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12

HiToP

®

184



gbo Medizintechnik AG

Version 2.0

2 Start of operation

2.1 Transport and installation

The High Tone Power Therapy device is a portable unit. In the base plate there is a carrying handle in the
form of a recessed grip. Each plane surface is appropriate to place the unit,. A wall distance of at least 20 cm
has to be observed. The device must not be placed in front of radiators.

The device for High Tone Therapy corresponds to the regulations EN 60601. It is a device of protection class
I. Within the scope of the MDD the High Tone Power Therapy device belongs to class IIa

(see also chapter

8.3.1 Cleaning the Device

For cleaning and disinfection of

the current stimulation device and its accessories do not use any agents

containing higher portions of phenol derivatives, alcohol, compounds of chlorine or peracetic acid. It is
recommended to use disinfectants on aldehyde basis. Never use an abrasive. Fingerprints on the display
should be cleaned with a dry cloth or some isopropanol.

Warning!



Unplug the mains plug out of the socket prior to cleaning and disinfection.



Do not clean the device under running water and do not use liquid abrasive cleaner!



The device is not suited for heat sterilization or for the sterilization with gases.

The

HiToP



184

is suited for wiping disinfection. Make sure that no liquids soak into the device. Under no

circumstances the plug or socket must get wet. Do not sprinkle the device for cleaning or disinfection. The
device is not suited for hot sterilisation or sterilisation with gases.

2.1.1 Cleaning the Elastic Straps

The elastic straps can be washed in a washing machine. Please observe the washing instructions of the
instruction label.

2.1.2 Cleaning the Electrodes

You can clean the rubber electrodes after a treatment with some warm water (appr. 40°C) and a soap suds on
the conductive (black) side. Dry the electrodes with a cleaning cloth or let them air-dry. The cleaning process
removes the film left by the Aloe spray or the contact spray and the electrodes will regain a good
conductivity.

!!

Note!

The conductivity of the electrodes is optimized by the use of a certain amount of graphite.
Consequently, when using and cleaning the electrodes, black color may come off.

2.1.3 Disinfecting the Electrodes

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Summary of Contents for HiToP 184

Page 1: ... gbo Medizintechnik AG Version 2 0 High Tone Power Therapy Device HiToP 184 Instruction manual ...

Page 2: ... 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 gbo Medizintechnik AG Kleiststrasse 6 D 64668 Rimbach Phone 49 6 25 3 808 0 Fax 49 6 25 3 808 245 E Mail info gbo med de Internet http www gbo med de Version 2 0 Date of issue December 14...

Page 3: ...ning Warnings which have to be observed by all means Caution Observe the instructions for use Note Information that will facilitate your work Glossary Stimulation frequency Frequency with which the frequency band is passed in a cyclic way between the lower and upper cut off frequency in the SimulFAM X application Scan range Range between the upper and lower cut off frequency If the lower and upper...

Page 4: ...N 12 2 1 Transport and installation 12 2 2 Connection and switch on 12 2 2 1 Voltage selection and fuses 13 2 3 Placing out of operation 13 2 4 Settings 14 2 4 1 The main menu 14 2 4 2 Basic and unit settings 14 2 4 3 Modification of the unit settings 15 2 4 4 Modification of the basic settings 16 2 4 5 Cable Check 18 2 5 Intensity monitoring 18 2 5 1 Intensity monitoring active 19 2 5 2 Deactivat...

Page 5: ...UNIT 37 5 1 Therapy I 37 5 2 Therapy II Therapy III 38 5 2 1 Selection without 39 5 2 2 Selection of channel I channel II channel III channel IV 40 5 2 3 Selection SimulFAM X 40 5 2 4 Selection nerve block 42 6 ELECTRODES 43 6 1 Hints for self Adhesive Electrodes 43 6 2 Electrode positioning 44 6 3 Multiple logitudinal whole body treatments in parallel 45 7 BEHAVIOR IN CASE OF FAILURES 46 8 MAINTE...

Page 6: ...6 HiToP 184 gbo Medizintechnik AG Version 2 0 11 TECHNICAL DATA 52 12 ACCESSORIES 53 INDEX 52 ...

Page 7: ...cy sine waves The therapy is absolutely free of d c components There are four channels available The frequency range used comprehends 3 octaves the range of 4096 32768 Hz The therapy frequency is scanned with a defined frequency This method is called SimulFAM for Simultanous Frequency Amplitude Modulation In the following the basic method is divided into two different ones SimulFAM i A slow freque...

