V. Mueller. V. Mueller Reusable Devices: Cleaning and Sterilization Guide USA. Rx Only

Transcription

1 V. Mueller en V. Mueller Reusable Devices: Cleaning and Sterilization Guide USA Rx Only V. Mueller, CareFusion and the CareFusion logo are trademarks or registered trademarks of CareFusion Corporation or one of its subsidiaries CareFusion Corporation or one of its subsidiaries. All rights reserved. Distributed by CareFusion 75 North Fairway Drive Vernon Hills, IL USA CareFusion France 309 S.A.S. 8 bis rue de la Renaissance Châteaubriant - France A Note: Refer to CE mark status as shown on current product labeling. 0123

2 en Catalog Numbers All products covered by these Instructions for Use are listed in the appendix on the back page. Indications For Use All products covered by these Indications for Use are listed in Appendix A. Retractors are devices intended to provide minimally invasive access to the spine by ensuring the placement/positioning of the retractor down the lamina. Its attachment to a flexible arm provides a self locking method of access to the spinal site through which tubes, endoscopes and surgical instruments can be manipulated. All products covered by these Indications for Use are listed in Appendix B. Rongeurs are devices intended to access, cut and bite soft tissue and bone during surgery involving the spinal column. All products covered by these Indications for Use are listed in Appendix C. Vascular clamps are devices intended for temporary or partial occlusion of blood vessels during vascular surgical procedures. All products covered by these Indications for Use are listed in Appendix D. Gynecological forceps are instruments with two blades and handles used to pull, grasp, or compress during gynecological examination. All products covered by these Indications for Use are listed in Appendix E. Vessel dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters. How Supplied Devices are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. Limitations on Reprocessing Repeated processing has minimal effect on these devices. End of life is normally determined by wear and damage due to use. Warnings Attention: Risk of damage- the instrument is a precision device. Careful handling is important for the accurate functioning of this product. Improper external handling (e.g. bending, banging, dropping, etc.) may cause product malfunction. Devices shall be used in accordance with these Instructions for Use. Read all sections of this insert prior to use. Improper use of these devices may cause serious injury. In addition, improper care and maintenance of the devices may render the devices non-sterile prior to patient use and may cause serious injury to the health care provider or the patient. If this device is or was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD) or another Transmissible Spongiform Encephalopathy (TSE), the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of cross-contamination. Cautions Federal U.S. laws restrict this device to sale, distribution, and use by or on the order of a physician. Surgical instruments should not be used by individuals who are not fully trained in proper surgical techniques and the potential complications associated with their use. Consult relevant medical literature for the appropriate indications, prerequisites, techniques, and risks applicable to the corresponding procedure. Read the Instructions for Use prior to using the device. If there are any variations between these Instructions for Use and either your facility s policies and/or your cleaning/sterilizing equipment manufacturer s instructions, those variations should be brought to the attention of the appropriate responsible hospital personnel for resolution before proceeding with cleaning and sterilizing your devices. Use of a device for a task other than what it is intended for will usually result in a damaged or broken device. Prior to use, inspect devices to ensure proper function and condition. Do not use devices if they do not satisfactorily perform their intended function or if they have physical damage. 1

