SMT ESU 60 M (MONO)
Contents
1. 70 60 50 Rz 50 40 100 5 200 2 30 500 850 20 e 1000 2000 10 0 Min 1 2 3 4 5 Max Setting Graph 1 Cut 60 50 Rz 40 5 100 5 30 200 a 500 20 850 1000 10 2000 0 f Min 1 2 3 4 5 Max Setting Graph 2 Blend 19 Operating manual ESU 60 M JIME Special Medical Technology Co Ltd 60 50 Rz 40 3550 100 5 30 200 e 500 20 se 850 1000 10 2000 0 Min 1 2 3 4 5 Max Setting Graph3 Coagulation 70 a ee a 4 E 8 40 Cut Io E s Blend 8 30 Coag E 5 20 sR a 10 0 0 500 1000 1500 2000 Rz 0 Graph 4 Dependence of input power on load 20 JIME Special Medical Technology Co Ltd 8 DEVICE WITH BASIC ACCESSORIES INCLUDED FIG 4 8 1 Accessories included 1 control unit 2 instrument with cable 3 neutral electrode flat or circle 4 foot switch 5 line cord 6 instrument holder user manual with certificate of warranty declaration of conformity and registration card packing 21 Operating manual ESU 60 M INDEMNITY AGREEMENT Product ELECTROCAUTER ELECTROSURGERY UNIT TYPE SMT ESU 60 M Serial number Date of sale Stamp and signature of expedition Guarantee Condit2. 1 Control unit The electrosurgical generators is a high frequency highly efficient oscillator the current of which may be modulated if it is appropriate for cutting coagulation and a combination of both The level of the output performance is managed by the operator so that it fully meets his needs It is optional within the Min Max range up to a max performance of 60 W The device allows work in the MONOPOLAR mode The current can be chosen for cutting for blended cutting or for coagulation 3 1 1 Lights signals GreenMAINS the device is switched on Yellow CUT output current for cutting Green BLENDED CUT output of the current for a blended cut Blue COAG output of the current for coagulation Red AA AA AA AA NEUTRAL ELECTRODE alarm fault in the circuit of the neutral electrode 3 2 Holder of the operating tool applicator ES pencil The applicator holds the selected active electrode operating tool for the electrosurgical procedure The applicator for monopolar use 2 4 mm is supplied with the device as the basic accessory com 2 FIG 4 Also the applicators diameter 1 6 mm or 0 8 mm can be supplied as optional access This procedure is carried out based on specialised medical procedures according to the recommendations in Chapter 2 above The most common use is for cutting using a scalpel LOOP or needle and coagulation with the aid of the BALL or flat electrode The manufacturer supplies any of
3. cut we recommend using the device in operating rooms with a backup supply of electricity and we recommend feeding the device from an uninterruptable power supply UPS for outpatient use 13 The device needs to be inspected by the manufacturer or authorised service centre for safety reasons at least once a year 2 GENERAL INFORMATION In order to achieve the best results it is important to understand the basics of electrosurgery and so we recommend that you read the following basic explanation carefully 2 1 How high frequency electrosurgery works The device s electrode concentrates HF RF energy to the required place The HF RF current passes through the tissue painlessly without shock and the sole effect is creating heat inside the tissue moderate intensity of the current only in the place that comes in contact with the active electrode The HF RF current passing through the tissue creates molecular heat Electrodes of various sizes are used in electrosurgery In the bipolar method energy is concentrated with very high intensity on both working tips of the bipolar electrodes usually the forceps When this is applied to the tissue the HF RF current creates such intensive molecular heat in each cell that it is possible to cut the tissue or coagulate according to the output option CUT or COAG or mix of both BLEND The main aim of good electrosurgical technique in general is to remove undesired tissue stop bleeding
4. may cause slight tissue surface dehydration at most without damaging it with an adequate cutting movement whereas too low a performance prevents the electrode from moving around the tissue JIME Special Medical Technology Co Ltd OPERATING OUTPUTS OF DEVICE ESU 60 M 2 2 Cutting This is the separation of biological tissue with the passage of HF RF current of high intensity concentrated in the cutting parts of the active electrode When the HF RF current is applied to the tissue with the aid of the active electrode it creates intensive molecular heat in the cell which destroys the cell and separates the tissue The cutting effect is achieved by moving the tissue electrode and gradual cell destruction one after another The continuous movement of the electrode prevents the lateral spread of heat in the tissue thereby limits destruction of the number of cells to a minimum The most appropriate current for cutting is fully balanced and filtered HF RF current without any modulation Such a current cuts very smoothly The following rules will help the operator to achieve a good cut however each user must follow his professional judgement as is always the case in practice Move the electrode continuously without stopping Activate the electrode just before contact with the tissue Keep the electrode clean If the output performance is selected correctly then The electrode moves without resistance No changes occur in the
