Medtronic CBCA User’s Manual
Sonicision™
Curved Jaw Cordless Ultrasonic Dissection System
User’s Guide
SCDA13
SCDA26
SCDA39
SCDA48
SCGAA
SCBA
SCBIGA
CBCA
Table of Contents
Symbols 6
Symbol Matrix 8
Equipment Covered in This Manual 13
Indications for Use 13
Contraindications 13
Clinical Benefits 13
Section I – The Curved Jaw Cordless Ultrasonic Dissection System Overview 14
The Curved Jaw Cordless Ultrasonic Dissection System Components 14
Curved Jaw Cordless Ultrasonic Dissector 15
Reusable Generator 16
Reusable Battery Pack 16
Battery Charger 17
Reusable Battery Insertion Guide 17
Section II – Before a Procedure 18
Before Assembly 20
Assemble the Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device 20
Assembly 21
Attaching the Generator 22
Inserting the Battery Pack 22
Selecting a Power Level 23
Dual Mode Energy Button Positions 23
Device Status and Troubleshooting 24
Section III – During a Procedure 27
2
Changing a Battery Pack During a Procedure 30
Section IV – After a Procedure 32
Disassembly 32
Remove the Battery Pack 33
Remove the Generator 33
After Use 34
Reusable System Components 34
Cleaning and Sterilizing the Battery Insertion Guide and Generator 34
Cleaning 35
Preparation for Cleaning - Gross Decontamination 36
Manual Cleaning 36
Automatic Cleaning 36
Inspection 38
Pre-Sterilization Wipe Down (Optional) 38
Sterilizing the Reusable Generator and the Battery Insertion Guides 39
Cleaning and Disinfecting the Battery Pack 41
Cleaning the Battery Pack 42
Disinfecting the Battery Pack 42
Charging a Battery Pack 43
Charging Indications and Troubleshooting 44
Battery Pack Storage 45
Optional Maintenance of the Battery Charger 45
Environmental Parameters 46
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Recycling and Disposal 46
Curved Jaw Cordless Ultrasonic Dissector 46
Reusable Battery Pack 47
Reusable Generator, Reusable Battery Insertion Guide, and Battery Charger 47
Residual Risk Summary 47
Section V – Pre-Clinical Studies 49
Section VI – Technical Description 50
Product Codes 50
Dimensions and Weight (unpackaged) 51
Standards 52
Electromagnetic Compatibility (EMC) 53
Protection Against Electric Shock 69
Enclosure Ingress Protection (IP Classification) 70
Input Power 70
Reusable Battery Pack 71
Duty Cycle (Mode of Operation) 72
Mains Frequency (50 Hz/60 Hz) Leakage Current 72
Mains Frequency DC Leakage Current 73
Power Cord 73
Equipotential Ground Connection 74
USB Connection 74
Alert Tones 74
Battery Charger Fuses 75
4
Limited Warranty 76
Technical Support 78
California Proposition 65 Statement 79
China RoHS Compliance 79
5
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Symbols
Sterilized using
ethylene oxide
Not made with
natural rubber
latex
Single sterile
barrier system
Do not reuse
Non-sterile
product
For prescription
use only
Caution! Read all
Do not resterilize
Consult the
instructions for
use
warnings and
cautions in
instructions for
use
¡'
Product is a
medical device
6
Humidity
limitations
¡$
Temperature
¡'
¡$
limitations
Keep product dry
316
0
Defibrillationproof type BF
applied part
Product uses
high density
polyethylene and
may be recycled
Fuse
en
Product contains
waste from
electrical and
electronic
equipment, and
should be
separately
collected and not
disposed of as
unsorted
municipal waste
Protection
against fluid
ingress: Dripproof
IP2X
Ingress
Protection Rating
Equipotential
ground
Standards
compliance mark
(3164410)
441
Alternating
current
Direct current USB port
Standards
compliance mark
(5010194)
Dangerous
voltage
GOST R
7
en
CE Mark (no
notified body)
Authorized
representative in
the European
Community
Use by date Lot number Serial number
Date of
manufacture
Symbol Matrix
Symbol Reusable
Sterilized using ethylene
oxide
8
generator
Reusable
battery pack
CE Mark (notified
body 2797)
Catalog number Manufacturer
Battery
charger
Reusable
battery
insertion guide
EurAsian
Conformity mark
Curved jaw
cordless
ultrasonic
dissector (All
models)
X
en
Symbol Reusable
