BD EleVation User manual

Breast Biopsy System
Instructions for Use
Français - BD EleVation™ Système de biopsie mammaire
Mode d’emploi
Deutsch - BD EleVation™ Brustbiopsie-System
Gebrauchsanweisung
Italiano - BD EleVation™ Sistema per biopsia
della mammella
Istruzioni per l’uso
Español - BD EleVation™ Sistema de biopsia mamaria
Instrucciones de uso
Nederlands - BD EleVation™ Borstbiopsiesysteem
Gebruiksaanwijzing
Português - BD EleVation™ Sistema de Biopsia Mamária
Instruções de utilização
ǼȜȜȘȞȚțȐ%'(OH9DWLRQȈȪıIJȘȝĮȕȚȠȥȓĮȢȝĮıIJȠȪ
Οδηγίες χρήσης
Dansk - BD EleVation™ Brystbiopsisystem
Brugsanvisning
Svenska - BD EleVation™ bröstbiopsisystem
Bruksanvisning
Suomi - BD EleVation™ Rintabiopsiajärjestelmä
Käyttöohjeet
Norsk - BD EleVation™ Brystbiopsisystem
Bruksanvisning
Polski - BD EleVation™ System do biopsji piersi
Instrukcja użycia
Magyar - BD EleVation™ Emlőbiopszia-rendszer
Használati utasítás
Česky - BD EleVation™ Systém pro biopsii prsu
Návod k použití
Türkçe - BD EleVation™ Meme Biyopsi Sistemi
Kullanım Talimatları
Pусский - BD EleVation™ Система для биопсии
молочной железы
Инструкции по применению
Chinese - BD EleVation™ 乳房切片系統
使用說明
Korean - BD EleVation™ 유방 생검 시스템
사용 지침

3
Breast Biopsy System
Instructions for Use
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
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. The device can obtain
and store multiple samples with a single insertion of the BD EleVation™ Probe. The components of
the BD EleVation™ Breast Biopsy System are designed to operate safely when used together for
diagnostic sampling during a breast biopsy procedure. The device consists of a battery-powered,
reusable BD EleVation™ Driver and a disposable BD EleVation™ Probe with a usable needle length
of 10cm and a sample container.
1
2
3
4
5
1 - TriConcave™ Tip
2 - Inner needle with sample notch
3 - Echogenic markings
4 - Cutting cannula
5 - Support cannula
6 - Sample container
6
10cm
Figure 1
Table 1: Available BD EleVation™ Product Codes
Product
Code Product Gauge Size Support Cannula Color
Sample
Notch
Length
Probe
Length
EVDriver EleVation Driver For use with all BD
EleVation Probes N/A N/A N/A
EV10 10G Probe 10G White
2 cm 10 cmEV12 12G Probe 12G Blue
EV14 14G Probe 14G Green
EVH10 10G Half-Notch Support
Cannula
For use with 10G BD
EleVation™ Probes White
1 cm
N/A
EVH12 12G Half-Notch Support
Cannula
For use with 12G BD
EleVation™ Probes Blue
EVH14 14G Half-Notch Support
Cannula
For use with 14G BD
EleVation™ ProbesGreen
EV10S 10G Stylet For use with 10G BD
EleVation™ Probes White
N/A
EV12S 12G Stylet For use with 12G BD
EleVation™ Probes Blue
EV14S 14G Stylet For use with 14G BD
EleVation™ Probes Green
EVSC Additional Sample
Containers For use with all BD
EleVation™ Probes N/A
EVCover Instrument Cover
Indications for Use
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.
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.
ENGLISH

4
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 mains. 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.
