Contraindications; Potential Complications - COOK Medical EchoTip Ultra Bedienungsanleitung

ENGLISH
INTENDED USE
This device is used to implant fiducials under endoscopic ultrasound to radiographically mark
soft tissue for future therapeutic procedures.
NOTES
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.
Do not use this device for any purpose other than stated intended use.
If 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 for return authorization.
Store in a dry location, away from temperature extremes.
Use of this device restricted to a trained healthcare professional.
Device may not be used prior to training by manufacturer.
Fiducial migration may occur following placement. Patients who experience fiducial migration
may require placement of additional fiducials prior to radiotherapy.

CONTRAINDICATIONS

Contraindications include those specific to the primary endoscopic procedure to be performed in
gaining access to the desired target site.
WARNINGS
This needle is not intended for aspiration. Misuse may result in tissue damage.
Do not deploy fiducials under inadequate ultrasound imaging conditions as this may result in the
fiducial being inadvertently placed in unintended locations such as the vasculature.

POTENTIAL COMPLICATIONS

Potential complications associated with gastrointestinal endoscopy include, but are not
limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication,
hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.
Potential complications from extra-luminal EUS guided procedures may include infection,
hemorrhage, perforation and tumor seeding.
PRECAUTIONS
Refer to package label for minimum channel size required for this device.
Needle must be retracted into sheath and thumbscrew on safety ring must be locked to hold
needle in place prior to introduction, advancement or withdrawal of device. Failure to retract
needle may result in damage to endoscope.
Stylet must not be retracted at any point.
4 5
3
6
2.
3.