Page 8: ...320 x 240 pixel resolution The parameters and measuring values of the selected current type are shown there 1 5 Optical and acoustical user support 1 5 1 Optical user support Optical user support is given in the form of LED lights incorporated into the keys LED key position flashing key was selected and remains active constantly lit key is active not lit key is not active Table 1 Optical user supp...

Page 9: ...0 20 Hz 20 200 Hz 10 Hz 20 Hz 100 Hz fmin fmin fmax fmax I II III IV HiToP 184 Therapy time Frequency fixing Modification knob Surge parameter CD Module Function key SimulFAM i Intensity regulator Figure 1 Device view I II III IV Figure 2 Device view from the right SimulFAM X Bar display SimulFAM i Bar display Application part ungrounded safety degree BF Caution Observe the instruction for use Pat...

Page 10: ... The activated channel is shown inversely Note If the intensity regulator is not advanced within the next 10 sec and or another type of current is selected the inverse display will be extinguished After advancing the intensity regulator the following note will appear Select channel Activate the desired channel again 8 Advance the Intensity regulator 9 On the display the message appears Increase in...

Page 11: ...ed channel is shown inversely 9 Select a current type of SimulFAM X by pressing the keys on the left of the display 10 The basic setting of the current type is set automatically Note If the intensity regulator is not advanced within the next 10 sec and or another type of current is selected the inverse display will be extinguished After advancing the intensity regulator the following will appear S...

Page 12: ...ug out of the socket prior to cleaning and disinfection Do not clean the device under running water and do not use liquid abrasive cleaner The device is not suited for heat sterilization or for the sterilization with gases The HiToP 184 is suited for wiping disinfection Make sure that no liquids soak into the device Under no circumstances the plug or socket must get wet Do not sprinkle the device ...

Page 13: ...ctrodes leave to soak and wipe off with a lint free cloth Please follow the recommendations of the manufacturer We recommend Bacillol AF for the disinfection of the electrodes Note The conductivity of the electrodes is optimized by the use of a certain amount of graphite Consequently when using and disinfecting the electrodes black color may come off ...

Page 14: ... medical device for high frequency heat therapy damage of the device or a threat to the patient cannot be excluded As a rule a distance of 3 m is sufficient 2 2 Connection and switch on The basic setting of the High Tone Power Therapy device has been set for a supply voltage of 230 V If needed the device can be switched over to the following supply voltages 230 V standard 115 V Irrespective of the...

Page 15: ...age selector out of the receiver and set the correct mains voltage Connect the High Tone Power Therapy device with the mains cable to a shockproof socket The High Tone Power Therapy device is switched on by the mains switch on 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 automa...

Page 16: ...tings The basic and unit settings are unit specific settings see Table 3 Table 4 and Table 5 These settings should be implemented during assembly by a medical product adviser or a service technician Once the device has been switched on and is ready you can start immediately with the standard settings Note During modification of the settings a return is always possible with the black menu key Retur...

Page 17: ...Effects menu Indication menu Effects menu Table 3 Unit settings 6 Move the scroll bar with the Modification knob to the unit setting to be changed 7 Confirm by pressing the white Softkey Continue 8 Move the cursor or change the value with the Modification knob to the desired value 9 Confirm by pressing the white Softkey Store 10 Exit the menu Unit settings by pressing the black Menu key Return 11 ...

Page 18: ...he therapy time which is preset upon switching on the device or selecting a channel 5 90 min 60 min Slope FAM X basic setting of slope for SimulFAM X which is preset upon switching on the device or selecting a channel 10 200 150 Blocking frequency basic setting of the frequency for nerve block which is preset upon selecting the blocking from the Indication menu 4096 12274 Hz 12274 Hz Intensity mon...

Page 19: ...0 min 30 min 30 min 30 min 30 min 15 min 30 min 30 min 30 min 30 min 30 min 60 min Slope FAM X basic setting of slope for SimulFAM X which is preset upon switching on the device or selecting a channel 10 200 120 Blocking frequency basic setting of the frequency for nerve block which is preset upon selecting the blocking from the Effects menu 4096 12274 Hz 12274 Hz Intensity monitoring see chapter ...

Page 20: ...bles If the message Error is displayed the distribution cable is damaged and must be replaced 13 Exit the Menu Cable Check by pressing the black Menu key Return 14 On the display the Main menu appears again 15 Exit the Main menu by pressing the black Menu key Return 16 On the display the Overview appears again 2 5 Intensity monitoring During the development of the HiToP 184 we have endeavored not ...

Page 21: ...ectrode is pressed closer during the treatment e g if the patient turns round and lies on the electrode this can also lead to a severe increase of the intensity of current 4 Please observe by all means the notice on the electrode position see chapter 6 Electrodes 2 5 1 Intensity monitoring active We at gbo Medizintechnik AG have expanded the device software by a special intensity monitoring routin...

