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.
AL 100user Manual
Oct 24, 2014
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Transcript
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.
IMPORTANT PRECAUTIONS
DO NOT REMOVE THE OUTER COVER of the instrument. If you
do, you may be subjected to direct high voltage.
i
ii
CONSULTING OF THIS MANUALComposition 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.
iii
SYMBOLS USED IN THIS MANUALThe 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.
CONTENTSIMPORTANT 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 Connecting the option parts ................................................................................................. 3-4
a) Inserting and removing the Memory Card ........................................................................... 3-4
b) Connecting with chin rest, AL-1100 .................................................................................... 3-5
3.3 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 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
3.4 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
v
3.5 Data storage, reading and deleting ................................................................................................ 3-53
3.5.1 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
3.6 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
3.7 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 Meintenance of biometry probe ........................................................................................... 5-3
a) Cleaning ............................................................................................................................... 5-3
b) Disinfection .......................................................................................................................... 5-3
5.3.2 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 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
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
8.3 Noises .............................................................................................................................................. 8-4
vii
1-1
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 inten-
sive electromagnetic field causes noises to inter-
rupt the Instrument from functioning proper diag-
nosis 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.
1-2
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.
1-3
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 compo-
nents are present and that none of them are visibly damaged.
If any items are missing or damaged, contact your Tomey represen-
tative.
Be sure to keep the box and the packing material
for use if the instrument is moved to another lo-
cation.
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
1-4
1.3 Symbols used in this manual
The symbols used in this manual represent the following:
[ ] :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
1-5
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 ca-
pability.
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.
1-6
IOL
MEASURE
EDIT
2 COMPONENTS
2.1 Front and right side of AL-100
2-1
2-2
(1) Screen(touch panel)
Measurement data and other information are displayed on the screen. The instrument is operated bytouching 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.
2-3
2.2 Back and left side of AL-100
(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
3-1
3 SETUP
3.1 Safety precautions
ALWAYS cleans the probe tip before taking a measurement on a humaneye.
NEVER use the probe if there is any visible damage to its tip. Such use maycause an incorrect maeasurement and/or damage to the cornea.
This instrument is designed exclusively for ophthalmic use. DO NOT usethe instrument for any purpose other than ophthalmic use.
DO NOT use any cables or memory cards other than those specified in thismanual. Such use may result in damage to the instrument.
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 aproper direction.
Plug the biometry probe connector (1) into the terminal (2)labeled BIO on the front side of the instrument. When it isproperly insetrted, you will hear it click.
b) Connecting the power cord
Power cord should be plugged into the terminal with aproper direction.
Plug the power cord connector (1) into the terminal (2) onthe back of the AL-100.
BIO
BIO
3-3
c) Connecting the foot switch
Connector should be plugged into terminal with a properdirection.
1) Plug the connector (1) for the foot switch to the terminal(2) labeled FOOT SW on the back of the AL-100. Lineup the slot of the connector with the tab on the terminal.
2) To source the connector, turn the locking ring (3) untilyou hear it click into place.
d) Inserting the probe holder
The holder should be installed onto the unit with a properdirection.
Insert the protruding rectangular tabs (1) on the probeholder 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 pullit downward to lock it in place.
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 forMemory 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 whenremoved, hold the edge of the card when pressing thebutton 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 theremoval button.
“Removing the car”
Remove the memory card (1) by pressing the button (2).
DO NOT INSERT or REMOVE the memory card, whendata is loaded from or saved into the memory card.
3-5
b) Chin rest installation (AL-1100)
An optional chin rest with a fixation light is available for usewhen measuring axial length.
“Installing the chin rest”
Make sure that the slider moves.
1) From the operator’s side, carefully insert the biometryprobe into the slider until it locks into place. (Be carefulnot to damage the eye contact area of the probe.)
2) Coil the probe cord twice (as shown) and secure it withthe cord hook (2). The cord length (3) from the probe tothe hook should be approximately 20 cm to preventtension on the cord when the slider is moved forwardduring the measurement.
Figure 1 Figure 2
①�
3-6
“Connecting the fixation lamp power plug”
Insert the power plug (1) for the chinrest fixation lamp intothe terminal (2) labeled “FIX LIGHT” on the back of the AL-100.
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).
3-8
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.
3-9
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.
3-10
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
3-11
3.3.3 Measurement
Press MEASURE button to go into measurement
mode.
