Canon CXDI-80C Service Manual page 5

According to the "IEC 60601-1-1:2000", equipments installed in the patient environment are
restricted to "medical electric equipment conforming to IEC 60601-1".
Note that the entire radiography system, including this product, is required to comply with IEC
60601-1-1. The details are as follows: Medical equipment such as an X-ray generator
complying with IEC 60601-1, an image capture computer and a display monitor complying with
IEC 60601-1 or IEC 60950-1.
The image capture computer, optional devices such as network equipment or magnetic card
readers, and display monitors that are classified as other than medical electrical equipment (IEC
60601), for example as information technology equipment (IEC 60950), cannot be installed in
the patient environment.
The appended documentation is to be provided to the user, operator, and installer of the
equipment configuring the system, such as the image capture computer and display monitor,
upon installation of such equipment.
Also, for the installation, the above items must be connected to a common protective earth.
Equipment connected to the image capture computer must satisfy state No. 3 in table BBB.201
of IEC 60601-1-1.
Either connect the image capture computer to a common protective ground, add a dedicated
protective ground, or install an isolation device.
The patient environment described below is an example cited from the "IEC 60601-1-1:2000" –
the measurements are only guidelines. However, the "IEC 60601-1-1:2000" example must be
treated as the standard.
Therefore, the image capture computer, optional devices such as network equipment or
magnetic card readers, and display monitors must be installed in a location separated by at least
the dimensions indicated below (outside the patient environment). In addition, the X-ray
interface box should be installed outside the patient environment.
* The areas through which patients move at times other than X-ray exposure (when
entering and leaving, etc.) are also included in the patient environment. Therefore,
always confirm (discuss) with the customer that the installation location is outside the
patient environment.
Example of patient environment
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