Laboratory Testing of Zebra’s Z-Band Direct Thermal Antimicrobial Wristbands
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Introduction


This document details the laboratory testing completed on Zebra® Z-Band direct thermal antimicrobial-coated wristbands. Independent laboratories and the Zebra Technologies Supplies research and development team tested the wristbands to ensure they meet Zebra’s high standards for image durability, scannability and comfort. The tests evaluated the following:
• MR Safety
• Durability
• Potential to cause skin irritation

MR Safety
Zebra contracted with an independent MRI testing company to test Zebra’s Z-Band wristbands (listed below) to determine if they would present a hazard or risk to a patient undergoing an MRI procedure. The testing on the products included:
• Magnetic field interactions
• MRI-related heating
• Image artifacts

Durability Testing
Optimum scanning performance and image durability are important, especially regarding the narrow 5 mil 128 Subset C bar codes that are printed on today’s hospital wristbands. A bar code that fails to scan or requires repeated attempts to scan, can both jeopardize patient safety and staff productivity. Zebra’s Supplies research and development team tested the image durability of Z-Band direct thermal wristbands to insure optimum image durability and scanning performance.



Skin Irritation Testing
Zebra’s Z-Band wristbands were tested for the potential to produce a primary dermal irritation after a single exposure to the skin.
Z-Band wristbands were tested to FDA 21CFR, Part 58, referencing:
• ISO 10993-10, 2002, Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-Type Hypersensitivity
• ISO 10993-12, 2002, Biological Evaluation of Medical Devices—Part 12: Sample Preparation and Reference Materials
• ISO/IEC 17025, 2005, General Requirements for the Competence of Testing and Calibration Laboratories


Conclusion
Zebra is committed to providing hospitals with wristbands that meet our high standards for image durability, scannability and comfort. Zebra’s Z-Band direct thermal wristbands:
• Do not appear to present an additional hazard or risk to a patient undergoing an MRI procedure.
• Are scannable after repeated exposure to water and common solvents found in hospitals, as well as abrasion.
• Show no signs of erythema or edema when testing for primary skin irritation.