ZIMMER

32mm VerSys Femoral Head Provisional 0

ZIMMER SURGICAL INSTRUMENTS Instruction Manual

2 Pages

ENGLISH  Ed. 2019/09 © Zimmer GmbH  &  & 2797  •  D011500192 EN 2019/09 Zimmer Switzerland Manufacturing (ZSM) GmbH Sulzerallee 8 8404 Winterthur, Switzerland Telephone +41/ (0) 58 854 80 00 Fax +41/ (0) 52 244 86 70 www.zimmerbiomet.com  SURGICAL INSTRUMENTS  ENGLISH  EN  •  The CE mark and Legal Manufacturer is valid only if it is also printed on the product label.  SURGICAL INSTRUMENTS For detailed information concerning the identification of the product (such as name, ref.no.) please refer to the labeling on the package and/or the marking on the device.  Important information for the operating surgeon Before using an instrument placed on the market by Zimmer, the operating surgeon, healthcare professionals and central sterile service staff should study carefully the following recommendations, warnings and instructions, as well as the available instrument specific information as e.g. product literature, surgical technique, the booklet Orthopaedic Reusable Devices (97‑5000‑170‑00), the Instruments Assembly Disassembly manual (1258 GLBL) and the Reusable Instrument lifespan manual (1219 GLBL). Zimmer Biomet is not liable for complications that may arise from use of the instruments in circumstances outside of Zimmer’s control including, but not limited to, deviations from the instruments’ indicated uses or surgical technique. Surgical instruments and provisionals are intended to be used by orthopedic surgeons to facilitate the implanting or explanting of specific implants described in the product-specific surgical technique. Refer to the implant specific IFU for information on the intended use, indications and contraindications of the implant” Sterilization case components are intended to facilitate the organization, identification, storage, transportation cleaning and sterilization reprocessing of instruments and provisionals. General surgical instruments are intended to facilitate surgical procedures. They can be used across multiple systems.  • • • • • • • • •  • • • • •  •  •  Failure to follow these instructions could result in instrument or provisional breakage and potential adverse effects on users or patients. Except for general surgical instruments and/or those instruments described in the product-specific surgical technique, use only instruments and provisionals specifically designed for use with their associated devices. No liability is accepted for instruments of third parties. Although not considered a third party, do only combine with Biomet products when such combinations are described in the surgical technique. Exception: use of Zimmer products in combination with motor/drive systems (power tools). In this case, the instructions provided by the manufacturer of the drive (power tools) for a combined use with other products must be followed precisely! Misuse reduces useful life and/or increases injury risk. Repeated processing according to these instructions has minimal effect on Zimmer’s reusable manual instruments. End of life is normally determined by wear and damage due to use.  INSTRUMENTS WITH MEASURING FUNCTION (EU class Im) •  Unless otherwise specified, rulers, calipers, and goniometers comply with the length measurements identified under class II accuracy in accordance with 2004/22/EC. This implies an accuracy of +/-0.5 mm over the total length of the scale and +/-0.2 mm between divisions on the scale. For angle measurements, goniometers are accurate to +/- 1° (180° angle).  •  Do not reuse instruments labeled for single use only. Re-use could adversely affect device performance.  WARNINGS  •  •  •  •  •  • •  Re-use 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 re-use of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents. 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. Automated cleaning alone may not be effective. A thorough, manual cleaning process is recommended prior to automated cleaning. Do not use cutting/sharp instruments with dull or deformed edges or instruments/ provisionals that are deformed, corroded, damaged or worn. They may not perform as intended. Do not subject instruments to high loads and/or impact as breakage can occur. 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. Do not clean polyetherimide components with phenol-based detergents. Crazing or cracking may occur. Disinfection is only acceptable as an adjunct to full sterilization for reusable surgical instruments and provisionals. Do not alter a device in any way unless this is expressly envisaged in the design and in the product-specific surgical technique.  PRECAUTIONS  INSTRUMENT/PROVISIONAL USE AND CARE •  Zimmer GmbH Sulzerallee 8 8404 Winterthur, Switzerland Telephone +41/ (0) 58 854 80 00 Fax +41/ (0) 52 244 86 70 www.zimmerbiomet.com  Biomet GSCC BV Hazeldonk 6530 4836 LD Breda The Netherlands  2WMEND0115001921  •  Inspect all instruments/provisionals carefully prior to use. Polymer provisionals may show eventual surface degradation from the heat and chemicals used in hospital cleaning and steam sterilization. Replace the provisional when degradation makes cleaning difficult or if the surface becomes chalky. Rasps – A rasp must advance each time it is struck with a mallet. There is a higher risk of bone fracture or rasp impaction when it does not advance or if the rasp is dull. 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 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 (note: the use of MRI for this purpose is not recommended). Polymer fragments can be located by medical ultrasonography examination, depending on the size, location, and properties of the polymer. Only devices manufactured and/or distributed by Zimmer should be included in Zimmer instrument trays. Zimmer’s validated reprocessing instructions are not applicable to Zimmer trays that include devices not manufactured and/or distributed by Zimmer. The presences over 0.1% of substances in the product which are potential carcinogenic, mutagenic or toxic to reproduction (CMR) or endocrine disrupters are indicated by the symbol on the product label followed by the respective substance identifier. For further details please review: https://echa.europa.eu/home. Patients/users hypersensitive to any of the instruments material may suffer an allergic reaction.  CLEANING  (See also Zimmer booklet “Orthopaedic Reusable Devices” 97‑5000‑170‑00, Instruments Assembly Disassembly Manual 1258 GLBL and the applicable system specific information from your Zimmer sales representative or at http://labeling.zimmerbiomet.com) – 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 orthopaedic instruments with lumens, cannulations, blind holes, mated surfaces and other complex features. A thorough, manual or combination manual/automated process is recommended.  Page 1 of 2  • •  • •  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 be difficult. If corrosive media such as silver nitrate, iodine preparations, albotyl and mercury compounds are used during the operation, 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 water soluble lubricant approved for use with medical devices. Reassemble and tighten screws where appropriate.  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 of 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-toreach 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.
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