Whittemore Enterprises Inc. EAGLE TWO PLUS Instructions/Service Manual

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EAGLE TWO PLUS

INSTRUCTION & SERVICE MANUAL

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Summary of Contents for Whittemore Enterprises Inc. EAGLE TWO PLUS

Page 1 EAGLE TWO PLUS INSTRUCTION & SERVICE MANUAL...
Page 2 USER GUIDE | EAGLE TWO+ Version: 3.3 This document is a user guide for EAGLE TWO+Electrosurgical unit. Guide is intended to be referred by qualified & trained physician and surgeon. This instrument is electrically hazardous, user operating this generator / consulted technician for servicing should read this user manual thoroughly. Please Note Manufacturer has every right to change specifications and/or functions of this equipment without any prior notice or announcement.
Page 3 USER GUIDE | EAGLE TWO+ Version: 3.3 Conventions and Symbols used in this document Symbol Meaning General warning sign Explains the possible damage which may occur to the machine OR minor injuries 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.
Page 4: Table Of Contents
USER GUIDE | EAGLE TWO+ Version: 3.3 INDEX 1. Introduction A. General Features B. Modes of Electrosurgery i. Monopolar Electrosurgery ii. Bipolar Electrosurgery iii. Vessel Sealing System iv. Saline Plasma Bipolar Resection C. Derivatives of EAGLE TWO+ 2. Safety Instructions 3.
Page 5: Introduction
USER GUIDE | EAGLE TWO+ Version: 3.3 CHAPTER 1 Introduction Electrosurgical Generator – the product of Whittemore Enterprises Inc. provides EAGLE TWO+ necessary High Frequency electrical power for different types of surgical needs in advance Medical Technologies. Vessel Sealing, Saline Resection with conventional Monopolar and Bipolar Electrosurgical applications with multiple options of effects with following features: A.
Page 6 USER GUIDE | EAGLE TWO+ Version: 3.3 Bipolar Cut & Coag with independent Display setting with independent foot-switches.  Sealing Program auto-select is available as per the selected accessory.  SECTION 3: Saline Plasma Bipolar Resection Electrode Disconnection / Non Saline activation Alarm. ...
Page 7 USER GUIDE | EAGLE TWO+ Version: 3.3  Macro – Voltage in this mode is higher than other bipolar modes.  Bicut – Comparatively low voltage Precious & clean bipolar cutting. 3. Vessel Sealing System: In Vessel Sealing System, both the active & return electrodes are in surgical site as in bipolar. Patient return electrode is not required as Vessel Sealing instrument contains an active electrode &...
Page 8 USER GUIDE | EAGLE TWO+ Version: 3.3 C. DERIVATIVES OF EAGLE TWO+ EAGLE TWO+unit comes with a number of options (derivatives) to choose from which have been listed below. RF Scalpel Vessel Derivatives Saline Electrosurgery (Monopolar 1 & Sealer Monopolar 2) EAGLE TWO+VSE √...
Page 9 USER GUIDE | EAGLE TWO+ Version: 3.3 CHAPTER 2 Safety Instructions Read all the warnings, cautions provided with this generator before using. Hazardous Electrical Output: This instrument is to be used only by trained, licensed physician/surgeon. If the patient has an internal pacemaker and internal cardiac defibrillator or any kind of orthopedic implant, consult the pacemaker, defibrillator &...
Page 10 USER GUIDE | EAGLE TWO+ Version: 3.3  Do not activate the generator in an open circuit condition. Do not short Active electrode with return electrode.  Do not activate electrodes while in contact with other instrument, an unintended tissue injury may occur.
Page 11 USER GUIDE | EAGLE TWO+ Version: 3.3 Bipolar Cautions:  Bipolar accessories must be connected to the bipolar socket only.  Bipolar mode should be utilized whenever possible. Vessel Sealing Warnings-  Make use of appropriate footswitch for vessel sealing operation; perform manual settings when using single paddle footswitch.
