- Kavandish
Contents
1. After Surgery V1 2 December 2014 27 36 K Chapter 6 General Warnings and Safety Notices KAVANDISH SYSTEM Before Surgery WARNING To ensure compliance with safety issues and suitable earth for the device use earthed outlets for connecting to supply mains Always be sure that the cylinder contains the argon gas the cylinder must have a label which shows that it is filled with argon gas Connecting the wrong cylinder such as oxygen cylinders can be dangerous for the patient or the operator No force of any kind should be exerted on cylinders cylinder connections or regulators Protect the argon cylinder by means of chains straps or safety belts from tipping over or falling during transport storage and use Argon cylinders may only be transported with valve protection cylinder cap in vertical position and secured in place Generally operation with electrosurgery unit on people who have peacemaker should be performed with caution This caution is especially applied while using argon system which has high voltage In those cases consult with a cardiologist Danger of suffocation due to uncontrolled argon flow Argon build up in the air being breathed can cause suffocation Symptoms are drowsiness rising blood pressure and breathing difficulties In an atmosphere of pure argon sudden loss of consciousness and suffocation occur without prior warning When the APS1 is used in the manner intended the concentration2. control valve 130ms l gt 1 gt Continuous Medium Low gas flow in device output in reference to the set value announcement duration of using the device in Once every 15 active mode seconds Activation request in zero gas flow Once every 10 seconds Low argon gas and at the cylinder pressure time of _ activation request Disconnection of cylinder pressure sensor Connection of cylinder At the time of pressure sensor error display Inactivating Auditory Signals At the time of error display By entering menu page and pressing off button auditory alarm signals with low priority and auditory Information signals can be inactivated In that case the sign XX is displayed on the LCD Upon occurrence of a medium priority alarm the auditory signals will be activated automatically V1 2 December 2014 25 36 IS Chapter 5 Alarms in APS1 KAVANDISH SYSTEM Priority in Alarm and Information Signals Generation 26 36 In case of alarm event with medium priority alarms signals with low priority and Information signals will not be generated In case of alarm event with low priority Information signals will not be generated Meaning that at any given time only alarms with the highest priority and or in the same priority are generated V1 2 December 2014 Chapter 6 General Warnings and Safety Notices Before Surgery During Surgery Endoscopy and Laparoscopy Surgeries
3. problem to the after sales service of Kavandish System Company It is not recommended to use the device Inform the problem to the after sales service of Kavandish System Company Check gas pressure through pneumatic gauge on regulator Gas pressure should not exceed 150 bar In case gas pressure is accuracy is confirmed inform the problem to after sales service of Kavandish System Company It is not recommended to use the device in this situation The maximum time for using the device in active mode is 75 seconds Set gas flow to a higher value than zero Necessary measures Low argon gas Continue of seins Low pressure of argon Replace argon gas cylinder as cylinder pressure cylinder soon as possible Disconnection of cylinder pressure Continue of activity Connection of cylinder pressure Continue of activity V1 2 December 2014 e Cylinder pressure sensor is not connected to the device e Cylinder pressure sensor becomes connected to the device Connect pressure sensor to the device 23 36 IS Chapter 5 Alarms in APS1 KAVANDISH SYSTEM Alarm and Information Visual Signals 24 36 Signs Symbols and Descriptions In case of generating medium priority alarm AN sign is displayed on the LCD In case of generating Y low priority alarm LN sign is displayed on the LCD Also every alarm has a symbol and a short description to guide the user However descriptions are displayed on the LCD
4. to 240 V 50 Hz 40 VA Standard 1 A 250 VAC 10 C to 40 C 25 to 85 non condensing 700 mbars to 1060 mbars Transport and Storage Parameters Temperature Relative humidity Atmospheric pressure Functional Parameters Output gas flow setting resolution Maximum input gas pressure Alarm Tone Volume non adjustable Frequency Duration V1 2 December 2014 20 C to 65 C 10 to 90 non condensing 500 mbars to 1060 mbars 0 1 Liter min 10 bar 79 dBA from 1 m distance 2300 Hz e Alarm with medium priority one burst includes 3 consecutive tones with 130 ms intervals repeated every 2 5 s e Alarm with low priority 2 consecutive tone with 130 ms intervals 11 36 IS Chapter 2 General and Technical Features and Specifications alananici SVEM Accessories e Pressure 150 bar Argon gas cylinder e Purity percentage 99 998 Class 4 8 or 99 999 Class 5 e Input 150 bar Regulator e Output 4 to 6 bar e Compatible with DIN477 NO 6 German standard Cylinder pressure sensor BD Sensor 4 20 mA 250 bar Gas hose 70 cm capable of tolerating 50 bar pressure Surgery pen and electrodes Made by BOWA and EMED Company NOTICE Proper electrode should be selected according to handle code see the compatible handle with the device table and specific application during surgery 12 36 V1 2 December 2014 K KAVANDISH SYSTEM Chapter 2 General and Technical Features and Specifications Compatible Han
5. to electric arc is normal to some extent In those modes that low voltage is needed and there is no electric arc this stimulation is not seen Neuromuscular stimulation is seen e Check earth wire in power cable of APS1 Iconic and Monitoring devices Interference with heart are properly connected monitoring device is saan e Check that surgery room earth is good and properly connected to the earth well Argon gas is leaking e Turn on and off the device If the gas leakage message is displayed inside the device contact Kavandish System Company service department e Check that fuse operational current is consistent with the given The fuse constantly specifications burns FRN e Check that part of the cable or other connections are not a short circuit After Sales Service One of the important feature and essential advantages of this device in comparison with similar ones is its ease and speed in after sale services This device has 24 months warranty from delivery date During that time any kind of device defection due to parts failure or error producing will be resolved free of charge in the company Also the company guarantees to provide its services in terms of repair spare part and support for 10 years NOTICE Dear customer In case of any problem or dissatisfaction regarding our product packaging delivery or recycling of the unit at the end of life time or in case of any suggestion that may help us improvi
