Zimmer ThermoTK User manual

Instructions for Use
ThermoTK
EN

Illustrations
Front of the device
Fig. 1
Selection/operating
elements
Fig. 2
1
Control unit
2Intensity adjuster
3Display
4Handpiece with applicator head
5Common electrode
6Port for common electrode
7Port for handpiece
2
3
4
5
1
7
6

Illustrations
Rear of the device
Fig. 3
Switches / ports
8Port for power cable
9Mains fuse
10 On/off switch
11 Ventilation opening
12 Serial no./identification plate
10
9
8
12
11

Illustrations
Screens / display
Fig. 4
Display views
13
Heading
14 Buttons on the screen
15 Navigation menu
Fig. 5
Navigation menu
Description of the
functions
(A) Home
Switches back to start page
(B) Back
Moves one step back
(C) Treatments
Switchesto the "Treatment recommendations"
menu
(D) Resistive
Switches to "Resistive" mode
(E) Capacitive
Switches to "Capacitive" mode
13
15
E
D
C
B
A
14

Illustrations
Accessories
Fig. 6
Applicator heads
16 Applicator head L, 85 mm
17 Applicator head M, 60 mm
18 Applicator head S, 35 mm
Common
electrodes
with connection tab
19 Common electrode XL,15 x 20 cm
20 Common electrode L,12 x 15 cm
21 Connection tab
without connection tab
24 Common electrode XL,
flexible,15 x20 cm
25 Common electrode, L,
flexible, 12 x 15 cm
Electrode cable
22 Electrode cable withplug
26 Electrode cable with crocodile
clip forcommon electrode flexible
Conductive cream
23 ThermoTK conductive cream with dosing aid
16
19
20
21
22
18
17
24
25
23

Illustrations
Accessories
Sponge pockets
for common
electrodes flexible
27 Sponge pocket, L, 14 x 16.5 cm for
common electrode 12 x 15 cm
28 Spongepocket, XL, 17 x21.5 cm
for common electrode 15 x20 cm
Velcro straps
29 Velcro strap, 60 cm
30 Velcro strap, 120 cm

Explanation of symbols
In the instructionsfor use this symbol indicates “Danger”.
Caution
!
In the instructionsfor use this symbol indicates "Caution" with regard to
possible damage of the device.
OUT
Patient connections
R/C
Applicator head connection
COM
Common electrode connection
Note instructions for use
Follow instructions foruse.
Serial number
Item number
Manufacturer
Date of manufacture
Device type BF
Rating of the accessible fuses
The device emits energyin the formof non-ionising electromagnetic radiation.

Content
Schematic illustrations
Front of the device
Rear of the device
Screens / display
Accessories
Explanation of symbols
Page
1
Indications / Contraindications 1
2
Side effects,
intended purpose
2
3
Application information 3
4
Warnings 4
5
ThermoTK – in brief 6
6
System set-up 7
7
Default settings
7.1 Configuration
7.2 Information
8
10
8
Operation instructions
8.1 Application recommendations
8.2 Performing the treatment
8.3 Displays and buttons
8.4 Therapy recommendations
11
13
15
17
9
Technical information 19
10
Cleaning / Disinfection 20

Content
11
CE mark 21
12
Scope of delivery and accessories 22
13
Device combination 23
14
Safety and maintenance
14.1 Safety
14.2 Maintenance
24
25
15
Functional test 26
16
Safety check / Metrological check 27
17
Error messages / Troubleshooting / Disposal 28
18
EMC declaration 30
Valid for the device ThermoTK.
These instructions for use are an integral part of the device. They must be
stored with the device and kept accessible at all times for anyone authorised to
operate this device.
The instructions for use are valid as of July 2015.

