Medtronic CBCA User’s Manual

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Sonicision™

Curved Jaw Cordless Ultrasonic Dissection System User’s Guide

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SCDA13

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SCDA26

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SCDA39

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SCDA48

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SCGAA

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SCBA

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SCBIGA

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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

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

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

Limited Warranty 76

Technical Support 78

California Proposition 65 Statement 79

China RoHS Compliance 79

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

Humidity limitations

¡$

Temperature

¡'

¡$

limitations

Keep product dry

316

Defibrillationproof type BF applied part

Product uses high density polyethylene and may be recycled

Fuse

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

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

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)

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

Battery charger

Reusable battery insertion guide

Curved jaw cordless ultrasonic dissector (All models)

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)

generator

Reusable battery pack

XXX

XX X

Battery charger

Reusable battery insertion guide

Curved jaw cordless ultrasonic dissector (All models)

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

Reusable battery insertion guide

Curved jaw cordless ultrasonic dissector (All models)

Sonicision™

Curved Jaw Cordless Ultrasonic Dissection System

཰Curved jaw cordless ultrasonic

dissector

ཱReusable generator ིReusable battery insertion guide

ཱི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.

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).

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

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

཰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

ཷ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.

Reusable Generator

up to 150 times, after which the generator is no longer usable and must be replaced.

Reusable Battery Pack

཰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

཰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

Reusable Battery Insertion Guide

཰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.

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.

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.

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

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.

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

1.21.1

1.3

1.51.4 1.6

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

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

཰

Off

ཱMinimum-power mode ིMaximum-power mode

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)

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

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.

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

Three pulses during

activation

Audio may or may not

occur

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.

Section III – During a Procedure

Warning

The safe and effective use of ultrasonic energy depends on many factors solely under the control of the properly trained clinician.

Contact between the active blade and other metal objects (for example, hemostats, clips, staples, and retractors) may result in product damage, such as a broken blade. Pieces of a broken blade may fall into the surgical cavity causing unintended tissue damage.

Applying excessive torque to the jaws while activating energy on tissue may result in device damage, such as a broken blade.

Warning

Use the device with caution when operating in close proximity to external or implanted electronic medical devices. Electromagnetic interference produced by the proximity of the ultrasonic generator can potentially cause a device to enter an unsafe mode. There is also a possibility that a nearby electronic device could alter the performance of the Sonicision™ curved jaw cordless ultrasonic dissection device. Consult the manufacturer of the external or implanted electronic device or responsible hospital department for further information when use is planned in close proximity to such devices.

Fire and Burn Hazard – The clamping jaw, active blade, and distal 6 cm of the shaft are hot during and immediately 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 immediately after use.

Warning

When using the 13 cm device for ENT procedures, take particular care to avoid unintended contact with thermally sensitive tissues such as nerves and the parathyroid glands. Adjunctive use of a nervemonitoring device is recommended during nerve-sparing procedures.

Do not activate the instrument with the

clamping jaw closed unless tissue is present. This could damage the device jaws and cause injury to the patient.

Infection hazard – Battery insertion guides and generators must be cleaned and sterilized before each use in accordance with the cleaning and sterilizing instructions. See

Cleaning and Sterilizing the Battery Insertion Guide and Generator on page 34. Non-sterile

battery insertion guides and generators will contaminate the sterile field and place the patient at risk for infection.

Examine the vessel for complete hemostasis. If hemostasis is not achieved, use appropriate techniques to maintain hemostasis. Failure to inspect the vessel may cause serious injury to the patient.

Warning

Smoke plume and aerosols generated during procedures can be potentially harmful to patients and the perioperative staff. Use of a smoke evacuation system is recommended to remove harmful fumes and particulates produced by heated tissue.

Caution

Close the instrument jaws before inserting or extracting from a trocar to prevent damage to the jaws and trocar.

Portable and mobile RF communications equipment can affect the device and battery charger. Refer to the Guidance and Declaration tables for Electromagnetic Compatibility (EMC) on page 53.

Use caution during surgical cases in which patients exhibit certain types of vascular pathology (atherosclerosis, aneurysmal vessels, and so forth). For best results, apply the energy to unaffected tissue.

Place vessels and tissue in the center of the jaws to assure optimal hemostatic effect. Do not place tissue in the jaw hinge.

Caution

Do not apply excessive force to the jaw lever when grasping tissue. Excessive force between the clamping jaw and active blade may result in unintended damage to tissue and failure of the device to operate as intended.

Do not release the dual-mode energy button until tissue is completely coagulated and/or divided.

The safety and efficacy of ultrasonic devices has not been established for use on lung parenchyma.

Keep the jaws clean during use. Buildup of eschar and tissue may reduce the effectiveness of the dissection and coagulation functions, and cause abnormally high temperatures at the distal end of the device. During the procedure, carefully wipe the clamping jaw and active blade with a wet gauze, or submerse the distal end in a sterile saline bath and activate with the clamping jaw open as needed.

Note: This guide and the equipment it describes are for use only by qualified medical professionals trained in the particular

technique and surgical procedure to be performed.

Changing a Battery Pack During a Procedure

Warning

Do not use a contaminated battery insertion guide from the previous assembly. A new sterile battery insertion guide must be used for each procedural battery exchange. Refer to Cleaning and Sterilizing the Battery Insertion Guide and Generator on page 34 for cleaning and sterilization instructions.

1. Scrubbed Person: Hold the device with

the battery compartment up. Press the battery door release button to open the compartment (step 2.1).

2. Scrubbed Person: Place the new sterile

battery insertion guide over the exposed battery pack and seat it onto the open dissector handle and hold firmly (step 2.2).

3. Circulating Person: Grasp the battery-

pack handle and pull the battery pack through the insertion guide out of the dissector and into a clean, non-sterile environment (step 2.3).

4. Circulating Person: Orient the new

battery pack as shown with the battery insertion guide. Insert the battery pack through the battery insertion guide into the dissector handle (step 2.4).

5. Circulating Person: After the battery pack

is seated in the dissector handle, remove the contaminated battery insertion guide from the sterile field (step 2.5).

