ON A DIFFERENT SCALEThe first VAB system right-sized for ultrasound

PERFORMANCE

The EnCor Ultra™ Breast Biopsy System is the firstvacuum-assisted biopsy (VAB) system for ultrasound that is powerful enough to deliver the performance you need and small enough to give you the convenience and efficiency you want.

Built on the proven EnCor® platform, the system eliminates the need for a bulky console by pairing a high-performing handpiece with a compact, fully powered vacuum unit. The EnCor Ultra™ Breast Biopsy System reliably obtains larger samples than systems up to 5 times its size. Finally, a system right-sized for ultrasound performance.

THE FIRST VAB SYSTEM RIGHT-SIZED FOR

ULTRASOUND PERFORMANCE

OPTIONAL STYLET HEADLIGHTSIlluminates biopsy area in darkened ultrasound rooms

OPTIONAL COAXIAL CANNULA

The ergonomic handpiece is the right fit for your hand, offering comfort and the greater level of control the ultrasound environment demands.

Utilizing the proven technology of the EnCor® Breast Biopsy System platform, the driver and powered vacuum unit deliver reliability and diagnostic confidence.

n Fully powered vacuum unit provides performance of systems 5 times its size

n Lightweight, flexible tubing gives you optimal handheld control

n Choice of 12G, 10G, and 7G needle sizes offers you flexibility to address your specific clinical needs

n Multiple, high quality samples from a single insertion improves procedural efficiency and accuracy–particularly when targeting smaller lesions

FOR

YOU

RIGHT-SIZED

The unobtrusive EnCor Ultra™ Breast Biopsy System tucks out of your patient’s sight. The system is also designed to improve your patient’s experience by reducing discomfort and procedure time:

n Sharp tip reduces tissue drag and discomfort and increases control, especially through dense tissue

n Quiet operation reduces ambient noise within the ultrasound procedure room

n Multiple quality samples from a single insertion reduces discomfort and can contribute to shorter procedures

FOR YOUR

PATIENT

RIGHT-SIZED

Right-sized for the ultrasound environ-ment, the EnCor Ultra™ Breast Biopsy System is always out of the way, yet right at hand. Small and lightweight-either with or without its space-saving procedure tray—the system is easy to place within your workflow and enhances your procedural efficiency.

The EnCor Ultra™ Breast Biopsy System impacts practice efficiency and economy beyond the benefits its size brings to your ultrasound room:

n Simple set up minimizes training requirements

n Medical waste is up to 67%* less than other systems n Common biopsy probes with EnCor EnspirE® Breast Biopsy System consolidates inventory requirements

n System offers lower cost of ownership

n Multiple samples collect in closed chamber for easy, efficient access

FOR YOUR

PRACTICE

RIGHT-SIZED

EnCor Ultra™ Breast Biopsy

SystemFootprint

Typical VAB System footprint

bardbiopsy.com 800.321.4254Bard, EnCor, EnCor Enspire, EnCor Ultra, Gel Mark UltraCor, SenoMark Ultra, StarchMark and UltraClip are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate.© Copyright 2013 C. R. Bard, Inc. All Rights Reserved. S120320 Rev. 0

Bard Biopsy Systems is a leader in breast tissue marker technology and offers a wide range of marker options, each designed to offer you the best choice for you and your patient. The following markers are specifically designed to be used in conjunction with the EnCor Ultra™ Breast Biopsy System.

For more information contact your Bard representative.

MARK OF AN EXPERT

Ordering Information

Item Number

E5115

SCCAN02

SCTUB4000

ECSTUS017G

ECSTUS0110G

ECSTUS0112G

ECP017G

ECP0110G

ECP0112G

Description

ENCOR ULTRA™ Breast Biopsy System 100-120V

ENCOR ULTRA™ Vacuum Canister (800 mL)ENCOR ULTRA™ Vacuum TubingENCOR® Ultrasound Stylet and Coaxial Cannula 7GENCOR® Ultrasound Stylet and Coaxial Cannula 10GENCOR® Ultrasound Stylet and Coaxial Cannula 12GENCOR® Breast Biopsy Probe – 7GENCOR® Breast Biopsy Probe – 10GENCOR® Breast Biopsy Probe – 12G

