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GP300 - Global Medical Solutions

1. A 12 Output power vs impedance for Spray Coag mode 1 1 1 A 13 Output power vs impedance for Lap Coag 006 A 13 Output power vs impedance for Macro Bipolar mode A 14 Output power vs impedance for Micro Bipolar mode A 14 Output power vs impedance for Gentle Bipolar mode A 15 Output power vs impedance for Bipolar Autostop mode A 15 Table of symbols found on the front panel 2 3 Table of symbols found on the back panel 2 5 Bovie Medical S ectuilon INTRODUCING THE ICON GP This section includes the following information Key Features Components and Accessories CAUTIONS Read all warnings cautions and instructions provided with this unit before using Read the instructions warnings and cautions provided with electrosurgpcal accessories before using Specific instructions are not included in this manual User s Guide Icon GP 1 1 KEY FEATURES The Icon GP includes the latest technology The unit utilizes a touch screen hardware interface in combination with a software graphical user interface GUI This allows for simple touch control features and functionality selection with unsurpassed performance flexibility reliability and convenience for the user during surgical procedures It includes the following features
2. GWE o USER S GUIDE User s Guide Icon GP i Bovie Medical 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 It is intended as a guide for using the Bovie Icon GP only Additional technical information is available in the Bovie Icon GP Service Guide Equipment Covered in this Manual GP300 Reference No GP300 For Information Contact Bovie Medical 5115 Ulmerton Road Clearwater FL 33760 USA U S Phone 1 800 537 2790 Fax 1 800 323 1640 International Phone 1 727 384 2323 Fax 1 727 347 9144 www boviemed com sales boviemed com 2013 Bovie Medical All rights reserved Contents of this publication may not be reproduced without the written permission of Bovie Medical Bovie Part Number MC 55 155 001 Rev 6 CONVENTIONS USED IN THIS GUIDE WARNING Indicates a potentially hazardous situation which if not avoided could result in death or serious injury CAUTION Indicates a hazardous situation which if not avoided may result in minor or moderate injury NOTICE Indicates an operating tip a maintenance suggestion or a hazard that may result in product damage User s Guide Icon GP iii TERMINOLOGY The following terminology is used throughout this guide to describe specialized features and functionality of the Bovie Icon GP Touch Screen Touch screen located on th
3. Unit Information Touch to view unit info such as model serial number and software version See Figure 2 10 NOTICE ABOUT Presets Touch this button to switch to Presets screen See Figure 2 11 VINER OL ES BRIGHTNESS VOLUME S N GP0711001 per Number The unit s serial number is displayed here Screen Brighthess Increases and decreases to desired Screen brightness Activation Tone Volume Increases and decreases to desired tone volume Exit Button Used to exit screen and return the user to the previous screen Any changes are discarded PRESETS RF Modes Touch this button to view mode RF MODES descriptions See Figure 2 9 ENGLISH Language Select Touch this button to enter the language selection screen See notice below English is the default language for the Icon GP Detailed directions for changing the language are provided in Section 4 of this manual See following page for additional Unit Properties screens 2 8 Bovie Medical ADDITIONAL SCREENS Exit Buttons Ea Used to exit screen and return the user to the previous screen Any changes are discarded Figure 2 8 View and select data exchange options from this pop up screen x Use this button to upload data to the unit from a memory stick NOTICE Only use BV USBGI 256 Icon GP USB Memory Stick with this unit Figure 2 9 RF Mode example Figure 2 10 View unit properties from thi
4. 2 Connect the appropriate electrode to the monopolar handpiece 3 Connect the Bovie footswitch to the footswitch receptacle on the rear of the unit Connecting Bipolar Accessories 1 Connect a Bipolar cable to the Bipolar receptacle on the front of the unit The unit accepts standard Bipolar or BiStat Gold probe accessory 2 Connect the appropriate electrode to the Bipolar connector 3 Connect the Bovie footswitch to the footswitch receptacle located on the rear of the unit Mode and Power Settings 1 Select the desired mode and power setting from the Main Screen User Presets or Main Screen power adjustments can be used For user Presets and settings follow the directions on page 4 6 For basic adjustments Main Screen adjustments follow the directions below Selecting the CUT BLEND Settings The Icon GP allows users to select from two Cut and three blended cut Modes and power settings From the Main Screen the power setting can be adjusted up and down using the Up Down arrows Selecting a Cut Blend Mode and Power Setting 1 From the Main Screen touch yellow section of screen The Set Mode and Power pop up screen appears 2 Touch the desired Mode 3 Use the numeric keypad to set the power for the selected mode The highest allowable power setting will also display in the upper right hand corner User s Guide Icon GP 4 9 4 Touch the Enter button to save changes and return to the Main Screen Touching Clear button will rese
5. Accepts Bovie BV1253B footswitch 2 2 Bovie Medical Symbols Table 2 1 Refer to the following table for descriptions of symbols found on the front of the Icon GP SYMBOLS DESCRIPTION Cut Blend Controls le Pure Cut s Blend Mode 1 al Blend Mode 2 Al Blend Mode 3 Special Cut E 5 Laparoscopic Cut zl Pinpoint Coag Gentle Coag P Spray A Laparoscopic Coag Bipolar Controls Macro Bipolar Micro Bipolar ll Gentle Bipolar i Auto Stop Bipolar Symbols continued on following page User s Guide Icon GP 2 3 Symbols Table 2 2 Refer to the following table for descriptions of symbols found on the front of the Icon GP SYMBOLS DESCRIPTION Indicators Split Pad green indicates proper placement red indicates incorrect placement Dive Activator Error Indicator Read instructions before use F Defibrillator Proof Type CF Equipment USB Communications Split Pad F RF Isolated patient connections are isolated from earth at high frequency M dd 4 Monopolar Handpiece Receptacle C L e Bipolar Handpiece Receptacle Monopolar Mode Bipolar Mode y Caution High Voltage Symbols continued on following page 2 4 Bovie Medical Table 2 3 Refer to the following table for descriptions of symbols found on the back of the Icon GP SYMBOLS DESCRIPTION Equipotential Ground Stud Non ionizing Radiation Fuse Enclosed Dan
6. Canceling a Bipolar Mode and Power Setting To exit without saving the settings touch the exit button ACTIVATING THE UNIT NOTICE Review Activation Safety in this section before activating the unit When you turn on your unit remember the following feature The Icon GP will power up to the last selected Presets Once settings are selected activate the unit by pressing the appropriate button on the handpiece or pedal on the footswitch NOTICE Footswitching operations are controlled by an independent foot control 4 10 Bovie Medical ACTIVATION SAFETY WARNINGS Do not wrap the accessory cords or patient return electrode cords around metal objects This may induce currents that could lead to shocks fires or injury to the patient or surgical team Danger Fire Explosion Hazard Do not use the Icon GP in the presence of flammable anes thetics 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 that may accumulate in body cavities such as the bowel Oxygen enriched atmospheres Oxidizing agents such as nitrous oxide N O 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
7. Follow the procedures approved by your institution or use a validated infection control procedure Do not allow fluids to enter the chassis Do not sterilize the unit PERIODIC INSPECTION Every six months visually inspect the Icon GP for signs of wear or damage In particular look for any of the following problems Damage to the power cord Damage to the power cable receptacle Obvious damage to the unit Damage to any receptacle Accumulation of lint or debris in or around the unit FUSE REPLACEMENT Fuses for the unit reside directly below the Power Cable Receptacle on the rear of the unit To replace the fuses follow this procedure 1 Unplug the power cord from the wall outlet 2 Remove the power cord from the Power Cable Receptacle on the rear panel 3 To release the fuse drawer insert a small flathead screwdriver into the slot on the drawer below the power cord receptacle Then slide the drawer out 4 Remove the two fuses and replace them with two T6 3A 250VAC fuses 5 Insert the fuse holder into the Power Cable Receptacle NOTICE If the unit does not display an error and does not power on check fuses Figure 5 1 Fuse holder 5 2 Bovie Medical TROUBLESHOOTING This section includes the following information O Fault Code Messages O Fatal Error Messages O Touch Screen Recalibration User s Guide Icon GP S e clon The Icon GP includes automatic self diagnostics If the diagnostics detect
8. Solid Pad Detected No activation will be possible until pad is removed NOTICE A split pad is not necessary when using the Bipolar modes Visual and Audible Indicators Visual Unit activation can easily be monitored by observing the Bovie Logo located on the front of the unit Yellow Cut Blend mode is activated ye Blue Coagulation Bipolar mode is activated Zo Red Unit error is detected See Error Codes in Section 6 White Unit is powered on Audible Unit activation can easily be monitored by listening to the output tone Cut Blend 610 Hz output tone Coag Bipolar 910 Hz output tone Checking Monopolar Mode with BV 1253B footswitch 1 Plug the footswitch in the rear of the unit N Select the Pure Cut mode and Pinpoint mode and set the power to one watt w Connect a split pad to the split pad receptacle on the front of the unit and attach securely to your bare skin Verify that the green split pad indicator displays symbol illuminates green to indicate the split pad is properly attached You will hear a ready chime Depress the Cut pedal yellow on the footswitch Verify that the Cut mode activates and that the unit sounds an activation tone and the Bovie logo illuminates yellow u1 Depress the Coag pedal blue on the footswitch Verify that the Coag mode activates and that the unit sounds an activation tone and the Bovie logo illuminates blue User s Guide Icon GP 3 3 Checking Monopolar Mode
9. substances or gases prevent their accumulation or pooling under surgical drapes or within the area where electrosurgery is performed Use the lowest output setting necessary to achieve the desired surgical effect Use the active electrode only for the minimum time necessary in order to lessen the possibility of unintended burn injury Pediatric applications and or procedures performed on small anatomic structures may require reduced power settings The higher the current flow and the longer the current is applied the greater the possibility of unintended thermal damage to tissue especially during use on small structures Use electrosurgery with caution in the presence of internal or external devices such as pacemakers or pulse generators Interference produced by the use of electrosurgical devices can cause devices such as pacemakers to enter an asynchronous mode or can block the pacemaker effect entirely Consult the device manufacturer or hospital Cardiology Department for further information when use of electrosurgical appliances is planned for patients with cardiac pacemakers or other implantable devices CAUTIONS The use of high frequency current can interfere with the function of other electromagnetic equipment When high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient place any monitoring electrodes as far as possible from the surgical electrodes Do not use