6. After Surgery CAUTION Close gas cylinder valve after surgery Do not remove cables while the device is on V1 2 December 2014 31 36 IS Chapter 6 General Warnings and Safety Notices a P TE SORTER 32 36 V1 2 December 2014 Chapter 7 Maintenance and Repair Routine Maintenance Device Cleaning and Disinfecting Washing and Disinfecting Accessories Common Problems and Necessary Measures After Sales Service V1 2 December 2014 33 36 K Chapter 7 Maintenance and Repair KAVANDISH SYSTEM Routine Maintenance It is recommended once each year to bring the device to Kavandish System Company or one of its authorized representatives for calibration and technical control and receive results of quality control and device safety standards tests along with the device from the company again WARNING Device repair and calibration must only be performed by authorized service personnel of Kavandish System Company or its authorized representatives Otherwise the manufacturer is not responsible for safety and proper performance of the device Device Cleaning and Disinfecting For cleaning the APS1 at first turn off the device and remove the cable from power outlet for cleaning Then clean all surfaces of the device through a moistened cloth and cleanser or mild disinfectant solution For cleaning APS1 at first turn off the device and remove the cable from power outlet Then clean all surfa
7. User Manual APSI Argon Gas Plasma Supplier VI 2 December 2014 Preface This User Manual and the device which is described have been only prepared for qualified medical professionals who have been trained for the particular technique and surgical procedure to be performed This manual is designed only for using APS1 device a product of Kavandish System Company More technical information for authorized service personnel of this company and its authorized representatives is available in the Service Manual This manual covers following device APS1 Made in IRAN Printed in IRAN ar Kavandish System Co Pardis technology park Damavand Rd 25 Km Tehran Iran Factory Tel 98 21 76250635 38 Fax 98 21 76250639 Sales Office Tel 98 21 88259599 Fax 498 21 88243986 E mail info kavandish com Http www kavandish com EC REP ELEKTROCOM ATTA Kaiserstr 27 a 1 2 5 4 44135 Dortmund Germany E mail aelektro yahoo de Tel 49 231 5864211 Fax 49 231 5864210 kOz Quality Management System according to A ISO 13485 ISO 9001 ISO 9001 ISO 13485 II Conventions Used in this Manual WARNING Indicates a potentially hazardous situation which if it is not avoided it could result in death or serious injury CAUTION Indicates a potentially hazardous situation which if it is not avoided it may result in medium or minor injury NOTICE Warranty gt This product is w
8. a probability of harm and rapid surgeon or operator reaction is required alarm with medium priority will be generated Also if in a surgery argon function is vital and is placed in essential performance group from safety point of view technical failure or device malfunction is not acceptable So for such conditions alarms with medium priority have also been defined Low Priority Alarms At the time of low priority alarm presence the possible harms are so mild that does not require user s immediate reaction However the user should be aware of that condition so proper action can be taken to the alarm at the appropriate time In APS1 some of user errors may cause improper or incorrect use of the device and therefore reduces advantages of argon system In those cases with a bit attention in using the device the optimal condition will be obtained For such cases alarms with low priority have also been defined Information Conditions Information signals are solely defined for providing information to the user and will be announced in cases when there is no harm to patient or operator and no need for immediate reaction from user For example one of the advantages of APSIdevice is the possibility of observing cylinder pressure condition on the device display In the cases that cylinder pressure is very low this pressure reduction will be informed to the user However the user can be informed of gas cylinder pressure by observing pneumatic
9. acdeckiauashdeosued EEA 19 COA UO a E E E N 19 Chapter 5 Alarms IN APS I wicaiccedcsessevcctsticsscedeacecatelocsdcseuseccctaiie thas A Alani and Intornmmanon Condon S creron EE E E EE E A A 22 Medi m Pront Alarms eeen a E E A A butvariniie wexhamuarae uae 22 LOVEPARADE te taaneapedonten yap POP ACO COMIC ONS fete acral gelesen tate E aacaetl Demme steams eee 22 Alarmiand Information Visual Signals eere r e a E a a E e 24 SIENS Sy M O and Deseript oN Sorne nsg rnain EEEa 24 Cal INCL CAL OM edar aaa E E E a oeamiadeeees 24 Alinman MifOriia ON Andory SIENAS esac sotniintd eterantetnest a S E 25 Ingetan A Udon S1 NAS a a es Danan a a Taeiactegcnely 25 Priority in Alarm and Information Signals Generation cccccsscececceceeeccaesesseessseeecceeeeeeeeeeaaaasaassssseeeeeeeees 26 Chapter 6 General Warnings and Safety NOtiCES eccccssscccccssscccecccssecccccseccecssssee Z 7 Ye 6 zee U1 O c a a RR et TE ON PE a E me era 28 PONS SUT OCI aa occas E E der au tautensaca dl ercowiacnoeedsatoutear E EA E arias acs 28 Endoscopy and Laparoscopy SUlSCTICS rooien nae a a A a a a a 30 ARNOLDU CTY o E E a hed taal Nae cs 31 Chapter 7 Maintenance and Repair sssssccccccccsssssccocccsssssscceeccccssssscececcccsssssseceeesss OO ROUGE Mamien ihe Guiro uneg oa E S E A TOA 34 Device Cleans and DisS ecin Seea E ae enae eae ace Uae Ore deacon etal 34 Washing and Disinfecting Accessories eesesssssssssssssettrereesss
10. ack Panel Connections Front Panel Connections V1 2 December 2014 15 36 K Chapter 3 Argon Gas Surgery System Installation and Connection Setup kavanoisH system Setting up Devices and Primary Connections 1 Place Iconic and APS1 devices on a fixed flat and with no vibration surface 2 Put argon gas cylinder on a proper place and fix it NOTICE 3 Tie regulator package including pressure gauge and pressure sensor on the gas cylinder and tight it via appropriate tool NOTICE ee ee Back Panel Connections 1 Connect the pressure sensor cable on regulator to the corresponding location on the back panel of APS1 device which is specified as Pressure Sensor 2 Connect the regulator installed on the gas cylinder through high pressure hose which is provided with the APS1 device in the box to the back panel of APS1 device To establish this connection you should not use any tool 3 Slowly open cylinder valve and check gas leakage using soapsuds The manometer shows internal pressure of gas cylinder If cylinder pressure is less than 10 bar gas cylinder must be replaced 4 Using the provided communication cable connect Argon Supplier receptacle on the back panel of Iconic device to ESU receptacle on the back panel of APS1 device 5 Connect input power cord of the device Front Panel Connections The cable of surgery pens used in argon system has two branches in the connection points to d
