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Valleylab Force 2, User Manual

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ii     

 

Force 2 User’s Guide

 

Foreword

 

This manual and the equipment it describes are for use only by qualified 
medical professionals trained in the particular technique and surgical 
procedure to be performed.

 

Equipment covered in this manual:

Valleylab Part Number:

 

  945 102 179 

 

Effective date:  

 

October 2004

Force™ 2, PolyHesive™ and REM™ are trademarks of Valleylab.
Teflon

 

®

 

 is a registered trademark of E.I. DuPont de Nemours & Co.

The Force 2 is protected by one or more of the following U.S. patents and 
their foreign counterparts: 4,632,109, 4,658,819, 4,658,820, 4,827,927, 
5,190,517.

 

Manufactured by: 

 

Valleylab, 
a division of Tyco Healthcare Group LP
Boulder, CO 80301-3299 USA

 

For information call:

 

 

1-800-255-8522 / 1-303-530-2300 

 

European Representative:

 

Tyco Healthcare UK Ltd.
Gosport, PO13 0AS, UK

Made in USA
Printed in USA

© 2004 Valleylab   All rights reserved.

 

Caution

 

Federal (USA) law restricts this device to sale by or on the order of a physician.

 

Electrosurgical Generator

Vac Nominal

Hertz

 

Force 2-2 PCH

 110-120 

50-60 

Force 2-8 PCH

 220-240

50-60 

Summary of Contents for Force 2

Page 1: ...User s Guide Force 2 Electrosurgical Generator...

Page 2: ...Co The Force 2 is protected by one or more of the following U S patents and their foreign counterparts 4 632 109 4 658 819 4 658 820 4 827 927 5 190 517 Manufactured by Valleylab a division of Tyco He...

Page 3: ...d with the capability of delivering smooth cutting cutting with increasing degrees of hemostasis desiccation and fulguration with minimum cutting The microbipolar output is intended for desiccation wi...

Page 4: ...Indicates a hazardous situation which if not avoided may result in minor or moderate injury Notice Indicates a hazard which may result in product damage ATTENTION Refer to the accompanying documents...

Page 5: ...212181 Fax 39 02 2640059 Tyco Healthcare Spain S L C Fructuos Gelabert 6 8 planta 8a 08970 Saint Joan DESPI Barcelona SPAIN Ph 34 93 680 3370 Fax 34 93 680 2457 Tyco Healthcare Belgium B V Generaal De...

Page 6: ...ries 1 5 Patient Return Electrodes 1 5 Generator 1 6 During Surgery 1 7 Contact with Metal Objects 1 7 Generator Power Settings 1 7 Forceps 1 7 Suction Coagulators 1 7 Active Accessories 1 8 Patient R...

Page 7: ...arm two tones 5 1 Conventional single section Patient Return Electrode 5 1 REM dual section Patient Return Electrode 5 1 No Output 5 4 Monitor Interference 5 4 Continuous Interference 5 4 Interference...

Page 8: ...requency Leakage 50 60 Hz A 4 Force 2 2 PCH Generator A 4 Force 2 8 PCH Generator IEC 60601 1 Section 19 for Class 1 Equipment A 4 REM Contact Quality Monitor A 5 Audio Volume A 5 Approximate Weight A...

Page 9: ...erating instructions supplied with this or any electrosurgical equipment be read understood and followed Electrosurgery has been used safely in numerous procedures Before starting any surgical procedu...

Page 10: ...t the pacemaker manufacturer or hospital cardiology department for further information when use of electrosurgical appliances is planned in patients with cardiac pacemakers Valleylab recommends agains...

Page 11: ...e area where electrosurgery is performed Warning Fire Explosion Hazard Verify that all oxygen circuit connections are leak free before and during the use of electrosurgery Verify that endotracheal tub...

Page 12: ...the patient return electrode to provide a direct current route between the surgical site and the return electrode which avoids skin to skin contact areas In addition place patient return electrodes ac...

Page 13: ...before testing an accessory Inspect accessories and cords especially reusable accessories and cords for breaks cracks nicks and other damage before every use If damaged do not use Failure to observe t...

Page 14: ...t on top of the generator or place the generator on top of electrical equipment This is an unstable configuration and does not allow for adequate cooling When using a smoke evacuator in conjunction wi...

