Purpose:

Surg-I-Band® Data Matrix and Patterns Sample Sheet labels are applied to surgical instruments and devices for identification purposes.  Surg-I-Band® Data Matrix and Patterns Sample Sheet labels are made of a flexible polymer that can be used on all shapes and sizes of surgical instruments.  This product may be used with steam, immediate use steam sterilization (IUSS), and ethylene oxide (EO) sterilization.

Surg-I-Band® Data Matrix and Patterns Sample Sheet labels come in red quarter inch strips conveniently packaged on a sheet.  The data matrices are 2D barcodes, each scanning with the barcode value: 8900000000.  For added ease of use, the Surg-I-Band® Remover is an optional accessory sold separately.

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® is intended for coding and identification of surgical instruments.

Instructions for Use:

1. CAUTION: Surg-I-Band® is not intended for application during decontamination/cleaning.
2. Surgical instruments and hands must be dry and free of residue.
3. Select a Surg-I-Band® label and overlap itself at least once but not more than twice around the selected site on the surgical instrument.
4. CAUTION: Do not overlap the data matrix barcode.
5. Place data matrix barcode in a visible location on a flat surface (minimum shaft diameter of 1/8”). Trim material with a sharp edge.
6. CAUTION: Surg-I-Band® must not be stretched (stretching will weaken Surg-I-Band® bonding capability).
7. CAUTION: Place Surg-I-Band® on the finger rings of scissors. It is not recommended that Surg-I-Band® be applied to the shanks of scissors, as this may interfere with the operation of the surgical instrument.
8. Color combinations may be used on the same surgical instrument. Place additional color coding so it does not block the data matrix barcode or the white border surrounding the barcode.
9. Upon completing the application of Surg-I-Band®, autoclave the surgical instrument(s). Surg-I-Band® will bond itself to the surgical instrument(s).
10. Inspect Surg-I-Band® and remove if it shows wear.
11. CAUTION: Surg-I-Band® is not intended for re-use if damage is observed.
12. Use the Surg-I-Band® Remover to assist in the removal of Surg-I-Band® and clean with facility approved surgical instrument cleaner.

Contraindications:

Surg-I-Band® is not intended for implantation.

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.

Warnings/Cautions:

CAUTION: Surg-I-Band® is not intended for use in dry heat sterilization.

CAUTION: Surg-I-Band® is not intended for use in hydrogen peroxide gas plasma.

CAUTION: Destroy Surg-I-Band® that might have been contaminated with prions including Creutzfeldt-Jakob Disease (CJD), variant Creutzfeldt-Jakob disease (vCJD), Gerstmann-Straussler-Scheinker (GSS) disease, and fatal familial insomnia (FFI).  Do not reuse!

CAUTION: Do not use the product after its expiration date.  Use of expired product may result in infection.

Risk of Reuse Statement:

Reprocessing or re-use of Surg-I-Band® is permitted if this IFU is followed; requiring thorough inspection each time a surgical 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.

Potential Adverse Events when using this device:

Infection.

Requirements for Special Facilities, Training, or Particular Qualifications of the User and/or Other Persons:

Not Applicable.

Storage Conditions:

Scanlan recommends that facilities where products are stored and handled are maintained in general warehouse conditions of 20°-25°C (68°-77°F).  Excursions between 15°-30°C (59°-86°F) are allowed, with transient spikes up to 40°C (104°F) permitted as long as they do not exceed 24 hours.  Additionally, such facilities should be cleaned regularly and have effective pest control procedures in place.  Failure to follow these guidelines may result in damage to the product.

Methods for Safe Disposal:

The user is responsible to dispose of the device and packaging according to local and national requirements.