The Zeiss IOL Master has been developed and tested in accordance with Carl Zeiss safety standards as well as national and international regulations. A high degree of instrument safety has been ensured.
Be sure to observe all the safety notes and information in the manual and on device labels. A copy of the complete manual is available for download at:
Throughout our site on the Zeiss IOL Master we have marked certain areas of importance with the following pictograms:
Warning -
safety information!
Caution - danger to instrument!
Proper operation of the IOL Master is imperative for its safe functioning. Therefore, please read these instructions thoroughly before using the instrument. You may obtain further information from the United States call Zeiss Customer Service, Ophthalmic Division by calling:
877-486-7473
Standards and Regulations:
The IOL Master has been designed in compliance with the standards and regulations as specified in section: Technical Data - Compliance.
Quality Assurance of Carl Zeiss meets the requirements as laid down in DIN ISO 9001/EN 46001.
The European Medical Device Directive (MDD) classifies the device as a Class lla device.
The device complies with the EC Medical Device Directive 93/42/EEC and their national equivalent in form of the German Medical Product Act (MPA).
Installation and Use:
Do not operate the IOL Master
- In explosion-risk areas
- In the presence of flammable anesthetics and volatile solvents such as alcohol, benzine or similar chemicals.
Do not store or use the IOL Master in damp rooms. Avoid dripping or splashing fluids near the instrument.
The IOL Master may only be modified and repaired by service technicians employed by Zeiss.
The manufacturer is not liable of damages caused by unauthorized persons tampering with the IOL Master; such tampering will also void any rights to claim under warranty.
Use the IOL Master only with accessory equipment delivered by Carl Zeiss.
Only instructed and trained personnel may operate the IOL Master.
Keep the users manuals always at hand.
The IOL Master may only be opened by service technicians employed with or authorized by Zeiss.
Safe Operation:
Electrical safety
The built-in power supply unit is short-circuit-proof and does not contain externally accessible fuses.
Electrical hazards to patients and operators are eliminated if the IOL Master is used properly.
Only Zeiss-authorized service technicians may open and setup the IOL Master.
Light emission from the IOL Master
The IOL Master emits light in the visible and infrared spectral regions. It keeps the limit values as specified by DIN EN ISO 15004 "Ophthalmic Instruments Fundamental requirements and test methods".
The limit values as specified for Class 1 laser devices by EN 60825-1 are kept only if the IOL Master is operated as intended (limiting 20 axial length measurements per eye and per day).
A maximum of 20 axial length measurements per eye and per day are permitted with the IOL Master. With proper operation of the IOL Master this value cannot be exceeded.
Operational requirements
Please take care that the following operational requirements are met when using the IOL Master:
Use the power cable supplied with the IOL Master. If the instrument is mounted to a Zeiss instrument table, it is powered through this table.
The IOL Master is plugged into a power outlet that has a properly connected protective ground connection.
All cords, cables and plugs are in perfect working condition and secured where provided.
Avoid the use of an extension cord or cable. If the protection is reduced or electrical cords are damaged, discontinue use and take care that the IOL Master is not operated inadvertently. Call Zeiss service.
Proper instrument use
Always enter patient data first (last name, first name, and date of birth).
Before measuring the anterior chamber depth, inform the patient that the light will flicker during the measurement.
Instantly turn off the power switch of the IOL Master and disconnect the power cable if uncertain problems arise.
If the IOL Master does not respond to your commands, turn off the power switch and then restart.
To exit the program when finished with use, click on the button of the toolbar.
Turn instrument off via the power switch.
Intended Use:
The IOL Master is to be used only for the measurement of axial length, corneal curvature, anterior chamber depth, and optionally for "White-To-White" determinations of the human eye, as well as for the calculation of the required intraocular lens.
The responsibility for any other use than the one intended exclusively lies with the user.
The IOL Master may only be used in combination with accessory units approved by Zeiss. Please consult Zeiss or an authorized service representative regarding use of other accessories.
Please check back at regular intervals for updates. Zeiss IOL Master
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Warning -
safety information!
Caution - danger to instrument!
