Shaw SG6 User manual

Shaw Scalpel System
Model SG6 Controller
Part Number 7013-0006
For use with the Model 9050 Disposable Scalpel Handles
Instructions for Use
3439300-RevB

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Introduction
Shaw scalpel blades are similar in size, shape, and sharpness to traditional steel scalpel blades; however,
Shaw blades can be heated to a user-selected temperature appropriate for sealing small vessels as they
are cut.
To cut and simultaneously seal blood vessels eectively with minimum tissue damage, the sharp steel cutting
edge of a heated scalpel blade must be uniformly maintained at the desired temperature within narrow
limits. The Shaw Scalpel System utilizes micro-circuitry incorporated within the blade itself to maintain the
cutting edge temperature within the necessary tolerance, selectively delivering additional thermal energy
only to those regions of the blade using heat due to tissue contact. By so doing, the Shaw Scalpel System
automatically compensates for the varying degrees of heat loss that occur during surgical procedures
(depending on the type of tissue being incised and the rate at which cutting is carried out), maintaining the
cutting edge in the desired temperature range.
In contrast with electrosurgical devices, the Shaw Scalpel System passes no electrical current through
the patient, and there is no sparking or electrical arcing to the tissue. Electrosurgical devices “cut” and/or
cauterize using electrical currents which pass through the patient vaporizing tissue at the point of contact
and generating heat and tissue damage down the path of the electrical current. The Shaw Scalpel System
cuts tissue with a sharpened steel edge, like a conventional cold-steel scalpel blade, and simultaneously
seals blood vessels using heat thermally conducted to the tissue from an elevated-temperature blade which is
electrically insulated from the patient. By thermally transferring heat from a uniformly-controlled, essentially
constant temperature blade, the amount of tissue damage associated with hemostatic cutting is minimized.
Indications For Use
The Shaw Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics
of the traditional steel scalpel while minimizing blood loss by simultaneously sealing blood vessels as
they are cut, with minimum damage to surrounding tissue and virtually no muscle stimulation, using heat
thermally conducted to the tissue from an elevated-temperature blade.
Rx Only – CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Contraindications
The Shaw Scalpel System is contraindicated in the presence of a FLAMMABLE ANESTHETIC MIXTURE
WITH AIR or OXYGEN or NITROUS OXIDE.

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Potential Adverse Eects
Known potential adverse eects include, but are not limited to, thermal injury to tissue, including nerves or
other delicate tissues, and inability to eectively provide hemostasis of larger vessels.
Notice To Users And/Or Patients
Any serious incident that occurs in relation to the device should be reported to the manufacturer and the
competent authority of the Member State in which the user and/or patient is established.
System Warnings
1. EXPLOSION HAZARD – The Shaw Scalpel System is contraindicated in the presence of a FLAMMABLE
ANESTHETIC MIXTURE WITH AIR or OXYGEN or NITROUS OXIDE.
2. NO MODIFICATION OF THIS EQUIPMENT IS ALLOWED.
3. Electrical shock hazard. Do not remove cover. Refer to manufacturer for service.
4. Do not attach unapproved components to the SG6 unit to avoid electrical shock.
5. Ensure the sound volume is adequately adjusted so that audio indications and alerts are clearly heard.
6. To avoid risk of electric shock, this equipment must only be connected to a supply main with
protective earth.
7. This equipment has been tested and found to comply with the limits for medical devices to the
IEC60601-1-2:20 {ed 4.1}. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. This equipment radiates electromagnetic fields and, if not
installed and used in accordance with the instructions, may cause harmful interference. However, there
is no guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference to other devices, which can be determined by turning the equipment o and on, or
is aected by interference from other devices, the user is encouraged to try to correct the interference
by one or more of the following measures:
• Reorient or relocate the receiving device.
• Increase the separation between the equipment.

