Bionix SecureVac SVRT-7130 Instructions For Use Manual

Caution: Federal Law restricts this device to sale by or on the order of a licensed Physician or Radiation Therapist.
DEVICE DESCRIPTION
Bionix Radiation Therapy SecureVac Cushions are reusable immobilization devices designed for
customizable, long-term multi-patient use. The SecureVac Cushions maintain their shape over the course
of external beam radiation therapy for the treatment of cancer and other diseases.
INTENDED USE
The Bionix Radiation Therapy SecureVac Cushions are intended to be used for the repeatable positioning
and repositioning of patients undergoing or receiving a course of external beam radiation therapy for the
treatment of cancer and other diseases.
INDICATIONS
The Bionix Radiation Therapy SecureVac Cushions are indicated for use by a healthcare professional to
externally support and immobilize patients that require repeatability and reproducibility while undergoing
or receiving external beam radiation therapy.
CONTRAINDICATIONS
No contraindications have been identified for the use of SecureVac Cushions.
ADVERSE REACTIONS
No adverse reactions have been identified for the use of SecureVac Cushions.
WARNINGS
•
SecureVac Cushions can burst if overinflated- DO NOT OVERINFLATE
•
Do NOT use SecureVac Cushions if the package is damaged or open.
•
Inspect the SecureVac Cushions before each use.
•
Do NOT attempt to sterilize the SecureVac Cushion. Attempts to sterilize the SecureVac Cushion
may result in product damage and / or patient injury.
•
Using alcohol based cleaners on this product can compromise integrity of device
•
DO NOT lift SecureVac Cushions by hose, may cause damage to device
STORAGE
Store in a cool, dry environment with cushions slightly evacuated.
RM95-0039 Rev. A
SecureVac™ Cushions Instructions for Use
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