Covidien HawkOne Instrucciones De Uso página 4

CAUTION: Do not use excessive force, pinch, or bend the tip of the catheter 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.
j. Retighten the hemostasis valve (if applicable) to prevent blood loss.
CAUTION: Do not over tighten the Tuohy-Borst hemostasis valve if using a Tuohy-Borst
sheath as this may inhibit smooth advancement and rotation of the HawkOne™ catheter or
possibly damage the shaft.
2. Lesion Treatment
a. Using fluoroscopic guidance, carefully advance the HawkOne catheter to the edge of the target
lesion.
WARNINg: Avoid excessive movement of the HawkOne catheter within the vessel at all times
as doing so could result in embolization or vessel damage. In addition, excessive catheter
manipulation with the cutter window open could result in embolization of previously excised
tissue fragments.
WARNINg: The cutter section of the HawkOne catheter is a rigid component. Do not use
excessive force or torque to advance the HawkOne catheter as device failure may result.
WARNINg: Do not use the HawkOne catheter in bends in excess of 90°. Doing so may result in
device failure.
NOTE: If the HawkOne catheter cannot be advanced across the lesion, it may be necessary to
carefully remove the HawkOne catheter and pre-dilate the lesion with a small diameter balloon
angioplasty catheter.
b. Carefully rotate the HawkOne catheter blade window toward the treatment site. Additional
angiographic assessment should be performed to confirm HawkOne catheter position in relation
to the lesion.
NOTE: The cutter housing surrounding the cutter and the entire distal tip are radiopaque to
facilitate angiographic visualization of the device orientation.
Right Anterior/Posterior
proximal
Distal
Figure 2. Cutter housing
CAUTION: If the HawkOne catheter is not rotating easily, do not torque the catheter shaft
more than 360º in one direction. Doing so could result in tip fracture or other device failure.
Device repositioning or lesion predilatation may be required.
c. To begin directional artherectomy, retract the thumb switch which will expose the rotating blade
and deflect the catheter tip.
NOTE: When advancing or retracting the thumb switch, the switch must be moved until a "click"
is felt at the end of the thumb switch travel. This indicates that the catheter has achieved its FULLY
retracted or FULLY advanced position.
WARNINg: Operation of the device with the blade partially opened or closed could result in
vessel trauma or possible embolization of previously excised tissue.
d. With the motor running, slowly advance the HawkOne catheter through the target lesion under
fluoroscopic guidance.
CAUTION: The cutter driver is not designed for continuous operation and should not be run
for more than 15 minutes in any 30 minute period.
WARNINg: When using the SpiderFX™ device in combination with the HawkOne catheter,
never advance the distal tip of the HawkOne catheter near the SpiderFX device proximal
radiopaque marker band. Contact with the marker band may result in distal embolization of
the captured debris, as well as vessel trauma or device failure.
Reference the following matrix for the length of cut that may be completed for the corresponding
catalog number. Recommended cut speed is 2 mm/sec.
Catalog number Length of Cut
H1-LS-INT 50 mm
H1-LX-INT 75 mm
Subsequent passes should not exceed remaining storage capacity in the tip. Determine fullness of
tip from tactile feel of the thumb switch and by using fluoroscopic guidance to assess how far the
cutter travels into the tip.
WARNINg: Exceeding the recommended maximum length or storage capacity of the catheter
tip prior to removing and emptying the device will increase the risk of embolization of
excised tissue fragments.
NOTE: If using the SpiderFX device, it should be frequently observed under fluoroscopy to verify
that the filter has not become occluded with debris, resulting in slow/no-flow. If the filter becomes
occluded or flow is compromised, the HawkOne catheter should be removed and the filter
recovered. Once recovered, the filter cannot be reintroduced into the body. A new filter should be
deployed per the SpiderFX™ embolic protection device Instructions for Use.
e. Once the end of the target segment is reached, stop advancing the catheter. Carefully advance
the thumb switch to close the cutter and turn off the cutter driver, this will be indicated by a
tactile "click".
