PediGuard

Dénomination commerciale

PediGuard

Code d'IUD-ID

03662674000471

IUD-ID de base

3662674P1AUXXXYJ

Numéro de référence/catalogue

P1-AU511

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

PediGuard® Gearshift is a pedicle preparation device that helps surgeons to drill a pilot hole through the pedicle of the vertebrae during spinal surgery. It serves to alert the surgeons prior to a possible cortex perforation while drilling through the pedicle, by accurately analyzing the electrical conductivity of the surrounding tissues

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.

• Z12130503ORTHOPAEDIC SURGICAL DRILLS

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

• CW999

  Do not use the device: - In the presence of flammable anesthetics - At room temperature above 30°C - In a humid environment. • Use of the PediGuard in conditions of extreme osteoporosis is not recommended. The condition of the bone in this situation must be closely evaluated prior to use of the device. • Only use components provided by SpineGuard. Using components from another manufacturer may cause malfunction of the device and be harmful to the patient. • No modification of this equipment is allowed. • Patient positioning on the operating table is critical: ensure that leg motions (if any) will not cause any injury to the patient or a fall from the operating table. • Avoid any contact between the PediGuard and the patient while using an electrocautery device or defibrillator. • Use of the device near the thorax may increase the risk of cardiac fibrillation. • Using the PediGuard in association with another electronic device requires special precautions: perturbations on the patient’s ECG monitor may be observed while the PediGuard is in use. These abnormalities will stop as soon as the instrument is removed. • IMPORTANT: Do not allow fluids or foreign bodies in the handle (immersion of the handle, even for a short period of time, is prohibited). In case of fluids or foreign bodies ingress in the electronics casing, do not use the device.
• CW999

  Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. • Portable RF communications equipment (including peripherals such as antenna cables and externals antennas) should be used no closer than 30 cm (12 inches) to any part of the PediGuard System. Otherwise degradation of the performance of this equipment could result. • Operation in close proximity (e.g. 1m) to a shortwave or microwave therapy ME equipment may produce instability in the device output.

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.