Certification; Input Signal Reproduction Accuracy; Emi/Emc/Rf Caution - GE SEER 1000 Operating Manual

Category
Degree of safety of application in
the presence of a flammable anes-
thetic mixture with air or with oxy-
gen or with nitrous oxide
Method(s) of sterilization recom-
mended by the manufacturer
Mode of operation

Certification

Input Signal Reproduction Accuracy

The frequency response meets the following IEC 60601-2-47 Part 51.5.9
requirements:

The response of the recorder to a 5 mV 100 ms rectangular pulse
does not show a baseline amplitude displacement after the pulse of
more than 0.1 mV referred to the baseline before the pulse. The slope
outside the pulse is less than 0.3 mV/s. The leading e dge overshoot is
less than 10%.

The responses to all pulses of a 1.5 mV, 40 ms triangular pulse train,
which simulates a series of narrow R-waves, is within 80% to 110% of
the response to a train of 1.5 mV, 200 ms triangular pulses.

EMI/EMC/RF Caution

This system is designed and tested to comply with applicable regulations
regarding EMC. Changes or modifications to this system not expressly ap-
proved by manufacturer could cause EMC issues with this or other equip-
ment.
2067634-077 Revision B
Medical Equipment
With respect to electric shock, fire, and mechanical and
other specified hazards only in accordance with
IEC 60601-1, CAN/USA C22.2 NO. 601.1, IEC 60601-1-2,
and IEC 60601-2-47
SEER™ 1000
Classification
Equipment is not suitable for use in the
presence of a flammable anesthetic
mixture with air or with oxygen or with
nitrous oxide.
Not applicable
Continuous operation.
Introduction
17