Equipment Required
The following equipment is required for a biopsy procedure:
• Appropriate ultrasound imaging system and accessories
• BD EleVation™ Driver
• BD EleVation™ Probe
• Surgical gloves and drapes
• Local anesthetic
• Scalpel
• Other equipment as necessary
• Optional BD EleVation™ Accessories
Directions for Use
BD EleVation™ Driver Button and Indicator Operations
Figure 2
• The PRIME/PIERCE button initiates the optional prime/pierce sequence. Before being pressed,
the PRIME/PIERCE button will illuminate green. Once engaged, the PRIME/PIERCE button
will turn red until the priming position has been reached. The PRIME/PIERCE button will
illuminate green when the cutting cannula and inner needle have retracted 2cm. The user
can advance the inner needle approximately 2cm by pressing the PRIME/PIERCE button a
second time. Using ultrasound guidance, the BD EleVation™ Probe’s post-pierce position can
be verified. While the BD EleVation™ Breast Biopsy System is primed, the SAMPLE button is
deactivated until the device completes the PRIME/PIERCE sequence. Once this sequence has
been completed, both the PRIME/PIERCE and SAMPLE buttons will illuminate green.
Figure 3
• The SAMPLE button will acquire tissue samples while in the breast. The SAMPLE button will
illuminate green when ready and initiate the sampling sequence when pressed. After the
sampling sequence has been initiated, the SAMPLE button will illuminate red indicating
SMART
MODE
LED
PRIME
PIERCE
SAMPLE
ERROR
LED
BATTERY
LED
2cm
Pierced / Closed:
Echogenic Markings
Open:
Dead Space: 10G - 0.7cm
12G - 0.5cm
14G - 0.4cm
Primed:

5
the sample sequence is in operation. During this time, the PRIME/PIERCE button will be o
and deactivated. During the automatic sampling process, the vacuum is turned on. The BD
Elevation Probe’s cutting cannula is pulled back exposing the sample notch. The tissue is
drawn into the sample notch. The cutting cannula moves rotationally forward over the sample
notch to cut the sample. The tissue sample is transported to the sample container. The
BD EleVation™ Breast Biopsy System will automatically reset for the next sampling or piercing
sequence, at which point the buttons will illuminate green.
• Also located on the BD EleVation™ Driver are three indicators: ERROR, BATTERY, and SMART
MODE. The ERROR indicator visually and audibly informs the user that action is required for
the BD EleVation™ Breast Biopsy System to become operable. The BATTERY indicator visually
informs the user of the BD EleVation™ Driver’s charge state. The BD EleVationn™ Breast
Biopsy System features SMART MODE, which automatically engages when the BD EleVation
Driver motors need additional time to ensure the sample is cut and transported to the sample
container, and therefore sampling time may be extended.
Loading the BD EleVation™ Probe into the BD EleVation™ Driver
1. Ensure the BD EleVation™ Driver has been fully charged prior to inserting the BD EleVation™
Probe. The BATTERY indicator will illuminate green when there is sucient charge to perform
a biopsy procedure. The BD EleVation™ Driver should be charged overnight after daily use.
2. The BD EleVation™ Probe may be inserted into the driver in either of the following ways:
• Remove the BD EleVation™ Probe from the package using aseptic technique by grasping the
BD EleVation™ Probe from below and carefully aligning BD EleVation™ Probe tabs and sample
container with corresponding BD EleVation™ Driver slots and slide the BD EleVation™ Probe
back to lock into place.
Figure 4
• 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, and slide the
BD EleVation™ Driver forward to lock into place.
Figure 5
Ensure the BD EleVation™ Probe remains sterile throughout insertion into the BD EleVation™ Driver.
Confirm the BD EleVation™ Probe tab is locked into the BD EleVation™ Driver after loading.
Figure 6
NOTE: Check BD EleVation™ Probe and sterile BD EleVation™ Accessories packaging for broken
seals or any foreign material present during unpacking or set-up prior to use. Do not use if there is
a broken seal, damage to the sterile barrier, or foreign material.
NOTE: The BD EleVation™ Driver automatically recognizes when a BD EleVation™ Probe has been
properly inserted, and the BD EleVation™ Driver will perform a calibration to synchronize with the
BD EleVation™ Probe. All buttons will be disabled during the calibration process. Upon completion
of the calibration, the BD EleVation™ Driver’s PRIME/PIERCE and SAMPLE buttons illuminate green
to indicate the BD EleVation™ Probe is properly inserted. During the calibration process, the motors
may be audible. Calibration of the BD EleVation™ Breast Biopsy System takes up to approximately
10 seconds.