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
3-12
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.
3-13
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
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
3-15
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.
3-16
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
3-17
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).
3-18
[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.
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
3-19
[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.
3-20
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.
3-21
[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 biometry probe with 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 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.
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
3-22
Figure 1
Setting of the measurement mode
The Hand, chin measurement (automatic measurement) or
the manual measurement can be selected.
3-23
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 usedfor determining the precision of the instrument or forcalibration of the instrment.
Check the performance of the AL-100 by using the biometry testpiece(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 testpiece 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.
3-24
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
3-25
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 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
3-26
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
3-27
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
3-28
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
Upright waveform
Sclera
A valley between Retina and Sclera
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
3-30
3.3.7 EDIT
Press EDIT button on the front, and show EDIT window.
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 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 1
Figure 2
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
3-33
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 a
vertical dashed line. Touch the Fix key (3) to set the
location.
Figure 1
Figure 2
3-34
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
<
3-35
3.3.8 IOL Power Calculation
Press “IOL” button to show IOL calculation window.
IOL powers are shown which satisfies "Postoperative desired ref."
Various lens constants are shownthat suits for selected IOL formulaEx. A-constant (SRK-II, SRK/T, HAIGIS standard)
Caculation result can bestored.
Calculation result can be printed.
Data Communication settings
3-36
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 inter-
nal valid numbers.
When imaginary number is created, the calculation re-
sult 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.
1 To select the desired IOL formula, touch the Formula
key (1) to go to formula selection display.
Figure 1
3-37
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 AL-
100.
3 T o u c h “ E x i t ” k e y ( 3 ) t o g o b a c k t o I O L
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 auto-
matically entered. Data entry by keys will not be allowed
in this case.
(AXIAL), (ACD) DATA ENTRY
Figure 1
Figure 2
3-38
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 : 15.00 ~ 40.00mm
ACD : 0.00 ~ 9.99mm
3 Touch AXIAL or ACD key to set the entered value.
K1/K2 Corneal refractive power / Corneal radius DATA ENTRY
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 Touch K1(1) or K2(2) key to set the entered value.
Figure 2
3-39
[D-Ref] Desired postoperative refraction
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 calcu-
lation window, or stored IOL models with pre-entered con-
stant values may be selected from the IOL data list.
This instrument can calculate with two lenses for one for-
mula. 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
Figure 3
3-40
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).
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.: 2.00 ~ 10.00
SF: -5.00 ~ +10.00
a0: -9.99 ~ 9.99
a1: -0.99 ~ 0.99
a2: -0.99 ~ 0.99
Figure 2
3-41
d) Entering IOL Power
If you wish to store the IOL power of the lens you have
selected for the patient:
1 Touch the “Entry” key (1) to show IOL Entry
Window(Fig2).
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 ACD-
Const, a0, a1 and a2.
Figure 2
Figure 1
3-42
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 calcu-
lated as follows.
1 Touch P/C Val key(1) on IOL calculation(Fig 1) to
display the P/C value calculation screen(Fig 2).
2 Touch the databox (3) for each item and enter the value
using the number keys(4).
Figure 2
Figure 1
3-43
3 The selected databox will be reverse highlighted.(Fig 3)
<Axial> Axial length
<ACD> Anterier Chamber Depth
<K1 / K2>
Corneal Refractive Power / Corneal Raduis
<Post Operative Ref> Postoperative refractive power
[Acceptable range] -10.00 - +10.00D
<Implanted IOL Power>
Refractive power of implanted IOL
[Acceptable range] -50.00 - +50.00D
<Aconst>
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).
Figure 3
3-44
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).
2 Touch the Imp-IOL key (1) in the screen (Fig. 1), so
the key and the Model display will be highlighted
(Fig. 2).
3 Select the Model display (2) for the lens used, so the
Imp-IOL key will be displayed.
Figure 1
Figure 2
3-45
Adding of the calculation equations
Additional calculation equations other than the six equa-
tions already registered to this Instrument can be regis-
tered.
Memory card with IOL formulae is necessary to register
extra eqations. Contact your TOMEY Representative for
more information.
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).
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).
Figure 1
Figure 2
3-46
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.
Figure 3
3-47
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
3-48
e) EDIT Window
Average data will be printed, when touch print key with-
out specifyng data by select key(2) on EDIT Window.
f) Communication Screen after transmitting data
1 The screen(1) will be shown after transmitting data. See
[3.5.6 a)]
Figure 1
Figure 1
3-49
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)
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3-50
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
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3-51
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
3-52
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
3-53
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)
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.
