gbo HiToP 184 Instruction Manual

High Tone Power Therapy Device

®

HiToP

Instruction manual

184

 gbo Medizintechnik AG Version 2.0

2 HiToP®184

The gbo Medizintechnik AG has taken care in preparation of this manual, but makes no expressed or implied
warranty of any kind and assumes no responsibility for errors or omissions.

All rights reserved. No part of this manual may be reproduced in any form or by any means (electronic,
mechanical, or otherwise) without the prior written permission of the gbo Medizintechnik AG.

© gbo Medizintechnik AG

gbo Medizintechnik AG
Kleiststrasse 6

D-64668 Rimbach

Phone: [phone]
Fax: [phone]
E-Mail: [e-mail]
Internet: http://www.gbo-med.de

Version 2.0
Date of issue December 14th, 2012
Part No. 017-7-0010

 gbo Medizintechnik AG Version 2.0

HiToP®184

Arial in type size 10

Notations

Times New Roman in type size 11 - descriptions and explanations;

- functions and control keys of the device;

Lucida in type size 10 or 11 - text appears on the display of the device;

marking - text appears on the display next to the soft key.

Warnings and safety precautions

Warning!

Warnings which have to be observed by all means!

3

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 cut-

off frequency have got the same quarter tone, this range can be indicated in
octaves.

Softkey A softkey is a key with context-sensitive meaning.

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4 HiToP®184

Contents

1 INTRODUCTION 7

1.1 Intended Use 7

1.2 Note concerning the operating personnel 7

1.3 Device description 7

1.4 Operating concept 8

1.4.1 Ergonomic control panel 8

1.4.2 Indication menu 8

1.4.3 Display 8

1.5 Optical and acoustical user support 8

1.5.1 Optical user support 8

1.5.2 Acoustical user support 8

1.6 View of HiToP184 9

1.7 Short instructions SimulFAM®i 10

1.8 Short instructions SimulFAM®X 11

2 START OF OPERATION 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 Deactivate intensity monitoring 20

3 DESCRIPTION OF FUNCTION 21

3.1 Description of the contents of display 21

3.1.1 General view 21

3.1.2 Detail view 22

3.2 Operating notes 22

3.2.1 Menu key 22

3.2.2 Softkey 23

3.2.3 Channel keys 23

3.2.4 Intensity regulator 23

3.2.5 Modification knob 24

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HiToP®184

3.2.6 SimulFAMX / Change slope 24

3.2.7 Surge parameters 24

3.2.8 Setting of the surge parameters 24

3.2.9 Keep therapy frequency constant 25

3.2.10 Therapy time 25

3.3 CD module 26

3.4 Instructions for use of the CD module 26

4 THERAPY 27

4.1 Therapy with SimulFAMi 27

4.2 Therapy with SimulFAMX 28

4.3 Indication menu 29

4.3.1 Operating steps for the selection from the indication menu, if necessary, multiple therapy 29

4.4 Effects menu 31

4.4.1 Programs of the Effects menu 32

5 PROGRAMMING OF PATIENT UNIT 37

5

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 MAINTENANCE 47

8.1 Safety controls 47

8.2 Disposal of the device and the accessories 47

8.3 Cleaning, disinfection and care 48

8.3.1 Cleaning the Device 48

8.3.2 Cleaning the Elastic Straps 48

8.3.3 Cleaning the Electrodes 48

8.3.4 Disinfecting the Electrodes 48

9 WARNINGS AND SAFETY PRECAUTIONS 49

9.1 Contraindications 50

10 EXPLANATION OF THE SIGNS USED 51

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11 TECHNICAL DATA 52

12 ACCESSORIES 53

INDEX 52

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HiToP®184

1 Introduction

1.1 Intended Use

Electrotherapy with sinusoidal alternating currents.

1.2 Note concerning the operating personnel

The device is to be operated by healthcare professionals only.

1.3 Device description

The HiToP®184 is a microprocessor-controlled HighTone Therapy device for electrotherapy. Its application
range predestines this device for the use in modern and well-equipped hospitals or practices.

Also patients with varicose veins, metal implants, endoprotheses and open wounds (ulcus cruris) may be
treated.

7

The High Tone Power Therapy device HiToP(High Tone Power) 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 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 frequency travers 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 travers of three octaves is realized. The frequency travers is realized with different speed
(0.1 - 200 Hz). This therapy activates the metabolism in the body, thus having an effect of irritation.

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





1.4 Operating concept

1.4.1 Ergonomic control panel

The control panel possesses softkeys as function and modification keys. Function keys activate a function of
the device, and modification keys are used for parameterization of a function. All keys are easy to feel and
have a pressure point. The parameter settings are carried out with the modification knob.

