AL 100user Manual Extract

8/17/2019 AL 100user Manual Extract

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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 speci-

fied in this Operator Manual.

Place this Operator Manual in a place of

access to the Operator while in opera-

tion.

If you lose this Operator Manual, ask

your local representative for a new copy.


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I O L

M E AS U R E

E D I T

2 COMPONENTS

2.1 Front and right side of AL-100

2-1


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2-2

(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 ButtonSwitch 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.


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2.2 Back and left side of AL-100


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(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


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3-1

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.


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3-2

3.2 Preparing the instrument for use

3.2.1 Connection of accessaries

a) Connecting the biometry probe

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.

O

O


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3-3

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.


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3-4

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 bat-

tery 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 in-

sert 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.


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3-5

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”

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.

Figure 1 Figure 2


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“ 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 AL-

100.


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3-7

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 con-

nected.

*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).


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3) Tilt the screen forward by pulling out the “legs” (3) on

the bottom of the instrument, if desired.

b) Start up screen

1) The probe is automatically calibrated, when the screen is

shown.

2) The catalog screen (Ready to measure screen) is shown,

when the calibration is completed without any problem.


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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.


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3-10

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 In-

dex data input, selecting the eye to be measured, Con-

tact/Immersion and selection of Measurement methods

are also done with this button.

2) IOL

The IOL calculation screen appears, when pushing this

button. IOL power calculation, Personal Correspon-

dence 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.

BIO METER AL-100

MEASURE IOL EDIT

MEASUREButton

IOLButton

EDITButton


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3.3.3 Measurement

Press MEASURE button to go into measurementmode.

Widow will be switched from Data re-

view to measurement automatically,

when it is taking data.

a)Data Review Window / Measurement Window

a-1 Data Review Window

a-2 Measurement Window


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3.3.4 Setting of the measurement conditions

Press “New” key and delete data of both eyes, before tak-

ing 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.


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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.

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.

Figure 1


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3-14

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 switch-over 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

Figure2


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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.


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e) Setting items for measurement

(Figure 1)

1 Touch Eye type/ Gain key(1) to go into its setting

window. “Figure2”

(Figure 2)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

(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


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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).


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[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 Nor-

mal mode.


Lens velocity(LENS) : 1540 ~ 1740 m/s

Anterier chamber velocity(ACD) : 1430 ~ 1630 m/s

Aphakic

Select when the patient’s eye is aphakic.


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


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[ACD] and [LENS] are not displayed with Aphakic, and

[LENS] is not displayed with Pseudophakic.

Posterier lens waveform might not be recognized, due to mul-

tiple 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 am-

plitude 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.


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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.


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[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 pro-

vided at the tip of the Immersion Attachment, when plac-

ing the ultrasound gel.

1 Apply a small amount of the ultrasound gel to the tip of

the Biometry probe. (Fig. 1)

2 Cover the b iometry probe wi th the immersion

attachment.(Fig.2)

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

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 veloc-

ity.

In immersion mode, the ultrasound gel must intervenebetween 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.

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 diag-

nose the data.

Measurement accuracy might be over 0.1mm, due to the

measurement condition or the difference among pa-

tients.

Figure 1

Figure 2

Figure 3

Figure 4


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Figure 1

Setting of the measurement mode

The Hand, chin measurement (automatic measurement) or

the manual measurement can be selected.


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3.3.5 Actual measurement

a) Checking the performance

The biometry test piece is used only for checking the op-

erating 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

Gain: 8 Measurement Mode: Hand-Held

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

b) Preparation for measurement

If the patient is relaxed and cooperative, the measure-

ment will be easier and more successful. Prior to taking

measurements, explain the purpose and method of mea-

surement 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)

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.

Figure 1


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3 When a sa tisfactory 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 therange of +/- 0.2 mm from the average value are taken. If

measurement data are largely scattered, “ERROR” is dis-

played.

When “ERROR” is displayed, the probe may not be ap-

plied properly. Touch “Retake” key for two seconds and

take the measurement again.

Figure 2


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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.

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.

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 taking-

in 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

proceed in the successive measurement.

6) Measurement will be followed in the same manner as

above. When ten measured data have been taken in, mea-

surement is finished with “beep” sound.

Figure 4

Figure 3

Figure 5


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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), manu-

ally 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.

1 Move cursor by pressing move keys to locate it on the

left side of the actual retina.

Figure 1


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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

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 theretina.

Dense Cataract:

The spike of the front of the lens and of the retina.

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.

Figure 2

Retina Select Cursor

Retina

Uprightwaveform

Sclera

A valley between Retina and Sclera


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3-29

The following items are used for checking to see if ultra-

sound can correctly catch the axial length and, therefore,

reasonable waveforms are obtainable, provided that these

items are not good conditions for taking-in of measure-

ment 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

For immersion mode, the following conditions are added

to those of Contact mode.

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.

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.

Initial Echo

Lens front surface echo

Retina echo

Lens rear surface echo

Corneal echo


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3.3.7 EDIT

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


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3-31

a) Data display and delete

The waveforms for each eye of the current patient mea-

surements can be retrieved and reviewed at any time dur-

ing the measuring process.

“Displayng a waveform”

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 bedisplayed. (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 1

Figure 2


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3-32

[Deleting individual measurements]

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.

Figure1


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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 read-

ing.

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

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

location.

Figure 1

Figure 2


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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.

4 The distance between the two points will be displayed

in real time. (Fig3)

Figure 3


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8-1

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


Crystalline lens sound velocity: 1,629m/s


Aphakic


Pseudophakic

IOL sound velocity (Pseudo1): 2,718m/s



Vitreous body sound velocity: 1,532m/s


IOL thickness (Pseudo1): 0.8mm




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IOL calculations

SRK ll equation

SRK/T equationHOLLADAY 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 Main unit

STN liquid crystal: 5.7 inch, color

Dimensions and weight: W220 × D222 × H275mm/4kg

8.1.3 Power source

Voltage: 100VAC

Frequency 50/60Hz

Consumption power: less than 35VA + 15%

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

AL 100user Manual Extract

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