Page 15: ...the contact point s Warning Confirm proper power settings before proceeding with surgery Use the lowest power setting possible for the minimum time necessary to achieve the desired effect Never incre...

Page 16: ...patient the table or the retractors while buzzing the hemostat Activate cut rather than coag Cut has a lower voltage than coag Use the lowest power setting possible for the minimum time necessary to a...

Page 17: ...all metal or all plastic systems At no time should electrical energy pass through hybrid systems Capacitive coupling of RF current may cause unintended burns When using laparoscopic instrumentation w...

Page 18: ...off and unplug the generator before cleaning Caution Do not reuse or resterilize accessories labeled disposable or single use only Notice Do not clean the generator with abrasive cleaning or disinfect...

Page 19: ...ot perform within specifications file a claim with the carrier All returns must have approval from Valleylab Responsibility of the Manufacturer Valleylab is responsible for safety reliability and perf...

Page 20: ...nominal 50 60 Hz The Force 2 8 PCH Electrosurgical Generator is designed to operate at 220 240 Vac nominal 50 60 Hz Check the Power Connector The Force 2 generator is supplied with a hospital grade po...

Page 21: ...ying power to the unit If required use the equipotential ground cable supplied with the unit The equipotential ground connector is located on the rear panel of the generator Routine Maintenance Valley...

Page 22: ...Notes 2 4 Force 2 User s Guide...

Page 23: ...Indicators and Receptacles The controls indicator and receptacles for accessories are located on the front panel of the Force 2 Unit This section describes each component of the unit and its function...

Page 24: ...ront View PCH Generator Rear View MONOPOLAR FOOTSWITCH BIPOLAR FOOTSWITCH FOREIGN EQUIVALENTS AND U S PATENTS 4416276 4416277 4632109 4658819 4658820 4827927 WARNING RISK OF FIRE REPLACE FUSE AS MARKE...

Page 25: ...Bipolar Press this button to select the bipolar output when using the monopolar footswitch Power Up Increases power in the selected mode A single press of the button increases the power setting by on...

Page 26: ...he generator in the ready mode The number displayed indicates the nominal power in watts which will be delivered to the patient when the mode is activated In the standby mode dashes are displayed Outp...

Page 27: ...essories or standard one pin accessories which can be activated by the monopolar footswitch Cut and coag modes may be activated at this receptacle The handswitching pencil can be footswitch activated...

Page 28: ...generators 8 PCH Bipolar Footswitch Receptacle This three pin receptacle accepts a single pedal bipolar footswitch connector Monopolar Footswitch Receptacle This four pin receptacle accepts a two peda...

Page 29: ...that 8s and then dashes appear on the displays The generator is then in the standby mode If any of the indicators do not illuminate contact your Biomedical Department 3 If necessary connect the foots...

Page 30: ...face Simultaneously using two generators If you are using two generators simultaneously on the same patient frequently one patient return electrode has a high positive voltage and the other has an opp...

Page 31: ...forceps or chuckhandles connect to the Monopolar Accessory receptacle Bipolar footswitching forceps connect to the Microbipolar receptacle 8 Press the Standby button to prevent inadvertent activation...

Page 32: ...bipolar Output Monopolar Handswitching Output Simultaneous Coag REM indicator illuminates but does not affect bipolar operation Bipolar Handswitching or Footswitching Forceps Patient Return Electrode...

Page 33: ...y Setups Instructions for Use Force 2 User s Guide 4 5 Monopolar and Bipolar Setup Monopolar Footswitching Output Patient Return Electrode Handswitching Pencil Bipolar Forceps Patient Return Electrode...

Page 34: ...cal circuit Microbipolar output provides the following advantages over monopolar output limited collateral tissue damage reduced electromagnetic interference with both video and other monitoring equip...

Page 35: ...typical power settings for various surgical procedures Low Power Under 30W Neurosurgery both bipolar and monopolar Laparoscopic sterilization both monopolar and bipolar Vasectomies Dermatology Oral su...

Page 36: ...s current and put less demand on the return electrode Cut by sparking tissue and not desiccating tissue Sparking cuts cleanly and quickly and delivers less current to the patient than desiccation Use...

