Whittemore Enterprises Inc. EAGLE TWO PLUS Instructions/Service Manual Download Page 59

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USER GUIDE |

EAGLE TWO+

Version: 3.3

AFTER SURGERY:



De-assemble the complete instrument, separate out the outer tubing & blade assembly, clean
the jaws for internal tissue inside the hinge area, the tunings and dry the instrument by using
pressurized (hot) air.



Check the physical damages to the insulation of inner & outer tubing and also check the
mechanical tear & wear at the jaws area.



In case of any kind of damage to the device, report it to the medical engineering department for
the necessary repair.



Do not send the faulty device for next surgical use.



Change the blade if required.



Prepare the device for next surgery as instructed in section “

Before Surgery”

Saline Resection Mode in Eagle 2+

Accessory Connection in Saline Resection Mode

Summary of Contents for EAGLE TWO PLUS

Page 1: ...EAGLE TWO PLUS INSTRUCTION SERVICE MANUAL ...

Page 2: ...ight to change specifications and or functions of this equipment without any prior notice or announcement Words referring to EAGLE TWO ESU in this document are Generator ESU and Machine Use for This document is drafted by taking EAGLE TWO ESU into account only which is a product of Whittemore Enterprises Inc Registered Trademarks EAGLE TWO Turoseal VesSeal Manufactured By Whittemore Enterprises In...

Page 3: ...njuries to person Electrical Hazard Explains the possible risk associated with personal injury or death Prohibition Sign Explains actions by which the possible damage which may occur to instruments associated with machine and or others so should be prohibited Pushing Prohibition Sitting Prohibition Stepping Prohibition General mandatory action to be taken by user Refer Manual or Booklet ...

Page 4: ...Output Characteristics D Output frequencies E Area of application F Output Power vs Load Graphs 5 Before Surgery A Preparing the generator B Setting the generator C Programming the generator D Patient Return Electrode Monitoring PREM E Surgery Modes and Accessory Connections 6 During Surgery A Preparing the Patient Return Electrode B Modes power settings C Helpful hints to avoid hemostat burns D S...

Page 5: ...y Section PREM Safety Patient return electrode monitoring PREM is ultimate Safety for return electrode site burns Surgical Assistant 999 Customizable User Programs Recall function for fast preprogrammed case settings Bipolar BiCoag Alarm Provides Audio feedback alarm after completion of Bipolar Coagulation This reduces charring sticking of tissue to forceps avoids over burning of tissue User can c...

Page 6: ...interval control Endo 2 Cut It is used for a cut with pauses large pulse interval control Hydro Cut It is used for efficient cutting under bodily fluids water Monopolar Coag Modes There are SEVEN Coag modes Soft Soft coagulation with deep tissue necrosis Swift Low voltage non contact coagulation Desiccate Coagulation for soft and delicate tissues Fulgurate This mode is suitable for long remote non...

Page 7: ...lectrode The generator produces a high initial voltage spike that establishes spark in a gap between the bipolar electrodes under saline When the activated bipolar electrode is not in contact with the tissue the electrolyte solution in the bladder dissipates it When the loop is sufficiently close to tissue the high bipolar voltage spike arc between the electrodes converts the conductive sodium chl...

Page 8: ...mber of options derivatives to choose from which have been listed below Sr No Derivatives Vessel Sealer Saline Electrosurgery Monopolar 1 Monopolar 2 RF Scalpel 1 EAGLE TWO VSE 2 EAGLE TWO VSE 3 EAGLE TWO SE 4 EAGLE TWO SE 5 EAGLE TWO VS 6 EAGLE TWO V 7 EAGLE TWO S 8 EAGLE TWO E 9 EAGLE TWO E ...

Page 9: ... case In any case patient should not touch any metal parts that are connected to earth floor ground Take excessive precaution use antistatic pads Do not lean on the patient while buzzing the hemostat accidental and unintended burn injury may occur To reduce the risk of an inadvertent burn at the electrode site due to monitoring equipment place the electrode and or probe as far away as possible fro...

Page 10: ...ays ensure proper connection of PREM electrode with the patient s skin do not apply any solution which dehydrates the skin of a patient where PREM is to be connected To avoid the electrosurgical burns beneath the patient return electrode it is necessary to follow all directions on the product package for proper return electrode placement use Place Patient Return Electrode as close as possible to t...

Page 11: ...ment occurs do not use it on the patient as this could be dangerous for Operator and the Patient Vessel sealing devices will not work in blood reach environment get the tissue clean before sealing Do not activate the blade without completion of sealing cycle as this may cut the live arteries resulting to blood loss during surgery Cautions Use vessel sealing accessories provided by Whittemore Enter...

Page 12: ...and or burn the tissue Simultaneously activating irrigation electrosurgical current may result in increased arcing at electrode tip burns to unintended tissues shocks burns to the surgical site Cautions Never use power plug adaptors Avoid the use of extension cord for the mains power supply Do not plug in or unplug power cord when mains switch or generator s switch is in the ON state Never defeat ...

