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Masimo NomoLine ISA CO2 Manuel De L'utilisateur page 14

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NomoLine ISA CO2
Guidance and Manufacturer's Declaration-Electromagnetic
Immunity
This section constitutes the guidance and Masimo's declaration regarding electromagnetic
immunity for NomoLine ISA CO2.
Essential performance of NomoLine ISA CO2 is gas measurement accuracy (according to
Accuracy on page 23) including gas reading alarm conditions, or generation of technical
alarm conditions, when exposed to the following immunity levels.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Immunity Test
Compliance Level
Electrostatic
±8 kV contact
discharge (ESD)
±2 kV, ±4 kV, ±8 kV,
IEC 61000-4-2
±15 kV air
Power frequency
30 A/m
(50 / 60 Hz)
magnetic field.
IEC 61000-4-8
Conducted RF
3 Vrms
IEC 61000-4-6
6 Vrms in ISM and
amateur radio bands
80%AM@1kHz
0.15 MHz to 80 MHz
Radiated RF
10 V/m
IEC 61000-4-3
80%AM@1kHz
80 MHz to 2.7 GHz and
Table 9
(60601-1-2:2015)
WARNING: Use of this equipment adjacent to or stacked with other equipment 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
properly.
WARNING: Use of accessories and cables other than those specified or provided could result
in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
WARNING: Make sure that NomoLine ISA CO2 system is used in the electromagnetic
environment specified in this manual.
WARNING: Portable and mobile 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 NomoLine ISA CO2 system including the cable. Otherwise, degradation of the
performance of the NomoLine ISA CO2 system could result.
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Chapter 6: Specifications
Electromagnetic Environment - Guidance
Floors should be wood, concrete, or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Portable and mobile RF communications
equipment should be used no closer than 30 cm
to any part of the NomoLine ISA CO2 system.
Otherwise, degradation of the performance of
this equipment could result.
29
Masimo
NomoLine ISA CO2
Symbols
The following symbols may appear on the product or product labeling:
Symbol
Description
Follow instructions for use
Separate collection for electrical
and electronic equipment (WEEE)
Protection from ingress of
IP34
particulates ≥ 2.5 mm and against
splashing water from all directions
Caution: Federal (USA) law restricts
this device to sale by or on the order
of a physician
Biohazardous Waste
CO
2
Lot Code
Storage temperature range
Keep dry
Storage humidity limitation
Gas inlet
Gas outlet
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Chapter 6: Specifications
Symbol
Description
Consult instructions for use
European Union Conformity
Mark
ETL Intertek certification
See Declarations on Page 1
for certifications
Defibrillation-proof. Type BF
applied part
Serial number
Catalog number (model
number)
Not made with natural
rubber latex
Fragile, handle with care
Atmospheric pressure
limitation
Do not use if package is
damaged
Date of manufacture
YYYY-MM-DD
Manufacturer
30
Masimo

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