User's Manual

Telemetry Transmitter User Manual Intended Use and Safety Guidance
31 The 30-meter indoor barrier-free distance of distinct vision is the coverage of wireless
network connecting telemetry transmitter and MFM-CMS. Telemetry transmitter is 30
meters (distinct vision) from wireless AP.
32 Nurse call is the only one function the patient can safely use. Other functions are all
prohibited for patient to operate.
33 The patient should wear the telemetry transmitter by leather cover, and leather cover.
34 Operation of the equipment exceeding the measurement range may cause inaccurate
results.
35 Portable and mobile RF communications equipment can affect medical electrical
equipment; Refer to the recommended separation distances provided in Appendix B
EMC Information.
36 Using accessories other than those specified may result in increased electromagnetic
emission or decreased electromagnetic immunity of telemetry transmitter.
37 Telemetry transmitter should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, you must check that normal operation is
possible in the necessary configuration before you start monitoring patients.
38 Assembly of the telemetry transmitter and modifications during actual service life shall
be evaluated based on the requirements of IEC60601-1.
39 Connecting any accessory (such as external printer) or other device (such as the
computer) to telemetry transmitter makes a medical system. In that case, additional
safety measures should be taken during installation of the system, and the system
shall provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
40 All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.
41 Additional multiple socket-outlet or extension cord can’t be connected to the system.
42 Only items that have been specified as part of the system or specified as being
compatible with the system can be connected to the system.
43 The appliance coupler or mains plug is used as isolation means from supply mains.
Position the MFM-CMS in a location where the operator can easily access the
disconnection device.
44 Do not touch accessible parts of non-medical electrical equipment in the patient
environment and the patient simultaneously.
WARNING
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