Duodynator - gbo Medizintechnik
Contents
1. M E 26 5 MAINTENANCE 27 6 DUOYI ONE a A 27 B22 INGOSOMV 27 SRM SAR 28 6 4 Disposal of equipment and accessories 28 6 5 Cleaning Disinfection and carePreventive inspection 29 6 5 1 Cleaning TNC Ontario 29 6 5 2 Cleaning of the Electrodes e 29 6 5 3 Disinfecting the Electrodes 29 6 5 4 Cleaning of the Suction Electrodes cccccccccseececeeeeesseeeeseeeeesaeeessaeees 29 6 5 5 Disinfecting of the Suction Electrodes 30 6 5 6 Cleaning of the elastic straps e 30 6 5 7 Cleaning of the Electrode Sponges and Electrode Pockets 30 7 WARNINGS AND HAZARDS eere rennen nnne nnne 31 8 CONTRAINDICATIONS 1 2122202202202202ss asse eeaee ee ee eee iee aeree 32 9 EXPLANATION OF SYMBOLS USED 33 10 TECHNICAL DATA ari 34 11 ACCESSORIES DUODY NAT OR viiririssdiininii MEER Sau EN EaE a REP E ea EUER ERES 35 12 ACGESSORIES NEOSERV il 36 IRSFROUBLESFOUTING im a 37 lisci Silii d ONOS E E LEE 3 15 EMO HNIS eec a 38 16 ANNEX I LIST OF LOW FREQUENCY CURRENTS 41 17 ANNEX II LIST OF THE MEDIUM FREQUENCY CURRENTS 42 18 ANNEX III LIST OF MEDIUM FREQUENCY PROGRAMS 432. gbo Medizintechnik AG reserves the right to change design and specifications without prior notice gbo Medizintechnik AG Version 1 2 Duodynator 35 11 Accessories Duodynator Included accessories 032 0 2000 Power cord Black User manual Other accessories for the Duodynator Description Therapy set Duodynator connection cable 4 conductive rubber electrodes 8 x 12 cm 10 sponge bags 4 Velcro Duo electrode set standard Duo electrode pair standard 45 38 310EH720 electrodes bags rubber bands Duoelektroden pair small Duoelektroden pair standard 45 38 773EH725 Electrodes bag small 10 pieces for Duoelektrode small Electrodes bag standard 10 pieces for Duoelektrode standard 017 0 0046 Device cart basic rack 026 0 3000 Mounting kit Duodynator Equipment storage and electrode holder 026 0 3030 Recommended accessories are highlighted in grey The picture shows the device cart for the Duodynator It consists of the baseic rack and the mounting kit Duodynator gbo Medizintechnik AG Version 1 2 36 Duodynator 12 Accessories Neoserv 032 0 4000 Power cord Black Installation Instructions Other accessories for the Neoserv Description Standard suction electrodes set 032 0 2110 2 x electrode hose red 2 x electrode hose blue 4 x suction electrode 2 60 mm 4 x contact sponge Electrode hose red 1750 mm long 014 0 0050 Electrodes blue hose 1750 mm long 019 0 0053 Su
3. 1 Cleaning the unit Clean the device with a clean lint free cloth dampened with water and mild detergent Please do not use abrasive cleaners Fingerprints on the display can be removed with a dry cloth or isopropanol Warning e Do not hold the device under running water and do not use liquid cleaners e Before cleaning or disinfecting always pull out the mains plug from the wall outlet The Duodynator is suitable for wipe disinfection It is important to ensure that no liquids get into the unit Do not wet plugs or sockets The device must not be sprayed for cleaning or disinfecting The device and its accessories are not suitable for heat sterilization or sterilization with gases 6 5 2 Cleaning of the Electrodes You can clean the electrodes after a treatment by using some warm water appr 40 C and a soap suds on the conductive black side Dry the electrodes with a cleaning tissue or let them air dry The cleaning process removes the film left by the Aloe spray or the contact spray and the electrodes will regain a good conductivity 6 5 3 Disinfecting the Electrodes The rubber electrodes can be disinfected by spray wipe disinfection Spray onto the black side of the electrodes leave to soak and wipe off with a lint free cloth Please follow the recommendations of the manufacturer We recommend Bacillol AF for the disinfection of the electrodes Note The conductivity of the electrodes is optimized by the use of a ce
4. At the end of treatment the Therapy end signal sounds and the intensity automatically goes to 0 0 4 3 2 Therapy with single channel currents 1 Turn on the power switch on the back of the unit 2 The unit performs an automatic self test of all functions 3 Error free self test 1s completed by displaying the Home screen 4 Connect the accessory for single circuit currents in the socket on the right side if necessary connect the cable to the Neoserv 5 Apply the electrodes to the patient see chapter 6 Press the button single channel The last selected therapy is automatically loaded 7 Select a channel button channel I or II The selected channel is connected to the detail window 8 If necessary change the therapy as described in chapter 4 2 Selection of therapies 9 If necessary change the parameters and the duration for therapy 10 Turn on the intensity knob until the desired stimulus success occurs 11 At the end of treatment the Therapy end signal sounds and the intensity automatically goes to 0 0 gbo Medizintechnik AG Version 1 2 Duodynator 21 4 4 Combination therapy with ultrasound 4 4 1 General information The Duodynator may only be operated with the Sonostat of gbo Medizintechnik AG When operating the Duodynator in combination with other devices gbo Medizintechnik AG assumes no product liability and warranty The necessary connection between the two devices 1s the input Jack
5. Neoserv connected and shall be used its operation is realized in Duodynator Touchscreen Display Connection for patient cable or Neoserv Connection for suction lines Connection for for channel 1 A suction lines Connection for for channel 1 D suction lines for channel 2 Connection for suction lines for channel 2 BD 3 1 Overview 3 1 1 Touchscreen display The touch screen should be operated with a distinct pressure of the fingertip Sharp objects are unsuitable for operation and can damage the screen The individual panels buttons are clearly labeled Visually accessible buttons are distinguished from non use buttons gbo Medizintechnik AG Version 1 2 3 1 2 Knob The knob is located on the front panel and is used as an intensity knob to adjust the output voltage as well as a modification controller for changing therapy parameters such as treatment duration or frequency The intensity controller is activated by the selection of the corresponding channel After a timeout of 20 seconds the intensity controller becomes inactive and must be released for a further intensity change again with the appropriate channel button The Knob will be used as a modification knob after pressing a button such as the changeable frequency When the button is pressed 1t 1s provided with a blue border and may be operated for 3 seconds 3 1 3 Home screen in the single circuit operation After power up and