Page 12 USER GUIDE | EAGLE TWO+ Version: 3.3 Electrical Connections & Power: Warnings-  Make use of a dry cheesecloth between patient and ground body.  Inspect electrode connections and contacts frequently.  Check all the power settings & each and every connection to the generator before using the device on patient.
Page 13 USER GUIDE | EAGLE TWO+ Version: 3.3 Cautions:  Place Foot paddles on flat, dry & clean surfaces.  Do not reuse or re-sterilize accessories labeled “disposable or single use only”.  Check all accessories before using, especially if they are endoscopic accessories. Radio Frequency Burns: Warnings- ...
Page 14 USER GUIDE | EAGLE TWO+ Version: 3.3  Shave off body hairs coming in contact with surgical site whenever necessary. Cautions:  Avoid the use of hybrid tracers that include both metal & plastic components.  Always maintain proper ventilation in the surgical room, as surgical smoke generated during surgery is harmful to health.
Page 15: Controls, Indicators & Output Sockets
USER GUIDE | EAGLE TWO+ Version: 3.3 CHAPTER 3 Controls, Indicators & Output Sockets A. Front Panel Saline Resection/Bipolar Socket: Accepts standard Bipolar/Saline Resection interface cables. Active HF cord in one hole & return HF cord from lure lock Keypad: adapter in other hole or standard two pin This is adjunct to LCD touchscreen input.
Page 16 USER GUIDE | EAGLE TWO+ Version: 3.3 B. Rear Panel Power Socket: To Fuse Socket: Fuse Rating supply AC (230V / (230V, 6A) or (110V, 10A) 50Hz) or (110V/60 Please Note: In case of fuse Hz) power to ESU malfunction replace fuse with the same rating Volume Control: For adjusting volume of...
Page 17 USER GUIDE | EAGLE TWO+ Version: 3.3 C. Main Screen Screen1 is the main menu screen appears once EAGLE TWO+has turned ON/ restarted. Touch interface and easily accessible menu makes it very user friendly. Details of symbols on the screen are given below.
Page 18 USER GUIDE | EAGLE TWO+ Version: 3.3 Touch buttons to increase and/or System Volume can be adjusted decrease the brightness. by turning volume control pot on the back panel of machine Warning: To be accessed only by trained professional. Please contact the manufacturer to obtain the Authorization code.
Page 19 USER GUIDE | EAGLE TWO+ Version: 3.3 D. How to select Power & Mode STEP 1:- Enter the desired surgical mode (Electro-surgery, Vessel Seal, and Saline Resection). STEP2:- Select desired procedural mode just by touching relevant icon or by using Front panel Keyboard.
Page 20 USER GUIDE | EAGLE TWO+ Version: 3.3 E. How To Select Power Using Handswitching Pencil OPTIONAL) EAGLE TWO+provides remote control using handswitching electrodes. This facilitates quick remote access to manipulation of settings for very recently activated mode, during surgery. Cut Switch Coag Switch During normal Monopolar operation, Handswitching electrode (Pencil) can be used for Monopolar Cut and Monopolar Coagulation operations.
Page 21 USER GUIDE | EAGLE TWO+ Version: 3.3 Let‟s assume if recently activated mode was Monopolar Cut Pure 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.
Page 22 USER GUIDE | EAGLE TWO+ Version: 3.3 F. Programming The Generator Touching any of the text boxes will open up user friendly QWERTY on-screen keyboard. PROGRAM 1 DR.XYZ Enter name of SCREEN 1 surgical-procedure for  Program function gives facility to edit, which setting is to be load &...
Page 23 USER GUIDE | EAGLE TWO+ Version: 3.3 Stand By 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 ;...
Page 24 USER GUIDE | EAGLE TWO+ Version: 3.3 CHAPTER 4 Technical Specifications A. GENERAL SPECIFICATIONS General Output Configuration: Isolated output with cardiac defibrillator protection. Duty Cycle of Operation: At maximum rated load conditions, pure cut-400 watt setting at 300 Ω s, The system is suitable for activation time of 10 seconds ON, 30 seconds OFF for one hour.
