Bd Elevation User manual

Device description

The BD EleVation™ Breast Biopsy System is a handheld, self-

contained, single insertion, multiple sample biopsy device and is

intended to be used with ultrasound guidance.

Loading and locking the BD EleVation™

Probe into the BD EleVation™ Driver

Step 1: Insert probe

The BD EleVation™ Probe may be inserted into the driver in either of

the following ways:

OPTION 1: Remove the BD EleVation™ probe from the package

using aseptic technique by grasping the BD EleVation™ probe from

below. Carefully align BD EleVation™ probe tabs and sample

container with corresponding BD EleVation™ Driver slots. Slide the

BD EleVation™ probe back to lock into place.

OPTION 2: While the BD EleVation™ Probe remains in the tray

packaging, align the BD EleVation™ Driver to the corresponding

BD EleVation™ Probe tabs and sample container opening. Slide the

BD EleVation™ Driver forward to lock into place.

Step 2: Locking the probe

After loading the probe in one of the following ways shown above,

conﬁrm the BD EleVation™ Probe tab is locked into the BD EleVation™

Driver after loading.

Removing the sample

Turn the sample container counterclockwise to remove from the

driver.

Remove the tissue samples from the sample container by hinging

it open. If additional samples are required, replace the sample

container into the device by turning clockwise to lock into place.

Ensure the sample container is secure before acquiring additional

samples.

Removing the cannula

The support cannula may be detached and remain in the breast to

retain a track to the biopsy site to place a breast tissue marker. To

remove the support cannula from the BD EleVation™ probe, depress

the coaxial arm and then twist the coaxial hub.

Sample container

closed

Sample container

hinges open

Removing the probe

Remove the BD EleVation™ Probe from the BD EleVation™ Driver

by pressing down on the locking tab, sliding the BD EleVation™

Probe cover completely forward and then pulling the BD EleVation™

Probe straight up from the BD EleVation™ Driver.

Cleaning and maintenance

• After each use, wipe the BD EleVation™ Driver with a Super

Sani-Cloth or a cloth dampened with water to remove any excess

blood or ﬂuids present on the device.

Following the initial wipe, throughly clean the BD EleVation™

Driver with Super Sani-Cloths, paying particular attention to the

buttons and indicators, locking tab, LED lights, internals gears,

and the sides of the driver. Allow the driver to remain wet for a

minimum of 3 minutes.

Allow the BD EleVation™ Driver to air dry throughly before

placing in the wireless charging stand.

• Other than routine cleaning, no other preventative maintenance

is required. However, it is recommended to return the device

to an authorized Service and Repair Facility once per year for

inspection and servicing.

• Do not spray the BD EleVation™ Driver with any ﬂuids.

Submerging the BD EleVation™ Driver in ﬂuids may cause it to

malfunction and will void the standard warranty.

• Sterilization and exposure to ﬂuids may damage the electrical

components of the device. If the BD EleVation™ Driver is

inappropriately cleaned, it may cause the BD EleVation™ Driver

to malfunction and will void the standard warranty.

• Do not autoclave. Do not heat over 54 (129 F).

• The wireless charging stand may be cleaned with the same

methods as the BD EleVation™ Driver.

Quick Reference Guide

Inner needle with

sample notch

Echogenic marking

Cutting cannula

Support cannula

Battery LED

Error LED

Smart Mode LED

Prime/Pierce

Sample

Sample container

10cm

TriConcave™ Tip

BD EleVationTM

Breast Biopsy System

Device description

The BD EleVation™ Breast Biopsy System is a handheld, self-

contained, single insertion, multiple sample biopsy device and is

intended to be used with ultrasound guidance.

Loading and locking the BD EleVation™

Probe into the BD EleVation™ Driver

Step 1: Insert probe

The BD EleVation™ Probe may be inserted into the driver in either of

the following ways:

OPTION 1: Remove the BD EleVation™ probe from the package

using aseptic technique by grasping the BD EleVation™ probe from

below. Carefully align BD EleVation™ probe tabs and sample

container with corresponding BD EleVation™ Driver slots. Slide the

BD EleVation™ probe back to lock into place.

OPTION 2: While the BD EleVation™ Probe remains in the tray

packaging, align the BD EleVation™ Driver to the corresponding

BD EleVation™ Probe tabs and sample container opening. Slide the

BD EleVation™ Driver forward to lock into place.

Step 2: Locking the probe

After loading the probe in one of the following ways shown above,

conﬁrm the BD EleVation™ Probe tab is locked into the BD EleVation™

Driver after loading.

