QUALITY POLICY
VORTRAN Medical Technology 1, Inc. is dedicated to achieving and sustaining consistent quality through the design and manufacturing of products that meet the needs of the worldwide medical market and the expectations of our customers.
Our objectives will be achieved through…
- Continuous improvements in an enhanced quality system and the team work of employees and distributors.
- Implementing and following a quality management system that meets the requirements of ISO 13485 in order to comply with customer requirements.
- Commitment to meeting applicable national and regional regulatory requirements.
- Communication of this policy to employees.
- Reviewing quality objectives and implementing improvements.
SHELF LIFE STATEMENT
Unless otherwise indicated, the shelf life for our disposable product(s) is five (5) years from the date of manufacture when stored under the specified environmental conditions.
|
MATERIALS STATEMENT
VORTRAN Medical Technology 1, Inc. manufactures respiratory medical products and is committed to meeting all regulatory requirements to achieve the highest quality. All of our products are manufactured in Sacramento, California, USA under strict quality control guidelines. We use only the best materials available to ensure your satisfaction. Our products are produced from certified latex-free materials of the highest quality molded and/or extruded medical grade thermoplastic resin available, such as high density polyethylene, styrene-butadiene copolymers, flexible PVC, silicon rubber, and SS302 stainless steel spring(s).
According to the vendor of the flexible PVC used in the oxygen supply tubing, the exudation one may experience is a natural phenomenon that occurs with all flexible vinyl compounds. When exposed to high temperatures, high humidity, or sunlight, the plasticizers present in the tubing, can migrate to the surface of the tubing, creating an oily film. This film does not indicate a harmful degradation or breakdown of the product. These conditions can also cause discoloration or stiffness in the product. The vendor states that proper stock rotation, using a “First In First Out” process, will minimize the likelihood of exposure to such environmental conditions. High heat, humidity and prolonged exposure to intense ultraviolet light will not cause an inability of the tubing to perform but could cause a loss of cosmetic quality.
WARRANTY STATEMENT
VORTRAN Medical Technology 1, Inc. warrants that each new product or parts thereof will be free of defects in workmanship or materials. Should any failure to conform to this warranty appears with substantiation that the product has been stored, installed, maintained and operated in accordance with manufacturer’s instructions and standard industry practice, and that no modifications, substitutions or alterations have been made to the product, VORTRAN Medical shall correct such defect by suitable repair or replacement. Any misuse of the products or parts thereof may void the warranty. All warranty decisions are made by the manufacturer.
|