Instructions for Use TherMedico NK 1 - schwa
Contents
1. Before every use of the TherMedico NK 1 the operator must run a probe test Probe test gt Test probe The operator must heat up the tip of the thermo probe without compromising its sterility If the temperature is increased by 3 C within a period of 5 seconds the display shows Probe OK Probe test gt Probe OK Furthermore the TherMedico NK 1 runs a plausibility test If the registered temperature is not between 10 C and 40 C this is shown accordingly The temperatures shown on needle display and the 7 segment display Lesion temperature room temperature should be about the same Stimulation There are two operating modes for stimulation e Stimulation 1 e Stimulation 2 The difference between these two modes is a different stimulation frequency The stimulation frequency can be modified using the appropriate modification buttons Value range 2 Hz 100 Hz Since stimulation 1 and stimulation 2 work in identical ways the following description of stimulation 1 is valid for both operating modes Stimulation 1 gt Impedance measurement Whilst stimulation is not active impedance is measured continuously via the patient circuit The impedance measurement display shows the impedance value that is being measured If the impedance value is greater than 3000 Q the patient circuit is recognized as not closed an audio signal sounds and the text display shows2. Pierenkemper 503714 Needle 150 mm 20 G 10 mm tip Thermo lesion needle Pierenkemper 500991 Neutral electrode Mono plate Erbe July 2005 Page 13 1 Instructions for Use TherMedico NK 1 14 14 1 14 2 July 2005 Addresses Manufacturer s address Pierenkemper GmbH H rnsheimer Eck 19 D 35578 Wetzlar Tel 49 0 6443 67923 0 Fax 49 0 6443 67923 33 Internet http www pieren tech de Email info pieren tech de 0197 451600 0231 Dealer s address schwa medico GmbH Fout Opmaakprofiel niet gedefinieerd Abteilung f r Spezialsysteme Department for Special Systems Am Geiersberg 6 D 35630 Ehringshausen Internet http www schwa medico com Email j fietie schwa medico com info opus medical com Page 14 1
3. o Temperature threshold o RF lesion check time o RF lesion number e Advanced settings and adjustment functions o Serial data transfer o Calling up factory settings o Adjustment functions September 2005 Page 4 1 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 4 1 Menu options The TherMedico NK 1 possesses the following menu sequence Laso tres Stimulation manual a Stimulation manual Lesion automatic manual HF lesion 2 4 _________ Esler automatic manual HF lesion pulsed Eon automatic manual Illustration No 22 Menu options If the device has been not been used for lesion or stimulation and if no button has been pressed for a period of 20 min the TherMedico NK 1 reverts to Standby mode 4 2 Display test TherMedico NK 1 Version 1 0 During the display test all the TherMedico NK 1 display segments are switched on in sequence The signaller signals the switch from one display to the next allowing the operator to check that the displays and the signaller are working September 2005 Page 4 2 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 4 3 4 4 4 5 At the same time the text display shows the current version of the software of the device Standby Standby Once the device has been switched on and the display test has run the TherMedico NK 1 goes into Standby mode Probe test
4. attention to potential damage of the insulation of the electrode leads September 2005 Seite 1 2 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd e Failure of the TherMedico NK 1 may result in an undesirable increase of the output power e The START STOP button is not suitable for emergency use In case of an emergency pull the thermo probe plug from the TherMedico NK1 September 2005 Seite 1 3 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 2 Description 2 1 Used Symbols 2 1 1 Front of the device Connection thermo probe u Connection neutral electrode F Neutral electrode is insulated against earth for high frequency A N Attention read accompanying literature 2 1 2 Label September 2005 Page 2 1 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd Pierenkemper GmbH H rnsheimer Eck 19 D 35578 Wetzlar TherMedico NK 1 REF 503710 SN 000001 A 230 V 50 60 Hz 0 3 A G25 W 100 Q 485 kHz CAT SN Device serial number REF Article or order number gt Device output power owe TJ 5 Short term use 5 min Attention read accompanying literature The device may not be disposed of in the normal way The device was put in circulation after 13 08 2005 LJ Application part type BF Non ionising electromagnetic radiation Year of construction of device JJJJ Year of manufacture September 2005 Page 2 2 Instruc