NOTE: Prior to the biopsy, remove the needle protector from the BD EleVation™ Probe.
Figure 7
NOTE: Corresponding sized BD EleVation™ Introducer Stylet to BD EleVation™ Probe may be used
to target the biopsy site under ultrasound-guided imaging. After creating a track to the biopsy site
and detaching the support cannula, the BD EleVation™ Probe may be inserted and attached to the
support cannula to obtain tissue samples.
NOTE: If the BD EleVation™ Driver is left undisturbed for 120 seconds after loading the BD
EleVation™ Probe, the BD EleVation™ Driver will enter a sleep mode to conserve battery charge.
During sleep mode, the PRIME/PIERCE and SAMPLE indicator lights will turn o and the buttons will
be deactivated. When the BD EleVation™ Driver is moved, a motion sensor is activated and the BD
EleVation™ Driver automatically turns on. The BD EleVation™ Driver will not enter sleep mode when
the BD EleVation™ Probe is primed.
Performing a Biopsy
1. Prepare the biopsy site using appropriate aseptic techniques and adequate local anesthesia.
Appropriate precautions should be followed for any percutaneous procedure (e.g. personal
protective gear such as gloves should be worn).
NOTE: The BD EleVation™ Breast Biopsy System has an integrated LED to facilitate visualization of
the biopsy site in procedure room.
2. Make a small incision or puncture the skin with a scalpel.
Optional: Prior to inserting the BD EleVation™ Probe into the breast, press the PRIME/PIERCE button
to retract the inner needle and cutting cannula 2cm. After inserting the BD EleVation™ Probe into
the breast, press the PRIME/PIERCE button a second time to advance the inner needle and cutting
cannula 2cm into the region of interest prior to taking the first tissue sample. (See Figure 3 for
dimensions.)
3. Using ultrasound imaging guidance, insert the BD EleVation™ Probe through the incision and
position the tip at the appropriate location:
a. If the lesion is going to be pierced: Position the tip of the BD EleVation™ Probe proximal at
the edge of the lesion.
b. If the lesion is not going to be pierced: Position the sample notch at the target region. See
Figure 3 for dimensions.

6
NOTE: Ultrasound image guidance should be used to confirm BD EleVation™ Probe position relative
to the target region to be sampled.
NOTE: Do not leave the BD EleVation™ Breast Biopsy System unattended with the BD EleVation™
Probe in the primed state.
NOTE: During the initial positioning of the BD EleVation™ Probe, it is possible to advance the
inner needle and cutting cannula into the tissue using the available PRIME/PIERCE option. During
subsequent samplings, the physician may wish to forego this step.
NOTE: The BD EleVation™ Probe may be primed for piercing while inside the patient if the needle
needs to be advanced to dense tissues or lesions.
4. Acquire sample by pressing the SAMPLE button. The sampling process proceeds automatically
a. BD EleVation™ Driver creates a vacuum
b. Cutting cannula of the BD EleVation™ Probe retracts to expose the sample notch
c. Tissue is drawn to the sample notch by vacuum
d. Cutting cannula advances to cut the tissue
e. Tissue is transported to the sample container by vacuum
During this process, the SAMPLE button continually illuminates red and the PRIME/PIERCE button is
deactivated. After the tissue sample is deposited into the sample container, the BD EleVation™ Breast
Biopsy System resets to acquire another sample, and the SAMPLE and PRIME/PIERCE buttons will
illuminate green.
NOTE: Do not twist the sample container or remove the sample container while acquiring tissue
samples. If the BD EleVation™ Breast Biopsy System detects an error related to the sample container
inhibiting the vacuum seal, the device will not work. To return the sample container into the BD
EleVation™ Driver, clear any tissue underneath the sample container or from the BD EleVation™ Probe
where the sample container is seated, insert the sample container back into the BD EleVation™ Probe
and twist clockwise to ensure the sample container is properly in place.
NOTE: The BD EleVation™ Half-Notch Support Cannula may be used for thin breasts and/or
superficial lesions. If utilized, the optional BD EleVation™ Half-Notch Support Cannula (Figure 7)
should be removed from the package using aseptic technique and replace the support cannula
included with the BD EleVation™ Probe. The BD EleVation™ Half-Notch Support Cannula will reduce
the length of the sample notch from 2cm to 1cm.