6. completely The sponge pockets or intermediate layers have to be cleaned after the expiration of treatment see chapter 6 5 7 Note Analogously the above described also for use with suction electrodes gbo Medizintechnik AG Version 1 2 Duodynator Warning e Do not apply the electrodes on skin injuries Even minor abrasions can cause a burning to the patient Herewith the intensity of current by the patient can be erroneously judged If this cannot be avoided apply zinc ointment to cover e The electrodes must adhere completely to the skin in order to avoid excessive local current density Otherwise erythemas and sometimes even burns may occur e Current densities exceeding 2 mA cm require the special attention to the operator e t is recommended not to exceed the current density of 0 2 mA cm in case of galvanization and 0 1 mA cm in case of iontophoresis e f currents with galvanic portions are used special attention have to be kept Keep care that the electrode sponges are always moistened very good e Do not use one way self adhesive electrodes in case of currents with galvanic portion there is the danger of acid burns e Pieces of jewellery and glasses have to be taken off during the treatment 5 2 Single pole electrodes single pole electrodes are applicable for all therapy currents For large area treatment we recommend to use large plate or conductive rubber electrodes Both electrode types have t
7. on the back side of the Sonostat The device s internal flow path is activated for the selected ultrasound probe Note If a different ultrasound device 1s connected the combination have to be approved according EN 60601 1 as a system Warning e Observe the operating instructions of the ultrasonic therapy device Sonostat e The ultrasound therapy must not be operated with the current form of electroplating due to the acidification of the contact gel e A current density of 2 mA cm should not be exceeded e Disable the current monitoring Chapter 3 4 Settings so that a smooth course of therapy is possible Note e Combination therapy should be performed only with biphasic e currents e We recommend medium frequency currents for the combination therapy e Useaconductive electrode gel to ensure a flow of current gbo Medizintechnik AG Version 1 2 2 Duodynator 4 4 2 Procedure for combination therapy l 2 3 eh goce 10 11 12 13 select the current form from the Duodynator set the desired modifications White plugs has a positive polarity in the primary position while the counter electrode the metallic surface of transducer is negative Connect the white plug of the patient cable to the neutral electrode and the black one with the Sonostat Apply the neutral electrode Select the desired treatment head by pressing the button head left and head right Choose an own therapy an indi
8. Duodynator and Combination Duodynator Neoserv ji IC Xdnaton Instructions for use 2 Duodynator This manual was created by gbo Medizintechnik AG and checked for accuracy However it does not claim to be complete All information and data is subject to change without notice No part of this manual may be reproduced for any purpose without the express written permission of gbo Medizintechnik AG regardless in which way or by any means electronic or mechanical are used gbo Medizintechnik AG Part No 032 7 0018 Edition Version 1 2 Date of issue 2015 01 21 Manufacturer gbo Medizintechnik AG Kleiststrabe 6 D 64668 Rimbach gbo Medizintechnik AG Version 1 2 Duodynator 3 Contents 1 INERODUC TION wisicesceinsitcescenatpecancsweancieeienvdseuenauductuunvenwaseudesenauianneaweanees 6 dall WMC HOSOMIS Conca ssnasesnte UU m 6 1 2 Note concerning the operating personnel 6 0 FAGIMISSION NR P 6 1 4 Device description Duodynator i 6 1 5 Device description Neoserv nennen 7 2 SIARFOFORERATION sa 8 2 1 Unpacking transport and installation 8 2 2 Combination with the NEOSErv een 8 23 Connect and SWITCH OM oni a E kia ele kane PONE Ud 8 24 Placing out OF ODETA MOV rde ape 9 3 OPERATION sana 10 3 1 OVErview i iii 10 3 1 1 TOUGCNSCIECn GISDI Yarra 10 3 1 2
9. Maximum Maximum currenttonm Graphic Pulse Pause rasi Frequency Voltage Ca m Tin duration in in Hz Rin mor PP PP m Peer EFT 0 1 toj100 wo DT D double circuit _ Interference a a 00 00 In 200 Dipole vector EA to 100 100 Ei n Isoplanar Vector 4 0 1 tojl00 100 gbo Medizintechnik AG Version 1 2 Duodynator 4 18 Annex III List of medium frequency programs Lipolysis 2 5 3 5 Hz Cellulite 2 5 3 5 Hz 10 20 Hz 10 min 5 min Fat Burning 2 5 3 5 Hz 10 30 Hz 8 min 2 min Body Shaping 20 30 Hz 150 200 Hz 05 05 20 5 5 min min Electric massage 0 5 to 3 Hz mE Shaking 3 10 Hz BEEN O2 Remark 5 Hz Adjustment phase 5s 5s 20s 14 s 228 10 Hz 100 Hz 0 3 Hz 10 Hz 10 30 Hz drainage 10 min 10 min LEN Be 1s Freq 1s Freq Adjustment phase 4 seconds 1 5 Hz Adjustment phase 1 53 H2 Adjustment phase k3 Hz Adjustment phase ses Ass Adjustment phase S ESS Z 3 7 5 358 s z ga PS Z o z E i O Note J l This list also applies also for interferential currents o oO Currents for muscle stimulation are excluded in the Interference treatment gbo Medizintechnik AG Version 1 2 44 19 Index A Accessories Duodynator 35 Accessories Neoserv 36 B Bipolar electrodes 26 C care 29 Cleaning 29 Combination therapy 21 Connect and switch on 8 Contraindications 32 D Desinfection 29 Device description Duodynator 6 Device descr
10. You may obtain technical support by the manufacturer or the dealers or service authorized by the manufacturer The manufacturer projects a product life of 7 years Duodynator is an electronic device Disposal has to be done according to regulations for electronic devices Consumables have to be disposed as residual waste On request the manufacturer will provide you with further technical descriptions for all serviceable parts of the device such as circuit diagrams spare part lists and adjustment instructions as far as these are of use for the qualified technical staff of the user Comments on electromagnetic compatibility EMC Medical electrical devices are subject to special precautions concerning the EMC They must be installed and operated according to the EMC advice given in the accompanying documents In particular medical electrical devices may be influenced by portable and mobile RF communication devices The manufacturer guarantees the conformity of the unit with the EMC requirements only when using accessories which are listed in the EC declaration of conformity The usage of other accessories may cause an increased emission of electromagnetic disturbances or may lead to a reduced electromagnetic immunity The unit must not be arranged physically close to other devices or stacked with them If such an order is necessary nevertheless the unit must be observed in order to check it for the intentional operation You find more EMC com
