Sharpsite Flexible ENT Scopes Users Guide Rev G July 2008

English 1. Device Description

A Sharpsite® [Ear, Nose and Throat] ENT endoscope provides access and allows observation or manipulation of nasal cavities, larynx and pharynx. The device consists of flexible instruments inserted into body spaces and includes an optical system for conveying an image to your eye.

Indications for Use

The naso-laryngo-pharyngoscope is indicated for visualization of pharynx and larynx.

Contraindications

Using an endoscope is contraindicated to the extent that endoscopic procedures are contraindicated. •

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Warnings

Only qualified healthcare professionals, with corresponding training and familiarity with endoscopic procedures, should perform endoscopic procedures. It is the user’s responsibility to stay updated regarding changes in indications, contraindications and possible risks, as well as developments of endoscopic procedures. Use by unauthorized and/or untrained personnel can cause injury and/or missed diagnoses. Read all instructions and notes carefully. Ignoring instructions, warnings and/or cautions can increase risks to patient and user. The endoscope is shipped non-sterile. Clean and disinfect your endoscope before use. See details in Section 3. Before each use, inspect your endoscope and its accessories for possible optical or mechanical defects to avoid risks of injury. Do not use damaged or defective endoscopes. Do not use an endoscope that does not pass inspection. If in doubt regarding repair needs, contact a Service Center listed in section 5. Follow Nuclear Magnetic Resonance (NMR) manufacturer‘s guidelines and safety instructions when using with your endoscope. Simultaneous use of NMR with an endoscope can cause overheating dangers and artifacts in the image. When using endoscope with electro-medical devices, maintain BF conditions (insulated, earth-free). Using endoscopes with electro-medical devices and/or power-driven endoscopic accessories can add leakage current. Failure of a light source can compromise patient and/or user safety. Keep an additional light source on hand or use light sources having a spare lamp. In combination with high-performance light sources, temperatures of light source and instruments can rise sufficiently enough to cause burns. Light with high radiance energy can lead to increased tissue temperature. Avoid directly contacting tissue and, if possible, ensure adequate rinsing of operation area. Before endoscopic high-frequency surgery, prepare patient for operation. Remove or avoid formation of combustible gases. Set appropriate performance setting on endoscope. In contrast to conventional high-frequency surgery, an unsuitable (especially too low) performance setting can produce a noticeable depression in surrounding tissue. Your experience with endoscopic techniques is basic to performance setting. You must have clinical references and/or suitable training. Switch on high-frequency current only after locating electrode through endoscope to avoid burns and/or undesirable depressions in surrounding tissue. When using laser devices, you and your patient must wear protection glasses as recommended by laser manufacturer to avoid eye damage. When using laser devices, avoid burns and/or undesirable depressions in surrounding tissue, locate laser-fiber tip through endoscope before activating laser

Caution

Thoroughly understand principles and methods of laser endoscopy and electrosurgical procedures to avoid damage to endoscope and other equipment. • Handle flexible endoscope with gentle care. Flexible endoscopes are highly susceptible to bending pressure, tight wrapping, and sudden impact, as well as torsion and drawing or pressure strain. Poor handling can damage optical components, resulting in malfunction. Overstressed parts may not pass inspection prior to each use. Note: If light shines through thin-walled sheath of highly flexible tip, a broken optic fiber may be present. Light shining with varying intensity has no effect on illumination intensity at tip of flexible endoscope.

2.

Leak Testing

If your flexible endoscope has an air-exhaust valve, become familiar with leak testing before soaking in any liquids. • Replace valve cap (FIG 1, 12) with air-exhaust valve (FIG 1, 2). • Connect tubing to air-exhaust valve (FIG 1, 2) and leak tester (FIG 1, 13). • Use leak tester (FIG 1, 13) to set a pressure of 160 mm Hg. • Wait 30 seconds and observe fall in pressure. A fall in pressure of about 2 mm Hg is normal. Warning: If pressure decreases constantly, endoscope’s integrity has been compromised. Send endoscope to a Service Center for repair.

