Tomey SP-100 User manual

OPERATION MANUAL

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 representative or local distributor.

y Do not use this instrument by any procedures other than those specified in this

Manual.

y Only well-trained or skilled personnel is allowed to operate this instrument.

y Keep the Operation Manual in a place where you can easily access while operating

the instrument.

HANDY PACHYMETER

SP-100

WARNINGS





DO NOT USE THE INSTRUMENT WITH THE OUTER COVER AS LEFT



OPEN OR REMOVED, otherwise you may be exposed to direct high voltage.

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

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.

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Such use may not only cause an incorrect measurement, but also damage the

cornea.

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

This instrument is designed exclusively for ophthalmic use.

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DO NOT USE the instrument for any purpose other than ophthalmic use.

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

DO NOT connect the terminals of the instrument with any cable other than



those specified in the Manual, otherwise the instrument may be damaged.

SIGNIFICANT WARNINGS

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.

2. NAMES AND FUNCTIONS OF THE COMONENTS

Names and functions of the components of the instrument

3. OPERATING PROCEDURES

Vital information, required for installing and using the instrument

4. TECHNICAL INFORMATION

Useful technical information, which may be convenient for your use

5. MAINENANCE AND INSPECTION

Routine replacement, maintenance, and inspection, including replac-

ing spare parts

6. TROUBLESHOOTING

Countermeasures for troubles

7. SPARE PARTS AND OPTIONAL PARTS

Accessories and optional parts

8. SPECIFICATIONS

Specifications for the instrument

9. INDEX

Refer to the index as a guide, if necessary.

HOW TO USE THIS OPERATION MANUAL

SYMBOLS USED IN THE MANUAL

The symbols, such as "DANGER", "WARNING", "CAUTION" and "NOTE" used in this

Operation Manual, represent the following messages.

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Precaution for an operation state that, if unheeded, will cause a haz-

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ardous situation where there is an imminent danger of serious injury

or death.

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Precaution for an operation state that, if unheeded, may cause a haz-



ardous situation where there is the possibility of serious injuries or

death.

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An operational precaution that, if unheeded, may cause or lead to

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minor or moderate injuries or property damages.

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Special precaution that is related either directly or indirectly to per-



sonal safety or to property protection.

SYMBOLS USED IN THE MANUAL

iii

Contents

1. PRIOR TO USE ............................................................................................................. 1-1

1.1 Precautions..................................................................................................................................... 1-1

1.2 Unpacking ...................................................................................................................................... 1-3

1.3 Symbols, used in this manual ........................................................................................................ 1-4

1.4 Outline of Measurement Principle .................................................................................................. 1-5

2. NAMES AND FUNCTIONS OF THE COMPONENTS ................................................... 2-1

2.1 Front and Right side of Main Unit ................................................................................................... 2-1

2.2 Rear and left side of Main Unit ....................................................................................................... 2-1

2.3 Operation Keys .............................................................................................................................. 2-2

3. OPERATING PROCEDURES ........................................................................................ 3-1

3.1 Safety precautions .......................................................................................................................... 3-1

3.2 Preparation before operation ......................................................................................................... 3-2

3.2.1 Connection of accessories ........................................................................................... 3-2

3.2.2 Disinfection of the probe ............................................................................................... 3-2

3.2.3 Optional components ................................................................................................... 3-3

3.3 Adjustment and Setting .................................................................................................................. 3-4

3.3.1 Main power on and screen adjustment ........................................................................ 3-4

3.3.2 Startup Display .............................................................................................................. 3-5

3.3.3 Screen Contents ........................................................................................................... 3-7

3.3.4 Measuring conditions ................................................................................................... 3-9

3.4 Preparation for measurement ........................................................................................................ 3-12

3.4.1 Calibration of the Probe ...............................................................................................3-12

3.4.2 Operation Check ..........................................................................................................3-13

3.4.3 Measurement Preparation for Patient .......................................................................... 3-13

3.5 Measurement.................................................................................................................................3-14

3.5.1 Single measurement .................................................................................................... 3-15

3.5.2 Delete Each Data Reading ..........................................................................................3-16

3.5.3 Delete Data (Eye by eye or patient by patient) ...........................................................3-17

3.6 Printout ...........................................................................................................................................3-19

3.6.1 How to Printout the data ...............................................................................................3-19

3.6.2 Description of Printout ..................................................................................................3-20

3.6.3 IOP Calculation Printout ...............................................................................................3-21

3.7 Menu .............................................................................................................................................. 3-22

3.7.1 Description of the Screen display ...............................................................................3-22

3.7.2 Operation for the MENU Screen ..................................................................................3-23

3.7.3 Operating procedures of the Menu Screen ................................................................3-24

CONTENTS

3.7.4 IOP Calculation .............................................................................................................3-29

3.8 Sending and receiving data .......................................................................................................... 3-32

3.8.1 How to connect the serial communication cable ......................................................... 3-32

3.8.2 Setting of communication conditions ...........................................................................3-33

3.8.3 Data Export .................................................................................................................. 3-35

3.8.4 Data Receiving ............................................................................................................. 3-37

3.9 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

3.10.3 Charge indicator ...........................................................................................................3-45

3.10.4 How to Install / Uninstall Battery ...................................................................................3-45

3.10.5 Lifetime of rechargeable battery .................................................................................. 3-46

3.10.6 Expected operating time of hours ............................................................................... 3-46

4. REFERENCE TECHNICAL INFORMATION .................................................................. 4-1

4.1 How to calculate corneal thickness ................................................................................................ 4-1

4.2 Acoustic Output .............................................................................................................................. 4-1

4.2.1 MI (Mechanical Index) ....................................................................................................... 4-1

4.2.2 TIS (Soft Tissue Thermal Index) ........................................................................................ 4-1

5. MAINTENANCE AND INSPECTION .............................................................................. 5-1

5.1 Warranty .......................................................................................................................................... 5-1

5.2 Routine maintenance ...................................................................................................................... 5-2

5.2.1 Measurement Probe ..................................................................................................... 5-2

5.2.2 Maintenance of the Main Unit ........................................................................................ 5-4

5.3 Replacing of the printer paper ....................................................................................................... 5-5

5.4 Storage........................................................................................................................................... 5-6

5.5 Precautions for disposal of packing materials ............................................................................... 5-6

6. TROUBLESHOOTING ................................................................................................... 6-1

7. SPARE PARTS AND OPTIONAL PARTS ....................................................................... 7-1

7.1 Spare parts ..................................................................................................................................... 7-1

7.2 Optional parts ................................................................................................................................. 7-1

8. SPECIFICATIONS.......................................................................................................... 8-1

8.1 Specifications ................................................................................................................................. 8-1

8.1.1 Measuring function ........................................................................................................ 8-1

8.1.2 Measuring Probe .......................................................................................................... 8-1

CONTENTS

8.1.3 Main unit ........................................................................................................................ 8-1

8.1.4 AC Adapter ................................................................................................................... 8-1

8.1.5 Enclosed battery ........................................................................................................... 8-1

8.2 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

8.3 Noise Generation ........................................................................................................................... 8-4

8.4 Operating Environment................................................................................................................... 8-4

8.5 Conformed Standard ...................................................................................................................... 8-4

9. INDEX ............................................................................................................................ A-1

CONTENTS

1. PRIOR TO USE



 Make sure that the instrument is free from any equipment



 Care must be taken not to place any object on the instru-



 Be sure to read this Manual before using the instrument



 Do not use the instrument in any procedures other than



1.1 Precautions

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.

ment.

for your safe and correct operation.

specified in this Manual.

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

Though measuring accuracy is +/- 5

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measurement may be out of the measuring accuracy, depending on

condition of cornea. Please review and retake the measurement or try

other inspections, when the result seems to be suspicious with past

corneal medical history of the patient.

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Only skilled operators are allowed to use this instrument.

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When installing the instrument, observe the following items.

