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STEREODYNATOR 928 - Frank`s Hospital Workshop

1. 0 2 i 02 var _ _ 400 200Hz 02 var x gbo Medizintechnik AG 2004 Curet Key Grafies I u m fiy i PT I ed p PPRA Menu ame 100 200 Hz I NT ms D Monophas fixe P MF ln Longues p riodes LP if Impulse galvanization galvanization IG 50 surged V Vegetat Stim II 1 10 Hz ah Vegetat Stim III 1 0 1 1 Hz af Universal 1 af 1 200 Hz 97 Good effect o Very good effect O No effect Q Slight effect I Analgesia Il Hyper mia III Muscle toning IV Muscle detoning Table 1 Modes of action of the therapeutic current types Version 1 9 18 STEREODYNATOR 928 2 Start of Operation 2 1 Transport and Assembly The current stimulation device is a portable unit There is a carrying handle in the form of a recessed grip in the base plate To place the unit each flat surface is appropriate A wall distance of at least 20 cm has to be provided The device should not be placed in front of radiators The current stimulation device corresponds to the regulations DIN VDE 0750 EN 60601 It is a device of protection class I Within the scope of the Medical Device Directive MDD
2. Attention Observe the instructions for use Note Information that will facilitate your work gbo Medizintechnik AG 2004 Version 1 9 Table of Contents OVERVIEW 1 INTRODUCTION 1 1 Intended Use 1 2 Operating Concept 1 33 Short Instructions 1 4 Modes of Action of the Therapeutic Current Types 2 START OF OPERATION 2 1 Transport and Assembly 2 2 Connection and Switch On 2 3 Settings 2 3 1 2 32 Device Settings Basic Settings of the Current Types 3 DESCRIPTION OF FUNCTION 3 1 Operating Notes 3 1 1 3 1 2 3 1 3 3 1 4 3 1 5 3 1 6 3 1 7 3 1 8 3 1 9 3 1 10 3 1 11 Optical and Acoustical User Support Intensity Regulator Current and Polarity Surge Parameters Galvanic Base Frequency Lock Pulse Parameter Therapy Time Stimulation shifting Menu Menu Programs 3 2 Integrated Suction Application Aid 3 3 Ultrasound Therapy Module 4 THERAPY 4 4 Therapy with interference currents 4 1 1 4 1 2 4 1 3 4 1 4 4 1 5 4 1 6 4 1 7 4 1 8 Sedat Myomot Vegetative Stimulation I Vegetative Stimulation II Vegetative Stimulation III Universal Sedation Modulation Automated programs 4 2 Menu Application With Electrotherapy 4 5 Menu Applications with ultrasound 4 4 One Touch Operation 4 4 1 4 4 2 44 3 4 44 Diadynamic Currents Strong Muscle Stimulation SMS According to Eichhorn Middle Frequency Currents Ultrastimulation Current gbo Medizintechnik AG 2004
3. STEREODYNATOR 928 Guidance and manufacturer s declaration electromagnetic immunity The equipment is intended for use in the electromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such an environment 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 the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vins 3 Vor d 1 2VP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3V m d 1 2VP IEC 61000 4 3 80 MHz to 2 5 GHz 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 m Interference may occur in the vicinity of equipment marked with the following symbol p Recommended separation distances to portable and mobile RF communication equipment The equipment is intended to be operated in an electromagnetic environment where radiated RF interference is controlled The user can help in avoiding interferences by means of meeting minimum
4. The middle frequency currents are applied in case of diseases and injury sequels of the locomotion and supporting system especially also in the wide rheumatic area There are seven middle frequency currents available By repeatedly pressing the MF key you can switch from MF 1 to MF VII Surged middle frequency MF I The surged middle frequency current MF I has a rise time of 2 0 s a duration time of 3 0 s and a pause time of 6 0 s in the basic setting Sinus surged middle frequency MF II The current type MF II is a sinus surged middle frequency current gbo Medizintechnik AG 2004 Version 1 9 38 STEREODYNATOR 928 Middle frequency with fix therapy frequencies MF III As a basic setting of the current type MF III a middle frequency current of 50 Hz is offered In this the current has a rise time of 2 0 s a duration time of 3 0 s and a pause time of 6 0 s for the surge i J Notes e The pause duration R can be modified with the Pause duration key and or the modification knob Hence an adjustable frequency range of 0 1 200 Hz is possible e The frequency adjusted with the pause duration is shown on the display e By turning the Intensity regulator the adjusted fix frequency will be taken over Frequency modulated middle frequencies MF IV MF VII In case of the frequency modulated middle frequency currents the therapy always starts with the lower frequencies whereas the frequency ranges will be passed twice within 15 s
5. In case of MF IV to MF VI pulse and pause duration vary In case of the middle frequency current MF VII only the pause duration R varies Pulse duration T will remain constant Press the MF key in accordance to the desired middle frequency The frequency range will be shown on the display Set the desired modifications The therapy is started by turning the Intensity regulator The intensity of the current will be shown on the display The frequency traverse can be stopped by pressing the FIX key The fixed frequency will be shown on the display The therapy time continues to pass 9 Press the white Soft key frequency 10 The frequency can be readjusted by turning the Modification knob 11 Press the FIX key again 12 The frequency traverse will be released again 13 The triad gong will sound three times after the expiration of the therapy NND Baur 4 4 4 Ultrastimulation Current The ultrastimulation current UR 1s applied in case of pain and muscle spasms peripheral circulatory disturbances and for producing isometric muscle contractions li Notes e Incase of patients with high current sensitivity apply the biphase mode Do not cause any continuous muscular contractions 4 4 5 High Voltage Currents The high voltage therapy includes diseases of the muscular ligament and skeleton systems peripheral nerves circulatory disturbances and the detection of trigger points gbo Medizintechnik AG 2004 Version 1 9
6. STEREODYNATOR 928 11 12 12 14 15 17 36 36 36 37 37 38 Version 19 STEREODYNATOR 928 4 4 5 High Voltage Currents 4 4 6 Galvanic Current and Iontophoresis 4 4 7 Faradic Current 4 4 8 Transcutaneous Electrical Nerve Stimulation 4 4 9 Transcutaneous Electrical Nerve Stimulation With Impulse Groups 4 4 10 Micro Stimulus Current 4 4 11 Universal Therapy 4 5 Special types of current Menu 4 5 1 Impulse Galvanization 4 5 2 Frequency Modulation 4 5 3 Diadynamic Currents MF Monophas Fixe and LP Longues P riodes 4 5 4 Rectangular Current for Incontinence 4 6 GYM 4 6 1 GYM current 4 6 2 GYM Training 4 6 3 Burning mode 5 GALVANOPALPATION 6 ELECTROKINETIC THERAPY 6 1 Detection of Trigger Points With the Electrode Handpiece 6 2 Stimulation Massage 7 ELECTRODES 7 1 Electrode Positioning 7 1 1 Monophase Electrode Techniques 7 1 2 Biphase Electrode Techniques 7 2 Single Pole Electrodes 7 3 Three pole electrodes 7 4 Suction Electrodes 7 4 Suction Electrodes 7 5 Electrode Handpiece 8 TROUBLESHOOTING 9 MAINTENANCE 9 1 Safety Controls 9 2 Cleaning Disinfection and Care 9 2 1 Current Stimulation Device 9 2 2 Electrode Fleece Electrode Pockets or Felts 10 WARNINGS AND SAFETY PRECAUTIONS 11 EXPLANATION OF THE SIGNS USED 12 TECHNICAL DATA 13 ACCESSORIES INDEX gbo Medizintechnik AG 2004 57 58 61 57 Version 1 9 10 STEREODYNATOR 928 APPENDIX STORING OF THERAPEUTIC C
7. STEREODYNATOR 928 39 As the stimulation impulses are biphase there do not exist any electrolytic side effects under the stimulation electrodes Negative and positive impulses have the same energy therefore a treatment in the area of metallic implants is possible There are five high voltage currents available You can change from HV I to HV V by repeatedly pressing the HV key High voltage with fix therapy frequencies HV I In the basic setting the high voltage current type HV I has a rise time of 2 0 s a duration period of 3 0 s and a pause time of 6 0 s with a frequency of 50 Hz f Notes e The pause time R can be modified with the Pause duration key and or the Modification knob Hence an adjustable frequency range of 0 1 200 Hz is possible e The fix frequency adjusted with the pause duration will be shown on the display e The adjusted frequency will be taken over by turning the Intensity regulator Frequency modulated high voltage current HV II HV V In case of the frequency modulated high voltage currents the therapy always starts with the low frequencies whereas the frequency ranges will be passed twice within 15 s 1 Press the HV key in accordance with the desired high voltage current types 2 The frequency range will be shown on the display 3 Setthe desired modifications 4 The therapy is started by turning the Intensity regulator up to the sensitive tolerance limit 5 The intensity of the current will be s
8. Treatment of pain muscle spasms functional diseases of the locomotor system such as sports injuries peripheral circulatory disturbances influencing of the vegetative system with diadynamic currents ultrastimulation current microstimulation current TENS and TENS Burst currents high voltage currents and middle frequency currents gbo Medizintechnik AG 2004 Version 1 9 14 STEREODYNATOR 928 1 3 Operating Concept One Touch Philosophy Immediately after pushing the key for the desired current type the therapy or diagnosis can be started Ergonomic Control Panel Function keys are colored black and modification keys are white Keys for identical functions on different models are located in the same position on all devices They are easy to recognize which is particularly important for the visually handicapped and also have a pressure point The parameter settings can be carried out with keys or the modification knob The modification knob has an upper and lower limit stop by software So the values can only be modified in a defined range of values even by overturning the knob The according limit stop can be equipped with a signal tone with the device setting see chapter 2 3 1 In case of key operating there is no limit stop after the last setting possibility it will restart with the first one Here it is also possible to have a key click by the appropriate device setting see chapter 2 3 1 After the expiration of the
9. fixing buttons elastic tapes with closure velcro Ultrasound probe with cable and plug ultrasound surface 5 cm 023 0 0141 Vaginal electrode ee en ee E a a device porter large 014 0 1020 device porter large 014 0 1020 he gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 Index A acoustic user support 13 alarm beep 19 Application errors 51 assembly 15 attention 15 27 32 47 48 52 53 Automatic programs 31 B biphase current 20 biphase electrode technics 47 C care 52 CC mode 20 connection 15 current value 19 D diadynamic currents 33 40 disinfection 52 display 18 duration time 21 E electrode handpiece 50 elektrode fleece 52 elektrode positioning 46 error messages 51 exceptions 51 F faradic current 37 FM 40 frequency lock 21 frequency modulation 40 G galvanic base 21 galvanic current 19 36 H high voltage currents 35 impuls galvanization 40 incontinence 40 intensity regulator 19 inverse representation 18 iontophoresis 36 gbo Medizintechnik AG 2004 63 L LED 13 18 longitudinal current flow 49 M maintenance 52 menu 24 menu application with electrotherapy 32 Menu Programs 31 menu special current types 39 MF 40 micro stimulus current 39 middle frequency currents 34 Monophase current 20 monophase electrode technics 47 monophas Fixe 40 Myomot 30 operation mode 20 45 optical user support 13 pause duration
10. for suction electrodes small 45 38 518EH722 45 38 922EH722 Electrode intermediate layers standard diameter 52 mm 12 pieces for suction electrode set standard 45 38 500EH 722 45 38 930EH722 Electrode intermediate layers large diameter 72 mm 12 pieces for suction electrodes large 45 38 526EH722 45 38 948EH722 Sponge pockets large 10 pieces for plate electrodes 45 38 468EH725 and conductive rubber electrodes 45 38 492EH725 45 38 203EH725 Sponge pockets large 10 pieces for plate electrodes 45 38 468EH725 and conductive rubber electrodes 45 38 492EH725 45 38 203EH725 Sponge pockets small 10 pieces for conductive rubber electrodes small 45 39 102EH725 Sponge pockets medium 10 pieces for conductive rubber electrodes medium 45 39 110EH725 Electrode pockets large 10 pcs for star electrode large 49 07 325E3020 gbo Medizintechnik AG 2004 Version 1 9 62 STEREODYNATOR 928 Article Article number Intermediate layer made of viscose sponge 30 cm x 20 cm x 1 cm 5 pieces Intermediate layer made of fleece 32 cm x 22 cm 5 pieces 45 38 211EH725 Sheet tin 18 cm x 28 cm 3 pieces for making plate electrodes use it with electrode Suction cub large diameter 70 mm 45 38 583EH722 Star electrode pair standard diameter 130 mm 45 38 716EH725 l Star electrode pair large diameter 180 mm 45 38 724EH725 l Stern electrode set Standard star electrodes 3 pole electrode pockets rubber tapes 45 38 260EH719 tapes
