gbo HiToP 191 User manual

High Tone Power Therapy Device
HiToP®191
User Manual

2HiToP®191
gbo Medizintechnik AG 2008 -2011 Version 2.2
gbo Medizintechnik AG has taken care in the preparation of this manual. However, the
company does not give any expressed or implied warranty nor do we 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 2008
gbo Medizintechnik AG
Kleiststrasse 6
DE 64668 Rimbach
Telefon: [phone]
Telefax: 06 25 3/808-245
E-Mail: [e-mail]
Internet: http://www.gbo-med.de
Version 2.2
Date of issue November 30thth, 2011

HiToP®191 3
gbo Medizintechnik AG 2008 - 2011 Version 2.2
Contents
1 INTRODUCTION...................................................................................... 5
1.1 Intended Use......................................................................................... 5
1.2 Description of the unit............................................................................ 5
1.3 What is High Tone Power Therapy?...................................................... 6
1.4 Operating the HiToPunit..................................................................... 6
2 OPERATING CONCEPT ......................................................................... 7
2.1 Control panel......................................................................................... 7
2.1.1 Ergonomic control panel.............................................................................7
2.1.2 Display........................................................................................................7
2.1.3 Intensity regulator/Modification regulator ...................................................7
2.2 Short instructions................................................................................... 8
3 START OF OPERATION....................................................................... 10
3.1 Transport and installation.................................................................... 10
3.2 Connection and switch-on................................................................... 10
3.3 Preparing the electrodes ..................................................................... 11
3.4 Basic settings...................................................................................... 12
3.4.1 Treatment time .........................................................................................12
3.4.2 Language .................................................................................................13
3.4.3 Service menu ...........................................................................................13
3.4.4 Exit menu .................................................................................................13
3.5 Important notes and safety precautions............................................... 14
4 THERAPY.............................................................................................. 15
4.1 General notes about the therapy......................................................... 15
4.2 Treatment details................................................................................. 15
4.3 Display details..................................................................................... 16
4.4 Duration and frequency of treatment ................................................... 17
5 ELECTRODES....................................................................................... 18
5.1 Electrode application........................................................................... 18
6 MAINTENANCE..................................................................................... 19
6.1 Safety controls .................................................................................... 19
6.2 Cleaning, disinfection and care............................................................ 20
6.2.1 Cleaning the device..................................................................................20
6.2.2 Cleaning Electrodes.................................................................................20
7 EXPLANATION OF THE USED SIGNS................................................. 21
8 TECHNICAL DATA ............................................................................... 22
9 ACCESSORIES..................................................................................... 23
10 ERROR MESSAGES.......................................................................... 24
10.1 Error messages on the display ......................................................... 24

4HiToP®191
gbo Medizintechnik AG 2008 -2011 Version 2.2
10.2 Further errors ................................................................................... 24
11 APPENDIX.......................................................................................... 25
12 INDEX................................................................................................. 28
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.

HiToP®191 5
gbo Medizintechnik AG 2008 - 2011 Version 2.2
1 Introduction
1.1 Intended Use
Electrotherapy with sinusoidal alternating currents.
1.2 Description of the unit
The HiToP®191 is a microprocessor-controlled HighTone Therapy device for
electrotherapy. Its application range predestines this device for the use at home, in
modern and well-equipped hospitals or medical practices.
Thus, the HiToP®(HighTone Power) 191 is well suited for:
Symptomatic treatment with polyneuropatic aliments
like i. E.
-pain
-burning
-prickling
-numbness
muscle stimulation
Through external muscle stimulation the metabolism is activated which again results
in an improvement of the sensibility to insulin.
Also patients with varicose veins, metal implants, endoprothesis and open
wounds (ulcus cruris) may be treated.
Since the electrodes are placed at this Polyneuropathy- treatment exclusively on
the legs, also patients with cardiac pacemakers may be treated.
The HighTone Power Therapy device HiToP®provides a therapy with middle
frequency sine waves. The therapy is absolutely free of d.c. components. 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.

6HiToP®191
gbo Medizintechnik AG 2008 -2011 Version 2.2
1.3 What is High Tone Power Therapy?
High Tone Power Therapy is a specific new development based on scientific
knowledge from a number of different disciplines, i. e. it is an inter-disciplinary new
development. The specialist knowledge involved is derived from medicine, physics,
mathematics, physiology, histology, cytology, chemistry, biochemistry and involves
their sub-disciplines.
Put briefly and simply:
High Tone Therapy takes the fact that electrical changes in the tissue are always
associated with biochemical changes, and vice versa, and puts it to use for therapeutic
purposes. In doing so it provides an alternative to medicinal, physical and operative
therapies that have so far proven unsatisfactory, risky, associated with side-effects or
even unsuccessful, and planned surgical treatment.
1.4 Operating the HiToPunit
You purchased a HiToP191. The unit is dedicated for private use.
If you use the unit commercially, it is subjected to the Medical Devices Operator
Ordinance. In this case you as the user are legally obligated to execute safety controls
as described in Chapter 6.1.

HiToP®191 7
gbo Medizintechnik AG 2008 - 2011 Version 2.2
2 Operating concept
2.1 Control panel
Figure 1: Front view
2.1.1 Ergonomic control panel
The control panel possesses a display, the main switch, the plug for the connector of the
patient cable and the intensity regulator. These elements are easy to recognize and to
operate and their functions are described in detail in the following chapters 2.1.2 to 2.1.3
.
2.1.2 Display
The device is equipped with a Graphic display .There, clear notes are provided to start the
therapy; the parameters of the selected type of current are indicated.
2.1.3 Intensity regulator/Modification regulator
With the Intensity regulator you can switch through the menu of the program. Push on the
button of the regulator if you want to choose the function indicated on the display.
During the therapy you can set the output voltage with the Intensity regulator.It is
furnished in the form of a rotor pulse generator. The current increases by turning right
(in +direction) and is reduced by turning left (in -direction). The numerical value is
shown on the display in mA. To find the wanted intensity you may possibly turn the
regulator clockwise for more than one rotation.
The Intensity regulator is also used as modification regulator for the basic settings.
(chapter 3.4).
Display
Output plug for
connector to the
patient cable
Main switch
Intensity and
modification
regulator
Box for
accessories

8HiToP®191
gbo Medizintechnik AG 2008 -2011 Version 2.2
2.2 Short instructions
Apply the electrodes to both thights like shown on these two pictures.
Figure 2: Electrode placement
First, wet the black side of the conductive rubber electrodes with contact spray. Push the
spray button for one or two times and disperse the fluid on the black side with your
fingers.
Apply one electrode (80 x 120) each to the thigh just above the knee and fix each
electrode with a velcro band.
Apply one electrode (80 x 120) each to the thigh just below the groin and fix each
electrode with a velcro band.
The electrodes above the knee must be connected with the black connectors of the
patient cable.
The electrodes below the groin must be connected with the white connectors of the
patient cable.
Start the unit with the main switch on the front of the device. „Adjust the intensity until
you get a muscle contraction“ appears on the display.
Increase the intensity until you can see a visible muscle contraction on the thigh (Maybe
some rotations clockwise, 5 is a normal value) A typical value for the current is about
160 mA. However intensities from 80 up to more than 250 mA are common practice.
The chosen intensity should be comfortable for the patient.
The therapy is now started.
During therapy the intensity may decrease about 10 – 20 mA. If required, the
intensity can be changed.. It is recommendable to do the adjustment in the active
phase (during the contraction).
At the end of the therapy, the current to the patient will be automatically reduced to
zero. If you want interrupt or stop the therapy, you can decrease the intensity to 0 by
turning the Intensity regulator counterclockwise. After use the electrodes can be
cleaned with a wet cloth.
White
connector
Black
connector

HiToP®191 9
gbo Medizintechnik AG 2008 - 2011 Version 2.2
Figure 3: therapy with the HiToP®191

