Nautilus Delta TCS System Instructions For Use May 2017

LIST OF ALL APPLICABLE ICONS

Rx Only

2

Manufacturer

Type CF applied part

Consult instructions for use

Do not dispose with ordinary municipal waste

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician

The Green Dot

Serial Number

Catalog Number

Date of Manufacture

Caution

Direct Current

Class II Electrical Equipment

Do not dispose of battery with ordinary municipal waste

Operate Indoors Only

Table of Contents 1.0 Nautilus D elta™ Tip Confirmation System (TCS) Description... 4 2.0 Indications for Use... 6 3.0 Contraindications... 6 4.0 Warnings... 6 5.0 Precautions... 9 6.0 Assembling the Nautilus D elta™ TCS 6.1 Attaching the Patient Module to the Roll Stand... 10 6.2 Connecting the Patient Module to the Display... 10 6.3 Connecting the ECG Cable to the Patient Module... 10 7.0 Nautilus D elta™ TCS Information 7.1 Nautilus D elta™ TCS Graphical Interface, Controls and Indicators... 11 7.2 Shutdown Menu... 16 7.3 Settings Icon ... 16

7.3.1 Settings – General... 16

7.3.2 Settings – Printers ... 17

7.3.3 Settings – File Management... 18

8.0 Nautilus D elta™ TCS Catheter Guidance... 19 9.0 Troubleshooting and Error Messages 9.1 Errors Screens ... 21 9.2 ECG Trouble Shooting... 22 10.0 Battery Installation and Removal 10.1 Installation... 25 10.2 Removal... 25 11.0 Remote Control Installation ... 26 12.0 Nautilus D elta™ TCS Printer Installation... 26 13.0 Cleaning and Disinfection 13.1 Cleaning... 26 13.2 Disinfection... 27 14.0 Warranty... 27 15.0 Service and Repair... 28 16.0 Technical Specifications... 28 17.0 Disposal Information ... 28 18.0 Deleting Patient Information... 28 19.0 Manufacturer’s Declaration... 29 3

1.0 Nautilus Delta™ TCS Description The Nautilus D elta™ TCS is designed to aid in central venous access device (CVAD) tip positioning through Electrocardiogram (ECG) technology. It is designed to operate with Bard catheter kits labeled [

]

ECG Confirmation The Nautilus D elta™ 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.

P-wave

Elevated P-wave

Initial negative P-wave deflection

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Biphasic P-wave

Inverted P-wave

ECG Navigation The Nautilus Delta™ TCS system displays a blue ECG navigation signal (when enabled) 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.

INTERNAL JUGULAR VEIN

INNOMINATE VEIN

SUBCLAVIAN VEIN SUBCLAVIAN VEIN

BRACHIAL/BASILIC VEIN SUPERIOR VENA VEIN

Nautilus Delta™ Tip Confirmation System (TCS) Components and Accessories The Nautilus D elta™ Tip Confirmation System can be used in the following indoor environments: Bedside, operating rooms, radiology suites, dedicated suites for placement of central venous catheters The following are components to the Nautilus D elta™ TCS: a)

N autilus D elta™ TCS ECG Cable (ECG Cable)

b) N autilus D elta™ TCS Patient Module (Patient Module) c)

N autilus D elta™ TCS Display (Display)

d)

N autilus D elta™ TCS Software running on the Display

The following are accessories, ancillary devices, or spare parts to the N autilus D elta™ TCS: a)

N autilus D elta™ E Electrical Adaptor

b) Sherlock 3CG™ TPS Stylet c)

Remote

d)

Optional Printer

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2.0 Indications for Use The N autilus D elta™ Tip Confirmation System (TCS) is indicated for navigation and positioning of central venous access devices (CVADs) of at least 3 Fr in size. The N autilus D elta™ TCS provides real-time catheter tip location information by using 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. In adult patients and in adolescents (greater than 12 through 21 years of age), the N autilus D elta™ 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), the N autilus D elta™ TCS can be used with PICCs and with centrally inserted central catheters (CICCs); in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), the N autilus D elta™ TCS can be used with 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 central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

3.0 Contraindications There are no contraindications specific to the N autilus D elta™ TCS.

4.0 Warnings Warning

Before using the Nautilus D elta™ TCS for the first time, be sure to read and understand all of the information in the Instructions for Use.

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 Nautilus D elta™ TCS.

Warning

In patients where alterations of cardiac rhythm significantly change the presentation of the P-wave (e.g., P-wave not present, P-wave not identifiable, P-wave intermittent) as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm, the use of an additional method, according to your institutional guidelines, is required to confirm catheter tip location.

Warning

In any situation in which you cannot unambiguously identify the specific ECG waveforms for different locations in the vasculature as described in the Instructions for Use, the use of an additional method, according to your institutional guidelines, is required to confirm catheter tip location.

