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SP-100 Read this Operation Manual carefully before using the SP-100 for proper and safe operation. If you come up any questions about this instrument or the Manual, ask your Tomey represen- tative or local distributor. Do not use this instrument by any procedures other than those specified in this Manual.
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WARNINGS DO NOT USE THE INSTRUMENT WITH THE OUTER COVER AS LEFT OPEN OR REMOVED, otherwise you may be exposed to direct high voltage. Always use the sterilized or disinfected Pachymeter Probes for measurement. NEVER USE the Probe if it may be subjected to any visible damage on its tip. Such use may not only cause an incorrect measurement, but also damage the cornea.
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HOW TO USE THIS OPERATION MANUAL THE COMPOSITION OF THE OPERATION MANUAL The following items are provided for your efficient and effective use of this instrument. The Operation Manual is composed of the following parts. 1. PRIOR TO USE Precaution and confirmation items related to the installation and us- age of the instrument.
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SYMBOLS USED IN THE MANUAL The symbols, such as "DANGER", "WARNING", "CAUTION" and "NOTE" used in this Operation Manual, represent the following messages. Precaution for an operation state that, if unheeded, will cause a haz- ardous situation where there is an imminent danger of serious injury or death.
Contents PRIOR TO USE ......................1-1 Precautions ............................. 1-1 Unpacking ............................1-3 Symbols, used in this manual ......................1-4 Outline of Measurement Principle ....................1-5 NAMES AND FUNCTIONS OF THE COMPONENTS ........... 2-1 Front and Right side of Main Unit ....................2-1 Rear and left side of Main Unit .......................
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3.8.2 Setting of communication conditions ................3-33 3.8.3 Data Export ........................3-35 3.8.4 Data Receiving ......................3-37 Data Management with TOMEY Link (Electronic Modical Record Support System) ....3-39 3.9.1 Patient Data Receiving ....................3-39 3.9.2 Data Sending .......................3-41 3.10 Battery ............................3-43 3.10.1 Battery charge balance ....................3-43 3.10.2 Low Battery Warning ....................3-44...
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8.1.3 Main unit ........................8-1 8.1.4 AC Adapter ........................8-1 8.1.5 Enclosed battery ......................8-1 Ultrasound energy and other information ..................8-2 8.2.1 Influences of ultrasound energy on the human body ........... 8-2 8.2.2 Ultrasound energy ......................8-2 Noise Generation ........................... 8-4 Operating Environment........................
1. PRIOR TO USE Make sure that the instrument is free from any equipment that may cause an intensive magnetic field, which other- wise causes the instrument with noises or may make it unable to allow correct diagnosis or measurement. Care must be taken not to place any object on the instru- ment.
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When using the instrument after recess for a while, make sure that it operates properly and safely. Please USE AC power adapter provided from TOMEY as SP-100 standard accessory. When using other AC power adapters, the warranty will be invalid and the unit may not work properly.
Be sure to keep all the shipping and packing materials, which may be used when the instrument is moved to the other place. Main unit, HANDY PACHYMETER SP-100 (Lithium-Ion Battery Included) ........1 Pachymeter Probe (with the protective cap and the case) ......1 Pachymeter test piece ............
1.3 Symbols, used in this manual The terms and symbols, used for the instrument, shall imply the following means. PROBE Pachymeter probe terminal Connects the Probe to this terminal. Power Switch Turns main power ON and OFF. Contrast adjusting volume Adjusts the contrast of the monitor Serial communication terminal Various data is sent and received through the external...
1.4 Outline of Measurement Principle After taking measurement, the oscillator is not emitting ultrasound waves. The SP-100 is designed for pachymeter or corneal thickness measurement by using ultrasound transducer, built in Pachymeter probe. SP-100 emits the ultrasound from the Pachymeter probe and the probe also receives the ultrasound reflected by surface between corneal posterior face and anterior chamber.
2. NAMES AND FUNCTIONS OF THE COMPONENTS 2.1 Front and Right side of Main Unit A A A A A SCREEN Measurement data and other information can be displayed. B B B B B OPERATING PANEL The keys are located on the panel with various functions.
