Iolmaster 5 PDF
Iolmaster 5 PDF
Iolmaster 5 PDF
User manual
Copyright 1
Page
Copyright ........................................................................................... 1
Trademarks ........................................................................................ 2
Contents............................................................................................. 3
Notes on the user manual ................................................................ 6
Symbols ...................................................................................... 6
Purpose of this documentation.................................................... 6
Accessibility of the user manual................................................... 6
Safety instructions ............................................................................ 7
Compliance with standards and regulations ................................ 7
Instructions for installation and use ............................................. 7
Safe operation ............................................................................ 9
Electrical safety .................................................................. 9
Light emission from the device........................................... 9
Requirements for operation ............................................... 9
Important when using the device ..................................... 10
Disposal .................................................................................... 10
Disposal of the product within the EU ....................................... 10
Package contents ...................................................................... 11
Warning and information labels on the device........................... 11
Customer’s safety obligations.................................................... 12
Description....................................................................................... 13
Intended use of the device ........................................................ 13
Functional description ............................................................... 13
Overall view .............................................................................. 15
Optional accessories.................................................................. 16
Power isolation transformer for external devices........................ 17
Setting up the device for use..................................................... 18
Installation....................................................................... 18
Electrical connection ........................................................ 19
Operation......................................................................................... 20
General notes on control........................................................... 20
Operation by touchpad and keyboard ....................................... 21
Screen layout ............................................................................ 22
Overview of buttons and shortcut keys...................................... 23
Menu overview ......................................................................... 26
Options menu ........................................................................... 27
Test eye ........................................................................... 27
User database .................................................................. 27
Data storage.................................................................... 29
Setup............................................................................... 32
Symbols
The following warning symbols refer to important safety information in
this user manual. Whenever you see these symbols, read the
accompanying notes carefully. They may warn against possible health
risks or mortal danger.
Observe all safety notes and information in this manual and on device
labels.
Warning
Correct operation of the device is imperative for safe functioning. Please
familiarise yourself thoroughly with the contents of this user manual
before using the device.
Safe operation
Electrical safety
Please take care that the following operational requirements are met
when using the IOLMaster:
R Use the power cable supplied with the device. If the device is
mounted on an IT3L instrument table, it will receive its power supply
through the table.
R The power supply plug must be inserted into a power outlet that has
an intact protective conductor connection.
R All cables and plugs may be used only if they are in perfect working
condition. In particular, the spring action plug for device control (7,
Fig. 3) must remain plugged in and should not be pulled out.
R If the earth contact is impaired, or if electrical wiring is damaged, the
device must be taken out of service and measures taken to prevent
inadvertent use. Following this, call Carl Zeiss Service.
R Do not cover/obstruct ventilation slots in the computer casing (right
and left)!
R If peripheral devices are connected (CRT monitor and/or PC are possible)
the user must ensure that safety requirements of DIN EN 60601-1-1
(medical electrical systems) are observed.
R A network isolator can be ordered from Carl Zeiss for connection to an
external network (NET).
R If either of the error messages "Laser adjustment too high" or "Laser
power measurement too high, measurement aborted" appears, the
device must be shut down.
Following this, call Carl Zeiss Service.
R Always enter the patient data (last and first name, date of birth) or ID
No. (depending on setting in Setup menu).
R Pull the power supply cable immediately if damage or unspecified
problems occur!
R Switch off the device as follows:
– Click on the EXIT icon on the toolbar.
– Confirm with OK and switch the device off at the power switch.
The program will automatically close; the readings for the last
patient will be saved and the device will shut down automatically
(lamp in the switch goes off).
Caution
For as long as the switch lamp is lit, internal components are still under
voltage, even after the device has been switched off at the power
switch! All-pole disconnection of the device has not been achieved until
the switch lamp goes off. The lamp must be off before the power
supply is unplugged or the device switched off at the main room switch.
Failure to observe these instructions may result in loss of data.
R The device contains a computer. Please follow the instructions for the
Switching off the device on page 74.
Disposal
The device’s internal control computer contains electronic components
and a lithium battery (type CR 2032). At the end of its useful life it must
be properly disposed of in compliance with local regulations.
Package contents
The device is delivered completely assembled in foam material
packaging. The enclosed accessory box contains the following
components:
– Keyboard
– Power cable
– This user manual
– Dust cover
– Test eye in its own case
– 2x CD/RW (formatted)
Save the original packaging for storing the device during extended
periods of non-use or returning it to the manufacturer, or dispose of it
properly.
Functional description
1
Literature on the formulae (in case of specific questions please contact Carl Zeiss Meditec):
x Haigis:
http://www.augenklinik.uni-wuerzburg.de/uslab/ioltxt/haid.htm
x HofferQ:
HOFFER KJ: The Hoffer Q formula: A comparison of theoretic and regression
formulas. J Cataract Refract Surg, 19:700-712, 1993; ERRATA 20:677, 1994
x Holladay:
HOLLADAY JT, PRAGER TC, CHANDLER TY, MUSGROVE KH, LEWIS JW, RUIZ RS: A
three-part system for refining intraocular lens power calculations. J Cataract Refract
Surg, 14:17-24, 1988
x SRKII:
RETZLAFF J: A new intraocular lens calculation formula, Am Intra-Ocular Implant
Soc J 6:148-152, 1980
x SRK/T:
RETZLAFF J, SANDERS DR, KRAFF MC: Development of the SRK/T intraocular lens
implant power calculation formula. J Cataract Refract Surg 16 (3):333-340, 1990
x Haigis L:
HAIGIS W: Publication in preparation
x Correction of corneal radii/corneal refraction after corneal refractive surgery:
HOLLADAY JT: IOL calcualtions following RK. Refract Corneal Surg 5(3):203, 1989
HOFFER KJ: Intraocular lens power calculation for eyes after refractive keratotomy.
J Refract Surg 11:490:493, 1995
x Calculation of phakic implants:
vd HEIJDE GL, FECHNER PU, WORST JGF: Optische Konsequenzen der Implantation
einer negativen Intraokularlinse bei myopen Patienten. Klin MB1 Augenheilk
192:99-102, 1988
HOLLADAY JT: Refractive power calculations for intraocular lenses in the phakic eye.
Am J Ophthalmol 116:63-66, 1993
HAIGIS W: Biometry in complicated situations, 9th Conv. of DGII 1995, Rochels et al
(Hrsg.), Springer, 17-26, 1996
Overall view
Optional accessories
R Instrument table IT 3L
R Holding bar for securing the IOLMaster on the instrument table
R Printer
R Keyboard support
R Narrow holding bracket for securing the IOLMaster on the keyboard
support
R Paper pads for patient chinrest
R Power isolation transformer for connection of external accessory units
R Network isolator
R Software option A plus
R Software option B
R Connecting cable for coupling with PC
Warning
Always connect all peripheral devices, printers and monitors to the
power isolation transformer. 1
No components other than those prescribed for the system may be 2
connected to the power isolation transformer or instrument table. Non-
compliance represents a violation of the regulations for use of medical
devices under DIN EN 60601-1-1.
1 Power cable connector with
Likewise excepted are laser printers, as their rated supply voltage fuses
usually exceeds the permissible connected load of the power isolation 2 Power switch
transformer. Position the laser printer outside the patient’s range
(1.5 m from the patient’s seat at the device). Fig. 4 Power isolation trans-
If the Carl Zeiss IT 3L instrument table is used, the power isolation former, input side
transformer may be mounted to the underside of the tabletop. It may
1
be secured elsewhere, but not placed on the floor.
Warning 2
The IOLMaster should never be operated via the power isolation
transformer!
2
The power isolation transformer is not a constituent part of the
IOLMaster.
1 Instrument connector
2 Power junction connector
Installation
Caution
The two holding brackets are mounted in the same way. Make sure you
use the correct holding bracket.
Do not lift or carry the device by the measuring head!
• Tilt the IOLMaster to one side so that it rests on the patient head
support.
• Remove the three hexagon socket (Allen) screws (SW3) (1, Fig. 7).
The screws may be very difficult to loosen.
Caution
Fig. 7 Mounting holding bracket Do not remove any other screws on the base plate! Damage may
otherwise be caused to the device.
• Attach the holding bracket with adhesive strips (2, Fig. 7) facing
outwards.
• Secure the holding bracket with the three hexagon socket screws. Do
not yet remove the protective film from the adhesive strips.
• Set the device upright and place it in the desired position.
