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Suros ATEC Sapphire Unit, Руководство оператора

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Congratulations!

Thank you for purchasing the 

ATEC

®

 

Breast Biopsy and Excision System: 

Sapphire

™ 

unit.

 

Contents

 
Precautions .......................................................................................1

Warnings and Cautions ....................................................................1

Introduction ......................................................................................4

Indications ........................................................................................4

Contraindications .............................................................................4

Components .....................................................................................6

Console Controls and Functions ......................................................9

ATEC

®

 Breast Biopsy and Excision System:  

Sapphire

™

 Unit Set Up ...................................................................10

ATEC

®

 Breast Biopsy and Excision System:   

Sapphire

™

 Unit Check Out .............................................................14

Using the ATEC

®

 Breast Biopsy and Excision System:  

Sapphire

™

 Unit ...............................................................................15

Performing a Biopsy Using MRI Guidance ...................................15

Performing a Biopsy Using STX or U/S Guidance .......................16

Performing a Biopsy Using a Stereotactic Adapter .......................17

ATEC

®

 Handpiece Operating Instructions .....................................18

Troubleshooting .............................................................................19

Warranty .........................................................................................21

Service and Maintenance ...............................................................22

Cleaning Instructions .....................................................................26

Owner’s Record .............................................................................27

Specifications .................................................................................28

Important Contact Information  .....................................................30

Содержание ATEC Sapphire Unit

Страница 1: ...Suros Surgical Systems Inc 6100 Technology Center Drive Indianapolis IN 46278 USA www SurosSurgical com CustomerSupport SurosSurgical com 877 887 8767 Operator s Manual...

Страница 2: ...ssionate Technologies are trademarks or registered trademarks of Suros Surgical Systems Inc in the United States and other countries All rights reserved Covered by one or more of the following patents...

Страница 3: ...re Unit Set Up 10 ATEC Breast Biopsy and Excision System Sapphire Unit Check Out 14 Using the ATEC Breast Biopsy and Excision System Sapphire Unit 15 Performing a Biopsy Using MRI Guidance 15 Performi...

Страница 4: ...aces or near materials that may block the ventilation openings v Do not install the console in a location near heat sources such as radiators or air ducts or in a place subject to direct sunlight exce...

Страница 5: ...EC Breast Biopsy and Excision System Sapphire unit console should only be opened or serviced by Suros or quali ed personnel who have been trained and certi ed by Suros Surgical Systems Inc Cautions v...

Страница 6: ...ntact Suros Customer Support or your distributor if you move your console to a signi cantly different physical address v If you are a Suros customer in the U S or in Canada consult your Suros Sales Re...

Страница 7: ...ue samples for diagnostic sampling of breast abnormalities The ATEC Breast Biopsy and Excision System is intended to provide breast tissue for histologic examination with partial or complete removal o...

Страница 8: ...e used The ATEC Introducer Localization System is available for localizing the area targeted for biopsy The ATEC MRI handpiece and ATEC Introducer Localization System is speci cally designed for use i...

Страница 9: ...ic Adapter for use on stereotactic systems Single Patient Use Disposable Components for Procedures Using Stereotactic or Ultrasound Guidance ATEC Handpiece ATEC Suction Canister ATEC Tissue Filters AT...

Страница 10: ...Footswitch v v v ATEC Power Cord v v v ATEC Vacuum Line Assembly v v v ATEC Stereotactic Adapter v Single Patient Use Disposable Components MRI Guided Biopsy Procedures Ultrasound Guided Biopsy Proce...

Страница 11: ...rt Equipment Type Handpiece with 12GA Cutting Cannula Handpiece with 9GA Cutting Cannula Handpiece with Petite Aperture ATEC Stereotactic Adapter Model Needle Guide Lorad Prone Stereotactic Systems AT...

Страница 12: ...ential problem 8 Return to Setup Indicator Does not illuminate under normal conditions Flashes red when Test mode is not completed due to vacuum failure Refer to the Troubleshooting section for sugges...

Страница 13: ...ece saline line Controls the ow of saline to the handpiece ATEC Breast Biopsy and Excision System Sapphire Unit Set Up This section provides information on how to make all necessary connections to set...

