Zeiss IOLMaster 500 User manual

IOLMaster 500
Option Reference Image
Documentation set

© 2022, Carl Zeiss Meditec AG, Jena
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Contents
User manual
IOLMaster 500, Option Reference Image
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Appendix
IOLMaster 500 - Option Reference Image - Quick instructions
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1

IOLMaster 500
Option Reference Image
User manual

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Contents
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Contents
Contents.....................................................................................1
Notes on the user manual ..........................................................3
Purpose and availability of documentation .................................................... 3
Questions and comments................................................................................ 3
Note on the addendum...................................................................................4
Explanation of symbols used ..........................................................................4
Package check list......................................................................5
Country-specific information and labels.....................................6
Classification/Manufacturer's declaration ......................................................6
Option Reference Image purpose ...................................................................6
Side effects and contraindications..................................................................6
Intended user profile....................................................................................... 6
Disposal of the product .................................................................................. 7
Labels.............................................................................................................. 8
Performance specifications ......................................................10
Functional description...................................................................................10
Description of the device..........................................................11
Installation ...............................................................................12
Software update to version 7.7 ....................................................................12
Installation of hardware components ......................................14
Operation of the instrument ....................................................17
User's safety obligations...............................................................................17
Activate Automatic Reference Image ...........................................................17
Automatic Reference Image................................................................................................... 17
Measurement and image capture in Reference Image mode .......................18
Printing the reference image ........................................................................22
Application guidelines for Reference Image measurement......23
Evaluation of reference image quality ..........................................................23
Ambient and room lighting conditions of device location...................................................... 23
Stray light from local light sources or lateral sunlight............................................................. 24
Eye is not correctly centered.................................................................................................. 25
The palpebral aperture is not large enough ........................................................................... 26
Excessive eye movements prevent images of sufficient quality from being obtained ............. 27
Few vessels near the limbus................................................................................................... 28
Fluctuations in keratometer values ........................................................................................ 29

Contents
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Care and cleaning .................................................................... 30
Technical data.......................................................................... 31
Essential performance of Option Reference Image ...................................... 31
Device specifications .................................................................................... 31
Abbreviations/Glossary ............................................................ 32
Figures ..................................................................................... 33
Index........................................................................................ 34

Notes on the user manual
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Notes on the user manual
The Option Reference Image may only be used in conjunction with the
IOLMaster 500 to capture images in which sclera vessels in the vicinity of the
limbus are discernible in conjunction with superposition of the principal
meridian of corneal curvature measurement.
Purpose and availability of documentation
This user manual explains the safety precautions, functions, usage,
performance parameters and measures for care and maintenance of the
Option Reference Image.
Correct operation of the system is imperative for its safe and successful
functioning. You should therefore ensure that you are thoroughly familiar
with this user manual before setting up and using the Option Reference
Image for the first time.
The user manuals and other documentation enclosed with the IOLMaster
500 should be kept accessible to users at all times to ensure that the
information required for use of the Option Reference Image is readily
available.
All safety notes and information on device and software operation in the
user manual and software description of the IOLMaster 500 must be
observed.
Questions and comments
If you have any questions or comments concerning this user manual or the
device, please contact ZEISS customer service or your local dealer. (Contact
details see reverse.)

Notes on the user manual
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Note on the addendum
This addendum is only valid in conjunction with the IOLMaster 500 user
manual.
Explanation of symbols used
The symbols used in this user manual refer to important safety information
which may warn against possible health risks or fatal injuries and contain
useful notes. Whenever you see these symbols, read the accompanying
information carefully and observe all safety notes and information in this
user manual and on device labels.
WARNING
Indicates a hazardous situation which could result in death or serious
injury if the appropriate safety precautions are not heeded.
CAUTION
Indicates a hazardous situation which could result in minor or moderate
injury if the appropriate safety precautions are not heeded.
CAUTION – PROPERTY DAMAGE
Indicates possible device damage if the appropriate safety precautions are
not heeded.

Information, hints and advice for better understanding of the
instructions to be observed in the operation of the device.