1.4.2 Indication menu

There is a user-guided selection method by means of the indication menu (see chapter 4.3 Indication menu).
By setting the indication group first, followed by selecting an indication within that group, the appropriate
current type is automatically selected and information about the electrode positioning is given.

1.4.3 Display

The device is equipped with a high-resolution graphic display (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 support

Furthermore, an optical user support is furnished on the display. A modification, which is just being
changed, is shown inversely.

1.5.2 Acoustical user support

The following table explains about the acoustic signals and their meaning:

Type of signal Cause

Confirmation beep
Information sound

Triad gong

Admissible pressing of a key.
The patient plug is unplugged during operation.

 A limit of voltage or power has been reached.
 When turning the intensity regulator without activated channel.

At the end of the faultless automatic check at the start of
operation.

 At the end of therapy.

Table 2: Acoustical user support

 gbo Medizintechnik AG Version 2.0

HiToP®184

+

Int

Mod

®

!

III

instruction for use !

I;II;III and IV

1.6 View of HiToP184

9

SimulFAMX

Bar display

Function keys:

SimulFAM®X -

types of current

f

min

3 Hz

10 Hz

20 Hz

100 Hz

0,1 - 1,5 Hz

1,5 -10 Hz

10 - 20 Hz

20 - 200 Hz

Channel keys Graphic display Softkey:

I

II

f

max

III

IV

FIX

Menu

Menü

SimulFAMi

Bar display

Softkeys:

Detail view/

Indication menu

®

f

min

®

f

max

®

HiToP

184

Therapy

time

Frequency

fixing

Figure 1: Device view

Modification

knob

I II

Patient cable connection

Surge

parameter

CD-

Module

IV

CD

Function key:
SimulFAM®i

Intensity
regulator

Application part ungrounded
safety degree BF

Caution! Observe the

Figure 2: Device view from the right

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10 HiToP®184

1.7 Short instructions SimulFAM®i

1. Connect the device through the mains switch at the back of the device. After that the device carries out
an automatic check of all functions. The faultless automatic check ends with an acoustic signal (triad
gong).

2. Connect the accessories with the according socket on the right side of the device.

3. The general window with the pre-setting SimulFAM®i for all plugged channels is shown on the
display.

4. After the automatic check, the Softkeys [Ind. Menu] as well as the Channel keys are active (constantly
lit) for all plugged channels. The CD module is active.

5. The black Menu key is active. It is used for calling the main menu. There you can modify the
presettings.

6. Apply the electrodes to the patient (see chapter Fehler! Verweisquelle konnte nicht gefunden werden.

Fehler! Verweisquelle konnte nicht gefunden werden.).

7. Select a channel with the Channel key. 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 intensity to patient`s sensitive threshold and press the „Continue“ key.

10. Confirm the intensity value of the lower setting frequency by pressing the Softkey [Continue].

11. On the display the message appears:

Increase intensity to patient`s sensitive threshold and press the „Continue“ key.

12. Confirm the intensity value of the upper setting frequency by pressing the Softkey [Continue] and the
therapy starts.

13. The bar display SimulFAM®i shows the frequency travers optically.

14. On the display there appears the general window. With the Softkey [Detail Display] it is possible to
move to the detail view of the allocated channel.

15. At the end of the therapy the triad gong will sound. The current to the patient will be automatically
reduced.

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HiToP®184

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1.8 Short instructions SimulFAM®X

1. Connect the device through the mains switch at the back of the device. After that the device carries out
an automatic check of all functions. The faultless automatic check ends with the acoustic signal (triad
gong).

2. Connect the accessories with the according socket on the right side of the device.

3. The general window with the presetting SimulFAM®i for all plugged channels is shown on the display.

4. After the automatic check, the Softkeys [Ind.Menü] as well as the Channel keys are active (constantly
lit). The CD module is active.

5. The black Softkey Menu is active. It is used for calling the main menu. There you can modify the
presettings.

6. Apply the electrodes to the patient (see chapter Fehler! Verweisquelle konnte nicht gefunden werden.
Fehler! Verweisquelle konnte nicht gefunden werden.).

7. Select a channel with the Channel key.

8. The activated 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:

Select channel

Activate the desired channel again.

11. Increase the current slowly with the Intensity regulator until the desired stimulation effect occurs.

12. The detail window is displayed automatically and the therapy starts. The bar display SimulFAM®X
shows the frequency travers optically.