Removing the sample

Turn the sample container counterclockwise to remove from the

driver.

Remove the tissue samples from the sample container by hinging

it open. If additional samples are required, replace the sample

container into the device by turning clockwise to lock into place.

Ensure the sample container is secure before acquiring additional

samples.

Removing the cannula

The support cannula may be detached and remain in the breast to

retain a track to the biopsy site to place a breast tissue marker. To

remove the support cannula from the BD EleVation™ probe, depress

the coaxial arm and then twist the coaxial hub.

Sample container

closed

Sample container

hinges open

Removing the probe

Remove the BD EleVation™ Probe from the BD EleVation™ Driver

by pressing down on the locking tab, sliding the BD EleVation™

Probe cover completely forward and then pulling the BD EleVation™

Probe straight up from the BD EleVation™ Driver.

Cleaning and maintenance

• After each use, wipe the BD EleVation™ Driver with a Super

Sani-Cloth or a cloth dampened with water to remove any excess

blood or ﬂuids present on the device.

Following the initial wipe, throughly clean the BD EleVation™

Driver with Super Sani-Cloths, paying particular attention to the

buttons and indicators, locking tab, LED lights, internals gears,

and the sides of the driver. Allow the driver to remain wet for a

minimum of 3 minutes.

Allow the BD EleVation™ Driver to air dry throughly before

placing in the wireless charging stand.

• Other than routine cleaning, no other preventative maintenance

is required. However, it is recommended to return the device

to an authorized Service and Repair Facility once per year for

inspection and servicing.

• Do not spray the BD EleVation™ Driver with any ﬂuids.

Submerging the BD EleVation™ Driver in ﬂuids may cause it to

malfunction and will void the standard warranty.

• Sterilization and exposure to ﬂuids may damage the electrical

components of the device. If the BD EleVation™ Driver is

inappropriately cleaned, it may cause the BD EleVation™ Driver

to malfunction and will void the standard warranty.

• Do not autoclave. Do not heat over 54 (129 F).

• The wireless charging stand may be cleaned with the same

methods as the BD EleVation™ Driver.

Quick Reference Guide

Inner needle with

sample notch

Echogenic marking

Cutting cannula

Support cannula

Battery LED

Error LED

Smart Mode LED

Prime/Pierce

Sample

Sample container

10cm

TriConcave™ Tip

BD EleVationTM

Breast Biopsy System

Device description

The BD EleVation™ Breast Biopsy System is a handheld, self-

contained, single insertion, multiple sample biopsy device and is

intended to be used with ultrasound guidance.

Loading and locking the BD EleVation™

Probe into the BD EleVation™ Driver

Step 1: Insert probe

The BD EleVation™ Probe may be inserted into the driver in either of

the following ways:

OPTION 1: Remove the BD EleVation™ probe from the package

using aseptic technique by grasping the BD EleVation™ probe from

below. Carefully align BD EleVation™ probe tabs and sample

container with corresponding BD EleVation™ Driver slots. Slide the

BD EleVation™ probe back to lock into place.

OPTION 2: While the BD EleVation™ Probe remains in the tray

packaging, align the BD EleVation™ Driver to the corresponding

BD EleVation™ Probe tabs and sample container opening. Slide the

BD EleVation™ Driver forward to lock into place.

Step 2: Locking the probe

After loading the probe in one of the following ways shown above,

conﬁrm the BD EleVation™ Probe tab is locked into the BD EleVation™

Driver after loading.

Removing the sample

Turn the sample container counterclockwise to remove from the

driver.

Remove the tissue samples from the sample container by hinging

it open. If additional samples are required, replace the sample

container into the device by turning clockwise to lock into place.

Ensure the sample container is secure before acquiring additional

samples.

Removing the cannula

The support cannula may be detached and remain in the breast to

retain a track to the biopsy site to place a breast tissue marker. To

remove the support cannula from the BD EleVation™ probe, depress

the coaxial arm and then twist the coaxial hub.

Sample container

closed

Sample container

hinges open

Removing the probe

Remove the BD EleVation™ Probe from the BD EleVation™ Driver

by pressing down on the locking tab, sliding the BD EleVation™

Probe cover completely forward and then pulling the BD EleVation™

Probe straight up from the BD EleVation™ Driver.

Cleaning and maintenance

• After each use, wipe the BD EleVation™ Driver with a Super

Sani-Cloth or a cloth dampened with water to remove any excess

blood or ﬂuids present on the device.

