Sherlock 3CG+ Tip Confirmation System Instructions

Consult instructions for use

Caution

Type CF applied part

Operate Indoors Only

Direct Current

Class II Equipment

Fragile, handle with care

Keep Dry

Temperature limit

Humidity limitation

Catalog Number

Serial Number

Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner.

Collect separately

Date of Manufacture

Manufacturer

1

Overview

1.1

Indications for Use The Sherlock 3CG+™ Tip Confirmation System (TCS) is indicated for navigation and positioning of central venous access devices (CVADs) of at least 2 F in size. The Sherlock 3CG+™ TCS provides real-time catheter tip location information by using catheter navigation technology along with the patient’s cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for CVAD tip placement confirmation of approaches from the superior vena cava. In adult patients and in adolescents (greater than 12 through 21 years of age), the Sherlock 3CG+™ TCS can be used with CVADs such as peripherally inserted central catheters (PICCs), central venous catheters (CVCs), implantable ports, and hemodialysis catheters. In children (greater than 2 to 12 years of age), in infants (greater than 1 month to 2 years of age), and in neonates (from birth to 1 month of age), the Sherlock 3CG+™ TCS can be used with PICCs and with centrally inserted central catheters (CICCs). In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD’s indications and instructions for use. Limiting, but not contraindicated, situations for this method 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 catheter tip location.

1.2

Post Market Clinical Trial The Sherlock 3CG+™ Tip Confirmation System (TCS) is the next generation of tip confirmation technology, incorporating both Sherlock™ IITip Location System (TLS) magnetic tip tracking and Sapiens TCS electrocardiogram (ECG) tip confirmation into a single integrated unit. 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 central venous catheters in adult patients. The primary endpoints were to assess the performance of the Sapiens technology with respect to: (1) compatibility with peripherally inserted central catheters (PICCs), tunneled catheters, and ports, (2) safety of using an invasive intracardiac electrode, and (3) the accuracy of the Sapiens technology with regard to correct positioning of the catheter tip when compared to postoperative chest x-ray. Three hundred thirty-two (332) subjects received a vascular access device in the form of a PICC, port, or tunneled catheter of the 332 subjects, 114 subjects (34%) received a PICC. Placement of the PICC was deemed acceptable in 99.1% (113/114) of the subjects. No adverse events occurred.

1.3

Sherlock 3CG+™ TCS Description The Sherlock 3CG+™ TCS is designed to aid in CVAD tip positioning through real-time navigation and ECG technology. It is designed to operate with BD catheter kits labeled [ ] and “Sherlock 3CG™ TPS Stylet”. Note: When used in conjunction with catheter kits labeled [ ] the device provides navigation information but does not allow positioning through ECG technology. Note: When used in conjunction with catheters smaller than 3 F, the system provides ECG information only with an electrically conductive stylet.

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1.3.1

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

Elevated P-wave P-wave

Biphasic P-wave

Initial negative P-wave deflection

Inverted P-wave

Warning: The Sherlock 3CG+™ TCS should be used for placements that approach the top of the cavo-atrial junction through the superior vena cava (SVC). The Sherlock 3CG+™ TCS should not be used for placements starting inferior to the cavo-atrial junction as this may result in ECG waveforms that are not described in the Instructions for Use. Note: When magnet tracking is utilized, in addition to the ECG signal, the magnet tracking stylet icon is augmented with the identified shape and color changes. Note: In instances where the P-wave is not present, not identifiable, or intermittent the stylet icon will remain a yellow circle.

1.3.2

Real-Time Navigation 1.3.2.1 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 magnettipped stylet to the sensor. It does this in two steps: • Sherlock 3CG+™ TCS takes a background measurement of the ambient magnetic field during the calibration cycle. • 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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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 the stylet tip under the sensor. The circle represents the tip of the sylet and the tail represents the body of the stylet.

Stylet icon Green Stylet tip at the maximum P-wave with no initial negative deflection.

Depth Gauge Relative stylet depth under the sensor.