Figure 1
3-54
4 Touch Save key (4) to show dialog window to select
“Internal” or “Card”.
“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.
Figure 2
3-55
b) Save Data on the IOL Calculation Window
1 Select the IOL front button to display the IOL
Calculation Window.
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 1
Figure 2
3-56
“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.
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 1
3-57
“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.
Figure 2
3-58
Figure 3 Figure 4
Figure 5
3-59
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
3)
Figure 1
Figure 2
3-60
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
reverse highlighted.
6 Touch Exit key to show sorted LOAD list.
Figure 3
Figure 4
3-61
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)
“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.
“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.
Figure 1
Figure 2
3-62
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 instruc-
tion. The memory card must be formatted before its ini-
tial use.
Once the memory card has been formatted, formerly
saved data cannot be restored. Please pay special atten-
tion 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)
3 Touch the Load key(1) in the Load window(Fig1) and
touch Card key(2).
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.
Figure 1 Figure 2
Figure 3
3-63
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 com-
pletely into the serial port.
Accessory equipment connected to the RS-232C inter-
face 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 addi-
tional 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 depart-
ment, 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 con-
nect with PC.
Insert the connector or adapter to the RS-232C connection
terminal on the back of the instrument and secure the con-
nection by tightening the screws.
1 Connect the RS-232C communication cable to the
adapter or connector and secure the connection by
tightening the screws.
3-64
“Pin positions of the RS-232C connection terminals”
Note: Pin# 4 and 6 are connected inside the instrument. So
as pin# 7 and 8.
9 pins D-sub
Pin # Signal
1 -
2 RxD
3 TxD
4 DTR
5 SG
6 DSR
7 RST
8 CTS
9 -
3-65
3 Select the Send key (2) in the Communication screen of
(Fi8g. 2) to display the Communications screen of (Fig.
3).
“EDIT screen”
1 Select the EDIT front button to
display the EDIT screen.
2 Display the date desired to be sent
in the EDIT screen of (Fig. 1) and
next select the COM key (1).
“IOL calculation screen”
1 Select the IOL front button to
display the IOL Calculation screen.
2 Display the data desired to be sent
in the IOL Calculation screen of
(Fig. 1) and select the COM key (1).
Figure 2
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.
Figure 1 Figure 1
3-66
Figure 4
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 3
3-67
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).
2 For changing the screen for data communications,
display the IOL Calculation screen or the EDIT screen
and select the COM key (2).
Figure 1
Figure 2-1 Figure 2-2
3-68
3 Select the Receive key (3) in the screen of (Fig. 3) to
display the Data Receiving screen of (Fig. 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.
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.
Figure 3
Figure 4
Figure 5
3-69
Figure 1
3.6 UTILITEIS
1 Press EDIT button to show EDIT window.
2 Touch Utility key(1) to show Utility window.(Fig 1)
3.6.1 Description of Utility Windows
3-70
3.6.2 Biometry/IOL power calculation Utilities
a) Date/Time setup
To set the date and time:
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).
3 Touc the Return key (4) to register each value.
4 Touch Exit key(5) to return to Utility screen (Fig 1).
Figure 1
3-71
b) Sound Setup
To adjust the sound:
1 Touch Sound Set key (1) on the biometry Utility screen
(Fig 1) to display the Sound Adjustment window (Fig 2)
2 Touch the Volume keys (2) to adjust the sound level.
3 Touch Exit key (3) to return to EDIT window (Fig 1).
Figure 1
Figure 2
3-72
c) Print Mode Setup
To set the printout options.
1 Touch Print Mode Key (1) to display Print Mode
screen(Fig 2).
Standard:
Standard Printing Contents
Simple:
Simple Printing Contents
2 Two Print modes can be set for Measurement (2) and
IOL (3).
3 Touch Exit key (4) to return to Utility screen(Fig 1).
Figure 1
Figure 2
3-73
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
3-74
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 bat-
tery varies as a function of the memory capacity, as indi-
cated 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 circum-
stances, where it is used.
