O3 Regional Oximeter Chapter 7: Specifications
www.masimo.com 45 Masimo
Guidance and Manufacturer's Declarations
Safety Classifications
1. Type of Protection against Electric Shock of the Module
Class II: Electrical equipment in which protection against electric shock does not
rely on BASIC INSULATION only, but in which additional safety precautions such
as DOUBLE INSULATION or REINFORCED INSULATION are provided, there being
no provision for protective earthing or reliance upon installation conditions.
2. Degree of Protection against Electric Shock of the Module with Sensor
An F-type applied part is isolated from all other parts of the equipment to such a
degree that the patient leakage current allowable in single fault condition is not
exceeded when a voltage equal to 1.1 times the highest rated AC supply voltage is
applied between the applied part and earth.
Root incorporates circuitry, creepage and clearance distances from the mains in
accordance with EN 60601-1. Root and the sensor provide patient isolation.
3. Degree of Protection against the Ingress of Liquid
Both Root and the Module have an ingress of liquid rating of IPX1 (drip proof).
4. Degree of safety of application in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide
Equipment not suitable for use in the presence of a flammable anesthetic mixture
with air, or with oxygen or nitrous oxide.
5. Mode of Operation of O3 Module
Continuous: The O3 Module may be operated under normal load for an unlimited
period, without the specified limits of temperature being exceeded.
Safety Compliance
Safety Compliance
IEC 60601-1, 2
nd
Ed.
EN 60601-2, 2
nd
Ed.
IEC 60601-1, 3
rd
Ed.
EN/ISO 80601-2-61:2011
EMC Compliance
EMC Compliance
See Operator's Manual for Root.
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