use. If you have any questions or comments on the operation of this Instrument, please contact your local representative. Do not use procedures other than specified in this Operator Manual. Place this Operator Manual in a place of access to the Operator while in operation. If you lose this Operator Manual, ask your local representative for a new copy.
IMPORTANT PRECAUTIONS
DO NOT REMOVE THE OUTER COVER of the instrument. If you do, you may be subjected to direct high voltage.
1.PRIOR TO USE Explains precautions and confirmations prior to installing and operating this instrument. 2.NAMES AND FUNCTIONS OF THE COMPONENTS Explains the names and functions of the components of this instrument 3.OPERATING PROCEDURES Explains significant information necessary for installing and operating of this instrument. 4.TECHNICAL REFERENCE Provides the technical information of this instrument 5.MAINTENANCE AND INSPECTION Explains your routine inspection and maintenance and replacing of spare parts. 6.TROUBLESHOOTING Explains the spare parts and option parts of this instrument 7.SPARE PARTS AND OPTIONAL PARTS Explains the spare parts and option parts of this instrument. 8.SPECIFICATIONS Explains the specifications for this instrument. 9.INDEX Refer to the index as a guide, if necessary.
ii
This is a precaution that, if unheeded, will result in a hazardous situation where there is an imminent danger of serious injury or death.
This is a precaution that, if unheeded, may cause a hazardous situation where there is the possibility of serious injury or death.
This is a precaution that, if unheeded, may cause minor or moderate injury or property damage.
This is a special precaution that is related, either directly or indirectly, to personal safety or to protection of property.
iii
CONTENTS
IMPORTANT PRECAUTIONS ......................................................................................................................i CONSULTING OF THIS MANUAL ............................................................................................................ ii SYMBOLS USED IN THIS MANUAL ....................................................................................................... iii CONTENTS ..................................................................................................................................................iv 1 PRIOR TO USE ............................................................................................................................................ 1-1 1.1 1.2 1.3 1.4 Precautions for use........................................................................................................................... 1-1 Unpacking and receiving inspection ............................................................................................... 1-3 Explanation of symbols ................................................................................................................... 1-4 Outline of operation ......................................................................................................................... 1-5
2 NAMES AND FUNCTIONS OF THE COMPONENTS ............................................................................. 2-1 2.1 2.2 Front and right side of AL-100 ........................................................................................................ 2-1 Back and left side of AL-100 ........................................................................................................... 2-3
3 OPERATION PROCEDURES ..................................................................................................................... 3-1 3.1 3.2 Safety precautions ............................................................................................................................ 3-1 Preparation before use ..................................................................................................................... 3-2 3.2.1 a) b) c) d) 3.2.2 a) b) 3.3 Connecting the accessaries .................................................................................................. 3-2 Connecting the probe ........................................................................................................... 3-2 Connecting the power cord .................................................................................................. 3-2 Connecting the foot switch .................................................................................................. 3-3 Installatin of the probe holder .............................................................................................. 3-3 Connecting the option parts ................................................................................................. 3-4 Inserting and removing the Memory Card ........................................................................... 3-4 Connecting with chin rest, AL-1100 .................................................................................... 3-5
Measurement procedures ................................................................................................................. 3-7 3.3.1 a) b) 3.3.2 3.3.3 a) Adjustings and settings ........................................................................................................ 3-7 Turning power switch and adjusting .................................................................................... 3-7 Start-up screen ..................................................................................................................... 3-8 Front button ....................................................................................................................... 3-10 Measurement screen .......................................................................................................... 3-11 Waiting screen and measurement screen ........................................................................... 3-11
iv
Settings and registration in the measurement screen ......................................................... 3-12 Setting of the eye to be measured ...................................................................................... 3-12 Clear screen ....................................................................................................................... 3-13 ID number / Patients name / sex / Physicians name ........................................................ 3-13 Registration of Physicians ................................................................................................. 3-15 Setting items for measurement ........................................................................................... 3-16 Measurement ...................................................................................................................... 3-23 Cheking of the performances ............................................................................................. 3-23 Preparation of measurement .............................................................................................. 3-23 Measurement ...................................................................................................................... 3-24 Retake ................................................................................................................................ 3-27 Selecting of retinal waveform ............................................................................................ 3-27 Good waveform ................................................................................................................. 3-28 Contact mode ..................................................................................................................... 3-28 Immersin mode .................................................................................................................. 3-29 Data EDIT screen ............................................................................................................... 3-30 Display and delete measured data ...................................................................................... 3-31 Caliper Setting ................................................................................................................... 3-33 IOL caliculation screen ...................................................................................................... 3-35 Calculation ......................................................................................................................... 3-36 Calculation conditions ....................................................................................................... 3-36 Equation select ................................................................................................................... 3-36 Calculation data input ........................................................................................................ 3-37 Lens constant ..................................................................................................................... 3-39 IOL data registration .......................................................................................................... 3-41 P/C Value (Personal / Corresponding Value) .................................................................... 3-42 Assistant function .............................................................................................................. 3-44
Printout .......................................................................................................................................... 3-47 3.4.1 3.4.2 a) b) c) d) Printout procedure ............................................................................................................. 3-47 Printout result ..................................................................................................................... 3-49 Biometr data printout ......................................................................................................... 3-49 IOL power calculation printout (e.g. SPK/T) ..................................................................... 3-50 P/C Value (Personal / Corresponding Value) Printout result ............................................ 3-51 Data transmission printout result ....................................................................................... 3-52
3.5
Data storage, reading and deleting ................................................................................................ 3-53 3.5.1 a) b) 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6 a) b) c) Storage ............................................................................................................................... 3-53 Store data on EDIT screen ................................................................................................. 3-53 Store data on IOL calculation screen ................................................................................. 3-55 Reading .............................................................................................................................. 3-56 Sorting ................................................................................................................................ 3-59 Deleting .............................................................................................................................. 3-61 Momery card format .......................................................................................................... 3-62 Sending and receiving data ................................................................................................ 3-63 PC communication ............................................................................................................. 3-63 Sending data ....................................................................................................................... 3-65 Receiving data ................................................................................................................... 3-67
3.6
Utilities .......................................................................................................................................... 3-69 3.6.1 3.6.2 a) b) c) Contents of Utilities ........................................................................................................... 3-69 Biometry function/IOL power calculation ssetting ............................................................ 3-70 Date and time ..................................................................................................................... 3-70 Sound volume .................................................................................................................... 3-71 Print mode .......................................................................................................................... 3-72
3.7
Memory card .................................................................................................................................. 3-73 3.7.1 3.7.2 a) b) c) 3.7.3 3.7.4 Optional memory specifications ........................................................................................ 3-73 Replacement of the battery inside memory card ................................................................ 3-74 No Battery! Warning ...................................................................................................... 3-74 Low Battery! Warning .................................................................................................... 3-74 Battery of the memory card is dying .................................................................................. 3-74 Load the stored data with PC through memory card........................................................................... 3-75 Ejecting memory card from PC ......................................................................................... 3-78
4 TECHNICAL REFERENCE ........................................................................................................................ 4-1 4.1 4.2 4.3 IOL power calculation ..................................................................................................................... 4-1 Axial length calculation with Biometry function ............................................................................ 4-8 Version information ......................................................................................................................... 4-9
5 SERVICE AND MEINTENANCE ............................................................................................................... 5-1 5.1 5.2 Warranty .......................................................................................................................................... 5-1 Fuse .................................................................................................................................................. 5-2
vi
5.3
Routine meintenance ....................................................................................................................... 5-3 5.3.1 a) b) 5.3.2 Meintenance of biometry probe ........................................................................................... 5-3 Cleaning ............................................................................................................................... 5-3 Disinfection .......................................................................................................................... 5-3 Meintenance of the main unit .............................................................................................. 5-4
Printer paper replacement ................................................................................................................ 5-5 Storing the instrument ..................................................................................................................... 5-6 Packing materials ............................................................................................................................. 5-7
6 TROUBLESHOOTING ................................................................................................................................ 6-1 7 SPARE PARTS AND OPTIONAL PARTS ................................................................................................... 7-1 7.1 7.2 Optional parts .................................................................................................................................. 7-1 Spare parts ....................................................................................................................................... 7-2
8 SPECIFICATIONS ....................................................................................................................................... 8-1 8.1 Specifications .................................................................................................................................. 8-1 8.1.1 8.1.2 8.1.3 8.2 Biometry function/IOL power calculation function ............................................................. 8-1 Main unit .............................................................................................................................. 8-2 Power supply ........................................................................................................................ 8-2
Energy and other consumptions ....................................................................................................... 8-3 8.2.1 8.2.2 Influences of ultrasound energy to human body .................................................................. 8-3 Ultrasound energy ................................................................................................................ 8-3
8.3
vii
1 PRIOR TO USE
1.1 Precautions for use
Make sure that this Instrument must be installed in a place without any intensive electromagnetic wave or the wave generating devices. An intensive electromagnetic field causes noises to interrupt the Instrument from functioning proper diagnosis and measurement. Nothing must be put on this unit. Read this Operator manual carefully before using the instrument in order to operate it properly and safely. Do not use any procedures that are not specified in the manual.
