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
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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
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The CE mark is valid only if it is also printed on the product label.
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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
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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.
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INSTRUMENT/TEMPLATE (PROVISIONAL) USE AND CARE • •
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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 •
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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.
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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.
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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
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2 minutes prewash with cold tap water
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20 seconds enzyme spray with hot tap water
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1 minute enzyme soak
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15 seconds cold tap water rinse (X2)
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2 minutes detergent wash with hot tap water (64-66°C/146-150°F)
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15 seconds hot tap water rinse
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2 minutes thermal rinse (80-93°C/176-200°F)
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10 seconds purified water rinse with optional lubricant (64-66°C/146-150°F)
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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
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10 min alkaline cleaning agent wash at 55°C
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2 min rinse with neutralizer
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1 min rinse with cold tap water
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Disinfection at 93°C with hot purified water until A0 3000 is reached (approx. 10 min)
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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).
Recommended Steam Sterilization Cycles
STERILE PACKAGING - ONLY APPLICABLE FOR INSTRUMENTS DELIVERED IN NON STERILE CONFIGURATION Packaging individual instruments • Single devices should be packaged in a medical grade sterilization pouch or wrap which conforms to the recommended specifications for steam sterilization provided in the table below. Ensure the package is large enough to contain the instrument without stressing the seals or tearing the pouch or wrap. • Sterilization wraps must be free of detergent residues. Reusable wraps are not recommended. Packaging instruments within defined, preconfigured Zimmer instrument trays and cases with lids Safety Precaution: The total weight of a wrapped instrument tray or case should not exceed 11.4 kg/25 lbs. When placed in a sterilization container with a gasketed lid the total package should not exceed 11.4 kg/25 lbs. • Trays and cases with lids may be wrapped in a standard, medical grade, steam sterilization wrap using the AAMI double wrap method or equivalent. Please refer to additional country-specific regulations such as the use of FDA-cleared wraps and pouches. • Trays and cases with lids may also be placed in an approved sterilization container with gasketed lid for sterilization. Packaging instruments in universal instrument trays and cases without defined, preconfigured layouts or containing undefined universal spaces or compartments should only be used under the following conditions: • All devices must be arranged to ensure steam penetration to all instrument surfaces. Instruments must not be stacked or placed in close contact. • The user must ensure that the instrument case is not tipped or the contents shifted once the devices are arranged. Silicone mats may be used to keep devices in place.
STERILE INSTRUMENTS •
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Gamma irradiation is indicated by the STERILE R symbol on the labeling. These devices remain sterile as long as the package integrity has not been violated. Inspect each package prior to use and do not use the component if any sterile barrier or seal is damaged, breached, or if the expiration date has been exceeded. Once opened, the component must be used, discarded, or resterilized (as outlined below).
STERILIZATION INSTRUCTIONS •
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These sterilization instructions are consistent with ANSI/AAMI/ISO standards and guidelines. They should be used for items supplied non-sterile, for reprocessing reusable devices, or sterile items that were opened but unused. In the event of inadvertent loss of sterility while preparing for surgery, sterile, single use metal instruments may be sterilized only once for immediate use, following the recommended sterilization specifications. This is subject to the exceptions listed below. - See also Zimmer booklet 97-5000-170-00 Orthopaedic Reusable Devices (available from your distributor or at www.zimmer.com) for detailed guidelines related to proper care, maintenance, reprocessing, and handling of surgical instruments. Do not reuse instruments labeled for single use only. Reuse could adversely affect performance. DO NOT RESTERILIZE: - Single use only components that have been contaminated with body fluids or debris or previously have been implanted. - Components with a packaging expiration date that has been exceeded. Do not use the original plastic cavities or lids for resterilization. Single devices should be packaged in a medical grade sterilization pouch or wrap which conforms to the recommended specifications for steam sterilization provided in the table below. Ensure that the pouch or wrap is large enough to contain the devices without stressing the seals or tearing. Items made from titanium and titanium alloys can form oxide layers from steam boiler treatment, chemicals or detergent residues. While these oxides are biocompatible, they can obliterate etchings and stampings. Sterilized instruments must be completely dry prior to storage.
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Type
Temperature
Exposure Time
UK Pre-vacuum/ Pulsating Vacuum1
134°C (273°F)
3 minutes
Pre-vacuum/ Pulsating Vacuum
132°C (270°F)
4 minutes
Pre-vacuum/ Pulsating Vacuum1,2
134°C (273°F)
18 minutes
Minimum Dry Time
Minimum Cooling Time
30 minutes
30 minutes
This cycle is not for use in the USA. This cycle is not to be used for the inactivation of prions.
Please contact Zimmer if you have additional questions. In the USA, call 1-800-348-2759. Outside the USA, call the local international access code +1-574-267-6131.
INSPECTION AND FUNCTIONAL TESTING • • • • •
Carefully inspect each device to ensure that all visible blood and debris have been removed. Check the action of moving parts to ensure smooth operation through the intended range of motion. Check instruments with long, slender features (particularly rotating instruments) for distortion. Where instruments form part of an assembly, check that the devices assemble readily with mating components. If damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your Zimmer representative for a replacement.
STORAGE AND HANDLING • •
Non-sterile instruments as supplied are to be stored in the appropriate instrument tray, or in other suitable packaging that protects the instruments from damage. Sterile instruments as supplied: - are to be stored unopened in their original packaging. - should be stored in a designated, limited access area that is well ventilated, and provides protection from dust, moisture, insects, vermin and from temperature and humidity extremes. - should be examined carefully prior to opening to ensure that there has been no loss of package integrity. This includes verification of the expiration date. - protective caps or other protective components shall not be removed until immediately before use.
All trademarks and logos referred to within this package insert are the property of Zimmer, Inc. or its affiliates. Caution: Federal law restricts this device to sale by or on the order of a physician. Do not use if package is damaged.
Recommended Sterilization/Resterilization Specifications Follow the sterilizer manufacturer’s instructions for loading patterns and selection of sterilization parameters. Drying times vary according to load size and should be increased for larger loads.
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