Compliance - Covidien Nellcor OxiMax N-600x Operator's Manual

Compliance

N-600x Operator's Manual
Item
Equipment classification
Type of protection
Degree of protection
Mode of operation
-
N 600x resistant to liquid
ingress
Degree of Safety in presence
of a flammable anaesthetic
Applied sensor label to
indicate Type BF applied part
N-600x exterior markings
Front panel and case
labeling
N-600x button spacing
Year of manufacture symbol
Operation during physical
shock
Operation during vibration
Electromagnetic
Compatibility
Compliant With
Safety Standards: IEC 60601
-
(same as EN60601 1), CSA 601.1,
UL 60601-1, EN865,
- -
EN/IEC 60601 1 2 (second edition)
Class I (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 60601-1, sub-clause 5.5, Not
suitable
IEC 60601-1 Symbol 2 of Table D of
Appendix D
IEC 60601-1, sub-clause 6.1, 6.3, and
6.4; EN 865, clause 6
IEC 60878, EN 980, ISO 7000,
EN 60417-1, EN 60417-2
ISO 7250
EN 980
IEC 60068-2-27 at 100 g
IEC 60068-2-6 and IEC 60068-2-34
IEC 60601-1, sub clause 36,
IEC/EN 60601-1-2 (second edition)
Specifications
-
1
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