10. 16 Modes of Operation Pure Cut Special Cut Laparoscopic Cut three levels of Blend four levels of Coag Pinpoint Spray Laparoscopic and Gentle and four levels of Bipolar These settings give the surgeon flexibility to cut all types of tissue without losing performance Special Cut allows for enhanced cutting ability when a procedure is performed in a liquid environment such as urology and arthroscopy Laparoscopic Coagulation utilizes a lower peak voltage to help prevent capacitive coupling with laparoscopic instruments The three Blend modes generate minimal moderate and maximum coagulation along wound edges The Bipolar modes require no patient return pad Touch Screen The Icon GP features touch screen functionality that allows the user to interact with the generator by touching the screen All user selections are entered on the touch screen Surgeon and Procedure Presets The Presets feature allows multiple surgeons to be programmed into the generator Each surgeon can program their preferred Procedure Presets including mode and power settings for quick changeover between cases Split Pad Sensing and Contact Quality Monitoring The Icon GP incorporates a split pad contact quality monitoring system Bovie NEM This system detects the split pad The system also continually monitors the contact quality between the patient and the split pad This feature is designed to minimize patient burns at the pad site A split pad must be used with
11. Bovie logo illuminates white NOTICE A split pad is not necessary when using the Bipolar modes IN SERVICE An initial orientation may be conducted with your Bovie representative All of the set up steps and function checks will be covered with your In Service The features and functionality of your unit will also be covered at that time PERFORMANCE CHECKS After the unit has passed the preliminary functional test it is ready for performance testing A qualified biomedical engineer who is thoroughly familiar with electrosurgical devices should conduct this testing The testing should include checking all modes of operation for proper function and power output 3 4 Bovie Medical Section USING THE ICON GP This section contains the following procedures Inspecting the Unit and Accessories Setup Safety Initial Set Up Selecting Unit Properties Surgeon and Procedure Presets Preparing for Surgery Activating the Unit Activation Safety User s Guide Icon GP 4 1 INSPECTING THE UNIT AND ACCESSORIES Before each use of the Icon GP verify that the unit and all accessories are in good working order Inspect for damage to the unit and all its connections Verify that the appropriate accessories and adapters are present See page 1 3 for a list of supplied and recommended accessories Inspect all cords and connectors for signs of wear damage and abrasion Check that the display illuminates and that the Main Screen app
12. GP gt 5 1 Clearing rrr ee nere En born 5 2 Periodic Inspeclion u une ante 5 2 Fuse Replacement ua anawa w err ero cene n dee t 5 2 Troubleshooting M 6 1 System Fault Code Messages seen 6 2 System Fatal Error Messages nennen tenentes 6 3 ReCalibration of the Touch Screen ennenennennnnnnennennnnennnnnnnnnnnenn 6 4 nnne tnnt AAA tens 7 1 Responsibility of the Manufacturer sese 7 2 Returning the Unit for Service 7 2 Step 1 Obtain a Returned Goods Authorization Number T 2 tenens 7 2 Step 3 Ship the Unit tr ree ne 7 3 Technical Specifications sees aa AA AAAA A 1 A 2 POWOFx cnl Rr Rr rre ac e Eh bert e ede ERIT A 2 Duty Cycle are re A 2 Dimensions and Weight mi it ds A 2 einen AAA A 2 Transport and Storage ettet n enint tene et eris A 2 Audio Volume eiie rrt portet t an ee di tree n A 3 Split Pad Sensing uctor det ipee te iere A A AA A 3 Low Frequency 50 60 Hz Leakage Current sse A 3 High Frequency RF Leakage Current senes A 4 Standards and IEC Classifications sees A 4 Class Equipment IEC 60601 1 sse A 4 Type CF Equipment IEC 60601 1 Defibrillator Proof A 4 Dri
13. GP inspect it visually Look for any signs of damage Verify that the shipping package contains all items listed on the packing list If the unit or any accessories are damaged notify Bovie Medical s Customer Service immediately Do not use any damaged equipment INSTALLATION Place the Icon GP on any flat surface with a tilt angle not more than 10 or on a Icon GP mobile stand Do not block rear fan vents Ensure that air flows freely on all sides of the unit Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit FUNCTION CHECKS Upon initial installation of the unit perform the tests listed below Refer to the figures in the previous chapter for the location of connectors and controls WARNING At no time should you touch the active or bipolar forceps A burn could result All accessories connected to the generator must be rated for at least the maximum peak output voltage of the Icon GP set at the intended output control setting in the intended operating mode NOTICE The Icon GP requires a split pad Connecting a solid pad will cause a unit fault and trigger a fault Setting Up the Unit 1 Verify that the Power Switch is in the Off O position and that no accessories are connected to the unit 2 Connect the Icon GP power cable or a hospital grade power cable to the AC power cable receptacle on the
14. Icon GP 4 5 SELECT Ram gt ES BLEND 1 SURGEON PROCEDURE LES EEG 0 Figure 4 4 Main Screen SAVE SURGEON PHEFERENGES BLEND 1 SURGEON PROCEDURE ADD EDIT DELETE ADD EDIT DELETE Figure 4 6 Surgeon Preferences Screen Figure 4 7 Surgeon Keypad Screen SURGEON AND PROCEDURE PRESETS The Icon GP incorporates user defined memory preset settings for easy recall of frequently used settings Each surgeon user can enter their name and procedure mode and wattage settings The physicians and procedures are then listed and can be quickly accessed and activated The user can store up to 8 Surgeon names and each surgeon can store up to 24 Procedures Select Presets Select Surgeon and Procedure To select a surgeon user name and select a procedure associated with that surgeon follow these steps 1 Touch the Surgeon field on the Main Screen See Figure 4 4 The Select Surgeon pop up screen appears See Figure 4 5 2 Touch the name from the list on the screen The Main Screen appears with the selected name listed in the Surgeon field 3 Touch the Procedure field on the Main Screen The Select Procedure pop up screen appears 4 Touch the procedure from the list on the screen The Main Screen appears with the selected procedure listed in the Procedure field Add Presets Add Surgeon and Procedure To add a surgeon user name and add a procedure follow these steps 1 Touch the Setup button on the Main
15. Icon GP Mobile Cart A1255A Foot control adaptor output receptacle on front of unit User s Guide Icon GP 1 3 SAFETY The safe and effective use of electrosurgery depends to a large degree on factors solely under the control of the operator There is no substitute for a properly trained and vigilant medical staff It is important that they read understand and follow the operating instructions supplied with this electrosurgical equipment Physicians have used electrosurgical equipment safely in numerous procedures Before starting any surgical procedure the surgeon should be familiar with the medical literature complications and hazards of using electrosurgery in that procedure To promote the safe use of the Icon GP this section presents the warnings and cautions that appear throughout this user s guide It is important that you read understand and follow the instructions in these warnings and cautions so that you can operate this equipment with maximum safety It is also important that you read understand and follow the instructions for use in this user s guide WARNINGS Hazardous Electrical Output This equipment is for use only by trained licensed physicians Danger Fire Explosion Hazard Do not use the Bovie Icon GP in the presence of flammable materials Fire Explosion Hazard The following substances will contribute to increased fire and explosion hazards in the operating room Flammable substa
16. Screen The Unit Properties screen appears 4 6 Bovie Medical 2 Touch the Presets button The Surgeon Preferences screen appears See Figure 4 6 3 Touch Add in the Surgeon field The Surgeon keypad screen appears See Figure 4 7 4 Type in the Surgeon name up to 20 characters then press Enter The Surgeon Preferences screen appears 5 Touch Add button in the Procedure field The Procedure keypad screen appears 6 Type in the Procedure name up to 20 characters then press Enter The Surgeon Preferences screen appears 7 Touch the Cut Blend section of the window The selected Set Mode amp Power pop up screen will appear 8 Touch the desired mode and key in the desired power setting 9 Touch Enter button The Surgeon Preferences screen appears 10 Touch the Coag section of the window The selected Set Mode amp Power pop up screen will appear 11 Touch the desired mode and key in the desired power setting 12 Touch Enter button The Surgeon Preferences screen appears 13 Touch the Bipolar section of the window The selected Set Mode amp Power pop up screen will appear 14 Touch the desired mode and key in the desired power setting 15 Touch Enter button The Surgeon Preferences screen appears 16 Touch Save button to save the name and procedures as Presets 17 Touch Exit twice to return to the Main Screen NOTICE As a shortcut to add a Preset touch the Surgeon or Procedure field on the Main Screen to view the S
17. This monopolar mode is optimized for dissection but has minimal coagulation characteristics Intended uses are for clean dissection of non vascular areas or areas that can be spot coagulated post dissection Special Cut This is a monopolar CUT mode that allows for enhanced cutting ability Laparoscopic Cut This is a monopolar CUT mode that utilizes a lower voltage to help prevent capacitive coupling with laparoscopic instruments Blend 1 This is a monopolar CUT mode that is modified to allow for minimal coagulation along the wound edges Intended uses are for areas that can be spot coagulated post dissection 75 Duty Cycle Blend 2 This is a monopolar CUT mode that is modified to allow for moderate coagulation along the wound edges Intended uses are for areas that can be spot coagulated post dissection 62 5 Duty Cycle Blend 3 This is a monopolar CUT mode that is modified to allow for maximum coagulation along the wound edges Intended uses are for areas that can be spot coagulated post dissection 50 Duty Cycle Continued on following page iv Bovie Medical Coag Modes Pinpoint Coag This is a monopolar COAGULATION mode that is most effective with the electrode tip in direct contact with the tissue at the point of bleeding This mode will provide maximum hemostasis but may also result with some char or sticking depending on the electrode utilized This mode may also be used to dissect tissue with hemostasis Gentle Coagulati
