St. Jude Medical Angio-Seal Evolution Скачать руководство пользователя страница 10

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3.  When hemostasis is achieved, push and hold the suture release button, and pull back until the suture is exposed (Figure 16). This will release the remaining suture within the device 

handle, and remove the compaction tube from the tissue tract. 

Figure 16

Press and Hold

Pull

Tissue
Artery

4.  Once the device has been pulled back and the compaction tube has been removed from the tissue tract, continue to maintain tension on the suture. Push down on the skin using a 

sterile instrument. Cut the suture below the skin level (Figure 17). 

Figure 17

Skin Level

Tissue

Artery

NOTE: Make sure the suture retracts below the skin level to avoid infection.

NOTE: If seeping of blood occurs after placing the Angio-Seal Device, application of gentle digital pressure (one or two fingers) at the puncture site is usually 
sufficient to produce hemostasis. If manual pressure is necessary, monitor pedal pulses.

5.  Clean the puncture site with an antiseptic solution/ointment.
6.  Apply a sterile dressing to the puncture site so that it can be easily observed during recovery.

LIMITED WARRANTY AND DISCLAIMER

St. Jude Medical (SJM) hereby warrants that if any SJM product fails to perform within normal tolerances for a patient due to a defect in materials or workmanship, SJM will 
provide, at no charge, a replacement SJM product for the patient’s use. This limited warranty applies only if each of the following conditions is met:
1. The product was packaged and labeled by SJM.
2. The failed product must be returned to SJM and becomes the property of SJM.
3. The product has not been mishandled, reprocessed or altered in any way.
4. The product was used before the “USE BY” date marked on the packaging of the product.
No representation or warranty is made that a SJM product will not fail. SJM disclaims responsibility for any medical complications, including death, resulting from the use of its 
products. Except as expressly provided by this limited warranty, SJM IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES BASED 
ON ANY DEFECT, FAILURE, OR MALFUNCTION OF ITS PRODUCTS, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE. Some 
states do not allow the exclusion or limitation of incidental or consequential damages however, so the above limitation or exclusion may not apply to you. 
Except as expressly provided by the limited warranty, SJM MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED 
WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE.

Содержание Angio-Seal Evolution

Страница 1: ...INSTRUCTIONS FOR USE Angio Seal Evolution Vascular Closure Device ...

Страница 2: ...f the puncture site is proximal to the inguinal ligament as this may result in a retroperitoneal hematoma PRECAUTIONS Special Patient Populations The safety and effectiveness of the Angio Seal Device has not been established in the following patient populations Patients undergoing an interventional procedure who are being treated with warfarin Patients who have known allergies to beef products col...

Страница 3: ...infection at the puncture site should be taken seriously and the patient monitored carefully Surgical removal of the device should be considered whenever an access site infection is suspected Collagen deposition into the artery or thrombosis at puncture site If this condition is suspected the diagnosis can be confirmed by duplex ultrasound Treatment of this event may include thrombolysis percutane...

Страница 4: ...gnostic angioplasty procedures using a 6 French or smaller procedural sheath The Angio Seal STS was evaluated for safety and efficacy when ambulating patients as soon as possible following device deployment and discharging patients as early as 30 minutes following ambulation Methods Patients who met all inclusion and no exclusion criteria were enrolled during a pre procedure screening evaluation F...

Страница 5: ...an angiogram 2 Using sterile technique remove the Angio Seal Device contents from the foil package taking care to pull foil apart completely before removing the Angio Seal Device NOTE The Angio Seal Device must be used within one hour after opening the foil pouch due to the moisture sensitive nature of the product 3 Insert the arteriotomy locator into the Angio Seal insertion sheath Figure 1 makin...

Страница 6: ...gure 3 Figure 3 8 From this point advance the arteriotomy locator insertion sheath assembly until blood begins to flow from the drip hole on the locator NOTE Over insertion of the arteriotomy locator insertion sheath assembly into the artery beyond 2 cm may increase the chance of premature anchor hook up or interfere with the anchor s performance to achieve hemostasis If blood flow does not resume...

Страница 7: ...on Figure 7 Reference Indicator Carrier Tube Ensure tab is in rear holding position prior to insertion Bypass Tube Hemostatic Valve 2 Confirm that the reference indicator on the insertion sheath is facing up To ensure proper orientation of the Angio Seal Device with the sheath the sheath cap and the device sleeve only fit together in the correct position The reference indicator on the device handl...

Страница 8: ...ble NOTE If the device sleeve separates from the sheath while attempting full rear lock positioning do not push the Angio Seal device forward to reattach to the sheath cap Complete sealing of the puncture following instructions in C 1 Figure 10 6 Incorrect Indicator Alignment Distal end of device handle completely covers the white band on the device sleeve Figure 11 If anchor catches prematurely a...

Страница 9: ...Pull back on the device handle at the angle of the puncture tract maintaining a steady uninterrupted motion Figure 13 until the colored compaction marker is revealed Figure 14 Pause and assess for hemostasis NOTE If hemostasis is not achieved check to see if the colored compaction marker is exposed If not repeat this step Figure 13 Figure 14 P u l l Compaction Tube Collagen Tissue Artery Sheath Ma...

Страница 10: ...ct fails to perform within normal tolerances for a patient due to a defect in materials or workmanship SJM will provide at no charge a replacement SJM product for the patient s use This limited warranty applies only if each of the following conditions is met 1 The product was packaged and labeled by SJM 2 The failed product must be returned to SJM and becomes the property of SJM 3 The product has ...

Страница 11: ...RILE R Sterilized by gamma radiation Do not use if temperature indicator dot on package has turned from light grey to dark grey or black Prescription Use Only Manufacture Date Manufacturer Quantity REF Reorder Number Lot Number Vascular Closure Device Vascular Closure Device Accessory Guidewire Product of Ireland Accessory Guidewire Product of Ireland SYMBOLS ...

Страница 12: ...NTROL LESS RISK are trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical All rights reserved St Jude Medical 14901 DeVeau Place Minnetonka MN 55345 2126 USA Phone 1 888 864 7444 1 952 933 4700 sjm com ART100041600 Ver A 04 2011 ...

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