Bard Site Rite 5 User Manual

User’s Manual 8403-060 Menu Driven Display 1120-445 I. CONTROLLER OPERATION ADJUSTING TEMPERATURE (Temporary Override when in Programmable mode) 1. Before you can adjust the temperature, a MODE must be selected. If you are already in a.

Bard Site Rite 6 VI Ultrasound System, 90 Day Warranty
Includes 9770001 Ultrasound Probe and All Pictured Accessories.
Easy-to-Use Ultrasound for Central Venous Access
Improved Patient Outcomes1
The Site~Rite* 6 Ultrasound System meets AHRQ (Agency for Healthcare Research and Quality) recommendations for use of real-time ultrasound guidance for central line placement.
Reduction of Complications2
Clear vessel visualization reduces risk of inadvertent arterial puncture, hematoma or pneumothorax.
Demonstrated Clinical Efficacy3
Clinical investigation has demonstrated increases in vascular access procedural success for central catheter placement among clinicians using real-time ultrasound guidance.
Features:
Large 12.1” screen
4 image options for a sharper or smoother image
Vessel wall sharpening
Vascular access image depths
- Superficial 1.5 cm image depth for
shallow imaging
- Deep 6 cm image depth for deeper needle guidance including bariatric patients
Ability to input patient information
Intuitive and easy-to-use control buttons
60-minute internal battery
Vascular access probe
- Solid state vascular access probe
- Buttons located on the probe allow control, including printing, from within the sterile field
Integrated carrying handle for portability

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Class 2 Device Recall Site Rite Vision Ultrasound System,

Z-2782-2011
Date Initiated by Firm	June 21, 2011
Date Posted	July 11, 2011
Recall Status¹	Terminated ³ on July 11, 2012
Recall Event ID	57012
K100402
Ultrasound System - Product CodeIYN
Product	Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Code Information	Serial numbers: DYUJA023, DYUJA024, DYUJA025, DYUJA026, DYUJA027, DYUJA028, DYUJA029, DYUJA030, DYUJA031, DYUJA032, DYUJA034, DYUJA036, DYUJA037, DYUJA038, DYUJA039, DYUJA040, DYUKA001, DYUKA002, DYUKA003, DYUKA004, DYUKA005, DYUKA006, DYUKA007, DYUKA008, DYUKA009, DYUKA010, DYUKA011, DYUKA012, DYUKA013, DYUKA014, DYUKA015, DYUKA015, DYUKA017, DYUKA018, DYUKA019, DYUKA020, DYVAA001, DYVAA002, DYVAA003, DYVAA004, DYVAA005, DYVAA006, DYVAA007, DYVAA012, DYVAA013, DYVAA014, DYVAA015, DYVAA016, DYVAA017, DYVAA018, DYVAA019, DYVAA020, DYVAA021, DYVAA022, DYVAA023, DYVAA024, DYVAA025, DYVAA026, DYVAA027, DYVAA028, DYVAA029, DYVAA030, DYVAA031, DYVAA032, DYVAA033, DYVAA036, DYVAA037, DYVAA038, DYVAA039, DYVAA040, DYVBA002, DYVBA003, DYVBA004, DYVBA005, DYVBA006, DYVBA007, DYVBA008, DYVBA009, DYVBA010, DYVBA011, DYVBA012, DYVBA013, DYVBA014, DYVBA015, DYVBA018, DYVBA019, DYVBA020.
Recalling Firm/ Manufacturer	Bard Access Systems 605 North 5600 West Salt Lake City UT 84116-3738
For Additional Information Contact	801-522-5614
Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.
Process control
Bard Access Systems, Inc sent out an 'Urgent' Medical Device Recall (User Level)' dated June 2011 to all affected customers The letter included: product name, description of problem and requested the return of units bearing 'B50' on the fan. Bard Access Systems, Inc. will replace the incorrect fan with the correct fan. For additional information call 1-724-779-3000.
86 units
Nationwide (USA) distribution including the states of AL, AR, AZ, CA, CO, FL, IA, IN, MD, MI, MO, MS, NC, NJ, NM, NY, OH, PA, RI, SC, TX, UT, VA, VT, and WA.
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) Database	510(K)s with Product Code = IYN and Original Applicant = BARD ACCESS SYSTEMS, INC.