPMENT Describ...

Страница 4: ...recaution that if unheeded could result in a hazardous situation where there is a possibility of serious injury or death This is a precaution that if unheeded may result in a situation where there is a possibility of minor or moderate injury or damage to property This is additional information which may contain special precautions on company policies related either directly or indirectly to the sa...

Страница 5: ... 14 1 4 Outline 1 15 1 4 1 Application purpose 1 15 1 4 2 Operational Principle 1 15 1 5 Symbols used for marking 1 17 2 NAMES AND FUNCTIONS 2 1 2 1 Physician s side 2 1 2 2 Patient s side 2 2 2 3 Side of main unit 2 3 2 4 Screen 2 4 3 OPERATION PROCEDURES 3 1 3 1 Preparation before use 3 1 3 1 1 Connection diagram of the system 3 1 3 1 2 Connecting the power cord and each cable 3 3 3 1 3 Starting...

Страница 6: ... and solution 6 1 6 2 Error messages and solutions 6 2 7 CONSUMABLES AND OPTIONAL EQUIPMENT 7 1 8 SPECIFICATIONS 8 1 8 1 Measurement performance 8 1 8 1 1 Refractive power measurement 8 1 8 1 2 Corneal curvature measurement 8 1 8 1 3 Intraocular pressure measurement 8 1 8 1 4 Corneal thickness measurement 8 1 8 1 5 Corneal shape measurement 8 2 8 2 Other measurements 8 2 8 2 1 Interpupillary dista...

Страница 7: ... voltage sections Turn power off and disconnect the power plug from the outlet and the cable connecting devices before transporting the instrument The cable may break resulting in fire or electric shock Do not measure a cornea weakened by disease or surgery Complications or damage may occur to the cornea The measurement window moves when the mode is switched to REF KRT Tono Pachy and or Topo Do no...

Страница 8: ...pressure Do not allow the patient to position their chin until the instrument stops completely and the measurement screen appears If any smoke offensive odor or abnormal sound occurs turn the instrument off immediately disconnect the power plug from the outlet and contact us or our local distributor Conduct regular inspections of the instrument and components Do not use the instrument for the peri...

Страница 9: ...ging disappears naturally and then use the instrument Depending on the installation environment it is possible for the surface of the forehead pad and the chinrest to reach the maximum temperature 43 3 Do not allow the forehead pad and the chinrest to be in contact with the patient for longer than 5 minutes Be very careful not to pinch the hand of the patient when moving the chinrest up and down D...

Страница 10: ...n this case perform manual measurement The reflection in the center of the cornea may not be clearly viewed when any deformation and or inflammation of the cornea is severe In this case an error may occur even in Manual mode If the patient information and measurement data already exists and the patient information needs to be edited make sure that both the patient information and existing measurem...

Страница 11: ... flammable substances explosives or chemicals are used or stored Any chemicals or vapor entering the instrument may result in fire or explosion Do not use the instrument near equipment with a strong electromagnetic wave disturbance source MRI high frequency electrosurgical device etc A strong magnetic field may cause noise and affect measurement Install the instrument in a location free of water o...

Страница 12: ... or a serious accident Install the instrument so that wiring is not disconnected or does not hinder the operation Install the instrument in a location where external light interference of sunlight illumination etc does not directly enter the patient s eye The measurement accuracy may be affected 1 1 3 Laser light safety This instrument is a Class 1 Laser product which has a safety standard IEC6082...

Страница 13: ... Otherwise a short circuit due to failure of the instrument may result in electric shock Fully insert the power plug into the outlet Faulty contact allowing any metal to contact the exposed terminal of the plug or dust accumulated on the exposed terminal of the plug may result in fire or electric shock Do not place any heavy object on the power cord or squash the power cord Fire or electric shock ...

Страница 14: ...equipment In case of setting the network be sure to do it after agreement of the network administrator For LAN connection be sure to connect the instrument via a hub The instrument will not operate correctly if connected directly In cases where the instrument is connected to a network there may be a risk to the patient operator or third party Changing network may present new risks Be sure to confi...

