Zimmer MicroPro User manual

Microwave Therapy Device
MicroPro
Instructions For Use

2MicroPro
©gbo Medizintechnik AG Version 1.4
gbo Medizintechnik AG has taken care in the preparation of this manual, but does
not assume any liability, expressed or implied, of any kind nor does it assume any
responsibility for errors or omissions.
All rights reserved. No part of this manual may be reproduced, in any form or by
any means (electronic, mechanical or otherwise) without the prior written permis-
sion of Zimmer MedizinSysteme GmbH.
© gbo Medizintechnik AG
Part No.: 10105289
Version: 1.4
Issue date: 2022-03-09
Manufacturer:
gbo Medizintechnik AG
Kleiststraße 6
D-64668 Rimbach
Telefon: [phone]
Telefax: +49 6 25 3/808-245
E-Mail: [e-mail]
Internet: https://www.gbo-med.de
Manufactured for:
Zimmer MedizinSysteme GmbH
Junkersstrasse 9
D-89231 Neu-Ulm
Telefon: [phone]
Fax: [phone]
E-Mail: [e-mail]
Internet: https://www.zimmer.de

MicroPro 3
©gbo Medizintechnik AG Version 1.4
Table of Contents
1Introduction..............................................................................................5
1.1 Preface ......................................................................................................5
1.2 Scope.........................................................................................................5
1.3 Intended use..............................................................................................5
1.4 Warranty....................................................................................................6
1.5 Exclusion of liability ...................................................................................6
1.6 Symbols used in the documentation .........................................................7
1.7 Explanation of key symbols.......................................................................7
2Safety instructions..................................................................................9
2.1 Responsibilities..........................................................................................9
2.2 Personal safety........................................................................................10
2.3 Device protection.....................................................................................11
3Installation..............................................................................................13
3.1 Requirements for installation...................................................................13
3.2 Characteristics of the installation location...............................................13
3.3 Transport of the unit ................................................................................14
3.4 Unpacking the unit...................................................................................14
3.5 Receiving inspection................................................................................14
3.6 Complaints...............................................................................................15
4Description of the unit ..........................................................................16
4.1 Operator side...........................................................................................16
4.2 Patient side..............................................................................................17
4.3 Accessories.............................................................................................18
5Description of functions.......................................................................19
5.1 Applications.............................................................................................19
5.2 Information for use of the radiator...........................................................19
5.3 Microwave therapy with circular-field radiator.........................................20
5.4 Microwave therapy with focus radiator....................................................21
5.5 Microwave therapy with cradle radiator...................................................21
5.6 Microwave therapy with long-field radiator..............................................21
6Start of operation...................................................................................22
6.1 Check for operational safety....................................................................22
6.2 Moving the device....................................................................................23
6.3 Positioning the radiator............................................................................23

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6.4 Switching on the unit ...............................................................................24
6.5 Beginning treatment ................................................................................24
6.6 Interrupting / ending treatment................................................................25
6.7 Placing out of operation...........................................................................25
7Operating................................................................................................26
7.1 Display and control elements..................................................................26
7.2 Main menu...............................................................................................28
7.3 Direct help ...............................................................................................29
7.4 Settings....................................................................................................30
8Therapy...................................................................................................31
8.1 Saving a therapy......................................................................................32
8.2 Frequently used therapy settings (favorites)...........................................33
9Maintenance...........................................................................................34
9.1 Legal requirements and regulations........................................................35
9.2 Technical safety checks ..........................................................................35
9.3 Cleaning and disinfection........................................................................36
9.4 Repair......................................................................................................37
9.5 Disposal of the device and accessories..................................................37
10 Troubleshooting....................................................................................38
11 Contraindications..................................................................................39
11.1 Absolute contraindications ......................................................................39
11.2 Local contraindications............................................................................39
11.3 Of particular importance..........................................................................40
11.4 Known side effects ..................................................................................41
11.5 Information for the therapist ....................................................................41
12 List of standard and optional accessories.........................................42
13 Technical data........................................................................................43
14 Appendix ................................................................................................45
15 Index .......................................................................................................48

MicroPro 5
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1 Introduction
1.1 Preface
Safe operation of the microwave therapy unit requires knowledge of both medicine
and electricity.
For this reason, the microwave therapy unit may be used only by persons 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 Zimmer
MedizinSysteme GmbH products.
Our address can be found at the beginning of this manual.
1.2 Scope
The information provided in these instructions for use refer to the
MicroPro microwave therapy unit
from Zimmer MedizinSysteme GmbH.
1.3 Intended use
The MicroPro is used for microwave therapy (diathermy).
By means of a high-frequency electro-magnetic field, a tissue warming effect in continuous
mode, and an athermal effect in pulsed mode is generated.
The patient group includes adults and youths persons. Operators are trained professionals
such as doctors, doctor’s assistants or physiotherapists in professional facilities such as
doctor’s or physiotherapist’s practices or clinics.
The microwave therapy unit MicroPro may be used only according the intended purpose for
this type –microwave therapy in the medical treatment of human beings for gently
tissue warming or athermal treatment –in compliance with Chapter 11 Contraindications!
Microwave therapy is always an auxiliary therapy in the set of standard therapies like manual
therapy, Ultrasound therapy and Current Stimulation therapy.
No side effects are known if the device is operated in compliance with the intended use.

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Any other use is deemed not authorized and can cause personal injury or damage to
property!
Indication
The device can be used to treat pain in the musculoskeletal system.
1.4 Warranty
For the microwave therapy unit MicroPro the legal warranty regulations apply.
!!
Note!
Repair of the unit be performed only by the manufacturer or a person or
company authorized by the manufacturer!
1.5 Exclusion of liability
All obligations of the manufacturer are regulated by the appropriate sales contract 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, radiator) or faults in the building’s power supply (protective conductor, resid-
ual-current circuit-breaker)
- Failure to comply with the information in these instructions for use concerning 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
- 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
Warning!
Warnings which have to be observed by all means!
Caution!
Observe the instructions for use!
!!
Note!
Information that will facilitate your work.
•
This dot identifies direct instructions for action.
-
This dash identifies enumerated items.
1.7 Explanation of key symbols
0123
CE –conformity sign
Follow the instructions for use!
Danger for persons with pacemakers or similar implanted de-
vices!
Do not push, rest on it and lean against it.
General warning sign. Here:
Adjustment or replacement of internal components can cause
failure to comply with EN 60601-1-2 and Clause 202 of EN
60601-2-6.
Non ionizing radiation

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Application part, protection degree Type B.
This product complies with WEEE Directive 2002/96/EG (waste
electrical and electronic equipment). Separate collection for elec-
trical and electronic equipment. The waste removal at the end of
the service life will be done by the manufacturer.
Indicates the medical device manufacturer, as defined in EU Di-
rective 90/385
Indicates the manufacturer’s catalogue number so that the medi-
cal device can be identified. The catalogue number is placed
adjacent to the symbol.
Indicates the manufacturer’s serial number so that a specific
medical device can be identified. The serial number is placed ad-
jacent to the symbol.
Indicates the manufacturer’s batch code so that the batch or lot
can be identified. The batch code is placed adjacent to the sym-
bol.
Indicates the maximum and minimum temperature at which the
item shall be stored, transported or used.
Indicates that the transport package shall be kept away from rain
and in dry conditions.
To indicate that the contents of the transport package are fragile
and the package shall be handled with care.
To indicate correct upright position of the transport package.

