Intended Use - Primedic HeartSave PAD Operating Instructions Manual

Intended use

2 Intended use
The PRIMEDIC™ HeartSave PAD is intended to be used by non-experts and trained
first-aiders. It may only be used on patients who are unconscious and who are not
breathing.
The main application is to carry out transthoracic defibrillation in asynchronous mode.
The decision about the necessity of applying a shock is carried out automatically by the
device.
The operator is guided by spoken instructions and clear written and pictorial
information. After switching on the device, the patient is connected to it using the
enclosed adhesive electrodes. After this, automatic rhythm analysis is carried out by the
device. Only if a rhythm is detected by the device as being ventricular fibrillation
(=shockable) does it suggest treatment with a high energy shock. All other rhythms are
classified as not requiring a shock. The time from the start of analysis until the shock is
applied is less than 30s.
The energy levels of the first, second and third shock are predefined by the maximum
set points for the electric current 20A, 25A and 30A, as well as by the capacitor voltage
which depends on the patient impedance.
For safety reasons, no shock is given with asystolia, as no therapeutic effect is to be
expected. Controlled ventricular electrical activity caused by supraventricular
tachycardia such as atrial fibrillation, atrial flutter, ventricular extra-systoles and
idioventricular rhythms does not lead to a shock being applied.
The device supports the user in the reanimation process depending on the factory-
setting in accordance with the current guidelines from the European Resuscitation
Councils (ERC) from 2005 or the American Heart Association (AHA) from 2005 for
immediate lifesaving measures to be taken when using an automatic defibrillator. This
includes acoustic instructions for carrying out artificial respiration and heart massage as
well as the cyclical process of rhythm analyses and, where necessary, the application of
further shock therapy according to the recommendation by the device.
The PRIMEDIC™ HeartSave PAD devices may only be used as described and
Note
under the conditions detailed in these operating instructions.
The operator of the HeartSave PAD has to make sure that the HeartSave PAD is only
used by authorised specialist personnel.
Operating instructions HeartSave PAD 22289 / GB / C
WARNING
Any use above or beyond this is not considered as intended
use and can lead to personal injury or damage to property.
Improper use of the defibrillator can lead to ventricular
fibrillation, asystolia or other dangerous dysrhythmia.
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