enpuls_2_user_s_manual_.pdf
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User Manual
enPuls
Version 2.0
USA
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Figures
Front view of device
Control unit / Handpiece / Footswitch
4
3
1
5
2
9
6
10
8
7
Selection and control
elements
1
2
3
4
5
6
Control unit
Pulse energy controller
Touch pen in holder
Display
Frequency controller
SD card slot
Handpiece
7
8
9
Handpiece with applicator head 25 mm
Air vents, front
Air vents with fan, rear
Footswitch
10
Footswitch
1
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Figures
Front view of device
Display
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14
12
11
Screen readouts
11
12
13
14
Status bar
Screen controls
Title bar
Navigation bar
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Figures
Rear view of device
Switch and connector sockets
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15 16 17
Switch /
Connector sockets
15
16
17
18
19
20
18
19
Main switch
Mains fuse
Port for mains cable
Port for handpiece
Port for footswitch
Serial number / manufacturer's plate
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Figures
Accessories
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22
21
22
23
24
Silicone cap
25 mm applicator head
15 mm applicator head
6 mm applicator head
4
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Contents
enPuls
Front view of device
Figures - Control unit / Handpiece / Footswitch
Figures - Display
Rear view of device
Figures – Switch and connector sockets
Accessories
Figures
1
enPuls briefly
1.1.
Summary
1.2.
Quick operation instruction
How to use enPuls
1.3.
1.4.
Handpiece
Applicator heads
1.5.
1.6.
Footswitch
7
8
10
11
12
13
2
Installation
2.1.
Fitting the cables, starting the system
Settings
2.2.
14
15
SD-Card
17
Treatment screen
18
5
Favorites and Memory list
5.1.
Saving modified programmes
5.2.
Retrieving and editing Favorites list and the
Memory list
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22
6
Description of the selection keys
24
7
Medical information
7.1.
Indications
7.2.
Contraindications
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27
3
4
5
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Contents
General Information
8.1.
Explanation of symbols
8.2.
Warnings
8.3.
Technical data
8.4.
Technical information
8.5.
CE Marking / Legal information
28
29
30
31
32
9
10
11
12
13
Maintenance
33
Troubleshooting
35
Function test
37
Error messages
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Scope of delivery - Accessories
39
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Manufacturer’s declaration of Electromagnetic
Compatibility
40
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Valid for the enPuls V.2.0 devices
These operating instructions are an integral part of the device.
They must be stored with the device and kept accessible at all times for anyone authorized to
operate this device. These Instructions form is a part of the appartures and must be kept with it
at all times. Full observation of these instructions is a requirement for the correct application
and operation of the equipment and for consequent saftey for patient and operator.
These operating instructions are valid from 01 June 2011.
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enPuls briefly
1.1.
1
Summary
What is enPuls?
A state of the art therapeutic massager
Radial Pulse Therapy
Radial Pulse Therapy is a procedure for relief of minor muscle aches and
pains and for temporary increase in local blood circulation
What does
enPuls do?
Creation of radial pulses using an ergonomic handpiece and the
transmittal of the radial pulses via special applicators.
enPuls has a maximum penetration depth of about 35 mm in human
tissue.
How are radial
pulses generated
with enPuls?
An electromagnetic field is generated via a coil in the back of the
handpiece.
A projectile is accelerated as a result of the field; this strikes against the
applicator head at the front of the handpiece and generates pulses,
which spread out radially in the tissue.
What are the
advantages
of enPuls?
The innovative technology allows a compact design with no need for a
compressor.
The clear and modern colour display shows all relevant parameters for
treatment and the modern touch operation ensures pleasure and
motivation when providing treatment.
Individual program start configuration and clear, simple menu navigation
make operation of the device easy and comfortable for users.
Infinitely variable frequencies and various applicators allow treatment to
be adapted to the particular condition of the patient.
The compact design saves room in the practice and is highly suited for
use in home visits.
The unit must only be operated by medical practitionars.
