DeVilbiss Drive 1025DS - Electromagnetic Compatibility Information; EMC Warnings and Safety Guidelines; Electromagnetic Compatibility Test Results

LT-2329
34
ELECTROMAGNETIC COMPATIBILITY INFORMATION
ELECTROMAGNETIC COMPATIBILITY INFORMATION
WARNING
MR Unsafe
Do not bring the device or accessories into a Magnetic Resonance (MR) environment as it may cause unacceptable risk to the patient or damage to the
oxygen concentrator or MR medical devices. The device and accessories have not been evaluated for safety in an MR environment.
Do not use the device or accessories in an environment with electromagnetic equipment such as CT scanners, Diathermy, RFID and electromagnetic security
systems (metal detectors) as it may cause unacceptable risk to the patient or damage to the oxygen concentrator. Some electromagnetic sources may not be
apparent, if you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, disconnect the power cord and
discontinue use. Contact your home care provider.
This device is suitable for use in home and healthcare environments except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME
SYSTEM for magnetic resonance imaging, where the intensity of Electromagnetic DISTURBANCES is high.
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 normally.
WARNING
Portable 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 oxygen concentrator, including cables specied by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
Electromagnetic Compatibility
TEST DESCRIPTION SPECIFICATION NOTES RESULTS
CISPR11 & IEC 60601-1-2:2014 (4TH EDITION)
RF Emissions CISPR 11 Group 1 Complies
RF Emissions CISPR 11 Class B Complies
Harmonic Current Emissions EN 61000-3-2:2014 AC Input Complies
Voltage Fluctuations & Flicker EN 61000-3-3:2013 AC Input Complies
Electrostatic Discharge Immunity EN 61000-4-2:2008 ±15kV (Air)
8kV (Contact)
Complies
Radiated Electromagnetic Field Immunity EN 61000-4-3:2006 80MHz to 2.7GHz @ 10V/m; 80% AM at 1kHz Complies
Fast Transient/Burst Immunity EN 61000-4-4:2004 ±2kV for Power Lines & ±1kV for I/O Lines Complies
Surge Immunity EN 61000-4-5:2006 ±1kV differential
±2kV common
Complies
Conducted RF Immunity EN 61000-4-6:2009 3Vrms 150kHz to 80MHz
6Vrms ISM Band frequencies between 150kHz-80MHz
Complies
Magnetic Field Immunity EN 61000-4-8:2010 30A/m Complies
Voltage Dips, Short Interruptions & Variations EN 61000-4-11:2004 100% dip 0.5 cycle
100% dip 1 cycles
30% dip 25 cycles
100% dip 5 sec
Complies