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 Manual V.4.

Any actions contrary to this manual will render all warranty claims invalid.

Safety Inspection: To ensure perfect and reliable operation, the IOLMaster must undergo a safety inspection once a year by a Carl Zeiss Service certified service representative.

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 Specifications.
• 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 personnel.
• In USA, the IOLMaster may only be purchased or ordered by physicians and ophthalmologists.
• 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 IOLMaster accessories.

Printer Selection

• 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 device.
• 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 Manual V.4) 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.

• The IOL Master may not be connected to portable multiple socket outlets or extension cables.
• The electrical supply used with the IOLMaster must conform to IEC 60364-7-710 guidelines. USA and Canada only: single-phase 120 V AC connections with plug type NEMA 5-15P.
• During use of the IOLMaster, do not use a cellular telephone and other devices not complying with EMC Class B requirements, as its signals may cause the IOLMaster to malfunction. The effect of radio signals on the IOLMaster is dependent on various factors and is therefore not predictable. To avoid electromagnetic interference, the IOLMaster must be installed and operated as described in the IOL Master Instruction Manual V.4 and using only those components supplied by Carl Zeiss Service.
• With the exception of compatible printer drivers, the installation of other software onto the IOLMaster is not permitted! The IOLMaster software programming prevents external (third party) software from being installed on the system.
• The IOL Master may only be connected to private networks that are protected from public networks (Internet) by firewalls conforming to the latest technical standards. Such actions will render any warranty claims invalid.
• The built-in power supply unit of the IOLMaster is short-circuit-proof, and does not contain any fuses accessible from the outside.
• Provided the IOLMaster is properly used, no electrical hazards exist to either patients or operators.
• Only service technicians authorized by Carl Zeiss Service may open or setup the IOLMaster.
• Use the power cable supplied with the IOLMaster. If the IOLMaster is mounted on an IT3L instrument table, it will receive its power supply through the table.
• The main plug of the IOLMaster must be inserted into a power outlet that has an intact protective conductor connection.
• All cables and plugs may be used only if they are in perfect working condition. In particular, the spring action plug for the IOLMaster control must remain plugged in and should not be pulled out.
• If the ground contact is impaired, or if electrical wiring is damaged, the IOLMaster must be taken out of service and measures taken to prevent inadvertent use. Following this, call:

  Carl Zeiss Meditec Service
  877-486-7473.

• Do not cover/obstruct ventilation slots in the computer casing (right and left).
• 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.
• A network isolator can be ordered from Carl Zeiss Service for connection to an external network (NET).
• If either of the error messages "Laser adjustment too high" or "Laser measurement power too high, measurement aborted" appears, the IOLMaster must be shut down Following this, call Carl Zeiss Meditec Service.
• Disconnect the power cable immediately if damage or unspecified problems occur.

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).

IMPORTANT: 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.

Disposal Requirements

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.

User Responsibilities

The user is responsible for ensuring that:

• The IOLMaster is used in accordance with the instructions provided in this manual.
• 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 functional impairment.
• 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 device.
• 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 precautions.
• None of the IOLMaster warning signs on the system are removed or rendered illegible.
• Before any patient measurements are taken, the IOLMaster is inspected according to Checking the Measurement Functions; read page 97 of the IOL Master Instruction Manual V.4.
• 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 Manual V.4, 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 Declaration.