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Bard Sherlock 3CG Instructions For Use Manual

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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, 2016
Bard, Sherlock and Sherlock 3CG are trademarks
and or registered trademarks of C. R. Bard, Inc.
All other trademarks are the property of their
respective owners.
©2016 C. R. Bard, Inc. All rights reserved.
Manufactured for:
Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 U.S.A.
1-(801) 522-5000
Customer Service: 1-(800) 545-0890
Technical/Clinical Support: 1-(800) 443-3385
www.bardaccess.com
www.discoversherlock.com
0741980 1603R

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Summary of Contents for Bard Sherlock 3CG

  • Page 1 Technical/Clinical Support: 1-(800) 443-3385 www.bardaccess.com Bard, Sherlock and Sherlock 3CG are trademarks www.discoversherlock.com and or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners. ©2016 C. R. Bard, Inc. All rights reserved.
  • Page 2 Standalone Instructions for Use INSTRUCTIONS FOR USE...
  • Page 3 Sherlock 3CG™ Tip Confirmation System Fragile, handle with care Keep Dry CF Type Equipment Manufacturer Storage humidity Consult instructions limitation for use Operating humidity Humidity limitation limitation Storage temperature Operating temperature limitation limitation Attention, see instructions Do not dispose with...

  • Page 4: Table Of Contents

    3.3.1 Settings – General Service and Repair 3.3.2 Settings – Remote Technical Specifications 3.3.3 Settings – Printers 13.1 Sherlock 3CG™ TCS Sensor and Display Operational and Storage Conditions 3.3.4 Settings – File Management Disposal Information 3.4 Remote Control Deleting Patient Information 3.5 Sherlock 3CG™...

  • Page 5: Overview

    Sherlock 3CG™ TCS provides real-time PICC tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the patient’s ECG signal, the Sherlock 3CG™ TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients.

  • Page 6: System Components

    Magnetic Navigation Permanent magnets are encapsulated within the tip of the Sherlock 3CG™ TPS Stylet. No magnetic energy is generated by the display or the sensor. The Sherlock 3CG™ TCS displays the relative position of the magnet-tipped stylet to the sensor. It does this in two steps: 1.

  • Page 7: Assembling The Sherlock 3Cg™ Tcs

    2.1 Attaching the Sherlock 3CG™ TCS Sensor Holster to the roll stand The Sherlock 3CG™ TCS Sensor can be placed in the holster when not in use. To attach the sensor holster to a roll stand see illustrations below. Caution: When the sensor is not in use, store in the holster, roll stand basket or other secure location to avoid damage.

  • Page 8: Sherlock 3Cg™ Tcs Information

    Instructions For Use 3 Sherlock 3CG™ TCS Information 3.1 Sherlock 3CG™ TCS Graphical Interface...
  • Page 9 Sherlock 3CG™ Tip Confirmation System SEARCHING FOR SIGNAL ICON Stylet tip had not been detected. OFF SCREEN ICON Location of the approaching stylet tip STYLET ICON Location and direction of stylet tip under the sensor. The circle represents the tip of the stylet and the tail represents the body of the stylet.

  • Page 10: Sherlock 3Cg™ Tcs Controls And Indicators

    Instructions For Use 3.2 Sherlock 3CG™ TCS Controls and Indicators Front Panel Controls/Indicators Shut down: Select to open the shutdown menu. Caution: To avoid damage to the operating system, use the Shutdown button to turn off the Sherlock 3CG™ TCS Display.
  • Page 11 Sherlock 3CG™ Tip Confirmation System Magnet Tracking Controls Calibrate: Select to calibrate magnet tracking. Audio: : Select to toggle sound on or off. ECG Menu Controls , below, are accessible when the ECG menu botton is activated. ECG Menu Controls Save: Select to stop and save the ECG waveform recording.
  • Page 12 Sherlock 3CG™: Restarts the Sherlock 3CG™ Software Application. Shutdown: Shuts down the Sherlock 3CG™ TCS Display. Restart: Restarts the Sherlock 3CG™ TCS Display. Lock: Locks the password enabled Sherlock 3CG™ TCS Display. Tools Menu Controls , below, are accessible when the Tools botton is activated.

  • Page 13: Settings Icon

    Restores software to factory default settings. Restore Defaults View and export system error logs. Upgrade Provides system software upgrades when a USB flash drive containing a Sherlock 3CG™ TCS com- patible installation is inserted. About Indicates system application version information.