Note:
enPuls has been constructed and designed solely for the treatment of
superficial orthopaedic problems in humans and animals.
! Caution
Federal law restricts this device to sale by or on the order of a physician.
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enPuls briefly
1.2.
Quick operation instruction
1
Note:
The following descriptions are all based on factory settings.
Note:
All buttons, menus and submenus are activated directly on the screen by
touching or using the touch pen.
Starting the program
Press the “Start” button to open the treatment screen for program
P 02.
Treatment screen
Applicator
Select the appropriate applicator head for the treatment you wish to carry
out and screw this correctly onto the handpiece.
Positioning handpiece /
applicator
Position the handpiece on the selected treatment point / field. To avoid
any friction on the skin, enPuls lotion may first be applied onto the
treatment area.
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enPuls briefly
1.2.
Quick operation instruction
1
! Caution
When using lubricants, the applicator head must be covered with a
silicone cap to protect it.
Setting the frequency
Adjust the frequency using the right controller, if necessary.
Setting
the pulse energy
Adjust the pulse energy using the left controller.
Starting treatment
Depress the footswitch to start the treatment.
The display in the bottom status bar changes from ‘Ready’ to ‘Active’.
Note:
Only activate the unit via the footswitch once the handpiece has been
positioned on the patient.
Ending treatment
Deactivating the footswitch interrupts or ends the treatment. The display
in the bottom status bar changes from ‘Active’ to ‘Ready’.
The device ends the treatment automatically once the preselected
number of pulses has been reached.
Note:
During treatment, the patient must be observed closely and the treatment
must be adjusted, if necessary, or discontinued, should any problems
arise.
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enPuls briefly
1.3.
Start treatment
1
How to use enPuls
enPuls operates with mechanical energy.
The energy is transmitted to the patient via a handpiece, which is usually
held in one hand.
To do this, the handpiece is placed on the area or point of treatment with
the applicator head held vertically.
When the unit is activated, it is possible to work either steadily on a
single site or dynamically over an area.
It is advisable to use enPuls lotion (included in the accessories) in order
to reduce friction on the skin.
The weight of the handpiece means that it is normally not necessary to
apply pressure to the treatment area / point.
The handpiece is placed on the treatment area / point and held loosely in
position with one hand.
If required, additional pressure may be applied in the direction of the
tissue, and the working angle can be varied.
! Caution
When using enPuls lotion or other lubricants, the applicator head must
be covered with a silicone cap to protect it.
Note:
Despite high internal damping as a result of the weight and design of the
handpiece, vibrations may cause strain to the user's hand.
Recommended protective measure:
- Limit the duration of exposure
Note:
The patient should be carefully monitored throughout the treatment.
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enPuls briefly
1.4.
1
Handpiece
The handpiece (7) contains the pulse generator, a fan to dissipate heat
and the slot for the different applicator heads. It is connected to the control
unit (1).
Note:
The pulse generator in the handpiece is an expendable part and has to be
replaced after a specific period of use, as its functionality decreases over
time.
Zimmer MedizinSystems guarantees unrestricted use of at least 2 million
pulses per pulse generator.
Wear on the pulse generator varies. Depending on performance and
frequency, sometimes far more than 2 million pulses can be delivered.
For more information on the need to replace the pulse generator, see
chapter 10.
To work with the handpiece on a patient, it is essential that one of the
applicator heads is screwed tightly onto the handpiece as far as it will go.
The cable should not be stretched beyond its maximum length and must
be protected against pinching or any other mechanical damage.
To avoid heat accumulating in the handpiece, it is essential to ensure that
the hand holding it or anything else does not block the air vents at the top,
and particularly, on the base of the handpiece.
Standby mode on device The fan in the handpiece is started by depressing the footswitch and stops
and handpiece
automatically after reaching a certain temperature.
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enPuls briefly
1.5.
1
Applicator heads
There are 3 different applicator heads available for treatment.
