Instructions for Use

enPuls
Version 2.0

GB
 Illustrations
Front View of Device

Fig. 1

3 5

2 9

10

8
6
Selection and control 1 Control unit
elements 2 Shock energy controller
3 Touch pen in holder
4 Display
5 Frequency controller
6 SD card slot

Handpiece 7 Handpiece with applicator head 25 mm

8 Air vents, front
9 Air vents with fan, rear

Foot switch 10 Foot switch

 Illustrations
Rear View of Device

Fig. 2

20

15

16
17 19 18
Switch / 15 Main switch
Connector sockets 16 Mains fuse
17 Port for mains cable
18 Port for foot switch
19 Port for handpiece
20 Serial number / identification plate
 Illustrations
Display

Fig. 3 13

14

12

11

Display 11 Status bar

12 Buttons on the screen
13 Title bar
14 Navigation bar

Fig. 4
H G

Navigation (A) Home Return to start screen

Description of function
(B) Back Move one step back
(C) Memory Open stored memory list
(D) Therapy Move to therapy menu
(E) Programmes Move to programme list
(F) Favourites Move to favourites
(G) Page back Scroll one page down
(H) Page forward Scroll one page up
 Illustrations
Applicator Heads and Accessories

Fig. 5

21 22 23 24

Applicator Head 21 Applicator head 25 mm

22 Applicator head 15 mm
23 Applicator head 6 mm

Accessories 24 Silicone protection cap

 Explanation of Symbols

In this manual, this symbol indicates Caution/Risk of Injury or Damage.

!
In this manual, this symbol indicates “Caution” with regard to possible damage of the
Caution device.
Handpiece port

Footswitch port

Operating instructions

Follow operating instructions

Serial number

Article number

Manufacturer

Manufacture date

Device type BF

Value of accessible fuses

 Contents

Illustrations
Front view of device
Rear view of device
Display
Applicator heads and accessories

Explanation of Symbols
Page
1 Indications / Contraindications 1

2 Side Effects 2

Application Information 3
3

Warnings 4
4

enPuls Version 2.0 – a brief overview 5

5

Installation 6
6

Settings 7
7

Operating Instructions
8.1 Description of the Device
11
8.2 Basics of Operation
13
8.3 Performing Treatments
14
8.4 Display Screens and Buttons
8 16
8.5 SD Card
18
8.6 Therapy Recommendations
19
8.7 Favourites and Memory Lists – Saving and Retrieving Programs,
21
Editing Lists

Technical Information 25
9

Cleaning and Disinfecting 26

10
 Contents

CE-Mark 27
11

Scope of Delivery and Accessories 28

12

Device Combination 29
13

Safety and Maintenance

14 15.1 Safety 30
15.2 Maintenance 31

Functional Test 32
15

Safety Check / Metrological Control 33

16

Error Messages, Troubleshooting, Disposal 34

17

Manufacturer’s EMC Declaration 38

18

Valid for enPuls Version 2.0 devices.

This instructions for use is an integral part of the device and should be kept with the unit so that persons
responsible for the operation of the device can access it at any time.

The instructions for use is valid from October 2014.

 Indications / Contraindications
1
Indications  radial and ulnar epicondylitis
 calcific tendinitis / shoulder problems
 post blunt muscular injuries
 chronic patellar tendon syndrome
 patellar tendinopathy
 chronic achillodynia
 plantar fasciitis
 heel spurs
 myofascial trigger point treatment in neck
 myofascial trigger point treatment in back, muscular back pain
 bursitis trochanterica
 periostitis / shin splints (post strain)

Contraindications  vascular diseases present in or near the treatment area

 open wounds in or near the treatment area
 local infections in the treatment area
 applications in the area of malignant or benign tumours
 direct application on cartilage surfaces or near the small facet joints of the spinal
column
 direct application over implanted electronic devices such as pacemakers,
analgesic pumps, etc.
 in areas where the mechanical energy from vibrations could lead to tissue damage
such as metal implants
 after fractures, torn muscle fibres or muscle tears.

In general we advise against treatments

 if blood clotting disorders are present or the patient is receiving treatment that
results in a change in blood clotting behaviour
 during pregnancy
 on patients with neurological diseases resulting in impairment of the vasomotor
function in the treatment area
 over air-filled cavities such as treatment on the thoracic spine, etc.
 generalised pain syndromes, such as fibromyalgia
 on children, particularly around the epiphyseal plates

Care is required for patients

 with impaired sensitivity
 with severe autonomic disorders
 under the influence of drugs and/or alcohol
because excess strain on the circulatory system and inadequate responses to
treatment cannot be excluded.

Page 1
 Side Effects
2
Side effects Treatment with enPuls Version 2.0 can occasionally cause irritation, petechiae,
bruising, swelling or pain.

Page 2
 Application Information
3
Before the device is used on a patient, the user should become acquainted with the
operating instructions and individual treatment methods as well as the
indications/contraindications, warnings and other instructions. Additional sources of
information about types of therapy should be consulted.

!
Before use, check that the device is connected with an earthed plug (electrical
Caution installation according to DIN VDE 0100 Pt. 710). The device may only be operated with
the supplied power cord. The power cord must be protected against mechanical stress.

!
Operating the device near strong electromagnetic fields (e.g. scanners, X-rays or
Caution diathermy devices) may interfere with its operation. Please keep a safe distance of
several metres.

enPuls Version 2.0 is not suitable for operation in areas containing explosive,
flammable or combustible materials.

