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Boston Scientific AutoElite Operator's Manual
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Boston Scientific AutoElite Operator's Manual

Boston Scientific AutoElite Operator's Manual

Thrombectomy system console
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OPERATOR'S MANUAL - DRAFT
AutoElite Thrombectomy System Console
DEVICE DESCRIPTION
The AutoElite Thrombectomy System (AutoElite System or System) allows for percutaneous removal of
thrombus located in peripheral arteries and veins, saphenous vein bypass grafts, native coronary arteries,
and native or synthetic AV access conduits. Thrombectomy is accomplished using high-pressure saline
jets contained in the catheter shaft. The saline jets create a low-pressure effect to draw thrombus into the
catheter, fragment the thrombus, and remove the thrombus from the treatment site. An additional feature
includes injection of physician-specified fluid using the Power Pulse technique for specific Thrombectomy
Sets. The AngioJet System consists of a single-use Thrombectomy Set (several models available) and a
free-standing mobile Console.
AutoElite Thrombectomy System Console (AutoElite Console or Console)
The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump, regulates
fluid inflow and outflow, and provides the operator with System setup prompts, total run time, total infused
fluid volume, and System malfunction information. The Console provides a user-interface controlled by a
touchscreen and is activated by pressing a foot switch.
Figure 1. AutoElite Console
AngioJet Thrombectomy Set (Thrombectomy Set)
A bag of heparinized saline (not included) supplies the pump with saline through the saline delivery
tubing. The pump pressurizes the saline. The Thrombectomy Set uses this pressurized, high-velocity
saline to create a low-pressure zone at the catheter tip. Thrombus is drawn into the catheter where it is
fragmented by the jets and evacuated from the body. The waste tubing transports the thrombus debris
from the catheter to the waste bag for ultimate disposal. An additional feature includes injection of
physician-specified fluid using the Power Pulse technique for specific Thrombectomy Sets.

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  • Page 1 AutoElite Thrombectomy System Console DEVICE DESCRIPTION The AutoElite Thrombectomy System (AutoElite System or System) allows for percutaneous removal of thrombus located in peripheral arteries and veins, saphenous vein bypass grafts, native coronary arteries, and native or synthetic AV access conduits. Thrombectomy is accomplished using high-pressure saline jets contained in the catheter shaft.
  • Page 2 The AutoElite System should only be used by physicians who have a thorough understanding of thrombectomy treatments and percutaneous interventional procedures. INTENDED USE The AutoElite Console is intended to be used with the AngioJet Thrombectomy Sets for the percutaneous removal of thrombus in the treatment of vascular disease. INDICATIONS FOR USE The AutoElite Console is intended for use only in conjunction with a AngioJet Thrombectomy Set.
  • Page 3 • Do not attempt to bypass any of the Console safety features. • The AutoElite System should not be used adjacent to or stacked with other equipment, and if adjacent use is necessary, the Console should be observed to verify normal operation in the configuration in which it will be used.
  • Page 4 • Physician-specified fluid (for Power Pulse Mode operation) Pre-Procedure Information A thorough understanding of each component in the AutoElite System is required for proper operation. Read this manual and the Thrombectomy Set(s) Instructions for Use before using any part of the AutoElite System.
  • Page 5 Note: Physician judgment should take priority when determining the run time for each procedure. Console Preparation Preparation of the AutoElite System requires the assistance of a sterile and a nonsterile user. The catheter is used within the defined sterile field; the Console and pump are operated outside the sterile field.
  • Page 6 2. Apply the brakes to prevent Console movement during operation (see Figure X). Figure X. The rear brake prevents the Console from moving or to lock the rear wheel orientation. The lowest position locks the rear casters in place and the upper position locks them in a straight configuration.
  • Page 7 Figure The touchscreen will display AUTOELITE while the Console performs a self-test (see Figure X). Figure X The doors will open, indicating a successful self-test. An appropriate error message will be shown if any abnormality is detected. The touchscreen will then display the Home screen.
  • Page 8 Figure X. 2. Nonsterile user: Remove the rest of the Thrombectomy Set from the tray by gripping the pump (not the piston head), then inserting the pump into the Console as shown (see Figures X and X). Figure X. Figure X. The Console will identify the Thrombectomy Set and all operating information from the pump.