Page 13: ...erator on the top of any electrical equipment Always keep as much distance as possible between monitoring equipment video equipment and electrosurgical generator Do not disconnect the generator from main line AC immediately after turning off keep it connected to the main line for at least for a minute If generator is relocated from cold to warm room keep generator ON at least for half an hour to l...

Page 14: ...gical smoke generated during surgery is harmful to health Always keep as much distance as possible between monitoring equipment video equipment and electrosurgical generator Do not disconnect the generator from main line AC immediately after turning off keep it connected to the main line for at least for a minute If generator is relocated from cold to warm room keep generator ON at least for half ...

Page 15: ...o confirm any mode and setting PREM Contact Contact indicator It indicates the contact adequacy using process bars Green or gives audio visual alarm flashes Red when contact with the patient is inadequate Sealer Electrode Socket Accepts standard two pins 4mm sealer interface cable hand switching cable for sealer Open Lapro sealing cables can be connected Saline Resection Bipolar Socket Accepts sta...

Page 16: ...lease Note Saline Resection will not work with this input Power Socket To supply AC 230V 50Hz or 110V 60 Hz power to ESU Grounding Lug To reduce noise in other equipments Connect it to the earthing receptacle Monopolar Footswitch Electro surgery Mode Activates Cut Co agulation modes Two input paddles One for Cut Yellow another Blue for co agulation Monopolar 2 Bipolar Footswitch ES mode Sealer Bip...

Page 17: ...ls Description Every symbol on the left side forms an individual touch button Touching on any of the touch button will open up the corresponding menu screen Recall function calls up the recently used settings Program function can be used to store frequently used settings facilitating user to store up to approx 50 user programs Demonstration mode Setup Function facilitates user to change system set...

Page 18: ...sed to calibrate machine s sensors Calibration mode is explained in later chapters Warning To be accessed only by trained professional Please contact the manufacturer to obtain the Authorization code System Volume can be adjusted by turning volume control pot on the back panel of machine Touch buttons to increase and or decrease the brightness ...

Page 19: ... modes using Touch Selective Icons SCREEN2 STEP4 Once desired sub mode procedure is selected increase decrease the power using on screen or front panel keypad s up down arrow keys to STEP5 Now once power is selected for the desired sub mode procedure press Enter Key On screen or Keypad Pressing appropriate foot paddle or Handswitch will make power available on relevant port Follow the same procedu...

Page 20: ...tates quick remote access to manipulation of settings for very recently activated mode during surgery During normal Monopolar operation Handswitching electrode Pencil can be used for Monopolar Cut and Monopolar Coagulation operations Pressing yellow button will activate Monopolar cut output and pressing blue button will activate coagulation output Coag Switch Cut Switch ...

Page 21: ...re at power setting of 40Watts Now if surgeon wants to change it to new mode Monopolar Coag Fulgar at power settings of 30Watts FOR ENTER Press Cut and Coag buttons simultaneously Increase Decrease Left Right STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 STEP 6 Press Coag switch on the electrode ENTER ENTER ENTER SELECT MODE SET POWER ...

Page 22: ... displayed on the screen To add new program follow the steps below Follow the same procedure for editing preset programs Select program and press Edit STEP1 Enter Program name surgeon name Choose desired surgical mode from Electrosurgery Vesseal Sealer or Saline Resection Press Set Power tab see SCREEN2 STEP2 Now Enter desired mode set appropriate power User can set power for multiple surgical pro...

Page 23: ...Pressing will disable any inputs to and outputs from the generator Generator will not respond to any sort of activation in standby mode User can exit standby mode anytime by pressing entering and exiting the mode will not affect any user settings ...

Page 24: ...used with flammable anesthetics Class I Equipment IEC 60601 1 Accessible conductive parts are connected to the protective earth conductor the way which they can t become live in the event of a basic insulation failure Type CF Equipment IEC 60601 1 Maximum allowable leakage current limit is as per established standard EAGLE TWO provides a high degree of protection against electric shock Instrument ...

Page 25: ...for defibrillator proof design Dimensions and Weight Length 42 5 cm Width 35 5 cm Height 15 5 cm Weight 7 5 kg Transport and Storage Temperature range 40 to 70 C Relative humidity 10 to 100 condensing Operating Parameters Temperature range 10 C to 40 C Relative humidity 30 to 75 noncondensing Warm up time Allow one hour for the generator to reach room temperature before use if transported or store...

Page 26: ...1 4 A Bipolar 3 2 A Coag 1 9 A Coag 5A Maximum VA at nominal line voltage Idle 60 VA Idle 60 VA Cut 920 VA Cut 810 VA Bipolar 390 VA Bipolar 432 VA Coag 520 VA Coag 675 VA Mains line frequency range nominal 50 to 60 Hz 50 to 60 Hz Fusing 6A 10A B AVAILABLE POWER SETTINGS in Watts Bipolar All modes 1 to 40 by step of 1 40 to 70 by step of 5 100 to 120 by step of 10 Monopolar Cut Pure Endo 1 Endo 2 ...

