For use with Site
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Rite Vision™ II Ultrasound System
INSTRUCTIONS FOR USE (IFU)
Page 1: ...For use with Site Rite Vision II Ultrasound System INSTRUCTIONS FOR USE IFU ...
Page 2: ...ty Limitation Operating Humidity Limitation Operating Temperature Limitation Keep Dry CF Type Equipment Storage Temperature Limitation Manufacturer Do not dispose with ordinary municipal waste Caution Federal U S A law restricts this device to sale by or on the order of a physician Fragile ...
Page 3: ...Sherlock 3CG Tip Confirmation System ...
Page 4: ...d Sherlock 3CG TCS Layout 8 SHERLOCK 3CG TCS GRAPHICAL INTERFACE 11 Site Rite Vision II Ultrasound System Mode with Sherlock 3CG TCS External ECG 11 Sherlock 3CG TCS Only TCS Mode Screen 12 Sherlock Magnet Tracking 13 Sherlock 3CG TCS Controls and Indicators 13 PICC Compatibility and Print Region Settings 15 Sherlock 3CG TCS Audio Information 17 Parallax 17 SHERLOCK 3CG TCS CATHETER CARE GUIDANCE ...
Page 5: ...3CG Tip Confirmation System 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 ...
Page 6: ...previously marketed Sapiens Tip Confirmation System The Sapiens TCS Post Market Clinical trial was a prospective single arm single center study designed to assess the efficacy of the ECG method for correctly positioning the tip of catheters in adult patients The primary endpoints were to assess the performance of the Sapiens technology with respect to 1 the accuracy of the Sapiens technology with ...
Page 7: ...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 Sherlock 3CG TCS takes a background measurement of the ambient magnetic field during the calibration cycle 2 Sherlock 3CG TCS senses changes in the magnetic field When the...
Page 8: ...pecially marked central venous catheter kits Sherlock TLS Stylet included with specially marked central venous catheter kits Fin Assembly included with specially marked central venous catheter kits Sherlock Sensor Holder ordered separately or with specially marked central venous catheter kits or Sherlock 3CG TCS Sensor Holster optional Bard Access Systems supplied printer purchased separately ...
Page 9: ...moving system labels by anyone other than Bard Access Systems authorized service personnel Connecting the sensor or applied patient components to any unauthorized system or accessory Refer to Section 1 4 for complete components Installation of unauthorized software Modification of system settings without authorization by Bard Access Systems Warning If the Site Rite Vision II Ultrasound System with...
Page 10: ...d the MRI device This magnetic attraction may also damage the equipment The magnetic and the RF fields associated with the MRI environment may interfere with the display of ECG waveforms Consult the MRI manufacturer for more information Warning The Sherlock 3CG TCS must only be charged with the Medical Grade Power Supply Warning Do not remove Sherlock 3CG TCS enclosures To avoid electrical shock u...
Page 11: ...ches jewelry electronics metal bedrails etc to be within 12 in 30 cm of the sensor once the calibration process is complete These items may interfere with the sensor s ability to accurately locate the Sherlock stylet tip Caution Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference which could affect the performance of this device Avoid operating th...
Page 12: ...g 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 II Ultrasound System roll stand ...
Page 13: ...lays 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 If your ultrasound screen layout shows ultrasound only No Sherlock 3CG TCS external waveform as shown below perform the following procedure to enable ultrasound and Sherlock 3CG TCS layout 1 From the ultrasound screen go to feature toolbar and select ...
Page 14: ...Sherlock 3CG Tip Confirmation System Page 9 2 In the settings screen select the Layout dropdown menu arrow and select Ultrasound and S3CG Then select Apply ...
Page 15: ...Sherlock 3CG Tip Confirmation System Page 10 3 Now the screen layout incorporates ultrasound and Sherlock 3CG TCS In this screen you may assess the presence of the external P wave ...
Page 16: ...on System Page 11 SHERLOCK 3CG TCS GRAPHICAL INTERFACE Site Rite Vision II Ultrasound System Mode with Sherlock 3CG TCS External ECG Ultrasound Imaging Sherlock 3CG TCS External ECG Sherlock 3CG TCS Only TCS Mode Calibrate Sensor ...
Page 17: ...Screen Calibrate Audio Mute Ultrasound Mode Magnet Tracking Window Feature Toolbar Main ECG Display Real time external and intravascular ECG waveforms Reference ECG Display Used for freezing the external and intravascular ECG waveforms to assist in maximum P wave identification ...
Page 18: ... not been detected Depth Icon Rela ive stylet depth under sensor Sherlock 3CG TCS Controls and Indicators Main Controls Ultrasound Mode Select to exit the Sherlock 3CG TCS Mode referred to as TCS Mode and enter Ultrasound Mode TCS Mode Select to exit Ultrasound Mode and enter TCS Mode Calibrate Button Select to calibrate magnet navigation in Ultrasound Mode and TCS Mode Successful Calibration Indi...
Page 19: ...t to adjust the ECG signal amplitude of the external white or intravascular yellow ECG waveforms up or down Level Up Select to increase or decrease the vertical position of the external white or intravascular yellow ECG waveforms on the Main Screen Speed Select to adjust the speed of the ECG waveforms on the Main Screen Exit Site Marking Select to open the Exit Site Marking Window Save ECG Select ...