  • Page 9 Figure X. Figure X 4. Tap the "Confirm" button on the touchscreen. Remove the cap from the Thrombectomy Set bag spike and insert the spike into the saline bag. Ensure hands are clear of the Pump Bay Doors and Roller Pump Clamp and tap the "Close Doors" button on the touchscreen (see Figure X).
  • Page 10 The touchscreen displays guidance on how to prime the catheter (see Figure X). Figure X. 1. Completely submerge the catheter tip in heparinized saline. Press and hold the foot switch for the displayed time to prime the catheter (see Figure X and X). Figure X.
  • Page 11 Figure X. If using Power Pulse Mode, go to the Power Pulse Spray Infusion Procedure section in this manual. If using Thrombectomy Mode, go to the Thrombectomy Set Operational Procedure section in this manual. Refer to the individual Thrombectomy Set Instructions for Use for catheter advancement. Time and Volume Tracking The console keeps track of the run times and volumes infused during operation in Thrombectomy Mode and Power Pulse Mode.
  • Page 12 Figure X. Recommended Max Total Run Time Exceeded – Partially Occluded Vessel When the total run time exceeds the partially occluded vessel recommended max total run time, the partially occluded run time label text will pulse and a chime will sound. A bell icon ( ) will appear next to the Partially Occluded Recommended Max Total Run Time label (Figure X).
  • Page 13 Refer to the individual Thrombectomy Set Instructions for Use in the Power Pulse Spray Infusion Procedure section for further operating instructions. Figure X. AutoElite Display Dwell Timer Dwell Timer is available for use to track dwell time after infusion of physician-specified fluid.
  • Page 14 2. To start the Dwell Timer, tap the Start button. Note: Tap the “Include time elapsed…” toggle to include the amount of time since the foot switch was released. Figure X. 3. To set a reminder, tap the Set Reminder button. Note: A default reminder time can be set before the procedure from the Settings screen (Figure X).
  • Page 15 Figure X. Track Dwell Time If a reminder has been set, a progress bar will appear. When the dwell time reaches the reminder time, the progress bar will turn blue, and a chime will sound. The Dwell Timer will continue to count after the reminder time has been reached.
  • Page 16 Note: Once the foot switch is released, the AutoElite System will continue to complete the current pump stroke. Switching Catheters Within Procedure To switch catheters, tap Additional Options in the lower-left corner of the touchscreen. Then tap Open Doors. Next, tap Switch Catheter.
  • Page 17 Console will provide prompts to continue the procedure upon restoration of power. AutoElite System End Procedure 1. To end the procedure, tap Additional Options in the lower-left corner of the touchscreen. Then tap Open Doors. On the pop-up, tap End Procedure. Tap Confirm to end the procedure and to show the Procedure Summary.
  • Page 18 Follow proper precautions for the handling of infectious waste. Reuse of the Thrombectomy Set is prohibited. Any serious incident that occurs in relation to this device should be reported to Boston Scientific and relevant local regulatory authority. Cleaning the Console Thorough cleaning is required after every use due to potential exposure to infectious material.
  • Page 19 Touchscreen • Do not wipe the screen with a cloth or sponge that could scratch the surface. • To clean the touchscreen, it is recommended to use window or glass cleaner applied to a clean cloth or sponge. Never apply the cleaner directly to the touchscreen. Do not use alcohol (methyl, ethyl or isopropyl), thinner, benzene, or other abrasive cleaners.
  • Page 20 Do not dispose of by incineration, burial or placement into common waste stream. Device should be safely disposed of in accordance with hospital, administrative, and/or local government policy. Contact Boston Scientific Customer Service for product returns. Biohazardous device (after use) Statement 1: 3.1.1.
  • Page 21 To minimize the risk of infection or microbial hazards after use, dispose device and packaging as follows: After use, device and packaging may contain biohazardous substances. Any device and packaging that came into contact with biohazardous substances should be treated and disposed of as biohazardous waste or be treated and disposed of in accordance with any applicable hospital, administrative, and/or local government regulations.
  • Page 22 Page 22 of 38...