5. To acquire multiple samples, repeat Step 4 above.
NOTE: Collecting multiple tissue samples may help minimize the risk of a false negative biopsy.
6. 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.
Figure 8 Figure 9
To replace sample container To remove sample container
Figure 10
NOTE: Removal of the sample container during the sample sequence will result in loss of vacuum.
Figure 11
NOTE: Prior to removing the BD EleVation™ Probe from the breast, the support cannula may be
detached and remain in the breast to retain a track to the biopsy site to place a tissue marker.
NOTE: To remove the support cannula from the BD EleVation™ Probe, depress the coaxial arm and
twist the coaxial hub.
Figure 12
7. After obtaining the final tissue sample, remove the BD EleVation™ Probe from the breast and
care for the incision site as appropriate.
NOTE: If experiencing diculty removing the BD EleVation™ Probe from the breast, first detach
integrated support cannula. Then, holding the support cannula in place, remove BD EleVation™
Probe from breast.
NOTE: The sample container may be removed before or after the BD EleVation™ Probe is removed
from the BD EleVation™ Driver.
8. 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 (Figure 13).
Figure 13
9. The BD EleVation™ Probe, support cannula, sample container, and any BD EleVation™
Accessory used in this procedure is for single-use only. After use, these products may be a
potential biohazard. Handle and dispose of in accordance with accepted medical practice and
local, state, and federal laws and regulations. Dispose of sharps in designated sharps disposal
containers; these are single-use devices and therefore should be disposed appropriately, not
recapped or resterilized.
Dead Space
1cm
OpenClosed
Sample Container

7
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, internal
gears, and the sides of the driver (Figure 1). 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°C (129°F).
• The wireless charging stand may be cleaned with same methods as the BD EleVation™ Driver.
BD EleVation™ Driver Charging
The BD EleVation™ Driver utilizes a rechargeable lithium-ion battery. 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.
NOTE: Use only with supplied EM1012AVRS power accessories.
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 as shown in Figure 14. The
BATTERY indicator on the BD EleVation™ Driver will illuminate per the table below to indicate
the battery is charging.
Figure 14
Table 2: Battery Status
BATTERY Indicator Color Battery Status Action Needed
6ROLG*UHHQ %DWWHU\LVVXႈFLHQWO\
FKDUJHGWRSHUIRUPD
ELRSV\SURFHGXUH
1RDFWLRQQHHGHG%'
(OH9DWLRQ%UHDVW%LRSV\
6\VWHPLVUHDG\WRSHUIRUP
DELRSV\
%OLQNLQJ*UHHQ %DWWHU\KDVVXႈFLHQW
FKDUJHWRFRPSOHWH
21(ELRSV\SURFHGXUH
3URFHHGZLWKSHUIRUPLQJ
WKHELRSV\$IWHUFRPSOHWLQJ
WKHSURFHGXUHWKH%'
(OH9DWLRQ'ULYHU0867
EHFKDUJHGSULRUWRWKHQH[W
ELRSV\
5HG %DWWHU\LV127
VXႈFLHQWO\FKDUJHG
WRSHUIRUPDELRSV\
SURFHGXUH
5HWXUQ%'(OH9DWLRQ
'ULYHUWRFKDUJLQJVWDQGWR
FKDUJHEDWWHU\
%DWWHU\/('LVQRWLOOXPLQDWHG±'ULYHUGRHV
QRWUHVSRQGZKHQSUREHLVORDGHG
%DWWHU\LVFRPSOHWHO\
GLVFKDUJHG
5HWXUQ%'(OH9DWLRQ
'ULYHUWRFKDUJLQJVWDQGWR
FKDUJHEDWWHU\
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. A regulator restricts overcharging the battery.
Do not place the BD EleVation™ Driver in the charging stand while the BD EleVation™ Probe is
loaded.
