Bard Sherlock 3CG Instructions For Use Manual
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
For use with
Site~Rite™ 6 Ultrasound System
Instructions for Use
Sherlock 3CG™ Tip Confirmation System
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Keep Dry
Manufacturer:
Consult instructions
for use
Operating Humidity Parameters
Storage Humidity Parameters
(unpackaged)
Operating Temperature
Parameters
Fragile
%
Rx Only
CF Type Equipment
Storage Humidity Parameters
(packaged)
Storage Temperature
Parameters
Do not dispose with
ordinary municipal waste
Federal (U.S.A.) law restricts
this device to sale by or on the
order of a physician
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- TABLE OF CONTENTS -
Section Section
Instructions For Use
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
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
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Sherlock 3CG™ Tip Confirmation System
1 Overview
1.1 Indications for Use
The Sherlock 3CG™ Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The
Sherlock 3CG™ TCS provides real-time PICC tip location information by using passive magnet navigation 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.
Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P wave as
in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to catheter insertion,
the use of an additional method is required to confirm PICC tip location.
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 previouslymarketed 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 regard to correct positioning of the catheter tip when compared
to postoperative chest x-ray, (2) safety of using an invasive intracardiac electrode, and (3) compatibility with peripherally inserted central catheters. One
hundred fourteen (114) subjects received a PICC. Final PICC tip location was confirmed at the cavoatrial junction or within +/- 1 cm in 99.1% (113/114)
of the subjects. No adverse events were reported.
1.3 Sherlock 3CG™ TCS Description
The Sherlock 3CG™ TCS is designed to aid in PICC tip positioning through magnet navigation and ECG technology. It is designed to operate with
Bard Access Systems’ catheter kits labeled [ ] and “Sherlock 3CG™ TPS Stylet”.
Note: When used in conjunction with catheter kits labeled [ ] the device provides magnetic navigation information but does not allow positioning
through ECG technology.
ECG Positioning
The Sherlock 3CG™ TCS displays an ECG signal detected by the intravascular and body electrodes, which can be used for catheter tip positioning.
In patients with a distinct P-wave, the P-wave will increase in amplitude as the catheter approaches the top of the cavoatrial junction. As the catheter
advances into the right atrium, the P-wave will decrease in amplitude and may be biphasic or invert. In addition to the ECG signal, the magnet tracking
stylet icon is augmented with the shape and color changes shown below.
Note: In instances where the P-wave is not present, not identifiable, or intermittent the stylet icon will remain a yellow circle.
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Instructions For Use
Magnetic Navigation
Permanent magnets are encapsulated within the tip of the Sherlock 3CG™ TPS Stylet. No magnetic energy is generated by the Site~Rite™ 6 Ultrasound System
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 Sherlock 3CG™ TCS detects the stylet, it displays the stylet tip location
and orientation.
1.4 System Components
Ultrasound probe:
Ultrasound System Display Controls:
- - System controls for using Sherlock 3CG™ TCS Mode on the Site~Rite™ 6 Ultrasound System
Authorized accessories include:
- Site~Rite™ 6 Ultrasound System
- Sherlock 3CG™ TCS Sensor
- Sherlock 3CG™ TPS Stylet (included with specially 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 .
- Bard Access Systems' supplied printer (purchased separately).
1.5 Warnings and Precautions
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.
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Sherlock 3CG™ Tip Confirmation System
Warnings
Warning: This product should only be operated by qualified medical personnel.
Warning: Do not power the Sherlock 3CG™ TCS in the presence of noncontained flammable anesthetic gases. Explosion may result.
Warning: Do not attempt to sterilize the sensor. Damage to the equipment may occur.
Warning: The following actions void the warranty of the Sherlock 3CG™ TCS and may result in injury or equipment damage.
- Opening or servicing the
- Removing 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 software settings without authorization by Bard Access Systems.
Warning: If the
Warning: Do not submerge the sensor in liquid or allow fluid to enter the connectors. Damage to the equipment may occur.
Warning: Sherlock 3CG™ TCS is not intended to diagnose or treat disease.
Warning: Only Bard Access Systems’ authorized service personnel should attempt to service this equipment.