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

The Nautilus D elta™ TCS can interfere with pacemaker devices. If you have a pacemaker or other electrical medical devices, you should consult your physician before using the product.

Warning

Do not power the Nautilus D elta™ TCS in the presence of flammable anesthetics or gases. Explosion may result.

Warning

If the Nautilus D elta™ TCS is visibly damaged or warmer than the ambient temperature, discontinue use immediately. Use of damaged device may result in injury or equipment damage.

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4.0 Warnings (cont’d) Warning

Read and follow the instructions for use provided with the Nautilus D elta™ E Electrical Adaptor when using it with the Nautilus D elta™ TCS.

Warning

The Nautilus D elta™ TCS is not intended to diagnose or treat disease.

Warning

The Nautilus D elta™ TCS is not intended to be used as monitoring equipment.

Warning

The Nautilus D elta™ TCS is not intended to be used as life-supporting equipment.

Warning

The Nautilus D elta™ TCS only works for a sinus rhythm of the heart.

Warning

If no ECG waveforms are detected, verify the connection between the patient’s skin and the electrodes, between the electrodes and the ECG cable, and between the Nautilus D elta™ E Electrical Adaptor and the ECG cable, as it may be caused by an impedance mismatch between the patient and the ECG electrodes. 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

In certain patients, unstable ECG waveforms may be detected because of the manipulation of the Nautilus D elta™ E Electrical Adaptor by the operator. Verify that the connection between the Nautilus D elta™ E Electrical Adaptor and the central venous catheter and the connection between the Nautilus D elta™ E Electrical Adaptor and the Patient Module are free from contact with any other material and do not touch the Nautilus D elta™ E 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

When using the saline technique, ensure that the catheter lumen is constantly filled with saline, such that electrical conductivity trough the catheter is ensured from the proximal to the distal end of the vascular access device.

Warning

Place skin electrodes carefully at locations indicated in these Instructions for Use and ensure good skin-electrode contact. Use commercially available skin electrodes/pads with snap buttons according to the manufacturer’s instructions for use. 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 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

Do not place and/or use the Nautilus D elta™ 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 personal 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 Nautilus D elta™ TCS must only be charged with the power supply provided with the Nautilus D elta™ TCS.

Warning

Do not charge the Nautilus D elta™ TCS while using the device in a medical procedure.

Warning

Do not remove the Nautilus D elta™ TCS labels.

Warning

Ensure all connecting cables and connections are electrically insulated and do not come into contact with other electrical cables or metal surfaces

Warning

Do not submerge or spray any of the Nautilus D elta™ TCS components or accessories or allow fluid to enter any of the connector(s). Damage to the equipment may occur.

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4.0 Warnings (cont’d) Warning

Use of incorrect cleaners can result in optical impairment of the LCD and/or damage to the mobile platform. Always refer to the cleaner manufacturer’s guidelines and material safety data sheets for proper handling and use of the products.

Warning

Dispose of the product according to local standards and regulations for electronic devices.

Warning

The battery used in this product may present a risk of fire or chemical burn if damaged or not handled properly.

Warning

Do not attempt to sterilize the Patient Module, Display or Printer. Damage to the equipment may occur.

Warning

Equipment such as CT scanners, X-rays and fluoroscopy systems, cauterizers and diathermy equipment, operating in close proximity may emit strong electromagnetic or radio frequency interference (RFI) which could interfere with the display of ECG waveforms by the Nautilus D elta™ TCS. Do not place and/or use the Nautilus D elta™ TCS in the presence of such equipment.

Warning

Active electric motor driven equipment, such as pumps, may interfere with the display of the ECG waveforms by the Nautilus D elta™ TCS. Do not place and/or use the Nautilus D elta™ TCS in the presence of such equipment.

Warning

Electric equipment which requires direct contact with the patient may interfere with the display of ECG waveforms by the Nautilus D elta™ TCS. Do not use electric cauterization, electric scalpels, and ablation equipment while using the device.

Warning

The use of accessories and cables other than those listed in the instructions for use may result in increased electromagnetic emission and/or decreased immunity of the device.

Warning

It is possible that an electrostatic discharge could result in equipment ceasing to operate. If this occurs, please restart the Patient Module and continue the procedure. 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

Field repair of this device is not possible. Do not attempt to open the case, repair or replace components of the Nautilus D elta™ TCS. The following actions void the warranty of the Nautilus D elta™ TCS and may result in injury or equipment damage: –– O  pening or servicing any component of the Nautilus D elta™ TCS by anyone other than Bard Access Systems’ authorized service personnel. This does not apply to changing the battery in the Printer or the Display. –– R emoving system labels by anyone other than Bard Access Systems’ authorized service personnel. –– Connecting the Nautilus D elta™ TCS or applied patient components to any unauthorized system or accessory. –– Installation of unauthorized software. –– M odification of system software settings without authorization by Bard Access Systems.