Indications / Contraindications
1
Page 1
Indications
•Radial and ulnar epicondylitis
•Tendinitis
•Bursitis
•Osteoarthritis
•Spondylarthrosis
•Cervicobrachial syndrome
•Neck pain
•Rotator cuff injury
•Impingement syndrome
•Carpal tunnel syndrome
•Low back pain
•Lumbosciatica
•Trochanteric bursitis
•Osteitis pubis
•Piriformis syndrome
•Supination trauma
•Achilles tendinitis
•Plantar fasciitis
•Myofascial trigger point treatment
•Fracture sequelae
•Muscle fibre injuries
Contraindications
•Pacemaker
•Hearing aids
•Metal implants and other metal objects in the electrical field
•Use in the region of malignant/benign tumours
•Haemorrhage and bleeding tendency
•Pregnancy
•Thromboses
•Active osteoarthritis and inflammation
•Open wounds
•Reduced skin or body temperature
•Treatment in the head region
•Treatment over the heart
Caution is indicated in the case of persons
•who have sensitivitydisorders
•who have temperatureperception disorders
•who have significantvegetative disorders
•who are under the influence of drugs and/or alcohol, since significant
circulatory stress and inadequate treatmentreactionscannot be ruled out.

Side effects,
intended purpose
2
Page 2
Side effects
No sideeffects are known if correct dosagesare used and attention is paidto
contraindications.
Intended purpose
The device is used forthe therapeuticapplicationof diathermy using long
waves.
Mode of action
The device useselectromagnetic fields of 460 to 540 KHz to bring about an
increase in temperature through interaction with the tissue. In this process,
there is more output in tissues with a high degree of electrical resistance than in
more conductive tissues. In the capacitive mode, tissue structures which are
rather close to the surface (subcutaneousfat tissue and underlying muscle
tissue) are heated. By contrast, the resistive mode is used to heat deeper
layers (bones, tendons, ligaments).
Internal organs are barelyheated, since they are oftensurrounded by a
protective layer of fat or other structures.
In comparison to the common electrode, there iscompression ofthe field lines
in the smallerhandpiece with applicatorhead. This is why it is used for
treatment.

Application information
3
Page 3
Priorto using the device on a patient, the user should become familiar with the
instructions for use and individual treatment methods to be used as well as the
indications / contraindications, warnings and application information. Additional
sources of information about the treatment should be followed.
Caution
!
Before use, ensure that the device is powered via a properly grounded mains
socket (electrical installationaccording to DIN VDE0100 Part 710 or similar).
The device mustonly beoperatedwith the supplied power cable. The power
cable must be protected against mechanical stress.
Caution
!
Operation of this device in the vicinity of strong electromagneticfields (e.g.
tomographs, x-ray or diathermy equipment) may interfere with the operation of
the device. Please keep a safe distance ofseveral meters.
ThermoTK is not suitable for use in areas with an explosive, flammable or
combustive environment.
During use, the device is to be located in a positionallowing direct access to
the device´s central mains supply so that it can be disconnected from the mains
at any time.
To avoidthe risk of electricshock, the plug must be disconnected fromthe
power supply before performing any cleaning or maintenance activities.
Inspect the device before use. If there is anydamage,it must not be used.
Caution
!
Only accessories provided by Zimmer MedizinSysteme GmbH which are
intended for this device may be used. This applies in particular to cables and
electrodes.
Caution
!
Remove the ThermoTK from the transport bag prior to startingup the system.
Operation in the bag is not intended.
Ensurethat the device is placed on a stable surface.

