AL 100user Manual

Be sure to read this Operation Manual throughout before using the AL-100 for your correct and safe use. If you have any questions or comments on the operation of this Instrument, please contact your local representative. Do not use procedures other than specified in this Operator Manual. Place this Operator Manual in a place of access to the Operator while in operation. If you lose this Operator Manual, ask your local representative for a new copy.

IMPORTANT PRECAUTIONS DO NOT REMOVE THE OUTER COVER of the instrument. If you do, you may be subjected to direct high voltage.

i

CONSULTING OF THIS MANUAL Composition of this operator manual

1.PRIOR TO USE Explains precautions and confirmations prior to installing and operating this instrument. 2.NAMES AND FUNCTIONS OF THE COMPONENTS Explains the names and functions of the components of this instrument 3.OPERATING PROCEDURES Explains significant information necessary for installing and operating of this instrument. 4.TECHNICAL REFERENCE Provides the technical information of this instrument 5.MAINTENANCE AND INSPECTION Explains your routine inspection and maintenance and replacing of spare parts. 6.TROUBLESHOOTING Explains the spare parts and option parts of this instrument 7.SPARE PARTS AND OPTIONAL PARTS Explains the spare parts and option parts of this instrument. 8.SPECIFICATIONS Explains the specifications for this instrument. 9.INDEX Refer to the index as a guide, if necessary.

ii

SYMBOLS USED IN THIS MANUAL The symbols used in this manual represent the following:

This is a precaution that, if unheeded, will result in a hazardous situation where there is an imminent danger of serious injury or death.

This is a precaution that, if unheeded, may cause a hazardous situation where there is the possibility of serious injury or death.

This is a precaution that, if unheeded, may cause minor or moderate injury or property damage.

This is a special precaution that is related, either directly or indirectly, to personal safety or to protection of property.

iii

CONTENTS IMPORTANT PRECAUTIONS ......................................................................................................................i CONSULTING OF THIS MANUAL ............................................................................................................ ii SYMBOLS USED IN THIS MANUAL ....................................................................................................... iii CONTENTS ..................................................................................................................................................iv 1 PRIOR TO USE ............................................................................................................................................ 1-1 1.1

Precautions for use........................................................................................................................... 1-1

1.2

Unpacking and receiving inspection ............................................................................................... 1-3

1.3

Explanation of symbols ................................................................................................................... 1-4

1.4

Outline of operation ......................................................................................................................... 1-5

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

Front and right side of AL-100 ........................................................................................................ 2-1

2.2

Back and left side of AL-100 ........................................................................................................... 2-3

3 OPERATION PROCEDURES ..................................................................................................................... 3-1 3.1

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

3.2

Preparation before use ..................................................................................................................... 3-2 3.2.1

Connecting the accessaries .................................................................................................. 3-2 a)

Connecting the probe ........................................................................................................... 3-2

b)

Connecting the power cord .................................................................................................. 3-2

c)

Connecting the foot switch .................................................................................................. 3-3

d)

Installatin of the probe holder .............................................................................................. 3-3

3.2.2

3.3

Connecting the option parts ................................................................................................. 3-4 a)

Inserting and removing the Memory Card ........................................................................... 3-4

b)

Connecting with chin rest, AL-1100 .................................................................................... 3-5

Measurement procedures ................................................................................................................. 3-7 3.3.1

Adjustings and settings ........................................................................................................ 3-7 a)

Turning power switch and adjusting .................................................................................... 3-7

b)

Start-up screen ..................................................................................................................... 3-8

3.3.2

Front button ....................................................................................................................... 3-10

3.3.3

Measurement screen .......................................................................................................... 3-11 a)

Waiting screen and measurement screen ........................................................................... 3-11

iv

3.3.4

Settings and registration in the measurement screen ......................................................... 3-12 a)

Setting of the eye to be measured ...................................................................................... 3-12

b)

Clear screen ....................................................................................................................... 3-13

c)

ID number / Patient’s name / sex / Physician’s name ........................................................ 3-13

d)

Registration of Physicians ................................................................................................. 3-15

e)

Setting items for measurement ........................................................................................... 3-16

3.3.5

Measurement ...................................................................................................................... 3-23 a)

Cheking of the performances ............................................................................................. 3-23

b)

Preparation of measurement .............................................................................................. 3-23

c)

Measurement ...................................................................................................................... 3-24

d)

Retake ................................................................................................................................ 3-27

e)

Selecting of retinal waveform ............................................................................................ 3-27

3.3.6

Good waveform ................................................................................................................. 3-28 a)

Contact mode ..................................................................................................................... 3-28

b)

Immersin mode .................................................................................................................. 3-29

3.3.7

3.4

v

Data EDIT screen ............................................................................................................... 3-30 a)

Display and delete measured data ...................................................................................... 3-31

b)

Caliper Setting ................................................................................................................... 3-33

3.3.8

IOL caliculation screen ...................................................................................................... 3-35

3.3.9

Calculation ......................................................................................................................... 3-36

3.3.10

Calculation conditions ....................................................................................................... 3-36

a)

Equation select ................................................................................................................... 3-36

b)

Calculation data input ........................................................................................................ 3-37

c)

Lens constant ..................................................................................................................... 3-39

d)

IOL data registration .......................................................................................................... 3-41

e)

P/C Value (Personal / Corresponding Value) .................................................................... 3-42

f)

Assistant function .............................................................................................................. 3-44

Printout .......................................................................................................................................... 3-47 3.4.1

Printout procedure ............................................................................................................. 3-47

3.4.2

Printout result ..................................................................................................................... 3-49 a)

Biometr data printout ......................................................................................................... 3-49

b)

IOL power calculation printout (e.g. SPK/T) ..................................................................... 3-50

c)

P/C Value (Personal / Corresponding Value) Printout result ............................................ 3-51

d)

Data transmission printout result ....................................................................................... 3-52

3.5

Data storage, reading and deleting ................................................................................................ 3-53 3.5.1

3.6

3.7

Storage ............................................................................................................................... 3-53 a)

Store data on EDIT screen ................................................................................................. 3-53

b)

Store data on IOL calculation screen ................................................................................. 3-55

3.5.2

Reading .............................................................................................................................. 3-56

3.5.3

Sorting ................................................................................................................................ 3-59

3.5.4

Deleting .............................................................................................................................. 3-61

3.5.5

Momery card format .......................................................................................................... 3-62

3.5.6

Sending and receiving data ................................................................................................ 3-63 a)

PC communication ............................................................................................................. 3-63

b)

Sending data ....................................................................................................................... 3-65

c)

Receiving data ................................................................................................................... 3-67

Utilities .......................................................................................................................................... 3-69 3.6.1

Contents of Utilities ........................................................................................................... 3-69

3.6.2

Biometry function/IOL power calculation ssetting ............................................................ 3-70 a)

Date and time ..................................................................................................................... 3-70

b)

Sound volume .................................................................................................................... 3-71

c)

Print mode .......................................................................................................................... 3-72

Memory card .................................................................................................................................. 3-73 3.7.1

Optional memory specifications ........................................................................................ 3-73

3.7.2

Replacement of the battery inside memory card ................................................................ 3-74 a)

“No Battery!” Warning ...................................................................................................... 3-74

b)

“Low Battery!” Warning .................................................................................................... 3-74

c)

Battery of the memory card is dying .................................................................................. 3-74

3.7.3

Load the stored data with PC through memory card........................................................................... 3-75

3.7.4

Ejecting memory card from PC ......................................................................................... 3-78

4 TECHNICAL REFERENCE ........................................................................................................................ 4-1 4.1

IOL power calculation ..................................................................................................................... 4-1

4.2

Axial length calculation with Biometry function ............................................................................ 4-8

4.3

Version information ......................................................................................................................... 4-9

5 SERVICE AND MEINTENANCE ............................................................................................................... 5-1 5.1

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

5.2

Fuse .................................................................................................................................................. 5-2

vi

5.3

Routine meintenance ....................................................................................................................... 5-3 5.3.1

5.3.2

Meintenance of biometry probe ........................................................................................... 5-3 a)

Cleaning ............................................................................................................................... 5-3

b)

Disinfection .......................................................................................................................... 5-3 Meintenance of the main unit .............................................................................................. 5-4

5.4

Printer paper replacement ................................................................................................................ 5-5

5.5

Storing the instrument ..................................................................................................................... 5-6

5.6

Packing materials ............................................................................................................................. 5-7

6 TROUBLESHOOTING ................................................................................................................................ 6-1 7 SPARE PARTS AND OPTIONAL PARTS ................................................................................................... 7-1 7.1

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

7.2

Spare parts ....................................................................................................................................... 7-2

8 SPECIFICATIONS ....................................................................................................................................... 8-1 8.1

8.2

8.3

vii

Specifications .................................................................................................................................. 8-1 8.1.1

Biometry function/IOL power calculation function ............................................................. 8-1

8.1.2

Main unit .............................................................................................................................. 8-2

8.1.3

Power supply ........................................................................................................................ 8-2

Energy and other consumptions ....................................................................................................... 8-3 8.2.1

Influences of ultrasound energy to human body .................................................................. 8-3

8.2.2

Ultrasound energy ................................................................................................................ 8-3

Noises .............................................................................................................................................. 8-4

1 PRIOR TO USE 1.1

Precautions for use Make sure that this Instrument must be installed in a place without any intensive electromagnetic wave or the wave generating devices. An intensive electromagnetic field causes noises to interrupt the Instrument from functioning proper diagnosis and measurement. Nothing must be put on this unit. Read this Operator manual carefully before using the instrument in order to operate it properly and safely. Do not use any procedures that are not specified in the manual.

Only well-trained personnel should operate this instrument. When installing this instrument, observe the following: - Do not install the instrument in a place where it might be exposed to moisture or chemicals. - Do not install the instrument in a place where it is subject to adverse condition, such as direct sunlight, high temparature, excessive humidity, dust, sulfur or salt. - Ascertain that any adverse factors such as excessive slope, vibration and impact will not endanger the instrument (including during transportation). - Do not install the instrument in or near the storage area of chemical substances or where any gas may be generated. - Follow frequency, voltage and allowable current (or allowable power consumption) specifications. - Be cautious of electrical power condition such as discharge, polarity, etc. - Ascertain that the power source is properly grounded.

1-1

Before using this instrument, observe the following: - Ascertain that all cables and cords are properly connected. - Carefully inspect the probe tip before using. - Ascertain that the power source is properly grounded. - When using this instrument with other unit, be careful not to cause any inaccurate diagnosis or danger. - Double-check the probe tip before using. While using this instrument, observe the following: - Always make sure that the patient is comfortable. - Always make sure that both instrument and patient are under normal condition. - If any complication or abnormality is encountered, either with the patient or instrument, ensure the safety of the patient by discontinuing testing. - Make sure that patient has no contact with the instrument (other than the probe) during testing. After using this instrument, observe the following: - Make sure that the unit is the same condition as initial, before turnning off the unit. - When disconnecting the power cord, hold the plug, not the cord, and do not use excessive force. - Be sure to clean the probe and other accessaries after each use. - If you do not plan to use the instrument for a considerable period of time, refer to Section 5.5 for storage instructions. - Be sure to clean the instrument to prepare for next use.

