Zimmer ThermoTK User manual

Instructions for Use
ThermoTK
EN

Figures
Front of the device
Fig. 1
1 Control unit
2 Intensity adjuster
3 Display
4 Therapy time adjuster
5 Slot for SD card
6 Handpiece with electrode
7 Common electrode
2
3
4
5
1
6
7

Figures
Rear of the device
Fig. 2
Switches and 8 On/off switch
connection ports 9 Ventilation opening
10 Identification plate
11 NE connection port for:
11.1 Cable for common electrode with grey connection (4-pin)
11.2 Handpiece with grey connection (4-pin)
12 Active connection port for:
12.1 Cable for common electrode with white connection (8-pin)
12.2 Handpiece with white connection (8-pin)
13 Connection for power cable
10
9
8
13
11 / 11.1 / 11.2
12 / 12.1 / 12.2
9

Figures
Screens / Display
Fig. 3
Display views
14 Status bar
15 Buttons on the screen
16 Buttons in the navigation menu
17 Buttons in the status bar
Fig. 4
Navigation bar
Description of
functions
(A) Back
Switches one page back or to the start-up
screen
(B) Therapy
Switches to the therapy screen
(C) Favourites
Switches to the Favourites area
(D) Protocols
Switches to Protocols
(E) Save
Switches to the Memory area
16
15
E
D
C
B
A
14
17

Figures
Accessories
Fig. 5
Handpieces Handpiece with grey Handpiece with white
connection (4-pin) connection (8-pin)
Electrodes Resistive electrodes Capacitive electrodes
S: 30 mm S: 30 mm
M: 50 mm M: 50 mm
L: 70 mm L: 70 mm
Common electrodes Common electrode Common electrode
140 mm x 240 mm self-adhesive 105 mm x 200 mm
Common Common electrode cable with Common electrode cable with
electrode cables with grey connection (4-pin) white connection (8-pin)
Conductive cream ThermoTK conductive cream with dosing aid
Holder Holder for electrodes and handpiece
Silicone sleeve Non-slip sleeve for handpiece

Explanation of symbols
General warning sign: This symbol points out hazards on the device.
In the instructions for use this symbol indicates “Dangers and warnings”.
Caution!
In the instructions for use this symbol indicates "Caution" with regard to
possible damage of the device.
Products which are marked with the adjacent symbol may not be discarded with
household waste.
Note instructions for use
Follow instructions for use
Switch on/switch off symbol
Serial number
LOT number
Article number
GTIN number (identification number)
Manufacturer

Explanation of symbols
Date of manufacture
Indication of the quantity contained
Use by
Non-sterile
Device type BF
The device emits energy in the form of non-ionising electromagnetic radiation.
CE mark with number of the notified body
Medical device
Do not reuse
Do not use if packaging is damaged
Protect from heat (sunlight)
Storage temperature range
Air humidity limit
Air pressure limit

Explanation of symbols
This side up
Fragile, handle with care
Protect from moisture
Maximum stacking height
Recyclable
Active
Active connection port
NE
NE connection port

Contents
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 / Mode of action
2
3
Application information
3
4
Warnings
5
5
ThermoTK –in brief
8
6
System set-up
6.1 Mounting the cables
6.2 Self-adhesive electrode
9
10
7
Configuration
12
8
Operation instructions
8.1 Application recommendations
8.2 Performing the treatment
8.3 Displays and buttons
8.4 Protocols
8.5 Favourites
13
14
15
17
18
9
Technical information
19
10
Cleaning / Disinfection
20

Contents
11
CE mark
22
12
Scope of delivery and accessories
23
13
Device combination
24
14
Safety and maintenance
14.1 Safety
14.2 Maintenance
25
26
15
Functional test
27
16
Safety check / Metrological check
28
17
Error messages / Troubleshooting / Disposal
26
18
EMC declaration
32
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 November 2020.

Indications / Contraindications
1
Page 1
Indications
Pain treatment in cases of acute and chronic pain
Inflammation of the musculoskeletal system
Improvement in blood circulation in the muscle tissue
Muscle relaxation through reduction in tension of the muscles
Tissue regeneration following physical activities
Trigger points
Contraindications
Pacemakers and all other active implants
Hearing aids
Metal implants and other metal objects in the electrical field, such as
copper IUDs
Use in the region of malignant/benign tumours
Pregnancy
Thromboses
Active osteoarthritis and inflammation
Open wounds
Treatment on mucous membranes
Reduced skin or body temperature
Treatment in the head region
Treatment over the heart
Epilepsy
Angina pectoris
Cardiovascular diseases
Nervous disorders
Neoplasms
Blood clotting disorders
Thrombophlebitis
Abnormal temperature perception
Caution is indicated in the case of persons
who have sensitivity disorders
who are not able to adequately express pain
who are under the influence of drugs and/or alcohol, as significant
circulatory stress and inadequate treatment reactions cannot be ruled out.