2.3 Operation Keys General key assignments are explained in this part. However, other functions are assigned on the same key, depending on the screen. Read each part of the manual carefully in order to understand the key operation completely. A A A A A FUNCTION KEYS Each key works as assigned function shown on (Example) the bottom of the screen.
3. OPERATING PROCEDURES 3.1 Safety precautions The Probe must always be disinfected before its use. Never use the Probe, if there is any visible damage on its tip, which may otherwise cause an incorrect measurement or damage the cornea. This instrument is Ophthalmic Medical Device, designed for only skilled operators.
3.2 Preparation before operation 3.2.1 Connection of accessories a) Connection of Pachymeter Probe Connector of the Probe should be inserted in speci- fied direction. Insert the connector as deep as it sounds "click". Insert the connector A into the connecting terminal B marked "PROBE"...
3.2.3 Optional components Assembling of the Disposal Tip Pachymeter Probe and alternative Probe shapes The Disposal Type Pachymeter Probe (supplied as an optional component) consists of the inner probe, case, fixed ring, and disposal tip. The Probe can be changed in two alternative shapes: (A) with 45 shape and (B) in straight shape, de- pending on the application convenience.
3.3 Adjustment and Setting 3.3.1 Main power on and screen adjustment Confirm the following items before turning the power on. Make sure the battery is sufficiently charged. If not, con- nect the AC adapter for power supply. (With battery opera- tion and 3 minutes of non operating time, the unit goes into Auto Power off mode and measured data will be lost) Make sure the Probe has been connected.
3.3.2 Startup Display 1) The startup screen is displayed immediately af- ter the power is on. The software version is seen on the screen. (Fig. 1) (Fig. 1) 2) The ultrasound velocity, set for measurement, is displayed. (Fig. 2) (Fig. 2) 3) The unit calibrates the probe automatically.
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6) Check the connection of the Probe and the Probe tip, then press the " " to recalibrate the Probe. (Fig. 6) When error appears in the screen, go to "6. TROUBLE-SHOOTING" for the solution. When "ERROR" repeatedly appears, contact TOMEY representative. Adjustment and Setting...
3.3.3 Screen Contents a) Pachy screen A The eye to be measured Either left or right eye, to be measured, is selected on this part of the screen. B Measurement data The data, taken by the unit will be listed. C Average Average value of the listed data will be displayed.
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b) Measurement screen A The eye to be measured Either left or right eye, to be measured, is se- lected on this part of the screen. B Measurement data The data, taken by the unit will be listed. While taking measurement, the screen automatically changes and shows large size measuring data.
3.3.4 Measuring conditions The following measuring conditions have been set, when turning the power on. Eye to be measured: Right eye (OD) Corneal ultrasound velocity: Last value, when it is turned off. a) Input Patient ID and name Please refer to "3.9 Data Management with TOMEYLink (Electronic Medical Record Support System)"...
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3) Press " " or " " keys to move Cursor I to the figures or letters, you wish to input. (Fig. 3) Then, press SEL G to enter selected character. 4) Press F1 key E to switch over input mode be- (Fig.
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b) The eye to be measured Select Right eye or Left eye, to be measured. Press F1 key A to switch over Right and Left dis- play. c) Corneal ultrasound velocity Ultrasound Velocity can be changed by going into setting Menu. Please refer to "3.7.3 c) corneal Ultra- sound Velocity (VELOCITY)"...
Be sure the tip of the Probe is dry and free from any water, before calibrating probe. In case of using the disposal tip Probe, the disposal tip is automatically detected by SP-100. Therefore, no measure- ment can be made without calibrating the Probe. 1) This instrument automatically calibrates the Probe, when the power is turned on and the probe is plugged.
3.4.2 Operation Check The test piece included in the accessory box is supplied for checking the operation of the instru- ment. The measurement result varies, depending on room temperature and other factors. The in- strument cannot test its accuracy by measuring this test piece.