Page 27: ...Bipolar and Monopolar Modes Power readouts agree with actual power into rated load to within 20 or 10watts whichever is greater Monopolar Cut Load 300 Ω Low Pure Blend 1 Blend 2 Endo 1 Endo 2 Hydro 1300 1700 2000 2300 1700 1700 1700 300 Ω 300 Ω 300 Ω 300 Ω 300 Ω 300 Ω 300 Ω 300 400 250 200 400 400 400 1 5 1 5 2 2 6 1 5 1 5 1 5 Monopolar Coag Load 500 Ω Soft Desiccate Swift Fulgurate Spray Hi Spray...

Page 28: ...not applied to the Coag modes because of their non contact capabilities Bipolar Micro Standard Force Macro Bicut 440 kHz sinusoidal 440 kHz sinusoidal 440 kHz sinusoidal 440 kHz sinusoidal 440 kHz sinusoidal Monopolar Cut Low Pure Cut Blend 1 Blend 2 Endo 1 Endo 2 Hydro Cut 390 kHz sinusoid Maximum voltage is limited to a lower value 390 kHz sinusoid 390 kHz bursts of sinusoid recurring at 29 kHz ...

Page 29: ...py ERCP o Oncosurgery o Heart Chest surgery CABG o Neurosurgery Spine o Arthroscopy o All other general surgical procedures Applications of Vessel Sealing System Section o Lap Assisted Vaginal Hysterectomy LAVH o Vaginal Hysterectomy o Gastrectomy o Gastric Bypass o Appendectomy o Colectomy o Nephrectomy o Nissen Fundoplication o Colon Resection o Cystectomy o Radical Hysterectomy o Liver Resectio...

Page 30: ...6 0 0 6 5 0 7 0 0 7 5 0 8 0 0 8 5 0 9 0 0 9 5 0 1 0 0 0 L o a d R e sista n c e o h m s O u t p u t P o w e r w a t t s 6 0 W 1 2 0 W B ip o la r M a c ro M o d e 0 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0 9 0 1 0 0 1 1 0 1 2 0 1 3 0 0 5 0 1 0 0 1 5 0 2 0 0 2 5 0 3 0 0 3 5 0 4 0 0 4 5 0 5 0 0 5 5 0 6 0 0 6 5 0 7 0 0 7 5 0 8 0 0 8 5 0 9 0 0 9 5 0 1 0 0 0 L o a d R e sista n c e o h m s O u t p u t P o w e r...

Page 31: ...7 5 0 8 0 0 8 5 0 9 0 0 9 5 0 1 0 0 0 L o a d R e sista n c e o h m s O u t p u t P o w e r w a t t s 6 0 W 1 2 0 W B ip o la r F o rc e B i_ c u t M o d e 0 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0 9 0 1 0 0 1 1 0 1 2 0 1 3 0 0 5 0 1 0 0 1 5 0 2 0 0 2 5 0 3 0 0 3 5 0 4 0 0 4 5 0 5 0 0 5 5 0 6 0 0 6 5 0 7 0 0 7 5 0 8 0 0 8 5 0 9 0 0 9 5 0 1 0 0 0 L o a d R e sista n c e o h m s O u t p u t P o w e r w a t ...

Page 32: ... 8 0 0 1 9 0 0 2 0 0 0 L o a d R e sista n c e o h m s O u t p u t P o w e r w a t t s M o n o p o la r P u re E n d o 1 E n d o 2 H yd ro M o d e 0 2 5 5 0 7 5 1 0 0 1 2 5 1 5 0 1 7 5 2 0 0 2 2 5 2 5 0 2 7 5 3 0 0 3 2 5 3 5 0 3 7 5 4 0 0 4 2 5 0 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0 6 0 0 7 0 0 8 0 0 9 0 0 1 0 0 0 1 1 0 0 1 2 0 0 1 3 0 0 1 4 0 0 1 5 0 0 1 6 0 0 1 7 0 0 1 8 0 0 1 9 0 0 2 0 0 0 L o a d R e...

Page 33: ... 0 0 1 6 0 0 1 7 0 0 1 8 0 0 1 9 0 0 2 0 0 0 L o a d R e sista n c e o h m s O u t p u t P o w e r w a t t s 1 2 5 W 2 5 0 W M o n o p o la r B le n d 2 C u t M o d e 0 2 5 5 0 7 5 1 0 0 1 2 5 1 5 0 1 7 5 2 0 0 2 2 5 0 2 0 0 3 0 0 4 0 0 5 0 0 6 0 0 7 0 0 8 0 0 9 0 0 1 0 0 0 1 1 0 0 1 2 0 0 1 3 0 0 1 4 0 0 1 5 0 0 1 6 0 0 1 7 0 0 1 8 0 0 1 9 0 0 2 0 0 0 L o a d R e sista n c e o h m s O u t p u t P...

Page 34: ... 6 0 0 1 7 0 0 1 8 0 0 1 9 0 0 2 0 0 0 L o a d R e sista n c e o h m s O u t p u t P o w e r w a t t s M o n o p o la r D e s ic c a te M o d e 0 2 0 4 0 6 0 8 0 1 0 0 1 2 0 1 4 0 1 6 0 1 8 0 2 0 0 2 2 0 0 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0 6 0 0 7 0 0 8 0 0 9 0 0 1 0 0 0 1 1 0 0 1 2 0 0 1 3 0 0 1 4 0 0 1 5 0 0 1 6 0 0 1 7 0 0 1 8 0 0 1 9 0 0 2 0 0 0 L o a d R e sista n c e o h m s O u t p u t P o w e ...