Page 25 USER GUIDE | EAGLE TWO+ Version: 3.3 Caution Do not stack equipment upon EAGLE TWO+or place the generator on top of other electrical equipment. This configuration does not allow proper cooling. Caution Do not place any chemical or solution in operating room, may spoil safety of electronic circuit by liquid spillage. Electromagnetic compatibility (IEC 60601-1-2) The Shalya fulfills the specifications regarding electromagnetic compatibility.
Page 26 USER GUIDE | EAGLE TWO+ Version: 3.3 o Dual Area PREM return electrode: 5 to 135 Ω s o Single Area Patient return electrode: 0 to 10 Ω s  Low Frequency (50 - 60 Hz) Leakage Current: o Source current, patient leads, all outputs: o Normal polarity, intact ground: <10µA o Normal polarity, ground open: <50 µA o Reverse polarity, ground open: <50µA...
Page 27 USER GUIDE | EAGLE TWO+ Version: 3.3 Monopolar Coag: Swift/Fulgar/Spray/Hydro 1 to 40 by step of 1, 40 to 100 by step of 5, 100 to 120 by step of 10. Monopolar Coag: Hi-Spray 1 to 40 by step of 1, 40 to 70 by step of Sealer: Vesseal Sealer: Fine /Rapid L1-80W...
Page 28 USER GUIDE | EAGLE TWO+ Version: 3.3 100 Ω Macro 100 Ω Bicut Load-10 Ω Sealer 100 Ω Micro Seal 100 Ω Standard Seal Load-100 Ω Saline Resection Saline Cut 100 Ω CutI 100 Ω CutII 1020 100 Ω CutIII 1160 Saline Coag 100 Ω...
Page 29 USER GUIDE | EAGLE TWO+ Version: 3.3 Sealer Fine Seal 440 kHz sinusoidal Rapid Seal 440 kHz sinusoidal Saline Resection Saline Cut I 390 kHz sinusoidal Saline Cut II 390 kHz sinusoidal Saline Cut II 390 kHz sinusoidal Saline Soft Coag 440 kHz sinusoidal Saline Standard Coag 440 kHz sinusoidal...
Page 30 USER GUIDE | EAGLE TWO+ Version: 3.3 F. OUTPUT POWER VS. LOAD GRAPHS B ip o la r M ic r o M o d e 1 3 0 1 2 0 1 1 0 1 0 0 6 0 W 1 2 0 W L o a d R e s is t a n c e ( o h m s ) B ip o la r M a c r o M o d e...
Page 31 USER GUIDE | EAGLE TWO+ Version: 3.3 B ip o la r S ta n d a r d M o d e 1 3 0 1 2 0 1 1 0 1 0 0 6 0 W 1 2 0 W L o a d R e s is t a n c e ( o h m s ) B ip o la r F o r c e / B i_ c u t M o d e 1 3 0...
Page 32 USER GUIDE | EAGLE TWO+ Version: 3.3 M o n o p o l a r L o w C u t M o d e 3 2 5 3 0 0 2 7 5 2 5 0 2 2 5 2 0 0 1 7 5 1 5 0...
Page 33 USER GUIDE | EAGLE TWO+ Version: 3.3 M o n o p o la r B le n d 1 C u t M o d e 2 7 5 2 5 0 2 2 5 2 0 0 1 7 5 1 5 0 1 2 5 W 2 5 0 W...
Page 34 USER GUIDE | EAGLE TWO+ Version: 3.3 Monopolar Soft Coag Mode M o n o p o la r S P C u t M o d e 3 2 5 3 0 0 2 7 5 2 5 0 2 2 5 2 0 0 1 7 5...
Page 35 USER GUIDE | EAGLE TWO+ Version: 3.3 M o n o p o la r S w ift M o d e 1 4 0 1 2 0 1 0 0 6 0 W 1 2 0 W L o a d R e s is t a n c e ( o h m s ) M o n o p o la r F u lg u ra t e M o d e 1 4 0 1 2 0...