Sterile barrier X
Non-sterile product X X X
Not made with natural
rubber latex
Do not reuse X
For prescription use only X X X X X
Do not resterilize X
Consult the instructions for
use
Caution! Read all warnings
and cautions in instructions
for use
Medical device X X X X X
HDPE X
Humidity limitations X X X X
Temperature limitations X X X X X
generator
Reusable
battery pack
XXX X X
XXX X X
XXX X
Battery
charger
Reusable
battery
insertion guide
Curved jaw
cordless
ultrasonic
dissector (All
models)
9
en
Symbol Reusable
Keep product dry X
Waste from electrical and
electronic equipment
Defibrillation-proof type BF
applied part
Fuse X
Protection against fluid
ingress: Drip-proof
Ingress protection rating X
Alternating current X
Dangerous voltage X
Equipotential ground X
Direct current X
USB port X
Standards compliance
mark (3164410)
10
generator
Reusable
battery pack
XXX
XX X
XX X
X
Battery
charger
Reusable
battery
insertion guide
Curved jaw
cordless
ultrasonic
dissector (All
models)
en
Symbol Reusable
Standards compliance
mark (5010194)
GOST R X X X X
CE Mark (no notified body) X X
CE Mark (notified body
2797)
EurAsian Conformity mark X X
Authorized representative
in the European
Community
Catalog number X X X X X
Manufacturer X X X X X
Use by date X
Serial number X X X
Lot number X X
Date of manufacture X X X X
generator
Reusable
battery pack
XX X
XXX X X
Battery
charger
X
Reusable
battery
insertion guide
Curved jaw
cordless
ultrasonic
dissector (All
models)
11
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Sonicision™
Curved Jaw Cordless Ultrasonic Dissection System
Curved jaw cordless ultrasonic
dissector
ཱReusable generator
ིReusable battery insertion guide
12
1
3
5
2
4
ཱིReusable battery pack (non-sterile)
ུBattery charger (non-sterile)
Equipment Covered in This Manual
Sonicision™ Curved Jaw Cordless Ultrasonic
Dissection System
Indications for Use
The Sonicision™ curved jaw cordless ultrasonic
dissection device is indicated for soft tissue
incisions when bleeding control and minimal
thermal injury are desired. The device can be
used as an adjunct to or substitute for
electrosurgery, lasers, and steel scalpels in
general, plastic, gynecologic, urologic, and
other open and endoscopic procedures. The
Sonicision™ curved jaw cordless ultrasonic
dissection device can be used to coagulate
isolated vessels up to and including 5 mm in
diameter.
The Sonicision™ 13 cm device is also indicated
for use in otorhinolaryngologic (ENT)
procedures.
Contraindications
• The device is not indicated for incising
bone.
• The device is not to be used for
contraceptive tubal occlusion.
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Clinical Benefits
The Sonicision™ curved jaw cordless ultrasonic
dissection device and compatible accessories
perform simultaneous cutting and
coagulation for soft tissue, and isolated vessels
up to and including 5 mm in diameter.
Ultrasonic dissectors have been shown to
reduce operative times and blood loss
compared to conventional techniques (cold
steel and manual ligation).
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Section I – The Curved Jaw Cordless
Ultrasonic Dissection System
Overview
The Sonicision™ curved jaw cordless ultrasonic
dissection system enables cordless
transection, dissection, and coagulation of
tissue during general surgery. The device can
be used in open procedures, or endoscopically
when used with a compatible 5 mm trocar.
When assembled, electrical power supplied by
the battery pack is converted to ultrasonic
energy in the generator. This energy is
transferred to the active blade, which is used
to accomplish the intended clinical use.
Intensity of the ultrasonic energy is controlled
by the clinician using the dual-mode energy
button. Minimum power mode (energy button
depressed to the first position) produces
slower dissection when increased hemostasis
is desired. Maximum power mode (energy
button fully depressed) produces faster
dissection.