Troubleshooting
The BD EleVation™ Driver will display any alert conditions that occur on the LED keypad illustrated
in Figure 2. Most alert conditions may be reset by removing the probe and pressing the SAMPLE
button. Reference the table below for specific troubleshooting steps. If any alert condition persists
after correcting known problems and replacing the BD EleVation™ Probe, contact an authorized
service representative.
NOTE: If the BD EleVation™ Breast Biopsy System error and troubleshooting action is not covered
in Table 3, please contact your authorized representative for further assistance.
Table 3: 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

8
Table 3: Troubleshooting
BD EleVation™
Breast Biopsy System Condition Action Required
ERROR indicator blinks red, PRIME/PIERCE and
SAMPLE buttons are solid red
Error during:
- Calibration
- PRIME/
PIERCE
- Sampling
- Remove the 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
ERROR indicator blinks red, BATTERY 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
Table 4: Specifications
Environmental
Conditions – Storage
Transport and store in a cool dry place.
Temperature: -18ºC to + 40ºC
Humidity: 10% - 90%
Atmospheric Pressure: 500 hPa - 1060 hPa
Environmental
Conditions – Operation
Operate the device in ambient conditions.
Temperature: 15ºC to 25ºC
Humidity: 30% - 75%
Atmospheric Pressure: 700 hPa - 1060 hPa
Ingress of Water Not protected against the ingress of water. IPX0.
Flammability Equipment not suitable for use in the presence of flammable anesthetic.
Dimensions Approximately 4 cm x 6 cm x 25 cm
Weight Approximately 0.4 kg
AC Power Accessories
and Ratings
Use only with supplied AC power accessories.
Power Input:
Input Voltage Range: 100~240 Vac
Input Frequency Range: 50~60Hz
Output Voltage: +5Vdc
Output Current Max: 2.4A
Removing the AC adapter from wall power shall serve as isolation mains. Do not
position the AC adapter and charging stand such that it is dicult to remove the AC
adapter from the wall outlet if needed to remove mains power.
Battery Type Lithium Ion
Applied Part BD EleVation™ Probe
Electrical Conformity This medical equipment has passed all required testing for electric shock, fire and
mechanical hazards in accordance with IEC/EN 60601-1, and CAN/CSA C22.2 No
601-1.
Classification Class II, internally powered Type BF equipment
Mode of Operation Continuous operation
Electromechanical
Compatibility
Medical 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 aect Medical Electrical
Equipment.
Table 5: Guidance and Manufacturer’s Declaration – Emissions
The BD EleVation™ Breast Biopsy System is intended for use in the electromagnetic environment specified below.
The user of the BD EleVation™ Breast Biopsy System should ensure that it is used in such an environment
Emissions Test Compliance Electromagnetic Environment – Guidance
RF Emissions
CISPR11 Group 1, Class A
The BD EleVation™ 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.
Harmonic
IEC 61000-3-2 Class A – Complies The The BD EleVation™ 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.
Flicker
IEC 61000-3-3 Complies

9
Guidance and Manufacturer’s Declaration – Immunity
All Equipment and Systems
Table 6: Guidance and Manufacturer’s Declaration – Immunity
The BD EleVation™ Breast Biopsy System is intended for use in the electromagnetic environment specified below.
The user of the BD EleVation™ 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
ESD EN/
IEC 61000-4-2
+/-2kV, +/-4kV, +/-8kV
Contact discharge
+/- 2kV, +/-4kV, +/-8kV,
+/-15kV
Air discharge
Pass
Floors should be wood, concrete or
ceramic tile. If floors are synthetic, the r/h
should be at least 30%.
EFT EN/
IEC 61000-4-4
+/-2 kV, 100 kHz PRF
+/-1 kV, 100 kHz PRF Pass
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge EN/
IED 61000-4-5 +/-0.5 kV, +/-1 kV Pass
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage Dips/
Dropout
EN/IEC 61000-
4-11
100% dip for 0.5 Cycle at
0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
100% dip , 1 cycle
30% dip, 25/30 cycles
100% Dip for 250/300
cycles
Pass
Pass
Pass
Pass
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the BD
EleVation™ Breast Biopsy System requires
continued operation during power mains
interruptions, it is recommended that the
BD EleVation™ Breast Biopsy System be
powered from an uninterruptible power
supply or battery.
