Warranty Disclaimer; Popis Výrobku - Claret Medical Sentinel Cerebral Protection System Instrucciones De Uso

WARNING: Never advance, manipulate, or withdraw the Sentinel System without proper fluoroscopic guidance to prevent damage to the
System and/or harm to the patient.
WARNING: The Sentinel System is not to be used to deliver any type of fluid to the patient e.g. contrast media, heparinized saline, etc.
1. Using standard interventional technique, place a 6 French introducer sheath into the radial or brachial artery of the patient's right arm.
Backload a floppy tip 0.014" coronary guidewire into the Distal Filter Tip located at the distal end of the Sentinel System until the guidewire
2.
tip is located just inside the distal tip of the Sentinel catheter.
Note: A stiff guidewire may impact the shape of the Articulating Sheath curve and make cannulation of the left common carotid difficult.
Note: Guidewires with intermediate coils may become deformed while cannulating the left common carotid resulting in compromised
guidewire movement.
3. Introduce the Sentinel System into the introducer sheath.
In the patient's right arm, advance the guidewire relative to the Sentinel System until the distal tip of the guidewire is a minimum of 10 cm
4.
beyond the distal tip of the Sentinel System using fluoroscopic guidance.
5. Advance the Sentinel System distally until it contacts the introducer sheath hemostasis valve. Gently advance the Sentinel System until it
is fully inserted into the introducer hemostasis valve.
6. Advance the Sentinel System and the guidewire together using standard interventional technique until the Proximal Filter is in the intended
target location in the brachiocephalic artery with the Articulating Sheath section of the catheter extending down the ascending aorta.
Should the catheter tip extend down the descending aorta, pull the system back and rotate to advance down the ascending aorta.
WARNING: Do not advance the Sentinel System without a guidewire extending distally past the tip of the catheter a minimum of 10 cm.
WARNING: Do not use excessive force on the Sentinel System while introducing or advancing through the introducer sheath or blood
vessels. Excessive force may cause damage to the device and/or patient harm.
Note: The Articulating Sheath will protrude into the aorta during proximal filter deployment.
7. Deploy the Proximal Filter by holding the Front Handle in a fixed position and slowly retracting the Proximal Filter Slider (#1) fully.
8. Confirm proper Proximal Filter position using fluoroscopy. The Proximal Filter should be positioned in the brachiocephalic artery to prevent
any debris from reaching the right carotid artery. See Figures 4 and 5.
9. If the filter position is not optimal, the filter may be retrieved and repositioned up to two times. This may be done by holding the Front
Handle in a stationary position and advancing the Proximal Filter Slider (#1) until the Proximal Filter is re-sheathed. The Proximal Filter
may then be repositioned by advancing or retracting the catheter until optimal positioning is achieved. Finally the Proximal Filter is
redeployed by retracting the Proximal Filter Slider (#1) while holding the Front Handle in a fixed position.
CAUTION: Repositioning, if required, should only occur during initial placement.
10. Confirm filter-to-vessel wall apposition using fluoroscopy, and ensure that the Proximal Filter and Proximal Sheath do not move after
placement.
11. Withdraw the guidewire until the tip is located just within the distal tip of Sentinel catheter.
12. Loosen the Front Handle Lock to facilitate positioning of the Articulating Sheath.
13. Position the Articulating Sheath by manipulating the Rear Handle relative to the Front Handle in order to position the catheter tip. Rotate
the Articulation Knob (#2) on the Rear Handle in the direction of the arrows in order to deflect the tip of the Articulating Sheath as
necessary toward the left common carotid artery ostium.
CAUTION: Do not move the Front Handle, and thus the Proximal Filter, while manipulating the Rear Handle.
Advance the 0.014" guidewire beyond the distal tip of the Articulating Sheath in order to place the guidewire in the left common carotid artery.
14.
CAUTION: Do not to advance the guidewire more than 5 cm into the left common carotid artery.
Position the Articulating Sheath so that the curvature matches the Brachiocephalic Artery – Aorta – Left Common Carotid Artery junction
15.
and is pulled up to the carina between the two vessels, see Figure 6.
Note: Ensure that the Articulating Sheath is well apposed to the carina, and does not protrude into the aortic space. See Figure 6 for
correct positioning and Figure 8 for incorrect positioning.
16. Secure the position of the Articulating Sheath by tightening the Front Handle Lock.
17. Loosen the Rear Handle Lock and advance the Distal Filter under fluoroscopy by pushing the Distal Filter Slider (#3) forward until the
Distal Filter frame is fully expanded and apposed to the vessel wall. The Distal Filter should be positioned just beyond the Articulating
Sheath tip and movement should be minimized once it is fully expanded in the vessel. See Figure 2.
WARNING: Minimize movement of the Sentinel System after filter deployment. Excessive movement may lead to embolization of debris,
and vessel and/or device damage.
18. Confirm filter-to-vessel wall apposition of the distal filter using fluoroscopy. See Figure 7.
19. Tighten the Rear Handle Lock. See Figure 1.
CAUTION: Verify that the Front Handle Lock and the Rear Handle Lock are tight and secure before any subsequent procedures.
WARNING: The Sentinel System is not to be used to deliver any type of fluid to the patient e.g. contrast media, heparinized saline, etc.
CAUTION: Repositioning, if required, should only occur during initial placement.
20. Cover the exposed portion of the Sentinel System with a drape to prevent movement during subsequent endovascular procedures.
CAUTION: Care must be taken NOT to kink the exposed catheter.
WARNING: Minimize movement of the Sentinel System and its filters after filter deployment. Excessive movement may lead to
embolization of debris, and vessel and/or device damage.
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CONFIDENTIAL—CLARET MEDICAL, INC.
WARNING: If gross movement of either the Proximal or Distal Filter is noted, check to ensure filters remain apposed to the vessel walls by
fluoroscopy.
WARNING: If the arterial flow is believed to be compromised (slow / no flow), the filters should be retrieved. See Retrieval below.
Procedural Use – Retrieval
WARNING: Do not pull excessively on the Sentinel System to avoid filter membrane tears, filter hoop detachment, system damage or
patient harm during use.
WARNING: Never advance or withdraw the Sentinel System without proper fluoroscopic guidance.
WARNING: Never withdraw or move an intravascular device against any resistance until the resistance cause is determined. Advancing or
retracting with resistance may lead to embolization of debris, and vessel and / or device damage.
There are two methods for Distal Filter recovery: Partial and Full Enclosure Recovery
1. Loosen the Rear Handle Lock. See Figure 1.
2. Recover the Distal Filter using one of the following two methods:
a. Full Enclosure Recovery: Gently withdraw the Distal Filter Slider (#3) relative to the Rear Handle until the radiopaque Distal
Filter Tip is flush with the Radiopaque Articulating Sheath Tip Marker as visualized on fluoroscopy. Tighten the Rear Handle Lock.
If resistance is felt during Distal Filter recovery, or if it is believed that the Distal Filter is excessively full, follow the Partial
Enclosure Recovery method detailed below.
b. Partial Enclosure Recovery: Gently withdraw the Distal Filter Slider (#3) relative to the Rear Handle until the Distal Filter
Radiopaque Hoop is collapsed inside the Articulating Sheath tip as visualized on fluoroscopy. Tighten the Rear Handle Lock.
WARNING: Exercise caution when using the partial enclosure recovery method. If resistance is felt during catheter withdrawal, advance
the Distal Filter and Articulating Sheath together distally and withdraw the Distal Filter more fully into the Articulating Sheath before re-
attempting withdrawal of the catheter.
3. Loosen the Front Handle Lock and withdraw the Articulating Sheath tip from the left common carotid artery by manipulating, straightening,
rotating, and advancing or withdrawing the Rear Handle and rotating the Articulation Knob (#2) until the Articulating Sheath tip is straight
and is within the aorta.
4. Advance the Articulating Sheath completely by advancing the Rear Handle until the Articulation Knob (#2) contacts the Front Handle Lock
to prevent interference with the Proximal Sheath or Proximal Filter during Proximal Filter retrieval. Tighten the Front Handle Lock. See
Figure 9.
5. Re-sheath the Proximal Filter by holding the Front Handle in a stationary position and slowly advancing the Proximal Filter Slider (#1) until
the Proximal Sheath Radiopaque Marker meets the Articulating Sheath as visualized on fluoroscopy. See Figure 9. Minimize retracting or
advancing the Front Handle during this step. Vessel damage may occur or debris may be lost should the Proximal Filter be moved when in
the deployed state.
6. Advance the guidewire prior to withdrawal of the Sentinel System. Withdraw the catheter system while using fluoroscopy.
Note: If there is any resistance to removing the Sentinel System from the introducer, remove the introducer and the Sentinel System
together.
CAUTION: Do not re-sterilize or reuse this device.
Storage:
- Do not store in direct sunlight
- Keep dry
Note: After use, dispose of product and packaging in accordance with hospital, administrative, and/or local government policy.

