Nipro TI-SE Instructions D'utilisation page 3

INDICATIONS FOR USE:
•
The Extension Set is designed for Long Term Hemodialysis and
Apheresis. It may be inserted percutaneously, and is ideally placed
in the internal jugular vein. Although this catheter may be inserted
into the subclavian vein, the internal jugular vein is the preferred
site.
CONTRAINDICATIONS:
•
This extension is not intended for any use other than that which is
indicated.
•
To maintain peak performance of the extension, it is recommended
that the extensions be replaced every 6 months.
DESCRIPTION:
•
The extension set is manufactured from biocompatible pellathane
material and consists of the extension with a clamp that has a
metal cannula at one end and a luer at the other end. Also included
in the kit is a collar and compression ring as part of the assembly.
POTENTIAL COMPLICATIONS:
Air Embolus
Bacteremia
Exsanguination
Hemorrage
Hematoma
WARNINGS:
•
In the rare event that a hub or connector separates from any
component during insertion or use, take all necessary steps and
precautions to prevent blood loss or air embolism and remove
catheter.
•
Federal Law (USA) restricts this device to sale by or on the order of a
physician.
•
This device is for Single Use Only.
•
Do not re-sterilize the catheter or accessories by any method.
•
Re-Use may lead to infection or illness/injury.
•
The manufacturer shall not be liable for any damages caused by
reuse or re-sterilization of this catheter or accessories.
•
Contents sterile and non-pyrogenic in unopened, undamaged
package.
STERILIZED BY ETHYLENE OXIDE
STERILE EO
•
Do not use if package is opened or damaged.
•
Do not use if any sign of product damage is visible.
•
The medical techniques and procedures described in these
instructions for use do not represent all medically acceptable
protocols, nor are they intended as a substitute for the physician's
experience and judgement in treating any specific patient.
PRECAUTIONS:
•
Do not use sharp instruments near the adapter tubing or catheter
lumen.
•
Do not use scissors to remove dressing.
•
Clamping of the tubing repeatedly in the same location may weaken
tubing. Avoid clamping near adapter or luer of the extensions.
•
Examine catheter lumen and arterial and venous extensions after
each treatment for damage.
•
To prevent accidents, assure the security of all caps and bloodline
connections prior to and between treatments.
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