STERIS® Revital-OxTM Resert® XL HLD High Level Disinfectant and PENTAX Medical Flexible Endoscopes (United States, Canada, and Latin America)
Dear Health Care Professional:
This letter provides information on STERIS® Revital-OxTM Resert® XL HLD High Level Disinfectant with regard to its material compatibility with PENTAX Medical flexible endoscopes and the resulting impact on both device functionality and conformance to their statements of intended use. PENTAX Medical does not list this high level disinfectant as compatible with its flexible endoscopes. PENTAX Medical has determined through examination of flexible endoscopes exposed to STERIS® Revital-OxTM Resert® XL HLD that this product negatively impacts the ability of PENTAX Medical flexible endoscopes to conform to their statements of intended use. As a result, the use of this product will void the PENTAX Medical equipment new product warranty against chemically induced damage. Conditions such as, among other things, degradation of adhesives, removal of marking paint, insertion tube alterations (e.g., delamination, deterioration, floppiness, or peeling) and unexplained fluid invasion into the endoscope resulting from the use of STERIS® Revital-OxTM Resert® XL HLD will not be covered under warranty or existing service agreements.
PENTAX Medical assumes no liability for customer use of STERIS® Revital-OxTM Resert® XL HLD with its flexible endoscopes. Any customer utilizing this product with a PENTAX Medical flexible endoscope will assume the risk that the instrument might not be able to conform to its statement of intended use. As a result, PENTAX Medical cannot be held responsible for any adverse events that might occur.
NON-PENTAX MEDICAL REPAIRS
If a product is repaired by a non-PENTAX Medical facility, the corresponding product warranty is void. PENTAX Medical cannot guarantee that any PENTAX Medical flexible endoscope that is repaired by a non-PENTAX Medical facility will be compatible with any detergent or liquid chemical germicide, nor can it guarantee that the endoscope can be considered to be biocompatible. In the event that your equipment has been repaired by a non-PENTAX Medical facility, please contact the repair facility directly for material compatibility information related to detergents and liquid chemical germicides, as well as laboratory data to support biocompatibility (e.g., cytotoxicity, irritation, and sensitization). Finally, the repair facility should also be contacted for validation data supporting that the instrument and any replaced component parts will
perform in accordance with their statements of intended use. If you have any questions, please contact your local PENTAX Medical sales representative or the PENTAX Medical Technical Assistance Center at (800) 736-8293 (United States) or (800) 750-5558 (Canada).
PENTAX Medical Americas
MK-404 Rev: A