ZIMMER

3.5 mm Preparation Chisel System, Straight, 2.7/3.5 mm V-TEK IVP System

Surgical Instruments Hand and Foot Systems Instructions for Use

2 Pages

Ed. 2015/11 © Zimmer GmbH  ENGLISH  & 0086  87-6204-402-23 EN 2015/11  only  Surgical Instruments Hand and Foot Systems  Zimmer GmbH Sulzerallee 8 8404 Winterthur, Switzerland Telephone +41/ (0)52 262 60 70 Fax +41/ (0)52 262 01 39 www.zimmer.com  Representative in the USA: Zimmer, Inc. 1800 West Center Street Warsaw, Indiana, 46580, USA  2WMEN876204402231 ENGLISH  -  The CE mark is valid only if it is also printed on the product label.  -  If provided, appropriate drill sleeves and drilling cannulas must be used to avoid tissue damage. Screwdriver blades and taps must not be used in combination with power tools.  Surgical Instruments - Hand and Foot Systems  PRECAUTIONS  Important information for the operating surgeon  • •  Before using a device placed on the market by Zimmer, the operating surgeon should study carefully the following recommendations, warnings and instructions, as well as the available device specific information (e.g., product literature, written surgical technique). Zimmer is not liable for complications that may arise from use of the device in circumstances outside Zimmer’s control including, but not limited to, deviations from the device’s indicated uses or surgical technique.  •  •  INSTRUMENT/TEMPLATE (PROVISIONAL) USE AND CARE • •  •  •  Failure to follow these instructions could result in instrument or template breakage and potential adverse effects on user(s) or patient. Except for general surgical instruments and/or those instruments described in the appropriate surgical technique, use only instruments and templates specifically designed for use with their associated devices. No liability is accepted for instruments manufactured by third parties. Exception: Surgical Instruments used in combination with motor/drive systems. In this case the instructions supplied by the drive manufacturer for the combined use with other products must be adhered to precisely. Misuse reduces useful life and/or increases injury risk. Repeated processing according to these instructions has minimal effect on Zimmer reusable instruments. End of life is normally determined by wear and damage due to use. The Kirschner wires and implants are single use products. They must be disposed after use. Please submit the surgical product for professional disposal (medical waste) after end of its life time.  WARNINGS •  • • • •  • • • •  •  • •  Universal Precautions should be observed by all hospital personnel that work with contaminated or potentially contaminated medical devices. Caution should be exercised when handling devices with sharp points or cutting edges. Instruments must be thoroughly cleaned prior to sterilization. Instruments that are not clean may not be effectively sterilized. Do not put reusable instruments that are contaminated with body fluids or debris back into the tray system before being thoroughly cleaned. Automated cleaning alone may not be effective. A thorough, manual cleaning process is recommended prior to automated cleaning. Do not subject plain or anodized aluminum components to acidic ultrasonic cleaning agents or stainless steel to chlorine or chloride-based agents. Corrosion or discoloration may occur. Disinfection is only acceptable as a supplement to full sterilization for reusable surgical instruments and templates. Do not alter a device in any way unless this is expressly stipulated in the design and/or in the surgical technique. Do not reuse instruments labeled for single use only. Reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents. Do not use cutting/sharp instruments with blunt or deformed edges or instruments/templates that are deformed, corroded, damaged or worn. They may not perform as intended. Do not subject instruments to high loads and/or high impact, as breakage can occur. Rotating instruments (e.g. drills, countersinks, etc.): - During procedures, appropriate irrigation must be provided, in order to avoid excessive heat development and to prevent potential irreversible bone and tissue damage. - The revolutions per minute and contact forces must be chosen appropriately, in order to avoid excessive strain and potential damage and/or breakage of the instrument which could lead to injuries of the user or patient.  •  •  Inspect all instruments carefully prior to each use. Cannulated Instruments - Clean cannulated instruments intraoperatively to prevent accumulation of debris. Guide Wires - Check the guide wire position frequently using fluoroscopy to prevent unintended guide wire advancement and/or penetration into the surrounding tissues. Any decision to leave or remove fragments of broken instruments (e.g., drill fragments) is left to the surgeon’s discretion and must take into account the associated risks. Metallic fragments can be located by external imaging devices such as X-ray radiography; polymer fragments can be located by medical ultrasonography examination, depending on the size, location, and properties of the polymer. MAGNETIC RESONANCE (MR) SAFETY AND COMPATIBILITY: In the event of exposure to foreseeable environmental conditions such as magnetic fields the user and/or patient should be informed of the following: - This device has not been evaluated for safety and compatibility in the MR environment. - This device has not been tested for heating or migration in the MR environment. - There is a potential for heating and migration in the MR environment. - There is the potential for metal devices to create MR imaging artifacts in the vicinity of the device. Only devices manufactured by Zimmer and/or distributed by Zimmer should be included in Zimmer instrument trays. Zimmer validated reprocessing instructions are not applicable to Zimmer instrument trays used for devices that have not been manufactured or distributed by Zimmer.  