User Guide for Reprocessing of the SUPER VIEW Wide Angle Viewing System Sterilizable Components and Accessories

Transcription

1 User Guide for Reprocessing of the SUPER VIEW Wide Angle Viewing System Sterilizable Components and Accessories

2 Table of Contents 1. Intended Use Statement Proper Use General Information Principles of Use Pre-Cleaning Manual and Ultrasonic Cleaning Washing Maintenance (Before Sterilization) Functional Test Packaging Sterilization Storage Sterile Area Use Reusability Disposal Material Compatibility Service Disclaimers CE European Authorized Representative Processing Matrix Insight Instruments, Inc. Page 2 of 14

3 1. Intended Use Statement The SUPER VIEW Wide Angle Viewing System (SUPER VIEW System) is intended for use with designated operating microscopes in conjunction with the SUPER VIEW Lenses to provide wide angle, non-contact visualization of ocular fundus, vitreous, and retinal structures during vitreoretinal surgery. 2. Proper Use The product is intended for use in Hospitals, Clinics, or other human/veterinary use institutions. The system is intended for use by properly trained physicians and their personnel. 3. General Information This reprocessing manual is for the cleaning and sterilization of the various components of the SUPER VIEW System. Please refer to the Processing Matrix (Sec. 20) for specific information on the reprocessing method approved for each component. Use of this product in a manner inconsistent with this labeling voids all warranties. Deviation from the current instructions, (i.e. cleaning or sterilization parameters of validated processes) must be independently validated for safety and efficacy. Insight Instruments, Inc. accepts no responsibility for damage or injury caused by un-validated methods or use. Insight Instruments, Inc. reserves the right to change this manual at any time. This manual may be ordered from Insight Instruments, Inc. 4. Principles of Use All sterilizable components of the system are delivered non-sterile and must be cleaned prior to each sterilization cycle. Successful cleaning is essential for effective sterilization of the products. If possible, an automated washer/disinfector should be used for cleaning. Processing in an un-approved instrument tray is not recommended. Close attention should be paid to ensure only validated methods for cleaning and sterilization are used, and that all current regulations of your country and the policies of your facility are followed. Wide Angle Module (WAM ) Please note that the following sterilization methods are not allowed: Dry Heat Radiation Formaldehyde or Ethylene Oxide When the instruments are used as directed, no part of the viewing system should come in direct contact with the body or body fluids of the patient. Avoid contact with blood or other body fluids when removing the system from the microscope for reprocessing after surgery. All sterilizable components must be cleaned and sterilized before every use. Insight Instruments, Inc. Page 3 of 14

4 5. Pre-Cleaning To ensure effective processing of the sterilizable components of the SUPER VIEW System, the pre-cleaning treatment should start immediately if possible, but within 30 minutes after use. Always clean the contaminated components of the system separately. Return only clean components to the instrument tray for reprocessing Pre-Cleaning Materials When selecting the cleaning products, make sure that cleaning agents meet compatibility requirements in Section 16. The following cleaning materials are not included with the system and are required for reprocessing: Figure 2 Potable water quality according to AAMI TIR 34:2011. Neutral ph enzymatic cleaning detergent A soft nylon brush Miltex Instrument Brush Model # or equivalent. Lint free cloth Always use concentration levels and contact times recommended by the manufacturer unless otherwise indicated. Handle contaminated components in accordance with OSHA 29 CFR and AAMI ST 79:2010 Never clean the system components or Instrument Tray with a metal brush, steel wool, or abrasive agents as they may damage surfaces and reduce sterilizability Dismantling Disconnect the Wide Angle Module (WAM ) cable from the SV Inverter as shown in figure 2. Loosen the thumbscrew on dovetail and remove adapter and WAM from microscope. Separate components of system as shown in figure Pre-Cleaning Figure 3 Within 30 minutes of use separate and properly dispose of any products that do not get reprocessed. Remove any gross contamination from the WAM, Adapter, and the accessories with a damp, lint free cloth or a dampened clean nylon brush. Manually pre-clean the WAM, Adapter and accessories as follows: Submerse the components into a solution of neutral ph enzymatic cleaning detergent, prepared according to the manufacturer s instructions at a temperature of 40 C (± 5 C). Soak for the time specified by the manufacturer for the effectiveness of the cleaning agent, but not less than 5 minutes. While immersed, rotate the adapter and move the hinge of the WAM back and forth about 10 times to wet all hinge surfaces and joints. Rinse under potable running warm water 40 C (± 5 C) for at least one minute. Insight Instruments, Inc. Page 4 of 14

