Elettronica Pagani STAR T-SHOCK User manual

CRYO GENERATION
STAR T-SHOCK
™
USER MANUAL
[e-mail]

User manual STAR T-SHOCK ELETTRONICA PAGANI
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1.!INTRODUCTION .......................................................................................................................1!
2.!INTENDED USE.........................................................................................................................2!
3.!INSTALLATION.........................................................................................................................4!
7.0!SOFTWARE DESCRIPTION.............................................................................................14!
7.1.!MANUAL OPERATION ....................................................................................................14!
7.1.1!SETTING OF THE STEPS AND OF STEP CYCLES .............................................18!
7.1.2!MANAGEMENT OF THE CYCLES........................................................................20!
7.2!PRESET PROGRAMS ........................................................................................................24!
7.2.1!AESTHETICS ............................................................................................................24!
7.3!RECORD MANAGEMENT ...............................................................................................29!
7.3.1!RECORD SAVING - METHOD 1 ............................................................................30!
7.3.2!RECORD SAVING - METHOD 2 ............................................................................34!
7.3.3!ACCESSING FREE RECORDS................................................................................36!
7.3.4!DELETING A RECORD ...........................................................................................38!
7.4!client ARCHIVE..................................................................................................................42!
7.4.1!ADDING A NEW CLIENT .......................................................................................44!
7.4.1.5!DELETING A CLIENT..................................................................................................63!
8!SAFETY AND MAINTENANCE.............................................................................................66!
8.1!INTRODUCTION ...............................................................................................................66!
8.2!INSTALLATION ................................................................................................................66!
8.3!MAINTENANCE AND INSPECTIONS............................................................................66!
8.4!ROUTINE MAINTENANCE..............................................................................................67!
8.5!PERIODIC MAINTENANCE BY THE T.A.S...................................................................68!
8.6!IMMEDIATE MAINTENANCE BY THE T.A.S. .............................................................69!
9!DATA ON PLATES AND SYMBOLS.....................................................................................69!
10!WARNINGS - RISK CONDITIONS ........................................................................................70!
11!WARRANTY.............................................................................................................................72!
12!MANUFACTURER'S LIABILITY...........................................................................................72!
APPENDIX A....................................................................................................................................73!
APPENDIX C (TOOLS)....................................................................................................................74!
APPENDIX D....................................................................................................................................83!
MESSAGES FROM THE DEVICE..................................................................................................83!
APPENDIX E (SOFTWARE UPDATE) ..........................................................................................86!
APPENDIX F (OPTIONAL CODES)...............................................................................................86!
1. INTRODUCTION

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This user manual provides detailed information about the STAR T-SHOCK device and its
components, contraindications and side effects, as well as recommendations for use, troubleshooting,
cleaning and maintenance. The STAR T-SHOCK offers specific characteristics. Above all, these
characteristics are achieved thanks to the interplay between the device’s information and the
operator’s settings.
The interface uses the Windows Embedded Compact 2013 operating system (WEC 2013) and it
implements an advanced microprocessor board connected to a 10.1" colour display with touch
screen.
The machine is based on a dual-component therapeutic system: a hyperthermic component, which
can generate heat with a sensitive and rapid increase of the local temperature up to a maximum of +
41 ° C, and a cryogenic component, which is adjustable up to - 10 ° C, and can subtract heat even on
deep layers thanks to an exogenous system.
The two components, administered sequentially according to precise therapeutic protocols, produce
the effect of localized and deep thermal shock.
The transmission to the human body takes place through a special applicator that can be manually
used by an operator while performing the technique;.
During the treatment, a dynamic graph at the center of the display shows the temperature of the
applicator. Throughout the session, the operator has an immediate control over the temperature
variation on the client.
2. INTENDED USE
The current device is non-invasive and is used for thermoshock application in aesthetics.
The device is intended to be used for the following purposes:
Aesthetics
General improvement of skin imperfections (dimpling, cellulite, wrinkles)
Contraindications for cold therapy:
- Hypersensitivity to cold
- Sensitive disorders
- Open wounds
- Skin blistering
- Arterial circulation disorders
- Ischemic lesions/vasculitis
- Acrocyanosis and Raynaud's syndrome
Contraindications to heat therapy:
- Hypersensitivity to heat
- Any injuries and/or trauma at acute stage
- Infections, since the therapy speeds up metabolism and bacterial growth
- Bleeding
- Open wounds
General contraindications:
- Sensitivity disorders
- Unconsciousness

