Bard Sherlock 3CG TCS Manuals

An issued or revision date for these instructions is included for the users information. In the event two years have elapsed between this date and product use, the user should contact Bard Access Systems, Inc. to see if additional product information is available. Revision date: March, 2014 Bard, Sherlock, Sherlock 3CG, and Site~Rite are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners. ©2014 C. R. Bard, Inc. All rights reserved. Manufacturer: Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, UT 84116 U.S.A. (801) 522-5000 Customer Service: (800) 545-0890 Technical/Clinical Support: (800) 443-3385 www.bardaccess.com www.discoversherlock.com ACCESS SYSTEMS 0736736 1403R For use with Site~Rite™ 6 Ultrasound System Instructions for Use 1 Sherlock 3CG™ Tip Confirmation System 15oC 38o C Storage Temperature Parameters Consult instructions for use 10o C 38o C Operating Temperature Parameters Do not dispose with ordinary municipal waste % Operating Humidity Parameters Storage Humidity Parameters (unpackaged) Storage Humidity Parameters (packaged) Keep Dry Manufacturer: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician Rx Only CF Type Equipment % Fragile ­2 Instructions For Use - TABLE OF CONTENTS - 1 Overview 3 1.1 Indications for Use 1.2 Post Market Clinical Trial 1.3 Sherlock 3CG™ Tip Confirmation System (TCS) Description 1.4 System Components 1.5 Warnings and Precautions 2 Assembling the Sherlock 3CG™ TCS 6 2.1 Attaching the Sherlock™ 3CG TCS Sensor Holster to the Roll Stand 2.2 Connecting the Sherlock 3CG™ TCS Sensor to the Site~Rite™ 6 Ultrasound System 3 Sherlock 3CG™ TCS Information 6 3.1 Switching Between Ultrasound and TCS 3.2 Sherlock 3CG™ TCS Graphical Interface 3.3 Sherlock 3CG™ TCS Controls and Indicators 3.4 Sherlock 3CG™ TCS Audio Information 3.5 Parallax 4 Sherlock 3CG™ TCS Catheter Guidance 14 4.1 Verifying Catheter Compatibility 4.2 Catheter Placement Step 1: Prepare Device Step 2: Position Patient and Perform Ultrasound Pre-scan Step 3: Measure Catheter Length Step 4: Prepare Sensor Step 5: Position Sensor and ECG electrodes Step 6: Evaluate External ECG waveform Step 7: Perform Initial Magnet Tracking Calibration Step 8: Prepare Catheter Sterile Field Step 9: Access the Vein Step 10: Attach Catheter Stylet to Fin Assembly Step 11: Perform Final Magnet Navigation Calibration Step 12: Insert Catheter Step 13: Catheter Tip Guidance and Positioning Step 14: Complete Catheter Placement Step 15: Procedural Record Section Section 5 Magnetic Navigation Only Mode 17 Step 1: Prepare Device Step 2: Position Patient and Perform Ultrasound Step 3: Measure Catheter Length Step 4: Prepare Sensor Step 5: Position Sensor Step 6: Perform Initial Magnet Navigation Calibration Step 7: Prepare Catheter Sterile Field Step 8: Access the Vein Step 9: Perform Final Magnet Navigation Calibration Step 10: Insert Catheter Step 11: Catheter Tip Guidance and Positioning 6 Troubleshooting and Error Messages 19 6.1 Error Screens 6.2 ECG Troubleshooting 6.3 Magnetic Navigation Troubleshooting 7 Magnetic Navigation Printing 23 8 Cleaning and Disinfection 23 8.1 Cleaning Procedure 8.2 Disinfection Procedure 9 Warranty 24 10 Service and Repair 25 11 Technical Specifications 25 11.1 Sherlock 3CG™ TCS Sensor and Display Operational and Storage Conditions 12 Disposal Information 25