Mindray BeneFusion uVP, Instructions For Use Manual

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Product Specifications
A.1 Specifications
Classifications
Connect to AC power source, type of protection against
electrical shock: CLASS I EQUIPMENT, equipment energized
from an internal electrical power source
Connect to DC power source, type of protection against
electrical shock: CLASS II EQUIPMENT, equipment energized
from an internal electrical power source
Degree of protection against electrical shock: Defibrillation-
proof type CF applied part (direct cardiac application)
Mode of operation: Continuous
Degree of protection against harmful ingress of water: IP44
Degree of mobility: Portable
Operating conditions
Temperature: 5ºC to 40ºC
Relative humidity (noncondensing): 15% to 95%
Barometric: 57.0 kPa to 107.4 kPa
Storage conditions
Temperature: –20ºC to 60ºC
Relative humidity (noncondensing): 10% to 95%
Barometric: 16.0 kPa to 107.4 kPa
Corrosive-free and ventilated
Shock
Complies with requirements for medical devices of 6.3.4,
EN1789 (10.1.3 a, IEC60601-1-12):
Peak acceleration: 300m/s
2
(30g)
Duration: 11ms
Pulse shape: half-sine
Number of shocks: 3 shocks per direction per axis (18 shocks in
total)
Vibration
Complies with requirements for medical devices of 6.3.4.2,
EN1789 (10.1.3 b, 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 2000 Hz: 1.0 (m/s
2
)
2
/Hz
Duration: 30 minutes per direction per vertical axis (3 axises in
total)
Free fall
Complies with requirements for medical devices of 6.3.4,
EN1789 (10.1.3 c, IEC60601-1-12):
Height of fall: 0.75 m
Number of falls: 1 on each of the six surfaces