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Medical and Healthcare Application Disclaimer: If the Purchaser intends to commercialize, market or
use any product for medical or healthcare applications, it is the sole responsibility of the Purchaser to ensure that
the product is adequate and appropriate for the Purchaser's intended use and complies with all applicable laws,
regulations, codes and standards including but not limited to the European Union Medical Device Directive, United
States Federal Food, Drug, and Cosmetic Act, regulations of the United States Food and Drug Administration (FDA),
and for obtaining and maintaining any required regulatory approvals including but not limited to any required market
clearances. Tyco Electronics has not sought nor received any rulings from the FDA or any other federal, state, or
local government agency or notified body as to the safety, effectiveness or appropriateness of its product for such
applications. Persons intending to evaluate or use Tyco Electronics' product for medical or healthcare purposes must
rely on their own medical and legal judgment without any representation on the part of Tyco Electronics.
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CAUTION-Life Support
Care must be taken when this touchmonitor is a critical component of a life support system or
device. In case of failure of this touchmonitor, appropriate redundant systems should be
incorporated into the system or device to prevent injury to the user or patient.
The following should be an integral part of the safety design of a life support system or device
using this touchmonitor for a critical function.
• An alternate interface or fail-safe must be available should the touchscreen fail to operate.
• The touchscreen interface must not be the only means of control of a critical function.
• An alternate video display should be incorporated into the safety design if used to monitor a
• The internal speakers of this touchscreen monitor must not be the sole method of warning of
Critical functions are:
1. Life support devices or systems are devices or systems which, (a) are intended for
2. A critical component is any component of a life support device or system whose failure to
Definitions:
" PATIENT ENVIRONMENT"
any environment in which intentional or unintentional contact can occur between a PATIENT
and parts of the ME EQUIPMENT or ME SYSTEM or between a PATIENT and other persons
touching parts of the ME EQUIPMENT or ME SYSTEM.
critical function.
a critical function.
surgical implant into the body, or (b) support or sustain life, or (c) whose failure to perform
when properly used in accordance with instructions for use provided in the labeling, can be
reasonably expected to result in significant injury to the user.
perform can be reasonably expected to cause the failure of the life support device or system,
or to affect its safety or effectiveness.
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