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Summary of Contents for AngioDynamics Solero
- Page 1 Microwave Tissue Ablation System Generator Operator’s Manual 16750970-21 REVE - English 2020-12...
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Page 3: Table Of Contents
AngioDynamics, Inc. Solero Microwave Tissue Ablation System CONTENTS SECTION 1 | INTRODUCTION ..................5 System Description ....................5 Indications for Use ....................5 Contraindications ....................5 Intended User ......................5 Intended Use Environment .................. 6 Warnings and Cautions ..................6 1.6.1... - Page 4 AngioDynamics, Inc. Solero Microwave Tissue Ablation System SECTION 6 | SYSTEM NOTIFICATIONS / WARNINGS / ERRORS ....20 6.1. Notifications ......................20 Connect Applicator ..................20 6.1.1 6.1.2 Turn on Pump ....................20 Close Pump Cover ..................21 6.1.3 6.1.4 Coolant Warm ....................
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Page 5: Section 1 | Introduction
Figure 1. System Diagram of the Solero System Components and Accessories The user may adjust microwave power output from 60 W to 140 W for up to 6 minutes. When the Solero system microwave energy is activated by the button on the generator front panel or by the footswitch, microwave energy (2.45 GHz ±... -
Page 6: Intended Use Environment
Solero Microwave Tissue Ablation System Intended Use Environment The Solero Microwave Tissue Ablation System is intended for use in control environments such as those found within surgical suites and emergency rooms. The exact details for environmental conditions and operating parameters may be found in Section 8.2. -
Page 7: Generator Care
Do not immerse or otherwise allow liquids to saturate or leak inside the generator. • The Solero generator is designed to be durable medical equipment. Physical damage caused by dropping, bumping or striking the generator may result in improper operation of the equipment and may lead to patient or operator injury. -
Page 8: Cautions
The Solero generator consists of a 2.45 GHz microwave source. The generator is specifically designed for use with Solero applicators. It has user-selectable controls on the front panel and displays microwave power output and time. It also has an input for an optional footswitch to control microwave activation. -
Page 9: Back Panel
AngioDynamics, Inc. Solero Microwave Tissue Ablation System Number Name Description Probe 1 Input Not currently available. Probe 2 Input Not currently available. Footswitch Input Allows the optional footswitch to be connected to the system. Back Panel Number Name Description Mains Power Switch Turns the generator on and off. -
Page 10: Screen Regions
AngioDynamics, Inc. Solero Microwave Tissue Ablation System Screen Regions The following regions are for general description only. Throughout a procedure, variations of this screen will be displayed and are fully explained in Section 5 and 6 for set up and implementation. -
Page 11: Section 3 | Disposables/Accessories
Solero Microwave Tissue Ablation System SECTION 3 | DISPOSABLES/ACCESSORIES Solero Applicators The following applicators are available for use with the Solero generator. To obtain more specific information, refer to the Directions for Use of the specific applicators. Part Number Description... -
Page 12: Section 5 | Operating Instructions
Turn on the generator using the mains power switch on the back of the generator. • The touchscreen will illuminate after several seconds and display the screen shown below. Below the AngioDynamics logo, the text “System Loading” is displayed in various languages. The languages displayed will change twice as the loading progresses. •... -
Page 13: Language Selection
AngioDynamics, Inc. Solero Microwave Tissue Ablation System Language Selection • When the language button has been pressed, and the initialization process has completed successfully, the language selection screen shown below will be displayed. • Press the up (1) or down (2) arrows to scroll through the list of available languages. -
Page 14: Standby Screen: Connecting The Applicator
• Inspect all devices and packaging for damage prior to use. Do not use any devices that are damaged or if the sterile barrier is breached. Do not use the Solero generator if it has been dropped or damaged. •... - Page 15 AngioDynamics, Inc. Solero Microwave Tissue Ablation System • Obtain a minimum of 1000 mL of sterile chilled saline. The saline will heat up as an ablation progresses and may eventually become too hot at which point the system will inhibit operation.
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Page 16: Setting Power And Time
AngioDynamics, Inc. Solero Microwave Tissue Ablation System • The system will transition to the Ready screen (1) as seen below and illuminate the green indicator light on the front panel (2). The pump indicator button will change as seen in (3) to indicate that the pump is now rotating and circulating coolant. -
Page 17: Beginning Ablation
AngioDynamics, Inc. Solero Microwave Tissue Ablation System Beginning Ablation • Use imaging techniques to confirm the proper placement of the applicator. Refer to the Directions for Use for the relevant applicator for detailed guidance. • Confirm that the screen shows the correct settings as selected from the applicator Direction for Use, and indicates “Ready.”... -
Page 18: During An Ablation
AngioDynamics, Inc. Solero Microwave Tissue Ablation System During an Ablation • Confirm delivery of microwave energy via the following indicators: A beep will sound every 5 seconds. The screen will read “Active.” The indicator light on the front panel will stay illuminated blue. -
Page 19: Track Ablation
AngioDynamics, Inc. Solero Microwave Tissue Ablation System Track Ablation • Track ablation may be used after an ablation is completed. The mode may be entered when the “Standby” or “Ready” screen is displayed. • Press the “Track” button located in the upper left corner of the screen as shown below (1) to enter track ablation mode. -
Page 20: Section 6 | System Notifications / Warnings / Errors
AngioDynamics, Inc. Solero Microwave Tissue Ablation System SECTION 6 | SYSTEM NOTIFICATIONS / WARNINGS / ERRORS 6.1. Notifications Persistent notifications are displayed in the upper right-hand corner of the Status Bar in an orange- colored panel. These notifications relate to conditions that may persist until action is taken by the user and they represent suggested actions to help facilitate ease of use, but do not represent hazardous scenarios or system errors. -
Page 21: Close Pump Cover
AngioDynamics, Inc. Solero Microwave Tissue Ablation System 6.1.3 Close Pump Cover The system will display a notification to close the pump cover when the pump housing cover is opened and an applicator is connected. If the pump is running when the cover is opened, the system will stop it. -
Page 22: Ablation Aborted
AngioDynamics, Inc. Solero Microwave Tissue Ablation System 6.1.6 Ablation Aborted The system will stop an ablation and display a dialog when the user manually terminates an ablation by pressing the Microwave Power Button as shown. Further progress is blocked until the dialog is acknowledged by pressing the checkmark button on the right side of the prompt. -
Page 23: Time Not Set
AngioDynamics, Inc. Solero Microwave Tissue Ablation System 6.2.3 Time not Set The system will display a warning when the Microwave Power Button is pressed while in the Ready state and the Time Setpoint is “0:00” as shown. The system will not activate... -
Page 24: Errors
If such an error occurs, the Solero unit will turn off and disable the microwave source, so there is no risk of immediate harm to the end user or the patient. -
Page 25: Unrecoverable System Errors
Maintenance The generator is not user serviceable. If there is a problem, see the troubleshooting guide in Section 13. If the problem persists, contact AngioDynamics for assistance. See Section 12 for contact information. Generator End of Life Dispose of the generator through standard hospital procedures for electronic devices, or return the Solero Generator to AngioDynamics for safe disposal. -
Page 26: Section 8 | Specifications And Standards
SECTION 8 | SPECIFICATIONS AND STANDARDS Essential Performance The essential performance of the Solero microwave system is maintained during normal use (as defined by the Operator’s Manual and the Directions for Use) and during electrical safety and electromagnetic compatibility testing (as defined by EN 60601-1), IEC 60601-1-2, and other relevant collateral standards. - Page 27 Connector Type - IEC 60320 C13 CE Marking - Yes Expected Service Life The Solero Generator is expected to function normally for 5 years Medical Electrical Specifications Type of protection against Electric Shock: Class 1 Suitability for use in oxygen rich...
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Page 28: Section 9 | Electromagnetic Compatibility (Emc)
This equipment can radiate radio frequency (RF) energy. If it is not installed and used in accordance with the instructions it may affect or be affected by other equipment. While the Solero System has been designed to comply with required standards, there is no guarantee that interference will not occur in a particular installation. -
Page 29: Electromagnetic Emissions
AngioDynamics, Inc. Solero Microwave Tissue Ablation System Electromagnetic Emissions The Solero MTA System has been tested and complies with relevant directives for electromagnetic compatibility of medical equipment in accordance to IEC 60601-1-2 4th edition. Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The system is intended for use in a Professional Healthcare facility for the electromagnetic environment specified below. -
Page 30: Electromagnetic Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity The Solero MTA System is intended for use in a Professional Healthcare facility electromagnetic environment specified below. The customer or the user of the Solero MTA System should assure that it is used in such an environment. - Page 31 To access the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Solero MTA System.
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Page 32: Recommended Separation
The Solero MTA System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Solero MTA System can help prevent electromagnetic interference by maintaining distance between portable and mobile RF communications equipment (transmitters) and the Solero MTA System as recommended below, according to the maximum output power of the communications equipment. - Page 33 AngioDynamics, Inc. Solero Microwave Tissue Ablation System Immunity to Proximity Fields from RF Wireless Communication Equipment Test Immunity Band Distance Frequency Service Modulation Power Test Level (MHz) (MHz) (V/m) Pulse 380-390 TETRA Modulation (18 Hz) GMRS 460 ± 5KHz 430-470...
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Page 34: Section 10 | Warranty And Contact Information
AngioDynamics Product it sells that is proven to have a material defect in material or workmanship and of which AngioDynamics, Inc. is notified in writing prior to its expiration date, if applicable, or prior to the date indicated on the warranty card accompanying the Product. If the Product does not have an expiration date or if no warranty card is available, AngioDynamics, Inc.’s obligation... -
Page 35: Section 11 | Symbology
AngioDynamics, Inc. Solero Microwave Tissue Ablation System SECTION 11 | SYMBOLOGY 11.1 Explanation of Symbols Symbol Description Consult accompanying instructions. Protective Earth Ground On (Power switch, Pump) Off (Power switch, Pump) Time (screen) Power (screen) On/Off button (generator) Type BF equipment... - Page 36 AngioDynamics, Inc. Solero Microwave Tissue Ablation System Symbol Description Caution: Federal Law (USA) restricts this device to sale by or on the order of a ONLY physician. Product Number Catalog Number X number Quantity of the Contents Legal Manufacturer Keep Dry...
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Page 37: Section 12 | Information And Registrations
AngioDynamics, Inc. Solero Microwave Tissue Ablation System SECTION 12 | INFORMATION AND REGISTRATIONS ETL listed mark is proof of product compliance to North American electrical AngioDynamics, Inc. safety standards. 26 Forest Street. Medical Electrical Marlborough, MA 01752 Equipment & Devices... -
Page 38: Section 13 | Appendix A: Troubleshooting
Contact AngioDynamics for technical support. The generator is not user-serviceable. Recyclable Package *AngioDynamics, the AngioDynamics Logo, Solero and the Solero logo are trademarks and / or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. © 2020 AngioDynamics, Inc. or its affiliates. All rights reserved. 16750970-21 REVE...
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