Страница 15: ...irectly such as the forehead pad with a cloth dampened with ethanol for disinfection before measuring the next patient Be sure to sterilize the measurement window after measuring an eye with infectious disease Tears may adhere to the measurement window and spread to the eye of another patient resulting in secondary infection ...

Страница 16: ...red value may differ depending on the cornea equivalent refractive index If an incorrect value is used to select intraocular lenses further surgery might be required Do not use the refractive power radius of corneal curvature PD value residual astigmatism etc for prescribing glasses or contact lenses There may be eye strain or corneal disorder Other examination methods should also be used in conju...

Страница 17: ...s for comprehensive review When using the intraocular pressure adjustment function set appropriate parameters for the adjustment formula The adjusted intraocular pressure to be calculated is a reference value The corneal irregular astigmatism display function is a simple measurement using keratometer measurement This function does not detect all cases of corneal irregular astigmatism Measurement i...

Страница 18: ...r wireless stations and amateur wireless stations for mobile object identification are not used near this instrument before use When this instrument causes wireless frequency interference harmful to the in house wireless station for mobile object identification change the frequency immediately or stop emission of electric waves and contact Tomey or our local distributor for measures to avoid inter...

Страница 19: ...they are not damaged If any item is missing or damaged contact our local distributor as soon as possible Main unit Chinrest paper 100 sheets Power cord 1 Chinrest paper pin 2 Model eye with securing pin 1 Built in printer paper 3 rolls 1 roll is set in the printer Spare fuse 2 CL holder 1 Dust cover INSTRUCTION MANUAL this book ...

Страница 20: ...Normal mode Touch Alignment When directly touching the screen the measuring head moves so that the touched point is displayed in the center of the screen This allows you to focus the sight in the up down left and right directions without using the joystick Touch panel Allows you to make various settings and execute the touch alignment function by directly touching the monitor Nozzle Opening to blo...

Страница 21: ...C motor for up and down right and left back and forward and to move the measurement head position on the appropriate position using the joystick operation or the touch panel operation on the LCD screen Furthermore it is possible to use the alignment mode which is moving the appropriate position automatically if it reaches within a specified range near the measurement alignment 1 4 2 2 Measurement ...

Страница 22: ... possible to know the cornea deformed state and calculate the intraocular pressure with the applanation pneumatic pressure Corneal thickness Emit the infrared light LED to the cornea in an oblique direction and detect the corneal surface and the corneal back side with the photodetector symmetrically located to the incident light Measure the distance between the corneal surface reflection image and...

Страница 23: ...or becomes illegible please contact us or our local distributor Refer to instruction manual Power standby B type attachment section Grounding earth Caution Manufacturer and manufacturing month Wireless communication devices Wired communication devices Fuse ...

Страница 24: ... 1 18 This page is intentionally left blank ...

Страница 25: ...FUNCTIONS 2 1 Physician s side 1 Head 2 Touch panel 3 Joystick 4 Joystick button 5 Power lamp Light up in yellow green during power on 6 Chinrest up down button 7 Eye level mark 8 Built in printer 1 7 2 6 4 5 8 fig 1 3 ...

Страница 26: ... 2 2 2 2 Patient s side 1 Forehead pad 2 Measurement window Switches according to measurement mode 1 3 Chinrest 4 Power switch 5 Power socket 1 REF KRT Topo Mode Tono Pachy Mode 1 2 3 4 5 fig 1 ...

Страница 27: ...2 3 2 3 Side of main unit 1 USB H connector 2 LAN connector 3 Maintenance switch This is used for maintenance Never touch this switch 1 2 3 fig 1 ...

Страница 28: ... results are displayed 3 Setup button Displays the System Setup screen and allows you to make various settings for the instrument 4 View button Displays the Reading screen 5 6 Save Print Export button Saves prints or exports the measurement results Functions can be selected by setup 7 Mode button Switches measurement modes 2 3 4 11 5 12 6 13 16 7 8 9 10 15 14 1 1 ...

