4
ENG
PRESCRIPTION INFORMATION
Device Indications
CE Mark: The VERSAJET™ Hydrosurgery System is intended to cut, ablate and remove tissue from wounds and to resect and
remove material in various surgical procedures including wound debridement.
In the USA: The VERSAJET™ Hydrosurgery System is intended for wound debridement, soft tissue debridement, and cleansing
of the surgical site in applications that, in the surgeon’s judgment, would require the use of a pulse lavage device with sharp
debridement. This device is not intended to be used on burns.
In Canada: The VERSAJET™ Hydrosurgery System is intended for the cutting, resection and removal of tissue, contaminants,
or fluids from the wound or surgical site.
Warnings
1. This device should be used with particular care in patients with hemophilia.
2. Only VERSAJET™ approved equipment should be connected to this device.
3. Use of the higher settings on the device console will lead to more aggressive tissue removal. Use caution near sensitive
tissues, such as neurovascular bundles.
4. This device can cut soft tissue.
Precautions
1. Use lower settings on the device console for deep wounds where visualization is obscured.
2. Do not allow saline bag to empty because this could allow air to enter the supply tube. Air in the supply tube will result
in temporary lower device efficiency and require re-priming of the system.
3. Subsequent debridement procedures may be necessary.
4. Use only sterile saline solution with this device.
5. Examine all components before use. If you believe a component to be faulty, damaged, or suspect, DO NOT USE.
6. Each Disposable Handpiece is intended for SINGLE USE ONLY. Do not resterilize. Discard after use.
7. Do not connect the waste hose, or any container connected to it, to a vacuum source.
USA law restricts this device to sale by or on the order of a physician.
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