CLEANING NOT APPLICABLE FOR INSTRUMENTS LABELED AS STERILE AND FOR SINGLE USE ONLY • Automated cleaning using a washer/disinfector machine alone may not be effective for orthopedic instruments with lumens, cannulations, blind holes, mated surfaces and other complex features. A thorough, manual or combination manual/ automated process is recommended. • Thoroughly clean and dry reusable instruments immediately after use to minimize corrosion and potential cross-contamination. • Validation of the cleaning, sterilization and resterilization procedures and the correct setting of the corresponding equipment must be checked regularly. • Do not allow instruments to contact substances containing chlorine or fluorine. Do not allow instruments made wholly or partly of plastic to contact strong acids or lyes, organic or ammonia-containing solvents, aromatic and/or halogen hydrocarbons or oxidizing chemicals. • Do not permit aluminum or materials containing aluminum to contact substances containing mercury. Even the smallest traces of mercury can lead to considerable corrosion. Instruments made from materials containing aluminum must only be wiped and cleaned with, or placed in, detergents and disinfectants that have a pH value between 4.5 and 8.5. With higher or lower pH values the protective neutral coating of materials containing aluminum dissolves and leads to corrosion. • Do not permit contaminants to dry on the instruments, as cleaning can become more difficult. • If corrosive media such as silver nitrate, iodine preparations, albotyl and mercury compounds are used during the operating procedure, all residues of these substances must be removed from the instruments immediately. • Instruments should not be placed in physiological saline solution, as prolonged contact with this medium can lead to corrosion and changes to the surface of the instruments. • Do not use metal brushes or scouring agents to clean instruments. In order to avoid water stains, a final rinsing with desalinated water is recommended. The instruments must then be dried immediately. Sterile compressed air can be used for drying. • Ultrasound is particularly suitable for the cleaning of metal instruments. Rinsing with desalinated water is recommended after cleaning. • After cleaning, lubricate metal, moving parts with a lubricant approved for use with medical devices. Reassemble and tighten screws where appropriate.  Page 1 of 2  MANUAL CLEANING/DISINFECTION INSTRUCTIONS - NOT APPLICABLE FOR INSTRUMENTS LABELED AS STERILE AND FOR SINGLE USE ONLY 1. Completely submerge the instruments in enzyme or alkaline (pH ≤12) solution and allow to soak for 20 minutes. Use a soft-bristled, nylon brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow, soft-bristled brush (e.g. pipe cleaner). 2. Remove the instruments from the cleaning solution and rinse in tap water for a minimum of 3 minutes. Thoroughly and aggressively flush lumens, blind holes and other difficult-to-reach areas. 3. Place prepared cleaning agents in a sonication unit. Completely submerge devices in cleaning solution and sonicate for 10 minutes at 45-50 kHz. 4. Rinse instruments in purified water for at least 3 minutes or until there is no sign of blood or soil on the device or in the rinse stream. Thoroughly and aggressively flush lumens, blind holes and other difficult-to-reach areas. 5. Repeat sonication and rinse steps above. 6. Remove excess moisture from the instrument with a clean, absorbent and non-shedding wipe. Note: If stainless steel instruments are stained or corroded, an acidic, anticorrosion agent in an ultrasonic cleaner may be sufficient to remove surface deposits. Care must be taken to thoroughly rinse acid from devices. Acidic, anti-corrosion agents should only be used on an as needed basis.  COMBINATION MANUAL/AUTOMATED CLEANING AND DISINFECTION INSTRUCTIONS - NOT APPLICABLE FOR INSTRUMENTS LABELED AS STERILE AND FOR SINGLE USE ONLY 1. Completely submerge instruments in enzyme or alkaline (pH ≤12) solution and allow to soak for 10 minutes. Use a soft, nylon-bristled brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow, soft-bristled brush (e.g. pipe cleaner). Note: Use of a sonicator at 45-50 kHz will aid in thorough cleaning of the devices. Note: Use of a syringe or water jet will improve flushing of difficult to reach areas and closely mated surfaces. 2. Remove instruments from cleaning solution and rinse in purified water for a minimum of 1 minute. Thoroughly and aggressively flush lumens, blind holes and other difficult-to-reach areas. 3. Place instruments in a suitable washer/disinfector basket and process through a standard instrument cycle. The following minimum parameters are essential for thorough cleaning and disinfection: Typical U.S. Automated Washer/Disinfector Cycle for Surgical Instruments Step  Description  1.  2 minutes prewash with cold tap water  2.  20 seconds enzyme spray with hot tap water  3.  1 minute enzyme soak  4.  15 seconds cold tap water rinse (X2)  5.  2 minutes detergent wash with hot tap water (64-66°C/146-150°F)  6.  15 seconds hot tap water rinse  7.  2 minutes thermal rinse (80-93°C/176-200°F)  8.  10 seconds purified water rinse with optional lubricant (64-66°C/146-150°F)  9.  7 to 30 minutes hot air dry (116°C/240°F)  Typical European Automated Washer/Disinfector Cycle for Surgical Instruments Step 1.  Description 5 min pre-rinse with cold tap water  2.  10 min alkaline cleaning agent wash at 55°C  3.  2 min rinse with neutralizer  4.  1 min rinse with cold tap water  5.  Disinfection at 93°C with hot purified water until A0 3000 is reached (approx. 10 min)  6.  40 min hot air drying at 110°C  Note: The washer/disinfector manufacturer’s instructions should be strictly adhered to. Use only cleaning agents recommended for the specific type of automated washer/disinfector. A washer/disinfector with approved efficacy (e.g. CE mark, FDA approval, and validation according to ISO 15883) should be used. For further information, see also Zimmer booklet 97-5000-170-00 Orthopaedic Reusable Devices (available from your distributor or at www.zimmer.com).
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