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HemoSphere Advanced Monitor G Guidance and Manufacturer’s Declaration
G.2 Instructions for Use
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in the following information and tables.
WARNING Use of accessories, sensors, and cables other than those specified may result in
increased electromagnetic emissions or decreased electromagnetic immunity.
No modification of the HemoSphere advanced monitor is allowed.
Portable and mobile RF communication equipment can potentially affect all electronic
medical equipment, including the HemoSphere advanced monitor.
Guidance on maintaining appropriate separation between communications equipment
and the HemoSphere advanced monitor is provided in table G-3.
CAUTION The instrument has been tested and complies with the limits of IEC 60601-1-2. 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 turning
the equipment off and on, the user is encouraged to try to correct the interference by
one or more of the following measures:
· Reorient or relocate the receiving device.
· Increase the separation between the equipment.
· Consult the manufacturer for help.
Table G-1 Electromagnetic emissions
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
The HemoSphere advanced monitor is intended for use in the electromagnetic
environment specified below. The customer or user of the HemoSphere advanced monitor
should assure that it is used in such an environment.
Emissions Compliance Description
RF emissions
CISPR 11
Group 1 The HemoSphere advanced monitor uses RF energy only for
its internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference with nearby
electronic equipment.
RF emissions
CISPR 11
Class A The HemoSphere advanced monitor is suitable for use in all
establishments other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuation/ Flicker
emissions
IEC 61000-3-3
Complies
Status = Released Printed Date: 2018-01-16 Released Date: 2017-09-14
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