3.5 Measurement The Probe should always be disinfected before its use. The disposal tip should be disinfected before its use. Do not use the Probe with its tip damaged. This causes inaccurate measurement as well as the corneal damage for patients. The corneal ultrasound velocity has direct influence on measurement results.
3.5.1 Single measurement a) Measuring procedures 1) Place the probe perpendicularly to the corneal surface, where the thickness needs to be taken. 2) When the measuring conditions meets a cer- tain level, the instrument automatically starts taking measurement (Fig.1). The instrument makes beep, when measurement has been taken into the unit.
3.5.2 Delete Each Data Reading When the data is once deleted, it can never be re- called and the deleted data will be lost. Please pay special attention, not to delete necessary measure- ments. 1) Press F3 key A on Pachy screen (Fig. 1) to change screen into EDIT (Fig.
3.5.3 Delete Data (Eye by eye or patient by patient) When the data is once deleted, it can never be recalled and the deleted data will be lost. Please pay special attention, not to delete necessary measurements. a) Delete Data of one eye (Retaking measurements of the same eye) Delete all data on screen.
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b) Delete Data of both Right and Left Eye including patient information (Ready for new patient measurement) Delete all the data on both eyes, as well as Patient ID and name. Press F4 key A on pachy screen and keep holding it for a while, until the instrument sounds "beep"...
3.6 Printout 3.6.1 How to Printout the data Prior to Printout, make sure the proper paper is set correctly and the paper remains suffi- ciently. Please be careful not to cut yourself, when cut- ting the paper by hand. Press the PRINT Key for operation in the Measure- ment Standby Screen (Fig.
3.6.2 Description of Printout a) Standard mode A Time/Data B ID number C Patient's name D Corneal Ultrasound Velocity E Type of display data F Eye to be measured G Measured data H Average of measured data I SD(Standard Deviation) of measured data b) Simple mode Patient Name and Breaking Line are out of printout paper on Simple Mode.
3.6.3 IOP Calculation Printout a) Standard mode A Time/Data B Patient ID C Patient's Name D Corneal Ultrasound Velocity E Right/Left F Eye to be measured G Measured data H Measured data average I Measured data SD (standard deviation) J Parameter 1 K Parameter 2 L CCT (Central Corneal Thickness) M IOP (Inter Ocular Pressure)
3.7 Menu 3.7.1 Description of the Screen display A TIME-DATE Date and time are set. B SOUND The sound volume is set. C VELOCITY The corneal ultrasound velocity is set. D DATA SEL The mode of display data is set. E PRINTOUT The print mode is set.
3.7.2 Operation for the MENU Screen 1) Press F3 Key A in the Measurement Standby Screen, to change the screen to the EDIT Screen (Fig. 2). (Fig. 1) 2) Press F4 Key B in the EDIT Screen, to change the screen to the MENU Screen (Fig. 3). (Fig.
3.7.3 Operating procedures of the Menu Screen a) Setting of date and time (TIME/DATE) 1) Press " " or " " of the Operation Panel, to align the Cursor to "TIME/DATE". Next press F3 Key A to change the screen to the Time/Date Screen (Fig.
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b) Sound volume (SOUND) 1) Press " " or " " of the Operation Panel, to align the cursor to "SOUND". Next, press the SEL key A to change the screen to the Sound Volume Setting Screen (Fig. 2). Pressing F4 key B returns the screen to the EDIT Screen.
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c) Corneal Ultrasound Velocity (VELOCITY) 1) Press " " or " " of the Operating Panel to align the cursor to "VELOCITY". Next press F3 Key A to change the screen to the Corneal Ultraound Velocity Screen (Fig. 2). Pressing F4 Key B returns the screen to the EDIT Screen.
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d) Setting of the type of display data (DATA SELECTION) 1) Press " " or " " of the Operating Panel to align the cursor to "DATA SEL". Next press F3 A and change the screen to the Setting Screen (Fig. 2) for the type of data to be displayed.
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e) Print mode 1) Press " " or " " of the Operation Panel, to align the cursor to "PRINTOUT". Next, press F3 key A to change the screen to the Printout Setting Screen (Fig. 2). Pressing F4 key B returns the screen to the EDIT Screen.
