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Bard Sherlock 3CG Tip Confirmation System Instructions For Use Manual

For use with site-rite vision ii ultrasound system
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For use with Site~Rite Vision™ II Ultrasound System
INSTRUCTIONS FOR USE (IFU)

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Summary of Contents for Bard Sherlock 3CG Tip Confirmation System

  • Page 1 For use with Site~Rite Vision™ II Ultrasound System INSTRUCTIONS FOR USE (IFU)
  • Page 2 SYMBOLS Storage Humidity Limitation Consult instructions for use Operating Temperature Operating Humidity Limitation Limitation CF Type Equipment Keep Dry Manufacturer Storage Temperature Limitation Caution: Federal (U.S.A.) Do not dispose with ordinary law restricts this device to municipal waste sale by or on the order of a physician Fragile Sherlock 3CG™...
  • Page 3 Sherlock 3CG™ Tip Confirmation System...

  • Page 4: Table Of Contents

    TABLE OF CONTENTS OVERVIEW ..............................1 Indications for Use ............................ 1 Post Market Clinical Trial .......................... 1 Sherlock 3CG™ Tip Confirmation System (TCS) Description ..............1 ECG Positioning ............................1 Magnetic Navigation ..........................2 System Components ..........................3 WARNINGS ..............................4 CAUTIONS ..............................
  • Page 5 WARRANTY ..............................32 SERVICE AND REPAIR ..........................33 TECHNICAL SPECIFICATIONS ........................34 Sherlock 3CG™ TCS Sensor and Display Operational and Storage Conditions ........34 DISPOSAL INFORMATION ..........................34 Cleaning Procedures ..........................34 Sherlock 3CG™ Tip Confirmation System...

  • Page 6: Overview

    PICC tip location. 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™...

  • Page 7: Magnetic Navigation

    amplitude as the catheter approaches the top of the cavo-atrial junction. As the catheter advances into the right atrium, the P-wave will decrease in amplitude and may be biphasic or invert. 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.

  • Page 8: System Components

    Fin Assembly (included with specially marked central venous catheter kits)  Sherlock™ Sensor Holder (ordered separately or with specially marked central venous catheter kits)  Sherlock 3CG™ TCS Sensor Holster (optional)  Bard Access Systems' supplied printer (purchased separately) Sherlock 3CG™ Tip Confirmation System Page 3...

  • Page 9: Warnings

    See the Bard Access Systems' catheter Instructions for Use (IFU) for possible complications associated with peripherally inserted central catheter (PICC) placements and ECG positioning. See the Bard Access Systems’ Site~Rite Vision™ II Ultrasound System IFU for warnings and precautions regarding the use of the Site~Rite Vision™ II Ultrasound System.
  • Page 10 Warning: Do not remove Sherlock 3CG™ TCS enclosures. To avoid electrical shock, use only the power cord supplied with the system and connect it only to properly grounded wall outlets. Only Bard Access Systems qualified personnel should service the system.

  • Page 11: Cautions

    Caution: Excessive twisting or bending of the sensor cable may cause system failure. Caution: Use only Bard Access Systems’ cleaning and disinfection procedures. Failure to do so may damage the device. Caution: Do not use excessive force when connecting or disconnecting the Fin Assembly to or from the sensor or equipment damage may occur.

  • Page 12: Assembling The Sherlock 3Cg™ Tcs

    ASSEMBLING THE SHERLOCK 3CG™ TCS Connecting the Sherlock 3CG™ TCS Sensor to the Site~Rite Vision™ II Ultrasound System The Sherlock 3CG™ TCS Sensor connects to the USB port on the roll stand. When not in use, the Sherlock 3CG™ TCS Sensor can be placed in the holster on the back of the Site~Rite Vision™...

  • Page 13: Sherlock 3Cg™ Tcs Information

    SHERLOCK 3CG™ TCS INFORMATION Enabling Ultrasound and Sherlock 3CG™ TCS Layout From the main ultrasound screen (Ultrasound Mode), the Site~Rite Vision™ II Ultrasound System displays ultrasound at the top half of the screen and the Sherlock 3CG™ TCS white external waveform for P-wave pre-assessment at the bottom of the screen.
  • Page 14 2. In the settings screen, select the ‘Layout’ dropdown menu arrow and select “Ultrasound and S3CG." Then select ‘Apply’. Sherlock 3CG™ Tip Confirmation System Page 9...
  • Page 15 3. Now the screen layout incorporates ultrasound and Sherlock 3CG™ TCS. In this screen you may assess the presence of the external P-wave. Sherlock 3CG™ Tip Confirmation System Page 10...

  • Page 16: Sherlock 3Cg™ Tcs Graphical Interface

    SHERLOCK 3CG™ TCS GRAPHICAL INTERFACE Site~Rite Vision™ II Ultrasound System Mode (with Sherlock 3CG™ TCS External ECG) Ultrasound Imaging Sherlock 3CG™ TCS Only (TCS Mode) Calibrate Sensor Sherlock 3CG™ TCS External ECG Sherlock 3CG™ Tip Confirmation System Page 11...

  • Page 17: Sherlock 3Cg™ Tcs Only (Tcs Mode) Screen

    Sherlock 3CG™ TCS Only (TCS Mode) Screen Calibrate Magnet Tracking Window Audio Mute Feature Toolbar Ultrasound Mode Main ECG Display Reference ECG Display Real-time external and Used for freezing the external and intravascular ECG waveforms intravascular ECG waveforms to assist in maximum P-wave identification Sherlock 3CG™...