18. in serious unintended patient injury including bowel perforation and unintended irreversible tissue necrosis For surgical procedures where the high frequency current could flow through parts of the body having a relatively small cross sectional area the use of bipolar techniques may be desirable to avoid unwanted coagulation For all Monopolar modes any associated equipment and active electrodes must be rated to with stand the combination of output voltage vp p and crest factor as stated in the table on page A 8 The generator is equipped with a return electrode sensing and contact quality monitoring system NEM which monitors the quality of the patient return electrode connection When a correctly functioning single plate return electrode is connected to the generator the NEM verifies the con nections between the generator and the single return electrode It DOES NOT verify that a single return electrode is in contact with the patient When using a split return electrode the NEM con firms the total resistance is within the preset safety range Proper application and visual inspection of the patient return electrode is required for safe operation In some circumstances potential exists for alternate site burns at points of skin contact e g between the arm and the side of the body This occurs when electrosurgical current seeks a path to the return electrode that includes the skin to skin contact point Current passing thr
19. or a hospital grade power cable to the AC power cable receptacle on the back of the unit then to a properly grounded wall outlet WARNING Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit 4 Turn on the generator by pressing the power switch On Verify the following The power switch illuminates green Display shows Bovie logo 5 There will be a period while the unit boots up and completes a self test Once the self test is complete the Main Screen will appear displaying the last selected Presets settings If the self test is not successful an alarm tone sounds A message may pop up or the Bovie logo will turn red the generator is disabled Note the fault or error code and refer to Section 6 Troubleshooting 6 Once the self test is successful connect additional accessories and set the generator controls User s Guide Icon GP 4 3 SELECTING UNIT PROPERTIES UNTEPROPERTIES EJ PRESETS RF MODES ENCUS DBASE I O TOUCH CAL SURGEON PROCEDURE ABOUT EE 06 Figure 4 1 Main Screen Touch Setup to access the Unit Figure 4 2 Unit Properties Screen Properties screen SIN GP071100 To access the Unit Properties screen touch the Setup button at the bottom of the Main Screen display See Figure 4 1 The Unit Properties screen will appear See Figure 4 2 Volume Touch the u
20. screen Add or Edit Surgeon or Procedure pop up Screens These pop up screens allow the user to enter or edit information corresponding to the Select Surgeon screen or the Select Procedure screen Touching Clear will reset information Use the Backspace button or arrow buttons to delete characters or replace characters Continued on following page 2 10 Bovie Medical Continued from previous page Figure 2 14 View and change user presets from this pop up screen Surgeon Preferences SAVE SURGEON PREEERENGES This screen is similar to the Main screen with the exception of the Add Edit and Delete options Touching the Save button stores user selections to a Preset Use this screen to Add Edit or Delete Surgeon and Procedure Presets SURGEON PROCEDURE See Figures 2 11 and 2 12 for examples The Procedure COLONOS pop ups are similar See Section 4 for details Figure 2 15 View and select procedures from this Figure 2 16 Enter and modify procedure from this pop up screen Use the arrows to view additional names pop up screen PROCEDURE LECT E ENENEN a s o Fr c u x LF iz x e v s u w LIST ee User s Guide Icon GP 2 11 Bovie Medical Serc tion GETTING STARTED This section includes the following information O Initial Inspection O Installation O Function Checks O In Service O Performance Checks User s Guide Icon GP 3 1 INITIAL INSPECTION When you first unpack your Icon
21. such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location which the Icon GP is used exceeds the applicable RF compliance level above the Icon GP should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Icon GP b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m User s Guide Icon GP A 7 OUTPUT CHARACTERISTICS Maximum Output for Monopolar and Bipolar Modes Power readouts agree with actual power into rated load to within 2096 or 5 watts whichever is greater Mode Output Power Output Frequency Repetition Rate Vp p max Crest Factor Pure Cut 300 W 300 Q 492 kHz N A 2000 V 1 7 20 2000 Q Blend 1 200 W 300 O 492 kHz 30 kHz 2300 V 1 8 20 2000 Q Blend 2 200 W 300 O 492 kHz 30 kHz 2500 V 2 0 20 2000 Q Blend 3 200 W 300 O 492 kHz 30 kHz 2700 V 2 2 20 2000 0 Lap Cut 300 W Q 300 Q 492 kHz N A 1500 V 1 7 20 2000 0 Special Cut 300 W 300 O 492 kHz N A 1500 V 1 7 20 2000 0 Pinpoint Coa 120 W 500 Q 492 kHz 30 kHz 4000 V 3 1 20 2000 Q Gentle Coag 120
22. the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Guidance and manufacturer s declaration electromagnetic emissions he Icon GP is intended for use in the electromagnetic environment listed below The customer or the user of the Icon GP should assure that is is used in such an environment Emissions test Compliance Electromagnetic environment guidance The Icon GP must emit electromagnetic energy in order RF Emissions CISPR 11 to perform its intended function Nearby electronic equipment may be affected cassa The Icon GP is suitable for use in all establishments other than Harmonic emissions Class A domestic and those directly IEC 61000 3 2 connected to the public low volt age power supply network that Voltage fluctuations flicker supplies buildings used in emissions Complies domestic purposes IEC 61000 3 3 User s Guide Icon GP A 5 Guidance and manufacturer s declaration electromagnetic immunity The Icon GP is intended for use in the electromagnetic environment listed below The customer or the user of the Icon GP should assure that is is used in such an environment IEC 60601 7 RE Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity sh
23. with handswitch Connect a handswitching handpiece to the Monopolar handpiece receptacle N Select the Pure Cut and Pinpoint mode and set the unit to one watt from your Cut and Coag touch screens Ww Connect split pad to front panel receptacle and attach securely to your bare skin Verify that the green spilt pad indicator displays symbol illuminates green to indicate the split pad is properly attached You will hear a ready chime A Depress the Cut button yellow on the handswitch Verify that the Cut mode activates and that the unit sounds an activation tone and the Bovie logo illuminates yellow wn Confirm that releasing the pedal returns the unit to an idle state and the Bovie logo illuminates white a Depress the Coag button blue on the handswitch Verify that the Coag mode activates and that the unit tones an activation tone and the Bovie logo illuminates blue N Confirm that releasing the pedal returns the unit to an idle state and the Bovie logo illuminates white Checking Bipolar Mode with BV 1254B footswitch 1 Plug the footswitch in the rear of the unit 2 Select the Micro Bipolar mode and set power to one watt from your Bipolar touch screen 3 Depress the blue Coag pedal on the footswitch Verify that the Bipolar mode activates and that the unit sounds an activation tone and the Bovie logo illuminates blue 4 Confirm that releasing the pedal returns the unit to an idle state and the
24. Bovie Medical The entire area of the neutral electrode should be reliably attached to the patient s body and as close to the operating field as possible The cables to surgical electrodes should be positioned in such a way that contact with the patient or other leads is avoided Temporarily unused active electrodes should be stored so that they are isolated from the patient CAUTIONS Do not stack equipment on top of the unit or place the unit on top of electrical equipment These configurations are unstable and or do not allow adequate cooling Provide as much distance as possible between the Icon GP unit and other electronic equipment such as monitors An activated unit may cause interference with them Non function of the unit may cause interruption of surgery A backup unit should be available for use Do not turn the activation tone down to an inaudible level The activation tone alerts the surgical team when an accessory is active NOTICE If required by local codes connect the unit to the hospital equalization connector with an equipotential cable INITIAL SET UP 1 Verify that the unit is Off by pressing the power switch Off 0 2 Place the generator on a stable flat surface or the Icon GP mobile stand Do not block the two rear vents NOTICE During normal operation the top sides and rear panel are warm when you use the generator continuously for extended periods of time 3 Connect the Icon GP power cable
25. The Unit Properties screen appears 2 Touch Presets button The Surgeon Preferences screen appears 3 Touch the Delete button under Surgeon field A Yes No pop up screen appears 4 Touch Yes to delete the name or No to return to the previous screen name will not be deleted 5 Touch Save button 6 Touch Exit button twice to return to the Main Screen Delete Procedure 1 Touch Setup button The Unit Properties screen appears 2 Touch Presets button The Surgeon Preferences screen appears Figure 4 8 Delete Procedure pop up Screen 3 Touch the Delete button under Procedure field A Yes No pop up screen appears See Figure 4 8 4 Touch Yes to delete the procedure or No to return to the previous screen procedure will not be deleted 5 Touch Save button 6 Touch Exit button twice to return to the Main Screen Cancel The user can Cancel preset changes and return to the Main Screen at any time 1 Touch the Exit button to exit each screen and return to the Main Screen NOTICES RET MODE amp POWER X When storing Procedure presets be aware that the Procedure 2 5 preset will be saved with the Surgeon name that appears in the Aa in ER 3 Surgeon field The maximum wattage available for each mode will be displayed in wow ne 4 5 5 g the upper right hand corner of the selected mode See Figure 4 9 PECIA 7 Ex ES Any time the Cut Blend Coag or Biploar sections of the screen are visible mode and power adjustment
26. W Q 125 O 492 kHz N A 600 V 1 6 20 800 Q Spray Coag 120 W 500 O 400 kHz 25 36 kHz 7000 V 6 0 20 2000 Q Lap Coag 120 W 500 Q 492 kHz 30 kHz 3000 V 3 0 20 Q 2000 0 Macro 80 W 100 Q 492 kHz N A 800 V 1 5 20 1000 Q Micro 80 W 1000 492 kHz N A 500 V 1 5 20 800 Q Gentle Bipolar 50W 500 492 kHz N A 250 V 1 5 20 200 Q Auto Auto Stop 80 W 100 Q 492 kHz N A 800 V 1 5 20 900 Q A 8 Bovie Medical OUTPUT POWER CURVES Figure A 1 illustrates output power delivered to rated load for all available modes Figure A 2 illustrates the maximum peak voltage available at any given power setting and output mode Figures A 3 through A 14 illustrate specific output power delivered to a range of load resistances for each mode Figure A 1 Figure A 2 Voltage Vpp Output power versus power setting for all modes 300 250 200 150 100 Power Output Watts to Rated Load e o 100 150 200 250 300 Displayed Setting o j Output power versus power setting for all modes Output Voltage vs Power Setting at Rated Load 2500 2000 1500 1000 500 0 20 40 60 80 100 Output Setting User s Guide Icon GP A 9 The curves that follow depict the changes for each mode at specific power settings Figure A 3 Output power vs impedance for Pure Cut mode Pure Cut Wattage 100 Watlage 50 Power Watts u 500 1000 1500 2000 im
