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.5.

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 Meditec certified service representative.

Identify and Read Safety Labels

LOCATE and READ the IOLMaster warning and information labels indicated below:

Instructions for Installation and Use

This device is a high-quality technical product. To ensure perfect and reliable operation, it must undergo a safety inspection once a year.

• The IOLMaster must ONLY be stored or operated in environmental conditions as prescribed in the IOLMaster Technical Specifications.
• Do not operate the IOLMaster:
  
  
  • in areas 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 rooms. Do not expose the IOLMaster to moisture of any kind, including water splashes, dripping water or sprayed water.
• Modifications and repairs, in particular those requiring the case of the IOLMaster to be opened, may only be performed by service technicians employed or authorized by Carl Zeiss Meditec.
• Carl Zeiss Meditec 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 Meditec. Mains-operated 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.5 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 must always be positioned outside the range of the patient (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 17 of the IOL Master Instruction Manual V.5) is connected to the printer power supply cable.
• Protection Class II printers (without protective ground terminal) whose wattage (power consumption) exceeds the permissible connected load of the power isolation transformer may not be used.
• 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 17 of the IOL Master Instruction Manual V.5) is connected into the printer power line. The required isolation transformer can be obtained from Carl Zeiss Meditec.
• The power isolation transformer may not be used for printers whose wattage (power consumption) exceeds the permissible connected load of the power isolation transformer (e.g. laser printers).

• Additional portable multiple sockets or extension cords may not to be used.
• 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.5 and using only those components supplied by Carl Zeiss Meditec.
• With the exception of compatible printer drivers, the installation of other software onto the IOLMaster is not permitted. The IOLMaster software is programmed to prevent 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 Meditec 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 power supply 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 Meditec 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.

Proper Shut Down Procedure

• Always enter the patient data (last and first name, date of birth) or ID No. (depending on setting in Setup menu).
• Pull the power supply cable immediately if damage or unspecified problems occur!
• Switch off the device as follows:
• Click on the EXIT icon on the toolbar (shown above) or <E> key..
• Confirm with OK or <ENTER>.
• When the "It's now safe to turn off" message appears, turn the IOLMaster off by the main power switch. The program will automatically close; the readings for the last patient will be saved and the IOLMaster will shut down automatically (lamp in the switch goes off).

IMPORTANT: 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. 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. The device may not be switched on again until the switch lamp goes off! The procedure described above does not apply in the case of breakdowns 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.

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

In accordance with applicable EU guidelines at the time at which the IOLMaster 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 more information on disposal of the IOLMaster, please contact Carl Zeiss Meditec or its legal successor company. Please also take note of the latest online information at Carl Zeiss Meditec.

If the IOLMaster 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.

User Safety Obligations

The user of the IOLMaster 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.5 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.5 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, as are contained within the IOL Master Instruction Manual V.5.
• 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, as are contained within the IOL Master Instruction Manual V.5, in order to guarantee its perfect operating condition.

Compliance with Standards and Regulations

• 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.