1-2

In case of a malfunction, do not attempt to repair the instrument yourself. Place a sign on the instrument indicating that it is malfunctioning and contact your Tomey representative. Do not technically modify this instrument. Please be informed that the instrument should be inspected reguraly. When using the instrument, which has not been used for a certain period of time, make sure that the instrument works normally and safely, before using.

1.2

Unpacking When unpacking the instrument, make sure that all of the components are present and that none of them are visibly damaged. If any items are missing or damaged, contact your Tomey representative. Be sure to keep the box and the packing material for use if the instrument is moved to another location.

AL-100 Main Unit ........................................................... 1 3 pin plug power cord ..................................................... 1 Biometry Test Piece ........................................................ 1 Paper for Built-in Printer ................................................. 1 Dust cover ....................................................................... 1 Fuses ................................................................................ 2 Operator Manual(This book) .......................................... 1 Foot Switch ..................................................................... 1

1-3

1.3

Symbols used in this manual The symbols used in this manual represent the following:

[

1-4

]

:Contrast Volume

[MEMORY CARD]

:PC card slot

[

]

:Main Switch ON

[

]

:Main Switch OFF

[

]

:RS-232C port

[

]

:Meintenace port and Switch (Manufacturer’s use)

[

]

:Fuses

[BIO PROBE]

:Biometry probe connector

[FIX LIGHT]

:Fixation Light connector with AL-1100 (Chin rest)

[FOOT SWITCH]

:Foot Switch Connector

1.4

Outline of Operation The AL-100 is an ultrasound instrument designed for measuring the axial length of the eye for medical ophthalmic use.

Ultrasound energy is emitted from the probe tip. The probe acts as both the transmitter and receiver of ultrasound energy. Some of the energy is reflected back toward the probe in the form of echoes. Measurement data can be calculated based on the time it takes the echoes to travel back to the probe from the eye and the present converted velocity.

L = V * t /2

where

L = Length of the biological object V = converted sound speed t = measuring time

The axial length measurement are acquired automatically and do not depend on the operator’s experience and capability. IOL power calculation can be performed immediately after measuring the axial length. Six atandard IOL formulae are provided. The instrument can store axial length and implanted IOL data, on the basis of which personal lens constants may be determined.

1-5

1-6

2 COMPONENTS 2.1

Front and right side of AL-100

MEA

SUR

E IOL EDIT

2-1

(1) Screen(touch panel) Measurement data and other information are displayed on the screen. The instrument is operated by touching the keys.

(2) Probe holder When the probe is not in use, place them in the holder.

(3) Terminal of Biometry Probe The Biometry probe is connected here.

(4) Power indicator Lit when power is on.

(5) MEASURE Button Switch display to Measurement mode

(6) IOL Calculation Button Switch display to IOL Calculation Mode

(7) EDIT button Switch display to EDIT Mode

(8) PC card slot Memory card (Optional) should be inserted to store acquired data.

(9) Printer Prints measured data and calculated results.

(10) Biometry probe Use for axial length measurement.

2-2

2.2

Back and left side of AL-100

2-3

(1) RS-232C terminal The RS-232C cable is connected here.

(2) Power supply terminal The power cord is connected here.

(3) Fuse holders Fuses are in use in these holders.

(4) Power switch Press the “ I ” side of the switch to turn on the power. Press the “ O ” side to turn it off.

(5) Contrast adjuster Controls the contrast of the screen

(6) Power cord with 3-prong plug Connection of this cord to a 3-prong power receptacle provides power to the AL-2000.

(7) Meintenance Switch Switch for Manufacturer’s use only. Do not change its position.

(8) Footswitch Terminal The footswitch is connected here.

(9) Power supply terminal for chin rest fixation light The power plug for the fixation light for the chin rest.

2-4

3 SETUP 3.1

Safety precautions

ALWAYS cleans the probe tip before taking a measurement on a human eye. NEVER use the probe if there is any visible damage to its tip. Such use may cause an incorrect maeasurement and/or damage to the cornea.

This instrument is designed exclusively for ophthalmic use. DO NOT use the instrument for any purpose other than ophthalmic use. DO NOT use any cables or memory cards other than those specified in this manual. Such use may result in damage to the instrument.

3-1

3.2

Preparing the instrument for use

3.2.1

Connection of accessaries a) Connecting the biometry probe BIO

BIO

Connector should be plugged into the terminal with a proper direction. Plug the biometry probe connector (1) into the terminal (2) labeled BIO on the front side of the instrument. When it is properly insetrted, you will hear it click.

b) Connecting the power cord

Power cord should be plugged into the terminal with a proper direction. Plug the power cord connector (1) into the terminal (2) on the back of the AL-100.

3-2

c) Connecting the foot switch

Connector should be plugged into terminal with a proper direction. 1)

Plug the connector (1) for the foot switch to the terminal (2) labeled FOOT SW on the back of the AL-100. Line up the slot of the connector with the tab on the terminal.

2)

To source the connector, turn the locking ring (3) until you hear it click into place.

d) Inserting the probe holder

The holder should be installed onto the unit with a proper direction. Insert the protruding rectangular tabs (1) on the probe holder into the holes (2) on the right ide of the instrument. DO NOT insert the holder upside down. Push inward on the center of the probe holder (3) and pull it downward to lock it in place.

3-3

3.2.2

Connection of the optional parts a) Inserting and removing the memory card Before using memory card for the first time, set the battery in accordance with the instruction Manual for Memory Card (located in the box that contains the catd). Follow the instructions for BN-HSR series. Since the memory card pops quickly out of the slot when removed, hold the edge of the card when pressing the button for card removal.

“Inserting the car”

Hold the front of the memory card (1) toward you and insert it into the slot (2) until the card is aligned with the removal button.

“Removing the car”

Remove the memory card (1) by pressing the button (2).

DO NOT INSERT or REMOVE the memory card, when data is loaded from or saved into the memory card.

3-4

b) Chin rest installation (AL-1100) An optional chin rest with a fixation light is available for use when measuring axial length.

“Installing the chin rest” Figure 1

Figure 2

①

Make sure that the slider moves. 1)

From the operator’s side, carefully insert the biometry probe into the slider until it locks into place. (Be careful not to damage the eye contact area of the probe.)

2)

Coil the probe cord twice (as shown) and secure it with the cord hook (2). The cord length (3) from the probe to the hook should be approximately 20 cm to prevent tension on the cord when the slider is moved forward during the measurement.

3-5

“Connecting the fixation lamp power plug” Insert the power plug (1) for the chinrest fixation lamp into the terminal (2) labeled “FIX LIGHT” on the back of the AL100.

3-6

3.3

Biometry

3.3.1

Biometry Mode Setup a) Turning the power on and initial adjustments ALWAYS clean the probe tip before taking a measurement on a human eye. NEVER use the probe if there is any visible damage to its tip. Such use may cause an incorrect measurement and/or damage to the cornea. As with any ultrasound instrument, it is recommended that we exposure be kept as low as reasonably achievable. (ALARA) Before turning on the power *Make sure that the power plug is properly connected to the receptacle. *Make sure that the biometry probe is properly connected. *If the power turns off, wait for over one mimute to turn it on again.

1)

Turning on the power switch (1) at the upper left side of the instrument initiates self-checking of the probe. If the biometry probe is not detected (i.e., no probe or wrong probe connected), the message “Probe error!” will be presented.

2)

Adjust the contrast of the screen with the contrast adjuster (2).

3-7

3)

Tilt the screen forward by pulling out the “legs” (3) on the bottom of the instrument, if desired.

1)

The probe is automatically calibrated, when the screen is

b) Start up screen

shown.

2)

The catalog screen (Ready to measure screen) is shown, when the calibration is completed without any problem.

3-8

3)

When “Probe error!” is shown on the area (1), “OK” key will be shown on the area (2). Press OK to go to the catalog screen. The measurement cannot be done even on the catalog screen, if “Probe error!” is displayed. See Troubleshooting if “Probe error!” shows many times. Contact your TOMEY Representative, if the problem remains.

3-9

3.3.2

Guide to use Front buttons 1) MEASURE

The catalog screen (Ready to measure) screen is shown, when pushing this button. The settings with Index data input, selecting the eye to be measured, Contact/Immersion and selection of Measurement methods are also done with this button.

MEASURE

IOL

EDIT

2) IOL MEASURE Button

IOL Button

EDIT Button BIO METER

AL-100

The IOL calculation screen appears, when pushing this button. IOL power calculation, Personal Correspondence value, IOL registration can be done with this function. The results can be printed out with the built-in printer.

3) EDIT

The EDIT screen appears, when pushing this button. Waveform, measured data, Caliper, Utility, Data Save/ Load and print out can be done with this function.

3-10

3.3.3

Measurement

Press MEASURE button to go into measurement mode.

a)Data Review Window / Measurement Window

a-1

Data Review Window

Widow will be switched from Data review to measurement automatically, when it is taking data.

a-2

Measurement Window

3-11

3.3.4 Setting of the measurement conditions Press “New” key and delete data of both eyes, before taking new patient. Otherwise two patients’f data may be mixed up and cause serious probelm.

a) Setting the eye to be measured Touch Eye key to select the eye you wish to measure (right or left). Axial length data and IOL power calculation result of each eye are aquired with different data storage. Please make sure the display is showing right eye, when measuring right eye, and left eye for left.

Figure 1 1) The right eye (OD) or the left eye (OS) is selected alternately each time the Eye key is touched.

3-12

b) New Patient Press the button (1) to measure new patient.

Figure 1 1)

Press (1) button (Figure 1) until you hear “beep” sound.

2)

New screen is ready to take new patient data.

Former ID / Patient’s name, sex / Physician’s name are deleted. K1 and K2 for IOL calculation are also deleted. Eye type will be set as “Normal”, and Eye to be measured will be set as “Right” eye.

c) ID / Patient’s name, sex / Physician’s name input Index Data (ID / Patient’s name, sex / Physician’s name) should be input on the screen.

Figure 1

3-13

Figure2

1)

Touch the Index key (1) on the measurement window (Fig.1 )to display the Name/ID entry window. (fig.2)

2)

Touch the number keys and the alphabetic character keys (2) to enter the patient name, ID number and physician’s name. If the physician’s name is already registered in the physician list, it can be selected by pressing the corresponding number. “.” and ”space” cannot be used as ID number.

3)

To switch between letters and numbers, use the switchover key (3). In the event of an erroneous entry, touch the Delete key.

4)

Male/Female will be selected with pressing icon buttons on the key board.

5)

To set the entered value and advance to the next entry, touch the Return key (5). The cursor location indicates the category of the next entry.

6)

Touch “Exit” key to return to the measurement window.

Setting the values for meausrement Eye type / Gain / Contact Immersion mode / Measurement mode can be selected as settings for measurement.

Setting the eye type and converted velocity

3-14

d) Physician’s list Entry Physician’s name can be stored in advance as a list.

Figure1 1)

Touch Entry key to reverse the color of “Entry” icon. [Figure1]

2)

Touch PhyList, which you wish to change and it reverses the color.

3)

Type the name with the alphabetic character keys.

4)

Touch the “Enter” key again to save change.

5)

Touch the “Phy. List” to put the name as the physician.

3-15

e) Setting items for measurement

(Figure 1) 1

Touch Eye type/ Gain key(1) to go into its setting window. “Figure2”

2

Select the Key (2) for measured eye which suits the eye to be measured. (See the next page.).

