VISUREF 100 User Manual May 2013

© 2013, Carl Zeiss Meditec AG, Jena All rights reserved in the event of granting of patents or registration as a utility patent. All names of companies and products cited in this documentation set may be trademarks or registered trademarks. References to products of other manufacturers are for information purposes only. Such references are intended neither as an approval nor a recommendation of these products. Carl Zeiss Meditec AG accepts no liability for the performance or use of such products. Other brand names, software and hardware names used in this documentation set are generally subject to trademark or patent protection. The quoting of products is for informational purposes only and does not represent a trademark misuse. The weblinks are dynamic hyperlinks. Before incorporating any links, Carl Zeiss Meditec AG checks their content to ensure that it is not likely to result in civil or criminal liability. It does not, however, continuously check for any changes which could form the basis for liability. If Carl Zeiss Meditec AG determines that a link which it has incorporated could result in civil or criminal liability, or is alerted to the fact by a third party, the link will be removed. This documentation set is protected by copyright. Unless expressly authorized in writing, dissemination, duplication or other commercial exploitation of this document or communication of its contents or parts of it is not permitted. In case of infringement, the violator may be liable to pay compensation for damages. Specifications due to technical developments are subject to change. This documentation set is not subject to the revision service. Please contact the manufacturer or authorized dealer to request the latest edition of the documentation set.

Contents

User Manual Autorefractor/Keratometer VISUREF 100 [000000-2006-367-GA-GB-150513]

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Contents

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Contents Contents ...1 Notes on the user manual ...4 Purpose and availability of documentation ... 4 Questions and comments... 4 Explanation of symbols used ... 5

Package check list ...6 Country-specific information and labels ...7 Classification/Manufacturer's declaration ... 7 Indication for use ... 8 Intended user profile... 8 Disposal of the product ... 9 External labels ... 10

Performance specifications ...12 Functional description... 12 Service life ... 12

Description of the instrument ...13 User interface ... 16 Function key assignment ... 17 Assignment of function keys in main measurement modes... 17 Assignment of function keys in SIZE measurement mode ... 18 Assignment of function keys in ILLUM measurement mode ... 18

Installation ...19 Notes on installation and use ... 19 Unpacking and installing the device ... 20

Daily use ...22 Switching on ... 22

Operation of the device...23 General information ... 23 Measurements with the test eye ... 24 Manual measurement ... 25 Automatic measurement ... 25 Printing ... 26

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Contents

Measuring a patient's eye ... 28 Selecting measurement mode ...28 Regulating the patient's eye level ...28 Focusing...28 Manual measurement (MANU) ...29 Automatic measurement (AUTO) ...29 Continuous measurement ...29 Measuring the other eye ...29 Printing ...29 Measurement modes ... 30 Refractometry (REF) ...31 Keratometry (KER) ...32 RK measurement mode ...33 CLBC measurement mode ...34 Size measurement of pupil and cornea (SIZE) ...36 Examination of the cornea (ILLUM)...38 Display measured data ... 43 User settings... 44 Measurement settings (MEASURE)...44 Printer setup (PRINT) ...46 System setup (SYSTEM) ...48 Other settings (ETC.) ...49

Shutting down ... 50 Switching off the instrument ... 50

Maintenance and care ... 51 Fault remedy ... 51 Error messages when switching on ...51 Error messages when measuring ...51 Error messages when printing ...52 Inserting printer paper ... 53 Maintenance ... 54 Care and cleaning ...54 Control of electrical safety ... 55

Optional accessories ... 57 Transport ... 58 Transport without packaging... 58 Transport with packaging ... 58

Technical data ... 60 Electromagnetic compatibility ... 62 Abbreviations/Glossary ... 67

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Contents

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Figures...68 Index ...69

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Notes on the user manual

Notes on the user manual Purpose and availability of documentation This user manual describes the safety precautions, functions, usage, performance parameters and care and maintenance measures of the VISUREF 100. Correct operation of the system is imperative for its safe and successful function. You should therefore ensure that you are thoroughly familiar with this user manual before setting up and using the VISUREF 100 for the first time. The user manuals and other documentation enclosed with the VISUREF 100 should be kept accessible to users at all times to ensure that the information required for use of the VISUREF 100 is readily available.

Questions and comments If you have any questions or comments concerning this user manual or the VISUREF 100, please contact Carl Zeiss Meditec customer service or your local dealer. (Contact details see reverse).

