Tono-Pen® XL Tonometer User’s Guide
©2014 AMETEK, Inc. 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. Specifications subject to change without notice. Reichert, Inc.
Table of Contents Warnings & Cautions ��������������������������������������������������������4 Symbols ����������������������������������������������������������������������������8 Introduction �����������������������������������������������������������������������9 Indications for Use �������������������������������������������������������9 Contraindications ���������������������������������������������������������9 Device Description ����������������������������������������������������10 Features �������
Warnings & Cautions Reichert Technologies (Reichert) is not responsible for the safety and reliability of this instrument when: • Assembly, disassembly, repair, or modification is made by unauthorized dealers or persons. • Instrument is not used in accordance with this User’s Guide. WARNING: AN INSTRUCTION THAT DRAWS ATTENTION TO RISK OF INJURY OR DEATH.
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. WARNING: THE CORNEAL SURFACE NEEDS ONLY TO BE MOMENTARILY CONTACTED, INDENTATION OR ADDITIONAL PRESSURE AFTER THE AUDIO “CHIRP” TONE IS HEARD IS NOT REQUIRED AND MAY LEAD TO DAMAGE TO THE EYE.
Warnings & Cautions (continued) WARNING: ALWAYS KEEP BATTERIES OUT OF THE REACH OF INFANTS AND YOUNG CHILDREN TO PREVENT THEM FROM BEING SWALLOWED. IF SWALLOWED, CONSULT A PHYSICIAN IMMEDIATELY. WARNING: THE USE OF ACCESSORIES OR CABLES OTHER THAN THOSE SPECIFIED, WITH THE EXCEPTION OF THOSE SOLD BY THE MANUFACTURER AS REPLACEMENT PARTS FOR INTERNAL COMPONENTS, MAY RESULT IN INCREASED EMISSIONS OR DECREASED IMMUNITY OF THE EQUIPMENT OR SYSTEM.
Warnings & Cautions (continued) CAUTION: DO NOT STORE THE TONO-PEN XL TONOMETER WITHOUT AN OCU-FILM + TIP COVER OR DEBRIS MAY ENTER THE TRANSDUCER ASSEMBLY AND CAUSE MALFUNCTIONS. CAUTION: MEDICAL ELECTRICAL EQUIPMENT NEEDS SPECIAL PRECAUTIONS REGARDING EMC AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE EMC INFORMATION PROVIDED IN THIS GUIDE. PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT.
Symbols Caution, See Instructions for use REF SN 2014 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 Authorized Representative in European Community Fragile Contents in Shipping Container - handle with care Do not get Shipping Container wet Type BF Applied Part SYMBOLS FOR OCU-FILM + TIP COVERS ONLY Do not reuse.
Introduction Congratulations on your purchase of the Reichert® Tono-Pen® XL 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. This User’s Guide is designed as a training and reference manual for operation, maintenance, and troubleshooting.
Introduction (continued) Device Description The Reichert Tono-Pen XL is a precision electronic tonometer which measures intraocular pressure (IOP). The body of the instrument is specially designed to fit comfortably in the user’s hand, facilitating fast and accurate measurements. The stainless steel probe on the Tono-Pen XL contains a solid state strain gauge which converts intraocular pressure (IOP) to an electrical signal. The probe tip must be covered by a protective membrane.
Introduction (continued) Parts Identification A. B. C. D. Tip – location of sensor. Transducer Assembly - housing for sensor. Activation Button - Applanation Mode select button. LCD - displays the IOP in mmHg, statistical confidence indicator, and battery life status. E. Battery Compartment- Where the batteries are located. A E C D B Figure 1 Parts Identification Available Accessories 230570 230651 23065070 23050140 68E3441 980079 68E3441 Rev.
Setup Battery Installation The Tono-Pen XL tonometer is shipped without the batteries installed. 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 batteries. Note: It is recommended that Reichert OCU-CEL XL Batteries be used when the batteries need replacement. 1.
Setup (continued) Tono-Pen XL Tonometer Preparation 1. 2. 3. 4. 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 Assembly. Visually inspect the Transducer Assembly for cracks, chips or other irregularities. Do not use if these conditions are present.
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.
Setup (continued) Calibration Procedure (continued) If several consecutive attempts at checking the calibration are unsuccessful: • Loosen or remove the Ocu-Film Tip Cover from the Tono-Pen XL probe tip and repeat the calibration check. • Spray the probe tip with compressed gas, and repeat the calibration check. • Replace the batteries and repeat the calibration check. Note: If [CAL] appears followed by a row of four dashes [- - - -], the unit did not go into calibration mode.