11. asures mentioned above Note Please note that the unit must be placed on a plane horizontal surface The device should neither be placed in front of radiators nor should it be covered with pillows or blankets while in operation Do not cover the ventilation slots on the bottom of the unit either gbo Medizintechnik AG Version 1 2 38 Duodynator 15 EMC Hints Comments According to the Medical Device Directive The Duodynator is a mains operated current stimulation device of protection class I The device is in accordance with the EC Medical Device Directive 93 42 EEC and therefore carries the CE sign with the number of the notified body for medical devices The respective graphical symbol 1s placed on the type plate According to the Medical Device Directive Duodynator is a device of class IIa The manufacturer is only responsible for the security operational reliability and functionality of the device if the device is used in accordance with the user manual the electrical installation of the location where the device will be used corresponds to the respective current requirements of electrical safety the device is not used in hazardous environments and humid locations the mountings add ons internal adjustments modifications or repairs are realized only by personnel authorized by the manufacturer the operator regulation of this EC directive is observed within the scope of the Medical Device Directive
12. cation or the individual setting on Sonostat Bring plenty of contact gel to the sonicated area of the patient Move the transducer surface under light pressure to the skin Set the current intensity so that the patient experiences a significant irritant effect on the stimulation current therapy unit by turning the intensity knob If the patient feels a pain reduce the stimulation current intensity Press the Start button to begin the Sonostat to the ultrasonic treatment now Move the transducer surface under light pressure with circular or straight even strokes on the area to be sonicated At the end of treatment the selected in the settings Therapy end signal is heard The power is automatically turned off and the ultrasonic intensity is automatically set to 0 0 Clean the probe from the contact means When the treatment duration of the Duodynator is the elapsed the selected in the settings Therapy end signal and the intensity 1s automatically set to 0 0 sound gbo Medizintechnik AG Version 1 2 Duodynator 23 5 Electrodes The therapy can be realized without any problem with suction electrodes conductive rubber electrodes or self adhesive electrodes Conductive rubber electrodes are appropriate for large area treatments 5 1 Electrode positioning The positioning of the patient and or muscle to be treated 1s very important The therapy shall always be carried out in a comfortable and relaxed position The joints shall be located
13. ction electrode Y 60 mm 014 0 0083 Suction electrode Z 90 mm Contact sponge 2 60 mm 4 pieces Contact sponge 2 90 mm 4 pieces Short circuit hose when using only one channel Connection cable Neoserv ultrasound Recommended accessories are highlighted in grey Note e Use only original accessories to ensure the safe operation of the appliance gbo Medizintechnik AG Version 1 2 Duodynator 37 13 Troubleshouting Each problem that occurs during operation of the unit will be shown in a message window on top of the display and also signalized by an acoustic tone Most of the problems can be solved by the instructions displayed In general 1 The malfunction is shown on the display 2 An acoustic signal is heard 3 Follow the instructions on the display Suggestions e Turn off and turn on the unit e A full selftest of all device functions is performed and the unit is reinitialized If the unit does not come up to normal state please call your local service 13 1 Further errors symptom cause and action Device cannot be switched on Please check the main plugs and sockets If no display shown necessary contact your service agents or the manufacturer No acoustic signal is heard Please check the settings of the acoustic End of therapy tones in the menu The volume must be greater than 0 Please contact your service agent or the manufacturer if the problems cannot be solved by the me
14. d of therapy tone error tone etc The sounds can be heard and assigned to the corresponding functions A sound can also be switched off Repetition of the therapy end sound Never 2 Minutes 10 Minutes Breaks between the repeated therapy end sound Yes No Repetition of the error sound Never 2 Minutes 10 Minutes Breaks between the repeated error sound Yes No gbo Medizintechnik AG Version 1 2 Duodynator 17 Therapy Setting the carrier frequency 2 to 10 kHz in 2 kHz steps Temporary deactivation of the intensity monitoring until the next switching on the device On Off Automatic pump stop after the end of treatment On Off Automatic switch on the pump when selecting a current from the Favorites list On Off Service Access to the service area Service area with access to service The service is reserved for service partners and helps in the search for faults in the hardware Release of the software Resetting to the factory settings gbo Medizintechnik AG Version 1 2 18 Duodynator 4 Therapy 4 1 General guidelines for therapy Always observe the instructions given to the electrode positioning see Chapter5 The maximum output power per channel 1s 5000 mW When this value is reached the intensity can not be further increased Depending on the selected current type limits for the current value can be considered see Appendix for details Please note the maximum current density for the electr
15. d screw back into the machine gbo Medizintechnik AG Version 1 2 28 Ouodynator 6 3 Safety checks The device is subject to the provisions of the Medical Device Directive The safety controls have to be carried out on the basis of this directive Thereby the operator regulation has to be observed in particular Irrespective of the legal rules or beyond the scope of the Medical Device Directive it is madatory to have the device checked at 12 months intervals by the manufacturer or by a maintenance service authorized by him The review must consist at least of the following criteria e Electrical safety check in accordance with the test plan of the manufacturer e Review of the device in respect of external integrity Review of all display and operating elements in respect of damages Review of all inscriptions in respect of immaculate legibility Review of power supply cord and all patient connecting cables Functional check 6 4 Disposal of equipment and accessories According to the WEEE Directive 2002 96 EG waste electrical and electronic equipment this device must not be disposed of with the domestic waste The device must be returned to the manufacturer for disposal The manufacturer is committed to guarantee the disposal of all devices marketed This 1s also indicated by the WEEE sign crossed out waste container gbo Medizintechnik AG Version 1 2 Duodynator 29 6 5 Cleaning Disinfection and carePreventive inspection 6 5
