Sarns 8000 Manual

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Manual drive 20 804372 Pole mount centrifugal 20 display bracket 816620 Flexible mounting arm 21 TLink Data Management System CATALOG # DESCRIPTION Call Data management software Flow Sensing CATALOG # DESCRIPTION DIAGRAM # 802018 Flow module 22 6382 Non-invasive flow sensor, 3/8 in 23 (9.5 mm) ID x 3/32 in (2.4 mm) wall, reusable.

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Terumo Sarns 8000 Service Manual 2/6 Downloaded from www1.reserveatlakekeowee.com on August 7, 2021 by guest Read Online Terumo Sarns 8000 Service Manual Cardiopulmonary Bypass-Christina T. Mora 2012-12-06 A definitive, comprehensive text on the technological developments and clinical applications of this critical subject matter. Acces PDF Sarns 8000 Manual Sarns 8000 Manual If you ally compulsion such a referred sarns 8000 manual ebook that will come up with the money for you worth, acquire the completely best seller from us currently from several preferred authors. If you want to entertaining books, lots of novels, tale, jokes, and more fictions collections are plus. Manuals and free owners instruction pdf guides. Find the user manual and the help you need for the products you own at ManualsOnline. The Terumo Sarns Modular Perfusion System 8000 is a flexible, dependable, and cost efficient modular blood pumping system.The Sarns 8000 is a modular heart-lung machine that is available in a variety of configurations. We offer 4 and 5 pumps units that are available with and without the built-in centrifugal pump. Adobe reader pro 11 for mac.

8000

Manuals can be downloaded free of charge. Paper manuals can also be purchased. Please note, Service Manuals are not available for all models. If a service manual is not available for your model, the pertinent service information has been added to the Owner's Manual.

Note: If you do not have your serial number, you may use 000101 to access a manual. In order to access complete and accurate product information, you must use your product's serial number.

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Sarns 8000 Manual
Sarns 8000 manual download
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Sarns 8000 Manual 2019

510(k)|DeNovo|Registration & Listing|Adverse Events|Recalls|PMA|HDE|Classification|Standards
CFR Title 21|Radiation-Emitting Products|X-Ray Assembler|Medsun Reports|CLIA|TPLC

Sarns 8000 Manual 2

Manual

Manuals can be downloaded free of charge. Paper manuals can also be purchased. Please note, Service Manuals are not available for all models. If a service manual is not available for your model, the pertinent service information has been added to the Owner's Manual.

Note: If you do not have your serial number, you may use 000101 to access a manual. In order to access complete and accurate product information, you must use your product's serial number.

For aquired product line Manuals Click the appropriate link

For Engine Manuals, please click on the applicable link

-

Sarns 8000 Manual 2019

510(k)|DeNovo|Registration & Listing|Adverse Events|Recalls|PMA|HDE|Classification|Standards
CFR Title 21|Radiation-Emitting Products|X-Ray Assembler|Medsun Reports|CLIA|TPLC

Sarns 8000 Manual 2

Sarns 8000 Manual Online


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Class 2 Device Recall Sams Modular Perfusion System 8000
Date Initiated by FirmSeptember 25, 2012
Date PostedNovember 13, 2012
Recall Status1Terminated 3 on July 11, 2013
Z-0281-2013
Recall Event ID62733
K915183
Console, heart-lung machine, cardiopulmonary bypass - Product CodeDTQ
ProductPerfusion System 8000, base 5 pump, 115V safety monitor included
The Sarns' Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Code Informationcatalog number: 16401 serial numbers: 1001-1243, 1247-1648, 1650-1821, and 1824-3003.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
734-741-6173
Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardio
Device Design
The firm, Terumo CVS, sent an 'URGENT MEDICAL DEVICE RECALL' notice/Safety Advisory Alert dated September 24, 2012 and an addendum to the Operator's Manual to alert all affected Customers. The notice described the product, problem and actions to be taken. The customers were instructed to review this medical device recall notice; assure that all users are aware to this notice; place the addendum in the Operator's Manual just before page 4.1 and complete and return the attached Customer Response Form via Fax to: 1-734-741-6149 or email to:www.termuo-cvs.com. If you have any questions or concerns contact Terumo CVS Customer Service at 1-800-521-1818; Monday - Friday, 8 AM - 6 PM ET.
1097
Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY; and countries of: ARGENTINA, AUSTRALIA, BANGLADESH, BRAZIL, CALI COLOMBIA, CALLO PERU, GERMANY, GUAYQUIL ECUADOR, HONG KONG, INDIA, INDONESIA, JAPAN, LEBANON, MADRID SPAIN, MEXICO, NEW ZEALAND, SANTIAGO, SANTIAGO CHILE, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SRI LANKA, TAIWAN, THAILAND, and UNITED ARAB EMIRATES (UAE).
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DTQ and Original Applicant = 3M HEALTH CARE, SARNS




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