BARD

BARD Biopsy System

EnCor Needle Guide (Fisher) Instructions for Use Rev 1 Dec 2019

Instructions for Use

44 Pages

• • • • • • • • Needle Guide (Fischer™) ENGLISH ENCFNGUIDE01 Appropriate biopsy probe and system Fischer™/Mammotest™ Stereotactic Biopsy Table EnCor™ Needle Guide EnCor™ Needle Guide Insert 6XUJLFDOJORYHVDQGGUDSHV Local anesthetic Scalpel 2WKHUHTXLSPHQWDVQHFHVVDU Directions For Use INSTRUCTIONS FOR USE 5HIHUWR)LJXUH CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. EnCor™ Needle Guide Insert (E) Information in the Instructions for Use should be discussed with the patient, at the discretion of the physician Needle Guide Insert Hole (F) Device Description 7KH(Q&RUŒ1HHGOH*XLGHSURYLGHVWKHEHQH¿WRIVXSSRUWLQJWRWKH(Q&RUŒ Breast Biopsy Probe when mounted to the Fischer™/Mammotest™1 stereotactic ELRSVWDEOH7KH(Q&RUŒ1HHGOH*XLGHLVUHXVDEOHDQGFRQWDLQVDVOLGLQJ and lockable clamp adaptable to the Fischer™/Mammotest™ rail. A sterile, disposable EnCor™ Needle Guide Insert (ENCFINSERT12G, ENCFINSERT10G, RU(1&),16(57* SDFNDJHGDQGVROGVHSDUDWHOLVLQVHUWHGLQWRWKH(Q&RUŒ 1HHGOH*XLGHWRSURYLGHDVWHULOHJXLGHIRUWKH(Q&RUŒ%UHDVW%LRSV3UREHWLS Table Rail (B) EnCor™ Needle Guide (A) Slider (D) Indications for Use Rail Clamp Lever (C) The EnCor™ Needle Guide is intended to support the EnCor™ Breast Biopsy Probe in a Fischer™/Mammotest™ prone biopsy table. Figure 1. EnCor™ Needle Guide (Fischer™/Mammotest™ Table) Contraindications Attaching the EnCor™ Needle Guide to the Table: This device is not intended for use except as indicated. 1. Remove the EnCor™ 1HHGOH*XLGH $ IURPSDFNDJLQJDQGYHULIWKDWWKH GHYLFHKDVQRWEHHQGDPDJHG Warnings • Do not use in the presence of infection. • The EnCor™ Needle Guide Insert has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and VPDOOOXPLQDMRLQWVDQGRUFUHYLFHVEHWZHHQFRPSRQHQWV±DUHGLႈFXOW RULPSRVVLEOHWRFOHDQRQFHERGÀXLGVRUWLVVXHVZLWKSRWHQWLDO pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications. • • 2. Install the EnCor™ Needle Guide (A) onto the Table Rail (B) from the front. 'HSUHVVWKH5DLO&ODPS/HYHU & RQWKH6OLGHU ' DQGVOLGHWKH(Q&RUŒ Needle Guide (A) rearward onto the Table Rail (B). Release the Rail Clamp Lever (C). Note: 7KH5DLO&ODPS/HYHU & PXVWEHGHSUHVVHGEHIRUHDWWHPSWLQJWRVOLGH the EnCor™ Needle Guide (A) on the Table Rail (B). 3. Install the EnCor™ 1HHGOH*XLGH,QVHUW ( ESXVKLQJLWWKURXJKWKH1HHGOH *XLGH,QVHUW+ROH ) DVVKRZQLQ)LJXUH Cleaning and Maintenance Do not resterilize the EnCor™ Needle Guide Insert. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/ or resterilization of the present medical device increases the probability WKDWWKHGHYLFHZLOOPDOIXQFWLRQGXHWRSRWHQWLDODGYHUVHHႇHFWVRQ FRPSRQHQWVWKDWDUHLQÀXHQFHGEWKHUPDODQGRUPHFKDQLFDOFKDQJHV Note: The EnCor™ Needle Guide is not intended to be sterilized. )RU&OHDQLQJ Instructions for the EnCor™ Fire Forward Accessory, refer to the EnCor™ Fire Forward Accessory Instructions for Use. Manual Cleaning After each use, immediately clean the EnCor™ Needle Guide with the steps outlined below. After use, the EnCor™ Needle Guide Insert may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practice and applicable local, state, and federal laws and regulations. 