Handling And Storage; Instructions For Use; Description; Inspection Prior To Use - Boston Scientific Emerge MONORAIL OVER-THE-WIRE Gebrauchsanweisung

HanDLInG anD storaGe

Store in a cool, dry, dark place.

InstrUctIons For Use

One or more of each of the following materials are required for PTCA with the Emerge™ Over-
The-Wire or Emerge Monorail™ PTCA Dilatation Catheter.

Description

• Guidewire(s) of appropriate size for advancement of guide catheter
• Arterial sheath and dilator set (for femoral approach only)
• Femoral or brachial guide catheter(s) in the appropriate size and configuration to select
the coronary artery; minimum I.D. of guide catheter = 0.066 in (1.68 mm) (Emerge Over-
The-Wire Catheter)
• Femoral or brachial guide catheter(s) in the appropriate size and configuration to select
the coronary artery; minimum I.D. of guide catheter = 0.056 in (1.42 mm) (Emerge Monorail
PTCA Catheter)
• Vial of contrast medium
• Sterile saline or heparinized normal sterile saline
• Inflation device with manometer
• Emerge Over-The-Wire PTCA Dilatation Catheter(s)
• Emerge Monorail PTCA Dilatation Catheter(s)
• ≤0.014 in (0.36 mm) x 300 cm guidewire(s) (Emerge Over-The-Wire Catheter)
• ≤0.014 in (0.36 mm) x 185 cm guidewire(s) (Emerge Monorail PTCA Catheter)
• 10, 12 or 20 ml (cc) luer-lock syringe
• Hemostatic adapter
• Three-way stopcock
• CLIPIT™ Clip (Emerge Monorail PTCA Catheter only)
• Torque device

Inspection prior to Use

Prior to angioplasty, carefully examine all equipment to be used during the procedure,
including the catheter, to verify proper function. Verify that the catheter and sterile packaging
have not been damaged. Verify that the catheter size is suitable for the specific procedure for
which it is intended. Do not use if sterile package is damaged.
note: Do not continue to use the catheter if damage occurs or sterility is compromised
during use.

Inflation Device preparation

1. Prepare the inflation device according to the manufacturer's instructions.
2. Purge the system of air.

catheter selection

The inflation diameter of the balloon catheter must not exceed the diameter of the coronary
artery proximal and distal to the stenosis. If the stenosis cannot be crossed with the desired
catheter, use a smaller diameter catheter to pre-dilate the stenosis to facilitate passage of a
more appropriately-sized catheter.

catheter preparation

1. Remove the catheter from the protective hoop. Use care when removing the catheter to
avoid damage (e.g., shaft kink).
2. Remove the balloon protector and mandrel by grasping the catheter just proximal to the
balloon catheter (at the proximal balloon catheter bond site). With the other hand, gently
grasp the balloon protector and remove distally. For Emerge Over-The-Wire Catheters,
the mandrel will slide off with the balloon catheter protector. For Emerge Monorail PTCA
Catheters, remove the mandrel distally after removing the balloon protector.
caution: If unusual resistance is felt during removal of the balloon protector or mandrel,
do not use the catheter and replace with another.
3. The Emerge Monorail PTCA Catheter may be coiled once and secured using the CLIPIT
Clip provided in the catheter package. Only the proximal shaft should be inserted into the
CLIPIT clip; the clip is not intended for the distal end of the catheter. Remove the CLIPIT
Clip prior to inserting the catheter into the patient's body.
note: Care should be taken not to kink the shaft of the catheter upon application or
removal of the CLIPIT Clip.
4. Prepare the catheter for purging. Fill a luer lock syringe or inflation device with
appropriate balloon catheter inflation medium (e.g., the equivalent of a 50:50 mixture of
contrast medium and sterile saline). Do not use air or any gaseous medium to inflate the
balloon catheter.
5. Connect a three-way stopcock to the port fitting on the catheter. Flush through the
stopcock. Connect syringe or inflation device to stopcock. Assure luer connections are
properly aligned to avoid stripping the luer thread causing subsequent leakage and use
care when connecting the catheter to avoid damage (e.g., shaft kink).
6. Hold the syringe or inflation device with the nozzle pointing downward and aspirate for 5
seconds. Release the plunger or open stopcock to air.
7. Remove the syringe or inflation device and evacuate all air from the barrel.
8. Reconnect the syringe and aspirate until bubbles no longer appear during aspiration.
If bubbles persist, check luer connections. If bubbles still persist, inflate the balloon to
verify that there are no leaks present prior to insertion. Do not use the balloon catheter if
there are any leaks.
9. To remove any air lodged in the distal luer fitting of the inflation device, purge
approximately 1 ml (cc) of contrast medium while holding the inflation device pointing
upwards.
10. Disconnect the syringe used in preparation. Verify that a meniscus of contrast medium is
evident in both the balloon catheter port and the inflation device connection to ensure a
fluid to fluid connection. Adding a drop of inflation medium to the port may be necessary.
Securely couple the inflation device to the balloon catheter port of the catheter.
11. Open the stopcock to the catheter and leave on neutral.

Insertion procedure

1. Guidewire Lumen Flush.
A. For Emerge Monorail PTCA Catheters, flush the guidewire lumen of the catheter with
sterile saline through the distal tip of the catheter.
B. For Emerge Over-The-Wire Catheters, flush the guidewire lumen of the catheter with
sterile saline through the guidewire port of the catheter hub.
C. Check for bends, kinks and other damage. Do not use if any defects are noted.
2. Catheter Advancement
A. Prepare the vascular access site according to standard practice.
B. Maintain neutral pressure on the inflation device attached to the catheter.
C. Insert a guidewire through the hemostatic adapter following the manufacturer's
instructions or standard practice. Advance the guidewire carefully into the guide
catheter. When complete, withdraw the guidewire introducer, if used.
D. Attach a torque device to the guidewire, if desired. Under fluoroscopy, advance the
guidewire to the desired vessel, then across the stenosis or stent.
E. Backload the distal tip of the catheter onto the guidewire ensuring that the guidewire
exits the midsection opening in the Emerge Monorail PTCA Catheter or the wire
port of the Emerge Over-The-Wire Catheter manifold. When loading or exchanging
the catheter, it is recommended to thoroughly wipe the guidewire clean for better
catheter movement on the guidewire.
5
Black (K) ∆E ≤5.0