6. 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 2.6).

7. With the clamping jaws open, test the

minimum-power mode (energy button depressed to first position) and maximumpower mode (energy button fully depressed) as described in Assemble the

Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device on page 20.

Section IV – After a Procedure

Disassembly

3.23.1

3.3

3.4

Warning

Disassembly of the device with these instructions should only occur after the procedure is complete and the sterile field is broken.

A thorough understanding of the principles and practices of electrical equipment is essential to avoid shock and hazards to the operators and/or the device and accessories. Ensure that electrical isolation and outlet grounding are not compromised.

The battery charger does not have a main power switch. During any observed unsafe operating conditions, immediately disconnect the battery charger’s AC power plug from the wall outlet.

If required by local codes, connect the battery charger’s equipotential post to the hospital connector with an equipotential cable. The battery charger’s equipotential post is located on the back panel.

Follow appropriate safety precautions when connecting the AC power plug. Ensure access to the power plug is unobstructed at all times.

Warning

The battery charger and power cord are nonsterile and cannot be sterilized.

Caution

Take particular care to keep the battery pack clean.

Remove the Battery Pack

1. Hold the dissector handle with the battery

compartment up. Press the battery door release button (step 3.1).

2. Use the battery-pack handle to pull the

battery pack out into a clean environment (step 3.2).

Refer to Cleaning and Disinfecting the Battery Pack on page 41 for cleaning and charging instructions.

Remove the Generator

1. To loosen the torque knob, hold the shaft-

rotation wheel firmly with one hand while turning the torque knob counterclockwise with the other hand (step 3.3).

2. Continue to turn the torque knob

counterclockwise until the generator can be removed from the dissector (step 3.4).

After Use

Reprocess the generator and battery insertion guides as soon as possible following use. If reprocessing cannot be performed immediately, cover the components with a moist towel.

Reusable System Components

Generators and battery insertion guides are designed to be sterilized up to 150 times. The battery pack is designed to be used up to 200 times. See Limited Warranty on page 76 for more information.

Cleaning and Sterilizing the Battery Insertion Guide and Generator

Warning

These instructions have been validated by Covidien as capable of preparing the Sonicision™ reusable battery insertion guides and reusable generators for use. It is the responsibility of the processor to ensure that sterilization is performed using equipment, materials, and trained personnel that will achieve the desired results. Any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences.

Infection hazard – Non-sterile components will contaminate the sterile field and place the patient at risk for infection. Generators and battery insertion guides are provided non-sterile and must be cleaned and sterilized before first use and each reuse.

Warning

Use only cleaning detergents specified in these instructions. Use of cleaning detergents not specified in these instructions will compromise sterility and damage components.

Thoroughly clean the battery insertion guide and generator. Attempting to sterilize contaminated components will compromise sterility.

Use only the sterilization method that is recommended and qualified as described in these instructions. Do not use immediate-

use (flash) steam sterilization, hydrogen peroxide gas plasma technology (such as STERRAD™* systems), ethylene oxide (EO), or gamma sterilization to sterilize any components of the Sonicision™ system. Exposure to these alternate forms of sterilization will damage the equipment and compromise sterility.

Clean and sterilize the reusable generator and the reusable battery insertion guide before each use. Reprocess as soon as possible following each use. If processing cannot be completed immediately, cover the components with a moist towel.

Warning

Battery insertion guides and generators that are to be stored before sterilization must be cleaned before storage. Storing contaminated battery insertion guides and generators may compromise their ability to be sterilized.

Caution

Do not use abrasive cleaning detergents as they may scratch the surface of the generator and battery insertion guide.

The cleaning and sterilization processes described in this section have been validated by Covidien as capable of preparing Sonicision™ reusable generators and Sonicision™ reusable battery insertion guides.

Sterility of the final product relies on the use of properly qualified personnel, equipment, and tools.

Cleaning

Use a cleaning solution of pH-neutral, pHneutral enzymatic, or mild alkaline detergent to clean the generator and battery insertion guides.

Preparation for Cleaning - Gross Decontamination

1. Visually inspect the battery insertion

guides and generator. Do not use the components if they are broken, cracked, nicked, or have any other damage.

Replace damaged components.

2. Under warm (32–40°C, 90–104°F) running

tap water scrub all components with a small, soft, nylon-bristle, general instrument- cleaning brush to remove surgical debris.

For hard to reach crevices, use a 4.0 mm soft nylon-bristle brush for the battery insertion guide, and use a 12.0 mm soft nylon-bristle brush for the generator.

3. Rinse under warm (32–40°C, 90–104°F)

running tap water for a minimum of 1 minute.

4. Prepare a cleaning solution according to

the manufacturer’s instructions.

Note: The battery insertion guides and the generator are tested for material compatibility with cleaners that have a pH range from neutral to 10.9.

Choose Manual Cleaning or Automatic Cleaning.

Manual Cleaning

1. Immerse the battery insertion guides and

generator in a warm (32–40°C, 90–104°F) detergent bath for 10 minutes.

2. Use a small, soft, nylon-bristle, general

instrument-cleaning brush to scrub each component in the detergent bath for a minimum of 1 minute.

For hard to reach crevices, use a 4.0 mm soft nylon-bristle brush for the battery insertion guide, and use a 12.0 mm soft nylon-bristle brush for the generator.

3. Rinse each component under warm

(32–40°C, 90–104°F) running tap water for a minimum of 1 minute.

4. Perform a final rinse under warm purified

water for a minimum of 1 minute for each component.

5. Use a clean, soft, lint-free cloth to dry the

components.

Automatic Cleaning

Run the automatic cleaning cycle. Refer to the following Automatic Cleaning Recommendations table on page 38.

Caution

To avoid mechanical damage, arrange the contents of the washer so that the generator and battery insertion guides will not contact other items during the wash cycle.

Do not wash the generator in an ultrasonic washer.