1. Remove the EnCor™ Needle Guide Insert (E) from the EnCor™ Needle Guide $ 5HIHUHQFH)LJXUH+DQGOHDQGGLVSRVHRIWKH(Q&RUŒ1HHGOH*XLGH Insert (E) in accordance with acceptable medical practice and applicable local, VWDWHDQGIHGHUDOODZVDQGUHJXODWLRQV Precautions • This device should only be used by physicians trained in percutaneous biopsy procedures. • Carefully inspect the device prior to use to verify that device has not been GDPDJHG'RQRWXVHLISURGXFWGDPDJHLVHYLGHQW • Sterilization of the EnCor™ Needle Guide is not necessary under normal use conditions.  7KRURXJKOZLSHDOOVXUIDFHDUHDVRIWKH(Q&RUŒ1HHGOH*XLGH $  LQFOXGLQJWKH1HHGOH*XLGH,QVHUW+ROH ) ZLWKDFOHDQLQJZLSH IRUH[DPSOH &DYL:LSHVRUHTXLYDOHQWFOHDQLQJZLSH  3. For the steps mentioned above, ensure all surfaces of the EnCor™ Needle Guide (A) are wiped continuously and remain wet with a contact time of 3 minutes minimum. Potential Complications Potential complications may include, but are not limited to hematoma, KHPRUUKDJHLQIHFWLRQDGMDFHQWWLVVXHLQMXUSDLQDOOHUJLFUHDFWLRQDQGWLVVXH DGKHUHQFHWRWKH(Q&RUŒ%UHDVW%LRSV3UREHGXULQJUHPRYDOIURPWKHEUHDVW DVSHUURXWLQHELRSVSURFHGXUHVLWPDEHQHFHVVDUWRFXWWLVVXHDGKHULQJWR WKHVWOHWRUFRD[LDOZKLOHUHPRYLQJLWIURPWKHEUHDVW   9LVXDOOLQVSHFWWKH(Q&RUŒ1HHGOH*XLGH $ WRFRQ¿UPWKHUHDUHQRUHVLGXDO FRQWDPLQDQWVVXFKDVEORRGRUERGLOÀXLGVSUHVHQW3HUIRUPWKHYLVXDO LQVSHFWLRQLQDZHOOOLWDUHDWKDWKDVJRRGOLJKWLQJFRQGLWLRQV HJÀXRUHVFHQW RULQFDQGHVFHQWRYHUKHDGOLJKWLQJ WRFRQ¿UPUHVLGXDOFRQWDPLQDQWVDUHQRW present. Note: Users and/or patients within the European Union, should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the Member State in which the user and/or patient is HVWDEOLVKHG KWWSVHFHXURSDHXJURZWKVHFWRUVPHGLFDOGHYLFHVFRQWDFWV  Users outside of the European Union should report any serious incident that has RFFXUUHGLQUHODWLRQWRWKHGHYLFHWRWKHPDQXIDFWXUHUDQGWKHUHJXODWRUDXWKRULW of the country in which the user and/or patient is established.  ,IYLVXDOFRQWDPLQDQWVDUHLGHQWL¿HGUHSHDWVWHSV  $IWHUVXFFHVVIXO0DQXDO&OHDQLQJPRYHRQWRWKH'LVLQIHFWLRQVWHSVRXWOLQHGLQ the next section. Disinfection 1. Re-wipeDOOH[WHUQDOVXUIDFHDUHDVRIWKH(Q&RUŒ1HHGOH*XLGH $ LQFOXGLQJ WKH1HHGOH*XLGH,QVHUW+ROH ) ZLWKDJHUPLFLGDOGLVSRVDEOHZLSHIRU GLVLQIHFWLRQ IRUH[DPSOHD&DYL:LSHVRUDQHTXLYDOHQWGLVLQIHFWLQJZLSH FRQWDLQLQJ$OFRKRODQG$PPRQLXP&KORULGH 5HIHUHQFH)LJXUH How Supplied/Stored 7KH(Q&RUŒ1HHGOH*XLGHLVVXSSOLHGQRQVWHULOH 7KH(Q&RUŒ1HHGOH*XLGH,QVHUWLVVXSSOLHGVWHULOHDQGLVLQWHQGHGIRUVLQJOH use only. Pay close attention to all cracks and crevices on the EnCor™ Needle Guide (A) during wipe-down. Equipment Required 7KHIROORZLQJHTXLSPHQWLVUHTXLUHGIRUDELRSVSURFHGXUH • 2. Ensure all surfaces of the EnCor™ Needle Guide (A) are wiped continuously, and remain wet, with a contact time of 3 minutes minimum. $SSURSULDWHLPDJLQJPRGDOLWDQGDFFHVVRULHV 1
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