Brennen Skin Graft Mesher Instructions for Use

BRENNEN SKIN GRAFT MESHER

INTRODUCTION Congratulations on your purchase of the Brennen Skin Graft Mesher. With proper care and maintenance, your Skin Graft Mesher will provide long dependable service. Please read all instructions before using this instrument. To ensure warranty protection, fill out the enclosed warranty card and return it to Brennen Medical. ECONOMICAL The Brennen Skin Graft Mesher is totally self-contained and eliminates the need for disposable parts such as plastic carriers and rolling pins. It saves the time, inconvenience, and cost of ordering and maintaining disposable components.

MESH RATIOS The Brennen Skin Graft Mesher is available in six mesh ratios: 1:1, 2:1, 3:1, 4:1, 6:1, 8:1 and PC. A meshed skin graft will be fully expanded when the interstices form a square or diamond pattern. Since donor skin contracts when removed with a dermatome, the actual expansion may appear less than anticipated. This should be taken into consideration when calculating the amount of donor skin needed to cover a wound.

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DESCRIPTION The Brennen Skin Graft Mesher is a surgical instrument designed to expand skin grafts. Grafts up to 4 1/2 inches (11.5 cm) wide by any length can be meshed.

Operation of the mesher is accomplished by easily pumping the Ratchet Lever back and forth. A clutch inside the Ratchet Lever converts the pumping action into a one-directional rotary motion that meshes the skin. The weighted stainless steel base provides added stability and holds the Brennen Skin Graft Mesher firmly in place for unassisted operation. The meshing mechanism consists of two parallel rollers (12 & 13) held in place by tube shafts connected by gears that turn the rollers simultaneously to mesh the skin.

Discs on the lower roller are notched and spaced to fit between spacers on the upper roller. When rotating, the notches in the lower roller discs punch slits into the skin as they pass between spacers on the upper roller. These are not knife blades that slice through the skin. Rather the edges of the discs create slits by a shearing action similar to a scissors. The discs do not have knife-like edges that become dull with use. Care must be taken however to avoid damage to the discs’ edges.

After meshing, the skin is rotated to the back of the mesher where a Rear Plate Comb assists in picking the skin off the roller for removal by the operator.

The carrying handle makes the unit easily transportable and allows an extra element of steadiness when meshing the skin. 2

(1) Oil Holes

(4) Ratchet Lever

(3) Thumb Screws

Brennen Skin Graft Mesher, rear view. 3

(2) Rear Plate Comb

(13) Upper Meshing Roller

(5) Handle

(12) Lower Meshing Roller

(4) Ratchet Lever

(11) Mineral Oil

(7) Face Plate

(10) Allen Wrench (9) Screwdriver

Brennen Skin Graft Mesher, front view. 4

(8) Cleaning Brush

INSTRUCTIONS FOR USE

1. The Brennen Skin Graft Mesher has been preset to mesh skin grafts between 0.010 and 0.015 inches (0.25 and 0.39 mm) thickness. 2. Once the skin graft has been removed with a dermatome, apply the graft dermal side down on the Face Plate (7).

3. Place the graft against the Lower Meshing Roller (12) of the meshing mechanism. While turning the Ratchet Lever (4), use your fingertips to align the graft into the meshing mechanism. Keep the graft flat on the Face Plate to avoid wrinkling. 4. As the Ratchet Lever is turned, the graft will be fed through the meshing mechanism.

5. Grasping the skin graft manually or with a flat-jawed forceps (preferably not metal as they may damage the meshing mechanism), remove the graft from the meshing mechanism as it emerges from the rear of the Skin Graft Mesher. 6. The meshed skin graft may be placed on wet gauze or other suitable carrier for transfer to the recipient site. 7. Graft should be applied to the recipient site according to your standard procedure. 5

MAINTENANCE The instrument is virtually maintenance free. There are no user serviceable parts. Normal cleaning, sterilization and lubrication are all that is required for continuous trouble-free operation. In the case of worn or damaged parts, return the mesher to Brennen Medical for service (See Returned Goods Policy on page 9).