3-75
3.7.3 Reading the Memory Card on a Windows Computer
a) Rewriting the Windows* PC system configuration file
<Windows* 95/98>
“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 dis-
played, click the button of “NO”. If the PC card wizard is
not displayed but the properties of PC (PCMCIA) is dis-
played, click the ”button:[cancel]” to proceed in the suc-
cessive 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 WIN-
DOW differs on the personal computer. Specify the direc-
tory 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.
3-76
<Windows* Me>
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.
<Windows* 2000>
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).
3-77
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.
3-78
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)
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 1
Figure 2
Figure 3
3-79
<WindowsR2000>
1) Display the control panel in the same manner as <In
case of Windows 95/98> and next double-click the
<Add and Delete Hardware>(Fig. 1), so the starting
window for “Add and Delete Hardware Wizard” will
be displayed. (Fig. 2)
2) Click the [Next] button (1), so the window for
selecting the operation related to hardware will be
displayed. (Fig. 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)
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)
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)
7) Take the Memory Card out.
8) Click the [Complete] button (10) to finish the wizard.
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6
Figure 7
3-80
4-1
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
4-2
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)
= -5.41 + 0.58412LC + 0.098K
LC: Modified axial length (mm)
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)
=(K1 + K2)/2
P: Power of IOL implant (D)
V: Vertex distance (mm) = 12
na: Refractive index of aqueous and vitreous = 1.336
nc: Refractive index of cornea = 1.333
4-3
d. Personal A-constant
A = P + AREF*RF + 2.5L + 0.9K - COR
Where:
P: Power of IOL implant (D)
AREF: Postoperative refraction <equivalent to the
spherical index (D)
= S + C/2
C: Cylindrical index (D)
S: Spherical index (D)
RF: Refractive factor
if P > 16, then RF = 1.25
if P ² 16, then RF = 1
L: 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
4-4
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)
4-5
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 <equivalent to the spherical
index (D) = S + C/2
P: Power of IOL implant (D)
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)
d. Corresponding SF
SF = 0.5663A - 65.60
Where:
A: A-constant
4-6
4.1.5 Haigis standard
a. IOL power (D)
P = 1000na
- na
L - d na - d
z 1000
Where:
z = DC + REF
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
DC = 1000 (nc - 1) 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)
V: Vertex distance (mm) = 12
P: Power of IOL implant (D)
a1: 0.4 (default value)
a2: 0.1 (default value)
4-7
c. Personal A-constant
A = d - a1*ACD - a2*L + 72.434
(ACD - 0) 0.62467
A = 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
z = DC + AREF
1 -
AREF*V 1000
DC = 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
4-8
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:
L: Axial length
V: Average ultrasound velocity
t: Time
4.2.2 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.
Axial length is calculated using the following formula:
Lp = Vacd * tacd
+ Th +
Vvit * tvit
2
2
Where:
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
Materials Ultrasound velocity in IOL
Pseudophakic 1 PMMA 2718m/s
Pseudophakic 2 Silicon 1049m/s
Pseudophakic 3 Acrylic 2200m/s
4-9
4.3 Start-up screen
Start up screen will be shown after turning on the unit.
The software version (1) is displayed to confirm.
(Figure 1)
4-10
5-1
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 (here-
inafter 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 num-
ber or batch number is removed, altered or effacted.
THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY AND ALL OTHER WARRAN-
TIES, EXPRESS OR IMPLIED (INCLUDING SPECIFICALLY, WITHOUT LIMITING
THE GENERALITY OF THE FOREGOING, ALL WARRANTIES OF MERCHANT-
ABILITY AND FITNESS FOR A PARTICULAR PURPOSE), AND ALL OTHER OBLI-
GATION AND LIABILITY ON THE PART OF THE SELLER AND TOMEY. NEITHER
THE SELLER NOR TOMEY SHALL BE LIABLE FOR INCIDENTAL, CONSEQUEN-
TIAL OR SPECIAL DAMAGES UNDER ANY CIRCUMSTANCES OR FOR MORE
THAN REPAIR, REPLACEMENT OR REFUND OF THE PURCHASE PRICE OF
DEFECTIVE GOODS.
5-2
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 Reinsert the fuse holders and turn clockwise to lock
them in place.
5-3
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 dam-
aged.
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 dam-
age 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% solu-
tion (1 to 10 dilution) of sodium hypochlorite for 10 to
20 minutes. Then rinse with distilled water and allow to
dry before use.
5-4
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 re-
move, 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.