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- Adolescence
WARNINGS
The use of the device has not been tested on children, pregnant or breastfeeding women or on clients
with:
- known sensitivity to cold such as in cases of cold urticaria, Raynaud's Syndrome or Chilblains
(perniosis).
- impaired vascular circulation in the area to be treated.
- impaired skin sensitivity.
- open or infected wounds.
- bleeding disorders or concomitant anticoagulant use.
- skin conditions such as eczema, dermatitis or skin rash in the area to be treated.
The STAR T-SHOCK device requires operators to utilize the manual massage technique. This
technique operates at a temperature below 0° C; if this temperature is protracted over time in a static
position, it can freeze tissues. Therefore, it is advisable to perform a constant massage technique,
without interruptions, and not to prolong the static position for more than 90 seconds.
The use of the device on areas with superficially localized nerve branches, arteries or veins has not
been tested.
Use of the device on active implanted devices such as pacemakers is not permitted.
The use of other electronic devices on a client undergoing treatment may interfere with the proper
functioning of the device in question, with possible injuries to the client. Do not use other electronic
devices on a client undergoing treatment.
WARNING
Before using the device, carefully read the operating instructions and the "Safety and Maintenance"
section with related appendices.
For treatments concerning the submental area (underneath the chin), please observe the following
warnings:
- During a Facial treatment, ALWAYS use a temperature above 0°C and properly massage the area.
- NEVER use static technique during a Facial treatment.
Precautions
If the operator observes a potential safety issue or an operational anomaly during the use of the
device the treatment must be halted immediately and customer service must be immediately
contacted. The use of other equipment and supplies than the ones supplied with the device have not
been tested and therefore may cause unexpected and hazardous risks.
Side Effects
The following effects may occur in the treated area during and after the treatment. These effects are
temporary and generally resolved within a few days or weeks.
During a treatment:
• Slight sensation of pulling and pinching
• Intense cold, tingling, stinging, aching, cramping

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• These feelings diminish as the area becomes numb
Immediately after a treatment:
• Hardening
• Redness
• Tingling and itching
One or two weeks after the treatment:
• Itching
• Skin sensitivity
• Tingling
• Numbness
Rare side effects
• Subcutaneous hardening inside the treated area may develop after the treatment.
• Hyper-pigmentation may occur immediately after the treatment. Typically, it disappears
spontaneously.
Potential for tissue damage.
The system operates at temperatures below 0° C, which, if protracted over time on the same
position, may freeze the tissues. Therefore, the display shows a dynamic graph related to the
temperature of the part of the wand in direct contact with the client corresponding to a tolerance of 1-
3° C in relation with client's surface temperature. In case of use with the thermal component (heat
generator), if the device is damaged and reaches a temperature of 48° C for more than 5 seconds
on the side of the wand in contact with the client, it emits an acoustic signal, shows the following
message, "Alarm Temperature Applicator!” and interrupts the treatment. If this message appears,
immediately remove the applicator from the client. Failure to follow the instructions may result in
minor burns to the client.
3. INSTALLATION
Before starting to use the device, it is suggested to run a functional test in order to ensure that no
alterations occurred during transport of the equipment.
Remember that the operating environment must meet the electric requirements described by the
Standard IEC 60601-1 and collaterals.
Before starting to use the device, it is recommended to consult all the paragraphs in this manual.
WARNING!
Please remember that any application of physical or aesthetic therapy must be performed on
CONSCIOUS clients. The use on clients under adult age may be carried only with consultation. It is
also recommended to pay the utmost attention to the sensations that the client feels when the output-
temperature changes.
4. DESCRIPTION OF PORTS AND COMPONENTS

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1. . Rear display ventilation grid: the purpose is to reduce the temperature inside the console. Do not
obstruct the grill when using the appliance
2. . Rear display ventilation grid: the purpose is to reduce the temperature inside the console. Do not
obstruct the grill when using the appliance
3. lemo connector for display-mobile connection + Knob for display-mobile fixing
4. USB port (enabled only for any software updates sent by ELETTRONICA PAGANI)
5. ON / OFF switch: to power the device
6. Power socket: where to insert the supplied mains cable
7. 24V and 0.5A output for optional trolley connection
8. Coolant top-up opening
9. Mobile side ventilation grilles: the purpose is to reduce the temperature inside the cabinet. Do not
obstruct the grill when using the appliance
10. Rear mobile ventilation grid: a fan is positioned inside whose purpose is to reduce the internal
temperature. Do not obstruct the grill when using the appliance.
11. Nut: is intended exclusively for use by authorized technical personnel to perform electrical safety
tests. Its use is prohibited to unauthorized personnel.
12. Nameplate data
13. CRPM code massage head
14. Massage head holder
15. Machine side connector for handpiece
16. Mains cable
17. Touch screen

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5. ACTIVATING THE DEVICE
setting up your machine step by step with images included
after placing the device on a stable and well-ventilated surface (ideally in proximity to the ventilation
grids), connect the massage head holder
connect the supplied applicator to the device following the instructions on its connector. warning! do
not switch on the device before connecting the applicator
push the tabs indicated by the arrows in the figure below and, matching the connector on the cable
with the port on the device, push until the tabs snap

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TO POWER THE DEVICE:
!connect the supplied main cable into the socket of the device

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!connect the other end of the cable into the grounded wall outlet
!press the power-switch on the back of the device to turn on (the green led light will
illuminate).
!the device turns on, and after having loaded the software, it will display on the screen the
main menu.
!using the head
step by step with images included
when using the massage head, the interposition of biocompatible gel, is recommended. (it is up to the
operator to obtain the biocompatible coverings and gels according to iso 10993-1)

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the purpose of the gel is to slide the handpiece on the area to be treated. glide the wand over the
treatment area as suggested in the videos loaded on the device and related to the specific area of the
body to be treated.
6. DESCRIPTION OF CONTROLS
(list of icons along with their functions, will format this)
Temperature slider: drag horizontally to change the temperature.
Time slider: drag vertically to change the duration of the treatment.
Enter: Confirm an operation on the inquiry screens; close an alert; confirm the data
entered.
Back: Return to the previous screen; Undo an operation
Cycle 1 is active. This control is always active since a treatment implies at least
one operational cycle.
Cycle 2 is not active.