Warnings
4
Page 4
Users of the ThermoTK system must be trained in proper use and have the
appropriate skills.
Any treatment instructions regarding location, durationand intensity require
medicalknowledge and should be given by authorisedphysicians,therapists
and medical paraprofessionals. These instructionsmust be followed.
The patient must notbe leftunattended during therapy.
Performing intracranial, transcardiac and cervical-occipital treatments is
prohibited. Failure to follow this information can lead tohazardsto the patient.
Simultaneouslyconnectinga patientto the ThermoTK system and a surgical
high-
frequency device is prohibited. Failure to follow this information can lead to
hazards to the patient, in particular through burns under the electrodes.
Use in wet areasis notpermitted and mayin case of non-compliance lead to
considerabledamage andendangerboth the patient and the user.
Never apply the handpiece without an applicator. Failure to follow this
information can lead to hazards to the patient.
The common electrode must always have extensive contact with the patient. It
may otherwise lead to undesired compression of the field lines and thus injury
to the patient.
Attention should thusalways bepaid to contact of this electrode during
treatment.
The function ofcertainimplanted electricaldevices, for example, cardiac
pacemakers, canbe disrupted through treatment with long-wave devices. If in
doubt, the physician in charge of the patient should be consulted for advice.
The function ofother devices connected tothe patientmay be disrupted
through operation of the long-wave treatment device.
Patients should normally not undergo long-wave treatment ifthey have reduced
heat perception in the bodyregion intended for treatment unless the physician
in charge is informed.
Long-wave treatment should not be performed onpatientsthrough clothing. It
should also notbe performed on patients who are wearing metal objects, such
as jewellery or clothing containing metal (for example,metal buttons, snap

Warnings
4
Page 5
fasteners or threads).
Patient body parts which contain metal implants (for example, a bone nail)
should normally be excluded from the treatmentif special techniques are not
used.
Hearing aids shouldbe removed.
Patients should notcome into contactwith conductive parts which are
grounded or which have a high capacity to ground and which may represent
undesired pathsfor the high frequency range. In particular, no beds or chairs
with metal frames should beused.
Cables to the applicator should be directed such that contact with the patientor
with conductive or energy-absorbing objects is avoided.

ThermoTK – in brief
5
Page 6
What is ThermoTK?
An ultramodern, innovative treatment system for deep heat treatment.
What does
ThermoTK do?
During use, a high-frequency current, imperceptible to the patient, is applied.
The high-frequency current penetrates into the tissue in the form of
electromagnetic energy and there it is converted into heat.
What are the benefits
of ThermoTK?
The modern, clear colour displayshowing all therapy-related parameters and
the modern touch operation ensure enjoyment and motivation during
treatment.
Individual program start adjustment and clear, simplemenus offer the user
maximum convenience.
The compact design enables space-saving work in anoffice and is ideally
suited for mobile use.
What's special about
ThermoTK
ThermoTK can be combined asan integrative therapywith nearlyall other
manual therapy methods oralso used as individual therapy.
Three easy-to-change applicators of different sizes allow optimal adaptation
to the treatmentarea.
Note:
Use of the device is reserved for medical professionals
(such as physicians, therapists, medical paraprofessionals).

System set-up
Mounting the cables
6
Page 7
Note:
Remove the ThermoTK fromthe transportbag prior tostartingup the system.
Operation in the bag is not intended.
Ensurethat the device is placed on a stable surface.
Note:
Make sure thatthe main switch of the device is setto “0”.
Connect power cable
Connect the power cable to the provided port (8) on the device and connect
the cable to the mains.
Note:
The device mayonly be connected to power outletswith a protective contact
Connect handpiece
Connect the handpiece to the provided port (7).
Note:
Ensurethat an applicatorhead isinserted in the handpiece and that it is
positioned correctly and completely.
Connect common
electrode to the
cable
Secure the plug ofthe cable to the tab of the common electrodeor secure the
crocodile clip to the common electrode flexible.
Connect
electrode
Connectthe electrode tothe providedport (6).
Switching device on
Switch onthe device using the toggle switch (10).
Switching device off
The device is switched off using the toggleswitch (10).
To fully (all poles) disconnect the device from the mains, the power cable must
be disconnected.
Caution
!
All cables must be protected from pinching or other mechanical damage.

