Bard Sherlock 3CG Tip Confirmation System User manual

For use with Site~Rite Vision™II Ultrasound System
INSTRUCTIONS FOR USE (IFU)

Sherlock 3CG™ Tip Confirmation System
SYMBOLS
Consult instructions for use
Storage Humidity
Limitation
Operating Humidity Limitation
Operating Temperature
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Keep Dry
CF Type Equipment
Storage Temperature
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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

Sherlock 3CG™ Tip Confirmation System

Sherlock 3CG™ Tip Confirmation System
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 ..................................................................................................................................................... 6
ASSEMBLING THE SHERLOCK 3CG™TCS....................................................................................................... 7
Connecting the Sherlock 3CG™TCS Sensor to the Site~Rite Vision™II Ultrasound System .................... 7
SHERLOCK 3CG™TCS INFORMATION ........................................................................................................... 8
Enabling Ultrasound and 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.....................................................................................18
MAGNETIC-NAVIGATION-ONLY MODE.......................................................................................................23
TROUBLESHOOTING AND ERROR MESSAGES ............................................................................................. 26
Error Screens........................................................................................................................................... 26
ECG Troubleshooting ..............................................................................................................................27
Magnetic Navigation Troubleshooting ................................................................................................... 29
CLEANING AND DISINFECTION.................................................................................................................... 31
Cleaning Procedure.................................................................................................................................31
Disinfection Procedure ........................................................................................................................... 31

Sherlock 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

Sherlock 3CG™ Tip Confirmation System Page 1
OVERVIEW
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 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.
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.
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. 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.
Sherlock 3CG™Tip Confirmation System (TCS) Description
The Sherlock 3CG™TCS is designed to aid in PICC tip positioning through magnet tracking 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

Sherlock 3CG™ Tip Confirmation System Page 2
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. 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.

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System Components
Authorized accessories include:
Site~Rite Vision™II 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
Sherlock 3CG™TCS Sensor Holster (optional)
Bard Access Systems' supplied printer (purchased separately)

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WARNINGS
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.
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.
Warning: This product should only be operated by qualified medical personnel.
Warning: Do not power the Sherlock 3CG™TCS in the presence of 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 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 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 Sherlock 3CG™TCS is visibly damaged,
discontinue use immediately. Use of the damaged system may result in injury or equipment damage.
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. The Sherlock 3CG™TCS contains static sensitive components and circuits. Failure to observe
proper static control procedures may result in damage to the system.
Warning: Do not rely on ECG signal detection for catheter tip positioning when interpretation of the
external or intravascular ECG P-wave is difficult. For example, when
P-wave is not present
P-wave is not identifiable

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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 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.
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, 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.
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. 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.
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, 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.
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 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.

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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).
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.

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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™II Ultrasound System roll stand.

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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. 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 the “settings” icon.

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2. In the settings screen, select the ‘Layout’ dropdown menu arrow and select “Ultrasound and
S3CG." Then select ‘Apply’.

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3. Now the screen layout incorporates ultrasound and Sherlock 3CG™TCS. In this screen you may
assess the presence of the external P-wave.

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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

Sherlock 3CG™ Tip Confirmation System Page 12
Sherlock 3CG™TCS Only (TCS Mode) 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

Sherlock 3CG™ Tip Confirmation System Page 13
Magnet Tracking
Stylet Icon: Location and direction of
stylet tip under the sensor. The circle
represents the tip of the stylet and the
tail represents he body of the stylet.
Off Screen Icon: Location of
the approaching stylet tip.
Searching For Signal Icon:
Stylet tip had 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: Indicates Sherlock 3CG™TCS Sensor has
been successfully calibrated.
Audio On: Select to mute the magnet navigation audio.

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Main Controls
Audio Mute: Select to turn the magnet navigation audio on.
Freeze: Select to copy the current ECG waveforms from the Main
Screen to the Reference Screen.
Print: Select to Print and Save the ECG and magnet navigation
data. Data will be printed to paper and saved to a file on an
external USB storage device.
ECG Settings Menu: Select to open the ECG Settings Controls (see
below)
Channel Select: Select either the external (white) or intravascular
(yellow) ECG waves for manipulation.
Scale: Select 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 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.
Playback Demo Mode: Select to continuously play a non-
interactive demonstration.

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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.