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- Install the instrument in a place where it is free from water and/or

chemicals.

- Install the instrument in a place where it is free from such adverse

influences as direct sunbeams, high temperature and moisture, dust, and

salts or sulfur-contained air.

- Install the instrument in a stable place where it is free from inclination,

vibration, and/or shocks.

- Do not install the instrument in or near the store area of chemical

substances or a place where any gas is generated.

- Use specified frequency, voltage and allowable current (or allowable

µµ

m, accuracy with actual

µµ

power consumption).

- Make sure that the conditions of power source (discharge, polarity, etc)

are proper.

1.1 Using precautions

1-1

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

Observe the following items before using the instrument.



- Check on the settings of switch connections, polarity, and volumes and

make sure that the instrument operates accurately.

- Make sure that all the cord connections are made properly.

- Recheck the components or parts that directly touch the Patient.

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

Observe the following items when you use the instrument.

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- Avoid using an excessive period of measurement for each Patient.

- Closely and continuously watch to check to see if the instrument works in

normal condition and the Patient is secured in safe condition.

- If any abnormal condition is found with the instrument or the Patient,

take appropriate actions or remedy, first to secure Patient's safety and

next to stop the operation of the instrument.

- Sufficient care should be given not to cause the Patient to touch the

instrument while the instrument is in operation.

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

Observe the following items after using the instrument.



- Before turning the power off, return the instrument to its original

condition in specified procedure.

- Do not apply undue force to the power cable when disconnecting, such as

by pulling the cord itself.

- As for storing the instrument and related components, see "5.4 Storage"

in this Manual.

- Store the Pachymeter Probe, accessories, and cords in order after

cleaning them properly.

- Be sure to properly clean the instrument to be ready for your next use.

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It is advised that in case the instrument is disorderd, stop using the

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instrument and contact your TOMEY representative for corrective

inspection and/or repair.

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Do not uncover except battery cover or remodel the main instrument in

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any ways.

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Do not remodel or redesign the instrument, or the Warranty will be

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invalid.

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Periodical inspection should be given to the instrument and related

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components.

1-2





When using the instrument after recess for a while, make sure that it

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operates properly and safely.

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

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.

1.1 Using precautions

1.2 Unpacking

Make sure, when unpacking the shipment, the instrument, including probe and

supplies all arrived at your place in their proper conditions. Check these com-

modities on any damages and malfunctions.



 Be sure to keep all the shipping and packing materials,



which may be used when the instrument is moved to the

other place.

z Main unit, HANDY PACHYMETER SP-100

(Lithium-Ion Battery Included) ....................................... 1

z Pachymeter Probe

(with the protective cap and the case) ......................... 1

z Pachymeter test piece .................................................... 1

z AC adapter ................................................................... 1

z Printer paper roll (1 roll in the instrument) ....................... 3

z Serial communication terminal protective cap .................. 1

z Operation Manual (this manual) ...................................... 1

z Carrying Bag ................................................................. 1

z Inner Case ..................................................................... 1

z Quick Guide .................................................................. 1

1.2 Unpacking

1-3

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

by using the serial communication cable.

Maintenance switch

This switch should be used for maintenance purpose only

Do not touch this switch for changing.

AC adapter terminal

Connects the AC adapter, included in the box.

1-4

1.3 Symbols used in this manual

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.

z 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.

z SP-100 measures the period of time from emitting ultrasound to

receiving the same ultrasound, reflected by corneal posterior part.

Applying a calculation formula shown below, corneal thickness

can be calculated.

V · t

L = ———

z This instrument is powered by rechargeable battery or AC power

adapter. Even when the battery power is running short, SP-100

can perform measurements, while charging the battery, by plug-

ging to AC power adapter.

z This instrument is designed to take corneal thickness measure-

ment automatically, when the probe is applied to cornea properly.

Where, L: Corneal Thickness

V: Converted sound velocity

(Ultrasound Velocity through cornea)

T: Measured time (Ultrasound transmission

time between emitting and receiving)

z This instrument is capable of sending and receiving patient infor-

mation and measurement data between the external equipment

through the serial communication port. (Additional cable must be

used, when using this function)

1.4 Outline of Measurement Principle

1-5

This page is left intentionary blank.

1-6

2. NAMES AND FUNCTIONS OF THE COMPONENTS

2.1 Front and Right side of Main Unit

A SCREEN

Measurement data and other information can be displayed.

B B

B OPERATING PANEL

B B

The keys are located on the panel with various functions.

C PACHYMETER PROBE TERMINAL

Pachymeter Probe should be connected to this terminal.

D SERIAL COMMUNICATION TERMINAL

Serial Communication Cable can be connected for data communication.

E AC ADAPTER TERMINAL

AC Adapter can be connected for supplying power for operation and charging battery.

F PROBE HOLDER

Pachymeter Probe can be hold and kept as stable position. Use the holder, while the probe is not in use.

G BUILT-IN THERMAL PRINTER

Patient and Measurement information can be printed by selected Standard or Simple mode.

2.2 Rear and left side of Main Unit

A INSTRUMENT STAND

The main unit stands on desk tilted for easy operation and monitoring.

B CONTRAST VOLUME DIAL

LCD contrast can be adjusted.

C MAINTENANCE SWITCH

This Switch is for maintenance use only. DO NOT change any setting this switch, or the unit is damaged.

2.1 Front and Right side of Main Unit 2.2 Rear and left side of Main Unit

2-1

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.

(Example)

A FUNCTION KEYS

Each key works as assigned function shown on the bottom of the screen. Four boxes from left to right on screen indicate each function of F1, F2, F3 and F4 keys.

B PRINT KEY

Patient and Measurement Data can be printed by built-in thermal paper. Please refer to [3.6 Printout] for details.

D CHARGE INDICATOR

E POWER KEY

X KEYS

Data selection, Patient ID & Name can be typed in by using the keys. Press both keys simultaneously to turn LED ON and OFF. (When the unit is only powered by battry and no operation for one minute, it automatically turns LED off)

The light keeps turning ON, while charging the internal battery. When it turns OFF, charging battery is completed.

The main power turns ON and OFF. When the unit is only powered by battery and no operation for three minutes, it automatically turns OFF to save battery power. (Auto Power OFF)

2-2

(F-keys Example) Each key, on this page, is assigned its func-

tion as follows:

x F1 ........... R/L

x F2 ........... INDEX

x F3 ........... EDIT

x F4. .......... NEW

2.3 Operation Keys

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.

- Do not use this instrument other than Ophthalmic applies.





Do not use any terminal other than specified in this Operation Manual,



which may otherwise cause to damage the instrument.





Do not leave the instrument plugged with the AC Adapter when the



battery is fully charged, otherwise, this may enshorten the lifetime of

built-in rechargeable battery.





When the probe is not in use, please place the probe cap and place the



probe to the holder to protect from getting damaged.

3.1 Safety precautions

3-1

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" on the front side of Main Unit.

b) Connection of AC Adapter

3.2.2 Disinfection of the probe

Insert the connector to the terminal completely

Insert AC adapter connector A into the connecting terminal B provided on the right side of the Unit.

Disinfect the probe with proper procedure, before its use. Please

3-2

refer to [5.2.2 Disinfecting Pachymeter Probe] for details.

3.2 Preparation before operation

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.

1) Cover the inner probe A with a pair of cases B to make the inner probe clipped in between and fix it with the rubber rings C.

2) Apply a small amount of methylcellulose (such

as Dry Eye Gel) on the tip of the inner probe A.

3) Then securely insert the disposal tip D not to

cause air bubbles inside of the tip.

1) Disassemble the disposal tip D, fixed ring C, and the case B in order.

2) Assemble the case B to be changed and next fix it with the rings C.

3) Next apply a small amount of methylcellulose

to the tip of the inner probe.

4) Then securely insert the disposal tip D not to

cause air bubbles inside of the tip.

