Sonicision System Product Manual

Energy whenever and wherever you want it

The SONICISION System  The industry’s first cordless ultrasonic dissection system now offers the widest portfolio and ease of standardization ™

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Table of Contents Why Ultrasonic?

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Complete Product Portfolio 13

Product Overview 5

Competitive Comparison 14

Clinical Performance 9

Assembly and Disassembly 15

Procedural Application 12

Cleaning and Sterilization

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Why Ultrasonic? Covidien has long been a pioneer in creating medical devices that use various forms of energy. Covidien Energy offers the largest energy-based, and now the most versatile cordless ultrasonic portfolio in the industry.

Laparoscopic

Open Vessel

Efficient

Monopolar

Multifunction

Sealing

and Versatile

Hundreds of products you use every day with over 40 years of innovation

Covidien’s first multifunctional instrument for vessel sealing and monopolar dissection in minimally invasive surgery

Instruments for hemostasis in open surgery

Multifunctional device offering one-step sealing, a Maryland dissector, grasper and cold scissors.

Valleylab™ Devices

MORE ENERGY MORE PLACES

Ultrasonic Energy

LigaSure™ Technology

ForceTriad™ Energy Platform ➤

Open Small Jaw Laparoscopic

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Bipolar

Vessel Sealing

Energy and instruments for specialty procedures in gynecology, urology and neurosurgery

Energy and instruments for hemostasis in minimally invasive surgery

Vessel Sealing Instrument for hemostasis and fine dissection in open surgery

With the Sonicision™ device, Covidien has an expanded portfolio and is a single solution provider for energy devices.

The energy portfolio available allows complete standardization to reduce costs.

Product Overview The Sonicision™ cordless ultrasonic dissection device is an unparalleled advancement in ultrasonic energy. The device delivers comparable clinical effectiveness associated with leading ultrasonic technologies and unique benefits from the industry’s first cordless design.

The Sonicision™ device also utilizes a unique dual-mode energy activation control for seamless transition between two power modes within a single button. This intuitive design allows a surgeon’s eyes to remain in the surgical field rather than on the instrument for improved procedural focus.

The Sonicision™ device allows improved freedom of movement in the operating room through the innovation of cordless technology. The streamlined design features a quick and simple set up that increases O.R. efficiency.

The Sonicision™ system is composed of single-use and reusable components for maximum efficiency and utilization in surgical specialties that include: general (including upper gastrointestinal), bariatric, colorectal, pediatrics, gynecological and urological procedures.

The Sonicision™ device reliably seals vessels up to 5 mm, provides faster dissection speed2 and up to 5x less plume than the Harmonic ACE™*3, and is comparable to the Harmonic ACE™* and Harmonic ACE+™* in thermal spread8, burst pressure11, sealing time9 and temperature.2,4,10

COMPONENTS

INDICATOR LED

REUSABLE GENERATOR

TORQUE WRENCH

AUDIO SPEAKER MULTIPLE LENGTHS AVAILABLE*

14.5 MM ACTIVE BLADE

360º SHAFT ROTATION WHEEL

* SONICISION™ IS AVAILABLE WITH THE FOLLOWING SHAFT LENGTHS: –– 13 CM –– 26 CM –– 39 CM –– 48 CM

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ULTRASONIC DISSECTOR DUAL-MODE ENERGY BUTTON REUSABLE BATTERY

STERILIZATION TRAY

BATTERY CHARGER

Product Overview AVAILABLE LENGTHS ULTRASONIC DISSECTOR

39 CM LENGTH

• Single patient use • 5 mm diameter • 14.5 mm active blade • Dual-mode energy button (minimum and maximum) Ordering Code: SCD396

SCD391 (select countries only) Order Quantity: 6 ultrasonic dissectors 39 cm 1 ultrasonic dissector 39 cm (1 torque wrench included (1 torque wrench included) with each dissector)

13 CM LENGTH

Ordering Code: SCD13 Order Quantity: 6 ultrasonic dissectors 13 cm (1 torque wrench included with each dissector)

48 CM LENGTH

26 CM LENGTH

Ordering Code: Order Quantity:

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SCD26 6 ultrasonic dissectors 26 cm (1 torque wrench included with each dissector)

DISTAL MEASUREMENT MARKERS

Ordering Code: Order Quantity:

SCD48 6 ultrasonic dissectors 48 cm (1 torque wrench included with each dissector)

Product Overview AVAILABLE LENGTHS

REUSABLE BATTERY

BATTERY CHARGER

Ordering Code: SCG Order Quantity: 1 battery pack • R eusable for up to 100 uses • Sterilizable via low temperature hydrogen peroxide • Advanced lithium polymer battery chemistry

