Mindray BeneHeart D6 - Contra-Indications; Side-Effects; Clinical Benefit; Applied Parts

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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
Through clinical data from literature and clinical data from post-market surveillance activity of device in
question, there is no side-effects identified.
After search the literature of similar device, the results of SOTA evaluation shown that undesirable effects may
include myocardial damage.
2.1.8 Clinical Benefit
Through the parameter monitoring, medical staff have established sufficient conditions to provide patients with
a better medical monitoring environment, and the benefits are obvious.
Although there is also the possibility of false positives and false negatives in parameter monitoring, the impact
of false positives and false negatives is limited and will not cause substantial harm to patients.
In addition, the parameter monitoring of the Defibrillator/Monitor has the advantages of simplicity of
equipment, convenient operation, timeliness, economy, etc. compared with other known ones.
Therefore, from the perspective of benefit and risk, the parameter monitoring of the Defibrillator/Monitor has
obvious benefits, controllable risks, and has strong clinical application popularization characteristics.
The Defibrillator/Monitors are life-saving device used in emergency situations. They have been shown to have a
high benefit for patients with underlying diseases that remain undetected until sudden cardiac arrest occurs.
The time from collapse to defibrillation is critical in-patient survival. For every minute that passes between
collapse and defibrillation, survival rates from VF SCA decrease 7% to 10%.
2.2 Applied Parts
WARNING
• When the equipment is placed at a an ambient temperate above 45ºC, the surface temperature of
applied parts should be limit to below 47ºC.