Following the initial wipe, throughly clean the BD EleVation™

Driver with Super Sani-Cloths, paying particular attention to the

buttons and indicators, locking tab, LED lights, internals gears,

and the sides of the driver. Allow the driver to remain wet for a

minimum of 3 minutes.

Allow the BD EleVation™ Driver to air dry throughly before

placing in the wireless charging stand.

• Other than routine cleaning, no other preventative maintenance

is required. However, it is recommended to return the device

to an authorized Service and Repair Facility once per year for

inspection and servicing.

• Do not spray the BD EleVation™ Driver with any ﬂuids.

Submerging the BD EleVation™ Driver in ﬂuids may cause it to

malfunction and will void the standard warranty.

• Sterilization and exposure to ﬂuids may damage the electrical

components of the device. If the BD EleVation™ Driver is

inappropriately cleaned, it may cause the BD EleVation™ Driver

to malfunction and will void the standard warranty.

• Do not autoclave. Do not heat over 54 (129 F).

• The wireless charging stand may be cleaned with the same

methods as the BD EleVation™ Driver.

Quick Reference Guide

Inner needle with

sample notch

Echogenic marking

Cutting cannula

Support cannula

Battery LED

Error LED

Smart Mode LED

Prime/Pierce

Sample

Sample container

10cm

TriConcave™ Tip

BD EleVationTM

Breast Biopsy System

BD EleVation™ Breast Biopsy System

Indications for use 1. The BD EleVation™ Breast Biopsy System is indicated to obtain tissue

samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.

The BD EleVation™ Breast Biopsy System is intended to provide breast tissue for histologic

examination with partial or complete removal of the imaged abnormality. 2. The extent of

histologic abnormality cannot be reliably determined from its mammographic appearance.

Therefore, the extent of removal of the imaged evidence of an abnormality does not predict

the extent of removal of a histologic abnormality, e.g. malignancy. When the sampled

abnormality is not histologically benign, it is essential that the tissue margins be examined

for completeness of removal using standard surgical procedures.

Contraindications 1. The BD EleVation™ Breast Biopsy System is for diagnostic use only,

NOT for therapeutic use. 2. The BD EleVation™ 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.

Warnings 1. Patients who may have a bleeding disorder, or who are receiving anticoagulant

therapy, may be at increased risk of complications. 2. As with any biopsy instrument, there is a

potential risk for infection. 3. The BD EleVation™ Breast Biopsy System should not be used in a

Magnetic Resonance Imaging (MRI) Suite. 4. The BD EleVation™ Breast Biopsy System has not

been tested using stereotactic guidance or for use with an MRI. 5. The BD EleVation™ Breast

Biopsy System should not be used in an operating room. 6. The BD EleVation™ Breast Biopsy

System is not classiﬁed as an AP or APG device. 7. The BD EleVation™ Breast Biopsy System is

not suitable for use in the presence of ﬂammable anesthetic. 8. The BD EleVation™ Breast Biopsy

System is not suitable for use in an oxygen rich environment. 9. The BD EleVation™ Driver must

only be used with BD EleVation™ Probes and BD EleVation™ Accessories. 10. All breast biopsies

should be performed under ultrasound guidance to conﬁrm the BD EleVation™ Probe’s position

relative to the target region to be sampled and to help mitigate the occurrence of a false

negative biopsy. The BD EleVation™ Breast Biopsy System is intended for use with ultrasound

imaging only. 11. The battery may only be replaced or disposed of by an authorized Service and

Repair facility. 12. Use only with supplied AC power BD EleVation™ Accessories. Removing the AC

adapter plug from wall power shall serve as isolation means. Do not position the AC adapter plug

and wireless charging stand such that it is dicult to remove the AC adapter plug from the wall

outlet if needed to remove mains power. 13. Do not reuse BD EleVation™ Probe. Reusing the BD

EleVation™ Probe bears the risk of cross-patient contamination as biopsy probes, particularly those

with long and small lumina, joints, and/or crevices between components, are dicult or impossible

to clean once body ﬂuids or tissues with potential pyrogenic or microbial contamination have

had contact with the BD EleVation™ Probe for an indeterminable period of time. The residue of

biological material can promote the contamination of the BD EleVation™ Probe with pyrogens or

microorganisms which may lead to infectious complications. 14. Do not resterilize BD EleVation™

Probe. After resterilization, the sterility of the BD EleVation™ Probe is not guaranteed because of

an indeterminable degree of potential pyrogenic or microbial contamination which may lead

to infectious complications. Cleaning, reprocessing and/or resterilizing the BD EleVation™ Probe

increases the probability that it will malfunction due to potential adverse eects on components

that are inﬂuenced by thermal and/or mechanical changes.