3 Only the cleaning and sterilization processes which are defined within these Instructions for Use have been validated. Use only neutral ph (6-8) detergent solutions. Autoclave temperatures should not exceed 280 F (138 C). Pre-processing Instructions Initiate cleaning of device within 2 hours of use. Transport devices via the institutions established transport procedure. Remove excess gross soil as soon as possible after use by rinsing or wiping the device. All devices must be processed in the completely open position (i.e. flushports, jaws, etc.) to allow solution contact of all surfaces. Manual Cleaning (Steps 5, 6, 7, 9 and 11 are required for lumen devices only.) 1. Ensure all pre-processing instructions are followed prior to cleaning. 2. Prepare the enzymatic/neutral ph detergent solution, utilizing drinking/potable water with a temperature range of 27 C to 44 C (81 F to 111 F), per manufacturer s instructions. 3. Place the device in the open/relaxed position, with flush port open. Completely immerse the device in the detergent solution and allow it to soak for a minimum of 5 minutes. Actuate all movable parts during the initiation of the soak time. 4. Using a soft bristled brush, remove all visible soil from the device. Actuate the device while brushing, paying particular attention to hinges, crevices and other difficult to clean areas. Note: It is recommended that the detergent solution be changed when it becomes grossly contaminated (bloody and/or turbid). 5. For lumen devices, use a soft bristled brush with a brush diameter and length that is equivalent to lumen diameter and length. Scrub the lumen (i.e. angulated/nonangulated positions) until no visible soil is detected in the lumen rinsing step below. 6. For lumen devices, place the device into the open/relaxed position with the distal tip pointed down. Flush the device with a minimum of 50 ml of detergent solution utilizing a temperature range of 27 C to 44 C (81 F to 111 F), by using the flushing port located on the handle/shaft. Repeat the flush process a minimum of 2 times (i.e. total of 3 times); ensuring all fluid exiting the lumen is clear of soil. 7. For lumen devices, if visible soil is detected during the final lumen flush, re-perform brushing and flushing of the lumen. Note: The final rinse steps (8 and 9) should be performed with treated water: deionized, distilled or reverse osmosis. 8. Rinse the device by completely immersing it in treated water with a temperature range of 27 C to 44 C (81 F to 111 F), for a minimum of 30 seconds to remove any residual detergent or debris. 9. For lumen devices, following the rinsing step, place the device into the open/relaxed position with the distal tip pointed down. Flush the device with a minimum of 50 ml of treated water utilizing a temperature range of 27 C to 44 C (81 F to 111 F), by using the flushing port located on the handle/shaft. Repeat the flush process a minimum of 2 times (i.e. total of 3 times). 10. Dry the device with a clean, lint-free towel. 11. For lumen devices, manipulate the device to allow rinse water to drain from the lumen. 12. Visually examine each device for cleanliness. 13. If visible soil remains, repeat cleaning procedure until the device is thoroughly clean. 2

4 Automatic Cleaning 1. Ensure all pre-processing instructions are followed prior to cleaning. 2. Clean the devices via the Automatic cleaning parameters below. PHASE Pre-Wash MINIMUM RECIRCULATION TIME 15 Seconds WATER TEMPERATURE Cold Drinking/Potable Water 1 C - 16 C (33 F - 60 F) DETERGENT TYPE AND CONCENTRATION (IF APPLICABLE) N/A Enzyme Wash 1 Minute Hot Drinking/Potable Water 43 C - 82 C (110 F F) Detergent: ph-neutral/enzymatic Concentration: Per the detergent manufacturer s recommendations Wash 2 Minutes Hot Drinking/Potable Water 43 C - 82 C (110 F F) Detergent: ph-neutral cleanser Concentration: Per the detergent manufacturer s recommendations Rinse 15 Seconds Hot Drinking/Potable Water 43 C - 82 C (110 F F) N/A Pure Rinse 10 Seconds Purified Water (Hot) 43 C - 82 C (110 F F) N/A Drying N/A N/A N/A 3. For lumen devices, manipulate the device to allow rinse water to drain from the lumen. 4. If visible moisture is present, dry the instrument with a clean, lint-free towel. 5. Visually examine each instrument for cleanliness. 6. If visible soil remains, repeat cleaning procedure until the device is thoroughly clean. Inspection/Maintenance Proper care and handling is essential for satisfactory performance of any surgical device. The previous cautions should be taken to ensure long and trouble-free service from all your surgical devices. Inspect devices before each use for broken, cracked, tarnished surfaces, movement of hinges, and chipped or worn parts. If any of these conditions appear, do not use the device. Return devices to an authorized repair service center for repair or replacement. - Before sterilizing, lubricate the device with instrument milk or a steam permeable/water soluble lubricant, following the lubricant manufacturer s instructions. - Let devices drip dry for three (3) minutes before packaging for sterilization. Packaging Devices can be loaded into dedicated packaging systems. Sterilization wrap material must be cleared for the applicable sterilization modality by your country s regulatory body. Use in accordance with packaging manufacturer s sterilization instructions being sure to protect jaws and cutting edges from damage. Sterilization All devices must be processed in the completely open position (i.e. flushports, jaws, etc.) to allow sterilant contact of all surfaces. Note that applicable device disassembly should not require any mechanical tooling (i.e. screwdriver, pliers etc.) unless otherwise indicated. All devices with concave surfaces shall be configured so that water pooling does not occur. 3

