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 atwwwwwwwwwwww.osha.gov.
8. Use continuous suction at 60-100 mmHg to keep operative or wound site clean.

Additional Warnings

1. Do not use in the presence of flammable substances due to explosion hazard.
2. In order to limit contact with infectious agents from mist and splashing, personnel using the Simpulse; SOLO Suction/Irrigator with tips for cleansing of wounds must wear personal protective equipment.
3. When using the Simpulse SOLO Suction/Irrigator Tips for the cleansing of wounds, to prevent possible exposure of other patients to aerosol, the patient should be treated in a private area, enclosed with walls and doors, separate from other patients.
4. When using the Simpulse SOLO Suction/Irrigator with tips containing splash shields for the cleansing of wounds, keep splash shield in contact with wound/periwound at all times to prevent aerosolization.
5. Do not occlude suction tip side holes or splash shield side holes as tissue damage may occur.
6. If SOLO is used stacked with or adjacent to other equipment, SOLO should be observed to verify normal operation.
7. SOLO is approved as a Class A device per IEC 60601-1-2 for use in hospital or health care setting. Testing for use in other environments (i.e. home use) has not been performed and may affect the operation of other devices in the same environment.

Precautions

1. Single use. Do not reuse.
2. If package is damaged or open, do not use product.
3. Read all instructions prior to use.
4. Do not submerge handle in liquid as this may compromise efficiency of the pump or alter the pH of the liquid.
5. Install medical equipment according to the EMC information provided.
6. Mobile RF communications equipment can effect medical equipment.

DAV/SIMS/0917/0005