Ordering Code: CBC Order Quantity: 1 battery charger (batteries not included) • F our charging bays • Supports charging of 4 batteries simultaneously STERILIZATION TRAY

REUSABLE GENERATOR

Ordering Code: SCG Ordering Quantity: 1 generator • Reusable for up to 100 uses • Sterilizable via low temperature hydrogen peroxide • Integrated LED provides device feedback

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Ordering Code: SCST (U.S. customers only) SCST1 (outside U.S. customers only) Order Quantity: 1 sterilization tray • Holds one generator and one battery

Award-Winning Device MDEA GOLD

RED DOT

ESP AWARD

BOULDER IQ

The Medical Design Excellence Awards (MDEA) competition is the MedTech Industry’s Premier Award - given to the most significant advances in medical product design and engineering of a groundbreaking product in the surgical equipment.

An international design and business competition awarded by the Design Zentrum Nordrhein, Westfalen in Essen, Germany. An internationally recognized quality label and award for excellent design selected by expert juries in the areas of product design, communication design and design concepts.

At the 2013 Excellence in Surgical Products Award, the Sonicision™ System won in the Best in Show category (2nd place). Based on products that have contributed to surgical performance, efficiency and safety.

The Innovation Quotient, or IQ, program honors the most innovative new products and services in Colorado. The Sonicision™ System won both the Innovation of the Year Award from the audience and the Business Products and Services category from a panel of judges. 2013 WINNER

2 0 1 3 GOLD WINNER

2013 WINNER 8

Clinical Performance Performance of the Sonicision™ Cordless Ultrasonic Dissection Device compared to the Harmonic ACE™* and Harmoic ACE+™*.

OVERVIEW •

The Sonicision™ device mean thermal spread, mean vessel burst pressure, hemostasis, mean seal time and mean peak active blade temperature are comparable to the Harmonic ACE™* and Harmonic ACE+™*2,4,8-11

•

The Sonicision™ device provides faster dissection speed than the Harmonic ACE™*2

•

The Sonicision™ device produces up to 5x less plume than the Harmonic ACE™*3

•

The Sonicision™ device provides faster active blade cool down time to 60°C than the Harmonic ACE™*1

•

The Sonicision™ device reliably seals vessels up to 5 mm in diameter2

BACKGROUND

Thermal spread, vessel burst pressure, hemostasis, seal time and blade temperature are comparable to the Harmonic ACE™* and Harmonic ACE+™*2, 4, 8-11 9

Energy-based hemostatic devices have evolved over the past century to become an essential tool in surgery. The latest innovation from Covidien into this arena is the completion of the Sonicision™ cordless ultrasonic portfolio. Now with four available shaft lengths, inclusive of the the longest and shortest pistol grip ultrasonic device on the market with optimized ergonomic design. In turn, this portfolio utilizes advanced ultrasonic technology to provide rapid dissection and hemostasis without the need for a stand-alone generator or cord, therefore increasing the ease of operation and freedom of movement. A variety of tests have been performed to date by Covidien to evaluate the performance of the Sonicision™ device compared to the Harmonic ACE™* and Harmonic ACE+™*.

The following table summarizes the pre-clinical comparative testing between the Sonicision™ device and the Harmonic ACE™*: SUMMARY Differences between the Sonicision™ cordless ultrasonic dissection device and the Harmonic ACE™* were found to be non-significant in regard to mean vessel burst pressure, mean thermal spread, mean peak active blade temperature and mean seal time. The Sonicision™ device was statistically faster in mean dissection speed and mean active blade cool down time to 60 degrees C in these tests.1,2,4 Mean Vessel Burst Pressure (mmHg ± SD)2

Mean Dissection Speed (sec ± SD)2

Mean Peak Active Blade Temperature (°C ± SD)4

Mean Active Blade Cool Down Time to 60°C (sec ± SD)1

Mean Thermal Spread (mm ± SD)2

Mean Seal Time (sec ± SD)2

Sonicision™

578 ± 284

24.8 ± 4.9

249.7 ± 24.3

41.2 ± 1.3

1.06 ± 0.05

5.2 ± 1.7

ACE™*

605 ± 288

33.8 ± 5.4

239.3 ± 28.4

50.4 ± 7.5

1.08 ± 0.5

4.9 ± 1.5

P-Value

0.48

<0.001

0.173

0.006

0.82

0.20

Statistical Relevance

NS

Statistically Significant

NS

Statistically Significant

NS

NS

Sonicision™ provides faster dissection2 and has a faster active blade cool down time4 than the Harmonic Ace™*.

