Sutter CURIS 36 0 00-01 Instructions For Use Manual Download

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INSTRUCTIONS FOR USE

CURIS

4 MHz Radiofrequency Generator

REF 36 0 00 – 01

These instructions for use apply for all devices according to chapter 5.1.

Summary of Contents for CURIS 36 0 00-01

Page 1: ...INSTRUCTIONS FOR USE CURIS 4 MHz Radiofrequency Generator REF 36 0 00 01 These instructions for use apply for all devices according to chapter 5 1...

Page 2: ......

Page 3: ...f 9 5 5 Self test 10 5 6 Connecting accessories 10 5 6 1 Connecting the neutral electrode 10 5 6 2 Connecting monopolar handles for cutting and coagulation 10 5 6 3 Connecting bipolar accessories 11 5...

Page 4: ...ication 24 9 2 Recurring safety related inspections 25 9 3 Diagrams 26 9 3 1 RF output 26 9 3 2 RF voltage 28 9 3 3 Control characteristic curve 30 9 4 Guidelines and manufacturer declaration for elec...

Page 5: ...ct current Display Indicator panel on the generator Err Error F Floating hPa Hectopascal Hz Hertz kHz Kilohertz mA Milliampere MDD 93 42 EEC EU Medical Device Directive MHz Megahertz MPG Medical Devic...

Page 6: ...e electrodes for monitoring may not be used Do not use the active surgery electrode in the vicinity of the ECG electrodes minimum distance 15 cm Compliance with the following general rules is required...

Page 7: ...ss only works moderately or not at all This method is used to sever or resect tissue using blade or needle shaped electrodes or wire or tape loops Electrosurgical coagulation Two active principles are...

Page 8: ...exist in other specialist fields The CURIS is suitable for electrosurgical cutting and coagulating Exclusions are application immersed in liquids and applications that require a higher RF output than...

Page 9: ...or a Sutter service center If this is not available packaging that properly protects the device being returned is mandatory In case of improper packaging liability rests exclusively with the sender Th...

Page 10: ...POLAR operating mode 9 MACRO selection button for bipolar coagulation 10 BICUT 1 selection button for bipolar cutting 11 PRECISE selection button for bipolar coagulation with fine instruments 12 BICUT...

Page 11: ...r coagulation operating modes 27 STANDARD special function button for working without automatic START STOP or TIMER functions 28 Connection socket for monopolar instruments 29 TIMER special function b...

Page 12: ...n for electric potential equalization 47 T V seal of approval 48 Hardware and software version four characters 49 Volume control NOTE In the chapters that follow the numbers in brackets for example X...

Page 13: ...tion 46 The required connecting cable is not included in the scope of delivery and can be obtained from us if needed 5 3 Mains supply WARNING To exclude the risk of electric shock this device may only...

Page 14: ...o the connection socket on the front of the device 30 One piece neutral electrodes or neutral electrodes with two partial areas that make it possible to monitor the contact to the patient may be conne...

Page 15: ...to the socket 38 on the back of the device see illustration below left The foot switch or for the coagulation electrodes the AUTO START function 26 is subsequently used for activation see chapter 6 1...

Page 16: ...urface coagulation with sparks fulguration BIPOLAR for bipolar electrodes Cutting yellow selection buttons BICUT 1 10 Smooth cut with no coagulation zone BICUT 2 12 Cutting current with coagulation zo...

Page 17: ...m value For the maximum values of the various operating modes see the technical information in chapter 9 NOTE Always select the lowest output setting for the desired effect On the other hand note that...

Page 18: ...in flawless condition The surface of the device may get very hot during the extended application of RF current 6 1 Special functions The device is equipped with the following special functions The Au...

Page 19: ...ve instrument cleaning If one switches to a monopolar operating mode during treatment also in case of accidental monopolar activation and an electrical contact is detected between the two bipolar cond...

Page 20: ...T button 26 This step protects against unintentional activation NOTE A manually selected output setting in a bipolar cutting operating mode cannot be saved for safety reasons In this case the output s...

Page 21: ...e chosen current with the finger switch on the electrode handle or the foot switch The operating mode indicator lamps for MONOPOLAR 8 and BIPOLAR 15 have to light up according to the current type that...

Page 22: ...rical equipment supplied by the mains network The patient must not have any contact with grounded metal components otherwise there is a risk of point burns at the contact points Especially the patient...

Page 23: ...ossible with a one piece neutral electrode No warning signal is triggered in case of poor contact Applying the neutral electrode to implants and other metal components or to bony protrusions and scar...

Page 24: ...ARNING Radio equipment mobile telephones or other transmitters operated in the immediate vicinity of the RF generator may impair its safe functioning See chapter 9 4 for the minimum distances from tra...

