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In the EU - Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the applicable member state.
REUSE PRECAUTION STATEMENT
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization
may compromise the structural integrity of the device and/or lead to device failure which, in turn, may
result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of
contamination of the device and/or cause patient infection or cross-infection, including, but not limited
to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may
lead to injury, illness or death of the patient.
POTENTIAL COMPLICATIONS
Possible complications that may result from use of this device include, but are not limited to: hematoma,
recurrent bleeding, local venous thrombosis, nerve damage, pain or numbness, complex regional pain
syndrome, allergic reaction, and artery occlusion.
INSTRUCTIONS FOR USE
Device Placement
1. Ensure site is clean and dry.
NOTE: This device needs to be positioned differently for the following uses:
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Radial artery use: Ensure the CURVED section of the clear plate is on the THUMB side of the
wrist.
•
Ulnar artery use: Ensure the CURVED section of the clear plate is on the LITTLE FINGER (fifth
digit) side of the wrist.
Curved Section
Figure 1.
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