Gima SP-10 Manuel De L'utilisateur page 25

25
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Chapter 10 Parameter Introduction
MEASURED PARAMETERS
Parameter Description
FVC Forced vital capacity
FEV1 Forced Expired Volume in one second
PEF Peak expiratory flow
FEV1% FEV1/FVC×100
FEF25 25% flow of the FVC
FEF2575 Average flow between 25% and 75% of the FVC
FEF75 75% flow of the FVC
Appendix Ⅰ
1. INSTRUCTIONS FOR USE
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare en-
vironments
Warning: Don't near active HF surgical equipment and the RF shielded ro-
om of an ME system for magnetic resonance imaging, where the intensity
of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equip-
ment should be avoided because it could result in improper operation. If
such use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.
Warning: Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no closer
than 30 cm (12 inches) to any part of the equipment, including cables
specified by the manufacturer. Otherwise, degradation of the performan-
ce of this equipment could result.
2. INSTRUCTIONS FOR USE
all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL
PERFORMANCE with regard to electromagnetic disturbances for the
excepted service life.
Guidance and manufacturer's declaration -electromagnetic emissions and
Immunity.
Table 1
Guidance and manufacturer's declaration – electromagnetic emission
Emission test
RF emissions
Unit
CISPR 11
L
RF emission
CISPR 11
L
Harmonic emissions
L/s
IEC 61000-3-2
%
Voltage fluctuations/ flicker emissions
L/s
IEC 61000-3-3
L/s
L/s Table 2
Guidance and manufacturer's declaration – electromagnetic immunity
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
magnetic field
IEC 61000-4-8
ENGLISH
IEC 60601-1-2 test level Compliance level
±8 kV contact ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air ±2 kV, ±4 kV, ±8 kV, ±15 kV air
±2 kV for power supply lines ±2 kV for power supply lines
±1 kV signal input/output Not applicable
100 kHz repetition frequency 100 kHz repetition frequency
±0.5 kV, ±1 kV differential ±0.5 kV, ±1 kV differential mode
mode Not applicable
±0.5 kV, ±1 kV, ±2 kV common
mode
0 % UT; 0,5 cycle. At 0°, 45°, 0 % UT; 0,5 cycle. At 0°, 45°,
90°, 135°, 180°, 225°, 270° 90°, 135°, 180°, 225°, 270°
and 315°. and 315°.
0 % UT; 1 cycle and 70 % UT; 0 % UT; 1 cycle and 70 % UT;
25/30 cycles; Single phase: 25/30 cycles; Single phase:
at 0°. at 0°.
0 % UT; 250/300 cycle 0 % UT; 250/300 cycle
30 A/m 30 A/m
50Hz/60Hz 50Hz/60Hz
Compliance
Group 1
Class B
Class A
Comply