• Now lift/tilt the device slightly and remove the protective film (2,
Fig. 7).
• Bring the device carefully into the proposed position. The adhesive
strips will hold immediately. The device can no longer be shifted once
it has been brought into position!
Caution
Use only printers recommended by Carl Zeiss Meditec! Only one printer
may be installed. De-install all surplus printer drivers using menu Setup Switch on printer and connect it
– Printer. to IOLMaster (USB/LPT 1).
Prior to using older printers, please consult Carl Zeiss Meditec whether The Windows installation routine
will be displayed.
the printer is approved for use with the IOLMaster.
Caution
All attempts to manipulate the operating system are strictly prohibited!
In particular, deactivation of the Windows firewall is not permitted!
Note
The system does not support all key combinations of Windows.
The special Windows keys that exist on some keyboards are
ineffective.
The software uses only a few forced processes. The user may switch
freely between the individual modes. For rational working the user is
urgently advised to observe the sequence of measurements described
from page 38 onwards.
In rare cases, Windows error messages may appear on the LC display.
This might be the case, for instance, if the program run is affected
(mostly by external disturbances).
Multiple safety mechanisms in the instrument’s hardware and software
ensure that there is no risk of injury.
Caution
If warning messages appear frequently, the device should be taken out
of service and labelled as such. Then call Carl Zeiss Service.
The device does not support the submission of automatically generated
problem reports to Microsoft!
1 Touchpad
2 Left button
3 Right button
R Move the cursor by touching the touchpad with your finger and
moving it as desired.
R Single and double clicks are possible by tapping a finger on the
touchpad or pressing the left button.
R To drag the cursor, hold the left mouse button depressed while
moving the finger across the touchpad.
R The right button is only functional for:
– resetting the zoom function (page 77)
– continuous positioning of the measuring cursor while dragging
(see page 79)
Screen layout
1
2 3 4
10 9 8 7 6 5
1 Menu bar
2 Display field for measurements of right eye
3 Display field for video images
4 Display field for measurements of left eye
5 Eye
6 Mode (additionally in ALM mode: number of measurements)
7 Last Name
8 First name
9 Icons
10 System messages/progress bar
SNR display and SNR Values for the peak below the
(signal-to-noise ratio) measuring cursor.
beside signal curve
SNR: 6.4
Measuring cursor is
positioned above signal
peak.
Menu overview
The illustration below provides an overview of available menus and
submenus for program operation using the menu commands.
Print preview
Displays print preview
Printer setup ?
Select printer options About IOLMaster
Display and print
information on program
Logout version
Logs current user off and
opens login window
Exit
Exits application and
Windows
Options menu
Test eye
The calibration of the device can be checked with this function (see
Section Checking the measurement functions on page 104).
User database
Since the device may be used for the preparation of eye surgery by a
number of surgeons at a group practice or clinic, surgeon-specific
records may be created. This is performed using the User Manager in
the Options menu.
• Click on User Database in the Options pull-down menu. The dialog
box for entering surgeon-specific data will appear.
Note
When the device is delivered, the User Database only contains the
administrator without any password specifications.
Only the administrator is entitled to add or delete users and edit their
databases.
Caution:
Individual users may edit their databases only if password protection
has been set. If no password protection was set, the databases are
accessible to all users!
Caution
A forgotten administrator password can only be recovered by Carl Zeiss
Service!
Data storage
Note
If you wish to export to a CD-RW, you must insert a formatted
CD-RW into the drive. The CD-RW must be formatted elsewhere
(e.g. office PC) in UDF format. Alternatively, use one of the
formatted CD-RWs as supplied. For exporting to an USB flash
drive the latter should enable at least a transfer rate to USB-1.1.
Caution:
A compressed and password-protected file is created in the CD-RW. Do
not attempt to read or manipulate this file using other programs!
The backup process also includes the tables used for IOL constant
optimisation (assignment of surgeon/lens/patient/eye/post-operative
data). Additionally, the IOL constants currently used for calculation will
be saved for all surgeons.
Note
In this way, all critical patient and IOL data can be saved together
with the data required for lens optimization. Individual values of
axial length, corneal curvature/refractive power, anterior chamber
depth, WTW are not saved and may get lost, e.g. in the case of a
hard disk fault.
Follow this procedure to create a backup copy:
• In the User Database activate Administrator.
• Click the BACKUP command button to initiate the backup process.
• Insert a UDF-formatted CD-RW into the drive.
• Confirm with OK.
• It may be necessary to delete existing data on the CD-RW (conform
with YES). Answering with NO will abort the backup process.
The data will now be copied to the CD-RW. A progress bar will show
the status of the copying process.
• Finally, you will be informed that data backup was successful.
Restore
By using the Restore function you can retransfer saved data from a CD-
RW to the IOLMaster. Follow this procedure to restore saved data:
• In the User Database activate Administrator.
• Click RESTORE.
• Insert the CD-RW with the latest backup copy; confirm with OK.
• Confirm with YES that all surgeon data currently stored on the
IOLMaster is to be copied, together with the respective IOL data and
patient data available for optimising the IOL constants.
Database data will now be copied from the CD-RW to the IOLMaster.
A progress bar will show the status of the copying process.
• Finally, the program will inform you if the restore action was a
success.
Caution:
After backed up data has been restored, the user database in the User
Manager will reflect the status at the time of backup. All newly
registered patients since this time will be irretrievably lost!
Import
The Import function permits IOL data (name and respective IOL
constants) to be transferred back to the IOLMaster from a database
saved to CD-RW or USB flash drive (Version 1.1 or later). Imported data
may be assigned to one or several surgeons.
Prior to import, download the available IOL data from the Internet.
Caution
Do not use a network-connected IOLMaster for the download!
• Log into www.meditec.zeiss.com/iolmaster.
• IOLMaster -> Download: Select Optimized IOL constants.
• Follow the prompts now appearing on the screen.
• Save the file (do not select Open!) on the desired storage medium.
• Do not extract the ZIP file!
• Choose the desired lenses; select several lenses with <CTRL> + cursor
+ click (selected lenses appear highlighted in blue).
• Choose the surgeon (one or more) with (<CTRL> + cursor + click
(selected surgeons appear highlighted in blue); if not already existent,
the desired surgeons must be created beforehand.
• Accept with >>. A progress bar will show the status of the copying
process. The selected lens data will be added to the selected
surgeons.
• Close the dialog box with EXIT.
Setup
R Program Settings/Program
– Language: IOLMaster dialogs in German, English or other
Fig. 16 Setup submenu languages (change requires system restart).
– Display of visual acuity: Decimal or Snellen. Entry of visual acuity
in Patient Data dialog box.
– Database: Storage time of datasets (5 ... 365 days). All figures
between 5 and 365 are possible. 365 days are set at the time of
delivery. Data records can be identified or sorted by "Name, first
name…" or by "ID Number".
Caution
Please note that when switching from Name, first name… mode to
ID Number all data records without an ID No. will not be listed (entry of
an ID is not essential). This also applies analogously to switching from
ID Number to Name, first name … if a name was not previously
entered.
– Send data:
Choose old, if the connected office management system only
allows import of data of interface software versions 1.01 to 2.02
(patient data, measured values).
Choose new (requires option A plus), if the connected office
management system can import all offered data according to
interface software version 3.0 and higher.
COM speed provides a choice of standard transfer rates in kBaud
– Keratometer display:
If you activate the adjustment aid, a traffic light will asist the
corneal curvature measurement. When the optimum
measurement position for the patient has been reached, the
traffic light will change from red to yellow to green. If Automatic
measurement is also activated, as soon as the best possible
adjustment to the patient has been reached and the traffic light
display turns to green, pressing the knob on the joystick will
automatically trigger three successive measurements
Following a software update, this function must be calibrated
prior to first use (see page 103).
Radius or Corneal K’s for IOL calculation.
- Cylinder or + Cylinder
Refractive Index: Entry of equivalent refractive index for
conversion of corneal radii to corneal K’s. Enter the refractive
index implemented on your keratometer (refer to respective user
manual).
– Printout of the IOL calculation: Choose whether you wish to
have the calculated IOLs of both eyes printed on a single page or
only one eye per page. In addition, in this field you may enter the
name of the clinic to appear on the printout of the IOL
calculation.
Select emmetropy IOL if desired.
Caution:
The option Operator login with password and screensaver, together
with password protection, should not be activated further users (see
below) have been registered and their passwords entered.
