Bard - 0067700 - Bard Simpulse Solo System With Ultrex Retractable Splash Shield Tip

Indications

The Simpulse SOLO Suction/Irrigator is designed to provide controlled powered irrigation during open orthopedic and general surgical procedures and for the cleansing of burns or wounds. Appropriate fluids for use include fluids with specific gravity of approximately 1 (e.g. saline). The pulsatile action of the pump helps to remove blood, tissue debris and foreign matter from the operative or wound site. When connected to a suction source, the device can be used to aspirate fluids from the operative or wound site.

Warnings

1. This device has been designed for single use only. Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, resterilization or repackaging 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 diseases from one patient to another. Contamination of the device may lead to injury, illness or death of the patient or end user.
2. Do not resterilize.
3. Do not use in an oxygen-enriched atmosphere due to explosion hazard.
4. Do not incinerate the batteries as this can cause a risk to the environment.
5. Do not recharge batteries, put in backwards, or mix with used or other battery types as these actions may cause explosion or leakage leading to personal injury or can cause a risk to the environment.
6. After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws (U.S.A) and regulations.
7. Follow Occupational Safety and Health Administration (OSHA) standards or Universal Precautions for bloodborne pathogens (29 CFR-1910.1030). These may be found by searching the OSHA website at wwwwwwwwwwww.osha.gov.
8. Use continuous suction at 60-100 mmHg to keep operative or wound site clean.