Page 36 USER GUIDE | EAGLE TWO+ Version: 3.3 M o n o p o la r S p ra y M o d e 1 4 0 1 2 0 1 0 0 6 0 W 1 2 0 W L o a d R e s is ta n c e ( o h m s ) M o n o p o la r H i-S p ra y M o d e 3 5 W 7 0 W...
Page 37 USER GUIDE | EAGLE TWO+ Version: 3.3 S e a le r M o d e 1 7 5 1 5 0 1 2 5 1 0 0 L o a d R e s is ta n c e ( o h m s )
Page 38 USER GUIDE | EAGLE TWO+ Version: 3.3...
Page 39 USER GUIDE | EAGLE TWO+ Version: 3.3...
Page 40 USER GUIDE | EAGLE TWO+ Version: 3.3...
Page 41 USER GUIDE | EAGLE TWO+ Version: 3.3 CHAPTER 5 Before Surgery Electric Shock Hazard: Warning - Never remove the cover of instrument. Before Surgery: Caution - Read all warnings, cautions provided with this generator before using. Active accessories: Electric Shock Hazard Warning - Avoid the connection of wet accessories to the generator.
Page 42 USER GUIDE | EAGLE TWO+ Version: 3.3 c. The PREM Alarm indicator illuminates red. If the self-test is successful, connect the Accessories and set the generator controls. PROGRAMMING THE GENERATOR Programming of User Programs: Please follow user programs guide.  (Chapter 3 –subsection F) D.
Page 43 USER GUIDE | EAGLE TWO+ Version: 3.3 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 Connection with patient (Monopolar Mode) Please Note: Patient Return Electrode is necessary for Monopolar electrosurgical modes only.
Page 45 USER GUIDE | EAGLE TWO+ Version: 3.3 Foot Switch Selection for Eagle 2+: Monopolar 1 Monopolar 2 Sealer & Sealer Bipolar Bipolar Default Configurations:- Every time generator is turned ON or restarted, machine loads by default settings for footswitching sockets. For Eagle Monopolar 1 Monopolar 2 /Bipolar...
Page 46 USER GUIDE | EAGLE TWO+ Version: 3.3 Please Note: User must cautiously make selection between appropriate inputs. 2Si-Coag: Eagle 2+ supports simultaneous coagulation outputs from Monopolar modes. User can obtain simultaneous coagulation output in any of the combination below: Sr.No. Monopolar-1 Monopolar-2 Handswitching Pencil...
Page 47 USER GUIDE | EAGLE TWO+ Version: 3.3  Single Paddle Footswitch in Sealer/Bipolar Footswitch socket. Activated After Turning on the generator, In Electro Surgery mode single paddle Double Paddle footswitch is configured for bipolar Selection activations; by default. If user intends to use single paddle foot switch for the sealer activations, it must be configured.
Page 48 USER GUIDE | EAGLE TWO+ Version: 3.3  Double Paddle Footswitch in Monopolar-2/ Bipolar Footswitch socket. In Eagle 2+ double footswitch paddle is configured for monopolar 2 Activated mode; by default, so user must make manual selection to make it functional for Bipolar-Sealer operations.
Page 49 USER GUIDE | EAGLE TWO+ Version: 3.3 2. Electrosurgery Mode in Eagle 2+ Accessories connection in ESU Mode...
Page 50 USER GUIDE | EAGLE TWO+ Version: 3.3 Foot Switch Selection for Eagle 2+: Monopolar Sealer & Bipolar Sealer Bipolar Default Configurations:- Every time generator is turned ON or restarted, machine loads by default settings for footswitching sockets. For Eagle 2+ only Monopolar 1 Monopolar 2 /Bipolar Bipolar/Sealer...
Page 51 USER GUIDE | EAGLE TWO+ Version: 3.3 Please Note: User must cautiously make selection between appropriate 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.
Page 52 USER GUIDE | EAGLE TWO+ Version: 3.3  Single Paddle Footswitch in Sealer/Bipolar Footswitch socket. After Turning on the generator, In Electro Surgery mode single paddle footswitch is configured for bipolar activations; by default. Activat Double If user intends to use single paddle foot switch for sealer activations, must...
