Bard Sherlock 3CG TCS Instructions For Use Manual
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Bard Sherlock 3CG TCS Instructions For Use Manual

For use with site-rite 6 ultrasound system
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ACCESS SYSTEMS
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
0736736 1403R

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  • Page 1 Technical/Clinical Support: (800) 443-3385 www.bardaccess.com Bard, Sherlock, Sherlock 3CG, and Site~Rite are www.discoversherlock.com 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. 0736736 1403R...
  • Page 2 For use with Site~Rite™ 6 Ultrasound System Instructions for Use...
  • Page 3 Sherlock 3CG™ Tip Confirmation System CF Type Equipment Keep Dry Storage Humidity Parameters Manufacturer: (packaged) Consult instructions Storage Temperature for use Parameters Operating Humidity Parameters Do not dispose with Storage Humidity Parameters ordinary municipal waste (unpackaged) Federal (U.S.A.) law restricts Rx Only Operating Temperature this device to sale by or on the...

  • Page 4: Table Of Contents

    Instructions For Use - TABLE OF CONTENTS - Section Section Overview Magnetic Navigation Only Mode 1.1 Indications for Use Step 1: Prepare Device 1.2 Post Market Clinical Trial Step 2: Position Patient and Perform Ultrasound 1.3 Sherlock 3CG™ Tip Confirmation System (TCS) Description Step 3: Measure Catheter Length 1.4 System Components Step 4: Prepare Sensor...

  • Page 5: Overview

    1.2 Post Market Clinical Trial The Sherlock 3CG™ Tip Confirmation System (TCS) is Bard’s next generation, fully integrated magnetic navigation and ECG-based peripherally inserted central catheter (PICC) tip confirmation technology, which represents the next evolution of the Sherlock™ II Tip Location System and the previously- marketed Sapiens Tip Confirmation System.

  • Page 6: System Components

    This section specifies warnings and precautions specific to the functionality of the Sherlock 3CG™ TCS. - See the Bard Access Systems' catheter Instructions for Use (IFU) for possible complications associated with peripherally inserted central catheter (PICC) placements and ECG positioning.
  • Page 7 Warning: The following actions void the warranty of the Sherlock 3CG™ TCS and may result in injury or equipment damage. - Opening or servicing the Site~Rite™ 6 Ultrasound System with Sherlock 3CG™ TCS by anyone other than Bard Access Systems’...

  • Page 8: Assembling The Sherlock 3Cg™ Tcs

    Instructions For Use Caution: Placement of red electrode outside of the correct region may result in reduced ECG performance. See Section 4. Caution: Discontinue electrode use immediately, if skin irritation occurs. Caution: To avoid damage to the device operating system, shutdown the device through the Power Control button from the Application Toolbar. 2 Assembling the Sherlock 3CG™...

  • Page 9: Sherlock 3Cg™ Tcs Graphical Interface

    Sherlock 3CG™ Tip Confirmation System 3.2 Sherlock 3CG™ TCS Graphical Interface...
  • Page 10 Instructions For Use...
  • Page 11 Sherlock 3CG™ Tip Confirmation System...

  • Page 12: Sherlock 3Cg™ Tcs Controls And Indicators

    Instructions For Use 3.3 Sherlock 3CG™ TCS Controls and Indicators Main Controls Ultrasound Mode: Select to exit the TCS Mode and enter Ultrasound Mode. Calibrate Button: Select to calibrate magnet navigation. Audio On: Select to mute the magnet navigation audio. Audio Mute: Select to turn the magnet navigation audio on.
  • Page 13 Sherlock 3CG™ Tip Confirmation System Menu: Select to open the Menu Window. Select the ‘F1’ key on the keyboard to open the Patient Information window. Select the ‘F2’ key on the keyboard to open the Menu Window Select the ‘F3’ key on the keyboard to open the Exit Site Marking Window. Select the ‘F6’...
  • Page 14 Confirmation Statement Printing: Select to enable or disable the confirmation statement printing on the ECG printout. Magnet Tracking Printout: Select to enable or disable the magnet navigation printout. Demonstration: Select to initiate demonstration mode. For training, contact your Bard Access Systems’ Sales Representatives. Exit: Select to close the Menu Window.

