Warnings
1. Contents supplied STERILE using ethylene oxide (EO). Non-Pyrogenic. Do not use if sterile barrier is opened or damaged. Single patient use only. Do not reuse, reprocess or re-sterilize. 2. This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications.
3. Do not resterilize. After resterilization, the sterility of the device is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.
4. After use, this device may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations.
5. To reduce the potential risk of air embolism, never use air or other gaseous medium to inflate angioplasty balloon dilatation catheters. Ensure all air has been purged from the entire fluid path prior to patient use.
6. Do not exceed 40 atm when inflating the device. Damage to the device or user injury may result.
7. Refer to the angioplasty balloon dilatation catheter instructions for use for additional warnings.
Precautions
1. Carefully inspect the device prior to use to verify that it has not been damaged during shipment. Do not use if device damage is evident.
2. Discontinue use of the device if damage, malfunction or contamination is suspected during use.
3. For experienced physician use only.
4. Refer to the angioplasty balloon dilatation catheter instructions for use for additional precautions.
