GE Datex-Ohmeda S/5 - Page 2

Intended purpose (Indications for use)
The Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 or L-ANE07A software is intended for
multiparameter patient monitoring with optional patient care documentation.
The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for monitoring of
hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory,
gastrointestinal/regional perfusion, Entropy (State Entropy and Response Entropy) and neurophysiological
status of all hospital patients.
When the BIS module is used with the S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A, it is intended
for use by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a
hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of
EEG signals. The Bispectral index (BIS), a processed EEG variable, and one component of the BIS module,
may be used in adults as an aid in monitoring the effects of certain anesthetic agents. The Bispectral
index is a complex technology, intended for use only as an adjunct to clinical judgement and training. In
addition, the clinical utility, risk/benefit, and application of BIS have not undergone full evaluation in the
pediatric population.
The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is also indicated for documenting
patient care related information.
The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for use by qualified
medical personnel only.
The Datex-Ohmeda S/5 Critical Care Monitor with L-ICU07 or L-ICU07A software is intended for
multiparameter patient monitoring.
The S/5 Critical Care Monitor with L-ICU07 and L-ICU07A software is indicated for monitoring of
hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory,
gastrointestinal/regional perfusion and neurophysiological status of all hospital patients.
When the BIS module is used with the S/5 Critical Care Monitor with L-ICU07 and L-ICU07A, it is intended
for use by personnel trained in its proper use. It is intended for use on adult and pediatric patients within
a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of
EEG signals. The Bispectral index (BIS), a processed EEG variable, and one component of the BIS module,
may be used in adults as an aid in monitoring the effects of certain anesthetic agents. The Bispectral
index is a complex technology, intended for use only as an adjunct to clinical judgement and training. In
addition, the clinical utility, risk/benefit, and application of BIS have not undergone full evaluation in the
pediatric population.
The S/5 Critical Care Monitor with L-ICU07 and L-ICU07A software is indicated for use by qualified medical
personnel only.
Classifications
In accordance with IEC 60601-1
Class I and internally powered 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
With F-CU8 Central Unit: IPX0 - the degree of protection against harmful ingress of water.
With F-CU5(P) Central Unit: IPX1 - the degree of protection against harmful ingress of water.
In accordance with EU Medical Device Directive
The Datex-Ohmeda S/5 Anesthesia Monitor is classified as IIb.
The Datex-Ohmeda S/5 Critical Care Monitor is classified as IIb.
In accordance with CISPR 11:
Group 1, Class A
• Group 1 contains all ISM (industrial, scientific and medical) equipment in which there is intentionally
generated and/or used conductively coupled radio-frequency energy which is necessary for the
internal functioning of the equipment itself.
• Class A equipment is suitable for use in all establishments other than domestic and those directly
connected the public low voltage power supply network which supplies buildings used for domestic
purposes.