BLACK & BLACK SURGICAL
Lipo and Suction and Irrigation Instruments
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](https://images.bioclinicalservices.com.au/10afbgklbhb2r778r5b4j5njjuzk/320w/BLACK%20%26%20BLACK%20SURGICAL%20-%20B%26B%20-%2025-0524%20-%20B%26B%20Suction%20and%20Irrigation%20Instruments%20Instructions%20for%20Use%20-%202020-08%20-%20Rev%207.png)
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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
Instructions for Use – Suction and Irrigation Instruments Issue Date: 7.2.
2020-08-20
Revision:
10. Controls and Testing
Precautions • •
•
• • • •
•
8.
A proper clinical examination, knowledge of the risk factors and a careful technique are necessary to reduce the occurrence of possible risks and complications. The primary factors increasing risk of death include excessive amounts of fluid and local anesthesia, excessive fat removal, performance of multiple unrelated procedures in the same surgical session, poor patient selection or patient health and inadequate post-operative monitoring of patients undergoing large-volume fat removal. Use of suction and irrigation instruments is limited to those physicians who, by means of formal professional training or sanctioned continuing medical education (including supervised operative experience), have attained proficiency in suction Lipoplasty and tissue transfer. Results of these procedures will vary depending upon patient age, surgical site, and experience of the physician. The amount of fat removed should be limited to that necessary to achieve a desired cosmetic effect. The aspiration of human fluids depends on the design of the cannula If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation. Retractors in “Tebbetts Fiberoptic Retractor” Family (B61084-B61191) should only be used with 3.5 mm fiberoptic bundle light cables. Using a bundle with a larger size could cause the metal at the insertion point of the light cable to the retractor to heat up and potentially cause thermal damage at points of contact. Do NOT lay lighted retractors down on patient.
Reprocessing Instructions
After each cleaning and before being placed into use, the suction and irrigation instruments should be visually inspected for fractures, cracks, dents, pitting, rust, burrs especially around the cutting orifices. If any of the above are observed, the instruments should not be used in surgery and should be disposed of following facility protocol. In addition the cannulas should be checked for secure fit in the handle. This can be checked by holding the handle in one hand and the cannula in the other hand and by a gentle pulling motion make sure the cannula is not loose in the handle. If the cannula is loose, it should not be used in surgery and should be disposed of following facility protocol.
11.
Storage
Suction and irrigation instruments must be stored until subsequent use in a suitable sterilization container for steam sterilization according to the standards. The storage room has to be dust-free, low microbiological contamination, dark and free of temperature fluctuations.
12. Used Symbols for IFU and Label Description Legal Manufacturer:
Cleaning and
It is the responsibility of the user to inspect the suction and irrigation instruments prior to use in surgery. If the instruments do not function properly or there are damages, the suction and irrigation instruments should be disposed of properly. For patients with Creutzfeld-Jakob-Disease, CJK-on-spec or its possible variants, Bovine Spongiform Encephalopathy or Transmissible Spongiform Encephalopathy country-specific regulations and laws concerning cleaning of instruments have to be observed
Manual Cleaning
Symbol for “Manufacturer”
Black & Black Surgical, Inc. 5175 South Royal Atlanta Dr. , Tucker Georgia 30084 USA
Tel.: 770-414-4880 Fax: 770-414-4879 Email: [email protected] Web: http://www.blackandblacksurgical.com/
Symbol for “Catalog Number” Symbol for “Batch Code”
The below validated steps have to be followed: Step
Process Step
Reagents / Actions
1 2
Soak Rinse
3
Ultrasonic Cleaning Bath
4
Manual Brush
5
Rinse
6
Post-Cleaning
Enzymatic cleaner (such as Miltex EZ-Zyme) Running tap water to loosen and remove gross debris Neutral enzymatic detergent solution (such as Miltex EZ-Zyme®) prepared according to the manufacturer’s instructions Remove any remaining debris from crevices using a cleaning brush, giving close attention to threads, crevices, seams, lumens, and any hard-to-reach areas. Running tap water to loosen and remove gross debris After cleaning and prior to sterilization instruments should be wrapped.
Symbol for “Consult the Instruction for Use” Time (min) 10 -
T (°C) -
Conformity to the essential requirements with notified body DQS Medizinprodukte GmbH, AugustSchanz-Str. 21, 60433 Frankfurt / Germany. Notified Body Code: 0297
10
-
Symbol for “Non-Sterile ”
-
-
Symbol for "Caution, consult accompanying documents”
-
-
-
-
Cleaning and rinsing must take place immediately after each use for best effect. Failure to clean promptly may result in adherent particles or dried secretions that may resist cleaning and complicate or resist future sterilization.
9.
Do not use damaged instruments. Instruments should meet the following visual inspection criteria
Symbol
The Black & Black suction and irrigation instruments are packaged non-sterile. sterilization must occur prior to use.
8.1.
7
Symbol for “European Representative”
MEDAGENT International GmbH Griesweg 47 78570 Mühlheim
Tel.: +49.7463.9954.0 Fax: +49.7463.9954.10 E-mail: [email protected]
Sterilization
Steam Pre-vacuum sterilization procedure: • • •
Temperature: 132°C (270°F) Time of exposure: 4 min Drying Time: 20 min
25-0524 Lipo and Suction and Irrigation
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