gbo Medizintechnik ULTRATHERM 1008 User manual

Instructions for use
ULTRATHERM 1008 short-wave therapy unit

ULTRATHERM 1008
© gbo Medizintechnik AG Version 1.7
2
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 er-
rors 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
GERMANY
Telefon: [phone]
Telefax: +49 (0) 6 25 3/808-245
E-Mail: [email protected]
Internet: http://www.gbo-med.de
Part no. 022-7-0002
Version 1.7
Date of issue September 1st, 2016

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Table of Contents
Chapter Topic Page
1Introduction 5
1.1 Preface 5
1.2 Scope 5
1.3 Intended use 5
1.4 Guarantee 6
1.5 Exclusion of liability 6
1.6 Symbols used in the documentation 7
1.7 Warning and information plates on the unit 7
2Safety instructions 8
2.1 General information 8
2.2 Responsibilities 8
2.3 Personal safety 9
2.4 Protection of unit 11
3Installation 13
3.1 Requirements for installation 13
3.2 Requirements of the installation location 13
3.3 Transport of the unit 13
3.4 Unpacking the unit 14
3.5 Inspection upon receipt 14
3.6 Damages 14
4Description of unit 15
4.1 Operator side 15
4.2 Patient side 16
4.3 Accessories 17
5Description of functions 18
5.1 Introduction 18
5.2 Applications 18
5.3 Short-wave therapy in the capacitor (dielectric) field 19
5.4 Short-wave therapy in the coil (induction) field 20
6Program description 21
6.1 Display and control elements 21
6.2 Main menu 22
6.3 Indications menu 24
6.4 Programming menu 27
6.5 Basic settings menu 28
7Putting the unit into operation 29
7.1 Preparing the unit for operation 29

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7.2 Check for operational safety 29
7.3 Moving the device 29
7.4 Positioning the electrodes 30
7.5 Setting the electrode-skin distance 33
7.6 Switching on the unit 34
7.7 Setting the parameters 34
7.8 Beginning the treatment 36
7.9 Interrupting/ending treatment 37
7.10 Changing the basic settings 37
7.11 Placing out of operation 37
8Maintenance and repairs 38
8.1 Routine maintenance 38
8.2 Cleaning and disinfection 38
8.3 Safety inspections 39
8.4 Error messages 40
8.5 Repairs 40
8.6 Disposal of equipment and accessories 40
9Technical specifications 41
9.1 Transport and storage conditions 41
9.2 Operating data and ratings 41
AIndications table 48
A.1 Important information 48
A.2 Dosage levels according to Schliephake 49
A.3 Indications 49
A.4 Orthopedics –Surgery / Neurology 50
A.5 Dermatological Indications 61
A.6 Gynecology 64
A.7 ENT / dentistry and oral medicine 67
A.8 Internal medicine, urology 69
BContraindications 76
B.1 Absolute contraindications 76
B.2 Local contraindications 77
B.3 Of particular importance 78

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1 Introduction
1.1 Preface
Safe operation of the short-wave therapy unit requires knowledge of
both medicine and electricity.
For this reason, the short-wave therapy unit may be used only by per-
sons with the appropriate training, knowledge and practical experience
necessary to ensure proper handling of the unit and who have been
properly trained in the use of the unit based on these instructions for
use
Therefore, please read this manual thoroughly and be sure to comply
with the safety instructions!
We will be glad to answer any questions you may have concerning this unit or
other gbo Medizintechnik AG products.
Our address can be found at the beginning of this manual..
1.2 Scope
The information provided in this instruction manual refers to the
ULTRATHERM 1008 short-wave therapy unit
from gbo Medizintechnik AG.
1.3 Intended use
The ULTRATHERM 1008 short-wave therapy unit may be used only for the in-
tended purposed –short-wave therapy in the medical treatment of human
beings!
Any other use is deemed not authorized and can cause personal injury
or damage to property!

