Zimmer ThermoPro User manual

User Manual
ThermoPro
USA

Illustrations
Side view of the Device
Fig. 1
Device and
Operating
Elements
1
Mounting bracket with caster including locking device
2Connection for supporting arm
3Applicator cable connection
4Supporting arm including applicator cable (4.1) and applicator (4.2)
5Cable clip
6Display
7 Slot for SD card
5
3
4.1
2
6
1
7
4
4.2

Illustrations
Rear view of the Device
Fig. 2
Device and
Operating
Elements
8Mains cable socket
9 Power switch
10 Recessed grip
11 Identification plate
12 Ventilation openings
9
12
8
10
11

Illustrations
Screens / Displays
Fig. 3
Displays/
Therapy screen
14
Status bar
15 Title bar
16 Buttons on screen
17 Navigation bar
Fig. 4
Navigation Bar
Description of functions
(A) Home
Returns to the Start page
(B) Back
Takes you one step back
(C) Memory
Switches to the Memory area
(D) Body Area
Switches to the Body Area screen
(E) Programs
Switches to the Program list
(F) Favorites
Switches to the Favorites area
(G) Scroll Forward
Moves down a page
(H) Scroll Backwards
Moves up a page
16
17
15
14
E
D
C
B
A
H
G
F

Contents
In the User Manual this symbol indicates “Danger”.
Caution
!
In the User Manual this symbol indicates
"Caution" with regard to possible damage of the device.
Operating instruction
Follow the User Manual.
Serial number
Article number
Manufacturer
Date of manufacture
Applied part type BF
The unit emits non-ionizing electromagnetic radiation.
CE Mark
The device is tested and manufactured in compliance with relevant safety
standards.
Rx only
U.S.A Federal law restricts this device to sale by or on the order of a licensed
healthcare practitioner licensed by the law of the State in which he/she
practices to use or order of the Device.

Contents
Illustrations
Side view of the Device
Rear view of the Device
Screens / Displays
Explanation of symbols
Page
1
Indications / Contraindications 1
2
Side effects 2
3
Application Information
Cautions and Precautions
3
4
Warning Notices 4
5
ThermoPro – in brief 10
6
Assembling the Device 11
7
Settings 12
8
Operation Instructions
8.1 Performing Treatment
8.2 Display and Buttons
8.3 Body area
8.4 Favorites and Memory Lists –
Selecting Programs, Editing Lists
14
15
18
19
9
Technical Information 22

Contents
10
Cleaning / Disinfection 23
11
CE-mark 24
12
Scope of Delivery / Accessories 25
13
Device combinations 26
14
Safety and Maintenance 27
15
Function Test 28
16
Error Messages / Troubleshooting / Disposal 29
17
EMC Manufacturer’s Declaration 31
Valid for the ThermoPro device.
This manual is an integral part of the device. It should be kept with the device
so that the persons assigned to operate the device can access it at any time.
The instruction manual is valid from software version 1.8.0
U.S.A Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner licensed by the law of the State in which he/she practices to use or order of the
Device.

Indications / Contraindications
1
Page 1
Indications
Indications for use in applying therapeutic deep heat in body tissues for the
treatment of selected medical conditions such as disorders of the
musculoskeletal system, muscle spasm, joint stiffness, contractures, and
chronic inflammatory or infective conditions such as tenosynovitis, bursitis,
synovitis and chronic inflammatory pelvic diseases.
Generally accepted indications for use:
•Pain Relief
•Reduce Muscle Spasm
•Localized Increase of Blood Flow
•Chronic Inflammatory Conditions
•Bursitis
•Decrease Joint Stiffness
•Tenosynovitis
•Contractures
•Synovitis
•Chronic Inflammatory Pelvic Disease
Contraindications
Shortwave diathermy is contraindicated if the patient
•does not understand the potential risks.
•is not able to co-operate with the operator in maintaining the proper position
and in reporting the presence of a heating sensation which is the only
indication of an adequate or excessive dose.
•is pregnant. If the device operator is pregnant, she should remain at least 5
meters away from the applicator when the unit is turned on, since the effects
of high-frequency fields on a fetus have not yet been sufficiently researched.
•does not possess normal pain and thermal sensation in the area to be
treated.
•has been diagnosed with
Acute/sub-acute thrombophlebitis
Peripheral arterial circulatory disorders
Lack of temperature sensation (e.g. polyneuropathies)
Pregnancy and menses
Acute pelvic inflammatory disease, parametritis, endometritis
Acute periarthropathia humeroscapularis
Acute traumatic lesions, haematoma
Sudeck syndrome stage I
Febrile infectious diseases, tuberculosis, acute neuritis
Acute prostatitis
Tumours and metastases