Instructions for Use Performing IOP Measurements CAUTION: OCU-FILM CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS. QUESTION PATIENTS ABOUT ALLERGIES TO LATEX BEFORE EXAMINING THEM WITH THE TONO-PEN XL. 1. Instill a drop of topical anesthetic onto the eye to be examined. 2. Position the patient, seated or supine, in front of a fixation target; or have the patient fixate on a point of reference (i.e. ear, nose, distant object) to minimize eye movement.
Instructions for Use (continued) Performing IOP Measurements (continued) Note: If a momentary display of [CAL] is seen, followed immediately by a single row of dashes [- - - -], it indicates that the Tono-Pen requires calibration before it will measure. 9. If a double row of dashes [====] is seen and a “beep” tone is heard, it indicates that the Tono-Pen is ready to measure IOP. Proceed with applanation within 15 seconds.
Instructions for Use (continued) Performing IOP Measurements (continued) 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. If this occurs, activate the TONO-PEN XL by pressing the Operator’s Button once. 13.
Instructions for Use (continued) Interpreting the LCD Screen The number display represents IOP in millimeters of mercury (mmHg.) A number with a single horizontal bar displayed at the bottom of the LCD is an average of the valid measurements. A number without the single bar is a single measurement of IOP. Refer to Figure 7. The display of one of four horizontal bars located along the lower border of the LCD block indicates the statistical reliability of the averaged measurement.
Cleaning & Maintenance Cleaning Instructions The Tono-Pen XL tonometer may have difficulty taking measurements or display “Fail” after a verification when its tip is dirty and requires cleaning. When the Transducer Assembly of the tonometer has dirt and contaminants in the tip, cleaning of the tip is necessary. When the tip contains contaminants, it cannot move freely and the Tono-Pen XL may have erratic readings and then show a “Fail” verification. Figure 8 Cleaning the Tip 1.
Cleaning & Maintenance (continued) Suggested Cleaning Schedule Number of Patients per Week 10 100 300 600 Number of Days Between Cleaning 30 15 7 1 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.
Cleaning & Maintenance (continued) 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. If the instrument is to be stored for an extended period, remove the Tono-Pen XL OCU-CEL Batteries to avoid possible damage to the instrument due to battery leakage.
Troubleshooting The table below provides a guide for troubleshooting some basic TonoPen XL tonometer operational problems. If a problem persists after using this guide contact Reichert technical services. SYMPTOM “Lob” displayed on LCD Screen Noticeable slowing in the calibration check process, in activating instrument Multiple inaccurate readings No beeps and/or no dashes upon activation Unable to obtain “Good’ calibration check Unit displays “CAL” then single dashed line then turns off. 68E3441 Rev.
Specifications PHYSICAL DIMENSIONS Size: 7 1/4” x 1” x 7/8” (18.42 x 2.54 x 2.22 cm) Weight: 2.1 oz. (59.4 g) 60°C -10°C 95% 50% 106 kPa 50 kPa ELECTRICAL Input Voltage (Tono-Pen OCU-CEL Batteries) 2 x 3V Lithium Manganese Dioxide batteries ENVIRONMENTAL REQUIREMENTS Operational Environment Ambient Temperature range: 15° to 35°C (59° to 95°F) Relative Humidity range: 30 to 75% Atmospheric Pressure range: 80 kPa to 106 kPa (23.6 to 31.3 in.
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 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.
Guidance & Manufacturer’s Declaration (continued) Table 202 – Guidance and Manufacturer’s Declaration Electromagnetic Immunity All Equipment and Systems 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.
Guidance & Manufacturer’s Declaration (continued) 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 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.
Guidance & Manufacturer’s Declaration (continued) Table 206 – Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Tono-Pen XL for ME Equipment and ME Systems that are NOT Life-supporting.
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.
Customer Service Information The Tono-Pen XL 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 Technical Service Group at Reichert Technologies, please have the appropriate product number, product serial number, date of purchase, and nature of inquiry available.
Notes 68E3441 Rev.
Reichert Technologies 3362 Walden Ave Depew, NY 14043 USA Toll Free: 888-849-8955 Phone: 716-686-4500 Fax: 716-686-4555 Email: reichert.information@ametek.com www.reichert.com 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. +49 (89) 315 891 99 ISO-9001/13485 Registered May 2, 2014 68E3441 Rev.