5 6. Manual and Ultrasonic Cleaning When available, an automatic washer/disinfector should be used. Cleaning should follow within 2 hours of Pre-Cleaning. Visually inspect the components for contamination. Repeat cleaning process if necessary to ensure no visible contamination remains. When selecting the cleaning product, make sure that the cleaning agent meets compatibility requirements in section Material for manual cleaning The following cleaning materials are required for manual cleaning. When selecting the cleaning agents, be sure to use: Cleaning agents that are compatible with the SUPER VIEW system sterilizable components (see material compatibility section 16). A soft nylon brush Miltex Instrument Brush Model # or equivalent. If possible, do not use any combined cleaning/disinfectant agents. This reduces the possibility of residue contamination. Always use concentration levels and contact times specified by the manufacturer of the cleaning products. Only use freshly prepared solutions with water quality applicable to the process being performed. Do not use Saline for rinsing. Use only clean compressed air for drying Manual Cleaning of WAM, Adapter, Instrument Tray, and Accessories Immerse the sterilizable components in an enzymatic pre-soak/cleaning solution containing a surfactant or wetting agent at a temperature of 40 C (± 5 C) for a minimum of 5 minutes (maximum 5% surfactant). Clean the entire surface of all components under warm 40 C (± 5 C) potable water quality or higher for at least 2 minutes using a clean brush until no visible contaminates remain. Pay particular attention to areas marked by pointers in Fig.4 Rinse the components under cold (approx. 23 C) running potable water quality for an additional 2 minutes. Allow the components to air dry or dry using clean compressed air. Figure 4 Never clean the system components or Instrument Tray with a metal brush, steel wool, or abrasive agents as they may damage surfaces and reduce sterilizability. Manual cleaning validation was performed with Neutral Enzymatic Detergent Manufactured by Ecolabs, Inc Ultrasonic Cleaning Cleaning by ultrasonic method is optional. When selecting the ultrasonic cleaning process, the following information should be considered: Remove all gross contaminates before proceeding with the ultrasonic process. The ultrasonic cleaner should produce high frequency sound waves above 20kH. The type of contaminates being removed. De-gassing the solution has a direct effect on the ability of the equipment to clean. Consult the ultrasonic manufacturers written instructions for use (IFU) for the length of time to de-gas a tank full of solution. Insight Instruments, Inc. Page 5 of 14

6 Cleaning detergent compatible with ultrasonic equipment and components. Water quality (e.g. Hardness and ph) Water Temperature per manufacturers IFU Time (length of exposure to cavitation) Human Factors such as loading procedures or proper use of the equipment Materials for Ultrasonic Cleaning The following ultrasonic cleaning materials are required for proper cleaning: Orientation for Cleaning Ultrasonic equipment suitable for cleaning the WAM, Adapter, and accessories. Cleaning agent compatible with the WAM, Adapter, and accessories (See materials compatibility section 16). Figure 5 Always use the concentration levels and contact times specified by the cleaning agent manufacturer s instructions. The cleaning solution has to be replaced regularly according to the ultrasonic manufacture s recommended guidelines. Ultrasonic cleaning of the Instrument Tray is not recommended. Aldehyde cleaners should not be used. They can denature blood protein, making cleaning much more difficult Ultrasonic Cleaning Process The following procedure is recommended: Place the sterilizable components (e.g. WAM, adapter, and accessories) into the ultrasonic cleaner with fresh cleaning agent prepared per the manufacturer s written instructions. The WAM should be in the position as shown in Fig. 5 below. The safety rod should be extended as shown in Fig. 5 below. All components must be completely covered by the cleaning solution. While immersed, rotate the adapter and move the hinge of the WAM back and forth 10 times to wet all hinge surfaces and joints. Sonicate for 20 minutes at 40 C (± 5 C). Remove from the ultrasonic cleaner and rinse the components under cold (approx. 23 C) running high purity water quality (RO) for an additional 5 minutes. Verify that all cleaning agent residues have been removed from components using the cleaning agent manufacturer s recommended method (e.g. ph test strip). Allow the components to air dry or dry using clean, compressed air. Visually inspect the components for contamination. Repeat the cleaning process if necessary to ensure that no contamination remains. Ultrasonic cleaning validation was performed with Neutral Enzymatic Detergent Manufactured by Ecolabs, Inc. Insight Instruments, Inc. Page 6 of 14