10 HiToP®191
gbo Medizintechnik AG 2008 -2011 Version 2.2
3 Start of operation
3.1 Transport and installation
The device for High Tone Therapy is a portable unit. The unit may be placed on any
plane horizontal surface. The distance between device and wall must be at least 20 cm.
The device for High Tone Therapy corresponds to the regulations DIN/VDE 0750, EN
60601. It is a device of safety class II. Within the scope of the Medical Device Directive
the device for High Tone Therapy belongs to class IIa (see also Chapter 3.5 and safety
precautions).
Warning!
Note for use in clinical practice:
The unit is not designed to be used at non-explosion-proof places. 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, a damage of the
device or a threat to the patient cannot be excluded. As a rule, a safety
clearance of 2 to 3 m is enough.
3.2 Connection and switch-on
The device for High Tone Power Therapy was set to be connected to a supply voltage of
100 V up to 240 V and will be switched automatically to the right supply voltage by the
unit. Irrespective of the supply voltage, the device is appropriate for power frequencies
of 48 to 62 Hz.
Connect the device for High Tone Therapy with the mains cable to a shockproof socket.
The device is switched on by the main switch at the front of the device. This inhibits
erroneous, unintended disconnection of the device during normal operation.
On the top of the device you find an integrated box for the accessory. When you open
the cover, you can put the accessories (electrodes, velcro band and patient cable) in this
box.

HiToP®191 11
gbo Medizintechnik AG 2008 - 2011 Version 2.2
Figure 4: device with opened accessory box
3.3 Preparing the electrodes
The 4 white velcro bands must be thread in the electrodes as shown on this picture:
Figure 5: velcro bands with threaded electrodes
The side of the velcro band, where the washing instructions are seen, must face upwards
and be placed 5 – 10 cm over the edge of the electrodes. The velcro fastener has to face
upwards on this side.

12 HiToP®191
gbo Medizintechnik AG 2008 -2011 Version 2.2
3.4 Basic settings
In the basic setting you can do modifications which will be stored in the non-volatile
memory.
Do the following steps to modify the parameters of HiToP191.
Switch off the unit.
Switch on the unit while pressing the Intensity regulator.
On the display you will see the selectable settings.
Menu
Language
Treatment time
Service menu
Exit menu
You can select between the settings with the Intensity regulator.
After selection confirm your choice by pressing the button of the Intensity regulator and
you can modify the values.
When you have taken your choice you can switch off the unit. Your modifications will
be stored in the nonvolatile memory.
If you want to start the therapy immediately afterwards you can select the “Exit menu”
to get into the therapy mode.
3.4.1 Treatment time
The treatment time can be set in steps of 5 minutes between 30 and 60 minutes.
Treatment time
55 min.
With the Intensity regulator you can modify the treatment time to the requested value. By
pressing the Intensity regulator you store the value to the non-volatile memory.

HiToP®191 13
gbo Medizintechnik AG 2008 - 2011 Version 2.2
3.4.2 Language
In the language setting you can select between german, english, spanish, italian, czech,
portuguese, russian and polish language.
Language
deutsch česky
english português
español pyccкий
italiano polski
With the Intensity regulator you can choose the language. By pressing the Intensity regulator
you store the value to the non-volatile memory.
3.4.3 Service menu
The service menu is only used by service agents.
3.4.4 Exit menu
With the Exit menu setting you can choose the therapy mode by pressing the button of
the Intensity regulator and start the therapy program by adjusting the intensity (see chapter
4.2 treatment details).