Automatic Cleaning Recommendations

Treatment Time (MM:SS) Temperature Chemical

Pre-wash 01:00 Cold tap water N/A

Wash 03:00 Hot tap water pH-neutral, pH-neutral enzymatic, or

Rinse 00:15 Hot tap water N/A

Wash 02:00 Hot tap water pH-neutral, pH-neutral enzymatic, or

Rinse 00:15 Hot tap water N/A

Thermal rinse 01:00 Heated purified water

Dry 06:00 High setting 95°C

Note: The components have been qualified to withstand the following parameters: Pre-wash of 4 minutes, total wash of 10 minutes, hot tap water rinse of 5 minutes, thermal rinse of 5 minutes at 95°C (203°F), and dry time of 30 minutes.

82°C (180°F)

(203°F)

mild alkaline detergent diluted per the

manufacturer’s specifications

mild alkaline detergent diluted per the

manufacturer’s specifications

N/A

Inspection

Visually inspect the battery insertion guides and generator for cleanliness. Repeat the cleaning cycle if necessary.

Pre-Sterilization Wipe Down (Optional)

In facilities that require additional preparation prior to sterilization, wipe the surfaces of the

battery insertion guides and generator with an isopropyl alcohol disinfectant (70%).

Sterilizing the Reusable Generator and the Battery Insertion Guides

Caution

Ensure that the selected sterile barrier and process indicators have been qualified for the sterilization exposure temperature and time that will be used. The minimum sterilization temperatures and times in each row of the recommended cycle parameters have been validated for achieving product sterility, and the Sonicision™ products have been qualified to withstand repeated exposure to the maximum temperatures and times listed. It is the responsibility of the user to select the appropriate sterile barrier and process indicators for each sterilization cycle.

Warning

The following list of sterilization barriers have been validated for effective sterilization of the generator and battery insertion guides. Do not use alternative sterilization

barriers or additional absorbent or protective materials as this may compromise sterility or functionality of the components.

1. After cleaning, use the manufacturer’s

instructions for the sterile barrier selected:

• Single Polypropylene Wrap - Wrap each component individually in a compatible polypropylene sterilization wrap.

• Double Polypropylene Wrap - Wrap each component individually in two compatible polypropylene sterilization wraps.

• Single Breathable Polyethylene Pouch - Place each component individually in its own single compatible breathable polyethylene pouch and seal. Place the pouch in the autoclave with the breathable side of the pouch facing up.

• Double Breathable Polyethylene Pouch - Place each component

individually within two compatible breathable polyethylene pouches, and seal. The breathable side of the inside pouch must be aligned with the breathable side of the outside pouch. Place the pouches in the autoclave with the breathable sides of the pouches facing up.

• Rigid Steam Sterilization Container* Place the components in a compatible rigid steam sterilization container. Ensure that the individual components are not touching, and the container is loaded according to manufacturer’s recommendations. *Validated with an Aesculap™* rigid container.

2. Place the generators and battery insertion

guides into the autoclave. Do not stack the generators and battery insertion guides.

Note: When sterilizing multiple instruments in one autoclave cycle, do not exceed the maximum load specified by the manufacturer.

3. Select one of the sterilization cycles in the

following Steam Sterilization Cycles table.

Warning

Generators and battery insertion guides can not be sterilized with rigid containers using a steam sterilization cycle of Gravity 132°C (270°F).

Steam Sterilization Cycles

Cycle type Exposure

Pre-vacuum 132°C (270°F) 4 20–40 Wrap(s), pouch(es), and rigid container

Pre-vacuum 135°C (275°F) 3 16–40 Wrap(s), pouch(es), and rigid container

Gravity 132°C (270°F) 15 15–40 Wrap(s) and pouch(es)

Gravity 135°C (275°F) 10 30 Wrap(s), pouch(es), and rigid container

Note: The generator and battery insertion guide have been tested to allow exposure to temperatures up to 135°C (275°F) for 18 minutes, in order to allow for variations in local requirements and regulations for sterilization protocols.

temperature

Exposure

time

(minutes)

Dry time

(minutes)

Compatible sterile barriers

Cleaning and Disinfecting the Battery Pack

Warning

Do not immerse the battery pack.

Do not disassemble or modify the battery pack.

Inspect the battery pack for damage before use. Do not use a damaged battery pack.

Warning

The battery pack is non-sterile, and cannot be sterilized. The battery pack will be damaged if sterilization is attempted.

Do not rinse the battery pack under running water or submerge the battery pack in water.

Do not use instrument lubricant on the battery pack.

Caution

The battery pack should be cleaned and disinfected after each use and before charging. Clean and disinfect the battery pack as instructed.

Note: Do not expose the battery pack connector to excessive moisture, conductive materials, or contaminants.

Cleaning the Battery Pack

1. Moisten a lint-free cloth with a disinfectant

solution or use a disinfectant wipe. Use one of the following disinfectants:

• Ethyl alcohol or isopropyl alcohol (70%)

• Hydrogen peroxide wipe (for example,

TM*

Oxivir

)

2. Using a clean disinfectant wipe, wipe all

external surfaces of the battery pack until visually clean. Ensure the surface remains thoroughly wet by continuously wiping for the contact time recommended per the manufacturer's instructions.

• If using 70% ethyl alcohol or isopropyl alcohol, ensure a contact time of 1 minute.

• Pay special attention to the battery pack handle.

• Avoid contact with the battery pack connector.

• Use additional wipes if needed.

3. Use a lint-free cloth to dry all exposed

surfaces of the battery pack, taking care to avoid damage to the electrical contacts.

4. Visually inspect the battery pack. If it is not

clean, repeat cleaning steps above.

Disinfecting the Battery Pack

1. Moisten a lint-free cloth with a disinfectant

solution or use a disinfectant wipe. Use one of the following disinfectants:

• Ethyl alcohol or isopropyl alcohol (70%)

• Hydrogen peroxide wipe (for example,

TM*

Oxivir

)

2. Using a clean disinfectant wipe, wipe all

external surfaces of the battery pack. Ensure the surface remains thoroughly wet by continuously wiping for the contact time recommended per the manufacturer's instructions.

• If using 70% ethyl alcohol or isopropyl alcohol, ensure a contact time of 1 minute.

• Pay special attention to the battery pack handle.

• Avoid contact with the battery pack connector.