13. In case of traversing frequencies the present stimulation frequency is shown. The frequency values are
increased and reduced every second.

14. Within 20 seconds after having activated the intensity regulator, the program returns to the overview
window. Here the frequency and the voltage for the chosen channels are shown.

15. At the end of the therapy the triad gong will sound. The current to the patient will be automatically
reduced.

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12 HiToP®184

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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HiToP®184

The rubber electrodes can be disinfected by spray/wipe disinfection. Spray onto the black side of the
electrodes, 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.

!!

13

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14 HiToP®184

Warnings and safety precautions).

Please check all components to be in external integrity before use.

Warning!

The unit is not designed to be used in non-explosion-proof areas. 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 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 adjusted mains voltage, the device is appropriate for power frequencies of 48 to 62 Hz.

Warning!

To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.

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HiToP®184

15

2.2.1 Voltage selection and fuses

1. Unplug the mains plug.

2. The device is protected by 2 fuses on the mains side that are located in a pluggable box at the back of the

device.

3. The adjusted supply can be seen through the small window of the box.

4. With a screw driver the box can be pulled out of the receiver by the small slot.

5. Take the voltage 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 automatic check of all functions will be carried out.

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.

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16 HiToP®184

Menu key

2.4 Settings

2.4.1 The main menu

You can open the main menu by pressing the black Menu key. It provides the following submenus:

 Program patient unit (see chapter 5)
 Basic settings (see chapter 2.4.4)
 Unit settings (see chapter 2.4.3)
 Cable check (see chapter 2.4.5).

Black

Figure 3: Main menu

2.4.2 Basic and unit settings

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 [Return].
 The main menu can be chosen with the black menu key only, if the intensity is „0.0“ in all

channels, i.e. no therapy is active any more.

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HiToP®184

2.4.3 Modification of the unit settings

To modify the unit settings proceed as follows:

1. Press the black Menu key.

2. You are in the Main menu (see Figure 3: Main menu).

3. Move the scroll bar with the Modification knob to Unit settings.

4. Confirm by pressing the white Softkey [Continue].

5. You are in the Menu Unit settings. The Menu provides the following options:

Unit settings Setting possibilities Delivery

Contrast Display 0 – 15 7
Volume of signals 0 – 15 7
Volume of gong 0 – 3 1
Language German

English
Spanish
Italian
French
Polish
Portuguese
Czech / n.a.*

Type of menu Effects menu

Indication menu

German

Effects menu

17

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. On the display the Main menu appears again.

12. Exit the Main menu by pressing the black Menu key [Return].

13. On the display the Overview window appears again.

!! Note!

 During the modification of the settings it is possible at any time to return with the black Menu key

[Return].

 If you have chosen the Effects menu, you get different settings in the basic menu, see chapter 2.4.4.

*n.a.: these languages are not active on delivery.

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18 HiToP®184

2.4.4 Modification of the basic settings

Indication Menu selected in Unit settings:

1. Press the black Menu key.

2. You are in the display window Main menu.

3. Move the scroll bar with the Modification knob to Basic settings.

4. Confirm by pressing the white Softkey [Continue].

You are in the menu Basic settings. The menu provides the following options:

Basic settings Setting possibilities Delivery

Scan – Starting frequency
= lower cut-off frequency for SimulFAM®i
Scan – Ending frequency
= upper cut-off frequency for SimulFAM®i
Treatment time FAM X
= basic setting of the therapy time which is preset upon
switching-on the device or selecting a channel.
Treatment time FAM i
= basic setting of the therapy time which is preset upon
switching-on the device or selecting a channel.
Slope FAM X
= basic setting of slope for SimulFAM®X which is preset
upon switching-on the device or selecting a channel.
Blocking frequency
= basic setting of the frequency for nerve block which is preset
upon selecting the blocking from the Indication menu.
Intensity monitoring
= see chapter 2.5 Intensity monitoring

Table 4: Basic settings (Indication Menu)

5. Move the scroll bar with the Modification knob to the basic setting to be changed.

6. Confirm by pressing the white Softkey [Continue].

7. Move the cursor or change the value with the Modification knob to the desired value.

8. Confirm by pressing the white Softkey [Store].

9. Exit the device setting menu by pressing the black Menu key [Return].

10. On the display the Main menu appears again.

11. Exit the Main menu by pressing the black Menu key [Return].

12. On the display the Overview window appears again.

4096 - 16384 Hz 4096 Hz

8192 - 32768 Hz 32768 Hz

5 – 90 min 60 min

5 – 90 min 60 min

10 – 200 % 150 %

4096 – 12274 Hz 12274 Hz

on / off on

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