5. be fixed to the patient s body as far away as possible from the active or neutral electrode We do not recommend the use of needle electrodes for monitoring We do recommend the use of monitoring systems which are equipped to limit high frequency currents The electrode leads should not touch either the patient or any of the other leads Electrodes that are not being used temporarily should be put away and not touch the patient The output power should be set at the lowest possible level suited to the intended use If the output value is apparently too low or if during standard procedures the TherMedico NK 1 displays intermittent functional deficiency this may be due to either faulty contact between the neutral electrode and the patient s body or faulty contacts in the leads Check the position of the neutral electrode and the check the leads before increasing the output power Patients with pacemakers or other active implants could be at risk in so far as the pacemaker could be affected or damaged In case of doubt please seek professional advice When the TherMedico NK 1 is switched on its interferences may affect other electronic equipment working Portable or mobile high frequency communication equipment can interfere with electric medical instruments Please read the notes about putting the system into operation as well as the accompanying manufacturer s notes The operator must check the accessories regularly paying particular
6. carried out before it is used again Always replace a fuse with one of the same type that has the same parameters Before connecting the device to the power supply ensure that the mains voltage and frequency corresponds to the one displayed on the device label September 2005 Seite 1 1 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd The operator is fully responsible to take these safety precautions 1 4 Safety Notes All the items that are listed under accessories may be used in conjunction with the TherMedico NK 1 Using the TherMedico NK 1 close to e g 1m a therapy device using short waves or microwaves may cause the base values of the TherMedico NK 1 to fluctuate In order to prevent unwanted burning the following points should be observed The surface area of the neutral electrode must have total contact with the patient s body and be fixed securely and as close to the area of operation as possible The patient s body must not touch any metal items that are earthed or have significant earthing potential e g operating table brackets etc The use of antistatic cloth is recommended for this purpose Skin to skin contact for example between the patient s arms and body should be avoided For this purpose dry gauze may be placed between potential contact areas When the TherMedico NK 1 is used simultaneously with other physiological monitoring equipment all the monitoring electrodes should
7. showing the different temperature limits in C degrees Celsius HF lesion Voltage 3 digit display showing the HF voltage in V Volt HF lesion Current 3 digit display showing the HF current in mA Milli ampere HF lesion Temperature 2 digit display showing the current temperature in C degrees Celsius When working with the TherMedico NK 1 the operator must continuously compare the temperatures shown on the needle display with the lesion temperature on the 7 segment display If there is a significant difference between the temperatures the device is not working properly 2 2 2 Text display VFD 2 2 3 The text display shows the various operating modes and it also conveys important information to the operator for instance cases of faulty operation or functional interference The operator should observe the text display carefully when working with the TherMedico NK 1 Needle display The needle display shows the dynamics of temperature measured in the thermo probe The temperature test circuit directly controls the needle display The needle display should be observed carefully when the TherMedico NK 1 is in operation When working with the TherMedico NK 1 the operator must continuously compare the temperatures on the needle display with the lesion temperature on the 7 segment display If there is a significant difference between the temperatures the device is not working properly The needle display is always ill
8. the set temperature level has been reached or when the two HF lesion time buttons are pressed at once You can adjust the temperature level using the menu option Settings HF lesion finishes automatically when the timer stops Push the START STOP button to halt the lesion process at any point The START STOP button is not suitable for use in an emergency In case of an emergency pull the thermo probe plug from the TherMedico NK 1 4 6 2 Manual HF lesion HF lesion 1 gt Active manual You can start manual HF lesion by turning the turning knob clockwise The 7 segment display now shows the temperature limit which can be manually adjusted using the turning knob A dot on the 7 segment display marks this value The temperature limit that has been set and is indicated on the 7 segment display must be reached and then maintained and this determines and regulates the HF performance Both the 7 segment display lesion temperature and the needle display show the temperature that is being registered HF voltage and HF current on the 7 segment display show the set HF voltage and HF current The lesion operates once the set temperature level has been reached or when the two HF lesion time buttons are pressed at once HF lesion finishes automatically when the timer stops You can adjust the temperature level using the menu option Settings September 2005 Page 4 5 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefi
