P/N 53063-50, Manual Revision: B Appendices
APP-11
APPENDIX D: IEC 60601-1 STANDARD REQUIREMENTS
Caution: The Cell Saver device must be operated in an environment compatible
to the requirements of the IEC 60601-1-2 Standard, Electromagnetic
compatibility.
Operation
precautions
To comply with the IEC 60601-1-2 Standard for Medical Electrical Equipment,
general requirements for safety, it is not permitted to power the Cell Saver device
using a power cord not supplied by Haemonetics, a multiple portable socket
outlet or an extension cord.
Mobile RF communication equipment not approved by Haemonetics and
portable 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-approved accessories and cables must not be used.
In addition, the Cell Saver device and accessories must not be placed directly
adjacent to, or top of other equipment, unless specifically approved by
Haemonetics.
Electromagnetic
immunity
The Cell Saver 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: 2001, Table 201: Guidance and manufacturer’s declaration - electromagnetic emissions
The Cell Saver system is intended for use in the electromagnetic environment specified below. The customer
or the user of the Cell Saver system should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment guidance
RF emissions
CSIPR 11
Group 1 The Cell Saver system uses RF energy only for its internal
functions. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF emissions
CSIPR 11
Class A
The Cell Saver system 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
fluctuations/
flicker emissions
IEC 61000-3-3
Complies
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