Changing
applicator heads
To change the various applicator heads, hold the handpiece in one hand
and unscrew the applicator head from the handpiece with the other hand
(anticlockwise). Screw the required head tightly onto the handpiece
(clockwise), until the black outside ring of the applicator head rests on the
handpiece (there should no longer be any thread visible).
Note:
Applicator heads are expendable parts and must be replaced after a
certain period of use.
Minor / slight deformation or shortening of the rear impact dome does not
affect functionality.
In cases of greater deformation or stronger shortening of the rear impact
dome the applicator head must be replaced.
A test template is supplied with the device that enables the user to test if
the wear limit has been reached
(see diagram).
Test template
Air gap applicator OK
Test template
Template makes contact or air gap at the tip Wear limit has been reached
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enPuls briefly
1.6.
1
Footswitch
Place the footswitch so that it can be reached easily during treatment.
The footswitch control unit is multi-directional so it is not necessary to
align the footswitch exactly.
To avoid damage, please note that only slight pressure needs to be
exerted on the switch. Use the front part of your foot, not the heel to
operate the footswitch.
The switch does not have a locking device, which means that it only
remains actuated as long as pressure is applied to it.
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Installation
2.1.
Fitting the cables, starting the
system
2
Note:
Before starting up the system, remove enPuls from its transport case.
Do not operate the device while it is in the case.
Ensure that enPuls is placed on a stable surface.
Note:
Make sure that the main switch on the device is set to '0'.
Connecting the
mains cable
Connect the mains cable to the designated port (17) of the device and
then plug into the mains.
Connecting
the handpiece
Plug the handpiece into the appropriate socket (18) of the device and
place it on the table.
Note:
Ensure that an applicator head is inserted into the handpiece and that it
is properly screwed in as far as it will go.
Connecting
the footswitch
Plug the footswitch into the appropriate socket (19) of the device and
then place it on the floor.
Switching on the device
Switch on the device using the main switch (15).
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Installation
2.2.
Note:
2
Settings
Changes to the default settings can only be made from the start screen.
Press button “Settings” to open the Settings screen
Figure 1
Language
Press this button to open the menu to select the language. The language
is selected by pressing on the appropriate row in the pull down menu.
Start settings
Start screen
Option to choose between 5 start screens.
Press the button to open the pull down menu to select the start screen.
The start screen is selected by pressing on the appropriate row.
Start display
Option to choose between 2 start displays:
Press the button to open the menu to select the start display.
The start display is selected by pressing on the appropriate row.
Welcome message
Option to configure an individual welcome message.
Activate the welcome message field to open the keyboard in order to
enter a welcome message.
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Installation
2.2.
2
Settings
Audio / graphic settings
Brightness
Option to adjust the brightness of the screen lighting.
Adjust the volume using the two arrow keys.
Volume
Option to adjust the volume of the signals when activating the control
fields.
Handpiece
counter status
The counter status for the handpiece that is currently connected, is
shown in this display field.
Version
Press the version button to open the window with information about the
current software version of the device.
Default
settings
Press the default button to reset the factory default settings.
Touch calibration
Press the “Touch Calibration” button to open the screen to carry out the
touch calibration.
This can be done to improve the touch input if it is not sufficiently
accurate.
First press the + symbol in the top left corner. A + symbol appears then
in the lower right corner.
Then precisely press the + symbol in the lower right corner.
Repeat the procedure to complete the touch calibration.
Alternative language
The option “Alternative language” is inactive.
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SD-Card
3
User-defined settings are saved on the SD card.
Note:
If the SD card is not inserted, the message ‘SD card not found’ appears
when the 'Favorites' and 'Memory' buttons are pressed.
Deactivate the message by pressing the button “OK” and continue.
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Treatment screen
4
Title bar
The title bar shows the name of the current program.
Status bar
The status bar shows the information about the current status of the
treatment. If the treatment is not active, it shows the word ‘Ready' and if
treatment is running the text 'Active' appears.
