Summary of Contents for 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...
- Page 2 By so doing, the Hemostatix Thermal Scalpel Member State in which the user and/or patient is established.
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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 Hemostatix the scalpel handle in the OFF position. Cutting with the blade personnel only. The port is not to be accessed, for any purpose, by unheated will eliminate the possibility of superficial skin scars due the customer. - Page 4 19. The Handle and Footswitch connector ports on the front of the 26. STERILIZATION – The Model P8400 Hemostatix Thermal Hemostatix controller are not to be utilized for any other purpose Scalpel Handle is provided STERILE provided the primary sterile than to connect to specified compatible components designed by packaging is unopened and undamaged.
- 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 Hemostatix Medical Technologies, LLC 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
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
UP/DOWN arrows on the handle. Thermal COAG diameter) as they are cut, producing near- bloodless incisions with Mode – The Hemostatix Thermal Scalpel System provides a high the precision of sharp surgical steel. temperature Thermal COAG Mode, suitable for sealing vessels not sealed as they are cut. -
Page 8: Power Off
Tangerine dot is visible when switch is in the “ON” position. Sliding the switch forward (toward the blade) deactivates the blade. • The Model P8400 Hemostatix Thermal Scalpel Controller is 2. THERMAL COAG SWITCH - Depressing the blue button on the compatible with the optional Footswitch (REF 7013-8410). - Page 9 NOTE: The handle should be in the “OFF” position before inserting the blade. 5. USING THE HEMOSTATIX THERMAL SCALPEL With the console powered ON, the handle attached and a blade inserted into the handle, VERIFY that the console display reads 70°...
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Page 10: Upgrade Features
2. AUXILIARY OUTPUT – Also located on the rear of the unit, The footswitch has two modes: (1) CUT/COAG and (2) TEMP this port is designed to power future Hemostatix add on modules. UP/DOWN. Switching from mode (1) to mode (2) and vice-... -
Page 11: Changing The Blade
3. SEALING BLEEDERS extremely hot to the touch. Always use a sponge, clamp or • The heat from the Hemostatix Thermal Scalpel blade will seal hemostat to grasp the used blade. Always follow proper most (less than 2mm in diameter) blood vessels as they are cut. -
Page 12: Maintenance
AC power source. SERVICING The Model P8400 Hemostatix Thermal 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 13: Warranty
≤ 100 microamperes AC – Normal Condition (From Patient Connection ≤ 500 microamperes AC – Single Fault Condition NOTE: Hemostatix scalpel handles and blades are warranted to be free from defects in to Earth) ≤ 10 microamperes DC – Normal Condition materials and workmanship for a period of SIXTY (60) days from the date of shipment ≤... - Page 14 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. 15 blades.
- 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 DECLARATION – ELECTROMAGNETIC EMISSIONS The Model P8400 Hemostatix Thermal Scalpel System is intended for use in the Consult instructions for use electromagnetic environment specified below. The customer or the user of the Model P8400 Hemostatix Thermal Scalpel System should assure that it is used in such an environment. -
Page 17: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
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. The customer or the user of the Model P8400 Hemostatix Thermal Scalpel electromagnetic environment specified below. - Page 18 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...
- Page 19 TROUBLESHOOTING CONSOLE FAULT MESSAGES © Hemostatix Medical Technologies, LLC All rights reserved HEMOSTATIX® is a U.S.A. Registered Trademark (#2128414) of HEMOSTATIX® 66– 07 Medical Technologies, LLC 3439 ECR 003 /2019 Hemostatix Medical Technologies, LLC 8400 Wolf Lake Drive, STE 109...
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