3

In case of changing the sound velocity, select the sound velocity setting key to display the number keys

(Figure 2)

(5) (as highlighted). In (Fig. 3) 4

Select the key, then change the entry item and set the sound velocity.. (As for the entry range, see the next

3-16

page.) (Figure 3)

5

When (3) is again selected, the highlighted display is released and the screen is returned to that in (Fig. 2).

6

If the EXIT key (4) is selected, the screen will be returned to that shown in (Fig. 1).

3-17

[Setting the eye type and converted velocity] The AL-100 can be set to measure the following tyoes of eyes: Normal Select when the lens nucleus of the patient’s eye is rather soft, e.g., incipient cataract. Average velocity Average axial length velocity (Avg) : 1500 ~ 1600 m/s Lens velocity(LENS) : 1540 ~ 1740 m/s Anterier chamber velocity(ACD) : 1430 ~ 1630 m/s Dense Cataract Select when the lens nucleus of the patient’s eye is rather hard e.g., hypermature cataract. Hard to measure with Normal mode. Average axial length velocity (Avg) : 1500 ~ 1600 m/s Lens velocity(LENS) : 1540 ~ 1740 m/s Anterier chamber velocity(ACD) : 1430 ~ 1630 m/s Aphakic Select when the patient’s eye is aphakic. Average axial length velocity (Avg) : 1430 ~ 1630 m/s Pseudophakic Select when the patient’s eye is pseudophakic. IOL velocity (LENS) : 800 ~ 3000 m/s Vitreous velocity (Vit) : 800 ~ 2000 m/s Anterier chamber velocity (ACD) : 1430 ~ 1630 m/s IOL thickness (Thickness) : 0.10 ~ 4.00 mm

3-18

[ACD] and [LENS] are not displayed with Aphakic, and [LENS] is not displayed with Pseudophakic.

Posterier lens waveform might not be recognized, due to multiple echo with Dense Cataract mode.

Measured data is displayed. Measured data may not be displayed. Measured data is not displayed.

Setting of the gain (ultrasound emitter power) Set the gain level based on the waveform amplitude. There are 8 levels. The higher you set the gain, the larger the amplitude will be.

Figure 1 1

Touch (1) keys to adjust the gain with the window (Fig. 1).

2

New value is displayed on main window.

3-19

Setting of the Contact / Immersion Contact / Immersion mode can be changed with touching “Contact” or “Immersion”.

Figure 1 1

Select Contact with contact mode and Immersion with immersion mode.

2

Selected key should be highlighted.

[How to apply biometry probe for Contact mode] The tip of the probe should be applied to the center of the cornea verticaly.

3-20

[Measurement of axial length with immersion mode] Measurement without using immersion attachment (cap) In case of using corneal protective gel, care must be taken not to put excessive amount of the agent, which may otherwise influence measurement data. Measurement with immersion attachment Care must be taken not to let air bubbles in the cup provided at the tip of the Immersion Attachment, when placing the ultrasound gel. 1

Apply a small amount of the ultrasound gel to the tip of the Biometry probe. (Fig. 1)

2

Cover the biometry probe with the immersion attachment.(Fig.2)

Figure 1

3

Put the ultrasound gel in the cup provided at the top of the immersion attachment.(Fig3)

4

Apply the immersion attachment to the probe so that its tip is aligned to the probe axis and the visual axis, but it is positioned in such a place where the tip of the immersion attachment does not touch the cornea. (Fig 4)

Hand, Chin Measurement mode

Figure 2

1

Select the key, (1) key or (2) key, depending on the measurement method.

2

The selected key is displayed as reverse highlighted.

The converted velocity directly affects the measurement. Ascertain that you have set the desired converted velocity. In immersion mode, the ultrasound gel must intervene between the eye contact area of the biometer probe and the cornea so that distance between the probe and the cornea is approximately 1.8 to 3.2 mm. Figure 3

Excessive ultrasound gel may affect the accuracy of the measurement. Auto measurement (Hand mode) assists the examiner to take measurement, and the function itself does not diagnose the data.

Figure 4

Measurement accuracy might be over 0.1mm, due to the measurement condition or the difference among patients.

3-21

Setting of the measurement mode The Hand, chin measurement (automatic measurement) or the manual measurement can be selected.

Figure 1

3-22

3.3.5

Actual measurement

a) Checking the performance The biometry test piece is used only for checking the operating performance of the instrument. It cannot be used for determining the precision of the instrument or for calibration of the instrment. Check the performance of the AL-100 by using the biometry test piece(found in the box containing the biometry probe).

1

Select the following settings: Eye type/converted velocity: Aphakic/1,532 m/s

2

Gain:

8

Measurement Mode:

Hand-Held

Apply a drop of water to the upper and to the lower test piece surfaces. Apply the biometer perpendicular to the upper surface.

b) Preparation for measurement If the patient is relaxed and cooperative, the measurement will be easier and more successful. Prior to taking measurements, explain the purpose and method of measurement to the patient to reduce his/her anxiety. 1

Confirm that the measurement conditions have been set.

2

Anesthetize the eye with an appropriate topical anesthetic.

3

When taking measurements using the chin rest, instruct the patient to sit in front of the chin rest. Adjust the height of the chair, the lift table and/or the chin rest to maximize patient comfort. When taking measurements holding the probe by hand, instruct the patient to be seated or to lie supine.

4

If the fixation light is used to guide the direction of gaze(when using the chin rest), set it at an appropriate height for the patient to fixate.

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c) Measurement methods There are two automatic modes, hand-held and chin rest, and one manual mode. Hand (Hand-held)

Figure 1 1

Touch “New” key(1) to measure new patient’s eye. Apply biometery probe perpendicular to the cornea.

2

The measurement window will be automatically shown, when certain waveform conditions are satisfied.

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Figure 2 3

When a satisfactory measurement is taken, the instrument makes a “beep” sound.

4

The instrument aquires the data automatically, when the data becomes stable. The instrument makes a “beep” sound, when a data is aquired.

5

The instrument shows the waveform, average axial length and maximum(as L) / minimum(as S) measurement data.

6

When data acquisition is complete, a higher-pitched beep sounds and the waveform for the measurement closest to the average value is displayed.

Using the hand-held method, up to 15 measurements in the range of +/- 0.2 mm from the average value are taken. If measurement data are largely scattered, “ERROR” is displayed. When “ERROR” is displayed, the probe may not be applied properly. Touch “Retake” key for two seconds and take the measurement again.

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Chin (Chin measurement) Select “Chin” for taking measurement using the Chin Rest. The operation and display of the Measure, Setting screen and the Measure screen are same as those done for Hand (hand measurement). (See Figs. 1 and 2.) 1) Measurement is performed by using the Chin Rest. 2) Assemble the Biometry Probe in accordance with “3.3.1 c) Assembling of the Biometry Probe”. Give a sufficient reach of the Probe cord between the Probe and the cord hook, which may otherwise apply an undue pressure against the cornea. Figure 3

3) When taking measurement, apply the Probe in such a manner that the planes of the slider moving plane and the fixed part are aligned. Insufficient application of the Probe may cause to measure a slightly longer axial length due to the corneal protective gel and tears. Care must also be given not to apply an excessive force against the cornea with the Probe. 4) Measurement must be continued until all the ten data come within the range of +/-0.1mm against the average value.

Figure 4

Measurement does not have to be completed, but can be stopped on its way.

Manual 1) When taking measurement from a new Patient in the screen shown in Fig. 1, select the New key (1) and apply the Probe to the cornea at a right angle. 2) When the Instrument has been fulfilled with waveform conditions to a certain extent, the screen is changed to that for measurement. 3) When the Instrument has been fulfilled with the takingin conditions, a monitor sound of “pee” is given. 4) For manual measurement, data taking is given by using the footswitch in (Fig. 5) 5) If the footswitch is again pressed, the operation will Figure 5

proceed in the successive measurement. 6) Measurement will be followed in the same manner as

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above. When ten measured data have been taken in, measurement is finished with “beep” sound.

d) Deleteing all data for one eye 1

To delete all data currently displayed for either the right or the left eye, press the Retake key (1) until you hear a beep.

Note: This deletes currently acquired data from the instrument memory; it does not delete data stored on the memory card.

e ) Selecting the location of the retina waveform In the event that a spike occurs between the back of the lens and the retina (e.g., due to a vitreous hemorrhage), manually reposition the retinal cursor (2) by pressing the retinal cursor shift keys (1). The waveform to the right of this cursor location is taken as the retinal waveform.

Figure 1 1

Move cursor by pressing move keys to locate it on the left side of the actual retina.

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Figure 2

2

The waveform to the right of this cursor(2) is taken as the retinal.(Fig2)

3.3.6

Acceptable waveforms a) Contact mode In the automatic measurement modes, waveforms are evaluated A valley between Retina and Sclera Retina

Sclera

and acquired only if the following criteria are met: 1. The following crests rise above the level cursor: Normal: The spikes of the back and front of the lens and of the retina.

Upright waveform

Dense Cataract: The spike of the front of the lens and of the retina. Retina Select Cursor

Aphakic: The spike of the retina. Pseudophakic1 ~ 3: The spikes of the front of the IOL and of the retina.

2. The retinal waveform stands upright. 3. The variability among measurements is low.

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The following items are used for checking to see if ultrasound can correctly catch the axial length and, therefore, reasonable waveforms are obtainable, provided that these items are not good conditions for taking-in of measurement data. i

The retinal echoes rise high.: implies that the probe is applied perpendicular to the cornea.

ii

The echo rises high in the front and at the rear of the crystalline lens: implies that the axial length was caught with the probe.

iii

The retinal and sclera echoes are distinctive.: implies that the probe is applied at a right angle. In canse of high gain, the drop (choroid) between two echoes cannot be identified, which is not always necessary to be detected.

iv

No tail waves followed after corneal echos.: implies that the probe directly touches the cornea. If there is any tear or corneal protective gel left between the cornea and the probe, the corneal echoes are followed by tail waves. If so, the measurement of axial length may not be stable or may be longer than its actual length.

b) Immersion mode Initial Echo

For immersion mode, the following conditions are added to those of Contact mode.

Lens front surface echo

The cornea front echoes must be within the range of 1.8 and 3.2 mm (which is shown as the range of dotted line in the left figure.)

The following items are not to indicate the conditions of data acquisition, but to confirm if acquired waveform is acceptable or not. Retina echo Corneal echo Lens rear surface echo

Also confirm “a Contact mode i - iii ”. i

No unnecessary echoes arise if there is air voids included in the ultrasound gel used in the inside of the tip of the immersion attachment or between the probe and the cornea.

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3.3.7 EDIT

Press EDIT button on the front, and show EDIT window.

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a) Data display and delete The waveforms for each eye of the current patient measurements can be retrieved and reviewed at any time during the measuring process. “Displayng a waveform”

Figure 1

1

If you wish to review the waveform for a particular measurement, select the measurement by pressing the up and down arrow keys. The selected data will be highlighted and the corresponding waveform will be displayed. (Fig1)

2

Press Select key (2) to select the data.

3

Press Echo key (3) to show Echo data (Fig2).

When pressing Echo without selecting any data, the data closest tothe average will be displayed. Average data will also be displayed as Ave. AXIAL.