Page 22: ...to the channel of which you want to deactivate the intensity monitoring 9 Confirm by pressing the white Softkey Continue 10 The Menu Intensity monitoring channel 1 or 2 or 3 or 4 depending on the selection opens 11 The device presetting is on 12 Modify it with the Modification knob to off 13 Confirm by pressing the white Softkey Confirm 14 You will return to the Menu Intensity monitoring channel 1...

Page 23: ... 4 channels max the remaining therapy time the selected type of current and or frequency the presently released voltage Ind Menu detail view see Figure 6 A summary of the released energy of all channels is shown at the upper right This display remains until the start of a new therapy The display of energy will be deleted and calculated again when all channels have been inactive voltage 0 0 and a n...

Page 24: ...ey again The display of patient impedance is shown in unit V A with medical and therapeutic precision 3 2 Operating notes Each current type can be modified specifically Certain modifications can be set only when the Intensity regulator is 0 0 Other modifications can be set also during the therapy Please observe the acoustical and optical user support 3 2 1 Menu key Menu Menu key Use the black Menu...

Page 25: ...es for setting the output voltage It is furnished in the form of a rotor pulse generator The current is increased by turning it right in direction and it is reduced by turning it left in direction The referring numerical value is shown on the display Note After expiration of therapy time the current to the patient is automatically switched off and the intensity regulator reverts to 0 0 Before chan...

Page 26: ...ly by a surge cycle The three surge parameters Rise time Duration time Pause time determine a surge cycle Each surge parameter can be changed within 0 to 60 s in steps of 1 s The descent time in a surge cycle is always set on 1 s constantly Figure 10 Surge parameters 3 2 8 Setting of the surge parameters 1 Select a channel with the Channel key 2 The Function keys Surge parameters are constantly li...

Page 27: ...erapy time key Depending on the type of current the therapy time defined in the basic settings will be suggested To change the therapy time proceed as follows 1 Press Function key Time 2 The therapy time will be shown inversely 3 Set the desired period of time with the Modification knob 4 The time can be modified by steps per minute The maximum therapy time to select is 90 minutes Additionally it ...

Page 28: ...n starts 4 Plug the cable of your headphones into the connecting socket of the CD module left side of the device 5 Put your headphones on 6 If the CD reproduction has not yet started please activate it by pressing once again the Function key Start 7 The volume can be regulated directly on the headphones 8 With both Function keys Figures 15 and 16 you can play the previous or next title 9 The CD re...

Page 29: ...ng frequency up to the stimulus threshold 5 Confirm by pressing the white Softkey Continue 6 With the Intensity regulator increase the voltage of the upper setting frequency up to the stimulus threshold 7 Confirm by pressing the white Softkey Continue 8 The therapy starts 9 The frequency and voltage value are shown in the general view The frequency values are increased and reduced every second 10 ...

Page 30: ...double speed by each rotation of the Intensity knob The software version V 1 26 is shown in the lower left corner of the display after starting the unit 1 With a Channel key select channel I II III or IV 2 Select the desired therapy frequency by pressing one of the SimulFAM X current type keys 3 Increase the current slowly with the Intensity regulator until the desired stimulation effect occurs 4 ...

Page 31: ...he start of therapy Menü FIX 30 22 14 5 V 4096 Hz 122 mA 118 V A 1769 mW 125 6 mWh 321 4 mWh 4096 Hz 32768 Hz SimulFAM X Int f I II III IV Change slope Figure 20 Detail view SimulFAM X 4 3 Indication menu This menu driven additional program facilitates high tone therapy by selecting an indication group and a specific indication within that group Each channel has got an allocated Softkey to call in...

Page 32: ... Intensity regulator until a minimal threshold has been achieved The therapy starts 12 Upon travers of the first type of current the triad gong sounds 13 Attention if that blinking signal appears on the display the therapy has not finished yet Note Here it is possible to escape the programmed therapy by selecting another type of current 14 The next type of current is shown on the display 15 Advanc...

Page 33: ...be selected in the unit settings see chapter 2 4 3 If you have chosen the Effects menu you get different settings in the basic menu see chapter 2 4 4 1 Press the allocated Softkey Indication menu for the desired channel 2 You will get a list of programs 3 Move the scroll bar cursor with the Modification knob to the desired program 4 Confirm by pressing the white Softkey Continue 5 Apply the electr...

