Angiojet Thrombectomy Set (Thrombectomy Set); Intended Use/Indications For Use; Contraindications; Warnings - Boston Scientific AngioJet Ultra 5000A Console Manual Del Usuario

AngioJet™ Thrombectomy Set (Thrombectomy Set)
A bag of sterile, heparinized saline (not included) supplies the pump with
saline through the saline delivery tubing. The pump pressurizes the saline. The
Thrombectomy Set uses this pressurized, high-velocity saline to create a low-
pressure zone at the catheter tip. This allows the catheter to break up and remove
thrombus. The waste tubing transports the thrombus debris from the catheter to the
collection bag for ultimate disposal.
Piston Head
Pump
Waste Tubing
Figure 2� Thrombectomy Set

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 Thrombectomy Set Directions for Use manual for
specific warnings and precautions.
• Refer to the 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 this
equipment could 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

• The AngioJet System should be used only by operators who have received
appropriate training on its installation and use.
• 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.
• This device may cause electromagnetic interference with other devices when
in use. Do not place the AngioJet System near sensitive equipment when
operating.
• Console bag hooks are intended for physician specified fluid and/or saline
bags only. Hanging other objects or applying additional weight to the bag
hooks may cause damage.
• When drawer is extended from Console, avoid knocking or leaning on the
drawer. This may damage the device.
• Do not move the collection bag during catheter operation as this may cause a
Catheter
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.
• In the event the foot switch is stuck in the "on" position (inadvertent
activation), press the POWER button or pull the power cord from the wall
outlet to deactivate the system. Contact Boston Scientific Customer Service.
Collection
Bag

Disposal

The user should follow local and national regulations for disposal of electronics
when disposing of this unit. Contact Boston Scientific Customer Service for
product returns.

POTENTIAL ADVERSE EFFECTS

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

HOW SUPPLIED

This product is supplied non-sterile and is intended for multiple use.
Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.

HANDLING AND STORAGE

Operating Environment

Temperature: 10 °C to 40 °C (50 °F to 104 °F)
Relative Humidity: 30% to 75% (noncondensing)
Atmospheric Pressure: 700 hPa to 1060 hPa

Transport Environment

Temperature: -25 °C to 55 °C (-13 °F to 131 °F)
Relative Humidity: 10% to 95% (noncondensing)
Atmospheric Pressure: 500 hPa to 1060 hPa

Storage Environment

Temperature: -25 °C to 55 °C (-13 °F to 131 °F)
Relative Humidity: 10% to 95% (noncondensing)
Atmospheric Pressure: 500 hPa to 1060 hPa
5
Black (K) ∆E ≤5.0