Electrical stimulator

Dénomination commerciale

Electrical stimulator

06970389634131

697038963FDESD3N8

Numéro de référence/catalogue

FDES113

GS1

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

It’s through electricity pulse wave after acting on the human body,the electric energy is sucked by the human body and the energy form is changed,which causes a series of physical and chemical changes,produces local or systemic physiological reactions, and finally affects the pathological process and plays a role Corresponding Role.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• N010103BIPOLAR NERVOUS ELECTROSTIMULATORS, BATTERY-POWERED

2 avertissements enregistrés — faire défiler le panneau pour tout voir.

• Avertissement

  1. Keep yourself informed of all the warnings. 2. Stimulation should not be applied over throat or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing. 3. Stimulation should not be applied anywhere on the front of the thorax in that the introduction of electrical current into the heart may cause cardiac arrhythmias and lead to cardiac arrest. 4. This stimulator not intended for unattended, personal use by patients who have noncompliant, emotionally disturbed, dementia, or low IQ. 5. The instruction of use was listed; any improper use may be dangerous. 6. Do not use this device for undiagnosed pain syndromes until consulting a physician. 7. Do not place electrodes on your head or at any sites(i.e. for head area electrode not allowed to be placed at front and back , or left and right in pairs) that may cause the electrical current to flow transcerebrally (through the head). 8. Patients with heart disease, cancer or any other health condition should not use this device without first consulting a physician. 9. If the stimulation levels are uncomfortable or become uncomfortable, reduce thestimulation Intensity to a comfortable level and contact your physician if problems persist. 10. Never use the device in rooms where aerosols (sprays) are used or pure oxygen is being administered. 11. Do not use it near any highly flammable substances, gases or explosives. 12. Inspect Applicator cables and associated connectors before each use. 13. Turn the device off before applying or removing electrodes. 14. only use the electrode wire by the manufacturer provided or specified ,Otherwise it may cause adverse effects on the impact of product performance or patients. For replacement, please contact the manufacturer or local distributor。 15.Must be regularly examined for damage to the cord,they must not be used until the damage has been repaired,

• 16.The electrode tablet should be in close contact with the treatment site during treatment, otherwise danger of burn." 17.When Unintended dislodgement，Insufficient adhesion of electrode pads, unintended movement during treatment,Should immediately stop use and ensure proper reconnection. 18.Please strictly observe the environmental conditions of transportation and storage, otherwise it will affect the accuracy of the equipment. 19.The number of times the electrode sheet can be reused and its service life (10-15 times or should not exceed three year), if the electrode sheet adhesion is found to be weakened, it should be replaced in time.