11. acle 5 Iconic electrosurgical device receptacle 6 Argon gas cylinder receptacle argon gas input receptacle V1 2 December 2014 9 36 K Chapter 2 General and Technical Features and Specifications CANDIS H SVEM Signs Used on Front and Back Panels 10 36 w zZ IEH PPP HR The degree of protection against electric shock is Cardiac Floating CF type Also the device is protected against high voltage due to defibrillator use for patient Study the instruction manual Study all related sections in User Manual and or Service Manual before installation and operation of the device and or opening it for repair High voltages warning Electrostatic discharge warning for connectors sensitive to electrostatic discharge and precautions should be made when working with them Device serial number Manufacturer Authorized representative in the European Community V1 2 December 2014 K KAVANDISH SYSTEM Chapter 2 General and Technical Features and Specifications Technical Specifications Displays Screen LED Dimensions and Weight Width 40 cm Depth 44 cm Height 8 cm Weight 5 kg Input Power Mains voltage Mains frequency Maximum power consumption Fuse Operating Parameters Temperature Relative humidity Atmospheric pressure e Graphical screen with high brightness e Vacuum florescent display VFD 256x64 e Red alarm condition with medium priority e Green active normal working mode 100 V
12. argon gas In this mode RF electric current will be continuously applied to the tissue Generally application of this mode is for the continuous and rapid coagulation of large surfaces Pulsed Argon Plasma Coagulations This mode is often used in endoscopy laparoscopy and in thin and sensitive tissues In this mode RF electric current is applied as pulse Therefore power and the applied energy to the tissue are reduced and have less coagulation depth Generally pulsed mode is used when usage of argon gas with low power and depth is desired Thus the possibility of perforation or thin tissue rupture will be minimized Argon Cut In Iconic device this mode is selectable to be used in tissue cutting with argon gas By selecting this mode concurrently with Iconic device operation in one of cut modes argon gas will be delivered to APS1 device from electrosurgical unit Thus simultaneous with applying RF current in one of cut modes Pure Blend1 argon gas flow will be maintained in tissue incision Using argon gas along with cutting will provide a clean cut with uniform surface coagulation for surgeon This mode can be used for cutting tissues with high impedance like cartilage Setting Power and Gas Flow 18 36 Generally the more the amount of bleeding and greater depth of as per surgeon s point of view more electric power should be used In case low powers are used for coagulation but the device couldn t establish electric arc i
13. arranted for 24 months from the date of device delivery to the user During this period any failure in the device due to defective parts or system error caused by manufacture will be fixed free of charge in the company gt To receive the warranty card please complete the yellow sheet related to warranty card request and post it to company at the earliest time before sending it note that it has been filled correctly and completely gt Failure due to negligence in transportation or incorrect use of the product will not be covered by the watranty gt During the warranty period any repair must be carried out by Kavandish System Company or its authorized representatives otherwise the warranty will be canceled gt Accessories are not covered by the warranty and in case of damage must be replaced Guarantee gt Kavandish System Company agrees to repair and provide the spare parts for 10 years from the delivery date of the product Ill Table of Contents Chapter 1 Concepts and Advantages of Using Argon Gas in Electrosurgery 1 Electrosurgical System with Argon Gas cccccccccccccsseeesssssssssseeeeeeceeccccssenecesssesesseeseeececccecssceeeeascseseeeeseeeess 2 Advantages of Using Argon Gas in Electrosurgery ssesssseeeeeccecccccccecaeaeesssssseeeecceccccesseeaaaageassssseseeeeeess 3 Clinical Applications of Using Argon Gas in Electrosurgery ccccccccccccccccesseseseeeseeeeccecececeeeeaaaaa
14. ces of the device by a moistened cloth and cleanser or mild disinfectant solution WARNING Use nonflammable material for cleaning and disinfecting If you have to use flammable materials wait a while until those material are completely evaporated before you turning on the device Washing and Disinfecting Accessories NOTICE For washing and sterilizing the accessories refer to the manufacturer s recommendations in the corresponding manual ee 34 36 V1 2 December 2014 K KAVANDISH SYSTEM Chapter 7 Maintenance and Repair Common Problems and Necessary Measures Problem Review and necessary measures Check e The power cable is connected to the outlet e The outlet has electricit The device does not turn y on e The power cable is not torn e The device switch is not broken e The back panel fuses are not burned otherwise replace the fuse while the device is off Check e The argon probe is correctly connected to the Iconic and ASP1 devices e The communication cable of APS1 and Iconic devices is connected through back panels of devices Electric arc is not e The electrosurgical unit is ready to work and power has been set to the established 8 y P adequate value e The three pin connector of argon probe is connected to Monol output of Iconic device e Argon probe is functional e Stop the surgery and check the accessories and connections accuracy e Reduce output power Neuromuscular stimulation due
