sistema topografico

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DISPOSITIVO MEDICO

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  • INSTRUCTION MANUAL

    Topographic Modeling System

    TMS-4N

    22CA9090-0B

    Carefully read this instruction manual before using this instrument to ensure correct and safe operation. If you have questions about operations, please contact Tomey Corporation or our local distributor.

    Always follow the operation procedures described in this manual.

    Keep this manual in a readily available location while operating the instrument.

    Contact our local distributor if you lose this instruction manual.

  • i-1

    i. IMPORTANT SAFETY INFOMATION

    DO NOT install this instrument in such a place where explosives or inflammables are used or stored. A fire or an explosion may result.

    DO NOT remove the cover of the instrument. You may directly be exposed to high electric voltage.

    DO NOT disassemble nor modify the instrument. You may directly exposed to high electric voltage.

    DO NOT stare into the laser beam for alignment irradiated from the measuring head.

    The personal computer specified in this manual and an isolation transformer that isolates the power source for the personal computer from the commercial power source are required to use this instrument. Be sure to observe the following precautions related to your personal computer and isolation transformer in order to safely use them as part of this medical equipment system. Refer to 8. Specifications for the performance requirements of the personal computer and isolation transformer. Contact our local distributor or Tomey Corporation if you have any questions.

    Pull off the power cable from the instrument at its maintenance.

    Use a personal computer conforming to IEC60950-1 and an isolation transformer conforming to IEC60601-1.Otherwise, they may not function safely as part of this medical equipment system.

    Connect the power cord of the personal computer to the isolation transformer, not directly to a commercial power source. Otherwise, they may not function safely as part of this medical equipment system.

    Do not place the isolation transformer directly on the floor when in use.

    Do not connect a plug-in socket or extension cord to the isolation transformer.

  • i-2

    DO NOT put water or chemicals on the instrument. An electric shock or a failure may result if those get into the instrument.

    DO NOT connect other things than the specified to avoid possible failure.

    Do not connect electrical appliances not provided in the system package to the isolation transformer. Otherwise, failure may occur in the isolation transformer or electrical appliances.

    This instrument is a diagnostic/measuring device specially designed for ophthalmology. DO NOT use it for other purposes.

    Output terminals are NOT isolated from the inner circuits. Wrong connection may break the inner circuits. Consult us for use of the output terminals.

    When operating this instrument connected to other devices, only use devices that satisfy IEC60601-1 or equivalent safety requirements, or that conform to IEC60950 and whose power source is insulated with the isolation transformer provided with the instrument, in order to satisfy the relevant safety requirements for medical equipment.

    The total rated input of devices to be connected to the isolation transformer is less than 500 VA. Use the transformer to supply power only to devices intended to comprise part of the system.

    Do not connect the power source of the personal computer connected to this instrument for operation directly to the socket on the wall. Otherwise, electric shock or failure may occur.

  • ii-1

    ii. How to read this manual

    Outline

    The Operator Manual is composed of the following parts.

    1. PRIOR TO USE

    Describes safety precautions and important information to be understood before installing and using the instrument.

    2. NAMES AND FUNCTIONS

    Describes names and functions of each section of the instrument.

    3. OPERATION PROCEDURES

    Describes information required for installing and using the instrument.

    4. TECHNICAL INFORMATION

    Describes useful technical information about the instrument.

    5. INSPECTION AND MAINTENANCE

    Describes procedures for replacing consumable parts, etc. that the user of the instrument should normally conduct.

    6. TROUBLESHOOTING

    Describes how to solve problems.

    7. CONSUMABLES AND OPTIONAL EQUIPMENT

    Describes consumable parts and optional equipment.

    8. SPECIFICATIONS

    Describes the specifications of the instrument.

  • ii-2

    SYMBOLS USED IN THIS MANUAL

    Descriptions accompanied by the symbols below indicate the following:

    This is a precaution that, if unheeded, will result in a hazardous situation where there is an imminent danger of serious injury or death.

    This is a precaution that, if unheeded, could result in a hazardous situation where there is a possibility of serious injury or death.

    This is a precaution that, if unheeded, may result in a situation where there is a possibility of minor or moderate injury or damage to property.

    This is additional information which may contain special precautions on company policies related, either directly or indirectly, to the safety of personnel or to the protection of property.

  • iii-1

    iii. CONTENTS

    i. IMPORTANT SAFETY INFOMATION.................................................................................................................. i-1 ii. How to read this manual ................................................................................................................................. ii-1

    Outline .................................................................................................................................................................... ii-1 SYMBOLS USED IN THIS MANUAL ..................................................................................................................... ii-2

    iii. CONTENTS ..................................................................................................................................................... iii-1 1. PRIOR TO USE ................................................................................................................................................. 1-1

    1.1 Precautions for use ................................................................................................................................. 1-1 1.2 Checking package contents ...................................................................................................................... 1-5 1.3 Glossary ..................................................................................................................................................... 1-6 1.4 Intended use .............................................................................................................................................. 1-9 1.5 Outline of operation ............................................................................................................................... 1-9

    2. NAME AND FUNCTIONS ................................................................................................................................. 2-1 2.1 Front side of the Instrument (Physicians side) ....................................................................................... 2-1 2.2 Rear of the instrument (patient's side) ....................................................................................................... 2-2 2.3 Icons on the screen ................................................................................................................................ 2-3 2.4 Symbols ..................................................................................................................................................... 2-4

    3. OPERATION PROCEDURES .......................................................................................................................... 3-1 3.1 Safety precautions ..................................................................................................................................... 3-1 3.2 Initial Setup .............................................................................................................................................. 3-3 3.3 Main Screen ............................................................................................................................................. 3-4 3.4 Patient Record ......................................................................................................................................... 3-14 3.5 Capture Screen (Picture Taking) ............................................................................................................. 3-16 3.6 PreMap Screen ........................................................................................................................................ 3-20 3.7 Exam Screen (Analysis) .......................................................................................................................... 3-20 3.8 Map Screen ............................................................................................................................................. 3-26 3.9 Map Options ............................................................................................................................................ 3-40 3.10 Other Map Display Methods and Applications .................................................................................. 3-48 3.11 Utilities ....................................................................