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Terumo CDI OneView - Electromagnetic Compatibility (EMC)

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B-8
System Specifications
Classications:
This equipment is Type CF and Class 1. Listed by Intertek with
respect to electrical shock, re and mechanical hazards in
accordance with IEC 60601-1:2005+A1:2012+A2:2020 and
CAN/CSA No. 60601-1:14:2014.
In accordance with IEC 60601-1: This equipment has been tested and found to
comply with the limits for medical devices to the IEC 60601-1-2:2014. These limits are
designed to provide reasonable protection against harmful interference in a typical
medical installation. This equipment generates, uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity. However, there is no guarantee
that interference will not occur in a particular installation.
If this equipment does cause harmful interference to other devices, which can be
determined by switching the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the follow ing measures:
Reorient or relocate the receiving device.
Increase the separation between the equipment.
Connect the equipment into an outlet on a circuit different from that to which the
other device(s) are connected.
Consult the manufacturer of the receiving device for help.
Electromagnetic Compatibility (EMC) Electromagnetic Compatibility (EMC)
The CDI OneView System is suitable for use only in the electromagnetic environments
specied in the following tables, in accordance with these standards:
IEC 60601-1:2005+A1:2012+A2:2020
IEC 60601-1-2:2014+A1:2020
IEC 80601-2-49:2018
Note: The emission characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11, Class A). If used in a residential environment
(for which CISPR 11 Class B is normally required), the system might not offer adequate
protection from radio frequency interference. The user might need to mitigate this
possibility by relocating or reorienting the equipment. The system is not indicated for
use in transportation environments, such as on aircraft.

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