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2.4 Exclusions and limitations of the
intended purpose
The device has not been approved for the following applications:
•
Operation in hyperbaric chambers
•
Operation in conjunction with magnetic resonance imaging
machines (MRI, MRT, NMR)
•
Operation in conjunction with high-frequency electrosurgical
equipment
•
Electrostimulation in an electrically conductive and damp
surroundings
•
Electrostimulation in an oxygen-enriched atmosphere with
simultaneous presence of combustible materials
•
Electrostimulation in an atmosphere with flammable gases
2.5 Requirements on the user
The user must meet the following requirements:
•
The user is medically trained and has the necessary technical
knowledge and experience in the emergency medical
treatment of patients.
•
On the basis of this technical knowledge and experience, the
user is in a position to perform the tasks assigned to him or her
safely, and independently to recognize, assess and avoid
potential risks to him or herself, to the patient or to bystanders.
•
The user has been trained and has received instruction in the
use of the device.
•
The user is trained in extended measures to treat emergency
patients and is able to use manual mode, cardioversion and
interpretation of 12-lead ECGs as a function of the options
purchased.
MEDUCORE Standard
2 Safety
2
EN
13
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