Ametek Tono-Pen XL User Manual
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Ametek Tono-Pen XL User Manual

Ametek Tono-Pen XL User Manual

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Tono-Pen
XL
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Tonometer
User's Guide

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Summary of Contents for Ametek Tono-Pen XL

  • Page 1 Tono-Pen ® Tonometer User’s Guide...

  • Page 2: Serial Number

    Reichert, Reichert Technologies, Tono-Pen and Ocu-Film are registered trademarks of Reichert, Inc. OCU-CEL is a trademark of Reichert, Inc. AMETEK is a registered trademark of AMETEK, Inc. All other trademarks are property of their respective owners. The information contained in this document was accurate at time of publication. Speci- fications subject to change without notice.

  • Page 3: Table Of Contents

    Device Description.............10 Features ..............10 Parts Identification ............. 11 Available Accessories ..........11 Setup ................12 Battery Installation .............12 Tono-Pen XL Tonometer Preparation ......13 Calibration Procedure ..........14 Instructions for Use............16 Performing IOP Measurements .........16 Interpreting the LCD Screen ........19 Cleaning & Maintenance ..........20 Cleaning Instructions ..........20...

  • Page 4: Warnings & 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 5 Warnings & Cautions (continued) WARNING: DO NOT USE THE TONO-PEN XL TONOMETER IF THE TRANSDUCER ASSEMBLY IS CRACKED, CHIPPED OR SHOWS ANY IRREGULARITY OF THE SURFACE, TO PREVENT PATIENT INJURY, AND/ OR INACCURATE READINGS. WARNING: DO NOT USE EXCESSIVE PRESSURE DURING APPLANATION OR EYE INJURY MAY OCCUR.
  • Page 6 DECREASED IMMUNITY OF THE EQUIPMENT OR SYSTEM. CAUTION: AN INSTRUCTION THAT DRAWS ATTENTION TO THE RISK OF DAMAGE TO THE PRODUCT. CAUTION: DO NOT USE THE TONO-PEN XL TONOMETER WITHOUT AN OCU-FILM + TIP COVER TO PREVENT DAMAGE TO THE TRANSDUCER ASSEMBLY.
  • Page 7 TEMPERATURES EXCEEDING THE RECOMMENDED TEMPERATURES INDICATED IN THE SPECIFICATIONS SECTION OF THIS MANUAL OR DAMAGE TO THE UNIT MAY OCCUR. CAUTION: DO NOT ATTEMPT TO MODIFY THE TONO-PEN XL TONOMETER OR THE TONO-PEN XL OCU-CEL BATTERIES OR DAMAGE TO THE DEVICE MAY OCCUR.

  • Page 8: Symbols

    Symbols Caution Catalog Number Serial Number Date of Manufacture 2017 Manufacturer Waste of Electrical and Electronic Equipment Compliance to Medical Device Directive 93/42/EEC Consult Instructions for Use Authorized Representative in European Community Fragile Contents in Shipping Container - handle with care Do not get Shipping Container wet Type BF Applied Part...

  • Page 9: Introduction

    ® ® tonometer. The Tono-Pen XL tonometer is a prescription only device intended for measuring intraocular pressure (IOP) during routine eye examinations or when increased intraocular pressure is suspected by properly trained eyecare professionals such as ophthalmologists, optometrists, opticians and eye care technicians.

  • Page 10: Device Description

    The Tono-Pen XL tonometer has the following features: • Easy to use - IOP can be measured reliably by medical professionals. • Portable - The Tono-Pen XL tonometer weighs just 59.4 g (2.1 oz) and is battery operated. • Accurate - The measurements from the Tono-Pen XL tonometer correlate strongly with Goldmann applanation tonometry and direct measurements of IOP.

  • Page 11: Parts Identification

    Introduction (continued) Parts Identification A. Tip – location of sensor. B. Transducer Assembly - housing for sensor. C. Activation Button - Applanation Mode select button. D. LCD - displays the IOP in mmHg, statistical confidence indicator, and battery life status. E.

  • Page 12: Setup

    The batteries need to be installed prior to using the instrument. The Tono-Pen XL is supplied with four OCU-CEL 3.0 volt lithium manganese dioxide batteries. Note: The Tono-Pen XL unit will not function properly with mercury bat- teries. Note: It is recommended that Reichert OCU-CEL XL Batteries be used when the batteries need replacement.

