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Optos P200TxE - Environmental Safety Guidelines; Electromagnetic Compatibility (EMC) Safety

Optos P200TxE
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Chapter 1 - Warnings and cautions
1.4 Environmental safety
WARNING
Do NOT operate the device:
l In the presence of explosive or flammable gases, flammable anaesthetic
mixtures or in oxygen rich environments.
l Inside the influence of the magnetic field of a magnetic resonance imaging
device.
l In environments that block the scan head air intake vents.
l In environments that exceed the environmental limits (see Environmental
considerations (ambient) on page72).
1.5 EMC safety
CAUTION
In order to provide reasonable interference protection against radio communication
services, this device has been tested and complies with 47 CFR Part 15, Sub Part B of
the FCC (U.S.A.) rules and IEC/EN 60601-1-2 standard requirements at the premises of
a typical user, and the CISPR11 standard emission limits (CISPR11 Group 1 Class B)
(see Guidance and manufacturer declaration electromagnetic emissions on page74).
Although compliant with all applicable international EMC standards, the equipment
generates, uses and can radiate radio frequency energy. The equipment may cause
radio frequency interference to other medical and non-medical devices and radio
communications nearby.
There is no guarantee that interference will NOT occur in a particular installation.
If this device is found to cause interference (which may be determined by turning the
equipment ON and OFF), the user or qualified service personnel should attempt to correct
the problem by one or more of the following measures:
l Relocate the affected device or devices
l Increase the separation between the equipment and the affected device
l Consult the Optos service representative for further suggestions
Part Number: G110230-003-ENG Page 15 of 84
Copyright 2019-2021, Optos plc. All rights reserved. English

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