Qty

1ea

10ea/case

10ea/case

5ea/case

5ea/case

5ea/case

5ea/case

5ea/case

5ea/case

Gel Mark UltraCor® Breast Tissue Markers

SenoMark® UltraBreast Tissue Markers

UltraClip® DUal triGGerBreast Tissue Markers

StarChMark® Breast Tissue Markers

EnCor Ultra™ Breast Biopsy SystemINDICATIONS: The EnCor Ultra™ Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. CONTRAINDICATIONS: EnCor Ultra™ Breast Biopsy System is contraindicated for those patients where there is an increased risk of complications associated with percutaneous removal of tissue samples. WARNINGS: The EnCor Ultra™ Breast Biopsy System must be properly grounded to ensure patient safety. • Use of accessories not compatible with the EnCor Ultra™ Breast Biopsy System may create potentially hazardous conditions. PRECAUTIONS: This equipment should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle tech-niques. • Patients who may have a bleeding disorder or who are receiving anticoagulant therapy may be at increased risk of complications. • As with any biopsy instrument, there is a potential for infection. POTENTIAL COMPLICATIONS: Potential complications are those associated with any percutaneous removal/biopsy technique for tissue collection. Potential complications are limited to the region surrounding the biopsy site and include hematoma, hemorrhage, infection, a non-healing wound, pain and tissue adherence to the biopsy probe while removing it from the breast. Please consult package insert for more detailed safety information and instructions for use.

* Data represents average weight of 5 samples. The probes used for comparison were the largest gauge size available for each console system.

enCor enSpire® Breast Biopsy System Versatile performance in Stereotactic, Ultrasound, and MRI modalities

EnCor Ultra™ Breast Biopsy SystemInstructions for Use

1

EnCor UltraTM Breast Biopsy SystemInstructions for UseCaution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

A. DEVICE DESCRIPTIONThe EnCor UltraTM Breast Biopsy System provides control operations for specialized biopsy instruments intended to acquire tissue samples of suspected breast abnormalities. The EnCor UltraTM Breast Biopsy System may be used with EnCor® drivers, foot pedals and probes. EnCor® Biopsy Probes and EnCor UltraTM vacuum tubing and Canisters are available separately. Reference Figure 1 – Figure 3 for photographs of the above mentioned accessories.

Figure 1 – EnCor® Biopsy Probes Figure 2 – EnCor® Driver and Probe Figure 3 – EnCor® Foot Pedal

B. INDICATIONS FOR USEThe EnCor UltraTM Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. • Itisintendedtoprovidebreasttissueforhistologicexaminationwithpartialorcompleteremovaloftheimagedabnormality.• Itisintendedtoprovidebreasttissueforhistologicexaminationwithpartialremovalofapalpableabnormality.Theextentofahistologicabnormalitycannotalwaysbereadilydeterminedfrompalpationorimagedappearance.Therefore,theextentofremovalofthepalpatedorimagedevidenceofanabnormalitydoesnotpredicttheextentofremovalofahistologicabnormality,e.g.,malignancy.Whenthesampledabnormalityisnothistologicallybenign,itisessentialthatthetissuemarginsbeexaminedforcompletenessofremovalusingstandardsurgicalprocedures.Ininstanceswhenapatientpresentswithapalpableabnormalitythathasbeenclassifiedasbenignthroughclinicaland/orradiologicalcriteria(e.g.fibroadenoma,fibrocysticlesion),theEnCor UltraTMBreastBiopsySystemmayalsobeusedtopartiallyremovesuchpalpablelesions.Wheneverbreasttissueisremoved,histologicalevaluationofthetissueisthestandardofcare.Whenthesampledabnormalityisnothistologicallybenign,itisessentialthat thetissuemarginsbeexaminedforcompletenessofremovalusingstandardsurgicalprocedures.

C. CONTRAINDICATIONS1. Thisdeviceisnotintendedforuseexceptasindicated.2. The EnCor UltraTM Breast Biopsy System is contraindicated for those patients where, in the physician’s judgment, there is an increased risk of complications

associated with percutaneous removal of tissue samples.

