Suros ATEC Sapphire Unit Operator'S Manual Download Page 24

ATEC

® 

Breast Biopsy and Excision System: 

Sapphire

 Unit 

Operator’s Manual

Warranty

This warranty and the rights and obligations hereunder shall be construed under and governed by the 
laws of the state of Indiana, USA. Suros Surgical Systems, Inc. (“Suros”) warrants the components 
of the ATEC

®

 Breast Biopsy and Excision System: 

Sapphire

 unit as described below to be free from 

defects in material and workmanship under normal use and preventive maintenance for the warranty 
period shown below. Suros’ obligation under this warranty is limited to the repair or replacement, at 
its option, of any product or part thereof which has been returned to Suros within the applicable time 
period shown below and which examination discloses, in Suros’ sole judgment, the product or part 
thereof to be defective. This warranty does not apply to any product or part thereof that has been: (1) 
adversely affected due to use with devices manufactured or distributed by parties not authorized by 
Suros, (2) repaired or altered outside Suros’ facilities in a way so as to, in Suros’ sole judgment, affect 
its functionality, stability or reliability, (3) subjected to improper use, negligence or accident, or (4) 
used other than in accordance with the design and use parameters set forth herein or standards for 
similar products generally accepted in the industry.

Suros’ products are warranted for the following periods beginning on the date of delivery to the 
original purchaser:

v

  ATEC

®

 Breast Biopsy and  

Excision System: 

Sapphire

 Unit 

 

One (1) Year, parts and labor

v

  ATEC

®

 Footswitch   

 

 

One (1) Year, parts and labor

v

  ATEC

®

 Power Cord  

 

 

One (1) Year, parts and labor

v

  ATEC

®

 Vacuum Line Assembly 

 

One (1) Year, parts and labor

v

  ATEC

®

 Stereotactic Adapter   

 

One (1) Year, parts and labor

THE WARRANTY PROVIDED IN THIS SECTION AND THE OBLIGATIONS AND LIABILITIES OF SUROS 
HEREUNDER ARE EXCLUSIVE AND IN LIEU OF (AND PURCHASER HEREBY WAIVES) ALL OTHER 
REMEDIES, GUARANTIES, LIABILITIES OR WARRANTIES, EXPRESSED OR IMPLIED, ARISING BY LAW 
OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY AND 
FITNESS FOR A PARTICULAR PURPOSE. PURCHASER HEREBY WAIVES ALL OTHER OBLIGATIONS OR 
LIABILITIES ON THE PART OF SUROS, WHETHER OR NOT OCCASSIONED BY SUROS’ NEGLIGENCE. 
THE REMEDIES SET FORTH HEREIN SHALL BE PURCHASER’S EXCLUSIVE REMEDIES FOR BREACH OF 
THE FOREGOING WARRANTIES.  IN NO EVENT SHALL SUROS BE LIABLE FOR SPECIAL, INCIDENTAL, 
CONSEQUENTIAL OR PUNITIVE DAMAGES, INCLUDING, WITHOUT LIMITATION, DAMAGES RESULTING 
FROM LOSS OF USE, PROFITS, BUSINESS OR GOODWILL.  THIS WARRANTY SHALL NOT BE EXTENDED, 
ALTERED OR VARIED EXCEPT BY A WRITTEN INSTRUMENT SIGNED BY SUROS AND PURCHASER.

Suros neither assumes nor authorizes any other person to assume for it any other liability in connection 
with the sale or use of any Suros products. Purchaser will indemnify and hold harmless Suros and its 
affiliates from and against any losses, damages, liabilities or expenses (including reasonable attorney’s 
fees) arising from claims or actions by third parties attributable to such purchaser’s negligence, 
violation of laws, or in violation of the precautions, warnings, cautions and instructions provided in 
this manual.  There are no warranties that extend beyond the terms hereof. Suros reserves the right to 
make changes to products built and/or sold by it at any time without incurring any obligation to make 
the same or similar changes on products previously built and/or sold.

