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ANGIOJET™ Ultra Coronary Thrombectomy System

Indications, Safety, and Warnings

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ANGIOJET Ultra 5000A Console

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The AngioJet Ultra Console is intended for use only in conjunction with an AngioJet Thrombectomy Set. Refer to the individual Thrombectomy Set Directions for Use manual for specific clinical applications.

CONTRAINDICATIONS

Refer to the individual Thrombectomy Set Directions for Use manual for specific contraindications.

WARNINGS

  • Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.
  • To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
  • Refer to the individual Ultra Thrombectomy Set Directions for Use manual for specific warnings and precautions.
  • Refer to individual Thrombectomy Set Directions for Use manual for specific instructions regarding heparinization of the Thrombectomy Set.
  • Do not attempt to bypass any of the Console safety features.
  • The AngioJet System should not be used adjacent to or stacked with other equipment, and if adjacent or stacked use is necessary, the Console should be observed to verify normal operation in the configuration in which it will be used.
  • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the AngioJet System, including cables specified by the manufacturer. Otherwise, degradation of the performance of the equipment can result.
  • Use of accessories, transducers and cables other than those specified or provided by Boston Scientific could result in increased electromagnetic emissions or decreased electromagnetic immunity of the AngioJet System and result in improper operation.>
  • The Console contains no user-serviceable parts. Refer service to qualified personnel.
  • Removal of outer covers may result in electrical shock.

PRECAUTIONS

  • Use the AngioJet Ultra Console only with an AngioJet Thrombectomy Set. • The AngioJet System requires special precautions regarding electromagnetic emissions and immunity and needs to be installed and put into service according to the information included in the Electronic and Electromagnetic Guidance Section of the manual.
  • This device may cause electromagnetic interference with other devices when in use. Do not place AngioJet System near sensitive equipment when operating.
  • Do not move the collection bag during catheter operation as this may cause a waste tubing error.
  • Do not reposition or push the Console from any point other than the handle designed for that purpose. A condition of overbalance or tipping may ensue.

Adverse Events

Refer to the individual Thrombectomy Set Directions for Use manual for specific observed and/or potential adverse events.

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