Default settings
7.1 Configuration
7
Page 8
Note:
Changes to the basicsettings and retrievalof information areonly possible in
the start-up screen.The following descriptionsare based on the factory
settings.
Start-up screen
After the device has been switched on and the self-testperformed, the start-up
screen opens.
Note:
Activating the "Start" button(3) switches directly to the "Capacitive mode"
therapy screen.
Select
configuration
Activating the "Settings"button (1)opens the "Settings" screen.
Settings menu
Factorysettings can be changed and individuallyadjusted in thesettings
menu.
Start-up settings
The setting optionsare described below.
The default settingsare pre-programmed in the factoryas shown on the
screen.
1
2
4
3
2
1
5
6
7
8
9
10
3

Default settings
7.1 Configuration
7
Page 9
(1) Sound
The volume of the signal sounds can be adjusted by activating the control
panels. The adjustment can be made using the two arrow buttons.
(2) Keyboard sound
The keyboard sounds can be activated and deactivated.
The selection ismade directly in thecorresponding line.
(3) Start settings
Option to individually select the start settings.
- Capacitive mode
- Resistive mode
- Treatment
The selection ismade directly in thecorresponding line.
(4) Language
Language selection:
- German
- English
- Italian
The selection ismade directly in thecorresponding line.
(5) Welcome
Activating the field opens a window with an alphabetical keyboard to enter an
individual welcome text in the start-up screen.
Activating the "Save" button saves the greeting text entered.
(6) Cable control
The cable control test checks thefunctionalityof the handpiece and the
electrode.
The selection ismade directly in thecorresponding line.
Detailed information on performing the test canbe found in chapter 15.
(7) Ok
Activating the button leadsback to the start-up screenand saves the modified
settings.
(8) Standard
Activating the button restores the factory default settings.
(9) Version
Activating the button opensa windowwith information on the currentsoftware
version.
(10) Brightness
Option to adjust the brightness of the screen illumination. The adjustment can
be made using the two arrow buttons.

Default settings
7.2 Information
7
Page 10
Select
information
Activating the "Informations" button (2)opens the "Informations" screen.
Information menu
Information (user information as wellas general information on the therapy
principle with ThermoTK) can beretrieved in the information menu.
(1) User guide
Activating the field opens the screen with user information.
Scroll forwards and backwards using the arrows.
(2) About ThermoTK
Activating the field opens the screen with general information on the therapy
principle with ThermoTK.
Scroll forwards and backwards using the arrows.
(3) Back
Activating the button leadsback to the start-up screen.
2
1
2
3

Operation instructions
8.1 Application recommendations
8
Page 11
Note:
The following recommendations are only guidelines and must of course be
adapted to the patient's individual situation.
Modes
There are 2 different treatment modes available for therapy.
1. Capacitive mode: For use in the case of structuresat the surface, suchas
muscles.
2. Resistive mode: Foruse in the case of deeper structures, such astendons
and ligaments.
Applicators
Common electrodes
Common electrode
flexible
Placement of the
common electrode
ThermoTK cream
Note:
Sponge pockets
3 applicatorsof different sizes:
L / M: For applicationsover larger areas
S: For targeted applications, such as trigger points
2 commonelectrodes of different sizes:
XL: for large treatment areas.
L: for small treatment areas.
2 commonelectrodes flexible ofdifferent sizes:
XL: for large treatment areas.
L: for small treatment areas.
If possible, the common electrode should be placedoppositethe area to be
treated.
Optimalenergy transfer canonly be guaranteed in connection with the special
conductive ThermoTK cream.
During treatment with ThermoTK, only usethe ThermoTK conductive cream
specially developed for this application.
ThermoTK cream makesit possible forthe therapistto achieveoptimalgliding
of the applicator onthe skin.
ThermoTK cream is very skin compatible and can even be used on very
sensitive skin.
ThermoTK creamhas excellent gliding properties. Because of this,the amount
of creamnormally needed for a therapeuticapplication can be reduced and
this decreases the cost of consumables.
In addition tousing the common electrode in connection with the ThermoTK
cream, it is possible, through an add-on accessory, to perform the application
with the common electrode flexible in connection with a moist sponge pocket.
2 sponge pockets of different sizes: