argon audio CLEANER 15 Manual

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English
All directions should be read before use
pages
Directions For Use in Peripheral Vasculature ....... 2-5
Directions For Use in Grafts and Fistulae.............. 6-9
Caution: Federal (USA) law restricts this device to sale by, or on the order of physician.
DEVICE DESCRIPTION:
The CLEANER 15™ Rotational Thrombectomy System is a 7Fr percutaneous catheter
based system (single piece construction). A disposable, hand-held battery operated
rotator drive unit is attached to a sinuous wire which rotates at approximately 4000 RPM.
The wire and atraumatic soft tip are radiopaque for fluoroscopic visualization.
Sliding Lever
(Sinuous Wire Cover/Uncover) Battery Operated Hand Held
Rotator Drive Unit
Sinuous Wire
7 Fr Catheter
Figure 1
On/Off Switch
Catheter Lumen
Flush/Infusion Port
& Stopcock

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Peripheral Vasculature
INDICATIONS FOR USE:
The CLEANER 15™ Rotational Thrombectomy System is indicated for mechanical
declotting of acute symptomatic deep vein thrombosis and controlled and selective
infusion of physician-specified fluids, including thrombolytics, in the peripheral
vasculature.
CONTRAINDICATIONS:
The CLEANER 15™ Rotational Thrombectomy System is contraindicated in the following:
- This system is contraindicated when, in the medical judgment of the physician, such
a procedure may compromise the patient’s condition.
- Not designed for peripheral vasculature dilation purposes.
- This system is not intended for the infusion of blood or bloodproducts.
- Refer to the product insert of the therapeutic solution of choice for indications,
contraindications, side effects, and precautions.
- In native vessels smaller than 6mm in diameter
WARNINGS AND PRECAUTIONS:
- Operation of a thrombectomy catheter may cause embolization of some
thrombus and/or thrombotic particulate. The potential for pulmonary
thromboembolism should be carefully considered when Cleaner is
used to break up and remove peripheral venous thrombus. Physician
discretion with regard to the use of the distal protection in patients
with DVT is advised.
- Prior to use, read all package insert warnings, precautions, and instructions. Failure
to do so may result in severe patient injury anddeath.
- These procedures should only be performed by physicians and staff familiar with the
equipment and techniques involved. The device has been sterilized by EtO and is
sterile unless the package is opened or damaged. The package should be examined
before use; if damaged, DO NOT USE. The device is intended for single patient use
only; DO NOT REUSE OR RE-STERILIZE.
- Prior to use, carefully examine the CLEANER 15™ Rotational Thrombectomy System
to verify that it has not been damaged during shipment. If the product components
show any sign of damage, DO NOTUSE.
- Due to the risk of exposure to HIV (Human Immunodeficiency Virus) or other blood
borne pathogens, health care workers should routinely use universal blood and body
fluid precautions in the care of all patients. Sterile technique must be strictly adhered
to during any handling of the device.
- Do not advance if resistance is met without first determining the cause of resistance
under fluoroscopy and taking any necessary remedial action. Excessive force against
resistance may result in damage to the device orvasculature.
- Prior to introduction, and anytime the CLEANER 15™ is removed from the vascular
system, the catheter should be flushed.
- If the catheter or guidewire becomes kinked or otherwise damaged during use,
discontinue use and replace.
- Practitioners must be aware of potential complications associated with peripheral
vasculature thrombolysis including:
Vessel perforation or rupture Distal embolization of blood clots
Vessel spasm Hemorrhage
Hematoma Pain and tenderness

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Peripheral Vasculature
Sepsis/Infection Thrombophlebitis
Intimal disruption Arterial dissection
Vascular thrombosis Drug reactions
Allergic reaction to contrast medium Arteriovenous fistula
Thromboembolic episodes Amputation
- Potential fatigue failure of the CLEANER 15™ sinuous wire may occur with prolonged
activation of the CLEANER 15™ device. A withdrawal rate of 1-2 cm/second is
recommended when sharp radii are encountered (i.e. radius of a loop graft or fistula,
radii < 3 cm).
A SUGGESTED PROCEDURE:
Use sterile technique.
Patient Preparation:
1. Premedicate with appropriate anxiolytic, analgesic and/or antibiotic per hospital
protocol.
Device Performance Testing:
2. Remove the CLEANER 15™ Rotational Thrombectomy System from the package.
Press the ON/OFF switch to ensure that the sinuous wire spins freely (refer to
Figure 2). Release the switch to stop the rotator. Precaution: Do not use the
device if it does not activate immediately when the switch is pressed, and
deactivate immediately when the switch is released.
Figure 2
3. Attach a syringe of therapeutic agent or heparinized saline to the catheter flush port
and flush the CLEANER 15™ catheter. Be sure that fluid exits from the most distal
catheter hole which is located near the end of the catheter. Close the stopcock to
“lock” the therapeutic agent or heparin in the catheter and remove thesyringe.
Treatment:
The exact treatment procedure is to be determined by the physician. The following
option describes how the procedure may be performed.
Sliding Lever
Sinuous Wire
On/Off Switch