• Use additional wipes if needed.

3. Use a lint-free cloth to dry all exposed

surfaces of the battery pack, taking care to avoid damage to the electrical contacts.

Caution

Store the battery charger in a clean dry place to avoid contamination from blood or other body fluids.

Battery packs must be cleaned and disinfected before being placed on the battery charger to avoid potential contamination of the charging bay.

Charging a Battery Pack

1. Connect the power cord to the battery

charger.

2. Connect the power cord to a grounded

electrical outlet. The green power-status light will illuminate when the battery charger has power.

3. Place the battery pack into a charging bay

and ensure the battery pack is fully seated.

The charging cycle will start automatically

when the battery pack is inserted correctly into the battery charger. Refer to Charging Indications and Troubleshooting on page 44 for more information.

Charging cycle time depends on the amount of charge remaining in the battery pack. An empty battery pack typically takes 3 hours to reach a full charge.

4. To remove a battery pack from a battery

charger bay, pull the battery pack straight up.

Charging Indications and Troubleshooting

Flashing green bars—Active

charging. Five solid bars indicate a full charge.

Flashing green bars with a number—The white number shows

the surgical uses remaining. This number is present when there are 20 or fewer surgical uses remaining for the battery pack.

White battery with “0”—The battery pack has exceeded the number of surgical uses and has reached its end-of-life. The battery pack must be replaced. Dispose of the old battery pack as required by local, state, and government regulations.

Red battery—The battery pack has a fault and is non-functional. Troubleshooting— Reinsert the battery pack into a different charger bay. If the error indication remains, then the battery pack is nonfunctional and must be replaced. Contact Covidien Customer Service.

Yellow caution—The charging bay has a fault and is non-functional. Troubleshooting— Unplug and replug the battery-charger power cord. If the error indication remains, that battery charger bay is nonfunctional. Contact Covidien Customer Service.

Yellow caution on all displays and red power-status light—the

battery charger has a system fault and is non-functional.

Y

Troubleshooting— Unplug and replug the battery-charger power cord. If the error indication remains, then the battery charger is nonfunctional. Contact Covidien Customer Service.

Battery Pack Storage

The service life of the battery pack is monitored by the battery charger. Store the battery pack in the battery charger between uses. If the battery pack is stored off of the charger, the battery pack should be returned to the charger before use to verify functionality and state of charge, and recharge as necessary. See Environmental Parameters on page 46.

Optional Maintenance of the Battery Charger

Warning

Electric shock hazard – Always unplug the

battery charger before cleaning.

Do not immerse the battery charger.

Caution

Do not rinse the battery charger under running water or submerge the battery charger in water.

Do not use instrument lubricant on the battery charger.

Caution

Do not sterilize the battery packs or the battery charger. The sterilization process will damage these components.

Do not spray or pour cleaning solutions or other liquids directly onto the battery charger or battery charger bays. Product damage may result.

1. Remove the battery charger power cord

from the wall outlet.

2. Wipe down all external surfaces of the

battery charger with a water-dampened lint-free cloth to completely remove any gross debris or dust.

3. The battery charger may also be wiped

with a hydrogen peroxide based wipe such

TM*

as Oxivir

or ethyl or isopropyl alcohol

(70%). Avoid contact with the battery charger

connectors.

4. Use a lint free cloth to dry all exposed

surfaces of the battery charger, taking care to avoid damage to the connectors.

Caution

Ensure that the battery charger is completely dry before connecting to power or inserting a battery pack to charge.

Environmental Parameters

Operation and Storage

Ambient temperature range

Relative humidity

Atmospheric pressure

System (except Battery Charger)

Battery Charger

15% to 85% noncondensing

700 millibars to 1060 millibars

10°C to 30°C (50°F to 86°F)

15°C to 30°C (59°F to 86°F)

Transport

Ambient temperature range

Relative humidity

-30°C to 60°C (-22°F to 140°F)

15% to 90% noncondensing

Note: Store battery packs at 18°C to 25°C (64°F to 77°F) in a dry, ventilated area to reduce possibility of lowered battery-service life from elevated temperatures. Note: If the battery pack is stored off of the charger, the battery pack should be returned to the charger before use to verify functionality, state of charge, and recharge as necessary.

Recycling and Disposal

Curved Jaw Cordless Ultrasonic Dissector

Discard biologically contaminated single-use electronic devices in accordance with your institution's hazardous medical waste procedures and local regulatory requirements.

Reusable Battery Pack

Covidien is committed to a healthy world and recommends that Sonicision™ reusable battery packs be recycled following decontamination.

Within the U.S. and Canada

Covidien has provided funding to support the recycling of Sonicision™ reusable battery packs. Visit www.call2recycle.org for more information and to receive a prepaid collection kit.

Outside the U.S. and Canada

Covidien recommends that Sonicision™ reusable battery packs be recycled in accordance with your local laws, rules and national regulations.

Caution

Failure to properly recycle or discard the single-use or reusable system components may lead to environmental contamination.

Reusable Generator, Reusable Battery Insertion Guide, and Battery Charger

Recycle or discard decontaminated reusable system components in accordance with your institution's waste procedures and local regulatory requirements.

Residual Risk Summary

While every attempt has been made to reduce patient and user risks, all surgeries using this system carry some residual risk, even when used by trained physicians. It is also to be noted that some of the listed risks are inherent in any surgical procedure and are not unique to the system. The potential adverse events associated with the use of the ultrasonic dissection system include, but are not limited to, the following risks:

• Airway obstruction (chemical exposure, smoke inhalation)

• Allergic reaction

• Arrhythmia or cardiac arrest (interaction with implanted electronic device)

• Bleeding

• Burn (thermal, external, bowel or to critical ENT structures)

• Carcinogen exposure (surgical plume)

• Chemical exposure (damaged battery)

• Electric shock

• Foreign body in patient

• Foreign body reaction

• Infection

• Nerve damage

• Perforation (vessel or organ)

• Thromboembolism

• Tissue damage

Note: Any serious incident that has occurred in relation to the device should be reported to the manufacturer and necessary regulatory authority (if European Union, the competent authority of the Member State) in which the user and/or patient is established.