Page 35: ... 6 0 0 1 7 0 0 1 8 0 0 1 9 0 0 2 0 0 0 L o a d R e sista n c e o h m s O u t p u t P o w e r w a t t s 6 0 W 1 2 0 W M o n o p o la r F u lg u ra te M o d e 0 2 0 4 0 6 0 8 0 1 0 0 1 2 0 1 4 0 0 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0 6 0 0 7 0 0 8 0 0 9 0 0 1 0 0 0 1 1 0 0 1 2 0 0 1 3 0 0 1 4 0 0 1 5 0 0 1 6 0 0 1 7 0 0 1 8 0 0 1 9 0 0 2 0 0 0 L o a d R e sista n c e o h m s O u tp u t P o w e r w a tts 6 ...

Page 36: ...0 0 1 6 0 0 1 7 0 0 1 8 0 0 1 9 0 0 2 0 0 0 L o a d R e sista n c e o h m s O u tp u t P o w e r w a tts 6 0 W 1 2 0 W M o n o p o la r H i S p ra y M o d e 0 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0 0 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0 6 0 0 7 0 0 8 0 0 9 0 0 1 0 0 0 1 1 0 0 1 2 0 0 1 3 0 0 1 4 0 0 1 5 0 0 1 6 0 0 1 7 0 0 1 8 0 0 1 9 0 0 2 0 0 0 L o a d R e sista n c e o h m s O u tp u t P o w e r w a tts 3 5 ...

Page 37: ...a le r M o d e 0 2 5 5 0 7 5 1 0 0 1 2 5 1 5 0 1 7 5 0 5 0 1 0 0 1 5 0 2 0 0 2 5 0 3 0 0 3 5 0 4 0 0 4 5 0 5 0 0 5 5 0 6 0 0 6 5 0 7 0 0 7 5 0 8 0 0 8 5 0 9 0 0 9 5 0 1 0 0 0 L o a d R e sista nc e o hm s O u tp u t P o w e r w a tts L 2 L 5 ...

Page 38: ...USER GUIDE EAGLE TWO Version 3 3 37 ...

Page 39: ...USER GUIDE EAGLE TWO Version 3 3 38 ...

Page 40: ...USER GUIDE EAGLE TWO Version 3 3 39 ...

Page 41: ...the mode power setting Optional Press the Recall key on the front panel to display standard setting if required Optional Press the Program key on main screen to display stored programs Change the mode or settings if required as surgical conditions patient placement may require change in settings This also varies as individual skills surgical conditions patient placement may require change in setti...

Page 42: ...re that the contact between Patient skin Patient Return Electrode is adequate Bar below PREM icon indicates the contact adequacy Icon Contact Quality Excellent 100 Contact with patient Safe Contact with patient is proper and safe Moderate Contact with patient is moderate viable If possible try to improve the contact connect PREM dual area plate properly Take appropriate measures to improve the con...

Page 43: ...USER GUIDE EAGLE TWO Version 3 3 42 E SURGERY MODES ACCESSORY CONNECTIONS 1 Electro Surgery Mode in Eagle 2 Accessories connection in ESU Mode ...

Page 44: ...USER GUIDE EAGLE TWO Version 3 3 43 Connection with patient Monopolar Mode Please Note Patient Return Electrode is necessary for Monopolar electrosurgical modes only ...

Page 45: ...olar 1 Cut Coag on From Monopolar 2 Bipolar Please Note For using these footswitching input sockets for functions other than default user must manually configure it When using footswitching electrodes user must connect footswitches to corresponding ports on the rear panel Monopolar As in this example if user intends to connect footswitching pencil in Monopolar 2 socket and Handswitching electrode ...

Page 46: ...cil 2 Handswitching Pencil Footswitching Pencil 3 Footswitching Pencil Handswitching Pencil 4 Footswitching Pencil Footswitching Pencil Please Note User must cautiously select appropriate footswitching or handswitching inputs Single paddle Footswitch Selection for Sealer Bipolar While using bipolar or sealer in Electro Surgery mode user has two options for footswitch selection 1 Single Paddle Foot...

Page 47: ...d Pressing touch icon in the sealer mode will remove the cross mark from the icon which makes the single paddle footswitch functional for sealer operations For making it functional for bipolar again user must configure footswitch into bipolar mode By going into bipolar mode and removing cross mark across the blue footswitch which is the icon of single paddle footswitch will make it functional for ...

Page 48: ...dle footswitch functional for Sealer Bipolar operations follow the similar procedure as described above for double paddle footswitch selection In this case enable double paddle footswitch icon by going into Bipolar or Sealer mode Connect double paddle footswitch in Monopolar 2 Bipolar footswitch socket Footswitch 1 Yellow in color can be used for Sealer activations Footswitch 2 Blue in color can b...

Page 49: ...USER GUIDE EAGLE TWO Version 3 3 48 2 Electrosurgery Mode in Eagle 2 Accessories connection in ESU Mode ...