Page 53 USER GUIDE | EAGLE TWO+ Version: 3.3 Accessories connection in Vessel Sealer Mode Footswitch connection in Vessel Sealer Mode...
Page 54 USER GUIDE | EAGLE TWO+ Version: 3.3 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 Sealer Instrument (10mm) Assembling BLADE STEP 1 SLIDE IT IN STEP 2 STEP 3 LOCK STEP 4...
Page 56 USER GUIDE | EAGLE TWO+ Version: 3.3 STEP 5 STEP 6 STEP 7 STEP 8 Whittemore Enterprises Inc.
Page 57 USER GUIDE | EAGLE TWO+ Version: 3.3 STEP 9 Please Note:-  As this instrument is reusable device, the user has to always inspect the device for breakage & general tear and wear of the device before sending it for re-sterilization. ...
Page 58 USER GUIDE | EAGLE TWO+ Version: 3.3 Vessel Sealing Instrument Guidelines BEFORE SURGERY:  Check all parts of Outer tubing, Blade assembly, Jaws and Insert assembly and Handle for mechanical deformities and insulation breakages. Open the Outer tubing & Blade assembly to check the proper cleaning of the instrument.
Page 59 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.
Page 60 USER GUIDE | EAGLE TWO+ Version: 3.3 Footswitch Connection 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 USER GUIDE | EAGLE TWO+ Version: 3.3 SALINE INSTRUMENTS 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 BIPOLAR WORKING ELEMENT ASSEMBLING:- Let‟s divide assemblies into two:- Assembly 1 & Assembly-2 EQUIPENTS...
Page 63 USER GUIDE | EAGLE TWO+ Version: 3.3 ASSEMBLY 1 STEP-1 Attach Bipolar loop with Active Bipolar working element longitudinally as shown in the picture below. Carefully insert loop wires into respective holes & gently press it, as shown in picture. STEP-2 Gently press bipolar loop against working element &...
Page 64 USER GUIDE | EAGLE TWO+ Version: 3.3 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 USER GUIDE | EAGLE TWO+ Version: 3.3 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 USER GUIDE | EAGLE TWO+ Version: 3.3 a) Remove all gross matter (blood, mucus, tissue etc.) by wiping the PK Connector Prepare the connector cable for steam sterilization according to the following cleaning procedure:  Remove all the residues of 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.
Page 67 USER GUIDE | EAGLE TWO+ Version: 3.3 CHAPTER 6 During Surgery Electric Shock Hazard: Warning - Never remove the cover of instrument. Generator Power Settings Warning - Use lowest power setting for desired surgical effect. Warning - Do not increase the power settings without first checking both active electrode & patient return electrode&...
Page 68 USER GUIDE | EAGLE TWO+ Version: 3.3 B. MODES & POWER SETTINGS: Changing the Mode: Operator should verify the selected mode with the surgeon. You cannot change mode while the generator is active. To change the mode, release the activation. You can activate only one mode at a time.
Page 69 USER GUIDE | EAGLE TWO+ Version: 3.3 D. SETTINGS FOR SURGERIES: a) Open Heart/CABG/Thoracic Surgery – Cut Pure: 1, Coag Fulgar: 40, Bip Macro: 1 b) Onco/Gynac /Fatty Tissues – Cut Pure: 35-45, Coag Spray: 40-50, Bip Macro: 15 to 25 c) Resection/ TCRE/under water Surgery –...
Page 70 USER GUIDE | EAGLE TWO+ Version: 3.3 CHAPTER 7 After Surgery Electric Shock Hazard: Warning – Never remove the cover of instrument. After Surgery: Electric Shock Hazard Warning - Always turn off & unplug the generator before cleaning. Cleaning Caution - Do not clean the generator with abrasive cleaning that could damage the generator.
Page 71 USER GUIDE | EAGLE TWO+ Version: 3.3 Note: It is advisable to soak longer if protein containing material is present. 2. Soak instruments vertically which cleans instrument thoroughly. 3. Rinse it thoroughly with tap water for 5 minutes. 4. Clean all surfaces of instrument using detergent solution. 5.
