Shaw SG6 Instructions For Use Manual

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Shaw Scalpel System

Model SG6 Controller

Instructions for Use

Part Number 7013-0006

For use with the Model 9050 Disposable Scalpel Handles

3439300-RevB

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Page 1 Shaw Scalpel System Model SG6 Controller Instructions for Use Part Number 7013-0006 For use with the Model 9050 Disposable Scalpel Handles 3439300-RevB...
Page 2: Indications For Use
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.
Page 3: System Warnings
Member State in which the user and/or patient is established. System Warnings EXPLOSION HAZARD – The Shaw Scalpel System is contraindicated in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR or OXYGEN or NITROUS OXIDE.
Page 4: System Precautions
Manual, its precautions, procedures, and safety issues. Read the complete operators manual before using this equipment. Do not position the SG6 unit to make it difficult to remove and insert the unit’s separable power cord plug. There are hazardous electrical and thermal outputs. This equipment should be used only by qualified medical personnel Disconnect power to the SG6 before cleaning the unit to avoid electrical shock.
Page 5 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.
Page 6 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.
Page 7 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.
Page 8: System Description
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 –...
Page 9: Important Features
“feel” of the conventional scalpel when cutting. 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.
Page 10 Ensure the sound volume is adequately adjusted so that audio indications are clearly heard. Visual Displays – The Model SG6 controller has one display on the front of the unit. IV Pole Mount – Secure the controller using the clamp on the back. Be sure to tighten snugly, but do not provide excessive force.
Page 11 Handle Controls And Indicators ON/OFF SWITCH - Sliding the black ON/OFF switch rearward (toward the cable) mechanically latches the switch and activates the blade. A red dot is visible when switch is in the “ON” position. Sliding the switch forward (toward the blade) deactivates the blade. MAX TEMP BUTTON - Depressing the red button on the handle activates the MAX TEMP mode as long as the switch is depressed.
Page 12 REF 7023-5815 – #15 Blade - Sterile Disposable - Quantity 10 FOOTSWITCH Compatiblity • The Model SG6 Controller is compatible with the optional Footswitch (REF 7013-8410). SYSTEM CHECKOUTS NOTE: The Model SG6 Controller unit is rated 100-240VAC ± 10%, 50 - 60Hz ± 1Hz.
Page 13: Graphical User Interface
Graphical User Interface The Model SG6 Controller’s touchscreen display provides step-by-step instructions and visual references throughout the operation. After system initialization, a home or default screen is presented to system users. This main screen serves as a landing and overview screen to communicate basic device status and information such as current temperature, handle/blade attachment status, device state (activated-deactivated), messaging, and navigation elements.
Page 14: Screen Controls
Screen Controls Set Temperature – Press the temperature + or – buttons to adjust the set point temperature. Temperature increases in increments of 10° C. NOTE: Temperature can only be adjusted if hande is OFF/De-activated. Adjust Volume - Press the volume control icon on the display and adjust to your desired volume using the + or –...
Page 15: Power Off
Operating Instructions POWER ON Turn on POWER to the system by pushing the POWER SWITCH located at the front lower left side of the controller in the UP or ‘l’ position. The unit will briefly undergo a self-test (less than 10 - 15 seconds). Once the self-test is completed, the display will illuminate with the default set-point temperature setting (200˚...
Page 16 If calibration with a second blade is not successful, then the controller unit is unable to read the blade via the handle. Replace the handle and reinsert a blade. USING THE SHAW SCALPEL With the controller powered ON, the handle attached and a blade inserted into the handle, VERIFY that the controller display reads 200°...
Page 17: Upgrade Features
Upgrade Features MAINTENANCE PORT – Located on the rear of the unit, this port allows easy diagnostic access for C2Dx personnel as well as future software upgrade access via a USB port. The maintenance port is covered with a maintenance port cover. WARNING: The maintenance port is to be used by C2Dx personnel only.
Page 18: Changing The Blade
SEALING BLEEDERS • The heat from the Shaw Scalpel blade will seal most (less than 2mm in diameter) blood vessels as they are cut. • For a vessel not sealed as it is cut, promptly use the blade’s heat to seal it by exerting light pressure on the bleeder with the flat side of the blade.