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2 Safety instructions
The microwave therapy device MicroPro and the accompanying components and individ-
ual elements fulfill singly and as a unit the currently valid safety standards and comply with
the requirements of EN 60601 and the medical device directive.
The device and its external components (accessory elements) are safe when used as in-
tended and in compliance with the explanations and instructions provided in this
documentation.
Warning!
Nevertheless, the unit or its external components can pose dangers!
We therefore advise all persons working with the microwave therapy device
to inform themselves about the potential dangers of the device and its ex-
ternal modules before carrying out any work!
Please read and observe all safety instructions in this instruction for use.
2.1 Responsibilities
- The microwave therapy unit may be used only by doctors, physiotherapists or trained
assistants under the direction of a doctor or physiotherapist!
- Before treating a patient, an anamnesis must be performed by the attending physi-
cian, during which the patient must be consulted concerning 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 carefully and ob-
serve 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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2.2 Personal safety
Warning!
In case of improper or unauthorized use of the unit, the operator, the patient
or other persons may be subjected to the danger of electric shock, the dan-
ger of influence on active implantations by electromagnetic fields produced
by the device and the danger of being burned due to metal parts in and on
the body or incorrectly positioned radiators or false parameters such as the
duration of treatment, power output or operating mode!
•Before operating the unit, please readthese instructions foruse carefully and observe
the information given!
•Pay special attention to the list of contraindications!
(See chapter 11 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 equip-
ment,
- the insulation of the power supply and radiator cable is not damaged,
- the radiator cable is properly connected and screwed, is not in contact with the
patient or with conductive or energy-absorbing objects,
- only accessories (cables, radiator) 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 telephones) and all conduc-
tive objects (e. g. rings, chains, watches, earrings or other jewelry, glasses) and
that they are not in the immediate vicinity of the unit,
- the patient is in a composed state and the bodily areas to be treated are dry on
the exterior,
- the radiator is positioned according to the doctor’s instructions (to be checked by
the doctor or physiotherapist if applied by assisting personnel),
- there is no danger of unwanted local warming due to electrode constrictions and
- no other persons are located within 1.5 m of the radiator!
•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 radiator cable, the radiator or other devices
or metal objects and
- he should (and can) let you know if he feels unwell!
•Do not treat patients on metal chairs or metal beds.

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•Do not touch simultaneous the patient and touchable contacts of connectors.
•Do not treat parts of the patient’s body containing metallic implants, unless special
techniques are used.
•At regular intervals during the treatment, check
- that the unit is functioning properly,
- for moisture development
1
(perspiration) in the area of the radiator and
- whether the patient feels well
2
!
•After the treatment, ask the patient about his tolerance of the treatment and visit the
treatment environment (doctor or physiotherapist).
During service and maintenance work it is not allowed to treat a patient!
2.3 Device protection
Caution!
Improper installation, operation or maintenance of the microwave therapy
unit may result in malfunctions of this device, other devices or other devices
connected to the patient!
Therefore, observe the following instructions in order to prevent mal-functions:
•In order to prevent electromagnetic disturbances, place the unit at least 3 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 electromag-
netic 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 metal elements (especially if they are earthed), such as heating radi-
ators, metal beds or other earthed devices!
•Before connecting the unit, make sure that
- the voltage rating on the rating plate corresponds to the mains voltage.
- the frequency rating on the rating plate corresponds to the system frequency,
- an earthed socket outlet with earthing contact is available for connecting 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 and that
1
The affected parts of the body should be unclothed during treatment, since accumulation of moisture on the
skin or in folds can cause local overheating of the skin. This is especially important in case of clothing made
of moisture-resistant fabric such as silk or synthetic fibers!
2
The output power must always be set according to the subjective sense of the patient! Particular care is to
be taken with patients who have a reduced capacity for heat perception!

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- the power supply of the building is designed for the comparatively high (possibly
additional) power input of the unit (see technical data) and the line is sufficiently
protected in accordance with regulations!
Do not connect the unit to the power supply until these requirements have been ful-
filled!
•Before putting the unit into operation, check to make sure that the radiator cable and
the radiator are undamaged and have been connected correctly to the unit!
The device must not be placed in front of a radiator or radiant heater.
The device must not be covered by pillows or blankets while in operation.
The device is not made for outdoor operation.
•Do not treat Patients on metal chairs or metal beds.
•Keep credit cards, camera, mobile phone, car key, USB sticks, memory cards and
other interference sensitive storage media away from the unit!
•Clean and disinfect the unit only when the power supply is deactivated (mains 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 moisture!
•Never clean the unit with abrasives, disinfectants or solvents that could scratch the
housing or damage the unit!
•Never perform service work on your own!
•The device must not be used as a step or a seat!
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!