The Curved Jaw Cordless Ultrasonic
Dissection System Components
The Sonicision™ curved jaw cordless ultrasonic
dissection system has both single-use and
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reusable components. Sonicision™ reusable
generators and reusable battery insertion
guides must be sterilized before use. Validated
sterilization methods and parameters are
provided in this document. Sonicision™
curved jaw cordless ultrasonic dissectors are
supplied sterile. They are intended for singlepatient use and cannot be adequately cleaned
and sterilized for reuse.
The assembled dissector, reusable generator,
and reusable battery pack are referred to as
the Sonicision™ curved jaw cordless ultrasonic
dissection device in this document. The
Sonicision™ curved jaw cordless ultrasonic
dissection system refers to all components,
including the assembled device, reusable
battery insertion guide, and battery charger.
Each component is further described in this
section.
The Sonicision™ curved jaw cordless ultrasonic
dissection system has no components made
with natural rubber latex.
Curved Jaw Cordless Ultrasonic Dissector
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1
2
8
Clamping jaw– Holds tissue against
active blade
ཱActive curved blade– Delivers energy
effect
ིShaft
ཱིShaft-rotation wheel (black)– Rotates
shaft 360°
ུSpeaker– Emits system status tones
ཱུDual-mode energy button (blue)–
Selects energy activation in minimum
or maximum mode
ྲྀJaw lever (black)– Closes and opens
clamping jaw
3
4
5
6
7
10
9
ཷShaft measurement marks– Measures
up to 10 cm from the distal end (not
available on all models)
ླྀBattery door (black)– Closes and seals
battery compartment
ཹBattery door release button (black)–
Opens the battery door
The Sonicision™ curved jaw cordless ultrasonic
dissector is a sterile, single-use component to
which the generator and battery pack attach.
This component provides control for device
functions such as selecting power levels, blade
placement and position, grasping,
coagulating, and dissecting tissue.
15
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Reusable Generator
up to 150 times, after which the generator is
no longer usable and must be replaced.
1
Reusable Battery Pack
2
LED indicator– Color of LED indicates
system status (see Device Status and
Troubleshooting on page 24 for color
indications and descriptions)
ཱTorque knob– Used to connect the
generator to the dissector
Generators are provided non-sterile and must
be sterilized before each use. Use a steam
autoclave to safely sterilize the generator. See
Cleaning and Sterilizing the Battery Insertion
Guide and Generator on page 34.
The Sonicision™ reusable generator converts
electrical power from the battery pack to
ultrasonic energy to drive the active blade. The
generator is designed to be sterilized and used
16
1
Battery-pack handle – Aids in holding
and positioning the battery pack for
insertion and extraction from the
dissector or battery charger
Battery packs are provided non-sterile and
must be cleaned, disinfected, and charged
prior to each use. See Cleaning and Disinfecting
the Battery Pack on page 41.
The Sonicision™ reusable battery pack is a
rechargeable, lithium-ion battery that
provides power to the Sonicision™ curved jaw
cordless ultrasonic dissection device. The
battery pack is designed to be used up to 200
times. It is compatible only with the
Sonicision™ curved jaw cordless ultrasonic
dissection device and battery charger.
Battery Charger
1
en
Reusable Battery Insertion Guide
2
3
Charging bays (4)
ཱBattery-charger power-status light
ིBattery-pack status display
The battery charger connects to a standard
wall outlet and charges the reusable battery
packs. Status displays on the battery charger
indicate the status of each battery pack. See
Charging Indications and Troubleshooting on
page 44.
The Sonicision™ reusable battery insertion
guide is intended to facilitate the aseptic
transfer of the non-sterile Sonicision™ battery
pack into the Sonicision™ curved jaw cordless
ultrasonic dissection device.
The battery insertion guides are provided nonsterile and must be sterilized before each use.
See Cleaning and Sterilizing the Battery
Insertion Guide and Generator on page 34.
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Section II – Before a Procedure
Warning
Safe use of the Sonicision™ curved jaw
cordless ultrasonic dissection system
requires the user to read, understand, and
follow the accompanying instructions.
The dissector cannot be adequately cleaned
or sterilized for safe reuse and is, therefore,
intended for single use. Attempts to clean
and sterilize the dissector for reuse may
result in infection or product-failure risks to
the patient and operator.