15. d correctly Simultaneous with Iconic device activation in addition to establishing HF voltage in output argon gas flow at the set value will also be delivered Thus gas will be ionized at the tip of probe and by forming argon gas plasma energy will be transferred to the tissue Starting electric arc depends on various factors such as voltage of electrosurgical device kind of surgical instrument and tissue type Also by closing surgery probe to tissue surface it will be more likely to create and maintain electric arc So when it seems difficult to establish electric arc you can get the probe closer to tissue surface The electrode angle relative to tissue surface should be between 45 to 60 degrees Thus by keeping away blood and fluids from tissue surface the desirable surface coagulation takes place V1 2 December 2014 19 36 K Chapter 4 Surgery Using Argon Gas KAVANDISH SYSTEM WARNING Never hold the probe tip toward open vessels This increases the risk of gas embolism Avoid holding the probe perpendicular to the tissue surface because it can cause gas entry into capillaries By maintaining the angle move the probe forward and to sides Moving probe backward reduces gas flow and efficiency Probe movement should be slow and soft The slower the probe movement the more coagulation depth will be and the possibility of larger vessels coagulation is higher Try to move your hand such that coagulates the surface for the fir
16. dle with the Device r Electrode handle for rigid electrodes 932 Open BOWA i 3 5 m cable 041 surgery 3 pin connector for HF i Luer Lock connection for i Argon gas Electrode handle for flexible electrodes 932 2 5 m cable E 045 AOSE OPI BVEA 7 3 pin connector for HF a Luer Lock connection for Argon gas Electrode handle with 2 switches 932 Open EMED 3 5 m cable 141 surgery 3 pin connector for HF Luer Lock connection for Argon gas Electrode handle for flexible electrodes 432 Standard plug round 145 Endoscopic EMED Si 3 5 m cable 3 pin connector for HF Luer Lock connection for Argon gas Electrode handle for flexible electrodes 432 New type plug oval 146 Endoscopic EMED f 3 5 m cable gt 3 pin connector for HF Luer Lock connection for Argon gas V1 2 December 2014 13 36 K Chapter 2 General and Technical Features and Specifications KAVANDISH SYSTEM Duty Cycle APS1 device duty cycle depends on normal duty cycle of Iconic device Hence it is recommended that for every 10 seconds activation period device to be inactivated for 30 seconds Output Gas Flow Graph Based on Set Flow a O Output Flow O e NUA UO N CO O 0 1 2 3 4 5 6 7 8 9 10 Adjusted Flow 14 36 V1 2 December 2014 Chapter 3 Argon Gas Surgery System Installation and Connection Setup Setting up Devices and Primary Connections B
17. em to burn The high temperature of argon plasma on the other hand can cause easily burning materials to ignite if oxygen or other burnable gases are nearby or are mixed with argon when applied to these materials for example plastic insulation at the distal end of the bronchoscope or a tracheal tube This is especially true of highly concentrated or pure oxygen For this reason please always observe the following rules e Never permit oxygen or other combustible gases or fluids to enter the tracheobronchial system before or above all during activation of the argon plasma in the tracheobronchial system e When using argon plasma in the tracheobronchial system for more than a few seconds alternate oxygen ventilation of the patient with argon plasma that is use them in turns e Always keep the distal end of the probe in view in the endoscope before and during activation of the argon plasma Never activate argon plasma if you cannot see the distal end Never use argon system for endometrial ablation because there is the possibility of gas embolism inside the uterine In endoscopy laparoscopy surgery after connecting the probe and before inserting the probe into the laparoscope endoscope purge the gas for 2 seconds to remove air from the direction of gas flow and replacing it with argon gas In endoscopy laparoscopy surgery it is recommended to use low gas flow about 0 3 L min to 1 L min otherwise it may cause bloating abdominal cavity swe
18. evices one is used for RF current and the other one is used for pneumatic tube for gas transfer to the probe tip Connect RF side of the cable to the Monopolarl connection on the Iconic device Place the probe gas on the front panel tube of APS1 device in the embedded location and tight it with a clockwise turn NOTICE In all Monopolar modes including those which are embedded for argon use it s essential that the patient plate be connected to the device Modes along with argon gas in Iconic device will only be activated on Monopolar1 output by activating footswitch or hand switch 16 36 V1 2 December 2014 Chapter 4 Surgery Using Argon Gas Determining Operating Mode Setting Power and Gas Flow Purge Starting Surgery Using Argon Gas V1 2 December 2014 17 36 IS Chapter 4 Surgery Using Argon Gas KAVANDISH SYSTEM Determining Operating Mode After setting up all required electrical and pneumatic connection By activating the device you can apply argon gas flow along with RF energy to tissue In Iconic device two modes for coagulation with argon gas have been considered Those modes easily provide required high voltage for argon gas ionization Also using a button cut with argon gas is provided in each cutting modes In the following features of each mode will be discussed Continuous Argon plasma Coagulations This mode is the most common and most widely used mode of electrosurgery with
19. gauge In fact this feature is considered only to improve the device use V1 2 December 2014 K KAVANDISH SYSTEM Chapter 5 Alarms in APS1 Alarm and Information conditions with the relevant specifications are given in following two tables Alarm condition Impact on the activity High gas flow in device output in reference to the set value Stop of activity Leakage in gas Deny the flow control Medium permission of valve activity Low gas flow in device output in reference to the set value Continue of Medium n act v ty Deny the Medium permission of activity Stop of activity Deny the Low permission of High pressure of argon cylinder High duration of using the device in active mode Activation request in zero gas flow activity Information aodan LOPE One cea Reasons e System internal failure e System internal failure e Exit route blockage e Lack of adequate gas pressure at the device input e System internal failure e Using argon gas cylinder with excessive pressure e Failure of gas pressure sensor e High duration of using the device in active mode e Activation request from device in Argon Cut or Argon Coag in case the set gas flow is zero Reasons Necessary measures It is not recommended to use the device Inform the problem to the after sales service of Kavandish System Company It is not recommended to use the device Inform the
