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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 Thermal 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 Thermal 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 Hemostatix Thermal 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 sufficient experience in the use of

the Thermal Scalpel.

6. Eliminates Patient Currents and Muscle Stimulation

 – Since

no electrical current passes through the patient when using the

Hemostatix Thermal 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

 – Hemostatix Thermal 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 Hemostatix Thermal 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° degrees C using the front panel 

“Temperature Up” 

 or “Temperature Down” 

 buttons OR 

by using the UP/DOWN arrows on the handle. Thermal COAG 

Mode – The Hemostatix Thermal Scalpel System provides a high 

temperature Thermal COAG Mode, suitable for sealing vessels 

not sealed as they are cut. The 

blue button

 on the handle 

provides convenient switching between the selected cutting and 

Thermal COAG temperatures. The Thermal COAG 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 turned up or down by the rotating switch on the back

 

of the unit. The audible functions include: pressing any button

 

on the console or handle, blade heating, blade cooling, Thermal

 

COAG, 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 alarms are clearly heard.

5. Visual Displays

 – The Model P8400 controller has one display

on the front of the unit.

6. Equipotential

 – Uniform potential. Means for eliminating

noise or interference with sensitive equipment by application

of a potential equalization conductor. If required by local code,

connect the HTSS unit to the hospital equalization connector

with an equipotential cable.

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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