11. gbo Medizintechnik AG 2004 Version 1 9
12. the current stimulation device belongs to class IIb see also chapter 10 Warnings and Safety Precautions Attention 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 If the patient and or the patient cable is directly exposed to a radiator of a medical device for high frequency heat therapy the damage of the device or a danger to the patient cannot be excluded As a rule a distance of 3 m is sufficient 2 2 Connection and Switch On The current stimulation device has been adjusted for the connection to a supply voltage of 230 V If needed the device can be switched over to the following supply voltages e 240V e 230V e 120V e 100 V Irrespective of the adjusted supply voltage the device is appropriate for mains frequencies of 48 to 62 Hz Voltage Selection and Fuses 1 Unplug the mains plug 2 The device is protected by 2 fuses on the mains side that are located in a pluggable box at the back of the device next to the power inlet see Figure 1 3 The adjusted supply can be seen through the small window of the box With a screw driver the box can be pulled out of the line filter unit by the small slot 5 Remove the voltage selector out of the holder and set the usual supply voltage B gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 19 Attention T
13. 1 20 or continuous wave The current impulse type is shown on the display 6 Press the Ultrasound power key and set the ultrasound power By repeatedly pressing the Ultrasound power key or e By turning the Modification knob 7 Put the ultrasound probe on the patient s treatment area important contact gel and move it slowly now the therapy time passes gt gt J Note If the ultrasound probe has not been coupled to the patient no therapy time will pass When the probe has been coupled again the therapy time will continue to pass Hence the ultrasound probe can be removed in between gbo Medizintechnik AG 2004 Version 1 9 32 STEREODYNATOR 928 4 Therapy 4 1 Therapy with interference currents Upon switching on the electrical stimulus device and its automatic check the interference current Sedat will always appear with its basic setting if multipolar electrodes are connected In addition the Menu for interference currents is available If there are no or single circuit electrodes connected the single circuit therapy current DF appears and the Menu for single circuit therapy currents is available Notice e Interference currents can only be applied with constant voltage mode CV e The frequency ranges are passed in a minute s rhythm e During therapy you can switch over between interference currents but not between the automatic programs e For visually handicapped interference current Sedat can be dub
14. 5 mA Notes e The Intensity regulator automatically reverts to 0 0 after the expiration of the therapy time e When changing over from one current type to another the Intensity regulator has to be set to 0 0 Control the current indication on the display 3 1 3 Current and Polarity On the display both the peak value of the stimulation current in mA peak as well as the polarity and or are shown The polarity sign always refers to the red plug of the accessories The polarity change over is not active in case of biphase currents When selecting biphase currents the polarity sign disappears 125 A mA peak EN Figure3 Current indication on the display with the Polarity key gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 23 Automatic pole changing By pressing the Polarity key polarity changes as follows 1 Press gt automatic pole changing at first the polarity is positive flashes and reverts to negative flashes after half of the therapy time 2 Press polarity changes from positive to negative 3 Press polarity is positive again When the polarity changes the current will be faded out and restored again within 10 s In case of combination of the current types DF and CP polarity will be changed after half of the therapy time 7 Notes e The automatic pole changing can only be set before starting the therapy e During therapy however the polarit
15. 9 2 2 there should not be used any agents containing higher portions of phenol derivatives alcohol compounds of chlorine or peracetic acid It is recommended to use disinfectants on aldehyde basis The device is not suited for heat sterilization or for sterilization with gases Attention Before cleaning or disinfection unplug the mains plug out of the socket The current stimulation device is suited for wiping disinfection It has to be observed that no liquids enter the device In no case shall the plug or socket get wet For cleaning or disinfection the device may not be drizzled 9 2 2 Electrode Fleece Electrode Pockets or Felts 1 Put the material into neutral soap suds and rub it slightly If necessary disinfect with disinfectant solution but do not put it into it 2 Leave the parts over the night in the neutral soap suds or tap water 3 Take them out and wash them several times thoroughly out under cold or warm running water 4 Let them drop but do not wring them out gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 55 10 Warnings and Safety Precautions AN Attention In case of patients with implanted electronic device carry out electrical stimulation treatment only after having checked whether there is any risk e Pieces of jewellery and glasses have to be taken off during the treatment e Turn off cellular phones and radiophone or place them in a distance of 3 m from the device e Cardi
16. 9 Transcutaneous Electrical Nerve Stimulation With Impulse Groups The application area of TENS Burst currents is very similar to that of TENS currents but with a less analgesic but more detoning effect There are five current types available You can go from TENS Burst I to TENS Burst V by repeatedly pressing the Tens Burst key TENS Burst with fix therapy frequencies TENS Burst I The current type TENS Burst I has a frequency of 50 Hz and a pause duration R of 18 ms in its basic setting if Notes e Pause duration R can be modified with the Pause duration key and or the Modification knob Hence an adjustable frequency range of 0 1 400 Hz is possible e The fixed frequency adjusted with the pause duration will be shown on the display e The fixed frequency will be taken over by turning the Intensity regulator Frequency modulated TENS Burst II TENS Burst V In case of the current types TENS Burst II TENS Burst V the pause duration R will alter within certain ranges and the pulse duration T remains constant at 2 ms The therapy always starts with the low frequencies whereas the frequency ranges will be passed twice within 15 s Press the Tens Burst key in accordance to the selected current type The frequency range will be shown on the display Set the desired modifications The therapy will be started by turning the Intensity regulator The intensity of current will be shown on the display The frequency traverse can be stopped
17. by pressing the FIX key DN EON beca pares gbo Medizintechnik AG 2004 Version 1 9 42 STEREODYNATOR 928 7 The fixed frequency will be shown on the display 8 The therapy time continues to pass 9 Press the white Soft key frequency 10 The frequency can be readjusted by turning the Modification knob 11 Press the FIX key again 12 The frequency traverse will be released again 13 The triad gong will sound three times after the expiration of the therapy time 4 4 10Micro Stimulus Current Micro stimulus current is applied in kinds and stages of diseases as well as in injury consequences for which depth warming seems to be a successful therapy It includes surgical traumatological orthopedic sports medicine and gynecological areas The impulse sequences of the micro stimulus current have an extremely low intensity which amounts to 5 mA maximum Note The pulse duration and pause duration can be adjusted only within a limited range The maximum period duration is 50 ms 4 4 11 Universal Therapy The basic setting of the Universal therapy T R is especially suited for the application in case of severe paralyses Pulse duration and pause duration are adjustable within wide limits for middle and mild paralyses 4 5 Special types of current Menu Some current types cannot be selected by key but within the menu The user support is driven by dialog on the display The following therapy current types are filed
18. e Do not forget the contact gel e Be careful with the ultrasound probe because rough external influences such as a mechanical shock or impact can alter its characteristics We recommend to carry out a visual examination at least once a year to check for fissures that allow liquids to enter as well as regarding the integrity of the cables and connectors Power for C 5 cm ultrasound probe MHz i 0 0 MHz 0 1107 W 0 110 1 5 Wem 0 1t02 5 W 0 1 to 1 5 W cm 3 MHz 0 1107 W 10 110 1 5 Wem 10 110 2 5 W 0 1 to 1 5 W cm Table 6 Setting possibilities of the ultrasound power increments are shown in bold For combined operation we recommend the following procedure 1 Select the current type 2 Setthe desired modification 3 Select the operation mode Combined Operation by pressing the Comb key gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 31 4 By pressing the Comb key once you reach the ultrasound frequency 1 MHz By pressing the Comb key twice you reach the ultrasound frequency 3 MHz 5 Setthe desired modification 6 In case of this operation mode the blue plug of the patient cable is currentless In the basic setting the red plug has positive polarity whereas the backplate electrode the metallic ultrasound probe surface is negative 7 Connect the red plug of the patient cable with the neutral electrode Apply the neutral electrode 9 By pressing the Continous Pulsed key select t
19. environment specified below The customer or the user of the equipment should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The equipment uses RF energy only for its internal function CISPR 11 Therefore 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 Harmonic emissions Class A low voltage power supply network that supplies buildings used for IEC 61000 3 2 domestic 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 use in the electromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC61000 4 2 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are covered with 1 kV for input output lines 8 kV air 8 kV air synthetic mater
20. 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 2YP d 1 2VP d 2 3VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 12 23 10 3 8 3 8 7 3 100 12 12 23 gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 EC DECLARATION OF CONFORMITY gbo Medizintechnik AG 6 Name of manufacturer Address Kleiststrasse 6 D 64668 Rimbach Germany We hereby declare under our sole responsibility that the product described below conforms in design and make as well as in the versions delivered to the corresponding safety and protection requirements defined in the applicable EC regulations Harmonized standards have been used for all conformity checks national standards have not been applied Any change to the product design that is not validated by us will render this declaration invalid Type of product Label Options Accessories Corresponding EC regulations Conformity assessment procedure Classification Name und registration no of the notified body Additional information Date Name of persons responsible Title Function Signature gbo Medizintechnik AG 2004 Stimulation Current Unit STEREODYNATOR 928 Part No 014 0 928 Part N