Page 25: ...be the scope of functionality in easily comprehensible terms The accessory has suitable plug connections that can be connected to the device without excessive force and problems The manufacturer is wi...

Page 26: ...cutting operating mode at 0 is recommended if using this operating mode is not intended 7 9 Risks due to high electric voltage The application of a current type with a high voltage in particular a mon...

Page 27: ...at disinfectant residues are fully removed before using the device NOTE Always keep accessories for RF devices in flawless functional condition Non functional damaged or defective accessories may pose...

Page 28: ...0 W 20 on 300 1 20 A 4 00 MHz BICUT 2 cutting max 80 W 20 on 300 1 30 A 4 00 MHz 33 kHz EXCISE cutting max 80 W 20 on 300 1 20 A 4 00 MHz 33 kHz MACRO coag max 80 W 20 on 50 2 20 A 4 00 MHz PRECISE co...

Page 29: ...he functionality of the rotary encoders 9 Verifying the functionality of activation the activation lamps and the activation tone 10 Verifying the functionality of the two pedal foot switch 11 Verifyin...

Page 30: ...s authorized by us with the maintenance repair of the CURIS The service manual also lists all assemblies that are available as replacement parts 9 3 Diagrams 9 3 1 RF output MONOPOLAR Curve 1 Output s...

Page 31: ...rve 1 Output setting maximum output Curve 2 Output setting half output RF power watts R BICUT 1 1 2 R RF power watts BICUT 2 1 2 R RF power watts EXCISE 1 2 R RF power watts MACRO 1 2 RF power watts R...

Page 32: ...RIS Instructions for Use 28 9 3 2 RF voltage MONOPOLAR CUT 1 Display watts Peak voltage V CUT 2 Display watts Peak voltage V CONTACT Display watts Peak voltage V SOFTSPRA Y Display watts Peak voltage...

Page 33: ...29 BIPOLAR BICUT 1 Display watts Peak voltage V BICUT 2 Display watts Peak voltage V EXCISE Display watts Peak voltage V MACRO Display watts Peak voltage V PRECISE Display watts Peak voltage V RaVoR D...

Page 34: ...on 600 1 CONTACT on 400 2 SOFTSPRAY on 600 1 BICUT 1 BICUT 2 EXCISE on 300 1 MACRO on 50 2 PRECISE on 50 3 RaVoR on 50 Display watts RF power watts MONOPOLAR CUT Display watts RF power watts MONOPOLAR...

Page 35: ...tromagnetic environment guidelines HF emissions according to CISPR 11 Group 2 The CURIS has to emit electromagnetic energy for its intended function Interference with devices in the vicinity is possib...

Page 36: ...ifferential mode voltage 2 kV common mode voltage 1 kV differential mode voltage 2 kV common mode voltage The quality of the supply voltage should correspond to a normal commercial or hospital environ...

Page 37: ...compliance levelb according to on site testing b Interference may occur in the vicinity of equipment marked with the following symbol Radiated HF interference according to IEC 61000 4 3 3 V m 80 MHz t...

Page 38: ...ona 217 Hz 9 0 3 800 960 810 870 930 Pulse modulationa 18 Hz 28 0 3 1700 1990 1720 1845 1970 Pulse modulationa 217 Hz 28 0 3 2400 2570 2450 Pulse modulationa 217 Hz 28 0 3 5100 5800 5240 5500 5785 Pul...

Page 39: ...e shall only be disposed of in household garbage or as hazardous waste after careful cleaning disinfection and if applicable sterilization Infected sharp components of disposable instruments are treat...

Page 40: ...continues flashing after it is acknowledged Disconnect and check the connected accessory Accessory is in contact with tissue or defective Even though the accessory was removed the button continues fla...

Page 41: ...ot switch before the power up test was complete short circuit in the foot switch or its connection cable or device defect If not caused by actuation disconnect the foot switch and turn the device off...

Page 42: ...ctants commonly used in hospitals NOTE For safety reasons always perform a functional test prior to surgical application Always activate the pedals with the electrosurgery device turned on To prevent...

Page 43: ...esigned especially for the CURIS features numerous extras such as storage baskets and a foot switch adapter It is fully assembled on delivery The CURIS is secured against sliding by engaging in the me...

Page 44: ...CURIS Instructions for Use 40 Notes...

Page 45: ...CURIS Instructions for Use 41 Notes...

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Page 48: ...Distributed by Manufacturer Sutter Medizintechnik GmbH Tullastr 87 79108 Freiburg Germany Telephone 49 0 761 51 551 0 Fax 49 0 761 51 551 30 E mail info sutter med de www sutter med de Changes reserv...

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