D. WARNINGS1. The EnCor UltraTM Breast Biopsy System must be properly grounded to ensure patient safety. The system is supplied with a medical grade power

cord with AC plug. Do not connect the included power cord to extension cords or three-prong to two-prong adapters. To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective earth.

2. To minimize interference with other equipment, cables should be positioned in such a manner to prevent contact with other cables.3. Use of accessories not compatible with the EnCor UltraTM Breast Biopsy System may create potentially hazardous conditions.4. Only use EnCor® drivers with script version 1.23 or greater, with the EnCor UltraTM Breast Biopsy System. The system is not compatible with

earlier driver scripts. 5. The EnCor UltraTM Breast Biopsy System console may not be placed in an MRI suite.6. Nomodificationofthisequipmentisallowed.DonotremovetheEnCor UltraTM Breast Biopsy System housing. Removal of the housing may

cause electrical shock. Contact Bard for service. 7. The EnCor UltraTMBreastBiopsySystemisnotclassifiedasanAPorAPGclassifieddevice.Thesystemisnotsuitableforuseinthepresenceof

flammableanesthetic.

E. PRECAUTIONS1. This equipment should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle techniques. 2. Locate the EnCor UltraTM Breast Biopsy System as far as possible from other electronic equipment to minimize interference.3. Inspectaccessoriesandcordsforbreaks,cracks,nicks,orotherdamagebeforeeveryuse.Ifdamaged,donotuse.Failuretoobservethisprecautionmay

result in injury or electrical shock to the patient or to the operator.4. Inspecttubingconnectionstothevacuumcanisterandthevacuumtubingtoensurepropervacuumlevelsareachievedandmaintained

during use. 5. Inspectthevacuumcanistertoensurethelidissecureandthatnodamagehasoccurredduringshippingorinstallation.Aheavilyscratchedcanistercan

break during use.6. Do not leave the EnCor UltraTM Breast Biopsy System powered on overnight. Damage may occur to the vacuum tubing.7. Connect the power cord to a hospital grade wall outlet having the correct voltage or product damage may result. 8. Patients who may have a bleeding disorder or who are receiving anticoagulant therapy may be at increased risk of complications.9. As with any biopsy instrument, there is a potential for infection.10.Allbreastbiopsiesshouldbeperformedunderimagingguidancetoconfirmtheprobepositionrelativetothetargetregiontobesampledandtohelp

mitigate the occurrence of a false negative biopsy. 11. WhenperformingabiopsywithEnCor® probes, the orientation of the sample notch is dictated by the image guidance selected. Prior to initiating the

procedure,confirmthatthesamplenotchorientationiscorrectfortheimageguidancebeingused.12. Ensure that the EnCor UltraTMBreastBiopsySystemispositionedinsuchawaythatthepowercordandretainerareaccessible.Intheeventthatthe

system power switch is inoperable, release retainer and remove cord to shut off system power.

ENGLISH

2

F. POTENTIAL COMPLICATIONS1. Potentialcomplicationsarethoseassociatedwithanypercutaneousremoval/biopsytechniquefortissuecollection.Potentialcomplicationsarelimitedtothe

region surrounding the biopsy site and include hematoma, hemorrhage, infection, a non-healing wound, pain and tissue adherence to the biopsy probe while removing it from the breast.

G. EQUIPMENT REQUIREDThe following equipment is required for a biopsy procedure:

• Appropriateimagingmodalityandaccessories• EnCor® Driver• EnCor® Probe• EnCor UltraTM Vacuum Tubing and Canister

• TissueMarker(optional)• Surgicalglovesanddrapes• Localanesthetic• Scalpel• Otherequipmentasnecessary

H. DIRECTIONS FOR USEUnpacking InstructionsCarefully remove the EnCor UltratM Breast Biopsy System from the packaging. Thoroughly inspect the packaging materials and the system for any signs of transit damage. Do not use the unit if it appears to have any damage. Contact Bard Customer Service for instructions on how to report shipping damage.