  • Page 18: Sherlock Magnet Tracking

    Magnet Tracking 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 Depth Icon: Rela ive stylet tip under the sensor. The circle stylet depth under sensor represents the tip of the stylet and the tail represents he body of the stylet.
  • Page 19 Save ECG: Select to electronically save the ECG and magnet navigation data to file. Demo: Select to initiate demonstration mode. For additional training, contact your local Bard Access Systems representative. Interactive Demo Mode: Select to demonstrate Sherlock 3CG™ TCS interactively.

  • Page 20: Picc Compatibility And Print Region Settings

    Main Controls Open: Select to open previously saved ECG and magnet navigation files. Settings: Select to bring up PICC Compatibility and Printout menu. PICC Compatibility and Print Region Settings 1. While in TCS Mode, go to the feature menu and select the “Settings” icon. Sherlock 3CG™...
  • Page 21 2. The Sherlock 3CG™ TCS Settings screen will appear. The Sherlock 3CG™ TCS on Site~Rite Vision™ II Ultrasound System is compatible with the following PICCs as described below:  The PICCS indicated with are compatible for ECG and Magnet Navigation. ...

  • Page 22: Sherlock 3Cg™ Tcs Audio Information

    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 23: Sherlock 3Cg™ Tcs Catheter Care Guidance

     Enter Patient Information as needed. Step 2: Position the patient and perform ultrasound pre-scan.  Refer to the Bard Access Systems’ Site~Rite Vision™ II Ultrasound System Instructions for Use. Step 3: Measure the catheter length.  Refer to Bard Access Systems’ Catheter Instructions for Use.
  • Page 24 Placement of red electrode outside of this region may result in reduced ECG performance. Place high on the patient’s chest, touching the neck, if possible. The Bard logo should face upward. The cord should be routed toward the patient’s feet. Warning: Place skin electrodes carefully at locations indicated in these Instructions for Use and ensure good skin-electrode contact.
  • Page 25 Refer to the Bard Access Systems’ catheter Instructions for Use. Step 9: Access the vein.  Refer to the Bard Access Systems’ Site~Rite Vision™ II Ultrasound System Instructions and Bard Access Systems’ catheter Instructions for Use. Step 10: Attach the catheter stylet to the fin assembly.
  • Page 26  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.  Select [ ] to freeze/save the current ECG waveforms in the reference screen.
  • Page 27 Step 15: Procedural record:  Select [ ] to directly print and save the ECG and magnet tracking procedural record without previewing. A typical ECG and Magnet Tracking printout is shown below: ECG PRINTOUT MAGNET TRACKING PRINTOUT Note: Printout Statement Enable/Disable from Sherlock 3CG™ TCS settings will control whether the following statement is visible on the ECG printout: “PICC tip location in the SVC confirmed by ECG technology”...

  • Page 28: Magnetic-Navigation-Only Mode

     Enter Patient Information as needed. Step 2: Position the patient and perform the ultrasound pre-scan.  Refer to the Bard Access Systems’ Site~Rite Vision™ II Ultrasound System Instructions for Use. Step 3: Measure the catheter length.  Refer to Bard Access Systems’ Catheter Instructions for Use.
  • Page 29 Refer to the Bard Access Systems’ catheter Instructions for Use. Step 8: Access the vein.  Refer to the Bard Access Systems’ Site~Rite Vision™ II Ultrasound System Instructions and Bard Access Systems’ catheter Instructions for Use. Step 9: Perform the final magnet-tracking calibration.
  • Page 30  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. Below is an image of Magnetic tracking only mode. Sherlock 3CG™ Tip Confirmation System...

  • Page 31: Troubleshooting And Error Messages

    TROUBLESHOOTING AND ERROR MESSAGES Error Screens Cause: Sensor not connected to the display Solution: Ensure the sensor is properly connected. Disconnect and Sensor Disconnected 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 32: Ecg Troubleshooting

    Solution: 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 33 Cause: Poor ECG electrode contact. Solution: Ensure that the area on the skin where the ECG electrodes were placed is oil free and completely dry. Cause: Patient movement. Solution: Ask the patient to remain still. Ensure the patient is warm and relaxed. Wandering ECG baseline Cause: Extraneous noise.

  • Page 34: Magnetic Navigation Troubleshooting

    Cause: Stylet not at the catheter tip. Solution: Ensure stylet tip is within 1 cm of distal end of catheter. Adjust as necessary. Cause: Incompatible catheter. Solution: Verify that the Bard Access Systems’ catheter kit has a icon or icon.
  • Page 35 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. Magnetic navigation Stylet icon has erratic Cause: Magnetic interference.

  • Page 36: Cleaning And Disinfection

    3. Gently wipe the dampened cloth over exterior surfaces. Disinfection Procedure For a list of disinfectants approved for use on the Sensor, Display and Remote Control contact Bard Access Systems, Inc. Warning: Do not submerge the sensor or allow fluid to enter the connector. Damage to the equipment may occur.

  • Page 37: Warranty

    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 price list.

  • Page 38: Service And Repair

    SERVICE AND REPAIR There is no periodic or preventative maintenance required for the Sherlock 3CG™ TCS. For servicing information or to return your Sherlock 3CG™ TCS for repair, please contact Bard Access Systems' technical support hotline at 1(800) 443-3385. Warning: Only qualified personnel should attempt to service this equipment. The Sherlock 3CG™ TCS contains static sensitive components and circuits.

  • Page 39: Technical Specifications

    Storage Humidity: 5% to 95% non-condensing DISPOSAL INFORMATION Cleaning Procedures 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. Sherlock 3CG™ Tip Confirmation System...
  • Page 40 An issued or revision date for these instructions is included for the user’s information. In the event that two years have lapsed between the issued revision date and use of the product, contact Bard Access Systems, Inc. to see if any additional product information is available.

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