Boston Scientific Encore 26 Mode D'emploi page 3

Encore 26
™
Inflation Device
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the
order of a physician.
REUSE WARNING
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.
DEVICE DESCRIPTION
The Encore 26 Inflation Device incorporates a pressure gauge with
a 0-26 atm/bar (0-2634 kPa) dial, a 20 ml (20 cc) syringe, and a
connecting tube. The gauge accuracy is 3-2-3, indicating an accuracy
of ± 3% in the upper and lower quarter of the scale and is ± 2% in the
middle half of the scale.
Contents
Package contents include:
• One (1) Single-Use Inflation Device and
• One (1) Single-Use Stopcock.
Operating Principle
The Encore 26 Inflation Device employs a threaded plunger and
locking mechanism activated by a finger latch. When the finger
latch is depressed, the threaded plunger is unlocked and may
be advanced or withdrawn as required. When the finger latch is
released, the device is in the locked position. This allows for the
generation and monitoring of pressure in atmospheres (atm) and
kilopascal (kPa). The stopcock is used in procedures where pressure
must be contained. Its luer fittings are compatible with the syringe
extension rotating adaptor and with the therapeutic devices with
which the Encore 26 Inflation Device is used. The stopcock rotating
handle is used to control pressures within the procedural set-up and
is provided with an OFF indicator to clearly indicate port closure.
User Information
This device is intended to be used by, or under the supervision of,
a skilled physician with a thorough understanding of the technical
principles, clinical applications, and risks associated with balloon
dilatation and/or ERCP.
INDICATIONS FOR USE/INTENDED USE
The Encore 26 Inflation Device is recommended for use with balloon
dilatation catheters to create and monitor pressure in the balloon,
and to deflate the balloon.
Target Patient Population
Patients with conditions that require the use of balloon dilatation
catheters during endoscopy procedures.
Clinical Benefit Statement
The clinical benefit of the Encore 26 Inflation Device is to inflate
and deflate balloon dilatation catheters while simultaneously
monitoring balloon pressure during balloon dilation.
CONTRAINDICATIONS
None known.
3
37 MB Drawing 50573137 Black (K) ∆E ≤5.0