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• Connect the equipment into an outlet on a circuit dierent from that to which the other device(s)
are connected.
• Consult the manufacturer.
8. Any attempt to plug non-Shaw equipment into the output connectors may result in damage to the SG6
unit thereby terminating any warranties and may result in an unsafe electrical condition, increased
electrical emissions, or decreased immunity of the Shaw system. Anyone who connects additional
equipment via the output connectors is therefore responsible for configuring a medical system and is
responsible that the newly configured system complies with the requirements of the system standards
IEC 60601-1 and IEC 60601-1-2
System Precautions
1. It is important that the Shaw Scalpel System (SG6) operator be familiar with the System’s Operator’s
Manual, its precautions, procedures, and safety issues. Read the complete operators manual before
using this equipment.
2. Do not position the SG6 unit to make it dicult to remove and insert the unit’s separable power cord plug.
3. There are hazardous electrical and thermal outputs. This equipment should be used only by qualified
medical personnel
4. Disconnect power to the SG6 before cleaning the unit to avoid electrical shock.
5. To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections.
Connect the SG6 unit to hospital grade receptacles only, using a hospital grade AC power cord.
6. The SG6 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use
is necessary, the SG6 should be observed to verify normal operation in the configuration in which it will
be used.
7. Do not operate the SG6 in the presence of Magnetic Resonance Imaging Equipment.
8. If choosing to mount to an IV Pole, follow the recommendations on page 10. Failure to comply could
result in an injury to the user or the patient.
9. The recommended temperature setting for skin incisions is 70° C. For minimal scarring, make the initial
skin incision with the scalpel handle in the OFF position. Cutting with the blade unheated will eliminate
the possibility of superficial skin scars due to contact with a heated blade. If you’d like to cut with a
heated blade, use lower temperature settings for skin incisions (70° C - 110°C).

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10. User should select the lowest set point temperature that will aord adequate hemostasis for the maximum
anticipated rate of tissue cutting, thereby minimizing unnecessary (thermal) necrosis of tissue.
11. Care should be taken when using the Shaw to dissect around nerves and other delicate structures to
avoid thermal injury to these structures.
12. The Shaw Scalpel System needs special precautions regarding EMC and needs to be installed and
operated according to the information in the tables presented at the back of this manual. Portable and
RF communications equipment can aect the operation of the product.
13. All service must be performed by C2Dx, Inc. personnel only.
14. Repair and/or modification of the SG6 by anyone other than qualified service personnel may significantly
compromise the unit’s ability to perform eectively and/or void the equipment warranty.
15. Opening the SG6 unit and/or breaking the tamper-proof seal will void the equipment warranty.
16. Shaw Scalpel handles are single-use devices.
17. Lists of all compatible components of the Shaw Scalpel System are provided on page 12 of this manual.
18. In the unlikely event that the handle is unable to be turned o normally due to a mechanical failure or
due to debris in the handle, the controller should be turned o and the disposable replaced.
19. The Handle and Footswitch connector ports on the front of the SG6 controller are not to be utilized for
any other purpose than to connect to specified compatible components designed by C2Dx.
20. DO NOT allow saline, or any other fluid, to enter the handle during use. Saline is highly conductive and
will interfere with the circuitry inside the handle causing the handle not to work properly.
21. USE WITH PLASTIC ADHESIVE DRAPES – When the skin incisions are to be made through a plastic
adhesive skin drape, use the scalpel handle and blade in the OFF position (handle switched OFF).
22. USE WITH ELECTROSURGICAL UNITS – DO NOT touch the Shaw Scalpel blade to any electrosurgical
(e.g., Bovie) tip as significant damage to the SG6 controller unit will result. Keep at least 1cm between
the blade and the electrosurgical tip. The Shaw Scalpel System CANNOT BE USED to conduct
electrosurgical current through clamps.
23. AVOIDING INADVERTENT PATIENT BURNS – DO NOT rest the Shaw Scalpel handle and/or blade on
surgical drapes or on the patient during use. When activated, the blade is suciently hot such that
patient burns can result from inadvertent patient contact. When the Shaw Scalpel handle is not being
used, it is HIGHLY RECOMMENDED that the handle ON/OFF switch be positioned OFF. Care should be