Page 34: ...e whole body treatment The program length is pre set to 30 minutes but can be changed by the user Lipolysis Lipolysis is the body s own process of freeing fatty cells from the tissue and making them accessible as energy carriers for the body to burn This Lipolysis can be stimulated by HighTone Therapy The scientifically proven frequency for maximum stimulation of lipolysis is 3 Hz In order to avoi...

Page 35: ...r we have evenly combined Lipolysis treatment with a efficient training of the muscles with SimulFAM X frequencies between 20 and 30 Hz Important for a effective muscle training is a strong contraction To achieve this the intensity is increased during the muscle stimulation period To give the muscle time to relax pauses are inserted corresponding to the Sport program The program is of fixed length...

Page 36: ...en 20 and 30 Hz The intensity should be clearly above the motoric threshold to ensure a strong contraction In order to let the muscle have the necessary relaxation pauses the training follows the cycle 5 s rise time 5 s holding time contraction and 20 s pause A important innovation that gbo HighTone Therapy adds to the muscle training is that we can use a sub threshold 32 kHz current i e the user ...

Page 37: ...ep of 90 110 Hz using the principle of counter irritation to suppress the pain sensation It is always applied between the point of pain and the CNS The program length is pre set to 30 minutes but can be changed by the user Nerveblock The pain block uses a fixed frequency of 12 kHz It is being applied directly to the pain point where it is fatiguing the pain receptors nociceptors Universal This pro...

Page 38: ...tes pre set 8 Reha 1 5 Hz adjustment 0 2 0 5 Hz 30 minutes pre set 9 Mobilization 1 5 Hz adjustment 0 5 Hz 14s 1 8 Hz 21 s 30 minutes pre set 10 Sport 20 Hz 5s 5s 20s 15 minutes pre set 11 Musclepump 1 5 Hz adjustment 0 3 Hz 30 minutes pre set 12 Trauma 10 Hz 1 2 time 100 Hz 1 2 time 30 minutes pre set 13 Lymphdrainage 0 3 Hz 10 min 10 Hz 10 min 10 30 Hz 10 min 3 x 10 min 30 min fix 14 Edema 10 Hz...

Page 39: ...the mains switch at the back of the device 3 The display of HiToP 181 H shows the following Therapy survey 1 I 00 Min 2 X 00 Min 3 B 0 days 4 The patient device may now be programmed 5 1 Therapy I Therapy I will always be allocated with the type of current SimulFAM i Only the therapy time and the number of treatments can be changed before programming the patient device 1 Press the black Menu key 2...

Page 40: ... 90 min number of treatments 20 1 50 unlimited Table 7 Menu Programming of patient unit Note Due to software version 2 02 the functionality for programming the HiToP 181 H is made more flexible The number of treatments increased from 20 to 50 Additionally you can set the number of treatments to unlimited This function is realized in HiToP 181 H software version 1 06 The procedure of programming wi...

Page 41: ...the following text Menü FIX Please place the patient unit on the side at a distance of 30 50 cm change it to the programming modus and press the Softkey I II III IV Patient unit Program Start Cancel Figure 25 Menu Programming of patient unit start 5 Press the Softkey Start 6 The programming starts 7 Upon correct transmission the following note will be shown on the display Menü FIX Therapy I SimulF...

Page 42: ...cessful data transmission see Figure 26 Menu Programming of patient unit Successful data transmission 5 2 2 Selection of channel I channel II channel III channel IV Here you select the type of current and its parameters set in the respective channel These can be SimulFAM i SimulFAM X or the nerve block These parameters can be changed in a changing mask before the programming 1 Move with the Modifi...

Page 43: ...se Pause Number of treatments 20 s 10 I II III IV Change Patient unit Program Confirm Return Figure 29 Menu Programming of patient unit modify the settings 8 Move the scroll bar with the Modification knob to the setting to be changed This will be shown inversely 9 Press the white Softkey Modify 10 The presetting will be flagged inversely 11 Set the desired value with the Modification knob 12 Confi...

Page 44: ...n Figure 30 Menu Programming of patient unit nerve block Selection Presetting Setting possibilities frequency from basic setting 4096 12274 Hz period of treatment 30 days 1 30 days Table 9 Setting possibilities nerve block 4 Move the scroll bar with the Modification knob to the setting to be changed This will be shown inversely 5 Press the white Softkey Modify 6 The presetting will be flagged inve...

Page 45: ...ully and only with adequate currents Experience has shown that the use of adhesive electrodes in combination with HiToP therapy might causes problems due to misuse Electrodes are being used with currents that are too high and with electrodes that have been used for too long old and worn electrodes As a possible consequence the adhesive electrodes get warm during the therapy and might even heat up ...

