Sarns 8000 Manual

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Sarns™ Modular Perfusion System 8000, continued SPECIFICATIONS, CONTINUED Battery Modules 16422‡ 3‡ Voltage 115V 220/240V 100V Battery backup Power for two pumps and all safety systems and accessories for 25 minutes Electronic Occluder Tubing requirements Min. 1/4' ID x 1/16' wall Max. 1/2' ID x 3/32' wall. 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. All units have either been factory refurbished or have been. Read Online Sarns 8000 Manual - Sarns 11160 The Teruno Sarns 11160 Dual Heater Cooler is a reliable, efficient patient cooling/heating system., The Teruno Sarns 11160 Dual Heate. Zen Topaz Manual. Sarns 8000 Manual - FC2 Sarns 8000 Manual Sarns 8000 Manual Right here, we have countless books Sarns 8000 Manual and collections to check out. The Sarns Modular Perfusion System 8000 offers uncompromised reliability and safety. Terumo's continued engineering efforts for the Sarns System 8000 testify to its support of perfusionists. This trusted heart-lung machine has been used in millions of cardiac surgery cases worldwide.


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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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Heart-Lung Bypass Unit

Sarns 8000 Manual Online

The Sarns Modular Perfusion System 8000 offers uncompromised reliability and safety. Terumo's continued engineering efforts for the Sarns System 8000 testify to its support of perfusionists. This trusted heart-lung machine has been used in millions of cardiac surgery cases worldwide

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-Engr.M.Saad
2 months ago
2 months agoService Manuals
I need operating & service manual of sarns 8000 heart lung machine. ..Thanks in advanceReply
-Pathway Preclinical Services
8 months ago
8 months agoNeed reservoir holder
I am looking for a reservior holder for our Sarns 8000 bypass pumpReply

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-prakash8053
a year ago
a year agoservie manuls
any one have service manulsReply
DOCUMENTS / MANUALSView All

Sarns 8000 manual download

FEATURES

  • Modular design
  • Four or five pump base
  • Roller or centrifugal pumps
  • Arterial and cardioplegia monitors for temperature, pressures and timers
  • Battery module
  • Electronic venous occluder
  • Pulse mode
  • Communications module for data acquisition

Sarns 8000 Manual Download

Additional Specifications

Sarns 8000 manual free

FEATURES

  • Modular design
  • Four or five pump base
  • Roller or centrifugal pumps
  • Arterial and cardioplegia monitors for temperature, pressures and timers
  • Battery module
  • Electronic venous occluder
  • Pulse mode
  • Communications module for data acquisition

Sarns 8000 Manual Download

Additional Specifications

  • Leakage Current: <100 microamperes for 115 V and 100 V bases (fully loaded);<200 microamperes for 220-240 V bases (fully loaded).
  • The maximum leakage current for the base without pumps is 45 microamperes for all input voltages
  • Ground resistance: 0.1 ohms maximum for all bases
  • Emergency power: 8000 system battery (two 12 volt, sealed gel cell batteries) will power the arterial pump (operating in continuous mode), the monitors, occluder and lamp for 40 minutes; when the arterial pump is operated in pulsatile mode or the cardioplegia pump is also operating on battery power, the battery time available will diminish to 25 minutes
  • The base is tested for high potential: 1200V~ for 100-115 VAC units; 1500V~ for 220-240 VAC units




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