Covidien HawkOne H1-LS-INT, Инструкция по эксплуатации

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INSTRUCTIONS FOR USE
DEvICE DESCRIpTION
The HawkOne™ directional atherectomy system (HawkOne™ catheter and cutter driver) is designed for
the treatment of de novo and restenotic atherosclerotic calcified and non-calcified lesions located in
native peripheral arteries. When used in complex, hard, calcified lesions, it is recommended that the
HawkOne catheter should be paired with the SpiderFX™ embolic protection device to mitigate risk of
distal embolization that may be generated by the breakdown of heavily calcified plaque. The HawkOne
catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the
HawkOne catheter is a small cutting assembly comprised of a rotating inner blade contained within a
tubular housing. The proximal end of the HawkOne catheter contains a connector and cutter positioning
lever (thumb switch) designed to fit into the cutter driver. The cutter driver (catalog number H1-14550)
is a battery-driven, internally powered device, designed to power the HawkOne directional atherectomy
catheter. For information about the SpiderFX embolic protection device, reference the Instructions for Use
provided with the device.
The HawkOne directional atherectomy system has two switches: 1) the cutter driver main power switch
and 2) the HawkOne catheter thumb switch. The cutter driver main power switch supplies power to the
device when turned On. The HawkOne catheter thumb switch activates the drive shaft and engages
the cutter when pulled proximally to the On position. With the cutter engaged, the HawkOne catheter
is slowly advanced across the lesion, shaving occlusive material from the artery. The excised tissue is
captured and stored in the tip of the device. The cutting process is completed by advancing the HawkOne
catheter thumb switch distally deactivating the drive shaft and disengaging the cutter. The HawkOne
catheter thumb switch is fully advanced distally to the Off position in order to pack the excised plaque
into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque
excision.
DEvICE COMpATIBILITY
The HawkOne™ cutter driver (catalog number H1-14550) is not backward compatible with previously
released TurboHawk™ and SilverHawk™ catheters. It is designed to work with the catheter models listed
in
Table 1
.
The HawkOne catheter models listed in Table 1 are not compatible with previously released cutter drivers
(catalog numbers FG-02550).
Table 1. HawkOne™ System Specifications and Cutter Driver Compatibility
Specification Catalog Number
Product Catalog Number H1-LS-INT H1-LX-INT
Model: LS LX
Cutter driver compatibility H1-14550 H1-14550
Effective length 107 cm 104 cm
Tip Length 6.6 cm 9.6 cm
Maximum catheter profile 2.6 mm 2.6 mm
Maximum guidewire diameter 0.014" (0.36 mm) 0.014" (0.36 mm)
Recommended sheath size 7 F (2.5 mm) 7 F (2.5 mm)
Vessel range 3.5 mm - 7.0 mm 3.5 mm - 7.0 mm
Nominal voltage: 9 V 9 V
NOTE:
The cutter driver is protected against electrical shock (defibrillation proof- type CF). Keep the
Cutter Driver dry (IPX0).
ILLUSTRATION AND NOMENCLATURE
CATHETER:
Cutter positioning lever (thumb switch)
Flush port
Torque knob
Strain relief
INDICATIONS FOR USE
The HawkOne™ directional atherectomy system is intended for use in atherectomy of the peripheral
vasculature. The HawkOne catheter is NOT intended for use in the coronary, carotid, iliac or renal
vasculature.
CONTRAINDICATIONS
• Do not use in the coronary arteries, carotid artery or in the iliac or renal vasculature.
• Do not use for in-stent restenosis at the peripheral vascular site.
WARNINgS
• The HawkOne catheter should only be used by physicians trained in percutaneous peripheral
interventional procedures.
• Use of this device should be limited to facilities where surgical support is readily available in the
event of a serious complication.
• The HawkOne catheter may only be used with the cutter driver (H1-14550).
• This device is supplied STERILE for single use only. Do not reprocess or re-sterilize. Reprocessing
and re-sterilizing could increase the risk of patient infection and risk of compromised device
performance. In case of damage to the packaging or the device, please discard the unit.
• Do not use the device after the labeled “Use By” expiration date.
• This device should not be used in the presence of combustible or flammable gases, anesthetics,
cleaners/disinfectants, or in an oxygen rich environment.
• Always use direct fluoroscopic observation when manipulating the HawkOne catheter in
the peripheral vessels. If resistance is met during manipulation, determine the cause of the
resistance before proceeding.
• Never advance the distal tip of the HawkOne catheter near the floppy end of the guidewire. A
HawkOne catheter advanced to this position may not follow the guidewire when it is retracted
and cause the guidewire to buckle into a loop. If this occurs, the catheter and guidewire should
be removed together to prevent potential damage to vessel walls. If resistance is still felt, the
sheath should also be removed as part of the unit.
• The cutter section of the HawkOne catheter is a rigid component. Do not use excessive force or
torque to advance the catheter device failure may result.
• Do not use the HawkOne catheter in bends in excess of 90°. Doing so may result in device failure.
• Operation of the device with the blade partially opened or closed could result in vessel trauma
or possible embolization of previously excised tissue.
• When using the HawkOne catheter with the SpiderFX™ device, 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.
• Exceeding the recommended maximum length of cut or storage capacity of the catheter tip
prior to removing and emptying the device will increase the risk of embolization of excised
tissue fragments.
• 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.
• 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.
• Use of the cutter driver is limited to a normal clinical environment (Temperature 10–28 °C;
Pressure 700–1060 hPa; Humidity 30–75 %).
CUTTER DRIvER:
Insert catheter into cutter driver handle
Main power switch
Cutter window
Closed
Cutter window
Open
Tip deflected