9. 0 54 kHz 0 5 kHz sinus 500 Q 250 Voltage adjustable by units of 0 1 V 2 0 3 0 V 10 2 100 Hz 1 Bi phase rectangle 1 msec negative 1 msec positive Type K 0 100 C 2 C Desired temperature adjustable by units of 1 C automatic performance regulation 1 application circuit floating max 4 automatic manual 0 25W on 1009 485 kHz 0 5 kHz amplitude modulated modulation grade maximum 100 300 s 95 C 1 300 s 1 Page 7 1 Instructions for Use TherMedico NK 1 July 2005 6 2 6 3 6 4 6 5 6 6 6 7 HF lesion pulsed General Number of programmes Modes of operation Output power Pulse frequency Pulse impulse breadth Max lesion temperature pulsed Output signals Tek Run nr PK Detect Fout Opmaakprofiel niet gedefinieerd Desired temperature adjustable by units of 1 C automatic performance regulation 1 application circuit floating 1 automatic manual set HF voltage 0 1 Won 100 Q equivalent to 25 W pulsed 2 Hz 20 msec 42 C Illustration No 1 Stimulation impulse on 500 Q real Page 7 2 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd Tek Roll 250 5 5 Pk Detect wi 00 ms CHT 1 64 V Illustration No 2 Stimulation impulses 2 Hz on 500 O real Tek STR ee 27 Acqs MTOOns Chi va OV Illustration No 5 HF impulse on 100 Q real July 2005 Page 7 3 Inst
10. Instructions for Use TherMedico NK 1 REF 503719 Table of Contents 1 2 30 Safety PreCaUtIONS iria AA aia E TE DeESCAPION tet atten is dlls Used Symbol ii os Frontot the devinon etto ados MalhS SUPplV ciar a a en e a ews a a dos Control pane lisasmanta 2 2 1 7 segment displays LED ninia an nun Oee RA 222 Textdisplay VPD renerne a A a eee inate A 2 2 3 Needle display ci re reinem 2 2 3 B tl ns a manner TITEL NIE hee ee tes 22 4 y Turning Kn ui dat riada tidad 283 SIgnaller cut tt reiner aii 3 Installation and putting into operation cece cece cece cece eeeeeeaeceeeeeeeeseceaaaeceeeeeeesecenaeceeeeeeeseesiceeeeees Ai e ODIN O NT 4 1 MenurOptlONS a abe icc tees as hss See a sio a a a a E ARA ROEE E ese AD A aar E OT A NT ATA O O NO A se a NO A O E a E Waa saate a E O Ra S TN 4 6 1 E O ete 4 6 2 MENE TO 4 6 E O 4 7 1 Automatic HF lesion pulSed oooooononocccccnnnncccconononcconcnncnnnnonnnncnnnnnnnnnnnnnnnnnnn cnn nnannn nn nn nnmnnn nenn 4 7 2 Manual HF lesion pulsed 4442444440040HRnnnnnnnnnnnnnnannnnnnnennnnnnnannnnnnnnnnnnnnnennnnnnnn nn 48 Temperature displayState aea daa a ra aei aa aia A aaa aaa i aa 5 Troublesh oting n dd ned Fa dd nie dh 6 Settings Dd O en 7 Technical data 22 2 2 252 re einige ad elder are 8 Maintenance and safety related checks 4s4nneeennnnnnnennnnnnnnennnnnnnnnnnnnnn nennen ennnnnnnnnnnnnnnnn
11. September 2005 Page 4 3 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 4 6 Stimulation 1 gt Check connection It is not possible to start stimulation When the impedance value is smaller than 3000 Q you can start stimulation by turning the turning knob clockwise The text display shows Stimulation 1 gt Active At this point the 7 segment display shows the Stimulation Voltage which may be adjusted using the turning knob TherMedico NK 1 now produces the desired stimulation voltage You can stop stimulation at any time using the START STOP button The START STOP button is not suitable for use in an emergency In case of an emergency pull the thermo probe plug from the TherMedico NK 1 Stimulation may also be halted by re setting the stimulation voltage to 0 0 V HF lesion There are up to four operating modes for HF lesion e HF lesion 1 e HF lesion 2 e HF lesion 3 e HF lesion 4 You can select the number of existing HF lesion operating modes using the settings The difference between the operating modes lies in the different times for the lesion timer as well as the temperature limits You can adjust these values using the relevant modification buttons Since HF lesions 1 2 3 and 4 work in identical ways the following description of HF lesion 1 is valid for all of the four operating modes HF lesion 1 gt Impedance measurement The 7 segment d
