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

SYSTEM CONTENTS
One (1) T-SPeC ® Surgical System, which includes:
• T-SPeC® Sound and Handle Assembly
• T-SPeC® Positioning Arm and Capture Housing Assembly
• T-SPeC® Mast
• 18 Fr. 100% Silicone Catheter with Integral Balloon
• 10 cc/ml Catheter Balloon Inflation Syringe
ADDITIONAL REQUIRED MATERIALS (NOT
SUPPLIED)
• Lubricant Jelly (sterile, water soluble, non-staining)
• Sterile Water for Catheter Balloon
• Flexible Cystoscope and Accessories for Performing Cystoscopy
• Scalpel
SYSTEM WARNINGS
WARNING: The T-SPeC® Surgical System contains a surgical blade.
Use with caution and closely follow the instructions for use of the
surgical blade to avoid risk of injury to the user and/or patient.
WARNING: After use, dispose of the cutting blade in accordance
with hospital, administrative and/or local government policy for
sharps disposal. Failure to properly dispose of cutting blade can
increase the risk of injury – including blood borne infection – to the
user, attending staff, and/or patient.
WARNING: Post-operative urinary tract and surgical site infections
are potential complications of suprapubic catheterization that can
lead to serious, life-threatening illness. Physician and patient
should observe for signs of post-operative urinary tract and/or
surgical site infection, such as redness, swelling and fever.
WARNING: Catheter blockage is a potential complication of
suprapubic catheterization that can lead to serious, life-threatening
illness, including, but not limited to, renal damage from urinary
retention. Physician and patient should observe for catheter kinking,
encrustation and/or slow or intermittent catheter drainage.
WARNING: Do not allow catheter to remain indwelling for more
than 29 days. Catheters that remain indwelling for more than 29
days can put the patient at increased risk of urinary tract infection,
catheter encrustation, and/or the formation of bladder calculi. Patients
predisposed to catheter encrustation should be examined for catheter
encrustation on more frequent interval than 29 days.
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SYSTEM PRECAUTIONS
CAUTION: Exercise care to prevent catheter damage from abrasion
or contact with sharp objects. If catheter is damaged, do not use. Do
not use petroleum based ointments or lubricants during procedure.
CAUTION: The T-SPeC® procedure should be performed under sterile
conditions with standard pre-operative preparations and anesthesia
for suprapubic catheter placement.
CAUTION: Before use, perform cystoscopy to confirm health of
bladder and lower urinary tract.
CAUTION: Before use, inflate and deflate catheter balloon to
confirm function and integrity.
CAUTION: After use, dispose of the T-SPeC® Surgical System and
packaging in accordance with hospital, administrative and/or local
government policy.