21. the Menu key Move the scroll bar cursor with the Modification knob to Application with electrotherapy Confirm by pressing the white Soft key Move the scroll bar cursor with the Modification knob to the desired application area e Head amp Neck e Vertebral column amp Trunk e Upper extremities e Lower extremities Confirm by pressing the white Soft key A list of the modes of action appears on the display e Analgesia e Hyperemia e Muscle toning e Muscle detoning Move the scroll bar cursor with the Modification knob to the desired mode of action Confirm by pressing the white Soft key The notes of application referring to the application area and the mode of action are shown on the display 10 Apply the electrodes in accordance to the suggestion given as long as there are not any contra indications 11 Confirm by pressing the white Soft key 12 If necessary modify the therapy time 13 Turn on the Intensity regulator and therapy starts i Notes e Only the therapy time can be modified e If there are suction electrodes connected the vacuum pump will be automatically switched on that means that it is not necessary to press the Vacuum key to switch on Attention The current type DF for Hyperemia has a d c portion Therefore a certain current density of 0 31 mA cm corresponds to 64 d c portion of the peak value should not be exceeded Depending on the electrode size there are the following current values R
22. 18 22 pause time 21 polarity 19 pole change 20 pulse duration 18 22 pulse rise 22 rise time 21 safety controls 52 Sedat 29 Sedation Modulation 30 settings 16 short instruction 12 single pole electrodes 47 soft key 24 Star display 18 strong muscle stimulation 34 suction application unit 26 suction electrodes 26 50 surge parameters 21 switching on 16 TENS 37 TENS Burst 38 therapy time 22 Three pole electrodes 49 transcutaneous electrical nerve stimulation 37 Version 1 9 64 transport 15 transverse current flow 49 troubleshooting 51 U ultrasound module 27 ultrasound current combination 27 ultrastimulation current 35 Universal 30 universal therapy 39 unsuitable electrode 51 gbo Medizintechnik AG 2003 Medical Devices Division STEREODYNATOR 928 V Vegetat Stim I 30 Vegetat Stim II 30 Vegetat Stim HI 30 Voltage Selection 15 W warning signal 19 51 warnings 15 53 wrong electrode 51 Version 1 9 STEREODYNATOR 928 EN 8 E Ed nn D s Number Current eE Remarks Storing of Therapeutic Current Types gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 66 Correction sheet gbo Medizintechnik AG Dokumentation KleiststraBe 6 64668 Rimbach Please work on the faults and or suggestions to the present documentation Page Line faulty text right text If needed please attach an additional sheet Address Part No 014 7 0019
23. 5 95 5 12 5 28 5 0 5 5 5 0 5 ms mo 330 0 140 14 50 167 140 14 16 140 14 140 14 a a a a E 00 200 Hz 14 LE a oO oO 0 4 5 4 5 4 5 0 2 1 lt N S 1 E D In case of using the suction electrodes the maximum current is reduced to 20 mA O gbo Medizintechnik AG 2004 Version 1 9 60 Current Grafics Pulse Pause duration T in duration ms R in ms dis l EN Tens III 10 30 Hz Tens IV 30 60 Hz 10 30 Hz var 30 60Hz STEREODYNATOR 928 D C Frequency Maximum output Max output portion in Hz voltage by CV in current by CC in in V peak MA peak T l 0 100 100 200 Hz I ms currents Tens Burst I 50H Tens Burst III 10 30 Hz Tens Burst IV 30 60 Hz Tens Burst V 100 200 H
24. M Training Modulated medium frequency Burning mode Modulated medium frequency Press the Menu key Move the scroll bar cursor with the Modification knob to the desired GYM current type Confirm by pressing the white Soft key The selected current type will be shown on the display Set the desired modifications Only GYM current slow med fast Turn on the Intensity regulator and therapy will be started ON c oe tur Eos 4 6 1 GYM current GYM current is a surged medium frequency current The carrier frequency is 8000 Hz It is possible to use this current in single channel mode and three channel mode The parameters of the GYM current are described below a 00 ms 400 ms 200 ms break Figure 26 GYM current The surge parameters are Rise time 200 ms Hold time 400 ms Fall time 200 ms break variable depends on the rythm slow med fast There are 3 different rythms for the GYM current Slow 15 rythms per minute Med 20 rythms per minute Fast 30 rythms per minute gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 45 4 6 2 GYM Training The GYM Training current is a modulated medium frequency current in surged mode The carrier frequency is 8000 Hz It is possible to use this current in single channel mode and three channel mode The parameters of the GYM Training current are described below 50 Hz al ll ally ATI 15 5 15 5 15 Figure 27 GYM Tr
25. URRENT TYPES 59 gbo Medizintechnik AG 2004 Version 19 STEREODYNATOR 928 11 Overview Chapter 1 describes the basic characteristics of the current stimulation device Chapter 2 explains the start of operation of the current stimulation device It describes its setting possibilities Chapter 3 describes all functions of the device and their operation Chapter 4 explains the realization of therapies Chapter 5 explains the realization of galvanopalpation Chapter 6 explains the realization of electrokinesis Chapter 7 refers to the arrangement and the use of the electrodes Chapter 8 explains the error messages and gives some hints in the case of faults Chapter 9 refers to safety controls in accordance with the MDD and to routine maintenance Chapter 10 shows the possible threats when using the current stimulation device Furthermore it indicates how to avoid possible threats Chapter 11 explains the signs used Chapter 12 speifies all relevant technical data of the current stimulation device Chapter 13 shows the scope of supply of the device and informs about further accessories indicating their order number gbo Medizintechnik AG 2004 Version 1 9 12 STEREODYNATOR 928 1 Introduction 1 1 Intended Use The devices with interference current are microprocessor controlled electrical stimulus devices for Electro Therapy Their wide range of usage predestinates these medical devices for use in physiotherapeutic departmen
26. With the movement the stimulating current will alter depending on the patient resistance and the electrode pressure After the expiration of treatment set the Intensity regulator and Therapy time as far as it has not automatically run down to 0 0 If the device remains unused for more than 2 minutes with the intensity adjusted the patient will be disconnected from the circuit gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 47 6 Electrokinetic Therapy Electrokinetic therapy is the application of stimulation current with moving electrodes The application is only carried out in operation mode CV constant voltage Attention Moisten the electrode intermediate layers dripping wet 6 1 Detection of Trigger Points With the Electrode Handpiece Sometimes it is advisable to detect the appropriate muscular trigger point by moving the electrode handpiece on the skin 1 Connect the electrode handpiece to the socket 1 2 Connect the electrolytically inactive electrode to the red cable The electrolytically inactive electrode will be placed as a cathode switch over of polarity s b away from the area to be examined Press the desired current type key Set the operation mode on CV by pressing the operation mode key Set the polarity to by pressing the Polarity key The active electrode handpiece is anode now Set the intensity by turning the Intensity regulator and put the electrode handpiece
27. ac pacemakers can extremely be disturbed In these cases the therapy should be only carried out under continuous pulse and ECG control e Ifthe patient and or the patient cable is in direct range of a high frequency short wave or micro wave therapeutic device a damage to the device or an injury of the patient cannot be excluded Please keep a 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 It is recommended not to exceed the current density of 2 mA cm on all electrode surfaces e For current types for which there exists the threat of cauterization currents with galvanic portion the maximum recommended current density is 0 5 mA cm electrode surface In case of galvanization the limit value is 0 2 mA cm and in case of iontophoresis 0 1 mA cm e Do not use one way self adhesive electrodes with currents with galvanic portion there 1s the threat of cauterization 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 Incase of all visible failures contact immediately gbo Medizintechnik AG or one of the service agencies authorized by gbo Medizintechnik AG gbo Medizintechnik AG 2004 Version 1 9 S6 Contraindications for use of ultrasound Ultrasonic therapy must no
28. activated in the Device settings menu see chapter 2 3 1 For the different suction electrodes the following current values must not be exceeded when galvanic current is applied Suction electrode Electrode plate small Electrode plate standard Electrode plate large Table 5 Current values of the suction electrodes in case of galvanic mode gbo Medizintechnik AG 2004 Version 1 9 30 STEREODYNATOR 928 3 3 Ultrasound Therapy Module Depending on the device configuration the ultrasound therapy module is either optional or standard The operating elements have already been integrated on the membrane keyboard Comb Sono ame aue Figure 21 Comb key 1 3 MHz Figure 22 Sono key 1 3 MHz LU ALLL Watt a O _ Figure 23 Continous Pulsed key Figure 24 Ultrasound power key Notes e The ultrasound frequency can be changed to 1 or 3 MHz e The frequency for pulsed mode 100 Hz e The pulse parameters are 1 5 1 10 or 1 20 e The coupling status of the probe is shown by an LED on the probe housing The LED will be off in case of insufficient coupling The LED will be flashing in case of good contact As a standard setting the ultrasound power is shown in W cm on the display In the device settings see chapter 2 3 1 you can select between the formats W and W cm e If you want to exit the ultrasound operation prematurely i e before expiration of the therapy time press the Sono and or Comb key again Attention
29. aining current The surge parameters are Rise time 3s Hold time 3s Break time 3s 4 6 3 Burning mode The Burning mode current is a modulated medium frequency current The carrier frequency is 8000 Hz It is possible to use this current in single channel mode and three channel mode The parameters of the GYM Training current are described below 3 Hz li UL lll ilii A AA a 300 33 300 30 300 Figure 28 Burning mode current gbo Medizintechnik AG 2004 Version 1 9 46 5 STEREODYNATOR 928 Galvanopalpation The sensitive and vasomotor cutaneous nerves in certain body segments are examined to get indirect conclusions on diseases of inner organs l 2 w 9o Ig AR 11 Connect the electrode handpiece to the socket 1 Connect the electrolytically inactive electrode to the red cable The electrolytically inactive electrode will be applied far from the examination place as a cathode switch over of polarity s b Press the Galv key Set the operation mode to CV by pressing the Operation mode key Set the polarity to by pressing the Polarity key Now the active electrode handpiece is the anode It serves for palpation Set the intensity by turning the Intensity regulator and place the electrode handpiece firmly on the examination area Turn the Intensity regulator slowly until the stimulus is just noticeable Now the electrode handpiece can be moved over the skin and herewith also removed
30. ane keyboards Note The suction application aid cannot be used during diagnostic programs Vac aufs rin aue oO e O Figure 18 Vacuum key Figure 19 Vacuum Intensity key Figure 20 Suction massage key 1 Press the Vacuum key the pump will be switched on The basic pressure is immediately available 2 Press the Vacuum Intensity key and set the vacuum intensity with the Modification knob or by repeated pressure of the key so that the suction electrodes can be comfortably applied to the patient The vacuum intensity is shown on the display in the form of a cylinder diagram Notes e The operating mode CC can be used without any comfort limitations there are no voltage sensations even in case of dropping electrodes e Incase of the galvanic mode the maximum admissible output current will be limited to 20 mA when suction electrodes are used to prevent cauterization e Incase of the galvanic mode the current density must not exceed 0 2 mA cm see also Table 5 3 Press the Vacuum massage key and set the suction massage frequency e By repeatedly pressing the Vacuum massage key or e By turning the Modification knob I Note The vacuum frequency can be modified in steps of 5 pulses minute within the range of 0 to 60 pulses minute 4 If upon switching on the vacuum application no current is applied for 2 min or if the therapy time has expired since 2 min the pump automatically switches off provided that this has been
