Intended purpose
Datex-Ohmeda S/5 Light Monitor, F-LM1, F-LMP1 is intended for stationary and mobile monitoring of
patient’s ECG, SpO2, body temperature, invasive and non-invasive blood pressures as well as respiration
and CO2 in hospitals and ambulances. When used outdoors, the monitor must be in the protective case. The
monitor is intended for use by qualified medical personnel only. The S/5 Light Monitor is intended for
patients with weight from 5 kg (11 lb.) up. Respiration monitoring is intended for patients three years old and
up.
Classification according to IEC 60601-1
• CLASS I EQUIPMENT and INTERNALLY POWERED EQUIPMENT according to the type of protection against
electrical shock.
• TYPE BF or CF equipment according to the degree of protection against electric shock is indicated with a
symbol beside each patient connector.
• Degree of protection against harmful ingress of water as detailed in the IEC 60529: Monitor: IPX1,
vertically falling water drops shall have no harmful effects (applicable when the monitor is in upright
position, or tilted backwards). In the protective case IPX4, splash proof, when the case is closed
properly, the monitor is intact and operates on battery power. Power adapter: IPX0, ordinary equipment.
• 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.
• CSPR 11: Group 1, Class A
Classification according to EU Medical Device Directive
• The monitor is classified as IIb.
Responsibility of the manufacturer
GE Healthcare Finland Oy (GE) is responsible for the safety, reliability and performance of the equipment only
if:
• assembly, operations, extensions, readjustments, modifications, service and repairs are carried out by
authorized personnel.
• the electrical installation of the relevant room complies with appropriate requirements.
• the equipment is used in accordance with the User’s Reference Manual and serviced and maintained in
accordance with the Technical Reference Manual.
The CO
2
measuring option (N-LCM) is manufactured for GE Healthcare Finland Oy by
Welch Allyn OEM Technologies, 8500 SW Creekside Place, Beaverton, OR 97008 USA.
Trademarks
Trademarks Datex, Ohmeda, S/5, MemCard, ComWheel and Oxytip+ are property of GE Healthcare Finland
Oy. All other product and company names are property of their respective owners.
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