27. al button 3 Touch Yes from the pop up screen Do you really want to calibrate touch screen 4 Follow the touch screen calibration instructions on the screen using a stylus 5 Touch the five markers 6 When prompted touch anywhere on the screen Once the screen calibrates the unit will switch back to the Unit Properties screen NOTICES Touch screen calibration may have to be repeated if calibration is not successful If after several attempts calibration is not successful unit should be return for service Refer to Section 7 Repair Policy and Procedures 6 4 Bovie Medical e icen GP Section REPAIR POLICY AND PROCEDURES Refer to this section for information on O Responsibility of the Manufacturer O Returning the Generator for Service User s Guide Icon GP 7 1 RESPONSIBILITY OF THE MANUFACTURER Bovie Medical is responsible for the safety reliability and performance of the generator only under the following circumstances The user has followed the Installation and Setup Procedures in this User s Guide Persons authorized by Bovie Medical performed assembly operation readjustments modifications or repairs The electrical installation of the relevant room complies with local codes and regulatory requirements such as IEC and BSI Equipment use is in accordance with the Bovie Medical instructions for use Equipment to be diposed recycled Please note that infected medical devices must
28. ay cause interruption of surgery A backup generator should be available for use Do not turn the activation tone down to an inaudible level The activation tone alerts the surgical team when an accessory is active When using a smoke evacuator in conjunction with the electrosurgical generator place the smoke evacuator a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard The use of high frequency current can interfere with the function of other electromagnetic equipment When high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient place any monitoring electrodes as far as possible from the surgical electrodes Monitoring systems incorporating high frequency current limiting devices are recommended Do not use needles as monitoring electrodes during electrosurgical procedures Inadvertent electrosurgical burns may result To avoid the possibility of an electrosurgical burn to either the patient or the physicians do not allow the patient to come in contact with a grounded metal object during activation When activating the unit do not allow direct skin contact between the patient and the physician The patient should not come in contact with metal parts which are earthed or which have an appreciable capacitance to earth for example operating table supports etc The use of antistatic sheeting is reco
29. back of the unit then to a properly grounded wall outlet 3 Connect an accessory to the appropriate receptacle The use of Bovie accessories is recommended 4 Do not connect a split pad at this time 5 Turn the unit on by switching the power switch to the On position Checking the Split Pad Alarm Proper Pad Placement Once set up is complete and unit is powered on you can check the unit s split pad alarm and indicator Connect split pad to front panel receptacle and attach securely to your bare skin LC Proper pad connection and placement is indicated by the split pad symbol in the Main screen illuminating green and an audible tone 3 2 Bovie Medical Improper Pad Placement Once set up is complete and unit is powered on you can check the units split pad alarm and indicator 1 Connect split pad and an accessory such as a hand switch to front panel receptacle Do not place the spilt pad to your skin 2 Activate the accessory Notice the screen A fault F10 will display Poor Split Pad Connection You will also notice that the pad symbol in the screen is illuminated red and an alert tones Split Pad Disconnection If the pad is removed from the patient or dislodged from the front panel receptacle after proper placement and connection no fault error will appear but the pad symbol will change from green to red and an alert will tone Solid Pad Detected If a solid pad is connected to the unit fault code F9 will display
30. be disposed of as medical biohazard waste and cannot be included in used electronic equipment disposal recycling programs In addition certain electronic products must be returned directly to Bovie Medical Contact your Bovie Medical representative for return instructions For warranty information refer to Appendix B Warranty RETURNING THE UNIT FOR SERVICE Before you return the unit call your Bovie Medical representative for assistance If instructed to send the unit to Bovie Medical first obtain a Returned Goods Authorization Number Then clean the Unit and package securely to ensure proper protection of the unit So as to aid in the processing of the unit please be sure to include a reference to the Bovie Return Goods Authorization Number on the outside of the box and ship directly to Bovie Medical Step 1 Obtain a Returned Goods Authorization Number Call the Bovie Medical Customer Service Center 727 384 2323 to obtain a Returned Goods Authorization Number Have the following information ready when you call Hospital clinic name customer number Description of the problem Telephone number fax number Type of repair to be done Department address city state and zip code PRO number Model number Step 2 Clean the Unit WARNING Electric Shock Hazard Always turn off and unplug the unit before cleaning The use of flammable anesthetics or oxidizing gases such as nitrous oxide N20 and oxygen should be a
31. cause simultaneous activation of the instruments Use the lowest output setting necessary to achieve the desired surgical effect Use the active electrode only for the minimum time necessary in order to lessen the possibility of unintended burn injury Pediatric applications and or procedures performed on small anatomic structures may require reduced power settings The higher the current flow and the longer the current is applied the greater the possibility of unintended thermal damage to tissue especially during use on small structures 1 4 Bovie Medical WARNINGS Use electrosurgery with caution in the presence of internal or external devices such as pacemakers or pulse generators Interference produced by the use of electrosurgical devices can cause devices such as pacemakers to enter an asynchronous mode or can block the pacemaker effect entirely Consult the device manufacturer or hospital Cardiology Department for further information when use of electrosurgical appliances is planned for patients with cardiac pacemakers or other implantable devices If the patient has an Implantable Cardioverter Defibrillator ICD contact the ICD manufacturer for instructions before performing an electrosurgical procedure Electrosurgery may cause multiple activation of ICDs Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken Use by physicians without such training has resulted
32. cial or hospital environment NOTE U is the a c mains voltage prior to application of the test level Bovie Medical Guidance and manufacturer s declaration electromagnetic immunity continued IEC 60601 Immunity test test lavel Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Icon GP including cables than the Conducted RF El recommended separation distance calculated IEC 61000 4 6 MHz 219 AM from the equation applicable to the frequency of the transmitter Recommended separation distance RE a gt 80 MHz to 800 MHz SMP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the Radiated RF 3 V m transmitter manufacturer and d is the IEC 61000 4 3 on recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range iei Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters
33. cy 2 4 kHz seconds 1 2 kHz seconds Duration 2 seconds Fault Tone Volume adjustable 40 60 dB Frequency 1 kHz seconds 2 kHz seconds Duration 2 seconds Split Pad Sensing The system presents audible and visible alarms when it senses no split pad The implementation of the split pad will require the generator to measure the impedance across the two contacting electrode pads Trip resistance 10 Q 5 Q to 135 O 100 Continuous measurement Once the system establishes the split pad resistance an increase of 40 in resistance will cause an alarm When the alarm condition exists the system deactivates output power Low Frequency 50 60 Hz Leakage Current Enclosure source current ground open Normal polarity intact ground gt 10 pA Source current patient leads all outputs Normal polarity ground open gt 10 uA Reverse polarity ground open gt 10 pA Sink current at high line all inputs User s Guide Icon GP A 3 High Frequency RF Leakage Current Bipolar RF leakage current gt 63 MA ims at 80 watt Monopolar RF leakage current additional tolerance gt 150 MA ms STANDARDS AND IEC CLASSIFICATIONS Class I Equipment IEC 60601 1 Accessible conductive parts cannot become live in the event of a basic insulation failure because of the way in which they are connected to the protective earth conductor Type CF Equipment IEC 60601 1 Defibrillator Proof The Icon GP provides a hig
34. defective This warranty does not apply to any product or part thereof which has been repaired or altered outside Bovie Medical s factory in a way so as in Bovie Medical s judgment to affect its stability or reliability or which has been subjected to misuse neg lect or accident The warranty periods for Bovie Medical products are as follows Electrosurgical Units Two years from date of shipment Mounting Fixtures all models Two years from date of shipment Footswitches all models Ninety days from date of shipment Patient Return Electrodes Shelf life only as stated on packaging Sterile Single Use Accessories Only as stated on packaging User s Guide Icon GP B 1 This warranty is in lieu of all other warranties express or implied including without limitation the warranties of merchantability and fitness for a particular purpose and of all other obligations or liabilities on the part of Bovie Medical Bovie Medical neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of Bovie Medicals products Notwithstanding any other provision herein or in any other document or communication Bovie Medical liability with respect to this agreement and products sold hereunder shall be limited to the aggregate purchase price for the goods sold by Bovie Medical to the customer Bovie Medical disclaims any liability hereunder or elsewhere in connection w
35. e units front panel This area is used to enter and view user selections such as modes power setting and presets From each screen the user can navigate to and from additional screens Pop Up Screen Additional input and information screens that appear on the unit s front panel These windows display and allow input for instructions warnings and cautions and other information about the unit and its functionality Pop up screens can also navigate the user to and from additional screens Bovie NEM The contact quality monitoring system NEM detects the return electrode and contact quality between the return pads and the patient This feature is designed to minimize patient burns at the return electrode site Graphical User Interface GUI This type of interface uses symbols images or icons along with or rather than text to make using the Icon GP more user friendly High Frequency Generator HF Generator This type of equipment is used in medical procedures requiring electro surgery Electrosurgical Unit ESU The ESU combined with the appropriate electrosurgical accessory is used for a variety of surgical procedures Split Pad With the exception of Warnings and Cautions the term split pad will be used throughout this manual when discussing patient pads return electrodes or patient return electrodes This accessory is used during monopolar surgery to maximize patient safety and site burns Cut Blend Modes Pure Cut
