AMS 800 Instrucciones De Uso página 6

coagulation.
4. Use of products with InhibiZone should be carefully
considered in patients using thionamides, isoniazid and
halothane, due to potential hepatic side effects that have
been reported in patients using these drugs and higher
doses of rifampin.
5. Devices with InhibiZone should not come into contact
with ethyl alcohol, isopropyl alcohol or other alcohols,
acetone or other nonpolar solvents. These solvents may
remove the antibiotics from the device.
6. InhibiZone components should not be soaked in saline or
other solutions prior to implantation. The components
may be briefly rinsed or dipped into a sterile solution,
immediately prior to implant, if desired.
7. InhibiZone does not replace your normal antibiotic
protocols. Continue using any prophylactic protocols
normally used for urological surgical procedures.
8. Because products with InhibiZone are impregnated with
a combination of rifampin and minocycline HCl, the
contraindications, warnings and precautions regarding
the use of these antimicrobial agents apply and should be
adhered to for the use of this device, although systemic
levels of minocycline HCl and rifampin in patients
receiving this device are unlikely to be detected.
Surgery Related
1. Improper cuff sizing, improper balloon selection, or
other causes may result in tissue erosion, migration of
components, or continued incontinence.
2. Component migration can occur if the cuff is sized
improperly, if the pump or balloon is not positioned
correctly, or if the tubing lengths are incorrect. Migration
can result in pain, complications, device malfunction and
surgical revision.
3. Unsuccessful outcomes may result from improper surgical
technique, improper sterile technique, anatomical
misplacement of components, improper sizing and/or
filling of components.
4. Although reinforced tubing has been designed to be more
resistant to tubing kinks, tubing kinks may still result from
tailoring the connecting tubing to an improper length
during the implant procedure.
Device Related
1. If the deactivation valve is closed when the cuff is inflated,
fluid cannot transfer from the cuff to the balloon and
sustained outflow obstruction may arise as a result:
a. In the event of large pressures within the bladder,
automatic pressure relief that normally occurs with
the device would be prevented. Cycling the device can
relieve the outflow obstruction.
b. Cycling the device may be difficult if deactivation
occurs when the pump bulb is deflated. If unable to
cycle the device, squeezing the sides adjacent to the
deactivation button will allow fluid to fill the pump
bulb and then the pump can be cycled normally.
c. Release of the deactivation valve may require greater
pressure than that used to cycle the device.
2. System pressure changes may occur over time if you
fill the balloon with radiopaque solution of incorrect
concentration. Follow the instructions in the Operating
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