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Peripheral Vasculature
4. Complete the procedure under continuous fluoroscopy. Do not initiate sinuous wire
rotation (device activation) unless proper device positioning is confirmed within the
peripheral vasculature.
5. Prepare and drape the puncture site as required.
6. Administer local anesthetic at the puncture site for venous sheathinsertion.
7. Select an appropriately sized sheath to accommodate the CLEANER 15™ catheter
and other devices/ catheters that may be used during the procedure. Maximum
guidewire size will be dependent upon the introducer sheath/dilator assembly
chosen. If crossing the iliac bifurcation, a long reinforced sheath should beused.
8. Prepare and place the venous introducer sheath per hospital protocol. The venous
sheath should be placed in the venous limb of the peripheral vasculature, and
directed toward the treatment site. The venous sheath placement can be optional
depending on the clot burden in the vessel.
9. Place the device in the covered position by pushing the sliding lever to the distal
position and rotating the sliding lever to lock in the covered position (refer to Figure
3). When in the covered position, only the flexible tip of the sinuous wire should
extend from the catheter. Warning: The device should not be activated in the
covered position.
10. Support the flexible tip between the thumb and index finger during insertion through
the sheath valve. Insert the covered device through the venous sheath and into the
venous limb of the peripheral vasculature.
11. Attach a 10cc syringe containing the therapeutic agent intended for infusion to the
stopcock. Open the stopcock to enable flow. Warning: Do not draw blood back
into the catheter.
Note: Follow the manufacturer’s instructions regarding reconstitution and
dilution of specified fluids.
Sliding Lever Locked in
Covered Position
Covered Sinuous Wire
(Do Not Activate Device
in Covered Position)
Figure 3

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Peripheral Vasculature
12. Advance the flexible tip up to the distal most extent of the clot. Uncover the sinuous
wire by unlocking, fully retracting the sliding lever and rotating the sliding lever until
an audible “click” is heard (refer to Figure 4). Confirm device positioning within the
treatment site via fluoroscopy. Press the ON/OFF switch to activaterotation.
Sliding Lever Locked In Uncovered Position (Deployed)
Figure 4
13. With the device activated, slowly withdraw the rotating sinuous wire along the
treatment site while infusing therapeutic agent through the infusion port to break up
the clot. Warning: A withdrawal rate of 1-2 cm/second is recommended when
sharp radii are encountered. When the sinuous wire reaches the tip of the venous
sheath, release the switch to turn off the rotating dispersionwire.
14. Cover the device and remove it from the peripheral vasculature. Flush the catheter
lumen with heparinized saline and manually remove any accumulated fibrin from the
sinuous wire.
15. Aspirate the macerated clot via the sheath and discard the aspirate. Precaution:
Continued unsuccessful aspiration may collapse the sheath andvessel.
16. Inject a small amount of contrast via the venous sheath to assess the degree of
thrombus removal accomplished. Warning: Avoid over-injection of contrast to
minimize the risk of embolization. Treat the residual thrombus by repeating steps
11-15 until acceptable thrombus removal is achieved.
17. When the thrombus removal is complete, treat any underlying disease or stenosis
per hospital protocol.
18. Perform the final angiogram.
19. Remove the sheaths from the peripheral vasculature.
20. Achieve hemostasis at the puncture site(s) per hospitalprotocol.
Deployed Position
(Uncovered For Device Activation)