Figure 4 – EnCor UltratM System with Handle Figure 5 – EnCor UltratM System with Optional Tray

The EnCor UltratMBreastBiopsySystemisdeliveredassembled,withtheexceptionoftheoptionalproceduretray,whichisdetachedandsuppliedandpackaged separately. To attach the procedure tray, carefully remove the tray from the packaging. Unlock the rear handle from the system by pressing release button under the system as illustrated in Figure 6. Remove the handle, and replace with the procedure tray stand, aligning the legs of the tray stand into position as illustrated in Figure 7. Place the removal tray on top of the stand.

Figure 6 – Release button to attach the procedure tray. Figure 7 – Insert the procedure tray stand

Procedure SetupPriortotransportingthesystem,unlockthesystemcasters.Whentransportingthesystem,pushorpullusingthesystemhandle,orthehandlelocatedontheoptional tray stand. To transport the system outside of normal hospital conditions (e.g. outdoors or to another facility) use Bard supplied packaging.1. Position the EnCor UltratM Breast Biopsy System as required for safe use and plug the power cord (located on the rear of the console) into a hospital grade

wall outlet. a. The system includes four casters with locking brakes on the front casters. After the system is positioned, lock the casters as illustrated in Figure 8. b.Optional:ThetrayheightmaybeadjustedbyreleasingthelockingleveronthestandandadjustingthetrayupordownasillustratedinFigure 9.

Figure 8 – Locking the system casters Figure 9 – Adjusting the tray height

3

2. Connect the EnCor® driver to the rectangular connector on the side of the console illustrated in Figure 10.ReferencetheapplicabledriverInstructionsforUseforfurtherinformationofdriversetup.Ifdesired,connecttheappropriatefootpedaltotheconnectorontherearoftheconsoleasillustratedinFigure 11.

Figure 10– Install the EnCor® driver to the rectangular connector on the side of the console

Figure 11 – Optional - Install the EnCor® footswitch to the round connector on the rear of the console

Figure 12 – Turn on the EnCor UltraTM system using the power switch located on the display panel

3. Turn the system on via the power switch on the display panel as illustrated in Figure 12.

4. InstallthevacuumtubingbyloadingtheT-connection,thenthreadingthroughtheVentcontrolandVacuumcontrolasillustratedinFigure13.Install the vacuum canister by placing the canister in the designated location. Attach the system tubing to the VACUUM port, and the disposable EnCor UltratM Vacuum tubingtothePATIENTport.Afterinstallingthevacuumcomponents,thesystemdoormaybeclosedtoconcealthecomponentsduringthebiopsyprocedure.

5.Allowthesystemtoinitialize.Whenthesystemisreadytocalibrate, theREADYLEDwillflashGREEN.Installandcalibratethebiopsyprobe. ReferencetheapplicableprobeInstructionsforUseforfurtherinformation on probe setup. After the probe calibration is complete, the READY will be solidGREEN.TheLEDsareillustratedinFigure15.Referencethe Troubleshooting section to address any alerts that occur during initialization and probe calibration.

Figure 13 – Installing the Vacuum Tubing and Canister Figure 14 – The EnCor UltraTM system door may be closed during the biopsy to conceal the vacuum components

Figure 15 – System Display

4

6. Complete the biopsy procedure per the “Directions for Use” section of the EnCor®DriverInstructionsforUse.7. The EnCor UltraTM Breast Biopsy System status is indicated on the display panel (Figure 15).

a.Tochangethesamplemodefromnormaltissuetodensetissue,presstheDENSEtissuebuttonasillustratedinFigure 15. The button will illuminate GREENwhen“densetissue”samplingisselected.PresstheDENSEtissuebuttonagaintoreturntonormaltissuesampling.

After Use8. Remove disposables and discard per your facility’s procedures. Clean and disinfect the system hardware per the instructions located under the cleaning and

maintenance section. Note:Thesystemmaybeleftonifadditionalproceduresaretobeperformed;itisnotrecommendedtoleavethemainpoweronovernight.Itisnot

recommended to unplug the drivers after each use. The drivers and foot pedal may be left connected to the EnCor UltraTM Breast Biopsy system if all procedures are to be performed with the same drivers.