3. Cleaning and Disinfecting 3.1 Introduction

The following parameters have been validated for cleaning and disinfecting the endoscope. Use of other cleaning and disinfecting parameters are solely the responsibility of the user and may void warranty. It is your responsibility is to prepare your endoscope for required degree of cleaning, disinfection, and/or sterilization. Choice of preparation method may have considerable bearing on endoscope’s useful life.

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3.2 Precleaning

Warning: Plan to clean endoscope immediately after use to protect staff by preventing blood, protein or other substances from drying on endoscope. Dried protein makes cleaning and disinfection more difficult. • • • • •

Instructions

Upon completion of the examination, cover the used endoscope with a towel moistened with distilled water. If there is no possibility for immediate cleaning, rinse flexible endoscope gently, carefully using a hand spray and cover the rinsed endoscope with a towel moistened with distilled water. Unscrew adapters used for different optic fibers from endoscope. See FIG. 1 to locate parts. Complete leak testing, per instructions in section 2. Before lowering the scope into the cleaning bath, remove all caps.

3.3 Cleaning • • • • • • •

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Caution:

Remove all caps prior to soaking to avoid damage to scope. Excessive soaking can damage endoscope. Do not clean endoscopes in an ultrasonic bath, which may damage materials and joints. Do not use sharp objects on endoscope surfaces. Avoid damage through excessive pressure, impact, bending or dropping. Clean endoscope with maximum care to prevent damage. Color-anodized endoscopy parts and plastic components, such as serial rings and ocular funnel, may fade with cleaning. Color changes do not diminish function.

Instructions

Prepare the cleaning solution. • Use Gigazyme®, an enzymatic cleaner for endoscopes (www.schuelke-mayr.com) • Dilute Gigazyme® to 0.5 to 10% of cleaning solution using tap water at 23-32oC. Immerse the endoscope and components in cleaning solution. Ensure that solution reaches all surfaces including working channels and hollow spaces. Ensure that no trapped air remains inside the endoscope or components. Use a soft, non-abrasive cloth or brush to clean the endoscope, especially threads, grooves and crevices, until no visible contamination remains on the endoscope or components. After cleaning, remove the items from the cleaning solution and thoroughly rinse all parts with distilled water to remove last traces of impurities and residues of the cleaning agent. Dry endoscope and individual components with a soft absorbent lint free cloth or tissue. Use compressed air to dry areas that the cloth or tissue cannot reach. Unless you plan disinfection immediately after cleaning, replace adapters.

3.4 Inspection • • • • •

Instructions

Inspect endoscope immediately before disinfecting. Complete leak testing

Checking optic fiber:

Hold distal end of optic fiber toward a bright ceiling lamp. (For this test, do not use a cold-light source.) View proximal end, at light connection, holding it relatively close to your eye. Individual fibers now appear bright. As you move distal end a little left and right, fiber brightness changes a little. Some fibers can remain dark without causing concern.

Caution:

• If fiber-rupture rate were to exceed 10-20%, the image will be sub-optimal. Note: If light shines through thin-walled sheath of highly flexible tip, a broken optic fiber may be present. Varying intensity has no effect on illumination intensity at tip of flexible endoscope. • Ensure that surfaces where light enters and exits are smooth and clean. If surfaces show deposits, or if rough fibers can be felt or are withdrawn, inadequate illumination can result. • To prevent further damage to an endoscope with rough surfaces or deposits on the fibers, cease utilization. Send damaged endoscope to a Service Center for repair.

Inspecting proximal and distal glass surfaces:

Warning • Do not use endoscope in any of the following conditions: • Stubborn residues remain after cleaning. • Optic fibers have rough surfaces or deposits. • Glass surfaces have damage or cracks. • Image quality is impaired. • Surface is noticeably damaged or distorted. •

Instructions

Set aside scopes that have failed inspection and send them to a Service Center for repair.

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Ensure that glass surfaces are clean and free from deposits. If you notice stubborn crusts, remove crusts using appropriate cleaning pastes. Inadequate rinsing or using hard water after cleaning and disinfecting often causes precipitations on surfaces. See clear and sharp images at appropriate working distance for planned procedure. Consider special optical properties of image bundle endoscopes. Troubleshoot dull, dusky images per instructions Ensure endoscope surfaces are free from damage and sharp edges. Pay attention to dents, mechanical/thermal defects due to high frequency or laser surgery instruments. Ensure that no cracks or chips appear on ocular eyecup.

