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About the Monitor
About the Monitor
Intended use
Intended purpose
The EX4342 is intended for the display of still images and moving images from various commercially
available devices commonly used in a medical environment, in particular endoscopic.The monitor is
optimized for the reproduction of colour images. The monitor is not suitable for mammography.
Intended patient population and medical conditions
The monitor can be used for the intended purpose irrespective of age, body weight and gender.
The monitor is intended to be used in combination with or mounted on medical devices. The monitor
therefore has no direct contact with the patient.
The monitor is intended to display still images and moving images from various commercially available
(medical) devices commonly used in a medical environment. The monitor cannot be used for direct
diagnosis and as main device for monitoring live support equipment.
Intended users
The intended users for the monitor are qualified healthcare professionals.
Intended environment
The monitor is intended to be used in professional healthcare facilities such as clinics and hospitals. The
monitor can be used in operating rooms (OR) or near patients, but is not limited to them. The monitor is
not intended for direct patient contact!
The monitor is not suited for the following environments:
• Home-based healthcare facilities.
• Near short-wave therapy devices.
• Near an MRI-System.
• Built into vehicles, including ambulances.
Note
Serious incident
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the
competent authority of the Member State in which the user and/or patient is established.