9. To turn off the system, press and hold the switch on the front of the console (illustrated in Figure 12) until the system shuts down.

I. CLEANING AND MAINTENANCETo clean the EnCor UltraTM Breast Biopsy System, turn off power and disconnect the power cord from the AC outlet. Leave all other cables connected. Clean all exposedsurfacesoftheEnCor UltraTM Breast Biopsy System, cables, and foot pedal with a soft, lint-free cloth dampened with a cleaning solution such as those recommended in the table below. Follow the procedures approved by your facility or use a validated infection control procedure. Always follow the instructions provided by the manufacturer of the cleaner or disinfectant used.

Recommended Cleaning Solutions

IsopropylAlcohol

Dispatch® Hospital Disinfectant

Sani-clothDisinfectantWipes

CaviWipesDisinfectantWipes

CidexDisinfectant

DonotuseabrasivecleanersorsprayanyfluidsdirectlyontoanypartoftheEnCor UltraTM Breast Biopsy System or cables. Spraying the system may cause it to malfunction and will void the warranty.

Do not submerge any component of the EnCor UltraTMBreastBiopsySysteminfluids.Submerginginfluidsmaycausethesystemtomalfunctionandwill voidthewarranty.Sterilizationandexposuretofluidsmaydamagetheelectricalcomponentsofthedevice.Ifthesystemisinappropriatelycleaneditmay cause the system to malfunction and will void the warranty. Do not autoclave any components of the EnCor UltraTM Breast Biopsy System. Do not heat over 54°C (129°F).

Disposal of Equipment

After following the cleaning recommendations above, there are no biohazard risks involved with the disposal of the EnCor UltraTM Breast Biopsy System or any of the reusable accessories at the end of the EnCor UltraTMBreastBiopsySystem’suseablelifeperWasteofElectricalandElectronicEquipment (WEEE)directive[Directive2002/96/EC].DisposeofanysingleusedevicepertheInstructionsforUseforthedisposabledevice.

Do not dispose of the EnCor UltraTM Breast Biopsy System by placing into trash receptacles.

Routine Maintenance

NocalibrationsoradjustmentsarenecessaryfortheEnCor UltraTM Breast Biopsy System outside of normaluse.Inaddition,thefollowingroutinemaintenanceactivitiesmaybecompleted:

Electrical safety testing should be performed at intervals no greater than 12 months, using a standard medical safety analyzer.

Regularly inspect all cables and connectors for possible wear or damage.

OdorControlFilterReplacement

TurnthePowerSwitchtooff.RemovetheoldOdorControlFilterbyrotatingitcounter-clockwiseanddiscard.InstallthenewOdorControlFilter(F3000)byrotatingclockwiseuntilsnug.ThelocationoftheOdorControlFilterisidentifiedinFigure 16.

Fuse Replacement

The fuse holder is accessible after the power cord is removed. Unplug the EnCor UltraTM Breast Biopsy System from the wall outlet, and remove the power cord from the power inlet connector on the rear panel of the console. Using a small slotted screwdriver, press the release tab located near the center of the fuse holder. Pull the fuse holder assembly outward to remove it. Use Fuse Kit ModelNumberFK4000.Installthefuseholder,asillustratedinFigure 17. Remove and replace any blown fuses in the fuse holder assembly, and snap it back into place. The fuse holder orientation determines the voltage. Figure 17 illustrates the 115V orientation. Rotate the fuse 180 degrees for 230V orientation. Replace the fuse holder assembly, and reconnect the power cord to the power inlet connector.

J. TROUBLESHOOTINGThe EnCor UltraTM Breast Biopsy System will display any alert conditions that occur on the front display panel illustrated in Figure 15.

Depending on the cause of the alert, different actions may be required to clear the alert. Certain alert conditions, when corrected, allow the system to recover automatically, andreturntoareadystate.Otheralertsrequirepressingabuttononthedisplaypaneltoclear.Ifadriverisconnectedandisthecauseofthealert,followthetroubleshootinginstructions in the EnCor® DriverInstructionsforUsetoclearthealert.