3.2 Preparation before operation

3-3

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)

x Make sure the Probe has been connected.

x Make sure the tip of the Probe is dry.

Tilt the LCD screen on the proper position in order to get bet-

ter view from the front

(

(

(

(

24+06

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2#%*;/'6'452

.+)*6

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219'4

1) Press the power key A to start operation. The

instrument will automatically calibrate the con-

nected Probe. If "PROBE ERROR!" is displayed

on the screen, check if the tip of the Probe is dry.

(Refer to [3.3.2 Startup Display] for details)

(Fig. 1)

(Fig. 2)

2) Adjust the LCD contrast, according to the

brightness of the clinical room by using contrast adjusting dial B on the left side of the

unit. When the room is dark, press the "W " and "X" keys C simultaneously to turn the lighting LED

on.

3) Adjust Instrument Stand D on back of the unit to

tilt it to get better screen view.

3-4

(Fig. 3)

3.3 Adjustment and Setting

3.3.2 Startup Display

(Fig. 1)

1) The startup screen is displayed immediately af-

ter the power is on. The software version is seen

on the screen.

(Fig. 1)

2) The ultrasound velocity, set for measurement, is

(Fig. 2)

displayed.

(Fig. 2)

3) The unit calibrates the probe automatically.

(Fig. 3)

3.3 Adjustment and Setting

3-5

(Fig. 4)

4) When the calibration has been completed prop-

erly, measurement Pachy screen (initial screen)

is displayed.

(Fig. 4)

5) When the Probe is not calibrated properly,

"PROBE ERROR!" will be displayed. Press F4 key A "OK" (Fig. 5) to show CALIBRATION

screen (Fig. 6).

(Fig. 5)

(Fig. 6)

6) Check the connection of the Probe and the Probe tip, then press the "W " to recalibrate the

Probe.

When error appears in the screen, go to "6.

TROUBLE-SHOOTING" for the solution.

When "ERROR" repeatedly appears, contact

3-6

TOMEY representative.

3.3 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.

D Battery Life Indicator

Remaining power in the built-in battery

appears. (Two Steps)

E Type of listed data

Average, Minimum or Latest options can be selected as a type of listed data

F R/L (F1 key)

Left or right eye for measurement is switched over.

G INDEX (F2 key)

Switch screen to INDEX, to input Patient ID and name.

H EDIT (F3 key)

Switch screen to EDIT, to edit measured data

I NEW (F4 key)

To measure new patient, use this key to clear Patient data and measured readings.

3.3 Adjustment and Setting

3-7

b) Measurement screen

c) Edit 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.

While taking measurement, the screen automatically

changes and shows large size measuring data.

A Cursor

Selected data is highlighted on the list. Other data is selected by using "W" or "X" keys.

B Pachy (F1 key)

Press this key to change screen to Pachy mode.

C CLR (F2 key)

Press this key and keep holding it to clear all measurement data.

D DEL (F3 key)

Press this key and keep holding it to clear only highlighted measurement data

E MENU (F4 key)

Press this key to change into MENU screen.

3-8

3.3 Adjustment and Setting

3.3.4 Measuring conditions

a) Input Patient ID and name

The Patient ID and name are input in the "INDEX" screen. 14 letters can be

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.

Please refer to "3.9 Data Management with TOMEYLink (Electronic Medical Record Support System)" to send Data to

TOMEYLink.

In case of using Data Communication, Patient ID must be typed in. Otherwise the data cannot be sent.

(Fig. 1)

typed in either the Patient ID or Patient name.

1) Press F2 key A to change into INDEX Screen.

(Fig. 2)

2) Press F2 key C to change into ID input screen

to type in Patient ID. (Fig. 3)

Press F3 key D to change into Patient NAME input screen to type in Patient Name. (Fig. 4)

(Fig. 2)

F1 key B to go back to Pachy Screen (Fig. 1).

3.3 Adjustment and Setting

3-9

3) Press "W" or "X" keys to move Cursor I to

the figures or letters, you wish to input. (Fig. 3) Then, press SEL G to enter selected character.

(Fig. 3)

4) Press F1 key E to switch over input mode be-

tween figures and letters.

5) Press F2 key F to enter Back Space.

6) When Patient ID type in completed, press F4 key H to go back to INDEX Screen (Fig. 1).

(Fig. 4)

3-10

7) Repeat the above procedure again to type in Pa-

tient name. (Fig.4)

3.3 Adjustment and Setting

b) The eye to be measured

c) Corneal ultrasound velocity

Select Right eye or Left eye, to be measured.

Press F1 key A to switch over Right and Left dis-

play.

d) Listed data on screen

Ultrasound Velocity can be changed by going into

setting Menu. Please refer to "3.7.3 c) corneal Ultra-

sound Velocity (VELOCITY)" for details.

One, out of three, data type A can be selected as

listed data type. The three options are as follows.



 AVERAGE



The mean value of each data box is listed.



 LATEST



The last measurement for each data box is listed.



 MINIMUM



The minimum value of all measurements for each data box is displayed.

Please refer to "3.7.3 d) Setting of the type of display

data (DATA SELECTION)" for details.

3.3 Adjustment and Setting

3-11

3.4 Preparation for measurement

3.4.1 Calibration of the Probe

y In case of using the disposal tip probe, be sure to calibrate

it with the disposal tip attached.

y Be sure the tip of the Probe is dry and free from any water,

before calibrating probe.

y 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. (Fig. 1)

(Fig. 1)

(Fig. 2)

2) When the probe is removed or the tip of the

probe is removed with disposable tip probe, the

instrument automatically detect the abnormal

situation and shows CALIBRATION screen

(Fig.2).

Check the connection of the probe and tip, then press "W" for re-calibration.

3-12

3.4 Preparation for measurement

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.

1) Go to Pachy screen

2) Place the test piece into water until it covers

over the piece. Apply the Probe into either of

the dents on the piece perpendicularly, so the

instrument will start measurement automati-

cally.

3.4.3 Measurement Preparation for Patient

Patients' cooperation is necessary for smooth op-

eration.

Prior to measurement, explain about the purpose

of examination and measuring procedures to the

Patient so as not to give fears, but to relax in a

good mood.

1) Review the settings and calibrate the Probe or

check the instrument, if necessary.

2) Give eye-drops anesthesia to the eye to be mea-

sured. The patient should be seated with the

Back Rest or should lie on a bed.

3) If the eye seems to be dry or has little tears,

apply balanced salt solution to avoid dry sur-

face of cornea.

3.4 Preparation for measurement

3-13

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.

y The corneal ultrasound velocity has direct influence on

measurement results. Before taking measurement, make

sure that the appropriate velocity is set for measurement.

Please refer to "3.7 Menu" for details.

y In case the corneal surface is dry, apply balanced salt so-

lution for moisture.

y Auto Measurement Function is an assistant function to

make measurement easy, but does not clinically determine

actual diagnosis. In case of applying results, the examiner

should always evaluate them for use.

3-14

3.5 Measurement

3.5.1 Single measurement

a) Measuring procedures

(Fig. 1)

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) When twenty measurements have been taken,

the instrument sounds two "beeps" to announce

the measurements are completed.

(Fig. 2)

4) Move the Probe away from cornea, so the cursor A will move to next memory in order to be

ready for another measurement (Fig.2). 20 mea-

surements will not be necessary to complete it

in one place. The instrument completes the

measurement in the position, when the probe

is taken away and it beeps twice.

5) Repeat the measurement process to fill 8 memo-

ries with data. When Retake measurement on cer-

tain memories with overwriting, go to EDIT screen

to move highlighted memory, then back to Pachy

screen to take the measurement.

6) For the measurement of the other eye, press F1 key B to switch between Right and Left.

3.5 Measurement

3-15

3.5.2 Delete Each Data Reading

(Fig. 1)

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. 2).