Page 50: ...ar OR Sealer By default Cut Coag on Monopolar Bipolar Sealer Bipolar Please Note For using these footswitching input sockets for functions other than default user must manually configure it When using footswitching electrodes user must connect footswitches to corresponding ports on the rear panel Monopolar As shown in this example user can connect either handswitching or footswitching electrodes P...

Page 51: ...ngle paddle Footswitch Selection for Sealer Bipolar While using bipolar or sealer in Electro Surgery mode user has two options for footswitch selection 1 Single Paddle Footswitch in Sealer Bipolar Footswitch socket on the rear panel 2 Double Paddle Footswitch in Monopolar 2 Bipolar Footswitch socket on rear panel ...

Page 52: ...al for sealer operations For making it functional for bipolar again user must configure footswitch into bipolar mode By going into bipolar mode and removing cross mark across the blue footswitch which is the icon of single paddle footswitch will make it functional for bipolar mode Double Paddle Footswitch in Monopolar 2 Bipolar Footswitch socket In Eagle 2 double footswitch paddle is configured fo...

Page 53: ...USER GUIDE EAGLE TWO Version 3 3 52 Accessories connection in Vessel Sealer Mode Footswitch connection in Vessel Sealer Mode ...

Page 54: ...USER GUIDE EAGLE TWO Version 3 3 53 Lapro Instrument 5mm for Sealer Mode in Eagle 2 Open Clamp for Sealer Mode in Vista Open Clamp for Sealer Mode ...

Page 55: ...USER GUIDE EAGLE TWO Version 3 3 54 Sealer Instrument 10mm Assembling LOCK BLADE SLIDE IT IN STEP 1 STEP 2 STEP 3 STEP 4 ...

Page 56: ...USER GUIDE EAGLE TWO Version 3 3 Whittemore Enterprises Inc 55 STEP 5 STEP 8 STEP 6 STEP 7 ...

Page 57: ...as to always inspect the device for breakage general tear and wear of the device before sending it for re sterilization Always check the insulation at Jaws outer tubing insulation and inner tubing insulation for breakages and damages Do not use the damage equipment for the further procedure STEP 9 ...

Page 58: ...DO NOT USE NORMAL SALINE NS FOR CLEANNING OF THE INSTRUMENT DURING THE SURGERY Open the sterilized bunch of the instrument in sterilized field in OT Operation Theatre open the cloth cover of all the assembly Inspect all assembly for physical damage and insulation failure during sterilization Assemble the instrument as per the assembly instruction and check the functioning before using it in surger...

Page 59: ...ysical damages to the insulation of inner outer tubing and also check the mechanical tear wear at the jaws area In case of any kind of damage to the device report it to the medical engineering department for the necessary repair Do not send the faulty device for next surgical use Change the blade if required Prepare the device for next surgery as instructed in section Before Surgery 4 Saline Resec...

Page 60: ...n in Saline Resection Mode In Saline Resection Mode user must connect double paddle footswitch to the Monopolar 2 Bipolar socket on the rear panel as shown in the figure User can select Saline Hi Cut yellow or Saline Force blue depending upon the application ...

Page 61: ...MENTS OPTION I Luer lock adapter conventional monopolar working element for bipolar resection OPTION II Conventional monopolar working element isolated I O sheath for bipolar resection OPTION III Bipolar working element with or without isolated sheath ...

Page 62: ...USER GUIDE EAGLE TWO Version 3 3 61 BIPOLAR WORKING ELEMENT ASSEMBLING Let s divide assemblies into two Assembly 1 Assembly 2 EQUIPENTS ...

Page 63: ...res into respective holes gently press it as shown in picture STEP 2 Gently press bipolar loop against working element tighten the screws in the direction as shown in figure beside to firmly attach bipolar loop with the working element While doing so do not retract the working element Once tightened check connection by retracting the working element As shown in the figure beside ...

Page 64: ...E EAGLE TWO Version 3 3 63 ASSEMBLY 2 STEP 3 Insert Sheath insert in Isolated Sheath as shown in figure Match the 0 on isolated sheath with slot on the sheath insert then press it and lock the assembly LOCK LOCK ...

Page 65: ... 64 JOINING ASSEMBLY 1 ASSEMBLY 2 STEP 4 Insert assembly 1 into assembly 2 carefully as shown in figure below STEP 5 Match the 0 on Assembly 1 with the notch on Assembly 2 insert it completely then lock it as shown in the figure below ...

Page 66: ...f blood tissue and other objects by wiping do not use abrasive material the Connector Cable with a cloth in a mild cleaning solution or detergent capable of removing organic deposits Do not use reprocessing solutions Rinse thoroughly in running water Remove any residues further by cleaning agents with a water damp cloth Dry the device thoroughly before sterilizing Sterilize the connector cable acc...

Page 67: ...trodes do not touch A PREPARING THE PATIENT RETURN ELCTRODE Warning Do not warp cloth over return electrode as it increases the tissue resistance more power will require for surgery Warning Avoid bony prominences scar tissue skin over an implanted metal prosthesis hairy surfaces pressure points and adipose tissue Warning Do not stress strain or pressurize electrode cable under any condition Cautio...