Page 46: ...ct spray to avoid current sensations on the skin 5 If you want to use the macroporous intermediate layers or fleece pockets they must be thoroughly washed under running water 6 Apply the electrodes to the patient 7 Apply the elastic tape with closure in a way that the electrode fits completely Warning Do not apply the electrodes on skin injuries Even minor abrasive burns can cause a burning sensat...

Page 47: ... a second electric circuit is added in parallel to the first longitudinal body treatment which is overlapping the first circuit for a large area of activity the total resistance in the first circuit is reduced suddenly at the moment of turning on the second circuit This rapid change in resistance causes a sudden current increase which in the end may lead to a current sensation or with acivated cur...

Page 48: ... If the operator does not react to the respective notes the previous correct status will be restored after a timeout Failures Failure alarm There is a problem in the power supply Suggestions Switch off and on again If the failure occurs again the device is out of function Please contact a service agent authorized by the manufacturer Application errors Failure Wrong electrode in the channel Suggest...

Page 49: ... regulation has to be observed in particular Irrespective of the legal rules or beyond the scope of the Medical Device Directive it is recommended to have the device checked at 12 months intervals by the manufacturer or by a maintenance service authorized by him The review shall consist at least of the following criteria Electrical safety check in accordance with the test plan of the manufacturer ...

Page 50: ...sation with gases 8 3 2 Cleaning the Elastic Straps The elastic straps can be washed in a washing machine Please observe the washing instructions of the instruction label 8 3 3 Cleaning the Electrodes You can clean the rubber electrodes after a treatment with some warm water appr 40 C and a soap suds on the conductive black side Dry the electrodes with a cleaning cloth or let them air dry The clea...

Page 51: ...mage to the device or an injury to the patient cannot be excluded Please keep a distance of at least 3 m A simultaneous connection of the patient to a high frequency surgery device can lead to burns under the electrical stimulus electrodes The device is not designed for use in non explosion proof areas If it is used in dangerous anesthesia areas an explosion cannot be excluded It is recommended no...

Page 52: ...pacemaker the treatment at the lower extremities is not contraindicated Note Patients with organ transplantation who take immunesuppresive medications should not be treated with SimulFAM i Note The above list is not exhaustive In individual cases the attending doctor should decide on contraindications and criteria for the treatment Note Patients with varicose veins metallic implants and endoprothe...

Page 53: ...sed 0123 CE Conformity sign Caution Observe the instructions for use Application part ungrounded protection degree Type BF This product complies with WEEE Directive 2002 96 EG waste electrical and electronic equipment Separate collection for electrical and electronic equipment ...

Page 54: ...uids IP X1 Dimensions max 15 cm x 41 cm x 48 cm H x D x W Weight max 13 kg without accessories Color white RAL 9002 and grey RAL 7016 Display LCD backlighted 320 x 240 dots full graphic Buffer battery CR 2032 Environmental conditions Operation of the device Temperature range 10 C 40 C Relative humidity 30 75 Transport and storage Temperature range 5 C 50 C Relative humidity 90 none condensing Curr...

Page 55: ...tion cable IV blue 150 cm 017 0 0033 Set of patient cables I red 6 cables of 100 cm each 017 0 0034 Set of patient cables II green 6 cables of 100 cm each 017 0 0035 Set of patient cables III yellow 6 cables of 100 cm each 017 0 0036 Set of patient cables IV blue 6 cables of 100 cm each 017 0 0037 Conductive rubber electrode 115 x 175 package of 2 017 0 0046 Conductive rubber electrode 80 x 120 pa...

Page 56: ...ufacturer is 10 years HiToP 184 is an electronic device For its disposal the according regulations for electronic devices have to be observed Incidentals have to be disposed with residual waste On request the manufacturer will provide you with further technical descriptions for all repairable parts of the device such as circuit diagrams spare parts lists and adjustment instructions as far as these...

Page 57: ...y test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output ...

Page 58: ...MHz to 800 MHz d 2 3 P 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 Recommended separation distances to portable and mobile RF communication equipment The equipment is...

Page 59: ...8 I Indication menu 29 K Keys and Regulator Menu key 22 Softkey 23 Channel keys 23 Modification knob 24 L LED 8 M Main menu Basic settings 14 Device settings 14 Program patient unit 14 Mains voltage 12 Maintenance 47 Modification inverse display 8 Modification keys 8 Modification knob 24 Multiple therapy 29 N Note 10 11 14 15 18 20 22 23 24 25 26 28 29 30 31 32 38 45 Notes Note 11 P parameter Dura...

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