User's Manual

Telemetry Transmitter User Manual Intended Use and Safety Guidance
Chapter 1 Intended Use and Safety Guidance
1.1 Intended Use/Indications for Use
Telemetry transmitter (hereinafter called iT20) must work with central monitoring system
(hereinafter called MFM-CMS) manufactured by EDAN.
Telemetry transmitter is intended to be used in clinical divisions of hospital environments,
including CCU and general wards (as Cardiology Dept., Respiratory Dept.). It is intended to be
used for adults and pediatrics. The monitored physiological parameters include: ECG, respiration
(RESP), oxygen saturation of arterial blood (SpO
2
) and pulse rate (PR).
1.2 Safety Guidance
Federal (U.S.) law restricts this device to sale by or on the order of a physician.
WARNING
1 Before using the device, the equipment, patient cable and electrodes etc. should be
checked. Replacement shall be taken if there is any evident defect or signs of aging
which may impair the safety or performance.
2 The electrodes expired are forbidden to be used.
3 Medical technical equipment such as telemetry monitoring system must only be used
by persons who have received adequate training in the use of such equipment and
who are capable of applying it properly. The user should have access to, and fully
read user manual (this book) before use. Harm to patient may occur if users’
operating is not in accordance with user manual.
4 It is prohibited that the operator touches battery and patient simultaneously.
5 Do not use the device with electrosurgical unit simultaneously.
6 EXPLOSION HAZARD-Do not use the device in a flammable atmosphere where
concentrations of flammable anesthetics or other materials may occur.
7 SHOCK HAZARD-To avoid the RISK of electric shock, MFM-CMS must only be
connected to a SUPPLY MAINS with protective earth. Never adapt the three-prong
plug from the MFM-CMS to fit a two-slot outlet.
8 Under simultaneous use of cardiac pacemaker and other patient-connected
equipment, the pacing impulse analysis function must be switched ON. Otherwise, the
pacing impulse may be counted as regular QRS complexes, which could prevent an
asystole event from being detected or could lead to false alarm of asystole.
9 Do not come into contact with the patient, table, or the telemetry transmitter during
defibrillation.
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