12. TherMedico NK 1 and how to put it into operation 1 7 Installation The device should be positioned on an even surface To enable heat to dissipate as required you must ensure that the aeration holes on the bottom of the device are not blocked To avoid mutual interference please do not place the TherMedico NK 1 directly next to on top of or underneath any other equipment If this is not possible you must watch each device when it is operating to ensure it is working normally Connection to the mains The socket for the mains lead is on the back of the device Having checked that the mains voltage and frequency corresponds to the one displayed on the device label plug the device into a safety socket that has been installed according to regulations using the mains lead that came with the device Switching the device on by using the mains switch The mains switch is on the back of the device When the device has been switched on the green indicator lamp l 0 should be on The device will run a display test please refer to section on display test The display test allows you to check that the displays and the signaller are working Following this the device will be on Standby Connecting the thermo probe Connect the thermo probe to the connector showing this symbol The markings on the plug and the socket must be lined up To pull the thermo probe out of the socket make sure you only pull it by the plug cas
13. e when delivered and must be sterilized before each use Please refer to the instructions accompanying the thermo probe that is used e The neutral electrodes are not sterile intended for single use only July 2005 Page 9 1 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 10 July 2005 Guarantee The TherMedico NK 1 is guaranteed for 2 years from the purchase date This guarantee does not cover thermo probes leads cables and electrodes The product is guaranteed to operate without defects for two years from the purchase date provided it is used as intended For products whose labelling indicates a shorter life than two years the guarantee ends on the expiry date as shown on the packaging or on the instructions for use The guarantee is not valid o if the instructions for use are not followed o if operating errors are made o if the device is improperly operated or handled o if unauthorized persons attempt repairs o in cases of acts of god e g lightning strikes etc o if the product is sent back to the manufacturer and damaged during that transport because it was improperly packaged o if maintenance or safety checks have not been carried out o in cases of normal wear and tear This includes the following components for example single use articles etc not using original spare parts or accessories Pierenkemper GmbH is not liable for consequential harm caused by a defect w
14. ency e percutaneous application of pulsed radio frequency Both methods are used in the area of pain therapy for the reduction or the elimination of pain Classification In line with the guideline for medical products 93 42 EWG Appendix IX and in accordance with rule 9 the TherMedico NK 1 is classed as a category IIb product Safety Precautions You must follow the instructions for use when using the TherMedico NK 1 The device may only be operated by qualified medical persons who are specifically trained to do so Adaptors or extension leads may not be used as this could result in increased emissions or render the TherMedico NK 1 more susceptible to interference Damaged leads or plugs must be replaced immediately If the device is damaged it must be returned to the manufacturer immediately for checking Before cleaning or servicing the device the power plug and any other connecting cables must be pulled The device may only be serviced or checked by skilled persons with training in the use of the device Checks and maintenance must be carried out following the service manual using tests with valid calibration Do not operate in proximity of flammable anaesthetic agents or gases Danger of explosion Keep the device far from containers with a liquid content Liquids must be prevented from getting into the device If liquid has penetrated the TherMedico NK 1 despite precautions the device must be dried and technical tests
15. here this is due to intent or gross negligence or in cases of slight negligence causing injury to life and limb This policy does not affect your statutory rights Page 10 1 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 11 Disposal The manufacturer is obliged to take back the TherMedico NK 1 and to dispose of it properly July 2005 Page 11 1 Instructions for Use TherMedico NK 1 12 Scope of delivery The TherMedico NK 1 comes with Fout Opmaakprofiel niet gedefinieerd Number REF Description 1 503710 TherMedico NK 1 1 106850 Neutral electrode cable 1 450810 0043 Mains cable 1 503719 Instructions for use 1 451710 0002 Service manual July 2005 Page 12 1 Instructions for Use TherMedico NK 1 13 Fout Opmaakprofiel niet gedefinieerd Accessories The TherMedico NK 1 may be used in conjunction with the following accessories REF Description Type Manufacturer 500882 Thermo probe 50 mm M 405 TCO5 RDG 500883 Thermo probe 100 mm M 406 TC10 RDG 500884 Thermo probe 150 mm M 407 TC15 RDG 500887 Needle 50 mm 22 G 5 mm tip Thermo lesion needle Pierenkemper 500888 Needle 100 mm 22 G 5 mm tip Thermo lesion needle Pierenkemper 503713 Needle 100 mm 22 G 10 mm tip Thermo lesion needle Pierenkemper 500890 Needle 100 mm 22 G 15 mm tip Thermo lesion needle Pierenkemper 500889 Needle 150 mm 20 G 5 mm tip Thermo lesion needle
