User's Manual

Page 87
<IEC60601-2-25> ECG-Electrocardiographs
l ME EQUIPMENT may show temporary DEGRADATION during ESD discharges. Within 10
s the ME EQUIPMENT shall resume normal operation in the previous operating mode,
without loss of any operator settings or stored data, and shall continue to perform its
intended function and maintain ESSENTIAL PERFORMANCE.
l When exposed to electrical fast transients and bursts, via the POWER SUPPLY CORD, the
ME EQUIPMENT shall continue to perform its intended function as described in the
particular standard. Testing of PATIENT CABLES and interconnecting cables specified to
be more than 3m in length may show temporary DEGRADATION during exposure to fast
transients and bursts. Within 10 s the ME EQUIPMENT shall resume normal operation in
the previous operating mode, without loss of any operator settings or stored data, and shall
continue to its intended function as described in the ACCOMPANYING DOCUMENTS. The
ME EQUIPMENT shall comply with the requirements of 201.12.1.101.2 when the signal
CAL20110 of Table GG.1 is applied.
<IEC60601-2-27> ECG / Heart Rate
l ME EQUIPMENT shall comply with subclasses 6.2.1.10 of IEC60601-1-2:2007 and the
accuracy of the detected heart rate shall be 60±6bpm.
l ME EQUIPMENT may show temporary DEGRADATION during ESD discharges. Within 10
s the ME EQUIPMENT shall resume normal operation in the previous operating mode,
without loss of any operator settings or stored data, and shall continue to perform its
intended function and maintain ESSENTIAL PERFORMANCE.
l When exposed to electrical fast transients and bursts, via the POWER SUPPLY CORD, the
ME EQUIPMENT shall continue to display the heart rate. the accuracy of the detected heart
rate shall be 60±6bpm. Testing of PATIENT CABLES and interconnecting cables specified
to be more than 3m in length may show temporary degradation during exposure of fast
transients and bursts. Within 10 s the ME EQUIPMENT shall resume normal operation in
the previous operating mode, without loss of any operator settings or stored data, and shall
continue to display the heart rate. The accuracy of the detected heart rate shall be
60±6bpm.
l When exposed to a conducted radio frequency voltage, via the POWER SUPPLY CORD,
the ME EQUIPMENT shall continue to display the heart rate. the accuracy of the detected
heart rate shall be 60± 6bpm. However, PATIENT CABLES are exempt from this
requirement.
<IEC80601-2-30> NIBP
l ME EQUIPMENT shall comply with subclasses 6.2.1.10 of IEC60601-1-2:2007 and the
accuracy of the CUFF pressure shall be 180±2mmHg.
<IEC60601-2-49> Multifunction Monitor
l ME EQUIPMENT may show temporary degradation during ESD discharges. Within 10 s the
ME EQUIPMENT shall resume normal operation in the previous operating mode, without
loss of any operator settings or stored data, and shall continue to perform its intended
function as described in the ACCOMPANYNG DOCUMENTS.
l When exposed to electrical fast transients and bursts(EFT/B), via the POWER SUPPLY
CORD, the ME EQUIPMENT shall continue to perform its intended function as described in
the DOCUMENTS. Testing of PATIENT CABLES, TRANCEDUCER cables and
interconnecting cables specified to be more than 3m in length may show temporary
DEGRADATION during exposure of fast transients and bursts. Within 10 s the ME
EQUIPMENT shall resume normal operation in the previous operating mode, without loss of