aspen surgical Suture Aid Booties Instruction Manual
- June 4, 2024
- aspen surgical
Table of Contents
aspen surgical Suture Aid Booties
Symbols
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
Device is intended for limited contact duration, less than or equal to 8 hours.
Sterilization Instructions
- Place device into a kit or sterilization tray.
- Using Ethylene Oxide sterilization method, validate according to ISO 11135, sterilize according to the following parameters:
| Cycle Parameter | Specification | Duration |
|---|
Preconditioning
Temperature| 110°F +/- 10°F|
Humidity| 65% +/- 15% RH| 10.35 Hrs – 72 Hrs
Chamber
Vacuum| 21”+/- 1.0 inHgA|
Humidification/Dwell| 22.5” +/- 1.0 HgA| 60 +30/-0 minutes
Gas Inject/Dwell| 10.3” +/- 0.5 Hg rise| 360 +5/-0 minutes
Jacket Temperature| 135°+/- 5° F|
Aeration *
Temperature| 120°+/- 10° F| 24 Hrs – 72 Hrs Max
*Proper aeration is essential to eliminating the risk of residuals to meet ISO 10993-7 requirements.
Warning
Reuse of device could result in infection/contamination and/or device failure which could lead to patient harm.
Disposal
Dispose 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 EU
Any serious incident that has occurred in relation to 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)
Customer Support
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