Page 68: ...rogram key to select Program for fast setting of the generator Technique for keeping Power Setting Low 1 Using a small active electrode to deliver current less power is required to produce the same surgical effect 2 Coagulate tissues by using fulguration rather than desiccation because fulguration sparks to a wider area of tissue surface coagulation can be achieved with lower power setting using F...

Page 69: ...is not connected to the generator when the generator is activated for monopolar surgery 2 The return electrode does not have adequate contact with the patient 3 The contact area is reduced due to movement loss of adhesion fluid pooling or dry gel 4 The return electrode cord is damaged causing excessive resistance System Alarm When the generator senses a system alarm condition an alarm tone sounds ...

Page 70: ...tly follow the procedures for cleaning as mentioned in the manual Do not allow fluids to enter the chassis The generator cannot be sterilized 3 Use generator only after machine is completely cleaned Instrument Cleaning Cleaning is required for all instruments with lumens and hollow spaces Abrasive materials should not be used on the any parts because they will damage the instrument s outer surface...

Page 71: ...e should be five minutes or less and water temperature should not exceed 50 C 8 Rinse thoroughly under running distilled water for at least five minutes Vessel Sealing Instrument Prepare the cleaning solution with 50 H2O 50 permissible disinfectant Do not use normal saline for cleaning of the instrument during the surgery In case of using non sterilized blades assemble the instrument with blade ea...

Page 72: ...issue density changes Hence produces fine cutting with coagulation effect Smart Endo Cut Change in cut pause as tissue demands dependent on the tissue impedance Randomized Spray Coag The real spray In conventional spray coag beam tends to follow the same path left by previous spark Hence no homogeneous coagulation over larger area By randomizing spray frequency amplitude spark takes multiple paths...

Page 73: ...nstruments and reduces smoke charring necrosis carbonization of tissue B BLOCK DIAGRAM DESCRIPTION System is divided in three basic parts 1 Processor and control circuit 2 Variable voltage power supply 3 Radio frequency output amplifier Processor Control circuit This is the main control system that calculates all the system parameters as per the selected mode and monitors the overall activity of t...

Page 74: ...rocessor for checking the contact quality of patient with return electrode 5 Power Supply Supervisory IC U02 circuit monitors the fluctuation in a power supply at the time of system shutdown it provides stand by time necessary for a system to store the crucial data 6 Display Circuit 5 5 inch touchscreen LCD Display is controlled by Display controller IC U10 7 Keyboard Circuit Front panel Key board...

Page 75: ...05 configuration is selected by primary relay K01 K02 Output stage is driven by switching devices Q09 to Q12 at various levels CR26 is also used to protect the device from reverse current 3 O P Resonator and filter RF o p of amplifier stage is supplied to patient via resonator stage which is resonating at particular load conditions This stage has two functions of resonator filter for RF frequencie...

Page 76: ... sense T08 T11 and IC U07 U08 converts the current in average value which is sensed by CPU as I sense 11 RF voltage sense O P voltage is sensed by voltage sense T07 T10 and processed by true rms converter in dc voltage by IC s U09 U10 which is sensed by CPU as V sense Also it gives the signal to spark controller 12 High voltage sense circuit This circuit continuously monitors that RF HV is not cro...

Page 77: ...USER GUIDE EAGLE TWO Version 3 3 76 Detailed circuit diagrams components list relevant to the purchased product will be made available to a valid customer upon request ...

Page 78: ...tion Plug the generator power cord into a grounded socket Grasp the plug not the power cord Do not pull the cord itself Warning Keep test leads to the minimum length usable lead inductance and stray capacitance can adversely affect readings Carefully select suitable ground points to avoid ground loop error in measurements The accuracy of most RF instruments is approximately 1 5 of full scale Do no...

Page 79: ...switch connector into respective socket 2 Remove the fuse and verify correct voltage and current rating 3 If either connection is loose replace the footswitch board Front Panel 1 Check the bipolar instrument socket for obstructions or damage Insert the bipolar instrument connector footswitching and handswitching into the appropriate socket to verify a secure fit If the connection is loose replace ...

Page 80: ...RMS voltmeter 100 300 and 500 Ω 1 noninductive power resistors Bipolar and monopolar footswitches Checking the Bipolar Output 1 Verify that the generator successfully completes the self test 2 Connect the test equipment for bipolar output a Connect the two test cables to the bipolar socket b Pass one test cable through the current transformer and connect the current transformer to the voltmeter c ...

Page 81: ...d2 Hydro mode and repeat step 5 Follow this procedure for every mode 8 Verify that the generator output for each mode is 516 26mA rms 9 If the output is outside the specified range calibrate the monopolar output as described in calibration steps 4 2 Then repeat this procedure If the output for one or more cut modes remains outside the specified range call the Whittemore Enterprises Inc Service Cen...

Page 82: ...ing the conventional 1 microamp per 1 millivolt 5 Verify under normal conditions ground closed normal polarity the leakage current is less than 100 microamps If the leakage current is greater than 100 microamps call the Whittemore Enterprises Inc Service center 6 Verify single fault conditions ground Open the leakage current is less than or equal to300 microamps If the leakage current is greater t...