5. reusable forceps A preventive visual inspection of the cables and forceps or other instruments is required after each sterilisation 5 3 Cleaning The surface of the control unit box can be wiped with damp gauze containing standard detergent however make sure the washing solution does not get into any opening The mains cable plug must be removed from the socket when being wiped The operating tools and the cable can be cleaned in a similar way as the control unit Moreover the active non insulated part of the operating instrument 15 Operating manual ESU 60 M JIME Special Medical Technology Co Ltd must be well cleaned mechanically and adequately rinsed in running water 5 4 Removal of faults repairs SERVICE If the instrument does not work and the function light signal lights up after the foot switch is pressed down and the continuous sound signal is activated check whether the forceps are correctly connected and if the high frequency current intensity is properly set In case the instrument is not responding after the unit is switched on and the foot switch pressed down the function control light is not lit up and the signal does not sound even after carefully checking that all the connectors are in place the fault may be in the circuits of the control unit In such a case you need to contact your supplier service organisation or the manufacturer directly 5 5 Service centre Preventive checks Preventive checks n
6. these tools See 3 3 3 3 Active electrodes operating tool Active electrodes concentrate high frequency HF or radio frequency RF current and apply it to the tissue NOTE High frequency with a frequency of over about 200 KHz is not dangerous for living tissue unlike the current of the standard mains frequency of 50 Hz 10 JIME Special Medical Technology Co Ltd Depending on their shape electrodes are intended mostly for cutting or coagulation Thin wire electrodes straight or looped are usually used for cutting Tissue excision is carried out using loops Spherical electrodes BALLs are mainly used for coagulation The normalised gripping 2 4 mm diameter of the electrode stem is used above all The cutting end of the electrode is partly sterilised by HF RF energy which destroys organisms which could occur in this area However most electrodes can be repeatedly sterilised using all conventional methods The manufacturer recommends sterilisation by steam see further Chapters 3 4 Neutral electrode The neutral electrode closes the circuit of the NF current It must therefore be fastened firmly along its entire area to the patient s organism as close to the working field as possible Usually this is a metal or conducting silicon board of about 6x14 cm or bigger It can also be a single use conducting plastic dispersal material This part of the electrosurgical set is very important and the international safety dire
7. tissue destruction Keep the operating device sterile and clean Monopolar forceps p an forceps or scissors can also be used for the coagulation In such a case both lines of instruments is one active electrode and another bigger passive electrode is the neutral electrode attached to the patient as close to the place of the procedure as possible 2 4 Blend In some cases it is advantageous to CUT and COAGULATE in one intervention by one operating instrument For these cases is the slection of the BLEND output suitable 2 5 Merits of the use of electrosurgery Some of the basic merits of the use of electrosurgery are Prevention or restriction of the loss of tissue Prevention or restriction of bleeding makes it difficult for the doctor to see into the operating field when using a traditional instrument scalpel Prevention of bone damage Provided that care is taken when carrying out the procedure with the electrode the bone tissue is not affected by the electrosurgical procedure The continuous movement of the electrode prevents heat accumulation Quick and positive healing of healthy tissue with good generation and with little scarring of the tissue The time required for healing does not differ from the time during a procedure performed with a traditional instrument scalpel Restriction of the pain of the procedure JME Special Medical Technology Co Ltd 3 ELECTROSURGICAL UNIT ESU 60 M FEATURES 3
8. without carbonisation of the surroundings or to gain a precisely orientated and not destroyed sample of tissue for biological analysis and diagnosis Some operating principles of electrosurgery need to be observed to achieve a good result Choose the optimum parameters Choose the right mode for the chosen device Remove all possible other conducting undesired diverters including conducting fluids e g disinfectants out of reach of the electrodes and the patient The procedure may not be perfect if Excessive power is used The power used is too small The moving through the tissue is too slow JIME Special Medical Technology Co Ltd The procedure is repeated in the same area too soon Too small power results in the tissue fibres stick to the electrode and cause problems during further work A somewhat greater power may cause slight dehydration of the tissue surface at most without damaging it If you choose the right operating output and performance of the device you will achieve the desired result lt must be realised that the output CUT is without modulation and therefore will reach a higher tissue temperature over 100 C Water inside the cell boils and the cell bursts it is destroyed for good On the contrary the output COAG has modulation for the purpose of reducing the max temperature of the water inside the cell to 40 90 C and thereby coagulation closing the cell not its destruction The device also co