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Notes on the user manual

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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 may result in fatal or serious bodily injury if the appropriate safety precautions are not heeded. CAUTION Indicates a hazardous situation which may result in minor 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 instrument.

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Package check list

Package check list The VISUREF 100 basic device is supplied with the parts shown in the following figure.

1 2 3 4 5 6

Power supply cable Test eye Printer paper (1 roll installed when delivered) Documentation set Dust cover 2 fuses (see section Technical data, page 60)

Fig. 1

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Package check list

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 60 and following.

This device complies with EU Medical Device Directive 93/42/EEC and its national implementation in the form of the German Medical Products Act (MPG). UMDNS No.:

0297

13-313 (Refractometer, ophthalmic) 12-811 (Ophthalmometer)

This declaration shall be rendered invalid if changes are made to the product without the manufacturer’s authorization. Further notes on electromagnetic compatibility are to be found in section Electromagnetic compatibility, page 62 and following.

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Country-specific information and labels

Indication for use An autorefractor/keratometer is used to determine the refractive and keratometric properties of the human eye. The measured values are used to assist opticians and eye care professionals in the process of prescribing eyeglasses and contact lenses.

Intended user profile CAUTION - RISK OF OPERATING ERRORS This device may only be installed, operated, used and maintained by persons who have been properly trained or who have the required knowledge and experience to do so. Please also adhere to the national qualification guidelines applicable in your country.

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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.

Disposal of the product within the EU In accordance with applicable EU guidelines and 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 internet information provided by the manufacturer. Where 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.

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Country-specific information and labels

External labels

Fig. 2

Labels on the VISUREF 100

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Country-specific information and labels

Item

Label

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Explanation VISUREF 100 type plate

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Manufacturer Date of manufacture Application part type B

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3

VISUREF 100 identification label REF Catalogue number/part number SN Serial number

XX/XXXX

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Sign with date of manufacture CE approval label and disposal advise for EU

0000-033-DE-Vs01

MWIB

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Sign with UL approval for USA and Canada

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Information label "Observe user manual!"

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Warning sign "Risk of electric shock"

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Crushing hazard sign

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Hand hazard sign

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Hand hazard sign

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Performance specifications

Performance specifications Functional description Measurement functions In addition to the usual refractometric and keratometric measurements, this instrument also enables measurement of corneal diameters and the base curve of contact lenses. Dioptric range The VISUREF 100 covers a wide measurement range from -25 D to +22 D so that even a patient with strong refractive errors can be measured. User interface The convenient user interface provides a large 6.4" color LCD screen with a simple and easy-to understand user interface. Illumination for observation This illumination option allows to observe the eye or contact lens surface. The system saves up to two images of each eye.

Service life WARNING - GENERAL HAZARDS The development, production and maintenance of this device, together with associated risks, are based on an expected service life of seven years. Modifications to the product or failure to follow the manufacturer’s instructions may substantially reduce the expected service life and significantly increase the risks associated with the use of this device. It is the responsibility of the institution operating this product to follow the manufacturer’s instructions and to decide on the risk/benefit ratio on reaching the expected service life.

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Description of the instrument

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Description of the instrument

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LCD monitor Print button to start printing Stage locking lever Joystick Measurement button Buttons for chin rest height adjustment Printer cover Function keys F1 to F6 (from left to right) Status LED (continuously lit - device switched on, flashing - screen saver activated)

Fig. 3

VISUREF 100 - View from user side

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Description of the instrument

1 2 3 4 5

Forehead rest Reference mark for optimum eye level of patient Chin rest Dust cap Measurement window

Fig. 4

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VISUREF 100 - View from patient side

Description of the instrument

1 2 3 4 5 6 7

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USB port for PC RS232 port Connection for external video equipment Power switch Power input socket Fuses Stage clamping screw to lock the stage during transportation

Fig. 5

VISUREF 100 - Bottom side

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Description of the instrument

User interface 12

1

11

2

10 9

3 4

5

8 7

6 1 2 3 4 5 6 7 8 9 10 11 12

Left eye symbol (not selected) Patient ID Increment Cylinder units Number of saved measurements in KER measurement mode for the selected eye Assignment of function keys F1 to F6 (from left to right) Selected measurement mode Number of saved measurements in REF measurement mode for the selected eye IOL icon (will only be shown if IOL function key has been pressed) Number of remaining measurements (in automatic mode only) Symbol for automatic/manual measurement release (AUTO/MANU) Right eye symbol (selected)

Fig. 6

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User interface