Visually inspect all system components for
breaks, cracks, nicks, or other damage. Do
not use damaged components. Use of
damaged components may result in injury
to the patient or operator.
Use caution when handling the assembled
device. The assembled device is capable of
creating dissecting energy when the dualmode energy button is depressed. Avoid fire
and unintended burns by always keeping
the distal end of the device in sight and away
from direct contact with adjacent tissue,
textiles, and flammable materials during and
immediately after use.
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Warning
Infection hazard Non-sterile components
may contaminate the sterile field and place
the patient at risk for infection.
• Do not use the dissector if the sterile
package is opened, damaged, or has
exceeded the expiration date.
• Generators and battery insertion guides
are provided non-sterile and must be
cleaned and sterilized prior to first use
and for each reuse. See Cleaning and
Sterilizing the Battery Insertion Guide and
Generator on page 34.
• Battery packs are non-sterile and cannot
be sterilized. The battery pack must be
aseptically inserted into the dissector
according to instructions. See Inserting
the Battery Pack on page 22.
Fire and Burn Hazard The clamping jaw,
active blade, and distal 6 cm of the shaft are
hot during, and for a period of time after
activating the device. Avoid the potential for
fire and unintended burns by always
keeping the distal end of the device in sight
and away from direct contact with adjacent
tissue, textiles, and other flammable
materials during and for a period of time
after activation.
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Warning
Avoid accidental activation by installing the
generator before installing the battery pack.
Accidental activation of the Sonicision™
curved jaw cordless ultrasonic dissection
device can cause serious injury to the patient
or surgical team.
No modification of this equipment is
allowed.
Caution
Use only Sonicision™ components listed in
the compatibility table on the front cover.
Components from other manufacturers are
not compatible with this system and may
cause injury to the patient and operator.
Do not bend or sharpen the blade. Altering
the blade will compromise the performance
of the device, which may result in patient or
user injury.
Caution
Successful hemostasis may require adjunct
measures when ultrasonic instruments are
used to incise or coagulate solid organs (for
example, liver parenchyma). Due to the
difficulty of visualizing internal structures,
avoid transecting large masses of tissue in a
single activation.
Ensure that the battery pack is sufficiently
charged before use. See Charging a Battery
Pack on page 43.
Use of a battery pack that is not fully charged
can result in a procedural delay.
If generators and battery insertion guides
are to be sterilized outside of the medical
facility, ensure packaging protects items
from potential damage and contamination
during transport.
Note: Ensure the availability of backup
equipment to protect against unexpected
system failure and provide additional battery
capacity.
Note: This device is intended to be used with a
5 mm trocar when used endoscopically. Verify
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proper trocar size and compatibility prior to
using the device in a procedure.
Note: Ensure the battery pack connector is
dry. Inserting the battery pack into the device
or the battery charger when the connector is
wet may damage the components.
Note: The Sonicision™ curved jaw cordless
ultrasonic dissection system is intended to be
used in a hospital environment.
Note: Battery packs are shipped with a low
state of charge and must be charged upon
receipt.
Note: To avoid electrostatic-damage to a
battery pack, do not touch the battery pack
connector.
Before Assembly
Battery insertion guides and generators must
be prepared before each use in accordance
with the cleaning and sterilizing instructions.
See Cleaning and Sterilizing the Battery
Insertion Guide and Generator on page 34.
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Assemble the Sonicision™ Curved Jaw
Cordless Ultrasonic Dissection Device
Complete assembly of a working Sonicision™
curved jaw cordless ultrasonic dissection
device requires:
• Single-use dissector
• Reusable generator
• Reusable battery pack
• Reusable battery insertion guide
Assembly
en
1.21.1
1.3
1.51.4 1.6
21
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Attaching the Generator
1. Circulating Person: Transfer the dissector,
battery insertion guide(s), and generator
aseptically into the sterile field.
2. Scrubbed Person: Slide the generator into
the opening until it makes contact with the
dissector (step 1.1). Hold the dissector
shaft-rotation wheel. Turn the torque knob
clockwise until it clicks twice (step 1.2).
Inserting the Battery Pack
Note: Attach the generator to the dissector
prior to inserting the battery pack.
1. Scrubbed Person: Hold the handle with
the open battery compartment up. Open
the battery compartment door.