Section V – Pre-Clinical Studies

Note: There is no animal data qualified to predict the effectiveness of this device in sealing vessels containing atherosclerotic plaque. Therefore, this device should not be used on vessels containing atherosclerotic plaque.

Clearance of the Sonicision™ curved jaw cordless ultrasonic dissection device in the United States was not based on human clinical testing; instead, the device was investigated in a chronic in vivo porcine animal model. The results showed that no animals studied experienced any hemostatic complications related to the device during the 21-day survival period. A variety of tissue types and vessels were evaluated (shown below).

Vessel type Vessel location Vessel size range

A/V bundle Omentum < 1.0 mm

Gastrosplenic 3.0 mm – 3.5 mm; up to 10.0 mm bundle

Short gastric bundle up to 6.5 mm bundle

L/R ovarian bundle bundles up to 4.0 mm

L/R broad ligament bundles up to 3.0 mm

Artery Splenic artery 4.5 mm – 5.0 mm

Left renal artery 3.0 mm – 5.0 mm

Note: Complete study data on file at Covidien.

Section VI – Technical Description

All specifications are nominal and subject to change due to variability. A specification referred to as “typical” is within ± 20% of a stated value at room temperature (25°C/77°F) and a nominal input voltage.

Product Codes

The assembled Sonicision™ curved jaw cordless ultrasonic 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, battery insertion guide, and battery charger.

SCDA13 Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 13 cm



SCDA26 Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 26 cm



SCDA39 Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 39 cm



SCDA48 Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 48 cm



SCBIGA Sonicision™ Reusable Battery Insertion Guide



SCBA Sonicision™ Reusable Battery Pack



CBCA Sonicision™ Battery Charger



SCGAA Sonicision™ Reusable Generator



Dimensions and Weight (unpackaged)

Component Dimensions (H x W x D) Weight

Assembled device

SCDA13 17.6 cm x 3.9 cm x 28.6 cm 0.45 kg

SCDA26 17.6 cm x 3.9 cm x 41.9 cm 0.47 kg

SCDA39 17.6 cm x 3.9 cm x 54.5 cm 0.48 kg

SCDA48 17.6 cm x 3.9 cm x 63.5 cm 0.49 kg

Cordless ultrasonic dissector

SCDA13 16.7 cm x 3.9 cm x 25.8 cm (13 cm shaft) 0.15 kg

SCDA26 16.7 cm x 3.9 cm x 38.9 cm (26 cm shaft) 0.17 kg

SCDA39 16.7 cm x 3.9 cm x 51.1 cm (39 cm shaft) 0.18 kg

SCDA48 16.7 cm x 3.9 cm x 60.7 cm (48 cm shaft) 0.19 kg

•Active blade length 14.5 mm

Reusable generator 5.7 cm x 3.9 cm x 11.7 cm 0.16 kg

Reusable battery pack 9.5 cm x 2.5 cm x 4.1 cm 0.14 kg

Battery charger 29.0 cm x 13.0 cm x 10.2 cm 1.13 kg

Battery insertion guide 3.6 cm x 18.9 cm x 5.5 cm 0.06 kg

Component Length Weight

Battery charger cord 3.0 m 0.34 kg

Standards

The Sonicision™ curved jaw cordless ultrasonic dissection system conforms to all applicable clauses of AAMI ES60601-1:2012, IEC 60601-1:2012 (Ed. 3.1), IEC 60601-1-6:2013, IEC 60601-12:2014, and CAN/CSA C22.2#60601-1*BEI Issued:2014/02/01 Ed:3 Medical Electrical Equipment Part 1.

In addition, the Sonicision™ reusable battery pack conforms to IEC 62133:2012, IEC 62133-2:2017, IEC 62281:2004, and UN DOT 38.3 (Ed. 5).

Cleaning and sterilization validations of Sonicision™ reusable components conform to ISO 17664:2004, ISO 17665:2013, AAMI TIR12:2010, AAMI TIR30:2011, AAMI ST77:2013, and AAMI ST81:2010.

Electromagnetic Compatibility (EMC)

Electromagnetic Compatibility (IEC 60601-1-2)

The Sonicision™ curved jaw cordless ultrasonic dissection device and battery charger comply with IEC 60601-1-2 specifications regarding electromagnetic compatibility.

The use of accessories other than those specified in the user’s guide and instructions for use may result in increased emissions or decreased immunity of the Sonicision™ curved jaw cordless ultrasonic dissection device and battery charger.

Medical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual.

Portable and mobile RF communications equipment can affect medical electrical equipment. The Sonicision™ curved jaw cordless ultrasonic dissection device and battery charger should not

be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, the Sonicision™ curved jaw cordless ultrasonic dissection device and battery charger should be observed to verify normal operation in the configuration in which they will be used.

Refer to the Guidance and Declaration tables for compliance levels of IEC 60601-1-2 3rd Ed. (2007).

Guidance and manufacturer’s declaration - electromagnetic emissions

The Sonicision™ curved jaw cordless ultrasonic dissection device is intended for use in the electromagnetic environment specified below. The customer or the user of the Sonicision™ curved jaw cordless ultrasonic dissection device should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage fluctuations/ flicker emissions

IEC 61000-3-3

Group 1 The Sonicision™ curved jaw cordless ultrasonic

Class A The Sonicision™ curved jaw cordless ultrasonic

Not applicable

dissection device 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.

dissection device 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.

Guidance and manufacturer’s declaration - electromagnetic immunity

Immunity test IEC 60601 test level Compliance level Electromagnetic

Electrostatic discharge (ESD)

IEC 61000-4-2 ± 8 kV air ± 8 kV air

Electrical fast transient/ burst

IEC 61000-4-4

± 6 kV contact ± 6 kV contact Floors should be wood,

± 2 kV for power supply lines

± 1 kV for input/output lines

(Continued)

Does not apply as the Sonicision™ curved jaw cordless ultrasonic dissection device is battery powered and has no signal leads.

environment guidance

concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Not applicable

Guidance and manufacturer’s declaration - electromagnetic immunity

Immunity test IEC 60601 test level Compliance level Electromagnetic

Surge IEC 61000-4-5

± 1 kV differential mode

± 2 kV common mode

<5% U

Does not apply as the Sonicision™ curved jaw cordless ultrasonic dissection device is battery powered.