The relative stylet depth under the sensor is shown in only one way, through the Depth Gauge depicted above.

1.3.2.2

ECG Navigation (when enabled) In patients with a distinct R-peak, the Sherlock 3CG+™ TCS displays a blue ECG navigation signal that displays the relative position of the catheter tip in the vasculature. • Advancing catheter in the correct direction: The R-peak will initially appear negative, will become flat in proximity to the blue electrode, and then becomes positive when you enter the superior vena cava. • Advancing catheter in wrong direction: The R-peak will remain negative. Note: Do not rely on ECG Navigation, for determining gross malposition of the catheter, when interpretation of the ECG R-wave is difficult. For example, when: • R-wave is not present • R-wave is not identifiable • R-wave is intermittent These conditions may be a result of heart rhythm abnormalities, or the presence of cardiac rhythm devices. Subclavian Vein

Internal Jugular Vein

Subclavian Vein

Innominate Vein

Innominate Vein

Brachial/Basilic Vein

Brachial/Basilic Vein

Superior Vena Vein

Note: When using the fin assembly for ECG navigation, place the black electrode at location 1. Place the red electrode at location 2.

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1.4

System Components • Ultrasound probe

Select button

Freeze button

The following are components to the Sherlock 3CG+™ TCS: • Display • Sherlock 3CG+™ TCS Mobile Medical Application running on the display • One of the following sensors: – Sherlock 3CG™ TCS sensor – Sherlock 3CG+™ TCS small sensor – Sherlock™ II TLS sensor (magnet only) The following are accessories, ancillary devices, or spare parts to the Sherlock 3CG+™ TCS: • Sherlock 3CG™ TPS Stylet • Nautilus Delta™ E electrical adaptor • Fin assembly • Sensor holster

1.5

• Sherlock™ Sensor holster • Medical Equiment Rollstand (MER) • Printer

Contraindications There are no contraindications specific to the Sherlock 3CG+™ TCS.

1.6

Warnings This section specifies warnings specific to the functionality of the Sherlock 3CG+™ TCS. See the catheter’s Instructions for Use (IFU) for possible complications associated with central venous access device (CVAD) placements and ECG positioning. Warning: Before using the Sherlock 3CG+™ TCS for the first time, be sure to read and understand all of the information in the IFU. Warning: This device should only be operated by qualified medical personnel trained in central venous catheter placement procedures and in assessing the ECG information provided by the Sherlock 3CG+™ TCS. Warning: Unstable ECG waveforms may be detected because of patient’s movements or manipulation by the user. In such a situation, the use of an additional method, according to your institutional guidelines is required to confirm catheter tip location. Warning: Read and follow the IFU provided with the Electrical Adaptor when using it with the Sherlock 3CG+™ TCS. Warning: The Sherlock 3CG+™ TCS is not intended to be used as monitoring equipment. Warning: The Sherlock 3CG+™ TCS is not intended to be used as life-supporting equipment. Warning: This product should only be operated by qualified medical personnel. Warning: In certain patients, unstable ECG waveforms may be detected because of the manipulation of the Electrical Adaptor by the operator. Verify that the connection between the Electrical Adaptor and the central venous catheter and the connection between the Electrical Adaptor and the sensor are free from contact with any other material and do not touch the Electrical Adaptor and any of its connections. If the problem persists, the use of an additional method for catheter tip location confirmation, according to your institutional guidelines is required to confirm catheter tip location. Warning: Do not operate the Sherlock 3CG+™ TCS or the AC adapter in the presence of flammable anesthetics or gases; explosion may result. Warning: Do not attempt to sterilize the sensor. Damage to the equipment may occur.