9. JIME Special Medical Technology Co Ltd HF RF Electrosurgery Unit SMT ESU 60 M mono Operating Manual JIME Special Medical Technology Co Ltd TABLE OF CONTENTS 1 INTRODUCTION NAA 4 1 1 Principles of safe use uuuusssssnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnn 4 2 GENERAL INFORMATION cceeeecceeeeeeceeeeeeeeaeeeeteneeeeeees 6 2 1 How high frequency electrosurgery works 6 2 2 GUNG maa NAAN AA ANAN AN 8 2 3 GCOagulation anne 8 2 4 A 9 2 5 Merits of the use of electrosurgery nn 9 3 ELECTROSURGICAL UNIT ESU 60 M FEATURES 10 3 1 Control Unites RR 10 3 2 Holder of the operating tool applicator ES pencil 10 3 3 Active electrodes operating tool 10 3 4 Neutral electrode ooooonnnccccccnnnncinnnncccncccnnncnnnnnnccnncnnnnos 11 4 TECHNICAL DESCRIPTION BASIC TECHNICAL PARAMETERS maana A 12 4 1 Control NULL 12 4 2 Special Highly Safe Pneumatic Foot Switch 13 5 PUTTING INTO OPERATION cccceeeeeeeeeeeseeeeeeesneeeeees 13 5 1 Maintenance instructions aaannnananwwwawananannnnnan 15 5 2 Sterilisation aaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaana 15 5 3 GlI6anINg maa ANAN AGA 15 5 4 Removal of faults repairs SERVICE osen 16 5 5 Service centre Preventive checks en 16 5 6 GUAM nassen 16 5 7 Free post guarantee SCrviCe ccceeeceeeeeeeeeeee
10. colour of the cut surface Fibres from the tissue should not remain on the electrode 2 3 Coagulation This is hemostasis of small blood vessels of body tissue caused by the passage of the HF RF current with the effect of active most commonly spherical electrodes If the current intensity is reduced and a large scale electrode is used for the purpose of dispersing the energy over a greater area this will cause the drying out of surface cells without deeper penetration and the onset of coagulation The surface of such coagulated cells behaves like an insulating layer which prevents the penetration of heat arising with the subsequent application of the current to a greater depth The current which is normally used for coagulation is always blended and modulated and the depth of modulation then depends on the quality of tissue hemostasis The deeper modulation of the HF RF JIME Special Medical Technology Co Ltd current causes somewhat rougher however more effective coagulation The following rules help the operator to achieve good coagulation however every user must follow their own professional judgement Select the appropriate size of the spherical electrode BALL or other appropriately shaped coagulating electrode Localise bleeding vessels Touch the bleeding vessels slightly before activating the electrode press the foot switch Terminate the activation of the electrode as soon as the tissue goes pale to prevent unnecessary
11. ctive requires that its safe attachment to the patient must be continuously monitored If this electrode is not attached to the device or if even one conductor of the double feed cable interrupted and therefore the electric circuit is not closed controlling the integrity of the feed conductors of neutral electrodes the warning red light on the back panel left flashes and the sound signal sounds repeatedly The function of the device is interrupted This warning is activated even with a break in the control electric circuit of the neutral electrode which controls the integrity of the feeds to the neutral electrode during the operating procedure If such a situation arises these electrodes must be inspected The visual control of the electrode and its feeds are recommended before each operation The use of neutral electrode is of fundamental importance for a precise surgical procedure with the smallest and safest possible current The neutral electrode must be placed so that some part of the patient s body forms a firm reliable and electric conducting contact with it without any separating pads gauze The principles in Chapter 1 1 must be followed when applying neutral electrode The basic operating electrode supplied by the manufacturer with this device is a multiuse stainless steel electrode As required it is possible to supply a neutral silicon electrode 11 JIME Special Medical Technology Co Ltd However when using the electrod