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Cycle 2 is active.
Cycle 3 is not active.
Cycle 3 is active.
Audio is not enabled; by tapping this icon, the audio is enabled.
Audio is enabled; by tapping this icon, the audio is disabled.
Alert: Level of the coolant is low.
Status: Active. The device is working and it is supplying.
Status: Inactive. The device is in standby and it is not supplying.
Current operating cycle.
Play: If this icon is tapped, the treatment starts.
Stop: If this icon is tapped, the treatment stops.
Save: If this icon is tapped, you save a new entry or updates to an existing
entry: a client; client’s records; or the changes made on client’s records.
Delete: If this icon is tapped when it is available on the screen, it is possible to
delete one of the steps among those that have been set (there must be more than
one step).

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Open: Open the preset program and/or open the last client record in the list.
Access Data: It allows to access the data of a client.
Add a New client or Record: It allows to add a new client and/or to add a new
record.
Down/Up: It shows the ability to scroll vertically in a list dragging with a
finger.
Information: If this icon is tapped, the information related to the area to be
treated are available. The information is available both as text and audio.
Video: If this icon is tapped, a video showing how to use the device in a
specific area of the body is displayed.
Selectable Body Areas: It shows selectable areas of the body.
Body Area Currently Selected: It shows the area of the body currently selected.
Delete client Record: If this icon is tapped, the selected client Record is
deleted.
First client Record: Shows the first client Record related to the selected client.

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Second client Record: Shows the second client Record related to the selected client.
Third client Record: Shows the third client Record related to the selected client.
Fourth client Record: Shows the fourth client Record related to the selected client.
First client Record Currently Selected: Shows the first client Record is selected.
Second client Record Currently Selected: Shows that the second client Record is
selected.
Third client Record Currently Selected: Shows that the third client Record is selected.
Fourth client Record Currently Selected: Shows that the fourth client Record is
selected.
Add New client Record: Allows to add a new client Record.
Decrease/Increase: Allows to decrease/increase the value to be modified.
Select a Field: Allows to select a field to set-up or in which it is necessary to
enter a value.

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System Settings: Allows access to the system settings of the device.
Audio is not enabled; by tapping this icon, the audio is enabled.
Audio is enabled; by tapping this icon, the audio is disabled.
Calibration: Allows access to the testing page (Calibration).
Language: Allows change in the language of the device.
Statistical Report: Allows to view a statistical report.
Celsius/Fahrenheit: Allows to switch the temperature display between Celsius
and Fahrenheit.
Touch Screen Calibration: Allows touchscreen calibration.
7.0 SOFTWARE DESCRIPTION
!
7.1. MANUAL OPERATION
When the device powers on, the following screen will appear:

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To use the manual mode, tap the icon shown below
The following screen will appear. The system loads default settings
To decrease the set temperature, drag to the left the cursor shown in the figure below. To increase the
temperature, drag the same cursor to the right

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To increase the treatment duration, drag up the cursor shown by the arrow in the figure below; to
decrease the duration, drag the same cursor down.
To start the treatment, tap the button shown by the arrow in the figure below
At the start, the following screen will appear.

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The total time decreases and the dot on the screen becomes green. The central area of the screen
shows a dynamic graph related to the instantaneous temperature of the applicator's surface in contact
with the client. At the start, it is not possible to modify the duration, but it is possible to modify the
temperature as shown previously.
When the treatment is finished, the following screen will appear. If the audio is enabled, the voice
message "Treatment completed" will be also audible
To close the message, tap the icon shown by the arrow in the figure above.
The following screen will appear. From here, it will be possible to start a new treatment with the last
settings or, if necessary, it is possible to modify the settings.

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7.1.1 SETTING OF THE STEPS AND OF STEP CYCLES
It is possible to set more steps for a single treatment. The steps are displayed on the left side of
the screen, as shown in the orange rectangle in the figure below.
To add a step, tap the empty circle on the left side of the display, as shown in the following
figure.
To add a step, tap the empty circle on the left side of the display, as shown in the following figure.
A step with the default settings (Duration and Temperature) will be added, as shown in the following
figure.

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In the column on the left side of the display, the circle highlighted in green shows the currently
selected step, as shown in the figure above. For each step, if necessary, you can change the settings. It
is possible to set a maximum number of 5 steps, as shown in the following figure
It is possible to select a step to modify the settings or to delete it. To select a step, tap the
corresponding step in the left side of the display. For example, the following figure shows how to
select ‘Step 3’
After tapping, the step appears highlighted and its parameters will be set in the cursors, as shown in
the following figure