7 7. Washing 7.1. Materials for Washing The following materials are required for automated washing: A machine suitable for the WAM, Adapter, and accessories that: Have been validated for effectiveness (e.g. DGHM, FDA, or CE marked according to ISO 15883:2009). Have sufficient rinsing capability to remove residual cleaning solutions. Are inspected and maintained on a regular basis. A cleaning agent compatible with the SUPER VIEW System sterilizable components (see material compatibility section 16). If an alkaline cleaning agent is used, neutralization according to the manufacturers guidelines is required to prevent damage. Only use freshly prepared solutions with water quality suitable for the process being performed. Always use the concentration levels of the cleaning and disinfecting agents specified by the manufacturers of the washer equipment. If possible, as part of an automated cycle, use the manufacturers approved thermal disinfection program. Using chemical disinfection may allow residual chemicals to remain on the surface of the components Washing Process Rinse the components with water of potable quality or higher at a temperature of >43 C for 15 seconds (hot tap water). Dry the components with heated air (115.5 C) for 7 minutes. Make sure they are completely dry. Verify that all cleaning agent residues have been removed from the components using the cleaning agent manufacturer s recommended method (e.g. ph test strip). Visually inspect the components for contamination. Repeat the cleaning process if necessary to ensure no contamination remains. Validation was performed with the Steris Washer/Disinfector Model 444. For the final rinse it is recommended to use demineralize, deionized, or higher quality water (Reverse Osmosis). This may improve the useful life of the components by removing tap water deposits that may react in the presence of heat. Place the sterilizable components separately into the washer. Pre-Wash the components with water of at least potable quality at a temperature of <16 C for 2 minutes (cold tap water). Enzyme Wash the components with a neutral enzymatic solution with water of potable quality or higher at a temperature of >43 C for 1 minute (hot tap water). Wash the components with water of potable quality or higher at a temperature of 66 C (set point) for 2 minutes. Insight Instruments, Inc. Page 7 of 14

8 8. Maintenance (Before Sterilization) After each cleaning process, all sterilizable components of the SUPER VIEW System must be visually inspected to ensure that no contaminates or residual cleaning chemicals remain. Components that are still contaminated must be cleaned again. Damaged or corroded components must not be used, as safe function and sterility cannot be assured. All sterilizable components must pass a functional test before each use. The movable parts of the components should be lubricated prior to the functional check to ensure proper action Materials Use only medical grade mineral based lubricants suitable and validated for Steam sterilization Lubrication The use of lubricating agents is an effective way to extend the useful life of the components Wide Angle Module (WAM) Apply lubricant sparingly to the areas indicated in Fig. 6 and 7. After application of the lubricant, wipe any remaining lubricant with a clean lint free cloth. Figure 7 Figure Adapter Figure 8 Apply lubricant sparingly to the areas as indicated in Fig. 8 above. Rotate the Adapter to distribute lubricant and remove excess with a lint free cloth. Images are representative of typical components used in the SUPER VIEW System. Insight Instruments, Inc. Page 8 of 14

9 9. Functional Test A functional test must be performed to ensure proper operation of the components prior to packaging in the Instrument Tray for sterilization. If a component fails in any one of these functional tests, then do not use until service has been completed and all components successfully pass all testing procedures. See Section 17 for service details. Refer to Fig. 9 and perform the following functional tests: 9.1. Wide Angle Module (WAM) Position Test: Actuate the Housing (1) between position A and B several times. The Housing movement should be smooth and lock into either position. The Housing should not extend beyond position A. Focus Test: Locate the Thumb Wheel and rotate it until the Elbow Tube stops in position (2) B. Rotate the Thumb Wheel until the Elbow Tube stops in position (2) A. Movement must be free and smooth. Return the Elbow Tube back into center of the Lead Screw as shown in figure 9. Safety Rod Test: Hold the WAM vertically as shown in Fig. 9. Locate the Safety Rod and slide it upward into the retracted position (3A). Allow the Safety Rod to return to the extended position (3B). Repeat these steps several times. The Safety Rod must return to position (3B) freely with minimal resistance. Figure 9 If any component fails testing procedures, Do Not Use and return to manufacturer for service. See section 17 for service information Adapter Rotational Test: Holding the Adapter firmly in hand, rotate the assembly several times and check for smooth and free movement. The Assembly should click into the positions located in thirty degree increments. Visually check all components for signs of loose screws, corrosion, discoloration, or fatigue. Any defects must be corrected before reuse. Due to the product design and the materials used, no definite limit to the maximum number of performable processing cycles can be specified. The service life of the components is determined by functional testing and by careful handling. Insight Instruments, Inc. Page 9 of 14