Page 83: ... Record the leakage current It should not exceed 150 mA for any mode 5 If the high frequency leakage exceeds 150 mA call the Whittemore Enterprises Inc Service Centre for further instructions Checking Bipolar High Frequency Leakage Current 1 Remove the monopolar accessories and connect the 200 Ω load from one side of the bipolar output through the current transformer to the equipotential ground lu...

Page 84: ... Equipments Bipolar footswitch and Monopolar footswitch Small test cables with banana plugs PREM plug modified Resistor substitution box Oscilloscope True RMS current meter Entering Calibration Mode To enter in calibration mode switch ON EAGLE TWO follow this procedure given below 1 Press Setup option 2 Press the Calibration touch key to enter calibration mode 3 Contact manufacturer for the authen...

Page 85: ...resistor as indicated by Load R on the screen across the PREM socket 3 Give single paddle for at least 3 seconds activation to get Fire count reading once reading is displayed on the screen press Write counts to program memory to store the acquired count 4 Once the memory write operation is successful press Back touch key 5 Follow the same Steps 1 to 4 for 1 2 REM Max Please Note Load R is differe...

Page 86: ...ocket to a 10 Ω resistor c Bipolar footswitch to the bipolar sealer single paddle footswitch socket on the rear panel 2 Check and adjust the I max for bipolar output a Select mode 2 1 BIP b Press the Bipolar footswitch pedal check if current reading is equivalent to 3082 mA 20 mA RMS c If not then stop activation If the output current is high decrease DAC Counts by pressing down touch key If low i...

Page 87: ...m for Monopolar b One test cable from Monopolar 1 socket to true RMS current meter in series with 200 Ω resistor c Monopolar footswitch to the Monopolar 1 footswitch socket on the rear panel 2 Check and adjust the I max for Monopolar cut output a Select mode 2 2 Pure Cut a Press the Monopolar cut footswitch pedal and check if the current is equivalent to 1224mA 20 mA RMS b If not then stop activat...

Page 88: ...y pressing down touch key If low increase it by pressing up touch key c Repeat step b c sequentially until the meter reading is not in the stated range d When reading is in stated range press Write Counts to program memory for storing the corresponding fire count reading in the system memory 3 Disconnect the test cables from Monopolar output Sub step 4 Blend 2 Mode Equipment Monopolar footswitch S...

Page 89: ...th the 10Ω c Monopolar footswitch to the Monopolar 1 footswitch socket on the rear panel 2 Check and adjust the I max for Saline Resection cut output a Select mode 2 5 BiTUR Cut Refer the connection diagram for Saline Resection a Press the Monopolar Cut footswitch pedal and check if the current reading is equivalent to 4472 mA 20 mA RMS b If not then stop activation If the output current is high d...

Page 90: ...e Monopolar 1 footswitch socket on the rear panel 2 Check and adjust the I max for Saline Resection Coag output a Select mode 2 6 BiTUR Coag a Press the Monopolar footswitch pedal and check if the current reading is equivalent to 3872 mA 20 mA RMS b If not then stop activation If the output current is high decrease DAC Counts by pressing down key If low increase it by pressing up key c Repeat step...

Page 91: ... Calibration Step 3 Close Loop Voltage Calibration Vmax Sub step 1 BIP mode Equipment Bipolar footswitch Small test cables with banana plugs True RMS current meter 1 kΩ non inductive power resistor Procedure 1 Connect a One test cable from Bipolar socket to RMS current meter in series with the 1 kΩ resistor Refer the connection diagram for bipolar b One test cable from Bipolar socket to 1 kΩ resis...

Page 92: ...adjusted 3 Disconnect the test cables from Monopolar output Sub step 3 Blend 1 Mode Equipment Monopolar footswitch Small test cables with banana plugs True RMS current meter 1 kΩ non inductive power resistor Procedure 1 Connect a One test cable from socket PREM plug to 1 kΩ Refer the connection diagram for Monopolar b Another test cable from Monopolar 1 socket to true RMS current meter in series w...

Page 93: ...ut Mode Equipment Monopolar footswitch Small test cables with banana plugs True RMS current meter 1k Ω non inductive power resistor Procedure 1 Connect a One test cable from Saline Resection plug to 1k Ω Refer the connection diagram for Saline Resection b One test cable from Saline Resection socket passing through true RMS current meter to 1kΩ c Monopolar footswitch to the Monopolar 1 footswitch s...

Page 94: ...st cable from Sealer socket to 210 Ω Refer the connection diagram for Sealer b One test cable from Sealer socket pass through true RMS current meter to 210 Ω c Sealer Bipolar footswitch to the sealer bipolar footswitch socket 2 Check and adjust the Vmax for Sealer output a Select mode 3 7 Seal b Press the Bipolar Sealer footswitch pedal and check if the current reading is equivalent to 845 mA 20 m...

Page 95: ...0Ω c Monopolar Cut footswitch to the Monopolar 1 footswitch socket on the rear panel 2 Check and adjust the Pmax for Monopolar cut output a Select mode 4 2 Pure Cut b Press the Monopolar cut footswitch pedal and check if the current is equivalent to 374mA 20 mA RMS c Stop activation If the output current is high decrease DAC Counts by pressing down key If low increase it by pressing up key d Repea...

