gbo Medizintechnik HiToP 4 touch User manual

HighTone Therapy Device
HiToP 4 touch
Instructions for use

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gbo Medizintechnik AG Version 1.3
gbo Medizintechnik AG has taken care in the preparation of this manual, but does not
assume any liability, expressed or implied, of any kind nor does it assume any
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 gbo
Medizintechnik AG.
© gbo Medizintechnik AG
Part No.: 027-7-0006
Version 1.3
Issue date: 2017-02-02
gbo Medizintechnik AG
Kleiststrasse 6
D-64668 Rimbach
Phone: + 49 6253/808-0
Telefax: + 49 6253/808-245
E-Mail: [e-mail]
Internet: http://www.gbo-med.de

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Table of Contents
1INTRODUCTION.............................................................................................5
1.1 Purpose........................................................................................................5
1.2 Note concerning the operating personnel....................................................5
1.3 Description of the unit ..................................................................................5
1.4 Short operating instructions for SimulFAM®i...............................................6
1.5 Short operating instructions for SimulFAM® X.............................................7
2START OF OPERATION................................................................................8
2.1 Transport and Assembly..............................................................................8
2.2Connection and Switch-On..........................................................................8
2.3 Placing out of operation...............................................................................9
3OPERATING.................................................................................................10
3.1 Control Panel .............................................................................................10
3.1.1 Touch screen.............................................................................................10
3.1.2 Intensity regulator......................................................................................11
3.2 Direct help menu........................................................................................12
3.3 Intensity monitoring....................................................................................13
3.3.1 Deactivate intensity monitoring .................................................................14
3.4 Settings......................................................................................................15
3.5 Music Playback (Audio) .............................................................................16
3.6 Sound.........................................................................................................16
4THERAPY.....................................................................................................17
4.1 Frequently used therapies and indications (favourites).............................18
4.2 Setting SimulFAM i.....................................................................................19
4.2.1 Setting of f-sens ........................................................................................19
4.3 Setting SimulFAM X...................................................................................19
4.4 Working with the patients...........................................................................20
4.4.1 Compilation of new patient........................................................................20
4.4.2 Load patient file for therapy.......................................................................21
4.4.3 Patient logbook..........................................................................................21
5ELECTRODES..............................................................................................22
5.1 General notes on conductive rubber electrodes........................................22
5.1.1 Check the resistance of the electrodes.....................................................22
5.2 Advise on self adhesive electrodes............................................................23
5.3 Electrode positioning..................................................................................24
5.4 Multiple longitudinal (whole-) body treatments in parallel..........................25
6MAINTENANCE............................................................................................26
6.1 Safety Controls...........................................................................................26
6.2 Disposal of the device and the accessories...............................................26
6.3 Cleaning, Disinfection and Care ................................................................27
6.3.1 Cleaning the Device..................................................................................27

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6.3.2 Cleaning the Elastic Straps.......................................................................27
6.3.3 Cleaning the Electrodes............................................................................27
6.3.4 Disinfecting the Electrodes........................................................................28
7WARNINGS AND SAFETY PRECAUTIONS...............................................29
7.1 Contraindications .......................................................................................30
8EXPLANATION OF THE PICTOGRAPHS USED .......................................31
9TECHNICAL DATA ......................................................................................32
9.1 Current Types ............................................................................................33
10 ACCESSORIES.........................................................................................34
11 TROUBLESHOUTING...............................................................................36
12 APPENDIX.................................................................................................37
13 INDEX ........................................................................................................40
Warnings and safety precautions
Warning!
Warnings which have to be observed by all means!
Caution!
Observe the instructions for use!
!!
Note!
Information that will facilitate your work.

