B&B Suction and Irrigation Instruments Instructions for Use

2 Pages

3.  Indication for Use  3.1.  Cannulas  Application for general surgical procedures. 3.2.  Application for aesthetic body contouring and general surgical procedures.  Instructions for Use – Suction and Irrigation Instruments  B61084 to B61099 B61184 to B61199 B63850 to B63851 B67000 to B67035 to  Revision: 7  B8BAS-1115LL to B8BAS-632L B8BEC-1120LL to B8BECD-532L  B8FIC-V-1120-LL to B8FIC-V-423-LL  B8BECS-1115-LL  B8KEL-315L to B8KEL-532L  B8III-1215-LL to B8III-CV226L  B8CC-215L to B8CC-632L  B8LV-1030-LL to B8LV-532-L  B8COB-315L to B8COB-532L  B8LVH-1220-LL to B8LVH-432L  B8DBAS-1115-LL to B8DAS-532-L  Elevators  Application for general surgical procedures.  B8FIC-III-CC1610-LL to B8FIC-III-CV1610-LL  B611xxS to B611xxS-XT  B87-BAS-XXXQSC B87-MER-XXXQSC  3.3.  Issue Date: 2020-08-20  English  Liposuction Cannulas  3.3.1.  Application for general surgical procedures.  4.  Intended Users  Black & Black Surgical instruments should be handled and operated by healthcare professionals completely familiar with their use, assembly, and disassembly. Use instruments for their intended surgical purposes only.  B8LVI-1420-LL  B89ASH-LL  B8DMER-420-SYR to B8DMER-432-SYR  B8LVI-CC1415LL to B8LVI-CC1425LL  B89IH-NC  B8DV-440L to B8DV-550L  B8MBAT-1215-LL to B8MBAT-536L  B89LL-XX  B8FAC-1115-LL to B8FAC-426-SYR  B89TAH-60CC  B8FAN-1235-LL to B8FAN-1615-LL  B8MER-1115-LL to B8MER-636SYR  B89TFL  B8FIC-I-1115-LL to B8FIC-I-426-SYR  B8SPA-1215-LL to B8SPA-615L  B89TIH-C  B8FIC-I-CC1215-LL to B8FIC-I-CV1610-LL  B89TML  B8FIC-II-1215-LL to B8FIC-II-197-LL  B8STD-1215-LL to B8STD-626L  B89TOOMEY  B8FIC-II-CC1410-LL to B8FIC-II-CV1610-LL  B8TI-1015-LL to B8TI-840-LL  B89TOMMEY W/LUER  B8FIC-III-1215-LL to B8FIC-III-197-LL  B8TON-1415-LL to B8TON-426-SYR  B8SAT-1215-LL to B8SAT-432SYR  B8STD-II-149-LL to B8STD-II-526L  Federal (USA) law restricts this device to sale by or on the order of a physician.  5.  Contraindications  The devices are contraindicated for all the intended uses other than the ones claimed in these instructions for use.  6.  Side effects, risks, and complications  6.1.  1.  Device Description  Black & Black has a wide range of suction and irrigation instruments applicable for surgical plastic procedures. This range include generic cannulas, liposuction cannulas, elevators and retractors.  Device related risks • •  6.2.  • • • • • • • •  Improper use of the instrument may cause a serious injury  Intended Use  2.1.  Cannulas  Collateral tissue laceration and damage Blockage of cannula due to aspiration of fibrous tissues Treatment related risks and complications  Carefully read these instructions before using B&B suction and irrigation instruments. Keep them in a safe place for future reference.  2.  Retractors  Perforation of one intraperitoneal organs Contour irregularities Infection Sepsis Necrotizing fasciitis Hypoesthesia Edema Ecchymosis  or  several  • • • • • • • •  Seroma Hematoma Skin discoloration Skin slough Pulmonary embolism Viscus perforation Lidocaine toxicity Death  • •  Long recovery Nausea  The suction and irrigation cannulas are intended for instillation or aspiration of fluid to/from a targeted area of the body. 2.2.  Liposuction Cannulas  6.3.  Undesired side effects • • •  The aspiration and infusion cannulas and needles are intended for aesthetic body contouring and general tissue aspiration. 2.3.  Elevators  The suction and irrigation elevators are intended for lifting tissues or anatomic structures. 2.4.  Scars Excessive blood loss Skin flaccidity  Retractors  The suction and irrigation retractors are intended for separating tissues or other anatomical parts.  7.  Warnings and Precautions  7.1.  Warnings • • •  25-0524 Lipo and Suction and Irrigation  This device will not, in and of itself, produce a significant weight reduction This device should be used with extreme caution in patients with chronic medical conditions, such as diabetes, heart, lung, or circulatory system disease or obesity. The volume of blood loss and endogenous body fluid loss may adversely affect intra and/or postoperative hemodynamic stability and patient safety. The capacity of providing adequate, timely replacement is essential for patient safety Page 1 of 2
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