Страница 29: ...patient 11 AA Auto Alignment button Green when Auto Alignment is available 12 AS Auto Shot button Green when Auto Shot is available 13 Measurement mode Displays the measurement mode The button of the available mode is shown in green 14 REF KRT Tono Pachy switching button Switches the mode between REF KRT and Tono Pachy 15 Head retreat button The head retreats when this button is held 16 Joystick b...

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Страница 31: ...llow the same safety guidelines when changing the connection system Be sure to connect with an isolation transformer directly without connecting to a power strip or extension cord Be sure to use devices which connect with this instrument after confirming the permission environment condition of each operation manual Inside the patient environment Outside the patient environment AC Power AC Power Is...

Страница 32: ...tor Save the measurement data If the external connection devices listed above break down the following problems may occur Connection devices Problem Network HUB malfunction It is impossible to connect with the network External Printer malfunction It is impossible to be printed by the external printer ID Input Device malfunction It is impossible to input the ID from ID Input Device USB Stick malfun...

Страница 33: ...2 Connecting the power cord and each cable Connect the power cord and each cable as below Power cord AC Power input fig 1 USB Cable External Printer ID Input Device USB Stick LAN Cable Network into the hospital ...

Страница 34: ...wn 1 Press the power button The measurement head and chinrest automatically move to the lower dead center and the system closes 3 1 4 Adjusting the monitor angle The angle of the monitor can be adjusted according to the view height and or illumination Hold the bottom of the monitor with your hands as shown in the illustration below and adjust the angle ...

Страница 35: ... patient s eye is positioned in the center of the screen When the center of the cornea enters the alignment ring with Auto Alignment turned on focusing in the X and Y axes automatically starts Perform alignment in the Z axis While pressing the center of the screen the measuring head advances towards the patient Touch the measuring head retreat button to retract the measuring head towards the physi...

Страница 36: ... or inflammation of the cornea is severe In this case an error may occur even in Manual mode There are two types of operations rough operation for roughly positioning the measuring head and fine operation for finely adjusting the position of the measuring head Rough operation Moving the joystick moves the measuring head back forth left and right When the up down ring is slid up and down the head m...

Страница 37: ...elect a patient 2 Checking measurement modes Check the measurement mode displayed on the screen If the mode is not appropriate change it with the mode switching button or REF KRT Tono Pachy switchng button 3 Adjusting patient s eye height When moving the head and or chinrest pay attention to the position of the patient s face hands and fingers Otherwise they may be injured by the movement of the h...

Страница 38: ...t s eye 5 Fixation target instructions Ask the patient to look at the fixation target 6 Alignment Do not allow any person to place their hands or fingers in the clearance between the head and neck or neck and base or the section under the chinrest Their hands or fingers may be caught and injured The Auto Alignment function may not work correctly when eyelids and eyelashes cover the cornea Ask the ...

Страница 39: ... switch to manual alignment 7 Capturing Perform alignment and take measurements with the joystick or the joystick button on the measurement screen If Auto Shot is turned on measurement starts automatically after alignment is complete 8 Saving printing exporting measurement data Touch the Save Print Export button ...

Страница 40: ...r surgery or severe complication such as keratoectasia Note that if diopter is used as the measurement unit for the radius of corneal curvature the measured value may differ depending on the cornea equivalent refractive index If an incorrect value is used to select intraocular lenses further surgery might be required The corneal irregular astigmatism display function is a simple measurement using ...

Страница 41: ...neal thickness This instrument calculates the intraocular pressure based on the Goldman applanation tonometer However it is recommended to take measurements using the Goldman applanation tonometer if more accurate measurements are needed Be sure to set the nozzle limiter for every intraocular pressure examination to ensure the safety of the patient Otherwise the nozzle may come into contact with t...

Страница 42: ...procedures 1 Switch the measurement mode to Tono Pachy Touch the Tono button when measuring intraocular pressure only and the Pachy button when measuring corneal thickness only 2 Perform alignment and take measurements with the joystick or the joystick button on the measurement screen If Auto Shot is turned on measurement starts automatically after alignment is complete The corneal thickness is me...

