Medivance
Sherlock 3cg Tip Confirmation System
Sherlock 3cg Tip Confirmation System Standalone Instructions for Use June 2012
Instructions for Use
32 Pages
Preview
Page 1
Standalone Instructions for Use
INSTRUCTIONS FOR USE
Sherlock 3CG* Tip Confirmation System
Keep Dry
Fragile
Manufacturer
CF Type Equipment
Attention, see instructions for use
Storage humidity limitation
Operating humidity limitation
40o C -18 C o
38o C 10 C o
Rx Only
1
Operating temperature limitation
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician
Storage temperature limitation
Do not dispose with ordinary municipal waste
Instructions For Use
- TABLE OF CONTENTS Section 1
Section
Overview 3
6
Troubleshooting and Error Messages
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1.1 Indications for Use
6.1 Error Screens
1.2 Post Market Clinical Trial
6.2 ECG Troubleshooting
1.3 Sherlock 3CG* TCS Description
6.3 Magnetic navigation troubleshooting
1.4 System Components
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Remote Control Installation
25
1.5 Warnings and Precautions
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Sherlock 3CG* TCS Printer Installation
26
2
Assembling the Sherlock 3CG* TCS
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8.1 Brother* Printer 8.2 Sony* Printer
2.1 Attaching the Sherlock* 3CG TCS Sensor holster to the roll stand
2.2 Connecting the Sherlock 3CG* TCS Sensor to the Sherlock 3CG* TCS Display
9.1 Cleaning Procedure
9.2 Disinfection Procedure
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Sherlock 3CG* TCS Information
3.1 Sherlock 3CG* TCS Graphical Interface
3.2 Sherlock 3CG* TCS Controls and Indicators
3.3 Settings Icon
3.3.1 Settings – General
3.3.2 Settings – Remote
3.3.3 Settings – Printers
3.3.4 Settings – File Management
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Cleaning and Disinfection
28
10
Warranty 28
11
Service and Repair
29
12
Technical Specifications
29
13
12.1 Sherlock 3CG* TCS Sensor and Display Operational and Storage Conditions
Disposal Information
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3.4 Remote Control
3.5 Sherlock 3CG* TCS Audio Information
3.6 Parallax
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Sherlock 3CG* TCS Catheter Guidance
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 Tracking Calibration
Step 12: Insert Catheter
Step 13: Catheter Tip Guidance and Positioning
Step 14: Complete Catheter Placement
Step 15: Procedural Record
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Magnetic Navigation Only Mode
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
Step 6: Perform Initial Magnet Tracking Calibration
Step 7: Prepare Catheter Sterile Field
Step 8: Access the Vein
Step 9: Perform Final Magnet Tracking Calibration
Step 10: Insert Catheter
Step 11: Catheter Tip Guidance and Positioning
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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 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 PICC 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 Ststem (TCS) is the next generation of tip confirmation technology, incorporating both Sherlock* II Tip Location System (TLS) magnetic tip tracking and Sapiens TCS 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 withregard 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 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 [ through ECG technology.
] the device provides magnetic navigation information but does not allow positioning
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 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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Instructions For Use
1.4 System Components The Sherlock 3CG* TCS Standalone and authorized accessories include: - Sherlock 3CG* TCS Sensor - Sherlock 3CG* TCS Display - Remote Control - Medical Grade Power Supply - 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 - Remote Control Holder - Bard Access Systems' supplied printer - USB Extension
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.
Warnings 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 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 - 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.
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Sherlock 3CG* Tip Confirmation System
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 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.
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 operating system, use the Shutdown button to turn off the Sherlock 3CG* TCS Display,
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 a 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 Sherlock 3CG* TCS Display
The Sherlock 3CG* TCS Sensor connects to the USB port on the display.
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Instructions For Use
3 Sherlock 3CG* TCS Information 3.1 Sherlock 3CG* TCS Graphical Interface Intravascular ECG
External (or baseline) ECG
Maximized magnet tracking window.
Magnet tracking requires calibration.
SOFTWARE VERSION
ECG MENU
ECG Display Adjustment
PATIENT INFORMATION Patient Information will be shown on the procedural record.
MENU: Select to open/close the ECG menu.
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Sherlock 3CG* Tip Confirmation System
SEARCHING FOR SIGNAL ICON Stylet tip had not been detected. DEPTH ICON Relative stylet depth under sensor.