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taken to avoid unintended activation of MAX TEMP mode by inadvertently depressing the MAX TEMP
button or foot pedal.
Warning: The scalpel can stay hot for up to 2 minutes after de-activation.
24. GROUNDING – Reliability can only be achieved when the equipment is connected to a properly
equivalent receptacle marked “Hospital Grade”.
25. The controller can be removed from Mains only by disconnecting the AC power cord from the Power Inlet.
26. STERILIZATION – The Shaw Scalpel Handle is provided STERILE, provided the primary sterile packaging
is unopened and undamaged. In the event that the sterile barrier has been compromised, discard the
handle and obtain a new one. The handle cannot be re-sterilized.
27. Remove and discard of used disposables following local regulations for proper disposal of
contaminated material.
28. Electrical shock hazard. Do not remove cover. Refer to manufacturer for service.
29. If the user has any questions regarding compatibility of accessories or cables they should contact
C2Dx, Inc.
Component Precautions
1. Shaw Scalpel System Blades are provided sterile and ARE NOT intended for reuse.
2. Blades are surgically sharp and used blades may be extremely hot to the touch. Always grasp the
insulated plastic hub when handling the blade and take care as this may also be hot to the touch.
3. DO NOT BEND THE BLADE – Care should be taken not to bend the blade while cleaning, insertion, or
reinsertion as the heater leads may become broken and the blade stop working.
4. The Shaw blade’s non-stick coating cleans most eectively when hot. Best results are obtained using
dry 4x4 gauze when the blade is hot.
5. Accurate calibration can only be achieved if the blade is at room temperature when it is inserted into
the handle. If the blade becomes accidentally dislodged from the handle, turn the handle OFF, dip the
blade in sterile water to cool it to room temperature, and then reinsert it.
6. Never use any type of abrasive pad to clean the blades. The abrasives will damage the circuit and
render the blade unusable.
7. To remove a blade from the handle, pull the blade straight out of the handle, using the insulated plastic hub.

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Bending, twisting or flexing the blade could damage the blade contacts and retainers within the handle
causing it to no longer function.
8. If you are getting multiple error messages during blade insertion, try inserting the blade into the handle
BEFORE plugging the handle into the controller unit.
9. DO NOT use any type of instrument (e.g. hemostats) to insert the blade into the handle as this would
damage the blade’s imprinted circuitry and render it inoperable.
10. The handle must be activated (ON) for the MAX TEMP button to work.
11. The handle contains a strong earth magnet. Take care of placement near electronic implantable devices.
12. DO NOT immerse the handle in liquid of ANY KIND. The handle contains electronic contacts and
moisture sensitive electrical components which can be damaged and fail to function if immersed in
liquids of any kind. DO NOT allow any solution to penetrate to the interior of the handle.
13. External cleaning is the only controller maintenance that can be performed by the user. The unit should
be wiped down with alcohol, mild soap, or detergent.
14. The SG6 controller requires cleaning after each use. The Touch-Panel display should not be exposed
to caustic chemicals used during this process. This includes Chlorine Dioxide, Sodium Hypochlorite
(Bleach), Ethyl Alcohol, Alconox, Liquinox, Cidex, Chlorides, or similar. EPA studies have shown these
chemicals cause damage to electronic devices.
15. Before cleaning the controller, detach the controller unit from the AC power source.
16. DO NOT immerse the controller.
17. DO NOT use an abrasive cloth or cleaners, especially on the display screen.
18. Servicing the controller unit by anyone other than a qualified service personnel approved by C2Dx, Inc
renders the warranty void.
19. DO NOT dispose of this product in the unsorted municipal waste stream. Dispose of this product
according to local regulations.

