Boston Scientific accounts are for healthcare professionals only.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.
Intended use/Indications for use
The AutoElite Console is intended to be used with the AngioJet Thrombectomy Sets for the percutaneous removal of thrombus in the treatment of vascular disease.
Indications for use
The AutoElite Console is intended for use only in conjunction with an AngioJet Thrombectomy Set. Refer to the individual Thrombectomy Set Instructions for Use for specific clinical applications.
Contraindications
Refer to the individual Thrombectomy Set Instructions for Use for specific contraindications.
Warnings
To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
Refer to the individual Thrombectomy Set Instructions for Use for specific warnings and precautions.
Use of the Thrombectomy Set may result in hemolysis which should be monitored to manage possible renal, pancreatic, or other adverse events. Evaluate the patient’s risk tolerance for hemolysis (such as body size, thrombus burden, and renal function) prior to the procedure. Consider appropriate hydration prior to, during, and after the procedure.
Do not attempt to bypass any of the Console safety features.
The AutoElite System should not be used adjacent to or stacked with other equipment, and if adjacent use is necessary, the Console should be observed to verify normal operation in the configuration in which it will be used.
Portable RF (radio frequency) communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than distances specified in Tables 5 and 6 to any part of the AutoElite System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Use of accessories and cables other than those provided by Boston Scientific could result in increased electromagnetic emissions or decreased electromagnetic immunity of the AutoElite System and/or result in improper operation.
No modification of this equipment is allowed. The Console contains limited user serviceable parts (see Part Replacement section). Refer service of all other parts to qualified personnel.
Precautions
Use the Console only with an AngioJet Thrombectomy Set.
The AutoElite 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.
This device may cause electromagnetic interference with other devices when in use. Do not place the AutoElite System near sensitive equipment when operating.
Visually inspect the Console, foot switch/cable, and power cord prior to use. Use of a damaged Console is not recommended, as performance may be impacted.
Avoid knocking into or putting weight on the touchscreen. This may damage the touchscreen.
Do not manually manipulate the doors. See Cleaning and Disinfection Instructions section for proper procedure to clean pump bay and doors.
Do not reposition or push the Console from any point other than the handle designed for that purpose to avoid overbalancing or tipping.
If the System continues to run after removal of foot from foot switch, pull the power cord from the wall outlet to deactivate the system.
Changes or modifications not expressly approved by Boston Scientific Corporation could void the user’s authority to operate the equipment.
Potential adverse events
Refer to the individual Thrombectomy Set Instructions for Use for specific observed and/or potential adverse events.
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