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Patient and Operating Room Safety

Force 2 User’s Guide

     1

-

3

Fire Hazard with Oxygen Circuit Connections 

Electrosurgical Smoke

1.  U.S. Department of Health and Human Services. National Institute for Occupational Safety 

and Health (NIOSH). Control of Smoke from Laser/Electric Surgical Procedures. HAZARD 
CONTROLS, Publication No. 96-128, September, 1996.

Inadvertent Radio Frequency (RF) Burns

Warning

Fire/Explosion Hazard: 

 The following substances will contribute to increased fire 

and explosion hazards in the operating room:

• flammable substances (such as alcohol based skin prepping agents and 

tinctures)

• naturally occurring flammable gases which may accumulate in body cavities 

such as the bowel

• oxygen enriched atmospheres

• oxidizing agents (such as nitrous oxide [

N2O

] atmospheres)

The sparking and heating associated with electrosurgery can provide an ignition 
source.  Observe fire precautions at all times.  When using electrosurgery in the 
same room with any of these substances or gases, prevent their accumulation or 
pooling under surgical drapes, or within the 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 tubes are 
leak free, and that the cuff is properly sealed to prevent oxygen leaks.  Enriched 
oxygen atmospheres may result in fires and burns to patients or surgical team.

Caution

Studies have shown that smoke generated during electrosurgical procedures can 
be potentially harmful to patients and the surgical team.  These studies 
recommend adequately ventilating the smoke by using a surgical smoke 
evacuator or other means.

1

Warning

Electrodes and probes used with monitoring, stimulation, and imaging devices (or 
similar equipment) can provide a path for high frequency current even if the 
electrodes or probes are isolated at 50-60 Hz, insulated, and/or battery operated.

To reduce the risk of an inadvertent electrosurgical burn at the electrode or probe 
site, place the electrode/probe as far away as possible from the electrosurgical 
site and/or patient return electrode.  Protective impedances (resistors or RF 
inductors) installed in the monitoring leads may reduce the risk of such burns.  
Consult the hospital biomedical engineer for further information.

Содержание Force 2

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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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