Terumo Titan T401231, Manual

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INTENDED USE
The stabilizers are intended for use in beating heart CABG (coronary artery
bypass graft) procedures to stabilize the anastomotic site (coronary artery
isolation).
CONTRAINDICATIONS
The stabilizers are contraindicated for use in patients with local or systemic
infection.
Do not position the stabilizers on newly infarcted tissue, aneurysmal tissue,
fragile tissue, or directly over a coronary artery.
WARNINGS
• This device is sterile and is intended FOR SINGLE USE
ONLY. DO NOT REUSE. DO NOT RESTERILIZE. DO NOT
REPROCESS. REPROCESSING MAY COMPROMISE
THE STERILITY, BIOCOMPATIBILITY AND FUNCTIONAL
INTEGRITY OF THE DEVICE.
• Do not use product if packaging or product is damaged as sterility
or integrity of the device may be compromised.
• Proper surgical procedure and technique is the responsibility of
the attending medical professional (physician). Each surgeon
must evaluate the appropriate use of this device, case by case,
based upon medical training, experience, and the type of surgical
procedure employed.
• Use of excessive negative vacuum pressure may cause tissue
damage.
CAUTION
United States Federal Law restricts this device to sale by or on the order of
a physician or other licensed practitioner.
INSTRUCTIONS FOR USE
1. Inspect the packaging and product thoroughly for damage prior to
use. Using aseptic technique, remove the contents and pass to the
surgical field for attachment to the compatible Terumo Stabilizer Arm.
• For connection to the Terumo Stabilizer Arm shaft configuration:
Slide the sleeve of the arm forward and insert the shaft of the
attachment into the quick connect with the detent on the shaft
(of the attachment) facing the flat area with the logo on the sleeve
of the Terumo Stabilizer Arm (see Figure 2). Return the sleeve
to its original position to lock the accessory device into the quick
connect. Check for secure connection.