31. apter 2 3 1 gbo Medizintechnik AG 2004 Version 1 9 28 STEREODYNATOR 928 3 1 11 Menu Programs Besides the current types which are already stored in the device there is a possibility to create your own programs of current types and to store and select them Program and store a current type 1 Select the desired current type 2 Selectall desired modifications 3 Press the Menu key 4 Move the cursor by means of the modification knob to Programs 5 Select by pressing the Soft key select 6 Thecursor points to store program 7 Select by pressing the Soft key store 8 Move the cursor by means of the modification knob to the wanted storage location Program NN 9 Select by pressing the Soft key store 10 The device exits the menu and returns to the current type Select a stored current type program Press the Menu key Move the cursor by means of the modification knob to Programs Select by pressing the Soft key select The cursor points to store program Move the cursor by means of the modification knob to the wanted storage location Program NN Select by pressing the Soft key select The device exits the menu and returns to the current type QU UN PEU Er gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 29 3 2 Integrated Suction Application Aid The suction application aid is optionally available The operating elements for the suction application aid are integrated on all membr
32. ause duration R of 70 ms 4 5 2 Frequency Modulation Frequency modulation is suited for electrostimulation of the muscles The frequency modulation FM consists of rectangular impulses The frequency range will be passed twice within 6 s 4 5 3 Diadynamic Currents MF Monophas Fixe and LP Longues P riodes The diadynamic currents monophas fixe MF and longues p riodes LP are used in pain therapy for stimulating blood circulation stimulating absorption post Trauma and for neuromuscular electrostimulation Attention Do not mistake the current type monophas fixe MF for the middle frequency currents MF I MF VII 4 5 4 Rectangular Current for Incontinence The current type Incontinence current is applied in case of incontinence caused by neurological damages transverse lesion of the cord with paraplegia paralyses after dislocation of the disk stress incontinence etc The current type is a biphase rectangular current d c free with a pulse duration T of 0 1 ms and a pause duration R of 40 ms 25 Hz In addition a surge cycle with a rise time of 2 s a duration time of 4 s and a pause time of 8 s are preset gbo Medizintechnik AG 2004 Version 1 9 44 STEREODYNATOR 928 4 6 GYM In the STEREODYNATOR 3 different types of Gymnastic currents are included This current types cannot be selected by key but within the menu The user support is driven by dialog on the display GYM current Surged medium frequency GY
33. ay star display serves as stimulation frequency display and electrode contact display The green luminous bars are lit in the three circuit mode and show the frequencies effective in the body The red LEDs indicate Red LEDs lit there is current flowing Red LED not lit there is no current flowing 5 Furthermore an acoustic user support is furnished Confirmation beep 1x admissible pressing of a key Information sound 1x inadmissible pressing of a key disconnection of the patient plug during operation Alarm ca 2s insufficient electrode contact dropping electrodes during the therapy CC in case of unintended current increase during therapy Triad gong 1x at the beginning of the automatic check to control the gong 3x at the end of therapy the key of the electrode handpiece has not been pressed for 2 min in operating mode CV no current has flown for 2 min 6 Putthe electrodes on to the patient exception in case of using the suction application aid the Vacuum key and the Types of stimulation current key have to be pressed first 7 Select the current type by pressing the corresponding current key or select it from the Menu 8 The default setting of the current type is activated automatically 9 Select additional modifications e By pressing the desired Modification key By turning the Modification knob or repeatedly pressing of the Modification key until the desired value has been set 10 Increase th
34. bed with a signal Generally there is the following procedure for therapy with interference current Connection through the mains switch at the back of the device The device executes an automatic check of all functions The faultless automatic check ends with the acoustic signal Connect the accessories for interferential currents with the according socket on the right side of the device Interference current Sedat is available with its basic settings Apply the electrodes on the patient 7 Select the required interference current by repeatedly pressing the Interference current key or the required automatic program by pressing the respective Program key or selecting from Menu Programs 8 Setthe required modification 9 Turn the Intensity regulator slowly until the current is clearly perceptible but do not generate any muscular contracture e The luminous bars of the stimulation frequency display move in the rhythm of the stimulation frequencies e Three red lights must be lit in the center of the stimulation frequency This is a control display for the correct electrode contact one red light has been assigned for each current circuit which extinguishes in case of faulty electrode contact in its current circuit 10 At the end of the therapy the triad gong will sound three times and intensity automatically reverts to 0 0 OD au 4 1 1 Sedat The interference current Sedat 200 Hz has an analgesic effect and at t
35. 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 my 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 comments 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 2004 Version 1 9 4 STEREODYNATOR 928 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 use in the electromagnetic
36. e current slowly with the Intensity regulator until the desired stimulation effect occurs 11 At the end of the therapy the triad gong will sound three times The current to the patient will be faded out within 10 s gbo Medizintechnik AG 2004 Version 19 STEREODYNATOR 928 17 1 4 Modes of Action of the Therapeutic Current Types Current Key Grafies I u TI IV Galvanic current Ultrastimulation current C F1 Faradic current ca i T 7n 10 100 100 Hz ll 250 250 Ill 250 i AUI M WW ms n 1 ms 3 10Hz y n 1 ms 0 30Hz jl n 1 j ms 4 ms n ms ms N N i n 10 N D 30 60 Hz In 100 200 H In 1 50 Hz 45 0 04 var ms ms ms ms
37. e duration R of 10 ms in its basic setting Notes e Pause duration R can be modified with the Pause duration key and or the Modification knob Hence an adjustable frequency range of 0 1 1400 Hz is possible e The fixed frequency adjusted with pause duration will be shown on the display e The fixed frequency will be taken over by turning the Intensity regulator gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 41 Frequency modulated TENS II TENS V In case of the current types TENS II TENS V the pause duration R will alter within certain areas and the pulse duration will remain constant at 0 2 ms The therapy always starts with the low frequencies whereas the frequency ranges will be passed twice within 15 s Press the Tens key in accordance to the desired current type The frequency range will be shown on the display Set the desired modifications The therapy is started by turning the Intensity regulator The intensity of the current will be shown on the display The frequency traverse can be stopped by pressing the FIX key The fixed frequency will be shown on the display The therapy time continues to pass Press the white Soft key frequency The frequency can be readjusted by turning the Modification knob Press the FIX key again The frequency traverse will be released again The triad gong will sound three times after the expiration of the therapy time INN eras Don ODO WNrF O 4 4
38. ection 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 according graphical symbol is placed on the type plate According to the Medical Device Directive STEREODYNATOR 928 is a device of class IIb The manufacturer is only responsible for the security operational reliability and functionality of the device if e the device is used in accordance with the user manual e the electrical installation of the location where the device will be used corresponds to the respective current requirements of electrical safety e the device is not used in hazardous environments and humid locations e the mountings add ons internal adjustments modifications or repairs are realized only by personnel authorized for that by the manufacturer e the operator regulation of this EC directive is observed within the scope of the Medical Device Directive You may obtain technical support by the manufacturer or the dealers or service authorized by the manufacturer The manufacturer provides a life time of at least 10 years for this product STEREODYNATOR 928 is a electronic device Disposing has to be done according to regulations for electronic devices Consumables have to be disposed as garbage On request the manufacturer will provide you with further technical descriptions for all serviceable parts of the device such as circuit
39. ens Micro T R Burst STi qO JHO JHO Myokinetics Prog Prog Prog A B C Of Of O Sono Vacuum Comb Sono Ili AL Watt dern a Vac dame GHO 0c O e Oe Odme Modifikation Intensitat Intensity knob STEREODYNATOR 928 Ultrasound therapy unit Modification Suction aid for Pulse Pause i vacuum therapy Automatic programs Surge parameter and or vacuum cable I socket 1 Attention Observe the instructions for use Carrying Connection for handle Vacuum cable I ultrasound probe socket 2 socket 3 O 3 e Service interface Mains e switch le e Fuses and voltage e selector gs Be depending on unit configuration Figure 1 STEREODYNATOR 928 gbo Medizintechnik AG 2004 Version 1 9 16 STEREODYNATOR 928 1l Switch on with the mains switch at the back of the device The device carries out an automatic test of all its functions The faultless selftest ends with the acoustic signal 2 Connect the accessories with the according socket on the right side of the device 3 Optical user support is furnished in the form of LED lights incorporated into the keys flashing key was selected and remains active constantly lit key is active and operational notlit key is not active and not operational 4 The three r
40. ent types can be surged individually by a surge cycle The three surge parameters L rise time Am duration time Al L pause time determine a surge cycle Each surge parameter can be changed within 0 to 60 s in steps of 0 5 s The descent time in each surge cycle is always set to 1 s constantly Js 3al 6s M 4m 4m Figure 8 Surge parameter key with the according displays 3 1 5 Galvanic Base Basis autom 0 Figure 9 Galvanic Base key with its display The current types DF CP MF and LP can be underlayed by a d c current whose amplitude corresponds to 20 and or 50 of the peak current By repeatedly pressing the key it can be changed between 0 20 and 50 of the d c current underlaying This is shown on the display 3 1 6 Frequency Lock FIX 1 p m a 0 Frequency Hz Figure 10 FIX key with the display of the fixed therapy frequency gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 25 In case of frequency modulated current types the frequency can be locked and released with this key during the treatment The first key pressure locks another actuation releases the frequency Note If you want to modify the frequency please press the white Soft key frequency The frequency now can be modified step by step with the modification knob The frequency can be modified by turning the modification knob Herewith also changes the pulse and or pause duration The acc
