Summary of Contents for C2Dx HEMOSTATIX PRECISION 8400
- Page 1 THERMAL SCALPEL SYSTEM MODEL PRECISION 8400 CONTROLLER Part Number 7013-8400 For use with the Model 9050 Disposable Scalpel Handles OPERATING MANUAL...
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Page 2: Indications For Use
CONTRAINDICATIONS INTRODUCTION The Hemostatix Thermal Scalpel System is contraindicated in the HEMOSTATIX THERMAL SCALPEL BLADES are similar in size, presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR shape, and sharpness to traditional steel scalpel blades; however, or OXYGEN or NITROUS OXIDE. Hemostatix blades can be heated to a user-selected temperature POTENTIAL ADVERSE EFFECTS appropriate for sealing small vessels as they are cut. -
Page 3: System Precautions
• Consult the manufacturer. C. For minimal scarring, make the initial skin incision with 8. The HTSS’s maintenance port is to be used by C2Dx personnel the scalpel handle in the OFF position. Cutting with the blade only. The port is not to be accessed, for any purpose, by the unheated will eliminate the possibility of superficial skin scars due customer. - Page 4 29. If the user has any questions regarding compatibility of accessories to sale by or on the order of a physician. or cables they should contact C2Dx, Inc. 22. 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).
- Page 5 13. External Cleaning is the only controller maintenance that can be performed by the user. 14. Servicing the controller unit by other than and qualified service personnel approved by C2Dx, Inc. renders the Warranty void. 15. Before cleaning the controller, detach the controller unit from the AC power source.
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Page 6: System Description
SYSTEM DESCRIPTION 3. DISPOSABLE BLADES – Various sizes and shapes of sterile MODEL P8400 HEMOSTATIx disposable scalpel blades are available which are similar in size and THERMAL SCALPEL SYSTEM shape to conventional cold-steel scalpel blades. Blades are single- use only and should never be reused. The Hemostatix blades incorporate heating and temperature-sensing micro-circuitry which provides heat for hemostasis and sensing feedback to the controller. -
Page 7: System Features
300° C in increments of 10° degrees C using the front panel its sharp, heated blade to a thin layer of tissue adjacent to the “Temperature Up” ▲ or “Temperature Down” ▼ buttons OR cutting edge. The heat seals most blood vessels (less than 2mm in by using the UP/DOWN arrows on the handle. -
Page 8: Power Off
HANDLE CONTROLS AND INDICATORS 2. BLADE Compatibility – The Model P8400 Hemostatix Thermal Scalpel Controller is compatible with the following thermal scalpel blades: • REF 7013-5810 – #10 Blade - Sterile Disposable - Quantity 24 • REF 7023-5810 – #10 Blade - Sterile Disposable - Quantity 10 •... - Page 9 If calibration is not successful, an error message will appear on controller console by aligning the arrow on the handle cable connector with the arrow on the mating front panel connector the controller unit’s display. In that case, remove the blade and and inserting it into the front panel receptacle.
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Page 10: Upgrade Features
10° C; whereas, depressing and releasing the right (blue) pedal designed by C2Dx. Any attempt to plug, non Hemostatix will increase the set point temperature by 10° C. equipment into the output connector may result in damage to... -
Page 11: Changing The Blade
maximum anticipated rate of tissue cutting, thereby minimizing new blade. unnecessary (thermal) necrosis of tissue. The determination of CAUTION: To remove a blade from the handle, grab the the appropriate set point temperature is determined by the plastic hub and pull the blade straight out of the handle. surgeon by raising the set point temperature until adequate Bending, twisting or flexing the blade could damage the hemostasis is achieved. -
Page 12: Maintenance
C2Dx, Inc. renders the Warranty void. Before returning a controller unit for servicing, please call, please call C2Dx, Inc. to obtain a Return Material Authorization (RMA) and instructions as to how and where to send the controller unit and accessories. -
Page 13: Warranty
(HTSS) CONTROLLER and that, when properly used, it will be free from defects in NOTE: The MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYTEM is material or workmanship for a period of one (1) year after the date of shipment from C2Dx or any of its authorized distributors. - Page 14 SPECIFICATIONS Model P8400 Hemostatix Thermal Scalpel System Handle - Model 9050 MODEL P8400 HEMOSTA TIX THERMAL SCALPEL SYSTEM BL ADES - SERIES 5810, 5812, and 5815. Model P8400 Hemostatix Thermal Scalpel System Blades are available in the following configurations (similar to cold, stainless steel scalpel blades): No.10, No. 12, and No.
- Page 15 Type BF applied Part Authorized Representative in the European Community ▼ Temperature decrease Equipotentiality ▲ Temperature increase On (power connection to mains) Volume increase / decrease Auxilliary output port Off (power disconnection from the mains) Auxilliary serial port Alternating current Serial number Output handle connector Reference number...
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Page 16: Guidance And Manufacturer'sdeclarations
GUIDANCE AND MANUFACTURER’S Do not dispose of this product in unsorted DECLARATIONS municipal waste stream. Dispose of this prod- uct according to Local Regulations. The Model P8400 Hemostatix Thermal Scalpel System 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 Follow instructions for use equipment can affect the operation of the product. -
Page 17: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
GUIDANCE AND MANUFACTURER’S DECLARATION – GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY ELECTROMAGNETIC IMMUNITY The Model P8400 Hemostatix Thermal Scalpel System is intended for use in the electromagnetic en- The Model P8400 Hemostatix Thermal Scalpel System is intended for use in the vironment specified below. - Page 18 TROUBLESHOOTING BLADE / HANDLE RECOMMENDED SEPARATION DISTANCES BETWEEN ERROR MESSAGES PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM The Model P8400 Hemostatix Thermal Scalpel System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model P8400 Hemostatix Thermal Scalpel System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Model P8400...
- Page 19 TROUBLESHOOTING CONSOLE FAULT MESSAGES C2Dx, Inc. All rights reserved HEMOSTATIX® is a U.S.A. Registered Trademark (#2128414) of C2Dx, Inc. 3439 REV D 12/1/2022 C2Dx, Inc. 8400 Wolf Lake Drive, STE 109 Bartlett, TN 38133 USA Telephone: +1 888-902-2239 Quality First International OU...
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