16. e These self defined therapies can then be retrieved by the use of the button Other therapies with the sub selection Own therapies Note di s After switching on the device the therapy last used will be loaded automatically y y Note e After the change between single circuit and interference therapies and therapies previously used will be reloaded each Note di For the polarity of the connection cable applies White cable connector or the interrupted circle on Neoserv Black cable connector or closed circle on Neoserv gbo Medizintechnik AG Version 1 2 20 Duodynator 4 3 Implementation of the treatment 4 3 1 Treatment with interference currents 1 Turn on the power switch on the back of the unit 2 The unit performs an automatic self test of all functions 3 Error free self test 1s completed by displaying the Home screen 4 Connect the accessory for interference currents to the socket on the right side 1f necessary connect the cable of the Neoserv 5 Apply the electrodes to the patient see section 5 1 REST PRA 6 Press the button interference The last selected therapy 1s automatically loaded 7 If necessary change the therapy as described in chapter 4 2 Selection of therapies If necessary change the parameters and the duration for therapy Turn the intensity up slowly until the interference current is clearly perceptible but not loosen muscular contraction duration from 10
17. ea 11 3 1 3 Home screen in the single circuit operation 11 3 1 4 Home screen panels in the interference operation 12 3 1 5 Screen for selecting an indication 13 3 1 6 Screen for selecting other therapieS i 13 Deo UCUN TV OUI ona dtoi vuv Questa lub enu prem us etus Qum eua Ub Fem Ovni FCR mens 14 5 9 ea ea a En MNE 15 od SSN m UTEM 16 a IMENAPiaiani ar 18 4 1 General guidelines for therapy ene 18 4 2 Selection of therapies ii 18 4 2 1 Selection of therapy by Other therapieS 18 4 2 2 Selection of therapy by indications 18 4 2 3 Selection of therapy from the favorites list 19 4 2 4 INGIVIGUaT Se Moscato 19 4 3 Implementation of the treatMent e 20 4 3 1 Treatment with interference CUFFentSs 20 4 3 2 Therapy with single channel Currents c scccceeccseeeceeeceeeeceeeeaeeeseueenaes 20 4 4 Combination therapy with ultrasound 21 4 4 1 General INFOMATION seo eerta aeter eausa eer deae etu xe des 21 4 4 2 Procedure for combination therapy 22 9 ELEGCIHODESu582255 1 083 aaa aaa 23 Hel EIEGITOGE POSINONING ria aaa 23 52 ONJE Dole elect rOQGS iien E t ter iaia ria 24 oM c o ela ac ta 25 gbo Medizintechnik AG Version 1 2 4 Ouodyator 54 silejel ig inifee ichem E
18. electromagnetic environment where radiated RF interference is controlled The user can help to avoid interferences by meeting the minimum separation distances between portable and mobile RF communication equipment transmitters according to the maximum output power of the communication equipment Rated power of the Separation distance according to the tranmission frequency m transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2VP d 1 2NP d 2 3VP gbo Medizintechnik AG Version 1 2 EY riri dt 4 LAE Maximum Maximum Current form Graphic Pulse Pause portion A in Voltage Vpeak Current in dieti in duration in a peak in ms Galvanic current i 100 sim 2r Faradic current A o 47 25 50 100 O NS O e UA oS jev CA gt O O O O O 5S NO QO ON N DF Diphase fixed CP Courtes p riodes UN E c c em EA 5 ME 31 5 Monophas med 46 50 100 Longves f iil lad poms L o modules 15 25 A syncope Impulse Gal galvanization IG 30 Impulse S l za E FI aly Frequency Mi Ath Ath 00 09 0 2 4 8 to 666 3 5 1 5 to 200 4 666 10 1 5 to 200 100 0 500 0 7 14 1 67 200 0 1000 0 7 14 Note All low frequency currents except Galvanic current are also available as metal acceptable biphasic variant gbo Medizintechnik AG Version 1 2 42 Duodynator 17 Annex IT List of the medium frequency currents
19. flexible bipolar duo electrode I and II and attached to a common patient cable There are two sizes available small and standard Electrode pockets are necessary for application and fixing material for bandage see accessorles Each bipolar electrode is placed into a well wetted pocket so that the black conductive rubber electrodes face the humidity carrier The reverse side of the pocket consists of transparent synthetic material in order to be able to check the correct positioning of the electrode Electrode position A If the electrodes are placed opposite to each other transverse current flow transregional the cable connections must point in opposite directions B If the electrodes are placed on one side longitudinal current flow their cables must point in the same direction Only in the case of these electrode positions the flow paths of current of the two circuits can transpose and optimal duodynamic stimulation currents are generated In special cases e g depending on the application in the case of shoulder hand syndrome it is possible to deviate from this general rule Electrode Duo Electrode small Duo Electrode large Table 3 Maximum currents rms for Duoelektroden gbo Medizintechnik AG Version 1 2 Duodynator 27 6 Maintenance 6 1 Duodynator Functionality reliability and safety characteristics of the Duodynator are guaranteed only upon handling the device in accordance wi
20. in an angular position so that they are placed in a mid position from which both the flexor as well as the extensor muscles can be stimulated In general the preparation and application of the electrodes is carried out as follows 1 Always put a wet electrode intermediate layer or electrode pocket between the electrode and the skin in order to avoid current sensations on the skin The layer must always be about 1 cm larger than the electrode itself 2 Put the electrode completely into the electrode pocket so that the pocket protrudes on the open side with about cm 3 After multiple use the electrode intermediate layer or electrode pocket can slightly shrink If the distance of about cm is no longer given the intermediate layer or pocket must be replaced 4 Prior to the initial use the macroporous intermediate layers and pockets made of viscose sponge must be thoroughly washed out under running water to remove manufacturing residues 5 To moisten the intermediate layer or pocket put them into normal tap water or better into 1 salt solution The intermediate layers or pockets should be soaked remove them and let them drop do not wring them out 6 If necessary flatten deformed electrodes insert them into the pocket and or put them on the intermediate layer Put them on the area to be treated and fit them to the given body surface Use only thick and well moistened sponges Apply the holding strap in a way that the electrode fits