14 HiToP®191
gbo Medizintechnik AG 2008 -2011 Version 2.2
3.5 Important notes and safety precautions
Warning!
It is imperative to comply with the notes and safety
precautions in this user manual. The unit should only be
used for the treatment described in this user manual.
In case of patients with an implanted electronic device please carry out high tone
therapy only after having checked whether there is any risk.
Turn off cell phones, or place them at a distance of 2 - 3 m from the device.
Cardiac pacemakers can extremely be disturbed. In these cases, the therapy should be
only carried out under continuous pulse and ECG control.
Take regards to the right electrode placement on the thighs. In this case, the
treatment may be performed without control.
If the patient and/or the patient cable is in direct range of high-frequency, short-wave
or micro-wave therapeutic devices, a damage to the device or an injury of the patient
cannot be excluded. Please keep a distance of at least 2 to 3 meters.
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 meant for use in non-explosion-proof places. If it is used in
dangerous anethesia areas, an explosion is possible.
Do not use the unit while taking a bath.
Apply the electrodes only to those parts of the body which are described in the user
manual.
Do not connect other persons with the electrodes.
Keep the unit away from children.
In case of all recognizable failures immediately contact gbo Medizintechnik AG, or one
of the service agencies authorized by gbo Medizintechnik AG.

HiToP®191 15
gbo Medizintechnik AG 2008 - 2011 Version 2.2
4 Therapy
4.1 General notes about the therapy
For the therapy we use a muscle stimulation. The muscle stimulation is generated with
HiToPfrequencies. The current is applied by rubber electrodes which are moistured
with contact spray. During the treatment the muscle is contracted in intervals. An
interval consists of a 3 seconds rise time (intensity increases), a 3 seconds hold time
(intensity is constant on the maximum setted before) and a 3 seconds break time
(Intensity = 0).
!! Note!
If you like to interrupt or stop the treatment, decrease the intensity
to zero by turning the Intensity regulator counterclockwise.
4.2 Treatment details
1. Switch on the unit
2. You see the start display:
3. On the display the following message appears:
HiToP 191
Adjust the intensity
u n t i l y o u g e t a
muscle contraction.
4. Increase the intensity clockwise by turning the Intensity regulator until you see a visible
muscle movement.
5. On the display the following message appears:
Time: 28:21
Int: 160 mA
This shown display is only for example!
Figures may differ in your therapy!

16 HiToP®191
gbo Medizintechnik AG 2008 -2011 Version 2.2
6. The therapy starts. The therapy timer is shown on the display and decreases in
steps of seconds. Above the timer the intensity of the released voltage is shown on
the display.
7. By pressing the Intensity regulator you can select between the overview display and the
detailed view (as shown in chapter 4.3 Display in Detail).
8. In the detailed view you see some additional informations:
Time: 59:22
U: 12.1 V R:75V/A
I: 160 mA
P: 2062 mW
9. The treatment stops after the treatment timer reaches zero. You can also stop or
interrupt the treatment by decreasing the intensity to zero.
4.3 Display details
In the detailed view, the following values are shown:
Display data Meaning
TIME:
remaining time of the actual therapy
U:
released voltage
R:
patient’s resistance
I:
released current
P:
released power
swelling active/inactive
Table 1: Information in the detailed view
Some information on the detailed view:
In the detailed view you can recall treatment values like shown in the table above.
The time shown is the treatment time and it is decreased in steps of seconds. When the
treatment timer reaches zero, the unit stops the treatment and the intensity is set to zero.
The values for voltage (U) and current (I) can be used as an indicator for the following
therapies. We are not able to give information about the absolute values of voltage and
current because each patient reacts differently sensible to the current.
A common value for muscle contraction is between 150 – 200 mA. This setting should
result in a contraction of both thights, visible and noticable by the patient.
This shown display is only for example!
Figures may differ in your therapy!

HiToP®191 17
gbo Medizintechnik AG 2008 - 2011 Version 2.2
The patient’s resistance (R) gives information about the electric conductivity of the
system. The resistance should fit to the area of 30 – 200 Ohms. The reason for a
resistance greater than 200 Ohms may be:
No contact spray was used to moisten the electrodes
Bad contact because of oil and/or creme on the skin
No contact of the distribution cable to one of the electrodes
The released power (P) is the product of voltage and current and gives some information
about the released energy for one treatment.
4.4 Duration and frequency of treatment
The duration of treatment is pre-set to 60 minutes. In the basic settings (see chapter 3.4.1
Treatment time) the treatment time can be set from 30 to 60 minutes.
The frequency of the treatments depends on the intensity of the polyneuropathic pain. In
the beginning of the therapy (first 2 – 4 weeks) the treatment should be done daily. Later
on the treatment interval of 3 days was very effective for many patients.
For the treatment of your polyneuropathic pain you should find your personal treatment
interval.
Please treat your polyneuropathic pain every day to prove the HiToPtherapy. If you
experience less pain or no pain, you can increase the interval of treatment. Evaluate
when the pain between the treatment comes back and increase the treatment interval.
With this method you can evaluate your personal optimum treatment interval.