WARNINg: If the HawkOne catheter does not advance easily, close the cutter by advancing
the thumb switch. Excessive force should not be used to advance the thumb switch. Device
repositioning or predilatation may be required.
f. At this point, a combination of angiographic and/or intravascular ultrasound imaging should be
used to assess the extent of directional atherectomy.
NOTE: If using the SpiderFX device, verify that the filter has not become occluded with debris,
prior to making additional cutting passes with the HawkOne catheter.
g. The HawkOne catheter may be re-advanced and positioned for the additional cut by repeating
steps 2a through 2f if there is adequate storage capacity remaining in the tip (see note below).
NOTE: If the thumb switch cannot be fully advanced (after completing a cut) the tip may be at full
capacity. Proceed to the Catheter Removal and Tissue Removal steps below.
3. Catheter Removal
a. The catheter should be carefully removed from the patient under fluoroscopic guidance.
b. Final angiographic and/or intravascular ultrasound evaluation should be post HawkOne catheter
treatment.
4. Tissue Removal
a. Offload the catheter from the 0.014" guidewire.
b. Fully advance the thumb switch to the closed and Off position. Turn the main power switch on the
cutter driver to Off.
c. Gently wipe down the outside of the tip and catheter with wet gauze.
d. Slide the Distal Flush Tool (DFT) onto the distal end of the catheter and gently seat the flush tool
against the hard stop at the distal end.
NOTE: The Flush window should be visible outside of the seal.
Left
e. 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.
f. Fill a syringe (10 cc recommended) with saline and attach the syringe to the luer on the DFT.
g. Retract the thumb switch to the On position to expose the cutter within the cutter window.
h. Flush the tip with one constant stroke of 5-10 cc/sec. (Repeat if necessary to remove tissue.)
i. Use tweezers to retrieve exposed tissue from the flush window if it does not fully exit the window.
CAUTION: Avoid using excessive force with tweezers when removing tissue to avoid
damaging the device.
j. Fully advance the thumb switch to the closed and Off position.
k. Rotate the distal end of the tip back to the closed position such that the guidewire lumens align.
l. Slide the DFT back to the proximal end of the catheter.
CAUTION: Do not attempt to remove the flush tool from the catheter. Doing so will damage
the catheter, making it non-functional.
m. Turn the main power switch of the cutter driver to the On position.
5. Repeated Insertion and Use
a. If additional insertions are to be made, repeat from step 1c in "Insertion and Use".
b. This cutting sequence can be repeated as necessary to achieve the desired degree of plaque
excision.
NOTE: In vitro testing in severely calcified cadaver lesions has demonstrated minimal cutter wear
after cutting calcified lesions totaling 500 mm in length. Device performance was maintained
throughout testing.
CAUTION: 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.
DISpOSAL
Follow local governing ordinances and recycling plans regarding disposal or recycling of device
components. Do not incinerate the cutter driver unit, as the enclosed batteries may explode at excessive
temperatures.
CAUTION: 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 Batteries Directive, 2006/66/EC, introduces new requirements, effective September 26, 2008,
regarding removability of batteries from waste equipment in EU Member States. To comply with this
directive, this device has been designed for safe removal of the batteries at end-of-life by a waste
treatment facility. Infected units should be de-contaminated before they are sent for recycling. In the
event that it is not possible to decontaminate the unit for recycling, the hospital should not attempt to
remove the batteries from waste equipment. Continued disposal of small amounts of portable batteries
to landfill and incineration is allowed under the Batteries Directive and Member State regulations.
ELECTROMAgNETIC COMpATIBILITY LIMITS
This equipment has been tested and found to comply with the EMC limits for the Medical Device
Directive 93/42/EEC (EN 55011 Class B and EN 60601-1-2) and the IEC 60601-1, 2012 (3.1 Edition). The
cutter driver needs special precautions regarding electromagnetic compatibility (EMC) and needs to be
installed and put into service according to the EMC information provided in this document. The cutter
driver can radiate radio frequency energy and users could experience harmful interference to or from
other devices (test by turning the cutter driver off and on). Correct the interference by reorientating
or relocating the receiving device, increasing the separation between devices or consulting the
manufacturer of the equipment experiencing the interference.
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Flush window
Figure 3. Distal Flush Tool