21. iption Neoserv 7 Direct help 15 E Electrode positioning 23 Electrodes 29 EMC Hints 38 H Home screen 11 Home screen interference 12 I indications 13 installation 8 Intended use 6 K Knob 11 gbo Medizintechnik AG Duodynator L low frequency currents 41 M mains voltage 8 Maintenance 27 medium frequency currents 42 medium frequency programs 43 O Operation 10 polarity 19 precautions 32 protective earth 9 Safety checks 28 SD card 9 Settings 16 Single pole electrodes 24 suction electrodes 25 Suction flyout 14 symbols 33 T Technical Data 34 Therapy 18 transport 8 Troubleshouting 37 W Warning 21 warnings 31 Warnings 24 Version 1 2 Duodynator 45 Notes gbo Medizintechnik AG Version 1 2 46 Duodynator Notes gbo Medizintechnik AG Version 1 2 Duodynator 47 gbo Medizintechnik AG Version 1 2
22. ments in the chapter Warnings and Safety Precautions of this manual as well as in the Technical Information on the next two pages gbo Medizintechnik AG Version 1 2 Duodynator 39 In accordance with the EMC regulations for medical products we are obliged by law to provide the following information Guidance and manufacturer s declaration electromagnetic emissions The equipment is intended for the use in the electromagnetic environment specified below The customer or the user of the equipment should ensure the compliance with this stipulation Emissions test Compliance Electromagnetic environment guidance RF emissions Group The equipment uses RF energy only for its internal function Therefore CISPR 11 its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The equipment is suitable for use in all establishments including CISPR 11 domestic establishments and those directly connected to the public low Harmonic emissions Class A voltage power supply network that supplies buildings used for domestic IEC 61000 3 2 purposes Voltage fluctuation flicker complies emissions IEC 61000 3 3 Note For devices with a power consumption between 75 W and 1000 W only Guidance and manufacturer s declaration electromagnetic immunity The equipment is intended for the use in the electromagnetic environment specified below The customer
23. mercial Or hospital environment If the user of the equipment requires continued operation during power mains interruptions it is recommended that the equipment be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Version 1 2 40 Duodynator Guidance and manufacturer s declaration electromagnetic immunity The equipment is intended for the use in the electromagnetic environment specified below The customer or the user of the equipment should ensure the compliance with this stipulation Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the equipment including cables than recommended separation distance calculated from the equation applicable to the frequency of the transmitter Radiated RF f IEC 61000 4 3 for 80 MHz to 800 MHz d 2 3VP for 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer and d is the recommended separation distance in meters Interference may occur in the vicinity of equipment marked with the following Recommended separation distances to portable and mobile RF communication equipment The equipment is intended to be operated in an
24. nator and the combination Duodynator Neoserv are designed for connection to a supply voltage of 100 to 240 V and are automatically set to the correct mains voltage Regardless of the supply voltage the device 1s suited for power frequencies of 50 to 60 Hz gbo Medizintechnik AG Version 1 2 Duodynator 9 Warning To avoid the risk of electric shock the Duodynator and also the combination of devices Duodynator Neoserv must only be connected to the mains with protective earth Turn on the Duodynator by the power button on the rear panel When Neoserv is connected and should also be used it must also be turned on using the power switch on the back ON Off switch for Duodynator Data connection between Duodynator and Neoserv AC power connector with fuse for Duodynator AC power connector ON Off switch for with fuse for Neoserv i Neoserv The Duodynator is equipped with a SD card slot located to the right of the display This port is intended only for service purposes SD card slot 2 4 Placing out of operation In order to disconnect the device just disconnect it from the mains power supply No other measures are to be taken gbo Medizintechnik AG Version 1 2 10 Duodynator 3 Operation The Duodynator has a touchscreen display a knob an on off switch and a socket for a patient cable or Neoserv The operation of the Duodynator is done by the controls of the touch screen and the knob Is the
25. nce method This allows the desired highest possible low frequency stimulation from the immediate area surrounding the electrode to be shifted 1nto deeper regions since this is where it is generated Apart from the two dimensional interference currents Duodynator offers a selection of single circuit currents and provides a therapy with medium sine waves This therapy is absolutely free of d c components There are two channels available The carrier frequency can be set from 4000 to 10000 Hz in steps of 2000 Hz Furthermore the Duodynator offers the classical Low Frequency currents including the galvanic current d c The galvanic current 1s used to stimulate the circulation in the area to be treated gbo Medizintechnik AG Version 1 2 Duodynator 7 The Duodynator thus is well suited for Pain Muscle relaxation Muscle training Muscle stimulation increase energy consumption Rehabilitation and mobilization Lymphatic drainage Lipolysis breakdown of fat cells in the epidermis tissue Cellulite Treatment Edema treatment Fat burning Also the operation of the Duodynator is facilitated by programs which automatically adjust the therapeutic frequencies and the treatment time 1 5 Device description Neoserv The Neoserv is a suction wave therapy unit designed for use with 1 4 suction electrodes The device is especially useful as an accessory for Duodynator and in the combined operation stimulation current with ultra
26. nkets while in operation The device is not made for outdoor operation Duodynator and Neoserv meet the requirements for electrical safety according to EN 60601 1 and are both devices of protection class I Within the scope of the Medical Devices Directive MDD Class IIa is assigned for the Duodynator The Neoserv is an accessory for Duodynator The combination Duodynator Neoserv is in Class Ha Warning Note for use in the clinical area e The unit is not designed to be operated in places with the inherent risk of explosions If it 1s used in dangerous areas of anesthesia departments the possibility of an explosion cannot be excluded e If the patient and or the patient cable is directly exposed to a radiator of a medical device for high frequency heat therapy damage of the device or danger to the patient cannot be excluded As a rule a clearance distance of 3 m 1s sufficient 2 2 Combination with the Neoserv When the Neoserv is used as an accessory Duodynator must be placed above the Neoserv and screwed on the back Do this slide the Duodynator from behind the retaining tab on the lid of Neoserv Align both devices and screw the two devices on the back of each other In the case of the combination with Neoserv the Duodynator is supplied with mains voltage from Neoserv Thus a line input on Neoserv is enough to power both devices A detailed pictorial instruction 1s supplied with the Neoserv 2 3 Connect and switch on The Duody
