44
4. Time to alarm for tachycardia: ≤12s.
5. Pacemaker pulse rejection:
Can reject the no-overshoot pacemaker pulse: amplitude: ±2mV ~ ±700mV; pulse width: 0.1 ms ~ 2 m
It's not applicable to overshoot pacemaker pulse.
6. Pacemaker pulse rejection for the ECG signal: the minimum input slew-rate is 2V/s RTI (it varies on different
filter modes, ).
7. This device (including the accessories, such as Cuff, SpO
2
probe and the internal ECG module) is designed
to have special protection against defibrillator.
8. When the device is used together with electro-surgical unit, the ECG signal display could return to its pre-
vious normal state within 10s after exposure to the field produced by the electro-surgical unit without loss
of any stored data.
9. When the power line interference (50Hz/60Hz) is very high, the pacemaker pulse might be falsely detected.
10. Pacemaker pulse rejection warning label: see Section 3.4.3 & Section 8.1.
11. Auxiliary output: Not provided
12. Remote technology: Not provided
6.10.2 Additional description for SpO
2
monitoring
1. The device is calibrated in the factory before sale, so there is no need to calibrate it during its life cycle.
Any SpO
2
simulators should not be used to validate the accuracy of the oximeter, they can only be used
as functional testers to verify its precision. The SpO
2
accuracy claimed in this manual is supported by the
clinical study conducted by inducing hypoxia on healthy, non-smoking, light-to-dark skinned subjects in an
independent research laboratory.
2. If it is necessary to verify the precision of the oximeter routinely, the user can do the verification by means
of SpO
2
simulator, or it can be done by the local third party test house. Please note that the specific calibra-
tion curve (so called R-curve) should be selected when use of SpO
2
simulator, e.g. for Index 2 series SpO
2
simulator from Fluke Biomedical Corporation, please set “Make” to “DownLoadMake: KRK”, then the user
can use this particular R-curve to test the oximeter. If the SpO
2
simulator does not contain “KRK” R-curve,
please ask the manufacturer for helping to download the given R-curve into the SpO
2
simulator.
3. The average data update period: ≤10s.
6.10.3 Additional description for NIBP measurement
The blood pressure measured by this device is essentially identical to that measured by auscultatory method.
6.10.4 Additional description for temperature measurement
This Gima Vital Signs Monitor adopts the thermistor-type probe to make temperature measurement. The con-
stant micro direct current of the temperature probe is 32μA, and the dissipation power (I2R) is related to the
probe type. If you choose KRK temperature probe, then the Static Power is less than 17 μW in the range from
15°C to 55°C; if you choose YSI temperature probe, then the Static Power is less than 3 μW in the range from
25°C to 45°C. The produced self-heating will not result in the measurement deviation exceeds the declared
specification.
6.10.5 Additional description for alarm system
1. Alarm indication: audial and visual alarm signal.
2. Audial alarm:
• High priority alarm: one group pulse string including 10 pulse; x, x, 2x + td, x, 1s, x, x, 2x + td, x, and
x=100ms, the pulse duration is160ms, pulse frequency is 400Hz, the pulse string interval is 3s.
• Medium priority alarm: one group pulse string including 3 pulse, the pulse string interval is y, y, and y=200ms,
the pulse duration is200ms, pulse frequency is 500Hz, the pulse string interval is 5s.
• Low priority alarm: the unrepeatable single pulse, frequency is 500Hz, and pulse duration is 200mx.
Input signal:
Detected HR (bpm)
Calculation formula
IEC60601-2-27Y2011(EF)
201.7.9.2.9 101 A1
80
Calculate all QRS waves
IEC60601-2-27Y2011(EF)
201.7.9.2.9 101 A2
60
IEC60601-2-27Y2011(EF)
201.7.9.2.9 101 A3
120
IEC60601-2-27Y2011(EF)
201.7.9.2.9 101 A4
90