Indications / Contraindications
1
Page 2
•has metal foreign body in the tissue (implants, pacemaker)
•has significant fluid retention in the body (for example, pleural effusion,
ascites)
•is unconscious or not fully responsive
•is a baby or infant
•has damp clothes or wet dressings
Do not apply shortwave diathermy
•if there are open wounds, hemorrhage, ischemic tissue, tuberculous joints, or
acute infections within the treatment area.
•over or in close proximity to active cancer, as therapy may increase blood
flow to the tumor.
•on patients, or within 10 feet of a person, with Cardiac Pacemakers or
implanted defibrillators.
•on patients, or within 10 feet of patients, who have ANY implanted systems
with RF programming, or metallic lead, or any implanted system that may or
may not contain a lead. Both the thermal and sub-thermal modes of operation
pose a risk of tissue destruction.

Side Effects
2
Page 3
Side effects Treatment with the ThermoPro can occasionally cause temporary
local reddening of the skin.

Application Information
Cautions and Precautions
3
Page 4
Prior to applying the device to the patient, the operator should be familiar with
the instructions for use and individual treatment methods, indications/ contra-
indications, warnings and application information. Additional sources of
information about the therapy should also be consulted.
Caution
!
Before use, ensure that the device is operated via a properly grounded power
point with safety contacts (electrical installation according to DIN VDE 0100
Part 710). Do NOT connect this device to any wall outlet that has not been
properly grounded, or to any electrically non-isolated medical device. The
device must be operated with the power cord supplied.
The power cord must be
protected against mechanical stress.
Caution
!
Do not lean on or hold the cables while the generator is activated. In addition to
the strong heating effect, a deteriorated cable could break down and expose
the user to high voltages.
Caution
!
Keep all line cords away from the diathermy unit cables. Do not store or coil line
cords where they can come close to the cables on an operating diathermy unit.
Caution
!
Operating the device in the vicinity of strong electromagnetic fields (e.g. MRI,
X-ray or other diathermy equipment) can interfere with the operation of the
device. Please maintain a safe distance of several meters.
Caution
!
ThermoPro is not suitable for use in areas having an explosive, flammable or
combustive environment.
Caution
!
During use, the device should be positioned to allow more direct access to the
central power supply of the device, so that it can be disconnected from the
mains at any time.
Caution
!
To avoid the risk of electric shock, before performing any maintenance or
cleaning activities, the device must be disconnected by removing the mains
plug from the mains supply.
Caution
!
Inspect the unit before use. If damage is found it must not be used. A device
that is not safe to operate must be taken out of operation and secured against
further use.
Caution
!
Only accessories from Zimmer MedizinSysteme GmbH should be used.
Replace defective parts, in particular the applicator and applicator cable, only
with original parts from Zimmer MedizinSysteme.
Caution
!
U.S.A Federal law restricts this device to sale by or on the order of a licensed
healthcare practitioner licensed by the law of the State in which he/she
practices to use or order of the Device.
Precaution
!
Application site and settings should be based on the guidance of the
prescribing practitioner.