(>95% dip in UT) for 0.5 cycle

Voltage dips, short interruptions, and voltage variations on power supply input lines

IEC 61000-4-11

40% U

(60% dip in UT) for 5 cycles

70% U

(30% dip in UT) for 25 cycles

<5% U

Does not apply as the Sonicision™ curved jaw cordless ultrasonic dissection device is battery powered and has no signal leads.

(>95% dip in UT) for 5 sec

(Continued)

environment guidance

Not applicable

Guidance and manufacturer’s declaration - electromagnetic immunity

Immunity test IEC 60601 test level Compliance level Electromagnetic

Power frequency (50/ 60 Hz) magnetic field

IEC 61000-4-8

Note: U

is the mains voltage prior to application of the test level.

3 A/m 3 A/m Power frequency

environment guidance

magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Guidance and manufacturer’s declaration - electromagnetic immunity

Immunity test IEC 60601 test

Conducted RF IEC 61000-4-6

level

3 Vrms 150 kHz to 80

MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5

GHz

Compliance

level

Electromagnetic environment - guidance

Portable and mobile RF communications equipment

Not applicable

should be used no closer to any part of the Sonicision™ curved jaw cordless ultrasonic dissection device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

Not Applicable

3 V/m d=1.2√P 80 MHz to 800 MHz

d=2.3√P 800 MHz to 2.5 GHz where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey should be less than the compliance level in each frequency range

(Continued)

Guidance and manufacturer’s declaration - electromagnetic immunity

Interference may occur in the vicinity of equipment marked with the following symbol.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Sonicision™ curved jaw cordless ultrasonic dissection device is used exceeds the applicable RF compliance level above, the Sonicision™ curved jaw cordless ultrasonic dissection device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Sonicision™ curved jaw cordless ultrasonic dissection device.

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 v/m.

Recommended separation distances between portable and mobile RF communication equipment

The Sonicision™ curved jaw cordless ultrasonic dissection device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Sonicision™ curved jaw cordless ultrasonic dissection device can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Sonicision™ curved jaw cordless ultrasonic dissection device as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of

transmitter (W)

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

and the Sonicision™ curved jaw cordless ultrasonic dissection device

Separation distance according to frequency of transmitter (m)

150 kHz to 80 MHz 80 MHz to 800 MHz

d=1.2√P

0.01 0.12 m 0.12 m 0.23 m

0.1 0.37 m 0.37 m 0.74 m

1 1.2 m 1.2 m 2.3 m

10 3.7 m 3.7 m 7.4 m

100 12 m 12 m 23 m

(Continued)

800 MHz to 2.5 GHz

d=2.3√P

Recommended separation distances between portable and mobile RF communication equipment

Note 1: At 80 MHz and 800 MHz, the separation distance for higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects, and people.

The battery charger is intended for use in the electromagnetic environment specified below. The customer or the user of the battery charger should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

and the Sonicision™ curved jaw cordless ultrasonic dissection device

Guidance and manufacturer’s declaration - electromagnetic emissions

Group 1 The battery charger 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.

(Continued)

Guidance and manufacturer’s declaration - electromagnetic emissions

The battery charger is intended for use in the electromagnetic environment specified below. The customer or the user of the battery charger should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage fluctuations/ flicker emissions

IEC 61000-3-3

Guidance and manufacturer’s declaration - electromagnetic immunity

The battery charger is intended for use in the electromagnetic environment specified below. The customer or the user of the battery charger should assure that it is used in such an environment.

Immunity test IEC 60601 test

Electrostatic discharge (ESD)

IEC 61000-4-2 ± 8 kV air ± 8 kV air

Class A The battery charger is suitable for use in all

establishments other than domestic and those

Class A

Complies

level

± 6 kV contact ± 6 kV contact Floors should be wood, concrete, or

directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Compliance

level

(Continued)

Electromagnetic environment -

ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

guidance

Guidance and manufacturer’s declaration - electromagnetic immunity

The battery charger is intended for use in the electromagnetic environment specified below. The customer or the user of the battery charger should assure that it is used in such an environment.

Immunity test IEC 60601 test

Electrical fast transient/ burst

IEC 61000-4-4

Surge IEC 61000-4-5

± 2 kV for power supply lines

± 1 kV for input/ output lines

± 1 kV differential mode

± 2 kV common mode

level

Compliance

level

± 2 kV for power supply lines

± 1 kV for input/ output lines

± 1 kV differential mode

± 2 kV common mode

(Continued)

Electromagnetic environment -

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

guidance

Guidance and manufacturer’s declaration - electromagnetic immunity

The battery charger is intended for use in the electromagnetic environment specified below. The customer or the user of the battery charger should assure that it is used in such an environment.

Immunity test IEC 60601 test

<5% U

level

(>95% dip in UT) for 0.5 cycle

40% U

Voltage dips, short interruptions, and voltage

(60% dip in UT) for 5 cycles

variations on power supply input lines

IEC 61000-4-11

70% U

(30% dip in UT) for 25 cycles

<5% U

(>95% dip in UT) for 5 sec

Power frequency (50/

3 A/m 3 A/m Power frequency magnetic fields should

60 Hz) magnetic field IEC 61000-4-8

Note: U

is the mains voltage prior to application of the test level.

Compliance

level

<5% U

(>95% dip in UT) for 0.5 cycle

40% U

(60% dip in UT) for 5 cycles

70% U

(30% dip in UT) for 25 cycles

<5% U

(>95% dip in UT) for 5 sec

Electromagnetic environment -

Mains power quality should be that of a typical commercial or hospital environment. If the user of the battery charger requires continued operation during power mains interruptions, it is recommended that the battery charger be powered from an uninterruptible power supply or a battery pack.

guidance

be at levels characteristic of a typical location in a typical commercial or hospital environment.

