Indications For Use; Intended Use - MedComp C3 WAVE Manual Del Usuario

English
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 display-
ing 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.
• Inspect package and product prior to use to verify that no
damage has occurred during shipping.

INDICATIONS FOR USE

INTENDED USE

CONTRAINDICATIONS
WARNINGS
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