Page 20: ...rols 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 ...
Page 21: ...Vision II Ultrasound System is compatible with the following PICCs as described below The PICCS indicated with are compatible for ECG and Magnet Navigation The PICCs indicated with are only compatible for Magnet Navigation Magnet Printing Enable Disable will determine if you print out ECG waveform and Magnet Navigation or ECG only ...
Page 22: ...and below the Bard logo Note Audio signals are only applicable to the magnetic navigation capability of the device 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 b...
Page 23: ...dure 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 Step 4 Prepare the sensor Slide the Fin Assembly onto the sensor until fully seated Place sensor in the sensor ho...
Page 24: ...e on patient s lower right shoulder Place red lead on patient s lower left side inferior to the umbilicus and laterally along the mid axillary line Caution Placement of red electrode outside of this region may result in reduced ECG performance Warning Place skin electrodes carefully at locations indicated in these Instructions for Use and ensure good skin electrode contact Failure to do so may cau...
Page 25: ...ss 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 Refer to Bard Access Systems catheter Instructions for Use Step 11 Perform the final magnet tracking calibration Switch unit to TCS Mode Ensure...
Page 26: ...ed 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 ECG Positioning In patients with a distinct P wave the P wave will increase in amplitude as the catheter approaches the cavo atrial junction As the catheter advances into the right atrium the P wave will decrease in amplitude ...
Page 27: ...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: ... 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 Step 4 Prepare the sensor Place the Sherlock 3CG TCS Sensor in the sensor holder and tighten the cinch ring Step 5 Position the sensor Remove the adhesive backing from the sensor holder and place the sensor directly on the patient s skin ...
Page 29: ...catheter insertion Once calibration is complete ask the patient to remain still and do not reposition the patient Refer to Bard Access Systems catheter Instructions for Use for catheter insertion Step 10 Insert the catheter Refer to Bard Access Systems catheter Instructions for Use for catheter insertion Step 11 Catheter tip guidance and positioning Refer to Bard Access Systems catheter Instructio...
Page 30: ...et icon on the display 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 Below is an image of Magnetic tracking only mode ...
Page 31: ...Lower bed rails 3 Move all active electronic devices at least 5 feet 1 5 m away 4 Do not move the sensor and ask the patient to remain still 5 Calibrate 6 If the error continues discontinue use and call the technical support hotline 1 800 443 3385 Cause Sensor malfunction Solution 1 Turn off and restart the system 2 If the error continues discontinue use and call the technical support hotline 1 80...
Page 32: ...use Poor ECG signal Cause Fin and or stylet connectors not fully seated Solution Fully seat fin on sensor Fully seat stylet connector on fin 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 Cause Extrane...
Page 33: ...lace ECG leads correctly Cause No distinct P wave Solution Do not rely on ECG guidance for catheter tip confirmation Refer to Warnings Section Absent ECG signal Cause Sensor sensor cables damaged Solution Call technical hotline at 1 800 443 3385 to replace sensor and or cables Cause Sensor disconnected Solution Ensure the sensor is properly connected Cause Sensor is not communicating with display ...
Page 34: ... by using a folded blanket Cause Too much time has passed since calibration Magnetic fields have changed Solution Pull catheter tip back at least 12 inches 30 cm from the sensor recalibrate and re advance catheter Cause Stylet did not advance under the sensor Solution Pull catheter back and re advance Cause Stylet not at the catheter tip Solution Ensure stylet tip is within 1 cm of distal end of c...
Page 35: ...from the sensor recalibrate and re advance catheter Magnetic navigation Stylet icon disappears sweeping magnifying glass displayed Cause Stylet is out 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 using ECG guidance and catheter measurement Cause Magnetic interference Solution...
Page 36: ...opropyl alcohol 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 Warning Do not attempt to sterilize the sensor Damage to the equipment may occur...
Page 37: ...sor or applied patient components to any unauthorized system or accessory Refer to System Component Section for complete components Installation of unauthorized software Modification of system settings without authorization by Bard Access Systems TO THE EXTENT ALLOWABLE BY APPLICABLE LAW THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES WHETHER EXPRESS OR IMPLIED INCLUDING BUT NOT L...
Page 38: ...ay result in injury or equipment damage Warning The following actions void the warranty of the Sherlock 3CG TCS and may result in injury or equipment damage Opening or servicing the Sherlock 3CG TCS by anyone other than Bard Access Systems authorized service personnel Removing system labels by anyone other than Bard Access Systems authorized service personnel Connecting the sensor or applied patie...
Page 39: ...Temperature 10 C to 40 C 50 F to 104 F Storage Temperature 18 C to 40 C 0 F to 104 F Operating Humidity 5 to 85 non condensing 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 ...
Page 40: ...tion is available Revision date December 2013 Manufacturer Bard Access Systems Inc 605 North 5600 West Salt Lake City UT 84116 U S A Customer Service 1 800 545 0890 Technical Clinical Support 1 800 443 3385 Fax 1 801 522 4948 www bardaccess com www discoversherlock com Bard Sherlock Sherlock 3CG Site Rite and Site Rite Vision are trademarks and or registered trademarks of C R Bard Inc All other tr...