Only well-trained personnel should operate this instrument. When installing this instrument, observe the following: - Do not install the instrument in a place where it might be exposed to moisture or chemicals. - Do not install the instrument in a place where it is subject to adverse condition, such as direct sunlight, high temparature, excessive humidity, dust, sulfur or salt. - Ascertain that any adverse factors such as excessive slope, vibration and impact will not endanger the instrument (including during transportation). - Do not install the instrument in or near the storage area of chemical substances or where any gas may be generated. - Follow frequency, voltage and allowable current (or allowable power consumption) specifications. - Be cautious of electrical power condition such as discharge, polarity, etc. - Ascertain that the power source is properly grounded.
1-1
Before using this instrument, observe the following: - Ascertain that all cables and cords are properly connected. - Carefully inspect the probe tip before using. - Ascertain that the power source is properly grounded. - When using this instrument with other unit, be careful not to cause any inaccurate diagnosis or danger. - Double-check the probe tip before using. While using this instrument, observe the following: - Always make sure that the patient is comfortable. - Always make sure that both instrument and patient are under normal condition. - If any complication or abnormality is encountered, either with the patient or instrument, ensure the safety of the patient by discontinuing testing. - Make sure that patient has no contact with the instrument (other than the probe) during testing. After using this instrument, observe the following: - Make sure that the unit is the same condition as initial, before turnning off the unit. - When disconnecting the power cord, hold the plug, not the cord, and do not use excessive force. - Be sure to clean the probe and other accessaries after each use. - If you do not plan to use the instrument for a considerable period of time, refer to Section 5.5 for storage instructions. - Be sure to clean the instrument to prepare for next use.
1-2
In case of a malfunction, do not attempt to repair the instrument yourself. Place a sign on the instrument indicating that it is malfunctioning and contact your Tomey representative. Do not technically modify this instrument. Please be informed that the instrument should be inspected reguraly. When using the instrument, which has not been used for a certain period of time, make sure that the instrument works normally and safely, before using.
1.2
Unpacking
When unpacking the instrument, make sure that all of the components are present and that none of them are visibly damaged. If any items are missing or damaged, contact your Tomey representative. Be sure to keep the box and the packing material for use if the instrument is moved to another location.
AL-100 Main Unit ........................................................... 1 3 pin plug power cord ..................................................... 1 Biometry Test Piece ........................................................ 1 Paper for Built-in Printer ................................................. 1 Dust cover ....................................................................... 1 Fuses ................................................................................ 2 Operator Manual(This book) .......................................... 1 Foot Switch ..................................................................... 1
1-3
1.3
:Contrast Volume :PC card slot :Main Switch ON :Main Switch OFF :RS-232C port :Meintenace port and Switch (Manufacturers use) :Fuses :Biometry probe connector :Fixation Light connector with AL-1100 (Chin rest)
[MEMORY CARD] [ [ [ [ [ ] ] ] ] ]
[FOOT SWITCH]
1-4
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
The axial length measurement are acquired automatically and do not depend on the operators experience and capability. IOL power calculation can be performed immediately after measuring the axial length. Six atandard IOL formulae are provided. The instrument can store axial length and implanted IOL data, on the basis of which personal lens constants may be determined.
1-5
1-6
2 COMPONENTS
2.1 Front and right side of AL-100
MEA
SUR
E IOL EDIT
2-1
(9) Printer
Prints measured data and calculated results.
2-2
2.2
2-3
2-4
3 SETUP
3.1 Safety precautions
ALWAYS cleans the probe tip before taking a measurement on a human eye. NEVER use the probe if there is any visible damage to its tip. Such use may cause an incorrect maeasurement and/or damage to the cornea.
This instrument is designed exclusively for ophthalmic use. DO NOT use the instrument for any purpose other than ophthalmic use. DO NOT use any cables or memory cards other than those specified in this manual. Such use may result in damage to the instrument.
3-1
3.2
3.2.1
BIO
Connector should be plugged into the terminal with a proper direction. Plug the biometry probe connector (1) into the terminal (2) labeled BIO on the front side of the instrument. When it is properly insetrted, you will hear it click.
Power cord should be plugged into the terminal with a proper direction. Plug the power cord connector (1) into the terminal (2) on the back of the AL-100.
3-2
The holder should be installed onto the unit with a proper direction. Insert the protruding rectangular tabs (1) on the probe holder into the holes (2) on the right ide of the instrument. DO NOT insert the holder upside down. Push inward on the center of the probe holder (3) and pull it downward to lock it in place.
3-3
3.2.2
Connection of the optional parts a) Inserting and removing the memory card
Before using memory card for the first time, set the battery in accordance with the instruction Manual for Memory Card (located in the box that contains the catd). Follow the instructions for BN-HSR series. Since the memory card pops quickly out of the slot when removed, hold the edge of the card when pressing the button for card removal.
Hold the front of the memory card (1) toward you and insert it into the slot (2) until the card is aligned with the removal button.
DO NOT INSERT or REMOVE the memory card, when data is loaded from or saved into the memory card.
3-4
3-5
3-6
3.3
3.3.1
Biometry
Biometry Mode Setup a) Turning the power on and initial adjustments ALWAYS clean the probe tip before taking a measurement on a human eye. NEVER use the probe if there is any visible damage to its tip. Such use may cause an incorrect measurement and/or damage to the cornea. As with any ultrasound instrument, it is recommended that we exposure be kept as low as reasonably achievable. (ALARA)
Before turning on the power *Make sure that the power plug is properly connected to the receptacle. *Make sure that the biometry probe is properly connected. *If the power turns off, wait for over one mimute to turn it on again.