Page 72 USER GUIDE | EAGLE TWO+ Version: 3.3 CHAPTER 8 Operating Principle Operating Principle: This section will emphasize on the working principle of the system. General description:  Block diagram:  Detailed description of each board with circuit description.  A. GENERAL DESCRIPTION ...
Page 73 USER GUIDE | EAGLE TWO+ Version: 3.3 Chapter 5. Programming the Generator. No footswitch is required in this mode hence provide flexibility in using bipolar energy.  BiCoag Alarm: The system is delivering an alarm after completion of coagulation in endoscopic &...
Page 74 USER GUIDE | EAGLE TWO+ Version: 3.3 Circuit Board Description: CPU and Display Board: Processor and control board consists of – 1. Main microcontroller: IC U01 is main microcontroller and brain of the system, which controls overall function of a system using inbuilt I/O ports. U01 has inbuilt program memory to store the system program.
Page 75 USER GUIDE | EAGLE TWO+ Version: 3.3 works in bridge configuration along with Transformer T03 and MOSFET are driven by T01,02 pulse transformer. IC‟s U01 & U02 controls the pulse width of ON Time depending on Error voltage between output dc voltage & set value in particular operating mode. This voltage is continuously changing during activation hence reflecting the change in pulse width.
Page 76 USER GUIDE | EAGLE TWO+ Version: 3.3 5. Monopolar Handswitch Decode: Handswitch decode circuitry works on floating principle. IC U17 & U18 is used for detecting the activation request if any. This circuitry is powered by isolated power supply separated for each channel. Activation requests pass on to activate request generator.
Page 77 USER GUIDE | EAGLE TWO+ Version: 3.3 Detailed circuit diagrams & components list relevant to the purchased product will be made available to a valid customer upon request.
Page 78 USER GUIDE | EAGLE TWO+ Version: 3.3 CHAPTER 9 Testing Procedures Warning- Electric Shock Hazard - the generator power cord must be connected only with a properly grounded socket. Do not use power plug adaptors. Warning- Fire Hazard - Do not use extension cords. Caution - Do not stack equipment on top of the EAGLE TWO+or do not place the generator on top of other electrical equipment.
Page 79 USER GUIDE | EAGLE TWO+ Version: 3.3 Handle circuit boards by their nonconductive edges. Use an antistatic container for transport of electrostatic – sensitive components and circuit boards. The summary of safety checks:  Inspect the generator and accessories.  Inspect the internal components. ...
Page 80 USER GUIDE | EAGLE TWO+ Version: 3.3 3. Reconnect the power cord to the generator and wall socket. Inspecting the Internal Components: Equipment Phillips screwdriver 1. Turn OFF (0) the generator by pressing the front panel power switch. 2. Loosen the chassis screws. Lift the cover off the chassis. Set the cover aside for reinstallation. 3.
Page 81 USER GUIDE | EAGLE TWO+ Version: 3.3 Checking the Monopolar Cut Output Check the output for the cut modes. 1. Verify that the generator successfully completes the self-test. 2. Connect the test equipment for monopolar output. a. Connect one test cable to the left jack in the Monopolar 1/UEM socket. Pass the test cable through the current transformer and connect the current transformer to the voltmeter.
Page 82 USER GUIDE | EAGLE TWO+ Version: 3.3 Checking Low Frequency Leakage Current and Ground Resistance Check the frequency leakage current and ground resistance before returning the EAGLE TWO +generator to clinical use. Equipment Leakage current tester Output Socket and PREM Source Current 1.
Page 83 USER GUIDE | EAGLE TWO+ Version: 3.3  True RMS voltmeter (Fluke 8920 or equivalent)  Bipolar and monopolar footswitches and handswitching accessories  Leakage setup per IEC 60601-2-2 clause 19.101 or 19.102 Checking Monopolar High Frequency Leakage Current 1. Connect the 200 Ω load from the active accessory through the current transformer to the equipotential ground plug on the rear of the generator.
