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CompressAR® System Overview Designed as hands-free mechanical compression systems used by clinicians to easily achieve post-catheterization femoral hemostasis, CompressAR Systems decrease blood contact and increase technician and nurse productivity. In addition, CompressAR Systems help avoid muscle strain and disabilities caused by repeated use of the muscles required for manual compression. Because of their consistent application of compression, CompressAR Systems also promote patient comfort and avoid complications during the hemostasis period, providing outcomes as good or better than manual compression.1 Simple and inexpensive to operate, CompressAR Systems are comprised of a non-disposable CompressAR Stand on which disposable CompressAR Discs are attached to provide vascular compression for purposes of achieving femoral hemostasis. A single, sterile CompressAR disc is used for each hemostasis. NEW: CompressAR StrongArmTM System Comprising the StrongArm and the 3-Finger JackTM sterile disc, the new CompressAR StrongArm System provides secure femoral compression and greater patient comfort during hemostasis, resulting in more stable Disc positioning and increased patient satisfaction. Clinicians use the CompressAR StrongArm System the same way that they've used the CompressAR Universal, and will quickly start enjoying the the new system's benefits. Because clinicians avoid having to use manual compression, muscular fatigue and risk of injury caused by repetitive motion is greatly reduced and clinicians minimize their exposure to blood during the hemostasis period. The StrongArm retrofits to CompressAR Universal Stands currently in use, enabling quick, easy conversion by current CompressAR users, with a simple Arm changeout. CompressAR StrongArm Stands are available in versions which have Arms of either standard and extended length, and which also fit the Hill-Rom TotalCare® Bed. Overview of Operation Typically, the CompressAR StrongArm Stand is placed on the bed on which the patient is located, with the Base inserted between the mattress and the base of the bed. The Shaft rotates to permit easy movement of the arm, enabling proper placement of compression. The Top Lever locks the Shaft in place. The CompressAR 3-Finger Jack Disc is attached to the movable Arm Slide on the Arm of the stand, which is then lowered onto the femoral artery immediately proximal and medial to the puncture site, with the sheath located in the V-notch of the disc. As the technician applies downward pressure on the Arm of the CompressAR StrongArm Stand, the sheath is pulled. Pressure sufficient to prevent any blood oozing from the puncture site should be continuously applied and distal blood flow should be monitored. Patients must not be left unattended while a CompressAR System is being used to apply pressure to the femoral artery. In the event that the patient has a large abdominal bulk, the CompressAR StrongArm Stand may be placed on the bed such that the Base and Arm are at an angle to the patient, with the distal end of the Arm "aimed" towards the opposite shoulder of the patient. This positioning reduces the possibility of the abdominal bulk disturbing the compression. The Arm Lever is used to ease off pressure in small increments, so as not to create a sudden blood pressure surge, which could dislodge the clot at the puncture site. Arm Lever adjustments should be made periodically so as to gradually increase distal blood flow while preventing oozing from the puncture site. Patients without anti-coagulation medications typically achieve hemostasis on average within 15-20 minutes, although this varies from patient to patient. Patients receiving anti-coagulation medications may experience longer times to hemostasis depending upon the type and amounts of medications administered. When pressure is completely removed and there is no oozing at the puncture site, the CompressAR StrongArm System may be removed from the patient. Bed rest, pressure dressings, and time to ambulation may be recommended as per existing protocols when manual compression is used.
Limited Warranty This limited warranty shall not apply to any product which has not been used in accordance with the manual, been misused, abused, altered or repaired by anyone other than AVD or its authorized representatives. This limited warranty does not cover CompressAR Discs which have been reprocessed or re-used in any way. Use of anything other than new CompressAR Discs in previously unopened sterile packaging immediately and permanently voids all warranties on any CompressAR Stands on which such unauthorized parts are used. AVD shall not be liable to any person for any indirect or direct consequential damages resulting from or caused by any defect, failure, or malfunction of the System or any component thereof. This limited warranty is in lieu of, and AVD specifically disclaims, all other warranties, express or implied, including any implied warranty of merchantability or fitness for a particular purpose, and AVD shall in no event be liable to any person for indirect, direct, incidental, special or consequential damages of any kind or character. No person is authorized to assume for AVD any other liability in connection with the sale of this System or its components. Some states or countries do not allow the exclusion or limitation of incidental or consequential damages or allow limitations on how long a limited warranty lasts, so the above limitations or exclusions may not apply to you. This limited warranty gives you specific legal rights, and you may also have other rights that vary from state to state or country to country. To obtain factory service, CompressAR Systems should be shipped, prepaid, to AVD, at the address shown below. In-warranty products will be returned, postage pre-paid. Contact AVD for a return authorization number prior to shipping the product. AVD can be reached by telephone in the USA at AVD Regulatory Clearances
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