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1Introduction
1.1 Purpose
Electrotherapy with sinusoidal alternating currents.
1.2 Note concerning the operating personnel
The device is to be operated by healthcare professionals only.
1.3 Description of the unit
The HiToP4 touch is a medical product and is well suited for:
knee arthrosis
hip arthrosis
lumbar spine syndrome
cervical spine syndrome
thoracic spine syndrome
shoulder-arm syndrome
tennis elbow
pain following injuries and operations
edema treatment
Diabetic PNP
The HiToP4 touch is also well suited for:
“refreshment treatment” for overall vitalisation
muscle relaxation
muscle training
muscle stimulation (increase of energy consumption)
rehabilitation
Also patients with varicose veins, metal implants, endoprothesis and open wounds (ulcus cruris)
may be treated. Patients with cardiac pacemakers may be treated at the lower extremities.
The Stimulator for nerve and muscle HiToPprovides a therapy with medium
frequency 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
being 4096 –32768 Hz. The therapy frequency is scanned with a defined frequency.
This method is called SimulFAMwhich stands for Simultaneous Frequency
Amplitude Modulation. In the following, the basic method is divided into two
different ones.

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SimulFAMi
A slow frequency scan of up to three octaves is realized. The minimum amplitude is
passed with the minimum frequency. The maximum amplitude is passed with the
maximum frequency. This therapy activates the metabolism of the body without any
effect of irritation.
SimulFAMX
A frequency scan of three octaves is realized. The frequency scan is realized with
different speed (0.1 - 200 Hz). This therapy activates the metabolism in the body,
thus having an effect of irritation.
1.4 Short operating instructions for SimulFAM®i
(1) Switch on the device with the mains switch in the back of the device. Now the
device carries out an automatic check of all functions. If faultless, the automatic
check ends with an acoustic signal.
(2) Connect the accessories to the respective socket on the right side of the device.
(3) The display shows the window with the settings of the last treatment.
(4) Select SimulFAM® i from the favorites’ list.
(5) Apply the electrodes to the patient (see chapter 5.3, Electrode Positioning).
Select the channel with the channel buttons. The active channel will show up in
the channel color.
(6) Increase the current slowly using the Intensity regulator.
(7) The display shows the message: “Increase the intensity at 4096 Hz until you
feel a tingling sensation and confirm with the button Continue“.
(8) Press the button “Continue” to accept the intensity at 4096 Hz.
(9) The display shows the message: “Increase the intensity at 16384 Hz until you
feel a tingling sensation and confirm with the button Continue“.
(10) Press the button “Continue” to accept the intensity at 16384 Hz.
(11) The bar display SimulFAM® i shows the frequency scan.
(12) A special tone marks the end of the treatment time.
(13) The current to the patient will decrease automatically.

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1.5 Short operating instructions for SimulFAM® X
(1) Connect the device with the mains switch at the back of the device. The device
will then carry out an automatic check of all functions. If faultless, the automatic
check ends with the acoustic signal.
(2) Connect the accessories with the respective socket on the right side of the
device.
(3) In the display you see the window with the settings of the last treatment.
(4) Select SimulFAM® X from the favourites’ list.
(5) Apply the electrodes to the patient (see chapter 5.3, Position of the Electrodes).
Select a channel with the channel buttons. The active channel shows up in the
color of the channel.
(6) Increase the current slowly with the Intensity regulator until the patient feels a
tingling sensation.
(7) In case of a frequency scan the current stimulation frequency is shown. The
frequency values increase and decrease every second.
(8) A special tone marks the end of the treatment time.
(9) The current to the patient will decrease automatically.

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2Start of Operation
2.1 Transport and Assembly
The unit may be placed on any flat surface. It must not be placed on the floor. Keep a
wall distance of at least 20 cm. The device should neither be placed in front of radiators
nor should it be covered by pillows or blankets while in operation. The device is not
made for outdoor operation.
For maximum usability there is a special device cart and also a special HiToPbed
available (see chapter 10, Accessories) which answers in design and function to the
HiToP4 touch. This device cart is perfect for the placement of the unit and various
accessories. Placed on top of the device cart, the HiToP4 touch is mobile and always
ready for use. The device cart can easily be moved next to the patient for the treatment.
With the HiToPbed patients as well as health care professionals benefit from functions
like faster application of patient cables and electrodes, heated surface of the bed and the
possibility to warm up the electrodes.
The HiToP4 touch corresponds to the regulations DIN EN 60601. It is a device of
protection class I. Within the scope of the Medical Device Directive (MDD) the current
stimulation device belongs to class IIa.
Warning!
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, damage of the device or
danger to the patient cannot be excluded. As a rule, a clearance distance
of 3 m is sufficient.
2.2 Connection and Switch-On
The HiToP4 touch is designed to be connected to a supply voltage of 100 to 240 V. It
is not necessary to switch over the voltage –the device adjusts automatically to the right
voltage.
Irrespective of the adjusted supply voltage, the device is appropriate for mains
frequencies of 50 to 60 Hz.
Connect the HiToP4 touch with the mains cable to a socket with protective ground.
The protective ground must work correctly.
The HiToP4 touch is switched on by the main switch on the back of the device.

