Sherlock 3cg Tip Confirmation System Site-Rite 8 Instructions for Use Rev Date July 2015

Sherlock 3CG™ Tip Confirmation System

Table of Contents Section 1

Overview

Section 3

5

Step 1: Prepare Device

1.2 Post Market Clinical Trial

Step 2: Position Patient and Perform Ultrasound Pre-scan

1.3 Sherlock 3CG™ TCS Description

Step 4: Prepare Sensor

1.5 Warnings and Precautions

Assembling the Sherlock 3CG™ TCS

Step 5: Position Sensor

6

Step 6: Perform Initial Magnet Navigation Calibration

2.1 Attaching the Sherlock 3CG™ TCS Sensor Holster to the Roll Stand

Step 7: Prepare Catheter Sterile Field Step 8: Access the Vein

2.2 Connecting the Sherlock 3CG™ TCS Sensor to the Site~Rite® 8 Ultrasound System

3

Sherlock 3CG™ TCS Information

Step 9: Perform Final Magnet Navigation Calibration

6

Step 10: Insert Catheter

3.1 Switching Between Ultrasound and TCS

Step 11: Catheter Tip Guidance and Positioning

3.2 Sherlock 3CG™ TCS Graphical Interface

6

3.3 Sherlock 3CG™ TCS Controls and Indicators

14

4.1 Verifying Catheter Compatibility 4.2 Catheter Placement

6.3 Magnetic Navigation Troubleshooting

7

Magnetic Navigation Printing

23

8

Cleaning and Disinfection

24

8.1 Cleaning Procedure

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 Navigation 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

2

19

6.2 ECG Troubleshooting

3.5 Parallax

Sherlock 3CG™ TCS Catheter Guidance

Trouble Shooting and Error Messages 6.1 Error Screens

3.4 Sherlock 3CG™ TCS Audio Information

4

17

Step 3: Measure Catheter Length

1.4 System Components

2

Magnet Navigation Only Mode

1.1 Indications for Use

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

Instructions For Use

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 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 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.

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 [ positioning through ECG technology.

] the device provides magnetic navigation information but does not allow

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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Sherlock 3CG™ Tip Confirmation System

Magnetic Navigation Permanent magnets are encapsulated within the tip of the Sherlock 3CG™ TPS Stylet. No magnetic energy is generated by the Site~Rite® 8 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:

Authorized accessories include: - Site~Rite® 8 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.

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 Site~Rite® 8 Ultrasound System with 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 software settings without authorization by Bard Access Systems.

4

Instructions For Use

Warning: If the Site~Rite® 8 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. Site~Rite® 8 Ultrasound System 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. 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 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 cleaning and disinfection products approved by Bard Access Systems. 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.

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Sherlock 3CG™ Tip Confirmation System

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® 8 Ultrasound System

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 select the TCS icon [

] via the touchscreen or the buttons on the probe.

To switch from TCS Mode to Ultrasound Mode, select the ULTRASOUND icon [

6

] via the touchscreen or the buttons on the probe.

Instructions For Use

3.2 Sherlock 3CG™ TCS Graphical Interface

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Sherlock 3CG™ Tip Confirmation System

8

Instructions For Use

9

Sherlock 3CG™ Tip Confirmation System

10

Instructions For Use

3.3 Sherlock 3CG™ TCS Controls and Indicators Main Controls Ultrasound Mode: Select to exit the TCS Mode and enter Ultrasound Mode.

Calibrate Button: Select to calibrate magnet navigation.

Audio On: Select to mute the magnet navigation audio.

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 Menu: Select to open the ECG Menu.

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

Level Up: Select to increase 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: Select to close the ECG Menu.

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Sherlock 3CG™ Tip Confirmation System

Tools: Select to open the Tools Menu.

Tools Menu 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 waveform changing color based on ECG changes.

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

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

ECG Toggle: Select to toggle between ECG & Magnet and Magnet Only Navigation . Magnet Navigation Only mode is compatible with PICCs labeled with [ Magnet Navigation mode is compatible with PICCs labeled with [

] . ECG and ].

Magnet Navigation Audio: Select to enable or disable the initial state of magnet navigation audio.

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

Magnet Navigation Printout: Select to enable or disable the magnet navigation printout.

Log: Select to stop and save the ECG recording.

Demonstration: Select to initiate playback / interactive demonstration mode respectively. For training, contact your Bard Access Systems’ Sales Representatives. Exit: Select to close the Tools Menu.

12

Instructions For Use

3.4 Sherlock 3CG™ TCS Audio Information When the audio is on, there are three possible tones: - Tone 1: The stylet tip is detected and the tip is not under the sensor. - Tone 2: The stylet tip is under the sensor and is at or above the Bard logo. - Tone 3: The stylet is under the sensor and below the Bard logo.

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

3.5 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.

13

Sherlock 3CG™ Tip Confirmation System

4 Sherlock 3CG™ TCS Catheter Guidance 4.1 Verifying Catheter Compatibility The Sherlock 3CG™ TCS on Site~Rite® 8 Ultrasound System is compatible with the following PICCs as described below: - The PICCS indicated with [

] are compatible for ECG and Magnet Navigation [

- The PICCs indicated with [

] are only compatible for Magnet Navigation [

]. ].