Page 37: ...re press the Ready button and the Cut Power Down button simultaneously on the generator front panel The generator responds by sounding a single tone and the RMOTE indicator illuminates Press the or bu...

Page 38: ...tivate by pressing either monopolar footswitch pedal with the front panel footswitch selector in the bipolar mode Warning When not using active accessories place them in a holster or in a clean dry no...

Page 39: ...If a REM alarm persists use a backup generator REM dual section Patient Return Electrode 1 Inspect the patient return electrode plug a Leave the generator in the ready mode b Unplug the patient retur...

Page 40: ...not remove the return electrode pad from the patient d Proceed to step 3 3 Apply a second patient REM pad a Apply a second REM electrode to the patient s thigh upper biceps calf or lower back b Place...

Page 41: ...ed place the generator in the standby mode e Unplug the patient return electrode from the generator f Proceed with step 5 5 Use a Multiple Return Adapter a Insert a Valleylab Multiple Return Adapter i...

Page 42: ...r and generator 2 Check all other electrical equipment in the operating room for defective grounds 3 If the electrical equipment is grounded to different objects rather than a common ground voltage di...

Page 43: ...voltage low voltage coag or cut may alleviate the problem Neuromuscular stimulation is more likely to occur in the coag mode when fulgurating than when cutting and is unlikely when desiccating 4 If n...

Page 44: ...Notes 5 6 Force 2 User s Guide...

Page 45: ...The REM contact quality monitor is activated when a REM patient return electrode connector is inserted in the Patient receptacle The REM contact quality monitor alarms and disables the monopolar outpu...

Page 46: ...between 5 ohms and 135 ohms the adaptive REM system measures the contact impedance and uses it as a reference value If the patient to pad impedance increases 40 above this reference value or above 135...

Page 47: ...asurement Unless otherwise indicated all measurements are specified at an ambient temperature of 21 degrees C 70 degrees F and 760 torr Operating Parameters Storage and Shipping Temperature Range 10 C...

Page 48: ...cycle recurring at 31 kHz Coag 510 kHz damped sinusoidal bursts with a repetition frequency of 31 kHz Low Voltage Coag 510 kHz bursts of sinusoid at 25 duty cycle recurring at 31 kHz Bipolar 510 kHz s...

Page 49: ...ts whichever is greater Force 2 8 PCH Generator Between 170 and 270 volts input output power into nominal load will vary no more than 15 or 5 watts whichever is greater Maximum Operating Range 85 135...

Page 50: ...leakage current 150 mA per IEC 60601 2 2 Source current normal polarity intact chassis ground 10 A Source current normal polarity ground open 25 A Source current reverse polarity ground open 25 A Sin...

Page 51: ...in Classification Type CF Equipment per IEC 60601 1 The Force 2 provides a high degree of protection against electrical shock particularly regarding allowable leakage current and has a CF type isolate...

Page 52: ...de using the set up referred to in IEC 60601 2 2 Figure 104 PCH Generator Typical Output Power vs Load Monopolar Cut Modes Pure Cut Blend 1 Generator Power Setting Generator Power Setting Output Power...

Page 53: ...cal Specifications PCH Generator Typical Output Power vs Load Monopolar Cut Modes continued Blend 2 Blend 3 Generator Power Setting Generator Power Setting Output Power watts Impedance ohms Impedance...

Page 54: ...s Guide PCH Generator Typical Output Power vs Load Monopolar Coag Modes Coag Low Voltage Coag Generator Power Setting Generator Power Setting Output Power watts Impedance ohms Impedance ohms Output Po...

Page 55: ...ions Bipolar measurements are made using bipolar forceps on the insulating surface referred to in IEC 60601 2 2 Figure 104 PCH Generator Typical Output Power vs Load Bipolar Mode Bipolar Generator Pow...

Page 56: ...Notes A 10 Force 2 User s Guide...

Page 57: ...ed or altered outside Valleylab s factory in a way so as in Valleylab s judgment to affect its stability or reliability or which has been subjected to misuse neglect or accident The warranty periods f...

Page 58: ...aggregate purchase price for the goods sold by Valleylab to the customer There are no warranties which extend beyond the terms hereof Valleylab disclaims any liability hereunder or elsewhere in connec...

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