Covidien HawkOne Instrucciones De Uso página 3

pRECAUTIONS
• Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.
• The HawkOne™ catheter (model numbers LX and LS) and the cutter driver (model number
H1-14550) are not backward compatible with previously released models. See Table 1 for
compatibility information.
• Do not sharply bend or kink the HawkOne catheter shaft during handling as this could damage
the device and impair its function.
• Do not use excessive force, pinch, or bend the tip when inserting the catheter through the
hemostasis valve of the sheath. Using excessive force, pinching, or bending the tip may damage
the device and impair its function.
• Once cutter driver and catheter are locked, they should not be disconnected. Do not attempt
to disconnect catheter and cutter driver. Doing so will damage the system, making it
non-functional.
• Do not attempt to remove the flush tool from the catheter. Doing so will damage the catheter,
making it non-functional.
• Refer to Table 1 for recommended sheath size requirements. Use of sheaths smaller than those
recommended may compromise device performance.
• When using the SpiderFX™ device in combination with the HawkOne catheter, the SpiderFX™
filter must be deployed such that the proximal radiopaque marker is no less than 8 cm (for LS
use) or 11 cm (for LX-C use) distal to the lesion. Failure to appropriately place the filter may
compromise device performance.
• The Guidewire MUST go through BOTH lumens; otherwise, the tip may be open. Operation of the
device with the tip open could result in embolization of excised tissue.
• If using a Tuohy-Borst sheath, do not over tighten the Tuohy-Borst hemostasis valve as this
may inhibit smooth advancement and rotation of the HawkOne catheter or possibly damage
the shaft.
• If HawkOne catheter is not rotating easily, do not torque the shaft more than 360° in one
direction. Doing so could result in tip fracture or other device failure. Device repositioning or
lesion predilatation may be required.
• Avoid using excessive force with tweezers when removing tissue to avoid damaging the device.
• Cutting extended lengths in severely calcified lesions may result in cutter wear. If increased
resistance is encountered during a cutting pass, this may indicate that the device needs to
be replaced.
• The cutter driver is a single use device. Do not open the cutter driver enclosure, modify the
cutter driver components, or change the cutter driver battery. Opening or modifying the cutter
driver could result in damage to the device and/or injury to the patient or physician.
• The cutter driver is not designed for continuous operation and should not be run for more than
15 minutes in any 30 minute period.
pOTENTIAL COMpLICATIONS / ADvERSE EvENTS
Potential adverse events associated with use of this device and other interventional
catheters include, but are not limited to, the following:
• Amputation • Embolism and/or arterial thrombosis
• Aneurysm • Emergency or non-emergency arterial bypass surgery
• Arterial dissection • Entry site complications
• Arterial perforation • Hypotension
• Arterial rupture • Infection
• Arterial spasm • Ischemia
• Arteriovenous fistula • Restenosis of the treated segment
• Bleeding complications • Total occlusion of the peripheral artery
• Death • Vascular complications which may require surgical repair
HOW SUppLIED
The HawkOne catheter and cutter driver are packaged and sterilized individually. Both are intended for
single patient use only.
STORAgE, TRANSpORT, AND USE CONDITIONS
Store the sterile packaged HawkOne catheter and cutter drivers in a cool dry place until ready to use.
The cutter drivers should be stored and transported within the following ranges: temperature, -29–60 °C;
pressure, 700–1060 hPa; and humidity, less than 85%.
Do not expose either device to organic solvents, ionizing radiation, ultraviolet light or alcohol-based
fluids.
WARNINg: This device should not be used in the presence of combustible or flammable gases,
anesthetics, cleaners/disinfectants, or in an oxygen rich environment.
DIRECTIONS FOR USE
INSpECTION
1. Prior to use, carefully inspect the HawkOne catheter and cutter driver to verify that neither the sterile
packaging nor the devices themselves have been damaged.
CAUTION: The HawkOne catheter (model numbers LX and LS) and the cutter driver (model
number H1-14550) are not backward compatible with previously released models. See Table 1
for compatibility information.
2. Connect the HawkOne catheter to the cutter driver by inserting the proximal end of the catheter into
the motor. Ensure the thumb switch aligns with the slot in the cutter driver. When fully inserted, the
catheter connector will lock into the cutter driver.
CAUTION: Once cutter driver and catheter are locked, they should not be disconnected. Do not
attempt to disconnect catheter and cutter driver. Doing so will damage the system, making it
non-functional.
NOTE: To avoid accidental activation of the cutter driver, be sure the thumb switch is in the fully
forward position prior to insertion into the cutter driver.
