Tono-Pen® XL Product Infomation and Instructions

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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. / ™ sono marchi di fabbrica e ® sono marchi registrati della Medtronic Xomed, Inc. / ™ sind Warenzeichen und ® sind eingetragene Warenzeichen von Medtronic Xomed, Inc. / ™ son marcas comerciales y ® son marcas registradas de Medtronic Xomed, Inc.

Table of Contents Table des Matières Indice Inhaltsverzeichnis Índice Product Information and Instructions ...

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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... 157

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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. 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. Medtronic Ocu-Film® Tip Covers are recommended. Utilizing a sophisticated “single chip” microprocessor and electronics housed in the body of the instrument, the waveform produced by each touch to the anesthetized corneal surface is analyzed and stored for a statistical comparison process. Each single valid IOP reading is digitally displayed on the liquid crystal display (LCD). When four valid readings are obtained, the mean IOP and the standard deviation for those readings (an indication of reliability) are shown on the LCD. 1.2 Intended Use The Tono-Pen XL is intended for measuring IOP as a screening/monitoring tool for Glaucoma or when increased IOP is suspected.

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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. Versatile - The Tono-Pen XL can be used in cases of irregular or high corneal astigmatism. It may be used easily with the patient in any position, making the instrument suitable for the office, during surgery, in glaucoma clinics, at the hospital bedside, and in remote locations.

1.4 Components The Tono-Pen XL unit (see Figure 1-1) is provided in a storage case, complete with: • • • • • •

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Ocu-Cel™ XL Batteries Ocu-Film® Tip Covers Stylus Blade for battery replacement Desiccant to keep the instrument and components dry. Instruction Manual Instruction video

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)

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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 9 Guidance and manufacturer’s declaration electromagnetic immunity and emissions See page 192

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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

2.1.1 Patient Safety

When using the Tono-Pen XL for IOP testing:

•

Be sure not to apply too much force to the probe tip as this may cause eye injury. A quick, gentle, tapping technique is sufficient to achieve 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.

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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. This will cause damage to the electronics and void the Warranty. • 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. • The Tono-Pen XL should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Tono-Pen XL should be observed to verify normal operation in the configuration in which it will be used. Batteries CAUTION • Do not incinerate. • Do not expose to high temperatures (140 °F). • Do not recharge. • Do not disassemble. • Do not carry batteries loose in a pocket or elsewhere as burn injury may result. • Dispose of batteries properly. 10

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. Notify Medtronic Customer Service (see Section 7, Warranty and Repairs) immediately if any components are missing or damaged. Install the batteries in the battery compartment. Perform the Calibration Procedure (see Section 3.3). Slide a new Ocu-Film Tip Cover over the Tono-Pen XL unit’s stainless steel probe until the Ocu-Film ridge is seated in the groove (see Figure 3-1). The Ocu-Film Tip Cover should fit over the probe tip (see Figure 3-2), without being too tight. Proper fit makes contact with the transducer surface (probe post), but still has pleats along the side of the transducer head assembly. 11

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

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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). Open the battery compartment by gently inserting the stylus blade (see Figure 3-3) in the end slot. After insertion, slowly push the stylus forward and pry the cover up to remove. 2. Using the other end of the stylus, insert the tip into the holes on the underside of the body mold. Insert the tip perpendicular into the battery removal holes on the bottom of the base housing to push the batteries out (see Figure 3-4). 3. Insert two batteries as shown in Figure 3-5 (also diagrammed on the floor of the battery compartment). 4. Replace the battery cover. CAUTION Check to be sure that the batteries are installed correctly. Incorrect installation could cause severe damage to the electronics and void the Warranty.

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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)

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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). The Tono-Pen will “beep” and display CAL. 3. Wait approximately 15 seconds for the Tono-Pen to “beep” and display UP (see Figure 3-6). 4. Immediately (within 1 second) invert the Tono-Pen smoothly, pointing the transducer end straight up up. 5. A properly functioning Tono-Pen will display Good followed by a “beep”. 6. Repeat this Calibration Procedure if bAd is displayed. 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). *Note: If the Tono-Pen XL fails to yield a “Good” calibration, call Medtronic Technical Service.

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Down





Up

Figure 3-6 Calibration Positions

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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). Do not use the instrument. 3. If the probe tip passes a visual inspection, proceed. 4. 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. 5. Cover the Tono-Pen XL probe tip with a new OcuFilm Tip Cover. Medtronic Ocu-Film Tip Covers are: • Individually wrapped and sterilized. • For Single Use only. • May be gas sterilized for intraoperative use. 6. Perform daily routine calibration. *Note: Calibration should only be performed on the TonoPen once daily, unless otherwise indicated by the instrument. The Tono-Pen does not require calibration after every patient examination.

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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. Calibration should also be performed whenever it is indicated by the LCD display, when batteries are replaced, or after an unsuccessful calibration. It is not necessary to check calibration prior to each use. *Note: If during operation the Operator’s Button is pushed only once and the Tono-Pen displays CAL, the Tono-Pen needs to be calibrated. The calibration procedure is as follows: 1. 2. 3. 4. 5. 6. 18

Point the transducer end of the Tono-Pen straight down towards the floor. Depress the Operator’s Button two times rapidly, (within 1.5 seconds). The Tono-Pen will “beep” and display CAL. Wait approximately 15 seconds for the Tono-Pen to “beep” and display UP. Immediately (within 1 second) invert the Tono-Pen smoothly, pointing the transducer end straight up up. A properly functioning Tono-Pen will display Good followed by a “beep”. Repeat this Calibration Procedure if bAd is displayed.

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).

4.2.1 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 (see Section 5 for details of this proce-dure), and repeat the calibration check. If still unsuccessful: Replace the batteries (see Section 3 for the procedure) and repeat the calibration check.

*Note: Do not take measurements with the instrument if two consecutive “good” calibration checks cannot be obtained. The instrument will not take a measurement when the prior calibration check was “bAd”. *Note: If the Tono-Pen XL fails to yield a “Good” calibration, call Medtronic Technical Service. 4.3 Performing IOP Measurements After the Tono-Pen XL has been prepared for operation, the patient must be prepared and then IOP measurements can be performed. 19

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. *Note: The Tono-Pen XL unit will function in any stable position. 1.

4.3.2 Patient Examination To perform an IOP measurement: 1. 2. 3. 4.

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Instruct the patient to look straight ahead at the fixation target with his/her eyes fully open. Hold the Tono-Pen XL unit as you would a pencil. Position yourself to facilitate viewing of the probe tip and patient’s cornea where contact will be made. 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 1/2 inch of the patient’s cornea. (See Figure 4-1 for correct positioning.)

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. 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. 21