Reichert TONO-PEN AVIA User Manual

Reichert TONO-PEN AVIA User Manual

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TONO-PEN AVIA
®
Tonometer
User's Guide

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Summary of Contents for Reichert TONO-PEN AVIA

  • Page 1 TONO-PEN AVIA ® Tonometer User’s Guide...
  • Page 2 ©2010 Reichert, Inc. The information contained in this document was accurate at time of publication. Reichert, Inc. reserves the right to make changes in the product described in this manual without notice and without incorporating those changes in any products already sold.
  • Page 3: Table Of Contents

    Table of Contents Introduction Warnings and Cautions General Overview TONO-PEN AVIA Tonometer Modes TONO-PEN AVIA Tonometer Verification TONO-PEN AVIA Tonometer Tones Battery Pack Installation and Replacement Liquid Crystal Display (User Interface) TONO-PEN AVIA Tonometer Preparation Verification Mode Performing IOP Measurements...
  • Page 4: Introduction

    CONTRAINDICATIONS None DEVICE DESCRIPTION The TONO-PEN AVIA tonometer is an ergonomic, hand-held tonometer that measures intraocular pressure. The body of the instrument is designed to fit comfortably in the user’s hand, facilitating fast and accurate measurements. The tip of the tonometer contains a sensor that houses a transducer assembly which converts applied force into an electrical signal.
  • Page 5 If used properly, the TONO-PEN AVIA tonometer will provide you with fast, accurate and reliable measurements for many years.
  • Page 6: Warnings And Cautions

    WARNING: An instruction that draws attention to risk of injury or death. CAUTION: An instruction that draws attention to the risk of damage to the product. WARNING: Do not use the TONO-PEN AVIA tonometer on a patient without an OCU-FILM tip cover or inaccurate readings may be obtained.
  • Page 7 CAUTION: Do not attempt to sterilize the TONO-PEN AVIA tonometer or damage to the electronics may occur. CAUTION: Do not attempt to modify the TONO-PEN AVIA tonometer or the TONO-PEN AVIA POWERCEL battery pack or damage to the device may occur.
  • Page 8: General Overview

    LCD - displays the IOP in mmHg, number of applanations collected, statistical confidence indicator, and battery life status LED - green light on in Applanation Mode. Power Supply - TONO-PEN AVIA POWERCEL battery pack Activation Button - Applanation Mode select button. Figure 1. Key Features...
  • Page 9: Tono-Pen Avia Tonometer Modes

    VERIFICATION MODE Pressing and holding the activation button for 5 seconds initiates an electronic self test mode. See “TONO-PEN AVIA Tonometer Verification” section for details. SLEEP MODE A power-saving mode automatically activated after 25 seconds of non-use.
  • Page 10: Tono-Pen Avia Tonometer Verification

    This will ensure that the sensor and electronics are performing correctly. VERIFICATION • Hold the TONO-PEN AVIA tonometer with the sensor end pointing down towards the floor. • Press and hold the activation button for 5 seconds - a beep will sound at one second intervals.
  • Page 11: Tono-Pen Avia Tonometer Tones

    TONO-PEN AVIA Tonometer Tones The TONO-PEN AVIA tonometer generates two different tones. A “BEEP” will sound when: • Power Up Mode fails • Verification Mode fails • Applanation Mode starts • IOP testing is completed • IOP values are out of range (<5 or >55) •...
  • Page 12: Battery Pack Installation And Replacement

    TONO-PEN AVIA POWERCEL battery pack is the only replacement battery that can be used with this device. Insert the TONO-PEN AVIA POWERCEL battery pack into the base of TONO-PEN AVIA tonometer until fully seated. The battery pack is “keyed” for correct installation. Press the Activation Button.
  • Page 13: Liquid Crystal Display (User Interface)

    Liquid Crystal Display (User Interface) ILLUSTRATION NAME RESULT POWER UP MODE - USER INTERFACE SEQUENCE OF EVENTS LED Off User Interface Passed Battery Life Test/ LCD/Battery Test Passed LCD Test 2 (SEE APPLANATION MODE) POWER UP MODE - USER INTERFACE ERROR CODES LED Off User Interface Battery Level Critical (when...
  • Page 14 Range (>55mm Hg) LED Off User Interface Timeout - not enough IOP Error Code values collected VERIFICATION MODE - SEQUENCE OF EVENTS Hold TONO-PEN AVIA User Interface tonometer with transducer Begin Verification down towards floor Mode (LED Off) User Interface...
  • Page 15: Tono-Pen Avia Tonometer Preparation

    Do not use if these conditions are present. Place a new OCU-FILM tip cover over the tip until the ridge is seated, taking care not to apply the tip cover too tightly or too loosely Figure 3. TONO-PEN AVIA Tonometer Preparation 68E3892 Rev. C...
  • Page 16: Verification Mode

