CLASSIFICATION
Type of Protection Against Electrical
Shock
Class II
Degree of Protection Against Electric
Shock
CF defibrillator-proof
Degree of Protection Against
Harmful Ingress of Water
IPX1, Drip proof
Degree of Safety in Presence of
Flammable Anesthetics
Not suitable
Mode of Operation
Continuous
Medical Equipment
UL 60601-1
CAN/CSA-C22.2 No. 601.1
ANSI/AAMI/ES60601-1 (2005)
CAN/CSA-C22.2 No. 60601.1 (2008)
Medical – General Medical Equipment
As to electrical shock, fire and mechanical hazards
only in accordance with
UL 60601-1,
CAN/CSA-C22.2 No. 601.1,
ANSI/AAMI/ES60601-1 (2005, 3
rd
ed.),
CAN/CSA- C22.2 No. 60601-1 (2008).
Medical Device Directive:
Council Directive
93/42/EEC
Hardware: Class IIb
Disposable Set: Class IIa
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