Figure 2

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[Deleting individual measurements]

Figure1 1

Touch the up and down arrow keys (2) to move to the measurement you wish to delete.

2

Touch Select key to select the data you wish to delete. Touch Delete/Recall key to delete the selected data.

At this time, touch Delete/Recall key again to recover the data.

When switching to the other window, deleted data can not be recovered by touching Delete/Recall key again.

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b) Caliper Function The distance between two points can be measured on the waveform. A reading displayed in the caliper mode is an appoximation and may be different from the actual reading.

Figure 1 1

After measurement, touch the Caliper key (1) to switch to Echo window. (Fig2)

2

Press the right or left arrow key (2) to set the point from

Figure 2

which to start measuring, which will be indicated by a vertical dashed line. Touch the Fix key (3) to set the location.

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3

Touch the right or left arrow key again to set the second measurement location, which will be indicated by a second vertical dashed line.

<

Figure 3

4

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The distance between the two points will be displayed in real time. (Fig3)

3.3.8 IOL Power Calculation

Press “IOL” button to show IOL calculation window.

Caculation result can be stored.

Calculation result can be printed. Data Communication settings

Various lens constants are shown that suits for selected IOL formula Ex. A-constant (SRK-II, SRK/T, HAIGIS standard)

IOL powers are shown which satisfies "Postoperative desired ref."

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3.3.9 Calculation The calculation result with the UD-6000 might be differ from that with the AL-100, due to the difference of internal valid numbers. When imaginary number is created, the calculation result will be displayed as an “ERROR”.

3.3.10 Setting the calculation conditions a)

Selecting the IOL formula IOL formula can be selected on this window.

Figure 1 1

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To select the desired IOL formula, touch the Formula key (1) to go to formula selection display.

Figure 2

2

Select the formula by touching the number on the left side of desired formula. Selected formula is shown as highlighted. Only one formula can be selected with AL100.

3

Touch “Exit” key (3) to go back to IOL calculation(Fig.1).

b) Data entry for IOL calculation AXIAL, ACD, K1/K2, D-Ref can be entered. Following axial length measurement, AXIAL(axial length) and ACD(anterier chamber depth) will be automatically entered. Data entry by keys will not be allowed in this case.

(AXIAL), (ACD) DATA ENTRY

Figure 1

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1

Prepare to enter axial length or ACD by touching the Axial key (2) or ACD key (1). The databox will be reverse highlighted.IOL

2

Touch the number keys (3) to enter the axial length value.(ACD key is shown only when it is used by a formula) [Acceptable range] AXIAL ACD

3

: 15.00 ~ 40.00mm : 0.00 ~ 9.99mm

Touch AXIAL or ACD key to set the entered value.

K1/K2 Corneal refractive power / Corneal radius DATA ENTRY

Figure 2 1

Prepare to enter the K values by touching K1(1) or K2(2) key. The databox will be reverse highlighted.

2

Touch the number keys(3) to enter the first K value. [Acceptable Range] K1/K2 Corneal Refractive Power: 30.00~60.00D Corneal Radius: 5.00~11.00mm

3

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Touch K1(1) or K2(2) key to set the entered value.

[D-Ref] Desired postoperative refraction

Figure 3

1

Prepare to enter the desired postoperative refraction by touching the D-Ref key(1). The databox will be reverse highlighted.

2

Touch the number keys (2) to enter the data. The acceptable range is -10.00 - + 10.00 D.

3

Complete the data entry by touching D-Ref key(1).

c) Constants (Aconst, SF, ACD) Values for A constant, Surgeon’s Factor and Anterier Chamber Depth constant may be entered on the IOL calculation window, or stored IOL models with pre-entered constant values may be selected from the IOL data list. This instrument can calculate with two lenses for one formula. To enter constants, there are two methods, prepared for this instrument(1, By touching number keys 2, Selects from IOL list) See [3.3.10 d)].

Figure 1

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1

Select the Lens Constant key (1) in the screen of (Fig. 1), so the key will be highlighted to display the screen of (Fig. 2).

Figure 2 2

Enter the lens constant with the Number Enter key (2) in the screen (Fig. 2). If the IOL registration has been made, enter the data from the lens data (3) displayed in the screen (Fig. 2). Move the cursor with the up / down keys (4) and enter the data with the Sel key (5). In order to display the data (such as ACD const, SF, a0, a1, a2, etc.), which are not displayed in the screen (3), select the Page Change key (6).

[Entry range] A-const.:

100.00 ~ 130.00

ACD-Const.:

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2.00 ~ 10.00

SF:

-5.00 ~ +10.00

a0:

-9.99 ~ 9.99

a1:

-0.99 ~ 0.99

a2:

-0.99 ~ 0.99

d) Entering IOL Power If you wish to store the IOL power of the lens you have selected for the patient:

Figure 1 1

Touch the “Entry” key (1) to show IOL Entry Window(Fig2).

Figure 2 2

Touch up and down cursor(4) to select the position to enter data.

3

Enter Company name(Company), Model No(Model No), A constant (Aconst) and Lens constants (Aconst, SF, ACD-Const, a0, a1 and a2). Press “Return” key to move entry index.

4

Use right arrow key to show extra page with ACDConst, a0, a1 and a2.

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e) P/C Value (Personal Corresponding Value) Settings and Calculation After the IOL has been implanted and the postoperative refraction has been determined, the optimal lens constants (personal A-const, and corresponding value) can be calculated as follows.

Figure 1 1

Touch P/C Val key(1) on IOL calculation(Fig 1) to display the P/C value calculation screen(Fig 2).

Figure 2 2

Touch the databox (3) for each item and enter the value using the number keys(4).

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Figure 3 3

The selected databox will be reverse highlighted.(Fig 3)

Axial length Anterier Chamber Depth Corneal Refractive Power / Corneal Raduis Postoperative refractive power [Acceptable range] -10.00 - +10.00D Refractive power of implanted IOL [Acceptable range] -50.00 - +50.00D Applied IOL lens constant (Aconst) When above values have already entered on (Fig 1) dis play, those are not changable on P/C value calculation screen. 4

Touch reverse highlighted key again to complete data entry.

5

After all values have been entered, the instrument will automatically display the calculation results.

6

Touch Exit key(5) to return to the IOL calculation window(Fig 1).

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f) Assistant function Imp-IOL Entry Enter the implanted IOL model name. This model name is saved in the internal memory or the Memory card.

1

Press the IOL front button provided in the front of the Main Unit to display the IOL Calculation screen (Fig. 1).

Figure 1

2

Touch the Imp-IOL key (1) in the screen (Fig. 1), so the key and the Model display will be highlighted (Fig. 2).

Figure 2 3

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Select the Model display (2) for the lens used, so the Imp-IOL key will be displayed.

Adding of the calculation equations Additional calculation equations other than the six equations already registered to this Instrument can be registered. Memory card with IOL formulae is necessary to register extra eqations. Contact your TOMEY Representative for more information.

Figure 1

1

Press the IOL front button to display the IOL Calculation screen of (Fig. 1).

2

Select the Equation Select key (1) in the screen (Fig. 1) to display the Equation Select screen of (Fig. 2).

Figure 2

3

Insert the Memory card with the IOL equations.

4

Touch the Load key (2) in the screen of (Fig. 2) to display the screen of ( Fig. 3).

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Figure 3

5

Select the OK key (3) in the screen (Fig. 3) to register the IOL calculation equations to the internal memory which have been registered in the Memory Card. The screen displays the data to be registered on the right side (5) and, when this registration has been completed, will be displayed on the left side (6).

6

Select the Exit key (4), if returning of the screen for selecting equations is desired.

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3.4 Printing 3.4.1 Initiating Printing After biometry measurement, IOL calculation or pachymetry measurement, touch the Print key(1) to initiate printing.

a) Data Review window

b) Echo Window

c) IOL Calculation Window

d) P/C Val Window

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e) EDIT Window Average data will be printed, when touch print key without specifyng data by select key(2) on EDIT Window.

Figure 1

f) Communication Screen after transmitting data 1

The screen(1) will be shown after transmitting data. See [3.5.6 a)]

Figure 1

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3.4.2 Sample Printouts a) Sample biometry printout

(1) Time/Date (2) Patient ID number (3) Patient name (4) Physician•fs name (5) Patien•fs sex (6) Eye (Right/Left) (7) Measurement mode (8) Eye type (9) Contact / Immersion (10) Average axial length velocity (11) Lens velocity (12) ACD velocity (13) Gain (14) Average axial length (15) Standard deviation of axial length data (16) Difference between minimum and maximum axial length (17) Memory number (18) Measurement data (axial length/ACD/lens thickness) (19) Mean measurement data values (20) Memory number of the displayed waveform (21) Waveform (22) Selection cursor for retina waveform (23) Scale (2 mm/div)

3-49

b) Sample IOL power calculation printout following biometry (SRK/T)

(1) Time/Date (2) Patient ID number (3) Patient name (4) Physician’s name (5) Patient’s sex (6) Eye (Right/Left) (7) Axial length (8) ACD (9) Corneal refractive power or Corneal Radius (10) Desired postoperative refraction (11) IOL calculation formula (12) Lens A/Lens B (13) Lens constants (14) Power calculation results (15) IOL model name (16) Nine IOL power levels and the predicted postoperative refraction for each lens model

3-50

c) Sample printout using P/C(Personal Corresponding) surgeon factor values

(1) Time/Date (2) Patient ID number (3) Patient name (4) Physician’s name (5) Patient’s sex (6) Eye(Right/Left) (7) Postoperative refraction (8) Implanted IOL power (9) Axial length (10) Anterier chamber depth (ACD) (11) Keratometry values (12) Lens constant (13) Results of calculations

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d) Sample Data communication printout

(1) Time/Date (2) Patient ID number (3) Patient name (4) Physician’s name (5) Patient’s sex (6) Eye (Right/Left) (7) Eye type (8) Average axial length velocity (9) Lens velocity (10) ACD velocity (11) Average axial length (12) ACD (13) Lens thickness (14) Keratometry values (15) Desired postoperative refraction (16) IOL calculation formula (17) IOL manufacturer name (18) IOL model name (19) Lens constants (20) Implanted IOL power (21) Predicted postoperative refraction

3-52

3.5

Data Save / Load / Delete Data saving, loading and deleting will be done on IOL calculation and EDIT screens.

3.5.1

Save data Measurement data and calculation result can be stored on the internal memory or Memory card. Patient ID number will be required to save data. The memory card must be formatted before its initial use.

a) Data saving (EDIT)

Figure 1

1

Press EDIT button in front of the instrument to show EDIT window. (Fig 1)

2

Select the Cursor Move key (1), to move the cursor up and down.

3

Select the Select key (2) by cursor, so the key will be highlighted to display the marker (3) for selected data.

In case not selecting the Select key (2), the average value of measured data is saved.

3-53

4

Touch Save key (4) to show dialog window to select “Internal” or “Card”.

Figure 2

“Save data on internal memory” Touch Internal key (4) The saving will be completed, when you hear short beep and the display return to the EDIT window. Less than 6 data can be stored with the internal memory. (The number, which can be stored onto the internal memory varies, depending on the size of the data) “Save data on Memory card” Touch Card key (5) The saving will be completed, when you hear short beep and the display return to the EDIT window. Memory card must be formatted before its initial use. “To cancel data saving” Touch Cancel key (6) to make short beep and return to EDIT window.