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Warning: In order to prevent the unauthorized access to patient information stored on the internal storage device of the display running the Sherlock 3CG+™ TCS Mobile Medical Application, setting up password protection on the display is recommended. To set up password protection on the display, follow the instructions provided in this document. Warning: When using the saline technique, ensure that the catheter lumen is constantly filled with saline, such that electrical conductivity through the catheter is ensured from the proximal to the distal end of the vascular access device. 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 BD authorized service personnel. This does not apply to changing the battery in the display. • Removing system labels by anyone other than BD 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 BD. Warning: If the 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 BD 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 • 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 or ECG 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 when magnet tracking is utilized, 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. When ECG Navigation is utilized, in any situation in which you cannot unambiguously identify the specific ECG waveforms for different locations in the vasculature as described in the IFU, rely on 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: Do not remove Sherlock 3CG+™ TCS enclosures. To avoid electrical shock, use only the power cord supplied with the system and connect only to properly grounded wall outlets. Only BD 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 this IFU and ensure good skin-electrode contact. Failure to do so may cause unstable ECG waveforms and/or ECG waveforms that are not described in this IFU . In such a case, rely on magnetic navigation, if utilized, 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. Warning: The Sherlock 3CG+™ TCS should be used for placements that approach the top of the cavo-atrial junction through the superior vena cava (SVC). The Sherlock 3CG+™ TCS should not be used for placements starting inferior to the cavo-atrial junction as this may result in ECG waveforms that are not described in the IFU.

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1.7

Precautions This section specifies precautions specific to the functionality of the Sherlock 3CG+™ TCS. See the catheter’s Instructions for Use (IFU) for possible complications associated with central venous access device (CVAD) placements and ECG positioning. Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner. 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 BD cleaning and disinfection procedures. Failure to do so may damage the device. Caution: Assess placement of patient applied parts as to not interfere with surgical site or sterile field. 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, rollstand basket or other secure location to avoid damage. Caution: When magnet tracking is utilized, do not allow any ferromagnetic objects, e.g. wired undergarments, metal instruments, watches, jewelry, electronics, metal bed rails, 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 operating system, use the Shutdown button to turn off the display. Caution: The Sherlock 3CG+™ TCS complies with IEC 60601-1-2 for electromagnetic compatibility (EMC) for medical electrical equipment. This standard is designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radiofrequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of this device. Medical electrical equipment needs special precautions regarding EMC, and all equipment must be installed and put into service according to the EMC information specified in the IFU. Caution: The Sherlock 3CG+™ TCS may interfere with wireless devices if not installed and used in accordance with the IFU. However, there is no guarantee that interference will not occur in a particular installation. Caution: Portable and mobile RF communications equipment may interfere with the display of ECG waveforms by the Sherlock 3CG+™ TCS.

1.8

Possible complications The potential exists for serious complications including the following: allergic reaction, anaphylactic shock, atrial fibrillation, cardiac arrhythmia, catheter malposition, clinician injury, discomfort to patient or user, increased heart rate, infection, misdiagnosis, patient injury, prolonged procedure, radiated interference.

2

Assembling the Sherlock 3CG+™ TCS

2.1

Attaching the sensor holster to the rollstand The sensor can be placed in the holster when not in use. To attach the holster to a rollstand see illustrations below.

Caution: When the sensor is not in use, store in the holster, rollstand basket or other secure location to avoid damage.

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2.2

Connecting the sensor to the display The sensor connects to the USB port on the display.

3

Sherlock 3CG+™ TCS Information

3.1

Sherlock 3CG+™ TCS Graphical Interface Title Bar (See SiteRite™ 9 Instructions for Use)

Magnet tracking window

External ECG waveform ECG display prior to freeze Intravascular ECG waveform

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ECG adjustments

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Tools Menu

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Reference Screen Used for freezing the external and intravascular ECG waveforms to assist in maximum P-wave identification

Main Screen Real-time external and intravascular ECG waveforms.

Nominal P-wave

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Higlighted P-wave

Maximum P-wave

3.2

Sherlock 3CG+™ TCS controls and indicators

Main controls and indicators Ultrasound Mode: Select to exit the TCS Mode and enter Ultrasound Mode. Main Toolbar Menu: Select to open the Main Toolbar Menu. Freeze Image: Select to copy the current ECG waveforms from the Main Screen to the Reference Screen. Save Image: Select to save and print the current ECG waveforms in the Reference Screen. (Saves to both the hard-drive and USB external storage device if connected.) Calibrate: Select to calibrate magnet navigation

Audio: Select to toggle sound on or off.