(Fig. 2)

2) Press "W" or "X" to move Cursor B to highlight

the measurement that should be deleted.

3) Press F3 key C and keep holding it for a while,

until the instrument sounds "beep" to complete

deleting.

3-16

3.5 Measurement

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.

1) Press F1 key A in Pachy Screen (Fig. 1) to se-

lect which eye data should be deleted.

(Fig. 1)

(Fig. 2)

2) Press F3 key B to change screen to EDIT (Fig.

2).

3) Press F2 key C and keep holding it for a while,

until the instrument sounds "beep" to confirm

all the data on screen has been deleted.

3.5 Measurement

3-17

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" to

confirm all the data has been deleted.

3-18

3.5 Measurement

3.6 Printout

3.6.1 How to Printout the data

y Prior to Printout, make sure the proper paper

is set correctly and the paper remains suffi-

ciently.

y 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. 1), the EDIT Screen (Fig.

2), or the DATA COMMUNICATION, SEND Screen

(Fig. 3) for Printout of measured data.

(Fig. 1)

(Fig. 2)

(Fig. 3)

3.6 Printout

3-19

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.

3-20

3.6 Printout

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)

b) Simple mode

N Adjusted IOP

D ~ I will not be printout, when there is no mea-

sured data.

Only Time/Date, Patient ID, Adjusted IOP related data

will be printout by Simple mode.

3.6 Printout

3-21

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.

F Pachy (F 1)

The screen is changed to the Measurement Standby Screen.

G IOP (F 2)

Move to IOP Calculation Main Screen.

H SEL (F 3)

The Highlighted function is selected.

I EXIT (F 4)

3-22

The screen is returned to the EDIT Screen.

3.7 Menu

3.7.2 Operation for the MENU Screen

(Fig. 1)

1) Press F3 Key A in the Measurement Standby

Screen, to change the screen to the EDIT Screen

(Fig. 2).

2) Press F4 Key B in the EDIT Screen, to change

the screen to the MENU Screen (Fig. 3).

(Fig. 2)

(Fig. 3)

3) Press " W " or " X " of the Operating Panel and next press F3 Key C by aligning the Select Cur-

sor to the item to be set, to change the screen for

each item.

Press F1 Key D to return the screen to the Mea-

surement Standby Screen (Fig. 1).

3.7 Menu

3-23

3.7.3 Operating procedures of the Menu Screen

a) Setting of date and time (TIME/DATE)

(Fig. 1)

1) Press "W" or "X" 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. 2). Press F4 Key B to return the screen to the EDIT

Screen.

2) Press "W" or "X" of the Operation Panel, to

(Fig. 2)

align the cursor C to YEAR. Next, press F3 key D to change the screen to the Setting Screen (Fig.

3).

Pressing of the EXIT key E returns the screen

to the MENU Screen (Fig. 1).

3) Press "W" or "X" of the Operation Panel, to

increase or decrease the dominical year at the cursor position. Pressing F3 key F after the

dominical year has been set returns the screen to

the Setting Screen (Fig. 2).

Set the other items in a similar manner.

(Fig. 3)

3-24

Pressing F4 Key E returns the screen to the Date

and Time Setting Screen (Fig. 2).

3.7 Menu

b) Sound volume (SOUND)

(Fig. 1)

1) Press " W " or " X " 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.

2) Press " W " or " X " of the Operating Panel, to

increase or decrease the sound volume.

(Fig. 2)

Pressing F4 Key C returns the screen to the

MENU Screen (Fig.1).

x "-": No SOUND

x "X": Small SOUND

x "XX": Medium SOUND

x "XXX": Large SOUND

3.7 Menu

3-25

c) Corneal Ultrasound Velocity (VELOCITY)

(Fig. 1)

1) Press "W" or "X " 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.

2) Pressing "W" or "X " of the Operating Panel in-

creases or decreases the sound velocity.

(Fig. 2)

[Input range] Corneal ultrasound velocity: 1,400 to 2,000 m/s

Pressing F4 Key C returns the screen to the

MENU Screen (Fig. 1).

3-26

3.7 Menu

d) Setting of the type of display data (DATA SELECTION)

1) Press "W" or "X " 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.

Pressing F4 Key B returns the screen to the EDIT

(Fig. 1)

(Fig. 2)

Screen.

2) Press "W" or "X" of the Operating Panel to align

the cursor to the type of data desired to be dis-

played.

Pressing F4 Key C returns the screen to the

MENU Screen (Fig. 1).

(Fig. 3)

If measured data are left remaining in the screen,

the type of display data cannot be changed.

Resetting of the type of display data shall be

made after deleting the data by returning the

screen to the Measurement Standby Screen (Fig.

3) and long pressing F4 Key D.

3.7 Menu

3-27

e) Print mode

(Fig. 1)

1) Press "W" or "X" 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.

2) Press "W" or "X" of the Operation Panel, to

align the cursor to "STANDARD" or

(Fig. 2)

"SIMPLE". (See 3.6.2 for the description.)

Pressing F4 key C returns the screen to the

MENU Screen (Fig. 1).

3-28

3.7 Menu

3.7.4 IOP Calculation

(Fig. 1)

1) Press F2 A to change the screen to IOP calcula-

tion (Fig.2).

2) Press F1 B to select either RIGHT/LEFT eye data should be calculated C.

(Fig. 2)

(Fig. 3)

3) Press F2 D to change the screen to Tonometry

Input (Fig.3).

Press F1 E to move cursor F between RIGHT

and LEFT.

Input the Tonometry for IOP Calculation formula. Press "W" or "X" to select the figures and press F3 G to enter.

[Tonometry Input Range] : 1 ~ 60 mm

Hg : 133~7998Pa

3.7 Menu

3-29

(Fig. 4)

Press F4 H to select the screen to IOP Calcula-

tion (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.

Press F1 J to move cursor K between RIGHT

and LEFT.

(Fig. 5)

(Fig. 6)

Press "W" or "X" to select the figures and press F3 L to enter.

[CCT Input Range] : 0 ~ 1,500 µm

4) Press F4 M to change the screen to PARAM-

ETERS INPUT (Fig.6)

Press F1 N to move highlighted cursor between Parameter 1 P and 2 Q.

Press "W" or "X" to select the figures and press F3 L to enter Parameter 1 P and 2 Q.

3-30

[Parameter Range]

Parameter 1 : 0 ~ 1,500 µm

Paramater 2 : 0 ~ 1.000 µm

3.7 Menu

(Fig. 7)

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).

3.7 Menu

3-31

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.

3.8.1 How to connect the serial communication cable

The insertion direction of the connector is speci-

fied. Securely insert the connector in specified

direction without looseness.

The serial communication cable used for this instrument is of

a female type. In case of connecting this connector with the

personal computer, connect the male/female adapter to the

male/female cable or the female/female cable in accordance

with the following procedure.

1) Connect the serial communication cable connector B to the serial communication cable terminal A and secure these parts with the fixed screw C.

[Positions of D-sub 9 pins] Pin No. Signal name 1 2 RxD 3 TxD 4 DTR 5 SG 6 DSR 7 RTS 8 CTS 9 -

It is noted that No. 4 and No.6 pins and No.7 and

3-32

No. 8 pins are shorted inside of the instrument.

3.8 Sending and receiving data

3.8.2 Setting of communication conditions

(Fig. 1)

1) Press F2 Key A to change the screen to the IN-

DEX Screen. (Fig. 2)

2) Press F4 Key B to change the screen to the DATA

COMMUNICATION Screen. (Fig. 3)

(Fig. 2)

(Fig. 3)

3) Use "W" or "X" keys to select "SETUP" to go to

the COM Set-up screen (Fig. 4).

Press F4 key D to go back to INDEX screen

(Fig. 2).

3.8 Sending and receiving data

3-33

4) Press "W" or "X" 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

(Fig. 4)

(Fig. 5)

changed as shown in Fig. 5. The Machine number can also be set by pressing "W" or "X" of the

Operating Panel.