1)
Turning on the power switch (1) at the upper left side of the instrument initiates self-checking of the probe. If the biometry probe is not detected (i.e., no probe or wrong probe connected), the message Probe error! will be presented.
2)
Adjust the contrast of the screen with the contrast adjuster (2).
3-7
3)
Tilt the screen forward by pulling out the legs (3) on the bottom of the instrument, if desired.
b) Start up screen
1)
2)
The catalog screen (Ready to measure screen) is shown, when the calibration is completed without any problem.
3-8
3)
When Probe error! is shown on the area (1), OK key will be shown on the area (2). Press OK to go to the catalog screen. The measurement cannot be done even on the catalog screen, if Probe error! is displayed. See Troubleshooting if Probe error! shows many times. Contact your TOMEY Representative, if the problem remains.
3-9
3.3.2
The catalog screen (Ready to measure) screen is shown, when pushing this button. The settings with Index data input, selecting the eye to be measured, Contact/Immersion and selection of Measurement methods are also done with this button.
MEASURE
IOL
EDIT
2) IOL
MEASURE Button IOL Button EDIT Button
BIO METER
The IOL calculation screen appears, when pushing this button. IOL power calculation, Personal Correspondence value, IOL registration can be done with this function. The results can be printed out with the built-in printer.
AL-100
3) EDIT
The EDIT screen appears, when pushing this button. Waveform, measured data, Caliper, Utility, Data Save/ Load and print out can be done with this function.
3-10
3.3.3
Measurement
a-1
Widow will be switched from Data review to measurement automatically, when it is taking data.
a-2
Measurement Window
3-11
Figure 1
1) The right eye (OD) or the left eye (OS) is selected alternately each time the Eye key is touched.
3-12
b) New Patient
Press the button (1) to measure new patient.
Figure 1
1) 2) Press (1) button (Figure 1) until you hear beep sound. New screen is ready to take new patient data.
Former ID / Patients name, sex / Physicians 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
3-13
Figure2
1)
Touch the Index key (1) on the measurement window (Fig.1 )to display the Name/ID entry window. (fig.2) Touch the number keys and the alphabetic character keys (2) to enter the patient name, ID number and physicians name. If the physicians 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.
2)
3)
To switch between letters and numbers, use the switchover key (3). In the event of an erroneous entry, touch the Delete key.
4)
Male/Female will be selected with pressing icon buttons on the key board.
5)
To set the entered value and advance to the next entry, touch the Return key (5). The cursor location indicates the category of the next entry.
6)
3-14
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) 4) 5) Type the name with the alphabetic character keys. Touch the Enter key again to save change. Touch the Phy. List to put the name as the physician.
3-15
(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.). In case of changing the sound velocity, select the sound velocity setting key to display the number keys (5) (as highlighted). In (Fig. 3)
Select the key, then change the entry item and set the sound velocity.. (As for the entry range, see the next
3-16
page.) (Figure 3)
When (3) is again selected, the highlighted display is released and the screen is returned to that in (Fig. 2).
If the EXIT key (4) is selected, the screen will be returned to that shown in (Fig. 1).
3-17
3-18
[ACD] and [LENS] are not displayed with Aphakic, and [LENS] is not displayed with Pseudophakic.
Posterier lens waveform might not be recognized, due to multiple echo with Dense Cataract mode.
Measured data is displayed. Measured data may not be displayed. Measured data is not displayed.
Figure 1
1 Touch (1) keys to adjust the gain with the window (Fig. 1). 2 New value is displayed on main window.
3-19
Figure 1
1 Select Contact with contact mode and Immersion with immersion mode. Selected key should be highlighted.
3-20
Figure 1
Figure 2
Select the key, (1) key or (2) key, depending on the measurement method. The selected key is displayed as reverse highlighted.
The converted velocity directly affects the measurement. Ascertain that you have set the desired converted velocity. In immersion mode, the ultrasound gel must intervene between the eye contact area of the biometer probe and the cornea so that distance between the probe and the cornea is approximately 1.8 to 3.2 mm. Figure 3 Excessive ultrasound gel may affect the accuracy of the measurement. Auto measurement (Hand mode) assists the examiner to take measurement, and the function itself does not diagnose the data. Measurement accuracy might be over 0.1mm, due to the measurement condition or the difference among patients.
Figure 4
3-21
Figure 1
3-22
3.3.5
Actual measurement
Select the following settings: Eye type/converted velocity: Aphakic/1,532 m/s Gain: Measurement Mode: 8 Hand-Held
Apply a drop of water to the upper and to the lower test piece surfaces. Apply the biometer perpendicular to the upper surface.
3-23
c) Measurement methods
There are two automatic modes, hand-held and chin rest, and one manual mode. Hand (Hand-held)
Figure 1
1 Touch New key(1) to measure new patients eye. Apply biometery probe perpendicular to the cornea. 2 The measurement window will be automatically shown, when certain waveform conditions are satisfied.
3-24
Figure 2
3 When a satisfactory measurement is taken, the instrument makes a beep sound. The instrument aquires the data automatically, when the data becomes stable. The instrument makes a beep sound, when a data is aquired. 5 The instrument shows the waveform, average axial length and maximum(as L) / minimum(as S) measurement data. 6 When data acquisition is complete, a higher-pitched beep sounds and the waveform for the measurement closest to the average value is displayed.
Using the hand-held method, up to 15 measurements in the range of +/- 0.2 mm from the average value are taken. If measurement data are largely scattered, ERROR is displayed. When ERROR is displayed, the probe may not be applied properly. Touch Retake key for two seconds and take the measurement again.
3-25
Figure 4
Manual
1) When taking measurement from a new Patient in the screen shown in Fig. 1, select the New key (1) and apply the Probe to the cornea at a right angle. 2) When the Instrument has been fulfilled with waveform conditions to a certain extent, the screen is changed to that for measurement. 3) When the Instrument has been fulfilled with the takingin conditions, a monitor sound of pee is given. 4) For manual measurement, data taking is given by using the footswitch in (Fig. 5) 5) If the footswitch is again pressed, the operation will Figure 5 proceed in the successive measurement. 6) Measurement will be followed in the same manner as
3-26
above. When ten measured data have been taken in, measurement is finished with beep sound.
Figure 1
1 Move cursor by pressing move keys to locate it on the left side of the actual retina.
3-27
Figure 2
3.3.6
and acquired only if the following criteria are met: 1. The following crests rise above the level cursor: Normal: The spikes of the back and front of the lens and of the retina. Dense Cataract: The spike of the front of the lens and of the retina.
Upright waveform
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.
3-28
The following items are used for checking to see if ultrasound can correctly catch the axial length and, therefore, reasonable waveforms are obtainable, provided that these items are not good conditions for taking-in of measurement data.
i The retinal echoes rise high.: implies that the probe is applied perpendicular to the cornea. ii The echo rises high in the front and at the rear of the crystalline lens: implies that the axial length was caught with the probe. iii The retinal and sclera echoes are distinctive.: implies that the probe is applied at a right angle. In canse of high gain, the drop (choroid) between two echoes cannot be identified, which is not always necessary to be detected. iv No tail waves followed after corneal echos.: implies that the probe directly touches the cornea. If there is any tear or corneal protective gel left between the cornea and the probe, the corneal echoes are followed by tail waves. If so, the measurement of axial length may not be stable or may be longer than its actual length.
b) Immersion mode
Initial Echo Lens front surface echo
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.