5-5
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)
(Figure 2)
BIO
BIO
5-6
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 pe-
riod, 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 %
5-7
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 lithium-
ion battery inside the body. If you discard the in-
strument, be sure to complay with local ordi-
nances or regulations for disposal.
5-8
6-1
6 TROUBLESHOOTINGBefore self-judging a trouble as a malfunction or failure, checkthe following items. If you cannot solve your trouble or problemby the following countermeasures, consult your local representa-tive.
Do not remove the enclosure of this Instrument, or you mayotherwise be exposed with high voltage.
Do not use any measures other than specified inthis chapter.
If your problem cannot be corrected by the fol-lowing countermeasures, ask your local repre-sentative for problem investigation and repair, ifnecessary.
<Common items>
l When turning the power on, the power supply indicatordo not light.
Cause1 Power plug failure
Solution Check to see if the power plug is suffi-ciently inserted into the receptacle untilit is stopped.
Cause 2 Power receptacle failure
Solution Check to see if the receptacle is suppliedwith power.
6-2
Cause 3 The fuse is broken.
Solution Disassemble the fuse holder and check tosee if the fuses are proper or broken. Inbroken, change the fuses as per pre-scribed "5.2 Replacing of fuses. If re-placed fuses are again broken, the Instru-ment will possibly not function properly.If so, ask your local representative for in-spection and repair of this Instrument.
l Nothing is displayed in the monitor screen.
Cause1 The Auto Power Off Function (which auto-matically turns the screen off if no opera-tion is given for 15 minutes) is in operation.
Solution Touch the monitor screen.
Cause 2 The switch for maintenance provided onthe rear side is off the center position. (See2.2 7.)
Solution Turn the power off and return the posi-tion of the switch to the center. Thenturn the power on.
l The whole monitor screen is dark and hard to see.
Cause1 The brightness of the monitor screen is low.
Solution Adjust the brightness of the monitorscreen by turning the Contrast AdjustVolume.
l No printout can be made with the built-in printer.
Cause1 Printer paper.
Solution Check to see if the Printer paper is suffi-ciently left.
Check to see if the Printer paper is placedproperly in the procedures specified by"5.4 Replacing of printing paper".
l A button which is different from that pressed in thetouch panel was reacted.
Cause1 The calibration of the touch panel wasshifted.
6-3
Solution Turn the power by pressing both Mea-sure button and the MAP button at thesame time. After this condition elapses,the touch panel calibration screen will beshown.
Touch the center position of [+] in thescreen, so the point will disappear andthe next [+] will appear again. Repeatthis calibration until [+] is not displayed.After this calibration is finished, ??????screen will be displayed to make the op-eration possible. In the event the calibra-tion of the touch panel is shifted manytimes while in operation, consult your lo-cal representative.
l The time display is not working
Cause1 The loading data is being displayed.
Solution While any loading data is being dis-played, the date ìand time of its measure-ment made is displayed. The time andminutes will then be displayed after thescreen is turned off.
<Biometry function>
l No Biometry measurement can be obtained.
Cause1 The connection of the Biometry Probe isnot proper.
Solution Properly and securely connect the Probeuntil it is locked, in accordance with "3.2.1b) Connecting of Biometry Probe".
Cause 2 The conditions of taking-in by Immersionmode are not satisfied.
Solution The Immersion mode takes in data if thecorneal echo is within a range of 1.8 to3.2mm from the initial echo. Supersounds must be placed within the corneaand the Probe tip to meet said conditions.
6-4
Cause 3 Measurement is in process by directly ap-plying the Probe to the cornea while settingthe Immersion mode, without placing supersound media.
Solution In process of setting the Immersionmode, use the Immersion attachment bymeans of the procedures specified in"3.6.5 a) Using of the Biometry Probe inthe Contact Mode/Immersion Mode" orgive measurement by placing supersounds. When directly applying theProbe to the cornea, select the Contactmode.
l No auto-measurement can be taken.
Cause1 The Manual measurement has been set.
Solution Set at Auto Measurement (Chin mea-surement or Hand measurement). (See"3.6.3 e) Setting of the MeasuringMethod".)
Cause 2 Surrounding noises
Solution If there is any source generating noises(such as motor, laser-operated equip-ment, or similar) near by the Instrument,move it away from the Instrument.
Cause 3 Patient's fixation is not proper.
Solution Guide Patient's measuring eye sight byusing the fixation lamp of the Chin Rest.