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The Shaw Scalpel System consists of four components:
1. CONTROLLER – An electronic power supply/controller that activates the blade and provides various
automatic calibrations, sensing, and control functions. It has user controls with visual and audible
indications of instrument status.
2. SINGLE-USE, DISPOSABLE HANDLE – A single-use, disposable handle connected to the controller
unit with a light-weight, flexible electrical cable. Disposable scalpel blades are inserted into the
disposable handle. The user is able to control blade temperature, on/o and MAX TEMP modes directly
from the handle.
3. DISPOSABLE BLADES – Various sizes and shapes of sterile disposable scalpel blades are available
which are similar in size and shape to conventional cold-steel scalpel blades. Blades are single-use
only and should never be reused. The Shaw blades incorporate heating and temperature-sensing
micro-circuitry which provides heat for hemostasis and sensing feedback to the controller. DO NOT
bend the blade – Care should be taken not to bend the blade while cleaning, insertion, or reinsertion
as the heater leads may become broken and the blade stop working.
4. FOOTSWITCH – An optional footswitch (REF 7013-8410) is available which allows the surgeon to set
the desired temperatures of the blades as well as ACTIVATE the scalpel or MAX TEMP mode. The
footswitch has two modes: (1) ACTIVATE/MAX TEMP and (2) TEMP UP/DOWN. Switching from mode
(1) to mode (2) and vice-versa is controlled by depressing the black MODE button on the top of the
footswitch. When in the TEMP UP/DOWN mode, depressing and releasing the left black pedal will
decrease the set point temperature by 10° C; whereas, depressing and releasing the right red pedal
will increase the set point temperature by 10° C. When in the ACTIVATE/MAX TEMP mode, depressing
and holding the left black pedal will activate the scalpel blade to come to the selected temperature.
Similarly, depressing and holding the right red pedal will activate the scalpel blade to come to the MAX
TEMP temperature of 300° C.
System Description
MODEL SG6 Shaw Scalpel System
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Important Features
SURGICAL FEATURES
1. Retains the Precision of Surgical Steel – Shaw Scalpel blades are similar in size and shape to
conventional scalpel blades and have the same sharp surgical steel cutting edges to retain the precision
and “feel” of the conventional scalpel when cutting.
2. Reduces Blood Loss – The Shaw Scalpel conducts heat from its sharp, heated blade to a thin layer of
tissue adjacent to the cutting edge. The heat seals most blood vessels (less than 2mm in diameter) as
they are cut, producing near-bloodless incisions with the precision of sharp surgical steel.
3. Maintains a Clean, Dry Surgical Field – The Shaw Scalpel seals as it cuts tissue, largely eliminating
the flow of blood into the incised area. This clean, clear operative field contributes to improved precision
and visibility at the incision site.
4. Minimizes Tissue Damage – Hemostatic incisions made with the Shaw Scalpel result in visibly less
tissue damage than when electrosurgical units are used. Independent experiments have shown that
the breaking strength and infection resistance of healing wounds made with the Shaw Scalpel were
essentially equal to those obtained with conventional cold-steel scalpels and better than those made
with electrosurgical units.
5. Shortens Surgery – Experience indicates that a net reduction in overall operating time generally
results when an appropriate technique is developed and with sucient experience in the use of the
Shaw Scalpel.
6. Eliminates Patient Currents and Muscle Stimulation – Since no electrical current passes through the
patient when using the Shaw Scalpel System, a grounding pad is not needed and the risk of accidental
electrical current burns at grounding sites is eliminated. Muscle stimulation associated with passing
electrical currents through the body is also eliminated, improving surgical precision.
SYSTEM FEATURES
1. Sterile, Disposable Scalpel blades – Shaw Scalpel blades are individually packaged sterile and ready
for use. They are discarded when they become dull, just like conventional cold-steel scalpel blades.
Blades are single-use only and should never be reused.
2. Automatic Calibration – The Shaw Scalpel System automatically calibrates each blade, typically within
6 seconds of its insertion into the handle. The blade is ready to be energized as soon as the calibration
is complete.
3. User-Selectable Cutting Temperature – The user is able to select the desired cutting temperature
over a range of 70° C to 300° C in increments of 10° C using the touchscreen “Temperature Up” + or

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“Temperature Down” - buttons OR by using the UP/DOWN arrows on the handle. The Shaw Scalpel
System provides a high temperature MAX TEMP Mode, suitable for sealing vessels. The MAX TEMP
Mode is preset to 300° C.
4. Audible Signals – The controller provides audible tones to indicate certain system functions and status.
The signal volume can be adjusted by selecting the volume icon on the screen and then turning up or
down. The audible functions include: pressing any button on the console, handle, or footswitch, blade
heating, blade cooling, MAX TEMP, and blade removal. Also, a tone is heard when there are certain
problems with the system. Ensure the sound volume is adequately adjusted so that audio indications are
clearly heard.
5. Visual Displays – The Model SG6 controller has one display on the front of the unit.
6. IV Pole Mount – Secure the controller using the clamp on the back. Be sure to tighten snugly, but do
not provide excessive force. Care should be taken in selecting a stable IV pole with a wide base (a
circular pattern with a diameter of at least 25in) with five locking casters (Pryor Products Model 176G
or equivalent). The unit should be mounted such that its top surface is no more than 48in from the floor.
Consult your biomedical department in the event there are any questions regarding the stability of the
intended IV pole and mounting location.