Warning; Device Description; Intended Use/Indications For Use; Contraindications - Boston Scientific IMAGER II Gebrauchsanweisung

IMAGER
Angiographic Catheter
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on
the order of a physician.

WARNING

Contents supplied STERILE using an ethylene oxide (EO)
process. Do not use if sterile barrier is damaged. If damage is
found, call your Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or lead to device failure
which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of
contamination of the device and/or cause patient infection or
cross-infection, including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination
of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance
with hospital, administrative and/or local government policy.

DEVICE DESCRIPTION

The IMAGER II Angiographic Catheters are sterile, single-
use diagnostic intravascular catheters. These catheters are
available in a variety of flush and selective shapes with lengths
of 40 cm, 65 cm, 90 cm and 100 cm. The distal segment of the
catheter is radiopaque to aid in visualization of the device
under fluoroscopy. Clinically, flush catheters are used to deliver
a bolus of contrast to a patient when obtaining an image of a
large area (aorta, leg-run off, etc.). Side-holes are also added
to disperse the contrast. Selective catheters are used to create
images of specific areas of interest.

INTENDED USE/INDICATIONS FOR USE

The IMAGER II Angiographic Catheters are designed to provide
a pathway for delivering contrast media to selected sites in the
vascular system, including the carotid arteries.
Additionally, the 5F Selective IMAGER II Angiographic Catheters
without side holes can also be used for the controlled and selective
delivery of the Boston Scientific Interlock
into the peripheral vasculature.

CONTRAINDICATIONS

No known contraindications.

WARNINGS

• Angiographic catheters are designed for use by physicians
engaged in the practice of a specialized branch of
medicine. Use of these devices should be restricted
to those specialists trained to perform the procedure.
A thorough understanding of the technical principles,
clinical applications, and risks associated with diagnostic
angiography is necessary before performing this procedure.
• Accordingly, the IMAGER II Angiographic Catheters should
only be used by physicians with a thorough understanding
of angiographic procedures.
• Due to the various sizes and shapes, and the relative
stiffness of angiographic catheters, extreme care must
be taken when selecting and using the IMAGER II
Angiographic Catheters to avoid damage to the vessel
walls through which this catheter passes.
II
™
- 35 Detachable Coils
TM
3
Black (K) ∆E ≤5.0