
LT-1859
10
PARTS RETURN AND ORDERING POLICY
XI. DEVILBISS GUIDANCE AND MANUFACTURER’S DECLARATION
WARNING
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put
into service according to the Electromagnetic Compatibility [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 conguration 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 – Electromagnetic Emissions
This device is intended for use in the electromagnetic environment specied below. The customer or the user of this device should
assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF Emissions CISPR 11 Group 1
This device uses RF energy only for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any interference in nearby electronic
equipment.
RF Emissions CISPR 11 Class B
This device is suitable for use in all establishments including domestic and those
directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2 N/A
Voltage uctuations /
icker emissions N/A
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
This device is intended for use in the electromagnetic environment specied below. The customer or the user of this device should
assure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance
Level Electromagnetic Environment - Guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
±6kV contact
±8kV air Complies Floors should be wood, concrete, or ceramic tile. If oors are covered
with synthetic material, the relative humidity should be at least 30%
Radiated RF
IEC 61000-4-3
3 V/m 80MHz to
2.5GHz Complies
Field strengths outside the shielded location from xed RF
transmitters, as determined by an electromagnetic site survey, should
be less than 3 V/m. Interference may occur in the vicinity of
equipment marked with the following symbol:
Conducted RF
IEC 61000-4-6
3 Vrms 150kHz to
80MHz N/A
Immunity Test
IEC 60601 Test
Level
Compliance
Level Electromagnetic Environment - Guidance
Electrical fast transient
IEC 61000-4-4
±2kV power line
±1kV I/O lines N/A Mains power quality should be that of a typical commercial or hospital
environment.
Surge IEC 61000-4-5 ±1kV differential
±2kV common N/A
Power frequency magnetic
eld IEC 61000-4-8 3 A/m Complies Power frequency magnetic elds should be at levels characteristic of
a typical location in a typical commercial or hospital environment.
Voltage dips, short
interrupts and voltage
variations on power supply
input lines IEC 61000-4-11
>95% dip 0.5 cycle
60% dip 5 cycles
70% dip 25 cycles
95% dip 5 secs.
N/A
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.
This device has been tested to and meets the EMC requirements of EN60601-1-2. Do not place the device near other equipment or
devices that create or attract electromagnetic elds. Examples of such equipment are debrillators, diathermy equipment, CB radios,
microwave ovens, etc. Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the
measured eld strength in the location in which the unit is used exceeds the applicable RF compliance level above, the unit should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the unit.