Page 19 NOTE: The Teflon non-stick coating cleans most effectively when hot. Best results are obtained using dry 4x4 gauze when the blade is hot. NOTE: If the blade becomes accidentally dislodged from the handle, turn the handle OFF, dip the blade in sterile water or saline solution to cool it to room temperature, and then reinsert it. Accurate calibration can only be achieved if the blade is at room temperature when it is inserted into the handle.
Page 20: Maintenance
Servicing The Shaw Scalpel System consists of the controller unit, a handle, and a blade. If a problem is encountered, any of the three may be the cause; therefore, it is important when returning a controller unit for servicing to also return the handle(s) and blade(s) that were in use when the problem occurred.
Page 21: Warranty
MODEL SG6 found to be defective. This warranty shall not apply (a) if that portion of the MODEL SG6 has been repaired or altered by anyone other than qualified service personnel approved by C2Dx or altered in any way which, in C2Dx’s judgment, affects its usability or reliability;...
Page 22: Specifications
Specifications Model SG6 Controller Unit NOTE: The MODEL SG6 SYTEM is suitable for continuous operation. Patient Leakage Current (From ≤ 100 microamperes AC – Normal Condition Patient Connection to Earth) ≤ 500 microamperes AC – Single Fault Condition ≤ 10 microamperes DC – Normal Condition ≤...
Page 23: Training Requirements
SG6 controller. Essential Performance The SG6 controller shall be capable of providing the appropriate amount of energy to maintain the temperature of the scalpel blade at a target temperature of between 70C° and 300C° at 10C° increments and shall provide a User Interface that informs the User of the system status, and allows the User to control the application of blade heating.
Page 24 Type BF applied Part On (power connection to mains) Off (power disconnection from the mains) Alternating current Serial number Reference number Manufacturer Manufacturing date Maximum DC Output Caution...
Page 25 Authorized Representative in the European Community Temperature decrease Temperature increase Speaker volume Menu Maintenance USB port Output handle connector CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. Fuse Foot pedal connector...
Page 26 Do not dispose of this product in unsorted municipal waste stream. Dispose of this prod- uct according to Local Regulations. Follow instructions for use Consult instructions for use Medical - General Medical Equipment as to electrical shock, fire,and mechanical hazards only in accordance with: IEC60601-1 Ed.
Page 27: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
Guidance And Manufacturer’s Declarations The Model SG6 needs special precautions regarding EMC and needs to be installed and operated according to the information in the tables given below and portable and RF communications equipment can affect the operation of the product.
Page 28: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The Model SG6 is intended for use in the electromagnetic environment specified below. The customer or the user of the Model SG6 should assure that it is used in such an environment. Immunity Test...
Page 29 Immunity Test Test Level Compliance Level Electromagnetic Environmental Guidance RFID Immunity AIM 7351731:2021 Methods: IEC61000-4-39:2017 65A/m @ 134.2kHz 65A/m @ 134.2kHz RFID methods typically Magnetic Field Immunity – used in a commercial 7.5A/m @ 13.56MHz 7.5A/m @ 13.56MHz RFID or hospital environment should be acceptable.
Page 30 SG6 Shaw Scalpel System is used exceeds the applicable rf compliance level above, the model SG6 Shaw Scalpel System should be observed to verify normal operation.
Page 31 MOBILE COMMUNICATIONS EQUIPMENT AND THE MODEL SG6 The Model SG6 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model SG6 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Model SG6.
Page 32 Troubleshooting Blade / Handle Error Messages Condition Description Visual Indication IFU Instructions The handle has been used Handle Usage Discard the handle being used previously and must be Warning and replace it. replaced to continue. When performing a Ensure that the handle is fully Defective handle diagnostic check, connected.
Page 33 • Replace blade. • If problem persists with a Console is unable to detect Insert Blade Insert Blade new blade, then the handle blade circuits. contacts may be damaged. Replace handle. • Normally not a problem with The console has not been the unit.
Page 34 Troubleshooting Controller Fault Messages Condition Description Visual Indication IFU Instructions The FAULT signal is an indication that a hardware fault has been detected. The system will not function • Cycle power to the unit using the POST Failure until the fault is corrected. In addition to the fault symbol, the switch on the front panel.
Page 35 Condition Description Visual Indication IFU instructions The software detected that • Cycle power to the unit using the Heel or Tip the heel or tip portion of switch on the front panel. Temperature • If message does not clear, then the console circuit is out of Fault unit must be returned for service.