Application Information
Cautions and Precautions
3
Page 5
Precaution
!
When cleaning the device, never submerge in water or other liquids
Precaution
!
Inspect and cleanse the skin prior to application. Following treatment, check the
skin for evidence of irritation or burns, and if present, treat as appropriate. If the
patient has, or complains of, skin irritation following treatment, shorten the
treatment time on the next treatment session or use an alternative type of
therapy or drum inductive applicator placement.
Precaution
!
The treatment area should be checked from time to time, and if there is
evidence of, or if the patient complains of, pain or overheating during treatment,
adjust the output downward until it is tolerated by the patient. If the patient
continues to complain of pain or overheating, discontinue the treatment and
shorten the treatment time on the next treatment session, or use an alternative
type of therapy or applicator placement
Precaution
!
Do not apply treatment directly over/under hot or cold packs due to possible
activation of chemical packs with diathermy treatment. Caution is
recommended when treatment follows the application of hot or cold therapy,
which may alter the patient’s sensation. Application of thermal agents over
areas of impaired circulation should be performed with caution as the
circulation may be insufficient to heat or cool the tissue, altering the patient’s
perception of warmth and pain. Burns or tissue necrosis may result from
subsequent treatment.
Precaution
!
Treatment should not follow the application of medicated patches, salves, or
creams. The presence of RF energy may be altered by the presence of these
materials on the patient’s skin. Some medications can alter the patient’s
sensation. Heat can also increase the absorption of medication and may be
contraindicated. If there is a medical necessity to perform such treatments,
these patients should be monitored diligently during application.
Precaution
!
Caution should be used in the presence of recent surgical procedures, fractures
or healing bone and soft tissue when therapy may disrupt the healing process.
Thermal shortwave diathermy should be applied with caution over bone where
minimal or no soft tissue is present.

Warning Notices
4
Page 6
Treatment instructions about the location of the treatment and the duration and
intensity of the treatment require medical knowledge and may only be given by
approved doctors, therapists and members of the paramedical professions.
These instructions must be followed.
The patient must not be left totally unattended during therapy.
Performing intracranial, cardiac trans occipital and occipital cervical treatments
is prohibited. Failure to observe this can endanger the patient.
Simultaneous connection of a patient to ThermoPro and a high-frequency
surgical device is prohibited. Failure to observe this can endanger the patient.
The function of certain implanted electrical devices, such as pacemakers or
hearing aids, can be affected by therapy with shortwave therapy devices. In
case of doubt, please seek advice from the physician responsible for the
patient.
Persons with implanted devices should not enter rooms in which diathermy
devices (such as ThermoPro) are operated.
Parts of the patient's body containing metal implants (for example, a bone pin)
should generally be excluded from the treatment, unless special techniques are
used.
Patients should not normally undergo shortwave therapy if they have reduced
heat sensitivity in the body region to be treated, unless the attending physician
is notified.
Shortwave treatment should not be performed on patients through items of
clothing. Conductive materials should be removed from the treatment area.
Shortwave treatment should also not be performed on patients wearing metallic
objects such as jewellery or clothing with metallic materials (e.g., metal buttons,
snap fasteners, buckles, zips or metal threads).
Ensure that the applicator is never directed towards the eyes and testicles
during operation. During irradiation of other parts of the body, the applicator
must be positioned so that the eyes and testicles are not within the irradiated
area.
The radiation issuing from the applicator should not be directed onto electronic
devices in the immediate vicinity or onto the ThermoPro itself. The devices can
be impaired or permanently damaged.
The function of other appliances connected to the patient may be affected by
the operation of shortwave therapy equipment.

