Nipro infraredx Dualpro IVUS+NIRS Instructions For Use Manual

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Catheter Description
The Dualpro™ IVUS+NIRS imaging catheter is a single use, disposable coronary catheter
designed for use with the Infraredx Makoto™ IVUS+NIRS Imaging System, TVC-MC10
and TVC-MC10i models. The catheter usable length is 160 cm with 2.4F, 3.4F, 3.2F and
3.6F profiles for the tip, Tracking Reinforcement Sleeve (TRS), window, and shaft,
respectively. The distal 50cm is coated with a low friction hydrophilic coating which is
activated on exposure to liquid. The catheter outer body is made up of a soft, atraumatic
tip, a clear imaging window, and a stiffer proximal shaft. The catheter is intended to be
introduced into the vasculature via a 0.014in coronary guidewire. A guidewire lumen at
the distal tip of the catheter allows the catheter to track along the wire. The guidewire is
allowed to exit approximately 12 mm proximal to the distal tip. A 17cm clear imaging
window is located proximal to the TRS. Two low-profile polymer markers are placed on
the stiff proximal shaft to aid the user in approximating when the distal tip will exit the
guiding catheter. The catheter fixed handle and priming extension tubing are affixed to the
proximal portion of the catheter sheath body. The catheter rotating hub is affixed to the
proximal portion of the transmission cable. The transmission cable is composed of a high
torque, flexible rotating drive cable, and contains the imaging core. The imaging core
contains a coaxial wire and two optical fibers with an imaging tip at the distal end. The
imaging tip contains an ultrasound transducer and two mirrored surfaces. With the
catheter fixed handle held stationary by the Makoto Controller, the rotating hub can be
advanced and retracted as well as rotated.
Actuation of the rotating hub and transmission cable imparts rotation and translation of
the imaging tip. The motion of the imaging tip within the clear window of the sheath
permits imaging of the artery.
Indications for Use
The Makoto IVUS+NIRS Imaging System is intended for the near-infrared examination
of coronary arteries in patients undergoing invasive coronary angiography. The System
is intended for the detection of lipid-core-containing plaques of interest. The System is
intended for the assessment of coronary artery lipid core burden.
The System is intended for ultrasound examination of coronary intravascular pathology.
Intravascular ultrasound imaging is indicated in patients who are candidates for
transluminal coronary interventional procedures.
Contraindications
Use of the Dualpro IVUS+NIRS catheter is contraindicated where introduction of any
catheter would constitute a threat to patient safety. Contraindications include:

Bacteremia or sepsis

Major coagulation system abnormalities

Severe hemodynamic instability or shock

Patients diagnosed with coronary artery spasm

Patients disqualified for CABG surgery

Total occlusion

Patients disqualified for PTCA

Patients who are not suitable for IVUS procedures
Complications
The following complications may occur as a consequence of intravascular examination:

Arterial dissection, injury, or perforation

Acute myocardial infarction

Ventricular fibrillation

Total occlusion

Unstable angina

Air embolism

Abrupt closure

Death

Cardiac Tamponade

Thrombus Formation
After use, dispose of the product and packaging in accordance with
hospital and/or local government policy.
WARNING
NEDERLANDS 12
pg.
SLOVENČINA 14
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For single use only. Do not reuse, reprocess, or resterilize. Reuse,
reprocessing, or resterilization may compromise the structural
WARNING
integrity and result in poor image quality or patient injury, illness, or
death. Reuse, reprocessing, or resterilization may also contaminate
the device and result in patient infection which may lead to patient
illness or death. Infraredx makes no performance claim for product
that is reused, reprocessed, or resterilized.
Materials and Equipment (*Sold Separately)
Dualpro IVUS+NIRS Imaging Catheter
Makoto Controller Sterile Barrier
Priming Accessories
*Makoto IVUS+NIRS Imaging System
*Makoto IVUS+NIRS Imaging System User Manual
*Pre-formed guide catheter (0.067 inches  1.70mm I.D. min., 6F)
*Guidewire, 0.014 inches (0.36mm) maximum diameter
*Heparinized normal saline
Instructions for Use
Refer to the Makoto IVUS+NIRS Imaging System User Manual for guidance on
preparation of the Makoto IVUS+NIRS Imaging System and Makoto Controller.
Inspection Prior to Use
Prior to use, ensure that the catheter has not been damaged or breached and that no
particulate is present inside the catheter. Prior to scanning, all equipment to be used
during the procedure should be carefully examined for defect to ensure proper
performance.
Catheter Preparation
1. Using sterile technique, open the pouch and remove entire card with catheter from
outer packaging. DO NOT remove catheter from the hoop until the hydrophilic
coating has been activated;
2. Remove priming syringes from packaging;
3. Fill 10mL and 3mL syringes with heparinized saline and connect to the three-way
stopcock.
4. Using the gray catheter cap, gently withdraw the catheter imaging core from the
catheter handle until it stops.
5. Prime the Dualpro catheter TWICE using the 3 mL syringe. Use the 10 mL syringe
as a reservoir to refill the 3 mL syringe. Priming the catheter in the hoop will activate
the hydrophilic coating.
6. Using the gray cap, turn the colored side of the rotating hub to match the
corresponding colored fixed handle button. Push the rotating and fixed handle
together. An audible click will signal complete closure.
The catheter is now primed. The gray protective cap should remain on the catheter until
ready to connect to the Makoto Controller.
DO NOT use any type of contrast media either in replacement of or
in combination with the saline as priming medium.
CAUTION
Connecting the Dualpro™ Imaging Catheter to the Makoto™ Controller
If Controller Sterile Barrier is contaminated or damaged at any time,
immediately replace with a new Controller Sterile Barrier.
WARNING
The catheter must be connected to the Makoto Controller by a sterile operator in the sterile
field. However, before connecting the catheter, you must:
1. Prepare the Controller for sterile use, by covering the Makoto Controller with the
sterile barrier (Refer to Makoto IVUS+NIRS Imaging System User Manual).
2. Confirm that the sterile barrier gasket is engaged to the Makoto Controller
connection socket.
3. Remove the blue covering from the sterile barrier that covers the catheter
connection socket by separating along the perforated tape.
Do not contaminate the fiber faces of the catheter or Makoto
Controller during the connection process.
CAUTION
.
4. Remove the Dualpro Imaging Catheter from the hoop.
5. Remove the protective cap from the catheter by holding the fixed hub and pulling
the gray cap.
6. Align the catheter, oriented with the colored side up, with the Makoto Controller
catheter connection socket.
7. Insert the catheter into the socket and turn the catheter handle clockwise until the
tactile response is felt.
8. Confirm the connection by observing the READY state indication on the Makoto
Controller.
When connected to the Makoto IVUS+NIRS Imaging System, laser
radiation is emitted from the distal end of the catheter. Do not stare
WARNING
into beam or view directly with optical instruments
9. With the connected catheter in the READY position, prime the system with
heparinized saline using the 3 mL priming syringe.
10. Assess the IVUS image on the screen by enabling Live IVUS. Concentric bright
rings will appear in the transverse IVUS image with a successful prime.
TVC-C195-42
IFU0158rB
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