SP-100 Operation Manual April 2004

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.

„ This instrument is designed exclusively for ophthalmic use. DO NOT USE the instrument for any purpose other than ophthalmic use. „ 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

i

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 usage 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 replacing 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.

ii

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.

„ Precaution for an operation state that, if unheeded, will cause a hazardous situation where there is an imminent danger of serious injury or death. „ Precaution for an operation state that, if unheeded, may cause a hazardous situation where there is the possibility of serious injuries or death. „ An operational precaution that, if unheeded, may cause or lead to minor or moderate injuries or property damages.

„ Special precaution that is related either directly or indirectly to personal safety or to property protection.

SYMBOLS USED IN THE MANUAL

iii

Contents 1.

PRIOR TO USE ... 1-1 1.1 1.2 1.3 1.4

2.

NAMES AND FUNCTIONS OF THE COMPONENTS ... 2-1 2.1 2.2 2.3

3.

Front and Right side of Main Unit ... 2-1 Rear and left side of Main Unit ... 2-1 Operation Keys ... 2-2

OPERATING PROCEDURES ... 3-1 3.1 3.2

3.3

3.4

3.5

3.6

3.7

iv

Precautions ... 1-1 Unpacking ... 1-3 Symbols, used in this manual ... 1-4 Outline of Measurement Principle ... 1-5

Safety precautions ... 3-1 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 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 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 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 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 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 4.2

5.

How to calculate corneal thickness ... 4-1 Acoustic Output ... 4-1 4.2.1 MI (Mechanical Index) ... 4-1 4.2.2 TIS (Soft Tissue Thermal Index) ... 4-1

MAINTENANCE AND INSPECTION ... 5-1 5.1 5.2

5.3 5.4 5.5

Warranty ... 5-1 Routine maintenance ... 5-2 5.2.1 Measurement Probe ... 5-2 5.2.2 Maintenance of the Main Unit ... 5-4 Replacing of the printer paper ... 5-5 Storage ... 5-6 Precautions for disposal of packing materials ... 5-6

6.

TROUBLESHOOTING ... 6-1

7.

SPARE PARTS AND OPTIONAL PARTS ... 7-1 7.1 7.2

8.

Spare parts ... 7-1 Optional parts ... 7-1

SPECIFICATIONS ... 8-1 8.1

Specifications ... 8-1 8.1.1 Measuring function ... 8-1 8.1.2 Measuring Probe ... 8-1 CONTENTS

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8.2

8.3 8.4 8.5

9.

vi

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

INDEX ... A-1

CONTENTS

1. PRIOR TO USE Š

Make sure that the instrument is free from any equipment that may cause an intensive magnetic field, which otherwise causes the instrument with noises or may make it unable to allow correct diagnosis or measurement.

Š

Care must be taken not to place any object on the instrument.

Š

Be sure to read this Manual before using the instrument for your safe and correct operation.

Š

Do not use the instrument in any procedures other than specified in this Manual.

1.1 Precautions „

„ „

Though measuring accuracy is +/- 5 µ m, accuracy with actual 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. Only skilled operators are allowed to use this instrument. When installing the instrument, observe the following items. - 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 power consumption). - Make sure that the conditions of power source (discharge, polarity, etc) are proper.

1.1 Using precautions

1-1

„

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.

„

Observe the following items when you use the instrument. - 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. 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. It is advised that in case the instrument is disorderd, stop using the instrument and contact your TOMEY representative for corrective inspection and/or repair. Do not uncover except battery cover or remodel the main instrument in any ways. Do not remodel or redesign the instrument, or the Warranty will be invalid. Periodical inspection should be given to the instrument and related components. 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.

„

„

„ „ „ „ „

1-2

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 commodities on any damages and malfunctions. Š

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 Š

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 = --- 2 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 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 plugging to AC power adapter. z This instrument is designed to take corneal thickness measurement automatically, when the probe is applied to cornea properly. z This instrument is capable of sending and receiving patient information 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 OPERATING PANEL 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. C W, 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) D CHARGE INDICATOR The light keeps turning ON, while charging the internal battery. When it turns OFF, charging battery is completed. E POWER KEY 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)

(F-keys Example) Each key, on this page, is assigned its function as follows: x F1 ... R/L x F2 ... INDEX x F3 ... EDIT x F4. ... NEW

2-2

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 specified 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 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.

3.2.2

Disinfection of the probe Disinfect the probe with proper procedure, before its use. Please refer to [5.2.2 Disinfecting Pachymeter Probe] for details.

3-2

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, depending on the application convenience.

<How to assemble> 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. <How to assemble the Probe in alternative shape> 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. x Make sure the battery is sufficiently charged. If not, con-

nect the AC adapter for power supply. (With battery operation 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 better view from the front

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1) Press the power key A to start operation. The instrument will automatically calibrate the connected 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)

219'4

(Fig. 1)

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.

(Fig. 2) 3) Adjust Instrument Stand D on back of the unit to tilt it to get better screen view.

(Fig. 3)

3-4

3.3

Adjustment and Setting

3.3.2

Startup Display

1) The startup screen is displayed immediately after 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. (Fig. 3)

(Fig. 3)

3.3

Adjustment and Setting

3-5