gbo HiToP Metabol User manual

High Tone Power Therapy Device
HiToP
®
Metabol
User Manual

2HiToP®Metabol
gbo Medizintechnik AG Version 1.4
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.
Version 1.4
Date of issue August 28th, 2012
© gbo Medizintechnik AG
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

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gbo Medizintechnik AG Version 1.4
Warnings and safety precautions
Warning!
Warnings which have to be observed by all means!
Caution!
Observe the instructions for use !
!! Note!
Information which facilitates the work.

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gbo Medizintechnik AG Version 1.4
Contents
1 INTRODUCTION...................................................................................5
1.1 Intended use.....................................................................................5
1.2 Description of the unit .....................................................................5
1.3 What is High Tone Power Therapy?................................................5
1.4 Operating the HiToPunit ...............................................................6
2 OPERATING CONCEPT ......................................................................6
2.1 Control panel....................................................................................6
2.1.1 Ergonomic control panel...............................................................6
2.1.2 Display..........................................................................................6
2.1.3 Softkey..........................................................................................7
2.1.4 Function keys................................................................................7
2.1.5 Intensity 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
3.2.1 Voltage change-over and fuses ..................................................11
3.3 Basic settings.................................................................................12
3.3.1 Treatment time............................................................................12
3.3.2 Language....................................................................................12
3.4 Important notes and safety precautions.......................................13
4 THERAPY...........................................................................................14
4.1 General notes about the therapy...................................................14
4.2 Treatment details............................................................................14
4.3 Detail view.......................................................................................15
4.4 Duration and frequency of treatment............................................16
5 ELECTRODES....................................................................................17
5.1 Electrode application.....................................................................17
6 MAINTENANCE..................................................................................18
6.1 Safety controls ...............................................................................18
6.2 Cleaning, disinfection and care.....................................................18
6.2.1 Cleaning the device....................................................................18
6.2.2 Cleaning Electrodes....................................................................19
7 EXPLANATION OF THE SIGNS USED..............................................19
8 TECHNICAL DATA ............................................................................20
9 ACCESSORIES..................................................................................21
10 ERROR MESSAGES.......................................................................22

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gbo Medizintechnik AG Version 1.4
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) Metabol is well suited for:
pain therapy for joint arthrosis
Also patients with varicose veins, metal implants, endoprotheses and open wounds
(ulcus cruris) may be treated.
The HighTone Power Therapy device HiToP(HighTone Power) provides a
therapy with middle frequency sine waves. The therapy is absolutely free of d.c.
components. There are two 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.
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 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 proved to have been unsatisfactory, risky,
associated with side-effects and even unsuccessful, and planned surgical treatment.

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gbo Medizintechnik AG Version 1.4
1.4 Operating the HiToPunit
You purchased a HiToPMetabol. 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.
2 Operating concept
2.1 Control panel
HiToP®
+
+Int
SimulFAM
X
®
®
Figure 1: Control panel
2.1.1 Ergonomic control panel
The control panel possesses a display, the white Softkey, two function keys 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 2.1.5 .
2.1.2 Display
The device is equipped with a Graphic display . There, clear notes are provided for
the starting of the programmed therapies. There, the parameters of the selected
type of current are indicated.
Display
Softkey
Function keys
Intensity
regulator

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2.1.3 Softkey
.
Figure 2: Softkey
ASoftkey is a key with context-sensitive meaning. It is easy to feel and also has a
pressure point. The Softkey serves as confirmation key and offers the possibility of
changing from the general view to the detail view (see Chapter 4.3 Detail view).
2.1.4 Function keys
HiToPMetabol is equipped with two black Function keys. These are easy to feel
and also have a pressure point. With them, you can scroll through the display
indications, so that you can see the complete summary of a menu.
2.1.5 Intensity regulator
The Intensity regulator serves for setting the output voltage. 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.