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b) Save Data on the IOL Calculation Window

1

Select the IOL front button to display the IOL Calculation Window.

Figure 1 2

Select the Save key (1) in the screen of (Fig. 1), to display the screen of (Fig. 2). Then, select “Internal” or “Card”

Figure 2

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“Save data on internal memory” Touch Internal key (4) The saving will be completed, when you hear short beep and the display return to the IOL window. Less than 6 data can be stored with the internal memory. (The number, which can be stored onto the internal memory varies, depending on the size of the data) * Biometry data, on the internal memory, will NOT be automatically deleted with this process. “Save data on Memory card” Touch Card key (5) The saving will be completed, when you hear short beep and the display return to the IOL window. Memory card must be formatted before its initial use. * Biometry data, on the internal memory, will NOT be automatically deleted with this process. “To cancel data saving” Touch Cancel key (6) to make short beep and return to IOL window.

3.5.2

Data Loading Saved data can be loaded from the internal memory or the Memory card.

Figure 1

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1

Press EDIT button to show EDIT window. (Fig 1)

2

Touch Load key (1) to show Dialog window to select “Internal”, “Card” or “Cancel”.

Figure 2 “Loading from the internal memory” 1

Touch Internal key (2). (Fig 2)

2

Desired data can be selected with up and down cursor (5) on Loading window (Fig 3). Touch Select key (6) to select the data.

“Loading from the memory card” 1

Touch Card key (3)

2

Desired data can be selected with up and down cursor (7) on Loading window (Fig 4). Touch Select key (8) to select the data.

3

Touch Page key (9) to be reverse highlighted and move down to the rest of the contents. (Fig 5)

4

Up and down arrow keys (10) will be reverse highlighted to switch Page number (11) and Data list (12).

5

Touch Page key (9) again to set the desired data.

6

Touch Select key (8) to select the data.

“To cancel data loading” 1

Touch Cancel key (4) to make short beep and cancel.

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Figure 3

Figure 4

Figure 5

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3.5.3

Sort Saved data can be sorted as desired.

1

Press EDIT button to show EDIT window. (Fig 1)

2

Touch Load key (1) to show the display on Figure 1.

3

Touch Card key (4) to show LOAD DATA display (Fig

Figure 1

Figure 2

3)

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4

Touch Sort key (6) on the display (Fig 3) to show Sort Condition screen.(Fig 4)

5

Select the items to sort from (7) and which order should be taken as alphabetical sorting. Selected keys will be

Figure 3

Figure 4

reverse highlighted. 6

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Touch Exit key to show sorted LOAD list.

3.5.4

Deleting Only data, saved by AL-100, can be deleted. 1

Touch the Load key on EDIT window, to go to LOAD Window(the internal memory or the Memory card) in which the memory to be deleted is preserved.(Fig1)

Figure 1

“Delete all data” 2

Touch ALL Clear key(1) and keep touching for over one sec. to hear short beep.

3

Cleared data means that the data deleting has been completed.

Figure 2 “Delete selected data” 2

Select data to be deleted by key(3), and press the Delete key (4) for over one sec. to hear short beep.(Fig 3)

3

Cleared data means that the data deleting has been completed.

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3.5.5

Formatting the Memory Card The memory card can be formatted with AL-100. The memory card must contain battery inside. Read the operation manual of the battery and follow the instruction. The memory card must be formatted before its initial use. Once the memory card has been formatted, formerly saved data cannot be restored. Please pay special attention not to lose important data, when formatting the memory card. 1

Hold the front of the memory card toward you and insert it into the slot. The slot is on the left side of the instrument.

2

Press EDIT button on the front to show EDIT window.(Fig1)

Figure 1

Figure 2 3

Touch the Load key(1) in the Load window(Fig1) and touch Card key(2).

Figure 3

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4

When the LOAD window is displayed, touch Format Key (3) for over one sec. to hear short beep.(Fig3)

5

When you hear short beep again, the formatting has been completed.

3.5.6

Data Communication Measured data may be transferred to a computer via a data communication port (RS-232C). The connector has its orientation, when connecting to the port. Check the direction of the connector and insert it completely into the serial port. Accessory equipment connected to the RS-232C interface must be certified according to the appropriate IEC601-1 standard for medical equipment.

a) Connection to PC All configurations must comply with IEC 601-1 or IEC950 system standard. Anyone who connects additional equipment to the single input port or signal output port is configuring a medical system and is, therefore, responsible for assuring that the system complies with the requirements of the IEC601-1 system standard. If indoubt, contact the Tomey technical service department, or your local Tomey representative. Connect the RS-232C communication cable (3) to the adapter and secure the connection by tightening the screws.

“Serial communication cable connection” This instrument has female connector. Use male-to-female cable or female-to-female cable with gender changer to connect with PC. Insert the connector or adapter to the RS-232C connection terminal on the back of the instrument and secure the connection by tightening the screws.

1

Connect the RS-232C communication cable to the adapter or connector and secure the connection by tightening the screws.

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“Pin positions of the RS-232C connection terminals” 9 pins D-sub Pin #

Signal

1

-

2

RxD

3

TxD

4

DTR

5

SG

6

DSR

7

RST

8

CTS

9

-

Note: Pin# 4 and 6 are connected inside the instrument. So

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as pin# 7 and 8.

b) Sending of data The Instrument is capable of sending data from the IOL Calculation screen and the EDIT screen to any external communication equipment.

“IOL calculation screen”

“EDIT screen”

1

1

Select the IOL front button to display the IOL Calculation screen.

Select the EDIT front button to display the EDIT screen.

Figure 1 2 Display the data desired to be sent

Figure 1 2 Display the date desired to be sent

in the IOL Calculation screen of

in the EDIT screen of (Fig. 1) and

(Fig. 1) and select the COM key (1).

next select the COM key (1).

Figure 2

3

Select the Send key (2) in the Communication screen of (Fi8g. 2) to display the Communications screen of (Fig. 3).

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Figure 3

4

Check the displayed data and select the OK key (3) to send the data. Next select the down key(4) to display the data of axial length.

5

If you want to cancel sending data, select the Cancel key (5).

6

When sending data is completed, the screen of (Fig. 4) is displayed.

7

Select the Exit key (6) to return the screen to that of (Fig. 2).

Figure 4

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c) Receiving of data 1

Since data receiving cannot be made if there is any data left in the screen, display the Measure, Wait screen of (Fig. 1) and select the New key (1).

Figure 1 2

For changing the screen for data communications, display the IOL Calculation screen or the EDIT screen and select the COM key (2).

Figure 2-1

Figure 2-2

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Figure 3

3

Select the Receive key (3) in the screen of (Fig. 3) to display the Data Receiving screen of (Fig. 4).

Figure 4

4

When the personal computer is ready for sending data to the Instrument, select the Start key (4) to start receiving data by Instrument.

Figure 5

5

When finishing sending data from the computer, received data are displayed in the screen of the Instrument. Then, the screen of the Instrument is returned to the IOL Calculation screen or to the EDIT screen.

6

If the Exit key is selected, received data will be disposed so that the screen will be returned to IOL Calculation screen or the EDIT screen.

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3.6

UTILITEIS

1

Press EDIT button to show EDIT window.

2

Touch Utility key(1) to show Utility window.(Fig 1)

Figure 1

3.6.1

Description of Utility Windows

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3.6.2

Biometry/IOL power calculation Utilities a) Date/Time setup To set the date and time:

Figure 1 1

Touch the Time and Date key (1) on the biometry Utility screen(Fig 1) to display Time and Date screen (Fig 2).

2

Touch each item key (2) to prepare to enter information for that item. The selected item will be reverse highlighted. Enter the information using the number keys(3).

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3

Touc the Return key (4) to register each value.

4

Touch Exit key(5) to return to Utility screen (Fig 1).

b) Sound Setup To adjust the sound:

Figure 1

1

Touch Sound Set key (1) on the biometry Utility screen (Fig 1) to display the Sound Adjustment window (Fig 2)

Figure 2 2

Touch the Volume keys (2) to adjust the sound level.

3

Touch Exit key (3) to return to EDIT window (Fig 1).

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c) Print Mode Setup To set the printout options.

Figure 1

1

Touch Print Mode Key (1) to display Print Mode screen(Fig 2).

Standard: Standard Printing Contents Simple: Simple Printing Contents

Figure 2 2

Two Print modes can be set for Measurement (2) and IOL (3).

3

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Touch Exit key (4) to return to Utility screen(Fig 1).

3.7

Optional MEMORY CARD Biometry measurements and IOL data can be stored on the memory card. If a memory card other than the one provided is used, there is no guarantee that the data will be properly stored. If data on the memory card are edited using a computer, the card no longer can be used with the AL-100. It will be necessary to reformat the card. The PC memory card used with the AL-100 is an SRAM type card. Therefore, an SRAM type card reader, not a Flash Memory reader, must be used. If a Flash Memory reader is used, data stored on the memory card may be corrupted. Reformatting the memory card deletes all stored data on the card.

3.7.1

Optional Memory Card Specifications The memory card is 68 pin SRAM card that complies with the PC card Standard. Configuration:

Type I

Bytes of memory:

512K, 1M, 2M, 4MByte

Power voltage:

5 +/- 0.5V

Access time:

200ns

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3.7.2

Memory Card Battery a) An error, [No Battery!] appears. The memory card does not have battery or the battery is over its life time. Replace the battery by following the directions in the memory card Instruction Manual. If the memory card is left without battery for over 10 minutes, or it is left without replacing the battery for a long time, the data will be lost in the memory card.

b) An error, [Low Battery!] appears. The memory card is running short of its battery. Replace the battery by following the directions in the memory card Instruction Manual. If the memory card is left without battery for over 10 minutes, or it is left without replacing the battery for a long time, the data will be lost in the memory card.

c) Battery life The Memory Card consume its battery even when the memory card is not used with AL-100. The life of the battery varies as a function of the memory capacity, as indicated below. IMPORTANT: If the battery is not replaced within 10 minutes of receiving the “low battery!” message, data stored on the memory card might be lost.

Battery life and the capacity of Memory Card Capacity of Memory Card Battery Life at 25 degree Celcius (77 degree Fahrenheit) 512Kbyte (Option)

Approximately 5 years

1Mbyte (Option)

Approximately 5 years

2Mbyte (Option)

Approximately 3 years

4MByte (Option)

Approximately 1 years

The battery life also varies with the conditions or circumstances, where it is used.

3-74

3.7.3

Reading the Memory Card on a Windows Computer a) Rewriting the Windows* PC system configuration file

“Windows 98 Second Edition” loading is to be performed from 1), while for other than that, loading is to be from 2). 1 Open the PC card “PC” card (PCMCIA) of the control panel “control panel” and run the PC card wizard. When a message to check on the restart of the Computer is displayed, click the button of “NO”. If the PC card wizard is not displayed but the properties of PC (PCMCIA) is displayed, click the ”button:[cancel]” to proceed in the successive procedures. 2 Open the “Config. Sys” files by using the “memo note” (“NOTEPAD”: application, etc.). 3 Add the following information to the last row of “Config. Sys”. It is also noted that the directory of WINDOW differs on the personal computer. Specify the directory in which the system file of Windows* is provided. In case of only one of the “PC card slot” in the underlined part, enter /SLOT=1, while in case of two cases, enter SLOT=2. DEVICE=C:\WINDOWS\SYSTEM\CSMAPPER.SYS XE "CSMAPPER.SYS" DEVICE=C:\WINDOWS\SYSTEM\CARDDRV.EXE XE "CARDDRV.EXE"/SLOT=2 4

Overwrite and save the “Config.sys” file.

