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VersaOne Fascial Closure System
VersaOne Reusable Suture Passer Cleaning and Sterilisation Guide
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CLEANING & STERILISATION GUIDE VersaOne™ Fascial Closure System Reusable Suture Passer
REPROCESSING INSTRUCTIONS Always ensure that the devices are handled and processed by qualified personnel who are specially trained & adequately experienced in regard of hospital hygiene and sterilisation technology. In order to ensure safe and effective reprocessing of the devices, the following instructions have been validated for efficacy and compatibility with the devices by the manufacturer. It is the responsibility of the end user to ensure that the cleaning and sterilisation is performed using appropriate equipment, materials, and personnel to achieve the desired result. Any deviation from these instructions should be evaluated for effectiveness and potential adverse consequences. WARNING Before initial use and any subsequent use, all reusable products have to be subjected to reprocessing as described in the following sections. Follow instructions and warnings as issued by manufacturers of any decontaminants, disinfectants, and cleaning agents used.
PREPARATION PRIOR TO FIRST USE The reusable products are delivered nonsterile and must be cleaned and sterilised before initial use and before each subsequent use. The packaging cannot withstand the high temperatures of autoclaving and should be discarded before sterilisation. PREPARATION AT THE POINT OF USE PRIOR TO REPROCESSING Remove all traces of contamination immediately after use to avoid incrustation. Do not use fixative agents or hot water (>40°C). Avoid using a metal brush, steel wool, or other cleaning devices containing metal in order to avoid risk of insulation damage or corrosion. Storage and transport of the instruments to the reprocessing location must be ensured in a sealed container.
CLEANING INSTRUCTIONS
MAINTENANCE
WARNING Failure to properly clean, rinse and dry a device may result in retention of potentially hazardous residues or in inadequate sterilisation.
Apply a small amount of high-grade surgical lubricant on all joints or other moveable parts which are supposed to move smoothly. Sort out all blunt or damaged instruments. Clearly damaged instruments (cracks on the insulation, breakage, strongly bleached polymer handles or coatings) are NOT to be reused but repaired or disposed of.
MANUAL PRE-CLEANING The instruments shall be brushed under cold water until all visible contamination is removed. After manual brushing, rinse the lumen of the sheath via its flushing port with a water jet pistol (static pressure above 4 bar) for at least 10 seconds. AUTOMATED CLEANING Associated parts are to be stored together in order to facilitate a subsequent identification. Make sure that instruments do not contact each other. Devices from different materials such as titanium, brass, aluminum, stainless steel, etc. need to be cleaned separately in order to avoid formation of a rust film. Composite instruments particularly stainless steel combined with ceramics need to be placed with sufficient distance to other products, so they do not break due to the pressure of different thermal expansions. RECOMMENDED PROCESS-EQUIPMENT ▪ Washer: Miele™* Type G7836 CD ▪ Cleaners: TWIN PH10™* and TWINZYME™* (Borer Switzerland) AUTOMATED CLEANING CYCLE Two-component alkaline-enzymatic cleaning program: A 3 minutes pre-washing with cold tap water B Drain C 10 minutes washing at 45°C with tap water and: ▪ 0.3% dosing TWIN PH10™* at 35°C ▪ 0.2% dosing TWIN ZYME™* at 40°C D Drain E 2 minutes intermediate rinsing with warm deionised water (>30°C) F Drain G 1 minute intermediate rinsing with cold deionised water H Drain I 5 minutes thermal disinfection at >90°C J 30 minutes drying
TESTING AND INSPECTION Jointed instruments are to be tested for ease of movement (avoid too much backlash). The functionality of ratchet mechanisms needs to be checked. All instruments: visually check for damage and wear. Blades should be even and without notches. Long and narrow instruments (especially jointed instruments) should be particularly checked for damages. If instruments are part of a larger set, they are to be checked together with all associated components. WARNING In case of present or suspected damage to the devices, do not try to repair the instrument. Avoid any further use of damaged instruments.
PACKAGING Packaging suitable for steam sterilisation must comply with the requirements according to DIN EN ISO 11607 / ANSI/ AAMI ST79 / AAMI TIR12:2010, for example, disposable sterilisation packs (single or double packs) temperature resistant up to at least 137°C (279°F) and sufficient steam permeability, which provide sufficient protection against mechanical damage, or sterilisation containers which need to be maintained according to the manufacturer‘s instructions.
STERILISATION
STORAGE
WARNING Autoclaves vary in design and performance characteristics. Cycle parameters should always be verified against the autoclave manufacturer’s written instructions for the specific autoclave and load configuration being used. Sterilisation is preferably performed by steam sterilisation. The following cycles has been validated in accordance with internationally harmonised standards regarding its suitability and efficacy for the devices fractionated prevacuum cycle. ▪ 132°C / 270°F, 4 minutes (wrapped), minimum 20 minutes drying. Or ▪ 134°C/ 273°F, 4 minutes (wrapped), minimum 20 minutes drying.
Store instruments secured against mechanical damage. Use additional wrapping to protect against dust. Do not stack instruments which are packed sterile; especially do not place heavy items on top in order to avoid damage to the sterile packaging of other instruments.
ADDITIONAL INFORMATION Do not exceed maximum loading capacity of the steriliser when processing multiple instruments in one sterilisation cycle.
Important: Always refer to the instructions for use (IFU) supplied with the product for complete instructions, indications, contraindications, warnings, and precautions. Medtronic Australasia Pty Ltd 2 Alma Road Macquarie Park, NSW 2113 Australia Tel: +61 2 9857 9000 Fax: +61 2 9889 5167 Toll Free: 1800 668 670
Medtronic New Zealand Ltd Level 3 - Building 5, Central Park Corporate Centre 666 Great South Road Penrose, Auckland 1051 New Zealand Fax: +64 9 918 3742 Toll Free: 0800 377 807
medtronic.com.au medtronic.co.nz
© Medtronic 2020 All Rights Reserved. ™* Third party brands are trademarks of their respective owners. EM 1156-02-20 ANZ. #7363-022020