Guidance and manufacturer’s declaration - electromagnetic immunity

The battery charger is intended for use in the electromagnetic environment specified below. The customer or the user of the battery charger should assure that it is used in such an environment.

Immunity test IEC 60601 test

level

Compliance

level

Electromagnetic environment - guidance

Portable and mobile RF communications equipment Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80

MHz

3 V/m 80 MHz to 2.5

GHz

3 Vrms

3 V/m

should be used no closer to any part of the battery

charger, including cables, than the recommended

separation distance calculated from the equation

applicable to the frequency of the transmitter.

Recommended separation distance

d=1.2√P

d=1.2√P 80 MHz to 800 MHz

d=2.3√P 800 MHz to 2.5 GHz

where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter

manufacturer and d is the recommended separation

distance in meters (m).

Field strengths from fixed RF transmitters, as determined

by an electromagnetic site survey

the compliance level in each frequency range

, should be less than

(Continued)

Guidance and manufacturer’s declaration - electromagnetic immunity

The battery charger is intended for use in the electromagnetic environment specified below. The customer or the user of the battery charger should assure that it is used in such an environment.

Interference may occur in the vicinity of equipment

marked with the following symbol.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the battery charger is used exceeds the applicable RF compliance level above, the battery charger should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the battery charger.

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communication equipment

The battery charger is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the battery charger can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the battery charger as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of

transmitter (W)

0.01 0.12 m 0.12 m 0.23 m

0.1 0.37 m 0.37 m 0.74 m

1 1.2 m 1.2 m 2.3 m

10 3.7 m 3.7 m 7.4 m

100 12 m 12 m 23 m

Note 1: At 80 MHz and 800 MHz, the separation distance for higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects, and people.

150 kHz to 80 MHz

and the battery charger

Separation distance according to frequency of transmitter (m)

d=1.2√P

80 MHz to 800 MHz

d=1.2√P

800 MHz to 2.5 GHz

d=2.3√P

Recommended separation distances between portable and mobile RF communication equipment

Frequency ranges and text condition on transmitter bands

Bands (MHz) Test frequencies (MHz) Modulation Claimed compliance level

380–390 385 Pulse

430–470 450 FM ± 5 kHz Deviation or

704–787 710, 745, 780 Pulsea – 217 Hz 9

800–960 810, 870, 930 Pulsea – 18 Hz 28

1700–1990 1720, 1845, 1970 Pulsea – 217Hz 28

2400–2570 2450 Pulsea – 217Hz 28

5100–5800 5240, 5500, 5785 Pulsea – 217Hz 9

a. Pulse modulation is defined as a square wave input with a 50% duty cycle at the listed frequency. Note 1: The minimum dwell time during test is 8 seconds. Note 2: A minimum separation distance of 0.3 meters should be maintained between any device

transmitting in this band and the battery charger. This includes devices such as mobile phones, PDAs, Wireless LANs, RFID, and Bluetooth™*.

and the battery charger

– 18 Hz 27

Pulsea – 18 Hz

(V/m)

Protection Against Electric Shock

Sonicision™ curved jaw cordless ultrasonic dissection device

Sonicision™ battery charger Class I Equipment

The Sonicision™ curved jaw cordless ultrasonic dissection device and battery charger provide a high degree of protection against electric shock, particularly regarding allowable leakage currents. Accessible conductive parts of the battery charger cannot become live in the event of a basic insulation failure because of the way in which they are connected to the protective earth conductor. The Sonicision™ curved jaw cordless ultrasonic dissection device is type BF isolated (floating) output but it is not intended for direct cardiac application.

Internally Powered Equipment; Defib-Proof Type BF Applied Part

Enclosure Ingress Protection (IP Classification)

Component Classification

Assembled device

Battery charger

Input Power

Battery charger

100–120 VAC, 50 Hz/60 Hz ± 10%, Mains current 2 A maximum

220–240 VAC, 50 Hz/60 Hz ± 10%, Mains current 1 A maximum

IPX2 The assembled Sonicision™ curved jaw cordless ultrasonic

IP2X The battery charger is constructed to prevent finger contact with

dissection device is constructed so that vertically falling drops shall have no harmful effects when the device enclosure is tilted at any angle up to 15 degrees on either side of the vertical.

hazardous parts within the charger, and penetration of an enclosure by a solid foreign object with a diameter equal to or greater than 12.5 mm.

Reusable Battery Pack

Battery-pack SKU SCBA

Battery-pack type Rechargeable lithium-ion

Mode of insertion Manual

Number of cells 2

Cell voltage 3.6 VDC nominal

Battery-pack voltage 7.2 VDC

Discharge rate Maximum 10 A

Battery-pack capacity See Sonicision™ reusable battery pack label for battery rating

Watt-hour rating See Sonicision™ reusable battery pack label for battery rating

Battery-charge time (typical) 180 minutes or less

Battery-pack life Designed to be used up to 200 times.

Battery storage Store battery packs at 18–25°C (64–77°F) in a dry, ventilated area.

information

Elevated temperatures can result in reduced battery-service life. If the battery pack is stored off of the charger, the battery pack should be returned to the charger before use to verify functionality, state of charge, and recharge as necessary.

Duty Cycle (Mode of Operation)

Caution

Use of a duty cycle no greater than 33% (3 seconds on, 5 seconds off and a rest period of 1 minute after 60 activations). Duty cycles above 33% increase the risk of overheating, increasing the risk of injury to the operator and failure of the device to operate as intended.

Use of the above mentioned duty cycle for an expected use of 300 activations in a procedure may result in temperatures up to and including 46.2°C (115°F) along the proximal portion of the shaft up to 6 cm from the distal end. Further distal of this point is considered an applied part intended to supply heat and will generate higher temperatures to achieve clinical tissue effect. A temperature of 46.2°C (115°F) is within the safe maximum touch temperature range as specified by IEC 60601-1 (2012/R, 2014) Edition 3.1 Table 24.

