Instructions For Use.
Clinical Benefits:
Surg-I-Band® color coding is applied to surgical instruments and devices for identification purposes. Surg-I-Band® is made of a flexible polymer that can be used on all shapes and sizes of surgical instruments. This product may be used with steam, flash, and ethylene oxide (EO) sterilization.
Surg-I-Band® color coding is offered in different widths, colors, and patterns. It is delivered on a spool and optionally with the Surg-I-Band® Dispenser and Carousel for ease of use. Use of Surg-I-Band® Remover is optional.
Intended User:
The intended users of Surg-I-Band® are Sterile Processing Department Personnel and associated areas within the health care facility setting.
Intended Use:
Surg-I-Band® color coding is intended for coding and identification of surgical instruments.
Instructions for Use:
- Instruments and hands must be dry and free of residue.
- Select the desired color, pattern, and width.
- Dispense enough Surg-I-Band® to overlap itself at least once but not more than twice around the selected site on the surgical instrument.
- Surg-I-Band® on spools must be cut with a sharp edge. The Surg-I-Band® Dispenser is recommended for the best application.
- CAUTION: Surg-I-Band® must not be stretched (stretching will weaken Surg-I-Band® bonding capability).
- CAUTION: Place Surg-I-Band® color coding on the finger rings of scissors. It is not recommended that Surg-I-Band® color coding be applied to the shanks of scissors, as this may interfere with the operation of the instrument.
- Upon completing the application of Surg-I-Band® color coding, autoclave the instrument(s). Surg-I-Band® color coding will bond itself to the instrument(s).
- Inspect Surg-I-Band® and remove if it shows wear or at least every six (6) months to ensure bright identifiable colors.
- Use the Surg-I-Band® Remover to assist in the removal of Surg-I-Band® color coding and clean with facility approved instrument cleaner.
- Use the Surg-I-Band® Carousel for organization and convenient storage.
Contraindications:
Surg-I-Band® is not intended for implantation.
Surg-I-Band® is not intended for re-use if damage is observed.
Surg-I-Band® is not intended for use in an EO cycle until after adhered to substrate by autoclave cycle.
Surg-I-Band® is not intended to be placed where it will interfere with device function.
Risk of Reuse Statement:
Reprocessing or re-use of Surg-I-Band® is permitted if this IFU is followed; requiring thorough inspection each time an instrument or device is reprocessed and removed, if necessary. Any misuse of Surg-I-Band® shall void any warranty or liability by the manufacturer for injury or loss associated with inappropriate use.
Requirements for Special Facilities, Training, or Particular Qualifications of the User and/or Other Persons:
Not Applicable
Methods for Safe Disposal:
The user is responsible to dispose of the device and packaging according to local and national requirements.
Incident Reporting Notice:
Any serious incident that has occurred in relation to the device should be reported to Scanlan International, Inc. and the competent authority of the Member State in which the user and/or patient is established.
Click HERE to download IFU
