VICTO Replacement Kit Gebrauchsanweisung Seite 4

WARNINGS
improper cuff sizing may limit the efficacy of
therapy or cause urethral erosion.
improper filling of components may limit
the performance of the product or cause
permanent damage.
All components are for single use. thus,
they should not be reused or resterilized, as
this can potentially result in compromised
device performance and increased risk
of inappropriate resterilization and cross
contamination.
the product must not be used if the package
is open or damaged.
the product must not be used after the
expiration date specified in the packaging.
PRECAUTIONS
improper cuff sizing may result in tissue
erosion, migration
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 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.
After use, the non-implanted product and
packaging should be disposed in accordance
with hospital, administrative and/or local
government policy.
right and complete connection between the
connector and the tubing (perfect fit) should
be checked. Confirm that there is no loss of
fluid in the joints. verify that the tubing is not
kinked, either pre- or post-connector.
MAGNETIC RESONANCE
IMAGING (MRI) ENvIRONMENT
non-clinical testing performed in the worst-
case scenario has demonstrated that viCto/
viCto+ implant is mr conditional. A patient
of components
with this device can be safely scanned in
an mr system that meets 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
•
whole-body averaged (WBA) specific
absorption rate (sAr) of
< 2 W/kg (normal operating mode)
under the scan conditions defined above,
the viCto+/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,
or
1.5 tesla)
(2 W/kg,
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.
in non-clinical testing, the image caused by
the device extends approximately 18.3 mm
from the implant at the port of the pump when
imaged with a gradient echo pulse sequence
and a 3 tesla mr system.
POSSIbLE COMPLICATIONS
the use of viCto/viCto+ may result in
complications associated with the methods
used during the surgical procedure or reaction
to the foreign body.
the efficacy of the device may be reduced
in the patient who has been treated with
radiotherapy for local recurrence of prostate
cancer.
some complications may require complete or
partial removal of the device.
infections that do not respond to antibiotic
treatment and/or chronic pain related to the
device failure may require the removal of the
device.
· 4 ·
estimated
maximum
3 tesla) rF-related