3. To confirm functionality of the HawkOne catheter, advance and retract the thumb switch. Ensure
that the motor turns on and off automatically and that the inner cutter moves freely. The catheter tip
should deflect and return to its original configuration as the cutter position is cycled. Advance the
thumb switch to close the cutter window and turn the motor to Off.
NOTE: The automatic motor control feature of the cutter driver can be disabled by using the main
power switch. When the switch is up, the automatic motor control is enabled. When the switch is
down, the thumb switch can be advanced and retracted without activating the motor.
4. Inspect the shaft, cutter housing and distal tip for smooth transitions. Do not use the catheter if a
sharp edge or protrusion is detected.
CAUTION: Do not sharply bend or kink the catheter shaft during handling as this could
damage the device and/or impair its function.
5. Check the catheter shaft for functionality of the hydrophilic coating. When wetted with sterile saline,
the catheter shaft should feel slippery.
NOTE: To facilitate catheter handling, the proximal most portion of shaft is not coated.
Should the catheter become kinked or damaged during use, replace the damaged catheter and
cutter driver with a new system and return the used system to Covidien for evaluation.
pREpARATION
1. purge Air from the Catheter
a. Fill a syringe (3 cc or larger) with heparinized saline.
b. Ensure the main power switch on the cutter driver is turned to the Off position. Retract the thumb
switch to the On position to expose the cutter within the cutter window.
c. Flush the HawkOne catheter shaft by attaching the heparinized saline filled syringe to the
HawkOne catheter flush port. Gently apply pressure to the syringe until all air has been flushed
from the HawkOne catheter and saline is seen exiting the cutter window.
d. Fully advance the thumb switch to the Off and closed position.
e. Submerge the catheter tip in saline and wet the entire catheter length to activate the hydrophilic
coating.
f. Slide the Distal Flush Tool (DFT) from the proximal to the distal end of the catheter and gently seat
the flush tool against the hard stop at the distal end.
NOTE: The flush window in the catheter tip should be visible outside the DFT distal seal.
Figure 1. Distal Flush Tool
g. Rotate the distal end of the tip 180° clockwise to open the flush window. Point tip away from all
individuals and/or cover with cloth to avoid spray.
h. Fill a syringe (10 cc recommended) with saline and attach it to the luer on the DFT.
i. Retract the thumb switch to the On position to expose the cutter within the cutter window.
j. Flush the tip until fluid exits the distal end of the tip.
k. Fully advance the thumb switch to the closed and Off position.
l. Rotate the distal end of the tip back to the closed position such that the guidewire lumens align.
CAUTION: Do not attempt to remove the flush tool from the catheter. Doing so will damage
the catheter, making it non-functional.
m. Slide the DFT back to the proximal end of the catheter.
n. Turn the main power switch of the cutter driver to the On position.
INSERTION AND USE
Once prepared, the catheter is ready for insertion into the patient.
1. Insertion
a. Prepare the patient and administer the appropriate anticoagulant and vasodilator therapy for
standard percutaneous intervention.
b. Insert the appropriate sized sheath and hemostasis valve using standard techniques.
CAUTION: Refer to Table 1 for recommended sheath size requirements. Use of sheaths
smaller than those recommended may compromise device performance.
c. Angiographic assessment of the vessel should be performed to locate the target lesion.
d. If severe calcium is detected in the treatment area, the SpiderFX™ embolic protection device may
be used in conjunction with the HawkOne catheter. Refer to the SpiderFX Instructions for Use for
appropriate filter sizing and deployment instructions.
CAUTION: When using the SpiderFX device in combination with the HawkOne catheter, the
SpiderFX filter must be deployed such that the proximal radiopaque marker is no less than
8 cm (for LS use) or 11 cm (for LX use) distal to the lesion. Failure to appropriately place the
filter may compromise device performance.
e. Using standard technique, place a guidewire across the target lesion. If using the SpiderFX device,
the capture wire will act as the primary guidewire for the HawkOne catheter.
NOTE: The minimum vessel diameter for the HawkOne catheter is 3.5 mm.
f. Ensure that the thumb switch is in its fully advanced, i.e. closed and off, position.
g. Carefully backload the end of the guidewire through the tip of the HawkOne catheter, making sure
the guidewire travels through BOTH guidewire lumens and exits proximal to the cutter.
CAUTION: The guidewire MUST go through BOTH lumens, otherwise, the tip may be open.
Operation of the device with the tip open could result in embolization of excised tissue.
h. Loosen the hemostasis valve (if applicable) and carefully insert the HawkOne catheter into the
sheath.
i. During insertion, hold the device close to the sheath hub and ensure axial alignment of the
catheter tip with the hemostasis valve.
3
Flush window