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Indications
The HARMONIC HD 1000i Shears instrument is indicated for soft tissue incisions when bleeding control
and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for
electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic,
exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic
vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up
to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.
Contraindications
•
The instruments are not indicated for incising bone.
•
The instruments are not intended for contraceptive tubal occlusion.
Undesirable Side Effects/Residual Risks
Undesirable side effects and risks associated with ultrasonic devices include the potential for bleeding,
tissue injury via mechanical or thermal damage, introduction of non-sterile surfaces or pathogen transfer,
inflammatory or unintended tissue reaction, electrical shock, foreign body or magnetic resonance
incompatibility, and property or environmental damage. Also, unintended harm, extended surgery, or altered
surgical approach may result from issues related to device activation, damaged devices, electromagnetic
interference, audible noise due to misassembly, misuse of the torque wrench, or an attempt to alter the
device.
Device Description
The HARMONIC HD 1000i Shears instrument is a sterile, single patient use instrument used for dissection,
grasping, coagulation, and cutting between the blade and clamp arm. It consists of an ergonomic handle
with an integrated hand piece and two energy delivery buttons:
1) Energy button
- user can adjust power levels from 1-5.
2) Energy button with Advanced Hemostasis
The instrument is available in two shaft lengths -- 20 cm and 36 cm.
An integrated audible and tactile mechanism in the handle indicates full trigger closure. The instrument
has a clamp arm and coated curved blade that are designed to work through a 5 mm trocar, through a 5 mm
reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instrument
shaft can be rotated continuously to facilitate visualization and access to targeted tissue. The two dashes on
the instrument are intended to represent relative vessel size. The Energy button is indicated for vessels up
to 5 mm in diameter. When the Energy button is used, cutting speed is the fastest. The Energy button with
Advanced Hemostasis is designed for larger vessels and is indicated for vessels up to 7 mm in diameter.
When the Energy button with Advanced Hemostasis is used, cutting speed is reduced and hemostasis is
maximized. The instrument utilizes Adaptive Tissue Technology. This provides the generator with the
ability to identify and monitor the instrument during use, which enables the generator to modulate and
adjust its power output as well as provide audible feedback to the user as appropriate.
The HARMONIC HD 1000i Shears instrument is designed for use exclusively with the Generator G11
(GEN11) software version 2016-1 or later. Software revision can be found under "System Information" in
the Generator G11 (GEN11) "Settings" menu. Refer to the Generator G11 (GEN11) Operator's Manual for
more information.
Illustration and Nomenclature (Illustration 1)
1. Coated Blade
5.
2. Clamp Arm and Tissue Pad
6.
3. Shaft
7.
4. Rotation Knob
8.
Transport and Storage Conditions
Temperature: -22°C to +60°C
Relative Humidity: 10-80%
- for large vessel sealing; user cannot adjust.
Energy Button
Energy Button with Advanced Hemostasis
Handle
Trigger
1
Warning and Caution Statements
WARNING: A Warning statement indicates an operating or maintenance procedure, practice, or condition
that, if not strictly observed, could result in personal injury or loss of life.
Caution: A Caution statement alerts the user of a potentially hazardous situation which, if not avoided, may
result in minor or moderate injury to the user or patient or damage to the equipment or other property. It
may also be used to alert against unsafe practices. This includes the special care necessary for the safe and
effective use of the device and the care necessary to avoid damage to a device that may occur as a result of
use or misuse.
Instructions for Use
Verify compatibility of all instruments and accessories prior to using this instrument (refer to Warnings and
Precautions).
1
Using sterile technique, remove the instrument from the package. To avoid damage, do not flip the
instrument into the sterile field.
2
Connect the instrument to the generator and turn the generator power on.
3
Select the desired power level using the INCREASE and DECREASE buttons on the generator
touchscreen. Only the power level for the Energy button can be adjusted (1-5). The system defaults to
power level 5. (Illustration 2) For greater tissue cutting speed use a higher generator power level, and
for greater coagulation use a lower generator power level. The amount of energy delivered to the tissue
and resultant tissue effects are a function of many factors, including the power level selected, blade
characteristics, grip force, tissue tension, tissue type, pathology, and surgical technique.
4
Close the clamp arm by closing the trigger, and insert the shaft through a trocar or incision
(Illustration 3).
5
Position the tissue within the jaws at the desired location. The instrument's shaft can be rotated
continuously using the rotation knob to facilitate visualization and access to target tissue.
6
Squeeze the trigger until it stops against the plastic handle (and a click is heard) to clamp targeted tissue
between the jaws.
•To achieve complete sealing, the trigger should be fully closed and the vessel fully contained between
clamp arm and blade of device. An audible and tactile "click" indicates full trigger closure. To achieve
full closure of the jaws of the device, squeeze the plastic trigger until you feel it stop against the plastic
handle (plastic to plastic). Grip force needs to be maintained throughout the transection to keep trigger
closed.
7
To activate the instrument blade, press one of the foot pedal switches or one of the energy buttons on the
instrument.
•Pressing the left foot pedal of the footswitch or the Energy button with Advanced Hemostasis on the
instrument activates Advanced Hemostasis. When using the Energy button with Advanced Hemostasis,
energy is not delivered unless the jaws are completely closed. This button activates an algorithm in the
generator that, in conjunction with full trigger closure, allows for sealing larger vessels (up to 7 mm in
diameter).
•Pressing the right foot pedal of the footswitch or Energy button on the instrument activates the selected
power level (1-5). The Energy button allows for sealing vessels up to 5 mm in diameter with full trigger
closure and can enable other soft tissue applications (backcutting, scoring, drilling/otomy creation, etc.),
where full trigger closure is not needed.
Foot Pedal
Right
Left
Energy Button with Advanced
Button
Energy Button
Hemostasis
2
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