Some conditions may require the user to clear the alert condition by turning off main power using the power switch on the display panel (illustrated in Figure 12).Wait20seconds, and turn the main power back on, and restart the EnCor UltraTM Breast Biopsy System with the power switch on the display panel (illustrated in Figure 12).

Ifanyalertconditionpersistsaftercorrectingknownproblemsandclearingthealertconditionusingthedisplaypanel,contactBardforservice.

Figure 17

Figure 16

5

LED Status System Status and Troubleshooting

READY light is FLASHING GREEN ReadytoCalibrateProbe.InstallprobeandpressSAMPLE on the driver or footswitch to continue.

READY light is SOLID GREEN System is ready to perform biopsy. Complete the biopsy procedure per the “Directions for Use” section of the EnCor® Driver InstructionsforUse.

PROBE light is ORANGE There is a probe error. Remove the probe to continue. After the system has reset, re-install the probe and press SAMPLE on the driver or footswitch to continue. NOTE: The EnCor Ultra™ system may only use EnCor® probes and is not compatible with EnCor®MRIorEnCor® 360 probes.

RESET VACUUM light is ORANGE There is a vacuum error. Check and secure the tubing and canister connections. Check for pinched tubing. Ensure the vacuum tubing is loaded properly. Press the RESET VACUUM button to continue. Iftheproblempersists,replacethedisposablecomponents.NOTE: The EnCor Ultra™ system may only use EnCor Ultra™ vacuum canisters and vacuum tubing.

SYSTEM light is ORANGE Thereisasystemordrivererror.Restartthesystem.Iftheproblempersists,removeandconnectadifferentdriver.

DENSE light is GREEN “Densetissue”samplingisselected.ToturnOFF“densetissue”sampling,presstheDENSE button.

DENSE light is OFF “Densetissue”samplingisNOTselected.ToturnON“densetissue”sampling,presstheDENSE button.

K. SPECIFICATIONSEnvironmental Conditions Operatethedeviceinambientconditions(between15ºCto25ºC,30%to75%relativehumidityand700to1060hPaatmosphericpressure).

Transportandstoreinacooldryplacebetween-20ºCto+60ºC,10%to90%relativehumidityand500to1060hPaatmosphericpressure.

IngressofWater Notprotectedagainsttheingressofwater.IPX0.

Flammability Equipmentnotsuitableforuseinthepresenceofflammableanesthetic.

Dimensions 20inx13inx14in(0.5mx0.3mx0.4m)

Weight 50 lbs (23 kgs)

SPECIFICATIONSSystem Power Ratings Maximum:

100-120VAC,600VA,50/60Hz,3-wire,groundedwithremovablepowercord220-240VAC,600VA,50/60Hz,3-wire,groundedwithremovablepowercord

Electrical Conformity Thismedicalequipmenthaspassedallrequiredtestingforelectricshock,fireandmechanicalhazardsinaccordancewithUL60601-1,IEC/EN60601-1,CAN/CSAC22.2No601-1.

Classification ClassI,TypeBFequipment.

Nominal Ratings Standby Nominal Ratings Operating

Voltage/Frequency 115 VAC ~ 50/60 Hz230 VAC ~ 50/60 Hz

Voltage/Frequency 115 VAC ~ 50/60 Hz230 VAC ~ 50/60 Hz

Current 4 Current 4

VA (Calculated) 600 VA (Calculated) 600

Watts 450 Watts 450

Power factor 0.75 Power factor 0.75

Electromagnetic Emissions and ImmunityMedical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below.

Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.

Guidance and Manufacturer’s Declaration – EmissionsAll Equipment and Systems

Guidance and Manufacturer’s Declaration - Emissions

The EnCor UltraTMBreastBiopsySystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.TheuseroftheEnCor UltraTM Breast Biopsy System should ensure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment – Guidance

RF Emissions CISPR11

Group1,ClassA The EnCor UltraTM Breast Biopsy System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

HarmonicsIEC61000-3-2

Class A - Complies The EnCor UltraTM Breast Biopsy System is suitable for use in all establishments, other than domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

FlickerIEC61000-3-3

Complies

Guidance and Manufacturer’s Declaration – ImmunityAll Equipment and Systems

Guidance and Manufacturer’s Declaration – Immunity

The EnCor UltraTMBreastBiopsySystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.TheuseroftheEnCor UltraTM Breast Biopsy System should ensure that it is used in such an environment.

