GE Dash 2500 Operator's Manual page 22

1-6
Introduction: Product Compliance
60601-1.
This Monitor conforms to particular safety standard for multifunction
patient monitoring equipment to IEC 60601-2-49.
This Monitor conforms to usability safety standard for medical devices to
IEC 60601-1-6.
This Monitor conforms to EMC safety standard to IEC 60601-1-2.
Software is developed in accordance with IEC 60601-1-4.
The ECG parameter conforms to IEC 60601-2-27.
The NIBP parameter conforms to IEC 60601-2-30, EN 1060-1, EN1060-3,
ANSI/AAMI SP10.
The TEMP parameter conforms to the accuracy defined in ASTM E 1112.
The application of risk management analysis to medical device conforms to
ISO 14971.
The alarm systems of the Monitor conform to IEC 60601-1-8.
NOTE: The alarm systems of the Monitor conform to IEC 60601-1-8: 2003
with the exception of Sub-clauses 201.3.2.2b and 201.3.3.1a:
The visual alarm indications do not display with different colors, and do
not flash at different rates.
For warning priority and procedural priority alarms, the pulse spacing
and repeat time of auditory alarm are tighter than as specified.
WARNING
These exceptions occur due to efforts to improve the
readability of the display and to reduce eyestrain, and Red is
much more distinguishable to user than Yellow. In consultation
with clinical practitioners, the pulse spacing and repeat time of
auditory alarm are deemed to be more appropriate. However,
the section 4 Alarm shall be read carefully to prevent any
potential hazard.
The ECG parameter conform to ANSI/AAMI EC13.
NOTE: The ECG parameter conforms to ANSI/AAMI EC13: 2002 with
exception of Sub-clauses 4.1.4.2 and 4.2.6.1 QRS detection.
WARNING
In clinical conditions, it is reasonable to assume that spurious
signals of this type are either random in occurrence, or related
to pacemaker activity. The arrhythmia analysis algorithm is
designed to factor the randomness of spikes into its rejection
logic, and this randomness is not exercised in the above
referenced testing. The algorithm does correctly reject pace
signals as prescribed by EC13.
Dash 2500 Patient Monitor 2042480-001 C