Precautions 1. The BD EleVation™ Breast Biopsy System should only be used by a physician

trained in its indicated use, limitations, and possible complications of percutaneous needle

techniques. 2. Do not attempt to remove the cover or modify the device in any way.

Potential Complications 1. 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, lymphedema, hemorrhage, infection, non-

healing wound, pain, nerve injury, and tissue adherence to the BD EleVation™ Probe while removing

it from the breast. 2. As per routine biopsy procedures, it may be necessary to cut tissue adhering to

the BD EleVation™ Probe while removing it from the breast.

Please consult product labels and instructions for use for indications,

contraindications, hazards, warnings and precautions and full directions for use.

BD EleVation™ Driver charging

Completely charge the BD EleVation™ Driver prior to ﬁrst use.

The battery must be adequately charged prior to beginning

each procedure.

To charge the BD EleVation™ Driver:

1. Ensure the appropriate AC adapter plug is installed on the

AC power adapter.

2. Connect the AC adapter cord to the wireless charging stand.

3. Connect the AC adapter plug into a power source. If the wireless

charging stand has current, the power light on the front of the

wireless charging stand will illuminate green.

4. Place the BD EleVation™ Driver in the wireless charging stand.

The BATTERY indicator on the BD EleVation™ Driver will

illuminate per the table to indicate the battery is charging.

Battery statusus

Battery indicator color Battery status Action required

Solid Green Battery is suciently charged to perform

biopsy procedure.

No action needed. BD EleVation™ Breast

Biopsy System is ready to perform a biopsy.

Blinking green Battery has sucient charge to complete

ONE biopsy procedure.

Proceed with performing the biopsy.

After completing the procedure the BD

EleVation™ Driver MUST be charged prior to

the next biopsy.

Solid Red Battery is NOT sucently charged to

perform a biopsy procedure.

Return BD Elevation™ Driver to charging

stand to charge battery.

Battery LED is not illuminated – Driver does

not respond when probe is loaded Battery is completely discharged. Return BD Elevation™ Driver to charging

stand to charge battery.

Troubleshooting

BD EleVation™ Breast Biopsy System Condition Action required

BATTERY indicator is

solid red Low battery • Place BD EleVation™ Driver on wireless

charging stand to charge battery

ERROR indicator blinks

red, PRIME/PIERCE and

SAMPLE buttons are

solid red

Error during:

• Calibration

• PRIME/PIERCE

• Sampling

• Remove BD EleVation™ Probe

• Place BD EleVation™ Driver on a ﬂat

surface with hand away from any

moving components

• Press SAMPLE button

ERROR indicator blinks red,

SMART MODE indicator

blinks red, PRIME/PIERCE

and SAMPLE buttons are

solid red

Smart Mode overloaded

• Remove BD EleVation™ Probe

• Place BD EleVation™ Driver on a ﬂat

surface with hand away from any

moving components

• Press SAMPLE button

BATTERY indicator blinks

red, ERROR indicator blinks

red, PRIME/PIERCE and

SAMPLE buttons are

solid red

BD EleVation™ Driver placed in wireless

charging stand while BD EleVation™ Probe is

loaded

• Remove BD EleVation™ Driver from

wireless charging stand

• Remove BD EleVation™ Probe

BATTERY indicator blinks

red, ERROR indicator blinks

red, PRIME/PIERCE and

SAMPLE buttons are

solid red

NOTE: Driver is also

beeping continuously

BD EleVation™ Driver placed in wireless

charging stand while in error

• Remove BD EleVation™ Driver from

wireless charging stand

• Remove BD EleVation™ Probe

• Place BD EleVation™ Driver on a ﬂat

surface with hand away from any

moving components

• Press SAMPLE button

are trademarks of Becton, Dickinson and Company or

its affiliates. All other trademarks are the property of

0121/6101 BD-26892

Time to charge the device from

zero to full battery charge

A completely exhausted battery will

require up to 12 hours to fully charge.

After every use, and when the driver is not

in use, the BD EleVation™ Driver should

remain in the charging stand.

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BD Switzerland Sarl

Terre Bonne Park – A4, Route De Crassier,

17, 1262 Eysins, Vaud, Switzerland

T: +41 21 556 3000 01467