If you change the Admin password, you are advised to note down the
new password, e.g. in the device record book. The user administration
system cannot be accessed without the Administrator password!
If the password is lost, a number code will be displayed after three
unsuccessful attempts. This number code will enable service personnel
to reset the device.
As soon as you have confirmed the new program settings with OK, a
login dialog will appear. From now on the IOLMaster can only be used
by logging in with password. The default setting is user Admin with the
password 0000 (4x zero) in the User Database. To change the
password, select the option Change password, enter your user name
and old password and confirm with OK.
Each user may be a member of one or more user groups. For this
purpose, highlight the respective user. The user groups to which this
user belongs are shown in the right-hand window Membership.
The user can be assigned to one of the following user groups by clicking
on ADD:
– The Administrator has unrestricted access rights to User
Management, the User Database (see page 27) and the Setup
menu.
– The Surgeon only has an access right to the respective tab in the
User Database. This tab is created automatically when the user
account is established in the User Manager.
– The Assistant has no right of access to the User Database.
All user groups may enter/rename patient data and perform
measurements / calculate IOLs.
Users who are not members of any of the above user groups may work
on the IOLMaster in the usual way, but they may not change any of the
system settings.
To remove a user from a user group, highlight the name and click on
REMOVE.
Note
The rights of the Surgeon and Assistant user groups in the User
Group Administration may be extended to include access to the
IOLMaster Setup menu and the deletion of patient data.
R Regional settings
Opens the Windows routine for regional settings.
R Printer
Opens the Windows printer folder This function is only needed for:
– showing the printer queue
– displaying the properties of the installed printer. Here you will find
advice on operating and maintaining the printer
– removing a printer that is no longer required (see also page 19).
R SW option
Installing or de-installing a software version.
R Update
To install a new software version from a CD:
– Insert an update CD into the drive.
– Click on Update to start the software update installation routine.
– Follow the instructions on the screen up to the restart prompt (see
Section Update Installation, page 102).
– Remove update CD from the drive. If the IOLMaster reappears in
New Patient mode after restarting, the installation of the
software update has been completed.
R Service
For servicing purposes and password-protected.
Caution:
Unauthorised persons may under no circumstances use the service
password. The safety warranty for the medical device will otherwise
become invalid!
• Turn the device on at the power switch (1, Fig. 9). The device will
start automatically and perform a self-test, after which the Patient
Manager screen will appear (Fig. 25).
• After switching on the device will prompt a daily calibration check
prior to patient measurements.
• After confirming with OK check the measurement functions as
described on page 104.
Caution:
Axial length [ALM], corneal curvature [KER], anterior chamber depth
[ACD] and white-to-white [WTW] should never be measured through
contact lenses as this produces incorrect results.
Minus -
Dot .
Apostrophe '
Underline _
The personal data of patients not yet listed in the database (New
Patient) must be entered via the keyboard; no special characters other
than "-", ".", "’" and "_" are permissible.
To move the text cursor to the next dialog box press the TAB or ENTER
key or click the mouse.
Note
Depending on the program setting (see page 32), the entry of
either the last and first name (case-sensitive) and date of birth or
an ID No. is mandatory.
The date of birth will be accepted depending on the Windows
setting; the year may also be entered as a four-digit number (yyyy)
– mandatory for patients over a hundred years old!
Note
It is recommended that the patient’s refraction data, if known, be
entered in the respective boxes. Visual acuity data can only be
entered in the data format set in Program Settings (see page 32).
Note
Refer to page 70 for working with the database field.
In Program Settings you can set the number of days after which
a data record is automatically deleted (5 to 365 days).
• To close, after entering the date of birth click on the NEW button or
press the ENTER key.
This will automatically activate the Overview [OVW] mode. The
fixation light and light spots will be switched on. The patient will see
a yellow fixation light in the centre and 6 light spots (reflex points in
the patient’s pupil) will appear in the video image.
• Press the NEW PATIENT button to open the New Patient dialog box
in the measurement mode.
• Press the EXIT icon in Patient Manager to quit the program and
Windows.
The corresponding display field next to the video image will show the
measured axial length. The video image will be overlaid with a red
graph similar to those in ultrasonic measuring instruments. The signal-
noise ration [SNR] will be displayed simultaneously as a value. This value
is a gauge of the quality of measurement. Measurements with an SNR
between 1.6 and 1.9 appear with an exclamation mark (!) after the
reading and the message "Borderline value!" will appear. (evaluation of
SNR see Post-run editing of axial length measurements, page 78 ff.).
Readings that deviate from the internally calculated mean value by more
than 50 μm are shown in red and marked "multiple peaks".
Note
"Borderline value!"(Uncertain value) does not necessarily mean
that the reading is incorrect and must be rejected. It rather means
that all axial length measurements for the eye should be checked
for plausibility and consistency, e.g. according to the usual
ultrasonic biometry criteria. If the "uncertain" values are
determined to concur with the other readings, the readings
marked "Borderline value!" should also be accepted as valid axial
lengths.
Note
The IOLMaster requires five measurements to be taken! The
message Measure again will thus appear. Only then will the
composite signal be calculated and displayed as a blue
measurement curve following the red individual measuring signal.
If an axial length measurement can be determined from this
composite signal, it will be transferred to the IOL calculation and
an evaluation will be performed. Only the number of
measurements is crucial here. To obtain consistent results we
recommend checking the individual axial length measurements
and carrying out further measurements if necessary.
Note
Defocusing and shifting the reflection within the circle will have
no effect on the result, because interferometric axial length
measurement is completely independent of distance.
• For the next measurement of this eye, press the button in the
joystick.
Warning
Up to 20 such measurements per eye may be taken on a single day.
Avoid measurements of eyes with retinal detachment. In such cases,
measuring errors cannot be precluded.
As a rule, the axial length should be viewed together with the values for
corneal refraction and overall refraction, and checked for plausibility. It
is likewise helpful to compare the right and left eyes.
Until an axial length can be determined from the composite signal, the
word Evaluation! will be displayed below the horizontal line in the list
of measurements. If necessary, the potential individual measurement
errors must be deleted or the composite signal post-run edited, as the
readings obtained will not otherwise be accepted for the IOL calculation
and database for optimisation of the lens constants. Until the fourth
individual measurement has been taken, the last reading will be
highlighted in blue. From the fifth individual measurement onwards, the
composite signal is highlighted in blue. The blue highlighting can be
moved through the table of individual readings with the aid of the
cursor buttons np. In this way the signal curves of the individual
measurements can be displayed. Deleted individual measurements can
be restored with the shortcut <CTRL> + <Z>. The composite signal can be
displayed by clicking on the composite reading.
Error in the display field denotes readings with an SNR smaller than 1.6.
The following plausibility tests are performed with the axial length
measurement (AL) from the composite signal:
AL < 22mm (indication of short ocular axis, use corresponding
biometric formula)
AL > 25mm (indication of long ocular axis, use corresponding
biometric formula)
When both eyes have been measured, the difference in axial lengths
between right and left is also checked. If the latter exceeds 0.3 mm, a
message appears to check the readings once again.
If this warning appears, be sure to verify that no pathological changes
have occurred in the eye. If necessary, the measurements must be
repeated (provided the maximum of 20 measurements per eye and day
has not already been reached). Only confirm the warning with OK if you
are certain that the readings are plausible. Otherwise, determine what
has caused the implausible readings. A reference to the displayed
plausibility test message will be transferred to the comments box.
If the axis length of eyes with phakic implants not listed in the additional
AL settings is to be measured, the following compensation values
according to PD Dr Wolfgang Haigis of Würzburg University Clinic,
Germany, should be used.
IOL centre
thickness 0.2 mm 0.5 mm 0.8 mm
Fig. 29 AL settings IOL material
Silicon 3 (SLM2) -0.02 mm -0.04 mm -0.07 mm
Sample calculation for a phakic PMMA -0.02 mm -0.06 mm -0.09 mm
implant (Acrysof) with a centre
thickness of 0.2 mm: Acrysof -0.03 mm -0.08 mm -0.13 mm
Measured value: 23.51 mm
Compensation value: -0.03 mm Every implant, e.g. a phakic IOL, influences the measurement of axial
Correct axial length: length in PCI biometry. If a phakic implant is measured in a normal
23.51 + (-0.03) = 23.48 mm phakic mode, the result will be slightly elevated. The reading must be
corrected, depending on the material used and the centre thickness.