  • Page 15: Sherlock 3Cg™ Tcs Audio Information

    - Tone 1: The stylet tip is detected and the tip is not under the sensor. - Tone 2: The stylet tip is under the sensor and is at or above the Bard logo. - Tone 3: The stylet is under the sensor and below the Bard logo.

  • Page 16: Sherlock 3Cg™ Tcs Catheter Guidance

    - Enter Patient Information as needed. Step 2: Position Patient and Perform Ultrasound Pre-scan - Refer to the Bard Access Systems’ Site~Rite™ 6 Ultrasound System Instructions for Use. Step 3: Measure Catheter Length - Refer to Bard Access Systems’ Catheter Instructions for Use.

  • Page 17: Step 5: Position Sensor And Ecg Electrodes

    Sherlock 3CG™ Tip Confirmation System Step 5: Position Sensor and ECG electrodes - Remove the adhesive backing from the sensor holder and lace the sensor directly on the patient’ skin with the adhesive side down. Place the sensor as flat as possible for best results.

  • Page 18: Step 6: Evaluate External Ecg Waveform

    - Insert the catheter until the magnetic navigation shows the stylet moving consistently downward. - Continue to slowly advance catheter until the catheter is inserted to the external measurement as determined in the Bard Access Systems’ catheter instructions for use.

  • Page 19: Magnetic Navigation Only Mode

    - Enter patient Information as needed. Step 2: Position Patient and Perform Ultrasound Pre-scan - Refer to the Bard access Systems’ Site~Rite™ 6 Ultrasound System Instructions for Use. Step 3: Measure Catheter Length - Refer to Bard Access Systems’ Catheter Instructions for Use.

  • Page 20: Step 5: Position Sensor

    - Insert the catheter until the magnetic navigation shows the stylet moving consistently downward. - Continue to slowly advance catheter until the catheter is inserted to the external measurements as determined in the Bard Access Systems’ catheter instructions for use.

  • Page 21: Troubleshooting And Error Messages

    Sherlock 3CG™ Tip Confirmation System - Below is an image of Magnetic Navigation only mode. 6 Trouble Shooting and Error Messages 6.1 Error Screens Cause: Sensor not connected to the display. Sensor Disconnected Solution: Ensure the sensor is properly connected. Disconnect and reconnect the sensor. Cause: The display power supply is connected to a noisy electrical outlet.
  • Page 22 Instructions For Use Cause: Interference caused by magnetic field changes or by sensor movement. Magnet Error Solution: 1. Move all metal objects at least 12 inches (30 cm) away from the sensor. 2. Lower bed rails. 3. Move all active electronic devices at least 5 feet (1.5m) away. 4.

  • Page 23: Ecg Troubleshooting

    Flush the catheter lumen containing the stylet with saline. Cause: No stylet-to-fin connection. Solution: Fully seat the stylet connector on the fin. Refer to the Bard Access Systems’ catheter instructions for use. Cause: Fin and/or stylet connectors not fully seated.

  • Page 24: Magnetic Navigation Troubleshooting

    Note: Depth icons will Cause: Stylet magnet trimmed off. not be present. Solution: Replace catheter with a new Bard Access Systems’ catheter from a kit labeled ] or Cause: Stylet is out of sensor's depth range (3 to 11 cm) Solution: 1.

  • Page 25: Magnetic Navigation Printing

    Sherlock 3CG™ Tip Confirmation System Cause: Stylet at edge of sensor’s depth range (3 to 11 cm). Solution: 1. Pull catheter back until stylet icon is stable. 2. Verify catheter is moving in the correct direction and continue placement. Cause: Magnetic interference.

  • Page 26: Cleaning And Disinfection

    The manufacturer, Bard Access Systems, Inc., warrants to the original purchaser that this product will be free from defects in material and workmanship for a period of one year from the date of purchase. If this product proves to be so defective, purchaser may return the same to Bard Access Systems, Inc. for repair, replacement or credit at Bard Access Systems Inc.'s option in accordance with Bard Access Systems Inc.'s Return Goods Policy found in the current...

  • Page 27: Service And Repair

    Operating Humidity: 5% to 85% non-condensing Storage Humidity: 5% to 95% non-condensing 12 Disposal Information To return the Sherlock 3CG™ TCS for end of life recycling, please contact your nearest Bard sales or distributor office in the country of purchase.
  • Page 28 Instructions For Use...

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