English; Contraindications - Medtronic Phenom Bedienungsanleitung

English

Instructions for Use
Phenom™ Catheter
CAUTION
• Federal (USA) law restricts this device to sale, distribution, and use by or on the order of a physician .
• This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures .
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 Phenom™ 17, 21, and 27 Catheters have a
hydrophilic coating that spans the distal 100cm . The Phenom™ Plus Catheters have a hydrophilic coating that
spans the distal 90cm . 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 . The Phenom™ Catheter is packaged with a shaping mandrel and may be accompanied with a split
introducer sheath .
DEVICE FEATURE AND 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
French Inch
2 . 2 0 . 0 29
1 . 8 0 . 0 24
- 0 . 0 17
- 0 . 0 17
- ≥ 0 . 0 35
- ≤ 0 . 0 14
French Inch
2 . 6 0 . 0 34
2 . 3 0 . 0 30
- 0 . 0 21
- 0 . 0 21
- ≥ 0 . 0 38
- ≤ 0 . 0 18
French Inch
3 . 1 0 . 0 40
2 . 8 0 . 0 36
- 0 . 0 27
- 0 . 0 27
- ≥ 0 . 0 45
- ≤ 0 . 0 25
French Inch
4 . 7 0 . 0 61
4 . 2 0 . 0 55
- 0 . 0 45
- 0 . 0 45
- ≥ 0 . 0 70
- ≤ 0 . 0 41
INTENDED PURPOSE / INDICATIONS FOR USE
en
Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the
neuro, peripheral, and coronary vasculatures .

CONTRAINDICATIONS

There are no known contraindications .
DIRECTIONS FOR USE
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
use .
2 . For catheters packaged in protective coil dispenser, flush the dispenser with saline/heparinized saline
through the luer fitting connected to the end of the coil dispenser . Repeat if friction is felt when
attempting to remove the catheter .
3 . For catheters packaged in a tray, hydrate the catheter in the tray with saline/heparinized saline .
CAUTIONS: Do not attempt to use catheters without flushing or hydrating first with saline/heparinized
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 .
WARNING
Do not use catheters that are damaged in any way . Damaged catheters may break or rupture causing vessel
damage or tip detachment during the procedure .
5 . Shaping mandrel:
mm
• Remove shaping mandrel from mandrel card and insert into distal tip of the catheter .
0 . 7 4
• Bend the catheter tip and shaping mandrel to desired shape .
0 . 6 1 • Hold shaping mandrel and catheter tip 1" from a steam source for approximately 10 seconds to
set shape . Remove from heat source and allow cooling in either air or saline prior to removing the
0 . 4 3
mandrel .
0 . 4 3
• Discard shaping mandrel .
≥ 0 . 8 9
WARNING
≤ 0 . 3 6
Shaping mandrel is not for in-vivo use .
6 . Prior to use, flush the lumen of the catheter with saline/heparinized saline solution by attaching a saline/
mm heparinized saline filled syringe to the catheter hub .
7 . Carefully insert an appropriate guidewire into the hub and advance into the catheter lumen .
0 . 8 6
8 . Place an appropriate guiding catheter using standard percutaneous technique . Attach a rotating
0 . 7 6
hemostasis valve to the guiding catheter luer connector and maintain a continuous flush .
0 . 5 3
9 . A split introducer sheath is included with Phenom™ 17 models to aid in insertion into hemostatic valve . To
use, slide the split Introducer sheath from the proximal end until it covers the distal end of the catheter .
0 . 5 3
10 . Introduce the catheter and guidewire into the guiding catheter through the hemostasis adaptor . Tighten
≥ 0 . 9 7
the valve around the catheter to prevent backflow but allowing movement of the catheter through the
≤ 0 . 4 6
valve .
11 . Advance the catheter and guidewire to the selected target site by alternately advancing the guidewire and
then tracking the catheter over the guidewire .
12 . If using split introducer, slide the introducer back to the proximal end of the catheter next to the hub .
mm
13 . Withdraw the guidewire from the catheter . Connect the desired syringe with infusate or interventional
1 . 0 2
device and continue the procedure according to the manufacturer's instructions .
0 . 9 1
14 . Withdraw the catheter and discard after completing the procedure . Follow your institutional procedures
for disposal of biohazards .
0 . 6 9
NOTE: Flow rates for given pressures and infusates are provided below as a reference and are approximate
0 . 6 9
values .
≥ 1 . 1 3
≤ 0 . 6 4
mm
1 . 5 5
1 . 4 0
1 . 1 3
1 . 1 3
≥ 1 . 7 8
≤ 1 . 0 4
3