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Warning!
It is only allowed to connect USB sticks for data backup and update!
Never connect a PC or another USB device to this connector!
Only headphones are allowed to be connected to the headphone
output. It is not allowed to connect active loudspeakers with a
connection to the mains.
To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
Figure 1: Back view of the device
2.3 Placing out of operation
In order to disconnect the device just disconnect it from the mains power supply. No
other measures are to be taken.
main switch,
mains fuse
and connecting plug
for the mains cable
connector for USB
stick
connector for
headphone

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3Operating
The HiToP4 touch is equipped with a touch screen display, one on/off switch, four
connecting plugs for patient cables and the intensity regulator.
The HiToP4 touch is being operated via the control panel of the large touch screen.
The user will obtain explanations regarding the device’s operation and functionality
of individual elements via a direct help system during operation. Consequently,
operation is explained in broad outline only.
3.1 Control Panel
Figure 2: Front view
3.1.1 Touch screen
The touch screen should be operated with a distinct pressure of the fingertip. Pointed
objects are unsuited for operation and can destroy the touch screen.
Every button is clearly labeled. Optically, the user can differentiate operating buttons
from non-operating buttons. In case of doubt the user can obtain further information via
the direct help system.
touch screen
display
intensity regulator
(knob)
connecting plugs
for patient cables
(applied part)
indication of
channel
red =channel 1
green =channel 2
yellow=channel3
blue = channel 4

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In order to adjust numerical data the arrow keys may either be pressed repeatedly or
pressed constantly for automatic increase/decrease of the value.
The scrollbars are used like with a PC: press the scrollbar and then pull into the desired
direction.
3.1.2 Intensity regulator
During the therapy the output voltage is set with the Intensity regulator. The current
increases by turning the intensity regulator clockwise and it is reduced by turning it
counter-clockwise. The current intensity is shown in mA on the display. In order to
reach the desired intensity the user might have to turn the regulator clockwise for more
than one rotation.
!!
Note!
In the event that the intensity is set to 5000 mW while turning the
button, the unit initiates a counterforce to the knob to signal to the user
that the limit is reached.

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3.2 Direct help menu
The user of the HiToP4 touch is guided on the screen. The direct help menu provides
information about the selected buttons directly on the screen.
To open the direct help menu, first touch the “?“-button on the screen and then the
button about which you desire information. A new window opens where the information
is shown. Touch the “X”-button in order to close this window.
Available buttons are indicated in light grey. Unavailable buttons are indicated in dark
grey. If you push an unavailable button, information about the use of this button is
shown on the screen automatically.
Figure 3: Direct help menu as shown on the display
direct help
window

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3.3 Intensity monitoring
During the development of the HiToP4 touch we have endeavored not only to offer
you a Stimulator for nerve and muscle device of a new generation with regard to its
efficiency and operability, but also to set new standards with regard to the patient’s
safety.
The intensity is increased at open circuits, i.e. no patient is connected to the device:
If the initial voltage is increased at open circuit and no current is measured, the
channel will be switched off for the patient´s safety. An acoustic signal is given and
the following message will be displayed: Therapy terminated by Intensity Monitoring
in channel 1. Please check for insufficiently attached electrodes or disconnected
patient cables.
!!
Note!
Please check the contact of the electrodes and the cables, resp., before
you set the intensity anew.
Abrupt resistance changes in the electrode application could cause problems:
1. Two electrodes touch each other and form a shunt during treatment. If the patient
moves during the therapy, that shunt can open and the patient becomes exposed to
an unintended high intensity of current.
2. The electrodes are shorted-out by a conductive part, such as a metallic temple in
case of a tinnitus treatment. If during the treatment that shunt is removed (e.g. the
glasses are taken off) this abrupt resistance change also leads to a severe
modification of the intensity of current.
3. Generally, please observe the notice regarding the electrode positioning (see
chapter 5.3).
We at gbo Medizintechnik AG expanded the device software by a special intensity
monitoring routine in order to get the application problems mentioned under control.
This safety circuit avoids an unintended high change in the intensity of current and
switches off the respective channel in such a case. On the display a note for the
respective channel is shown.

