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3 – ACQUISITION OF BIOMEDICAL PARAMETERS
3.1.5 ECG ESSENTIAL PERFORMANCE (REF. EN 60601-2-27:2014)
1.
Defibrillation protection
2.
Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT: If the SUPPLY MAINS to the ME
EQUIPMENT is interrupted for 30 s or less, no change of OPERATOR settings occur, including the mode of
operation, and all stored PATIENT data shall remain available.
3.
Protection against depletation of battery: ME EQUIPMENT powered from an INTERNAL ELECTRICAL POWER
SOURCE shall not cause a HAZARDOUS SITUATION to the PATIENT when the state of discharge can no
longer maintain the NORMAL USE of the ME EQUIPMENT.
4.
Accuracy of signal reproduction: Input signals in the range of ±5 mV, varying at a rate up to 125 mV/s, is
reproduced on the output with an error of ≤ ±20 % of the nominal value of the output or ±100 μV,
whichever is greater.
5.
Input dynamic range and differential offset voltage: with a d.c. offset voltage in the range of ±300 mV
and differential input signal voltages of ±5 mV that vary at rates up to 320 mV/s, when applied to any
LEAD WIRE, the time-varying output signal amplitude not changes by more than ±10 % over the specified
range of d.c. offset.
6.
Input impedance: The input impedance is at least 2,5 MΩ within a d.c. offset voltage range of ±300 mV.
7.
Input noise: The signal NOISE caused by the ECG amplifier and PATIENT CABLE shall not exceed 30 μV
peak-to-valley referred to the input (RTI) for a period of at least 10 s. Any mains frequency notch filter, if
provided, is to be turned on during this test.
8.
Multichannel crosstalk: When an input signal limited in amplitude and rate as per 201.12.1.101.2 is applied
to selected LEAD of the multi-channel ME EQUIPMENT, with all other LEAD WIRES connected to the N (RL)
LEAD WIRE, the unwanted output in the unused LEADS is not greater than 5 % of the applied input signal.
9.
Gain control: ME EQUIPMENT having PERMANENT and NON-PERMANENT DISPLAYS provides at least one
fixed GAIN setting of (10 ± 1,0) mm/mV. In addition, continuously variable GAIN control is provided, if this
mode is clearly indicated on all provided displays.
10. Sweep speed: ME EQUIPMENT with provides at least one sweep speed of 25 mm/s ±10 %. The sweep
speed accuracy for any settings not varies by more than ±10 % over the complete horizontal ECG-
channel width.
11. Frequency response: ME EQUIPMENT meet the requirement for a frequency response (bandwidth) of at
least 0,67 Hz to 40 Hz when tested with the input signals from methods A and B.
12. Impulse response: The extended low-frequency response not produces a displacement greater than 0,1
mV RTI, nor a slope exceeding 0,3 mV/s immediately following the end of the impulse on the output when
an input impulse of 0,3 mV•s (3 mV for 100 ms) is applied.
13. Gain indicator: A GAIN INDICATOR is provided that indicates the amplitude of an input voltage of 1 mV
for each GAIN setting on PERMANENT and NON-PERMANENT DISPLAYS. The amplitude variation in display
output shall be within ±10 % when applying a (1,00 ± 0,01) mV input signal at the appropriate LEAD. It is
available for all LEADS. The GAIN setting may be provided alternatively as a numerical value expressed in
mm/mV. ME EQUIPMENT providing only one fixed GAIN is exempt from the requirement to provide a GAIN
INDICATOR.
14. Common mode rejection: A 10 V r.m.s. signal at mains frequency with 200 pF source capacitance,
connected between earth and all LEAD WIRES connected together not produces an output signal
greater than10 mm peak-to-valley at a GAIN setting of 10 mm/mV for not less than 15 s. In series with
each ELECTRODE shall be a 51 kΩ resistor in parallel with a 47 nF capacitor. The PATIENT CABLE specified
by the MANUFACTURER is used.
9
Rescue Life
– Instruction For Use
3-12
Rev.0.5 – 30/03/2022
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