9
Beam®, Operating Manual, Rev. 4.6.1 01/2016, GmbH
2. Directions for use
2.1 Intended Use
The intended use is the recording of ECG events for adults.
The indications for an examination with an ECG Loop-/Event Recorder are:
Infrequently (Not daily) occurring palpitations, mild dizziness, mild faintness, car-
diac presyncopes, cardiac syncopes with longer lasting aura.
These indications are the same as for the execution of a long term-ECG but the
diagnostic accuracy is significantly higher for symptoms not occurring everyday
due to the longer operating time of the ECG Loop-/Event Recorders. A two week
recording by a ECG Loop-/Event Recorder appears optimal for the clarification of
palpitations.
The ECG Loop-/Event Recorder Beam
®
may only be used after medical attention
and instruction. The ECG signal is exclusively displayed in a raw format and is not
analysed by the accompanying HMS CS software.
2.2 Not intended use
The ECG Loop-/Event Recorder Beam
®
may not be used for ECG recordings in
intensive care units and at surgeries.
The diagnosis may not be solely based on the ECG Data of the ECG Loop-/Event
Recorder Beam
®
.
The ECG Loop-/Event Recorder, Beam
®
is not appropriate for
ECG-recordings of
syncopes without prodromes.
The ECG Loop-/Event Recorder, Beam
®
is not approved for children with a body
weight of less than 10 Kg.
2.5 Important Notes for the Physician
■
The diagnosis may not be based solely on the ECG Loop-/Event Recorder,
Beam
®
ECG Data, because the position and the distance of the electrodes is
not standardised.
■
The recording of pacemaker signals is not always possible because of the
sampling rate.
■
Please inform the patient that the electrodes should be removed upon the
occurrence of skin rashes or itching in the area, where the electrodes touch the
skin, or if the electrodes no longer touch the skin.
■
Please inform the patient about the importance of the correct positioning of the
electrodes.
■
The device may not be operated in areas close to a MRI or other significant
magnetic fields.
■
The use of components, which were not in the scope of the delivery, can lead
to faulty recordings. Only use original parts by I.E.M. GmbH.
■
The ECG Loop-/Event Recorder Beam
®
was designed for battery-powered
operation and may not be operated by an external power source, e.g. a DC
adapter, or be in a direct connection with the power circuits.
■
Please maintain hygiene according to maintenance plan.
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