Lifewarmer Quantum - EMC Compliance Statement

-21-
LIFEWARMER
™
EMISSIONS TEST COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT -
GUIDANCE
RF Emissions,
CISPR 11
Group 1, Class B
The Quantum 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.
IMMUNITY TEST COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT -
GUIDANCE
Radiated RF EM Fields, IEC
61000-4-3
80 MHz – 2.7 GHz, 10 V/m
Amplitude modulation 80% 1 KHz
Rated Power Frequency
Magnetic Fields, IEC 61000-4-8
30 A/m, 60 Hz
Electrostatic Discharge, IEC
61000-4-2
± 8 kV contact,
±2, ±4, ±8, ±15 kV air discharge
EMC COMPLIANCE and
WARNING STATEMENT
The Quantum Blood & Fluid Warming System equipment has been tested and found to comply with the limits of the
standard for medical devices, IEC 60601-1-2:2014. These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation. The Quantum Equipment is Class B. Class B equipment is
equipment suitable for use in all establishments, including domestic establishments and those directly connected to
the public low-voltage power supply network that supplies buildings used for domestic purposes. However, there is no
guarantee that interference will not occur in a particular installation. If the Quantum System should cause interference
to other devices, the following actions may be taken to attempt to correct the interference:
•
Ensure the Quantum System is at least 30 cm (12 inches) away from any portable RF communication system.
•
Conrm proper functioning of Controller by disconnecting the Battery and restarting the System.
•
Consult the manufacturer for assistance.
The Quantum is intended for use in the electromagnetic environment specied below. The customer or the user of the
Quantum should assure that it is used in such an environment.
FAA Regulations: In accordance with the US Department of Transportation (DOT) and the Federal Aviation
Administration (FAA), the operational Quantum components (Battery, Controller, TIS/TTS-B) meets the applicable
safety requirements for Medical Portable Electronic Devices (M-PED) by not exceeding the maximum level of radiated
radio frequency interference as described in the RTCA/DO 160F, Section 21, Category M.
The Quantum Charger should only be used in hospital and protected xed structure environments, and has not been
tested for use on aircraft.