User's Manual

12
MAY CONTAIN U.S. AND INTERNATIONAL EXPORT CONTROLLED INFORMATION
4.2 Medical Equipment Standards
Table 4-2. IEC 60601-1-2 Performance Criteria – Electromagnetic
Emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The 2net Hub is intended for use in the electromagnetic environment specified below. The customer or the user of
the 2net Hub should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1 The 2net Hub must emit electromagnetic energy in order to perform
its intended function as a communication device. Nearby electronic
equipment may be affected.
The 2net Hub is not a Group 2 device as RF energy is not used as a
form of patient treatment.
RF emissions,
CISPR 11
Class B The 2net Hub is suitable for use in domestic establishments 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 fluctuations/
flicker emissions/
IEC 61000-3-3
Complies
MAY CONTAIN U.S. AND INTERNATIONAL EXPORT CONTROLLED INFORMATION
5
3 2net Hub Regulatory Information
3.1 Food and Drug Administration (FDA) Classi cation
The 2net Hub is classified by the FDA under the definition of a Medical
Device Data System (MDDS) Class I Device. The 2net Hub MDDS
device is intended to transfer, store, convert from one format to another
according to preset specifications or display medical device data. MDDSs
perform all intended functions without controlling or altering the function
or parameters of any connected medical devices. An MDDS is not
intended to be used in connection with active patient monitoring.
The 2net Hub is not intended to be:
A diagnostic tool
Used for accessing the Internet
Used in hospitals or emergency rooms
Used for active patient monitoring
Operate the 2net Hub only as intended. Do not use the 2net Hub for any
other purpose.
3.2 Safety Warnings
• CAUTION: Medical electrical equipment needs special precautions
regarding EMC and needs to be installed and put into service
according to the EMC information provided in section 3.4.4. Portable
and mobile RF communications equipment can affect medical electrical
equipment.
• CAUTION: The 2net Hub should not be used in airplanes, hospitals or
locations where cellular telephones and other electronic devices are
prohibited.