10 10. Packaging Prior to sterilization, the sterilizable components of the system should be placed in a sterilization container to prevent damage and wrapped to prevent recontamination Materials needed for Packaging The following materials should be considered for the packaging of the components prior to sterilization: Place the Instrument Tray in a sterilization wrap and seal per the manufacturer s instructions. A Sterilization Wrap that: Has FDA or CE approved effectiveness as a microbial barrier. Is suitable for Steam sterilization processes. Conforms to DIN EN 868-5:2009 or ISO 11607:2006. A Container System that: Is suitable for Steam sterilization processes. Is validated for Immediate Use Steam Sterilization, where required. Is validated for use in Pre-vacuum and Gravity Steam cycles. Conforms to ANSI/AAMI ST 77:2006 and DIN EN 868-5:2009 or ISO 11607:2006 where required. Always follow the product manufacturer s written instructions for use (e.g. IFU Sterilization Wrap, Rigid Sterilization Case). Validation was performed with an Insight Instrument Tray and full load configuration as shown in Figure 10. Validation was performed with Cardinal Health DuraBlue CH600 Sterilization Wrap. Figure Packaging of Components for use with the Instrument Tray Place the cleaned sterilizable components into a sterile wrap as follows: Place the WAM, Adapter, and accessories into the positions of the instrument tray as shown in Figure 10. Make sure the WAM s Safety Rod is fully extended as show in Figure 10. Secure lid in place on the Instrument Tray. Insight Instruments, Inc. Page 10 of 14

11 11. Sterilization Only cleaned components can be sterilized. Also note: The equipment used should be regularly checked and serviced. Only validated processes should be used Steam Sterilization with the Instrument Tray Fractionated vacuum (Pre-Vacuum) method or gravity displacement method (with sufficient drying time). Steam sterilizer according to EN ISO 13060:2010, DIN EN 285:2009 or ANSI/AAMI ST 79:2010. The Steam Sterilizer used should be validated in accordance with the requirements of EN ISO 17665:2006, or ANSI/AAMI ISO 17665:2006. Sterilization Temperature 132 C-138 C plus tolerance according to EN ISO 17665:2006, or ANSI AAMI 17665:2006. Sterilization Time of at least 4 minutes (Fractionated pre-vacuum method) or at least 15 minutes (gravitation method) at a minimum of 132 C to a Maximum of 138 C. Drying time of at least 50 minutes. Allow the Instrument Tray, WAM, Adapter and accessories to cool down before re-use, service, or disposal. A longer sterilization time is possible, but may have a negative effect on the service life of the system components and the Instrument tray. Use demineralized, filtered water for steam sterilization to increase the life of the WAM, Adapter, and Accessories. Do not expose the Instrument Tray to temperatures above 141 C (286 F). All components intended to be sterilized by IUSS should go through a validated cleaning process and then placed within a container that is validated and intended for immediate use. It should be transferred immediately using aseptic techniques, from the sterilizer to the actual point of use, usually a sterile operating field. All user instructions for manufacturer s container systems should be followed. Refer to AAMI ST 79:2010 for additional information Immediate Use Steam Sterilization (IUSS) with Instrument Tray Fractionated vacuum (Pre-Vacuum) method or gravity displacement method (with sufficient drying time). Steam sterilizer according to EN ISO 13060:2010, DIN EN 285:2009 or ANSI/AAMI ST 79:2010. The Steam Sterilizer used should be validated in accordance with the requirements of EN ISO 17665:2006, or ANSI/AAMI ISO 17665:2006. Sterilization Temperature 132 C-138 C plus tolerance according to EN ISO 17665:2006, or ANSI AAMI 17665:2006. Sterilization Time of at least 4 minutes (Fractionated pre-vacuum method) or at least 15 minutes (gravitation method) at a minimum of 132 C to a Maximum of 138 C. IUSS sterilization cycles have little or no drying time. The processed components are assumed wet at the conclusion of the cycle. Validation for Steam Sterilization was performed with STERIS Lab Immediate Use Steam Sterilization (IUSS) It is recommended to use a validated containment device for IUSS to ensure aseptic transfer from the sterilizer to the point of use. Insight Instruments, Inc. Page 11 of 14