Страница 43: ...age by eyelashes and eyelids misalignment of the center due to unstable sight faulty ring image due to corneal disorder and secretions etc might occur Incorrect analytical results may be displayed if the Mires projected ring was not traced correctly If the color maps are significantly different between the right eye and left eye or if the center is significantly different from other parts such as ...

Страница 44: ...or button to select Topo 2 Perform alignment and take measurements with the joystick or the joystick button the measurement screen If Auto Shot is turned on measurement starts automatically after alignment is complete 3 After measurement completes the single map is displayed on the screen ...

Страница 45: ... et al Bull Soc belge Ophthalmol 276 15 18 2000 2 corrected IOP measured IOP CCT 550 x 0 05 Michelson G Online J Ophthalmol 1 2 2001 All of these correction formulae are linear regressions of corneal thickness and intraocular pressure However in reality because other elements are involved including ethnic differences refractive degree and radius of corneal curvature it cannot be determined which f...

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Страница 47: ...on for proper installation use and maintenance of product This warranty is only applicable to the new product and DOES NOT cover any damage resulting from or caused by accident or negligence abuse misuse mishandling improper modification of this product by persons other than personnel duty authorized by Tomey not to a product whose serial number or batch number is removed altered or effaced THIS W...

Страница 48: ...ted and serviced 5 3 Inspection When measuring the model eyes check that there is no dust or stains on them REF KRT Topo measurement function Use the chinrest paper pins to fix the model eyes to the chinrest Perform measurement in the same manner as measuring a patient s eyes Check that the measured values are within the range specified on the model eyes ...

Страница 49: ...ents Therefore the measurement window is easily contaminated with dirt dust tears etc Clean the measurement window as needed according to the following procedure 1 Use a commercial blower brush etc on the measurement window to remove dust 2 Without rubbing lightly wipe the glass section with a swab or soft cloth dampened with a small amount of ethanol for disinfection 5 4 2 Forehead pad and chinre...

Страница 50: ... not work correctly after fuses have been replaced there may be other causes of the problem Turn off the instrument immediately and contact our local distributor 1 Turn power off and disconnect the power plug from the outlet 2 Disconnect the power cord from the power socket 3 Insert a flat screwdriver into the groove of the fuse holder under the power socket to release the lock and remove the hold...

Страница 51: ...1 Push the printer cover notch 1 upward and open it 2 Remove the old printer paper roll and install a new roll If the paper roll is installed in the wrong direction nothing will be printed 3 Close the printer cover with the end of the paper protruding 2cm from the outlet Press the cover firmly until you hear a click 1 fig 1 ...

Страница 52: ...ls Location not influenced by air containing dust salt and or sulfur Leveled and stable location free of vibration or mechanical impact 5 7 Disposal When disposing of the packing materials sort them by type and dispose of them as directed by relevant laws and local rules and regulations A lithium battery is used in the instrument Handling of the lithium battery varies depending on governing bodies...

Страница 53: ...ghtness of the monitor is low Adjust the brightness of the monitor screen Printing is not conducted The data is not printed The printer paper is not set Set the printer paper The printer paper is set in the reverse direction Check the front and rear side of the paper and correctly set the paper The printer paper is set at an angle Set the printer paper correctly The printer cover is open Close the...

Страница 54: ...his machine and try again Capacity of the storage device is full Delete saved data to increase the capacity Delete saved data Failed to save data Try it again or delete saved data to increase the capacity Try again or delete saved data An error occurred internally Check the printer connection and try again Check the printer connection and try again Printer is not connected Connect the printer Prin...

Страница 55: ...ur local distributor Press Yes button to continue under this condition But never open any enclosure Drive mechanism inside the device may cause injury Restart this machine Printer paper jam has occurred Fix the paper jam Printer paper is not set correctly Check if the printer paper is set correctly USB device is not inserted Insert USB device USB connection error has occurred Remove USB device and...

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Страница 57: ...umable parts are available from your local distributor Contact your local distributor to order them Built in printer paper Specify the paper type as Built in printer paper for MR 6000 Chinrest paper 100 sheets set Fuse Specify the fuse type as Fuse for MR 6000 ...