CLEANING AND LUBRICATION After each procedure, the Skin Graft Mesher should be cleaned by washing with water and non-caustic liquid detergent followed by rinsing in water. DO NOT USE POWDERED DETERGENTS. Instructions for Cleaning Skin Graft Mesher: 1. Detach Rear Plate Comb (2). Loosen two Thumb Screws (3) under unit. Pull Rear Plate Comb up and back to remove. 2. Detach Face Plate (7). Remove three screws using Philips Screwdriver (9). 3. Detach Stainless Steel Weighted Base underneath mesher by removing the two machine screws using Hex Wrench (10). 4. Rotate meshing mechanism using the Ratchet Lever (4) when washing and rinsing. 5. Use soft bristled Cleaning Brush (8) to aid in cleaning. 6. Prior to reassembly, place a drop of Mineral Oil (11) or light machine oil into the three Face Plate screw holes and two Weighted Base screw holes. 7. Reassemble mesher by reattaching Face Plate and Weighted Base. 6

8. To correctly position the Rear Comb Plate (2), insert the Rear Comb Plate at a 45º angle until Rear Comb Plate teeth mesh with the Lower Meshing Roller. Carefully lower the Rear Comb Plate until the alignment pin on the frame enters the slotted hole on the underside of the Rear Comb Plate. Without tightening, attach the Rear Comb Plate to the base using Thumb Screws (3). Gently push the Rear Comb Plate forward to ensure comb teeth and Lower Meshing Roller remain intermeshed. Hand tighten Thumb Screws. 9. The Brennen Skin Graft Mesher should be lubricated with three or four drops of mineral oil (supplied with each Brennen Skin Graft Mesher), or light machine oil. The lubricants should be placed in each of the two Oil Holes (1) located at the top left and right of the Handle (5). The mesher is now ready for sterilization. 10. Wipe dry after cleaning.

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STERILIZATION

The Brennen Skin Graft Mesher may be autoclaved using a Standard Gravity Sterilizer or a high speed instrument (flash) Sterilizer. Dry heat sterilization or gas sterilization (ethylene oxide) can be substituted according to your normal sterilization procedure. Do not attempt to use the mesher until it is thoroughly cooled. The instrument may be cooled more rapidly by immersion in room temperature or cool, sterile water. The Brennen Skin Graft Mesher can withstand typical sterilization conditions as outlined in the AAMI Standards and Recommended Practices, Vol. 1: Sterilization, Good Hospital Practices, Steam Sterilization and Sterility Assurance (SSSA). For example, the AAMI Standard for:

Sterilization Cycle parameters for Wrapped or Containerized Items. The sterilizer manufacturer’s written instructions for cycle parameters should be followed. In general, though, the most common temperature and time parameters are: for gravity-displacement cycles, a 10 to 15 minute exposure time at 270 °F to 275 °F (133 °C - 135 °C) and a 15 to 30 minute exposure time at 250 °F (121 °C); for prevacuum cycle, 3 to 4 minutes at 270 °F to 275 °F (133 °C - 135 °C).

Brennen Medical cannot guarantee sterility, as each institution should establish the efficacy of its sterilization procedure by appropriate validation methods, including the use of commercially available chemical or biological monitors as appropriate. 8

LIMITED WARRANTY

Brennen Medical, LLC warrants each Skin Graft Mesher to be free from defects in material and workmanship for a period of one year from the date of purchase and agrees to repair or replace at its option, free of charge, any Skin Graft Mesher or any part of it, if it proves defective in normal O.R. use. No responsibility is assumed for improper use or maintenance, including modifications of the unit. RETURNED GOODS POLICY

IMPORTANT! EACH SKIN GRAFT MESHER MUST BE CLEANED AND STERILIZED BEFORE RETURNING IT TO BRENNEN MEDICAL.

Authorization must be received from Brennen Medical, LLC prior to the return of merchandise. Merchandise returned must be sterilized subsequent to its last use and have labels intact. Call the Customer Service Department to receive a Return Authorization Number. Non-sterilized meshers returned will not be accepted. PRODUCT ORDER INFORMATION

To place an order or for product information, please contact Brennen Medical, LLC Customer Service Department at 1290 Hammond Road, St. Paul, Minnesota 55110, or at the following telephone and fax numbers: Phone: 651-429-7413 • 800-328-9105 • Fax: 651-429-8020 • E-mail: [email protected] 9

Brennen Medical, LLC 1290 Hammond Road St. Paul, Minnesota 55110 USA Authorized Representative: Scanlan Group B.V. Postbus 75664, 1118ZS Schiphol Triport, The Netherlands Ph: (31) 20 653 0553 * Fax: (31) 20 653 3053

Tel:

651-429-7413 800-328-9105 (Toll Free) Fax: 651-429-8020 E-mail: [email protected]

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