When F2 Key is pressed again, the screen will be

returned to the screen shown in Fig. 4.

[Communication Setup]

BAUD RATE: 9600, 19200, 38400

DATA BIT: 8BIT (Fixed)

PARITY: NONE (Fixed)

STOP BIT: 1BIT (Fixed)

FLOW: NONE (Fixed)

MACHINE: 0 to 99

Press F4 key I to go back to DATA COMMUNICATION screen (Fig.3).

3-34

3.8 Sending and receiving data

3.8.3 Data Export

(Fig. 1)

Please refer to "3.9 Data Management with TOMEYLink (Elec-

tronic Medical Record Support System)" to send Data to

TOMEYLink.

1) Press "W" or "X" of the Operating Panel in the

DATA COMMUNICATION Screen and align the

cursor to "SEND". Press F3 Key A to change the screen to the Data

Communication Screen (Fig. 2).

(Fig. 2)

2) Press F2 Key B to change the screen to the Data

Confirmation Screen (Fig.3)

Make sure in this screen that the serial commu-

nication cable is connected to the external equipment and press F3 Key D, so the data will

be sent to the external equipment. (It should be

noted that no data can be sent unless related ID

has been entered.)

(Fig. 3)

3.8 Sending and receiving data

3-35

(Fig. 4)

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.

4) When data is properly sent, "SENT COM-

PLETE!" is displayed. (Fig. 5) Then, press F4 F to return the screen to the Data Communica-

tion Screen (Fig. 2).

(Fig. 5)

3-36

3.8 Sending and receiving data

3.8.4 Data Receiving

(Fig. 1)

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.

2). If any data is left remaining in the screen, delete such data by long pressing F4 Key A.

(Fig. 2)

2) Next press "W" or "X" of the Operating Panel

and align the cursor to "RECEIVE". Then press F3 Key B to change the screen to the Data Re-

ceiving Screen (Fig. 3).

3) When F3 Key C is pressed, the screen will be

ready for receiving data. Then, operate the data

sending side to send data.

(Fig. 3)

3.8 Sending and receiving data

3-37

(Fig. 4)

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.

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. 2).

(Fig. 5)

3-38

3.8 Sending and receiving data

3.9 Data Management with

(Electronic Medical Record Support System)

Please refer to Operation Manual of TOMEYLink (Electronic

Medical Record Support System) to setup TOMEYLink soft-

ware and LAN adapter (LA-100).

Patient ID is necessary in order to send the data outside the unit

by TOMEYLink. Optional Key-Pad is used in this manual to ex-

plain how to input Patient ID.

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.

3.9.1 Patient Data Receiving

(Fig. 1)

1) On Main Screen (Fig.1), press F2 key A to go

to INDEX screen (Fig.2).

2) Press F4 key B to go to DATA COMMUNI-

CATION (Fig.3).

(Fig. 2)

3.9 Data Management with TOMEY Link

3-39

(Fig. 3)

3) Press "W" or "X" key to move the cursor to RE-

CEIVE. Press F3 key C to go to Data Receiving (Fig.4).

4) When F3 key D is pressed, data receiving will be

ready. Input Patient ID through Key pad, connect-

ing with LAN adapter (LA-100).

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.

5) "NOW COMMUNICATING" will be displayed,

while SP-100 is receiving data (Fig.5). Press F4 key F to cancel receiving data.

(Fig.5)

3-40

3.9 Data Management with TOMEY Link

(Fig. 6)

6) When data is properly received, RECEIVED

COMPLETE! is displayed (Fig.6). When there is

no registered patient on TOMEYLink, according

to input ID, only the ID will be received. Press F4 key G to go back to DATA COMMUNICA-

TION (Fig.3).

7) Press F1 key H to return to the Measurement

Screen (Fig.1) and start taking measurement.

Patient Data can also be received, after taking mea-

surement. Please follow the instruction 2), after

taking measurement.

3.9.2 Data Sending

(Fig. 1)

(Fig. 7)

1) Press "W" or "X" button to move cursor to SEND

on DATA COMMUNICATION (Fig.1). Press F3 key A to go to DATA SENDING screen

(Fig.2).

3.9 Data Management with TOMEY Link

3-41

2) Press F2 key B to switch screen from DATA

SENDING (Fig.2) to DATA CONFIRMATION

(Fig.3).

Make sure Serial Communication Cable is prop-

erly connected to external device. Press F3 key C to send data to TOMEYLink. When ID is

(Fig. 2)

(Fig. 3)

missing, whole data will not be sent.

Press F4 key D to go back to DATA COMMU-

NICATION (Fig.1).

3) "NOW COMMUNICATING" is displayed, while data is sent (Fig.4). Press F4 key E to cancel

sending data.

(Fig. 4)

(Fig. 5)

3-42

4) When data is properly sent, SENTCOMPLETE! is displayed (Fig.5). Press F3 key F to go back

to DATA SENDING screen (Fig.2).

3.9 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.

y After the battery has been charged, pull off

the AC Adapter from the instrument. If the

battery is left as being connected to the instru-

ment for long time, the service life of the bat-

tery may be affected.

y This instrument is enclosed with its exclusive

battery; therefore, it can be used without the

AC Adapter as connected.

3.10.1 Battery charge balance

The remaining amount of battery charge is displayed in the

Monitor Screen, which is displayed in the following two steps.

: Sufficient charge left in the battery

: Less charge left in the batter

(Battery Recharging is necessary)

Recharge the battery if the charge level becomes low.

3.10 Battery

3-43

3.10.2 Low Battery Warning

(Fig. 1)

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. Auto Power Off waiting time is 3 minutes, but it will be extended to 10 minutes, when the battery is low, in order to keep a certain time to start recharging the unit. When the unit is powered by AC adapter, it starts charging battery, then blinking and beeping stop automatically.

2) When the battery is low A, built-in printer becomes out of service. When PRINT is pressed, a warning (Fig.2) comes up on screen. Press F4 key (B) to go back to main screen.

(Fig. 2)

(Fig. 3)

If the measured data is on screen (Fig.3), when battery icon becomes to , printout is available only once within 9 minutes. After 9 minnutes, since the battery becomes low or printout is provided once, the printer becomes out of service and a warning (Fig.2) comes up, when PRINT is pressed.

3-44

3.10 Battery

3.10.3 Charge indicator

3.10.4 How to Install / Uninstall Battery

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.

Please pay special attention not to disconnect the battery

cable.

Please be careful not to cut the battery cables by putting

them between main unit and its cover, pulling them hard

or carrying the battery by holding only these cables.

1) Remove the Screw on backside of the unit A, then

remove the battery cover B .

2) Unplug the Battery Connector C carefully with

tweezers. Then, remove the battery D slowly from the

unit.

3) Connect the new battery D and plug the connec-

tor carefully.

4) Place the battery cover back and tighten the screw

5) Please refer to “5.5 Precautions for disposal of

packing materials” on this book, for battery disposal.

3.10 Battery

3-45

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-

lowing operating time with its fully charged condition provided in

its initial stage.

 3 minutes measurement for one Patient, without printout:

Approx. 6 hours.

 3 minutes measurement for one Patient with printouts for

both eyes: Approximately 4 hours.

The above operating time is only an assumed measure, which

varies upon the using environments and conditions.

3-46

3.10 Battery

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.

4.2 Acoustic Output

4.2.1 MI (Mechanical Index)

Tc =

MI is a parameter to show mechanical bio-effects of ultrasound.

Examples of mechanical

effects are motion (or streaming) around compressible gas bubbles

V x t

where,

Tc: Corneal thickness

V: Converted sound velocity in the cornea

t: Measuring time

4.2.2 TIS (Soft Tissue Thermal Index)

as ultrasound pressure

waves pass through tissues, and energy released in the collapse,

via cavitation, of

transient gas bubbles.