  • Page 13: Tono-Pen Xl Tonometer Preparation

    Setup (continued) Tono-Pen XL Tonometer Preparation Allow the instrument to thermally stabilize to room temperature for approximately 30 minutes prior to use. Remove the storage Ocu-Film + tip cover from the Transducer As- sembly. Visually inspect the Transducer Assembly for cracks, chips or other irregularities.

  • Page 14: Calibration Procedure

    Setup (continued) 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 15 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. J...

  • Page 16: Instructions For Use

    3. Instruct the patient to look straight ahead at the fixation target (i.e. ear, nose, distant object) to minimize eye movement, with eyes fully open. 4. Hold the Tono-Pen XL unit as you would a pencil and position your- self to facilitate viewing of the probe tip and patient’s cornea where contact will be made.
  • Page 17 10. Once activated, after [====] is displayed and a “beep” tone is heard, gently apply the Tono-Pen XL tip to the cornea in a brief tapping motion, then withdraw. Repeat several times. The corneal surface needs only to be momentarily contacted; indentation or excessive force is not required and may lead to inaccurate readings or patient injury.
  • Page 18 To take another measurement, reactivate the Tono-Pen XL unit by pressing and releasing the activation switch as described in step 5. Note: If not reactivated within 25 seconds, the Tono-Pen XL unit will automatically turn off and the LCD will clear, placing the device in sleep mode, to conserve battery life.

  • Page 19: Interpreting The Lcd Screen

    • [Good] indicates the calibration check procedure was successful. After two [Good] calibration checks, the Tono-Pen XL unit is ready for use in Figure 7 patient examinations. LCD Showing A Single • [bAd] indicates the calibration check...

  • Page 20: Cleaning & Maintenance

    Note: Ocu-Film + tip covers are the only manufacturer approved covers for use with the Tono-Pen XL tonometer. Use of any other type of branded tip cover may affect readings or may void your warranty. 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 21: Tono-Pen Xl Body

    Tono-Pen XL Body Avoid any shock or excessive vibration which will damage the unit. Clean with a non-abrasive, dry cloth. CAUTION: DO NOT IMMERSE TONO-PEN XL BODY IN FLUIDS. THIS WILL CAUSE DAMAGE TO THE ELECTRONICS AND VOID THE WARRANTY. Battery Replacement The batteries need replacing when multiple beeps sound and “Lob”...

  • Page 22: Storage

    • Cover the tip with an Ocu-Film + tip cover for protection. • If the Tono-Pen XL tonometer is not to be used until a subsequent day, the instrument and accessories should be placed in the storage case provided. •...

  • Page 23: Troubleshooting

    Replace Tono-Pen XL OCU-CEL Noticeable slowing Battery capacity Batteries in the calibration check process, Compressed air cleaning has Allow Tono-Pen XL unit to warm to in activating lowered the temperature of the room temperature instrument instrument Improper technique (Example: too much or too little force used, Review “INSTRUCTIONS FOR USE”...

  • Page 24: Specifications

    Specifications PHYSICAL ENVIRONMENTAL REQUIREMENTS DIMENSIONS Operational Environment Size: 7 1/4” x 1” x 7/8” Ambient Temperature range: 15° to (18.42 x 2.54 x 2.22 cm) 35°C (59° to 95°F) Weight: 2.1 oz. (59.4 g) Relative Humidity range: 30 to 75% Atmospheric Pressure range: 80 kPa to 106 kPa (23.6 to 31.3 in.Hg) 60°C...

  • Page 25: Classifications

    Classifications Tono-Pen XL Regulatory Classification • Insulation Protection: internally powered, 6V battery • Ingress Protection: IPX0 • Applied Part Type: BF • Mode of Operation: Continuous 68E3441 Rev. J...

  • Page 26: Guidance And Manufacturer's Declaration

    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...
  • Page 27 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Tono-Pen XL is suitable for use in 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 28 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 29 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 30: Warranty

    Warranty This product is warranted by Reichert, Inc. against defective material and work- manship under normal use for a period of one year from the date of invoice to the original purchaser. (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.
  • Page 31 Notes 68E3441 Rev. J...
  • Page 32 Manufactured By Reichert, Inc. 3362 Walden Ave Depew, NY 14043 Toll Free: 888-849-8955 Phone: 716-686-4500 Fax: 716-686-4555 Email: reichert.information@ametek.com www.reichert.com Authorized European Representative AMETEK GmbH Business Unit Reichert Carl-von-Linde-Strasse 42 85716 Unterschleissheim/Munich GERMANY Email: info.reichert-de@ametek.com Tel. +49 (89) 315 891 10 Fax.

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