TONO-PEN AVIA VET™ Veterinary Tonometer User’s Guide
The following are registered trademarks of Reichert, Inc. Reichert ® TONO-PEN AVIA VET™ TONO-PEN AVIA VET POWERCEL® OCU-FILM® ©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.
Table of Contents Introduction 4 Warnings and Cautions 6 General Overview 8 TONO-PEN AVIA VET Tonometer Modes 9 TONO-PEN AVIA VET Verification 10 TONO-PEN AVIA VET Tonometer Tones 11 Battery Pack Installation and Replacement 12 Liquid Crystal Display (User Interface) 13 TONO-PEN AVIA VET Tonometer Preparation 15 Verification Mode 16 Performing IOP Measurements 17 Applanation 18 Interpreting the IOP Measurement 19 Maintenance and Storage 20 Troubleshooting 22
Introduction INTENDED USE The TONO-PEN AVIA® VET 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 veterinarians, and veterinary technicians. Note: The TONO-PEN AVIA VET is not approved for use on humans.
Introduction (continued) This User’s Guide is designed as a training and reference manual for operation, maintenance, and troubleshooting. We recommend that you read it carefully prior to use and follow the instructions in the guide to ensure optimum performance of your new instrument. If used properly, the TONO-PEN AVIA VET tonometer will provide you with fast, accurate and reliable measurements for many years. Please retain this manual for future reference and to share with other users.
Warnings and Cautions WARNING: An instruction that draws attention to risk of injury or death. WARNING: Any repair or service to this instrument must be performed by experienced personnel or dealers who are trained by Reichert so that correct operation of this instrument is maintained. WARNING: Modifications to this instrument is not allowed. Any modification to this unit must be authorized by Reichert so that correct operation is maintained.
Warnings and Cautions (continued) CAUTION: Do not touch the sensor without an OCU-FILM tip cover applied or damage to the sensor and transducer assembly may result. CAUTION: Do not bump, jar or drop the device, or damage to the electronics may occur. CAUTION: Do not immerse the TONO-PEN AVIA VET tonometer in fluids or damage to the electronics may occur. CAUTION: Do not attempt to sterilize the TONO-PEN AVIA VET tonometer or damage to the electronics may occur.
General Overview PRIMARY COMPONENTS AND CONTROLS A. Tip – location of sensor. B. Transducer Assembly - housing for sensor. C. LCD - displays the IOP in mmHg, number of applanations collected, statistical confidence indicator, and battery. life status D. LED - green light on in Applanation Mode. E. Power Supply - TONO-PEN AVIA VET POWERCEL battery pack. F. Activation Button - Applanation Mode select button. D E F A C B Figure 1. Key Features 8 230750-101, Rev. C.
TONO-PEN AVIA VET Tonometer Modes POWER UP MODE Pressing the activation button initiates the battery life, LCD, sensor, and electronic self-test. A successful power-up puts the device automatically into applanation mode. APPLANATION MODE A 15 second interval within which the user should complete the 6 applanations needed to acquire an IOP value. During applanation mode, the LCD will display the IOP and number of applanations collected.
TONO-PEN AVIA VET VERIFICATION If suspect readings are observed, a Verification Procedure routine should be performed. This will ensure that the sensor and electronics are performing correctly. VERIFICATION PROCEDURE • Hold the TONO-PEN AVIA VET 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. At the end of the 5 second button hold, the display will show “dn”.
TONO-PEN AVIA VET Tonometer Tones The TONO-PEN AVIA VET tonometer generates two different tones. A “BEEP” will sound when: • • • • • • Power Up Mode fails Verification Procedure fails Applanation Mode starts IOP testing is completed IOP values are out of range ( >99mhg) At various points during the Verification Procedure. A “CHIRP” will sound when: • A valid IOP measurement has been taken during applanation. 230750-101, Rev. C.
Battery Pack Installation and Replacement The TONO-PEN AVIA VET tonometer is supplied with a TONO-PEN AVIA VET POWERCEL battery pack that needs to be installed prior to use. The TONO-PEN AVIA VET POWERCEL battery pack is the only replacement battery that can be used with this device. 1. Insert the TONO-PEN AVIA VET POWERCEL battery pack into the base of TONO-PEN AVIA VET tonometer until fully seated. The battery pack is “keyed” for correct installation. 2. Press the Activation Button. 3.
Liquid Crystal Display (User Interface) ILLUSTRATION NAME RESULT POWER UP MODE - USER INTERFACE SEQUENCE OF EVENTS 1 User Interface LCD/Battery Test LED Off Passed Battery Life Test/ Passed LCD Test 2 (SEE APPLANATION MODE) POWER UP MODE - USER INTERFACE ERROR CODES User Interface Error Code LED Off Battery Level Critical (when low, symbol will flash) User Interface Error Code LED Off Failed Self Test APPLANATION MODE - USER INTERFACE SEQUENCE OF EVENTS LED On, 1 Beep User Interface Ready to Begi
Liquid Crystal Display (continued) APPLANATION MODE - USER INTERFACE ERROR CODES User Interface Error Code LED Off Error- IOP Value Over Range (>99mm Hg) User Interface Error Code LED Off Timeout - not enough IOP values collected VERIFICATION MODE - SEQUENCE OF EVENTS User Interface Begin Verification Procedure Hold TONO-PEN AVIA VET tonometer with transducer down towards floor (LED Off) User Interface Invert Pen Invert TONO-PEN AVIA VET tonometer (LED Off) User Interface Successful Verification S
TONO-PEN AVIA VET Tonometer Preparation 1. Allow the instrument to thermally stabilize to room temperature for approximately 30 minutes prior to use. 2. Remove the storage OCU-FILM tip cover from the tip. 3. Visually inspect the tonometer’s sensor for cracks, chips or other irregularities. Do not use if these conditions are present. 4. 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.