TIS is a parameter to show thermal bio-effects of ultrasound.

Thermal effect is

temperature rise of tissue by ultrasonic exposure.

4.1 How to calculate corneal thickness

4-1

This page is left intentionary blank.

4-2

5. MAINTENANCE AND INSPECTION

5.1 Warranty

One-Year Limited Warranty

The seller warrants this product to be free from defects in material and work-

manship under the normal use of this product for one (1) year or other term

complying with local regulations from the date of invoice issued by Seller to the

original purchaser.

Lamps, paper and other consumable items shall not be covered by this war-

ranty.

This warranty also shall NOT apply if the product has not been installed, oper-

ated or maintained in accordance with the OPERATOR MANUAL of Tomey

Corporation (here in after called "Tomey"). Neither seller not Tomey shall be

liable for any damages caused by purchaser's failure to follow instruction 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 per-

sonnel duty authorized by Tomey, not to a product whose serial number or

batch number is removed, altered or effaced.

THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY AND ALL OTHER

WARRANTIES, EXPRESS OR IMPLIED (INCLUDING SPECIFICALLY,

WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, ALL

WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PAR-

TICULAR PURPOSE), AND ALL OTHER OBLIGATION AND LIABIL-

ITY ON THE PART OF SELLER AND TOMEY. NEITHER SELLER NOR

TOMEY SHALL BE LIABLE FOR INCIDENTAL, CONSEQUENTIAL

OR SPECIAL DAMAGES UNDER ANY CIRCUMSTANCES OR FOR

MORE THAN REPAIR, REPLACEMENT OR REFUND OF THE PUR-

CHASE PRICE OF DEFECTIVE GOODS.

5.1 Warranty

5-1

5.2 Routine maintenance

5.2.1 Measurement Probe

y 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.

y Do not touch the connector, or the Probe may be damaged.

y Before applying the probe to patient, please make sure

there is no damage, such as crack or split, on the probe tip.

y Please make sure there is no loose connector nor discon-

necting cable.

a) Cleaning

y Use sanitary cotton for cleaning of the eye contacting part

of the Probe not to damage.

y Do not pull the cord of the Probe while cleaning.

y Do not wet the connector contacting part of the Probe when

cleaning.

z For cleaning of the Probe, wipe stains with sanitary cotton ab-

sorbed with ethanol for disinfection and then clean it with water soaked cloth.

z Completely remove water from the Probe after cleaning.

5-2

5.2 Routine maintenance

b) Disinfection

z For disinfecting of the Probe, immerse the part of the Probe

within 15mm from the eye contacting part it in disinfection ethanol or 0.5% sodium hydrochloride water solution for 10 to 20 minutes and then wash it with distilled water and then dry sufficiently.

c) Sterilization

The use of the autoclave for sterilization of the Probe is pro-

hibited, or the Probe is severely damaged otherwise.

EtO: Ethylene oxide 20%, and carbon dioxide 80%.

Sterilization temperature: 50±5C

Sterilization pressure: (9.8±0.98)×10000Pa

Sterilization time: 5±1 hr.

Aeration time: Pachymeter Probe....More than 10 hours

Disposable Tip.....20 sets of 30 minutes aeration

5.2 Routine maintenance

5-3

5.2.2 Maintenance of the Main Unit

—

y 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.

y Do not pull the power cord with an undue force.

y Care is to be taken not to touch the Probe connecting ter-

minals.

z Remove stains from the instrument body by lightly rubbing the

surface with a piece of cloth which has been wetted with water and then squeezed to remove water, and then by finishing with a piece of dry cloth. In case of an excessive amount of stains, wet the stained surface with a piece of cloth which has been wetted with a diluted neutral agent. Furthermore, carefully wipe the surface with wet and dry cloths.

z Cleaning of stained monitor display is to be given by dry cloth. In

case of an excessive amount of stains, remove the stains with a piece of cloth which has been wetted with a neutral cleanser and tightly squeezed and furthermore by wiping wet and dry cloth.

z If the instrument is suspended for a while, disconnect the power

plug from the receptacle and place the dust cover over the instrument.

5-4

5.2 Routine maintenance

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.

1) Open the Printer Cover A to your side.

2) Remove the roll shaft for printing paper to be

replaced.

3) The printer paper is set by inserting and push-

(Fig. 1)

ing the paper end is inserted into the Printer

and, at the same time, pressing the PRINT Key B. Make sure that the paper has been placed

with its face side turned on the printing side.

(Fig. 1)

4) Close the Printer Cover. Be sure to securely close

the Cover until it snicks. (Fig. 2)

5) Trim an extra length of paper.

(Fig. 2)

5.3 Replacing of the printing paper

5-5

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.

Minute care must be given not to cause the instrument with inclination,

vibration, or shock in routine operation and also when moving it from one

place to the other.

Do not store the instrument in or close to a place where chemicals or any

gases are stored or used.

z After using the Probe, clean and dry it. The protective cap should

be used for the Probe tip and stored in the Probe case.

z If the instrument is used after a long period of recession, make

sure that it functions properly and safely before use.

z Store the instrument under following Storing conditions to avoid

enshortening lifetime of built-in battery.

Ambient temperature range: -20 to +45C

Relative humidity range: lower than 95%

5.5 Precautions for disposal of packing materials

y Keep the containers and packing materials for future use.

The packing container and cushion materials will be neces-

sary when moving or transporting the instrument.

y Be sure to store the cushion materials when storing the

container.

y Disposing of the instrument and packing materials shall be

done in accordance with the national and local environ-

mental rules and regulations.

y This instrument is provided with the printed board using

the lithium cells. It is specially noted the disposal of

lithium cells differ in local rules, so please follow your local

rules and regulations.

5-6

5.4 Storage 5.5 Precautions for disposal of packing materials

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.

y Do not attempt to use the instrument for any purposes other

than those specified in this Manual.

y If the following items do not correct the malfunction, ask

your local representative for inspection and repair.

z When the power is turned on, the Monitor Screen is not dis-

played.

Cause1

Remedy

Cause2

Remedy

Improper connection of the AC Adapter.

Check to see if the AC Adapter is securely connected to

the instrument and the power receptacle.

No power is supplied.

Check to see if the power is supplied to the power recep-

tacle.

6. TROUBLESHOOTING

6-1

z No information is displayed in the Monitor Screen.

Cause1

Remedy

Cause2

Remedy

z The Monitor Screen is too dark to see.

Cause1

The Auto Power-off Function is in actuation, which automati-

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.

The switch for maintenance which is located at the rear side

of the instrument, is in its middle position (A).

Turn the power off, next return the switch to its middle

position (A), and then turn the power on.

The brightness of the Monitor is low.

Remedy

z No printout can be made.

Cause1

Remedy

Adjust the contrast of the Monitor Screen by turning

the Contrast Adjusting Volume. Turu the backlight LED ON,

if necessary. (2.3 Operation Keys)

The Printer paper has run out.

Check to see if the Printer paper is left sufficient for

printout.

Also check to see if the Printer paper is provided prop-

erly in such a manner that is specified in "5.4 How to

replace the Printer paper".

6-2

6. TROUBLESHOOTING

z The Clock in the screen is in cease.

Cause1

Remedy

z The LED does not light.

Cause1

The INDEX Screen displayed after data measurement has

been made is shown.

In case the INDEX Screen displayed after data measure-

ment has been made is shown, the date and time when data

measurement was made are displayed in the screen.

The then time will be displayed by first deleting the data and

then displaying the INDEX Screen.

The Auto LED Off Function is in actuation, which auto-

matically turns the LED off if the instrument ceases op-

eration longer than one minute.

Remedy

z Ultrasound Velocity and Display Settings cannot be changed.

Cause1

Remedy

Pressing "W" and "X" keys in the Operation Panel con-

currently lights up the LED.

The measured data is stored in main memory.

