11.1 System
11.1.1 General
Standards
• EN/IEC 60601-1: 2005, continuous
operation
• ISO 80601-2-12:2011
• ISO 80601-2-55:2011
Electromagnetic compatibility (EMC)
According to IEC 60601-1-2:2014
Refer to Electromagnetic Compatibility,
SERVO-s Ventilator System.
Patient Range (kg)
Weight 10 – 250 kg.
IP classification
IP 21
2
The IP 21 classification implies that the
enclosure is protected against solid foreign
objects represented by a test finger with a
diameter of 12 mm pressed with a force of
10 N, and a sphere with a diameter of 12.5 mm
pressed with a force of 30 N against all
openings in the enclosure, as well as dripping
water with a flow rate of 1 ml/min for ten
minutes.
Noise
• A-weighted sound pressure level (L
pA
):
<41 dB, measured at a distance of 1 m
• A-weighted sound power level (L
WA
): <50 dB
11.1.2 Operating Conditions
• Operating Temperature range: +10 to +40°C
• Relative humidity: 15 to 95%
non-condensing
• Atmospheric pressure: 660 to 1060 hPa
• Lowest pressure in patient circuit:
-400 cmH
2
O
Mechanical strength
Vibration, shock and fall according to specified
standards with the addition of impact below.
• Peak acceleration: 15 g
• Pulse duration: 6 ms
• Number of impacts:1000
11.1.3 Non operating conditions
• Storage temperature: -25 to +60°C (-13 to
140°F)
• Storage relative humidity: < 95%.
• Storage atmospheric pressure: 470 —
1060 hPa
2. from serial no. 25001
146
SERVO-s VENTILATOR SYSTEM V8.0, User's Manual
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