5

Restart the Windows*.

6

Activate the “Explore” (application) and make sure that the removable disk have newly been displayed. If the removable disk does not exist, check again by activating the Windows* again.

3-75

There are some cases that, even if this method is given, the information saved in the Memory Card cannot be read. In such a case, consult the Manufacturer or your local representative. 1

Open the Explorer to move such information files to the Drivers\Storage\Flash folder of Windows* Me CD-ROM. (There are some personal computers of which CD does not primarily contained necessary files, if such personal computer has been installed with the WindowsR Me from the beginning, depending on the type of the computer. If so, check on C:\WINMEADD\Driver\Strage\Flash which is supposed to be provided in the computer.)

2

Click the file of “TRUEEFFS.INF” with the right button of the mouse and next click “install”.

3

After the computer is restarted, activate the Explorer (application) and make sure that a new removable disk is displayed. If no removable disk exists in the screen, reactivate the Windows* to check.

There are some types of personal computers that, even if this method is employed, the information saved in the Memory Card cannot be referred. If so, consult the Manufacturer or your local representative. 1

Insert the SRAM Card into the PC card slot, so the window shown in Fig. 1 will be displayed.

2

A while after above, the Window will be displayed. When the Window disappears with a sound of “pepo” and if the personal computer does not show its movement, the SRAM Card has been identified. Then, proceed in 11). If such a Window as shown in Fig. 3 is displayed, proceed in 3).

3-76

3

Click the [Next] button (1) and proceed in the window of (Fig. 4).

4

Select [Display known driver of this device and select its list.], next click the [Next] button (3), and proceed in the next Window of (Fig. 5).

5

Select “Memory technology driver” (4) and click the [Next] button (5), to proceed in the next Window of (Fig. 6).

6

Select [Standard] (6) from the [Manufacturer] Window*, next select “Standard PCMCIA Memory Card”, and “Standard PCMCIA Memory Card” (7). Then click [Next] button (8) to proceed in the next Window of (Fig. 8).

7

Since the warning Window is displayed, click the [Yes] button.

8

Click the [Next] button in Fig. 8, so installing of the driver will start. When this installing is finished, the Window shown in Fig. 9 is displayed.

9

Click the [Complete] button.

10 In case such a Window as shown in Fig. 10, which

induces reactivation of the Window, is displayed, click the [Yes] button to restart the system. 11

Start the Explorer (application) and make sure that the removable disk has been displayed again.

3-77

3.7.4

Taking out the Memory Card from the personal computer Windows* 95/98/Me Figs show the cases of Windows* 95

Take out the Memory Card from the personal com puter in the following procedures, which may other wise cause the personal computer to malfunction. 1

Click the [Start] button(1), next point the [Setting], and then click (2), so the control panel will be displayed. (Fig. 2)

Figure 1

Figure 2

2

Double-click the icon (3) of “PC card” (PCMCIA), so the properties of the PC card will be displayed. (Fig. 3)

3

Select the socket in which the Memory Card is inserted, and next click the [Stop] button (4).

4

When [This device can be removed safely.] is displayed, click the [OK] button and next take the Memory Card out.

Figure 3

3-78



1)

Figure 1

Display the control panel in the same manner as and next double-click the (Fig. 1), so the starting window for “Add and Delete Hardware Wizard” will be displayed. (Fig. 2)

Figure 2

2)

Click the [Next] button (1), so the window for selecting the operation related to hardware will be displayed. (Fig. 3)

Figure 3

3)

Next, select [Delete/Remove Device](2) and click the [Next] button (3), so the window for selecting deleting procedures will be displayed. (Fig. 4)

4)

1) Select [Remove device](4) and click the [Next] button (5), so the window for selecting the device will be displayed. (Fig. 5)

Figure 4

5)

Select [Standard PCMCIA Memory Card](6) and click the [Next] button (7), so the confirmation window of the device will be displayed. (Fig. 6)

Figure 5

6)

Make sure that [Standard OCNCUA Memory Card] (8) has been selected and click the [Next] button (9), so the window for completion of hardware addition and deletion will be displayed. (Fig. 7)

Figure 6 7)

Take the Memory Card out.

8)

Click the [Complete] button (10) to finish the wizard.

Figure 7

3-79

3-80

4 TECHNICAL INFORMATION 4.1 IOL Calculation Formulae 4.1.1

SRK/II a. Emmetropic IOL power (D) Pemme = A1 - 0.9K - 2.5L b. Ametropic IOL power (D) Pament = Pemme - REF x CR c. Desired postoperative refraction (D) REFiol = (Pemme - P) / CR Where: if

L < 20.0 mm, then A1 = A + 3

if 20.0 < L < 21.0 mm, then A1 = A + 2 if 21.0 < L < 22.0 mm, then A1 = A + 1 if 22.0 < L < 24.5 mm, then A1 = A if

L > 24.5 mm, then A1 = A - 0.5

if Pemme < 14, then CR = 1.00 if Pemme > 14, then CR = 1.25

A:

A - constant

K:

Corneal refraction (D) = (K1 + K2) /2

L:

Axial length (mm)

P:

Power of IOL implant (D)

REF: Postoperative refractive power

4-1

4.1.2

SRK/T a. Emmetropic IOL power (D) Pemmme =

1000na*X (L1 - C1) Y

b. Ametropic IOL power (D) Pame t =

1000na {X - 0.001REF (V*X + L1*r)} (L1 - C1) {Y - 0.001REF (V*Y + C1*r)}

c. Desired postoperative refraction (D) REFiol =

1000na*X - P*Y (L1 - C1)} na (V*X + L1*r) - 0.001P (L1 - C1) (V*Y + C1*r)

Where: X = na*r - L1 (nc - 1) Y = na*r - C1 (nc - 1) L1:

Optical axial length (mm) = L + (0.65696 - 0.02029L)

L:

Measured axial length (mm)

REF: Desired postoperative refraction (D) r:

Average corneal radius of curvature (mm) = 337.5/K

W:

Corneal thickness by calculation (mm)

LC:

Modified axial length (mm)

= -5.41 + 0.58412LC + 0.098K if L ² 24.2, then LC = L if L > 24.2, then LC = -3.446 + 1.716L - 0.0237L2 C1:

Estimated postoperative anterior chamber depth (mm) = H + Ofst.

Ofst:

Calculated distance between the iris surface and IOL optical surface (including the corneal thickness) (mm) = ACD const = -3.336 = (0.62467A - 68.747) - 3.336

H:

Height of the corneal dome (mm) = r - SQRT

r2 - W2/4

A:

A-constant

K:

Average corneal refractive power (D)

P:

Power of IOL implant (D)

=(K1 + K2)/2

4-2

V:

Vertex distance (mm) = 12

na:

Refractive index of aqueous and vitreous = 1.336

nc:

Refractive index of cornea = 1.333

d. Personal A-constant A = P + AREF*RF + 2.5L + 0.9K - COR Where: P:

Power of IOL implant (D)

AREF: Postoperative refraction 16, then RF = 1.25

L:

if P ² 16, then RF = 1 Axial length

K:

Average corneal refraction (D)

(K1 + K2) / 2 COR: Correcting value if

L < 20.0, then COR = 3

if 20.0 < L < 21.0, then COR = 2 if 21.0 < L < 22.0, then COR = 1 if 22.0 < L < 24.5, then COR = 0 if L> 24.5, then COR = -0.5

4-3

4.1.3

Holladay a. IOL power (D) P=

1000na {X - 0.001REF (V*X + L2*r) (L2 - C2 - SF) [Y - 0.001REF {V*Y+ r (C2 + SF)

b. Desired postoperative refraction (D) Pemme =

1000na * X - P * Q * Y na (V*X + L2*r) - 0.001P*Q {V*Y + r (C2 + SF)}

Where: X:

na*r - L2 (nc - 1)

Y:

na*r - (nc - 1) (C2 + SF)

Q:

L2 - C2 - SF

na:

Refractive index of aqueous and vitreous = 1.336

nc:

Refractive index of cornea = 4.0/3.0

L:

Measured axial length (mm)

r:

Average corneal radius of curvature (mm) = 337.5/K

K:

Average corneal refractive power = (K1 + K2)/2 (D)

SF:

Surgeon factor (Distance between iris surface and optical center of IOL) (mm)

REF: Desired postoperative refraction V:

Vertex distance (mm) = 12

P:

Power of IOL implant (D)

L2:

Modified axial length (mm) = L + 0.2

C2:

Anatomical anterior chamber depth (mm) (distance between corneal apex and iris surface) (mm)

= 0.56 + Rag -

Rag2 - AG2/4

if r < 7 mm, then Rag = 7 mm if r > 7 mm, then Rag = r AG = 12.5L/23.45 (if AG > 13.5 mm, then AG = 13.5 mm)

4-4

c. Personal SF SF = { -BQ -

BQ2 - 4AQ*CQ} / (2AQ) - C2

Where: AQ = (nc - 0.001AREF {V (nc - 1) - r} BQ = 0.001AREF {L2*V (nc - 1) - r ( L2 - V*na)} {L2(nc - 1) + na*r} CQ1 = 0.001AREF [V {na*r - L2 (nc - 1)} + L2*r] CQ2 = 1000na {na*r - L2 (nc - 1) - CQ1} / P CQ3 = L2*na*r - 0.001AREF *L2*V*r*na CQ = CQ3 - CQ2

nc:

Refractive index of cornea = 4.0/3.0

na:

Refractive index of aqueous and vitreous = 1.336

r:

Average corneal radius of curvature (mm) = 337.5/K

K:

Average corneal refractive power = (K1 + K2)/2 (D)

V:

Vertex distance (mm) = 12

L:

Measured axial length (mm)

L2:

Modified axial length (mm) = L + 0.2 (mm)

S:

Spherical index (D)

C:

Cylindrical index (D)

AREF: Postoperative refraction 7 mm, then Rag = r AG = 12.5L/23.45 (if AG > 13.5 mm, then AG = 13.5 mm)

d. Corresponding SF SF = 0.5663A - 65.60 Where: A: A-constant

4-5

4.1.5

Haigis standard a. IOL power (D) P=

1000na L-d

-

na na z

-

d 1000

Where: REF

z = DC + 1-

REF * V 1000

d = a0 + a1*ACD + a2*L

(ACD - 0)

d = (a0 - 0.241*a1) + (a2 + 0.139*a1)L

(ACD = 0)

a0 = 0.62467A - 72.434 1000 (nc - 1) DC = RC

b. Predicted postoperative refractive power (D) REFiol =

1000 (1000Y - DC * X) V (1000Y - DC * X) + 1000X

Where: X = d*P + 1000L* na - d*L*P Y = na (1000*na - L*P + d*P) na:

Refractive index of aqueous and vitreous = 1.336

nc:

Refractive index of cornea = 1.3315

RC:

Average corneal radius of curvature (mm) = (K1 + K2) / 2

DC:

Average corneal refractive power (D)

L:

Axial length (mm)

ACD: Anterior chamber depth (mm) REF: Desired postoperative refractive power (D)

4-6

V:

Vertex distance (mm) = 12

P:

Power of IOL implant (D)

a1:

0.4 (default value)

a2:

0.1 (default value)

c. Personal A-constant d - a1*ACD - a2*L + 72.434

A=

A=

0.62467

(ACD - 0)

d - L(a2 + 0.139*a1) + 0.241*a1 + 72.434 0.62467

(ACD = 0)

Where: d=

P (L*z+1000na) - P2 (L*z + 1000na)2- 4P*z (1000L*na*z + 1000L*na*P - 10002*na2) 2P*z AREF

z = DC + 1-

DC =

AREF*V 1000

1000 (nc - 1) r

a1:

0.4

a2:

0.1

RC:

Average corneal radius of curvature (mm)

ACD: Anterior chamber depth (mm) L:

Axial length (mm)

P:

Power of IOL implant (D)

na:

Refractive index of aqueous and vitreous

nc:

Refractive index of cornea = 1.3315

DC:

Average corneal refractive power (D)

AREF: Postoperative refractive power (D) V:

Vertex distance (mm) = 12

4-7

4.2 Ultrasound Velocity used in Axial Length Measurement 4.2.1

Normal Axial length is calculated using the following formula: L=

V*t 2

Where:

4.2.2

L: V:

Axial length Average ultrasound velocity

t:

Time

Dense Cataract Axial length is calculated using the same formula as for the normal lens.