ECG Navigation: Select to enable or disable ECG Navigation via R-Peak. (Only available in ECG Only Mode.) Measurements: Select to add patient measurement information.

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ECG menu controls Expand/Collapse: Select to open and close the ECG settings menu.

Channel Scale: Select to adjust the ECG signal amplitude of the external (white), intravascular (yellow) or navigation (blue) ECG waveforms on the Main Screen.

Channel Level: Select to adjust the vertical position of the external (white), intravascular (yellow) or navigation (blue) ECG waveforms on the Main Screen.

Display Speed: Select to adjust the speed of the ECG playback.

Tools menu controls P-wave Highlighting: Select to enable or disable highlighting the P-wave on the ECG signals.

ECG Color: Select to enable or disable the intravascular (yellow) ECG waveforms changing color to green and yellow in sync with the stylet icon.

Stylet Color: Select to enable or disable the stylet icon changing color and shape based on ECG changes.

Depth Indicator: Select to enable or disable the depth gauge.

R-Peak Highlight: Select to enable or disable R-Peak Highlight.

Print Statement: Select to enable or disable the confirmation statement printing on the ECG printout.

Navigation Trace: Select to enable or disable Navigation Trace dots.

Sherlock Audio Default: Select to enable or disable magnet navigation audio as the default setting.

ECG Only: Select to view only the ECG display, magnet navigation will be disabled.

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Tools menu controls Sherlock Only: Select to view only magnet navigation, the ECG display will be disabled.

Both (Sherlock 3CG+™): Select to enable the ECG display and magnet navigation.

Sherlock Volume: Select to toggle Sherlock Volume up and down. IV Gain: Select to toggle through each of the IV Gain levels. (Only available in ECG Only Mode.) CE Gain: Select to toggle through each of the CE Gain levels. (Only available in ECG Only Mode.) Close: Select to close the menu window. Save Data Log: Select to save a data log. Default Settings: Select to reset Sherlock 3CG+ settings to factory default.

3.3

Sherlock 3CG+™ TCS audio information When the audio is on, there are three possible tones: • Tone 1: Stylet tip detected and the tip is not under the sensor. See image below. • Tone 2: Stylet tip is under the top half of the sensor. See image below. • Tone 3: Stylet tip is under the bottom half of the sensor. See image below. Tone 1 Tone 2

Tone 3

Note: Audio signals are only applicable to the magnetic navigation capability of the device, when utilized.

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3.4

Magnet tracking perspective When a patient’s chest is not flat, the sensor will rest at an angle, causing a difference in the apparent location of the catheter tip from two different points of view. The perceived location (user view) can be several centimeters higher or lower than the actual location (sensor view). Refer to the diagram below.

Perceived Location (user view) Actual Location (sensor view)

Note: This difference in perspective should only be considered in relation to magnetic navigation, when utilized. This has no impact to ECG tip confirmation.

4

Magnet and ECG Catheter Guidance 1. Prepare Device 1.1. Connect the sensor to the display via USB cord. 1.2. Verify that the ECG flatline signal is scrolling. 1.3. Verify the battery charge is sufficient for the procedure. 1.4. Enter Patient Information as needed. 2. Position Patient and Perform Ultrasound Pre-scan Refer to the ultrasound system IFU. Warning: The Sherlock 3CG+™ TCS should be used for placements that approach the top of the cavo-atrial junction through the superior vena cava (SVC). The Sherlock 3CG+™ TCS should not be used for placements starting inferior to the cavo-atrial junction as this may result in ECG waveforms that are not described in the IFU. 3. Measure Catheter Length (if applicable) Refer to catheter IFU. 4. Prepare Sensor 4.1. Slide the Fin Assembly onto the sensor until fully seated.

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4.2. Place sensor in the sensor holder with the fin and ECG electrodes remaining outside the holder and tighten the cinch ring.

