Zimmer enPuls User manual

Operating Instructions
enPuls
Version 2.0
GB

Figures
Front view of device
1
Control unit / Handpiece / Footswitch
Selection and control
elements
1 Control unit
2 Shock energy controller
3 Touch pen in holder
4 Display
5 Fre uency controller
6 SD card slot
Handpiece 7 Handpiece with applicator head 25 mm
8 Air vents, front
9 Air vents with fan, rear
Footswitch 10 Footswitch
1
4
5
6
8
3
9
7
10
2

Figures
Front view of device
2
Display
Screen readouts 11 Status bar
12 Buttons on the screen
13 Title bar
14 Navigation bar
14
12
11
13

Figures
Rear view of device
3
Switch and connector sockets
Switch /
Connector sockets
15 Main switch
16 Mains fuse
17 Port for mains cable
18 Port for footswitch
19 Port for handpiece
20 Serial number / manufacturer's plate
19 18 17 16
15
20

Figures
Accessories
4
21 Silicone cap
22 25 mm applicator head
23 15 mm applicator head
24 6 mm applicator head
21 22 23 24

Contents
5
enPuls Front iew of de ice
Figures - Control unit / Handpiece / Footswitch
Figures - Display
Rear iew of de ice
Figures – Switch and connector sockets
Accessories
Figures
1
enPuls briefly
1.1. Summary
1.2. Quick operation instruction
1.3. How to use enPuls
1.4. Handpiece
1.5. Applicator heads
1.6. Footswitch
7
8
10
11
12
13
2
Installation
2.1. Fitting the cables, starting the system
2.2. Settings
14
15
3 SD-Card 17
4 Treatment screen 18
5
Fa ourites and Memory list
5.1. Saving modified programmes
5.2. Retrieving and editing Favourites list and the
Memory list
21
22
6 Description of the selection keys 24
7 Treatment recommendation 26
8
Medical information
8.1. Indications
8.2. Contraindications
30
31

Contents
6
9
General Information
9.1. Explanation of symbols
9.2. Warnings
9.3. Technical data
9.4. Technical information
9.5. CE Marking / Legal information
32
33
34
35
36
10 Maintenance 37
11 Troubleshooting 39
12 Function test 41
13 Error messages 42
14 Scope of deli ery - Accessories 43
15 Manufacturer’s declaration of Electromagnetic
Compatibility
44
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 authorised to
operate this device.
These operating instructions are valid from 01 March 2010.

enPuls briefly
1.1. Summary 1
7
What is enPuls? A state of the art innovative shockwave treatment device.
Shockwa e treatment Radial, ballistic shockwave treatment is a procedure with a wide range of
applications ranging from superficial orthopaedic problems to myofascial
trigger point treatment.
What does
enPuls do?
Creation of shockwaves using an ergonomic handpiece and the
transmittal of the shockwaves via special applicators.
enPuls has a maximum penetration depth of about 35 mm in human
tissue.
How are
shock wa es
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 shockwaves,
which spread out radially in the tissue.
What are the
ad antages
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 programme start configuration and clear, simple menu
navigation make operation of the device easy and comfortable for users.
Infinitely variable fre uencies 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.
Note: The device should only be used by medical specialists
(e.g., doctors, therapists and health paraprofessionals).
enPuls has been constructed and designed solely for the treatment of
superficial orthopaedic problems in humans and animals.

enPuls briefly
1.2. Quick operation instruction 1
8
Note: The following descriptions are all based on the factory settings.
Note: All buttons, menus and submenus are activated directly on the screen by
touching it or using the touch pen.
Starting the programme
Press the “Start” button to open the treatment screen for programme
P 02.
Treatment screen
Applicator
Positioning handpiece /
applicator
Select the appropriate applicator head for the treatment you wish to carry
out and screw this correctly onto the handpiece.
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.

enPuls briefly
1.2. Quick operation instruction 1
9
Caution! When using lubricants, the applicator head must be covered with a
silicone cap to protect it.
Setting
the shock energy
Adjust the shock 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 shockwave 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’.
Note: During treatment, the patient must be observed closely and the treatment
must be adjusted, if necessary, or discontinued, should any problems
arise.

enPuls briefly
1.3. How to use enPuls 1
10
Start treatment 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 shockwave 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 re uired, 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.

enPuls briefly
1.4. Handpiece 1
11
The handpiece (7) contains the shockwave generator, a fan to dissipate
heat and the slot for the different applicator heads. It is connected to the
control
unit (1).
Note: The shockwave 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 MedizinSysteme GmbH guarantees unrestricted use of at least 2
million shocks per shockwave generator.
Wear on the shockwave generator varies. Depending on performance and
frequency, sometimes far more than 2 million shocks can be delivered.
For more information on the need to replace the shockwave generator,
see chapter 11.
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 de ice
and
handpiece
The fan in the handpiece is started by depressing the footswitch and stops
automatically after reaching a certain temperature.

enPuls briefly
1.5. Applicator heads 1
12
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 re uired 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).
Air gap

applicator OK
Test template
Test template
Template makes contact or air gap at the tip

Wear limit has been reached

enPuls briefly
1.6. Footswitch 1
13
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.

Installation
2.1. Fitting the cables, starting the
system 2
14
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 (19) 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 (18) of the device and
then place it on the floor.
Switching on the de ice Switch on the device using the main switch (15).

Installation
2.2. Settings 2
15
Note: 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.

Installation
2.2. Settings 2
16
Audio / graphic settings
Brightness
Volume
Option to adjust the brightness of the screen lighting.
Option to adjust the volume of the signals when activating the control
fields.
Adjust the volume using the two arrow keys.
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.
Alternati e language The option “Alternative language” is inactive.

SD-Card 3
17
User-defined settings and the treatment recommendation list are saved
on the SD card.
Note: If the SD card is not inserted, the message ‘SD card not found’ appears
when the 'Favourites' and 'Memory' buttons are pressed.
The ‘Therapy‘ button is not shown.
Deactivate the message by pressing the button “OK” and continue.

Treatment screen 4
18
Title bar The title bar shows the name of the current programme.
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 Shock, Burst 8 Shock, Burst 12
Shock)
Frequency Shows the selected fre uency.
Change the fre uency using the right controller.
Fre uency range: 1 Hz – 16 Hz, adjustable using the right controller in
1 Hz steps.