Tono-Pen® XL Product Information and Instructions Informations et instructions concernant le produit Informazioni sul prodotto ed istruzioni per l’uso Produktinformation und Gebrauchsanweisung Instrucciones e información sobre el producto Rx Only
0123 EC Manufacturer: Medtronic Ophthalmics, Inc. A Division of Medtronic Xomed Inc. 6743 Southpoint Drive Jacksonville, FL 32216 USA Authorized Representative (for EC regulatory matters) Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel.: 011-31-45-566-8000 Fax: 011-31-45-566-8668 © Medtronic 2005 ™ are trademarks and ® are registered marks of Medtronic Xomed, Inc. / ™ sont des propriétés et ® sont des marques déposées de Medtronic Xomed, Inc.
Table of Contents Table des Matières Indice Inhaltsverzeichnis Índice Product Information and Instructions ..................................... 5 Informations et instructions concernant le produit................ 41 Informazioni sul prodotto ed istruzioni per l’uso .................. 79 Produktinformation und Gebrauchsanweisung...................... 117 Instrucciones e información sobre el producto........................
SECTION 1 Introduction 1.1 Overview This manual describes components, setup, procedures, and operation of the Medtronic Tono-Pen XL Tonometer. The Medtronic 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.
1.3 Features The Tono-Pen XL has the following features: • • • • Easy to use - IOP can be measured reliably by ophthalmologists, optometrists, technicians and other medical professionals. Portable - The Tono-Pen XL weighs just 2.1 ounces and is battery operated. Accurate - The accuracy of the Tono-Pen XL equals or exceeds that of other electronic applanation tonometers. It is highly correlated with Goldmann® applanation tonometry and direct measurements of intraocular pressure.
Instruction Manual Ocu-Film Tip Covers Desiccant Stylus Blade Ocu-Cel XL Batteries Tono-Pen XL Tonometer Figure 1-1 Tono-Pen XL Components (in Storage Case) 7
1.5 Manual Contents The following sections of this document are organized as follows: Section 2 Summarizes safety precautions, warnings, and terms. Section 3 Provides instrument set up instructions. Section 4 Provides detailed steps for Tono-Pen XL operation and calibration instructions. Section 5 Provides preventive maintenance instructions. Section 6 Troubleshooting guide. Section 7 Specifications Section 8 Warranty and Repair instructions.
SECTION 2 Safety 2.1 Safety Precautions and Warnings The Tono-Pen XL is used in non-invasive IOP measurement procedures. Hazards exist from improper use of the instrument. Damage to the instrument may also occur from improper usage. This section lists Cautions (which indicate conditions that may cause damage) associated with the TonoPen XL and provides an overview of safety precautions for: • • Patients Equipment 2.1.
2.1.2 Equipment Safety This unit should not be modified in any way by any user. Unauthorized modifications to the unit may cause it to malfunction or fail in use. This will also cause the Warranty to become void. CAUTION • The tip of theTono-Pen XL is a sensitive electronic component. Be careful not to bump or jar the unit as this may damage the tip and effect operation. • Do not immerse probe in fluids. This will cause damage to the electronics and invalidate the Warranty. • Do not sterilize probe.
SECTION 3 Set Up 3.1 Set Up Instructions To set up the Tono-Pen XL for operation, follow the instructions listed below. 1. 2. 3. 4. 5. 6. 7. 8. 9. Remove all protective packaging materials. Remove and discard the desiccant. Carefully remove the tonometer and accessories from the case. Check for missing items. Visually check the instrument and accessories for damage. Remove the Ocu-Film Tip Cover shipped with the Tono-Pen.
Probe Post Groove Probe Tip Operator’s Button LCD Battery Compartment Figure 3-1 Tono-Pen XL Top and Side Views Ocu-Film Tip Cover - Correct Ocu-Film Tip Cover - Too Loose Ocu-Film Tip Cover - Too Tight Figure 3-2 Ocu-Film Tip Cover Placement 12
3.2 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 Medtronic Ocu-Cel XL Batteries also be used when the batteries need replacement. *Note: The Tono-Pen XL unit will not function properly with mercury batteries. 3.2.1 Installation Procedure 1. Locate the battery compartment (see Figure 3-1).
Figure 3-3 Battery Cover Removal Figure 3-4 Ejecting Batteries (Bottom of Tono-Pen XL) - + + - Battery Terminals Figure 3-5 Battery Placement (in Compartment) 14
3.3 Calibration Procedure Calibration must be performed whenever batteries are replaced or after an unsuccessful calibration. The calibration procedure must also be routinely and successfully performed once daily prior to instrument use, or whenever indicated by the LCD display. To calibrate the Tono-Pen XL: 1. Point the transducer end of the Tono-Pen straight down towards the floor (see Figure 3-6). 2. Depress the Operator’s Button two times rapidly, (within 1.5 seconds).
Down Up Figure 3-6 Calibration Positions 16
SECTION 4 Tono-Pen XL Operation 4.1 Instrument Preparation Prior to using the Tono-Pen XL for IOP measurement prepare the instrument according to the instructions below. 1. Allow the instrument to thermally stabilize at room temperature (72-82° F, 22 - 28° C) for approximately 30 minutes prior to use. 2. Remove the Ocu-Film Tip Cover from the probe. Visually inspect the tonometer’s probe tip for cracks, chips or other irregularities. If irregularities are present, contact Medtronic (see Section 7).
CAUTION Do not use the instrument without an Ocu-Film Tip Cover. Use without an Ocu-Film Tip Cover will damage the instrument and void the Warranty. 4.2 Calibration 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.
7. After Good is displayed, depress the Operator’s Button one time and the Tono-Pen will display [8.8.8.8], followed by a single row of dashes, [- - - -], and then by a double row of dashes [====] followed by a “beep” tone, indicating the instrument is ready to measure IOP (Depressing the activation button a second time will interrupt this process and send the unit to calibration mode). 4.2.
