Indications For Use
Refer to the operator's manual for complete instructions for use.
The purpose of this system is to minimize contrast waste and allow one container of contrast media to be used on more than one patient.
Maintenance of sterility can only be achieved through proper set-up and use. Use proper aseptic technique when handling this device.
Do not attempt to flush contrast media or air bubbles back through the contrast delivery system when the Squeeze™ Contrast Controller™ chamber is full of fluid. Flushing back through a full Squeeze™ chamber could damage the two checkvalves above the chamber and compromise the sterility of the spike assembly and contrast container.
Do not use the spike assembly on more than one container of contrast media.
Do not use the tubing assembly on more than one patient.
Do not leave the spike assembly intact in a container of contrast for longer than six (6) hours.
Do not replace the tubing assembly more than two (2) times.
If there is any possibility that contamination may have occurred during set-up or use, disassemble and set up new sterile product.
Ensure that you are making secure connections when using this device to prevent the introduction of air into the system. All connections should be finger tightened. Over tightening can cause cracks and leaks to occur.
Examine product carefully for entrapped air and fully debubble prior to injection.
Potential Adverse Effects
No potential adverse effects are described in the operator's manual. Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Navilyst Medical representative. Carefully read these instructions completely prior to use.
The chamber must hang vertically for the green ball to operate effectively.
Inspect prior to use to verify that no damage has occurred during shipping.
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.
NAMIC is a registered trademark and Squeeze is a trademark of Navilyst Medical or its affiliates.