Mode
Shows the selected operational mode (continuous in this case).
Press the 'Mode' button to open the 'Input' window and select the
operational mode (continuous, Burst 4 Pulses, Burst 8 Pulses, Burst 12
Pulses)
Frequency
Shows the selected frequency.
Change the frequency using the right controller.
Frequency range: 1 Hz – 16 Hz, adjustable using the right controller in
1 Hz steps.
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Treatment screen
4
Energy/ Bar graph
Shows the selected pulse energy. When treatment is active the bar
graph is filled in.
Setting the pulse energy can be done either before or during pulse
delivery.
The pulse energy can be set at the levels 60, 90, 120 or 185 mJ.
Save
After changing the parameters, based on individual needs, press the
button “Save” for saving the settings either in the Favourites list or the
Memory list.
Count direction
Press to set the count direction (increasing or decreasing) of the number
of pulses set.
Number of pulses
Shows the pre-selected pulse numbers as well as the current number of
pulses delivered to the patient.
Also the count direction (increasing in this case) is shown.
Pressing the “Number of pulses” field opens the Input window, defining
pre-selection.
Note:
enPuls offers two options for pulse delivery:
Pulse delivery without
pre-selecting the pulse
number
For pulse delivery with no pre-selected number of pulses, the device
does not end the treatment. As long as the footswitch is activated, pulses
will be delivered.
For pulse delivery with no pre-selected number of pulses, only the
upward count direction is active.
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Treatment screen
Pulse delivery with
pre-selection of the
number of pulses
4
For pulse delivery with a pre-selected pulse number, the device ends the
treatment once the pre-selected number of pulses has been reached.
The footswitch is deactivated and pulse delivery is no longer possible.
The treatment can be continued by resetting the current number of
pulses or by adjusting the pre-selection.
When the number of pulses is pre-selected the count direction is
automatically set to decreasing. By pressing the 'Count direction' button
on the treatment screen the increasing count direction button can be
selected.
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Favorites and Memory list
5.1.
Saving modified program
5
Programs can be stored either in the Favorites list or the Memory list.
Program name
For saving the program enter the program name using the keyboard
Favorites
Press the “Favorites” button to open the Favourites list and automatically
save the program.
The program is automatically saved in the first free space in the list.
Memory
Press the “Memory” button to open the Memory list and automatically
save the program.
The program is automatically saved in the first free space in the list.
Note:
If the 'Memory' or ‘Favorites’ button is pressed without entering a
program name, an error message appears.
Acknowledge these message with ‘OK’, enter a program name and
repeat the save procedure as described above.
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Favorites and Memory list
5.2.
Note
Retrieving and editing Favorites
list and the Memory list
5
The following steps to edit the Favourites list correspond exactly to those
used to edit the Memory list.
Individual saved programs are listed in Favorites or Memory list.
From here they can be:
1. retrieved for treatment or
2. edited (sequence changed or deleted).
Selecting the Memory or
Favorites list
Retrieving a
program
In the navigation bar press the ‘Favourites’ or ‘Memory’ button to open
the corresponding list.
In the list select the desired program by pressing the appropriate row.
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Favorites and Memory list
5.2.
Editing
Retrieving and editing Favorites
list and the Memory list
Press the ‘Edit’ button to open the 'Edit Favorites' screen
Activate the desired program by pressing the appropriate row.
You are now able to
• Move or
• Delete
the selected program.
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Description of the selection keys
6
Press the button to open the screen to save a program.
The “Save” button can only be pressed from the treatment screen.
Can be used to reverse the counting direction.
Pressing the key reset the current number of pulses
• to 0 by increasing counting direction
• to the preset value by decreasing counting direction.
Press the button to move an item of the list upwards by one position.
Press the button to move an item of the list downwards by one position.
Press the button to delete the selected program from the list.
Scrolling forwards
Press the button to scroll one page down the list.
Scrolling backwards
Press the button to scroll one page up the list.
The changes are applied by pressing the button.
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