Страница 14: ...ur ATEC Breast Biopsy and Excision System Sapphire unit 2 Circuit Breaker Part of the AC Inlet If the circuit breaker has been tripped the black button will not be ush and a white dot will be visible...

Страница 15: ...tions require that you use an ATEC Suction Canister from Suros v Assemble the suction canister as shown in Figure 2 and place in the canister holder on the top of the console in the canister seating a...

Страница 16: ...he protective sheath on handpiece tip v Remove the terminal ends of the 4 lines from the handpiece tray o Install the spike to the saline bag and insert the silicone section into the pinch valve label...

Страница 17: ...ng section of this manual for suggested steps to diagnose and correct a potential problem v Insert the silicone section of the saline tubing line into the pinch valve labeled Saline PV as shown in Fig...

Страница 18: ...le Needle Guide into the compression grid at the identi ed target area in the appropriate cube v Insert the Introducer Stylet that is hubbed to the Introducer Sheath The depth stop on the Introducer S...

Страница 19: ...g the footswitch allows the user to independently control aspiration without taking a tissue sample This function may be used to vacuum or irrigate the biopsy cavity Additional operating instructions...

Страница 20: ...ill return by spring action to its at rest position Note The stereotactic adapter can only be cocked if the handpiece retaining clamp is in the lock position v To rapid advance the ATEC handpiece into...

Страница 21: ...to depress the footswitch v To vacuum the cavity select Manual Aspiration mode and depress the footswitch Removing your foot from the footswitch will inactivate or stop vacuum to the ATEC handpiece v...

Страница 22: ...er lid not seated on canister bottom Suction canister cracked Large port on suction canister lid not capped with large plug Handpiece suction tting not connected to the suction canister lid Handpiece...

Страница 23: ...ot capped with large plug d Handpiece suction tting not connected to the suction canister lid e Handpiece suction tting not connected to the correct port on suction canister lid 2 Inner cutting cannul...

Страница 24: ...iod shown below assuming the performance of ordinary preventative maintenance Suros obligation under this warranty is limited to the repair or replacement at its option of any Product or part thereof...

Страница 25: ...tional ATEC Users All international users of the ATEC Breast Biopsy and Excision System Sapphire unit should contact their distributor directly with questions comments and or technical service issues...

Страница 26: ...en vacuum ready light console audible beeps at the end of each cycle and cycling of the pinch valve d Release footswitch pedal and verify that the solid green vacuum light turns off and cycling stops...

Страница 27: ...white collar 4 While holding down the white collar pull the vacuum line assembly up and out of the vacuum line assembly connector Installation with the console powered off 1 Press the new vacuum line...

Страница 28: ...et Turn console power on Verify console powers on beeps and defaults to the biopsy mode 1 2 3 4 1 2 3 1 2 3 Cord Management Plate Power Cord 25 Removal with the console powered off 1 Unplug console po...

Страница 29: ...of the biopsy procedure immediately rinse with warm water 2 Spray adapter with a cleaner 3 Rinse with warm water 4 Wipe dry with cloth or paper towel 5 Cycle hub retaining clamps handpiece retaining...

Страница 30: ...phire unit Model Number ATEC Breast Biopsy and Excision System Sapphire Unit Serial Number ATEC Stereotactic Adapter The serial number of your ATEC stereotactic adapter is located on the bottom of the...

Страница 31: ...aker Power Cord Length 15 ft 5m 15 ft 5m Vacuum Generated 28 Hg 71cmHg 28 Hg 71cmHg at sea level at sea level ATEC Footswitch MRI Compatible Size 6 in 16cm Long 4 in 9cm Wide 2 in 5cm High Weight 1 lb...

Страница 32: ...ating altitude less than or equal to 3 657 meters above sea level Classi cation Type of protection against electric shock Class I Degree of protection against electric shock Type BF Degree of protecti...

Страница 33: ...tact Information ATEC Breast Biopsy and Excision System Sapphire Unit Suros Sales Representative Name Phone Email Suros Clinical Education Specialist Name Phone Email Suros Customer Support CustomerSu...

Страница 34: ...Suros Surgical Systems Inc 6100 Technology Center Drive Indianapolis IN 46278 USA www SurosSurgical com 877 887 8767...

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