EN DA DE ES FI FR IT NL NO PT SV - T-SPeC® Instructions For Use ...

T-SPEC®
TRANSURETHRAL SUPRAPUBIC
ENDO-CYSTOSTOMY SURGICAL
SYSTEM
DEFINED SYMBOLS:
QTY: Quantity
2
CAUTION: Federal law (USA) restricts this device
to sale by or on the order of a physician.
WARNING: This device should be used only by physicians with
a thorough understanding of suprapubic catheter placement.
The physician must be thoroughly familiar with the device and
surgical procedure prior to performing surgery. The physician must
evaluate each situation individually based on the patient’s clinical
presentation in making any decision regarding the use of this device
and model selection. The technique actually employed in each case
always depends on the medical judgment of the surgeon exercised
before and during surgery as to the best mode of treatment for
each patient. The physician using this device is responsible in full
for assessing each situation based on her or his own experience
and on the patient’s condition. Do not use this device if there is any
instruction, direction, precaution, caution, note or warning that you
do not understand or which is unclear.
CAUTION: This device is intended for SINGLE USE ONLY. Do not reuse,
reprocess or resterilize, as these may compromise the structural
integrity of the device and/or lead to device failure, potentially
resulting in patient injury, illness or death.
CAUTION: Carefully read all instructions, warnings, precautions and
notes prior to use. Failure to do so may result in patient injury, illness
or death.
CAUTION: Prior to use, inspect the packaging and product for
damage. Do not use if the product is damaged or the sterile barrier is
compromised. Use aseptic technique when handling this product to
prevent accidental contamination.
INTENDED USE
The T-SPeC ® Surgical System is intended for suprapubic bladder
catheterization (cystostomy) and drainage. The catheter should not
be allowed to remain indwelling for more than 29 days.
CONTRAINDICATIONS
The T-SPeC ® Surgical System is contraindicated for use in:
• Patients with urethral strictures or occlusions that preclude the
safe introduction of the T-SPeC® urethral sound.
• Patients with uncorrected bleeding disorders or uncontrolled
coagulopathy.
• Patients with known active bladder cancer.
• Patients who are pregnant.
• Patients who have undergone prior abdominal or pelvic
surgery and/or radiation that could create bowel adhesions or
interposition of bowel at the surgical site.
• Patients with untreated urinary tract infection.
• Patients with intestinal obstruction.
• Patients with femoral to femoral bypass graft.