36. ears when you turn on the unit Verify that no faults or errors display SETUP SAFETY 4 2 Hazardous Electrical Output This equipment is for use only by trained licensed physicians Electric Shock Hazard Connect the unit power cord to a properly grounded receptacle Do not use power plug adapters Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit Fire Hazard Do not use extension cords Patient Safety Use the unit only if the self test has been completed as described Otherwise inaccurate power outputs may result The instrument receptacles on this unit are designed to accept only one instrument at a time Do not attempt to connect more than one instrument at a time into a given receptacle Doing so will cause simultaneous activation of the instruments Failure of the high frequency electrosurgical equipment could result in an unintended increase of output power Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken Use by physicians without such training has resulted in serious unintended patient injury including bowel perforation and unintended irreversible tissue necrosis For surgical procedures where the high frequency current could flow through parts of the body having a relatively small cross sectional area the u
37. elect Surgeon and Select Procedure pop up screens Then touch a blank field in the list Follow instructions above starting at step 3 add surgeon or step 5 add procedure Edit Presets Edit Surgeon and Procedure To edit a surgeon user name follow these steps 1 Touch Setup button The Unit Properties screen appears 2 Touch Presets button The Surgeon Preferences screen appears 3 Touch the Edit button under the Surgeon field The Surgeon keypad screen appears 4 Edit the name 5 Touch Enter button The Surgeon Preferences screen appears 6 Touch Edit button under the Procedure field 7 Edit the name 8 Touch Enter button The Surgeon Preferences screen appears Mode and power can be changed also 9 Touch the Cut Blend Coag or Bipolar section of the window The selected Set Mode amp Power pop up screen will appear 10 Touch the desired mode enter power setting and touch Enter The Surgeon Preferences screen appears User s Guide Icon GP 4 7 11 If necessary touch the other mode section of the screen to make additional changes 12 Touch Save button to save the edited name and procedure 13 Touch Exit button twice to return to the Main Screen Delete Presets Delete Surgeon To remove a surgeon s name and the procedures associated with the surgeon s preset information follow these steps NOTICE Deleting a Preset Surgeon name also deletes the procedures associated with that name 1 Touch Setup button
38. er and view user selections such as modes power setting and presets From each screen the user can navigate to and from additional screens pop up screens Illuminated Activation Indicator The Bovie logo illuminates yellow when Cut Blend or Laparoscopic Cut mode is activated blue when Coag or Bipolar is activated red when errors are detected and white at all other times that the unit is powered on Power On Off Switch Turns the unit on or off Green illuminated power on indicator built into switch Type A USB Port Foot Control Receptacle Accepts cables or adapters A1255A Connects footswitching accessories Split Pad Receptacle Accepts a standard Split pad plug Reserved Monopolar Receptacle Bipolar Combination Receptacle R d for fut Accepts standard 3 pin Receptacle un handpieces Connects Accepts standard bipolar and BiStat i handswitching acces Gold probe sories Figure 2 2 Layout of receptacles on the rear panel Ethernet USB Types B and A Used to transfer data toand Used to transfer data to and from the Icon GP from the Icon GP 4 Power Cord get NEAT Receptacle d ses Accepts hospital 2 2 T d d grade power cort RESO Fuse Holder a2 isa Port Refer to Section 5 for R RF OS fuse replacement WZA SST PA rr PC rem information wa C3 POA Bipolar Footswitch Receptacle Monopolar Footswitch Ground Accepts Bovie BV1254B Receptacle stud footswitch
39. er s Guide Icon GP A 13 Figure A 11 Output power vs impedance for Macro Bipolar mode Macro Bipolar Vatlaae 100 wor Wattage 50 ma a Power Watts a 40 30 20 10 0 0 200 400 600 800 impedance OHMS Figure A 12 Output power vs impedance for Micro Bipolar mode Micro Bipolar Nattage 100 Wattage 50 0 200 400 600 800 Impedance OHMS 1000 7000 Bovie Medical Figure A 13 Output power vs impedance for Gentle Bipolar mode Gentle Bipolar aj astage TOO 50 M atte 20 Power Watts Lis Z 200 400 600 800 1000 Impedance OHMS Figure A 14 Output power vs impedance for Bipolar Auto Stop mode Bipolar Autostop n altagg 100 30 Wattage 50 ma a Power Watts 40 30 20 10 0 0 200 400 600 800 1000 impedance OHMS User s Guide Icon GP A 15 Bovie Medical WARRANTY Bovie Medical warrants each product manufactured by it to be free from defects in material and workmanship under normal use and service for the period s set forth below Bovie Medical s 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 Bovie Medical satisfaction that the product is indeed
40. ers and modes The Surgeon and Procedure Presets are also displayed in this screen 2 6 Bovie Medical CUT BLEND COAG AND BIPOLAR KEYPAD SCREENS Figure 2 4 2 5 and 2 6 Controls for the Cut Blend Coag and Bipolar modes are selected and adjusted from these pop up screen Cut and Blend Screen BLEND SET MODE amp POWER X 2 LIKE BLEND 1 PURE BLEND 2 SPECIAL 9 BLEND 3 CLEAR ENTER Keypad Screens Use this screen to select touch modes and enter the desired power setting by touching the keypad Mode and power setting will be displayed illuminated in the upper left hand corner of the pop up screen The number in the upper right corner indicates the highest power available for that mode Bipolar Screen SET MODE 8 POWER User s Guide Icon GP Exit Buttons Used to exit screen and return the user to the previous screen Any changes are discarded Coagulation Screen SETE X 4 2 CLEAR ENTER Clear Buttons Used to reset selections so user can re enter desired settings Enter Buttons Your settings will be saved and you are returned to the previous screen PINPOINT GENTLE 2 7 UNIT PROPERTIES SCREEN Figure 2 7 View unit properties and adjust user preferences from this pop up screen Data Exchange Touch this button to enter the Data Exchange screen See Figure 2 8 RN 08888 I O TOUCH CAL Calibration Touch this but enter touch screen calibration ton to
41. f flammable anesthetics or oxidizing gases such as nitrous oxide N20 and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax or the head unless these agents are sucked away User s Guide Icon GP 1 5 1 6 Non flammable agents should be used for cleaning and disinfection wherever possible Flammable agents used for cleaning or disinfecting or as solvents of adhesives should be allowed to evaporate before the application if HF surgery There is a risk of pooling flammable solutions under the patient or in body depressions such as the umbilicus and in body cavities such as the vagina Any fluids pooled in these areas should be mopped up before HF surgical equipment is used Attention should be called to the danger of ignition of endogenous gases Some materials for example cotton wool and gauze when saturated with oxygen may be ignited by sparks produced in Normal Use of the HF surgical equipment CAUTIONS At no time should you touch the active electrode or bipolar forceps A burn could result Do not stack equipment on top of the generator or place the generator on top of electrical equipment These configurations are unstable and or do not allow adequate cooling Provide as much distance as possible between the electrosurgical generator and other electronic equipment such as monitors An activated electrosurgical generator may cause interference with them Non function of the generator m
42. f the error code reappears record the number and contact E3 Output Current Delta Error Bore customer sevice E4 DC Voltage Error E5 Temperature Sense 1 1 Turn the unit off E6 Temperature Sense 2 2 Allow the unit to cool for 20 minutes 3 Turn the unit on E7 Temperature Sense 3 4 If the error code reappears record the number and contact E8 Temperature Sense 4 Bovie customer service E9 DEM Rea LET 1 Turn the unit off E10 NEM Calibration Error 2 Turn the unit on 3 If the error code reappears record the number and contact E11 Analog to Digital Error Bovie customer service ERROR E4 DC Voltage Error Unit Requires Qualified Service Power off unit and call 727 384 2323 Figure 6 2 Warning Pop up Screen indicating an Error message NOTICES If the unit does not power on to display an error check fuses as described in Section 5 of this guide If a fatal error message is displayed follow the instructions in the display Unit Requires Qualified Service Power off unit and and call 727 384 2323 All system faults and errors are recorded and stored for future diagnostic reference User s Guide Icon GP 6 3 RECALIBRATION OF THE TOUCH SCREEN Your Icon GP is calibrated before it is packaged and shipped If the Touch Screen is not responding properly to screen taps recalibrate Touch Screen 1 From the Main screen touch the Setup button The Unit Properties screen appears 2 Touch the Touch C
43. ger Explosion Risk If Used With Flammable Anesthetics Footswitch Input Jack Do not dispose of this device in the unsorted municipal waste stream Caution Read directions for use prior to using equipment RS 232 Serial Communications USB Communications Ethernet Port NOTICE Please note that infected medical devices must be disposed of as medical biohazard waste and cannot be included in used electronic equipment disposal recycling programs In addition certain electronic products must be returned directly to Bovie Medical Contact your Bovie sales representative for return instructions User s Guide Icon GP 2 5 MAIN SCREEN Figure 2 3 Controls for selecting and adjusting the Cut Blend Coagulation and Bipolar power pre programmed surgeon and procedure selections Cut Blend Power Coagulation Power Bipolar Power Displays Cut Mode settings Displays Coag Mode settings Displays Bipolar Mode settings 1 m EM SURGEON PROCEDURE DR SMITH Select Surgeon Select Procedure Split Pad Displays Surgeon Displays Procedure The symbol illuminates green when a split pad is properly connected and placed on the patient The symbol illuminates red if pad is not connected to the unit or is improperly placed on the patient Select Unit Properties Selects the unit s setup controls i e brightness volume language NOTICES Activation is only available from the Main Screen and shows the requested pow
44. h degree of protection against electric shock particularly regarding allowable O F leakage currents It is type CF equipment Patient connections are isolated from earth and resist the effects of defibrillator discharge Drip Proof IEC 60601 2 2 The Icon GP enclosure is constructed so that liquid spillage in normal use does not wet electrical insulation or other components which when wet are likely to affect adversely the safety of the generator Electromagnetic Compatibility IEC 60601 1 2 and IEC 60601 2 2 The Icon GP complies with the appropriate IEC 60601 1 2 and IEC 60601 2 2 specifications regarding electromagnetic compatibility Voltage Transients Emergency Generator Mains Transfer The Icon GP operates in a safe manner when the transfer is made between line AC and an emergency generator voltage source EMC COMPLIANCE Special precautions should be taken regarding the Icon GP Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual Understand that only the Accessories supplied with or ordered from Bovie Medical should be used with your device The use of Accessories transducers and cables other than those specified may result in increased Emissions or decreased Immunity of the Icon GP The Icon GP and its accessories are not suitable for interconnection with other equipment Portable and mobile RF commu