3.5 Disinfecting

Warning:Before disinfecting, ensure that the endoscope is clean. Endoscope must have passed inspection with no findings that impose restrictions on use. • • • • • • • • •

Caution:

Do not autoclave. Materials and joints of flexible probe cannot withstand high-temperature steam sterilization. Do not disinfect endoscopes in an ultrasonic bath, which may damage materials and joints.

Cold Soak Disinfecting

Unscrew adapters used for different optic fibers from endoscope. See FIG. 1 to locate parts. Prepare the disinfecting bath solution. Use Cidexplus®, a 3.4% glutaraldehyde solution. Completely immerse the endoscope and components in the disinfecting bath solution. Ensure that solution reaches all surfaces including working channels and hollow spaces. Ensure that no trapped air remains inside the endoscope or components. Soak endoscope and components for a minimum of twenty (20) minutes. After soaking, thoroughly rinse endoscope and components with running water or sterile water depending upon application. Place endoscope and components on a clean, dry surface. Dry endoscope appropriately for its next use. Ensure all lenses are free of residue.

4. Operating Instructions 4.1 Before Each Use • •

Warning

Inspect endoscope before each use per instructions. Do not use an endoscope that fails inspection. Using an optic fiber cable of low isolation (< 4kV) may compromise Type BF isolation, protecting the patient. Operating endoscope with low-insulation fiber optic light guides can result in too much touch current or patient leakage current. • Plan for operating endoscope with optic fibers of high isolation between light source and endoscope. Optic fibers provided with your endoscope meet isolation requirement and isolation tested with high voltage. • Compatible use with your endoscope includes any of the following appropriate light sources: • Flexilux® 180 Watts or 250 Watts • Xenon light source, of less than 300 Watts • Halogen light source, 250 Watts • Do not use high-power light sources with higher power than appropriate light sources. For example, a 300-Watt Xenon source can heat and damage fibers at input of optic fiber guide. Temperatures greater than 40 °C may develop on light post of endoscope. •

4.2 During Each Use

Replace the valve-cap (Fig. 1, 12) with the appropriate cap or adapter.

5.

Warranty, Maintenance and Repair

5.1 Warranty

A.This LIMITED WARRANTY provides assurance for the customer who purchases a Sharpsite® Flexible ENT Endoscope (hereinafter the “Product”) that should the Product fail to function to Medtronic Xomed’s published specifications during the term of this LIMITED WARRANTY (one year from the date of shipment), Medtronic Xomed will either replace, repair, or issue a credit (adjusted to reflect the age of the Product) for the Product or any portion thereof. This LIMITED WARRANTY is extended only to the buyer purchasing the Product directly from Medtronic Xomed or from its affiliate or its authorized distributor or representative. B.To qualify for this LIMITED WARRANTY, the following conditions must be met: (1)The Product must be used on or before its “Use By” or “Use Before” date, if applicable. (2)The Product must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse, accident or improper handling. (3)Medtronic Xomed must be notified in writing within thirty (30) days following discovery of a defect. (4)The Product must be returned to Medtronic Xomed within thirty (30) days of Medtronic Xomed receiving notice as provided for in (3) above. (5)Upon examination of the Product by Medtronic Xomed, Medtronic Xomed shall have determined that: (i) the Product was not repaired or altered by anyone other than Medtronic Xomed or its authorized representative, (ii) the Product was not operated under conditions 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. In no event shall Medtronic Xomed be liable for any consequential, incidental, prospective or other similar damage resulting from a defect, failure, or malfunction of the Product, whether a claim for such damage is based upon the warranty, contract, negligence or otherwise.

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Manufactured for Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 U.S.A. www.medtronicENT.com

Sharpsite® is a registered trademark of Medtronic Xomed, Inc. Flexilux® is a registered trademark of Schölly Fiberoptic GmbH Cidexplus® is a registered trademark of Johnson & Johnson Gigazyme® is a registered trademark of Schülke & Mayr Storz® is a registered trademark of Storz Instrument Company Wolf® is a registered trademark of Richard Wolf GmbH 68E3879 G 07/08

© Medtronic 2008