Nom de l'organisation

MicroAire Surgical Instruments LLC

SRN

US-MF-000004063

Statut du fabricant

Actif

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

• Contraindication: Patients with chronic medical conditions, such as diabetes, heart, lung, or circulatory system disease.;Contraindication: For the treatment of obesity. ;Contraindication: Patients with severe skin laxity in the area of treatment.;Contraindication: Pregnant women.;Warning: This device will not, in and of itself, produce significant weight reduction.;Warning: The volume of blood loss and endogenous fluid loss may adversely affect intra and/or postoperative hemodynamic stability and patient safety. The capability of providing adequate, timely replacement is essential for patient safety.;Warning: Consult and follow the appropriate Instructions for Use for the instrument to be used. See the table under Compatible Instruments.;Warning: Use only MicroAire approved accessories. Use of unapproved accessories may result in increased electromagnetic emissions or decreased immunity of the system and will void the warranty. Do not modify any accessory. Failure to comply may result in patient and/or healthcare professional injury.;Warning: Use of accessories, transducers or cables other than those specified or provided by MicroAire could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.;Warning: Use personal protective equipment as required. Failure to comply may result in patient and/or healthcare professional injury.;Warning: Cleaning and Sterilization of all system components used inside the sterile field are required before each use.

  AUTRE

• See MicroAire’s Cleaning and Sterilization Procedures in the appropriate instrument Instructions for Use.;Warning: This product does not comply with the ATEX directive and must not be used with explosive atmospheres.;Warning: If a device is involved in an adverse event/incident, contact MicroAire for evaluation and do not use the device on another patient.;Warning: Upon receipt and before each use, inspect the system and its components for visible damage, including proper fit of top cover to the chassis and damage to the LCD display. Do not use if there is apparent damage to any component. Failure to comply may result in healthcare professional and/or patient injury.;Warning: AC mains disconnect must be achieved by removing cord from wall outlet. Ensure that the Console is positioned so that the power cord can be unplugged.;Warning: Use only with a medically approved type SJT three wire (protective earth) grounded power cord rated for 125V or 250V AC, 10A, constructed with 18/3 AWG wires and an IEC 320 appliance connector, or an equivalent power cord as specified in the Technical Description.;Warning: DO NOT modify the ground connection or any portion of the Console power cord. Failure to comply may result in healthcare professional injury.;Warning: Grounding reliability can only be achieved when the equipment is connected to an equipment receptacle marked as “Hospital Grade”.;Warning: Anyone who connects additional equipment to the contact closure connector configures a medical system, and is therefore responsible that the system complies with the requirements of clause 16 of ANSI/AAMI ES60601-1:2005 + Am1 (2012) + Am2 (2020). ;Warning: The USB port is to be used only for diagnostics and/or software upgrade by MicroAire approved technicians only. The USB port must not be connected to any cable or device while in operation.;Warning: Not for use in Oxygen Rich Environments. ;Warning: Explosion Hazard.

  AUTRE

• Do not use this equipment in the presence of flammable anesthetics.;Warning: Do not modify equipment. Failure to comply may result in healthcare professional and/or patient injury.;Warning: Electric Shock. Do not remove cover. Refer servicing to authorized MicroAire personnel only.;Warning: Take special precautions with electromagnetic compatibility (EMC) when using the MicroAire Electric Instrument Console. Ensure that the Console is installed and placed into service according to the EMC information contained in the Instructions for Use.;Warning: The 5020-CE Electric Instrument Control Console and associated instruments have been tested for use in the vicinity of High Frequency Electrosurgical/ Electrocoagulation equipment. Use of such equipment in close proximity to the MicroAire instruments or instrument cables may cause unintended interruptions or unintended motion of durations up to 1 second. Place MicroAire Instruments on a safe surface when not in use. Do not place MicroAire Instruments on the patient when not in use. Avoid entwining HF surgical cables with MicroAire Instrument Cables. ;Warning: Portable RF communications equipment should be used no closer than 30 cm (12 inches) away from any part of the 5020-CE Console, its associated cables, or the handpieces it is controlling, otherwise degradation of the performance of the PAL-750-CE could result.;Warning: Use of the 5020-CE Console adjacent to or stacked with other equipment should be avoided because it could result in improper operation.

  AUTRE

• If such use is necessary, the 5020-CE and the adjacent equipment should be observed to verify that they are operating normally.;Warning: The following items should be periodically inspected for signs of damage and repaired or replaced as needed to ensure continued safety with regard to electromagnetic disturbances over the life of the system: 5020-CE Electric Instrument Control Console, Proper Fit of the top cover to the chassis, Damage to the LCD Display, Test that the Protective Earth Connection meets ES60601-1 requirements, and Inspect the 5006-PAL instrument cables for signs of physical damage to the cable. ;Warning: The 5020-CE & PAL-750-CE Liposuction handpiece are suitable for use in hospitals and surgery centers. These systems should not be used near Magnetic Resonance Imaging equipment.

  AUTRE

Marché principal en Italie ; disponible dans 13 pays au total.

Dénomination commerciale

PAL Electric Console

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

00847399017796

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

08473990PALCONSOLEFG

Numéro de référence/catalogue

5020-CE

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

GS1

Catégorie de risque

Classes de risque MDR

Les classes de risque du MDR classent les dispositifs médicaux du risque le plus faible (classe I) au plus élevé (classe III), ce qui détermine le niveau de contrôle réglementaire.

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

https://microaire.eifu.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

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

• Z12040214LIPOSUCTION SYSTEMS

• Dispositifs médicaux de Classe IIa dans EUDAMED

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