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1.4 Guarantee
The ULTRATHERM 1008 short-wave therapy unit is guaranteed for 2 years
from the date of delivery by gbo Medizintechnik AG.
The unit is covered by the guarantee policy of gbo Medizintechnik AG.
Repair of the unit may be performed only by the manufacturer or a per-
son or company authorized by the manufacturer!
1.5 Exclusion of liability
All obligations of the manufacturer are regulated by the appropriate sales con-
tract or in case of claims for liability, by the product liability law.
Liability claims for personal injury or property damage are excluded if they are
the result of one or more of the following causes:
–Unauthorized use of the unit
–Improper operation and maintenance of the unit
–Operation of the unit with protective covers removed, apparent damage
to insulators (cables, electrodes) or faults in the building’s power supply
(protective conductor, residual-current circuit-breaker)
–Failure to comply with the information in this instruction manual concern-
ing the operation, maintenance and repair of the unit
–Use of accessories and replacement parts of other manufacturers
–Unauthorized modification, repairs or structural modifications to the unit
–Unauthorized modification of the unit controls
–Unauthorized exceeding of the power limits
–Failure to inspect parts that are subject to wear
–Treatment of patients without a medical indication
–Catastrophes due to foreign objects or superior force

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1.6 Symbols used in the documentation
Information in bold type that is accompanied by this symbol is very im-
portant; also for preventing personal injury! You must comply with this
information!
Information in bold type that is accompanied by this symbol is im-
portant; also for preventing damage to property! You must comply with
this information!
Information accompanied by this symbol contains comments, suggestions or
tips.
This arrow identifies cross-references.
This dot identifies direct instructions for action.
–This dash identifies enumerated items.
1.7 Warning and information plates on the unit
Read the instructions for use
Danger for persons with pacemakers or similar implanted devices!
6
Device of type BF (insulated (non-earthed) application element).
Non ionizing radiation
CE –Conformity sign
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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2 Safety instructions
2.1 General information
The ULTRATHERM 1008 short-wave therapy unit and the accompanying
components and individual elements fulfill singly and as a unit the currently
valid safety standards and comply with the stipulations of EN 60601 and the
medical device directive.
The unit and its external components (accessory elements) are safe if used
properly and in compliance with the explanations and instructions provided in
this documentation.
Nevertheless, the unit or its external components can pose dangers!
Therefore, we urgently recommend that anyone operating the short-wave
therapy unit become aware of the potential dangers of the unit and its
external components before beginning work.
Please read and observe all safety instructions in this operating manual.
2.2 Responsibilities
–The short-wave therapy unit may be used only by doctors, physiothera-
pists or trained assistants under the direction of a doctor or physiothera-
pist!
–Before treating a patient, an anamnesis must be performed by the at-
tending physician, during which the patient must be consulted concern-
ing possible contraindications!
An accurate diagnosis is always required for each treatment!
–All service work (safety inspections and repairs) must be performed only
by service technicians who have been authorized by the manufacturer!
For your own safety, please read the following safety instructions care-
fully and observe the information contained therein!
Perform all work
–according to the explanations in this instruction manual,
–correctly and as precisely as possible and
–in compliance with the relevant safety and accident prevention
regulations!

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2.3 Personal safety
In case of improper or unauthorized use of the unit, the operator, the pa-
tient or other persons may be subjected to the danger of electric shock
due to high voltage produced by the unit, the danger of influence on ac-
tive implantations by magnetic fields produced by the unit and the dan-
ger of being burned due to erroneously positioned electrodes or false
parameters such as the duration of treatment, power output or operating
mode!
Before operating the unit, please read this instruction manual carefully
and observe the information contained therein!
Pay special attention to the list of contraindications at the end of the in-
struction manual!
(Annex B Contraindications)
Before operating the unit each time, check whether
–the unit has been correctly connected to the building’s power supply,
–the unit has been set up so that it is free-standing and the patient is not
in direct contact with metal objects such as heating radiators, metal beds
or other equipment,
–the insulation of the power supply and electrode connection cables is not
damaged,
–the electrode connection cable is connected properly and is not cross-
routed (which may cause capacitive short circuits),
–only accessories (cables, electrodes) approved by the manufacturer are
connected,
–the patient to be treated (and the personnel) have removed all electric
devices (e. g. hearing aids, electrotherapy electrodes, mobile tele-
phones) and all conductive objects (e. g. rings, chains, watches, earrings
or other jewelry, eyeglasses) and that they are not in the immediate vi-
cinity of the unit,
–the patient is in a composed state and the bodily areas to be treated are
dry on the exterior,
–the electrodes are positioned according to the doctor’s instructions (to be
checked by the doctor or physiotherapist if applied by assisting person-
nel),
–there is no danger of unwanted local warming due to electrode con-
strictions and
–no other persons are located within 2 meters of the unit!