27. o be connected to the device with a patient cable The electrode positioning 1s realized as described in chapter 5 1 The electrode size depends on the area that should be passed by the current Under small electrodes the current flow will be more concentrated and more localized than when applying large electrodes The application area depends on the clinical picture Electrode Surface Maximum current Galv iontophoresis Rubber electrodes 8 cm x 12 cm 192 mA 19 2 9 6 Rubber electrodes 11 5 cm x 17 5 cm 201 cm2 400 mA 40 20 Table 1 Maximum currents rms for Rubber electrodes gbo Medizintechnik AG Version 1 2 Duodynator 25 5 3 Suction electrodes Instead of the above mentioned electrodes suction electrodes can be used for faster application in connection with the suction massage device Single pole suction electrodes are applicable for all therapy currents For this please plug in the connection cable of the Neoserv to the socket of the current stimulation device Duodynator Suction electrode Surface Maximum current Electrode plate 2 60 mm with sponge 2 60 mm Electrode plate 2 90 mm with sponge 2 90 mm 63 5 cm2 127 mA Table 2 Maximum currents rms for suction electrodes gbo Medizintechnik AG Version 1 2 26 Duodynator 5 4 Bipolar electrodes The bipolar electrodes can be used for the duodynamic interference currents The conductive rubber electrodes of the two current circuits are located in two
28. ode which are defined in Table 1 Table 2 and Table 3 Depending on the particular application plate electrodes or the suction electrodes can be used When plate electrodes are used they are connected to the patient cable Channel I 1s indicated by the red color Channel II 1s indicated by a blue color According to the used channel the red or blue channel must be selected on the unit to change the current for this channel If suction electrodes are used a Neoserv must be present and connected Instead of the patient cable the cable of the Neoserv is connected to the socket of the Duodynator The suction function is operated using the suction flyout In the suction flyout the suction can be switched on and off the suction strength can be chosen within certain limits and the suction massage frequency can be set 4 2 Selection of therapies More Therapies 4 2 1 Selection of therapy by Other therapies In this selection all low all medium and all self defined currents are filed The selection is made from a list which is filtered Thus only low frequency monophasic only low frequency biphasic only medium frequency or user defined currents can be displayed from the appropriate list and then selected If Interference is used the selection is only between standard and Own therapies 4 2 2 Selection of therapy by indications Sin In Duodynator an indication menu is integrated This provides a list of programs with pictures indication to
29. onic device electrical stimulation treatment is to be carried out only after having checked any risks e Turn off cellular phones and radiophones or place them in a distance of 3 m from the device e Cardiac pacemakers are extremely vulnerable Here the therapy should only be carried out under continuous pulse and ECG control e If the patient and or the patient cable is in the direct range of a high frequency short wave or micro wave therapeutic device a damage to the device or an injury to the patient cannot be excluded Please keep a clearance distance of 3 m e A simultaneous connection of the patient to a high frequency surgery device can lead to burns under the electrical stimulus electrodes e The unit is not designed to be operated in places with the inherent risk of explosions If it is used in dangerous areas of anesthesia departments the possibility of an explosion cannot be excluded e Current densities exceeding 2 mA cm require the special attention to the operator e t is recommended not to exceed the current density of 0 2 mA cm in case of galvanization and 0 1 mA cm in case of iontophoresis e If currents with galvanic portions are used special attention have to be kept Keep care that the electrode sponges are always moistened very good e Do not use self adhesive electrodes at currents with galvanic portion they contain corrosive e The electrodes must be fully covered rest with the entire electrode surface in
30. or is guided on the screen The direct help menu provides information about the selected buttons directly on the screen To open the direct help menu first touch the button and then the button about which you desire information A window opens where the information is shown Touch to the help window in order to close it Save as More Therapies Indications a Lo Direct Help window Example here Button requency Note Available buttons are indicated in light grey Unavailable buttons are indicated in dark grey If you push an unavailable button information about the use of this button is shown on the screen automatically gbo Medizintechnik AG Version 1 2 16 Duodynator 3 4 Settings H Using the Settings button to access the setup menu of the Duodynator In this menu parameters such as languages output of different sounds eg for the end of treatment and various treatment parameters are defined Also the access to service is located in the settings menu Only if no therapy is active you can switch to the setup menu y y Note o Only if no therapy 1s working you can switch to the setup menu Language Display Touch calib Audio Therapy Service The following items are available in the Settings menu Display Setting the national language Calibration of the touch screen Audio Setting the system sounds like the en
31. or the user of the equipment should ensure the compliance with this stipulation Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be made of wood concrete IEC61000 4 2 or ceramic tile If floors are covered with 48 kV air synthetic material the relative humidity should be at least 30 96 Electrical fast transient burst 2 kV for power supply 2 kV for power supply Mains power quality should be that of a IEC 61000 4 4 lines lines typical commercial Or hospital environment 1 kV for input output lines t1 kV for input output lines Surge t KV differential mode 1 kV differential mode Mains power quality should be that of a IEC 61000 4 5 typical commercial Or hospital 2 kV common mode 2 kV common mode environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 lt 5 U for 2 cycle gt 95 dip 40 U for 5 cycles 60 dip 70 U for 25 cycles 30 dip lt 95 U for 5 s gt 5 dip lt 5 U for V cycle gt 95 dip 40 U for 5 cycles 60 dip 70 U for 25 cycles 30 dip lt 95 U for5s 2596 dip Note U is the a c mains voltage prior to application of the test level gbo Medizintechnik AG Mains power quality should be that of a typical com
