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a) the cuff is deflated by squeezing the
control pump unit located in the scrotum; fluid
is transferred to the prB, leaving the cuff
empty and allowing the patient to void.
B) the cuff slowly re-inflates through a
slow bleed valve. rapid re-inflation can be
achieved by squeezing the top of the control
pump. the cuff exerts sufficient pressure to
maintain continence without compromising
the urethral tissues.
CONTRAINDICATIONS
the
main
contraindications
implantation of victo are listed as follows:
1. unmanaged detrusor instability.
2. problems affecting manual dexterity or
motivation, which may prevent the patient
from operating the device.
3. acute urinary tract infection which may
lead to post-operative complications.
4. patients whom the surgeon determines
to be not suitable due to risks associated
with open surgical procedures and/or with
the patients' medical history (physical or
mental problems).
5. known sensitivity to silicone rubber.
WArNiNgS
improper cuff sizing may cause low efficacy
therapy or urethral erosion.
improper filling of components may cause
low performance of the product or implant
permanent damage.
all components are for single use. therefore,
they should not be re-used or re-sterilized,
as this can potentially result in compromised
device performance and increased risk
of inappropriate re-sterilization and cross
contamination.
the product must not be used if the package
is open or damaged.
the product must not be used after the expiry
date specified on the packaging.
PRECAUTIONS
improper cuff sizing may result in tissue
erosion,
continued incontinence.
unsuccessful outcomes may result from
improper sizing and/or filling of components.
the kits' components must be handled only
by surgeons and/or operating room staff who
are familiar with the device and the surgical
technique.
adequate precautions must be taken to
avoid contamination during the intraoperative
procedure.
operating rooms conditions should be in
accordance with hospital, administrative and/
or local government policy.
for
the
after use, the non-implanted product and
packaging should be disposed in accordance
with hospital, administrative and/or local
government policy.
mAgNEtic rESoNANcE (mr)
ENvIRONmENT
non-clinical testing performed in the worst
case product has demonstrated that victo
implant is mr conditional. a patient with
this device can be safely scanned in an mr
system meeting the following conditions:
• static magnetic field of 1.5 tesla and 3
tesla, with
• maximum spatial field gradient of 12,800
g/cm (128 t/m)
• maximum force product of 231 t²/m
• theoretically estimated maximum whole
body averaged (WBa) specific absorption
rate (sar) of
< 2 W/kg (normal operating mode)
under the scan conditions defined above,
the victo implant is expected to produce a
maximum temperature rise of less than 1.0°c
(2 W/kg, 1.5 tesla) rF-related temperature
increase with a background temperature
increase of ≈ 1.0°c (2 W/kg, 1.5 tesla)
0.9°c
temperature increase with a background
temperature increase of ≈ 1.0°c (2 W/kg,
3 tesla)
after 15 minutes of continuous scanning.
· 4 ·
migration
of
components,
(2
W/kg,
3
tesla)
or
rF-related
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