Warning
Two peaks may appear when measuring pseudophakic eyes and with
certain intraocular lenses. The first peak is a side maximum of the IOL,
while the second peak is produced by the retina. In this case, manual
correction is necessary (see Measuring errors with pseudophakic eyes on
page 76). It is expedient to measure at a number of different points.
Warning
Use the psph (pseudophakic) button to calculate secondary piggy-back
IOLs. For this purpose, the ACD should be measured by a method other
than the IOLMaster and the readings thus obtained entered into the
appropriate boxes.
Note
Ensure that all 6 peripheral points are visible and located in the
field between the two auxiliary circles on the display. It is
recommended that the patient blink his/her eye shortly before
the measurement to produce a continuous tear film. This will
improve the reflectivity of the cornea. The measuring points
should be circular or ellipsoid. If the measuring points are
irregular (i. e. corneal scar) measurement is not possible. Precise
measurements are possible only if the 6 peripheral measuring
points appear optimally focused on the display.
• Trigger the measurement by pressing the knob on the joystick.
Depending on the setting under Program settings/Program (see
page 33), a traffic light will assist in finding the optimum measurement Fig. 30 Setting for keratometer
setting. When the optimum measurement position has been reached, measurement
the traffic light will change from red to yellow to green. Once the
optimum measurement setting (green traffic light) has been reached
and remains constant for all three measurements, pressing the knob on
the joystick in Automatic mode (Automatic activated) will trigger
three consecutive measurements. The automatic measurement
procedure will be interrupted if the optimum measurement setting
(green light) wavers and is resumed when the optimum setting is
reinstated.
Note
The IOLMaster requires three measurements to be taken! The
message Measure again will thus appear. Only then will a mean
value be passed on to the IOL calculation and an evaluation
Fig. 31 Measurement point not enabled. Only the number of measurements is crucial here.
identified
Note
In some cases (keratoconus, keratoglobus, corneal lesions, etc.) it
may not be possible to reach the green traffic light. In such cases
the traffic light display can be briefly deactivated, enabling a
measurement to be taken even when the light is on yellow or red.
To do this, press the <M> key. The Automatic display will
disappear. However, now pay attention to the correct setting, as
described above. Press the <M> key once again to reactivate
automatic. Automatic will always be switched back on for a new
patient.
If the last three readings differ by > 0.5 D (mean value of the spherical
equivalent of the last three measurements) or if the tolerance of the
mean radius of the last three readings of 0.08 to 0.1 is exceeded
(dependent on n), the Evaluation! message will appear on the screen.
• In this case, check the tear film of the eye being examined, ask the
patient to blink if necessary and repeat the measurements until the
results are within the tolerances. The Evaluation! message will then
disappear.
Warning
To obtain consistent results we recommend checking the individual
keratometer measurements and carrying out further measurements if
necessary.
When both eyes have been measured, the difference in the keratometer
readings between the right and left eye will be checked. If this exceeds
0.2 mm or 1 D, you will be prompted to check the readings once again.
As a rule, the image of the fixation point will lie between the images of
the cornea and the crystalline lens. It should be close to (but not within)
the optical section of the crystalline lens! For system reasons, the
corneal image will be out of focus.
Note
The alignment of the device, particularly in the case of small
pupils, requires a certain amount of practice on the part of the
operator and cooperativeness on the part of the patient. The
alignment procedure is easier on a dilated pupil (see also Tips for
anterior chamber depth measurement, page 93 ff.).
• Trigger the measurement by pressing the knob on the joystick.
Note
Before starting, tell the patient to look steadily at the fixation light
– not into the slit projector, as the latter will flicker during the
measurement! When an acoustic signal is heard – the slit will
again illuminate steadily – the measurement has been completed
and the ACD values will be calculated.
A blue status bar will appear in the message bar. Five ACD readings will
be listed in the display field next to the video image, together with the
calculated mean value.
Note
This UNDO function itself is irrevocable!
Warning
The patient should be asked if he or she sees the fixation point. If the
patient fails to fixate properly, the visual axis will not be correctly
recognised, which may result in measuring errors.
• Trigger the measurement by pressing the knob on the joystick.
Each time the joystick knob is pressed, an image of the eye is displayed,
in which the detected iris edge is marked. After checking that the iris
and fixation point have been correctly recognised, confirm with OK.
Only then will the data be valid and available for further processing.
Warning
The validity of the WTW determination depends on this check of
correct recognition of the iris edge.
The WTW value is the horizontal diameter of the iris. In addition to the
WTW value, the deviation of the visual axis from the centre of the iris
(x, y) will also be displayed (Fig. 34).
The values are stated in millimetres with reference to a Cartesian
coordinate system, the zero point of which is assumed to be in the
established centre of the iris or pupil. If the visual axis is above the iris or
pupil centre, the Y value will be positive; if it is below, the value will be
negative.
X values to the left of the centre are negative; those to the right are
positive.
Note
If the software has difficulty detecting the iris or fixation point,
this may be due to inadequate room lighting. It is recommended
that the front panel and examined eye be shielded from direct or
lateral light. The best results will be obtained when the
examination room is slightly darkened.
WTW measurement may be repeated as often as desired.
Note
After each change of side, the overview mode [OVW] is
automatically activated for coarse alignment.
Printout of results
Once the measurements have been completed, the readings, composite
signal and a diagram of iris, pupil and WTW can be printed out.
Caution
Consult the user manual supplied with the printer. Connect the printer
as described in Setting up the device for use on page 19.
Note
The following print formats are supported (upright format only):
A4 (210 x 297 mm), Letter (8.5” x 11.0”), B5 (182 x 257 mm).
Note
Do not take any further measurements during the printing
process.
Press the PRINT icon or <P> key to start the printing process
Note
In ALM mode the printout of the graph with the blue highlighted
reading can be enlarged by pressing <CTR> + <P>. For enlarging
the display of the graph see page 77.
In WTW mode the current reading can be printed out using
<CTR> + <P>.
Warning
If the ACD constant is not available, you may click the ADD button after
entering the A constant. All parameters will automatically be calculated
from the A constant according to standard formulae. However, the
manufacturer’s A constants are not optimal for optic biometry and may
result in refractive deviations.
Note
Only constants optimized for optical biometry should be used for
calculating the suggested strength of the intraocular lens to be
implanted with the IOL Master, not the manufacturer’s IOL
constants (see also pages 63 and 82).
• If you use lenses graded in 0.25 D intervals (in future), activate the
Power Steps 0.25 D radio button.
• To add data to the database, click the ADD button.
• To delete the data of the lens type selected in the Lens field, click the
ERASE button.
• By clicking the SET button, existing lens data will be overwritten by
edited data.
• To enter the data of the next lens, overwrite the name of the lens.
Exit the User Database by clicking on OK.
IOL calculation
Start the calculation by:
• clicking on IOL or pressing the <I> button.
• Click on the appropriate tab to select the desired formula. The IOL
Haigis, HofferQ, Holladay, SRK II, and SRK®/T formulae are
implemented as standards.
• After refractive corneal surgery the Haigis-L or Prior refractive
surgery tabs may be selected.
• Selected phakal implants may be calculated with the Phakic IOL tab.
• Select the eye surgeon’s name. This gives the surgeon access to lens
types saved to his database.
• The measured values may be edited if desired.
Warning
Edited readings appear with an asterisk (*) in the printout of the lens
calculation and the lens calculation is no longer based on the
IOLMaster readings!
• Select an eye for which the IOL is to be calculated on the screen.
• Enter the desired target refraction. No entry means 0 D (plano).
• Select suitable lenses from the lens types shown.
• After you have entered the necessary data, click on the IOL
CALCULATION button. This will start IOL calculation of each lens type
selected. The calculation will be performed for every measured eye.
However, only the data of the selected eye is displayed on the
screen.
• To change the display, select the other eye under Surgical Eye. The
lenses calculated for the other eye will now be displayed.
In the columns below each specified lens you will find the calculated
refractive powers and target refractions for those lenses. The middle line
appearing in bold type indicates which refraction of the corresponding
IOL comes closest to the desired target refraction.
Warning
The IOL calculation is valid only if the biometric measurement was
correct, an appropriate IOL calculation formula was selected and the IOL
constants were optimized for the specific application.
The data calculated for the IOL to be implanted can be printed out.
• For this purpose, click on the PRINT button.