Cause 4 The eye contact part of the Biometry Probeis damaged.
Solution If the Probe is damaged, promptly stopmeasurement and consult your local rep-resentative.
6-5
l No manual measurement can be give.
Cause1 The connection of the footswitch is notproper.
Solution Connect the footswitch until it is se-curely locked, in accordance with theprocedures prescribed in "3.2.1 e) Con-necting of the Footswitch".
Cause 2 Auto Measurement (Chin measurement orHand measurement) has been set.
Solution Set for Manual measurement. (See "3.6.3e) Setting of Measurement Method.")
l Measurement data are not stable or proper.
Cause1 The Probe is not connected correctly.
Solution Connect the Probe correctly until it is se-curely locked, by specified proceduresmentioned in "3.2.1 b) Connecting of theBiometry Probe".)
Cause 2 The cornea is applied with an undue pres-sure.
Solution In case of the Chin Rest, give a sufficientlength from the Probe to the cord hook sothat the Probe cord does not pull theslider of the Chin Rest. (See "3.6.6 b)Handling of the Slider when using theChin Rest for Measurement".)
Cause 3 The position of setting the retinal waveformselecting cursor is not proper.
Solution Set the retinal waveform selecting cursorat immediately right side of actual retinalecho, in such a manner that any unneces-sary echo may not be placed between thecursor and the retinal echo.
Cause 4 The Biometry Probe is not applied prop-erly.
Solution Apply the Probe to the center of the cor-nea at a right angel so the retinal echocan quickly rise up.
6-6
Cause 5 An excessive amount of the cornea protec-tive gel makes a gap between the Probe andthe cornea, possibly resulting in longermeasured data.
Solution Always give the appropriate amount ofgel.
The Immersion Attachment is being usedwhile setting the Contact Mode. A largeamount of super sounds are used.
Solution Measured data are as much longer as thethickness of super sounds used. Properlygive the settings of the Immersion Modeand the Contact Mode and take measure-ments in the procedures prescribed in"3.6.5 a) Handling of the Biometry Probein the Contact Mode and the ImmersionMode."
Cause 7 Measurement is given by directly applyingthe Probe to the cornea, without using supersounds in the Immersion Mode.
Solution In process of setting the Immersionmode, use the Immersion attachment bymeans of the procedures specified in"3.6.5 a) Using of the Biometry Probe inthe Contact Mode/Immersion Mode" orgive measurement by placing supersounds. When directly applying theProbe to the cornea, select the Contactmode.
Cause 8 The setting of converted sound velocity isnot proper.
Solution Check to see if the setting of convertedsound velocity is proper. Convertedsound velocity can be set for left andright respectively. Make sure that thesound velocities for both left and righthave been set properly.
(See "3.6.3 b) Settings of eyes to bemeasured and converted sound veloci-ties.)
6-7
Cause 9 The eye contact part of the Probe is dam-aged.
Solution If the eye contact part of the Probe isfound damaged, stop measurement im-mediately and consult your local repre-sentative.
l The monitor sounds for Biometry does not stop, ormeasurement values are taken at the time when mea-surement is not being taken.
Cause1 The tip of the Biometry Probe is wettedwith water.
Solution Remove the water from the tip of theProbe.
l The Biometry monitor sounds are not made.
Cause1 The sound volume setting is off.
Solution Turn the sound volume ON by using theprocedures prescribed in "3.11.6 c) Set-ting of souns".
l The waveforms are mixed with noises.
Cause1 The connection of the Biometry Probe isnot proper.
Solution Connect the Probe until the connection islocked, in accordance with the proce-dures prescribed in "3.2.1 b) Connectingof the Biometry Probe."
Cause 2 The grounding is not connected.
Solution Make sure that the grounding of thepower plug is connected.
Cause 3 Surrounding noises.
Solution Where the noise generating sources(such as motor, laser surgery equipment,etc.) are placed close to the Instrument,
6-8
l "Probe Error!" is displayed when turning the power on.
Cause1 The connection of the Biometry Probe isnot proper.
Solution Connect the Probe until it is securelylocked, in accordance with the proce-dures prescribed in "3.2.1 b) Connectingof the Biometry Probe".
<Data saving>
l Data cannot be saved in the internal memory.
Cause1 An ID number has not been inputted fordata to be saved.
Solution Since ID number is saved as the name ofthe file, first input an ID number for datato be saved before proceeding in its sav-ing operation.
