Use Instructions

Electromagnetic compatibility
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11 Electromagnetic compatibility
CAUTION!
Accessories
To ensure compliance with the requirements of IEC 60601-1-2 in the current ver-
sion, the device PNEUMOCLEAR™
must be used only with the accessories listed in
ChapterAccessories [
}69].
Precautionary measures
Medical devices are subject to special safety and protective measures concerning
electromagnetic compatibility (hereafter abbreviated as EMC).
The device is to be used only for the purposes described in the Instructions for Use
and is intended for use in environments in Professional Healthcare Facility Environ-
ment. This applies even if individual requirements meet the conditions for deviat-
ing electromagnetic environments. During installation and commissioning as well
as during operation of the device, the compliance with the notes and instructions
for EMC must be strictly observed.
To ensure the basic safety and essential functionality in relation to electromagnetic
interference over the life of the device, the device must be restarted after 24 hours
so that a diagnostic self-test can be performed. The maintenance intervals indic-
ated in Chapter Maintenance Intervals [
}55] must also be observed.
This device complies with the electromagnetic compatibility (EMC) requirements
for medical electrical devices as defined by IEC 60601-1-2. The limits used in testing
provide a basic level of safety against typical electromagnetic interference likely to
occur in professional health care facilities. Nevertheless, it can happen that indi-
vidual performance features are no longer available or only to a limited extent due
to the presence of EM interference.
In the presence of EM interference, it may happen that the heating function is af-
fected. If the heating function is influenced by EM interference, it will be switched
off for safety reasons. After the EM interference has faded, the heating function is
reactivated.
11.1 Electrical Connections
ESD (Electrostatic Discharge)
precautionary measures
The following are ESD precautionary measures:
• Apply potential equalization (PE), if available on your equipment, to all devices
to be connected.
• Use only the listed equipment and accessories.
Hospital employees should be informed about and trained in ESD precautionary
measures.
11.2 Guidance and Manufacturer's Declaration - Electromagnetic
Emissions
The device
PNEUMOCLEAR™
is intended for use in an environment as described be-
low. The user/operator of the device
PNEUMOCLEAR™
should make sure the device
is operated within such an environment.
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DRAFT