Promedon TUBE Serie Instruccion De Uso página 2

INSTRUCTIONS FOR USE
DESCRIPTION
The TUBE Penile Prosthesis has been designed to be implanted into the penis
for the management of impotence. It serves as a stiffener that helps a patient
suffering from erectile impotence to achieve vaginal penetration (intercourse).
It is inserted into the corpora cavernosa through surgery.
The TUBE Penile Prothesis consists of two hemiprosthesis. The twisted and
welded silver wires placed in the nuclei are surrounded by a teflon tube which
contains a medical grade silicone elastomer cover.
Each hemiprosthesis is implanted in each corpus cavernosum. The TUBE Penile
Prosthesis is available in different diameters. The final length of the implant
can be adapted by means of its trimmable extreme as well as by the rear tips.
For vaginal penetration (intercourse) the prosthesis should be placed in erected
position by hand. However, it is also possible to place the penis in relaxed
position, due to its excellent placing memory that is given by the implant
nucleous.
PRESENTATION
ORDER NUmBER AND DImENSIONS
Order
Number
T-090
T-100
T-110
T-120
T-120VS
T-130
T-130VS
Each set includes 2 rear tips of 10 mm and 15 mm.
*The functional length is measured without considering the length of the rear tips.
Sterilization method: Ethylene Oxide.
INDICATIONS
Designed for implantation into the penis, TUBE malleable penile prosthesis is
advisable for all those patients who suffer from erectile impotence and who
are considered candidates for surgical implants.
The TUBE Penile prosthesis has been used for treatment of erectile impotence
derived from various causes: spinal cord injuries, post-surgical lesions, multiple
sclerosis, arteriosclerosis, arterial hypertension, and others. The prosthesis can
also be used in selected patients with psychogenic impotence.
CONTRAINDICATIONS
The prosthesis implant is not recommended if there is infection in some parts
of the body, particularly if it is genital or in the urinary tract.
TUBE malleable penile prosthesis cannot be used in patients with urological
problems, such as urethral obstruction, urine residues, etc.
TUBE malleable penile prosthesis must be used with caution in patients with
diabetes.
WARNINGS
The prosthesis must be implanted in both corpora cavernosa. Only one
hemiprosthesis will provide insufficient stiffness for satisfactory use, and it can
even impede vaginal penetration (intercourse).
Each hemiprosthesis must be checked before and during implant. A damaged
prosthesis must not be used for implant.
The prostheses should not be handled with pointed, toothed, or sharp
cornered instruments, as any nick can be the focus for subsequent failure of
the implant. Care should be taken even in manipulating the prosthesis with
blunt instruments, to avoid deformations, damage or other problems.
Dirt, fingerprints, talc or any other contaminants can be the cause of
foreign body reactions. Serious preventive measures must be taken to avoid
contamination.
Any point or mark in the prosthesis is a possible cause of failure, because it
may serve as a surface to keep materials that may cause reactions to foreign
objects or infections in the patient.
Prosthesis excessive length may result in voiding difficulties, inflammation,
pressure necrosis, and erosion into theurethra or through the tunica albuginea
of the corpus cavernosum.
Extreme care should be taken in the dilation of the corpus cavernosum to
avoid penetration or over-stretching of the corpus wall and the urethra.
The malleable prosthesis produces an increase in the urethral resistance.
Therefore, it should be used with caution in patients with borderline bladder
decompensation or enlargement of the prostate, since T.U.R. will be impossible
with implanted prosthesis.
2
Trimmable Length
(mm)
65
65
70
80
60
80
80
Functional Length*
(mm)
135
155
170
180
155
187
172
ENGLISH
Diameter
(mm)
9
10
11
12
12
13
13