Warning Notices
4
Page 7
Use in wet areas is not permitted: non-compliance may lead to considerable
damage and endanger both the patient and the operator.
Patients should not come into contact with conductive parts that are earthed or
have a high capacitance to earth and may represent unwanted pathways for
high-frequency current. In particular, no bearings or chairs with metal frames
should be used.
Cabling to the applicator should be performed in such a way as to avoid contact
with the patient or with conductive or energy-absorbing articles.
Ensure that the applicator is not directed onto metallic surfaces (e.g., bed, sink,
equipment housing, etc.).
Ensure that hearing aids as well as other electronic equipment the patient
wears on the body are removed before treatment.
Ensure that the applicator and the applicator cable are handled with the
necessary care. Severe shocks and impacts can change the radiation pattern.
Ensure that the device is not opened. Opening the device can generate life-
threatening voltage.
Make sure that the device is not operated with a damaged applicator or
applicator cable.
Make sure that the device is operated only when the applicator cable and
supporting arm are fully and correctly mounted on the device housing.
Ensure that the ventilation openings at the back of the device are kept clear.
Make sure that if liquid or foreign matter gets inside the casing, the power cord
is immediately unplugged from the mains socket and the appliance checked by
an authorized service center before you return it to operation.
Be sure to observe a safe distance of 17 feet from simultaneously operated
medical equipment.
If case of faults, stop the treatment.
To completely disconnect the device from the mains, unplug the power cord
from the outlet.

Warning Notices
4
Page 8
Non-ionizing radiation is generated in the device!
Internal burns can occur with the incorrect application of shortwave diathermy
due to excessive intensity or excessive exposure time!
Do not apply shortwave diathermy over the carotid sinus nerves, (located in
the anterior neck triangle), including, stellate ganglion, vagus nerve, or
laryngeal or pharyngeal muscle!
Particular care should be taken for patients
with a known sensitivity to the carotid sinus reflex, as carotid sinus
stimulation may alter blood pressure and cardiac contractility.
over testes, heart or eyes. Electromagnetic effects may affect organ function.
over or in close proximity to active cancer (except in terminal / palliative /
hospice care), as therapy may increase blood flow to the tumor.
when high fever is present, over swollen, severe infection, (osteomyelitis,
sepsis, tuberculosis, etc.), or inflamed areas or skin eruptions, (e.g., phlebitis,
thrombophlebitis, varicose veins, etc.).
over the lumbar or abdominal region, or over the uterus during pregnancy (to
prevent uterine contraction), or during menstruation as therapy may
temporarily increase menstrual flow. over exposed spinal cord (i.e. following
laminectomy, spinal fusion, etc.).
directly over the cranial region, as little is known about the electromagnetic
effects on the cerebrum to determine if it represents a serious hazard when
shortwave diathermy is applied to the head.
in the vicinity of the heart.
directly over the epiphysis of growing bones in children and adolescents
because shortwave diathermy may enhance or inhibit bone growth. Note that
the mean age for skeletal maturity is 15.5 years in females and 17.5 years in
males.
over areas with excess adipose tissue.
over areas of hemorrhage or active bleeding.
over areas with compromised circulation.
directly over or in close proximity to Deep Vein Thrombosis (DVT). Thermal
agents should be avoided in early phases of a DVT.
Therapists should follow the guidelines provided by the referring physician on
recommended activity level and modality use.
Before increasing generator output in response to a report of inadequate
patient heating, verify that cables are properly routed, evenly spaced, and away
from any metal or grounded objects.
The heating effect may be misdirected and
heating may be occurring in an unwanted area!

Warning Notices
4
Page 9
All equipment and accessories should be kept out of the reach of children or
unqualified persons!
Caution should be used when applying thermal shortwave over areas of body
which lack normal sensation. Absent or diminished sensation should be
avoided or, if unavoidable, treated with caution. Establishment of acceptable
intensity levels for desensitized areas may be related to the intensity levels
tolerated on normal skin in opposite or related body parts!
The device generates lethal high voltage!
Ensure that there is no power output during the positioning of the applicator and
thus no accidental irradiation of patient and user.
Ensure that the user doesn’t stay in the applicator’s field during therapy.
All persons not treated should stay further than 5 feet from the applicator.