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Grafts and Fistulae
INDICATIONS FOR USE:
The CLEANER 15™Rotational Thrombectomy System is indicated for mechanical
declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
CONTRAINDICATIONS:
The CLEANER 15™Rotational Thrombectomy System is contraindicated in the following:
- When in the medical judgment of the physician, such a procedure may compromise
the patient’s condition.
- In native vessels smaller than 6mm in diameter
- Existing hemodialysis access site infection.
- Immature native vessel dialysis fistulae (fistulae that have not been used for at least
one hemodialysis treatment).
WARNINGS AND PRECAUTIONS:
- Prior to use, read all package insert warnings, precautions, and instructions. Failure
to do so may result in severe patient injury anddeath.
- These procedures should only be performed by physicians and staff familiar with the
equipment and techniques involved. The device has been sterilized by EtO and is
sterile unless the package is opened or damaged. The package should be examined
before use; if damaged, DO NOT USE. The device is intended for single patient use
only; DO NOT REUSE OR RE-STERILIZE.
- Prior to use, carefully examine the CLEANER 15™Rotational Thrombectomy System
to verify that it has not been damaged during shipment. If the product components
show any sign of damage, DO NOTUSE.
- Due to the risk of exposure to HIV (Human Immunodeficiency Virus) or other blood
borne pathogens, health care workers should routinely use universal blood and body
fluid precautions in the care of all patients. Sterile technique must be strictly adhered
to during any handling of the device.
- Practitioners must be aware of potential complications associated with dialysis fistula
and graft thrombolysis including:
Hemorrhage Vessel tear or disruption
Symptomatic pulmonary embolism Infection
Arterial embolization Perforation of the artery orvein
Allergic reaction to contrast media Hematoma
Pseudoaneurysm Death
Pain and/or tenderness
- Caution should be used when dislodging the plug at the arterial anastomosis to
minimize the risk of arterial embolization.
- Due to the lack of excretion associated with hemodialysis patients, use of contrast
should be kept to a minimum throughout this procedure.
- Potential fatigue failure of the CLEANER 15™sinuous wire may occur with prolonged
activation of the CLEANER 15™device. A withdrawal rate of 1-2 cm/second is
recommended when sharp radii are encountered (i.e. radius of a loop graft or fistula,
radii < 3 cm).

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English
Grafts and Fistulae
A SUGGESTED PROCEDURE:
Use sterile technique.
Patient Preparation:
1. Premedicate with appropriate anxiolytic, analgesic and/or antibiotic per hospital
protocol.
Device Performance Testing:
2. Remove the CLEANER 15™Rotational Thrombectomy System from the package.
Press the ON/OFF switch to ensure that the sinuous wire spins freely (refer to
Figure 2). Release the switch to stop the rotator. Precaution: Do not use the
device if it does not activate immediately when the switch is pressed, and
deactivate immediately when the switch is released.
3. Flush the CLEANER 15™catheter with heparinized saline through the catheter lumen
flush port. Return the stopcock to the off position prior tooperation.
Thrombolysis Procedure:
4. Complete the CLEANER 15™thrombolysis procedure under continuous fluoroscopy.
Do not initiate sinuous wire rotation (device activation) unless proper device
positioning is confirmed within the fistula orgraft.
5. Prepare and drape the puncture site as required.
6. Administer local anesthetic at the puncture site for venous sheathinsertion.
7. Select an appropriately sized sheath to accommodate the CLEANER 15™catheter
and other devices/ catheters that may be used during the procedure. Maximum
guidewire size will be dependent upon the introducer sheath/dilator assembly
chosen.
8. Prepare and place the venous introducer sheath per hospital protocol. The venous
sheath should be placed in the venous limb of the graft, and directed toward the
venous anastomosis. In fistulae, the venous sheath placement can be optional
depending on the clot burden in the vessel. If a venous sheath is used, it should be
placed in the venous limb of the fistula and directed toward the central venous
outflow. Note: If no venous sheath is used in the AV fistula, then go to step16.
9. Place the device in the covered position by pushing the sliding lever to the distal
position and rotating the sliding lever to lock in the covered position (refer to Figure
3). When in the covered position, only the flexible tip of the sinuous wire should
extend from the catheter. The device should not be activated in the coveredposition.
10. Support the flexible tip between the thumb and index finger during insertion through
the sheath valve. Insert the covered device through the venous sheath and into the
venous limb of the fistula or graft.
11. In a graft, advance the flexible tip up to the venous anastomosis. Warning: Do not
advance it beyond the anastomosis. In a fistula, advance the flexible tip up to the
central most extent of the clot. Uncover the sinuous wire by unlocking, fully
retracting the sliding lever and rotating the sliding lever until an audible “click” is
heard (refer to Figure 4). Confirm device positioning within the fistula or graft via
fluoroscopy. Press the ON/OFF switch to activate rotation.
Note: Caution should be taken while uncovering the wire to avoid advancing
the wire into the clot and past the anastomosis.
12. With the device activated, slowly withdraw the rotating sinuous wire along the graft
or fistula to break up the clot. Warning: A withdrawal rate of 1-2 cm/second is
recommended when sharp radii are encountered. When the sinuous wire
reaches the tip of the venous sheath, release the switch to turn off therotator.

