Contraindications None known. Warnings

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.

Precautions

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. 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.

Latex

The presence or absence of latex is indicated on the device labeling: If the device contains latex, a Caution Notice, as required by Federal (U.S.A.) law, will be included in the pouch and unit of sale box labeling. If the device is latex free, the symbol, @, followed by the words, "Latex Free", will be included in the pouch and unit of sale box labeling. Refer to the pouch and unit of sale box labeling for the relevant latex information for your device.

Storage Conditions

Do not store product at extreme temperatures. Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. Rx Only.&

Warranty

Navilyst Medical warrants that reasonable care has been used in the design and manufacture of this instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness.

Handling, storage, cleaning and sterilization of this instrument, as well as other factors relating to the patient, diagnosis, treatment, surgical procedures, and other matters beyond Navilyst Medical's control, directly affect the instrument and the results obtained from its use.

Navilyst Medical's obligation under this warranty is limited to the repair or replacement of this instrument and Navilyst Medical shall not be liable for any incidental or consequential loss, damage, or expense directly or indirectly arising from the use of this instrument.

Navilyst Medical neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this instrument.

Navilyst Medical assumes no liability with respect to instruments reused, reprocessed or resterilized and makes no warranties, expressed or implied, including but not limited to merchantability or fitness for intended use, with respect to such instrument.