2. Scrubbed Person: Seat the sterile battery
insertion guide onto the open dissector
handle and hold firmly (step 1.3).
3. Circulating Person: Orient the battery
pack as shown with the battery insertion
guide. Insert the battery pack through the
battery insertion guide into the dissector
handle (step 1.4).
4. Circulating Person: After the battery pack
is seated in the dissector handle, remove
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the contaminated battery insertion guide
from the sterile field (step 1.5).
5. Scrubbed Person: Do not touch the
battery pack. Close the battery
compartment door from the outside until
there is tactile feedback and an audible
click (step 1.6).
A series of audible tones and an
illuminated green LED on the generator
indicate correct assembly.
6. In order to ensure the device meets
required essential performance, it should
be tested after assembly and each battery
exchange as follows:
With the clamping jaws open, test the
minimum-power mode (energy button
depressed to first position) and maximumpower mode (energy button fully
depressed). If the device generates
different pulsating tones for each power
mode and a green LED is present, assembly
is complete and the device is ready for use.
If inaudible or undifferentiated tones or a
non-green LED are present, refer to Device
Status and Troubleshooting on page 24.
Selecting a Power Level
The dual-mode energy button activates the
ultrasonic power to the active blade. Two
power settings are available:
• Minimum-power mode
– Energy button depressed to first position
(2)
– A low-pitch, slow pulsating tone
indicates minimum-power activation
– Produces slower dissection when
increased hemostasis is needed
• Maximum-power mode
– Energy button fully depressed (3)
– A high-pitch, fast pulsating tone
indicates maximum-power activation
– Produces faster dissection
Dual Mode Energy Button Positions
1
2
3
Off
ཱMinimum-power mode
ིMaximum-power mode
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23
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Device Status and Troubleshooting
The generator LED indicator changes color to
signify the status of the Sonicision™ curved
jaw cordless ultrasonic dissection device. The
LED color in combination with various audible
tones indicate the operational status of the
system. The table below provides an
explanation of system conditions indicated by
a combination of LED colors and emitted
tones. Where applicable, troubleshooting tips
are provided.
LED indicator Tone Status Possible remedy
Six pulses - start up tone System is ready. N/A
Pulsing - low
Green
Pulsing - high
No audio (during assembly
or activation)
Purple and green
alternating
(flashing)
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Six pulses - start up tone
Note: When performing remedy actions,
follow instructions provided in this user's
guide for maintaining the sterile field.
Note: Test device after each remedy step for
functionality.
Activation of minimum power
(energy button depressed to
first position).
Activation of maximum
power (energy button fully
depressed).
Device is not functional.
Generator is on its last surgical
use.
Replace the dissector.
Press activation button to
N/A
N/A
begin use.
LED indicator Tone Status Possible remedy
Purple (flashing) Three pulses
Red
(during assembly)
LED not
illuminated
(during assembly)
Yellow (flashing)
Three pulses
No audio
Six pulses - start up tone
Nine pulses Battery charge is low (< 15%).
Four descending tones Low-battery reminder.
Twelve pulses followed by a
constant tone
Generator has reached its
maximum use life and is no
longer functional.
System error during assembly.
The device is not functional.
Device is not functional.
Battery pack is depleted. The
device is not functional.
Replace the generator.
1) Fully detach and reattach
the generator.
Ensure two clicks occur
when tightening the
generator.
2) Replace the battery pack.
3) Replace the generator.
4) Replace the dissector.
1) Replace the battery pack.
2) Replace the generator.
1) Replace the battery pack.
2) Replace the generator.
Replace the battery pack.
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25
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LED indicator Tone Status Possible remedy
1) Clean jaw and blade. Test
with open jaw.
Red
(during activation)
Green
(after activation)
Red (during use) No audio
LED not
illuminated
26
Three pulses during
activation
Audio may or may not
occur
System error during use.
Device is not functional.
System error during use.
Device is not functional.
Device is not functional.
2) Fully detach and reattach
the generator.
Ensure two clicks occur
when tightening the
generator.
3) Replace the dissector.
4) Replace the generator.
Replace all components:
dissector, generator, and
battery pack.
1) Replace the battery pack.
2) Replace the dissector.
3) Replace the generator.
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