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Before using the unit, speak with the patient to make sure that
–he is in a comfortable position during the entire treatment,
–he is not in contact with the unit, the electrode connection cable, the
electrodes or other devices or metal objects and
–he should (and can) let you know if he feels unwell!
Before using the unit, determine the maximum nominal output power of
the respective applicators in order to avoid overheating of tissue!
Do not treat Patients on metal chairs or metal beds.
(7.8 Beginning the treatment)
At regular intervals during the treatment, check
–that the unit is functioning properly,
–for moisture development* (perspiration) in the area of the electrodes
and
–whether the patient feels well**!
After the treatment, ask the patient about his tolerance of the treatment
and visit the treatment environment (doctor or physiotherapist).
* The affected parts of the body should be unclothed during treatment, since
accumulation of moisture on the skin or in folds can cause local overheat-
ing of the skin. This is especially important in case of clothing made of
moisture-resistant fabric such as silk or synthetic fibers!
** The output power must always be set according to the subjective response
of the patient! Particular care is to be taken with patients who have a re-
duced capacity for heat perception!
(A.2 Dosage levels according to Schliephake)
During service and maintenance work it is not allowed to treat a patient!

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2.4 Protection of unit
Improper installation, operation or maintenance of the short-wave thera-
py unit may result in malfunctions of this unit or other devices!
Therefore, observe the following instructions in order to prevent mal-
functions:
In order to prevent electromagnetic disturbances, place the unit at least
6 meters from any other devices! Also make sure that there is sufficient
distance between the unit and power supply or data cables in walls,
ceilings and floors, since the electromagnetic radiation from the unit
can pass these essentially without hindrance!
In selecting the location for the unit, make sure that the patient has
contact during the treatment to the non-earthed application element
and, due to equalizing currents in case of differing potentials, that the
patient is never in contact with metal elements (especially if they are
earthed), such as heating radiators, metal beds or other earthed de-
vices!
Before connecting the unit, make sure that
–the voltage selected by the voltage selector corresponds to the available
system voltage,
–the frequency rating on the rating plate corresponds to the system fre-
quency,
–an earthed (!) socket outlet with earthing contact is available for connect-
ing the unit,
–the routing of the power cable from the unit to the socket outlet with
earthing contact does not pose a danger for personnel or the patient
–the building’s power supply is designed for the comparatively high (pos-
sibly additional) power input of the unit (~ 1500 VA) and the line is suffi-
ciently protected in accordance with regulations!
Do not connect the unit to the power supply until these requirements
have been fulfilled!
Before putting the unit into operation, check to make sure that the elec-
trode connection cable and the electrodes are undamaged and have
been connected correctly to the unit!
Never operate the unit with open outputs (i.e. without electrodes)!
The device should neither be placed in front of heating radiators nor
should it be covered by pillows or blankets while in operation. The device
is not made for outdoor operation.

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Do not operate the unit for an extended period with no load (without
a patient), especially in coil (induction field) mode! When operating the
unit without power output, induction field electrodes could be
destroyed due to overheating!
Pay attention to the routing of the electrode connection cables. These
must always be in the air and must never lie on metal surfaces!
Do not treat Patients on metal chairs or metal beds.
Keep chip cards, magnetic cards, audio and video cassettes and other
data media that are susceptible to interference away from the unit!
Clean and disinfect the unit only when the power supply is deactivated
(power switch off, power plug disconnected)!
Clean and disinfect the unit only by means of disinfection by wiping!
Disinfecting by spraying can damage the unit due to penetrating mois-
ture!
Never clean the unit with abrasives, disinfectants or solvents that could
scratch the housing or damage the unit!
Never perform unauthorized service work!
All service work (safety inspections and repairs) must be performed only by
service technicians who have been authorized by the manufacturer!
During service and maintenance work it is not allowed to treat a patient!
The device must not be used as a step or a seat!