Warning

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Only qualified personnel should attempt to service this equipment. The Nautilus D elta™ TCS contains static sensitive components and circuits. Failure to observe proper static control procedures may result in damage to the system.

5.0 Precautions Caution

Federal (USA) law restricts this device to sale by or on the order of a physician.

Caution

The Nautilus D elta™ TCS complies with International 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 instructions for use.

Caution

The Nautilus D elta™ TCS may interfere with wireless devices if not installed and used in accordance with the instructions for use. 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 Nautilus D elta™ TCS.

Caution

Use the Nautilus D elta™ TCS within its designated range of approximately 10 meters. Moving outside this range may cause missing or lost data.

Caution

The full performance of a new battery is achieved only after two or three complete charge and discharge cycles.

Caution

Do not leave a fully charged battery connected to a charger, since overcharging may shorten its lifetime.

Caution

If left unused, a fully charged battery will lose its charge over time.

Caution

In order to prevent the unauthorized access to patient information stored on the internal storage device of the Display running the Nautilus D elta™ TCS Mobile Medical Application, setting up password protection on the Display is recommended. Additional protection can be obtained by enabling the encryption protection provided with the Display. To set up a password and/or encryption protection on the Display, follow the instructions for use provided by the manufacturer of the Display.

Caution

For detailed central venous catheter preparation and insertion information, follow the instructions stated in the catheter’s instructions for use provided by the catheter manufacturer.

Caution

When the Patient Module is not in use, store in the holster, roll stand basket or other secure location to avoid damage.

Caution

Electrodes should be applied only to intact, clean skin (e.g., not over open wounds, lesions, infected or inflamed areas).

Caution

Placement of electrodes outside of their correct regions may result in reduced ECG performance. See section 7.

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 Nautilus D elta™ TCS Display.

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6.0 Assembling the Nautilus Delta™ TCS 6.1 Attaching the Patient Module to the Roll Stand The Patient Module can be placed in the holster when not in use. To attach the patient module holster to a roll stand see illustrations below.

Caution: When the Patient Module is not in use, store in the holster, roll stand basket or other secure location to avoid damage.

6.2 Connecting the Patient Module to the Display The Patient Module connects to the USB port on the Display.

6.3 Connecting the ECG Cable to the Patient Module The ECG Cable connects to the Patient Module.

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7.0 Nautilus Delta™ TCS Information 7.1 Nautilus Delta™ TCS Graphical Interface, Controls and Indicators INTRAVASCULAR ECG VIEW 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.

External (baseline) ECG R-Peak Indicator Enabled Intravascular ECG

Press for Navigation ECG view

FRONT PANEL CONTROLS/INDICATORS

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NAVIGATION ECG VIEW

External (baseline) ECG

Navigation ECG

Press for Intravascular ECG view

FRONT PANEL CONTROLS/INDICATORS

FRONT PANEL CONTROLS/INDICATORS Shutdown: Select to open the shutdown menu. Caution: To avoid damage to the operating system, use the Shutdown button to turn off the N autilus D elta™ TCS Display. Settings: Select to open the system settings menu.

Battery Charging: When the unit is charging the battery, the AC connected indicator will overlay the battery status. 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.

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FRONT PANEL CONTROLS/INDICATORS Waveform Selection: Select either the Intravascular (yellow) or Navigation (blue) ECG waves for manipulation.

Intravascular

Navigation Freeze: Select to copy the current ECG waveforms from the Main Screen to the Reference Screen.

Print: 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 menu.

SOFTWARE VERSION

MENU

TOOLS Select to open the ECG Tools Menu ECG DISPLAY ADJUSTMENT PATIENT INFORMATION Patient Information will be shown on the procedural record.

MENU Select to open/close the Menu The Menu Controls below are accessible when the Menu button [

] is activated.

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MENU CONTROLS R-peak: Select to turn off and on R-peak Identifier.

R-peak Enabled

R-peak Disabled Demo: Select to initiate demonstration mode. For training, contact your Bard Access Systems’ Sales Representative. Tools: Open ECG Tools Menu.

Scale: Select to adjust the ECG signal amplitude of the External (white), Intravascular (yellow), or Navigation (blue) ECG waveforms on the Main Screen. External

Intravascular

Navigation Level: Select to adjust the vertical position of the External (white), Intravascular (yellow), or Navigation (blue) ECG waveforms on the Main Screen.

External

Intravascular

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

Exit: Select to close Menu.