OFF SCREEN ICON Location of the approaching stylet tip
STYLET ICON Location and direction of stylet tip under the sensor. The circle represents the tip of the stylet and the tail represents the body of the stylet.
MAIN SCREEN
REFERENCE SCREEN
Real-time external and intravascular ECG waveforms.
Used for freezing the external and intravascular ECG waveforms to assist in maximum P-Wave identification.
Minimized magnet tracking window.
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Instructions For Use
3.2 Sherlock 3CG* TCS Controls and Indicators
Front Panel Controls/Indicators Shut down: Select to open the shutdown menu.
Caution: To avoid damage to the operating system, use the Shutdown button to turn off the Sherlock 3CG* TCS Display. Settings: Select to open the system settings menu.
Battery Status: There are 5 charge levels on the battery indicator. When the unit is operating on battery power, the battery indicator changes to yellow at 40% and red/blinking at 20% of the remaining battery life. When the unit is charging the battery the AC connected indicator will overlay the battery status.
Freeze: Select to copy the current ECG waveforms from the Main Screen to the Reference Screen.
Print to file: 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).
Menu: Select to open/close the ECG menu.
Shutdown Menu Controls Sherlock 3CG*: Restarts the Sherlock 3CG* Software Application.
Shutdown: Shuts down the Sherlock 3CG* TCS Display.
Restart: Restarts the Sherlock 3CG* TCS Display.
Lock: Locks the password enabled Sherlock 3CG* TCS Display.
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Sherlock 3CG* Tip Confirmation System
ECG Menu Controls
Save: Select to stop and save the ECG waveform recording.
Demo: Select to initiate demonstration mode. For training, contact your Bard Access Systems’ Sales Representative.
Channel Channel Selection: Select either the external (white) or intravascular (yellow) ECG waves for manipulation.
Scale Channel Scale: Select to adjust the ECG signal amplitude of the external (white) or intravascular (yellow) ECG waveforms on the Main Screen.
Level Channel Level:Select to adjust the vertical position of the external (white) or intravascular (yellow) ECG waveforms on the Main Screen.
Speed Display Speed: Select to adjust the speed of the ECG playback.
Magnet Tracking Controls
Calibrate: Select to calibrate magnet tracking.
Audio: : Select to toggle sound on or off.
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Instructions For Use
3.3 Settings Icon
Select
to open the Sherlock 3CG* TCS Settings Window.
3.3.1 Settings – General
Change Date/Time
Opens Date and Time properties window.
Change Language
Changes system language settings.
Restore Defaults
Restores software to factory default settings.
Log
View and export system error logs.
Upgrade
Provides system software upgrades when a USB flash drive containing a Sherlock 3CG* TCS compatible installation is inserted.
About
Indicates system application version information.
Password
To enable or disable password protection, see figure below.
Enable Magnet Printing PICC Compatibility
Enables magnet tracking printing. Selects magnet tracking compatibility between Sherlock* TLS and Sherlock 3CG* TPS stylets.
Close
Closes the General window and Settings menu.
Enable
Enables the password protection, according to the value entered.
Disable
Disables the password protection.
Close
Closes the password window.
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Sherlock 3CG* Tip Confirmation System
3.3.2 Settings – Remote
Add Remote Control Show Bluetooth* Devices Close
Initiates process to detect and add the remote control for use with the system interface. Launches the Bluetooth* Devices window. Closes the Remote window and Settings menu.
3.3.3 Settings – Printers
Set Current Printer
Sets the selected printer as current. Note – Sherlock 3CG* TCS Application will print to the current printer.
Close
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Closes the Printer window and Settings menu.
Instructions For Use
3.3.4 Settings – File Management
Refresh
Refreshes the file(s) listing in the viewer.
Hide LOG / Show LOG
Hides/Shows all files with a .log extension from appearing in the viewer.
Hide/Show Images
Hides/Shows all files with a .jpg extension from appearing in the viewer.
New Folder
Provides functionality for the user to create and name a new storage folder under the C:Data archive.
Delete
Deletes selected files or folders displayed in the viewer and under the C:Data archive. Note - The user is prompted again after initiating this command. Additionally, archives listed under the Refresh button cannot be deleted or moved.
Copy Select All
Automatically copies selected files or folders to the operating system clipboard. Selects all files displayed in the viewer.
Paste
Provides functionality for the user to paste to a designated storage location.
