natus Dantec Keypoint G4, Инструкции по эксплуатации оборудования

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Hardware Instructions for Use
7
Safety Information
The system is intended to be used in electrophysiological tests such as: Electromyography
(EMG), Nerve Conduction Studies (NCS) and Evoked Potential (EP) recordings.
For safety information related to the patient or the use of the Keypoint.NET application software, refer to the
Software Instructions for Use. Make sure to read and understand the information before proceeding to use
this equipment.
Intended Use
Keypoint G4 is intended as an electrophysiological aid to assess diagnosis and prognosis, and to
monitor diseases of the central and peripheral nervous system. It can also be used to study
functional aspects of nerves and muscles in other fields such as rehabilitation (physical
medicine), occupational medicine and sports medicine.
Contraindications
It is a medical decision whether the risk of use clearly outweighs any possible benefit in each case.
A patient with an implanted electronic device (i.e., a cardiac pacemaker) should not be subjected to
electrical stimulation unless medical specialist opinion has first been obtained.
In conditions with bleeding tendency certain care should be taken when needles are used.
Conventional precautions should be taken with patients with infectious diseases.
Age and sex do not in themselves present contraindications for any procedure.
For contraindications with needles / electrodes, refer to their accompanying instructions for use.
Danger
Possible explosion hazard, if used in the presence of flammable anesthetics.