Side effects / Intended purpose / Mode
of action
2
Page 2
Side effects
No side effects are known if correct dosages are used and attention is paid to
contraindications.
Intended purpose
ThermoTK is a medical diathermy device for the external heating of tissues on
human skin with the purpose of an increase in tissue temperature and the
resultant improvement in blood circulation in the treatment area. It is used for
the treatment of selected diseases of the musculoskeletal system with the goal
of relieving pain or muscle cramps.
In addition, ThermoTK is used in sports physiotherapy for
Muscle relaxation
Preparation of the muscle for physical exertion
Prevention of injuries
Counteraction in cases of muscle fatigue
Treatment of direct or indirect trauma
Intended users
ThermoTK is exclusively intended for medical professionals such as physicians,
therapists, medical paraprofessionals. There are no further limitations for the
users.
Target patient group
ThermoTK should not be used on infants and young children.
ThermoTK should not be used on patients who have the contraindications
listed. There are no further limitations with regard to the target patient group.
Mode of action
The device uses electromagnetic 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 (subcutaneous fat tissue and underlying muscle
tissue) are heated. By contrast, the resistive mode is used to heat deeper
layers (tendons, ligaments).
Internal organs are barely heated, since they are often surrounded by a
protective layer of fat or other structures.
In comparison to the common electrode, there is compression of the field lines
in the smaller handpiece with the electrode. This is why it is used for therapy.

Application information
3
Page 3
Prior to 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 therapy should also be followed.
Please report any serious incidents which occur in connection with the product
to the manufacturer and competent authority.
Caution!
ThermoTK should not be placed and used in hygienically critical medical areas
such as operating rooms, intensive care units or emergency departments.
Caution!
Before use, ensure that the device is powered via a properly grounded mains
socket (electrical installation according to DIN VDE 0100 Part 710 or similar).
The device must only be operated with the supplied power cable. The power
cable must be protected against mechanical stress.
Caution!
Medical electric devices are subject to special precautionary measures with
regard to electromagnetic compatibility (EMC) and must be installed according
to the EMC information in the accompanying documentation. For more
information, see chapter 18 “Manufacturer's EMC declaration”.
Operation of this device in the vicinity of strong electromagnetic fields (e.g.
tomographs, X-ray or diathermy equipment) may interfere with the operation of
the device. Please keep a safe distance of 5 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 position allowing direct access to
the device´s central mains supply so that it can be disconnected from the mains
at any time.
To avoid the risk of electric shock, the plug must be disconnected from the
power supply before performing any cleaning or maintenance activities.
Inspect the device and applied parts before use. If there is any damage, 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. ThermoTK should not be combined with any other medical or non-
medical device.
During the service life of the device, no changes may be made to the device or
medical system.
Do not modify this device without written approval from the manufacturer.

Application information
3
Page 4
Caution!
If no SD card is inserted in the device, no images will be displayed in the
“Protocols” menu.

Warnings
4
Page 5
Treatment instructions regarding location, duration and intensity of the
treatment require medical knowledge and should be given only by authorised
physicians, therapists and medical paraprofessionals. These instructions must
be followed.
The patient must not be left unattended during the therapy.
Performing intercranial, transcardiac and cervical-occipital treatments is
prohibited. Failure to follow this information can lead to hazards to the patient.
Simultaneously connecting a patient to 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 areas is not permitted and may in case of non-compliance lead to
considerable damage and endanger both the patient and the user.
Never use the handpiece without an electrode or with a damaged electrode.
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 thus always be paid to contact of this electrode during
treatment.
The function of certain implanted electrical devices, for example, cardiac
pacemakers, can be disrupted through treatment with long-wave devices.
Patients should normally not undergo long-wave therapy if they have reduced
heat and pain perception in the body region intended for treatment.
Long-wave therapy should not be performed on patients through clothing. It
should also not be performed on patients who are wearing metal objects, such
as jewellery or clothing containing metal (for example, metal buttons, snap
fasteners or threads).
Patient body parts which contain metal implants (for example, a bone nail, IUD,
etc.) should normally be excluded from the treatment.

