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Mindray BeneHeart D60 - Page 82

Mindray BeneHeart D60
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A - 2
Complies with requirements for medical devices of 6.3.4.2, EN1789 (10.1.3, IEC60601-1-12):
Peak acceleration: 1000m/s
2
(102g)
Duration: 6ms
Pulse shape: half-sine
Number of shocks: 3 shocks per direction per axis (18 shocks in total)
Bump
Complies with the requirements for road ambulances of 6.3.4.2, EN1789.
Peak acceleration: 15g
Pulse duration: 6ms
Number of bumps: 1000
Direction: vertical, with the equipment in its normal operating position.
Vibration
Complies with requirements for medical devices of 6.3.4.2, EN1789 (10.1.3, IEC60601-1-12).
10 Hz to100 Hz: 5.0 (m/s
2
)
2
/Hz
100 Hz to 200 Hz: -7 dB/Octave
200 Hz to 2 000 Hz: 1.0 (m/s
2
)
2
/Hz
Duration: 30 minutes per direction per vertical axis (3 axises in total)
Vibration (for fixed wing aircrafts): complies with requirements of 10.1.4, IEC60601-1-12
Test category: S
Curve: C
Frequency: 10 to 2000Hz
Grms: 4.12
Direction: 1 hour per direction per axis (3 axises in total)
Vibration (for helicopters): complies with requirements of 10.1.4, IEC60601-1-12
Test category: U2
Curve: F (performance level test)
Frequency: 5Hz to 300Hz; APSD 5Hz to 40Hz: 0.0063 g²/Hz,+3 dB/Octave; APSD 40Hz to 200Hz: 0.05 g²/Hz; APSD 200Hz to
300Hz: 0.05 g²/Hz, -12 dB/Octave
Grms: 3.37
Curve: F1 (endurance level test)
Frequency: 5Hz to 300Hz; APSD 5Hz to 40Hz: 0.0126 g²/Hz,+3 dB/Octave; APSD 40Hz to 200Hz: 0.1 g²/Hz; APSD 200Hz to
300Hz: 0.1 g²/Hz, -12 dB/Octave
Grms: 4.76
Duration: performance level test for minimum of 10 minutes at the beginning and end of the test, endurance level test for
3 hours (repeated per axis)
Free fall
1 fall on each surface (6 surfaces in total), at the height of 1.5 m
1 fall from the normal operation position of the equipment configured with a carrying case, at the height of 3.0 m
Sidestream CO
2
module
Item Temper at ure Relative humidity Barometric
Operating condition 5ºC to 40ºC 5% to 95%,
non-condensing
430mmHg to 790mmHg
(57.3kPa to 105.3kPa)
Storage condition -20ºC to 60ºC
Mainstream CO
2
module
Item Temperature Relative humidity Barometric
Operating condition 10ºC to 40ºC 10% to 90%,
non-condensing
-382m to 4575m
(57.0 kPa to 106.2kPa)
Storage condition -10ºC to 55ºC <90%,
non-condensing

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