The IOL data of both eyes or of one eye and emmetropic IOL will be
printed out either on a single page or on separate pages, depending
on the option selected in the Program Settings menu (page 32).
• Click on OK to finish IOL calculation.
Warning
This step is necessary only with corneas pretreated by refractive
surgery. With untreated corneas, IOL calculation starts instantly upon
selection of the biometric formula (see IOL calculation on page 56).
For the calculation of the IOL, the corneal K’s selected by the examiner
with APPLY will be transferred to the IOL calculation table. The IOL
calculation can be started after selection of the biometric formula.
In the ideal case, the refractive power of the contact lens back surface is
equal to the unknown corneal refraction. For this purpose, several hard
plane contact lenses with refractions of the back surface between 30
and 45 D should be available. For the calculation of the corneal
refraction, enter the appropriate patient data into the display mask. The
values will now be calculated.
For the calculation of the IOL, the corneal K’s selected by the examiner
with APPLY will be transferred to the IOL calculation table. The IOL
calculation can be started after selection of the biometric formula.
Warning
The calculated refractive power/radii values may not be edited in the IOL
calculation window for the selected formula!
The corneal K’s transferred to the IOL calculation are marked in the
printout of the lens calculation with (**) and the calculation method.
Haigis L method
In contrast to the above-described methods of determining corneal
refraction, the Haigis formula allows for surgical changes to the cornea
and permits the calculation of the IOL from the measured values AL,
Corneal K’s and ACD.
Warning
The formula may only be used for eyes with myopic Lasik, myopic PRK
and myopic Lasek.
Lenses by hyperopic Lasik/Lasek/PRK or myopic/hyperopic RK should
never be calculated.
The corneal radii and axial lengths measured by the IOLMaster are
required for the formula! The measured values cannot be edited here.
The manufacturer’s IOL constants are used for calculating lens strength.
Fig. 41 Lens model
Warning
Please observe the manufacturer’s recommendations for the phakic IOL
employed with regard to choice of lens type and critical distance to the
endothelium.
4-in-1 calculation
Special filter functions allow fast selection of patient data. The right
column shows the list of all patients available for optimisation.
• Click on the desired patient data record in this list to select it.
• Select the eye to be used for the optimisation calculation. The fields
below show the measurement data of the IOLMaster.
• If you wish the data of the other eye to be kept in the data table for
further optimisation, activate Keep other side in the check box.
• Click on the << button to load the selected data record in the left-
hand table. These data records are intended for IOL optimisation.
• Transfer at least 11 data records into the left-hand table in this way.
• Click on the >> button to return the selected data record to the right-
hand table if it is not to be used for optimisation, but should be kept
for possible later use.
• Click on the ERASE button to irrevocably delete the data record to the
right or left.
• When all the desired data records have been loaded into the left-
hand table, press OK to return to the optimisation box (Fig. 44).
• Further patient records can be added to the left-hand list for
subsequent additional optimisations.
Note
The data contained in the database (right- and left-hand table)
will not be deleted automatically and are thus available for later
additional optimisations. A backup should be made at regular
intervals by transferring data to an office management system or
a printout.
This will bring up an input mask for creating a new data record to be
optimised. However, this data record may be used for optimisation only,
not for IOL calculation. Nor does it appear in the patient database.
Warning
Only data obtained from the IOLMaster may be entered in the fields for
pre-operative data! When entering the refractive power, make sure
that the same keratometer refractive index is set on the IOLMaster as on
the keratometer used for the measurement (see page 33).
The entry of data measured on ultrasound devices will yield
incorrect results!
Warning
The data records of patients who have undergone refractive surgery of
the cornea should be excluded from optimisation.
• Complete the entries in the input mask.
Note
The entry of the Exam date is mandatory!
Entry of ACD data, Surgery Date and Post-Op Date is optional.
Note
There should be a period of at least 8 weeks between the surgery
and post-op dates. (This period, however, will not be checked!)
• If you wish to reject the entries made and return to the optimisation
calculation, click on the CANCEL button.
• To confirm the new data record and add it to the list of data records
to be used for optimisation, click on the OK button. The new data
record is shown in the Data Records field. It is displayed in the list of
data records.
Note
There should be a period of at least 8 weeks between the surgery
and post-op dates. (This period, however, will not be checked!)
• Complete all selected patient data records in this way. The number
of data records containing IOL and post-op ref data and the total
number of loaded data records is specified in the Data Records box.
The boxes beneath it show the number of data records in the specified
axial length ranges.
Once all IOL and post-op data has been entered, the requirements for
the optimisation calculation have been met.
R If a patient data record is highlighted in red, no IOL and/or post-op
ref data has been entered for this data record or a measured value
(AL or KER) is missing!
R If a data record is highlighted in yellow, no ACD values exist as yet:
a0 (Haigis formula) will not be optimised with such data records!
R Patient data records appearing on a white background contain all the
data required for optimisation.
Note
Only the a0 can be optimised with the device software for the
Haigis formula. For the optimisation of a0, a1 and a2 (more than
200 data records required) please send this clinical data to
Carl Zeiss Meditec.
Starting optimisation
• Start the optimisation calculation by clicking on the OPTIMIZE button.
Depending on the number of data records to be processed, the
computing process may take some seconds.
The optimised lens constants will now be displayed in the New column.
Note
Data records with an IOL power of 0 D will not be included in the
optimisation process.
If less than 11 data records exist for optimisation or data records are
rejected (0 D), "---" will appear in the New column. In this case the
optimisation has failed.
Note
The displayed a0 value does not take into account the data
records highlighted in yellow!
• To reject the last optimisation run, click on CANCEL. In this case, the
optimised constants will not be saved to the lens data base, even if a
new data record has been entered.
• Confirm the newly optimised lens constants by clicking on the <<
button to the right of the Basis field. In this case, all optimised
constants will be accepted. If you want to accept a special constant
only (e. g. a0), click on the << button right of this constant.
New patient
Note
Data is available in the internal database for the period preset in
the Database box under Program Settings (see page 32).
After entering new patient data and confirming with <ENTER> or NEW,
the device switches to Overview (OVW) mode
Note
The above order of measurements is only an example. You may
also run the above-described measurements in a different order.
The only requirement is that the keratometer measurement
precedes the anterior chamber depth measurement.
The IOLMaster keeps an internal patient file. All data is stored here and
can be retrieved (viewing, post-treatment, printing).
Note
The file is not designed for archiving patient and measurement
data.
The database field is structured similar to Windows Explorer (see Fig. 25,
left side). A + sign at the branch indicates that the database already
contains measurement results for this patient.
• Click on + to display the treatment data for the last measurement(s).
To close, click on the – sign.
The data records are sorted alphabetically by last name.
Use the Search textbox to quickly access a data record. Place the cursor
in this box and type in the desired last name to list all relevant data
records. The following letters of the name can also be entered; this
ensures fast access to the desired data record.
To take a new measurement, click the NEW button or use the keyboard
shortcut <ALT> +< N>.
Deleting a patient/measurement
• To delete a patient from the patient list, highlight the name and
press <DEL> or select Erase from the Patient menu.
• Confirm the delete action with YES. Personal data and individual
measurements for this patient will be irrevocably deleted in the
Patient Manager. The numerical measurement data will still be
available in the database for optimisation of lens constants.
Note
If you are working with the option User login with password,
you may only delete patient data if you have the appropriate
rights (see User Manager on page 35).
If a measurement date is highlighted, only the data for this examination
date will be deleted. The patient name and other measurement data will
be retained.
Note
In Options – Setup – Program Settings you can set the number
of days after which a data record is automatically deleted (5 to
365 days).
Renaming a patient
To edit the last name, first name, date of birth or ID No. of a patient,
follow this procedure:
• Highlight the patient’s name and press <CTRL> + <U> or select
Rename in the Patient menu.
The patient data can be edited in the dialog box which now appears.
Once the renaming has been confirmed, patient data for all
measurements will be changed. Measurement results cannot be
renamed!
• Confirm the changes with RENAME.
Note
Transmitting/exporting does not work in the Patient Manager,
only in measurement modes!
Note
The PC must have been switched on and the software for data
receipt started. A progress bar will be visible on the IOLMaster
screen. Data can be archived on the PC or processed in the
appropriate form.
Note
The export of measured values depends on whether the additional
software Option A plus is installed:
– Without Option A plus: only the measured values and the
marked IOL will be exported.