3.7.4 IOP Calculation 1) Press F2 A to change the screen to IOP calcula- tion (Fig.2). (Fig. 1) 2) Press F1 B to select either RIGHT/LEFT eye data should be calculated C. (Fig. 2) 3) Press F2 D to change the screen to Tonometry Input (Fig.3).
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Press F4 H to select the screen to IOP Calcula- tion (Fig.4) (Fig. 4) 3) Press F3 I to change the screen to CCT Input (Fig.5) Average of total measurement data will be automatically input, when there is any data for cal- culation.
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5) Press F4 R to change the screen to IOP Calcula- tion (Fig.7) to show calculation result S. 6) Press F4 T to go back to Main MENU (Fig.1). (Fig. 7) 3-31 Menu...
3.8 Sending and receiving data Connect the instrument to the equipment which complies with the IEC06-1 or the IEC950 and of which power source is isolated with the dielectric transformer, by using the serial communication cable. This instrument can send and receive data to and from the external equipment, by using the serial communication cable.
3.8.2 Setting of communication conditions 1) Press F2 Key A to change the screen to the IN- DEX Screen. (Fig. 2) (Fig. 1) 2) Press F4 Key B to change the screen to the DATA COMMUNICATION Screen. (Fig. 3) (Fig. 2) 3) Use "...
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4) Press " " or " " of the Operating Panel to set the BAUD RATE. The baud rate is selective from three stages of 9600, 19200, and 38400. Press F1 key E to set as 38400 (default). When F2 Key F is pressed, the screen will be changed as shown in Fig.
3.8.3 Data Export Please refer to "3.9 Data Management with TOMEYLink (Elec- tronic Medical Record Support System)" to send Data to TOMEYLink. 1) Press " " or " " of the Operating Panel in the DATA COMMUNICATION Screen and align the cursor to "SEND".
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3) "NOW COMMUNICATING" is displayed while data is being sent. (Fig. 4) When F4 Key E is pressed, while data is being sent, the process of sending data is cancelled. (Fig. 4) 4) When data is properly sent, "SENT COM- PLETE!"...
3.8.4 Data Receiving Please refer to "3.9 Data Management with TOMEYLink (Elec- tronic Medical Record Support System)" to send Data to TOMEYLink. 1) Make sure before receiving data that there is no data left in the Data Standby Screen. Then, change the screen to the Data Communication Screen (Fig.
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4) The screen displays "NOW COMMUNICAT- ING" while in the process of receiving data. (Fig. 4) When F4 Key E is pressed, receiving data is cancelled. (Fig. 4) 5) When data is properly received, "RECEIVED COMPLETE!" is displayed.(Fig. 5) Then press F4 F to return the screen to the Data Communication Screen (Fig.
3.9 Data Management with (Electronic Medical Record Support System) SP-100 must be connected with external devices,complied with IEC601-1 Standard or the devices complied with IEC950 Standard and elec- trically insulated by insulation transformer. Please refer to Operation Manual of TOMEYLink (Electronic Medical Record Support System) to setup TOMEYLink soft- ware and LAN adapter (LA-100).
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Press F4 key E to go back to DATA COMMU- NICATION (Fig.3). (Fig. 4) Patient ID, typed in SP-100 has nothing to do with TOMEYLink Patient ID. TOMEYLink Pa- tient ID will always have priority to register data on TOMEYLink. Please note that the ID on SP- 100 will be ignored.
(Fig. 7) 3.9.2 Data Sending 1) Press " " or " " button to move cursor to SEND on DATA COMMUNICATION (Fig.1). Press F3 key A to go to DATA SENDING screen (Fig.2). (Fig. 1) 3-41 Data Management with TOMEY Link...
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(Fig.4). Press F4 key E to cancel sending data. (Fig. 4) 4) When data is properly sent, SENTCOMPLETE! is displayed (Fig.5). Press F3 key F to go back to DATA SENDING screen (Fig.2). (Fig. 5) 3-42 Data Management with TOMEY Link...
