SedLine Sedation Monitor Chapter 9: Specifications
www.masimo.com 60 Masimo
Symbols Definition Symbols Definition
Instructions/Directions for Use/Manuals are available in electronic format
@http://www.Masimo.com/TechDocs
Note: eIFU is not available for CE mark countries.
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
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 that provide isolation from the mains in accordance with
EN 60601-1. The module also provides patient isolation.
3. Degree of Protection against effects of Defibrillation
SedLine provides protection for the patient and operator during defibrillation
when using the SedLine Sensor. The isolation barrier within the module provides
this protection.
4. Degree of Protection against the Ingress of Water
Both Root and the module have an ingress of water rating of IPX1 (drip proof).
5. Degree of safety of application in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide
Equipment is not suitable for use in the presence of a flammable anesthetic
mixture with air, or with oxygen or nitrous oxide.
6. Mode of Operation of SedLine
Continuous: The SedLine may be operated under normal load for a normal period
without exceeding the specified limits of temperature.
7. Classification:
Medical electrical equipment with respect to electric shock, fire and mechanical
hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1 and IEC
60601-2-26
To Next Page
Loading...
Need help?
General