4.2.3

Aphakic Axial length is calculated using the same formula as for the normal lens.

4.2.4

Pseudophakic (1~ 3) Ultrasound velocity may vary between materials and manufacturers and depending on temperature. Materials

Ultrasound velocity in IOL

Pseudophakic 1

PMMA

2718m/s

Pseudophakic 2

Silicon

1049m/s

Pseudophakic 3

Acrylic

2200m/s

Axial length is calculated using the following formula:

Lp =

Vacd * tacd 2

+ Th +

Vvit * tvit 2

Where:

4-8

Lp:

Axial length (mm)

Th:

Central thickness of IOL (must be entered)

Vacd:

Anterior depth sound Velocity

Vvit:

Vitreous sound Velocity

tacd:

Measuring Time for anterior drpth

tvit:

Measuring Time for vitreous

4.3 Start-up screen

(Figure 1) Start up screen will be shown after turning on the unit. The software version (1) is displayed to confirm.

4-9

4-10

5 MAINTENANCE 5.1

TOMEY One-Year Warranty

The Seller warrants this product to be free from defects in material and workmanship under the normal use of this product for one year or other terms complying with local regulations from the date of invoice issued by the Seller to the original purchaser. This warranty shall apply only to the original purchaser and shall NOT, in any way, be transferable or assignable to any other party than the original purchaser. Lamps, paper and consunable items shall not be covered by this warranty. This warranty also shall NOT apply if the product has not been installed, operated or maintained in accordance with the OPERATOR MANUAL of Tomey Corporation (hereinafter called “Tomey”). Neither the Seller nor Tomey shall be liable for any damages caused by the purchaser’s failure to follow instructions for proper installation, use and maintenance of the 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 installation, improper repair or improper modification of this product whose serial number or batch number is removed, altered or effacted. 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 PARTICULAR PURPOSE), AND ALL OTHER OBLIGATION AND LIABILITY ON THE PART OF THE SELLER AND TOMEY. NEITHER THE 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 PURCHASE PRICE OF DEFECTIVE GOODS.

5-1

5.2

Replacing fuses

Unplug the power cord when replacing

1

Turn the AL-100 off and unplug the power cord from the power outlet.

2

Rotate the fuse holders counter clockwise approximately 90 degrees using a coin or a screwdriver, and the holders will pop out.

3

Pick the holder with fingers and pull it out of the unit. Another holder should also be pulled out.

4

Check both fuses and replace them if necessary. A good fuse will have a thin strip of metal from one end to the other without any noticeable breaks. A blown fuse will have all or a portion of the metal melted away inside.

5

5-2

Reinsert the fuse holders and turn clockwise to lock them in place.

5.3

Routine Maintenance

5.3.1

Maintenance of the probe When disconnecting the probes, be sure to hold the plug, not the cable, otherwise the cable will be damaged. Do not use an autoclave or EOG to sterilize the probes since this may severely damage them.

a) Cleaning the probe handle and cord Use cotton cloth to wipe the tip of the probe, not to damage it. The connector part does not have to clean.

Wipe the probe handle with a soapy or alcohol-soaked cloth and then rinse it with water. Clean the cord using a wet cloth After cleaning, remove excess water from the probe and the cord.

b) Disinfecting the probes Do not use an autoclave or EOG to sterilize the probes since this may severely damage them.

Disinfect the probe by immersing the tip in a 0.5% solution (1 to 10 dilution) of sodium hypochlorite for 10 to 20 minutes. Then rinse with distilled water and allow to dry before use.

5-3

5.3.2

Maintenance of the main unit Do not use organic solvents for cleaning the AL-100 a sthey may cause damage to the surface. When removing the power cord, grasp the plug, not the cord and do not apply undue force.

Do not touch pins inside the connector.

Wipe off dirt gently with a wet cloth and then remove excess water with a dry cloth. If dirt is difficult to remove, use a diluted, mild detergent.

Since touch panel LCD is weak in humidity, do not leave it with water or other liquid on its surface. The surface will be damaged and the panel can not be used.

Clean the surface of the monitor with a dry cloth. If dirt is difficult to remove, use diluted, mild detergent on a soft cloth. Then rinse and remove excess moisture with a dry cloth. While the unit is used, put dust cover to avoid dust. When the unit is not used for a certain period of time, unplug the power cord.

5-4

5.4

Replacing Printer Paper Replace the paper when red lines appear on both sides of the paper.

When opening the printer cover, pay special attention to the paper cutter on the cover, not to cut your finger or hand.

1

Open printer cover (1).

2

Remove the used roll of paper.

3

Insert the leading end of the new roll of paper into the paper insertion slot. The paper will be detected and automatically fed into the printer. (See figure1) Care should be taken to place the paper with the correct side up, as indicated in the diagram.

4

Close the printer cover until you hear “click” sound.(See figure2)

5

Cut off the excess paper.

(Figure 1)

BIO

BIO

(Figure 2)

5-5

5.5

Storage

Do not store this instrument in a location where it might be exposed to water or chemicals. Avoid excessive atmospheric pressure, high temparature, excessive humidity, poor ventilation, direct sunlight, dust, salt or sulfer in the air. Do not store this instrument near chemical substances or in a location where gas may be generated. Store this instrument in a location where there is no tilt, vibration, shock(during transportation).

When shoring the AL-2000, the protective cap should be placed on the clean biometry probe tip and should be placed in the case provided. If the instrument is not to be used for a prolonged period, disconnect the power cord and place the dust cover over the instrument. When using it again, make sure if the instrument works without any problem. Storage Condition Atmospheric temparature range: -20 to +70 degree Celucius (-4 to +158 degree Fahrenheit) Relative humidity range: 10 to 95 %

5-6

5.6

Packing materials Keep the carton and packing materials for future use. If you discard the packing materials, be sure to comply with local ordinances and regulations for disposal. This instrument contains the board with lithiumion battery inside the body. If you discard the instrument, be sure to complay with local ordinances or regulations for disposal.

5-7

5-8

6 TROUBLESHOOTING Before self-judging a trouble as a malfunction or failure, check the following items. If you cannot solve your trouble or problem by the following countermeasures, consult your local representative.

Do not remove the enclosure of this Instrument, or you may otherwise be exposed with high voltage. Do not use any measures other than specified in this chapter. If your problem cannot be corrected by the following countermeasures, ask your local representative for problem investigation and repair, if necessary. l

When turning the power on, the power supply indicator do not light.

Cause1 Power plug failure Solution

Check to see if the power plug is sufficiently inserted into the receptacle until it is stopped.

Cause 2 Power receptacle failure

Solution

Check to see if the receptacle is supplied with power.

6-1

Cause 3

Solution

l

The fuse is broken. Disassemble the fuse holder and check to see if the fuses are proper or broken. In broken, change the fuses as per prescribed "5.2 Replacing of fuses. If replaced fuses are again broken, the Instrument will possibly not function properly. If so, ask your local representative for inspection and repair of this Instrument.

Nothing is displayed in the monitor screen.

Cause1 The Auto Power Off Function (which automatically turns the screen off if no operation is given for 15 minutes) is in operation. Solution

Touch the monitor screen.

Cause 2 The switch for maintenance provided on the rear side is off the center position. (See

2.2 7.)

Solution

l

Turn the power off and return the position of the switch to the center. Then turn the power on.

The whole monitor screen is dark and hard to see.

Cause1 The brightness of the monitor screen is low.

Solution

l

Adjust the brightness of the monitor screen by turning the Contrast Adjust Volume.

No printout can be made with the built-in printer.

Cause1 Printer paper.

Solution

Check to see if the Printer paper is sufficiently left. Check to see if the Printer paper is placed properly in the procedures specified by "5.4 Replacing of printing paper".

l

A button which is different from that pressed in the touch panel was reacted.

Cause1 The calibration of the touch panel was shifted.

6-2

Solution

Turn the power by pressing both Measure button and the MAP button at the same time. After this condition elapses, the touch panel calibration screen will be shown. Touch the center position of [+] in the screen, so the point will disappear and the next [+] will appear again. Repeat this calibration until [+] is not displayed. After this calibration is finished, ?????? screen will be displayed to make the operation possible. In the event the calibration of the touch panel is shifted many times while in operation, consult your local representative.

l

The time display is not working

Cause1 The loading data is being displayed. Solution

While any loading data is being displayed, the date ìand time of its measurement made is displayed. The time and minutes will then be displayed after the screen is turned off.

l

No Biometry measurement can be obtained.

Cause1 The connection of the Biometry Probe is not proper. Solution

Properly and securely connect the Probe until it is locked, in accordance with "3.2.1 b) Connecting of Biometry Probe".

Cause 2 The conditions of taking-in by Immersion

mode are not satisfied.

Solution

The Immersion mode takes in data if the corneal echo is within a range of 1.8 to 3.2mm from the initial echo. Super sounds must be placed within the cornea and the Probe tip to meet said conditions.

6-3

Cause 3

Solution

l

Measurement is in process by directly applying the Probe to the cornea while setting the Immersion mode, without placing super sound media. In process of setting the Immersion mode, use the Immersion attachment by means of the procedures specified in "3.6.5 a) Using of the Biometry Probe in the Contact Mode/Immersion Mode" or give measurement by placing super sounds. When directly applying the Probe to the cornea, select the Contact mode.

No auto-measurement can be taken.

Cause1 The Manual measurement has been set. Solution

Set at Auto Measurement (Chin measurement or Hand measurement). (See "3.6.3 e) Setting of the Measuring Method".)

Cause 2 Surrounding noises

Solution

Cause 3

Solution

Cause 4

Solution

6-4

If there is any source generating noises (such as motor, laser-operated equipment, or similar) near by the Instrument, move it away from the Instrument. Patient's fixation is not proper. Guide Patient's measuring eye sight by using the fixation lamp of the Chin Rest. The eye contact part of the Biometry Probe is damaged. If the Probe is damaged, promptly stop measurement and consult your local representative.

l

No manual measurement can be give.

