ATEC
®
Breast Biopsy and Excision System:
Sapphire
™
Unit
Operator’s Manual
Precautions
Please read all contents of the Operator’s Manual for your ATEC
®
Breast Biopsy and Excision System:
Sapphire
™
unit prior to installation and operation. Follow all warnings and instructions as stated in
this manual and retain for future reference. Physicians should inform patients about all potential risks
and adverse events discussed in this manual with respect to the use of the ATEC
®
Breast Biopsy and
Excision System:
Sapphire
™
unit.
As used below, the term “Suros
™
” means Suros Surgical Systems, Inc., a Delaware corporation. As
used below, the term “ATEC
®
Breast Biopsy and Excision System:
Sapphire
™
unit” means the ATEC
Sapphire
™
console unit and all available ATEC
®
Breast Biopsy and Excision System components, as
more fully described in the Components section below (unless the context dictates otherwise).
v
Should any object or liquid fall into the ATEC
Sapphire
™
console, unplug the console
and have it checked by qualified personnel before operating it any further.
v
Unplug the console from the electrical outlet if it is not to be used for several days
or an extended period of time.
v
Allow adequate air circulation around the console to prevent internal heat build-up. Do
not place the console on surfaces 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, excessive dust, mechanical vibration or shock.
v
To keep the console looking new, periodically clean it with a soft cloth. Stubborn stains
may be removed with a cloth lightly dampened with a mild detergent solution. Never
use strong solvents or abrasive cleansers since these will damage the console casing.
The console should only be cleaned after the power cord is disconnected from the power
outlet and the console.
v
Do not place the console on an unstable surface. The console may fall, causing serious
injury and damage to the appliance. Quick stops, excessive force and uneven surfaces
may cause the console to overturn.
Warnings and Cautions
Warnings
v
THE COMPONENTS OF THE ATEC
®
BREAST BIOPSY AND EXCISION
SYSTEM:
SAPPHIRE
™ UNIT ARE FOR USE ONLY BY QUALIFIED MEDICAL
PERSONNEL TRAINED IN THEIR USE AND APPLICATION
. Qualified medical
personnel should perform a test of the ATEC
®
Breast Biopsy and Excision System:
Sapphire
™
unit prior to each procedure or prior to each time a new single patient use
disposable is attached to the console.
v
To prevent fire or shock hazard, do not expose the console to rain or moisture.
v
To prevent shock hazard, do not use the console’s polarized plug with a receptacle
or other outlet unless the blades can be fully inserted to prevent blade exposure.
1