20. his case will have brightness with a special blue light which is called argon beam or plasma jet PJ By collision of argon plasma with the tissue energy is transferred to the tissue and causes a shallow coagulation which clinically has significant features i _ V1 2 December 2014 K kavannisH system Chapterl Concepts and Advantages of Using Argon Gas in Electrosurgery The figure below shows physical principles and procedure of coagulation technique using argon gas plasma I Argon Ar if Electrode Be ft Wy d UH Argon Plasma Beam Ar A ear conn 7 NE IHF IHF IHF IHF Advantages of Using Argon Gas in Electrosurgery Generally argon system is used for both coagulation and cut However argon application is very limited in cut and its major application is in shallow coagulations When argon gas is not provided the common technique for shallow coagulation is using spray mode In this mode the electrode tip is in low distance from the tissue and electric arc by passing from this aerial distance and collision with tissue surface creates the required coagulation effects But in such technique accidental movements of electric arc is not controllable and sometimes the arc is collided with healthy tissue around the desired position and leads to unwanted healthy tissue necrosis Moreover the arcs energy is not controllable and sometimes frequent collision of high energy arcs with a poin
21. ings Alarm Sound In this option auditory alarm signals with low priority and auditory Information signals can be activated or inactivated In the case of inactivation the sign DX is displayed on the LCD Upon occurrence of a medium priority alarm the auditory signals will be activated automatically Max Adjust Flow By this setting the maximum gas flow can be adjusted by the user This value is adjustable between 1 L min to 10 L min Default Cut Flow By this setting the default gas flow for cut can be adjusted by the user This value is adjustable between 0 L min to the adjusted value in the Max Adjust Flow setting Default Coag Flow By this setting the default gas flow for coagulation can be adjusted by the user This value is adjustable between 0 L min to the adjusted value in the Max Adjust Flow setting By pressing save button in all the above settings changes will be saved and current gas flow for both cut and coagulation changes to the new adjusted default values V1 2 December 2014 K KAVANDISH SYSTEM Chapter 2 General and Technical Features and Specifications Back Panel Features i jipe krai ARGON eae amp SS hax Prossuro 10bar ire i A f ETS pe ee Ce Y 4 ya 4 j Fi 3 mE LLLI Fa Fuse 250 TA Simian a Wig Hepiioe he p3 marked 1 Device identification label 2 Power cord receptacle and input fuse holder 3 Main on off power switch 4 Pressure sensor recept
22. lling or gas embolism In endoscopy laparoscopy surgery care should always be taken that argon gas exit path from the patient s body is open especially in long surgeries it is needed that the surgeon check internal pressure using measurement instruments and if necessary take the gas out of the abdominal cavity by using peripheral devices such as smoke evacuator or decompression catheter CAUTION This device should be used by trained personnel or under supervision of an expert Always use low power Need for high electric power can be a sign of weak plate connection with patient s body or other connections Be cautious while operating close to sensitive tissues such as intestine bile urinary tract and large vessels V1 2 December 2014 29 36 IS Chapter 6 General Warnings and Safety Notices KAVANDISH SYSTEM CAUTION When the device is activated even before creating electric arc and formation of argon gas plasma there is a high voltage at the tip of probe surgery that can establish electric arc in unwanted conditions Therefore avoid keeping electrode tip close to other metal objects such as patient leads forceps clip etc During surgery argon ray must not contact with surgical tools such as scissors forceps clip etc During surgery it should be prevented from patient s body contacting metal objects connected to the earth such as patient s bed or metal objects around it Because in that case current leakage can ca
23. n e Protection classification Class I e Compliance with IEC 60601 1 standard third edition e Compliance with IEC 60601 1 8 standard second edition V1 2 December 2014 K KAVANDISH SYSTEM Chapter 2 General and Technical Features and Specifications Front Panel Features Pressure y 90 Argon Purge Oy C1 Argon gas output receptacle for instrument connection 2 Purge button to provide 10 L min gas flow 3 Increment button for gas flow in Cut mode 4 Increment button for gas flow in Coag mode 5 Entering menu page button 6 Decrement button for gas flow in Coag mode 7 Display of argon gas cylinder pressure alarms and Information signals 8 Decrement button for gas flow in Cut mode V1 2 December 2014 7 36 IS Chapter 2 General and Technical Features and Specifications alananicis SVEM Some Settings Option in Menu Page 8 36 By pressing Menu button on front panel we entered into the Menu page Four settings are provided in this page Using the four buttons that are adjacent to the display on front panel the following tools are available to perform these settings These tools include Select Selecting the desired option to adjust On Activating auditory alarm signals and auditory information signals Off Inactivating auditory alarm signals and auditory information signals Incr Increasing the value of the selected option Decr Decreasing the value of the selected option Save Saving the sett
24. ng our service and product quality please contact our after sales support department in Kavandish System Company V1 2 December 2014 35 36 K Chapter 7 Maintenance and Repair KAVANDISH SYSTEM NOTICE At the end of device life time except case parts which are made of metal or PVC the remaining parts are not recyclable and must be destroyed 36 36 V1 2 December 2014
25. nscn seta ceicesed ascarccsaecaasen sctaceae 1 PCC CS SOIC S esha cag E T T eco nsauir sedan ana A ed aes eagneu A soea env TE 12 Compauble Handle with he De Vice trades deste ih a A E Gil baer 13 TUG Cy CMe is sia sarrivonnscatsenhand oonantaebysosanse T AE E EE meats E TE AE A 14 Output Gas Flow Graph Based on Set FlOW ccsssseeecececcceeeeeaceessssseeeeeccccceeeceeeeeeaeauaesssseeseeeeeeseeqqaas 14 Chapter 3 Argon Gas Surgery System Installation and Connection Setup 15 Seine up Devices and Pma Connec Honts a a aaa enrra aioe halons tesa 16 Backs Panel C Gite C1 ONS crass ses uses ceased acct te oes ae eters acca se eae a aaah cay aes oes ecw ke to aloe es 16 Pront Pane CONNEC COONS corns ese ca ccenocmcececlaniecscunnetece ican ace shancestou ne dee NNa 16 Chapter 4 Surgery Using Argon Gas cccccccsssssssssssssccccccccsssssscsccccsscccsssssssssccoees 7 Determine Operas MOUS icisicutaitstsen tein botuidandaetetantutnosatusunteartaneatabdactalaitee a E 18 Continuous Argon plasma Coagulations secciecensicdowsctiora elev ceharcendanelunerandoowalububialeatavamecanss neuuatarwadae kesahantawineds 18 Pulsed Arron Plasma Coar Ula OMe isisi5 satin ea EE EE E 18 ASO a E E EE E Seance 18 SENS PO Wer aiid GaS FION e E Soe aawaccedwancnelcan stun te besamacoeeusanens 18 BUS gcse ain wes lassie oa boca E E ON E A es A are susan seo sa A E EE E E E A E 19 Sarn me SuLccery USINE ATS OMG AS orao EE ET EA iawavadl