Warnings
4
Page 6
Ensure that hearing aids and other electronic devices worn by the patient are
removed before treatment.
Patients should not come into contact with conductive parts which are
grounded or which have a high capacity to ground and which may represent
undesired paths for the high frequency range. In particular, no beds or chairs
with metal frames should be used.
Cables to the electrode should be directed such that contact with the patient or
with conductive or energy-absorbing objects is avoided.
Non-ionising radiation is generated in the device.
Use the self-adhesive common electrode only for one treatment on a patient
and discard it after treatment. If used multiple times, there can be cross-
contaminations or poor adhesion which can result in burns!

Warnings
4
Page 7
Ensure that the handpiece with electrode is never directed towards the eyes
during operation.
Ensure that the handpiece with electrode is not directed at metallic surfaces
(such as a couch, washbasin, device housing, etc.).
Ensure that the device is not opened. Opening the device can generate life-
threatening voltage.
Ensure that the ventilation openings on the back of the device are kept clear.
Ensure that the power cable is immediately disconnected from the mains if
liquid or foreign bodies penetrate the housing.
Ensure that the device is inspected by an authorised service employee before it
is put back into operation.
To completely disconnect the device from the mains, pull the power cable out of
the socket.
If the output power appears to be too low or if no power can be adjusted, the
cause may be improper application of the neutral electrode or poor contact in
the connection of the neutral electrode. In this case, the correct application of
the neutral electrode and the connections must be checked before the output
power can be increased once again.

ThermoTK –in brief
5
Page 8
What is ThermoTK?
An ultramodern, innovative therapy system for deep heat therapy.
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 display showing all therapy-related parameters
and the modern touch operation ensure enjoyment and motivation during
treatment.
Individual program start adjustment and clear, simple menus offer the user
maximum convenience.
The compact design enables space-saving work in an office and is ideally
suited for mobile use.
What's special about
ThermoTK
ThermoTK can be combined as an integrative therapy with nearly all other
manual therapy methods or also used as individual therapy.
Three easy-to-change electrodes of different sizes allow optimal adaptation
to the treatment area.
Note:
Use of the device is reserved for medical professionals
(such as physicians, therapists, medical paraprofessionals).

System set-up
6.1 Mounting the cables
6
Page 9
Note:
Note:
Note
Silicone sleeve:
Note:
One active and one neutral electrode (common electrode) are needed for the
therapy.
Independent of which method is selected for performing the treatment, power
is always emitted via the ACTIVE output and the patient electrical circuit is
closed via the neutral electrode.
The use of the silicone sleeve allows the handpiece to be guided more
conveniently by the user. This is pulled with the wider side onto the electrode
connection on the handpiece.
ThermoTK offers various methods for performing the treatment.
Dynamic1: 1 dynamic electrode (only use “active” port!, otherwise the
dynamic electrode will not be detected)
+ 1 static common electrode
Dynamic2: 2 dynamic electrodes
Hands-free: 2 static self-adhesive electrodes
Ensure that the device is placed on a stable surface.
Note:
Make sure that the power switch of the device is set to “0”.
Connect power cable
Connect the power cable to the provided port (13) on the device and connect
the cable to the mains.
Note:
The device may only be connected to power outlets with a protective contact.
Dynamic 1 method
1 dynamic electrode + 1 static common electrode
Connect handpiece
Connect the handpiece with the white connection to the white ACTIVE
connection port.
Note:
Ensure that an electrode is inserted in the handpiece and that it is positioned
correctly and completely on the handpiece.
Connect common
electrode with cable
Attach the plug connector of the cable to the tab of the common electrode
(reusable electrode or self-adhesive single-use electrode).
Connect common
electrode cable
Connect the common electrode cable with the grey connection to the grey
NE connection port.

System set-up
6.2 Self-adhesive electrode
6
Page 10
Dynamic 2 method
2 dynamic electrodes
Connect handpiece
Connect the handpiece with the white connection to the white ACTIVE
connection port.
Connect the handpiece with the grey connection to the grey NE connection
port.
Note:
Ensure that an electrode is inserted in the handpiece and that it is positioned
correctly and completely on the handpiece.
Ensure that you have connected the same type of electrode to both
handpieces (either both capacitive or both resistive).
Note the size of the electrodes.
The following combinations are recommended:
S + M, M + L.
Hands-free method
2 static self-adhesive electrodes
Connect common
electrode cable
Connect the common electrode cable with the grey connection to the grey
NE connection port.
Connect the electrode cable with the white connection to the white ACTIVE
connection port.
Connect common
electrode with cable
Attach the plug connectors of the cable in each case to the tab of the self-
adhesive common electrode.
Connect electrode
with cable
Attach the plug connector of the cable to the tab of the self-adhesive
electrodes.
Switching device off
The device is switched off using the on/off switch (8).
To fully disconnect the device from the mains, the power cable must be
disconnected.
Caution!
All cables must be protected from pinching or other mechanical damage.