Power Frequency
50/60Hz
Magnetic Field
EN/IEC 61000-4-8
30A/m Pass
Power frequency magnetic fields should
be that of a typical commercial or
hospital environment.
Guidance and Manufacturer’s Declaration – Immunity
Equipment and Systems which are NOT Life-supporting
Table 7: Guidance and Manufacturer’s Declaration – Immunity
The BD EleVation™ Breast Biopsy System is intended for use in the electromagnetic environment specified below.
The user of the BD EleVation™ 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
Conducted RF EN/
IEC 61000-4-6
Radiated RF EN/
IEC 61000-4-3
3 Vrms 150 kHz to
80 MHz
3 V/m 80 MHz to 2.7GHz
Pass
Pass
Portable and mobile communications
equipment should be separated from the
BD EleVation™ Breast Biopsy System by
no less than the distances calculated/
listed below:
D=(3.5/V1)(√P)
D=(3.5/E1)(√P) 80 to 800 MHz.
D=(7/E1)(√P) 800 MHz to 2.7GHz
Where P is the max power in watts and D
is the recommended separation distance
in meters.
Field strengths from fixed transmitters,
as determined by an electromagnetic
site survey, should be less than the
compliance levels (V1 and E1).
Interference may occur in the vicinity of
equipment containing a transmitter.
Guidance and Manufacturer’s Declaration – Emissions
Equipment and Systems which are NOT Life-supporting
Table 8: Recommended Separations Distances for the BD EleVation™ Breast Biopsy System
The BD EleVation™ Breast Biopsy System is intended for use in the electromagnetic environment in which
radiated disturbances are controlled. The customer or user of the BD EleVation™ Breast Biopsy System can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
Communications Equipment and the BD EleVation™ Breast Biopsy System as recommended below, according to
the maximum output power of the communications equipment.
Max Output Power
(Watts)
Separation (m)
150kHz to 80MHz
D=(3.5/V1)(√P)
Separation (m)
80MHz to 800MHz
D=(3.5/E1)(√P)
Separation (m)
800MHz to 2.7GHz
D=(7/E1)(√P)
0.01 0.1166 0.1166 0.2333
0.1 0.3689 0.3689 0.7378
1 1.1666 1.1666 2.3333
10 3.6893 3.6893 7.3786
100 11.6666 11.6666 23.3333
Recommended Separation Distances between portable and mobile RF Communications
equipment and the BD EleVation™ Breast Biopsy System Equipment and Systems which are
NOT Life-supporting
How Supplied
• The BD EleVation™ Driver is supplied with a wireless charging stand, AC cord, and AC power
adapter plugs. During unpacking, check for missing or damaged components.
• The BD EleVation™ Driver is supplied non-sterile and should be cleaned prior to each use.
• The BD EleVation™ Probes are sold separately. The BD EleVation™ Probes are supplied sterile
for single use only.
• The BD EleVation™ Accessories are sold separately. The BD EleVation™ Accessories are
supplied sterile for single use only.
Warranty
Bard Peripheral Vascular, Inc. warrants to the first purchaser of this product that this product will
be free from defects in materials and workmanship for a period of one year from the date of first
purchase and liability under this limited product warranty will be limited to repair or replacement
of the defective product, in Bard Peripheral Vascular, Inc.’s sole discretion or refunding your net
price paid. Wear and tear from normal use or defects resulting from misuse of this product are not
covered by this limited warranty.

10
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 OR MERCHANTABILITY OR FITNESS FOR
A PARTICULAR PURPOSE. IN NO EVENT WILL BPV BE LIABLE TO YOU FOR ANY INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM YOUR HANDLING OR USE
OF THIS PRODUCT.
Some states/countries do not allow an exclusion of implied warranties, incidental or consequential
damages. You may be entitled to additional remedies under the laws of your state/country.
An issue or revision date and a revision number for these instructions are included for the user’s
information on the last page of this booklet. In the event 36 months have elapsed between this
date and product use, the user should contact Bard Peripheral Vascular, Inc. to see if additional
product information is available.
Made in Poland.