QuickLatch Sheath Instructions for Use

ENGLISH/INSTRUCTIONS FOR USE

QuickLatch® Sheath REF

Description

QL5531

Single Stopcock Sheath System, 5.5mm

QL5532

Double Stopcock Sheath System, 5.5mm

QL6131

Single Stopcock Sheath System, 5.9mm

QL6132

Dual Stopcock Sheath System, 5.9mm

QLR6132

Dual Stopcock Sheath System, 5.9mm

DESCRIPTION The QuickLatch Sheath system provides excellent inflow rates while maximizing protection for the endoscope. The sheath system includes: a sheath, a stopcock assembly, and an obturator.

INDICATIONS FOR USE The QuickLatch Sheath is intended to provide fluid inflow and/ or outflow through one portal during arthroscopic procedures.

CONTRAINDICATIONS The QuickLatch Sheath is not intended to be used in any procedure outside of arthroscopy.

PRECAUTIONS 1.Before each assembly, inspect all visible o rings in the sheath to ensure they are firmly seated in place. 2.To avoid fluid leakage, the sheath must be properly assembled and locked. 3.Care should be used before entering tight spaces to avoid damaging anatomical structures.

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WARNING

!

As in any arthroscopic procedure the surgeon should thoroughly inspect the conditions of the joint for capsular space upon entering, and before distending the joint. The use of a mechanized infusion system is not advised in the presence of a compromised capsule. Failure to inspect the joint may result in extravasation and subsequent compromise of the extremity's neurovascular function. Care should also be taken to inspect the extremity periodically throughout the procedure.

CLEANING AND STERILIZATION INFORMATION Cleaning 1. Follow universal precautions for protective apparel when handling and cleaning contaminated equipment. 2. It is recommended that instruments are cleaned as soon as reasonably practical following use. 3. Clean sheath and stopcock assembly using a neutral pH cleaning solution and a nonabrasive brush. Repeat the cleaning process until the sheath and stopcock assembly is completely clean.

Preparation for Cleaning 4. Disassemble sheath from scope. Open and/or disassemble the sheath from the stopcock assembly immediately after use. Unscrew valve and nut from stopcock (Figure 1), and make sure valves are in the “OPEN” position if applicable. Place in a basin of deionized water. NOTE: Saline solution is not recommended as it has a corrosive effect on certain metals.

Figure 1*

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5. Pre-clean instruments at point of use to prevent drying of bioburden and organic soil: Open all ports, wipe with moistened towel/sponge, rinse off gross debris using cool water, flush devices with cannulations with cool water then soak in water at 22°C-43°C/ 72°F-110°F to prevent coagulation of blood and proteins on the device. Temperature of pre-rinse water should not exceed 45°C (113°F). 6. Maintain moisture during transport from point of use to decontamination area.

Manual Cleaning 7. Manually clean devices under running tap water to prevent aerosolization. Scrub all interior and exterior surfaces while manipulating movable parts of the device using a soft-bristle brush and mild neutral pH detergent. Follow solution manufacturer's instructions for preparation and use. Clean all cannulation and holes using an appropriate size brush to ensure full depth of feature is reached. 8. Rinse under running tap water (minimum temperature 38°C/100.4°F) for a minimum of 30 seconds using a minimum of 1 liter of rinse water. Ensure running water passes through cannulation, and that blind holes are repeatedly filled and emptied. 9. Ensure instrument is visibly free of detergent or cleaning residues.

Final Rinse 10.Rinse under running deionized water (minimum temperature 25°C/ 77°F) using a minimum volume of 1 liter of rinse water for a minimum of 30 seconds.

Inspection 11.Inspect for cleanliness. Ensure instrument is free of visible debris and/or soil. Failure to follow cleaning instructions may compromise the sterility of the device.

Drying 12.Dry the device using a clean, lint free towel until visibly free of water droplets and/or condensation.

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Lubricant 13.If applicable, a commercial water-based lubricant should be used to minimize wear of movable parts. Wipe off excess lubricant.

Steam Sterilization

14.For sterilization of instruments in a tray, consult the guidelines provided with the specific sterilization tray. 15.Disassemble the sheath and stopcock before steam sterilization. If applicable, make sure valves are in the “OPEN” position. 16.Prepare sheaths such that all surfaces have direct contact with steam. 17.Reassemble as needed for use, after sterilization. 18.Double wrap instruments using FDA cleared sterilization wrap. Method

Cycle

Minimum Minimum Minimum Temperature Exposure Dry Cycle

Steam Pre-Vacuum 270°F (132°C) (Double Wrapped) Steam (Double Wrapped)

Gravity

3 minutes

8 minutes

250°F (121°C) 30 minutes

8 minutes

NOTES: Sterilization validation is based on AAMI guidelines (Association for the Advancement of Medical Instrumentation).

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REASSEMBLY 19.For stopcock, reassemble by placing the valve and the nut back into place (Figure 2). Confirm the valve and the nut are in place and the valve can be easily moved. Figure 2*

REPLACEMENT PARTS AND ACCESSORIES Parts can be ordered by contacting Linvatec Customer Service at 1-800-237-0169 in the U.S. or your local representative..

REF

Description

QL5530

Arthroscopy Sheath Body 5.5 mm

QL6101

QuickLatch Blunt Obturator (for 5.5mm or 5.9mm sheaths)

QL6102

QuickLatch Conical Obturator (for 5.5mm or 5.9mm sheaths)

QL6103

QuickLatch Sharp Trocar (for 5.5mm or 5.9mm sheaths)

QL6130

Arthroscopy Sheath Body 5.9 mm

T4904

Replacement O ring 7.9mm ID (Qty. 2)

T4905

Locking Nut Replacement

T4908

Replacement O ring 7.6mm ID (Qty. 4)

T5801

Single Stopcock Replacement Assembly

T5802

Dual Stopcock Replacement Assembly

T0009

Replacement Nut and Valve for Stopcock Assembly

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PACKAGING AND LABELING 1. This device should only be used if the original packaging and labeling are intact. 2. If packaging has been opened or altered, contact the Customer Service Department.

CONTACT INFORMATION For more information or a product demonstration, contact your regional Linvatec sales representative, or call 1-800-237-0169 in the U.S. *Pictures are for reference only.

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2797 EC REP MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany

ConMed Corporation 525 French Road Utica, NY 13502-5994 USA Phone: (727) 392-6464 Customer Service: 1-800-237-0169 USA FAX: (727) 399-5256 International FAX: +1(727) 397-4540 email: [email protected] www.conmed.com ©2012, 2013 ConMed Corporation. All rights reserved. P000016184

Rev A

01/2020