Aspen Surgical Products X-Tra 053030PBX Suture Aid Booties Instruction Manual

Aspen Surgical Products X-Tra 053030PBX Suture Aid Booties

Product Information

• Specifications:
  • Product Name: Suture Aid Booties
  • Manufacturer: Aspen Surgical Products Inc. Emergo Europe
  • Model Number: X-Tra 053030PBX
  • Material: DINP
  • Country of Origin : Refer to the Product Label

The Suture Aid Booties are designed to provide protection and assist in suturing procedures. They are intended for use by healthcare professionals on patients requiring medical interventions.

Product Usage Instructions

• Ensure the Suture
  • Ensure the Suture Aid Booties are clean and sterile before each use.
  • Place the booties over the patient’s feet, ensuring a snug fit for comfort and effectiveness.
  • Use the booties as a barrier to protect against contamination during suturing procedures.
  • Dispose of the booties after single use to prevent infections and ensure patient safety.
• Disposal Instructions:
  • Dispose of the Suture Aid Booties by your institution’s protocols and local, regional, and national laws and regulations governing medical waste disposal.
• Warnings:
  • Avoid reusing the booties to prevent infections or complications. Use a new pair for each patient.

FAQs

• Q: Can the Suture Aid Booties be reused?
  • A: No, the booties are designed for single use only to prevent infections and ensure patient safety.
• Q: What material are the booties made of?
  • A: The booties are made of DINP material for protection and effectiveness during suturing procedures.

Intended Use

• Suture Aid Booties are intended to protect, tag and help locate sutures

Intended User/ Patient Target Groups

• Intended to be used by Healthcare Professionals on patients requiring medical procedures.

Instructions for Use

• The device is intended for a limited contact duration, less than or equal to 8 hours.
• Do not use the product if the product is damaged.

Warning

• Reuse of the device could result in infection/contamination and/or device failure which could lead to patient harm.

Disposal

• Dispose of or recycle general surgical devices per facility protocol and all applicable federal, state, regional, and/or local laws and regulations.

Notice to Users and/or Patients in the EU

• Any serious incident that has occurred about the device, should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

WARNING:

• This product can expose you to Diisononyl phthalate (DINP), which is known to the State of California to cause cancer.
• For more information go to www.P65Warnings.ca.gov. (Excluding X-Tra 053030PBX)

CONTACT

• Aspen Surgical Products Inc.
• 6945 Southbelt Drive SE
• Caledonia, MI 49316
• Phone +1 616-698-7100
• Toll-Free 888-364-7004
• aspensurgical.com.
• Emergo Europe
• Westervoortsedijk 60
• 6827 AT Arnhem
• The Netherlands
• For Country of Origin See Product Label

References

• Aspen Surgical
• www.ca.gov | California State Portal
• P65Warnings.ca.gov
• P65Warnings.ca
• P65Warnings.ca.gov

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