Product: SurgiWrap® Bioresorbable Sheet Catalog #: 27202-05 Description: 5 pack Size: 100mm x 130mm x 0.02mm	Product: SurgiWrap® Bioresorbable Sheet Catalog #: 27502-05 Description: 5 pack Size: 100mm x 130 x 0.05mm
Product: SurgiWrap® Bioresorbable Sheet Catalog #: 27204-05 Description: 5 pack Size: 130mm x 200mm x 0.02mm	Product: SurgiWrap® Bioresorbable Sheet Catalog #: 27504-05 Description: 5 pack Size: 130mm x 200mm x 0.05mm

In-Service Guide

Product Packaging

• Check the Expiration Date
  (3 year shelf life for the device)
• Ensure Sterilization Square is RED
• The protective envelope provides detailed warnings, precautions, and storage and handling instructions
• The implant is delivered sterile in a multi-layered package starting with
  the envelope
• The envelope contains the Instructions-For-Use and a foil pouch.
• The foil pouch provides the first sterile barrier and contains a sterile Tyvek® pouch which contains the implant
• This is a resorbable Implant, no explant is required
• Implant Stickers for the patient’s chart are located on the foil pouch
• A non-sterile operator (circulator) opens the foil pouch to expose the Tyvek® pouch inside
• The Tyvek® pouch should then be received by a sterile operator and opened within the sterile field

Implant Delivery

• One corner of the Tyvek® pouch is tabbed to facilitate opening
• The SurgiWrap® Bioresorbable Sheet is clear and can easily be misplaced.
  It is recommended to keep the
  sheet in the Tyvek® sleeve until
  ready to use.
• Remove the Tyvek® sleeve from the Tyvek® pouch
• The implant is located within this Tyvek® pouch, between a folded sleeve of white Tyvek® material
• Please note the difference between the folded white Tyvek® sleeve material (A) and the clear Bioresorbable sheet implant (B)
• No preparation is required for
  the implant
• The SurgiWrap® Bioresorbable
  Sheet is removed and handed to
  the clinician

SurgiWrap® Bioresorbable Sheet

SurgiWrap®  Bioresorbable Sheet’s polymer material is fabricated from the same lactic acid molecular building blocks that occur naturally in the human body. The polymers, which result from lactic acid derivatives, are generally referred to as PLA or polylactide. The SurgiWrap® Bioresorbable Sheet is made from an amorphous bioresorbable copolymer of 70:30 Poly(L-lactide-co-D,L-lactide).

The degradation of polylactide polymer (PLA) occurs in two phases:

• Water penetrates the implant and severs the polymer chains into smaller units
• Individual lactide molecules are metabolized in the liver into CO₂ and H₂O and excreted or exhaled

The 0.02mm and 0.05mm sheet retain significant tensile strength (greater than 80% and 100%, respectively) for the initial 8 weeks, and decreases in a controlled fashion through 24 weeks of aging (see Figure 1). Independent laboratory testing determined that the SurgiWrap® Bioresorbable Sheet was capable of maintaining an impermeable sheet throughout the critical healing period, which has been described as several hours for soft tissue attachments and up to 8 weeks for reinforcing weak tissues.

Features and Benefits

FEATURE	BENEFIT
PLA	Safe resorbtion and metabolization with minimal risk of inflammatory reaction
Impermeable	Maintains an impermeable sheet between opposing soft tissues Retains tensile strength for 6-8 weeks ensuring tissue separation during the critical wound healing period
Repositionable in a wet environment	Easily repositioned if already in contact with anatomy Will not stick to surgical gloves or instruments
Can be cut, trimmed, or folded	Enables SurgiWrap® to be placed precisely where it is needed, around different anatomical structures and repairs
Transparent	Allows for constant visualization of the entire surgical field, resulting in easy intra-operative placement and repositioning of the product if needed
Can be anchored in place with sutures, clips, or surgical tacks	Ensures the device does not migrate from the desired area of protection

Packaging and Labels

Review the packaging warning symbols prior to use.

	Avoid extreme heat. Do not expose above 120°F (49°C).		Do not re-use. For single use only. Do not resterilize.
	Do not use after the expiration date		Use only if sterilization indicator SQUARE is RED
	Attention, see Instructions for use		Do not use if temperature indicator DOT is BLACK
	Keep package dry

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Label Nomenclature

Contraindications

• Where permanent implants are needed
• Active infection
• Patient conditions including blood supply limitations, or latent infection

Open Surgery Procedure

Intraoperative Placement 
Before fascial closure begins, sterile scissors can be used to customize the sheet to any desired shape or configuration as needed. The SurgiWrap® Bioresorbable Sheet is placed on the weakened tissue or fascial defect. The edges of the SurgiWrap®  sheet should extend beyond both ends of the wound. The SurgiWrap® sheet can be easily repositioned intraoperatively.

Fascial Closure
To prevent postoperative migration of the sheet, it is recommended that the sheet be held in place. During the facial closure, loop one of the first and one of the last sutures of either an interrupted or continuous series through the sheet. The SurgiWrap® Bioresorbable Sheet is transparent, and allows direct surgical visualization of underlying abdominal contents for simplified suture placement.

Laparoscopy/ Closed Procedure

Preparation and Delivery
Sterile scissors may be used to customize the sheet to any desired shape or configuration. The SurgiWrap® Bioresorbable Sheet is loosely rolled lengthwise and held, at a slight angle at one end, by the laparoscopic graspers. The SurgiWrap® sheet is then easily delivered through a trocar 10mm or larger and released into the operative site.

Intraoperative Placement
Once released into the operative site, the sheet will unroll to the extent allowed by the surrounding soft tissue. The SurgiWrap® Bioresorbable Sheet can be anchored in place with one or two fine sutures or clips. The SurgiWrap® sheet can be repositioned intraoperatively with graspers while its transparent nature allows for direct surgical visualization of underlying anatomy to facilitate placement.