Device Description; Intended Use; Contraindications - COOK Medical Spectrum Gebrauchsanweisung

SPECTRUM
VENOUS CATHETERS
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician
(or properly licensed practitioner).

DEVICE DESCRIPTION

Spectrum and Spectrum Glide polyurethane central venous catheters incorporate separate, non-
communicating vascular access lumens within a single catheter body.
Spectrum and Spectrum Glide catheters are impregnated with antimicrobial agents, minocycline and
rifampin (average concentration 503 µg/cm and 480 µg/cm respectively) to help provide protection
against catheter-related bloodstream infections (CRBSI).
In addition to the antimicrobial agents described above, Spectrum Glide catheters have an EZ-Pass
hydrophilic coating on the distal 10 cm, consisting of polyacrylamide and polyvinylpyrrolidone, to
enhance insertion. The Spectrum Glide catheter is designated by the suffix -HC in the reorder number.
Minipuncture Access Sets and Trays (denoted by –MNP suffix)
™
Used for the insertion of 5.0 French or larger central venous catheters (single and multi-lumen)
through the use of a 20 gage extra-thinwall access needle and a specially designed .025 inch diameter
Amplatz Extra Stiff Wire Guide using percutaneous entry (Seldinger) technique. All Minipuncture
central venous catheters have a removable inner cannula, which must be removed after introduction.

INTENDED USE

The central venous catheter is designed for treatment of critically ill patients and is suggested for:
1. Continuous or intermittent drug infusions
2. Central venous blood pressure monitoring (CVP)
3. Acute hyperalimentation
4. Blood sampling
5. Delivery of whole blood or blood products
6. Simultaneous, separate infusion of drugs
The activity of the antimicrobial agents, minocycline and rifampin, is localized at the internal and
external catheter surface and is not intended for treatment of systemic infections. The device is a
short-term use catheter.

CONTRAINDICATIONS

•
Allergy or history of allergy to tetracyclines (including minocycline) or rifampin.
NOTE: The warnings and precautions regarding use of minocycline (a derivative of tetracycline)
and rifampin (a derivative of rifamycin B) apply and should be adhered to for use of this device,
although systemic levels of minocycline and rifampin in patients receiving this device are highly
unlikely to result from its use.
•
Minocycline and rifampin are agents that do not induce any genotoxic risks except a possible
teratogenic effect in pregnant women. We therefore do not recommend the use of Spectrum or
Spectrum Glide catheters in pregnant women.
WARNINGS
•
Every effort must be made to ascertain proper tip position in order to prevent erosion or
perforation of central venous system. Tip position should be verified by x-ray and monitored on
a routine basis. Periodic lateral view x-ray is suggested to assess tip location in relation to vessel
wall. Tip position should appear to be parallel to vessel wall.
•
To avoid vascular injury, do not use excessive force when advancing dilators. Use the smallest
size dilator catheter placement will allow. Wire guide must always lead dilator by several
centimeters. Do not advance dilator more than a few centimeters into the vessel.
•
Do not power inject contrast medium through catheter. Catheter rupture may result. Use of
10 cc or larger syringe will reduce the risk of catheter rupture.
AND SPECTRUM GLIDE
®
3
ENGLISH
CENTRAL
™
®