41. f Interference Current Stimulation Devices STEREODYNATOR 928 User Manual gbo Medizintechnik AG 2004 Version 1 9 2 STEREODYNATOR 928 Das vorliegende Handbuch wurde von der gbo Medizintechnik AG erstellt und auf seine Richtigkeit berpr ft Es erhebt jedoch keinen Anspruch auf Vollst ndigkeit Alle Angaben und Daten k nnen ohne vorherige Ank ndigung ge ndert werden Ohne ausdr ckliche schriftliche Genehmigung der gbo Medizintechnik AG darf kein Teil dieses Handbuch f r irgendwelche Zwecke vervielf ltigt oder bertragen werden unabh ngig davon auf welche Art und Weise oder mit welchen Mitteln elektronisch oder mechanisch dies geschieht The gbo Medizintechnik AG has taken care in preparation of this manual but makes no expressed or implied warranty of any kind and assume no responsibility for errors or omissions All rights reserved No part of this manual may be reproduced in any form or by any means electronic mechanical or otherwise without the prior written permission of the gbo Medizintechnik AG gbo Medizintechnik AG 2004 gbo Medizintechnik AG KleiststraBe 6 D 64668 Rimbach Telephone 49 6 25 3 808 0 Telefax 49 6 25 3 808 300 E Mail info gbo med de Internet http www gbo med de gbo Medizintechnik AG 2004 Version 19 STEREODYNATOR 928 3 Comments According to the Medical Device Directive The STEREODYNATOR 928 is a mains operated current stimulation device of prot
42. firmly on the area to be examined Turn the Intensity regulator slowly until stimulation is slightly noticeable 10 Now you can move the electrode handpiece over the skin and you can also remove it The stimulating current alters according to the patient resistance and the electrode pressure 11 Set the Intensity regulator and Therapy time as long as it has not yet expired itself to 0 0 after the expiration of examination If you do not work with the device for more than 2 minute with the intensity adjusted the patient will be interrupted from the circuit w porc As 6 2 Stimulation Massage The stimulation massage will be realized with a moving plate electrode under current conduction 1 Use two plate electrodes in well moistened electrode pockets One electrode will be fixed firmly on the skin The second active mobile electrode will be moved over the skin It is advisable to put on rubber gloves in order not to get electrified yourself when you touch the active electrode Press the desired current type key Set the operation mode to CV by pressing the Operation mode key Put the mobile electrode firmly on the skin Turn the Intensity regulator slowly until the desired stimulation has been achieved Move the mobile electrode over the skin There is no adverse effect 1f you take off the electrode depo Q ooo cd gy pA gbo Medizintechnik AG 2004 Version 1 9 48 STEREODYNATOR 928 7 Electrodes Basical
43. he eurrent type CP is suited very well for the treatment of functional disturbances of the locomotion system circulatory disturbances neuralgia and radiculopathies It is mostly applied after the DF program but it is also possible the other way round Therapy with the combination of the current types DF and CP 1 Press the DF key 2 Setthe desired modifications for DF 3 On the display there appears combination with CP next to the Soft key 4 Selectthe combination mode by pressing the Soft key 5 Setthe desired modifications for CP 6 Turn the Intensity regulator to the sensitive tolerance limit 7 Onthe display the selected current type and the total therapy time are shown e Notes e When changing from one current type to another the first current will be faded out within 10 s and then the second one will rise within 40 s to 80 and within further 20 s to 100 of ist intensity e A maximum of two current types can be combined in sequence 4 4 2 Strong Muscle Stimulation SMS According to Eichhorn In case of long lasting chronic muscle detriments the muscular apparatus can be built up again with SMS Visible and palpable continuous muscular contractions will be caused whereas the patients tolerate higher intensities of current due to biphase stimulation impulses The current type SMS consists of a biphase rectangular pulse with a pulse duration of 10 ms and a pause duration of 100 ms 4 4 3 Middle Frequency Currents
44. he mains socket has been sealed with a scotch tape This is to remember to check prior to switch on whether the adjusted voltage corresponds to the supply voltage of the treatment room The scotch tape over the mains socket is easy to remove Connect the current stimulation device with the mains cable to a grounded safety power outlet The current stimulation device is switched on by the mains switch at the back of the device By this arrangement erroneous unintended disconnection of the device during normal operations shall be avoided After switching on the device an automatic selftest of all device functions will be performed see chapter 1 3 Short Instructions 2 3 Settings 2 3 1 Device Settings Once the unit has been switched on and is ready you can start immediately with the standard settings Device settings Signal for adjustment knob Signal for keys Max value of therapy time 2 Ultrasound power emission W Automatic pump switch off Signal volume Language English Italian Portuguese Spanish Czech French Contrast of display Inverse representation Display mode of action Therapy time adjustment 1 min max value standard Vacuum default intensity 0 100 Table2 Device settings gbo Medizintechnik AG 2004 Version 1 9 20 STEREODYNATOR 928 If you would like to change them please proceed as follows 1 Press the black Menu key 2 Youarein the Main menu 3 Move the scroll bar
45. he pulse wave 1 5 1 10 1 20 or continuous wave The current impulse type is shown on the display 10 Press the Ultrasound power key and set the ultrasound power e By repeatedly pressing the Ultrasound power key or e By turning the Modification knob 11 Put the ultrasound probe on the patient s treatment area important contact gel and move it slowly 12 Set the current intensity by turning the Intensity regulator If the patient experiences a pain reduce the stimulation intensity Notes e By combined operation the therapy time will pass if the Intensity regulator is turned and or the ultrasound probe has been coupled to the patient e Combined operation is only possible in CV Mode since the ultrasound probe can be moved and or removed during the therapy e Due to the acidification of the contact gel the ultrasound therapy cannot be operated with the Galvanic current type e In combined operation it is not possible to apply the electrode handpiece e The current density should not exceed 2 mA cm For pure ultrasound operation we recommend the following procedure 1 Select the operation mode by pressing the Sono key 2 By pressing the Sono key once you reach the ultrasound frequency 1 MHz By pressing the Sono key twice you reach the ultrasound frequency 3 MHz The therapy time will be set to 10 minutes If needed modify the therapy time 5 By pressing the Continous Pulsed key select the pulse wave 1 5 1 10
46. he same time a sedative effect on the Nervus sympathicus by this it indirectly stimulates the blood flow in case of hypertonia of the vascular walls Almost all therapies of painful functional disturbances can be initiated with this frequency The first interference current that appears is Sedat gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 33 4 1 2 Myomot Interference current Myomot 50 Hz stimulates the skeletal muscles The dynamics of the area being stimulated and of the intensity generate a special physiological kind of muscle contraction As opposed to the classical method the individual muscle fibers are activated alternately By this a fatigue effect through continuous contractions is avoided Proceed as indicated in chapter 4 1 You must press the Interference current key twice 4 1 3 Vegetative Stimulation I Interference current Vegetat Stim I 2 5 Hz bis 25 Hz leads to normal tonus of the vegetative nerve system accompanied by vibrations This frequency range is also indicated in case of peripheral venous circulatory disturbances and blockings The rhythmical muscle contractions press out the contents of veins In addition with low frequencies there is a stimulation of the sympathic nervous system Lullies Proceed as indicated in chapter Kapitel 4 1 You must press the Interference current key three times 4 1 4 Vegetative Stimulation II Interference current Vegetat Stim II 10 Hz leads to a norma
47. hown on the display 6 The frequency traverse can be stopped by pressing the FIX key 7 The fixed frequency will be shown on the display 8 The therapy time continues to pass 9 Press the white Soft key frequency 10 The frequency can be readjusted by turning the Modification knob 11 Press the FIX key again 12 The frequency traverse will be released again 13 The triad gong will sound three times after the therapy time expires 4 4 6 Galvanic Current and Iontophoresis The galvanic current is used to stimulate the circulation in the area to be treated It has alleviating characteristics and can be recommended as a preparing measure for electrogymnastics see chapter 4 4 7 Furthermore with iontophoresis it serves for percutaneous penetration of drugs Here the procedure is the same as in case of galvanization The quantity of the penetrated drug depends on the purity of its solution the size of the electrodes the intensity of current the polarity and the penetration time The knowledge of the loading of the drug is especially important for a successful treatment Acids are always transported to the anode bases to the cathode gbo Medizintechnik AG 2004 Version 1 9 40 STEREODYNATOR 928 Notes e Turn the Intensity regulator only until the patient notices a slightly increasing current e Apply the intermediate layers dripping wet e In case of anode effective drugs the layer of the anode will be saturated wi
48. ial the relative humidity should be at least 30 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 1 kV for input output lines environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment magnetic field IEC 61000 4 8 Voltage dips short lt 5 U lt 5 U Mains power quality should be that of a interruptions and voltage for cycle for cycle typical commercial or hospital variations on power supply 79596 dip 79595 dip environment input lines IEC 61000 4 11 40 U 40 U If the user of the equipment requires for 5 cycles for 5 cycles continued operation during power mains 60 dip 60 dip interruptions it is recommended that the equipment be powered from an 70 U 70 U uninterruptible power supply or a for 25 cycles for 25 cycles battery 30 dip 30 dip lt 95 U lt 95 U for 5 s for 5 s 7596 dip 7596 dip Power frequency 50 60 Hz 3 A m 3 A m Power frequency magnetic fields should Note U is the a c mains voltage prior to application of the test level be at levels characteristic of a typical location in a typical commercial or hospital environment gbo Medizintechnik AG 2004 Version 19
49. in the Special types of current menu IG 30 Impulse galvanization with 30 ms single pulse duration IG 50 Impulse galvanization with 50 ms group pulse duration FM Frequency modulation MF Diadynamic current monophas fixe LP Diadynamic current longues p riodes Incontinence Rectangular current for incontinence Press the Menu key Move the scroll bar cursor with the Modification knob to Special types of current Confirm by pressing the white Soft key The content of the display will be shown inversely to indicate that you are in the Special types of current menu Move the scroll bar cursor with the Modification knob to the desired special current type 6 Confirm by pressing the white Soft key Pow rs gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 43 7 The selected current type will be shown on the display 8 Setthe desired modifications 9 Turnon the Intensity regulator and therapy will be started 4 5 1 Impulse Galvanization The impulse galvanization currents are so called shaking frequency currents Hyperemia analgesia and detoning are the main fields of application The current type IG 30 consists of triangular impulses with a pulse duration T of 30 ms and a pause duration R of 50 ms The current type IG 50 consists of rectangular impulses with a pulse duration of 1 ms and a pause duration of 19 ms 50 Hz The rectangular impulses are released in groups with a pulse duration T of 50 ms and a p
50. ing instructions Safety control maintenance work repair work and modifications shall be carried out only by the manufacturer or by service agents authorized by him In case of a failure parts which influence the safety of the device shall be only 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 9 1 Safety Controls 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 especially observed Irrespective of the legal rules or beyond the scope of the Medical Device Directive it is recommended to have the device checked by the manufacturer or by a service agency authorized by him at 12 months intervals The check shall consist of at least the following criteria e Electrical safety check in accordance with the test plan of the manufacturer e Check of the device in respect of external integrity Check of all display and operating elements in respect of damages e Check of all inscriptions in respect of legibility 9 2 Cleaning Disinfection and Care 9 2 1 Current Stimulation Device For cleaning and disinfection of the current stimulation device and its accessories except electrode fleece electrode pockets or felts see chapter
