Haemonetics MCS+, Operation Manual

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Consulting Reference Information 8-7
P/N 85213-30, Manual revision: B
IEC 60601-1-2
STANDARD REQUIREMENTS
Operation
precautions
Caution: The Haemonetics device must be operated in an environment compat-
ible to the requirements of the IEC 60601-1-2 Standard, Electromagnetic compat-
ibility.
To comply with the IEC 60601-1 collateral standards for medical electrical equip-
ment, general requirements for safety, do not connect more than one multiple
portable socket outlet or extension cord to the system. In addition, do not power
the MCS+ device using a power cord other than the one originally supplied by
Haemonetics for your instrument. Always ensure the power cord is connected to
an appropriately grounded power source.
Mobile RF communication equipment not approved by Haemonetics and porta-
ble communication equipment can affect the system. Any accessories and cables
not approved by Haemonetics used in conjunction with the device may increase
hazards and influence compatibility with EMC requirements. Therefore, non-ap-
proved accessories and cables must not be used.
In addition, the Haemonetics device and accessories must not be placed directly
adjacent to, or top of other equipment, unless specifically approved by Haemon-
etics.
Electromagnetic
immunity
The Haemonetics system is intended for use in the electromagnetic environment
specified in the following tables and the operator must ensure that each system
is used in such an environment.
IEC 60601-1-2, Table 201: Guidance and manufacturer’s declaration - electromagnetic immunity
Emissions test Compliance Electromagnetic environment guidance
RF emissions
CSIPR 11 Group 1 The Haemonetics system uses RF energy only
for its internal functions. Therefore, its RF emis-
sions are very low and are not likely to cause
any interference in nearby electronic equip-
ment.
RF emissions
CSIPR 11 Class B The Haemonetics system is suitable for use in all
establishments including domestic establish-
ment 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 emis-
sions
IEC 61000-3-3 Complies