User's Manual

Telemetry Transmitter User Manual Intended Use and Safety Guidance
WARNING
10 Extreme care must be exercised when applying medical electrical equipment. Many
parts of the human/machine circuit are conductive, such as the patient, connectors,
electrodes, transducers. It is very important that these conductive parts do not come
into contact with other grounded, conductive parts when connected to the isolated
patient input of the device. Such contact would bridge the patient's isolation and
cancel the protection provided by the isolated input. In particular, there must be no
contact of the neutral electrode and ground.
11 Magnetic and electrical fields are capable of interfering with the proper performance
of the device. For this reason make sure that all external devices operated in the
vicinity of the telemetry transmitter comply with the relevant EMC requirements. X-ray
equipment or MRI devices are a possible source of interference as they may emit
higher levels of electromagnetic radiation.
12 Route all cables away from patient’s throat to avoid possible strangulation.
13 Two batteries must be used as power supply.
14 Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment
of alarm volume to a low level or off during patient monitoring may result in a hazard
to the patient. Remember that the most reliable method of patient monitoring
combines close personal surveillance with correct operation of monitoring equipment.
15 Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards. Furthermore all configurations shall
comply with the valid version of the standard IEC/EN 60601-1. Therefore anybody,
who connects additional equipment to the signal input or output connector to
configure a medical system, must make sure that it complies with the requirements of
the valid version of the system standard IEC/EN60601-1. If in doubt, consult our
technical service department or your local distributor.
16 Telemetry transmitter is connected to MFM-CMS via wireless network. Therefore, any
other equipment complying with CISPR radiation requirements may also interfere with
the wireless communication and make it interrupted.
17 Telemetry transmitter will sent technical alarm information of low battery power to
MFM-CMS informing user of changing battery when battery power is 0-level.
Meanwhile, telemetry transmitter gives out a periodic sound of “du-du-du” whose
interval is 10 seconds till shutdown. After shutdown, module configuration and patient
information can be saved. User should restart the device after changing battery.
18 Clinical decision making based on the output of the device is left to the discretion of
the provider.
WARNING
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