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Hologic ATEC SAPPHIRE, Руководство оператора

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29

Symbol

Definition

Authorised Representative in the European Community

Humidity Limitation

Temperature Limitation

Non - Sterile

To identify a type BF applied part complying with IEC 60601-1.
Note 1 - B = Body.
Note 2 - F = Floating applied part.
ATEC and Eviva biopsy devices

Alternating Current

Manually Reset Breaker

Keep away from rain

Dangerous Voltage

WEEE Symbol - indicates separate collection of electrical and electronic equipment in 

accordance with European Directive 2002/96/EC on Waste Electrical and Electronic 

Equipment (WEEE)

Atmospheric pressure limitation

Equipotential Ground

 

Содержание ATEC SAPPHIRE

Страница 1: ...Drive Marlborough MA 01752 USA www hologic com 877 887 8767 Hologic UK Ltd Unit 2 Link 10 Napier Way Crawley West Sussex RH10 9 RA UK Hologic Ltd Heron House Oaks Business Park Crewe Road Wythenshawe...

Страница 2: ...Multicare and StereoLoc are trademarks and or registered trademarks of Hologic Inc and or its subsidiaries in the United states and or other countries All other trademarks registered trademarks and p...

Страница 3: ...opsy and Excision System Sapphire Unit Check Out 14 ATEC Breast Biopsy and Excision System Sapphire Unit Operating Instructions 14 Performing a Biopsy Using MRI Guidance 14 Performing a Biopsy Using S...

Страница 4: ...ay cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular installation If the console does cause harmful interferenc...

Страница 5: ...oduction This manual is written for medical personnel who will be responsible for operating the ATEC Sapphire unit It is extremely important that the operator read and thoroughly understand the conten...

Страница 6: ...on the Stereotactic and Ultrasound Environment 1 ATEC handpieces designed for use with stereotactic STX and ultrasound U S guidance are compatible with the red receptacle marked US STX on the console...

Страница 7: ...rture MR MR dedicated handpiece EVIVA 12 12 guage 12 12 cm long 20 20 mm aperture T Petite 13 13 cm long 10 10 cm long TABLE4 EVIVABIOPSYDEVICECOMPATIBILITY Biopsy Device Needle Guide Stereotactic Ada...

Страница 8: ...14 12 OB ATEC RTFA Stereotactic STX Hologic MultiCare Platinum Hologic Stereloc II Hologic Affirm Siemens Fischer Mammotest Siemens Fischer Mammotest Lateral Approach Siemens Opdima GE Senographe DS a...

Страница 9: ...cavity 6 ManualAspiration Button When placed in Manual Aspiration mode the Saline PV is closed and the inner cutting cannula is retracted In this mode the user can vacuum the biopsy cavity by depress...

Страница 10: ...ection NOTE Refer to Eviva IFU for Eviva biopsy device operating instructions and warnings ATEC Power Cord Connection and Circuit Breaker CAUTION Grounding reliability can only be achieved when this e...

Страница 11: ...ower Cord plug 4 InstructionsPlacardHook Attachment site for the instructions placard 5 ATECHospitalGradePowerCord Connect the ATEC Power Cord into the power cord receptacle on the side panel AC inlet...

Страница 12: ...cap are secure and sealed to avoid vacuum leaks 3 Plug the vacuum line assembly on the console into the top port labeled VACUUM on the suction canister lid FIGURE2 ATECCANISTER NOTE The ATEC Canister...

Страница 13: ...g the red banded line into the receptacle on the console with the red ring 1 Eviva Biopsy Devices designed for use with stereotactic STX guidance are compatible with the red receptacle marked US STX o...

Страница 14: ...ystem Sapphire Unit Operating Instructions Using the System in MRI Stereotactic or Ultrasound Guidance 1 When the console is in Biopsy mode depressing the footswitch will activate the vacuum and opera...