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gbo Medizintechnik AG Version 1.4
2.2 Short instructions
Fix one of the elastic Velcro straps directly under the
knee needing treatent.
Moisten one of the electrodes on the black side with
Aloe Vera spray. Then push the electrode down
between leg and strap.
The black side of the electrode must point towards
your skin.
Now moisten the other electrode on the black side
with Aloe Vera spray. Then push the electrode down
between leg and strap.
The black side of the electrode must point towards
your skin.
Now fix the electrodes with a second elastic Velcro
strap. Connect one electrode with a black connector
and the other electrode with a white connector of the
distribution cable.
We recommend to treat both knees at the same time since the healthy knee is
stressed more with patients with arthrosis. According to the scheme shown above,
fix the electrodes on the other knee.

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Switch on the unit with the switch on the backside of the unit. The display shows:
„Please increase the intensity until you feel a prickle“
Increase the intensity until you notice a light pulsastion. (Possibly several turns
clockwise.).
The therapy has started.
During treatment, you can change the intensity. While changing the intensity you
will always notice a pulsation
The display shows the treatment time remaining and the frequency used at that
time. At the end of the treatment time (60 minutes) the therapy is automatically
terminated.
As shown on the picture, sit down comfortly. During the entire therapy you will
notice a comfortable prickle in both knees.

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gbo Medizintechnik AG Version 1.4
3 Start of operation
3.1 Transport and installation
The device for high tone therapy is a portable unit. To place it, each plane
horizontal surface is appropriate. A wall distance to the back of the device 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 DIN/VDE 0750,
EN 60601. It is a device of safety class I. Within the scope of the Medical Device
Directive the device for high tone therapy belongs to class IIa (see also Chapter3.4
Important notes and safety precautions).
Warning!
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 distance of 2 to 3 m is enough.
3.2 Connection and switch-on
The device for High Tone Power Therapy has been set to be connected to 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 adjusted supply voltage, the device is appropriate for power
frequencies of 48 to 62 Hz.

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gbo Medizintechnik AG Version 1.4
Figure 1: back view
3.2.1 Voltage change-over and fuses
The voltage chosen is indicated on the round voltage selector. The actual voltage is
marked by an arrow.
To change the fuses, unplug the mains cable. The device is protected by two fuses
on the mains side that are located in a pluggable box at the back of the device.
With a screw driver the box can be pulled out of the receiver by the small slot.
Warning!
The mains socket is sealed with a scotch tape. This is to remind to
check prior to switch-on, whether the voltage set corresponds to
the supply voltage in your country.
The scotch tape over the mains socket is easy to remove. Connect the device for
High Tone Therapy with the mains cable to a shockproof socket.
The device is switched on by the mains switch at the back of the device. This
inhibits erroneous, unintended disconnection of the device during normal
operation.
Main switch
Voltage selector
Main input
Fuses

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gbo Medizintechnik AG Version 1.4
3.3 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Metabol.
Switch off the unit.
Switch on the unit while pressing the two black buttons with the arrows.
In the display you will see the selectable settings.
DURATION
LANGUAGE
You can select between the two settings with the arrow keys.
After selection confirm your choice with the white softkey and you can modify the
values.
3.3.1 Treatment time
The treatment time can be set in steps of 5 minutes between 30 and 60 minutes.
TREATMENT TIME
60 MIN.
With the arrow keys you can modify the treatment time to the requested value. By
pressing the white softkey you store the value to the non-volatile memory.
3.3.2 Language
In the language setting you can select between German, English and Russian
language. Language
ENGLISH
With the arrow keys you can choice the language. By pressing the white softkey
you store the value to the non-volatile memory.

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gbo Medizintechnik AG Version 1.4
3.4 Important notes and safety precautions
Caution!
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.
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.