ThermoPro – in brief
5
Page 10
What is ThermoPro?
A modern shortwave therapy system.
How does
ThermoPro work?
In contrast to the heat treatment method in which heat (e.g. heat packs) is
supplied from the outside, at shortwave therapy conversion of electric power
into heat energy takes place directly inside the tissue.
How is electrical
energy converted into
heat energy?
The high-frequency field generates eddy currents in the treated tissues that
lead to molecular excitations and convert the electrical energy into heat.
Why ThermoPro?
The modern and clear color display which displays all the parameters relating
to the therapy and the modern touch controls, which ensure enthusiasm and
motivation during treatment.
Individual program start setting and a clear, simple menu provide maximum
user comfort.
User information on indications will support you during therapy.
What else does
ThermoPro offer?
The option of either pulsed or continuous application opens up a wide range
of indications to the operator.
Intended Use
ThermoPro is a shortwave diathermy device for use in applying therapeutic
deep heat for selected medical conditions by applying electromagnetic
energy in the radio frequency band of 27.12 MHz and that is intended to
generate deep heat within body tissues for the treatment of selected medical
conditions such as relief of pain, muscle spasms, and joint contractures, but
not for the treatment of malignancies.
See Section 1 of this User Manual for the detailed Indications for Use for this
device.
Essential
performance
Therapy frequency of 27,12 MHz +/-0,5%
Maximum power of 100 W
Pulse parameters adjustable
Note:
The application of the device is reserved to medical professionals
(e.g. doctors, therapists, members of the paramedical professions).

Assembling the Device
6
Page 11
Note:
Make sure that the power switch on the device is set to "0".
Assembling
mounting bracket
Install the 4 mounting brackets including castors (1) on the bottom of the unit.
Assembling
supporting arm
Assembling
applicator cable
Connecting the
power cable
Slide the supporting arm (4) into the connection for the supporting arm (2).
Bolt the applicator cable (4.1) to the cable connection of the applicator cable
(3).
Connect the power cable to the provided socket (8) on the unit, connect the
cable to the mains.
Note:
The device may only be connected to power outlets with a properly grounded
contact.
Note:
After completion of the assembly, check again to see whether the supporting
arm connection is properly inserted into the connector.
Check that the applicator cable is properly connected to the connector.
The device may only be operated when the applicator cable has been properly
connected. Otherwise a risk to people and environment or damage the device
may occur.
Switching on the
device
Turn on the unit with the mains switch (9).
Switching off the
device
The device is switched off using the power switch (9).
To completely disconnect the device (all-pole) from the mains, the power cord
must be disconnected.
Caution
!
All cables must be protected against twisting or other mechanical damage.

Settings
7
Page 12
Note:
Changes to the basic settings can only be made in the start-up screen.
Start-up screen
After switching on the device and performing the self-test, the start-up screen
opens.
Note:
Activating the "Start" (2) button will immediately switch to the application
screen.
Settings menu
In the settings menu, the factory settings can be individually changed and
adjusted.
Selecting settings
Pressing the "Settings" (1) button opens the "Settings" screen.
The settings are described below.
The default settings are pre-programmed as shown on the screen.
1
2
3
4
5
6
1
2
7

Settings
7
Page 13
(1) Start Settings
1. Start menu:
Individual selection options for start settings.
2. Start screen:
Choice of two start screens.
The selection is made in the corresponding row.
(2) Language
Select the language.
The selection is made in the corresponding row.
(3) Audio/graphics
settings
1. Brightness:
Adjust the screen brightness.
2. Volume:
Set the volume of the confirmation beeps that sound when the control panels
are activated.
Adjustment is done by using the two arrow keys.
(4) OK
Touch the "OK" button to switch to the start screen.
(5) Version
Touching the "Version" button opens a window with information about the
current software version.
(6) Default settings
Touching the "default" button restores the default factory settings.
(7) Welcome
Clicking in the "Welcome" field opens a window with an alphabetic keyboard
for entering a customised welcome message on the start screen.
Touching the "OK" button saves the entered text.
Touching the "Cancel" button returns to the configuration menu.