SLS Clip Appliers Important Information

IMPORTANT INFORMATION FOR THE USE AND HANDLING OF SURGICAL INSTRUMENTS SLS CLIP APPLIERS CAUTION: Please read all information. Incorrect handling and care as well as misuse can lead to premature wear of surgical instruments. INITIAL USE FOR NEW INSTRUMENTS: Every instrument must be cleaned prior to sterilization before it is used for the first time. The clip appliers were developed for sterilization by autoclave and are also compatible with STERRAD® and STERIS® methods of sterilization. See manufacturers recommendation for sterilization procedures of Stainless Steel instruments. INSPECTION AND FUNCTIONAL CHECK: It is very important to carefully examine each surgical instrument for breaks, cracks or malfunctions before use. It is especially essential to check areas such as jaws as well as all movable parts. DO NOT USE A DAMAGED INSTRUMENT. Never attempt to repair appliers yourself or via an unauthorized repair facility. Service and repairs should be referred to a trained qualified technician only. Refer questions about repair to the manufacturer or your biomedical engineering department. DECONTAMINATION, CLEANING AND MAINTENANCE: Every surgical instrument must be disinfected and thoroughly cleaned after each use. Clean, inspect and test each instrument carefully. Sterilize all instruments before surgery. A proper cleaning and maintenance procedure will extend the life time of the appliers. Special attention should be paid to the jaws. During cleaning and sterilization, the standard clip appliers (open surgery) must be opened. 1) Disengage the middle spring (slight closing pressure may need to be exerted on the finger rings to unlock middle spring) 2) Open the handle completely after middle spring is disengaged Laparoscopic clip appliers must be cleaned and dismantled (refer to specific instruction for use supplied with the product) CAUTIONS:  Do not use corrosive cleaning agents. Clean solutions and rinses at or near a neutral pH (7.0) are best  Do not use abrasive cleaners  Only a soft brush should be used  Rinse thoroughly with distilled water  Prepare for sterilization After cleaning and rinsing, dry instrument completely and carefully with compressed air STANDARD STERILIZATION METHODS: Steam autoclave sterilization is recommended. Do not sterilize in hot air. Standard autoclave cycle: 134°C for 18 minutes. Other time and steam temperature cycle may be used. However, user must validate any deviation from recommended time and temperature. Autoclave temperature should not exceed 137°C (280°F). STERILIZATION FOR THE USA MARKET:   

Sterilization of the device may be accomplished by steam Aesculap does not recommended the device be sterilized by “Flash” or “chemical sterilization” Surgical instruments may also be placed with an Aesculap rigid sterilization container (sterilecontainer) for processing under generally accepted hospital in‐use conditions.

The recommended sterilization parameters are as follows: Sterilization Method Pre‐Vacuum

Temperature

Minimum Exposure time

270‐275°F (132‐135°C)

Wrapped 4 minutes

In a sterile container system 4 minutes

WARNING FOR USA MARKET: If this device is/was used in a patient with, or suspected of having Creutzfeldt –Jacob disease (CJD) , the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross‐contamination. HANDLING: All surgical instruments should be handled with the greatest of care, cleaned, treated, sterilized and stored safely. WARRANTY: All products are guaranteed to be free from defects in material and workmanship for one full year. We cannot accept any liability for failure of product´s, which have been modified in any way from their original form, for any failure due to misuse or application which is not in accordance with the designer´s intentions. Manufactured by: ITM S/A – Indústria de Tecnologias Médicas Rua Berto Círio 751, Canoas, Brazil – www.edlo.com.br

CE Mark

Manufactured for: Aesculap, Inc. 3773 Corporate Parkway, Center Valley , PA 18034 STERRAD®: © Advanced Sterilization Products 2002 STERIS®: © 1998‐2003, Steris Corporation. All rights reserved.

SOP‐AIC‐5000273 Rev. 02

Rev.11/2013