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gbo Medizintechnik AG Version 1.4
4 Therapy
4.1 General notes about the therapy
This therapy is a therapy against pain. This therapy is generated by a current flux
with HiToPfrequencies. The current is being transported to the parts of the body
to be treated by means of rubber electrodes being moistened with Aloe Vera spray.
During treatment only a light prickle is noticed.
!! Note!
If you like to interrupt or stop the treatment, decrease the
intensity to 0 by turning the intensity knob counterclockwise.
4.2 Treatment details
1. Switch on the unit
2. You see the start display:
3. In the display the following message appears:
Increase intensity until you feel
a light prickle
4. Increase the intensity clockwise until you feel a pulsation.
5. In the display the following message appears:
TIME: 56:22
FREQ: 4096 H*z
6. The therapy starts. The therapy timer is shown in the display and decreases in
steps of seconds.
7. With the white softkey-button you can select between the the overview display
and the detailed view.
*All values shown on the display are examples!

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gbo Medizintechnik AG Version 1.4
8. In the detailed view you see some additional information:
TIME: 59:22
U: 12.5 V R: 75 V/A 
I: 165 mA
P: 2062 mW IDX: 55
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 Detail view
In the detail 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.
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.
The patient’s resistance (R) gives information about the electric conductivity of the
system. The resistance should fit to the area of 30 – 150 Ohms. The reason for a
resistance greater than 150 Ohms may be:
No Aloe Vera 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.
*) All values shown on the display are examples!

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gbo Medizintechnik AG Version 1.4
4.4 Duration and frequency of treatment
The duration of treatment is pre-set to 60 minutes. In the basic settings the
treatment time can be set from 30 to 60 minutes.
Treatment of osteoarthrosis can be executed three times a week. After about 10
treatment sessions, an improvement should be noticeable.

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gbo Medizintechnik AG Version 1.4
5 Electrodes
The standard accessories for HiToPMetabol include rubber electrodes of 120 x
80 mm.
5.1 Electrode application
The positioning of the patient 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:
1. Connect the electrodes to the patient cable.
2. Connect the patient cable to the distribution cable.
3. Plug in the patient plug of the distribution cable to the socket of the unit.
4. Wet the conductive rubber electrodes with Aloe contact 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 holding 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 to the patient. Herewith the
intensity of the current can be erroneously judged by the patient.
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.

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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
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. 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 a service agency authorized by him.
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.
6.2 Cleaning, disinfection and care
6.2.1 Cleaning the device
For cleaning and disinfection of the device for High Tone Therapy and its
accessories there shall not be used any agents containing higher portions of phenol
derivates, alcohol, compounds of chlorine or peracetic acid. It is recommended to
use disinfectants on aldehyde basis.
The device is suited neither for heat sterilization nor sterilization with gases.

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gbo Medizintechnik AG Version 1.4
Warning!
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 aloe vera 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
colour may come off.
7 Explanation of the signs used
0123 CE Conformity sign.
Caution!
Observe the instructions for use!
Application part ungrounded, safety degree type
BF.
This product complies with WEEE Directive
2002/96/EG (waste electrical and electronic
equipment). Separate collection for electrical
and electronic equipment.

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gbo Medizintechnik AG Version 1.4
8 Technical data
Mains voltage and frequency: 115, 230 V, 48 - 62 Hz
Current consumption: With 115 V: max. 700 mA
With 230 V: max. 350 mA
Mains fuses: With 115 V: 2,5 AT
with 230 V: 2,5 AT
Output current: max. 250 mA
Output voltage: max. 70 V eff.
Admissible loaded
impedance: 30

...5 k

MDD device class: IIa
Safety class: I in accordance to IEC 601 / VDE 0750
Safety degree: BF in accordance to IEC 601
Protection against ingress of
water: IP X1
Dimensions: 6 cm x 23 cm x 32 cm (H x D x W)
Weight: max. 3,7 kg (without accessories)
Color: white RAL 9002 and grey RAL 7016
Display: LCD backlighted, 122 x 32 dots full graphic
Buffer battery: CR 2032
Surrounding conditions: Operation
of the
device:
Temperature range +10 °C ... +40 °C
Relative air humidity 30 ... 75 %
Transport
and storage: Temperature range +5 °C ... +50 °C Relative air humidity < 90 %, none
condensing
Types of current: Sinusoidal currents of 4096 - 32768 Hz
gbo Medizintechnik AG reserves the right to modify the design and specification
without prior notice.