System Preparation - COOK Medical EchoTip ProCore Instructions For Use Manual

This device is designed for single use only. Attempts to reprocess, resterilize,
and/or reuse may lead to device failure and/or transmission of disease.
If the package is opened or damaged when received, do not use. Visually
inspect with particular attention to kinks, bends and breaks. If an abnormality
is detected that would prohibit proper working condition, do not use. Please
notify Cook Medical for return authorization.
PRECAUTIONS
Refer to package label for minimum channel size required for this device.
Ensure the stylet is fully inserted when advancing the needle into the
target site.
The needle must be retracted into the sheath and the thumbscrew on the
safety ring must be locked at the 0 cm mark to hold the needle in place prior
to introduction, advancement or withdrawal of the device. Failure to retract the
needle may result in damage to the scope.
Do not use this device for any purpose other than stated intended use.
Use of this device is restricted to a trained healthcare professional (Rx only).
When targeting multiple sites, adequate care should be taken to minimize the
risk of tumor seeding.
This device is intended for use with a Pentax EBUS scope.

SYSTEM PREPARATION

1. Examine syringe. It has two plunger locks that must be depressed to advance
plunger. The tip of the syringe has a Luer lock fitting with a stopcock on the
side port. Air can be exchanged when the stopcock is in "open" position, aligned
with syringe (Fig. 1).
2. Prepare syringe as follows:
a) With stopcock in "open" position, depress plunger locks and fully advance
plunger into syringe.
b) Turn stopcock to "closed" position.
c) Pull plunger back until it is locked into place at desired setting, creating
a vacuum.
d) Set prepared syringe aside until biopsy is required.
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Illustrations