Страница 15: ...tissue select Lavage mode It is not necessary to depress the footswitch 5 To vacuum the cavity in Lavage mode disconnect the luer lock of Y valve to open the saline line to the vent to atmosphere resu...

Страница 16: ...a fully 1 Re install protective sheath 2 Suction canister lid is not seated onto canister 2 Properly seat lid on canister 3 Suction canister is cracked 3 Replace with new suction canister 4 Large port...

Страница 17: ...itting is not connected to the suction canister lid d Connect suction fitting to patient port marked patient on the lid e Handpiece suction fitting is not connected to the correct port on suction cani...

Страница 18: ...zed or a period of ninety 90 days from the date of shipment whichever period is longer Disposable supplies shall be warranted to conform to published specifications for a period ending on the expirati...

Страница 19: ...cy Action Inspect footswitch cord Weekly Verify that the 90 connectors are facing toward rear of the console Verify that the footswitch cord is wrapped in the counterclockwise CCW direction around the...

Страница 20: ...tops Vacuum releases from thumb Vacuum Line Assembly Removal with the console powered off 1 Locate the white lock collar where the vacuum line assembly attaches to the console 2 Lift up on the vacuum...

Страница 21: ...le Installation with the console powered off 1 Press the new power cord into the cord receptacle 2 With 1 Philips screwdriver tighten fastener located on bottom of retaining bracket Verification of In...

Страница 22: ...ild detergent Wipe dry WARNING Do not immerse console in water Immersion in water will cause console damage and may cause electric shock or death ATEC Footswitch Clean the ATEC Footswitch thoroughly w...

Страница 23: ...in Wide 63cm 37 in High 93cm 21 in Deep 53cm Footprint 525 in 3400 cm 525 in 3400 cm Weight 100 lbs 45kg 100 lbs 45kg Maximum Power 1320W 1200W Voltage 120V AC 240V AC Frequency 60 Hz 50 Hz Maximum C...

Страница 24: ...for US STX handpiece 20 ft 6 10m for MRI handpiece Sterilization Gamma Irradiation Eviva Biopsy Device Handpiece Size 1 81 in 4 60cm High x 1 48 in 3 76cm Wide x 8 17 in 20 75cm long Weight 8 7 oz 24...

Страница 25: ...ther equipment If adjacent or stacked use is necessary the ATEC Sapphire Console should be observed to verify normal operation in the configuration in which it will be used GUIDANCEANDMANUFACTURER SDE...

Страница 26: ...power supply or battery Power Frequency 50 60Hz Magnetic Field EN IEC 61000 4 8 3A m 3A m Power frequency magnetic fields should be that of a typical commercial or hospital environment Conducted RF I...

Страница 27: ...output power of the communications device Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 8...

Страница 28: ...or on the order of a physician YYYY MM DD Expiration date is represented by the following YYYY represents the year MM represents the month DD represents the day MRI Conditional an item that has been...

Страница 29: ...Note 1 B Body Note 2 F Floating applied part ATEC and Eviva biopsy devices Alternating Current Manually Reset Breaker Keep away from rain Dangerous Voltage WEEE Symbol indicates separate collection o...

Страница 30: ...________________ Email __________________________________________________________________________ Clinical Education Specialist Name ___________________________________________________________________...

Страница 31: ...Representative Information Name _________________________________________________________________________ Phone _________________________________________________________________________ Email _______...

Страница 32: ...rther forward movement The cocking lever will 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...

Страница 33: ...th warm water 5 Wipe the adapter dry with a cloth or a paper towel 6 Cycle hub retaining clamps handpiece retaining clamp cock and fire adapter 7 Re Clean the stereotactic adapter if any component doe...

Страница 34: ...ereoloc are trademarks and or registered trademarks of Hologic Inc and or its subsidiaries in the United States and or other countries All other trademarks registered trademarks and product names used...

Страница 35: ...35...

Страница 36: ...36 Hologic Inc 250 Campus Drive Marlborough MA 01752 USA www hologic com 877 887 8767...

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