3.10 Battery Please use the battery only specified for SP-100. The use of wrong type may cause Heating/Fire/Explosion of the battery and main unit. After the battery has been charged, pull off the AC Adapter from the instrument. If the...
3.10.2 Low Battery Warning 1) When capacity of the battery becomes low A, SP-100 screen starts blinking and beeping (Fig.1). Under this condition, the unit shuts down after 10 minutes of non-operating time, automatically. Within 10 minutes, the battery needs to be charged or measured data will be lost.
3.10.3 Charge indicator The charge indicator A on the Operating Panel lights up, while the battery is being recharged. When the charge indicator light goes off (Full Charged), discon- nect the AC Adapter from the instrument. 3.10.4 How to Install / Uninstall Battery Please pay special attention not to disconnect the battery cable.
3.10.5 Lifetime of rechargeable battery The battery, built-in the instrument, keeps 85% of its capacity even after 500 times recharge and discharge under 25 degree Celsius room temperature. Since any battery has its lifetime, replace with new battery, when its discharging time is getting shorter than it used to be. 3.10.6 Expected operating time of hours The battery enclosed in the instrument is serviceable for the fol-...
4. REFERENCE TECHNICAL INFORMATION 4.1 How to calculate corneal thickness The corneal thickness is calculated in the following calcula- tion by using the converted sound velocity in the cornea. Tc = where, Tc:Corneal thickness V: Converted sound velocity in the cornea t: Measuring time 4.2 Acoustic Output 4.2.1 MI (Mechanical Index)
5.2 Routine maintenance 5.2.1 Measurement Probe Be sure to hold the connector of the Probe cable to disen- gage the Probe from the instrument. Do not pull the cord itself, which may cause to damage the cord or to ruin its power connection.
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b) Disinfection For disinfecting of the Probe, immerse the part of the Probe within 15mm from the eye contacting part it in disinfection etha- nol or 0.5% sodium hydrochloride water solution for 10 to 20 minutes and then wash it with distilled water and then dry suffi- ciently.
5.2.2 Maintenance of the Main Unit — Do not use such organic solvents as thinners for cleaning the Main Unit of the instrument. Such organic solvents may cause to damage the surface of the Main Unit. Do not pull the power cord with an undue force. Care is to be taken not to touch the Probe connecting ter- minals.
5.3 Replacing of the printer paper Replace the printing paper when the red lines appear on the both sides of the roll paper, according to the following procedure. Care is to be taken not to damage your hand with the paper cutter, when opening and closing the Printer Cover.
5.4 Storage Store the instrument in a place where it is free of water, moisture and chemicals. Do not store the instrument in a place where it is subjected to high temperature and high humidity and to any adverse influences that the instrument may be exposed to dust, salts, and/or sulfur.
6. TROUBLESHOOTING Before presuming the instrument is disordered, check the following items. If the following items do not correct the malfunction, consult with your local rep- resentative for countermeasures. Do not remove the outer cover of this instrument while in operation, which will otherwise expose you to the direct high voltage.
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No information is displayed in the Monitor Screen. The Auto Power-off Function is in actuation, which automati- Cause 1 cally turns the power of the instrument off if it does not con- tinue operation for longer than 3 minutes. Turn the power for the instrument on. Remedy The switch for maintenance which is located at the rear side Cause 2...
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The Clock in the screen is in cease. The INDEX Screen displayed after data measurement has Cause 1 been made is shown. In case the INDEX Screen displayed after data measure- Remedy ment has been made is shown, the date and time when data measurement was made are displayed in the screen.
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<Measuring Function> "PROBE ERROR!" is displayed in the calibration of the Pachymeter Probe given when the power is turned on. The connection of the Pachymeter Probe is not proper. Cause 1 Properly connect the Probe, in accordance with the pro- Remedy cedure specified in "3.2.1 a Connecting of the Pachymeter Probe".
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The Pachymeter Probe has not been properly calibrated. Cause 5 Clean the tip of the Probe and re-calibrate the Probe in the Remedy procedure specified in "3.4.1 Calibrating of the Pachymeter Probe" or once turn the power off, next reboot the instru- ment, and the calibrate the Probe.
