IOLMaster — Safety Instructions.
Proper operation of the IOLMaster is imperative for its safe functioning.
Before using the IOLMaster, read the entire IOLMaster Instruction Manual,
which may be downloaded by following this link: IOL Master Instruction
Any actions contrary to this manual will
render all warranty claims invalid.
Inspection: To ensure perfect and reliable operation, the IOLMaster
must undergo a safety inspection once a year by a Carl Zeiss Service certified
Identify and Read Safety Labels
LOCATE and READ the IOLMaster warning and information
labels indicated below:
Storage and Conduct
- The IOLMaster must only be stored or operated in environmental
conditions as prescribed in the IOLMaster Technical
Do not operate the IOLMaster:
- in locations subject to hazards, concussion or explosion
- in the presence of inflammable anesthetics or volatile solvents,
such as alcohol, benzene or similar.
Do not store or use the IOLMaster in damp locations. Do not expose the
IOLMaster to moisture of any kind, including water drips, gushes or splashes.
Modifications and repairs, in particular those requiring the IOLMaster casing
to be opened, may only be performed by service technicians employed
or authorized by Carl Zeiss Service.
- Carl Zeiss Service accepts no liability for damage caused by
unauthorized access to the interior of the IOLMaster. Such actions
will render any warranty claims invalid.
- The IOL Master may only be used with accessories and software supplied
by Carl Zeiss Service. Accessories must conform
to IEC 60950-1 or 60601-1.
- The IOL Master may only be operated by trained
In USA, the IOLMaster may only be purchased or ordered by physicians
The IOL Master Instruction
Manual V.4 should always be kept at hand for easy reference.
It is vital to comply with the instructions supplied with
Use only printers approved by Carl Zeiss Meditec.
- Use only the CD supplied by the printer manufacturer to install
the printer software.
- Consult Support.Microsoft.com before using older printers to determine whether printer drivers compatible with the
Windows®XP operating system are available and use these.
- Position the printer at least 1.5 m from the patient's seat at the
- The operator should not simultaneously touch the patient and metal
parts of the printer.
- If a Protection Class II printer (without protective ground terminal) is
used, make sure that a power isolation transformer (see page 19 of the IOL Master Instruction
is connected to the printer power supply cable.
- If a Protection Class I printer (with protective ground terminal) is
used, make sure that it is connected to its own stationary wall
socket of the room's electrical installation or that a power
isolation transformer (see page 19 of the IOL Master Instruction
Manual V.4) is connected into the printer
power line. The required isolation transformer can be obtained
from Carl Zeiss Service.
Light emission from the IOLMaster
The limit values as specified for Class 1 laser devices to EN 60825-1 will
be observed if the IOLMaster is operated as intended.
Shut Down Procedure
- Click on the EXIT icon on the toolbar (shown above).
- Confirm with OK.
- When the "It's now safe to turn off" message appears, turn the
IOLMaster off by the main switch.
The program will automatically close; the readings for the last
patient will be saved and the IOLMaster will shut down automatically
(display goes off).
Internal components remain electrically live after
the IOLMaster has been switched off at the main.
To completely disconnect from the
power supply the IOLMaster must be unplugged. The power cable
should not be pulled or the main switch of the room installation
activated until the screen is blank. Failure to observe these instructions
may result in loss of data.
The IOLMaster'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.
Disposal of the product within the EU
EU directives and national regulations currently in force at the time of
marketing prohibit the disposal of the IOLMaster specified on the delivery
note in domestic waste or by municipal waste disposal companies.
For more information on disposal of the IOLMaster, please contact Carl Zeiss Service or
their legal successors. Please also take note of the current online
information at Carl Zeiss Service.
If the IOLMaster or its components are resold, the seller has the duty to
notify the buyer that the product must be disposed of in accordance
with currently valid national regulations.
The user is responsible for ensuring that:
- The IOLMaster is used in accordance with the instructions provided in this
- Deviations from the target refraction are precluded by proper
handling of the device:
- Patient must fixate correctly
- The IOLMaster must be precisely focused for keratometry or anterior
chamber depth measurements.
- Biometry formula must be properly used
- Only adjusted IOLMaster constants may be used
- The IOLMaster is only used in a perfect operating condition without
- The IOL Master Instruction
Manual V.4 and all accompanying documents are maintained in
good condition and kept on or in the immediate vicinity of the
- Only sufficiently trained and authorized personnel is permitted to
operate, maintain and repair the IOLMaster.
- All operating personnel receives regular instruction on all issues
concerning the IOLMaster and its components, that such persons are
familiar with the IOL Master Instruction
Manual V.4 and, in particular, the safety
- None of the IOLMaster warning signs on the system are removed or rendered
- Before any patient measurements are taken, the IOLMaster is inspected
according to Checking the Measurement Functions; read page 97 of the IOL Master Instruction
- Each day no more than 20 axial length measurements are taken on
each patient's eye.
- An IOLMaster safety inspection is performed on the device each year; read
page 101, of the IOL Master Instruction
in order to guarantee its perfect operating condition.
Medical Standard and Regulation
- The IOLMaster is a Class Ila medical instrument as defined by the
European Medical Device Directive (MDD).
- The IOL Master complies with the EC Medical Device Directive 93/42/EEC
and its national equivalent in the form of the German Medical
Products Act (MPG), as specified in section: Manufacturer's