5. Position Sensor 5.1. Remove the adhesive backing from the sensor holder. 5.2. Place the sensor directly on the patient’s skin with the adhesive side down. Place the sensor as flat as possible for best results. Caution: Assess placement of patient applied parts as to not interfere with surgical site or sterile field. Note: The sensor should be positioned the same for left or right side placements. 6. Prepare and attach external ECG electrodes per the following steps: 6.1. Ensure electrode locations are oil-free and completely dry. Caution: Electrodes should be applied only to intact, clean skin (e.g., not over open wounds, lesions, infected or inflamed areas). 6.2. Attach electrodes to all lead wires. 6.3. Remove backing and press electrodes firmly onto skin at the specified locations • Place the black electrode on the patients lower right shoulder • Place red electrode on the patient’s lower left abdomen, 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. Place high on the patient’s chest touching the neck, if possible. Fin receptable or Bard logo facing upward.

Cord routed towards the patient’s feet.

Warning: Place skin electrodes carefully at locations indicated in this IFU and ensure good skin-electrode contact. Failure to do so may cause unstable ECG waveforms and/or ECG waveforms that are not described in this IFU. In such a case, rely on magnetic navigation, if utilized, 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. Caution: Discontinue electrode use immediately if skin irritation occurs. Tips: • Prior to securing the sensor holder to the patient, it may be necessary to clean the skin and remove excess hair. • Do not move the sensor after it is secure. Best results will be achieved if the patient remains still and the sensor is not placed on open wounds, over bandages, drapes, gowns or other coverings.

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7. Evaluate External ECG waveform Refer to the catheter IFU. 8. Perform Initial Magnet Tracking Calibration Calibrate the Sherlock 3CG+™ TCS by selecting CALIBRATE prior to setting up the sterile field to ensure there is no environmental interference. Tip: If calibration fails, remove any items that may be causing magnetic interference (e.g. active motor driven equipment, monitor leads, cell phones, name tags, jewelry, etc.). 9. Prepare Catheter Sterile Field Refer to the catheter IFU. 10. Access the Vein Refer to the ultrasound system IFU and catheter IFU. 11. Attach Catheter Stylet to Fin Assembly Refer to catheter IFU. 12. Perform Final Magnet Tracking Calibration 12.1. Ensure the catheter tip is at least 12 inches (30 cm) away from the sensor before calibrating. 12.2. Select CALIBRATE immediately prior to catheter insertion. 12.3. Once calibration is complete, ask the patient to remain still and do not reposition the patient. 12.4. Refer to catheter IFU for catheter insertion. 13. Insert Catheter Refer to catheter IFU for catheter insertion. 14. Catheter Tip Guidance and Positioning 14.1. Refer to catheter IFU for catheter insertion. Note: Initially a searching magnifying glass will indicate that the stylet tip is outside the sensor range. 14.2. Use a slow steady motion while advancing the catheter. 14.3. Magnetic Navigation As the stylet tip approaches the sensor, an icon appears at the edge of the screen indicating the approach of the stylet tip. When the stylet is under the sensor, the stylet and depth icons will display the location, orientation, and depth of the stylet in relation to the sensor. 14.3.1. Advance the catheter slowly to achieve optimal performance (1 cm per second). There may be a slight delay from the time the catheter is moved until the stylet icon moves on the display. Advancing the catheter too quickly may result in erratic movements of the stylet icon on the display. 14.3.2. Insert the catheter until the magnetic navigation shows the stylet moving consistently downward. 14.3.3. Continue to slowly advance catheter until the catheter is inserted to the external measurement as determined in the catheter IFU. 14.3.4. Select Freeze to minimize the magnetic navigation window and freeze/save the current ECG waveforms in the reference screen. Note: Select the minimized magnetic navigation window to return to a maximized state. 14.4. ECG Confirmation 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 and may become biphasic or inverted. Note: If the intravascular ECG waveform is not displayed, flush the catheter with saline. If the problem continues, check the stylet-to-fin connection. To freeze and compare ECG waveforms, select Freeze to copy ECG waveforms in the reference window. Note: Pause to let the rhythm settle before freezing the reference ECG waveforms. For final catheter positioning, refer to catheter IFU. 15. Complete Catheter Placement Complete catheter insertion, securement and remaining procedure according to the catheter IFU and facility protocol.