Retina echo Corneal echo Lens rear surface echo
3-29
3.3.7 EDIT
3-30
Figure 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 3
Press Select key (2) to select the data. Press Echo key (3) to show Echo data (Fig2).
When pressing Echo without selecting any data, the data closest tothe average will be displayed. Average data will also be displayed as Ave. AXIAL.
Figure 2
3-31
Figure1
1 Touch the up and down arrow keys (2) to move to the measurement you wish to delete. 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.
3-32
b) Caliper Function
The distance between two points can be measured on the waveform. A reading displayed in the caliper mode is an appoximation and may be different from the actual reading.
Figure 1
1 After measurement, touch the Caliper key (1) to switch to Echo window. (Fig2)
Figure 2
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.
3-33
Touch the right or left arrow key again to set the second measurement location, which will be indicated by a second vertical dashed line.
<
Figure 3
The distance between the two points will be displayed in real time. (Fig3)
3-34
Various lens constants are shown that suits for selected IOL formula Ex. A-constant (SRK-II, SRK/T, HAIGIS standard)
3-35
3.3.9 Calculation
The calculation result with the UD-6000 might be differ from that with the AL-100, due to the difference of internal valid numbers. When imaginary number is created, the calculation result will be displayed as an ERROR.
Figure 1
1 To select the desired IOL formula, touch the Formula key (1) to go to formula selection display.
3-36
Figure 2
Select the formula by touching the number on the left side of desired formula. Selected formula is shown as highlighted. Only one formula can be selected with AL100.
Figure 1
3-37
Prepare to enter axial length or ACD by touching the Axial key (2) or ACD key (1). The databox will be reverse highlighted.IOL
Touch the number keys (3) to enter the axial length value.(ACD key is shown only when it is used by a formula) [Acceptable range] AXIAL ACD : 15.00 ~ 40.00mm : 0.00 ~ 9.99mm
Figure 2
1 Prepare to enter the K values by touching K1(1) or K2(2) key. The databox will be reverse highlighted. 2 Touch the number keys(3) to enter the first K value. [Acceptable Range] K1/K2 Corneal Refractive Power: 30.00~60.00D Corneal Radius: 5.00~11.00mm 3 Touch K1(1) or K2(2) key to set the entered value.
3-38
Figure 3
Prepare to enter the desired postoperative refraction by touching the D-Ref key(1). The databox will be reverse highlighted.
Touch the number keys (2) to enter the data. The acceptable range is -10.00 - + 10.00 D. Complete the data entry by touching D-Ref key(1).
Figure 1
3-39
Select the Lens Constant key (1) in the screen of (Fig. 1), so the key will be highlighted to display the screen of (Fig. 2).
Figure 2
2 Enter the lens constant with the Number Enter key (2) in the screen (Fig. 2). If the IOL registration has been made, enter the data from the lens data (3) displayed in the screen (Fig. 2). Move the cursor with the up / down keys (4) and enter the data with the Sel key (5). In order to display the data (such as ACD const, SF, a0, a1, a2, etc.), which are not displayed in the screen (3), select the Page Change key (6).
3-40
Figure 1
1 Touch the Entry key (1) to show IOL Entry Window(Fig2).
Figure 2
2 Touch up and down cursor(4) to select the position to enter data. Enter Company name(Company), Model No(Model No), A constant (Aconst) and Lens constants (Aconst, SF, ACD-Const, a0, a1 and a2). Press Return key to move entry index. 4 Use right arrow key to show extra page with ACDConst, a0, a1 and a2.
3-41
Figure 1
1 Touch P/C Val key(1) on IOL calculation(Fig 1) to display the P/C value calculation screen(Fig 2).
Figure 2
2 Touch the databox (3) for each item and enter the value using the number keys(4).
3-42
Figure 3
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).
3-43
Press the IOL front button provided in the front of the Main Unit to display the IOL Calculation screen (Fig. 1).
Figure 1
Touch the Imp-IOL key (1) in the screen (Fig. 1), so the key and the Model display will be highlighted (Fig. 2).
Figure 2
3
Select the Model display (2) for the lens used, so the Imp-IOL key will be displayed.
3-44
Press the IOL front button to display the IOL Calculation screen of (Fig. 1).
Figure 1
Select the Equation Select key (1) in the screen (Fig. 1) to display the Equation Select screen of (Fig. 2).
Figure 2
Touch the Load key (2) in the screen of (Fig. 2) to display the screen of ( Fig. 3).
3-45
Figure 3
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).
Select the Exit key (4), if returning of the screen for selecting equations is desired.
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3.4 Printing
3.4.1 Initiating Printing
After biometry measurement, IOL calculation or pachymetry measurement, touch the Print key(1) to initiate printing.
b) Echo Window
3-47
e) EDIT Window
Average data will be printed, when touch print key without specifyng data by select key(2) on EDIT Window.
Figure 1
Figure 1
3-48
(1) Time/Date (2) Patient ID number (3) Patient name (4) Physicianfs name (5) Patienfs sex (6) Eye (Right/Left) (7) Measurement mode (8) Eye type (9) Contact / Immersion (10) Average axial length velocity (11) Lens velocity (12) ACD velocity (13) Gain (14) Average axial length (15) Standard deviation of axial length data (16) Difference between minimum and maximum axial length (17) Memory number (18) Measurement data (axial length/ACD/lens thickness) (19) Mean measurement data values (20) Memory number of the displayed waveform
(21) Waveform (22) Selection cursor for retina waveform (23) Scale (2 mm/div)
3-49
(1) Time/Date (2) Patient ID number (3) Patient name (4) Physicians name (5) Patients sex (6) Eye (Right/Left) (7) Axial length (8) ACD (9) Corneal refractive power or Corneal Radius (10) Desired postoperative refraction (11) IOL calculation formula (12) Lens A/Lens B (13) Lens constants (14) Power calculation results (15) IOL model name (16) Nine IOL power levels and the predicted postoperative refraction for each lens model
3-50
(1) Time/Date (2) Patient ID number (3) Patient name (4) Physicians name (5) Patients 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
3-51
(1) Time/Date (2) Patient ID number (3) Patient name (4) Physicians name (5) Patients sex (6) Eye (Right/Left) (7) Eye type (8) Average axial length velocity (9) Lens velocity (10) ACD velocity (11) Average axial length (12) ACD (13) Lens thickness (14) Keratometry values (15) Desired postoperative refraction (16) IOL calculation formula (17) IOL manufacturer name (18) IOL model name (19) Lens constants (20) Implanted IOL power (21) Predicted postoperative refraction
3-52
3.5
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.
Press EDIT button in front of the instrument to show EDIT window. (Fig 1)
Figure 1
Select the Cursor Move key (1), to move the cursor up and down.
Select the Select key (2) by cursor, so the key will be highlighted to display the marker (3) for selected data.
In case not selecting the Select key (2), the average value of measured data is saved.
3-53
Touch Save key (4) to show dialog window to select Internal or Card.