6

Immunity Test EN/IEC 60601 Test Level Compliance Level

Electromagnetic Environment – Guidance

ESDEN/IEC61000-4-2 ±2kV, ±4kV, ±6kV Contact discharge ±2kV, ±4kV, ±6kV, ±8kV Air discharge

Pass Floorsshouldbewood,concreteorceramictile.Iffloorsaresynthetic,ther/hshouldbeatleast30%

EFTEN/IEC61000-4-4 ±2kVMains±1kVI/Os Pass Mains power quality should be that of a typical commercial or hospital environment.

SurgeEN/IEC61000-4-5 ±1kV Differential±2kV Common

Pass Mains power quality should be that of a typical commercial or hospital environment.

VoltageDips/DropoutEN/IEC61000-4-11

>95%Dipfor0.5Cycle

60%Dipfor5Cycles

30%Dipfor25Cycles

>95%Dipfor5Seconds

Pass

Pass

Pass

Pass

Mains power quality should be that of a typical commercial or hospitalenvironment.IftheuseroftheEnCor UltraTM Breast Biopsy System requires continued operation during power mains interruptions, it is recommended that the EnCor UltraTM Breast Biopsy System be powered from an uninterruptible power supply or battery.

PowerFrequency50/60HzMagneticFieldEN/IEC61000-4-8

3A/m Pass Powerfrequencymagneticfieldsshouldbethatofatypicalcommercial or hospital environment.

Guidance and Manufacturer’s Declaration – EmissionsEquipment and Systems that are NOT Life-supporting

Guidance and Manufacturer’s Declaration – Emissions

The EnCor UltraTMBreastBiopsySystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.TheuseroftheEnCor UltraTM Breast Biopsy System should ensure that it is used in such an environment.

Immunity Test EN/IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance

ConductedRFEN/IEC61000-4-6RadiatedRFEN/IEC61000-4-3

3 Vrms 150 kHz to 80 MHz 3V/m80MHzto2.5GHz

Pass Pass

Portable and mobile communications equipment should be separated from the EnCor UltraTM Breast Biopsy System by no less than the distances calculated/listedbelow:

D=(3.5/V1)(√P)

D=(3.5/E1)(√P)80to800MHz

D=(7/E1)(√P)800MHzto2.5GHz

wherePisthemaxpowerinwattsandDistherecommendedseparationdistance in meters.

Fieldstrengthsfromfixedtransmitters,asdeterminedbyanelectromagneticsite survey, should be less than the compliance levels (V1 and E1).

Interferencemayoccurinthevicinityofequipmentcontainingatransmitter.

Recommended Separation Distances between portable and mobile RF Communications equipment and the EnCor UltraTM Breast Biopsy SystemEquipment and Systems that are NOT Life-supporting

Recommended Separations Distances for the EnCor UltraTM Breast Biopsy System

The EnCor UltraTM Breast Biopsy System is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the EnCor UltraTM Breast Biopsy System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the EnCor UltraTMBreastBiopsySystemasrecommendedbelow,accordingtothemaximumoutputpowerofthecommunicationsequipment.

Max Output Power (Watts) Separation (m) 150kHz to 80MHz D=(3.5/V1)(√P)

Separation (m) 80 to 800MHz D=(3.5/E1)(√P)

Separation (m) 800MHz to 2.5GHz D=(7/E1)(√P)

0.01 .1166 .1166 .2333

0.1 .3689 .3689 .7378

1 1.1666 1.1666 2.3333

10 3.6893 3.6893 7.3786

100 11.6666 11.6666 23.3333

Cable Length

Cable Length

ACPowerCord(PC3100/PC3200/PC3300/PC3400/PC3500/PC3600) 12ft(US)/2.5m(International)

Equipotential Post:ThepurposeoftheIndustryStandardEquipotentialPostontherearoftheEnCor UltraTM Breast Biopsy System is to provide a connection point to reduce the possibilityofvoltagepotentialsbetweentouchableconductivepartsofallthedifferentMedicalEquipmentSystemswithinthePatientandOperatorarea.