  • Page 14: Settings - Remote

    Closes the Remote window and Settings menu. Close 3.3.3 Settings – Printers Set Current Printer Sets the selected printer as current. Note – Sherlock 3CG™ TCS Application will print to the current printer. Close Closes the Printer window and Settings menu.

  • Page 15: Settings - File Management

    Sherlock 3CG™ Tip Confirmation System 3.3.4 Settings – File Management Refresh Refreshes the file(s) listing in the viewer. Hide LOG / Show LOG Hides/Shows all f les with a .log extension from appearing in the viewer. Hides/Shows all f les with a .jpg extension from appearing in the viewer.

  • Page 16: Remote Control

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

  • Page 17: Parallax

    Sherlock 3CG™ Tip Confirmation System 3.6 Parallax When a patient's chest is not flat, the sensor will rest at an angle, causing an effect known as parallax. Parallax is the difference in the apparent location of an object from two different points of view. The difference between the point of view of the sensor and the user can be several centimeters.

  • Page 18: Sherlock 3Cg™ Tcs Catheter Guidance

    4 Sherlock 3CG™ TCS Catheter Guidance Step 1: Prepare Device - Connect the sensor to the Sherlock 3CG™ TCS Display via USB cord. - Verify that the ECG flatline signal is scrolling. - Verify the battery charge is sufficient for the procedure.

  • Page 19: 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 place the sensor directly on the patient's skin with the adhesive side down. Place the sensor as flat as possible for best results.

  • Page 20: 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 21: Step 15: Procedural Record

    Sherlock 3CG™ Tip Confirmation System Step 15: Procedural Record - Select [ ] to print / save a procedural record. Note: Selecting [ ] will send the procedural record to a storage device and approved printer, if connected. A typical printout is shown below.

  • Page 22: Magnetic Navigation Only Mode

    - Refer to Bard Access Systems’ Catheter Instructions for Use. Step 4: Prepare Sensor -Place the Sherlock 3CG™ Sensor in the sensor holder and tighten the cinch ring Step 5: Position Sensor - Remove the adhesive backing from the sensor holder and place the sensor directly on the patient's skin with the adhesive side down. Place the sensor as flat as possible for best results.

  • Page 23: Step 6: Perform Initial Magnet Tracking Calibration

    - 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 24: Troubleshooting And Error Messages

    Instructions For Use 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. Solution: Disconnect the display power supply from the electrical outlet to run the system on battery power.

  • Page 25: 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 26 Instructions For Use Cause: Body ECG leads swapped. Place ECG leads correctly. Solution: ECG signal abnormal Cause: No distinct P-wave. Solution: Do not rely on ECG guidance for catheter tip confirmation. Refer to Warnings Section. Cause: Sensor / sensor cables damaged. Solution: Call technical hotline at 1-800-443-3385 to replace sensor and/or cables.

  • Page 27: Magnetic Navigation Troubleshooting

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

  • Page 28: Battery Installation And Removal

    Instructions For Use 7 Battery Installation and Removal 7.1 Installation 1. Align the battery pack and insert into the battery bay. 2. Slide the battery pack firmly until it locks into place. 3. Verify the battery switch is in the locked position.

  • Page 29: Removal

    Sherlock 3CG™ Tip Confirmation System 7.2 Removal 1. Slide the battery switch to the unlocked position. 2. After the battery switch is in the unlocked position, the battery will lift up from the battery bay. 3. Lift the battery pack from the battery bay.

  • Page 30: Remote Control Installation

    3. Click the Remote button in the system settings menu that appears. 4. Position the remote control within two feet of the Sherlock 3CG™ TCS Display. On the left side of the remote control, press and hold the connect button until the blue LED on the remote control starts blinking rapidly.

  • Page 31: Sherlock 3Cg™ Tcs Printer Installation

    9 Sherlock 3CG™ TCS Printer Installation 9.1 Brother™ Printer 1. Connect the USB cable to an available USB port on the Sherlock 3CG™ TCS Display. 2. Turn on the display and the Brother™ Printer. 3. Select the Settings icon from the Application Toolbar.

  • Page 32: Sony™ Printer

    Instructions For Use 9.2 Sony™ Printer 1. Connect the printer USB cable to an available USB port on the Sherlock 3CG™ TCS Display. 2. Ensure the printer is plugged in and powered on and the printer display window reads “READY.”...

  • Page 33: 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 34: Service And Repair

    Storage Humidity: 5% to 95% non-condensing 14 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. 15 Deleting Patient Information Note: This procedure will permanently delete all patient information from your system.

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