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16. Procedural Record Select Print to print/save a procedural record. Note: Selecting Print will send the procedural record to a storage device and approved printer, if connected. A typical printout is shown below.

5

Magnet-Only Catheter Guidance 1. Prepare Device 1.1. Connect the sensor to the display via USB cord. 1.2. Verify the battery charge is sufficient for the procedure. 1.3. Enter Patient Information as needed. 2. Position Patient and Perform Ultrasound Pre-scan Refer to the ultrasound system IFU. 3. Measure Catheter Length Refer to catheter IFU. 4. Prepare Sensor Place the sensor in the sensor holder and tighten the cinch ring.

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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. Caution: Assess placement of patient applied parts as to not interfere with surgical site or sterile field. Note: The sensor should be positioned the same for left or right side placements.

Place high on the patient’s chest touching the neck, if possible. Fin receptable or Bard logo facing upward.

Cord routed towards the patient’s feet.

6. Perform Initial Magnet Tracking Calibration Calibrate the Sherlock 3CG+™ TCS by selecting CALIBRATE prior to setting up the sterile field to ensure there is no environmental interference. Tip: If calibration fails, remove any items that may be causing magnetic interference (e.g. active motor driven equipment, monitor leads, cell phones, name tags, jewelry, etc.). 7. Prepare Catheter Sterile Field Refer to the catheter IFU. 8. Access the Vein Refer to the ultrasound system IFU and catheter IFU. 9. Perform Final Magnet Tracking Calibration 9.1. Ensure the catheter tip is at least 12 inches (30 cm) away from the sensor before calibrating. 9.2. Select CALIBRATE immediately prior to catheter insertion. 9.3. After calibration is complete, ask the patient to remain still and do not reposition the patient. 9.4. Refer to catheter IFU for catheter insertion. 10. Insert Catheter Refer to catheter IFU for catheter insertion. 11. Catheter Tip Guidance and Positioning 11.1. Refer to catheter IFU for catheter insertion. 11.2. Initially a searching magnifying glass will indicate that the stylet tip is outside the sensor range. 11.3. Use a slow steady motion while advancing the catheter. 12. Magnetic Navigation 12.1. As the stylet tip approaches the sensor, an icon appears at the edge of the screen indicating the approach of the stylet tip. 12.2. When the stylet is under the sensor, the stylet and depth icons will display the location, orientation, and depth of the stylet in relation to the sensor. 12.3. Advance the catheter slowly to achieve optimal performance (1 cm per second). There may be a slight delay from the time the catheter is moved until the stylet icon moves on the display. Advancing the catheter too quickly may result in erratic movements of the stylet icon on the display. 12.4. Insert the catheter until the magnetic navigation shows the stylet moving consistently downward. 12.5. Continue to slowly advance catheter until the catheter is inserted to the external measurement as determined in the catheter IFU.

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An image of Magnet Tracking Only mode is shown below.

6

ECG-Only Catheter Guidance 1. Prepare Device 1.1. Connect the sensor to the display via USB cord. 1.2. Verify that the ECG flatline signal is scrolling. 1.3. Verify the battery charge is sufficient for the procedure. 1.4. Enter Patient Information as needed. 2. Position Patient and Perform Ultrasound Pre-scan Refer to the ultrasound system IFU. Warning: The Sherlock 3CG+™ TCS should be used for placements that approach the top of the cavo-atrial junction through the superior vena cava (SVC). The Sherlock 3CG+™ TCS should not be used for placements starting inferior to the cavo-atrial junction as this may result in ECG waveforms that are not described in the IFU. 3. Measure Catheter Length (if applicable) Refer to catheter IFU. 4. Prepare Sensor 4.1. Slide the Fin Assembly onto the sensor until fully seated.

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