1 Introduction
SenTec Digital Monitoring System
WARNING: The SDM should not be used adjacent to or stacked
with other equipment as these can cause electromagnetic
interference and thereby result in incorrect measurements. If
adjacent or stacked use is necessary, the SDM should be
observed to verify normal operation in the configuration it is to
be used.
WARNING: Certain types of mobile telecommunication
equipment could potentially interfere with SDM operation. Mobile
telecommunication equipment should not be used within five
meters (16.4 feet) of the SDM. Otherwise, degradation of the
device performance could result.
WARNING: The use of accessories, sensors, and cables other
than those specified may result in increased emission and/or
decreased immunity and inaccurate readings of the SDM.
WARNING: When connecting/ mounting the SDM to accessory
equipment (e.g. PCs, PSG-Systems, (wireless) networks, roll
stands, mounting plates, incubators, etc.)), verify proper
operation before clinical use of the SDM and accessory
equipment. In certain cases it may be required that the SDM and
the accessory equipment must be connected to a grounded AC
outlet. In case of doubt consult qualified technicians.
WARNING: Accessory equipment (e.g. a PC) connected to the
SDM’s data ports must be certified according to the IEC 60950
standard. All resulting combinations of equipment must be in
compliance with the IEC standard 60601-1 systems
requirements. Anyone who connects accessory equipment to the
SDM configures a medical system and is, therefore, responsible
for ensuring that the resulting system complies with the
requirements of standard IEC 60601-1 and the electromagnetic
compatibility standard IEC 60601-1-2.
WARNING: The mains power supply of the SenTec Digital
Monitor (SDM) is separated by two Means of Patient Protection
(MOPPs) between the sensor port (for the applied part, the
sensor) and the interface connectors. The three interface
connectors - serial data port, Multipurpose I/O port (analog
outputs, nurse call), LAN port - of the SDM are not separated
from each other. If at a time accessory equipment is connected
to only one of the three interface connectors no additional safety
measures are necessary to comply with the requirements of IEC
60601-1. If however accessory equipment is simultaneously
connected to two or three of the SDM’s interface connectors
To Next Page
Loading...