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Monitor sounds do not stop. Measurement data is taken when measurement is not in process. The tip of the Pachymeter Probe is wet with water. Cause 1 Remedy Remove the water from the tip of the Probe. Monitor sound is not made. The sound volume is set as OFF.
The following spare parts and optional parts are available upon ordering to your Tomey local distributor or representative. 7.1 Spare parts Printer paper Specify your order article as "Printer paper for SP-100 " when you order. 7.2 Optional parts Pachymeter Probe (Standard Probe) Specify your order part as "Standard Pachymeter Probe...
8. SPECIFICATIONS 8.1 Specifications 8.1.1 Measuring function Default Converted Ultrasound Velocity and Setting Range Corneal Ultrasound Velocity : 1,640 m/s (1,400 to 2,000 m/s) Measuring range Corneal thickness Standard Probe : 150 to 1,200µm Disposal tip type Probe : 150 to 1,200µm Instrument accuracy Measuring accuracy : ±5µm...
8.2 Ultrasound energy and other information 8.2.1 Influences of ultrasound energy on the human body SP-100 Pachymeter is exclusively designed and built for ophthalmic use. Do not use the instrument for any purposes other than ophthalmic use. SP-100 Pachymeter, exclusively designed and built for ophthalmic pachymeter purpose, is set at very weak ultrasound energy ap- propriate for ophthalmic application.
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PD : the pulse duration PRF : the puls repetition frequency EBD : the entrance beam dimensions for the azimuthal and elevational planes Acoustic Output Report (IEC60601-2-37) Index label Non-scan(Aaprt 1cm Maximum index value 0.15 2.005 10 [Mpa] 0.44 P [mW] 0.0211 Min.of [P (zs),Ita, (zs)] Associated...
DISTANCE FROM THE SOURCE TO A SPECIFIED POINT zb : DEPTH FOR TIB zbp : BREAK-POINT DEPTH zs : DEPTH FOR TIS 8.3 Noise Generation This instrument makes monitoring sounds at the following occa- sions. When turning the power on. When Printout When operating various keys and buttons When taking measurement (such as taking data)
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Table 201 The SP-100 is intended for use in the electromagnetic environment specified below. The customer or the user of the SP-100 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...
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Guidance and manufacturer's declaration - electromagnetic immunity Table 202 The SP-100 is intended for use in the electromagnetic environment specified below. The customer or the user of the SP-100 should assure that it is used in such an environment. Immunity test...
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If the measured field strength in the location in which the SP-100 is used exceeds the applicable RF compliance level above, the SP-100 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SP-100.
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SP-100 Table 206 The SP-100 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SP-100 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SP-100 as recommended below, according to the maximum output power of the communications equipment.
9. Index Disinfection 3-2, 5-3 INDEX disposal 5-6 Disposal Tip 3-3 Disposal tip 3-14, 7-1 AC Adapter 2-1, 3-2, 3-39, 6-1 EDIT 3-7, 3-15, 3-16, 3-17, 3-26 AC adapter terminal 1-4 EOG 5-3 AC power adapter 1-5 ERROR 3-6 Acoustic Output 4-1 EXIT 3-21 Auto Measurement Function 3-14 Explosion 3-39...
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SOUND 3-21, 3-24 sound volume 6-6 NEW 3-7 Spare parts 7-1 NOW COMMUNICATING 3-32, 3-34, 3-36, 3-38 Specifications 8-1 Standard Probe 7-1 Sterilization 5-3 OPERATING PANEL 2-1 STOP BIT 3-30 Optional parts 7-1 Storage 5-6, 8-4 Symbols 1-4 Pachy 3-8, 3-21 Pachy screen 3-7 test piece 1-3, 3-13 Pachymeter Probe 3-2...
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Fax: +81 52-561-4735 EC-representative Tomey GmbH Am Weichselgarten 19a 91058 Erlangen GERMANY Tel: +49 9131-77710 Fax: +49 9131-777120 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...
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