Average Coagulation Obstruction

Average Cutting Obstruction

Maximum Obstruction (%)3

Maximum Obstruction (%)3

Sonicision™

4.80 ± 0.86

8.76 ± 1.49

ACE™*

26.63 ± 3.70

12.65 ± 0.97

P-Value

<0.001

0.026

Statistically Significant

NS

Statistical Relevance

Sonicision™ produces up to 5x less plume than the Harmonic Ace™*3

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The following table summarizes benchtop testing between the Sonicision™ device and the Harmonic ACE+™*: Mean Vessel Burst Pressure (mmHg ± SD)11

Mean Dissection Speed (sec ± SD)10

Mean Peak Active Blade Temperature (°C ± SD)10

Mean Active Blade Cool Down Time to 60°C (sec ± SD)10

Mean Thermal Spread (mm ± SD)8

Mean Seal Time (sec ± SD)9

Sonicision™

868.4 ± 419.9

43.4 ± 7.0

263.1 ± 18.8

37.6 ± 4.4

1.44 ± 0.5

8.40 ± 3.60

ACE+™*

1030.1 ± 405.1

44.6 ± 4.3

266.3 ± 20.2

37.4 ± 5.8

1.25 ± 0.2

8.12 ± 3.74

P-Value

P = 0.18

P = 0.777

P = 0.771

P = 0.704

P = 0.100

P = 0.62

Statistical Relevance

NS

NS

NS

NS

NS

NS

The Harmonic Ace+™* showed no statistical improvements compared to the Sonicision™ ultrasonic dissector.

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Procedural Applications OPEN PROCEDURES Colorectal • Abdominoperineal Resection • Low Anterior Resection General • Axillary Node Dissection • Liver Resection • Mastectomy • Ventral Hernia Gynecology • Myomectomy • Total Abdominal Hysterectomy

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LAPAROSCOPIC PROCEDURES Pediatrics • Appendectomy • Colectomy • Splenectomy

Bariatric • Gastric Band • Roux-en-Y • Sleeve Gastrectomy

Thoracic • Pneumonectomy • Pulmonary Lymph Node Dissection

Colorectal • Colectomy

Urology • Prostatetomy

General • Adrenalectomy • Appendectomy • Cholecystectomy • Nissen Fundoplication • Splenectomy

Gynecology • Hysterectomy • Lysis Pelvic Adhesions • Salpingo-Oophorectomy • Supracervical Hysterectomy Thoracic • Lobectomy • Minimally Invasive Esphogectomy Urology • Cystectomy • Nephrectomy

Complete Product Portfolio The right energy solution for procedural need and surgeon preference - from a single manufacturer Dissection

Multi-Function

• Smaller vessels

• Primarily dissection with

• Primarily vessel sealing

Vessel Sealing • Up to 7 mm vessels

some vessel sealing

with some dissection

Electrosurgery

Ultrasonic

RF and ES

RF

Force TriVerse™

Sonicision™

LigaSure Advance™ II

LigaSure™ 5 mm

• Sterile field power

control •A  ccess to Valleylab

™

mode

• Freedom (cordless)

• Multi-functionality

• Proven LS performance

• Standardization

• Bariatric length (44 cm)

• Independent cutting and

•F  aster set up and

• Valleylab™ mode

dissection2

dissection

sealing • Cooler temperature

profile

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Competitive Comparison ULTRASONIC DISSECTOR COMPARISON

Measure:

Sonicision

J&J Harmonic™* ACE

Shaft Length

- 13 cm - 26 cm - 39 cm - 48 cm

- 14 cm - 23 cm - 36 cm - 45 cm

- 23 cm - 36 cm

- 10 cm - 20 cm - 35 cm - 45 cm

Method of Activation

Hand 1 button, 2 stage

Hand 2 buttons

Hand 2 buttons

Hand 2 buttons

Frequency

55.5 khz

55.5 khz

55.5 khz

47.7 khz

Jaw Length12

14.5 mm

11.1 mm

10.7 mm

16.5 mm

337.47 grams

341.86 grams

386.86 grams

™

Total Weight of Device Assembled13 394.25 grams (with cords and transducer)

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J&J Harmonic ACE+™*

Olympus Thunderbeat™*

Assembly and Disassembly STEP 1 – ATTACH AND TORQUE GENERATOR Shaft Rotation Wheel

1 Generator

Torque Knob

1. S lide the generator into the opening of the ultrasonic dissector and hand tighten clockwise while holding the shaft rotation wheel.

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3

2. Place torque wrench over the generator torque knob. 3. Rotate clockwise while holding rotation wheel in place until two clicks are felt or heard. Remove torque wrench and keep in sterile field.