Figure 2
Save data on internal memory Touch Internal key (4) The saving will be completed, when you hear short beep and the display return to the EDIT window. Less than 6 data can be stored with the internal memory. (The number, which can be stored onto the internal memory varies, depending on the size of the data) Save data on Memory card Touch Card key (5) The saving will be completed, when you hear short beep and the display return to the EDIT window. Memory card must be formatted before its initial use. To cancel data saving Touch Cancel key (6) to make short beep and return to EDIT window.
3-54
Select the IOL front button to display the IOL Calculation Window.
Figure 1
2
Select the Save key (1) in the screen of (Fig. 1), to display the screen of (Fig. 2). Then, select Internal or Card
Figure 2
3-55
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)
Figure 1
Touch Load key (1) to show Dialog window to select Internal, Card or Cancel.
3-56
Figure 2
Loading from the internal memory 1 2 Touch Internal key (2). (Fig 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 2 Touch Card key (3) 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 6 Touch Page key (9) again to set the desired data. Touch Select key (8) to select the data.
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Figure 3
Figure 4
Figure 5
3-58
3.5.3
Sort
Saved data can be sorted as desired.
Figure 1
2 Touch Load key (1) to show the display on Figure 1.
Figure 2
3-59
Touch Sort key (6) on the display (Fig 3) to show Sort Condition screen.(Fig 4)
Figure 3
Figure 4
Select the items to sort from (7) and which order should be taken as alphabetical sorting. Selected keys will be reverse highlighted.
3-60
3.5.4
Deleting
Only data, saved by AL-100, can be deleted.
1 Touch the Load key on EDIT window, to go to LOAD Window(the internal memory or the Memory card) in which the memory to be deleted is preserved.(Fig1)
Figure 1
Delete all data 2 Touch ALL Clear key(1) and keep touching for over one sec. to hear short beep. Cleared data means that the data deleting has been completed.
Figure 2
Delete selected data 2 Select data to be deleted by key(3), and press the Delete key (4) for over one sec. to hear short beep.(Fig 3) Cleared data means that the data deleting has been completed.
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3.5.5
Figure 1
3
Figure 2
Touch the Load key(1) in the Load window(Fig1) and touch Card key(2).
When the LOAD window is displayed, touch Format Key (3) for over one sec. to hear short beep.(Fig3) When you hear short beep again, the formatting has been completed.
Figure 3
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3.5.6
Data Communication
Measured data may be transferred to a computer via a data communication port (RS-232C). The connector has its orientation, when connecting to the port. Check the direction of the connector and insert it completely into the serial port. Accessory equipment connected to the RS-232C interface must be certified according to the appropriate IEC601-1 standard for medical equipment.
a) Connection to PC
All configurations must comply with IEC 601-1 or IEC950 system standard. Anyone who connects additional equipment to the single input port or signal output port is configuring a medical system and is, therefore, responsible for assuring that the system complies with the requirements of the IEC601-1 system standard. If indoubt, contact the Tomey technical service department, or your local Tomey representative. Connect the RS-232C communication cable (3) to the adapter and secure the connection by tightening the screws.
Connect the RS-232C communication cable to the adapter or connector and secure the connection by tightening the screws.
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3-64
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.
EDIT screen
Select the IOL front button to display the IOL Calculation screen.
Figure 1 2 Display the data desired to be sent in the IOL Calculation screen of (Fig. 1) and select the COM key (1).
Figure 1 2 Display the date desired to be sent in the EDIT screen of (Fig. 1) and next select the COM key (1).
Figure 2
Select the Send key (2) in the Communication screen of (Fi8g. 2) to display the Communications screen of (Fig. 3).
3-65
Figure 3
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.
If you want to cancel sending data, select the Cancel key (5).
When sending data is completed, the screen of (Fig. 4) is displayed. Select the Exit key (6) to return the screen to that of (Fig. 2).
Figure 4
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c) Receiving of data
1 Since data receiving cannot be made if there is any data left in the screen, display the Measure, Wait screen of (Fig. 1) and select the New key (1).
Figure 1
2 For changing the screen for data communications, display the IOL Calculation screen or the EDIT screen and select the COM key (2).
Figure 2-1
Figure 2-2
3-67
Figure 3
Select the Receive key (3) in the screen of (Fig. 3) to display the Data Receiving screen of (Fig. 4).
Figure 4
When the personal computer is ready for sending data to the Instrument, select the Start key (4) to start receiving data by Instrument.
Figure 5
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.
If the Exit key is selected, received data will be disposed so that the screen will be returned to IOL Calculation screen or the EDIT screen.
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3.6
UTILITEIS
Figure 1
2 Touch Utility key(1) to show Utility window.(Fig 1)
3.6.1
3-69
3.6.2
Figure 1
1 Touch the Time and Date key (1) on the biometry Utility screen(Fig 1) to display Time and Date screen (Fig 2).
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 4
Touc the Return key (4) to register each value. Touch Exit key(5) to return to Utility screen (Fig 1).
3-70
b) Sound Setup
To adjust the sound:
Figure 1
Touch Sound Set key (1) on the biometry Utility screen (Fig 1) to display the Sound Adjustment window (Fig 2)
Figure 2
2 Touch the Volume keys (2) to adjust the sound level.
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Figure 1
Touch Print Mode Key (1) to display Print Mode screen(Fig 2).
Figure 2
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).
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3.7
3.7.1
3-73
3.7.2
c) Battery life
The Memory Card consume its battery even when the memory card is not used with AL-100. The life of the battery varies as a function of the memory capacity, as indicated below. IMPORTANT: If the battery is not replaced within 10 minutes of receiving the low battery! message, data stored on the memory card might be lost.
Battery life and the capacity of Memory Card Capacity of Memory Card Battery Life at 25 degree Celcius (77 degree Fahrenheit) 512Kbyte (Option) 1Mbyte (Option) 2Mbyte (Option) 4MByte (Option) Approximately 5 years Approximately 5 years Approximately 3 years Approximately 1 years
The battery life also varies with the conditions or circumstances, where it is used.
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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 displayed, click the button of NO. If the PC card wizard is not displayed but the properties of PC (PCMCIA) is displayed, click the button:[cancel] to proceed in the successive procedures. 2 Open the Config. Sys files by using the memo note (NOTEPAD: application, etc.). 3 Add the following information to the last row of Config. Sys. It is also noted that the directory of WINDOW differs on the personal computer. Specify the directory in which the system file of Windows* is provided. In case of only one of the PC card slot in the underlined part, enter /SLOT=1, while in case of two cases, enter SLOT=2. DEVICE=C:\WINDOWS\SYSTEM\CSMAPPER.SYS XE "CSMAPPER.SYS" DEVICE=C:\WINDOWS\SYSTEM\CARDDRV.EXE XE "CARDDRV.EXE"/SLOT=2
4 5 6
Overwrite and save the Config.sys file. Restart the Windows*. 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.
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<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.)
Click the file of TRUEEFFS.INF with the right button of the mouse and next click install.
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. 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).
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Click the [Next] button (1) and proceed in the window of (Fig. 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).
Select Memory technology driver (4) and click the [Next] button (5), to proceed in the next Window of (Fig. 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).
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.
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.
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3.7.4
Taking out the Memory Card from the personal computer Windows* 95/98/Me
Figs show the cases of Windows* 95
Take out the Memory Card from the personal com puter in the following procedures, which may other wise cause the personal computer to malfunction.
