Reichert TONO-PEN XL User Manual
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Reichert TONO-PEN XL User Manual

Tonometer
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TONO-PEN
XL Tonometer
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User's Guide

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Summary of Contents for Reichert TONO-PEN XL

  • Page 1 TONO-PEN XL Tonometer ® User’s Guide...
  • Page 2 ©2012 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 Setup Calibration Taking a Measurement Interpreting the LCD Maintenance & Storage Specifications Symbols Troubleshooting Guidance and Manufacturer’s Declaration Accessories Warranty 68E3441 Rev.F...

  • Page 4: Introduction

    (IOP) for suspected glaucoma, or when increased intraocular pressure is suspected. Contraindications None: Components The Tono-Pen XL unit (see Figure 1) is provided in a storage case, complete with: • OCU-CEL™ XL Batteries (P/N 230570) • Stylus Blade for battery replacement (P/N 23050140) •...
  • Page 5 Introduction (Continued) Instruction Manual Tono-Pen XL OCU-CEL XL Tonometer Batteries Stylus Blade Figure 1 Tono-Pen XL Components (in Storage Case) 68E3441 Rev.F...

  • Page 6: Warnings And Cautions

    WARNING: If this instrument is modified, appropriate inspection and testing must be conducted to ensure continued safe use of this instrument. WARNING: Do not use the TONO-PEN XL tonometer on a patient without an OCU-FILM tip cover or inaccurate readings may be obtained.
  • Page 7 CAUTION: Do not attempt to modify the TONO-PEN XL tonometer or the TONO-PEN XL POWERCEL battery pack or damage to the device may occur. CAUTION: Do not store the TONO-PEN XL tonometer without an OCU-FILM tip cover or debris may enter the sensor and transducer assembly and cause malfunctions.

  • Page 8: Setup

    Setup Set Up Instructions To set up the Tono-Pen XL for operation, follow the instructions listed below: Remove all protective packaging materials. Carefully remove the tonometer and accessories from the case. Check for missing items. Visually check the instrument and accessories for damage.

  • Page 9: Battery Installation

    Figure 3 Ocu-Film Tip Cover Placement Battery Installation The Tono-Pen XL is supplied with four OCU-CEL XL 3.0 volt lithium manganese dioxide batteries that need to be installed in the Tono-Pen XL. It is recommended that Reichert OCU-CEL XL Batteries be used when the batteries need replacement.
  • Page 10 Setup (Continued) Figure 4 Replacing Batteries 68E3441 Rev.F...

  • Page 11: Calibration

    Calibration Calibration Procedure The TONO PEN XL unit is internally calibrated, thus the instrument calibration should be checked only before the first use each day or in the event of unanticipated readings. Calibration must be routinely and successfully performed once daily prior to instrument use. Calibration should also be performed whenever it is indicated by the LCD display, when batteries are replaced, or after an unsuccessful calibration.
  • Page 12 Note: Do not take measurements with the instrument if two consecutive [good] calibration checks cannot be obtained. The instrument will not take a measurement when the prior calibration check was [bAd]. Note: If the Tono-Pen XL fails to yield a [Good] calibration, call Reichert Technical Service. 68E3441 Rev.F...

  • Page 13: Taking A Measurement

    To help prevent build-up of debris around the probe tip, spray the probe tip with compressed gas before the first use of the day. Cover the Tono-Pen XL probe tip with a new Ocu-Film Tip Cover. Reichert Ocu-Film Tip Covers are: •...
  • Page 14 Brace the heel of your hand on the patient’s cheek for stability while holding the Tono-Pen XL unit perpendicular to and within 1/2 inch of the patient’s cornea. (See Figure 6 for correct positioning.) To initiate an IOP measurement, depress the Operator’s Button once, and only once.
  • Page 15 Once activated, after [====] is displayed and a “beep” tone is heard, touch the Tono-Pen XL unit to the cornea lightly and briefly, then withdraw. Repeat several times. The corneal surface needs only to be momentarily contacted; indentation is not required and may lead to inaccurate readings.