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ECG TOOLS MENU CONTROLS

The ECG Tools Menu Controls below are accessible when the ECG Tools Menu button [

] is activated.

ECG TOOLS MENU CONTROLS Save: Select to stop and save the ECG waveform recording.

ivGain ceGain Reset

ivGain: Select [

] to toggle through each of the ivGain levels.

ceGain: Select [ levels.

] to toggle through each of the ceGain

Reset: Resets the N autilus D elta™ TCS ECG Tools. Exit: Select to close ECG Tools Menu.

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7.2 Shutdown Menu The Shutdown Menu Controls below are accessible when the Shutdown button [

] is activated.

SHUTDOWN MENU CONTROLS Nautilus Delta: Restarts the Nautilus D elta™ TCS Software Application. Nautilus Delta

Shutdown

Restart

Lock

Cancel

Shutdown: Shuts down the Display.

Restart: Restarts the Display.

Lock: Locks the password enabled Display.

Cancel: Closes the Shutdown Menu Controls.

7.3 Settings Icon Select

to open the N autilus D elta™ TCS Settings Window.

7.3.1 Settings – General

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Change Date and Time

Opens Date and Time properties window.

Change Language

Opens 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 Nautilus D elta™ TCS compatible installation is inserted.

About

Indicates system application version information.

Password

To enable or disable password protection, see figure below.

Close

Closes the Settings Menu.

Enable

Enables the password protection, according to the value entered.

Disable

Disables the password protection.

Close

Closes the Password Window.

7.3.2 Settings – Printers

Set Current Printer

Sets the selected printer as current. Note – Nautilus D elta™ TCS Application will print to the current printer.

Close

Closes the Printer Window and Settings Menu.

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7.3.3 Settings – File Management

Refresh

Refreshes the file(s) listing in the viewer.

Hide LOG / Show LOG

Hides/shows log files 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.

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Copy

Automatically copies selected files or folders to the operating system clipboard.

Select All

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.

8.0 Nautilus Delta™ TCS Catheter Guidance Step 1: Prepare Device –– Place the Display in a location visible to the operator performing the placement procedure. –– Connect the Patient Module to the Display via USB cord. –– Connect the ECG Cable to the Patient Module –– 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’ Ultrasound System instructions for use.

Step 3: Measure Catheter Length (if applicable) –– Refer to catheter instructions for use.

Step 4: Prepare Patient Module –– P lace Patient Module in the holder with the USB and ECG electrodes remaining outside the holder and tighten holder around cords with rubber bands.

Step 5: Position Patient Module –– P lace the Patient Module in a location that accommodates the ECG Cable connection and operation throughout the placement procedure. –– It is recommended that the Bard logo on the Patient Module be face up and USB cord routed toward the patient’s feet.

Step 6: Prepare and Attach External ECG Electrodes –– Prepare and attach external ECG electrodes per the following steps: 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). 2. Attach electrodes to all lead wires. 3. Remove backing and press electrodes firmly onto skin at the specified locations. a)

P lace red electrode on the patient’s lower left abdomen, inferior to the umbilicus and laterally along the mid-axillary line.

b)

Place green electrode on the patient’s lower right abdomen.

c)

Place blue electrode on the patient’s skin below the jugular notch over the manubrium of the sternum.

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Caution: Placement of electrodes outside of their correct regions 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. Use commercially available skin electrodes/pads with snap buttons according to manufacturer’s instructions for use. 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 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.

Step 7: Evaluate External ECG waveform –– Refer to the catheter instructions for use.

Step 8: Prepare Catheter Sterile Field –– Refer to the catheter instructions for use.

Step 9: Access the Vein –– Refer to the catheter instructions for use and ultrasound system instructions for use.

Step 10: Attach Through-Drape Connector to Patient Module –– Attach Through–Drape Connector to Patient Module via the Patient Module Fin connection. –– Refer to catheter instructions for use.

Step 11: Insert Catheter –– Refer to catheter instructions for use for catheter insertion.

Step 12: Catheter Tip Navigation and Confirmation –– Refer to catheter instructions for use for catheter insertion. –– Use a slow steady motion while advancing the catheter.

ECG Navigation (Blue ECG Signal if enabled) In patients with a distinct R-peak, the R-peak will first present as a large negative amplitude when entering the vasculature, moving to a flatline as it approaches the blue ECG lead, and becoming positive in amplitude as the catheter enters the superior vena cava. As the catheter advances to the cavo-atrial junction, clinicians should refer to the ECG Confirmation instructions below.

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 Through–Drape Connector to Patient Module 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 catheter instructions for use. Warning: In any situation in which you cannot unambiguously identify the specific ECG waveforms for different locations in the vasculature as described in the Instructions for Use, the use of an additional method, according to your institutional guidelines, is required to confirm catheter tip location.

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