1
Click the [Start] button(1), next point the [Setting], and then click (2), so the control panel will be displayed. (Fig. 2)
Figure 1
Figure 2
Double-click the icon (3) of PC card (PCMCIA), so the properties of the PC card will be displayed. (Fig. 3)
Select the socket in which the Memory Card is inserted, and next click the [Stop] button (4). When [This device can be removed safely.] is displayed, click the [OK] button and next take the Memory Card out.
Figure 3
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<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)
Figure 1
Figure 2
2)
Click the [Next] button (1), so the window for selecting the operation related to hardware will be displayed. (Fig. 3)
Figure 3
3)
Next, select [Delete/Remove Device](2) and click the [Next] button (3), so the window for selecting deleting procedures will be displayed. (Fig. 4)
4)
1) Select [Remove device](4) and click the [Next] button (5), so the window for selecting the device will be displayed. (Fig. 5)
Figure 4
5)
Select [Standard PCMCIA Memory Card](6) and click the [Next] button (7), so the confirmation window of the device will be displayed. (Fig. 6)
Figure 5
6)
Make sure that [Standard OCNCUA Memory Card] (8) has been selected and click the [Next] button (9), so the window for completion of hardware addition and deletion will be displayed. (Fig. 7)
Figure 6
7) 8)
Take the Memory Card out. Click the [Complete] button (10) to finish the wizard.
Figure 7
3-79
3-80
4 TECHNICAL INFORMATION
4.1 IOL Calculation Formulae
4.1.1 SRK/II
a. Emmetropic IOL power (D) Pemme = A1 - 0.9K - 2.5L b. Ametropic IOL power (D) Pament = Pemme - REF x CR c. Desired postoperative refraction (D) REFiol = (Pemme - P) / CR Where: if L < 20.0 mm, then A1 = A + 3
if 20.0 < L < 21.0 mm, then A1 = A + 2 if 21.0 < L < 22.0 mm, then A1 = A + 1 if 22.0 < L < 24.5 mm, then A1 = A if L > 24.5 mm, then A1 = A - 0.5
if Pemme < 14, then CR = 1.00 if Pemme > 14, then CR = 1.25
A: K: L: P:
A - constant Corneal refraction (D) = (K1 + K2) /2 Axial length (mm) Power of IOL implant (D)
4-1
4.1.2
SRK/T
a. Emmetropic IOL power (D) Pemmme = 1000na*X (L1 - C1) Y
b. Ametropic IOL power (D) Pame t = 1000na {X - 0.001REF (V*X + L1*r)} (L1 - C1) {Y - 0.001REF (V*Y + C1*r)}
c. Desired postoperative refraction (D) REFiol = 1000na*X - P*Y (L1 - C1)} na (V*X + L1*r) - 0.001P (L1 - C1) (V*Y + C1*r)
4-2
(K1 + K2) / 2 COR: Correcting value if L < 20.0, then COR = 3 if 20.0 < L < 21.0, then COR = 2 if 21.0 < L < 22.0, then COR = 1 if 22.0 < L < 24.5, then COR = 0 if L> 24.5, then COR = -0.5
4-3
4.1.3
Holladay
a. IOL power (D) P= 1000na {X - 0.001REF (V*X + L2*r) (L2 - C2 - SF) [Y - 0.001REF {V*Y+ r (C2 + SF)
b. Desired postoperative refraction (D) Pemme = 1000na * X - P * Q * Y na (V*X + L2*r) - 0.001P*Q {V*Y + r (C2 + SF)}
Where:
X: Y: Q:
na: nc: L: r: K: SF:
REF: Desired postoperative refraction V: P: L2: C2: Vertex distance (mm) = 12 Power of IOL implant (D) Modified axial length (mm) = L + 0.2 Anatomical anterior chamber depth (mm) (distance between corneal apex and iris surface) (mm)
= 0.56 + Rag -
Rag2 - AG2/4
if r < 7 mm, then Rag = 7 mm if r > 7 mm, then Rag = r AG = 12.5L/23.45 (if AG > 13.5 mm, then AG = 13.5 mm)
4-4
c. Personal SF
SF = { -BQ BQ2 - 4AQ*CQ} / (2AQ) - C2
Where:
AQ = (nc - 0.001AREF {V (nc - 1) - r} BQ = 0.001AREF {L2*V (nc - 1) - r ( L2 - V*na)} {L2(nc - 1) + na*r} CQ1 = 0.001AREF [V {na*r - L2 (nc - 1)} + L2*r] CQ2 = 1000na {na*r - L2 (nc - 1) - CQ1} / P CQ3 = L2*na*r - 0.001AREF *L2*V*r*na CQ = CQ3 - CQ2
Refractive index of cornea = 4.0/3.0 Refractive index of aqueous and vitreous = 1.336 Average corneal radius of curvature (mm) = 337.5/K Average corneal refractive power = (K1 + K2)/2 (D) Vertex distance (mm) = 12 Measured axial length (mm) Modified axial length (mm) = L + 0.2 (mm) Spherical index (D) Cylindrical index (D) index (D) = S + C/2
AREF: Postoperative refraction <equivalent to the spherical P: C2: Power of IOL implant (D) 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
4.1.5
Haigis standard
a. IOL power (D)
P= 1000na L-d na na z d 1000
Where:
z = DC + 1REF REF * V 1000 (ACD - 0) (ACD = 0)
d = a0 + a1*ACD + a2*L d = (a0 - 0.241*a1) + (a2 + 0.139*a1)L a0 = 0.62467A - 72.434 1000 (nc - 1) DC = RC
Where:
X = d*P + 1000L* na - d*L*P Y = na (1000*na - L*P + d*P)
na: nc: RC: DC: L: Refractive index of aqueous and vitreous = 1.336 Refractive index of cornea = 1.3315 Average corneal radius of curvature (mm) = (K1 + K2) / 2 Average corneal refractive power (D) Axial length (mm)
ACD: Anterior chamber depth (mm) REF: Desired postoperative refractive power (D) V: P: a1: a2: Vertex distance (mm) = 12 Power of IOL implant (D) 0.4 (default value) 0.1 (default value)
4-6
c. Personal A-constant
A= d - a1*ACD - a2*L + 72.434 0.62467 (ACD - 0)
A=
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 + 1AREF AREF*V 1000
DC =
a1: a2: RC: L: P: na: nc: DC: V:
1000 (nc - 1) r
0.4 0.1 Average corneal radius of curvature (mm) Axial length (mm) Power of IOL implant (D) Refractive index of aqueous and vitreous Refractive index of cornea = 1.3315 Average corneal refractive power (D) Vertex distance (mm) = 12
4-7
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. Materials Pseudophakic 1 Pseudophakic 2 Pseudophakic 3 PMMA Silicon Acrylic Ultrasound velocity in IOL 2718m/s 1049m/s 2200m/s
Axial length is calculated using the following formula: Vacd * tacd 2 Vvit * tvit 2
Lp =
+ Th +
Where: Lp: Th: Vacd: Vvit: tacd: tvit: Axial length (mm) Central thickness of IOL (must be entered) Anterior depth sound Velocity Vitreous sound Velocity Measuring Time for anterior drpth Measuring Time for vitreous
4-8
(Figure 1) Start up screen will be shown after turning on the unit. The software version (1) is displayed to confirm.