16. ing to open the automatic lock of the connector Do not pull the lead Pulling the lead may damage or break the thermo probe Connecting the neutral electrode Connect the plug of the neutral electrode lead into the socket with this symbol September 2005 Page 3 1 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 8 Thermo probe test Before using the device you should run a thermo probe test For this purpose the device must be in the thermo probe test operating mode and the temperature in the probe tip increased please refer to the probe test section 9 The device is now ready for use and you can select the desired operating mode Attention The length of the needle and the thermo probe must correspond to work safely and effectively September 2005 Page 3 2 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 4 Operating The TherMedico NK 1 has several operating modes These may be selected using the mode buttons or the device activates or deactivates them automatically The operating modes are as follows e Display test e Standby e Probe test e Stimulation 1 e Stimulation 2 e HF lesion 1 e HF lesion 2 e HF lesion 3 e HF lesion 4 e HF lesion pulsed The number of operating modes for HF lesion may be changed using the settings The following operating modes can only be accessed using special combinations of buttons e Basic settings o Language
17. isplay Time shows the current setting for the Lesion time It can be adjusted using the appropriate modification buttons Value range 1 s 300s The 7 segment display Temperature limit shows the current setting for the Temperature limit This can be adjusted using the appropriate modification buttons Value range 20 C 95 C Whilst stimulation is not active impedance is measured continuously via the patient circuit The impedance measurement display shows the impedance value that is currently being registered If the impedance value is greater than 3000 Q September 2005 Page 4 4 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 4 6 1 the patient circuit is recognized as not closed an audio signal sounds and the text display shows HF lesion 1 gt Check connection It is not possible to start HF lesion There are two ways to start HF lesion impedance smaller than 3000 O e Automatic START STOP button e Manual turning knob Automatic HF lesion HF lesion 1 gt Active Push the START STOP button to activate automatic HF lesion The temperature limit that has been set and is indicated on the 7 segment display must be reached and then maintained and this determines and regulates the HF performance Both the 7 segment display lesion temperature and the needle display show the temperature that is currently being registered The lesion timer operates once
18. matically when the timer stops Push the START STOP button to halt the lesion process at any point The START STOP button is not suitable for use in an emergency In case of an emergency pull the thermo probe plug from the TherMedico NK 1 4 7 2 Manual HF lesion pulsed HF lesion pulsed gt Active manual For this operating mode the required HF voltage is set directly not the desired temperature September 2005 Page 4 6 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 4 8 Start manual HF lesion pulsed by turning the turning knob clockwise The 7 segment display now shows the HF voltage which can be adjusted using the turning knob A dot on the 7 segment display marks this value The 7 segment display temperature limit is switched off because this operating mode does not use a temperature limit The operator is responsible for regulating the temperature Both the 7 segment display lesion temperature and the needle display show the temperature that is being registered HF current on the 7 segment display shows the HF current that is being measured The lesion starts immediately Manual HF lesion finishes automatically when the timer stops Push the START STOP button to halt the lesion process at any point The START STOP button is not suitable for use in an emergency In case of an emergency pull the thermo probe plug from the TherMedico NK 1 Temperature displays The TherMedic
19. n 9 Sterilisation cleaning and care 442444444sHnnnnnnnennnnnnnnenennnnennnnnnnnnnnnnnennnnnnnnannnnnnnennnnn sn nnannn 10 G aranteera A nun eel ae nee Ae dee aie ner 1 11 DISPO iii ied tates hae eee a A a eae ene 1 12 Scope Of delivery nee A edd bed 1 13 ACCESSOMNES A A GL ee oe yell a 1 14 AddreSSeS NN 1 14 1 Manufacturers address iii it Haren anderes ernennen 1 14 2 Dealer s address a ricota henioccectnateciecdsd cent 1 List of Illustrations Fig 1 Control Panel 2 3 Fig 2 Menu Options 4 2 Fig 3 Stimulation impulse on 500 Q real 7 2 Fig 4 Stimulation impulses 2 Hz on 500 O real 7 3 Fig 5 HF impulse on 100 Q real 7 3 Fig 6 HF impulse pulsed on 100 Q real 7 4 Fig 7 Total performance and half performance depending on load resistance 7 4 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 1 1 1 2 1 3 General These instructions describe the areas of application and the mode of operation of the TherMedico NK 1 Please refer to the service manual for information about the TherMedico NK 1 maintenance and repairs Intended Use The TherMedico NK 1 is used in the field of human pain therapy and works by means of temperature controlled nerve lesion using high frequency energy as well as high frequency therapy without nerve lesion Using electrodes and needles the device is designed for e percutaneous coagulation of soft tissue using radio frequ