32. order to avoid local current density peaks Otherwise skin redness may occur in severe cases even burns Note In case of any visible failure contact gbo Medizintechnik AG or one of the service agencies authorized by gbo Medizintechnik AG immediately gbo Medizintechnik AG Version 1 2 32 Duodynator 8 Contraindications Despite the low dosage 1s definite contraindications have emerged Warning stimulation should not be applied in the following syndromes e Open wounds in the treatment area e Malignant tumors in the treatment area e Feverish conditions stimulation current to be applied to the following symptoms only after consultation with the doctor e Patients with implanted electronic devices e Patients with metallic prostheses only biphasic currents should be used preferably medium frequency current used e Pregnancy Additional precautions e n patients with diagnosed heart problems e n treatment on areas of the skin which lack normal sensation assets e For muscle stimulation after recently running operations in which muscle contraction may disrupt the healing process Note di e This list is not exhaustive In individual cases the attending doctor should decide on contraindications and criterias for the treatment e n case of all visible failures contact gbo Medizintechnik AG or one of the service agencies authorized by gbo Medizintechnik AG immediately gbo Medizintechnik AG Ve
33. ready for operation the device displays the home screen Save the set therapy parameters as own therapy Channel I selection Channel II selection Therapy and information and information duration Selection Favourite list Selection More therapies Selection Indications Selection Single circuit interference Direct aid Button Suction Single circuit is Button settings Button selected green Detailed Settings Swelling parameters therapy parameters with activated swelling gbo Medizintechnik AG Version 1 2 12 Duodynator 3 1 4 Home screen panels in the interference operation After power up and ready for operation the device displays the home screen Save the set therapy parameters as own therapy Channel selection Here is presented and information linking both channels Selection Favourite list Selection Save as B STH wil XJJ M a t y Wc Frequency 100 200 Hz Frequency scan C Selection More Therapies Indications Indications More therapies Selection Single circuit interference Direct aid Button Suction Interference is Button settings Button selected green Detailed Settings therapy parameters Note f In the interference mode both channels are adjusted simultaneously with e the intensity controller Note e f the Neoserv is switched on and connected to the current stimulation output of Duodynator suction will au
34. rsion 1 2 Duodynator 33 9 Explanation of symbols used gbo Medizintechnik AG CE Conformity mark Read the instruction Caution Application part of Type BF floating This product complies with WEEE Directive 2002 96 EG waste electrical and electronic equipment Separate collection for electrical and electronic eguipment The waste removal at the end of the service life will be done by the manufacturer Version 1 2 34 Duodynator 10 Technical Data Mains voltage and Duodynator 100 240 V 50 60 Hz Frequency Neoserv 100 240 V 50 60 Hz Power consumption Duodynator Max 65 VA Neoserv Max 105 VA incl Duodynator Main fuses Duodynator T 2A H 250V Neoserv T 5A H 250V 5000 mW 100mA to 500 ohms per channel displayed impedance Protection class of IP XO Duodynator and combination housing Dimensions Duodynator 27 cm x 19 3 cm x 28 cm W x H x D combination Duodynator and Neoserv 27 cm x 27 cm x 28 cm W x H x D Duodynator 4 4 kg accessories Combination Duodynator Neoserv 7 7 kg Environmental conditions Operation Temperature range 10 C 35 C of the relative humidity 30 75 device Transport Temperature range 10 C 50 C relative humidity lt 90 non condensing By request of technical personnel gbo Medizintechnik can offer spare part lists and circuit diagrams The IEC connector is used for all pole disconnection from the mains
35. rtain 6 amount of graphite Consequently when using and disinfecting the electrodes black color may come off 6 5 4 Cleaning of the Suction Electrodes You can clean the electrodes after a treatment by using some warm water appr 40 C and a soap suds Dry the electrodes with a cleaning tissue or let them air dry gbo Medizintechnik AG Version 1 2 30 Duodynator 6 5 5 Disinfecting of the Suction Electrodes The suction electrodes can be disinfected by spray wipe disinfection Spray onto the black side of the electrodes leave to soak and wipe off with a lint free cloth Please follow the recommendations of the manufacturer We recommend Bacillol AF for the disinfection of the electrodes 6 5 6 Cleaning of the elastic straps The eleastic straps can be washed in a washing machine Please observe the washing instructions of the sewed label or the instructions on the label of the packaging 6 5 7 Cleaning of the Electrode Sponges and Electrode Pockets The Electrode sponges and pockets can be washed in a washing machine with 95 C or be disinfected with disinfectant solution We recommend Dismozon pur chemical agent Magnesium monoperoxyphthalat Hexahydrat Note e After desinfection the sponges and pockets have to be wringed out closely at least 6 times under warm running water Version 1 2 gbo Medizintechnik AG Duodynator 31 7 Warnings and hazards Warning e For patients with implanted electr
36. sound additionally with the ultrasound therapy device Sonostat The Neoserv works as suction wave massage unit Liquids dirt or bacteria which are sucked up by the suction electrodes are caught in a space consuming and frequently to be drained water separator In the areas where the suction electrodes are applied increased hyperemia occurs As a consequence tissue conductivity 1s improved beneath the electrodes Moreover the patient s sensitivity to the electric current 1s significantly masked by the pulsating sucking action of the electrodes a fact that makes the device particularly useful in cases where electro stimulation treatment needs to be administered to patients who are specially sensitive to electric currents The suction electrodes can be applied in a fast and easy manner and they also pleasantly adapt themselves to the skin surface Optimum skin contact is ensured by the flexible edges of the electrodes Because the Neoserv is an accessory device for Duodynator which may not work alone it is described within this manual gbo Medizintechnik AG Version 1 2 8 Duodynator 2 Start of operation 2 1 Unpacking transport and installation After unpacking check all components for external integrity The unit may be placed on any flat surface It must not be placed on the floor Keep a wall distance of at least 20 cm The device should neither be placed in front of radiators nor should it be covered by pillows or bla