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Grafts and Fistulae
13. Cover the device and remove it from the graft or fistula. Flush the catheter lumen
with heparinized saline and manually remove any accumulated fibrin from the
sinuous wire.
14. Aspirate the macerated clot via the sheath and discard the aspirate. Precaution:
Continued unsuccessful aspiration may collapse the sheath andgraft/fistula.
15. Inject a small amount of contrast via the venous sheath to assess the degree of
thrombus removal accomplished. Warning: Avoid over-injection of contrast to
minimize the risk of arterial embolization. Treat the residual thrombus by
repeating steps 11-14 until acceptable thrombus removal is achieved.
16. Administer local anesthetic at the puncture site for arterial sheath insertion. Prepare
and place the arterial introducer sheath per hospital protocol. The arterial sheath
should be directed toward the arterial anastomosis. Precaution: The arterial and
venous sheath tips must not overlap.
17. Support the flexible tip between the thumb and index finger during insertion through
the sheath valve. Insert the covered device through the arterial sheath into the
arterial limb of the fistula or graft.
18. In a graft, advance the flexible tip up to the arterial anastomosis. Warning: Do not
advance it beyond the anastomosis. In a fistula, advance the flexible tip up to the
central most extent of the clot. Uncover the sinuous wire by unlocking, fully
retracting the sliding lever and rotating the sliding lever until an audible “click” is
heard. Confirm device positioning within the fistula or graft via fluoroscopy. Press
the ON/OFF switch to activate rotation.
19. With the device activated, slowly withdraw the rotating sinuous wire, in the
uncovered position, along the graft or fistula to break up the clot. Warning: A
withdraw rate of 1-2 cm/second is recommended when sharp radii are
encountered. When the sinuous wire reaches the tip of the arterial sheath, release
the switch to turn off the rotator.
20. Cover the device and remove it from the graft or fistula. Flush the catheter lumen
with heparinized saline and manually remove any accumulated fibrin from the
sinuous wire.
21. Aspirate the macerated clot using either sheath and discard the aspirate.
Precaution: Continued unsuccessful aspiration may collapse the sheath and
graft/fistula.
22. Pass an appropriate catheter through the arterial sheath, and carefully feed it past
the arterial anastomosis of the graft or fistula. Inflate the balloon, if it is a balloon
catheter. Pull the arterial plug into the middle of the arterial limb. Deflate the balloon
and remove the balloon catheter.
23. Reinsert the covered CLEANER 15™device through the arterial sheath into the
arterial limb of the graft or fistula.
24. Uncover the sinuous wire and activate the device to break up the arterial plug, using
contrast to guide maceration.
25. Cover the device and remove it from the graft or fistula. Flush the catheter lumen
with heparinized saline and manually remove any accumulated fibrin from the
sinuous wire.
26. Aspirate the macerated clot via the sheath and discard theaspirate.
27. Inject contrast to assess the degree of thrombus removal. Treat any residual
thrombus using the CLEANER 15™via either sheath, asneeded.
28. When the thrombus removal is complete, treat any underlying disease or stenosis
per hospital protocol.
29. Perform the final fistulogram.

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Grafts and Fistulae
30. Remove the sheaths from the fistula or graft.
31. Achieve hemostasis at the puncture site(s) per hospital protocol.

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WARNING:
For single use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or
re-sterilization may compromise the structural integrity of the device and/or lead to
device failure which in turn may result in patient injury, illness or death. Reuse,
reprocessing or re-sterilization may also create a risk of contamination of the device
and/or cause patient infection or cross-infection, including, but not limited to, the
transmission of infectious disease(s) from one patient to another. Contamination of the
device may lead to injury, illness or death of thepatient.
STORAGE:
Store at controlled room temperature. Do not expose to organic solvents, ionizing
radiation or ultraviolet light.
DISPOSAL:
Dispose of the catheter system in accordance with the Waste Electrical and Electronic
Equipment Directive 2002/96/EC (WEEE) and according to the standard institutional
procedures for medical waste including single-use, blood contacting devices.
DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY:
There is no express or implied warranty, including without limitation and implied warranty
of merchantability or fitness for a particular purpose, on the Argon Medical product(s)
described in this publication. Under no circumstances shall Argon Medical be liable for
any direct, incidental or consequential damages other than as expressly provided by
specific law. No person has the authority to bind Argon Medical to any representation or
warranty except as specifically set forth herein.
Descriptions or specifications in Argon Medical printed matter, including this publication,
are meant solely to generally describe the product at the time of manufacture and do not
constitute any express warranties.
Argon Medical will not be responsible for any direct, incidental or consequential
damages from reuse of the product.