CAIRE Eclipse 5 with autoSAT - Independent Safety Testing and Certifications; Eclipse System Safety Certifications

Oxygen Concentrator Technical Service Manual | PN 20631679 Rev G
9
Independent Safety Testing
Eclipse System and Eclipse Concentrator
Safety
IEC 60601-1 :1988 + A1 :1991 + A2 :1995 + Corrigendum (6/95)
EN 60601-1(1990) + A1(1993) + A2(1995) + A12(1993) + A13(1996) + Corrigenda (7/94)
Electromagnetic
Compatibility
FCC 15B (Sec. 107 & 109), EN55011, EN60601-1-2 :2014 and EN 60601-1-2:2015: ETSI EN
301 489-1 V2.1.1 and ETSI EN 301489-17 V3.1.1 (2017-02); EN6100-3-2, EN61000-3-3,
IEC61000-4-2, IEC61000- 4-3, IEC61000-4-4, IEC61000-4-5, IEC61000-4-6, IEC61000-4-8,
IEC61000-4-11, IEC 60601-1-2 :2001, RTCA DO 160 Rev G
AC Power Supply (3 LED model, Model 5941)
Safety
IEC 60601-1:1988 + A1:1991 + A2:1995
Electromagnetic
Compatibility
FCC 15B (Sec. 107 & 109), EN55011, EN60601-1-2 :2001, EN6100-3-2, EN61000-3-3, IEC61000-4-2,
IEC61000-4-3, IEC61000-4-4, IEC61000-4-5, IEC61000-4-6, IEC61000-4-8, IEC61000-4-11, EN55014-
1
AC Power Supply (2 LED model)
Safety
IEC60601-1, 3rd Edition, ANSI / AAMI ES60601-1, CSA 22.2 No. 60601-1, EN60601-1, 3rd Edition, CE Mark
(LVD)
Electromagnetic
Compatibility
Emissions: EN55011, FCC Part J15, Class B, Conducted, EN55011, FCC Part J15, Class B, Radiated
EN61000-3-2, EN61000-3-3, EN61000-4-2, EN61000-4-3, EN61000-4-4, EN61000-4-5, EN61000-4-6,
EN61000-4-11
DC Power Supply, Model 5942
Safety
Portions of IEC 60601-1:1988 + A1:1991 + A2:1995
Electromagnetic
Compatibility
FCC 15B (Sec. 107 & 109), EN55011, EN60601-1-2 :2014 and EN 60601-1-2:2015: ETSI EN
301 489-1 V2.1.1 and ETSI EN 301489-17 V3.1.1 (2017-02); EN6100-3-2, EN61000-3-3,
IEC61000-4-2, IEC61000- 4-3, IEC61000-4-4, IEC61000-4-5, IEC61000-4-6, IEC61000-4-8,
IEC61000-4-11, IEC 60601-1-2 :2001, RTCA DO 160 Rev G
Power Cartridge 2400, PN 7082
Safety
IEC 62133:2013 and IEC 62133 (edit), UL60950-1, First Edition (UL File MH29443), IEC 60601-
1:1988 +
A1:1991 + A2:1995, UN Transportation Tests T1-T8
Electromagnetic
Compatibility
FCC 15B (Sec. 107 & 109), EN55011, EN60601-1-2 :2014 and EN 60601-1-2:2015: ETSI EN
301 489-1 V2.1.1 and ETSI EN 301489-17 V3.1.1 (2017-02); EN6100-3-2, EN61000-3-3,
IEC61000-4-2, IEC61000- 4-3, IEC61000-4-4, IEC61000-4-5, IEC61000-4-6, IEC61000-4-8,
IEC61000-4-11, IEC 60601-1-2 :2001, RTCA DO 160 Rev G
Any CSA-CUS mark for the Eclipse 5 system does not encompass operation with the DC Power Supply Model 5942.