Compliance - Nellcor OxiMax N-595 Service Manual

Compliance

N-595
Item
Equipment classification
Type of protection
Degree of protection
Mode of operation
N-595 resistant to liquid ingress
Degree of Safety in presence of a
flammable anaesthetic
Applied sensor label to indicate Type
BF applied part
Equipotential lug symbol to indicate a
potential equalization conductor
Attention symbol, consult
accompanying documentation
External case made with
non-conductive plastic
No holes in case top
115/230 voltage selector switch
Rigid case
Case mechanically strong
Case handle
N-595 resistant to rough handling
N-595 tip/tilt test
N-595 resistant to liquid ingress due to
spills
Environmental
Cleaning
Case surface made of non-toxic
materials
Case resistant to heat and fire
Compliant With
Safety Standards: IEC 60601-1 (same as
EN60601-1), CSA 601.1,
UL 2601-1, EN865, EN/IEC 60601-1-2
(second edition)
Class 1 (on AC power)
Internally powered (on battery power)
Type BF - Applied part
Continuous
IEC 60601-1, sub-clause 44.6 for class IPX1
Drip-Proof equipment
UL 2601-1, sub-clause 5.5, Not suitable
IEC 60601-1 Symbol 2 of Table DII of
Appendix D
IEC 60601-1 Symbol 9 of Table DI of
Appendix D
IEC 60601-1 Symbols 14 of Table DI of
Appendix D
IEC 60601-1, sub-clause 16(a)
IEC 60601-1, sub-clause 16(b)
IEC 60601-1, sub-clause 16(f)
IEC 60601-1, sub-clause 21(a)
IEC 60601-1, sub-clause 21(b)
IEC 60601-1, sub-clause 21(c)
IEC 60601-1, sub-clause 21.6
IEC 60601-1, sub-clause 24.1
IEC 60601-1, sub-clause 44.3 as modified by
EN 865, clause 4
IEC 60601-1, sub-clause 44.5
IEC 60601-1, sub-clause 44.7
IEC 60601-1, sub-clause 48
IEC 60601-1, sub-clause 59.2(b)
Specifications
93