Page 84: Calibration Procedure
USER GUIDE | EAGLE TWO+ Version: 3.3 CHAPTER 10 Calibration Procedures Calibrating the EAGLE TWO+ For normal running program requires data constants, which are dependent on the hardware. All this data is stored in NV Ram after calibration process is completed. Calibration is recommended after: ...
Page 85 USER GUIDE | EAGLE TWO+ Version: 3.3 Figure 1 Calibration Step1 - PREM Calibration Equipment:  PREM plug (modified)  Resistor substitution box Procedure: 1) Select mode „1:1 REM min‟. 2) Connect PREM plug in the power socket and connect appropriate substitution resistor as indicated by „Load R‟...
Page 86 USER GUIDE | EAGLE TWO+ Version: 3.3 Calibration Step 2 - Close Loop Current Calibration (I-max) Sub step-1(BIP mode) Equipment  Bipolar single paddle footswitch.  Small test cables with banana plugs  True RMS current meter.  10 Ω non-inductive power resistor. Procedure: 1) Connect: a) One test cable from Bipolar socket to the RMS current meter in series with the 10 Ω...
Page 87 USER GUIDE | EAGLE TWO+ Version: 3.3 f) I-max for all the bipolar modes will be set. 3) Disconnect the test cables from bipolar output. Sub step- 2 (Pure Cut Mode) Equipment:  Monopolar footswitch.  Small test cables with banana plugs ...
Page 88 USER GUIDE | EAGLE TWO+ Version: 3.3 d) When reading is in stated range, press „Write Counts to program memory‟ for storing the corresponding fire count reading in the system memory. e) The „I‟ max for Low, Pure, Hydro, Endo-1 & Endo- 2 Cut mode is adjusted. 3) Disconnect the test cables from Monopolar output.
Page 89 USER GUIDE | EAGLE TWO+ Version: 3.3 d) When reading is in stated range, press „Write Counts to program memory‟ for storing corresponding fire count reading in the system memory. Sub step- 5 (Saline Resection Cut Mode) Equipment:  Monopolar footswitch. ...
Page 90 USER GUIDE | EAGLE TWO+ Version: 3.3 e) I-max for Saline Low & High Cut is adjusted. Sub step- 6 (Saline Resection Coag Mode) Equipment:  Monopolar footswitch.  Small test cables with banana plugs  True RMS current meter ...
Page 91 USER GUIDE | EAGLE TWO+ Version: 3.3 Equipment:  Bipolar/ Sealer footswitch.  Small test cables with banana plugs  True RMS current meter  10 Ω non-inductive power resistor. Procedure: 1) Connect: a) One test cable from Sealer socket to 10 Ω. (Refer the connection diagram for Sealer) b) Another test cable from Sealer socket to true RMS current meter in series with 10 Ω.
Page 92 USER GUIDE | EAGLE TWO+ Version: 3.3  True RMS current meter  1 kΩ non-inductive power resistor.  PREM plug modified. 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 with the 1kΩ.
Page 93 USER GUIDE | EAGLE TWO+ Version: 3.3  True RMS current meter  1k Ω non-inductive power resistor. Procedure: 1) Connect: a) One test cable from socket PREM plug to 1k Ω. (Refer the connection diagram for Monopolar) b) Another test cable from Monopolar 1 socket to true RMS current meter in series with 1kΩ. c) Monopolar footswitch to the Monopolar 1 footswitch socket on the rear panel.
Page 94 USER GUIDE | EAGLE TWO+ Version: 3.3 a) One test cable from Saline Resection plug to 1kΩ. (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 socket on the rear panel.
Page 95 USER GUIDE | EAGLE TWO+ Version: 3.3 2) Check and adjust the Pmax for bipolar output. a) Select mode „4:1 BIP‟. b) Press the Bipolar/Sealer footswitch pedal & check if current reading is equivalent to 301 mA ± 20 mA RMS. c) Stop activation.
Page 96 USER GUIDE | EAGLE TWO+ Version: 3.3 a) Select mode „4:3 Blend 1‟. b) Press the Monopolar Cut footswitch pedal and check if the current reading for a reading equivalent to 374 mA ± 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.
