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maximum anticipated rate of tissue cutting, thereby minimizing 

unnecessary (thermal) necrosis of tissue. The determination of 

the appropriate set point temperature is determined by the 

surgeon by raising the set point temperature 

until 

adequate 

hemostasis is achieved. Alternatively, the surgeon can, at any 

selected point temperature, modulate the speed of tissue cutting 

according to the vascularity of the tissue being incised. 

3.

SEALING BLEEDERS

The heat from the Hemostatix Thermal 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.

For larger bleeders, activate the Thermal COAG mode by

depressing and holding down the 

blue 

Thermal COAG switch

(or

 

optional footswitch pedal) and holding the flat side of the

blade

 

on the bleeder until hemostasis is achieved.

4.

MAINTAIN A DRY OPERATIVE FIELD

The most effective use of the Hemostatix Thermal Scalpel

thermal energy such that bleeding does not begin. This is done

by making incisions using long, relatively slow, authoritative

strokes (rather than short, “choppy” strokes) to maintain

constant and meticulous hemostasis at every step, and prevent

the onset of bleeding.

Bleeding vessels are sealed by the direct contact of the hot

 

blade

to tissue, thus providing heat transfer to the tissue at the

bleeding site. Accordingly, if pools of blood occur from vessels

not sealed as they are cut, suction or sponge the area before

applying the Hemostatix Thermal Scalpel blade to seal the

bleeders. Heat from the blade dissipates in pools of blood and

cannot get through these pools to reach the tissue to seal the

bleeder. Pools of blood simply coagulate on the blade, thermally

insulating it.

5.

CHANGING THE BLADE

If the blade becomes dull or the change blade message appears on

the controller display, switch the handle ON/OFF switch to off

and wait for the temperature display to turn Green indicating the

blade is safe to handle. Replace the dull or damaged blade with a

new blade.

CAUTION:  To remove a blade from the handle, 

grab the 

plastic hub and 

pull the blade straight out of the handle. 

Bending, twisting or flexing the blade could damage the 

blade contacts and retainers within the handle causing it 

to no longer function. 
CAUTION: Used blades are surgically sharp and may be 

extremely hot to the touch. Always use a sponge, clamp or 

hemostat to grasp the used blade. Always follow proper 

sharps precautions when handling a blade and biohazard 

disposal techniques when discarding a used blade.

6. CLEANING THE BLADE DURING USE

Clean any coagulated blood or tissue debris from a HOT blade by

LIGHTLY wiping the blade using DRY 4x4 gauze. Using WET

gauze will cool the blade causing the blood and coagulum to

adhere to the surface of the blade. Only light pressure is needed.

Excess pressure will result in the bending of the blade and the

subsequent damage to the blade electrical circuit.

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.

CAUTION: 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.
CAUTION: Never use any type of abrasive pad to clean the 

blades. The abrasives will damage the circuit and render 

the blade unusable. 

Summary of Contents for 7013-8400

Page 1: ...OPERATING MANUAL THERMAL SCALPEL SYSTEM MODEL PRECISION 8400 CONTROLLER Part Number 7013 8400 For use with the Model 9050 Disposable Scalpel Handles...

Page 2: ...pel blade must be uniformly maintained at the desired temperature within narrow limits The Hemostatix Thermal Scalpel System utilizes micro circuitry incorporated within the blade itself to maintain t...

Page 3: ...TSS 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 HTSS unit to hospital grade...

Page 4: ...dal 25 GROUNDING Reliability can only be achieved when the equipment is connected to a properly equivalent receptacle marked Hospital Grade 26 STERILIZATION The Model P8400 Hemostatix Thermal Scalpel...

Page 5: ...into the handle as this would damage the blade s imprinted circuitry and render it inoperable 11 The handle must be energized for the COAG switch to work 12 DO NOT immerse the handle in liquid of ANY...

Page 6: ...s 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...

Page 7: ...y 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 Calibra...

Page 8: ...Thermal Scalpel Controller REF 7013 8400 is compatible with the following Hemostatix Thermal Scalpel handle cable configurations REF 7013 9050 Model P8400 Handle w Integral Cable Assembly Qty 1 REF 7...

Page 9: ...te the thermal COAG mode depress the blue Thermal COAG switch on the top of the handle The blade temperature will approximate 300 C in the thermal COAG mode NOTE The handle must be energized for the C...

Page 10: ...auxiliary output connector is to potentially offer other modules i e irrigation suction etc that would complement the existing Hemostatix technology WARNING The auxiliary port is not to be utilized fo...

Page 11: ...oagulate on the blade thermally insulating it 5 CHANGING THE BLADE If the blade becomes dull or the change blade message appears on the controller display switch the handle ON OFF switch to off and wa...

Page 12: ...E Before cleaning the controller detach the controller unit from the AC power source servicing The Model P8400 Hemostatix Thermal Scalpel System consists of the controller unit a handle and a blade If...

Page 13: ...tained before any part of the MODEL P8400 HTSS is returned NOTE Handles and blades being returned must be cleaned sterilized and packaged in sterile packaging with labeling which verifies the sterilit...

Page 14: ...statix 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 Model P8400 Hemostatix Thermal Scalpel Sy...

Page 15: ...Manufacturer Manufacturing date Maximum DC Output Caution Authorized Representative in the European Community Temperature decrease Temperature increase Volume increase decrease Auxilliary output port...

Page 16: ...can affect the operation of the product GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The Model P8400 Hemostatix Thermal Scalpel System is intended for use in the electromagnetic e...

Page 17: ...e user of the Model P8400 Hemostatix Thermal Scalpel System should assure that it is used in such an environment Immunity Test Test Level Compliance Level Electromagnetic Environmental Guidance Conduc...

Page 18: ...cording to frequency of transmitter m 150 kHz to 80 MHz outside ISM bands d 3 5 V1 P 80 kHz to 800 MHz in ISM bands d 3 5 E1 P 800 MHz to 2 5 GHz d 7 E1 P 0 01 d 3 5 3 0 01 d 3 5 3 0 01 d 7 3 0 01 0 1...

Page 19: ...TE 109 Bartlett TN 38133 USA Telephone 1 901 261 0012 Quality First International OU Laki 30 12915 Tallinn Estonia Hemostatix Medical Technologies LLC All rights reserved HEMOSTATIX is a U S A Registe...

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