37. t9 MN A Ce ZEM 44 gbo Medizintechnik AG Version 1 2 Duodynator Warnings and Notes Warning Warnings which must be observed Attention Read the instruction Note Information that will facilitate the work O gbo Medizintechnik AG Version 1 2 6 Duodynator 1 Introduction 1 1 Intended use Therapy with low medium and interference currents 1 2 Note concerning the operating personnel The operation of the device must be performed only by trained medical professionals 1 3 Admission We recommend that the operator should be trained when using the unit 1 4 Device description Duodynator The Duodynator is a microprocessor controlled electrical stimulation device for electrotherapy The application makes the device ideal for use in the physiotherapy department of hospitals and 1n the modern and well equipped practice The Duodynator is a therapeutic device for the classic electro therapy with single circuit currents particularly in multi channel operation as well as for therapy with two dimensional interference currents If two middle frequency electrical circuits of different frequencies or those which are phase shifted towards each other transpose a new frequency the interference frequency is generated at the intersection point through superpositioning of the superposed amplitudes Duodynator uses this two dimensional interfere
38. th the operating instructions Safety control maintenance work repair work and modifications must only be carried out by the manufacturer or by service agents authorized by him In case of a failure parts which influence the safety of the device must only be replaced by original spare parts of the manufacturer The electric installation must correspond to the requirements in accordance with VDE IEC The device does not contain any parts which need maintenance work done by the user 6 2 Neoserv The Neoserv is a suction application device An under pressure is generated in the device which sucks the air from electrodes into the device In the device a water and dirt separator keeps liquids away from the pump liquids This container is provided with a water level control When filing the container beyond a certain limit a message is displayed which recalled that the container needs to be drained Hold a container ready and pull the hose to empty the container at the back of the device from the lock nipple Turn the hose down and let the liquid of the container drain into the receiving vessel Is all the liquid out of the container put the hose back on the sealing nipple At the annual safety inspection the service technician should clean the container This 1s accessible from the rear of the Neoserv First drain the tank as described above Then tilt it slightly backwards and unscrew the container You can now clean it under running water an
39. the electrode positioning specify the parameters current form possibly modulating frequency and duration This treatment parameters are indicative and recommendations are the responsibility of the treating physician gbo Medizintechnik AG Version 1 2 Duodynator 19 4 2 3 Selection of therapy from the favorites list The Favorites list can be filled by the user as desired Thus the users can define the order of his frequently used therapies by himself spondyitis Indications own therapies and individual treatment settings may be transferred to the Favorites list A simple push on the button loads the EYE therapy from the favorite list as current therapy SIBI Achilondynie The Favorites list can be easily filled Select a treatment from the list of indications the list of other therapies or set the parameters individually This therapy can now be selected by pressing and holding 2 2 5 seconds the corresponding button on the right location of the favorites list One no longer required entry can be easily deleted by push away to the right 4 2 4 Individual settings In the home screen there 1s the possibility to change parameters for a selected current waveform within certain limits The duration can be changed accordingly The current form as newly generated can be directly applied It can be stored in the Favorite list There 1s also the possibility to save this modified current form as Own Therapy under a user specified nam
40. therapy Rename the selected therapy Parameters for the List of own therapies Pre selection of the selected list entry in alphabetical order current type gbo Medizintechnik AG Version 1 2 14 Duodynator 3 2 Suction flyout When using the Duodynator together with the Neoserv the suction operation will be activated after the Neoserv is switched on Pressing the suction button a flyout folded up in which you can set the parameters for the suction The suction which means the negative pressure in the suction electrodes can be adjusted from 40 to 300 mbar The suction massage can be adjusted between 0 and 20 pulses minute Save as Frequency 0 10 80 LOL Suction strength Freguency scan SJUUU 6 pulse min More Therapies surge Vacuum C suction massage Suction Suction on off Button switch Note f e Ifthe suction is to be used the Neoserv must be switched on with its power switch on the back of the unit before e If the Duodynator is switched off using the power switch the Neoserv sounds a warning signal which indicates that the Neoserv is still on and must be switched off Note e If the Neoserv is switched on and connected to the current stimulation output of Duodynator suction will automatically switched on when selecting a current from the Favorite list gbo Medizintechnik AG Version 1 2 Duodynator 15 3 3 Direct help The user of the Duodynat
41. tomatically switched on when selecting a current from the Favorite list gbo Medizintechnik AG Version 1 2 Duodynator 13 3 1 5 Screen for selecting an indication After pressing the button indications the device displays the following screen Return to the Home screen without saving the indication Arthrosis of the ankle joint Arthrosis of the ankle joint Return to the Home screen with the acquisition of indication More Therapies eC Indications Indication image Indication list in Range selection to Display of electrode alphabetical order restrict the list of placement indications 3 1 6 Screen for selecting other therapies After pressing the button other therapies the device displays the following screen Return to the Home screen without applying their own therapy Cancel Change name Delete Accept j j 7 d ET B corem my therapy my therap _ monopha MESIA MERA AIA RR edid b ira oe JE A HTML Ie MA RAZER RA INIT MC AUI RS LATA SEL ai Eni una D dia x MS s Lie O Na o IN PESI Re turn to the Lu AMAA MM LF Standard Home screen with eli ITA Di Mor r gup uil acero hiphase i IM UM WI l o oec oU Sen creer assumption of MF Sine modulated eci dana MF Standard P PY 10 min Therapies ot ne nee chess More Therapies 1 0s 1 0s 1 0s 1 0s Therapies Delete the selected M Indications
Download Pdf Manuals
Related Search