20. nieerd 4 7 Push the START STOP button to halt the lesion process at any point The START STOP button is not suitable for use in an emergency In case of an emergency pull the thermo probe plug from the TherMedico NK 1 HF lesion pulsed When the operating mode is in HF lesion pulsed the HF signal is emitted pulsed The temperature limit is fixed at 42 C HF lesion pulsed gt Impedance measurement The 7 segment display Time shows the current setting for the Lesion time lt can be adjusted using the appropriate modification buttons Value range 1 s 300s Whilst stimulation is not active impedance is measured continuously via the patient circuit The impedance measurement display shows the impedance value that is being measured If the impedance value is greater than 3000 Q the patient circuit is recognized as not closed an audio signal sounds and the text display shows HF lesion pulsed gt Check connection It is not possible to start HF lesion There are two ways to start HF lesion pulsed impedance smaller than 3000 Q e Automatic START STOP button e Manual turning knob 4 7 1 Automatic HF lesion pulsed HF lesion pulsed gt Active Push the START STOP button to start automatic HF lesion HF performance is determined and regulated by reaching and maintaining a temperature temperature limit of 42 C The lesion timer starts immediately Automatic HF lesion finishes auto
21. o NK 1 has two temperature displays for the temperature that is being measured e Needle display lesion temperature e 7 segment display lesion temperature The control unit micro controller of the TherMedico NK 1 controls the 7 segment display The temperature shown on the needle display on the other hand is derived directly from the temperature measurement control This makes a plausibility test using both displays possible Different values on the displays indicate a malfunctioning You should immediately stop any running HF lesion If the TherMedico NK 1 does not respond to any button being pushed you can pull either the thermo probe plug or the neutral electrode plug from the device emergency stop September 2005 Page 4 7 Instructions for Use TherMedico NK 1 5 Troubleshooting Faults may occur when the TherMedico NK 1 is running They are shown on the text display or an audio signal is given You may come across the following faults Fout Opmaakprofiel niet gedefinieerd Fault Description Possible cause message solution No probe Probe is not connected or probe lead is damaged Check thermo probe l BIRS and connect or Consequence Running stimulation or HF lesion is replace suddenly cut off Stimulation or lesion cannot be restarted whilst the problem persists Device switches to operating mode Probe test Check Circuit thermo probe neutral electrode not clo
22. pped and this fault message appears July 2005 Page 5 1 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 6 Settings The TherMedico NK 1 has several possible basic settings They are programmed according to the client s requirements at the time of delivery The available setting options and the selected settings are described or documented in the service manual July 2005 Page 6 1 Instructions for Use TherMedico NK 1 July 2005 Technical data 1 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 1 2 2 2 3 3 1 3 2 3 3 3 4 3 5 4 1 4 2 5 2 5 3 5 4 5 5 5 6 5 7 5 8 General Nominal voltage Nominal current Operating frequency Mains fuses Protection class Application part Mode of operation Dimensions Weight Impedance measurement Range digital display Frequency Internal test resistance Stimulation General Number of programmes Voltage range Frequency range Wave form Temperature measurement Thermo element Measurement range HF lesion General Number of programmes Modes of operation Output power Frequency Modulation type Max lesion time Max lesion temperature Timer Fout Opmaakprofiel niet gedefinieerd 230 VAC 300 mA 50 60 Hz 2x T 500 mA H 250 V IEC 127 Type BF 1 active and 1 neutral electrode Short term operation 5 min 350 x 380 x 170 mm WxHxD ca 8 kg without accessories 0 3000 Q precision 2
23. ructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd Tek Roll 250 5 5 Pk Detect MN 20 0 Om CHT 14 00 Illustration No 6 HF impulse pulsed on 100 Q real 30 2 ls 25 Ss E D S 5 20 ju z Io 15 e P f RL 32 4 1 2P f RL o e s 10 3 o 3 3 lt 5 o p 0 100 200 500 1000 2000 Lastwiderstand RL Ohm resistance load Illustration No 7 Total performance and half performance depending on load resistance July 2005 Page 7 4 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 8 Maintenance and safety related checks Every 12months staff must run safety checks on the TherMedico NK 1 and all its accessories Please refer to the service manual for a detailed description of all the required checks July 2005 Page 8 1 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 9 Sterilisation cleaning and care e You should clean the TherMedico NK 1 regularly You will need a soft lint free cloth and a little mild detergent or isopropanol Do not use any abrasive cleaning materials When cleaning do make sure that the inside of the device does not get wet Flammable cleaning agents must have fully evaporated before the device is used again e The needles are sterile when they are delivered and are intended for single use only e The thermo probes are not steril
24. sed Check circuit check connection Consequence Stimulation or lesion cannot be started plug and socket whilst the problem persists connection check i neutral electrode lead Check contact neutral electrode and patient Audio signal Display module disconnected The device must be an nS Consequence Stimulation or lesion cannot be started repaired isplays whilst the problem persists E 10 In stimulation mode The device must be Faulty generation of stimulation pulse repaired Consequence Stimulation or lesion cannot be started whilst the problem persists E 20 In probe test mode Faulty thermo probe Measured temperature is not room temperature range of replace 10 40 C E 30 In lesion mode Once the desired set temperature is reached the control value for HF is controlled If it does not change within a certain set check time time span lesion is stopped and this fault message appears Possibly no contact E 31 In lesion mode between thermo probe and tissue Check After starting lesion the temperature is controlled for a EA combination needle certain set check time time span If it does not change lesion is stopped and this fault message appears mero prong lenght Otherwise the device E 32 In lesion mode must be repaired After starting lesion the temperature is controlled for a certain set check time time span If it does not increase by at least 5 C lesion is sto
25. tions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 0197 This product conforms to the guideline for medical products 93 42 EWG 2 1 3 Mains supply Before opening the device pull power plug Me Mains fuse 2x T 500 mA H 250 V 2 2 Control panel The displays and buttons on the control panel are in order of use e Impedance e Stimulation e HF lesion e Mode The following illustration shows the control panel without activated 7 segment displays or text displays September 2005 Page 2 3 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd IMPEDANZ THERIVIEDICO NK1 Impedanz 2 STIMULATION frequency k HF L SION i temperature limit lesion temperature mens Y Illustration No 1 Control panel 2 2 1 7 segment displays LED The TherMedico NK 1 is equipped with LEDs showing the various parameters You should watch these displays carefully when the TherMedico NK 1 is in use Impedance 4 digit display showing the impedance value in Q Ohm Stimulation voltage 3 digit display showing the stimulation voltage in V Volt Stimulation frequency 3 digit display showing the stimulation frequency in Hz Hertz HF lesion Time 3 digit display showing the lesion time in s seconds September 2005 Page 2 4 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd HF lesion Temperature limit 3 digit display
26. uminated 2 2 3 Buttons START STOP button You can stop stimulation and HF lesion by pushing the START STOP button and you can also start manual lesion with it The START STOP button is not suitable for emergency use In case of an emergency pull the thermo probe plug from the TherMedico NK 1 September 2005 Page 2 5 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd Mode buttons The two mode buttons allow you to select the desired operating mode of the TherMedico NK 1 Modification buttons The modification buttons are used to change the parameters on their left Some operating modes however do not allow the changing of the displayed parameter If a modification button is pressed for longer than a second the display will change more quickly The modification buttons are e Stimulation frequency e HF lesion time e HF lesion temperature limit 2 2 4 Turning knob 2 3 You can change certain parameters using the turning knob e Stimulation intensity operating mode stimulation e Manual temperature limit operating mode HF lesion e HF voltage operating mode HF lesion pulsed Signaller The TherMedico NK 1 is equipped with an integrated signaller This signaller emits system specific audio signals September 2005 Page 2 6 Instructions for Use TherMedico NK 1 Fout Opmaakprofiel niet gedefinieerd 3 Installation and putting into operation The following describes how to install the
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