PL-61044_B
12
The UltraMIST Therapy System is intended for use in the electromagnetic environment specified below. The customer or the user
of the UltraMIST Therapy System should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF emissions
CISPR 11
Group 1
The UltraMIST System 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 A
The UltraMIST System is suitable for use in all establishments other
than domestic, and may be used in domestic establishments and those
directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes, provided the following
warning is heeded:
Warning:
This equipment/system is intended for use by healthcare
professionals only. This equipment/system may cause radio
interference or may disrupt the operation of nearby equipment. It
may be necessary to take mitigation measures, such as re-orienting or
relocating the UltraMIST System or shielding the location.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations / flicker
emissions
IEC 61000-3-3
Complies
Ref. IEC 60601-1-2:2007 §5.2.1.1
Emissions Test
Compliance
Radiation Guidance
Maximum Acoustic Output
Power
Complies
The UltraMIST System requirement for the Maximum Acoustic Output
Power is that the measured value be less than 3W/cm2, which is a
requirement established by the World Health Organization for acoustic
safety. The actual output is significantly less than the above limit, which
is considered to be safe.
Sidewall Radiation
Complies
The UltraMIST System requirement for Sidewall Radiation is that the
measured value be less than 100mW/cm2, which is a requirement
established by the World Health Organization for acoustic safety.
The actual output is significantly less than the above limit, which is
considered to be safe.
Ref. TR-75143 on file at Celleration
GUIDANCE AND MANUFACTURER’S DECLARATION – RADIATION EMISSIONS
GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTRONIC EMISSIONS
ULTRAMIST
™
SYSTEM
INSTRUCTIONS FOR USE