  • Page 16: Interpreting The Lcd

    • “Good” indicates the calibration check procedure was successful. After two “Good” calibration checks, the Tono-Pen XL unit is ready for use in patient examinations. • “bAd” indicates the calibration check procedure was unsuccessful and must be repeated.

  • Page 17: Maintenance & Storage

    If the Tono-Pen XL unit is not to be used until a subsequent day, the instrument and accessories should be replaced in the storage case provided. If the Tono-Pen XL unit is not to be used for an extended period of time, remove the batteries from the instrument. Tono-Pen XL Body Avoid any shock or excessive vibration which will damage the unit.
  • Page 18 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 XL tonometer with an Ocu-Film tip cover installed to protect the tonometer tip from dirt and contaminants.
  • Page 19 Tono-Pen XL batteries to avoid possible damage to the instrument due to battery leakage. Disposal At the end of their service life, dispose of the Tono-Pen XL, Ocu-Film, and batteries according to your local laws and ordinances regarding the proper disposal of any of the above items.

  • Page 20: Specifications

    5 - 80 mmHg batteries OCU-FILM TIP COVER Contains natural rubber latex. SOFTWARE REVISION The software revision can be obtained by contacting Reichert, Inc. The serial number identifies the manufacture date and will provide access to the software version 68E3441 Rev.F...

  • Page 21: Symbols

    Symbols Attention, See Instructions for use Catalog Number Serial Number Date of Manufacture 2012 Waste of Electrical and Electronic Equipment Compliance to Medical Device Directive 93/42/EEC Consult Instructions for Use Fragile Contents in Shipping Container Do not get Shipping Container wet Type B Applied Part SYMBOLS FOR Ocu-Film TIP COVERS ONLY Do not reuse.

  • Page 22: Troubleshooting

    Overview This section provides a guide for troubleshooting some basic Tono-Pen XL operational problems. If a problem persists after using this guide contact Reichert technical service. Table 6-1: Tono-Pen XL Troubleshooting Guide Symptom Probable Cause Correction “Lob” Batteries are displayed...

  • Page 23: Guidance And Manufacturer's Declaration

    All Equipment and Systems Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Tono-Pen XL is intended for use in the electromagnetic environment specified below. The customer or user of the Tono-Pen XL should ensure that it is used in such an environment. Electromagnetic Environment Emissions Test...
  • Page 24 Equipment and Systems that are NOT Life-supporting Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Tono-Pen XL is intended for use in the electromagnetic environment specified below. The customer or user of the Tono-Pen XL should ensure that it is used in such an environment. Immunity IEC 60601...
  • Page 25 Portable and Mobile RF Communications Equipment and the Tono-Pen XL The Tono-Pen XL is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Tono-Pen XL can help prevent elec-...

  • Page 26: Accessories

    Accessories The Tono-Pen XL has the following accessories: Part Number Description 980079 Instructional DVD 230570 Tono-Pen XL batteries (4 per package) 230635-104 Tono-Pen XL Cleaning Instructions 230651 Blue Ocu-Film (150 per box) 23065070 Carrying Case 23050140 Stylus (opening case and battery removal)

  • Page 27: Warranty

    Lamps, bulbs, charts, cards and other expendable items are not covered by this war- ranty. All claims under this warranty must be in writing and directed to the Reichert factory, Technical Service Center, or authorized instrument dealer making the original sale and must be accompanied by a copy of the purchaser’s invoice.
  • Page 28 Depew, NY 14043 Toll Free: 888-849-8955 Phone: 716-686-4500 Fax: 716-686-4545 reichert.information@ametek.com www.reichert.com AMETEK GmbH Business Unit Reichert Carl-von-Linde-Strasse 42 85716 Unterschleissheim / Munich , GERMANY Tel: +49 (89) 315 8911 0 Fax: +49 (89) 315 891 99 ISO-9001/13485 Registered September 2012...

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