The CARESCAPE R860 is a sophisticated medical device developed and distributed by GE Healthcare, used primarily in medical settings for respiratory management. The user manual in question is designed to provide comprehensive instructions for operating the latest software revision of the CARESCAPE R860.
Product Usage and User Responsibility
The first two pages of the manual clearly outline the user’s responsibility regarding the device. It emphasizes the need for the product to be used as described within the manual, accompanied by regular checking and immediate replacement of parts characterized as broken, missing, worn, or contaminated. The device’s performance is contingent upon being assembled, operated, maintained, and repaired according to the instructions provided.
Maintenance and Repair
The manual specifies that any necessary repair or replacement should be carried out by personnel trained by Datex-Ohmeda, one of GE Healthcare’s business entities. Users are cautioned against unauthorized repairs or alterations, which may lead to malfunctions and are reminded that the device must not be altered without Datex-Ohmeda’s written consent.
Legal and Regulatory Information
Attention is drawn to the legal restrictions concerning the device, such as the U.S. Federal law that limits the sale of the device to licensed medical practitioners. Additionally, users outside the United States are advised to comply with applicable local laws regarding the use of medical devices.
Overall, these pages serve as an orientation to the user’s obligations and the legal context in which the CARESCAPE R860 is to be operated, highlighting the importance of adherence to professional standards of maintenance and compliance with regulatory provisions for the safe and effective use of the device.
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