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.
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If used properly, the TONO-PEN AVIA tonometer will provide you with fast, accurate and reliable measurements for many years.
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.
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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.
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...
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.
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.
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) •...
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.
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...
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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...
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...
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...
(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.
” 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.
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...
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.
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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. •...
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...
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.
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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...
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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.
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.
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.
(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...
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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.
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