Press New, CLR or DEL button to delete the stored data

to change current settings.

6. TROUBLESHOOTING

6-3

z "PROBE ERROR!" is displayed in the calibration of the Pachymeter

Probe given when the power is turned on.

Cause1

Remedy

z Measurement data is not stable or proper.

Cause1

Remedy

The connection of the Pachymeter Probe is not proper.

Properly connect the Probe, in accordance with the pro-

cedure specified in "3.2.1 a Connecting of the

Pachymeter Probe".

After the above, calibrate the Probe in the procedure

specified in "3.4.1 Calibration of the Pachymeter Probe"

or after once turning the power off and then rebooting

the the instrument.

The connection of the Pachymeter Probe is not proper.

Properly connect the Probe in accordance with the pro-

cedure specified in "3.2.1 a Connecting of the

Cause2

Remedy

Cause3

Remedy

Cause4

Remedy

Pachymeter Probe".

Using of the Probe is not proper.

Apply the Probe at a right angle to the corneal part to be

measured.

Setting of the conversion sound velocity has not been

properly set.

Make sure that the converted sound velocity has been set

properly.

The eye contact part of the Pachymeter Probe is damaged.

If such damage is found, stop measurement immediately

and consult with your local representative.

6-4

6. TROUBLESHOOTING

Cause5

The Pachymeter Probe has not been properly calibrated.

Remedy

z No automatic measurement can be given.

Cause1

Remedy

Cause2

Clean the tip of the Probe and re-calibrate the Probe in the

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.

The Pachymeter Probe has not been properly calibrated.

Clean the end of the Probe and re-calibrate the Probe in

the procedure specified in "3.4.1 Calibrating of the

Pachymeter Probe" or once turn the power off, next

reboot the instrument, and the calibrate the Probe.

Surrounding noises have been interfered.

Remedy

Cause3

Remedy

Such noise sources as motor and laser surgery equip-

ment, if provided close to the instrument, must be moved

away from the instrument.

The eye contact part of the Pachymeter Probe is dam-

aged.

If so damaged, promptly discontinue measurement and

consult with your local representative.

6. TROUBLESHOOTING

6-5

z Monitor sounds do not stop. Measurement data is taken when

measurement is not in process.

Cause1

Remedy

z Monitor sound is not made.

Cause1

Remedy

The tip of the Pachymeter Probe is wet with water.

Remove the water from the tip of the Probe.

The sound volume is set as OFF.

Turn the Sound Volume to a position other than OFF, in

accordance with "3.10.2 Sound Setting".

6-6

6. TROUBLESHOOTING

7. SPARE PARTS AND OPTIONAL PARTS

The following spare parts and optional parts are available upon

ordering to your Tomey local distributor or representative.

7.1 Spare parts

z Printer paper

Specify your order article as "Printer paper for SP-100 "

when you order.

7.2 Optional parts

z Pachymeter Probe (Standard Probe)

Specify your order part as "Standard Pachymeter Probe

for SP-100" when you order.

z Disposal tip type Pachymeter Probe

Specify your order part as "Disposal tip type Pachymeter

Probe for SP-100" when you order.

z Disposal tip

Specify your order part as "Disposal tip for SP-100" when

you order.

7. SPARE PARTS AND OPTIONAL PARTS

7-1

This page is left intentionary blank.

7-2

8. SPECIFICATIONS

8.1 Specifications

8.1.1 Measuring function

z Default Converted Ultrasound Velocity and Setting Range

 Corneal Ultrasound Velocity : 1,640 m/s

z Measuring range

 Corneal thickness

Standard Probe : 150 to 1,200µm Disposal tip type Probe : 150 to 1,200µm

z Instrument accuracy

 Measuring accuracy : ±5µm

z Minimum Display Unit : 1µm

8.1.2 Measuring Probe

z Probe type

 Standard Probe : Solid type/45 with angle  Disposal tip type Probe : Solid type/45 with angle,

(1,400 to 2,000 m/s)

straight

8.1.3 Main unit

8.1.4 AC Adapter

8.1.5 Enclosed battery

z Transducer frequency : 20MHz±20%

z Printer : Enclosed thermal printer z Monitor screen : STN liquid crystalline display panel, 2.7 inch

black and white

z Dimensions / Weight : 118(W)×207(D)×59(H)mm/530g z Power Concumption : 23VA + less than 15%

z Power Voltage & Frequency : AC 120V 60Hz 30W

AC 230V 50Hz 125mA

z Manufacturer : Globtek, Inc. z Product Name : WD24C2000LCP-N-MED

WD24C2000L1P-N-MED

z Battery : Lithium ion battery

Rated capacity 1,000mAh

Nominal voltage 3.7V

* The above specifications and exterior appearance may be revised for improved performances of

the instrument.

8.1 Specifications

8-1

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. Minutes care should be taken

not to cause the Patient to be excessively exposed with ultra-

sound energy while measurement.

8.2.2 Ultrasound energy

Acoustic Output Reportimg Table (FDA)

0.23

0.15

0.44

19.98

0.05

0.075 8000

MI : the Mechanical index

Ispta3 : the derated spatial-peak temporal-average intensity.

Isppa3 : the derated spatial-peak pulse-average intensity.

pr : the peak rarefactional pressure.

12.71

0.021

19.92

0.05

0.065

0.19

0.18

26.21

0.021

19.89

0.05

0.065

0.075 8000

8-2

pr.3 : the deratad peak rarefactional pressure.

Wo : the ultrasonic power

fc : the center frequency

Zsp : the axial distance at which the reported parameter is measured.

x-6, y-6 : are respectively the in-plane(azimuthal) and out of plane(elevational)

-6dB dimensions in the x-y plane where Zsp is found

8.2 Ultrasound energy and other consumptions

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 MI

Maximum index value

[Mpa]

pr, P [mW]

Min.of [P Zs zbp

Associated Zb

acoustic Z at max.Ipi,

parameters deq (zb) fawf [MHz]

Dim of Aaprt [cm]

Td [us]

Other Pr at max.Ipi [MPa] information

Operating control conditions

Prr [Hz]

deq at max.Ipi

Ipa,

Control

(zs),Ita, (zs)]

[cm]

at max.MI [W / cm2]

Non-scan(Aaprt 1cm2)

0.15

0.44 NA NA NA NA NA

0.05 NA

19.9

X Y

NA NA

0.075 8000

0.45 NA

26.21

TIS

2.005

0.0211

19.9

0.19

0.18

NA NA NA NA NA NA

NA NA NA NA NA

-3

NA : Not Applicable

a : ACOUSTIC ATTENUATION COEFFICIENT

Aaprt : -12dB OUTPUT BEAM AREA

Deq : EQUIVALENT APERTURE DIAMETER

deq : EQUIVALENT BEAM DIAMETER

fawf : ACOUSTIC WORKING FREQUENCY

Ipa : PULSE-AVERAGE INTENSITY

Ipa, a : ATTENUATED PULSE-AVERAGE INTENSITY

Ipi : PULSE-INTENSITY INTEGRAL

Ipi, a : ATTENUATED PULSE-INTENSITY INTEGRAL

MI : MECHANICAL INDEX

P : OUTPUT POWER

Pa : ATTENUATED OUTPUT POWER

Pr : PEAK-RAREFACTIONAL ACOUSTIC PRESSURE

Prr : PULSE REPETITION RATE

TIS : SOFT-TISSUE THERMAL INDEX

td : PULSE DURATION

X,Y : -12dB OUTPUT BEAM DIMENSIONS

8.2 Ultrasound energy and other consumptions

8-3

z : 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)

8.4 Operating Environment

This instrument must be used under following environment.

 Ambient temperature range : +10 to 40C

 Relative humidity range : 3 0 to 75% non-condensing

Store the instrument under following Storing conditions to avoid

enshortening lifetime of built-in battery.