WARRANTY DISCLAIMER

Although the product has been manufactured under careful controlled conditions, Claret Medical, Inc. has no control over the conditions under which the
product is used. Claret Medical, Inc. therefore disclaims all warranties, both expressed and implied, with respect to product including, but not limited to,
any implied warranty of merchantability or fitness for a particular purpose. Claret Medical, Inc. shall not be liable to any person or entity for any medical
expenses or any direct, incidental or consequential damages caused by any use, defect, failure or malfunction of the product, whether a claim for such
damages is based upon warranty, contract, tort or otherwise. No person has any authority to bind Claret Medical, Inc. to any representation or warranty
with respect to the product. The exclusions and limitations set out above, are not intended to, and should not be construed so as to contravene mandatory
provisions of applicable law. If any part of this Disclaimer of Warranty is held to be illegal, unenforceable or in conflict with applicable law by a court of
competent jurisdiction, the validity of the remaining portions of this Disclaimer of Warranty shall not be affected, and the rights and obligations shall be
construed and enforced as if this Disclaimer of Warranty did not contain the particular parts or term held to be invalid.
Claret Medical TM
Sentinel TM Cerebral Protection System
Only (Pouze na predpis)
Návod k použití
POPIS VÝROBKU
Sentinel Cerebral Protection System společnosti Claret Medical je perkutánně zaváděné protiembolické zařízení určené k zachycení a odstranění
detritu uvolněného při endovaskulárních zákrocích. Systém Sentinel využívá protiembolický filtr zaváděný do a. brachiocephalica (proximální filtr) a druhý
protiembolický filtr zaváděný do a. carotis communis sinistra (distální filtr). Po dokončení zákroku se filtry a detritus zachytí zpět do katetru a vyjmou
z těla pacienta.
Systém Sentinel obsahuje katetr velikosti 6 FR s filtry k zavedení (proximální a distální filtr), ovladatelný sheath a integrovanou sestavu rukojeti. Hrot
ovladatelného sheathu, hrot proximálního sheathu, smyčka proximálního filtru, smyčka distálního sheathu a hrot distálního filtru jsou rentgenokontrastní,
aby je bylo možné při zákroku pozorovat. Viz obrázky 1 a 2.
PL-10600-02 Rev H
DCR# 2370 4/16/2018