18 HiToP®191
gbo Medizintechnik AG 2008 -2011 Version 2.2
5 Electrodes
The standard accessories for HiToP191 include rubber electrodes of 120 x 80 mm.
5.1 Electrode application
The therapy shall always be carried out in a comfortable and relaxed position. The joints
shall be placed in an angular position, so that they are placed in a relaxed position, from
which both the flexor as well as the extensor muscles can be stimulated.
In general, the preparation and application of the electrodes is carried out as follows:
1. Connect the electrodes to the patient cable.
2. Connect the patient cable connector to the output plug on the frontside of the device.
3. Wet the conductive rubber electrodes with contact spray to avoid current sensations
on the skin. Push the spray button for one or two times and disperse the fluid on the
black side of the electrodes with your fingers
4. Remove oil and creme of the skin with a cleaning tissue.
5. Apply the electrodes as shown on page 8.
6. Apply the Velcro strap in a way that the electrode fits completely.
Warning!
 Do not apply the electrodes on skin injuries. Even minor
abrasions can cause a burning. Also, you may not be able to
judge the current intensity objectively. If this cannot be avoided,
apply zinc ointment or vaseline to cover the affected parts of the
skin.
 The electrodes must adhere completely to the skin in order to
avoid excessive local current density. Otherwise there can
occur erythemas, and sometimes even burns.

HiToP®191 19
gbo Medizintechnik AG 2008 - 2011 Version 2.2
6 Maintenance
Efficiency, reliability and safety characteristics of the device for High Tone Therapy are
only guaranteed in case of proper use in accordance with the operating instructions.
Safety control, maintenance work, repair work and modifications shall be carried out
only by the manufacturer or the 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 shall be carried out in accordance
with the requirements of VDE/IEC. The device does not contain any parts which need
maintenance work done by the user.
6.1 Safety controls
Commercial users are obligated to keep the Medical Device Directive and
documentation of the safety controls. The safety controls have to be carried out on the
basis of this directive. Here, 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 at 12-months intervals by the manufacturer or
by an authorized service agency.
The check shall consist of at least the following:
Electrical safety check in accordance with the check plan of the manufacturer;
Check of the device in regard to external integrity;
Check of all display and operating elements in regard to damage;
Check of all inscriptions in regard to legibility
Check of all functions according to the user manual.
!! Note!
Private users do not obligate to the duties mentioned above.
The Medical Devices Operator Ordinance is not valid for countries
outside EU.

20 HiToP®191
gbo Medizintechnik AG 2008 -2011 Version 2.2
6.2 Cleaning, disinfection and care
6.2.1 Cleaning the device
For cleaning the device for High Tone Therapy and its accessories, do use only a soft,
fluffless cleaning tissue or common cleaner for plastic material. Do not use any abrasive
cleaner.
Warning!
Do not clean the device under running water and do not use
even liquid abrasive cleaner!
Prior to cleaning or disinfection unplug the mains plug out of
the socket!
The device is suited for wiping disinfection. No liquids should penetrate the device.
Plugs or sockets must never get wet. For cleaning or disinfection, the device may not be
sprayed on.
6.2.2 Cleaning Electrodes
You can clean the electrodes after a treatment by using some warm water. Wash off the
rest of the contact spray. Dry the electrodes with a cleaning tissue or let them air-dry.
Note!: The conductivity of the electrodes is optimized by using a big part of graphite.
Therefore, while using and also while cleaning the electrodes black color may come off.