51. itial use the macroporous intermediate layers and pockets made of viscose sponge must be thoroughly washed out under running water to remove manufacturing residues 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 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 completely The sponge pockets or intermediate layers have to be cleaned after the expiration of treatment see chapter 9 2 2 Note The above mentioned applies for the application of suction electrodes accordingly gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 49 Attention 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 t is recommended not to exceed the current density of 2 mA cm in all electrode surfaces In case of galvanization the limiting value is 0 2 mA cm and in case of iontophoresis it is 0 1 mA cm e Do not use one way self adhesive electrodes in case of cur
52. l tonus of the vegetative nerve system accompanied by a shaking Ankyloses and muscular contractions can be mobilized Proceed as indicated in chapter 4 1 You must press the Interference current key four times 4 1 5 Vegetative Stimulation III Interference current Vegetat Stim III 0 1 bis 1 Hz leads to a normal tonus of the vegetative nerve system and it is often combined with Sedat Individual muscle contractions can be generated Proceed as indicated in chapter 4 1 You must press the Interference current key five times 4 1 6 Universal Interference current Universal contains the therapy frequencies from 1 to 200 Hz Proceed as indicated in chapter 4 1 You must press the Interference current key six times 4 1 7 Sedation Modulation Interference current Sedation Modulation contains the therapy frequencies from 100 to 200 Hz Proceed as indicated in chapter 4 1 You must press the Interference current key seven times gbo Medizintechnik AG 2004 Version 1 9 34 STEREODYNATOR 928 4 1 8 Automated programs The electrical stimulus device is equipped with five automated programs to facilitate the adjustment of therapy frequencies and times If you press the respective Program key programs A B and C or select in the Menu the menu entry Programs programs D and E the programs indicated in the table below will automatically run If you wish to select the programs D and E proceed as indicated in chapter Menu special type
53. ly all usual electrodes are connectable in electrotherapy Plate electrodes and rubber electrodes are appropriate for large area treatments The electrode handpiece with fingertip switch and connecting cable has proved effective for diagnostics Current can flow only when the key is pressed Additionally you need an electrode set see chapter 13 Accessories The therapy can be realized without any problem with suction electrodes or plate electrodes 7 1 Electrode Positioning The positioning of the patient and or muscle to be treated is very important The therapy shall always be carried out in a comfortable and relaxed position The joints shall be located 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 l I 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 Put the electrode completely into the electrode pocket so that the pocket protrudes on the open side with about 1 cm After multiple use the electrode intermediate layer or electrode pocket can slightly shrink If the distance of about 1 cm is no longer given the intermediate layer or pocket must be replaced Prior to the in
54. nous that means they have an intense effect The stimulation effect can be shifted towards electrode I or II by pressing the end ex I key or end ex Il key By that the stereodynamic interference currents are exogenous that means that the stimulating effect takes place on the body surface As the following figure shows the actual status of stimulation shifting is indicated below the current type i Notice The stimulation shifting can not be switched over during therapy gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 27 C 05 00 Therapy Timer Care n ME Min Sek 5 10 20 x 12 5 is FIX 50 er a Frequency m peak Hz EN CV CC Myokinetics B SAM MM dme basi EAU NER y autom O endogenous l endogenous II eX e etd etd et Figure 16 Stimulation shifting switched off 3 1 10Menu Men amo Menu key The black Menu key serves for calling the menus a O Soft key Within the menu the white Soft key serves as a confirmation key Figure 17 Menu key and Soft key A soft key is a key with a context sensitive meaning The according meaning of the key is shown on the display right next to the key The main menu puts the following menus at your disposal Special current types see chapter 4 5 Programs see chapter 3 1 11 Application with Electro Therapy see chapter 4 2 Application with ultrasound see chapter 4 3 Device settings see ch
55. ns operation of the temperature range 10 C 40 C device relative humidity of air 30 75 96 transport and temperature range 5 C 50 C storage relative humidity of air lt 90 non condensing Current types Galvanic current Strong muscle stimulation according to Eichhorn Diadynamic currents Ultra stimulation current micro stimulus current Faradic current high voltage Universal Therapy Transcutaneous electrical nerve stimulation TENS Burst Trans electr nerve stimulation in impulse groups MF I VII Middle frequency currents Impulse galvanization Frequency modulation Diadynamic currents Incontinence Rectangular current incontinence Sedat Interference current 200 Hz Myomot Interference current 50 Hz Vegetat Stim I Interference current 2 5 25 Hz Vegetat Stim Interference current 10 Hz Vegetat Stim Interference current 0 1 1 Hz Universal Interference current 200 Hz Sedat Mod Interference current 100 200 Hz GYM current surged MF current in single and three channel mode GYM Training modulated MF current in single and three channel mode Burning mode modulated MF current in single and three channel mode Therap ultrasound module Continuous and pulse mode 1 5 1 10 1 20 Ultrasound frequency 1 3 MHz Ultrasound power max 3 W per 1 cm radiating surface at 1 MHz max 1 5 W per 1 cm radiating surface at 3 MHz Ultrasound probe 2 5 cm and 5 cm radiating s
56. nt see chapter 7 1 Electrode 2 Connect the accessories with the according socket on the right side of the device 3 Select the current therapy type by pressing the according Current type key or by selecting the Special current types menu or by selecting the Application menu 4 Setthe required modifications 5 Turn on the Intensity regulator up to the sensitive tolerance limit as far as it has not been described otherwise 6 The intensity of current is shown on the display 7 Atthe end of therapy time the triad gong will sound three times Notes e Before switching over from one current type to another you have to set the Intensity regulator to 0 0 e Atthe beginning the polarity of mono polar current types is always positive e For the visually handicapped the multiple allocation keys can be dubbed with a signal for the first current type MF key HV key Tens key and Tens Burst key see chapter 2 3 1 e In the case of multiple allocation of the current type keys the LED flashes during the selection of the according currents This shows that the key remains active 4 4 1 Diadynamic Currents The current type DF serves for the treatment of sympathicotonic states e g spastic circulatory disturbances It produces a local analgesia in the area to be treated With it e g the symptoms hardening gt pain hardening can be eliminated for a while gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 37 T
57. o 014 0 928 U Part No 014 0 928 V Ultrasound therapy module Suction application module Description Bow electrode Handle with finger tip Rubber electrode 3 x 4 cm Rubber electrode 6 x 8 cm Rubber electrode 8 x 12 cm Part No 011 0 0024 45 38 401EH725 45 38 880EH725 45 38 898EH725 45 38 492EH725 45 38 468EH725 45 38 435EH725 45 38 518EH722 45 38 526EH722 45 38 500EH722 Tin plate electrode 9 x 12 cm Patient cable Suction electrode 34 mm Suction electrode 70 mm Suction electrode 50 mm Ultrasound probe 2 5 cm 023 0 0140 Ultrasound probe 5 cm 023 0 0141 Vaginal electrode 014 0 0006 Rectal electrode 014 0 0007 45 38 708EH725 45 38 716EH725 45 38 724EH725 45 38 856EH722 EC medical devices directive 93 42 EEC Star electrode small Star electrode standard Star electrode large Stereo suction electrode Annex II of the directive 93 42 EEC IIb according to MDD appendix IX TUV Product Service in Munich Germany with the registration no 0123 none January 1 2006 Dr Eberhard Keck CEO Version 19 STEREODYNATOR 928 7 Notations Times New Roman in type size 11 descriptions and explanations Arial in type size 10 functions and keys of the current stimulation device Lucida in type size 11 text appears on the display of the current stimulation device Descriptions text appears on the display next to the soft key Pictographs Attention Warnings which have to be observed by all means
58. ording times change in the current type display and will not be shown by the T and or R display 3 1 7 Pulse Parameter Pulse rise Figure 11 Pulse rise key as displayed on the screen The stimulation impulses can be modified in 5 steps to a rectangular trapecoidal or triangular shape Setting possibilities for the pulse duration and pause duration 4 0 ms 16 ms T R Figure 12 Pulse duration key as displayed Figure 13 Pause duration key as displayed on the on the display Pulse duration T and pause duration R can be modified before and during the treatment display e Ifin case ofa current type Pulse duration T and Pause duration R are modifiable only T and R will be shown under the current type diagram The numerical values are shown above the Pulse duration key and or the Pause duration key e fin case of a current type Pulse duration T and Pause duration R are not modifiable the letters T and R will be shown with the according numerical values under the current type diagram e The pulse and or pause duration can be modified via the frequency by pressing the FIX key The according times change in the diagram and are not shown above the T and or R keys e If for pulse duration T or pause duration R there have been set higher values than 9000 ms the unit will change from ms to s 3 1 8 Therapy Time D Therapy Timer 05 00 amp m se 10 20 Figure 14 Therapy time key as displayed on the displa
59. rent flow will be more concentrated and more localized than when applying large electrodes The application area depends on the clinical picture gbo Medizintechnik AG 2004 Version 1 9 50 STEREODYNATOR 928 Attention For current types for which there exists the threat of cauterization currents with galvanic portion the maximum recommended current density is 0 5 mA cm electrode surface In case of galvanization the limit value is 0 2 mA cm and in case of iontophoresis 0 1 mA cm Conductive rubber electrode 3 cm x 4 cm 24mA 2 4 mA 1 2 mA Conductive rubber electrode 6 cm x 8 cm 96mA 9 6mA 4 8 mA Conductive rubber electrode 8 cm x 12 cm 192mA 19 2 mA 9 6 mA Plate electrode 9 cm x 12 cm 108 cm 216mA 21 6mA 10 8 mA Table 1 Maximum Current of conductive rubber electrodes and plate electrode gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 7 3 Three pole electrodes The triple pole electrodes can be used for stereodynamic interference currents The conductive rubber electrodes of the three circuits are placed in two flexible three pole star electrode sets I and II and attached to a common patient cable There are three sizes available small standard and large Electrode pockets are necessary for the application and fixing material for the bandage see accessories Each stereodynamic electrode set is placed into a well wetted pocket so that the black conductive rubber electrode
60. rents with galvanic portion there is the danger of acid burns 7 1 1 Monophase Electrode Techniques In case of monophase techniques direct and indirect stimulation are distinguished Generally the cathode is used as a stimulating electrode In case of direct stimulation it is applied on the nervous stimulant point all muscles react and in case of indirect stimulation on the muscle stimulant point only the stimulated muscle reacts Apply the electrolytically inactive electrode mostly a large anode distally For differentiated therapeutic treatments and easy electro diagnostics it is recommended to use the electrode handpiece as a electrolytically active electrode 7 1 2 Biphase Electrode Techniques A characteristic of this method is that both mostly equally large electrodes are applied on the muscle to be stimulated or on the functionally related muscle group The cathode is to be placed distally 7 2 Single Pole Electrodes Single pole electrodes are applicable for all therapy currents For large area treatment we recommend to use plate electrodes for all other applications self cut electrodes The last mentioned need an electrode connector for current supply Both electrode types have to be connected to the device with a patient cable The electrode positioning is realized as described in chapter 7 1 Electrode positioning The electrode size depends on the area that should be passed by the current Under small electrodes the cur
61. s 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 three circuits can transpose and optimal stereodynamic 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 You can also use triple pole suction electrodes if your device is equipped with a suction application aid The above mentioned also applies to the application with suction electrodes gbo Medizintechnik AG 2004 51 Version 1 9 32 STEREODYNATOR 928 7 4 Suction Electrodes Instead of the above mentioned electrodes suction electrodes can be used for faster application The device technics necessary for this is described in chapter 3 2 Integrated Suction Application Aid Achtung e For current types for which there exists the threat of cauterization currents with galvanic portion the maximum recommended current density is 0 5 mA cm elec
62. s of current Prog Prog Prog A B C O OECO Figure 25 Program keys Automated Therapy time Effects Program 3 min 10 min 2 min 200 Hz Sedat 50 Hz 200 Hz Sedat analgesia Myomot hyperemia muscle stimulation 200 Hz Sedat 2 5 25 Hz 200 Hz Sedat analgesia Vegetat Stim I venous relaxation hyperemia C 200 Hz Sedat 10 Hz 200 Hz Sedat analgesia hyperemia Vegetat Stim II mobilization of ankyloses and muscular contractions 200 Hz Sedat 0 1 1Hz 200 Hz Sedat analgesia Vegetat Stim III hyperemia vegetative stimulation 200 Hz Sedat 1 Hz 200 Hz Sedat analgesia Vegetat Stim IV hyperemia vegetative stimulation Table 7 Automated programs Proceed as indicated in chapter 4 1 Notices e The therapy time of an automated program always takes 15 minutes and cannot be modified e During therapy it is not possible to switch over between the automated programs e The three types of interference currents are shown on the current type window of the display The actual type of current is clearly displayed Sedat Vegetat Stim III Sedat e Incase of the automated programs frequency cannot be stopped gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 35 4 2 Menu Application With Electrotherapy This menu driven additional program facilitates stimulation therapy by selecting area of application and mode of action 1 2 3 4 5 6 7 8 9 Press
63. t be used in the following instances Patients with a fever Infectious diseases dermatological conditions Blood coagulation problems Pregnancy Tuberculosis stomach ulcers Peripheral vascular disease Tumors circulatory instability and coronary diseases Acute rheumatoid arthritis Diabetes mellitus Septic inflammation Following recent thorium X treatment or x ray depth treatment The following organs must not be treated directly Eyes Medulla Laminectomy related spinal incisions Heart lungs Anesthetized areas gbo Medizintechnik AG 2004 STEREODYNATOR 928 Version 1 9 STEREODYNATOR 928 57 11 Explanation of the Signs Used C 0123 CE conformity sign Attention Observe the instructions for use Application part ungrounded protection degree Type BF Ultrasound probe connection Patient cable connection Vac cB Suction electrode I connection Suction electrode II connection This product complies with WEEE Directive 2002 96 EG x waste electrical and electronic equipment Separate collection for electrical and electronic equipment xi gbo Medizintechnik AG 2004 Version 1 9 58 STEREODYNATOR 928 12 Technical Data Mains voltage and frequency 100 120 230 240 V 48 62 Hz 120 V max 3 3 A 230 V max 1 65 A 120 V T3 2 A 230 V TL6 A max 200 mA Output voltage max 200 V LCD backlighted 320 X 240 dots full graphic CR 2032 HGR 2032 OC environmental conditio
64. th the solution of the drug and in case of cathode effective drugs the same is made with the layer of the cathode e The electrode layers have to be washed out thoroughly after the expiration of ionthophoresis There should not remain any residuals see chapter 9 2 2 Attention e n case of iontophoresis do not exceed the intensity of current of 0 1 mA cm active electrode surface e In case of galvanization do not exceed the intensity of current of 0 2 mA cm active electrode surface e The patient must not feel a burning 4 4 7 Faradic Current Neofardic currents are applied for electrogymnastics of the faradising or restimulating muscles This applies especially for atrophies due to inactivity after longer periods of inactivity and for post operation electrogymnastics to avoid thromboses Note Turn the Intensity regulator until the stimulation effect becomes obvious 4 4 8 Transcutaneous Electrical Nerve Stimulation The TENS current types are applied in case of chronic and also acute pain syndromes such as the post operative pain birth pain and acute post traumatic and rheumatic pain This includes neurological internal surgical traumatological orthopedic sports medicine and gynecological areas There are five current types available You can change from TENS I to TENS V by repeatedly pressing the Tens key TENS with fixed therapy frequency TENS I The current type TENS I has a frequency of 100 Hz and a paus
65. the handling The STEREODYNATOR 928 is equipped with several programs which automatically adjust the treatment frequency and the treatment time Treatment frequencies particularly for sedation myokinetics and vegetative stimulation are available The stimulating effect can alternatively be administrated endogenously or exogenously During endogenous application the interference is generated through superposition of the electrical circuits in the body This allows an intense effect During exogenous application the interference is created in the medical device The stimulating effect takes place directly underneath the electrodes on the body surface In addition to the three circuit interference current STEREODYNATOR 928 offers a complete selection of single circuit currents for all known therapeutic procedures gbo Medizintechnik AG 2004 Version 19 STEREODYNATOR 928 13 The STEREODYNATOR 928 is particularly suitable for Pain therapy with three dimensional interference current Muscle toning and muscle detoning Galvanization and iontophoresis Pelvic floor stimulation Treatment of urinary and fecal incontinence Neurodiagnostic examination with galvano palpations Treatment of paralyses with complete or partial muscular degeneration Treatment of atrophies due to inactivity or weakened muscles after longer periods of inactivity Electrical stimulation therapy without electrolytic side effects and only slight muscle fatigue
66. therapy time the current to the patient automatically is switched off and the intensity is set to 0 0 Display All devices are equipped with a high resolution graphic display The selected stimulation current type is shown graphically The parameters are also shown They are modified using the white modification keys located around the display or by the modification knob LED keys Optical user support is furnished in the form of LED lights incorporated into the keys flashing key was selected and remains active constantly lit key is active and operational notlit key is not active and not operational Menu In addition to the One Touch operation a user guided method for selection can also be chosen by way of the menu By selecting the desired effect analgesia hyperemia muscle toning muscle detoning and the site of action head and neck spinal column and trunk upper extremities lower extremities the appropriate current type is automatically selected and a recommendation for the electrode application is provided The menu also allows the use of special types of current gbo Medizintechnik AG 2004 Version 19 STEREODYNATOR 928 15 1 3 Short Instructions Types of therapy i i rrents Therapie ee amo que ame 50 125 Frequency mA peak Hz CP UR FEV ame game aae cv MM ARAN AMA M VW VV VIN VV ns end ex end Galv F1 Tens ex Il T
67. tor drill hole and pin diameter 4 mm in case of use with older accessories with new cable to the patient 45 38 245EH725 Bow electrode 011 0 0024 Conductive rubber electrode with cable 3 cm x 4 cm fleece pockets small 45 38 880EH725 Conductive rubber electrode with cable 6 cm x 8 cm fleece pockets medium 45 38 898EH725 Conductive rubber electrode with cable 8 cm x 12 cm fleece pockets 45 38 203EH725 or viscose sponge pockets 22 73 621Q1408 45 38 492EH725 Contact gel Lectro Sonic 250 ml 45 39 128EH725 Device cart UNICAR 900 014 0 0008 Diagnostic set patient cable sheet tins with cutting template intermediate fleece 45 39 177EH 725 layers electrode connector connecting terminals rubber straps fixing buttons Diagnosis sheet I T curves 100 pieces 71 21 635E2200 Diagnosis sheet trigger points trunk 100 pieces 71 21 643E2200 Diagnosis sheet upper extremities 100 pieces 71 21 650E2200 Diagnosis sheet lower extremities 100 pieces 71 21 668E2200 Elastic tape with closure velcro 70 cm long 7 5 cm wide 2 pieces 45 38 997EH725 Electrode handpiece with finger tip switch 45 38 401EH725 Electrode set for electrode handpiece 45 38 450EH725 Electrode pockets small 10 pcs for star electrode small 49 07 317E3020 Electrode pockets standard 10 pcs for star electrode standard 49 07 309E3020 Electrode pockets large 10 pcs for star electrode large 49 07 325E3020 Electrode intermediate layers small diameter 36mm 12 pieces
68. trode surface In case of galvanization the limit value is 0 2 mA cm e Incase of iontophoresis don t use suction electrodes Suction electrode Max current value Galv Electrode plate small 12 mA 1 2 mA Electrode plate standard 24 mA 2 4 mA Electrode plate large 56 mA 6 mA Table 2 Maximum current of the suction electrodes 7 5 Electrode Handpiece The electrode handpiece is applicable for small local treatments and simple electro diagnostics see also chapter 7 1 1 Monophase Electrode Tcs The electrode handpiece electrolytically active electrode is firmly connected to the patient cable With a second wire the plate electrode is connected electrolytically inactive electrode In addition an electrode set is necessary which consists of metal shaft electrode pockets and rubber rings see chapter 13 Accessories The following procedure is advisable 1 Connect the electrode handpiece 2 The electrode handpiece will be recognized by the device Note The fingertip is without any function in the therapy mode The selected current is issued independently from the switch position gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 53 8 Troubleshooting The following exceptions are signaled by the current stimulation device optically via the display and acoustically Most of the exceptions can be cleared by following the displayed instructions In general an exception is characterized by the follo
69. ts of clinics as well as in modern well equipped private practices The devices with interference current represent a continued development based on the 8 series equipment All accessories of the 8 series can also be used with the 9 generation in the same manner A suction application aid for vacuum therapy as well as a module for ultrasound therapy with continuous and impulse ultrasound waves are optionally available The control elements for suction application aid and ultrasound have already been integrated on the keyboard A stereodynamic interference current is generated through the superposition of three middle frequency currents flowing in different directions The stimulating lower frequencies are already generated through interference of two phase shifted circuits in the area being stipulated The additional third circuit generates as opposed to classical interference methods on one side a slow change in intensity and on the other side a rhythmic shifting of the interference field These dynamics of the stimulation location and the intensity dynamics decrease the habituation effect and therefore improve the therapeutic effect The STEREODYNATOR 928 uses the three dimensional interference method The special characteristics are as follows Local stimulation effect Multi site stimulation effect Intensity dynamics Dynamic behavior of stimulation site coupled with endogenous exogenous stimulation shifting Automated programs improve
70. tween circuit 1 and circuit 2 the left bar between circuit 2 and circuit 3 and the right bar between circuit 1 and circuit 3 gbo Medizintechnik AG 2004 Version 1 9 22 STEREODYNATOR 928 The red LEDs in the center of the star are lit when current is flowing Without current flowing all red LEDs are turned off The following table explains the acoustic signals and their meaning Cause Confirmation beep e incase of an admissible key operation Information sound 1 e incase of disconnecting the patient plug during operation Alarm approx 2 s in case of insufficient electrode contact and dropping electrodes during therapy CC in case of unintended current increase during therapy CV x x e incase ofan inadmissible key operation Triad gong 1x at the beginning of the automatic check to control the gong 3x at the end of therapy if in manual operation the key has not been pressed for 2 min if in CV there was no current flows for 2 min Table 4 Acoustical user support 3 1 2 Intensity Regulator The Intensity regulator serves for setting the current intensity It is furnished in the form of a incremental encoder The current increases by turning right in direction and it is reduced by turning left in direction The numerical value is shown on the display The current value can be set in the following steps e Galvanic Current Micro Stimulus Current gt 0 1 mA e all the rest of therapy current types gt 0
71. ubber electrode small 3 x 4 cm 3 7 mA Rubber electrode standard 6 x 8 cm 15 mA Rubber electrode large 8 x 12 cm 29 mA Suction electrode small 6 cm 1 9 mA Suction electrode standard 12 cm 3 6 mA Suction electrode large 28 cm 8 mA gbo Medizintechnik AG 2004 Version 1 9 36 STEREODYNATOR 928 4 3 Menu Applications with ultrasound Tthe additional program Menu includes the Application with ultrasound for the single circuit therapy The procedure is described correspondingly in the previous chapter The only difference is by point 6 there appears a list of indications not a list of modes of action 4 4 One Touch Operation The following therapy current types are assigned to keys on the membrane keyboard DF Diadynamic current diphas fixe CP Diadynamic current modul en courtes p riodes SMS Strong muscle stimulation according to Eichhorn MF I to VII Middle frequency I to VII UR Ultrastimulation current HVItoV High voltage I to V Galv Galvanic current F1 Faradic current TENS I to V Transcutaneous electric nerve stimulation I to V TENS Burst to V Transcutaneous electric nerve stimulation in impulse groups Ito V Micro Micro stimulus current T R Universal Therapy Chapter 4 1 is also valid correspondingly for the therapy with single circuit currents The procedure for the single circuit therapy is as follows as far as it has not been described otherwise 1 Put the electrodes on to the patie
72. urface Suction application module Suction At least 150 mbar in maximum position Suction massage frequency 0 60 pulses per minute dependent on the device type and or whether the device is equipped with therapeutic ultrasound modules and suction application modules gbo Medizintechnik AG reserves the right to modify the design and specification without prior notice gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 Current Galvanic current Ultrastimulation current Faradic current Strong muscle stimulation Micro stimulus Universal therapy Diphas fixe Courtes p riodes Middle frequency current 8 kHz MF I surged MF II sinus surged MF III 50 Hz MFIV 3 10Hz MF V 10 30Hz MF VI MF VII 100 200 Hz High voltage currents HV II 3 10 Hz HV III 10 30 Hz 30 60 Hz 100 200 Hz Tens currents Tens I 100 Hz 3 10Hz e d 5 30 60 Hz AE 3 HV 1 50 Hz DE 04 HVIV 0 04 HVV Tens II 2 59 Frequency Maximum output Max output in Hz m by CV in current d CC in V peak MA peak EE NE NN 70 Pulse Pause duration T in duration aco R in ms in 5 0 28 6 Grafics 1 0 3 0 17 0 19 0 2 6 50 70 70 100 Hz 250 250 D 250 0 02 0 5 ms 1 5 Umen 7 TE 325 5 28
73. wing sequence of events 1 The device does not react on a command given by a key or by turning a regulator 1 A warning signal is sounded 2 An error message is displayed 3 If the user does not react according to the displayed messages the most recent faultless device condition is restored after a time out Global Error Conditions Error messages Error in the 386 EX module Error DSP is not responding Error while booting the DSP Error while writing to the DSP Task Timeout Overheating Defect of the power amplifier Turn off unit and call service 999 9 9 9 Suggestions Turn off and turn on unit A full selftest of all device functions is performed and the unit is reinitialized If the unit does not come up in normal state please call your local service Application Errors Error message Wrong electrode Suggestion You have connected an unsuitable electrode Please use a suitable electrode for the current type of your choice see chapter 7 Electrodes Error Messages Check placement of electrodes Patient cables are shortcircuited Suggestion The current loop to the patient is cut off Please check electrodes cables and connectors gbo Medizintechnik AG 2004 Version 1 9 54 STEREODYNATOR 928 9 Maintenance Functionality reliability and safety characteristics of the current stimulation device are only guaranteed in case of proper use in accordance with the operat
74. with the Modification knob to Device settings 4 Confirm by pressing the white Soft key 5 Youare in the Device settings menu 6 Move the scroll bar with the Modification knob to the device setting to be changed 7 Confirm by pressing the white Soft key 8 Move the cursor with the Modification knob to the desired value 9 Confirm by pressing the white Soft key 10 Exit the Device settings menu by pressing the black Menu key 11 On the display the Main menu appears again J Note On Vacuum default intensity setting the pump is switched off if no suction electrodes are connected If suction electrodes are connected the pump will run corresponding to the set value 2 3 2 Basic Settings of the Current Types Upon pressing the desired current type key the default settings for this current type are set Altered parameters are canceled by pressing the current type key again i e the default settings are available again Modifications will not be stored J Note If the default settings for the therapy time have been modified by therapy time adjustment the new settings are permanently stored and recalled each time after pressing the current type key gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 21 3 Description of Function 3 1 Operating Notes Each current type can be modified specifically Certain modifications can be set only when the intensity control is 0 0 Other modifications can be set also during therap
75. y gbo Medizintechnik AG 2004 30 Version 1 9 26 STEREODYNATOR 928 You can set the therapy time as follows 1 Depending on the current type an appropriate therapy time will be suggested 2 If you want to change the therapy time press the Therapy time key The time can be modified in steps of 1 minute The maximum therapy time to select is 40 min see chapter 2 3 1 Device Settings 3 Set the desired therapy time e By repeatedly pressing the Therapy time key or e By using the Modification knob if Notes e The selected or given therapy time passes only if the Intensity regulator is turned out of its 0 0 position e The therapy time can be modified during the treatment e At the end of the therapy time the stimulation current to the patient will be faded out automatically within 10 s The Intensity automatically reverts to 0 0 after cutting off the stimulation current to the patient The selected current type and possible modifications will be kept The therapy time setting remains on 0 min The triad gong sounds 3 times see also Table 4 Acoustical user support The therapy can be continued by setting a new therapy time and turning on the intensity Pressing again the same current type key leads to the basic setting of this current type X X X X X 3 1 9 Stimulation shifting end end ex ex Il Figure 15 stimulation shifting keys In the basic setting the stereodynamic interference currents are endoge
76. y Please observe the acoustical and optical user support 3 1 1 Optical and Acoustical User Support Optical user support is furnished in the form of LEDs incorporated into the keys E Condition of the key Flashing key was selected and remains active Constantly lit key is active and operational not lit key is not active and not operational Table 3 Optical user support Furthermore optical user support is furnished on the display e A modification which is just being changed is shown inversely e fin case of a current type Pulse duration T and or Pause duration R are modifiable only the letter T and or R will be shown under the current type diagram The numerical values are shown next to the Pulse duration key and or Pause duration key see Figure 12 and Figure 13 e Ifin case ofa current type Pulse duration T and or Pause duration R are not modifiable the numerical values are shown under the current type diagram Star display Interferenz Figure 2 Three ray star display The three ray star display has multiple functions and serves as stimulation frequency display and electrode contact display In case of single circuit mode the star display is switched off The green luminous bars indicate the stimulation frequencies In case of the three circuit mode all three bars are lit If stereodynamic interference current is applied they show the beat frequencies effective in the body The vertical bar shows the interference be
77. y can be changed by pressing the Polarity key By this the current will also be faded out and restored again within 10 s Monophase current _ O Figure 4 Monophase current The current flows only in one direction Biphase current Figure 5 Biphase current Each pulse consists of two parts with different polarities Current display in CC Mode cc Figure 6 Operating mode key as displayed on the screen The current set with the Intensity regulator remains constant even when the patient resistance changes The display shows the peak value that is also constantly shown during puls pauses A dynamic current limiter reduces the released current and or the voltage to such a minimal deviation from the set value that this will not lead to any comfort losses for the patient even in irregular application modes Therefore the operating mode CC can be used without any comfort limitations There are no voltage sensations even in case of insufficient electrode contact or dropping electrodes gbo Medizintechnik AG 2004 Version 1 9 24 STEREODYNATOR 928 Display in CV Mode us CV Figure 7 Operating mode key as displayed on the screen Constant voltage is set with the Intensity regulator The value of the current to the patient depends on the patient resistance The value of the Voltage is shown in V peak f Note In CV Mode the intensity will be shown in V peak not in mA peak 3 1 4 Surge Parameters Some curr
78. z Monophas fixe MF Longues p riodes LP Impulse galvanization galvanization IG 50 surged F m F Incontinence Interference currents2 req odu M eda 00 5 10H l 2 ency lation 7 14 Hz z 5 Hz Hz 0 Hz u Sedat Rn 200 H NT Myomot 1 50 Hz Vegetat Stim I 1 2 5 2 Vegetat Stim II 1 Z Vegetat Stim III 0 1 1 Universal 1 1 20 Sedat Modulation h 100 200 Hz 50 Hz ms 10 30 Hz ms ms 100 200 H a ms lo o L I a S a E S T 30 50 ms z Z il 70 ms L 2 0 0 5 ms 10 S 0 328 0 2 0 98 0 328 0 0 100 100 MI icis EH is 00 3 0 10 pr RE BE a c RE Cup w x 70 70 0 5 70 9 0 4 7 14 70 70 142 4 The output current is reduced to 100 mA gbo Medizintechnik AG 2004 Version 1 9 STEREODYNATOR 928 61 13 Accessories STEREODYNATOR 928 014 0 928 U inclusive ultrasonic therapy module inclusive 1 ultrasonic transducer 5 cm inclusive 1 contact gel 250 ml STEREODYNATOR 928 014 0 928 UV inclusive ultrasonic therapy module inclusive 1 ultrasonic transducer 5 cm inclusive 1 contact gel 250 ml and inclusive suction application aid Adapter connec

STEREODYNATOR 928 - Frank`s Hospital Workshop

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