 Ambient temperature range : -20 to +45C

 Relative humidity range : Less than 95%

8.5 Conformed Standard

IEC60601-1 : 1988

Amendment 1 : 1991

Amendment 2 : 1995

8-4

IEC60601-1-2 : 2001

IEC60601-2-37 : 2001

8.3 Nose Generation 8.4 Operating Environment 8.5 Conformed Standard

Appendix:

Electromagnetic guidance

Caution: Medical electrical equipment. EMC (Electro Magnetic Compatibility) must be considered before any medical electrical equipment is installed or put into service. Follow the information in the accompanying documentation when installing and operating the SP-100. Caution: Portable or mobile RF communication equipment can effect Medical Electrical equipment.

Guidance and manufacturer's declaration -

electromagnetic emissions

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 RF emissions CISPR 11

RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3

Compliance Group 1

Class B

Complies

Electromagnetic environment - guidance The SP-100 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The SP-100 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Table 201

8.5 Conformed Standard

8-5

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

Electrostatic Discharge(ESD) IEC 61000-4-2

Electrical fast transient/ Burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

IEC 60601 test level

± 6kV contact ± 8kV air

± 2kV for power

supply lines ± 1kV for input/output lines ± 1kV differential mode ± 2kV common mode < 5 % U

(> 95 % dip in UT ) for 0,5 cycle

40 % U

(60 % dip in UT ) for 5 cycles

70 % U

(30 % dip in UT ) for 25 cycles

Compliance level

± 6kV contact ± 8kV air

± 2kV for power

supply lines ± 1kV for input/output lines ± 1kV differential mode ± 2kV common mode < 5 % U

(> 95 % dip in UT ) for 0,5 cycle

40 % U

(60 % dip in UT ) for 5 cycles

70 % U

(30 % dip in UT ) for 25 cycles

Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the SP-100 requires continued operation during power mains interruptions, it is recommended that the SP-100 is powered from an uninterruptible power supply or a battery.

Power frequency

< 5 % U

(> 95 % dip in UT ) for 5 sec 3 A/m

< 5 % U

(> 95 % dip in UT ) for 5 sec

3 A/m (50/60 Hz) magnetic field IEC 61000-4-8 NOTE : UT is the a.c. mains voltage prior to application of the test level.

8-6

8.5 Conformed Standard

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Guidance and manufacturer's declaration -

electromagnetic immunity

Table 204

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

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Portable and mobile RF communication equipment should be used no closer to any part of the SP-100, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

d =1.2

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 V rms 150kHz to 80MHz

3 V/m 80MHz to 2,5GHz

3 V

3 V/m

d =1.2 d =2.3

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

80 MHz to 800 MHz

800 MHz to 2.5 GHz

Note1 : At 80MHz and 800MHz, the higher frequency range applies. Note2 : These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. 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.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

8.5 Conformed Standard

8-7

Recommended separation distances between

portable and mobile RF communications equipment and the

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.

Rated maximum output

power of transmitter

0.01

0.1 1

100 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

150 kHz to 80 MHz

Separation distance according to frequency of transmitter

80 MHz to 800 MHz

d =1.2

0.12

0.37

1.2

3.7 12

d =1.2

0.12

0.37

1.2

3.7 12

800 MHz to 2.5 GHz

d =2.3

0.23

0.74

2.3

7.4 23

NOTE 1 : At 80MHz and 800MHz, the separation distance for the higher frequency range applies.

NOTE 2 : These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

8-8

8.5 Conformed Standard

9. Index

INDEX

Disinfection 3-2, 5-3

disposal 5-6

Disposal Tip 3-3

Disposal tip 3-14, 7-1

AC Adapter 2-1, 3-2, 3-39, 6-1

AC adapter terminal 1-4

AC power adapter 1-5

Acoustic Output 4-1

Auto Measurement Function 3-14

Auto Power Off 3-4, 6-2

Average 3-7, 3-11, 3-20

Battery 3-7, 3-35, 3-39, 8-1

BAUD RATE 3-30

Biometry probe 1-3

calculation formula 1-5

CALIBRATION 3-6, 3-12

Charge indicator 2-2, 3-41

Cleaning 5-2

CLR (F2 key) 3-8

COM 3-29

Communication Setup 3-30

Contrast 1-4, 2-1, 6-2

converted sound velocity 6-4

Corneal thickness 4-1, 8-1

Corneal Ultrasound Velocity 3-9, 3-14, 3-20, 3-21, 3-

25, 8-1

Cursor 3-8, 3-16

D-sub 9 pins 3-28

DATA BIT 3-30

DATA COMMUNICATION 3-19, 3-29, 3-30, 3-31

DATA SEL 3-21, 3-26

DEL (F3 key) 3-8

Delete 3-17, 3-18

EDIT 3-7, 3-15, 3-16, 3-17, 3-26

EOG 5-3

ERROR 3-6

EXIT 3-21

Explosion 3-39

Eye to be measured 3-20

Fire 3-39

FLOW 3-30

Frequency 8-1

FUNCTION KEYS 2-2

Heating 3-39

ID number 3-20

INDEX 3-7, 3-9, 3-10, 6-3

Instrument Stand 2-1, 3-4

LATEST 3-11

LED 6-3

Low Battery 3-40

MACHINE 3-30

Maintenance switch 1-4, 2-1

Measured data 3-20

Measurement data 3-7, 3-8

Measurement Standby Screen 3-22

Measuring time 4-1

Memory card 1-3

MENU 3-22, 3-26

MENU (F4 key) 3-8

MI (Mechanical Index) 4-1

MINIMUM 3-11

INDEX

A-1

NEW 3-7

NOW COMMUNICATING 3-32, 3-34, 3-36, 3-38

OPERATING PANEL 2-1

Optional parts 7-1

SOUND 3-21, 3-24

sound volume 6-6

Spare parts 7-1

Specifications 8-1

Standard Probe 7-1

Sterilization 5-3

STOP BIT 3-30

Storage 5-6, 8-4

Symbols 1-4

Pachy 3-8, 3-21

Pachy screen 3-7

Pachymeter Probe 3-2

Pachymeter probe terminal 1-4, 2-1

packing materials 5-6

PARITY 3-30

Patient ID 3-9, 3-10

Patient name 3-9, 3-10, 3-20

Power cable 1-3

power cable 1-2

Power consumption 8-1

POWER KEY 2-2

Power Switch 1-4

Power voltage 8-1

PRINT 2-2, 3-19, 5-5

PRINTER 2-1

Printer Cover 5-5

Printer paper 1-3, 5-5, 7-1

Printout 3-19, 3-20, 3-21, 3-27

PROBE ERROR! 3-4, 3-6, 6-4

PROBE HOLDER 2-1

test piece 1-3, 3-13

The eye to be measured 3-7, 3-8

TIME/DATE 3-20, 3-21, 3-23

TIS (Soft Tissue Thermal Index) 4-1

TROUBLESHOOTING 6-1

Type of display data 3-20

Type of listed data 3-7

Ultrasound energy 8-2

ultrasound velocity 3-5

VELOCITY 3-21

Warranty 5-1

Working Environment 8-4

R/L (F1 key) 3-7

RECEIVE 3-33

Resolution 8-1

Retake 3-15

Routine maintenance 5-2

SCREEN 2-1

SD 3-20

SEL 3-10, 3-21

SEND 3-19, 3-31

Serial communication 1-3, 1-4, 2-1, 3-28

SETUP 3-29

Simple mode 3-20

software version 3-5

A-2

INDEX

YEAR 3-23

Manufacturer

Tomey Corporation

2-11-33 Noritakeshinmachi

Nishi-ku, Nagoya 451-0051 JAPAN

Tel: +81 52-581-5327

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

Tomey GmbH

Am Weichselgarten 19a

91058 Erlangen GERMANY

Tel: +49 9131-77710

Fax: +49 9131-777120

ID: 0410

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Tomey SP-100 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual