Safety Instructions - Bowa LOTUS Serie Instrucciones De Uso

4 STEPS FOR USE
1. Ensure that the device has been cleaned and sterilized.
2. Ensure that the Transducer is disconnected from the Generator.
3. Ensure that the jaw of the Handpiece is in the open position with the trigger
fully forward.
4. Insert the waveguide into the appropriate Handpiece / Double blade sleeve.
Refer to instructions provided with the single use Handpiece / sleeve or the
LOTUS Series 4 Ultrasonic Surgical Systems & Accessories instructions for use.
5. Remove the end cap of the Transducer in the non-sterile area and connect the
Transducer to the generator.
6. For detailed information and operating technique of the full system, refer to the
LOTUS Series 4 Ultrasonic Surgical Systems & Accessories instructions for use.
5 SAFETY INSTRUCTIONS
5.1 DEVICE SPECIFIC
1. Replace the Transducer if it becomes damaged or deformed in any way, either
prior to or during use.
2. Minimally invasive devices can vary in dimension from one manufacturer to
another. If combining devices from different manufacturers, always ensure
compatibility prior to commencing the procedure.
3. Handle the device with care. Do not attempt to modify the device. Damage or
changes can affect the ability to attain resonance and reduce the effectiveness
of the device. Do not use if damage is suspected.
4. Blood and tissue may build up between the jaw and waveguide during surgery.
This can cause the tip of the device to become abnormally hot. Remove any visible
tissue build up from the device to prevent the increased risk of burn injury.
5. Ensure the jaw is closed when inserting the device into, and removing from, a
trocar.
6. Do not bend the jaw backwards. Take care when inserting the device into a
quiver.
7. As with all energy sources (electrosurgery, laser or ultrasound) there are con-
cerns over carcinogenic and infectious potential of the procedure by-products
e.g. tissue smoke plume and aerosols. Effective protective equipment should be
used for both open and laparoscopic procedures.
8. If the jaw becomes bent do not attempt to straighten it. Dispose of the device
and open a new one.
9. If the waveguide touches anything metal while activated, sparks may be
produced. Therefore, exercise caution when using in the presence of flammable
gases or liquids.
10. If the waveguide touches anything metal or plastic while activated, the device
may become damaged.
11. Use only LOTUS accessories to assure compatibility.
12. Ensure that electrical insulation or grounding is not compromised.
13. After significant activation, the distal end of the device may become hot. Do not
allow the blade to contact tissue immediately following activation.
14. Do not allow the device to contact tissue while not in use in case accidental
activation should occur.
15. The jaw liner may be damaged if the jaw is closed against an activated wave-
guide without tissue between them.
16. In case of equipment failure, always ensure adequate backup equipment is
available.
17. Avoid clamping the jaw too hard on incompressible "soft" tissue, bone or
inorganic objects, such as rubber gastric bands as the Handpiece can generate
high forces in this state which could result in damage to the instrument or, in
extreme cases, detachment of the jaw during use. Clamp lightly and let the
ultrasound do the work.
18. Follow the LOTUS Series 4 Ultrasonic Surgical Systems & Accessories instruc-
tions for use.
19. Follow the user instructions for the Handpiece.
20. The area under the Transducer end cap may not be sterile after reprocessing.
Connect the Transducer to the generator in the non-sterile area.
5.2 APPLICATION SPECIFIC
1. This device must only be used by surgeons who are
- trained in the types of surgical procedures that are to be carried out and
- trained in the specific use of ultrasonic surgical instruments.
2. The user must be trained and competent in the basics and the rules of application.
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