45. horization Number and the information hospital phone number etc listed in Step 1 Obtain a Returned Goods Authorization Number B Be sure the unit is completely dry before you pack it for shipment Although the preference is to have the unit repackaged using its original packaging Bovie understands that this may not always be possible If necessary contact Customer Service for the proper packaging to ship the unit Please be sure to include a reference of the Bovie Return Goods Authorization Number on the outside of the box container C Ship the unit prepaid to the address given to you by the Bovie Medical Service Center User s Guide Icon GP 7 3 7 4 Bovie Medical ze m Appendix TECHNICAL SPECIFICATIONS All specifications are nominal and subject to change without notice A specification referred to as typical is within 20 of a stated value at room temperature 25 C 77 F and a nominal input power voltage User s Guide Icon GP A 1 PERFORMANCE CHARACTERISTICS Input Power Input Voltage 100 240 VAC 10 Mains line frequency range nominal 50 60 Hz Power consumption 550 VA Fuses two 6 3 A slow blow Duty Cycle Under maximum power settings and rated load conditions Pure Cut 300 watt the unit is suitable for activation times of 10 seconds ON followed by 30 seconds OFF for 30 minutes The internal temperature of the unit is continuously monitored If the temperature rises abo
46. ith the sale of this product for indirect or consequential damages This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Florida USA The sole forum for resolving disputes arising under or relating in any way to this warranty is the District Court of the County of Pinellas State of Florida USA Bovie Medical its dealers and representatives reserve the right to make changes in equipment built and or sold by them at any time without incurring any obligation to make the same or similar changes on equipment previously built and or sold by them B 2 Bovie Medical Cart Sold Separately MC 55 155 001 Rev 6 204 2013 03 15
47. mmended for this purpose Examine all accessories and connections to the electrosurgical generator before use Ensure that the accessories function as intended Improper connection may result in arcs sparks accessory malfunction or unintended surgical effects When not using active accessories place them in a holster or in a clean dry non conductive and highly visible area not in contact with the patient Inadvertent contact with the patient may result in burns Avoid HF output settings where maximum output voltage may exceed rated accessory voltage Refer to the accessory s voltage rating To avoid incompatibility and unsafe operation use suitable cables accessories active and neutral electrodes including values for the highest allowed H F peak voltage The output power selected should be as low as possible for the intended purpose Certain devices or accessories may present a safety hazard at low power settings Bovie Medical Apparent low output or failure of the Icon GP to function correctly at the normal operating settings may indicate faulty application of the neutral electrode or poor contact in its connections In this case the application of the neutral electrode and its connections should be checked before select ing a higher output power When using Cut II mode associated equipment and active accessories should be selected that have a voltage rating of 1750 vp p pr greater When using Bipolar mode associated equi
48. n the unit is activated to dispense An example of this functionality includes when the handpiece Cut button is pressed the unit is activated for Cut If a footswitch is simultaneously pressed for Coag the unit will F8 Sirnianeous actvation eror continue in the Cut mode as long as the handpiece Cut button is pressed If the Cut button is released the unit will sense an error and both functions will be disabled 1 Release either the cut or coag button on the handpiece or the cut or coag pedal on the footswitch 2 If the fault code reappears follow the instructions in the display Unit Requires Qualified Service Power off unit and and call 721 384 2323 F9 NEM Solid Pad Detected Disconnect the solid pad accessory Connect a split pad to the unit Split pad may not be properly connected to patient or to the unit Check BO Roars pi pad Comme top placement Use only spilt pad with the unit Bovie Medical FAULT F8 Simultaneous Activation Error Foot pedal and pencil switches activated together Figure 6 1 Warning Pop up Screen Indicating a Fault message SYSTEM FATAL ERROR MESSAGES Error messages E indicate system errors These error messages display in the Warning pop up screen red text See Figure 6 2 below Error Code Description Recommended Action Output current too high digital 1 check 1 Turn the unit off E2 Output Voltage Delta Error 2 Turn the unit on 3 I
49. nces 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 N 0 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 Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit Electric Shock Hazard Connect the generator power cord to a properly grounded receptacle Do not use power plug adapters Electric Shock Hazard Always turn off and unplug the generator before cleaning Fire Hazard Do not use extension cords Patient Safety Use the generator only if the self test has been completed as described Otherwise inaccurate power outputs may result Failure of the high frequency electrosurgical equipment could result in an unintended increase of output power The instrument receptacles on this generator are designed to accept only one instrument at a time Do not attempt to connect more than one instrument at a time into a given receptacle Doing so will
50. needles as monitoring electrodes during electrosurgical procedures Inadvertent electrosurgical burns may result To avoid the possibility of an electrosurgical burn to either the patient or the physicians do not allow the patient to come in contact with a grounded metal object during activation When activating the unit do not allow direct skin contact between the patient and the surgeon 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 Examine all accessories and connections to the electrosurgical generator before use Ensure that the accessories function as intended Improper connection may result in arcs sparks accessory malfunction or unintended surgical effects Avoid HF output settings where maximum output voltage may exceed rated accessory voltage Refer to the accessory s voltage rating User s Guide Icon GP 4 11 The output power selected should be as low as possible for the intended purpose Certain devices or accessories may present a safety hazard at low power settings Apparent low output or failure of the Icon GP to function correctly at the normal operating settings may indicate faulty application of the neutral electrode or poor contact in its connections In this case the application of the neutral electrode and its connection
51. nications equipment can affect Medical Electrical Equipment The Icon GP should not be used adja cent to or stacked with other equipment and that if adjacent or stacked use is necessary the Icon GP should be observed to verify normal operation in the configuration in which it will be used A 4 Bovie Medical Recommended separation distances between portable and mobile RF communications equipment and the Icon GP The Icon GP is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Icon GP can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Icon GP as recommended below according to the maximum output power of the communications equipment Rated maximum output separation distance according to frequency of transmitter power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz w a SVP 94 5 d e 0 12 0 12 0 23 0 38 0 38 0 73 1 2 1 2 2 3 3 8 3 8 7 8 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz
52. on This is a monopolar COAGULATION mode that will result in minimal charring or sticking of the electrode The electrode must be in direct contact with the tissue for positive results It has no dissection ability Spray Coag This is a monopolar COAGULATION mode that is effective with the electrode kept slightly off the target tis sue The energy jumps from the electrode to the surface of the tissue and provides superficial coagulation Some char may occur at the target tissue Lap Coag This is a monopolar COAGULATION mode that utilizes a lower peak voltage to help prevent capacitive cou pling with laparoscopic instruments Bipolar Modes Macro This is a bipolar COAGULATION mode that does not require a neutral electrode and is the most aggressive bipo lar mode for providing hemostasis It can also be used for bipolar CUTTING instruments Micro This is a bipolar COAGULATION mode that is slightly less aggressive to minimize sticking of tissue to the elec trodes A neutral electrode is not required Gentle Bipolar This is a bipolar COAGULATION mode that significantly reduces charring and sticking of the electrode It should be used in direct contact with the tissue and does not require a neutral electrode Auto Stop Bipolar This is a bipolar COAGULATION mode that will automatically deactivate when the generator senses an impedance level consistent with coagulated tissue An audible tone will sound to indicate when the power delivery ha
53. ort is only intended for use during data exchange and is not for use with a USB cable accessory 2 Touch the desired exchange A new pop up screen appears with additional instructions See Figure 4 3 3 Follow the instructions Additional selections may be necessary The exchange takes a few moments Wait until exchange is com plete before removing the Bovie Memory Stick 4 Touch the Exit button to return to the Unit Properties screen New Presets information is available NOTICES When importing information from the Bovie Memory Stick all stored Presets information will be replaced Use only the Bovie Memory Stick intended for the Icon GP Calibrate Touchscreen Touch Cal Touch the Touch Cal button to recalibrate the Touch Screen See Section 6 Troubleshooting for detailed directions RF Modes Modes Explanation Touch the RF Modes button to reference the descriptions for each RF mode available on the unit Use the arrows at the bottom of the RF Modes screen to scroll through the list of descriptions About Touch the About button to access the Unit Information pop up screen The Unit Information screen displays the unit s serial number model model number software release number hardware number and firmware version number Presets Touch the Presets button to select view add edit save and delete surgeon and procedure presets See Adding Surgeon and Procedure Presets on page 4 6 for detailed instructions User s Guide
