GETINGE GROUP Maquet SERVO-s VENTILATOR SYSTEM V7.0 User Manual page 144

| 11 | Technical data |
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 60601-1-2:2007
The EMC declaration: Information to the
Responsible Organization is available from
MAQUET.
Patient Range (kg)
Weight 10 – 250 kg.
IP classification
2
IP 21
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
<41 dB, measured at a distance of 1 m
A-weighted sound power level (L
2. from serial no. 25001
144
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
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
):
pA
): <50 dB
WA
O
2
SERVO-s VENTILATOR SYSTEM V7.0, User's Manual