Fukuda Denshi LX-8000 Series, Operation Manual

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CAUTION
 For management, make sure to follow the precautions below.
 The Institution should appoint a person (hereinafter referred to as the
"Coordinator") to manage the wireless channels for the whole Institution.
 The Coordinator must be selected from people who understand the
characteristics and functionality of telemetry systems, and are skilled in
operating telemetry.
 When installing telemetry, the Coordinator has to understand the
precautions for use of the telemetry in advance.
 The Coordinator is responsible for maintenance of wireless channels and
storage and maintenance of telemeter in the overall medical facilities to
give proper instructions to the telemetry users.
 The Coordinator should create a management log (hereinafter referred to
as the "log"), which contains a list of the management status of the
wireless channels for the whole Institution. When changing a wireless
channel, register it in the log and give proper instructions to the user.
 The telemetry user verifies operation of the transmitter/receiver before use.
 When interference or breakdown occurs in telemetry communication, the
user is required to inform the Coordinator of the problems. The Coordinator
is to deal with the problem properly and/or contact their nearest Fukuda
Denshi representative for service.
Electromagnetic Compatibility
This equipment complies with IEC 60601-1-2 (2014), safety standard
regarding the electromagnetic disturbances of medical electrical equipment.
To ensure maximum performance against the electromagnetic disturbances,
make sure to follow the precautions for installation and usage described in this
manual.
● This equipment is intended for use in the medical facility (except inside the
shield room of MRI device), and satisfies the immunity level for professional
healthcare facility environment stipulated in IEC 60601-1-2.
● An excessive magnetic disturbance may degrade the HR and SpO
2
measurement accuracy (refer to “15. Specification”), which is the essential
performance of this equipment, and may cause delay in treatment or
inaccurate diagnosis.
● When using this equipment, interference with other medical electrical
equipments or non-medical electrical equipments may occur. Make sure that
no interference is present before usage.
● To ensure basic safety and essential performance related to electromagnetic
distrubances during the expected service life of this equipment, “Daily
Check” and “Periodic Check” must be performed.
(refer to “13. Maintenance and Inspection”)