12 12. Storage The Instrument Tray may become recontaminated if it is stored for an extended period. If the sterile barrier is compromised, bacteria can re-contaminate the sterile components. It is therefore recommended to follow the sterilization wrap manufacturer s guidelines or facility policy. Sterilized components should be stored in a clean, dry, dust free environment at recommended temperatures according to AAMI ST 79: Sterile Area Use The following recommended guideline should be followed: Only handle Instrument Tray and components under sterile conditions and only in sterile areas. Remove the sterile components and mount them on the system. Make sure that they are securely fastened. Repeat the cleaning and sterilization process after each use. 14. Reusability The sterilizable components of the SUPER VIEW system may be reused as long as they meet the criteria outlined in section Disposal Clean and sterilize all system components prior to disposal. Observe all legal provisions and follow any disposal guidelines of your facility. 16. Material Compatibility When selecting the cleaning products, make sure that they do not contain any of the following: 17. Service Never clean the system components or Instrument Tray with a metal brush, steel wool, or abrasive agents as they may damage surfaces and reduce sterilizability. Components must be cleaned and sterilized according to Insight Instruments, Inc. reprocessing guidelines, AAMI ST79:2010, or applicable facility regulations prior to the return of system components to the manufacturer for service. A Returned Material Authorization (RMA) or Repair Order (RO) is required for acceptance at our facility. Please make all service inquiries to: Technical Support Insight Instruments, Inc SE Willoughby Blvd, Stuart, FL USA TEL: FA: A signed Repair Order & Sterilization Declaration Form must be completed for all used components returned to our facility. Any attempt at repairs by unauthorized persons will void the warranty. Always pack components in an original or adequate shipping container to protect them from possible damage. All validations were performed with representative sets of SUPER VIEW System components. Organic, mineral, or oxidizing acids (minimum ph value of 5.5) Strong bases (maximum ph value of 11 at temperature of use) Organic solvents (e.g. alcohol, ether, ketone, benzene) Halogens (chlorine, iodine, bromine) Aromatic/halogenated hydrocarbons Insight Instruments, Inc. Page 12 of 14

13 18. Disclaimers Insight Instruments, Inc. reserves the right to change the system components and User Instructions without notice. Components may vary according to microscope type and configuration. Insight Instruments, Inc. will only accept responsibility for the safety, reliability and serviceability of the unit where the SUPER VIEW System is used in compliance with the instructions contained herein. No liability is accepted for misuse. Insight Instruments, Inc. shall not assume any liability if assembly, extensions, adjustments, changes or repairs and any other unauthorized modifications are carried out by unauthorized personnel, if the unit is maintained improperly, or if it is handled incorrectly. 19. CE European Authorized Representative CEpartner4U, BV Esdoornlaan 13, 3951 DB Maarn The Netherlands TEL: FA: Insight Instruments, Inc. Page 13 of 14

14 20. Processing Matrix Description Cleaning Sterilization Methods Allowed Autoclave Wide Angle Module SUPER VIEW Wide Angle Module, Manual SUPER VIEW Wide Angle Module, Adapter Adapter, SV WAM Mounting, R1/R3 Adapter, SV WAM Mounting, GP Adapter, SV WAM Mounting, OPMI 6/T Adapter, SV WAM Mounting, M690/M Accessories for The SUPER VIEW System Tray, Instrument, SV WAM & Adapter Cover, SV Inverter Knob, Sterilizable Cover, SV Dovetail Thumbscrew, Sterilizable For all other items, please refer to UI for additional maintenance instructions. Insight Instruments, Inc. Page 14 of 14