4-9
4-10
5 MAINTENANCE
5.1 TOMEY One-Year Warranty
The Seller warrants this product to be free from defects in material and workmanship under the normal use of this product for one year or other terms complying with local regulations from the date of invoice issued by the Seller to the original purchaser. This warranty shall apply only to the original purchaser and shall NOT, in any way, be transferable or assignable to any other party than the original purchaser. Lamps, paper and consunable items shall not be covered by this warranty. This warranty also shall NOT apply if the product has not been installed, operated or maintained in accordance with the OPERATOR MANUAL of Tomey Corporation (hereinafter called Tomey). Neither the Seller nor Tomey shall be liable for any damages caused by the purchasers failure to follow instructions for proper installation, use and maintenance of the product. This warranty is only applicable to the new product and does NOT cover any damage resulting from or caused by accident or negligence, abuse misuse, mishandling, improper installation, improper repair or improper modification of this product whose serial number or batch number is removed, altered or effacted. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY AND ALL OTHER WARRANTIES, EXPRESS OR IMPLIED (INCLUDING SPECIFICALLY, WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, ALL WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE), AND ALL OTHER OBLIGATION AND LIABILITY ON THE PART OF THE SELLER AND TOMEY. NEITHER THE SELLER NOR TOMEY SHALL BE LIABLE FOR INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES UNDER ANY CIRCUMSTANCES OR FOR MORE THAN REPAIR, REPLACEMENT OR REFUND OF THE PURCHASE PRICE OF DEFECTIVE GOODS.
5-1
5.2
Replacing fuses
Turn the AL-100 off and unplug the power cord from the power outlet.
Rotate the fuse holders counter clockwise approximately 90 degrees using a coin or a screwdriver, and the holders will pop out.
Pick the holder with fingers and pull it out of the unit. Another holder should also be pulled out.
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.
Reinsert the fuse holders and turn clockwise to lock them in place.
5-2
5.3
5.3.1
Routine Maintenance
Maintenance of the probe
When disconnecting the probes, be sure to hold the plug, not the cable, otherwise the cable will be damaged. Do not use an autoclave or EOG to sterilize the probes since this may severely damage them.
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.
Disinfect the probe by immersing the tip in a 0.5% solution (1 to 10 dilution) of sodium hypochlorite for 10 to 20 minutes. Then rinse with distilled water and allow to dry before use.
5-3
5.3.2
Wipe off dirt gently with a wet cloth and then remove excess water with a dry cloth. If dirt is difficult to remove, use a diluted, mild detergent.
Since touch panel LCD is weak in humidity, do not leave it with water or other liquid on its surface. The surface will be damaged and the panel can not be used.
Clean the surface of the monitor with a dry cloth. If dirt is difficult to remove, use diluted, mild detergent on a soft cloth. Then rinse and remove excess moisture with a dry cloth. While the unit is used, put dust cover to avoid dust. When the unit is not used for a certain period of time, unplug the power cord.
5-4
5.4
When opening the printer cover, pay special attention to the paper cutter on the cover, not to cut your finger or hand.
1 2 3
Open printer cover (1). Remove the used roll of paper. 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.
Close the printer cover until you hear click sound.(See figure2) Cut off the excess paper.
(Figure 1)
BIO
BIO
(Figure 2)
5-5
5.5
Storage
Do not store this instrument in a location where it might be exposed to water or chemicals. Avoid excessive atmospheric pressure, high temparature, excessive humidity, poor ventilation, direct sunlight, dust, salt or sulfer in the air. Do not store this instrument near chemical substances or in a location where gas may be generated. Store this instrument in a location where there is no tilt, vibration, shock(during transportation).
When shoring the AL-2000, the protective cap should be placed on the clean biometry probe tip and should be placed in the case provided. If the instrument is not to be used for a prolonged period, disconnect the power cord and place the dust cover over the instrument. When using it again, make sure if the instrument works without any problem. Storage Condition Atmospheric temparature range: -20 to +70 degree Celucius (-4 to +158 degree Fahrenheit) Relative humidity range: 10 to 95 %
5-6
5.6
Packing materials
Keep the carton and packing materials for future use. If you discard the packing materials, be sure to comply with local ordinances and regulations for disposal. This instrument contains the board with lithiumion battery inside the body. If you discard the instrument, be sure to complay with local ordinances or regulations for disposal.
5-7
5-8
6 TROUBLESHOOTING
Before self-judging a trouble as a malfunction or failure, check the following items. If you cannot solve your trouble or problem by the following countermeasures, consult your local representative.
Do not remove the enclosure of this Instrument, or you may otherwise be exposed with high voltage.
Do not use any measures other than specified in this chapter. If your problem cannot be corrected by the following countermeasures, ask your local representative for problem investigation and repair, if necessary. <Common items> l When turning the power on, the power supply indicator do not light.
Solution
6-1
Cause 3
The fuse is broken. Disassemble the fuse holder and check to see if the fuses are proper or broken. In broken, change the fuses as per prescribed "5.2 Replacing of fuses. If replaced fuses are again broken, the Instrument will possibly not function properly. If so, ask your local representative for inspection and repair of this Instrument.
Solution
Cause1 The Auto Power Off Function (which automatically turns the screen off if no operation is given for 15 minutes) is in operation. Solution
Touch the monitor screen.
Cause 2 The switch for maintenance provided on the rear side is off the center position. (See
2.2 7.)
Solution
Turn the power off and return the position of the switch to the center. Then turn the power on.
Solution
Adjust the brightness of the monitor screen by turning the Contrast Adjust Volume.
Solution
Check to see if the Printer paper is sufficiently left. Check to see if the Printer paper is placed properly in the procedures specified by "5.4 Replacing of printing paper".
A button which is different from that pressed in the touch panel was reacted.
6-2
Solution
Turn the power by pressing both Measure button and the MAP button at the same time. After this condition elapses, the touch panel calibration screen will be shown. Touch the center position of [+] in the screen, so the point will disappear and the next [+] will appear again. Repeat this calibration until [+] is not displayed. After this calibration is finished, ?????? screen will be displayed to make the operation possible. In the event the calibration of the touch panel is shifted many times while in operation, consult your local representative.
Solution
The Immersion mode takes in data if the corneal echo is within a range of 1.8 to 3.2mm from the initial echo. Super sounds must be placed within the cornea and the Probe tip to meet said conditions.
6-3
Cause 3
Measurement is in process by directly applying the Probe to the cornea while setting the Immersion mode, without placing super sound media. In process of setting the Immersion mode, use the Immersion attachment by means of the procedures specified in "3.6.5 a) Using of the Biometry Probe in the Contact Mode/Immersion Mode" or give measurement by placing super sounds. When directly applying the Probe to the cornea, select the Contact mode.
Solution
Solution
If there is any source generating noises (such as motor, laser-operated equipment, or similar) near by the Instrument, move it away from the Instrument. Patient's fixation is not proper. Guide Patient's measuring eye sight by using the fixation lamp of the Chin Rest. The eye contact part of the Biometry Probe is damaged. If the Probe is damaged, promptly stop measurement and consult your local representative.
Cause 3
Solution
Cause 4
Solution
6-4
Solution
l
Solution
Connect the Probe correctly until it is securely locked, by specified procedures mentioned in "3.2.1 b) Connecting of the Biometry Probe".)