4.2 Catheter Placement Step 1: Prepare Device - Connect the sensor to the Site~Rite® 8 Ultrasound System via USB cable. - 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® 8 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 on to 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.

14

[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.

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 Navigation Calibration - Calibrate the Sherlock 3CG™ TCS by selecting CALIBRATE [ interference.

] prior to setting up the sterile field to ensure there is no environmental

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® 8 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 Navigation 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 and Catheter Tip 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 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 cavoatrial 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 screen.

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.

16

Instructions For Use

Step 15: Procedural Record - Select [

] to print / save a procedural record.

Note: Selecting [ below.

] will send the procedural record to a storage device and/or an approved printer, if connected. A typical printout is shown

5 Magnet Navigation Only Mode Step 1: Prepare Device - Connect the sensor to the Site~Rite® 8 Ultrasound System 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® 8 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™ TCS Sensor in the sensor holder and tighten the cinch ring.

1]

2]

3]

4]

17

Sherlock 3CG™ Tip Confirmation System

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.

Step 6: Perform Initial Magnet Navigation Calibration

- Calibrate the Sherlock 3CG™ TCS by selecting CALIBRATE [ interference.

] prior to setting up the sterile field to ensure there is no environmental

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 7: Prepare Catheter Sterile Field Refer to the Bard Access Systems’ catheter Instructions for Use.

Step 8: Access the Vein - Refer to the Bard Access Systems’ Site~Rite® 8 Ultrasound System Instructions for Use and Bard Access Systems’ catheter Instructions for Use.

Step 9: Perform Final Magnet Navigation 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 10: Insert Catheter - Refer to Bard Access Systems’ catheter Instructions for Use for catheter insertion.

Step 11: Catheter Tip Guidance and Positioning - Refer to Bard Access Systems’ catheter 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 measurements as determined in the Bard Access Systems’ catheter instructions for use.

18

Instructions For Use

- Below is an image of Magnetic Navigation only mode.

6 Trouble Shooting and Error Messages 6.1 Error Screens Sensor Disconnected

Sensor Error

Cause:

Sensor not connected to the display.

Solution:

Ensure the sensor is properly connected. Disconnect and reconnect the sensor.

Cause:

The display power supply is connected to a noisy electrical outlet.

Solution:

Disconnect the display power supply from the electrical outlet to run the system on battery power.

Cause:

Sensor cannot be detected by the display

Solution:

Call the technical support hotline at (800) 443-3385.

Cause:

Interference caused by magnetic field changes or by sensor movement.

Solution:

1. Move all metal objects at least 12 inches (30 cm) away from the sensor. 2. Lower bed rails. 3. Move all active electronic devices at least 5 feet (1.5 m) away. 4. Do not move the sensor and ask the patient to remain still. 5. Calibrate. 6. If the error continues, discontinue use and call the technical support hotline at (800) 443-3385.

Cause: Solution:

Sensor malfunction. 1. Turn off and restart the system. 2. If the error continues, discontinue use and call the technical support hotline at (800) 443-3385

19

Sherlock 3CG™ Tip Confirmation System

Magnet Error

Cause:

Interference caused by magnetic field changes or by sensor movement.

Solution:

1. Move all metal objects at least 12 inches (30 cm) away from the sensor. 2. Lower bed rails. 3. Move all active electronic devices at least 5 feet (1.5m) away. 4. Do not move the sensor and ask the patient to remain still. 5. Ensure catheter tip is at least 12 inches (30 cm) away from the sensor. 6. Calibrate. 7. If the error continues, discontinue use and call the technical support hotline at (800) 443-3385.

6.2 ECG Troubleshooting

Flat-line ECG signal

Poor ECG signal

20

Cause:

No fin connection.

Solution:

Fully seat fin on the sensor.

Cause:

No ECG electrode connection.

Solution:

Ensure that the area on the skin where the ECG electrodes were placed is oil free and completely dry.

Cause:

Damaged ECG electrodes.

Solution:

Ensure catheter T-lock connections are fully seated. Replace electrodes.

Cause:

Air bubble at the catheter tip.

Solution:

Flush the catheter lumen containing the stylet with saline.

Cause:

No stylet-to-fin connection.

Solution:

Fully seat the stylet connector on the fin. Refer to the Bard Access Systems’ catheter instructions for use.

Cause:

Fin and/or stylet connectors not fully seated.

Solution:

Fully seat fin on sensor. Fully seat stylet connector on fin.

Cause:

Poor ECG electrode contact.

Solution:

Ensure that the area on the skin where the ECG electrodes were placed is oil free and completely dry.

Cause:

Patient movement.

Solution:

Ask the patient to remain still. Ensure the patient is warm and relaxed.

Cause:

Extraneous noise.

Solution:

Unplug the Site~Rite® 8 Ultrasound System from AC power.

Solution:

Make Sure the Ultrasound probe is not in close proximity to the sensor and/or lead wires.

Cause:

Damaged ECG electrodes.

Solution:

Replace electrodes.

Cause:

Catheter not locked with saline.

Solution:

Ensure catheter T-lock connections are fully seated. Flush the catheter lumen containing the stylet with saline.

Cause:

The External ECG signal, with black electrode on the patient’s left shoulder (Lead III view) is weak.

Solution:

Place black electrode on the patient’s right shoulder (Lead II view)