– With Option A plus the measured values and all calculated
lenses will be exported (see page 32 f), depending on the
setting in Program Settings/Export.
Note
If you wish to export to a CD-RW, you must insert a formatted
CD-RW into the drive. The CD-RW must be formatted elsewhere
(e.g. office PC) in UDF format. Alternatively, use one of the
formatted CD-RWs as supplied. For exporting to an USB flash
drive the latter should enable at least a transfer rate to USB-1.1.
• To export data to a USB storage medium or a CD-RW press the <X>
key or the EXPORT icon.
Data will be available in a text file conforming to the export settings (see
page 34) for archiving and data analysis.
Note
The device may not be switched on again until the switch lamp
goes off!
Caution
If the device is switched off at the power switch while it is in operation,
the program will quit automatically before the device shuts down. It is
thus important to wait until the switch lamp goes off before pulling the
power supply plug or switching off at the main room switch.
If the device is unplugged or switched off at the main room switch
while the device is still running, the program cannot quit and the
operating system cannot be shutdown properly; this can lead to loss of
saved data and/or defects in the devices’s control software. This does
not present a hazard to patients or the operator.
Note
The procedure described below does not apply in the case of
breakdowns (see page 101) or if the device does not respond to
your input! If this occurs, switch off the device immediately and
pull the power supply plug! Label the device as being defective
and call Carl Zeiss Service.
Warning
This reading may be used after verification and comparison with other
data from this series of measurements.
Possible reasons:
– unsteady (non-fixating) patient,
– strong ametropia,
– dense medial opacity along the visual axis.
Fig. 51 Axial length measurement of pseudophakic eyes; double peaks with certain
IOL; Source: W. Hill, Mesa, Arizona
Note
In zoomed views, the axial
length scale is not visible!
For simplification reasons, the illustrations below do not show the video
image.
Fig. 52 Presentation of the graph of the third axial length measurement without video
image
SNR categories
The SNR is automatically analysed while the system is internally
calculating the axial length from the interference signal.
Note
In this case, "Borderline SNR" or "uncertain" does not mean an
incorrect result, it is only to remind you to verify this
measurement!
Example:
Fig. 53 Moving the measuring cursor to a different peak (signal curve zoomed in 3
times)
Note:
This manipulation will work only if the measuring cursor is moved across
the (local) maximum of the desired target peak. This procedure is
necessary for the search algorithm to reliably find the desired peak
without returning and snapping in to the original (higher) peak.
Closely adjacent peaks (double peaks) cannot be separated by this
automatic method unless the curve adjoining them drops down below a
value which is less than half the amplitude of their maxima.
Note
While the measuring cursor is being dragged, the original reading
and SNR are always displayed alongside the composite signal. The
new axial length value and corresponding SNR will be calculated
and displayed only when the button is released.
Note
This manipulation should always be performed in a zoomed view!
• Proceed as described above under item 1, but use the right button to
drag the measuring cursor. This way the automatic peak detection is
deactivated and the white dot can be positioned at any point over
the measuring curve.
• When the button is released, the current axial length and the new
SNR will be calculated and displayed.
Here again, the recalculated axial length is shown in the display field
with an asterisk (*).
Note:
Even if the manipulations are undone with the measuring cursor (by
moving it back to the automatically found maximal peak) and the
measured value agrees with the original one, the asterisk after the
measured value will remain, indicating that the curve has been
deliberately manipulated!
Note
Ultrasonic biometrical instruments measure the axial length as the
distance between the cornea and the inner limiting membrane,
because the sound waves are reflected at this membrane.
To ensure that the measured values obtained with the IOLMaster
are compatible with those obtained through acoustic axial length
measurement, the system automatically adjusts for the distance
difference between the inner limiting membrane and the
pigmented epithelium. The displayed axial length values are thus
directly comparable to those obtained by immersion ultrasound!
Deviations may nevertheless occur between the displayed axial
lengths and ultrasonic readings (particularly in the applanation
procedure). At this point, the importance of re-personalising the
"lens constants" should be stressed, because the IOLMaster is
based on a new, more precise measuring technology.
Refer to the specialist literature and publications by the originators
of the IOL formulae regarding the personalisation of constants.
With an optimally aligned device, relatively clear eye media and slight
ametropia (< 6 D), the secondary maxima will be detected symmetrically
on each side of the actual measuring peak. These are caused by the
measuring light source used and maintain a constant distance of
approx. 0.8 mm to the measurement signal and to each other,
irrespective of the specific circumstances of the measured object. For
this reason, the secondary maxima are similarly always visible in
measurements of the supplied test eye.
Examples:
or or or
Note
The resolution of fine retinal structures is clearly distinguishable
from the previously mentioned secondary maxima, which are
further away from the multiple peaks and symmetrical to them.
The distance between the maximum peak and internal limiting
membrane or choroid is 350 μm (whereas the secondary maxima
are about 800 μm from the maximum peak!).
Usually, the signal amplitude of the peak from the inner limiting
membrane is smaller than that of the interference on the pigmented
epithelium. In such a case the automatic algorithm finds the correct
axial length.
Warning
Never move the measuring cursor manually to the (left) peak produced
by the inner limiting membrane (see above)!
In rare cases the amplitude of the signal from the inner limiting
membrane may be higher than that of the reflected light from the
pigmented epithelium. In this case, the automatic peak detection will
recognise the signal from the ILM.
Fig. 56 Signal curve with higher signal from inner limiting membrane (double zoom)
Triple peaks
In rare cases, the measuring beam may also be reflected by the vessels
of the choroid.
In the above example, the signal from the RPE (middle peak) has the
highest amplitude. The automatic peak detection system has correctly
recognised this measured value as the axial length, so that the
measuring cursor may not be moved.
This type of rare triple peak clearly differs from the secondary maxima
produced through the light source by the distance from the RPE
reflected peak.
The automatic peak detection system will find an axial length value that
is too short by approximately 150 to 350 μm.
Following the comparison of all measured values and curves for this eye,
the measuring cursor must be moved manually to the middle (smaller)
peak produced by the RPE. This measured value is thus corrected and
shown in the display field with an asterisk.
Double peaks
In very rare cases signals may be produced by both the pigmented
epithelium and the choroid.
Fig. 59 Double peak produced by pigmented epithelium and choroid (double zoom)
Here again, the automatic peak detection system has placed the
measuring cursor at the correct position, as the (correct axial length)
signal from the pigmented epithelium has the greater amplitude. The
measuring cursor may not be moved.
Note
Such a curve may only be evaluated correctly by viewing all
measuring curves of this eye. Such a curve must be clearly
distinguished from double peaks produced by the inner limiting
membrane and the RPE (see Fig. 55)! It may be advisable to
perform further individual measurements. Up to 20 measurements
may be taken on one day.
Note
The peripheral infrared measuring marks will be invisible to the
patient. (However, in a darkened room an attentive observer may
perceive the measuring marks as faint red dots when looking into
the projectors of the keratometer.)
When adjusting the device, make sure that all 6 peripheral points are
visible and located in the field between the two auxiliary circles, as
closely as possible to the centre of the display. The images of the
measuring marks on the display must be optimally focused by varying
the distance between patient and device. The images of the measuring
marks should be circular or ellipsoid. Provided the traffic light function
has been activated, a green light will appear when the measurement
setting is optimum.
Fig. 60 Optimally aligned device (shown without cross hairs and auxiliary circles; the
central fixation point is distinctly fainter than the measuring points)
Note
Depending on the reflectivity of the cornea, the image of the fixation
point may be barely visible. This is irrelevant for the calculation of the
corneal curvature, as the position of the fixation point will not be
evaluated.
Measuring errors
The "Error" message may have two basic causes:
R The results of the internal individual measurements vary by more than
0.05 mm (very rare, defocused device).
R The measuring marks are either indiscernible or not recognised as
such.
Misadjustments
Defocused device
Cause The images of the measuring marks are too large, because the device is
defocused. The system cannot calculate a measured value and "Error"
appears in the display field.
Remedy The measurement can be retaken after correcting the focus adjustment
to minimise the peripheral mark size. Sometimes, with exactly adjusted
focus, small circles (like haloes) may be visible around the six peripheral
measuring points. In this case, focusing is optimum.
Fig. 62 The upper two measuring marks are concealed by the eyelid
"Error" appears the display field. This error may also occur if the Cause
patient blinks during measurement (0.5 s). This is particularly the case
with restless or anxious patients.