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3.3.1 Deactivate intensity monitoring
!!
Note!
The intensity monitoring is automatically activated for all
channels after each restart of the unit! The function can be
manually deactivated with the button “Intensity monitoring”
after starting the unit.
Only deactivate the intensity monitoring as an exception, e. g.
in case of the Big-Tast-Therapy!
1. Select the respective channel with the channel buttons.
2. Press the button ”Intensity monitoring“.
3. The blue bar which indicates Intensity monitoring is active will get grey.
!!
Note!
If the “Intensity monitoring” for a channel is deactivated, the
bar in the button “Intensity monitoring“ will be grey.
If the “Intensity monitoring” for a channel is deactivated, the
following symbol will be shown in the channel overview.
The Intensity monitoring remains deactivated for a channel
until it is modified manually into “on“ by pressing the button
“Intensity monitoring”.
Upon each restart of the device the Intensity monitoring is
automatically activated.

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3.4 Settings
The device HiToP4 touch has a setting menu which is activated by pressing the setting
button. This can be done only when the therapy is not yet active.
You find the following items in the settings menu:
Service You get into the Service menu. This item is reserved for service
personnel only and helps to locate failures within the hardware.
Cable test Patient cables and the distribution cable may be checked for
failures.
Audio Here you can load your own music which the patient may listen
to during therapy. When delivered an album with music for
relaxation is pre-installed. In order to install music the respective
music data must be converted into the .Ogg (Ogg-Vorbis) format.
The data converted must then be loaded onto an USB stick into a
HiToP_Audio folder. With the function “Audio import“ music
titles may then be allocated to one of max. 8 albums.
Please note! For each album a maximum of 30 titles may be
imported.
Display You may change the language, date format and time format. Also
time and date may be set here.
Sounds You may change system sounds like the sound signaling the end
of the therapy etc.. You may listen to the sounds and allocate
them to the respective functions.
Systeminformation The software version is shown.
Delete patient Patients may be deleted.
User There is the possibility to compile different users. Each user gets
his own language, he may store his own therapies and his list of
favorites will fill up according to the therapies used by him.
Therapy Personal therapies may be redefined or deleted. You can define
basic settings for the treatment time of SimulFAM i and
SimulFAM X.
This menu item can be used to determine whether the rotary
encoder is locked after a certain time in which it is not used and
has to be released before the next operation.
Import/Export You can compile a back up of the data. It may then be loaded to
another device. A new language version may be loaded. A
software update may easily be installed in this sub-menu. A USB
stick is used for the transfer of the data. The USB stick must be
placed in the back side of the unit.

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3.5 Music Playback (Audio)
With the unit HiToP4 touch you may listen to music titles over a head set connected
to the back side of the unit. Upon delivery an album with relaxation music is pre-
installed and can directly be selected and listened to. If you press the button “audio” a
flyout will open up. Now you can select an album and adjust the volume within the
flyout. By pressing the button Play/Pause you can start and stop the playback.
Additional albums may be loaded in the menu “Audio” in the settings. (See chapter 3.4)
3.6 Sound
HighTone Therapy comprises a frequency range from 4096 Hz to 32768 Hz. The
lower part of this frequency range lies within the audible range. In order to make
clear to the user or patient, respectively, the kind of frequencies they are treated with
it is possible to make these frequencies audible on the internal loudspeaker. If you
press the button “sound” a flyout will open up. Now you can switch on the tone and
also the volume may be adjusted in this flyout.
!!
NOTE!
The activated sound is indicated by a blue bar within the button.