Page 96: ...eck and adjust the Pmax for Monopolar Blend 2 cut output a Select mode 4 4 Blend 2 b Press the Monopolar Cut footswitch pedal and check if the current reading for a reading equivalent to 374mA 20 mA RMS c Stop activation If the output current is high decrease DAC Counts by pressing down key If low increase it by pressing up key d Repeat step b c sequentially until the meter reading is not in the s...

Page 97: ...RMS c Stop activation If the output current is high decrease DAC Counts by pressing down key If low increase it by pressing up key d Repeat step b c sequentially until the meter reading is not in the stated range e When reading is in stated range press Write Counts to program memory for storing corresponding fire count reading in the system memory Sub step 7 Sealer Mode Equipment Monopolar footswi...

Page 98: ...ressing up key d Repeat step b c sequentially until the meter reading is not in the stated range e When reading is in stated range press Write Counts to program memory for storing corresponding fire count reading in the system memory 3 Disconnect the test cables from Monopolar output 4 Use same equipments repeat the same procedure for calibrating Econ of different modes Dessicate Swift Fulgar Spra...

Page 99: ...ing up key d Repeat step b c sequentially until the meter reading is not in the stated range e When reading is in stated range press Write Counts to program memory for storing corresponding fire count reading in the system memory 3 Disconnect the test cables from Monopolar output 4 Use same equipments repeat the same procedure for calibrating Vpk of different modes Desiccate Swift Fulgar Spray Hi ...

Page 100: ... first wipe off all gross debris using neutral detergent then wipe its surface with a lint free cloth moistened with a surface disinfectant 3 To remove dust dirt and non patient debris wipe the electrosurgical unit and foot switch using a soft lint free cloth moistened with 70 ethyl or isopropyl alcohol 4 Make sure that the electrosurgical unit and foot switch are completely dry before storage WAR...

Page 101: ...h If dirt persists moisten the cloth with 70 ethyl or isopropyl alcohol and wipe again 2 Dry thoroughly after wiping A cable that is not completely dry may cause an electric shock 11 4 STORAGE OF MAINS CABLE WARNING Never store the cable in shipping box as this may pose an infection control risk 1 Store under the conditions away from direct sunlight and source of liquids 2 Store the cable with the...

Page 102: ...ntify and correct specific malfunctions After you correct malfunction verify that the generator completes the self test Situation Possible Cause Recommended Action ESU does not respond when Turned on Improper contact of power cord with the socket faulty wall socket or faulty power cord Check power cord connections with wall socket and ESU Connect the power cord to a functional wall socket If neces...

Page 103: ...tswitch board Check correct connection If indicated replace the Footswitch board Faulty connections or speaker on Footswitch board Replace the footswitch Speaker board or Speaker Audio signal malfunction on Control board Replace the control board Blank or confusing LEDs of Ports Faulty ribbon cable between CPU and Display board Check connect ribbon cable that connects the Display board to the CPU ...

Page 104: ...y RF board verify T_ON pulses at R77 If pulses are present Check all MOSFET Q09 to Q12 replace with same part no if require Check Diodes CR26 replace with same part no If T_ON pulses are not present verify T_ON pulses at TP 19 If pulses are not present replace the CPU Check IC U14 replace with same part no if require Footswitch will not activate output Malfunctioning or damaged footswitch socket R...

Page 105: ...y and keep a defibrillator available Consult the pacemaker manufacturer or hospital Cardiology Department for further information when use of Electrosurgery is planned on patients with cardiac pacemakers Abnormal neuromuscular stimulation stop surgery immediately Metal to metal sparking Check all connections to the generator patient return electrode and active electrode Can occur during coag Use a...

Page 106: ...vation error Turn OFF and again turn ON the generator Do not press any Key during self test If the alarm repeats disconnect all accessories Check connect the ribbon cable that connects the Display board to the front panel Turn OFF and again turn ON the generator If the alarm repeats replace front keypad Call Whittemore Enterprises Inc Pvt Ltd service cell 602 FootSwitch1 Handswitch1 Co agulation a...

Page 107: ...ittemore Enterprises Inc Sealer Close warnings Causes Sealer clamp is activated on conducting material in conducting fluid Connector is not properly connected in the sealer port Sealer clamp cable is shorted internally Sealer clamp head opening is bent or damages due to excessive external pressure from clamp head opening is not cleaned properly Measures Clean sealer clamp s head clip openings prop...

Page 108: ...e disposables Shelf life only as stated on packaging Non Sterile Electrodes Cables Warranty on manufacturing defects only Single use patient return electrodes Shelf life only as stated on packaging Please Note Warranty on accessories is subject to manufacturing defect before usage only Please Note Whittemore Enterprises Inc will not be liable to pay fund any sort of penalty due other than the aggr...

Page 109: ... any kind of losses to equipment patient user caused due to the incorrect operation maintenance of the equipment by an unauthorized untrained person 6 Consumables accessories have to be used as per the instructions given in the accompanying documents Use of expired or re used accessories beyond the lifecycle may lead to injury damage complication to patient or user Company will not be responsible ...

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