B&B Suction and Irrigation Instruments Instructions for Use

Instructions for Use – Suction and Irrigation Instruments Issue Date: 7.2.

2020-08-20

Revision:

10. Controls and Testing

Precautions • •

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• • • •

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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 ”

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-

Symbol for "Caution, consult accompanying documents”

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-

-

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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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