4.3.1 Patient Preparation 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. To prepare a patient for an IOP measurement: 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.
Correct Incorrect Figure 4-1 Corneal Applanation 5. • • • To initiate an IOP measurement, depress the Operator’s Button once, and only once. Initially you will see a brief display of [8.8.8.8]. This is a self-test of the LCD (Liquid Crystal Display). If any of the LCD segments are not displayed, the Tono-Pen requires service. 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.
*Note: After acquiring the double row of dashes [====], if more than 15 seconds elapses prior to applanation, the Tono-Pen will not measure. The software will have initiated a batterysaving function, indicated initially by the display of a single row of dashes [- - - -], then followed in sequence by a blank display [ ]. A new IOP measurement can be initiated by depressing the operator’s button once. *Note: Anytime the operator’s button is depressed twice within 1.
occurs, repeat the patient examination procedure, starting at step 1. 9. 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. 10.
4.4 Interpreting the LCD 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. (See Figure 4-2).
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. For example, if the 5% bar is displayed, the standard deviation of the valid measurements is 5% or less of the number shown. If the reliability measure is 20% or > 20%, a repeat measurement is recommended. A single row of dashes [- - - -] indicates that the instrument is activated.
4.5 Instrument Storage 1. Cover the probe tip with an Ocu-Film Tip Cover for protection. 2. 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. 3. If the Tono-Pen XL unit is not to be used for an extended period of time, remove the batteries from the instrument.
SECTION 5 Maintenance 5.1 Maintenance Procedures Maintenance that should be performed on the Tono-Pen XL consists of activities such as protecting the probe tip, keeping surfaces free of dust and dirt and storing in a dry and cool place so as not to adversely affect electronic parts, and replacing the batteries. 1. Keep the probe tip protected with an Ocu-Film Tip Cover when in use or in storage. Avoid any contact with the probe tip when not protected by an Ocu-Film Tip Cover.
5.2 Tono-Pen XL Body 1. Avoid any shock or excessive vibration which will damage the unit. 2. 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. 5.3 Battery Replacement 1. The batteries need replacing when multiple beeps sound and “Lob” appears on the LCD upon depressing the activation switch.
5.4 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 manufacturer. WARNING Removal of the Attachment Screw will void the warranty.
SECTION 6 Troubleshooting 6.1 Overview This section provides a guide for troubleshooting some basic Tono-Pen XL operational problems. If a problem persists after using this guide contact your nearest Medtronic Representative.
Symptom Multiple inaccurate readings No beeps and/or no dashes upon activation Unable to obtain “Good’ calibration check Probable Cause Correction Need to check calibration Perform calibration check procedure (see Section 4) Batteries are low Replace batteries Mechanical or electronic damage Arrange for repair through Medtronic Technical Service Group Activation switch not depressed long enough Depress activation switch longer Incorrect battery installation Check batteries Batteries are low
6.1.1 Further Assistance If a malfunction persists call the Medtronic Technical Service Group. Please be sure to contact this group before returning the unit for repair. (See Section 8 for return details).
SECTION 7 Specifications 7.1 Overview Table 7-1 lists the physical and operational specification for the Tono-Pen XL. Table 7-1: Tono-Pen Specifications Dimensions 7 1/4” X 1” X 7/8” Weight 59.4g (2.1 oz.) Range of Measurement 5 - 80 mmHg Power Source 3V Lithium Manganese Dioxide Batteries.
SECTION 8 8.1 LIMITED WARRANTY A.
other than normal use, and (iii) the prescribed periodic maintenance and services have been performed on the Product. C. This LIMITED WARRANTY is limited to its express terms. THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED WHETHER STATUTORY OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
8.1.1 Unpacking The Medtronic Tono-Pen XL is shipped in a case. Upon receipt, open the case carefully and inventory all parts against the shipping list. Check for any damage that may have ccurred during shipping. If shipping damage is present immediately notify the freight carrier and Medtronic Customer Service. If the Unit must be returned or repaired, repack it in the shipping case. Take care that the Medtronic Tono-Pen XL or its components are not excessively bumped or dropped.
A. All merchandise (except battery-powered devices) returned intact within 45 days of date of purchase will be credited at customer’s purchase price. Battery-powered devices returned within 45 days of date of purchase will be credited at purchase price less 30%. All merchandise returned intact after 45 days and up to 90 days from date of purchase will be credited at purchase price less 50%. Merchandise returned more than 90 days from date of purchase is not eligible for credit. B.
All repairs should be shipped freight prepaid to: Repair Department Medtronic Ophthalmics A Division of Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216-0980 8.3 Non-Returnable Merchandise Medtronic will not authorize a return for merchandise held longer than 30 days, or for sterile products that have been opened or that are not in original packaging.
SECTION 9 Guidance and manufacturer’s declaration – electromagnetic immunity - Part 1 Guidance and manufacturer’s declaration – electromagnetic immunity - Part I 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. Immunity test EN 60601 Compliance level Electromagnetic test level environment guidance Electrostatic disFloors should be wood, charge (ESD) concrete, or ceramic tile.
Guidance and manufacturer’s declaration – electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions 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. Emissions Compliance Electromagnetic environment guidance RF emissions Group 1 The Tono-Pen® XL uses RF energy only CISPR 11 for its internal function.
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.
Guidance and manufacturer’s declaration – electromagnetic immunity - Part II The TTono-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.
Medtronic Ophthalmics A Division of Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216-0980 U.S.A. 1-800-535-4646 or 1-904-296-9600 www.medtronicophthalmics.com The information contained in this document was accurate at time of publication. Medtronic Xomed 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.