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4Therapy
The HiToP4 touch guides the user through the application of the therapy. With the
direct help menu all buttons and their functions are explained directly on the screen.
On the right side of the screen therapy programs can be selected directly from this list of
favourites or with the sub-menues “More Therapies” or “Indications”.
First, choose the channel you want to use and then you can select the desired program or
indication. The direct help menu will give you information about the following steps of
the therapy.
Figure 4: Touch screen with selected indication
Favorites:
Programs and
indications
selection for therapy
access or patient
administration
(the choice is indicated
by a blue bar)
shortlist for
indications
(the choice is
highlighted in blue)
shortlist for the
indication group
(the activated group
is indicated by a
green hook)
picture showing the
application for the
selected indication
button for selection
of indication
(the choice is
highlighted in blue)

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4.1 Frequently used therapies and indications (favourites)
Frequently used functions are directly accessible on the front screen. To this purpose, the
eleven most used therapies are listed on the right side. From here, they can directly be
selected.
Figure 5: View of Touch screen display
The user can recall typically used therapies with only one touch. Additional therapies
can either be recalled according to a patient’s name, i.e. via log book, or by referring to
indications or the name of the therapy.
display channel 2 (active window)
favorites
button for shortlist
of
therapy programs
button for shortlist
of indications
selection for therapy
access or patient
administration
(the choice is
indicated by a blue
bar)
details for the
therapy program or
indication for the
selected channel
settings
direct help
intensity
monitoring
therapy
sound
audio

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4.2 Setting SimulFAM i
If the current form SimulFAM i is selected with its frequencies of 4096 and 16384,
the current intensity must be such that the patient feels a light tingling only. It is the
aim of this setting to emit the maximum output during therapy. The frequencies of
4096 –32768 Hz are being emitted as quarter tone steps every second. The current
should be comfortable to the patient with all frequencies. There is no stimulation of
the nerve or muscle, the patient feels a light tingling only. In general, the current form
SimulFAM i is applied for whole body treatment however, it may also be used for a
local lateral throughflow.
!!
Note!
The amplitude values move on the threshold curve determined.
Therapy time may also be modified during treatment.
With the frequency button the frequency flow may be stopped
and released upon new activation.
The frequency set may be changed with the bar beneath the
graphics.
The intensity of SimulFAM i may also be changed during
therapy.
4.2.1 Setting of f-sens
If both intensity values at 4096 Hz and 16384 Hz are set and the therapy is started,
the calculated value for f-sens is indicated. This value indicates the relation of the
current value at 16384 Hz relative to the current value at 4096 Hz.
As already mentioned above the patient should feel a tingling during the therapy with
all 72 frequencies running. In the event that the tingling cannot be felt equally, it can
be improved with a change in f-sens. When pressing the button f-sens, the device will
switch into a faster run with a lower amount of frequencies. With the aid of the arrow
key you can set the upper and the lower frequencies equally.
After a short timeout the regular frequency scan will restart. Now one can judge
whether the adjustment improved which means that with all frequencies almost an
identical current feeling is perceived.
4.3 Setting SimulFAM X
If the current form SimulFAM X is selected, the frequencies are run through faster.
The frequency run can be set between 01 Hz up to 200 Hz.

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In contrast to SimulFAM i, with SimulFAM X we try to generate specifically a
stimulation of the nerves and the muscles. E.g. with the frequency of 20 Hz you
generate a muscle stimulation. Here the current is increased up to a range above
threshold. Now the patient will show a stimulation of the muscle. Please choose a
current intensity which turns the therapy well tolerable to the patient.
!!
Note!
Therapy time can be modified during the treatment.
4.4 Working with the patients
Figure 6: View touch screen-display select patient
4.4.1 Compilation of new patient
If you choose the button “patient“ and then the button “new“ you get to the virtual
keyboard for the compilation of a new patient. Mandatory are the first name, last
Change patient data
with Edit
Search for a patient
within large patient
list
großPaitientenliste
Compilation of new
patient
Select patient or
last therapy
Display of
therapy
List of compiled
patients
Commentary
to the current
therapy
Reference to
a patient
Display of
the indication
Edit commentary for
treatment