Verification Mode A Verification Procedure may be performed to ensure that the sensor and electronics are performing as expected. A Verification Procedure may also be initiated if suspect readings are observed. (See earlier section TONO-PEN AVIA VET verification for details.) If the Verification Procedure resulted with the LCD displaying “Fail”, repeat the Verification Procedure, or reference the Troubleshooting section for potential causes for test failure.
Performing IOP Measurements WARNING: OCU-FILM tip covers contain natural rubber Latex which may cause allergic reactions. 1. I nstill a drop of topical anesthetic into the eye to be examined. 2. S ecure and position the patient to be measured. Note: The TONO-PEN AVIA VET tonometer will function in any orientation. 3. H old the TONO-PEN AVIA VET 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.
Applanation 1. Press and release the activation button once to initiate the applanation mode. 2. A brief display of “88888” 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 VET tonometer is ready to measure intraocular pressure. 3. 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. 4.
Interpreting the IOP Measurement During the measurement, the LCD shows the IOP and cumulative number of applanations detected. Once 6 applanations are achieved, the LCD will display the average IOP in millimeters of mercury (mmHg), along with a statistical confidence indicator. A statistical confidence indicator of 95 means that the standard deviation of the valid measurements is 5% or less of the number shown. The higher the statistical confidence indicator, the more reliable the measurement.
Maintenance and Storage Cleaning Instructions The TONO-PEN AVIA VET tonometer may have difficulty taking measurements or display “Fail” after a calibration when its tip is dirty and requires cleaning. When the tip of the tonometer has dirt and contaminants in the airspace between the sensor and the housing, cleaning of the tip is necessary. When the airspace contains contaminants, the sensor cannot move freely and the tonometer may have erratic readings and then show a “Fail” calibration.
Maintenance and Storage (continued) Cleaning Instructions (Continued) Suggested Cleaning Schedule Number of Patients per Week 10 100 300 600 Number of Days Between Cleaning 30 15 7 1 Battery Replace the TONO-PEN AVIA VET POWERCEL battery pack when: • The battery indicator shows low battery after depressing the activation button • There are no beeps, the LCD remains blank after pressing the activation button, or a noticeable slowing occurs when activating the device.
Troubleshooting The table below provides a guide for troubleshooting some basic TONO-PEN AVIA VET tonometer difficulties. If a problem persists after using this guide contact Reichert technical services. SYMPTOM PROBABLE CAUSE Battery symbol flashes. Low TONO-PEN AVIA Replace TONO-PEN VET POWERCEL battery AVIA VET POWERCEL pack capacity. battery pack. Improper technique. Multiple inaccurate readings. No beeps and/or no dashes upon activation. Verification Procedure Failure.
Specifications PHYSICAL DIMENSIONS ENVIRONMENTAL REQUIREMENTS Size: 16 x 2 x 4.4 cm (6 1/4” x 3/4” x 1 3/4”) Weight: 71 g (2.4 oz) 35°C 15°C 75% 30% 106 kPa 80 kPa RANGE OF IOP MEASUREMENTS 1 - 99 mmHg Operational Environment Ambient Temperature range: 15° to 35°C (59° to 95°F) Relative Humidity range: 30 to 75% RH Atmospheric Pressure range: 80 kPa to 106 kPa (23.6 to 31.3 mm.
Guidance & Manufacturer’s Declaration Table 201 – Guidance and Manufacturer’s Declaration Electromagnetic Emissions All Equipment and Systems Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The TONO-PEN AVIA VET is intended for use in the electromagnetic environment specified below. The customer or user of the TONO-PEN AVIA VET should ensure that it is used in such an environment.
Guidance & Manufacturer’s Declaration Table 204 – Guidance and Manufacturer’s Declaration Electromagnetic Immunity Equipment and Systems that are NOT Life-supporting Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The TONO-PEN AVIA VET is intended for use in the electromagnetic environment specified below. The customer or user of the TONO-PEN AVIA VET should ensure that it is used in such an environment.
Guidance & Manufacturer’s Declaration Table 206 – Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the TONO-PEN AVIA VET for ME Equipment and ME Systems that are NOT Life-supporting.
Symbols Attention, See Instructions for use REF SN 2012 Catalog Number Serial Number Date of Manufacture 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. Single Use Use By Lot Number 230750-101, Rev. C.
Customer Service Information The TONO-PEN AVIA VET TONOMETER Help line Should you need immediate help with a technical question or guidance through the appropriate procedure, just call the 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. Product Number: Serial Number: Date of Purchase: 28 230750-101, Rev. C.
Warranty This product is warranted by Reichert, Inc. against defective material and workmanship 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.
Warranty (continued) PATENT WARRANTY If notified promptly in writing of any action brought against the purchaser based on a claim that the instrument infringes a U.S. 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.
Notes 230750-101, Rev. C.
Reichert, Inc. 3362 Walden Ave Depew, NY 14043 USA Toll Free: 888-849-8955 Phone: 716-686-4500 Fax: 716-686-4545 reichert.information@ametek.com www.reichert.