Warning: Do not rely on ECG signal detection for catheter tip positioning when interpretation of the external or intravascular ECG P-wave is difficult.
- P-wave is not present
- P-wave is not identifiable
- P-wave is intermittent
These conditions may be a result of heart rhythm abnormalities, atrial fibrillation, atrial flutter, severe tachycardia or presence of cardiac rhythm
Warning: Do not rely on ECG signal detection for catheter tip positioning when there are no observable changes in the intravascular P-wave. In this case,
Warning: Do not place and/or use the Sherlock 3CG™ TCS in the presence of strong magnetic fields such as Magnetic Resonance Imaging (MRI) devices.
Warning: Do not remove Sherlock 3CG™ TCS enclosures. To avoid electrical shock, use only the power cord supplied with the system and connect only to
Warning: Ensure all connecting cables and connections are electrically insulated and do not come into contact with other electrical cables or metal surfaces.
Warning: Ensure that the patient does not directly or indirectly contact non-insulated metal surfaces.
Warning: Place skin electrodes carefully at locations indicated in these Instructions for Use and ensure good skin-electrode contact. Failure to do so may cause
authorized service personnel.
Site~Rite™ 6 Ultrasound System with Sherlock 3CG™ TCS is visibly damaged, discontinue use immediately. Use of the damaged system
may result in injury or equipment damage.
sensitive components and circuits. Failure to observe proper static control procedures may result in damage to the system.
For example, when:
devices. In these cases, rely on magnetic navigation and external measurement for tip positioning and use chest x-ray or fluoroscopy to confirm
catheter tip location, as indicated by institutional guidelines and clinical judgment.
rely on magnetic navigation and external measurement for tip positioning and use chest X-ray or fluoroscopy to confirm catheter tip location, as
indicated by institutional guidelines and clinical judgment.
The high magnetic fields created by an MRI device will attract the equipment with a force sufficient to cause death or serious injury to persons
between the equipment and 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.
properly grounded wall outlets. Only Bard Access Systems qualified personnel should service the system
unstable ECG waveforms and/or ECG waveforms that are not described in these Instructions for Use. In such a case, rely on magnetic navigation
and external measurement for tip positioning and use chest X-ray or fluoroscopy to confirm catheter tip location, as indicated by the institutional
guidelines and clinical judgment.
Site~Rite™ 6 Ultrasound System with Sherlock 3CG™ TCS by anyone other than Bard Access Systems’
Site~Rite™ 6 Ultrasound System contains static
Precautions
Caution:
Federal (U.S.A) law restricts this device to sale by or on the order of a physician.
Caution: Do not pull the cables to disconnect from the system. Pulling the cable may damage the cable or cable connection.
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.
Caution: When the sensor is not in use, store in the holster, roll stand basket or other secure location to avoid damage.
Caution: Do not allow any ferromagnetic objects, e.g., wired undergarments, metal instruments, watches, 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 the device near pumps, cauterizers, diathermy equipment, cellular phones, or other portable and mobile radio
frequency communications equipment. Maintain equipment separation of at least 5 ft (1.5 m).
Caution: Electrodes should be applied only to intact, clean skin (e.g., not over open wounds, lesions, infected or inflamed areas).
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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™ 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 the 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.
2.2 Connecting the Sherlock 3CG™ TCS Sensor to the Site~Rite™ 6 Ultrasound System
Instructions For Use
The Sherlock 3CG™ TCS Sensor connects to the USB port on the display.
3 Sherlock 3CG™ TCS Information
3.1 Switching Between Ultrasound and TCS
To switch from Ultrasound mode to TCS mode the buttons [ ] and [ ] need to be pressed simultaneously.
To switch from TCS Mode to Ultrasound Mode, select the ULTRASOUND icon [ ] by:
1. Selecting the UP [ ] and DOWN [ ] buttons on the Ultrasound Probe, or on the Ultrasound Machine, to navigate to the Ultrasound icon.
2. Once the Ultrasound icon is highlighted [ ], select the [ ] button to switch back to Ultrasound Mode.
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Sherlock 3CG™ Tip Confirmation System
3.2 Sherlock 3CG™ TCS Graphical Interface
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