Cause1 The connection of the footswitch is not proper. Solution

Connect the footswitch until it is securely locked, in accordance with the procedures prescribed in "3.2.1 e) Connecting of the Footswitch".

Cause 2 Auto Measurement (Chin measurement or

Hand measurement) has been set.

Solution l

Set for Manual measurement. (See "3.6.3 e) Setting of Measurement Method.")

Measurement data are not stable or proper.

Cause1 The Probe is not connected correctly.

Solution

Connect the Probe correctly until it is securely locked, by specified procedures mentioned in "3.2.1 b) Connecting of the Biometry Probe".)

Cause 2 The cornea is applied with an undue pressure.

Solution

Cause 3

Solution

Cause 4

Solution

In case of the Chin Rest, give a sufficient length from the Probe to the cord hook so that the Probe cord does not pull the slider of the Chin Rest. (See "3.6.6 b) Handling of the Slider when using the Chin Rest for Measurement".) The position of setting the retinal waveform selecting cursor is not proper. Set the retinal waveform selecting cursor at immediately right side of actual retinal echo, in such a manner that any unnecessary echo may not be placed between the cursor and the retinal echo. The Biometry Probe is not applied properly. Apply the Probe to the center of the cornea at a right angel so the retinal echo can quickly rise up.

6-5

Cause 5

Solution

An excessive amount of the cornea protective gel makes a gap between the Probe and the cornea, possibly resulting in longer measured data. Always give the appropriate amount of gel. The Immersion Attachment is being used while setting the Contact Mode. A large amount of super sounds are used.

Solution

Cause 7

Solution

Cause 8

Solution

Measured data are as much longer as the thickness of super sounds used. Properly give the settings of the Immersion Mode and the Contact Mode and take measurements in the procedures prescribed in "3.6.5 a) Handling of the Biometry Probe in the Contact Mode and the Immersion Mode." Measurement is given by directly applying the Probe to the cornea, without using super sounds in the Immersion Mode. In process of setting the Immersion mode, use the Immersion attachment by means of the procedures specified in "3.6.5 a) Using of the Biometry Probe in the Contact Mode/Immersion Mode" or give measurement by placing super sounds. When directly applying the Probe to the cornea, select the Contact mode. The setting of converted sound velocity is not proper. Check to see if the setting of converted sound velocity is proper. Converted sound velocity can be set for left and right respectively. Make sure that the sound velocities for both left and right have been set properly. (See "3.6.3 b) Settings of eyes to be measured and converted sound velocities.)

6-6

Cause 9

Solution

l

The eye contact part of the Probe is damaged. If the eye contact part of the Probe is found damaged, stop measurement immediately and consult your local representative.

The monitor sounds for Biometry does not stop, or measurement values are taken at the time when measurement is not being taken.

Cause1 The tip of the Biometry Probe is wetted with water. Solution l

Remove the water from the tip of the Probe.

The Biometry monitor sounds are not made.

Cause1 The sound volume setting is off. Solution

l

Turn the sound volume ON by using the procedures prescribed in "3.11.6 c) Setting of souns".

The waveforms are mixed with noises.

Cause1 The connection of the Biometry Probe is not proper.

Solution

Connect the Probe until the connection is locked, in accordance with the procedures prescribed in "3.2.1 b) Connecting of the Biometry Probe."

Cause 2 The grounding is not connected.

Solution

Cause 3

Solution

Make sure that the grounding of the power plug is connected. Surrounding noises. Where the noise generating sources (such as motor, laser surgery equipment, etc.) are placed close to the Instrument,

6-7

l

"Probe Error!" is displayed when turning the power on.

Cause1 The connection of the Biometry Probe is not proper. Solution

Connect the Probe until it is securely locked, in accordance with the procedures prescribed in "3.2.1 b) Connecting of the Biometry Probe".

l

Data cannot be saved in the internal memory.

Cause1 An ID number has not been inputted for data to be saved. Solution

Since ID number is saved as the name of the file, first input an ID number for data to be saved before proceeding in its saving operation.

Cause 2 The memory does not have a sufficient space.

Solution

l

Delete unnecessary data from the memory before carrying out the operation of saving. Up to six pieces of data can be saved.

Data cannot be saved in the Memory Card.

Cause1 The Memory Card is not inserted in its proper position.

Solution

Insert the Memory Card properly, in accordance with the procedures prescribed in 3.2.2 Connecting of Option Parts, b) Inserting and removing of the Memory Card.

Cause 2 The ID number is not inputted.

Solution

6-8

Since the Echo Data type and the Biometry data are saved with their ID numbers as files, first input the ID numbers before saving related information.

Cause 3

Solution

Cause 4

Solution

Cause 5

Solution

The names of files have not been inputted. In case of JPEG Data type, the file name must be inputted. Input the file name before saving. The Memory Card is protected from light. Release the light-protection, by the procedures specified in the Handling Manual for Memory Card. The Memory Card has no sufficient space. ("Memory Full!!" is displayed.) Replace the Memory Card in trouble with the new Memory Card, or delete unnecessary data before saving. Deleting of data must be done with this Instrument. The Memory Card has not been formatted.

Solution

Cause 7

Solution

l

Data cannot be saved in the Memory Card, unless it has not been formatted. Use the formatting memory card function provided for this Instrument, before saving data in the Memory Card. The format is not proper. Three different formatting types are used for this Instrument ( B-mode image diagnosis, Echo, JPEG, and Biometry function), of which data to be saved are specified. Formatting is to be given with the utility of which function corresponds to the data to be saved.

Data saved in the Memory Card disappear.

Cause1 The battery is not in position. Solution

Install the battery in position, by referring to the Handling Instructions for Memory Card.

6-9

Cause 2 The battery is old. ("Low Battery" is dis-

played.)

Solution

l

Replace the battery with the new part, in accordance with the Handling Instructions for the Memory Card.

The data saved in the Memory Card cannot be loaded into the personal computer.

Cause1 The Memory Card is not installed in position. Solution

Correctly insert the Memory Card into the personal computer, by referring to the Handling Manual for Personal Computer.

Cause 2 The contents in the Config. Sys are wrong, or the device driver has not been added.

Solution

Cause 3

Solution

6-10

Correct the contents in the Cong.sys in the procedures prescribed in "3.7.3 Loading the data saved in the Memory Card into the Windows personal computer, a) Rewriting of Config. Sys file of Windows personal computer provided with the PC card slot. No device driver of the Memory Card exists. If the personal computer provided with the Memory Card slot is installed with the Windows, "CSMAPPER. SYS" as the driver for Memory Card and "CARDDRV. EXE" have automatically been saved in the directory in which the system file exists. If such file has been deleted for some reasons, the Windows must be reinstalled. It is noted that sufficient knowledge is required for reinstalling the Windows and that the environments for such personal computer may largely be changed. No unskilled person is permitted to give to reinstall the Windows.

7 SPARE PARTS AND OPTION PARTS The following spare parts and option parts are available from your local representative or distributor of Tomey Corporation.

7.1

Option parts Memory Cards (512Kbyte, 1Mbyte, 2Mbyte, 4Mbyte) Specify a “Memory Card for AL-100”. Chin Rest AL-1100 Specify a “Chin Rest for AL-1100”.

7-1

7.2

Spare parts Printer paper roll for built-in Printer Specify a “Printer Paper Roll for Built-in Printer for AL-100”. Super sound diagnosis gel Specify “Super Sound Diagnosis Gel”. Immersion attachment Specify “Immersion Attachment for AL-100”.

7-2

8 SPECIFICATIONS 8.1

Specifications for the Instrument

8.1.1

Biometry Function and IOL Calculation Function Measurement range Axial length:

15:00 - 40.00 mm

Anterior depth:

1.80 - 7.00mm

Crystalline lens thickness:

2.00 - 6.00mm

Instrument accuracy Measuring accuracy:

± 0.1mm

Resolution:

0.01mm

Converted sound velocity set when shipped Normal Average axial length sound velocity: 1,550m/s Crystalline lens sound velocity:

1,641m/s

Anterior depth sound velocity:

1,532m/s

Dence Average axial length sound velocity: 1,548m/s Crystalline lens sound velocity:

1,629m/s

Anterior depth sound velocity:

1,532m/s

Aphakic Average axial length sound velocity: 1,532m/s Pseudophakic IOL sound velocity (Pseudo1):

2,718m/s

IOL sound velocity (Pseudo2):

1,049m/s

IOL sound velocity (Pseudo3):

2,200m/s

Vitreous body sound velocity:

1,532m/s

Anterior depth sound velocity:

1,532m/s

IOL thickness (Pseudo1):

0.8mm

IOL thickness (Pseudo2):

1.0mm

IOL thickness (Pseudo3):

0.8mm

8-1

IOL calculations SRK ll equation SRK/T equation HOLLADAY equation HOFFER Q equation HAIGIS optimized equation HAIGIS standard equation

Biometry Probe Type:

Solid type

Fixation lamp:

Built in the Probe (red LED)

Oscillator frequency:

10MHz

Tip diameter:

5.3mmφ (Concaved)

Dimensions and weight: 8mmφ × 97mm/30g

8.1.2

8.1.3

Main unit STN liquid crystal:

5.7 inch, color

Dimensions and weight:

W220 × D222 × H275mm/4kg

Power source Voltage:

100VAC

Frequency

50/60Hz

Consumption power:

less than 35VA + 15%

* The specifications and outer appearance may be changed for improved performances.

8-2

8.2

Energy and other consumptions

8.2.1

Influences of super sound energy on human body

Since this Instrument is exclusively designed for ophthalmic applications only, do not use it for any purposes other than for its designed purpose. This Instrument is designed as the super sound diagnosis equipment specialized for ophthalmic applications. This Instrument has, therefore, been set with a very weak super sound energy. It is suggested that the Operator of this Instrument should limit the time of diagnosis and measurement to a minimum extent, in consideration of the general precautions on super sound diagnosis and measurement equipment.

8.2.2

Amount of super sound energy Ispta. 3:

less than 17mW/cm2

Isppa. 3:

less than 28W/cm2

MI:

Less than 0.23

Super sound output in the eye as per the FDA 510(k) guideline Ispta. 3:

Average in-air peak time strength

Isppa. 3:

Average in-air peak pulse strength

MI:

Mechanical index

8-3

8.3

Generation of noises This Instrument makes mechanical noises at the following operations.

When turning the power on, When self-diagnosing, When starting printout, When operating the various key buttons, When taking measurements (such as when taking measured data).

8-4

Authorized Tomey Service Centers: Headquarters, Pacific rim Tomey Corporation (Tomey Japan) 2-11-33 Noritakeshinmachi Nishi-ku, Nagoya 451-0051 JAPAN Tel: +81 52-581-5327 Fax: +81 52-561-4735

North/South America Tomey Corporation USA (Tomey USA) 300 Second Ave. Waltham, MA 02451 USA Tel: +1 781-890-1515 Fax: +1 781-290-5885 Europe Tomey GmbH (Tomey Europe) Am Weichselgarten 19a 91058 Erlangen-Tennenlohe GERMANY Tel: +49 9131-77710 Fax: +49 9131-777120

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