26. of Using Argon Gas in Electrosurgery KAVANDISH SYSTEM e Removing oxygen from surgery position by Argon gas flow prevents carbonization and reducing smoke and odor of tissue burns during surgery Reducing smoke in endoscopic surgeries significantly increases surgeon s visibility and has a great impact on the speed and precision of the surgeon e General bleeding during surgery is significantly reduced up to 50 and therefore the patient needs to receive blood units are also decreased e Surgery duration is significantly reduced e By using pulsed argon the applied energy rate to the tissue is reduced and coagulation depth is smaller and more controllable Thus the possibility of perforation or unwanted damage to tissues with thin wall is reduced e Using argon gas for cut reduces electrode adhesion to the tissue e Cutting with argon reduces surgery odor and smoke and also prevents melting Clinical Applications of Using Argon Gas in Electrosurgery 4 36 Overall by using argon plasma during surgery bleeding surfaces can be coagulated accurately by applying controlled energy Also in tissues with high impedance like bones cartilages ligaments and organ membranes for which using the conventional coagulation methods are inefficient using argon will be very effective Clinical applications of using argon device are e Stomach surgery e Surgery in thoracic cavity and respiratory tract e Intestine surgery e Removing small apophasis
27. of argon in a room reaches about 1 in a room measuring 6m x 6m x 3m in 100min this argon air mixture is completely harmless A short hissing noise will be heard when the gas valves are opened due to the argon flowing in the hoses If this hissing continues for longer than 2 sec when a cylinder is opened there is a leak and the argon cylinder must be closed again immediately The unit may not be used until the leak has been rectified Make sure that the hoses are faultlessly tightly connected to the device and the gas cylinder This also applies to the connection of the regulator to the argon cylinder CAUTION It is not permitted to use the device without a careful study of User Manual NOTICE The case is not absolutely watertight For this reason do not set up the unit in the direct vicinity of tubes or vessels containing liquids Do not place any liquids on the device It is recommended to blow out at least a liter of argon gas to remove any left gas inside the tubes before using the device To do so press Purge button on the front panel of APS1 for a few seconds and deliver out the gas During Surgery WARNING All safety regulations concerning monopolar high frequency surgery are applicable In case of using the device in the chest cavity and around head avoid using flammable anesthetic substances such as nitrogen oxide and oxygen unless these substances are discharged from the environment simultaneously Prevent accum
28. placing it with argon gas In endoscopy laparoscopy surgery always test argon plasma ignition and the electric arc outside the endoscope laparoscope before inserting the probe into the working channel In endoscopy laparoscopy surgery it is recommended to use low gas flow about 0 3 L min to 1 L min otherwise it may cause bloating abdominal cavity swelling or gas embolism In endoscopy laparoscopy surgery care should always be taken that argon gas exit path from the patient s body is open especially in long surgeries it is needed that the surgeon check internal pressure using measurement instruments and if necessary take the gas out of abdominal cavity by using peripheral devices such as smoke evacuator 30 36 V1 2 December 2014 K KAVANDISH SYSTEM Chapter 6 General Warnings and Safety Notices WARNING During argon plasma activation distention of the organ being treated can cause discomfort to the patient To avoid this e Set the argon flow rate as low as possible e Apply repeated suction if using a single channel endoscope e Apply continuous or interrupted suction through the second channel if using a double channel therapeutic endoscope e Insert a deflation tube 3 5 mm parallel to the endoscope e g when using argon plasma in the rectum e Always monitor the patient s abdominal wall tension You shall not confuse argon plasma coagulation with argon laser The two are completely different CAUTION P
29. robe tip should always be visible through endoscope Never activate the device when the probe tip cannot be controlled through eyes Gas flow should not be more than 4 L min Cannula valve should always be open Use suction to remove gas NOTICE Preoperative test of probe function Check the function of the probe as follows before inserting it into the working channel of an endoscope laparoscope e Hold the tip of the probe approx 3 5 mm from a non insulated bare metal object This must not have any electrically conductive contact with the patient other people or electrical appliances e Activate the device e Note whether argon plasma develops between the probe tip and the metal object Do not touch the tip with bare fingers when it is activated Insert the probe into the endoscope laparoscope Insert the probe into the working channel of the endoscope laparoscope until the distal end emerges at least 10 mm from the distal end of the endoscope This is indicated when the first black ring on the distal end of the probe is seen to emerge from the endoscope Intraoperative cleaning of the probe s distal tip Coarse crusts of debris or tissue on the tip of the probe may inhibit argon flow through the probe In such a case remove the probe and clean its tip with a wet swab Before reinserting the probe into the endoscope laparoscope recheck its function as described in the notice related to preoperative test of probe function
30. seasasenseeeeess 4 Chapter 2 General and Technical Features and Specifications sssssssssoee D CMC GAL FCAT E eens ee areata E tanta ata aanauannine ateanac ted 6 Safely Related Features anat cade ceutayhs cei EE a E EEE 6 Print Panel ECU O zan a a a A 7 Some Settings Option n Menu Pap Curera e A r davensehloveaues tovtguceiaee 8 Alarm SOU ees T E E TET 8 Max ANGUS FION snene sacanecece E E E E a E S 8 Derine UC BIOW ouea A E E 8 Sra Cae TOW osem NAT ween ino melon eaamaet E E ata nse eak erred E han eanemtoremetas 8 Back Panel Reavis etccctesce cet tare ceriee erate E as a Lela orcad eda aaa re done A 9 Sicns Used on FProntand Back Panel Siess ner osten eorn bande wie ii cant e e ote col ohn Cue e nE ENERE oa be caiee 10 TECHNIC AS PEC CALiOni Ss oss assraca cesta souetesdussee i esea r uesen cone edema 1 PIS PIAVS wiistins aise san cusvatanaetarantenssandas E acausddetan stand amie dinereduaas sued T NE 1 Dinen ons ANG W ele Miesa E E A E eaaacabdion dann E E 1 Input POW acc sasaki ia ett date a ace nlnce el adetaa EE N celeron 1 CPD EAU Ul al AMG LMG ieests cadence Neate th cctteiia ce cane ctetasa Sosa Naat den E E E 1 Transport and Storage Parameters s suman Guede eseetotinsen canna tavare dere atti dasamdincnnda usenet uvodamnsnousaee 1 Functional Parameters sis osaccsdrescav culo esiagsoil oriveewsass eavit sivas cass wol oxi tees vata ners olen adi auieciaees 1 PANN AM MOM a E senses N ss saacatcasalaeesseeacauesso
