Overview of Philips iU22 Ultrasound System User Manual
The user manual for the Philips iU22 Ultrasound System is a guide for healthcare professionals detailing the operation, maintenance, and specifications of this medical device. Philips Electronics N.V., the manufacturer and owner of all proprietary rights to the manual, released this publication in August 2010.
Intended Use and Restrictions
The iU22 ultrasound system is designed for a wide range of clinical applications, and its use is strictly limited to qualified physicians or by their order, in compliance with United States federal law. The Philips iU22 allows for medical diagnostics using ultrasonographic imaging, and it is crucial that the device is operated as per the guidelines prescribed in this manual.
Ownership and Intellectual Property
Philips Medical Systems states that the manual contains proprietary information, and thus unauthorized reproduction, copying, adaptation, modification, disclosure, or dissemination without Philips’ written consent is prohibited. The manual is issued as a licensed document to customers with the purchase of the iU22 system and should not be used by unauthorized persons. Furthermore, Philips asserts that although care has been taken to assure accuracy, no warranties are made regarding the content of the manual.
Regulatory Compliance
The Philips iU22 system conforms to the Medical Device Directive 2007/47/EC, which ensures compliance with the essential requirements for medical devices in the European Union. Philips Electronics N.V. specifies the system’s regulatory status and lists the European Union Representative responsible for regulatory affairs.
Patents and Licenses
The manual references a comprehensive list of U.S. patent numbers and indicates the potential for equivalent patents in other countries, demonstrating the extensive innovation and intellectual property portection behind the Philips iU22 Ultrasound System. It also discloses that the product may include remanufactured parts or parts that have been used incidentally, provided such parts are equivalent to new in terms of performance.
Product Evolution
Philips reserves the right to make changes to the iU22 system without notice, improving the reliability, function, or design of the equipment. The company also retains the flexibility to enhance products described in the manual, indicating a commitment to continuous product development and innovation.
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