54. ough small skin to skin contact points is concentrated and may cause a burn This is true for grounded ground referenced and isolated output generators To reduce the potential for alternate site burns do one or more of the following Avoid skin to skin contact points such as fingers touching leg when positioning the patient Place 5 to 8 cm 2 to 3 in of dry gauze between contact points to ensure that contact does not occur Position the return electrode to provide a direct current route between the surgical site and the return electrode which avoids skin to skin contact areas n addition place patient return electrodes according to the manufacturer s instructions Potential for alternate site burns increases if the return electrode is compromised Bovie recom mends the use of split return electrodes and Bovie generators with a contact quality monitoring system The entire area of the neutral electrode should be reliably attached to the patient s body and as close to the operating field as possible The cables to surgical electrodes should be positioned in such a way that contact with the patient or other leads is avoided Temporarily unused active electrodes should be stored so that they are isolated from the patient Do not wrap the accessory cords or return electrode cords around metal objects This may induce currents that could lead to shocks fires or injury to the patient or surgical team The use o
55. ould be at least 30 Electrostatic discharge 6 kV contact 6 kV contact ESD IEC 61000 4 2 8 kV air 8 kV air 2 kV for power 2 kV for power supply lines supply lines x1 kV for 1 kV for input output lines input output lines 1 KV differential 1 kV differential Mains power quality should be that Surge IEC 61000 4 5 enn ener mode of a typical commercial or hospital z 2 kV common environment mode b 96 U lt 5 96 U gt 95 dip in U gt 95 dip in U for for 0 5 cycle 0 5 cycle 40 Uy 40 Ut Voltage dips short 60 dip in U 60 dip in U for interruptions and voltage Electrical fast tran sient burst IEC 61000 4 4 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Icon a for 5 cycles 5 cycles GP requires continued operation variations ort power Supply during power mains interruptions input lines 70 U 70 Up guring p en IEC 61000 4 11 30 dip in U 80 dip in U for it is recommended that t e Icon GP be powered from an uninter for 25 cycles 25 cycles ruptible power supply or a battery b 96 U lt 5 U gt 95 dip in U lt 95 dip in U for for 5 sec 5 sec Power frequency magnetic fields Power frequency 50 60 should be at levels characteristic Hz magnetic field of a typical location in a typical IEC 61000 4 8 commer
56. p Proof IEC 60601 2 2 sse A 4 Electromagnetic Compatibility IEC 60601 1 2 and IEC 60601 2 2 A 4 Voltage Transients Emergency Generator Mains Transfer A 4 EMO Corrpliarice iter duet edt dye I RR ERE Ga A 4 Output Characteristics sinnen Aalen air A 8 Maximum Output for Monopolar and Bipolar Modes sss A 8 Output Power CUtVes saa wata reet tre oreet p en e s A 9 Lupi E S B 1 User s Guide Icon GP vii LIST OF FIGURES LISTOF TABLES Table 2 1 Table 2 2 viii Figure 2 1 Figure 2 2 Figure 2 3 Figure 2 4 Figure 2 5 Figure 2 6 Figure 2 7 Figure 2 8 Figure 2 9 Figure 2 10 Figure 2 11 Figure 2 12 Figure 4 1 Figure 4 2 Figure 4 3 Figure 4 4 Figure 4 5 Figure 4 6 Figure 4 7 Figure 4 8 Figure 4 9 Figure 5 1 Figure 6 1 Figure 6 2 Figure A 1 Figure A 2 Figure A 3 Figure A 4 Figure A 5 Figure A 6 Figure A 7 Figure A 8 Figure A 9 Figure A 10 Figure A 11 Figure A 12 Figure A 13 Figure A 14 Layout of touch screen and receptacles on the front panel 2 2 Layout of receptacles on the rear 2 2 Controls for selecting and adjusting the Cut Blend and Coag Bipolar power 2 5 Controls for the Cut Blend Coag and Bipolar modes 2 6 Controls for the Coag and Bipola
57. p down arrows to increase and decrease the volume The green illuminated bar increases and decreases as the volume is adjusted Brightness Touch the up down arrows to increase and decrease the brightness The green illuminated bar increases and decreases as the brightness is adjusted Language default English NOTICE English is the default language for the Icon GP If language is changed from default the button on the Unit Properties screen will change to display the user set language To change the language from the Unit Properties screen 1 Touch Language button 2 Select your desired language from the list 3 Touch the Enter button to save the selected language The user is returned to the Unit Properties screen The user interface will be configured for the selected language when the unit is re started Touching the exit button will return the user to the Unit Properties screen No changes will be saved 4 4 Bovie Medical Data Exchange DBase 1 0 DBASEEXCHANGE X The Icon GP allows users to import and export surgeon and procedure information into from the Icon GP To import or export surgeon and procedure preset information to and from the Bovie Memory Stick touch the DBase 1 O button to enter the DBase Exchange pop up screen 1 Plug your Bovie Memory Stick into the USB port located on the front of the unit NOTICES Use only the USB A port located on the front unit Figure 4 3 Data Exchange Screen This p
58. pedance OHMS Figure A 4 Output power vs impedance for Blend modes 1 2 and 3 Blend 1 2 3 250 allage 100 www Wattage 50 200 2 150 a 100 a 50 500 1000 1500 2000 Impedance OHMS Bovie Medical Figure A 5 Output power vs impedance for Laproscopic Cut mode Lap Cut 35 300 ri tn z 5 Power Watts 100 50 0 500 1000 Impedance DHMS Figure A 6 Output power versus impedance for Special Cut mode Special Cut 0 500 1000 Impedance OHMS User s Guide Icon GP omen Wattage 100 Wattage 50 1600 atlage 100 Wattage 50 1500 2000 2000 Figure A 7 Output power versus impedance for Pinpoint mode Pinpoint Coag 140 tt ge 100 120 Wattage 50 100 Power Watts 0 500 1000 1500 2000 impedance OHMS Figure A 8 Output power versus impedance for Gentle Coag mode Gentle Coag t40 120 attaga 100 Wattage 50 100 Power Watts 20 0 500 1000 1800 2000 impedance OHMS A 12 Bovie Medical Figure A 9 Output power vs impedance for Spray mode Spray Coag 140 WVallage 100 Nattage 50 120 100 80 60 Power Watts 50D 1900 1500 2000 impedance OHMS Figure A 10 Output power vs impedance for Laparoscopic Coag mode Lap Coag 140 wwe Wattage 100 Nattage 50 120 Power Watts 8 0 500 1000 1500 2000 impedance OHMS Us
59. pment and active accessories should be selected that have a voltage rating of 950 vp p pr greater When using Spray mode the active accessory used should have a voltage rating equal to or greater than 6500 vp p 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 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 NOTICES If required by local codes connect the generator to the hospital equalization connector with an equipotential cable Do not clean the generator with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the generator User s Guide Icon GP 1 8 Bovie Medical a icen GP Section TOUCH SCREEN AND RECEPTACLES This section describes o The Front and Rear Panels o Touch Screen Controls Indicators Receptacles and Symbology Descriptions NOTICE Refer to Section 4 of this guide for instructions on using the Icon GP ESU User s Guide Icon GP 2 1 FRONT PANEL Figure 2 1 Layout oftouch screen and receptacles on the front panel Touch Screen The touch screen is used to ent
60. r modes s sees 2 7 Unit properties and user preferences sse 2 8 Data exchange pop up screen 2 9 RF mode example aer e Be HI npe i ER e ei En 2 9 Unit information pop up screen 2 9 Physician Preferences sCreen een tris 2 9 Select physician screen ssssssseeeneee eene 2 10 Physician keypad screen 2 10 ied 4 4 Unit Properties Screens ta e epe Bean 4 4 Data Exchange screen sennennennenennennennnnnennnennnnnnnnn nenn 4 5 Main Sereen wa EE 4 5 Select Physician screen diner andes 4 5 Physician Preferences screen 4 5 Physician keypad screen 4 6 Delete Procedure pop up 097 4 6 Max wattage available example sss 4 7 Fuse 5 2 Fault Error Pop up screen 6 2 Fatal Error Pop up screen 2 2e sse teens 6 3 Output power vs power for all modes sse A 9 Output power versus power setting for all modes sss A 9 Output power vs impedance for Cut Pure 006 A 10 Output power vs impedance for Blend 1 2 amp 3 modes A 10 Output power versus impedance for Laparoscopic Cut mode A 11 Output power vs impedance for Special Cut mode 1 1 1 1 A 11 Output power vs impedance for Pinpoint Coag mode 1 1 1 A 12 Output power vs impedance for Gentle Coag mode
61. s ended User s Guide Icon GP TABLE OF CONTENTS vi Equipment Covered in this Manual sss iii For Information Cohtact u iii Conventions Used in this Guide nee iii Terminology cai tre e ed retro GA RUE EON OR dE d iv Introducing the 1 1 Key Features acr rrt e o E reo HO ER rd rr ro ER TR 1 2 Components and Accessories tenente tnnt tenen 1 3 Additional 06059005 ote t tee eem iie tem 1 3 Safely caecis ee Ente ud te dea E Ap tite atteso Pat ts 1 4 Touch Screen and Receptacles aaa a aaa aaa aaa eene anna 2 1 Front Panel HI re MERE REDE REED RR REPRE 2 2 Rear Panelne reist ote ten 2 2 SYMONS e ww a e y t a d kn 2 3 Main S Cre 8n I ERU ER HE ERU EP NE RISO REED yo 2 6 Cut Blend and Coag Bipolar Keypad Screens sse 2 7 Unit Properties Screen ae en e AE A dven anaes 2 8 Additional Screens utet eee gv ter 2 9 Select or Edit Preset Screens sess 2 10 Getting Started 3 1 Initial InSpectlOlt x atte Rr ERE n a rennen 3 2 Installation rss te ten 3 2 Function CHECKS erret er e era eee eh 3 2 Seng UP He Unit nen coit E t et tete eb t inta 3 2 Checking the Split Pad 3 2 Proper Pad Placement tt eei en anc deti na 3 2 Improper Pad Placement orte teet ete e 3 3 Split Pad Disconnection eee ea 3 3 Solid Detected
62. s a fault or error the system displays an error message in the Warning pop up screen sounds an audible tone and deactivates the unit s output power Most fault codes result from faults in accessories attached to the unit The following tables list the system fault codes and error codes describes the faults and recom mendis actions to take to resolve them If the unit displays any other error code it requires service SYSTEM FAULT CODE MESSAGES Fault messages F indicate improper unit setup or faulty accessories These fault messages appear in the Warning pop up screen red text See Figure 6 1 below 6 2 Fault Code Description Recommended Action F1 Cut handpiece button may be stuck Coag handpiece button may 1 Turn off then turn on the generator 2 be stuck 2 If the fault code reappears disconnect all accessories Turn off then turn on the generator again 3 If the problem persists replace the handpiece of footswitch and repeat the restart FS Cut footswitch pedal may be stuck 4 It the fault code reappears follow the instructions in the display Unit Requires Qualified Service Power off unit and and call F6 Coag footswitch pedal may be stuck 727 384 2323 Bipolar Footswitch zi may be stuck The unit does not allow simultaneous activation of the cut and coagulation modes The activation mode is first come first serve This means that whichever mode is selected first will be the functio