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Assembly and Disassembly STEP 2 – ATTACH BATTERY

STEP 3 – TEST

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u

2 1

1. Orient battery pack as shown. 2. Swing the battery forward and snap into place.

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When properly assembled, a series of tones sound and the LED on the generator illuminates green.

1. W  ith jaws open, activate the dual-mode energy button in minimum (half squeeze) and maximum (full squeeze) power modes. Device is ready for use if minimum and maximum power pulsating tones are heard.

Assembly and Disassembly REPLACING BATTERY

INTRAOPERATIVE TROUBLESHOOTING

1 2 3

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1. R  emove battery by pushing up on the battery pack release latch. 2. S wing the battery toward the rear of the ultrasonic dissector to disconnect. 3. Attach new battery as shown in Step 2 above. When the device is fully assembled repeat STEP 3 - TEST.

RED INDICATOR LIGHT Device is non-functional

1. Clean  jaw and blade (wipe with wet gauze and/or immerse in saline and activate energy with jaws open). 2. Disconnect and reconnect battery. 3. Replace battery. 4. Replace ultrasonic dissector.

Assembly and Disassembly GENERATOR INDICATOR LIGHTS

GREEN

RED

FLASHING YELLOW

FLASHING PURPLE

System is ready (minimum or maximum power).

Device is non-functional (see intraoperative troubleshooting section or IFU).

Battery charge is less than 20% capacity (approximately 10-20 activations remaining upon initial notice).

Generator has reached end of life (replace generator).

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Cleaning and Sterilization CLEANING 1. Preparation for Cleaning • Visually inspect the generator, battery, and sterilization tray for damage. Replace if damaged. • Prepare a solution of pH neutral, pH neutral enzymatic or alkaline detergent in accordance with the manufacturer’s instructions. 2. Soaking • Soak the generator, battery and sterilization tray in the detergent mix for 5 to 10 minutes. 3. Manual Cleaning • Manually clean the battery, generator and sterilization tray using a stiff, nylon bristle brush and the detergent solution. • Thoroughly clean the generator retention ring, generator seam, battery seam, battery pack release latch and battery contact points. Do not use abrasive cleaning agents or metal cleaning tools, such as stainless steel brushes. • Thoroughly rinse components with clean water. CAUTION: DO NOT wash components in automatic instrument washer or ultrasonic washer. 19

4. Drying • Dry generator, battery and sterilization tray with a clean, lint-free cloth. With cool, clean oil-free air, blow dry all components until completely dry. 5. Disinfecting (optional) • If facility processes require disinfection prior to sterilization, wipe the surfaces of the generator, battery and sterilization tray with an isopropyl-alcohol (up to 100%) surface disinfectant.

BATTERY CONTACT POINTS

GENERATOR RETENTION RING

GENERATOR SEAM

BATTERY PACK RELEASE LATCH BATTERY SEAM

Cleaning and Sterilization STERILIZING 1. Ensure generator, battery and sterilization tray are clean and dry before sterilization. 2. Place the generator and battery in the tray. 3. Cover sterilization tray base with lid and latch. 4. Utilize one of the following sterilization configurations: Sterilizer

Sterile Barrier

STERRAD™* 100S STERRAD™* NX™* STERRAD

™*

100NX

™*

Polypropylene Wrap

Tyvek Pouch (Single)

Tyvek Pouch (Double)

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5. Follow these steps according to the sterile barrier selected: • Polypropylene Wrap – Wrap the sterilization tray in a compatible polypropylene sterilization wrap according to the manufacturer’s instructions. • Single Tyvek Pouch – Place the sterilization tray in a single compatible Tyvek pouch, and seal according to the manufacturer’s instructions. • Double Tyvek Pouch – Place the sterilization tray within two compatible Tyvek pouches, and seal according to the manufacturer’s instructions. The Tyvek side of the inside pouch must be aligned with the Tyvek side of the outside pouch. 6. Sterilize the generator and battery within the enclosed sterilization tray using the following STERRAD™* or STERIS V-PRO™* models/cycles in accordance with manufacturer’s instructions:

CAUTION: DO NOT STEAM AUTOCLAVE, FLASH or use EtO to sterilize any part of the device or accessories. Use low-temperature hydrogen peroxide sterilization only.

Model Cycle ™* STERRAD 100S Standard, Short or Long* STERRAD™* NX™* Standard ™* ™* STERRAD 100NX Standard STERIS AMSCO™* V-PRO™* 1 Lumen ™* ™* STERIS AMSCO V-PRO 1 Plus Lumen STERIS AMSCO™* V-PRO™* maX Lumen

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*Short and Long cycles are not available on 100S models sold in the United States

STERIS V-PRO

™*

1

STERIS V-PRO™* 1 PLUS STERIS V-PRO™* maX