    If the verification test resulted with the LCD displaying “Fail”, repeat the verification test, or reference the troubleshooting section for potential causes for test failure. Note: The TONO-PEN AVIA tonometer will remain in the Verification mode until it passes verification. 68E3892 Rev. C...
  • Page 17: Performing Iop Measurements

    (i.e. ear, nose, distant object) to minimize eye movement, with eyes fully open. 4. Hold the TONO-PEN AVIA tonometer as you would a pencil and position yourself to allow viewing of the sensor and the patient’s cornea where contact will be made.
  • Page 18: Applanation

    ” will flash on the LCD, a double row of dashes “===” will be displayed, the green LED will turn on, and a “beep” tone will sound, indicating the TONO-PEN AVIA tonometer is ready to measure intraocular pressure. Tap the sensor very lightly and briefly on the corneal surface, the device will chirp and the DATA field on the LCD will increment for each valid IOP reading obtained.
  • Page 19: Interpreting The Iop Measurement

    If the statistical confidence indicator is 80 or 80-, a repeat measurement is recommended. Figure 4. Closeup of TONO-PEN AVIA Tonometer LCD showing an IOP measurement of 16 and statistical confidence indicator of 95 68E3892 Rev. C...
  • Page 20: Maintenance And Storage

    Do not clean more than 3 times in a row. If the tonometer still will not calibrate, contact Reichert. Note: Always store the TONO-PEN AVIA tonometer with an OCU-FILM tip cover installed to protect the tonometer tip from dirt and contaminants.
  • Page 21 STORAGE • Cover the tip with an OCU-FILM tip cover for protection. • If the TONO-PEN AVIA tonometer is not to be used until a subsequent day, the instrument and accessories should be placed in the storage case provided. •...
  • Page 22: Troubleshooting

    Troubleshooting The table below provides a guide for troubleshooting some basic TONO-PEN AVIA tonometer operational problems. If a problem persists after using this guide contact Reichert technical services. SYMPTOM PROBABLE CAUSE CORRECTION Low TONO-PEN AVIA Replace TONO-PEN Battery symbol POWERCEL battery...
  • Page 23: Specifications

    Relative Humidity range: 50 to 95% RH Atmospheric Pressure range: 500 to 1060 hPa (0.5 to 1.06 bar) RANGE OF IOP ELECTRICAL MEASUREMENTS Input Voltage (TONO-PEN AVIA POWERCEL battery pack) 5 - 55 mmHg 2 x 3 V Lithium Manganese Dioxide batteries OCU-FILM TIP COVER Contains natural rubber latex.
  • Page 24: Guidance & Manufacturer's Declaration

    Guidance and manufacturer’s declaration – electromagnetic immunity - Part I The TONO-PEN AVIA tonometer is intended for use in the electromagnetic environ- ment specified below. The customer or the user of the TONO-PEN AVIA tonometer should ensure that it is used in such an environment.
  • Page 25 Recommended separation distances between portable and mobile RF communications equipment and the TONO-PEN AVIA tonometer The TONO-PEN AVIA tonometer is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the TONO-PEN AVIA tonometer can help prevent electromagnetic...
  • Page 26 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the TONO-PEN AVIA tonometer is used exceeds the applicable RF compliance level above, the TONO-PEN AVIA tonometer should be observed to verify normal operation.
  • Page 27: Symbols

    Symbols Attention, See Instructions for use Catalog Number Serial Number Date of Manufacture Waste of Electrical and Electronic Equipment Compliance to Medical Device Directive 93/42/EEC SYMBOLS FOR OCU-FILM TIP COVERS ONLY Do not reuse. Single Use Use By Lot Number 68E3892 Rev.
  • Page 28: Customer Service Information

    Help Line at 888-849-8955 Note: When contacting our Customer Service and Reichert, Inc. Technical Service Group, please have the appropriate product number, product serial number, date of purchase, and nature of inquiry available.
  • Page 29: Warranty

    (An authorized dealer shall not be considered an original purchaser.) Under this warranty, Reichert’s sole obligation is to repair or replace the defective part or product at Reichert’s discretion. This warranty applies to new products and does not apply to a...
  • Page 30 Patent, Reichert will defend such action at its expense and will pay costs and damages awarded in any such action, provided that Reichert shall have sole control of the defense of any such action with information and assistance (at Reichert’s expense) for such defense, and of all negotiation for the settlement and compromise thereof.
  • Page 31 Notes 68E3892 Rev. C...
  • Page 32 Reichert, Inc. 3362 Walden Ave Depew, NY 14043 Toll Free: 888-849-8955 Phone: 716-686-4500 Email: info@reichert.com www.reichert.com www.tonopen.com Reichert GmbH Hubertusstrasse 2 D-82229 Seefeld Germany Tel: +49-8152-993530 ISO-9001/13485 Registered August 2010 68E3892 Rev C...

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