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The following is a trademark of Reichert, Inc. OCU-CEL™ 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.
The TONO-PEN XL is intended for measuring IOP as a screening/monitoring tool for Glaucoma or when increased IOP is suspected. Components The TONO-PEN XL unit (see Figure 1) is provided in a storage case, complete with: • Ocu-Cel™ XL Batteries •...
Warnings and Cautions WARNING: AN INSTRUCTION THAT DRAWS ATTENTION TO RISK OF INJURY OR DEATH WARNING: THE TONO-PEN XL SHOULD BE USED IN STRICT ACCORDANCE WITH THE INSTRUCTIONS OUTLINED IN THIS USER’S GUIDE. THE SAFETY OF THE PATIENT AND THE PERFORMANCE OF THE INSTRUMENT CAN NOT BE GUARANTEED IF USED IN A MANNER NOT SPECIFIED BY REICHERT, INC.
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INCORRECT INSTALLATION COULD CAUSE SEVERE DAMAGE TO THE ELECTRONICS AND VOID THE WARRANTY. CAUTION: USE OR STORAGE OF THE TONO-PEN XL UNIT WITHOUT AN OCU-FILM TIP COVER CAN CAUSE SEVERE DAMAGE TO THE INSTRUMENT AND VOID THE WARRANTY. CAUTION: REMOVAL OF THE ATTACHMENT SCREW WILL VOID THE WARRANTY.
Setup Set Up Instructions To set up the TONO-PEN XL for operation, follow the instructions listed below: Remove all protective packaging materials. Remove and discard the desiccant. Carefully remove the tonometer and accessories from the case. Check for missing items.
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.
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.
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Calibration Unsuccessful Calibration 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. If still unsuccessful: Spray the probe tip with compressed gas, and repeat the calibration check.
To help prevent build-up of debris around the probe post, 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: •...
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For normal corneas, central corneal contact is recommended. 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/ inch of the patient’s cornea. (See Figure 6 for correct positioning.) Correct...
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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.
“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.
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.
Maintenance & Storage Replace the batteries using the procedure described on page 9. If the instrument is not to be operated for an extended period of time, remove both batteries. This will avoid possible damage to the instrument due to battery leakage Attachment Screw The attachment screw, located on the underside of the instrument, is used to protect the sensitive electronics against intrusion and should be removed only by the...
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...
Guidance & Manufacturer’s Declaration Guidance and manufacturer’s declaration – electromagnetic immunity - Part The TONO-PEN is intended for use in the electromagnetic environment specified below. The customer or the user of the TONO-PEN® XL should assure that it is used in such an environment. Electromagnetic EN 60601 Immunity test...
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Guidance & Manufacturer’s Declaration Recommended separation distances between portable and mobile RF communications equipment and the TONO-PEN The TONO-PEN® XL is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the TONO-PEN® XL can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the TONO-PEN as recommended below, according to the maximum output power of the communications equipment.
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Guidance & Manufacturer’s Declaration Guidance and manufacturer’s declaration – electromagnetic immunity - Part II The TONO-PEN® XL is intended for use in the electromagnetic environment specified below. The customer or the user of the TONO-PEN should assure that it is used in such an environment. EN 60601 Compliance Immunity test...
PRODUCT CHANGES Reichert reserves the right to make changes in design or to make additions to or improvements in its products without obligation to add such to products previously manufactured.
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Reichert, Inc. 3362 Walden Ave. Depew, NY 14043 www.reichert.com 68E3441 REV C...
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