Datex-Ohmeda S/5 Compact Anesthesia Monitor, Техническое справочное руководство

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S/5™ Compact Anesthesia Monitor
Intended use
The Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 or L-CANE03A software is intended for
multiparameter patient monitoring with optional patient care documentation.
Indications for use
The S/5 Compact Anesthesia Monitor with L-CANE03 or L-CANE03A software is indicated for monitoring of
hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory,
gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response Entropy)
and neurophysiological status of all hospital patients.
The S/5 Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software when using BIS is for
monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and
may be used as an aid in monitoring the effects of certain anesthetic agents.
The S/5 Compact Anesthesia Monitor with L-CANE03 or L-CANE03A software is also indicated for
documenting patient care related information.
The S/5 Compact Anesthesia Monitor with L-CANE03 or L-CANE03A software is indicated for use by
qualified medical personnel only.
S/5™ Compact Critical Care Monitor
Intended use
The Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU03 or L-CICU03A software is intended for
multiparameter patient monitoring.
Indications for use
The S/5 Compact Critical Care Monitor with L-CICU03 and L-CICU03A software is indicated for monitoring of
hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory,
gastrointestinal/regional perfusion, Bispectral index (BIS) and neurophysiological status of all hospital
patients.
The S/5 Compact Critical Care Monitor with L-CICU03 and L-CICU03A software when using BIS is for
monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and
may be used as an aid in monitoring the effects of certain anesthetic agents.
The S/5 Compact Critical Care Monitor with L-CICU03 and L-CICU03A software is indicated for use by
qualified medical personnel only.
Classifications
In accordance with IEC 60601-1
CLASS I EQUIPMENT - the type of protection against electric shock.
TYPE BF or CF equipment. The degree of protection against electric shock is indicated by a symbol
on each parameter module.
EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR
OR WITH OXYGEN OR NITROUS OXIDE.
CONTINUOUS OPERATION according to the mode of operation.
In accordance with IEC 60529
Degree of protection against the harmful ingress of water as detailed in the IEC 60529: IPX1
In accordance with EU Medical Device Directive
The Datex-Ohmeda S/5 Compact Anesthesia Monitor and S/5 Compact Critical Care Monitor are
classified as IIb.
The Datex-Ohmeda S/5 Compact Anesthesia Monitor and S/5 Compact Critical Care Monitor, is
CE marked in accordance with the Medical Device Directive 93/42/EEC.