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O3® Regional Oximeter
Chapter 7: Specifications
www.masimo.com
41
Masimo
Symbol
Description
Symbol
Description
USB port
Ethernet
Less than
Greater than
China Restriction of
Hazardous Substances
The names and content of the
toxic and hazardous substances
or elements shall be provided in
the product instruction manual.
Instructions/Directions for Use/Manuals are available in electronic format
@http://www.Masimo.com/TechDocs
Note: eIFU is not available for CE mark countries.
Guidance and Manufacturer's Declarations
Safety Classifications
1.
Type of Protection against Electric Shock of the O3
®
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 O3
®
Module with O3
®
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 O3
®
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 the O3
®
Module
Continuous: The O3
®
Module may be operated under normal load for an unlimited
period, without the specified limits of temperature being exceeded.