Indications For Use; Contraindications; Instructions For Use; Intended Use - Angiodynamics C3 Wave System Gebrauchsanweisung

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Caution: Federal Law (USA) restricts this device to sale by
or on the order of a physician.
• C3 Wave* System Instructions for Use: These instructions
are for use in conjunction with the C3 Wave System Owner's
Manual.
• The C3 Wave System is indicated for use in the positioning
of Peripherally Inserted Central Catheters (PICC). The C3
Wave provides real-time catheter tip location information by
displaying changes in the patient's cardiac electrical activity.
The C3 Wave is indicated for use as an alternative method to
chest X-ray or fluoroscopy confirmation of PICC tip placement
in adult patients.
Note: Limiting, but not contraindicated, situations for this
technique are patients where cardiac rhythms may change
presentation of the P-Wave:
- Atrial fibrillation
- Atrial flutter
- Severe tachycardia
- Pacemaker-driven rhythm
- Chronic obstructive pulmonary disorder (COPD)
Such patients are easily identified prior to PICC insertion. Use
of an additional confirmation method is necessary to confirm
catheter tip location.
• C3 Wave System is intended to provide real time tip location
information of a central venous catheter by utilization of ECG to
observe P-wave changes as the tip approaches the right atrium
of the heart via the superior vena cava.
• There are no contraindications associated with the C3 Wave
system. Consult catheter Instructions for Use for Possible
Catheter Contraindications.
• The C3 Wave system works with the normal sinus rhythm of
the heart. Do not rely on ECG signal detection for catheter tip
positioning when interpretation of the external or intravascular
ECG P-wave is difficult.
For example, when:
P-wave is not present
•
P-wave is not identifiable
•
P-wave is intermittent
•
• Place ECG adhesive electrodes carefully at locations indicated
in these Instructions for Use and ensure good skin-electrode
contact. Failure to do so may cause unstable ECG waveforms
and/or ECG waveforms that are not described in these

Instructions for Use.

• All components in the accessory pack are single use items. Do
not reuse or reprocess.
• Monitor catheter tip placement during insertion procedure and
verify catheter tip location placement using your institutions'
guidelines.
• Failure to verify catheter placement may result in serious
trauma or fatal complications.

INDICATIONS FOR USE

INTENDED USE

CONTRAINDICATIONS

WARNINGS
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