English; Product Description - Medtronic Phenom Bedienungsanleitung

English

Instructions for Use
Phenom™ Catheter

PRODUCT DESCRIPTION

The Phenom™ Catheters are variable stiffness, single lumen catheters designed to access small, tortuous
vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface
of the catheter is coated to enhance navigation in the vessel. The catheter also incorporates a liner to facilitate
movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid
visualization and positioning under fluoroscopy.
PRODUCT FEATURE & COMPATIBILITY
Phenom™ 17 Catheter
Proximal OD
Distal OD
Proximal ID
Distal ID
Guiding Catheter or Catheter ID
Guidewire OD
Phenom™ 21 Catheter
Proximal OD
Distal OD
Proximal ID
Distal ID
Guiding Catheter or Catheter ID
Guidewire OD
Phenom™ 27 Catheter
Proximal OD
Distal OD
Proximal ID
Distal ID
Guiding Catheter or Catheter ID
Guidewire OD
Phenom™ Plus Catheter
Proximal OD
Distal OD
Proximal ID
Distal ID
Guiding Catheter or Catheter ID
Guidewire OD
Contents:
1 ea Phenom Catheter
1 ea Shaping Mandrel
French Inch
2.2 -
1.8 -
- 0.017
- 0.017
- ≥ 0.035
- ≤ 0.014
French Inch
2.6 -
2.3 -
- 0.021
- 0.021
- ≥ 0.038
- ≤ 0.018
French Inch
3.1 -
2.8 -
- 0.027
- 0.027
- ≥ 0.0445
- ≤ 0.025
French Inch
4.7 -
4.2 -
- 0.0445
- 0.0445
- ≥ 0.070
- ≤ 0.041
INDICATION FOR USE
en
Phenom™ Catheters are intended for the introduction of interventional devices and infusion of diagnostic or
therapeutic agents into the neuro, peripheral, and coronary vasculatures.
POTENTIAL COMPLICATIONS
Potential complications include, but are not limited to, the following:
• Distal emboli (air, foreign material, tissue
or thrombus)
• Hematoma
• Hemorrhage
• Infection
• Ischemia
CONTRAINDICATIONS
None known.
PRECAUTIONS
1. This device should be used only by physicians trained in percutaneous, intravascular techniques and
mm
procedures.
0.74
2. Inspect the catheter prior to use for any kinks or bends. Any catheter damage may decrease the desired
0.61
performance characteristics.
3. Do not use if package is open or damaged. Contents of unopened, undamaged package are sterile.
0.43
4. Use prior to the "Use By" Date.
0.43
5. Carefully read all instructions prior to use. Failure to observe all warnings and precautions may result in
≥ 0.89
complications.
≤ 0.36
WARNINGS
1. THIS DEVICE IS INTENDED FOR SINGLE USE ONLY. Discard after one procedure. Reuse and/or re-
sterilization can potentially result in compromised device performance and cross contamination.
mm
2. The catheter should be manipulated under fluoroscopy only. Do not attempt to move the catheter
0.86
without observing the resultant tip response.
0.76
3. Never advance or withdraw an intralumenal device against resistance until the cause of resistance is
determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of
0.53
the catheter against resistance may result in damage to the catheter, or the vessel.
0.53
4. The infusion pressure should not exceed the listed pressure as indicated in flowrate charts (below).
≥ 0.97
STERILIZATION/STORAGE
≤ 0.46
• Catheter is sterilized with ethylene oxide gas. Do not re-sterilize.
• Catheter is non-pyrogenic.
• Store in a cool, dark, dry place.
mm
INSTRUCTIONS FOR USE
1.02
1. The Phenom™ Catheters may be packaged in a protective coil dispenser fitted with a flushing luer
connector or in a packaging tray. The catheters have a hydrophilic coating and require hydration prior to
0.91
use.
0.69
2. For catheters packaged in protective coil dispenser, flush the dispenser with heparinized saline through
the luer fitting connected to the end of the coil dispenser. Repeat if friction is felt when attempting to
0.69
remove the catheter.
≥ 1.13
3. For catheters packaged in a tray, hydrate the catheter in the tray with heparinized saline.
≤ 0.64
CAUTIONS: Do not attempt to use catheters without flushing or hydrating first with saline. Failure to do so, may
compromise the coating and lubricity of the catheter.
4. After removing catheter from coil dispenser or tray, inspect to verify that it is undamaged.
mm
WARNING: Do not use catheters that are damaged in any way. Damaged catheters may break or rupture
1.55
causing vessel damage or tip detachment during the procedure.
1.40 5. Shaping mandrel:
• Remove shaping mandrel from mandrel card and insert into distal tip of the catheter.
1.13
• Bend the catheter tip and shaping mandrel to desired shape.
1.13
• Hold shaping mandrel and catheter tip 1" from a steam source for approximately 10 seconds to
≥ 1.78
set shape. Remove from heat source and allow cooling in either air or saline prior to removing the
mandrel.
≤ 1.04
• Discard shaping mandrel.
WARNING: Shaping mandrel is not for in-vivo use.
6. Prior to use, flush the lumen of the catheter with heparinized saline solution by attaching a saline filled
syringe to the catheter hub.
7. Carefully insert an appropriate guidewire into the hub and advance into the catheter lumen.
4
• Neurological deficit that could lead to stroke
and death
• Pain at insertion site
• Vessel spasm, dissection, perforation or
injury