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3 Installation
3.1 Requirements for installation
Before the unit can be installed and put into operation, certain requirements
must be fulfilled in the building where the unit is to be operated!
If the unit cannot be installed immediately after delivery, the unit and its
external components or accessory elements must be stored in their orig-
inal packaging in a dry place!
Do not store or operate the unit in a dusty environment!
3.2 Requirements of the installation location
The unit must be installed so that there is no danger to the patient, the
operator or other persons!
Therefore, you must read the safety instruction in Chapter 2 and the fol-
lowing information!
–By selecting a suitable location for setting up the unit or by means of
structural measures, contact during the treatment by the personnel or
the patient with conductive materials that are earthed or have a high ca-
pacity to earth must be prevented (e.g. heating pipes, water faucets,
metal chairs, metal beds or other earthed devices).
–The unit must be set up so that the (normal) release of electromagnetic
radiation during operation does not hinder the function of other devices
or data media. The minimum distance to other devices or their power
supplies or data transfer lines is 6 meters! Please note that the radiation
can easily pass walls, ceilings and floors.
–The room and the installation location must be large enough so that the
unit can be operated from the front even if the electrodes are positioned
inconveniently.
3.3 Transport of the unit
Measures concerning the transport of the unit from the manufacturer to the
operator are based on the individual circumstances and are defined in the
general terms of business.
In the event of subsequent transport of the unit, the dealer or the operator is
responsible for the unit and for compliance with the safety and accident pre-
vention regulations.

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3.4 Unpacking the unit
The unit is generally delivered with the packaging material supplied by the
manufacturer. Since the unit weight about 60 kg, it must be unpacked by at
least 2 persons!
Proceed as follows:
Position the transport packaging so that the UP mark is pointing up-
ward.
Remove the safety bands from the transport packaging.
Remove the transport packaging upward.
Remove the remaining foam material.
Lift (at least two persons) the unit from the lower packaging element.
3.5 Inspection upon receipt
Verify the delivery documents to make sure that the delivery is com-
plete.
Immediately after unpacking the unit, check the external components
and accessories for possible damage due to transport..
In case of damage from transport that could endanger personal safety, the
unit must not be connected to the power supply!


3.6 Damages
Claims for damages resulting from damage due to transport are valid only if
the carrier and the manufacture are notified without delay. Notification of the
manufacturer and the remedy of the damages generally takes place by the
dealer.
Prepare a damage report at once and send it to the carrier and to the
dealer.
When returning the unit, include the following information:
–Name and address of the sender and receiver
–Type and serial number of the unit
–Description of the defect (damage report)
–Date and signature

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4 Description of unit
4.1 Operator side
1 Plastic plate electrode
2 Electrode connection cable with sponge rubber covering
3 Self-locking plastic electrode arm, extractable
4 Control panel with graphic display
5 Metal housing
6 Locking castor
7 Power switch
Fig. 4 - 1 Front view of ULTRATHERM 1008

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4.2 Patient side
1 Self-locking plastic electrode arm, extractable
2 Male end of the electrode connection cable
3 Power safety devices
4 Voltage selector
5 High-load non-heating appliance plug
6 Rating plate
7 Female end of the electrode connection cable
8 Adjusting element for electrode-skin distance
9 Locking screw on electrode arm
Fig. 4 - 2 Back view of ULTRATHERM 1008

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4.3 Accessories
1 Plastic plate electrode
 165 mm
(020-453218)
2 Plastic plate electrode  120 mm
(020-453217)
3 Plastic plate electrode  80 mm
(020-453216)
4 Electrode connecting cable with
sponge rubber covering (020-453220)
Fig. 4 - 3 Plastic plate electrodes,
capacitor (dielectric) field
1 Rubber capacitor electrode
250 x 145 mm (020-453267)
2 Rubber capacitor electrode
180 x 120 mm (020-453266)
3 Felt layer with linen bag (included at
the rubber capacitor electrodes)
4 Perforated rubber band (45-38-
963EH725) with 2 buttons(22-74-
801Q1320)
Fig. 4 - 4 Rubber capacitor electrodes,
capacitor (dielectric) field
1 Eddy-current electrode (Diplode) with
cable
2 Eddy-current electrode (Monode) with
cable
Fig. 4 - 5 Plastic eddy-current elec-
trodes, coil (induction) field
Use only original accessories to ensure the safe operation of the appli-
ance!