5 Prevacuum Steam Sterilization Parameters Preconditioning Pulses: 3 Temperature: 132 C (270 F) Exposure Time: 4 minutes Dry Time: 30 minutes Sterilization Configuration: Cleared (i.e. FDA, etc.) Gravity Steam Sterilization Parameters Temperature: 132 C (270 F) Exposure Time: 15 minutes Dry Time (lumens): 45 minutes Dry Time (non-lumens): 30 minutes Sterilization Configuration: Cleared (i.e. FDA, etc.) Gravity Steam Sterilization Parameters Non-lumen devices Temperature: 121 C (250 F) Exposure Time: 30 minutes Dry Time (non-lumens): 30 minutes Sterilization Configuration: Cleared (i.e. FDA, etc.) EO Sterilization Parameters Sterilizer Cycle: 100% Ethylene Oxide (EO) Preconditioning Time: 30 minutes EO Gas Concentration: 725 mg/l Temperature: 55 C (130 F) Humidity: 50-80% Exposure Time: 60 minutes Aeration: 8 43 C (110 F) Sterilization Configuration: Cleared (i.e. FDA, etc.) Sterilization for outside United States Market Prevacuum Steam Sterilization Parameters Preconditioning Pulses: 3 Temperature: 132 C (270 F) C (275 F) Exposure Time: 3-18 minutes Dry Time: 30 minutes Sterilization Configuration: Cleared Sterilization for outside United States Market Gravity Steam Sterilization Parameters Temperature: 132 C (270 F) C (275 F) Exposure Time: minutes Dry Time: 30 minutes Sterilization Configuration: Cleared Storage After sterilization, devices should remain in sterilization packaging and be stored in a clean, dry environment. 4

6 Warranty CareFusion offers a lifetime guarantee on every surgical device bearing the V. Mueller brand name (unless otherwise noted). Surgical devices are guaranteed to be free of functional defects in workmanship and materials when used normally for its intended surgical purpose. Any V. Mueller device proving to be defective will be replaced or repaired at no cost to the customer. Repair Service Regardless of age, if any V. Mueller device requires service, return the device to an authorized repair service center. For repairs outside the U.S., please contact your local distributor. Note: All devices being returned for maintenance, repair, etc. must be cleaned and sterilized per these instructions prior to shipment. Contact Information CareFusion 75 North Fairway Drive, Vernon Hills, IL USA For domestic inquiries GMB-VMueller-Cust-Support@carefusion.com For international inquiries GMB-SIT-International-Team@carefusion.com Other Resources To learn more about sterilization practices and what is required of manufacturers and end users, visit or Note: Refer to CE mark status as shown on current product labeling

