For orthopedic surgery, the choice is simple.
Simpulse™ SOLO provides controlled powered irrigation that accommodates multiple surgical and clinical situations.
Simpulse™ SOLO provides controlled powered irrigation that accommodates multiple surgical and clinical situations.
GTIN - Case
10801741010306
10
GTIN - Each
00801741010309
1
GTIN - Case | 10801741010306 | 10 |
GTIN - Each | 00801741010309 | 1 |
If you are a patient or end user, you can contact us yourself, or you may have your caregiver or your physician do that for you. To help us process your
information quickly and effectively, please contact our customer complaints
team.
To better facilitate our investigation, please include the following information in your reporting:
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
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.
Additional Warnings
Do not use in the presence of flammable substances due to explosion hazard. 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.
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. 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.
Do not occlude suction tip side holes or splash shield side holes as tissue damage may occur.
If SOLO is used stacked with or adjacent to other equipment, SOLO should be observed to verify normal operation.
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