Ask the patient to open his or her eyes wide and repeat the Remedy
measurement. If measurement is still not possible, gently lift the upper
eyelid, as is usual in tonometry.
Warning
Take care not to deform the eyeball! Pressure on the globe causes a
deformation of the cornea and results in incorrect radius and refraction
measurements.
Other findings
Pseudophakic eyes
Reflections from
cornea
Remedy Try moving the device approximately 1 mm away from the patient’s eye
(defocusing) and take the measurement. The images produced at the
cornea will now be slightly larger, while the artifacts of the IOL become
fainter, such that the evaluation process may not identify them as
measuring points; a measurement is then possible. If this procedure
does not succeed, the corneal curvature cannot be measured.
Dry eye
Fig. 65 Light trail (bottom) due to a dry eye (at top additional disturbance by an
eyelash)
If the tear film is suddenly interrupted, the reflectivity of the cornea will
be greatly reduced at these points and the cornea will scatter the light
Cause
more strongly. If a measuring mark is projected to such a region, the
otherwise circular or ellipsoid image of the measuring mark will become
irregular. Irregular marks and/or multiple reflections will form. In this
case, a precise measurement of the corneal curvature will not be
possible. The results will fluctuate or the "Error" message will be
displayed.
Ask the to patient blink several times to replenish the tear film on the Remedy
cornea, then take the measurement immediately or use a tear
supplement to prevent rapid drying.
Scars and local irregularities on the corneal surface impair the imaging
Cause quality of the measuring marks. Depending on the extent and location
of the artefacts, measuring errors may occur.
Remedy Try to position the measuring mark adjacent to, above or below the scar
by slightly displacing the device relative to the eye, then take a
measurement. In such cases, it is advisable to repeat the measurement
several times. Depending on the degree of irregularity, fluctuations or
measuring errors may occur.
Note
In this case, keratometer measurements cannot be taken with the
IOLMaster.
Fig. 68 Optimally adjusted optical section for anterior chamber depth measurement
Note
The image of the fixation point may not lie in the image of the
lens or cornea!
If the device has been properly aligned, the images of the fixation point
and the anterior crystalline lens will be simultaneously in focus, as they
are approximately in the same plane.
As a rule, the image of the fixation point lies between the image of the
anterior lens and that of the cornea if the device is optimally aligned.
Note
The image of the fixation point should be near (but not in!) the
image of the lens.
The patterns to the left of the corneal image are direct reflections of the
luminous light exit aperture of the lateral slit projector. These reflections
are not needed for the calculation of the anterior chamber depth. They
must not affect the image of the cornea (see below).
Warning
Failing to satisfy the above requirements for the measurement of the
anterior chamber depth will either result in measuring errors or the
measured values shown will be incorrect. Because of the complexity of
the images measured, measuring errors may under certain
circumstances not be recognised as such.
The IOLMaster must be adjusted very carefully for anterior chamber
depth measurements.
Note
It is advisable to measure accommodating patients under
cycloplegia.
Measuring errors
The "Error" message may have two basic causes:
R The results of the five internal individual measurements vary by more
than 0.15 mm (very rare), or
R the images produced (optical sections) do not contain relevant
structures (normally without the edge of the crystalline lens) or
disturbances are preventing their detection.
Incorrect settings
Defocused device
If the device is not optimally focused, the image of the fixation point
will be larger and fainter. At the same time, the images of the front
Cause
edge of the lens and/or the cornea may become so faint that they
cannot be recognised as such. In such a case, the system displays an
"Error" message and an explanatory text indicates which image details
are either missing or could not be recognised correctly.
Improve the focus adjustment of the device and repeat the Remedy
measurement. The fixation point must be optimally focused.
Note
As a rule, slight defocusing of the device does not have a
significant affect on the anterior chamber depth measurement.
Cause Particularly in the case of eyes with small pupils, it is possible that no
light is reflected back into the viewing optics of the device. A slight
lateral misalignment may make the lens invisible. This problem may also
appear with patients who are restless or fixate poorly.
In such a case, the slit image on the iris is (almost) continuously visible.
Cause The automatic evaluation software does not recognise this kind of
maladjustment. The system will display values that are too short.
These values do not correspond to the actual anterior chamber depth,
but represent the distance between the anterior cornea and the iris. The
value displayed is not the exact reading for the anterior chamber depth!
Remedy Adjust the device laterally until the anterior lens becomes visible. If
necessary, ask the patient to look steadily at the fixation light. Then,
repeat the measurement.
Note
It suffices if a relatively small section of the lens is visible. The
picture below shows an alignment which permits accurate
measurement.
If the image is laterally misaligned, the image of the fixation point may
possibly lie within the lens image.
Cause
Position the device so that the fixation point lies between the images of Remedy
crystalline lens and cornea. Then, repeat the measurement.
Remedy Adjust the device laterally until the corneal image is undisturbed. As a
rule, the fixation point will then be between the image of the anterior
lens and that of the cornea. Repeat the measurement.
Pathological findings
Dry eye
Ask the to patient blink several times to replenish the tear film on the Remedy
cornea, then take the measurement immediately or use a tear
supplement to prevent rapid drying.
Fig. 76 Condition after keratoplasty (same eye as shown in Section Tips for
keratometer measurement, Fig. 67, page 92)
Scars and local irregularities of the anterior cornea impair the image
Cause quality of the optical section of the cornea.
Depending on the extent and degree of these irregularities, this may
lead to measuring errors.
Warning
To obtain reliable data, all the other known facts and findings of this
eye should be included in the evaluation.
Ask the patient to relax and look at the yellow fixation light.
Focus on the iris, not on the light spots. Adequate room lighting will
facilitate the detection of iris structures. Avoid direct exposure of the
eye and device front panel to extraneous light.
In particular, ensure that the visible right and left edge of the iris is not
disturbed by reflections from lamps and windows.
If the iris structure is not discernible, focus on the edge of either iris or
pupil.
After the image has been taken, the operator should check if the
software has correctly detected the edge of the iris. If the circle
segments drawn in the image do not define the iris correctly, the result
must be discarded. Click on OK to confirm the results and save the data.
Troubleshooting
If the system fails during operation, take the following steps to restart:
• Switch on the power supply at the power switch (1, Fig. 9).
An automatic test program will run before Windows is launched.
Once this has been successfully completed, Windows and the device
program will be restarted and work can be resumed.
Caution
Pulling the power supply plug or cutting off the power while the device
is running may cause a loss of data and/or defects in the device’s control
software. However, no danger to the patient or user ensues as a result.
If you wish to switch off the IOLMaster after the software update, click
on the EXIT icon and confirm with OK. Do not switch the IOLMaster off
at the power switch until the cursor on the screen can no longer be
moved using the touchpad (for IOLMaster with black power switch) or
the screen is completely black (IOLMaster with green illuminated power
switch).
The test eye must be clean. If the test eye for the IOLMaster is not
available, abort the calibration process with Cancel. The
Adjustment aid will then be deactivated in the Program Settings
dialog and can no longer be used.
If the software is unable to perform the calibration (message
described under item 10 is repeatedly displayed), the cause may be
inadequate room lighting. It is recommended that the front panel
and test eye be shielded from direct or lateral light. The best results
will be obtained when the examination room is slightly darkened.
The test eyes supplied with the device (1, Fig. 77) are for verifying that
the device is serviceable and properly calibrated. Measurements can be
performed on these test eyes as with a human eye. Last, first name and
date of birth are mandatory here as well! The supplied scale is to be
used for checking the WTW value (optional).
Warning
The calibration must be checked every day before starting
measurements on a patient. The measured values can be printed out
and filed for documentation purposes. If the values obtained from the
test eye are not within the given tolerances, no patient measurements
may be taken! The device must be shut down immediately and secured
against inadvertent use. Then notify Carl Zeiss Service.
• Insert the asymmetrical holder (5, Fig. 77) into the holes adjacent to
the chin rest (the holding pins for the paper pads (4, Fig. 77) may
1 Test eye holder need to be removed beforehand).
2 Test eye for [ACD] The test eye (1, Fig. 77) is secured by a locking screw and mounted on a
3 Set values and tolerances mandrel which allows it to rotate (7, Fig. 77). The respective set value
4 Location hole and tolerance (3 and 6, Fig. 77) for checking the calibration status are
5 Asymmetrical holder marked on the test eye (1, Fig. 77).
6 Set value and tolerance
7 Locking screw In the delivery condition a patient !CHECK DEVICE! with birth date
8 Test eye for ALM and KER 01/01/1911 has been entered. Because of the exclamation mark in front
of the name, this "patient" will always be at the top of the patient tree
in the Patient Manager and can thus be easily found every day.