Cause 2 The memory does not have a sufficientspace.
Solution Delete unnecessary data from thememory before carrying out the opera-tion of saving. Up to six pieces of datacan be saved.
l Data cannot be saved in the Memory Card.
Cause1 The Memory Card is not inserted in itsproper position.
Solution Insert the Memory Card properly, in ac-cordance with the procedures prescribedin 3.2.2 Connecting of Option Parts, b)Inserting and removing of the MemoryCard.
Cause 2 The ID number is not inputted.
Solution Since the Echo Data type and the Biom-etry data are saved with their ID numbersas files, first input the ID numbers beforesaving related information.
6-9
Cause 3 The names of files have not been inputted.
Solution In case of JPEG Data type, the file namemust be inputted. Input the file name be-fore saving.
Cause 4 The Memory Card is protected from light.
Solution Release the light-protection, by the pro-cedures specified in the HandlingManual for Memory Card.
Cause 5 The Memory Card has no sufficient space.("Memory Full!!" is displayed.)
Solution Replace the Memory Card in troublewith the new Memory Card, or delete un-necessary data before saving. Deletingof data must be done with this Instru-ment.
The Memory Card has not been formatted.
Solution Data cannot be saved in the MemoryCard, unless it has not been formatted.Use the formatting memory card func-tion provided for this Instrument, beforesaving data in the Memory Card.
Cause 7 The format is not proper.
Solution Three different formatting types are usedfor this Instrument ( B-mode image diag-nosis, Echo, JPEG, and Biometry func-tion), of which data to be saved are speci-fied. Formatting is to be given with theutility of which function corresponds tothe data to be saved.
l Data saved in the Memory Card disappear.
Cause1 The battery is not in position.
Solution Install the battery in position, by refer-ring to the Handling Instructions forMemory Card.
6-10
Cause 2 The battery is old. ("Low Battery" is dis-played.)
Solution Replace the battery with the new part, inaccordance with the Handling Instruc-tions for the Memory Card.
l The data saved in the Memory Card cannot be loadedinto the personal computer.
Cause1 The Memory Card is not installed in posi-tion.
Solution Correctly insert the Memory Card intothe personal computer, by referring tothe Handling Manual for Personal Com-puter.
Cause 2 The contents in the Config. Sys are wrong,or the device driver has not been added.
Solution Correct the contents in the Cong.sys inthe procedures prescribed in "3.7.3Loading the data saved in the MemoryCard into the Windows personal com-puter, a) Rewriting of Config. Sys file ofWindows personal computer providedwith the PC card slot.
Cause 3 No device driver of the Memory Card ex-ists.
Solution If the personal computer provided withthe Memory Card slot is installed withthe Windows, "CSMAPPER. SYS" asthe driver for Memory Card and"CARDDRV. EXE" have automaticallybeen saved in the directory in which thesystem file exists. If such file has beendeleted for some reasons, the Windowsmust be reinstalled. It is noted that suffi-cient knowledge is required for reinstall-ing the Windows and that the environ-ments for such personal computer maylargely be changed. No unskilled personis permitted to give to reinstall the Win-dows.
7-1
7 SPARE PARTS AND OPTION PARTS
The following spare parts and option parts are available fromyour local representative or distributor of Tomey Corporation.
7.1 Option partsMemory Cards (512Kbyte, 1Mbyte, 2Mbyte, 4Mbyte)Specify a “Memory Card for AL-100”.
Chin Rest AL-1100Specify a “Chin Rest for AL-1100”.
7-2
7.2 Spare partsPrinter paper roll for built-in PrinterSpecify a “Printer Paper Roll for Built-in Printer forAL-100”.
Super sound diagnosis gelSpecify “Super Sound Diagnosis Gel”.
Immersion attachmentSpecify “Immersion Attachment for AL-100”.
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
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
8-2
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 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.
8-3
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 applicationsonly, do not use it for any purposes other than for its designed purpose.
This Instrument is designed as the super sound diagnosisequipment specialized for ophthalmic applications.
This Instrument has, therefore, been set with a very weaksuper sound energy. It is suggested that the Operator ofthis Instrument should limit the time of diagnosis and mea-surement to a minimum extent, in consideration of the gen-eral precautions on super sound diagnosis and measure-ment 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
8-4
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 measureddata).
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
ID: 0208
0123
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