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5 Description of functions
5.1 Introduction
The ULTRATHERM 1008 short-wave therapy unit can produce dielectric
warming by means of electric or electromagnetic fields of varying intensity in
essentially any region of the body and can therefore be used for a wide variety
of applications.
Treatments can be carried out using either the capacitor (dielectric-field) or the
coil (induction-field) method.
In the dielectric-field method, the body part to be treated is within the electric
field between two plate electrodes. The “radiation” produces a warming of the
body part located within the induction field. Fat layers are warmed considera-
bly more than muscle tissue. When applying the induction-field method, the
body part is within a magnetic field, which warms especially tissue containing
liquid located near the surface, such as muscles.
5.2 Applications
The short-wave therapy unit is suitable for nearly all heat therapy processes
for use in clinics and private practices.
Classical therapy applications can be conducted with the induction-field and
dielectric-field methods in continuous or pulsed mode.
The application of high-frequency energy in heat therapy has the advantage of
greater depth penetration as opposed to simpler methods, such as packs,
baths, infrared light and heat cushions.
The endogenous heat that is formed triggers a series of physiological pro-
cesses, producing a spasmolytic effect on muscles, tendons and other struc-
tures containing connective tissue, increasing the cell metabolism and the en-
zyme reaction speed and stimulating perfusion in the treated zone.
The capability of applying the high-frequency energy in short, intense pulses
(pulsed mode) can further increase the depth effectiveness, especially the
stimulation of perfusion, while the heat generation is hardly felt in the skin,
which is more sensitive to heat.
The applications for the high-frequency therapy are diverse. This therapy is
especially effective in treating rheumatic disorders of the joints and muscles, in-
flammatory disorders of the respiratory organs, the kidneys and bile ducts and
all disorders due to insufficient perfusion. The pulsed mode is advantageous in
the treatment of acute conditions.
gbo Medizintechnik AG short-wave therapy units are therefore used for a wide
range of applications in hospitals and in private practices by doctors and phys-
iotherapists.

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5.3 Short-wave therapy in the capacitor (dielectric) field
1 2
3 4
1 Heat distribution with a small electrode-skin distance (ESD)
2 Heat distribution with a large electrode-skin distance (ESD)
3 Heat distribution with an unequal electrode-skin distance (ESD)
4 Heat distribution with unequal electrodes and an unequal ESD
Fig. 5 - 1
With the capacitor (dielectric field) method, the body part being treated is lo-
cated in the high-frequency electric field between two insulated electrodes.
The body and the electrodes together form a capacitor. This causes heat to
be generated in the entire treatment field located between the electrodes.
With the capacitor method, fat tissue is warmed more effectively than muscle
tissue.
Rigid electrodes (plate electrodes) and soft rubber electrodes are used for the
capacitor method.
An adjusting device on the plate electrodes or layers of felt with the rubber ca-
pacitor electrodes can be used to achieve different electrode-skin distances
(ESD).
The ESD must be small for surface warming and large for depth warming! A
larger ESD is necessary for patients with a thick layer of subcutaneous fat in
order to achieve the necessary warming of deep-lying tissue!

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5.4 Short-wave therapy in the coil (induction) field
The coil or induction field produces the high-frequency electric currents within
the body tissue by means of induction (induction field). The high-frequency
circuit of closed currents occurring in the tissue as a result of induction are re-
ferred to as eddy currents. The density of these eddy currents, which is im-
portant for the warming effect, is proportional to the electrical conductivity of
the tissue. At the same field intensity, therefore, tissue with better conductivity,
such as muscles and inner organs, are warmed more than fat tissue. The
danger of excessive heating of the outer layers of tissue is therefore signifi-
cantly reduced, while effective warming down into the muscles is primary.
Two different eddy-current electrodes are available as induction field elec-
trodes:
–Monode for treatment of mid-sized areas
–Three-part Diplode for treatment of large areas and for treatment of suit-
able body parts that can be warmed from three sides at the same time.
With the induction field electrodes, the perception of warming is delayed. It is
recommended to remain below the desired power output at the beginning of
the treatment and then to increase the power in increments.
For maximum depth effectiveness, the inductive field electrodes should be in
direct contact with the body.
Induction field electrodes that are operated without a patient could be de-
stroyed due to overheating!