12. e it needs to undergo repeated inspection to check its electric conductivity at least once every 6 months because silicon electrodes lose their conductivity in time The service life of silicon neutral electrodes is limited to a period of 12 months Once this period expires the silicon electrode must be replaced with a new one Simple and cheap neutral electrodes with conducting gel usually self adhesive are intended for single use Feeds to these electrodes are checked by the above described electric circuit and its interruption is indicated just as in previous types visually and acoustically on the control unit panel with the current automatic interruption of the device s function The use of single use self adhesive neutral electrodes is a full alternative Despite a neutral electrode the current circuit is closed so it must be reliably attached for conductivity With a bad connection a patient could be burnt in the place of the neutral electrode or even in a different place e g there where an unwanted conducting connection arises e g conducting disinfectant which is absorbed into the cushion under the patient The neutral electrode set is insulated as its insulation complies with type F which complies with mark F on the device The neutral electrode stainless steel is supplied with the device as its basic accessories com 3 FIG 4 4 TECHNICAL DESCRIPTION BASIC TECHNICAL PARAMETERS 4 1 Control unit Feed v
13. eed to be carried out as the law requires at least once every 12 months additional parts and the cables once every 6 months In case of sterilisation in the above recommended way run a visual check of the instrument and any other additional part with the cable after each sterilisation Preventive safety inspections at the manufacturer or the authorised service centre must be carried out once a year During each inspection the HF RF output of the device must be measured at each power degree and each operating output 5 6 Guarantee The manufacturer provides a 24 month guarantee from the date of sale for the correct and faultless function of the unit During this guarantee period the manufacturer will ensure free repair if the product was not damaged by bad handling an unprofessional procedure or due to non observance of the instructions contained in this manual 5 6 1 Instructions for guarantee repairs Send the properly wrapped up unit and accessory if possible in its original packaging or transport in person with the attached certificate of guarantee and a description of the fault to the address of the supplier or manufacturer or upon a telephone agreement with the manufacturer to the address of the nearest relevant service organisation sme Special Medical Technology Co Ltd 5 7 Free post guarantee service Besides a guarantee the manufacturer also provides an additional two year free service provided that the legal requ
14. he figure of the front panel com 2 FIG 1 Select the operating output with the function switch com 7 FIG 1 Set the preliminary value of the power with the intensity regulator com 3 FIG 1 Now the Operating Process may begin by pressing the foot switch The relevant light signal lights up to indicate that the preselected operating output is activated com 6 FIG 1 while a continuous acoustic signal sounds out FIG 1 Front control unit panel Legend neutral electrode socket active electrode socket regulator of intensity W red light signal indicating bad connection of neutral electrode green signal indicating that the mains is switched on function signal operating outputs indicator function switch operating outputs selector NOA 14 JIME Special Medical Technology Co Ltd FIG 2 Back control unit panel Legend 1 pneumatic foot switch connector 2 mains cable socket 3 mains switch 4 production label 5 1 Maintenance instructions The high frequency unit does not require any special maintenance besides standard cleaning of all parts Any repairs must be ordered with the supplier authorised repair shop or with the very manufacturer 5 2 Sterilisation An autoclave formaldehyde or ethylene oxide can be used to sterilise cables and operating instruments designed by the manufacturer for sterilisation Hot air at a temperature of 160 C can also be used to sterilise the actual
15. ions a At observing Operating Instructions the manufacturer guarantees that the product shall have characteristics assessed by the relevant technical conditions and standards for the duration of 24 months from the date of sale b In case of failure in function of the product not caused by the end user or by an inevitable event within the guarantee period the product will be repaired free of charge c The free of charge repair within the guarantee period will be done after the presentation of the Indemnity Agreement by an accredited service or by manufacturer d The guarantee period shall be extended for a term of the guarantee repair e The Indemnity Agreement is at the same time The Certificate of the Quality and Completeness of the Product RECORDS OF REPAIRS Date of reception Description of malfunction Completion date Signature and stamp of the service Date of reception Description of malfunction Completion date Signature and stamp of the service Date of reception Description of malfunction Completion date Signature and stamp of the service Date of reception Description of malfunction Completion date Signature and stamp of the service END USER REGISTRATION CARD PRODUCT ELECTROSURGERY SYSTEM SMT TYPE SMT ESU 60 M Serial number Sales clerk User Name Organization Address Phone Fax Herewith confirm that have got acquainted wi