31. sssssssssseetrrereosssssssssssssseeeerereeessssseseeeerereessssss 34 Common Problems and Necessary Measure Sersriria aiae a EE a EEEE AEE AAEE EEEE 35 PATLCK OIE S SET VACE a a E A T ee cuetttecnnuataedeaesieonves 35 VI Chapter 1 Concepts and Advantages of Using Argon Gas in Electrosurgery Electrosurgical System with Argon Gas Advantages of Using Argon Gas in Electrosurgery Clinical Applications of Using Argon Gas in Electrosurgery V1 2 December 2014 1 36 IS Chapter 1 Concepts and Advantages of Using Argon Gas in Electrosurgery KAVANDISH SYSTEM Electrosurgical System with Argon Gas 2 36 An electrosurgical system with argon gas has two main components 1 Iconic high frequency electrosurgical generator is responsible for applying high frequency electric current RF on the tissue 2 APS1 argon gas supplier device is responsible for controlling and directing argon gas toward the surgery electrode The figure below shows the general block diagram of electrosurgical device with argon gas APS1 Argon Gas RF current Hand switch I Footswitch conic Argon gas is directed toward surgery probe through gas supplier and control device and exit from the tip of surgery probe By placing high voltage between electrode tip and tissue surface 7 KVp p the argon gas is ionized and a direct path with low impedance will be created for electric current flow as argon gas plasma The ionized gas flow in t
32. st time By using argon gas plasma you can coagulate maximum 2 to 3 mm vessels NOTICE Cut Using argon gas with cut reduces electrode adhesion to tissue Gas flow pressure increases surgeon s visibility by removing smoke blood and fluid from the incision In addition gas flow causes underlying and adjacent tissues to be cool and peripheral damage to tissues is reduced So that a concentrated cut with high quality is provided for the surgeon Cut with argon during surgery reduces odor and smoke and prevents melting of thin electrodes at high powers Cut with argon is only possible by using special electrodes 20 36 V1 2 December 2014 Chapter 5 Alarms in APS1 Alarm and Information Conditions Alarm and Information Visual Signals Alarm and Information Auditory Signals Priority in Alarm and Information Signals Generation V1 2 December 2014 21 36 IS Chapter 5 Alarms in APS1 KAVANDISH SYSTEM Alarm and Information Conditions 22 36 Considering definitions and requirements of IEC 60601 1 8 standard a set of alarms has been defined in APS1 device Those alarms are divided into two medium and low priorities In addition to the alarm signals that are generated during the event of an alarm condition Information signals are generated in those conditions which event is harmless to the patient or operator but require the user s attention Medium Priority Alarms In a condition where there is
33. t s better to use pulsed argon Although this mode has low power the device ability to establish electric arc is high WARNING Generally in electrosurgery to observe safety and avoid unwanted side effects it s recommended to use the lowest possible power But in Continuous Argon and Pulsed Argon that the risk of gas embolism increases it s better not to use low powers Using increment or decrement buttons on the APSI device you can set gas flow in both cutting and coagulation modes Gas flow is adjustable between 0 1 to 10 Li min with the precision of 0 1 L min It is generally recommended when high power is used and coagulation of large surface of the tissue in high speed is required higher gas flow is applied WARNING In endoscopy laparoscopy surgery it is recommended to use low gas flow of about 0 3 L min to 1 L min Otherwise it can cause bloating abdominal swelling or gas embolism In endoscopy laparoscopy surgery should always be careful that argon gas exit direction from patient s body is open Especially in long surgery it is required that surgeon check internal pressure with measurement instrument and if necessary pull out the gas from abdominal cavity with peripheral devices such as smoke evacuator V1 2 December 2014 K KAVANDISH SYSTEM Chapter 4 Surgery Using Argon Gas NOTICE In open surgery it s recommended to use 2 L min to 4 L min gas flow In this condition using 40 Watt power in Con
34. t of tissue surface can cause deep holes in the surface fragile of coagulation area or tearing and perforating in the tissues with thin wall But using argon gas has helped to fix those problems Advantages of using argon gas system are as follows e Using coagulation system under argon gas plasma allow us to perform shallow coagulation of tissues with high speed and wide scale e Argon beam energy toward the applied area is controllable therefore it minimizes unwanted adjacent tissue necrosis e Reducing damage to the tissues reduces the recovery time and infection possibility e Flexible and thin eschar layer formation on tissue surface reduces the risk of recurrent bleeding due to tissue strain or movement e Coagulation depth is uniform all around the surface and risk of deep holes or perforation is reduced e The probe distance from tissue surface reduces problems of tissue adhesion to the electrode and is prevented from tissue strain and the possibility of recurrent bleeding e Low coagulation depth increases argon application especially in tissues with thin walls like intestine Depending on the selected power coagulation depth will be between 1 mm to 3 mm e Argon gas flow keeps away blood and fluids from surgery position and causes energy transfer to the tissue surface and effective coagulation In addition to surgery position in this situation is very well visible V1 2 December 2014 3 36 IS Chapter 1 Concepts and Advantages