  • Page 23 Duty cycle symbol ETL Listed Mark Page 23 of 38...
  • Page 24 INSTALLATION If lifting the Console is necessary, it is recommended to use a lifting device or two or more people. Initial Set-up 1) After removal from crate, inspect the Console for visible damage. PRECAUTION: Visually inspect the Console, foot switch/cable, and power cord prior to use. Use of a damaged Console is not recommended, as performance may be impacted.
  • Page 25 The Console will indicate when maintenance is recommended. The maintenance interval recommended by Boston Scientific is based on usage and is approximately every five years. Console service is only performed by qualified BSC-approved service personnel except for component replacement described in this manual.
  • Page 26 IEC 62353 at an interval of every 24 months or as per local regulations. If the AutoElite Console exceeds the limits described in table above, immediately discontinue use of the Console and contact your Boston Scientific Representative.
  • Page 27 To search by date, set the start date by tapping the field below From and select the date using the date picker. Set the end date by tapping the field below To and select the date using the date picker. To clear the date criteria, tap the X on the right side of the date fields.
  • Page 28 Diagnostics To view diagnostic information, from the home screen navigate to Maintenance, then Diagnostics. Error Messages Error messages and error codes will appear with an orange banner when a fault is detected within the system (see Figure The error message will provide guidance for troubleshooting. If the condition persists, the Thrombectomy Set may need to be removed from the Console.
  • Page 29 Figure X. Make note of each error title and number to report to Boston Scientific Technical Assistance. If necessary, refer to the log in the Maintenance screen for errors and error codes that have occurred on the Console. If the Console becomes unresponsive, cycle the power using the rocker switch next to the power cord.
  • Page 30 Part Replacement (in the Torx spec there may be good photos) It may be necessary to replace components on the AutoElite Console. The user may replace the components outlined in the instructions below. For all other parts, contact Boston Scientific Technical Support using contact information in Table X.
  • Page 31 Figure 4. Lightly tug on the cord just below the connector to ensure secure connection. 5. Test the foot switch. From the Home Screen, tap the Maintenance button Tap the Diagnostics button c. Look under the STATUS & VOLTAGES tab and scroll down until “Foot Switch Pressed”...
  • Page 32 Power cord Figure X. 1. Power off the Console. Unplug the power cord from the electrical outlet. 2. The power cord connection to the Console includes a red locking mechanism. To disconnect, grasp the red locking mechanism with a finger and thumb. Pull back on the red locking mechanism to release the cord from the Console.
  • Page 33 3. Screw each screw hand tight. Ensure the new part is not loose. No testing is needed. SPECIFICATIONS Model AutoElite Dimensions, D x W x H 23.0 in x 16.7 in x 54.0 in (58.42 cm x 42.42 cm x 137.16 cm) Weight 162 lb (73.48 kg)
  • Page 34 The AutoElite System is intended for use in the electromagnetic environment specified below. The customer or the user of the AutoElite System should assure that it is used in such an environment. (In chart, remove AngioJet and change Ultra to AutoElite, 2 instances) Table 2.
  • Page 35 (In notes above, remove AngioJet, change Ultra to AutoElite) Proximity magnetic field 134.2 kHz: 65 A/m, 2.1 134.2 kHz: 65 A/m, 2.1 Proximity magnetic fields IEC61000-4-39 kHz pulse modulation kHz pulse modulation should be at levels 13.56 MHz: 7.5 A/m, 50 13.56 MHz: 7.5 A/m, 50...
  • Page 36 Boston Scientific hereby declares that the AutoElite Console, Model (Global UPN): M001AJAEC0200 is in conformity with the relevant Union harmonization legislation, Radio Equipment Directive 2014/53/EU. To obtain a full text Declaration of Conformity, contact Boston Scientific using the information on the back cover of this manual.
  • Page 37 The Instructions for Use (IFU) for this product are supplied in electronic form over the Internet at www.IFU-BSCI.com. AngioJet is a registered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners.
  • Page 38 Back Cover Update Australia and Argentina to current symbology. Update symbology to current no- text version CE2797 © 2024 Boston Scientific Corporation or its affiliates. All rights reserved. Page 38 of 38...