16. irements of regular technical inspections by the manufacturer are carried out This service does not apply to normal wear and tear to damage from unprofessional intervention mechanical damage e g the unit falling or to the accessories which are consumer material 5 8 Unit disposal The ES unit must be disposed of in accordance with valid legislative standards and regulations The manufacturer is registered under the legislative requirements at the Ministry of Environment under registration number 00794 05 ECZ and is obliged to accept the unit for liquidation 6 THE FULFILMENT OF LEGISLATIVE REQUIREMENTS The conformity was reviewed with the product The manufacturer declares at its own responsibility exclusively that the product fulfils basic requirements stated in Annex 1 of Regulations of the Czech Government No 336 2004 Coll 93 42 EEC in the relevant valid readings For the review were used these harmonised standards in a valid reading EN ISO 13485 EN 60601 1 EN 60601 1 2 EN 60601 2 2 The examination of the conformity was carried out in participation of the Authoritative person Notified Body No 1014 The Manufacturer issued a Declaration of Conformity on this matter 17 smE Special Medical Technology Co Ltd 7 PERFORMANCE CHARACTERISTICS FIG 3 Situating power setting values Maximum performance values are achieved at an impedance of 850 Q JIME Special Medical Technology Co Ltd
17. ntains the output BLEND which can be used to advantage where a combination of advantages is required of both outputs with partial destruction of the tissue A characteristic odour arises during electrosurgical procedures which can be removed by central suction from the operated place A suction unit is available or designed for this holding a suction hose as close to the place of the procedure as possible In the field of gynaecology or proctology a speculla with a connector for the suction can be used during open surgery It is constructed for this purpose In endoscopic methods complex suction of the cavity moreover for clearing the operating field is available The manufacturer of this device also offers effective suction units which eliminate this sole disadvantage of all electrosurgical devices How to operate Firmly attach the neutral electrode to the patient Remove all possible other conducting undesired diverters including conducting fluids such as disinfectants out of reach of the electrodes and the patient Move the device with the electrode continuously during the procedure to prevent heat accumulating in some part of the tissue Too great a performance results in tissue dehydration and when moving the electrode in the tissue it is possible to observe sparks Too low a performance results in tissue dehydration and tissue fibre stick to the electrode and cause problems with their removal Somewhat greater performance
18. oltage eeens 230V 50Hz or as ordered Maximum input Cut 85 VA at impedance of 500 Q Blended cut 75 VA at impedance of 500 Q Coagulation 75 VA at impedance of 500 Q No load IDDU as a etecee eee eae saa 5 VA Working output CUT at impedance 500 1500 Q 60 W Max output CUT at impedance 850 Q uu nennen 68 W Working frequency controlled by crystal 460 85 kHz Class LinSulation nananana symbol El DIMENSIONS cerraran 260 x 160 x 80 mm JIME Special Medical Technology Co Ltd NG 2 25 kg Mains transformer Talema Pilzen Type 52643 Prim 230V sec 1 45V sec 2 16V 100 VA EN 60 601 1 Operation and storage of device surrounding temperature Na TE 10 C 50 F to 40 C 104 F Relat NUMIGItY cece eee eeeecceeeeeeeeeeeeeeteeeeeeeees from 30 to 75 Atm Pressure sssnssnnnssnnnnnnnnnnnnnnnnnnnnnnn from 700 to 1060 kPa Level of protection against unwanted water seepage cover IP21 EMC The device was checked for electromagnetic compatibility according to international standard EN 60 601 1 2 Output data The device is BF type with protection against defibrillating discharge which complies with the mark on the unit Ar The unit uses high frequency energy with non ionising radiation as marked by Ml SU Operating output nennen cut blended cut coagulation Method of Operation a kien len NANANA aan constant opera
19. ombustible substances used for cleaning disinfection or as solvents must be left to evaporate before applying high frequency surgery Some substances such as cotton wool and gauze with absorbed oxygen may ignite due to possible sparks during normal use of the device In patients with cardiostimulators or other active implants there may be a risk in view of the interference with the activity of the cardiostimulator or it may be damaged It must be expected that the disruption caused by the operation of the high frequency surgical device may have a negative effect on the operation of other electronic equipment If telecommunication or other equipment is disrupted the user should take such precautions to remove the disruption At the time of activated output the device could become a source of the disruption of electromagnetically sensitive devices located nearby One of the possible precautions is to locate the HF RF generator and the disrupted device as far apart from each other as possible 10 Regular preventive checks of the device and its accessories are essential with special attention payed to the condition of the insulation of the feeds of the active bipolar electrodes 11 There should be no unqualified intervention with the device Request all repairs and inspections from the manufacturer or authorised repair shop JIME Special Medical Technology Co Ltd 12 In order to minimise risks arising from a possible power