Close
Closes the File Management window and Settings menu.
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Sherlock 3CG* Tip Confirmation System
3.4 Remote Control
BLUETOOTH* LED
ACTIVITY LED
FREEZE
PRINT TO FILE POWER
TOUCH PAD
RIGHT MOUSE BUTTON
LEFT MOUSE BUTTON
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Instructions For Use
3.5 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. - 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.
1 2
3
Note: Audio signals are only applicable to the magnetic navigation capability of the device.
3.6 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 be several centimeters.
Note: Parallax should only be considered in relation to magnetic navigation.
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Sherlock 3CG* Tip Confirmation System
4 Sherlock 3CG* TCS Catheter Guidance Step 1: Prepare Device - Connect the sensor to the Sherlock 3CG* TCS Display via USB cord. - Verify that the ECG flatline signal is scrolling. - Verify the battery charge is sufficient for the procedure. - Enter Patient Information as needed.
Step 2: Position Patient and Perform Ultrasound Pre-scan - Refer to the Bard Access Systems’ Site~Rite* Ultrasound System Instructions for Use.
Step 3: Measure Catheter Length - Refer to Bard Access Systems’ Catheter Instructions for Use.
Step 4: Prepare Sensor - Slide the Fin Assembly onto the sensor until fully seated.
- Place sensor in the sensor holder with the fin and ECG electrodes remaining outside the holder and tighten the cinch ring.
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[1]
[2]
[3]
[4]
Instructions For Use
Step 5: Position Sensor and ECG electrodes - 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. Note: The sensor should be positioned the same for left or right side placements. - Prepare and attach external ECG electrodes per the following steps: •
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). -
Attach electrodes to all lead wires.
-
Remove backing and press electrodes firmly onto skin at the specified locations. •
Place black electrode 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.
Place high on the patient’s chest -touching the neck, if possible. Bard logo face up.
Cord 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. 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. 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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Sherlock 3CG* Tip Confirmation System
Step 6: Evaluate External ECG waveform - Refer to the Bard Access Systems’ catheter Instructions for Use.
Step 7: 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.).
Step 8: Prepare Catheter Sterile Field - Refer to the Bard Access Systems’ catheter Instructions for Use.
Step 9: Access the Vein - Refer to the Bard Access Systems’ Site~Rite* Ultrasound System Instructions and Bard Access Systems’ catheter Instructions for Use.
Step 10: Attach Catheter Stylet to Fin Assembly - Refer to Bard Access Systems’ catheter Instructions for Use.
Step 11: Perform Final Magnet Tracking Calibration - Ensure the catheter tip is at least 12 inches (30 cm) away from the sensor before calibrating. - Select CALIBRATE [
] immediately prior to 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 12: Insert Catheter - Refer to Bard Access Systems’ catheter Instructions for Use for catheter insertion.
Step 13: Catheter Tip Guidance and Positioning - Refer to Bard Access Systems’ catheter Instructions for Use for catheter insertion. - Initially a searching magnifying glass will indicate that the stylet tip is outside the sensor range. - Use a slow steady motion while advancing the catheter. 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. - 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. - 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. - Select [
] 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 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 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 [
] 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 Bard Access Systems' catheter Instructions for Use.
Step 14: Complete Catheter Placement - Complete catheter insertion, securement and remaining procedure according to the catheter Instructions for Use and facility protocol.
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Instructions For Use
Step 15: Procedural Record - Select [ Note: Selecting [
] to print / save a procedural record. ] will send the procedural record to a storage device and approved printer, if connected. A typical printout is shown below.
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Sherlock 3CG* Tip Confirmation System
5 Magnetic Navigation Only Mode Step 1: Prepare Device - Connect the sensor to the Sherlock 3CG* TCS Display via USB cord. - Verify the battery charge is sufficient for the procedure. - Enter Patient Information as needed.
Step 2: Position Patient and Perform Ultrasound Pre-scan - Refer to the Bard Access Systems’ Site~Rite* Ultrasound System Instructions for Use.
Step 3: Measure Catheter Length - Refer to Bard Access Systems’ Catheter Instructions for Use.
Step 4: Prepare Sensor -Place the Sherlock 3CG* Sensor in the sensor holder and tighten the cinch ring
[1]
[2]
[3]
[4]
Step 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. 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. Bard logo face up.
Cord routed towards the patient's feet.
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