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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!
Caution!
If the unit cannot be installed immediately after delivery, the unit and its ex-
ternal components or accessory elements must be stored in their original
packaging in a dry place!
Do not store or operate the unit in a dusty environment!
3.2 Characteristics of the installation location
Warning!
The unit must be installed so that there is no danger to the patient, the op-
erator or other persons!
To place the unit, each plane surface is appropriate. Please take notice of having enough
space around the device to reach the power switch comfortably and to be able to pull off the
mains plug. Keep a wall distance of at least 20 cm.
Warning!
The mains plug is used for all pin disconnection from the mains power sup-
ply. Make sure that the mains plug is easily reachable to the operator.
Therefore, you must read the safety instruction in Chapter 2 and the following infor-
mation!
- 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 conduc-
tive materials that are earthed or have a high capacity to earth must be prevented
and which may provide unwanted pathways forthe radio-frequency current (e.g. heat-
ing 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
3 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 radiator is positioned inconveniently.
- The unit is not intended for use in potentially explosive areas.
- The unit is not intended for use in areas with inflammable anaesthetics.

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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 transport position, the support arm points vertically upwards. Radiator and radiator
cable may be mounted in the transport position.
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 prevention regulations.
3.4 Unpacking the unit
The unit is generally delivered with the packaging material supplied by the manufacturer.
Since the unit weighs approximately 44 kg without support arm, radiator and radiator cable,
it must be unpacked by at least two persons.
Proceed as follows:
•Position the transport packaging so that the arrow mark is pointing upward.
•Remove the safety bands from the transport packaging.
•Remove the transport packaging upward.
•Remove the remaining foam material.
•At least two people should lift the device out of the lower part of the packaging using
the two handles.
3.5 Receiving inspection
Perform the following steps directly after unpacking the device:
•Verify the delivery documents to make sure that the delivery is complete.
•Check all components (device, external components and accessories) for possible
damage due to transport and defects.
In case of damage from the transport, report to the forwarding company and the distributor.
Do not put the device into operation if it is damaged.
Warning!
In case of damage from transport that could endanger personal safety, the
unit must not be connected to the power supply!

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3.6 Complaints
Claims for damages resulting from transport damage can only by asserted if the transport
company and the manufacturer are informed immediately. Notification of the manufacturer
and the remedy of the damage are generally carried out by the dealer.
•Immediately create a damage report and send it to the transport company 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 the unit
4.1 Operator side
Fig. 4-1 Front view –MicroPro
Radiator
Radiator cable
Self-locking plastic support arm,
extractable
Display/Touchscreen
Housing
Locking castor

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4.2 Patient side
Fig. 4-2 Back view –MicroPro
Mains fuse
Appliance inlet
Marking plate
Connector for the radiator cable
Mains switch

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4.3 Accessories
Fig. 4-3 Radiator cable
Fig. 4-4 Focus radiator
Fig. 4-4 Cradle radiator
Fig. 4-6 Long-field radiator
Fig. 4-5 Circular-field radiator
Treatment side
Treatment side
Device Connection
Radiator cable
Device Connection
Device Connection
Treatment side
Device Connection
Treatment side

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5 Description of functions
The microwave therapy unit MicroPro can produce dielectric warming by means of electro-
magnetic 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 a variety of different radiators. Depending on the treat-
ment the circular-field, the focus, the cradle or the long-field radiator may be used.
5.1 Applications
The microwave therapy unit is suitable for nearly all heat therapy processes for use in clinics
and private practices.
Classical therapy applications can be conducted with different radiators 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.
Zimmer MedizinSysteme GmbH microwave therapy units are therefore used for a wide
range of applications in hospitals, by doctors and physiotherapists.
5.2 Information for use of the radiator
- Patients with diminished capacity for perception of heat in the area intended for
microwave therapy should not be treated.
- Patients who are not able to give quick response according to the microwave
treatment should not be treated.
- Radiators should not be oriented to eyes or testicles.
- If necessary patients should wear radiation protection goggles.
- Persons who are not treated should at least stay away 1.5 m to the radiator.

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5.3 Microwave therapy with circular-field radiator
The circular-field radiator, the so called distance radiator, is used for irradiation of body parts
with locally defined disease processes. Typical application areas are e.g. shoulder or knee
joint, jaw joint, lower arm carpal region, tenovaginitis, etc.
The proper treatment distance between radiator and body part should be about 10 cm. If
the distance is increased the set power output is distributed upon a larger area and thus
upon a larger body volume. This means that the power output meeting the affected body per
surface unit is decreased. By that also the yielded warmth is reduced.