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Страница 59: ...D steps Astigmatic axis A Measurement range 0 to 180 Display unit 1 step 8 1 2 Corneal curvature measurement Corneal curvature radius Measurement range 5 00 mm to 13 00 mm Display unit 0 01 mm step Corneal astigmatic axis Measurement range 0 to 180 Display unit 1 step 8 1 3 Intraocular pressure measurement Measurement range 1 mmHg to 60 mmHg 1 hPa to 80 hPa Display unit 1 mmHg 1 hPa step 0 1 mmHg ...

Страница 60: ...pupil diameter measurement Measurement range 1 0 mm to 14 0 mm Display unit 0 1 mm step 8 3 Main unit Display type 10 4 inch color TFT LCD Dimensions and weight 312 W X 491 D X 450 H mm Approx 23 0 kg Voltage 100 VAC to 240 VAC Frequency 50 60 Hz Power consumption 110 VA 8 4 Environmental conditions Operate the instrument under the following environmental conditions Installation Indoors not in dir...

Страница 61: ...fication by operation mode Continuous operation instrument Laser class Class 1 Laser Product IEC 60825 1 2007 8 6 Energy information Measurement light source Maximum power 100μW 8 7 Wireless LAN wireless LAN installed instrument only Compliance standards IEE802 11b 802 11g 802 11n Transmission method OFDM with BPSK QPSK 16 QAM and 64 QAM 802 11b with CCK and DSSS Frequency 2 412 MHz 2 484 MHz Effe...

Страница 62: ... 0 to 999 deg N_R The refractive index of Right eye The refractive index 4 Unsigned decimal 1 00 to 14 00 When 2nd digit is 0 blank is filled up by changing field position POWER_L S C A Value of Left eye SPH value 6 Signed decimal 30 00 to 25 00 When 2nd digit is 0 blank is filled up by changing field position D CYL value 6 Signed decimal 0 to 12 50 When 2nd digit is 0 blank is filled up by changi...

Страница 63: ...apacitive coupling for processing of materials or inspection analysis and that it is suitable for use in facilities directly connected to a low voltage power network that supplies power to general household facilities and buildings used for home use The MR 6000 can be used in a specialized health care facility such as hospitals and clinics except anywhere near the source of a strong EMI and a gene...

Страница 64: ...Class A Voltage fluctuations and flicker IEC 61000 3 3 Complies Test Standard IMMUNITY TEST LEVELS HOME HEALTHCARE ENVIRONMENT ELECTROSTATIC DISCHARGE IEC 61000 4 2 土8 kV contact 土2 kV 土4 kV 土8 kV 土15 kV air Radiated RF EM fields IEC 61000 4 3 10 V m 80MHz 2 7GHz 80 AM at 1kHz Proximity fields from RF wireless communications equipment IEC 61000 4 3 See Table 2 RATED power frequency magnetic fields...

Страница 65: ...iation 1kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation 217Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18Hz 2 0 3 28 870 930 1 720 1 700 1 990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217Hz 2 0 3 28 1 845 1 970 2 450 2 400 2 570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation 21...

Страница 66: ...io bands between 0 15MHz and 80MHz 80 AM at 1kHz Voltage dips IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 Voltage interruptions IEC 61000 4 11 0 UT 250 300 cycle Test Standard IMMUNITY TEST LEVELS HOME HEALTHCARE ENVIRONMENT ELECTROSTATIC DISCHARGE IEC 61000 4 2 土 8 kV contact 土 2 kV 土4 kV 土8 kV 土15 kV air Electrical fast t...

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Страница 69: ...r Straße 21 90427 Nürnberg Germany Tel 49 911 9385462 0 Fax 49 911 9385462 20 AUTHORIZED TOMEY SERVICE CENTERS Headquarters Pacific Rim Tomey Corporation 2 11 33 Noritakeshinmachi Nishi ku Nagoya 451 0051 JAPAN Tel 81 52 581 5327 Fax 81 52 561 4735 Europe Tomey GmbH Wiesbadener Straße 21 90427 Nürnberg Germany Tel 49 911 9385462 0 Fax 49 911 9385462 20 Original instructions ...

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