21

ATEC

®

 Breast Biopsy and Excision System

Suros Surgical Systems, Inc. (“Suros”) warrants that the products which are the subject of this warranty (the “Products”) 
will perform in substantial conformity with the specifications for the Products which are described in operating manuals or 
instructions for use provided by Suros

 for the Products and that the Products will be free from defects in material and work-

manship under normal use and proper operating conditions for the warranty period 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, which has been returned to Suros for examination within the applicable time period described 
below and which examination confirms, to Suros’ satisfaction, such Product or part to be defective. This warranty does not 
apply to any Product, or part thereof, that has been: (1) adversely affected due to use with devices manufactured or distributed 
by persons not authorized by Suros, (2) repaired or altered by persons not authorized by Suros in a way so as to, in Suros’ 
judgment, affect its stability or reliability, (3) subjected to improper use, negligence or accident, or as to which the purchaser 
or user has failed to implement all updates or other instructions provided by Suros, or (4) used other than in accordance with 
the instructions for such Product established by Suros in the operating manuals or instructions for use provided by Suros or 
with standards generally accepted in the industry for similar products.

Products are warranted for the following periods beginning on the date of installation at the site of the customer who will  
use the Product or three months after delivery to the original purchaser, whichever is later:

• Console unit (inclusive of power cord and footswitch)     

One (1) Year, parts and labor

• ATEC

®

 Stereotactic Adapter 

 

 

 

One (1) Year, parts and labor

Replacement parts supplied under this warranty shall be warranted for the remaining portion of the original warranty for the 
Product as to which the replacement part is utilized or a period of ninety (90) days from the date of installation by authorized 
personnel of the replacement part at the site of the customer who is using the Product, whichever period is longer.

This warranty is not applicable to single patient use devices associated with Suros ATEC

®

 Breast Biopsy and Excision Systems.

THIS WARRANTY CONSTITUTES THE EXCLUSIVE REMEDY OF THE PURCHASER OR USER AND INCOR- 
PORATES THE ONLY WARRANTIES MADE BY SUROS AND IS IN LIEU OF ALL OTHER WARRANTIES,  
EXPRESSED OR IMPLIED BY LAW, LEGISLATION OR OTHERWISE ARISING AND WHICH ARE HEREBY  
EXPRESSLY EXCLUDED, AND ALL SUCH WARRANTIES, INCLUDING, WITHOUT LIMITATION, THE  
WARRANTIES OF MERCHANTABILITY, SATISFACTORY QUALITY, FITNESS FOR A PARTICULAR PURPOSE 
AND FITNESS FOR ALL OTHER PURPOSES EXCEPT AS SPECIFICALLY PROVIDED FOR IN THE OPERATING 
MANUALS AND INSTRUCTIONS FOR USE PROVIDED BY SUROS, AS APPLICABLE, ARE HEREBY EXPRESSLY 
DISCLAIMED AND EXCLUDED. THIS WARRANTY SETS FORTH THE ENTIRE OBLIGATION AND LIABILITY 
OF SUROS AS TO THE SALE AND USE OF SUROS’ PRODUCTS. IN NO EVENT SHALL SUROS BE LIABLE 
FOR SPECIAL, INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITA-
TION, DAMAGES RESULTING FROM LOSS OF USE, PROFITS, BUSINESS OR GOODWILL EVEN IF SUROS IS 
ADVISED OF THE POSSIBILITY OF SUCH DAMAGE, IT BEING UNDERSTOOD THAT THE PURCH   ASER OR 
CUSTOMER MAY CHOOSE TO MAKE ITS OWN INSURANCE OR OTHER ARRANGEMENTS TO REDUCE ANY 
SUCH DAMAGES IT MAY INCUR.  IN ANY EVENT, SUROS’ LIABILITY FOR ANY DAMAGES UNDER THIS 
WARRANTY WILL NOT EXCEED THE TOTAL PURCHASE PRICE FOR THE PRODUCT.  THIS WARRANTY  
DOES NOT AFFECT STATUTORY OBLIGATIONS WHICH MAY NOT BE DISCLAIMED OR LIMITED BY  
APPLICABLE LAW.  

Suros neither assumes nor authorizes any other person to assume for it any liability in connection with the sale or use of  
any Products. Suros reserves the right to make changes to Products built and/or sold by it at any time without incurring any 
obligation to make the same or similar changes on Products previously built and/or sold.

This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Indiana, 
United States of America.  Any disputes arising under this warranty must be brought exclusively in the relevant federal or state 
district courts located in Indianapolis, Indiana, USA.

ATEC

 

and Suros Compassionate Technologies are trademarks or registered trademarks of Suros Surgical Systems, Inc.  All rights reserved.

 

Summary of Contents for ATEC Sapphire Unit

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

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