HEMOSTATIX 7013-8400, Operating Manual

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...