35. that cannot be separated by conventional methods due to their small sizes e Creating shallow coagulation in bleeding area e Cancerous tissue necrosis at higher powers Coagulation with argon system is used for both open and endoscopy laparoscopy surgery V1 2 December 2014 Chapter 2 General and Technical Features and Specifications General Features Safety Related Features Front Panel Features Some Settings Option in Menu Page Back Panel Features Signs Used on Front and Back Panels Technical Specifications V1 2 December 2014 5 36 IS Chapter 2 General and Technical Features and Specifications alananicis SVEM General Features Argon gas supplier device APS1 model has been designed to support Iconic product model of electrosurgical unit using proper interconnection between them APS1 is responsible to control and direct argon gas toward surgery probe APS1 general features are e Gas flow adjustable from 0 L min to 10 L min and with a precision of 0 1 L min e Capable of separately setting gas flow for Cut and Coag modes e The possibility of gas purging with 10 L min flow e Menu page for some user settings e Capable of displaying argon gas cylinder pressure e Intelligent alarm system Safety Related Features 6 36 e Continuously monitoring and measuring the output gas flow e Continuously monitoring and measuring argon gas pressure e Argon gas leak detectio
36. tinuous Argon mode seems appropriate for reliable coagulation For cutting with needle electrodes 60 Watt power and for cutting with knife electrodes 90 Watt power is appropriate Purge Gas can be pushed out using Purge button without electrosurgical device activation and RF current In this case gas flow is blown with high intensity Purge is needed when it is required that gas direction is removed from air and replaced with argon gas For example when a new probe is connected to the device gas should be blown for a few seconds in order to empty the air from tube and argon gas to be filled in WARNING In endoscopy laparoscopy surgery after connecting the probe and before inserting the probe into the laparoscope endoscope purge the gas for 2 seconds to remove air from the direction of gas flow and replacing it with argon gas Generally by pressing Purge button you can check and confirm the pneumatic connections accuracy and gas flow establishment Starting Surgery Using Argon Gas Coagulation After establishing the required connections determining working mode setting power gas flow and probe type first remove air from gas direction and replace it with argon gas by pressing Purge button for a few seconds then place the argon probe close to the tissue less than 1cm and activate the device by pressing hand switch or footswitch If all connections including communication cable between the Iconic and APS1 have been establishe
37. ulation of flammable substances under and around patient s body 28 36 V1 2 December 2014 K KAVANDISH SYSTEM Chapter 6 General Warnings and Safety Notices WARNING If possible use inflammable substances for cleaning and disinfecting Otherwise after using those flammable cleaners let them to dry completely in sufficient time Generally there is the possibility of accumulation of flammable solutions under patient umbilicus or vagina Danger of explosion of endogenic gases particularly in the colon When performing electrosurgery on the gastrointestinal tract no flammable or potentially explosive endogenic gases must be present Particular care is required during the resection or coagulation of tumors obstructing the colon using an HF loop or argon plasma coagulation Flammable gases must be suspected behind every stenosis in the colon Be certain to flush out at risk sections of the intestine with CO2 or argon before activating the electrosurgical unit or argon plasma coagulator To prevent gas embolism argon gas flow should not be too high When gas flow is high it s possible that gas enters into open vessels Also the probe tip shouldn t be directly positioned against open vessels Never press the activated probe into tissue or against the organ wall since this can lead emphysema wall damage Danger of fires in the tracheobronchial system Argon gas is non combustible It does not cause fire in burnable materials or help th
38. use unwanted burn It is recommended to use antistatic sheets under the patient Contact of different organs with each other during surgery can cause unwanted burn Because passing electric current through small cross section can cause heat Use dry gas between the organs Avoid wrapping plate and probe cable around metal objects This situation can cause induction of intense currents and unwanted burns for the patient and surgery team Wet and humid probe should never be connected to the device NOTICE In case creating and maintaining electric arc is difficult one of the following three methods increases the probability of establishing electric arc e Closing argon probe to tissue surface e Increasing power e Using pulsed argon mode During coagulation with argon plasma bloods and fluids should not be accumulated around coagulation position In that case a layer of coagulum is formed in the fluid surface while energy is not reached the tissue and coagulation is not occurred Video interference Due to the relatively high voltages required for argon modes interference can occur in video systems Digital video systems are normally less sensitive to this interference than analog systems Endoscopy and Laparoscopy Surgeries WARNING In endoscopy laparoscopy surgery after connecting the probe and before inserting the probe into the laparoscope endoscope purge the gas for 2 seconds to remove air from the direction of gas flow and re
39. when there is only one alarm condition has been created in the device If several alarms occur simultaneously due to space restriction on display only symbols of alarms will appear Following table shows all signs symbols and descriptions related to alarms and Information signals Alarm condition Sign appears on display Symbol Description High gas flow in device output in HF High Flow reference to the set value Leakage in gas flow control valve gt Low gas flow in device output in LF Low Flow reference to the set value High pressure of argon cylinder Cy H Press High durati f using the device 1 igh duration of using the device in active mode D Activation request in zero gas flow Disconnection of cylinder pressure Press Sensor sensor Optical Indicator In case of alarm with medium priority a red optical indicator will start flashing on the front panel The flashing pattern of this indicator is 500 ms on and 800 ms off This indicator is off and inactive in normal conditions and turns green in activation state V1 2 December 2014 K KAVANDISH SYSTEM Chapter 5 Alarms in APS1 Alarm and Information Auditory Signals Alarms and Information signals are also informed to the user using a beep generator Beep generation pattern for alarms and Information signals has been mentioned in following two tables oe Alarm wee High gas flow in device output in reference to the set value Leakage in gas flow
Download Pdf Manuals
Related Search