BOMTECH

Dénomination commerciale

BOMTECH

08800016000368

B-08800016000368

Numéro de référence/catalogue

RF COMBO JECTOR

GS1

Classe IIb

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

- Intended Purpose This product is that injects a certain amount of medicine and delivers a high frequency to coagulation of tissue. - Configuration This device consists of Main body, Cradle, RF fixer and Adaptor. This product is intended to be used by charging battery (3.7 V 3000 mAh) inside the product through adapter (AC 100 240 V, 50/60 Hz, 0.5 0.3 A / DC 5 V, 3.0 A) and cradle. When charging with adapter, connect the adapter to the DC jack of the product and ch arge it. It consists of an LCD panel, control components, high frequency output section and multi needle. RF needle and Multi needles deliver high frequency energy to the human body and inject a certain amount of medicine. Bipolar electrode type RF needle and infusion multi needles are connected to the unit and used for coagulation and medicine delivery of patient tissue.

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.

• Z12030302SYRINGE PUMPS

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• Warning 1) The interference caused by the operation of the high frequency surgical instrument can adversely affect the operation of other electric devices. 2) If the high frequency surgical device got damaged, it may bring unintentional output power increase. 3) Use syringe with the same standard Luer Lock (Syringe according to ISO 594) as the cartridge needle. 4) Cartridge needle, syringe and medicine not packaged with this product must be used in accordance with the applicable IFU. 5) The cartridge needle and syringe must be used after the expiration date is checked. 6) Cartridge needle and syringe must be discarded after use.

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