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2.1.6 Contra-indications
■ AED
The AED mode is contraindicated in the treatment when the patient is showing any of the following:
◆ Consciousness
◆ Breathing
◆ Detectable pulse or other signs of circulation
■ Manual Defibrillation
Manual defibrillation is contraindicated in the treatment when the patient is showing any of the following:
◆ Consciousness
◆ Breathing
◆ Detectable pulse or other signs of circulation
2.1.7 Side-effects
None.
• According to the conclusion of clinical evaluation and residual risk evaluation, for the intended
patients, there is no known side effects that can occur during or after the use of the medical device.
And there is no need for the operator to make extra preparations. Thus, no residual risk associated
with using the medical device should be disclosed.
2.2 Applied Parts
The applied parts of the equipment are:
■ ECG electrodes and leadwires
■ SpO
2
sensor
■ NIBP cuff
■ CO
2
sampling line/nasal sampling cannula and airway adapter
■ Multifunction electrode pads
■ External defibrillation paddles
■ Internal defibrillation paddles
■ CPR sensor
• When the equipment is placed at a an ambient temperate above 55ºC, the surface temperature of
applied parts should be limit to below 58ºC.
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