To connect the EnCor UltraTMBreastBiopsySystemtoanEquipotentialNetwork,snaptheEquipotentialNetworkSocketovertheEquipotentialPostontherearof the EnCor UltraTM Breast Biopsy System base unit. To remove The EnCor UltraTMBreastBiopsySystemfromtheEquipotentialNetwork,pulltheequipotentialNetworkSocketofftheEquipotentialPost.

7

L. HOW SUPPLIED

The EnCor UltraTMBreastBiopsySystemissuppliednon-sterileandshouldbecleanedpriortofirstusepertheCleaningandMaintenanceinstructions.

• EnCor®driversaresoldseparately.Thedriversaresuppliednon-sterile.ReferencetheInstructionsforUseincludedwitheachdriverforCleaningandMaintenance instructions.

• TheEnCor Ultra™ Vacuum Canister, EnCor Ultra™ Vacuum Tubing, and EnCor® probes are sold separately. The EnCor® probes are supplied sterile. The vacuum canister, vacuum tubing, and probes are for single use only.

M. REFERENCESIU0072(EnCor® driver and probe IFU)andIU0073(EnCor® MRIdriverandprobeIFU)

N. WARRANTYBardPeripheralVascularwarrantstothefirstpurchaserofthisproductthatthisproductwillbefreefromdefectsinmaterialsandworkmanshipforaperiodofoneyearfromthedateoffirstpurchaseandliabilityunderthislimitedproductwarrantywillbelimitedtorepairorreplacementofthedefectiveproduct,inBardPeripheralVascular’ssolediscretionorrefundingyournetpricepaid.Wearandtearfromnormaluseordefectsresultingfrommisuseofthisproductarenotcovered by this limited warranty.

TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL BARD PERIPHERAL VASCULAR BE LIABLE TO YOU FOR ANY INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM YOUR HANDLING OR USE OF THIS PRODUCT.

Somestates/countriesdonotallowanexclusionofimpliedwarranties,incidentalorconsequentialdamages.Youmaybeentitledtoadditionalremediesunderthelawsofyourstate/country.

Extendedwarrantyserviceagreementsareavailable.ConsultaBardrepresentativefordetailsregardingtermsandconditions.

Anissueorrevisiondateandarevisionnumberfortheseinstructionsareincludedfortheuser’sinformationonthelastpageofthisbooklet.Intheevent 36monthshaveelapsedbetweenthisdateandproductuse,theusershouldcontactBardPeripheralVascular,Inc.toseeifadditionalproductinformation is available.

ManufacturerType BF Applied Part Catalogue Number

Date Of Manufacture Serial Number Non-Sterile

Do Not Re-Sterilize Do Not Immerse Device In Fluids Wipe With Damp Cloth

Fuse Inside Do Not Spray Fluids Directly Into The Device Quality Assurance Seal at Intertek

1060 hPa

500 hPa

Atmospheric Pressure LimitationDo Not Use If Package Is Damaged Consult Instructions for Use

90%

10%

60º C

-20º C

Humidity Limitation Temperature Limitation Contents

Dangerous Voltage Equipotential Single Use

Ethernet PortFoot Pedal Contains or presence of Phthalates

Copyright © 2013 C.R. Bard, Inc. All rights reserved.

Only For Use Indoors/Do Not Use Outdoors Do not dispose of the device by placing into trash receptacles

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician

Attention: Ground Reliability can only be achieved when equipment is connected to a receptacle marked “HOSPITAL ONLY” or “HOSPITAL GRADE”. For Canada and USA only

Bard, SenoRx, EnCor and EnCor Ultra aretrademarks and/or registered trademarks of C.R.Bard,Inc.oranAffiliate

PK1320500Rev.006/13

Manufacturer:SenoRx, Inc.1625West3rdStreetTempe, AZ 85281USATEL: 1-480-894-9515 1-800-321-4254FAX: 1-480-966-7062

1-800-440-5376www.bardbiopsy.com