7 Appendix A B-0008 B-0011 B-0012 B-0013 B-0014 B-0041 B-0043 B-0102 B-0103 B-0105 B-0106 B-0110 B-0120 B-0121 B-0122 B-0124 B-0200 B-0201 B-0202 B-0203 B-0204 B-0205 B-0206 B-0207 B-0208 B-0209 B-0210 B-0211 M-5000 M-5001 NL5090 NL5095 NL C NL510313NL NL C NL510318NL NL C NL510320NL NL C NL NL NL NL510418NL NL510420NL NL NL5105 NL5241 NL5242 NL NL NL NL NL NL NL NL NL5244 NL NL NL NL NL NL NL NL NL5245 NL NL NL NL NL NL NL NL NL NL NL NL NL NL NL NL NL OS1314 OS1315 Appendix B J-0050 J-0065 J-0110 J-0111 J-0120 J-0121 J-0123 J-0125 J-0140 J-0141 J-0142 J-0143 J-0144 J-0145 J-0153 J-0154 J-0155 J-0160 J-0162 J-0163 J-0164 J-0165 K-0095 K-0096 K-0110 K-0111 K-0112 K-0120 K-0121 K-0122 K-0123 K-0124 K-0125 K-0133 K-0134 K-0135 K-0136 K-0137 K-0163 K-0170 K-0171 K-0172 K-0176 K-0177 K-0182 K-0183 K-0184 K-0185 K-0188 K-0189 K-0190 K-0191 K-0194 K-0195 K-0196 K-0197 K-0200 K-0210 K-0211 K-0212 K-0267 K-0268 K-0270 K-0271 K-0272 K-0273 K-0274 K-0275 K-0276 K-0277 K-0301 K-0400 K-0402 K-0403 K-0405 K-0406 K-0407 K-0414 K-0416 K-0420 K-0421 K-0422 K-0423 L-0071 L-0099 L-0100 L-0101 L-0102 L-0103 L-0106 L-0107 L-0108 L-0110 L-0111 L-0112 L-0119 L-0120 L-0121 L-0122 L-0123 L-0124 L-0125 L-0126 L-0127 L-0128 L-0172 L-0300 L-0301 L-0302 NL501 NL633 NL634 NL650 NL NL NL NL NL NL NL NL6030 NL6038 NL NL NL NL NL NL NL NL NL NL NL NL NL NL NL NL NL NL6255 NL NL NL633 NL NL NL NL OS1112 OS OS4740 OS4745 OS4750 OS4900 OS4915 OS4920 OS4930 OS4980 OS4985 OS4990 OS4995 6

8 Appendix C CH1670 CH1675 CH CH CH CH CH CH5200 CH5883-T CH5885-T CH5900-T CH5903 CH5906-T CH5907 CH5908 CH CH5910 CH CH5912 CH CH5912-T CH5914-T CH5916-T CH5918-T CH5920 CH5922 CH5924 CH5926 CH5930 CH5931 CH5932 CH5934 CH5935 CH5936 CH6076 CH6089 CH6090 CH6091 CH CH CH6094 CH6143 CH6144 CH6145 CH6148 CH6510 CH6512 CH6516 CH6517 CH6518 CH6519 CH6521 CH6800 CH6801 CH6802 CH6803 CH6807 CH6808 CH6809 CH6814 CH6818 CH7116 CH7117 CH7180 CH7182 CH7184 CH7186 CH7188 CH7190 CH7202 CH7204 CH7206 CH7212 CH7214 CH7216 CH7219 CH7222 CH7224 CH7225 CH7265 CH7280 CH7284 CH7286 CH7288 CH7301 CH7305 CH7450 CH7452 CH7454 CH7456 CH7458 CH7460 CH7470 CH7474 CH7480 CH7490 CH7492 CH7510 CH7512 CH7600 CH7602 CH7815 CH7902 CH7910 CH7912 CH8400 CH CH CH11000 CH11001 CH11002 CH11003 CH11004 CH11005 CH11006 CH11007 CH11008 CH11009 CH11010 CH11011 CH11012 CH11016 CH11020 CH11022 CH12000 CH12001 CH12002 CH12003 CH12004 CH12005 CH12006 CH12008 CH12009 CH12010 CH12011 CH12012 CH12013 CH12014 CH12015 CH12016 CH12017 CH12018 CH12019 CH12020 CH12021 CH12022 CH12023 CH13029 CH13030 CH13034 CH13035 CH13036 CH13037 CH13062 CH13063 CH13064 CH13155 Appendix D GL851 GL1820 GL3035 GL3123 GL3124 GL3188 GL3189 GL3190 GL3191 GL3268 GL3269 GL3270 GL3271 GL3292 GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL GL5712 GL5714 GL5716 GL5719 SU2746 Appendix E CH5560 CH CH CH CH CH CH CH CH CH CH CH CH CH