Package check list
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Package check list
The scope of supply of the Option Reference Image contains the following
components:
•Documentation set
•Green Illumination with USB control
•1 USB flash drive with IOLMaster 500 update software
•2 Sleeves
•5 Holding clips
•2 Clip-on side covers for head rest

Country-specific information and labels
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Country-specific information and
labels
Classification/Manufacturer's declaration
WARNING – GENERAL HAZARDS
This device may only be set up, operated and used for the specified
purpose and according to national regulations, consistent with the
applicable industry standards and occupational safety and accident
prevention regulations. Further notes on classification are to be found in
section Technical data,page 31 and following.
This declaration shall be rendered invalid if changes are made to the product
without the manufacturer’s authorization.
The product is RoHS-compliant according to Directive 2011/65/EU.
Option Reference Image purpose
The Option Reference Image may only be used in conjunction with the
IOLMaster 500 and is intended for use as a preoperative and postoperative
image capture tool.
The user is liable for any use of the device other than intended.
Side effects and contraindications
The Option Reference Image should not be used on patients with rotational
nystagmus.
Intended user profile
CAUTION - RISK OF OPERATING ERRORS
Federal law restricts this device to sale by or on the order of a physician or
practitioner.

Country-specific information and labels
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Disposal of the product
CAUTION – RISK OF ENVIRONMENTAL POLLUTION
Packaging materials should be retained for future relocation or repair.
If you decide to dispose of the packaging material, submit it to a recognized
collection system for recycling.
The device contains electronic components. At the end of its lifetime, the
device and its integrated batteries should be disposed of in accordance with
the relevant national regulations.
In accordance with national regulations at the time at which the product
was brought onto the market, the product specified on the consignment
note is not to be disposed of via the domestic waste disposal system or
communal waste disposal facilities.
For further information on disposing of this product please contact your
local dealer or the manufacturer or its legal successor company. Please read
the latest information provided on the manufacturer's website.
If the product or its components are resold, the seller must inform the buyer
that the product must be disposed of in accordance with the currently
applicable national regulations.

Country-specific information and labels
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Labels
Fig. 1Warning and information labels on the device

Country-specific information and labels
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Item Label Explanation
1
Type label IOLMaster 500 Option
Reference Image
Manufacturer
2
Identification label
IOLMaster 500 Option Reference Image
REF Catalogue number/part number
SN Serial number
3
Sign with manufacturing date
Date of manufacture
4
Sign with CSA approval for USA and
Canada
5
Not applicable Not applicable

Performance specifications
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Performance specifications
Functional description
The Option Reference Image is an accessory of the IOLMaster 500. In
conjunction with keratometer measurement it allows images to be captured
in which the vessels near the limbus are highlighted using contrast-
enhancing illumination. To this end, the patient's eye is illuminated by four
green LEDs during adjustment of the optimum measurement position and
image capture.
As soon as the Option Reference Image is connected to the USB port of the
IOLMaster 500, the Reference Image mode is enabled as indicated by a new
icon appearing in the navigation bar of the IOLMaster 500 user interface.
The Option Reference Image functionality can be accessed and processed in
Reference Image mode.

Description of the device
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Description of the device
1Holder
2Connecting cable
35 holding clips
44 green LEDs
52 sleeves to insert into the drill holes on the IOLMaster 500
6USB control for green LED
7Right and left pins on the holder
8Protecting cap of USB control
92 clip-on side covers for head rest
Fig.
2 Option Reference Image

Installation
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Installation
Software update to version 7.7
1 Button for starting software update
Fig. 3 Software update
To install a new software version from a USB flash drive, proceed as follows:
1. Connect the USB flash drive with the new software version.

Prior to installation all other flash drives must be removed from the
IOLMaster. During installation only the USB flash drive with the
new software may be plugged in.

A software update to Version 7.7 requires the installation of
Version 7.x. If you do not have Version 7.x you must perform the
update in two steps (first to Version 7.x, then to Version 7.7).
1

Installation
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2. To start the installation routine of the software update, click the Update
button of the Program tab in the Settings menu.
3. Follow the instructions on the screen until prompted to reboot.
4. Remove the USB flash drive. When the New patient tab reappears in the
Patient manager after the IOLMaster has been rebooted, the software
update installation is complete.

Installation of hardware components
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Installation of hardware
components
WARNING – GENERAL HAZARDS
The device may not be stored or operated in ambient conditions other
than those prescribed (see Technical data section on page 31 and
following).
CAUTION – GENERAL HAZARDS
When mounting the Option Reference Image ensure that you do not trap
your fingers between the device and the spring holder.
•Insert the two sleeves (2, Fig. 4) into the two upper drill holes (1, Fig. 4)
on the right and left side of the IOLMaster 500 facing the patient.
•First insert the pin (3or 5, Fig. 4) into the sleeve on one side of the
holder.
•Carefully pull the holder (4, Fig. 4) apart and put the second pin
(3or 5, Fig. 4) of the holder into the sleeve on the other side of the
IOLMaster 500 so that it clicks into place.
1Drill hole
2 Sleeve
3 Left pin of holder
4 Holder
5 Right pin of holder
Fig.
4 Mounting the holder