Solution
In case of the Chin Rest, give a sufficient length from the Probe to the cord hook so that the Probe cord does not pull the slider of the Chin Rest. (See "3.6.6 b) Handling of the Slider when using the Chin Rest for Measurement".) The position of setting the retinal waveform selecting cursor is not proper. Set the retinal waveform selecting cursor at immediately right side of actual retinal echo, in such a manner that any unnecessary echo may not be placed between the cursor and the retinal echo. The Biometry Probe is not applied properly. Apply the Probe to the center of the cornea at a right angel so the retinal echo can quickly rise up.
Cause 3
Solution
Cause 4
Solution
6-5
Cause 5
An excessive amount of the cornea protective gel makes a gap between the Probe and the cornea, possibly resulting in longer measured data. Always give the appropriate amount of gel. The Immersion Attachment is being used while setting the Contact Mode. A large amount of super sounds are used.
Solution
Solution
Measured data are as much longer as the thickness of super sounds used. Properly give the settings of the Immersion Mode and the Contact Mode and take measurements in the procedures prescribed in "3.6.5 a) Handling of the Biometry Probe in the Contact Mode and the Immersion Mode." Measurement is given by directly applying the Probe to the cornea, without using super sounds in the Immersion Mode. In process of setting the Immersion mode, use the Immersion attachment by means of the procedures specified in "3.6.5 a) Using of the Biometry Probe in the Contact Mode/Immersion Mode" or give measurement by placing super sounds. When directly applying the Probe to the cornea, select the Contact mode. The setting of converted sound velocity is not proper. Check to see if the setting of converted sound velocity is proper. Converted sound velocity can be set for left and right respectively. Make sure that the sound velocities for both left and right have been set properly. (See "3.6.3 b) Settings of eyes to be measured and converted sound velocities.)
Cause 7
Solution
Cause 8
Solution
6-6
Cause 9
The eye contact part of the Probe is damaged. If the eye contact part of the Probe is found damaged, stop measurement immediately and consult your local representative.
Solution
The monitor sounds for Biometry does not stop, or measurement values are taken at the time when measurement is not being taken.
Solution
Connect the Probe until the connection is locked, in accordance with the procedures prescribed in "3.2.1 b) Connecting of the Biometry Probe."
Solution
Make sure that the grounding of the power plug is connected. Surrounding noises. Where the noise generating sources (such as motor, laser surgery equipment, etc.) are placed close to the Instrument,
Cause 3
Solution
6-7
Cause1 An ID number has not been inputted for data to be saved. Solution
Since ID number is saved as the name of the file, first input an ID number for data to be saved before proceeding in its saving operation.
Solution
Delete unnecessary data from the memory before carrying out the operation of saving. Up to six pieces of data can be saved.
Solution
Insert the Memory Card properly, in accordance with the procedures prescribed in 3.2.2 Connecting of Option Parts, b) Inserting and removing of the Memory Card.
Solution
Since the Echo Data type and the Biometry data are saved with their ID numbers as files, first input the ID numbers before saving related information.
6-8
Cause 3
The names of files have not been inputted. In case of JPEG Data type, the file name must be inputted. Input the file name before saving. The Memory Card is protected from light. Release the light-protection, by the procedures specified in the Handling Manual for Memory Card. The Memory Card has no sufficient space. ("Memory Full!!" is displayed.) Replace the Memory Card in trouble with the new Memory Card, or delete unnecessary data before saving. Deleting of data must be done with this Instrument. The Memory Card has not been formatted.
Solution
Cause 4
Solution
Cause 5
Solution
Solution
Data cannot be saved in the Memory Card, unless it has not been formatted. Use the formatting memory card function provided for this Instrument, before saving data in the Memory Card. The format is not proper. Three different formatting types are used for this Instrument ( B-mode image diagnosis, Echo, JPEG, and Biometry function), of which data to be saved are specified. Formatting is to be given with the utility of which function corresponds to the data to be saved.
Cause 7
Solution
6-9
played.)
Solution
Replace the battery with the new part, in accordance with the Handling Instructions for the Memory Card.
The data saved in the Memory Card cannot be loaded into the personal computer.
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 in the procedures prescribed in "3.7.3 Loading the data saved in the Memory Card into the Windows personal computer, a) Rewriting of Config. Sys file of Windows personal computer provided with the PC card slot. No device driver of the Memory Card exists. If the personal computer provided with the Memory Card slot is installed with the Windows, "CSMAPPER. SYS" as the driver for Memory Card and "CARDDRV. EXE" have automatically been saved in the directory in which the system file exists. If such file has been deleted for some reasons, the Windows must be reinstalled. It is noted that sufficient knowledge is required for reinstalling the Windows and that the environments for such personal computer may largely be changed. No unskilled person is permitted to give to reinstall the Windows.
Cause 3
Solution
6-10
7.1
Option parts
Memory Cards (512Kbyte, 1Mbyte, 2Mbyte, 4Mbyte) Specify a Memory Card for AL-100. Chin Rest AL-1100 Specify a Chin Rest for AL-1100.
7-1
7.2
Spare parts
Printer paper roll for built-in Printer Specify a Printer Paper Roll for Built-in Printer for AL-100. Super sound diagnosis gel Specify Super Sound Diagnosis Gel. Immersion attachment Specify Immersion Attachment for AL-100.
7-2
8 SPECIFICATIONS
8.1
8.1.1
8-1
IOL calculations SRK ll equation SRK/T equation HOLLADAY equation HOFFER Q equation HAIGIS optimized equation HAIGIS standard equation
Biometry Probe Type: Fixation lamp: Oscillator frequency: Tip diameter: Solid type Built in the Probe (red LED) 10MHz 5.3mm (Concaved)
8.1.2
Main unit
STN liquid crystal: Dimensions and weight: 5.7 inch, color W220 D222 H275mm/4kg
8.1.3
Power source
Voltage: Frequency Consumption power: 100VAC 50/60Hz less than 35VA + 15%
* The specifications and outer appearance may be changed for improved performances.
8-2
8.2
8.2.1
Since this Instrument is exclusively designed for ophthalmic applications only, do not use it for any purposes other than for its designed purpose.
This Instrument is designed as the super sound diagnosis equipment specialized for ophthalmic applications. This Instrument has, therefore, been set with a very weak super sound energy. It is suggested that the Operator of this Instrument should limit the time of diagnosis and measurement to a minimum extent, in consideration of the general precautions on super sound diagnosis and measurement equipment.
8.2.2
Super sound output in the eye as per the FDA 510(k) guideline Ispta. 3: Isppa. 3: MI: Average in-air peak time strength Average in-air peak pulse strength Mechanical index
8-3
8.3
Generation of noises
This Instrument makes mechanical noises at the following operations.
When turning the power on, When self-diagnosing, When starting printout, When operating the various key buttons, When taking measurements (such as when taking measured data).
8-4
North/South America Tomey Corporation USA (Tomey USA) 300 Second Ave. Waltham, MA 02451 USA Tel: +1 781-890-1515 Fax: +1 781-290-5885 Europe Tomey GmbH (Tomey Europe) Am Weichselgarten 19a 91058 Erlangen-Tennenlohe GERMANY Tel: +49 9131-77710 Fax: +49 9131-777120
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ID: 0208