Boston Scientific Encore 26 Mode D'emploi page 4

WARNINGS
To prevent balloon burst and patient injury, do not exceed the
inflation pressure specified on the balloon.
ADVERSE EVENTS
Potential adverse events associated with procedures where the
inflation devices are used may include, but are not limited to,
the following:
• Allergic reaction
• Hemorrhage
• Infection
• Inflammation
• Pain
• Perforation
• Tissue Damage
HOW SUPPLIED
Device is supplied sterile using an ethylene oxide (EO) process. The
packaging and device should be inspected prior to use.
Device Details
Do not use if package is damaged or unintentionally opened
before use.
Do not use if labeling is incomplete or illegible.
Handling and Storage
This product has no special handling or storage requirements.
Check device label for expiration date.
OPERATIONAL INSTRUCTIONS
Preparation
1. Hold the device in one hand and depress the finger latch to
unlock or disengage the threaded plunger (Figure 1).
2. Place the Encore 26 Inflation Device connecting
tube into a vial of inflation media (see catheter
manufacturer's recommendations).
3. Pull back on the threaded plunger to fill the syringe with the
inflation media.
4. Aspirate 5 ml (5 cc) to 8 ml (8 cc) into syringe, then hold upright
and eliminate any air that may have collected in the syringe
and tubing.
Note: A small amount of lubricant fluid visible in the syringe barrel
when the device is unpacked.
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[1] Figure 1 [2] Figure 2 [3] Unlocked [4] Locked
Figure 1. Encore device unlocking mechanism
Figure 2. Encore device locking mechanism
Procedure
1. Place a meniscus of fluid on the balloon luer port of the
prepared catheter and attach the connecting tube to the
luer port.
Precaution: Do not overtighten the connection to avoid
damaging the luers.
Black (K) ∆E ≤5.0
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MB Drawing 50573137