63. s can be made If adjustments __ are made the Procedure field will be blank allowing the user to gt V FAR activate this setting or proceed with Editing the last listed Procedure Preset with the new settings BLEND 1 Figure 4 9 Max wattage available 4 8 Bovie Medical PREPARING FOR SURGERY NOTICE Monopolar surgery requires a split pad Applying the Split Pad Refer to the manufacturer s instructions for application site and placement procedures When using metal plate split pad use a conductive gel specifically designed for electrosurgery Select a split pad site with good blood flow While a properly applied split pad results in minimal tissue heating beneath the pad a good blood flow helps carry heat away from the site 1 Connect the cable to the Split Pad receptacle on the front of the unit 2 Secure split pad to patient The unit will automatically sense the contact of the split pad and if pad is properly attached The unit will monitor contact quality between the pad and the patient NOTICE The Split Pad symbol in the lower right hand corner of the Main Screen illuminates green when a Split pad is properly connected and placed on the patient The symbol illuminates red if pad is not connected to the unit or is improperly placed on the patient Connecting Monopolar Accessories 1 Connect a monopolar cable into the monopolar receptacle on the front of the unit The unit accepts standard 3 pin handpieces
64. s pop up screen UNIT INFORMATION GPO711001 ICON GP RF Modes Use arrows to advance through to the desired mode description by touching the arrows User s Guide Icon GP Use this button to download data from the unit to the memory stick 2 9 SELECT OR EDIT PRESET SCREENS NOTICE You can type up to 20 characters in the keypad screens Names and procedures will be displayed in alphabetical order You can save up to 8 Surgeon names and up to 24 Procedures for each Surgeon Exit Buttons x Used to exit screen and return the user to the previous screen Any changes are discarded Figure 2 11 View and change user presets from this pop up screen x Surgeon Preferences SAVE SURGEON EREEERENGENS This screen is similar to the Main screen with the exception of the Add Edit and Delete options Touching the Save button stores user selections to a Preset NJ JE Use this screen to Add Edit or Delete Surgeon and Procedure Presets SURGEON PROCEDURE See Figures 2 12 and 2 13 for examples The Procedure DR SMITH COLONOS pop ups are similar See Section 4 for details Figure 2 12 View and select surgeon names from this Figure 2 13 Enter and modify surgeon names from this pop up screen Use the arrows to view additional names pop up screen SELECT x SURGEON a ES i NELINE Soe PITT PST EE Touching a blank field brings the user back to the Surgeon Preferences
65. s should be checked before select ing a higher output power When not using active accessories place them in a holster or in a clean dry non conductive and highly visible area not in contact with the patient Inadvertent contact with the patient may result in burns 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 Bovie Medical 4 icon GP SSKCHUKOMA MAINTAINING THE IGON GP This section covers the following topics O Cleaning O Periodic Inspection O Fuse Replacement User s Guide Icon GP 5 1 Bovie Medical recommends that you complete periodic inspection and performance testing Perform inspections and performance testing every six months A qualified biomedical technician should conduct this testing to ensure that the unit is operating effectively and safely CLEANING After each use clean the unit WARNING Electric Shock Hazard Always turn off and unplug the unit before cleaning NOTICE Do not clean the unit with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the unit 1 Turn off the unit and unplug the power cord from the wall outlet 2 Thoroughly wipe all surfaces of the unit and power cord with a mild cleaning solution or disinfectant and a damp cloth
66. se of bipolar techniques may be desirable to avoid unwanted coagulation If the patient has an Implantable Cardioverter Defibrillator ICD contact the ICD manufacturer for instructions before performing an electrosurgical procedure Electrosurgery may cause multiple activation of ICDs In some circumstances potential exists for alternate site burns at points of skin contact e g between the arm and the side of the body This occurs when electrosurgical current seeks a path to the patient return electrode that includes the skin to skin contact point Current passing through small skin to skin contact points is concentrated and may cause a burn This is true for grounded ground referenced and isolated output units To reduce the potential for alternate site burns do one or more of the following Avoid skin to skin contact points such as fingers touching leg when positioning the patient Place 5 to 8 cm 2 to 3 in of dry gauze between contact points to ensure that contact does not occur Position the return electrode to provide a direct current route between the surgical site and the return electrode which avoids skin to skin contact areas n addition place return electrodes according to the manufacturer s instructions Potential for alternate site burns increases if the return electrode is compromised Bovie Medical recommends the use of split return electrodes and Bovie units with a contact quality monitoring system
67. t Power back to zero Canceling a Cut Blend Mode and Power Setting To exit without saving the settings touch the exit button Selecting the COAG Settings The Icon GP allows users to select from four Coag Modes and power settings From the Main Screen the power setting can be adjusted up and down using the Up Down arrows Selecting a Coag Mode and Power Setting 1 From the Main Screen touch blue section of screen The Set Mode and Power pop up screen appears 2 Touch the desired Mode 3 Use the numeric keypad to set the power for the selected mode The highest allowable power setting will also display 4 Touch the Enter button to save changes and return to the Main Screen Touching Clear button will reset Power back to zero Canceling a Coag Mode and Power Setting To exit without saving the settings touch the exit button Selecting the BIPOLAR Settings The Icon GP allows users to select from six Bipolar Modes and power settings From the Main Screen the power setting can be adjusted up and down using the Up Down arrows Selecting a Bipolar Mode and Power Setting 1 From the Main Screen touch blue section of screen The Set Mode and Power pop up screen appears 2 Touch the desired Mode 3 Use the numeric keypad to set the power for the selected mode The highest allowable power setting will also display 4 Touch the Enter button to save changes and return to the Main Screen Touching Clear button will reset Power back to zero
68. the Icon GP An alarm will sound if a solid pad is detected Refer to Section 3 Getting Started to learn more NOTICE The Icon GP requires a split pad Connecting a solid pad and activating a mode will cause a unit fault and trigger an alarm Isolated RF output This minimizes the potential of alternate site burns Lighted Connector Panel Illuminated panel makes connection of accessories easier to use in any surgical setting Standard Accessory Connectors These connectors accept the latest monopolar and bipolar instruments Refer to Section 2 Touch Screen and Receptacles to learn more Multiple Communication Ports There are three USB connections two on the rear and one on the front Also the rear panel has an ethernet and RS232 connection Data Exchange Used to exchange data from unit to unit 1 2 Bovie Medical COMPONENTS AND ACCESSORIES You should receive the following components with your unit Icon GP Electrosurgical Generator 110 VAC Hospital grade power cord replacement part number 09 005 001 220 VAC Hospital grade power cord replacement part number 09 009 001 con GP USB Memory Stick Users Guide ADDITIONAL ACCESSORIES To avoid incompatibility and unsafe operation we recommend using the following Bovie accessories with the Icon GP ESREC split pad with 2 8 M cable BV 1253B footswitch for Monopolar procedures BV 1254B footswitch for Bipolar procedures BV ICON CS GP
69. ve 859 C the alarm will sound and output power will be deactivated Dimensions and Weight Width 28 3 cm 11 2 in Depth 52 7 cm 20 7 in Height 17 5 cm 6 8 in Weight 7 5 kg lt 16 5 Ibs Operating Parameters Ambient temperature range 10 to 40 C 50 to 104 F Relative humidity 30 to 75 non condensing Atmospheric pressure 700 hPa to 1060 hPa If transported or stored at temperatures outside the operating temperature range Warm up time p allow one hour for the generator to reach room temperature before use Transport and Storage The device should be stored and used in a room temperature of approximately 770 F 250 C Ambient temperature range 34 to 65 C 29 to 149 F Relative humidity 0 to 75 condensing during transport non condensing during storage Atmospheric pressure 500 hPa to 1060 hPa A 2 Bovie Medical Audio Volume The audio levels stated below are for activation tones cut coag and bipolar and alarm tones split pad and system alarms at a distance of one meter Alarm tones meet the requirements for IEC 60601 2 2 Activation Tone Volume adjustable 40 to 65 dB Frequency All Cut Modes 610 Hz All Coagulation Modes 910 Hz All Bipolar Modes 910 Hz Duration Continuous while the generator is activated The Auto Stop mode has a unique stop mode 2KHz for 150ms on 150 ms off Total of 3 pulses Alarm Tone Volume not adjustable 70 dB 5 dB Frequen
70. voided if a surgical procedure is carried out in the region of the thorax or the head unless these agents are sucked away Non flammable agents should be used for cleaning and disinfection wherever possible Flammable agents used for cleaning or disinfecting or as solvents of adhesives should be allowed to evaporate before the application if HF surgery There is a risk of pooling flammable solutions under the patient or in body depressions such as the umbilicus and in body cavities such as the vagina Any fluids pooled in these areas should be mopped up before HF surgical equipment is used Attention should be called to the danger of ignition of endogenous gases Some materials for example cotton wool and gauze when saturated with oxygen may be ignited by sparks produced in Normal Use of the HF surgical equipment NOTICE Do not clean the unit with abrasive cleaning or disinfectant compounds solvents or other materi als that could scratch the panels or damage the unit 7 2 Bovie Medical A Turn off the unit and unplug the power cord from the wall outlet B Thoroughly wipe all surfaces of the unit and power cord with a mild cleaning solution or disinfectant and a damp cloth Follow the procedures approved by your institution or use a validated infection control procedure Do not allow fluids to enter the chassis You cannot sterilize the unit Step 3 Ship the Unit A Attach a tag to the unit that includes the Returned Goods Aut
71. wy armen pe een 3 3 Visual and Audible Indicators sse 3 3 Checking Monopolar Mode with BV 1253B footswitch 3 3 Checking Monopolar Mode with handswitch see 3 4 Checking Bipolar Mode with BV 1254B footswitch css 3 4 IN SETVICE scia iem rtr Rt en du E Oed detect 3 4 Performa ce Checks ea ea ea Rn 3 4 Using the Icon GP 4 1 Inspecting the Unit and AccesSorieS 2 e eee 4 2 Setup Safely i sett eed een 4 2 Initial Set UJ puisse ee anne 4 3 selecting Unit Properties 4 4 Surgeon and Procedure Presets eee eee aaa aaa 4 6 Select Presels oda eh e tmr iere i Pr vr HE HERE KAL 4 6 Add Presets secrete uet egeret iet re diete 4 6 Edit 09005 aee e e Rape Ree eo ta e ird ana 4 7 Delete Presets ua 22 22 RER et tani AAAA 4 8 Preparing tor Surgery adno ette pete einen 4 9 Applying the Split Pad ee tea 4 9 Connecting Monopolar Accessories 4 9 Connecting Bipolar Accessories uneennnnnnennennenennennenennennnennennen 4 9 Mode and Power Settings 4 9 Bovie Medical Selecting the CUT BLEND Settings sse 4 9 Selecting the COAG Settings sssssseeeeneeene 4 10 Selecting the BIPOLAR Settings 4 10 Activating the 4 10 Activation Safety cte eet Ree ii ute ped ei be UE Da eet RU dud 4 11 Maintaining the Icon

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