20. se rules are mentioned again further in the text These instructions were compiled for your safety and for the safety of other persons therefore we request that you read them carefully before installing and using the device 1 An operator with a university medical degree is required to work with the electrosurgical device HF RF generator 2 If other than the accessories cables and instruments supplied by the manufacturer are used the manufacturer needs to be consulted to prevent incompatibility dangerous operation and personal risk sme Special Medical Technology Co Ltd THE PATIENT may not come into contact with metal parts which are not earthed or have a greater capacity against earth e g operating table supports etc In these cases we recommend using antistatic bed linen If a high frequency surgical device and monitoring instrument is used on a PATIENT simultaneously the monitoring electrodes should be located as far as possible from the surgical electrodes It is not recommended using needle monitoring electrodes The electrode feeds must be allocated in a way to exclude contact with the PATIENT or with other conductors Temporarily unused active electrodes must be stored away from the PATIENT Combustible anaesthetics or oxidising gases such as nitrous oxide N20 and oxygen should not be used if these agents cannot be sucked away Non combustible substances should be used everywhere where possible C
21. th the Operating Instructions and with the Guarantee Conditions and will observe them Date Signature Dear customers Will you tear this registration card out and forward it to the address Special Medical Technology Ltd Papirenska 114 5 160 00 Prague 6 Czech Republic The objective of this registration is partly to improve the quality of services our firm offers to its customers and partly to observe strict requirements of standards ISO 9001 ISO 13485 and EEC 93 42 our firm conforms and the user of medical technology must be acquainted with Thank You Special Medical Technology Co Ltd Papirenska 114 5 160 00 Prague 6 Czech Republic Tel 420 233 320 201 Fax 420 224 318 011 obchod smt praha com N 00146 01 www smt praha com The last revision and issue of this Operating Instructions 10 15 2012
22. tion with interrupted load see Chapter 5 The information ATTENTION read the accompanying documentation complies with the marking on the device A The maximum peak output voltage of unloaded circuit is achieved in the mode BLEND of 1140 Vsp p The device does not contain and does not use any dangerous substances 4 2 Special Highly Safe Pneumatic Foot Switch DIMENSIONS ccccoocnccccccccnnnccnannnnnnnnnnn nn non nnnnn nn nncnnn rca diameter 70 mm Length of feed hose ooocccccncccccccccnncconanannnnncnnnn cnn nnnnn nn ncnnnnnos cca 3 m Weight 2 nie ee ine eae 0 25 kg Foot switch complies with this marking on the back panel ae 5 PUTTING INTO OPERATION In order to determine the technical limits the following method of operation is defined INTERRUPTED Practically in usual medical practice the device can work continuously Place the device in a stable place where there is no blazing heat or direct sunrays Slide the mains cable firstly into the back panel of the 13 JIME Special Medical Technology Co Ltd control unit com 2 FIG 2 then connect to a properly installed electric mains socket Slide the flexible tube of the foot pneumatic switch into the opening on the back panel com 1 FIG 2 Switch on the mains switch on the back of the panel com 3 FIG 2 light warning signal com 5 FIG 1 Slide the instrument cable into the relevant connection as seen in t
23. ttteeeeeees 17 5 8 Unit disposal prision 2 2 17 6 THE FULFILMENT OF LEGISLATIVE REQUIREMENTS 17 7 PERFORMANCE CHARAGTERISTICS nn 18 8 DEVICE WITH BASIC ACCESSORIES INCLUDED 21 8 1 Accessories included 44444400ssnnnnnnnnnnnnnnnnnnnnnnnnn 21 INDEMNITY AGREEMENT END USER REGISTRATION CARD DECLARATION OF CONFORMITY JIME Special Medical Technology Co Ltd Manufacturer Special Medical Technology Co Ltd Papirenska 114 5 160 00 Prague 6 Czech Republic Phone 420 233 320 201 Fax 420 224 318 011 E mail smt praha smt praha com obchod smt praha com Internet www smt praha com Device classification class a Il b 1 INTRODUCTION In view of the continuously ongoing development some of the device s characteristics and technical data may be changed without prior warning No part of this document may be photographed reproduced or translated into another language without the written permission of the manufacturer In the event that technical assistance is required contact the supplier It is very important that this manual is kept for future consultation 1 1 Principles of safe use Operation of all high frequency HF or radio frequency RF surgical devices brings certain risks and specific rules need to be observed to minimise these risks In terms of transparency we provide a general outline of these rules here and many of the
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