Guidance And Manufacturer's Declaration - DeVilbiss 7305 Servicehandbuch

GUIDANCE AND MANUFACTURER'S DECLARATION

DEVILBISS GUIDANCE AND MANUFACTURER'S DECLARATION
WARNING
Medical Electrical Equipment needs special precautions regarding Electromagnetic Compatibility (EMC) and
needs to be installed and put into service according to the EMC information provided in the accompanying
documents.
Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.
The equipment or system should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the equipment or system should be observed to verify normal
operation in the configuration in which it will be used.
NOTE– The EMC tables and other guidelines provide information to the customer or user that is essential in
determining the suitability of the Equipment or System for the Electromagnetic Environment of use, and in managing
the Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without
disturbing other Equipment and Systems or non-medical electrical equipment.
Guidance and Manufacturer's Declaration – Emissions All Equipment and Systems
This device is intended for use in the electromagnetic environment specified below. The customer or user of this
device should assure that it is used in such an environment.
Emissions Test
RF Emissions CISPR 11
RF Emissions CISPR 11
Harmonics IEC 61000-3-2 Class A
Flicker IEC 61000-3-3
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
LT-1819
Compliance Electromagnetic Enforcement – Guidance
This device uses RF energy only for its internal function.
Group 1 Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Class B Radiated
This device is suitable for use in all establishments including
and Conducted
domestic, and those directly connected to the public low-voltage
Emissions
power supply network that supplies buildings used for domestic
purposes.
Complies
IEC 60601 Test Level Compliance Level
±6kV contact ±6kV contact
±8kV air ±8kV air
±2kV on AC Mains ±2kV on AC Mains
±1kV Differential ±1kV Differential
±2kV Common ±2kV Common
>95% Dip for 0.5 >95% Dip for 0.5
Cycle Cycle
60% Dip for 5 60% Dip for 5
Cycles Cycles
30% Dip for 25 30% Dip for 25
Cycles Cycles
>95% Dip for 5 >95% Dip for 5
Seconds Seconds
Electromagnetic Environment - Guidance
Floors should be wood, concrete or ceramic
tile. If floors are synthetic, the relative
humidity should be at least 30%.
Mains power quality should be that of a
typical commercial or hospital environment.
Mains power quality should be that of a
typical commercial or hospital environment.
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of this device requires continued
operation during power mains interruptions,
it is recommended that the device be
powered from an uninterruptible power
supply or battery.
14