Fig. 77 Setting up the test eye
The test eye (8, Fig. 77), marked with AL, R, the respective set values
and tolerances (6, Fig. 77) is used for checking the axial length (AL) and
keratometer (R).
The measurements should be taken in the same way as for a human
eye.
If the readings (in the case of the keratometer, the radius) are within the
tolerances stated on the holder (6, Fig. 77), the device is properly
calibrated.
The (larger) test eye (2, Fig. 77) on the side of the test eye holder (1, Fig.
77) (marked with the ACD, set value and tolerance) is for checking the
anterior chamber depth measuring device. The surface structure
simulates the cornea. Before starting measurements it must therefore be
clean and grease-free (wipe off with a dry cloth!).
• The measurements should be taken in the same way as for a human
eye. On the video screen verify that the adjustment criteria for an
optimum optical section are correct, as for measuring the ACD on
the human eye (see page 50).
• Here again, if the measured values lie within the given tolerance, the
anterior chamber depth measurement is functioning correctly.
Note
Although the side (right or left on the simulated eye) is immaterial for
checking the axial length measurement and keratometer, because the
beam path for the measurements is rotationally symmetric, it is
recommended that the asymmetrical holder (5, Fig. 77) be reversed
when checking the anterior chamber depth measurement and the check
performed on the other side. When comparing right and left, however,
care must be taken to ensure that in both cases the test eye (2, Fig. 77)
is positioned exactly vertically in front of the device.
Note
The test eyes are ideally suited to practising the operation of the
IOLMaster.
The status of the Test eye is also reset each time a new patient (<N> or
icon) is admitted.
Warning
If the test eye readings are not within the given tolerances, the device
must be shut down. Notify Carl Zeiss Service.
1 The WTW scale (optional) (2, Fig. 78) is for verifying the WTW reading.
• Take a measurement.
If the reading is within the tolerances, WTW determination has been
properly calibrated.
Note
The WTW scale must completely fill the video window. The scale
(black lines) must appear in focus.
Printer troubleshooting
Please use only printers recommended by Carl Zeiss Meditec. The
printers currently recommended can be found at:
http://www.meditec.zeiss.com/iolmaster.
The printer models listed there have been tested in conjunction with the
IOLMaster and provided the instructions for setting up (see page 19) are
observed, the IOLMaster/printer system will operate reliably.
Should printing problems occur, delete all printer drivers not used.
• Click on Printer from the Options - Setup pulldown menu.
• Select the connected printer and designate it as the standard printer
(check the appropriate box in the File menu).
• Open the queue by double-clicking on the standard printer and
delete all print jobs in the list by highlighting and pressing the <DEL>
key.
• Select the printers not connected (except New Printer) and press the
<DEL> key. Follow the instructions displayed on screen.
• Re-close the printer file once the unwanted printer drivers have been
removed.
Caution
When cleaning, the greatest care must be taken to prevent moisture
from penetrating the device or keyboard, as this may cause damage.
R All parts of the casing may be wiped off with a moist but not drip-wet
cloth. Wipe off any marks or stains with distilled water, to which a
drop of household washing up liquid has been added.
R Never use aggressive or abrasive cleaning agents.
R Use conventional cleaning cloths for wiping off the display and
keyboard of computers and monitors.
R Contaminated parts with which the patient has come into contact
during the examination (chin rest, forehead rest) should be cleaned
with a disinfectant approved for the purpose. These parts are resistant
to wiping off with low toxic agents (e.g. suds, quaternary ammonium
compounds) and intermediate agents (e.g. alcohol, Javel water, iodine;
classification pursuant to: Disinfectants and activity spectrum
according to the Center for Disease Control and Prevention, Atlanta,
USA).
R Remove dust from optical surfaces by means of a fine brush.
R If necessary, carefully clean these surfaces with a water-free ether/spirit
mixture (9:1) applied with a cotton swab. The swab or lens-cleaning
instrument should be moved with a circular motion from the centre of
the lens to the edge. Ensure that the regulations for inflammable
liquids are observed,
R To protect from dust, cover the system using the dust cover provided
when not in use.
R Packaging materials should be retained for future relocation or repair
or may be returned to the supplier as required.
Safety inspections
To ensure it remains in perfect operating condition, the device should
undergo an annual safety check (visual inspection, protective conductor
resistance and discharge current measurement). The safety checks must
be carried out by an authorised specialist.
Please observe national safety regulations.
Storage environment
Temperature –10 to +55 °C
Relative humidity 10 to 95 %, no condensation
Air pressure 700 to 1060 hPa
Measuring range
Axial length
Area 14 to 40 mm
Resolution of display 0.01 mm
Keratometer
Area 5 to 10 mm
Resolution of display 0.01 mm
Anterior chamber depth
Area 1.5 to 6.5 mm
Resolution of display 0.01 mm
White to White (optional)
Area 8 to 16 mm
Resolution of display 0.1 mm
Comparison/reproducibility
Comparison of IOLMaster measurements vs. conventional measurements of the human eye
Mean value of deviation Standard deviation
Axial length* -0.03 mm ±0.21 mm
Corneal curvature ** -0.01 mm ±0.06 mm
Anterior chamber depth* +0.12 mm ±0.18 mm
IOLMaster reproducibility ***
Relative to standard deviation in
human eye
Axial length ±0.0256 mm
Corneal curvature ±0.0129 mm
Anterior chamber depth ±0.0334 mm
* In comparison to precision immersion ultrasound instrument
** In comparison to manual keratometer1
*** Standard deviation (basic calculated simple standard deviation)2
1
acc. to abstract "First experiences with a New Optical Biometry System" by B.A.M. Lege, W. Haigis
2
cf. "Reproducibility of Measurement in Optical Biometry: Intraobserver and Interobserver Variability"
by A. Vogel, B. Dick
Optical radiation
Light spots/WTW determination
Source LED
Wavelength 880 nm
Delivered power < 100 μW
Axial length measurement
Source Semiconductor diode laser (MMLD)
Wavelength 780 nm
Max. power for measurement 450 μW
Max. power for alignment 80 μW
Measuring time for individual
measurement 0.5 s
Pulse width 20 per eye and day
Number of possible individual 1 (DIN EN 60825-1:2003)
measurements 3B
Laser class
Embedded (not accessible)
Fixation light for keratometer and anterior
chamber depth measurement and WTW
determination LED
Source 590 nm
Wavelength < 1 μW
Delivered power
Illumination for keratometer measurement
Source LED
Wavelength 880 nm
Delivered power < 50 μW
Slit illumination for anterior chamber depth
measurement, integral irradiance
UV (300 to 400 nm) 0.00087 mW cm-2
IR (700 to 1100 nm) 0.04 mW cm-2
(in spectral range of 860 to 1100 nm no detectable emission
from light source)
LB (phakic eye) 122.8 W (m2 sr)-1
LA (aphakic eye) 125.5 W (m2 sr)-1
Spectral irradiance
"Optical axis" or "0°" corresponds to the direct view into the illuminating projector.
33° is the angle for the intended use in anterior chamber depth measurement.
3.5
3
LA in (W/(m 2 sr))/nm
2.5
1.5
0.5
0
300 350 400 450 500 550 600 650 700
The spectrally assessed photochemical radiation densities LB and LA are a measure of the risk of
photochemical damage of the retina through light. LB represents the measure for the phakic eye, LA
represents the measure for the aphakic eye or for the eyes of very young children. Readings of LB and LA in
2 -1
excess of 800 W(m sr) are considered high. The radiation dose of the retina for a photochemical risk is
calculated as the product of radiation density and exposure time.
The recommended radiation dose is based on calculations of the American Conference of Governmental
and Industrial Hygienists (ACGIH) Threshold Limit Values for Chemical Substances and Physical Agents
(Edition: 1995-1996).
The measured photometric values of the IOLMaster are far below the levels that are regarded as high.
Thus, the risk of damage through optical radiation is extremely low. Nevertheless, anterior chamber depth
measurement with the IOLMaster should be limited to the time absolutely necessary for the diagnosis.
The risk of damage may be higher, if fundus photography of the patient to be examined has been taken
within the last 24 hours.