Mains Frequency (50 Hz/60 Hz) Leakage Current

Sonicision™ battery charger

Enclosure (touch) current • Ground intact (normal condition) < 100 μA

• Ground open (single fault condition) < 500 μA

Mains Frequency DC Leakage Current

Sonicision™ curved jaw cordless ultrasonic dissection device

Enclosure (touch) current • 10 μA Normal use

• 50 μA Single fault

Power Cord

The battery charger is equipped with a power cord (unshielded). Should the AC power cord need to be replaced, the replacement plug/cable/receptacle must meet or exceed the following specifications:

100–120 VAC

Electrical ratings 125 VAC, 10 A

Cable SJT18/3, maximum length 3.05 m (10 ft)

Unit receptacle IEC female

220–240 VAC

Electrical ratings 250 VAC, 6 A

Cable H05VVF3G1.0 VDE, maximum length 4.57 m (15 ft)

Unit receptacle IEC female

Equipotential Ground Connection

An equipotential ground connection is provided to allow optional connection of the battery charger to ground.

USB Connection

The USB port on the back of the battery charger is for factory use only.

Alert Tones

The audio levels stated below represent activation and system-alert tones at a distance of 38-51 cm. (Refer to Device Status and Troubleshooting on page 24 for additional information on alert tones.)

Volume (non-adjustable) 50–80 dBA

Frequency 250–1150 Hz

Duration 50–750 ms

Battery Charger Fuses

Type 5 mm x 20 mm

Voltage 250 VAC

Current 2.5 A

Operating speed Fast blow

Interrupt rating 35 A at 250 VAC

Limited Warranty

Covidien warrants each covered product listed below to be free from defects in material and workmanship for normal use as specifically described herein. Covidien’s obligation under this limited warranty is limited to the repair or replacement, at its sole option, of any product, or part thereof, which has been returned to it (or its authorized distributor) within the applicable time period shown below after delivery of the product to the original purchaser, and which examination discloses, to Covidien’s satisfaction, that the product does not conform to this warranty. This limited warranty does not apply to any product, or part thereof, which has been repaired, or altered in a way so as, in Covidien’s judgment, to affect its stability or reliability. In addition, this limited warranty does not cover misuse, neglect, or accident, such as but not limited to: improper cleaning or sterilizing (for example, ultrasonic cleaner, immediate-use (flash) steam sterilization, hydrogen peroxide, ethylene oxide [EO]), improper handling (for example, dropping), non-intended use (for example, incising bone, contraceptive tubal occlusion), refurbishing, or attempted reuse of single use components.

The warranty periods for the Sonicision™ curved jaw cordless ultrasonic dissection system is as follows:

Sonicision™ reusable generator

Sonicision™ reusable battery pack

Sonicision™ battery charger

Sonicision™ curved jaw cordless ultrasonic dissector

Sonicision™ reusable battery insertion guide

One year from date of shipment, 150 sterilization cycles, or 150 surgical uses (whichever comes first)

One year from date of shipment, or 200 surgical uses (whichever comes first)

One year from date of shipment

Sterility only as stated on packaging

One year from date of shipment or 150 sterilization cycles (whichever comes first)

Notwithstanding any other provision herein or in any other document or communication, Covidien’s liability with respect to this limited warranty and the products sold hereunder shall be limited to the aggregate purchase price for the products sold to the customer. This limited warranty is non-transferable and runs only to the original purchaser of the covered product(s). There are no warranties which extend beyond the terms hereof. Covidien disclaims any liability hereunder or elsewhere in connection with the sale of products and for any form of indirect, tort, or consequential damages.

For purposes of this limited warranty, Covidien shall consider a sterilization cycle to be following the steps contained in the Sterilizing Section of this user's guide.

This limited warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Colorado, USA. The sole forum for resolving disputes arising under or relating in any way to this limited warranty is the District Court of the County of Boulder, State of Colorado, USA.

Covidien reserves the right to make changes in covered products built or sold by it at any time without incurring any obligation to make the same or similar changes to equipment previously built or sold by it.

THE OBLIGATION TO REPAIR OR REPLACE A DEFECTIVE OR NONPERFORMING PRODUCT IS THE SOLE REMEDY OF THE CUSTOMER UNDER THIS LIMITED WARRANTY. EXCEPT AS EXPRESSLY

PROVIDED HEREIN, COVIDIEN DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO PRODUCTS, INCLUDING WITHOUT LIMITATION ALL IMPLIED WARRANTIES, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

Technical Support

Within the U.S. +1 800 255 8522

Outside the U.S. To contact your local Covidien support, go to

http://www.medtronic.com/covidien/support/service-centers or call +1 303 476 7996

California Proposition 65 Statement

For information regarding California Proposition 65, please refer to www.covidien.com/ caprop65.

China RoHS Compliance

Hazardous Substance Table

(Part Name)

(Pb) (Hg) (Cd) (CR(VI))

SCGAA

XOO O O O

SCDAXX

OOO O O O

SCBA

XOO O X X

CBCA

XOO O X X

(Toxic and Hazardous Substances or Elements)

(PBB)

(PBDE)

O: GB/T 26572.

O: indicates that the content of the toxic and hazardous substance in all the Homogenous Materials of the part is below the concentration limit requirement as described in GB/T 26572.

X: GB/T 26572 ( SJ/T 11364

X: indicates that the content of the toxic and hazardous substance in at least one Homogenous Material of the part exceeds the concentration limit requirement as described in GB/T 26572.

(Information provided in this table is solely for compliance with SJ/T 11364 and the Management Measures for the Control of Pollution by Electronic Information Products.)

)



Not made with natural rubber latex



Consult

Instructions

for Use







Caution





ÑPT00101127_Ó

Part No. PT00101127

COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. ™* brands are trademarks of their respective owners. Other brands are trademarks of a Covidien company. May be covered by U.S. Patents: www.covidien.com/patents

 Covidien llc,

15 Hampshire Street, Mansfield, MA 02048 USA.

Medtronic B.V. Earl Bakkenstraat 10,



6422 PJ Heerlen, The Netherlands.

Product of

www.covidien.com

REV 05/2020

PT00101127

USA (from US and foreign materials).

Medtronic CBCA User’s Manual

Specifications and Main Features

Frequently Asked Questions

User Manual