Page 97 USER GUIDE | EAGLE TWO+ Version: 3.3 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‟...
Page 98 USER GUIDE | EAGLE TWO+ Version: 3.3 Calibration Step 5 - Open Loop Power Calibration (Econ) (Desiccate/Swift/Fulgar/Spray/Hi-Spray) Equipment:  Monopolar footswitch.  Small test cables with banana plugs  True RMS current meter  500 Ω non-inductive power resistor.  PREM plug modified. Procedure: 1) Connect: a) One test cable from socket PREM plug to 500 Ω.
Page 99 USER GUIDE | EAGLE TWO+ Version: 3.3 b) Press the Monopolar coag footswitch pedal and check the current equivalent to 89 mA ± 5 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.
Page 100: Care, Storage And Disposal
USER GUIDE | EAGLE TWO+ Version: 3.3 CHAPTER 11 Care, Storage and Disposal After each use, perform the following cleaning procedures immediately. If cleaning is delayed, debris encrustation may become a source of infection. Encrustation may also result in electrosurgical unit malfunction.
Page 101 USER GUIDE | EAGLE TWO+ Version: 3.3 11.3 CARE OF MAINS CABLE CAUTION The cable should be sterilized by EtO gas or autoclaving. These methods will cause deformation and damage that will render the cable useless. Make sure that foreign mains cable matter does not enter the cord end connection as this will result in poor connection.
Page 102: Troubleshooting
USER GUIDE | EAGLE TWO+ Version: 3.3 CHAPTER 12 Troubleshooting Troubleshooting If the generator is not functioning properly, use the information in this section to perform the following tasks:  Identify and correct the malfunction.  If a system alarm number is displayed, take the appropriate action to correct the alarm conditions.
Page 103 USER GUIDE | EAGLE TWO+ Version: 3.3 components Generator is An alarm condition exists Check the display for an error code. Note the number on, but did not and refer to Responding to System Alarms in this complete the section. self-test Software malfunction Turn off and then turn on the generator.
Page 104 USER GUIDE | EAGLE TWO+ Version: 3.3 but generator Footswitch connected to Connect the footswitch & the footswitching instrument does not Monopolar 1/UEM socket & to the proper instrumentation socket. deliver output instrument connected to Monopolar 2 instrument socket Or vice-versa Power set too low Increase the power setting.
Page 105 USER GUIDE | EAGLE TWO+ Version: 3.3 responding to radiated generator is activated and minimizes the potential for an frequencies. electrosurgical burn at the site of the monitor electrode. Pacemaker Intermittent connections or Check all connections to the generator. interference metal-to-metal sparking It may be necessary to reprogram the pacemaker.
Page 106 USER GUIDE | EAGLE TWO+ Version: 3.3 Note down the error code and type of error and take necessary measures to eliminate as described in the following table. Error Code Description Recommended Action  Turn OFF and again turn ON the generator. Up key pressed Do not press any activation during self-test.
Page 107 USER GUIDE | EAGLE TWO+ Version: 3.3 Sealer Open warnings:- Causes:-  Sealer clamp is not applied / not properly applied on a vessel when sealer is activated.  Connector is not properly connected in the sealer port.  Sealer clamp wire breakage. Measures:- ...
Page 108: Warranty
USER GUIDE | EAGLE TWO+ Version: 3.3 Warranty Whittemore Enterprises Inc. warrants each product manufactured by it to be free from defects in material and workmanship under normal use and service for the period. Whittemore Enterprises Inc. obligation under this warranty is limited to the repair or replacement, at its sole option, of any product, or part thereof, which has been returned to it or its Distributor within the applicable time period shown below after delivery of the product to the original purchaser, and which examination discloses, to company‟s satisfaction, that the product is defective.
Page 109: Disclaimer
USER GUIDE | EAGLE TWO+ Version: 3.3 Disclaimer 1) Electro Surgery is proven in surgical applications over more than 60 yrs. If safety instructions are not followed/ implemented, usage of this equipment in operation theatre can be hazardous. Risk associated with the product/procedure cannot be denied, if not used as per „user & safety instructions‟...