When in operation, the unit should be placed to allow immediate access to the central
power source, so that it can be unplugged at any time.

To avoid the risk of electric shock, the unit must be disconnected from the mains by
unplugging the power cord before performing any maintenance or cleaning activities.

Inspect the unit before use. In case of damage, it must not be used.

Caution ! Only accessories from Zimmer Medizin Systeme GmbH should be used.

!
The handpiece of the device is not designed for continuous operation. After a
Caution maximum of 6000 shocks, there must be a break of 15 minutes.

!
Remove enPuls Version 2.0 from the carrying case before use. It should not be
Caution operated in the case.
Make sure that enPuls Version 2.0 is placed on a stable surface.

!
To prevent the handpiece from overheating, ensure that the ventilation openings on
Caution the top and especially the bottom of the handpiece are not blocked by the user’s hand
or anything else.

Page 3
Warnings
4
Users of the enPuls Version 2.0 shockwave treatment device must be trained in how to
use the system properly and have the appropriate skills.

Any treatment instructions regarding treatment location, duration and strength require
medical knowledge and should only be given by authorised physicians, therapists and
health paraprofessionals. It is imperative that these instructions are followed.

The patient should not be left unattended during therapy.

Patients currently under treatment that reduces or changes blood clotting or lengthens
the time it takes for blood to clot (such as aspirin treatments) should consult their
therapist about the potential risks associated with this treatment because the
application of radial shockwaves may result in increased haemorrhages and bruising.

Shockwaves scatter in air pockets and create reflections that may have negative
effects. Therefore, treatment should never be applied over the lungs (intercostal
spaces) or the gastrointestinal area.

Do not use in wet areas. If it is used in wet areas, significant damage to the unit may
result and patients and users may be at risk of injury.
.

In worst case condition maximum therapy time is limited to 4 minutes treatment

time and a break time of 5 min. If you will exceed this duty cycle the handpiece
can be in overtemperature.

Page 4
 enPuls Version 2.0 – a Brief Overview
5
What is A state-of-the-art innovative shockwave treatment device.
enPuls Version 2.0?

Shockwave 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 Shockwaves are created using an ergonomic handpiece and transmitted via
enPuls Version 2.0 do? special applicators. enPuls Version 2.0 has a maximum penetration depth of
about 35 mm in human tissue.

How are An electromagnetic field is generated via a coil in the back of the handpiece.
shock waves This field accelerates a projectile that strikes against the applicator head at the
generated front of the handpiece and generates shockwaves, which spread out radially
with enPuls Version 2.0? into the tissue.

What are the The innovative technology has a compact design with no need for a
advantages compressor. The clear and modern colour display shows all relevant treatment
of enPuls Version 2.0? parameters and offers touch-screen operation for ease of use during treatment.
Individual programme start configurations 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.

Intended use enPuls Version 2.0 is a treatment system for creating electromagnetic fields to
apply radial shockwaves for use in orthopaedic and physical therapy settings.

Note: The device should only be used by medical specialists

(such as physicians, therapists and health paraprofessionals).

enPuls Version 2.0 has been designed solely for the treatment of superficial
orthopaedic problems in humans and animals.

Page 5
 Installation
Connecting Cables 6
Note: Before putting into operation, remove enPuls Version 2.0 from its transport
case. Do not operate the device while it is in the case. Ensure that enPuls
Version 2.0 is placed on a stable surface.

Note: Make sure that the main switch on the device is set to '0'.

Connecting the Connect the mains cable to the designated port (17) of the device and then plug
mains cable into the mains.

Note: The device may only be plugged into earthed sockets.

Connecting Plug the handpiece into the appropriate socket (19) of the device and place it
the handpiece on the table.

Note: Ensure that an applicator head is inserted into the handpiece and that it is
properly screwed in as far as possible.

Connecting Plug the foot switch into the appropriate socket (18) of the device and then
the foot switch place it on the floor.

Switching the device on Switch on the device using the main switch (15).

Switching the device off Switch off the device using the main switch (15).
To separate the device from the mains, pull out the mains cable.

!
All cables must be protected from getting caught and other mechanical
Caution damage.

Page 6
 Settings
7
Note: Changes to the default settings can only be made from the start screen.

Start screen After starting up the device and the self-test has ended, the start screen will open.

Configure settings Touch to open the settings menu.

Settings menu The settings menu allows factory settings to be adjusted and individual settings to be
made.
Once you select the settings menu, the settings screen is active.

General settings

Setting options are shown below.

Settings shown in the screen are pre-programmed.

Language Select language

Selection is done by touching the corresponding row of the pull down menue.

Page 7
 Settings
7
Start settings Individual options for the start settings:
- Start menu
- Start picture
- Welcome message

Start menu Choice of 5 start menus:

Selection is done by touching the corresponding row of the pull down menue.

Start image Choice of 2 start images:

Selection is done by touching the corresponding row of the pull down menue.

Welcome Enter your own welcome message.

Page 8
 Settings
7
Audio and graphics
settings

Adjustment is done by using the two arrow keys

Brightness Adjusts the brightness of the backlighting.

Volume Adjusts the volume of the tones when activating controls.

Handpiece

The counter status for the currently connected handpiece is displayed.

Version

Touch to open a window with information about the current Version of the
device software.

Default settings
Touch to reset the default factory settings.

Page 9
 Settings
7
Touch calibration

Press to perform touch calibration.

This can be done to improve the accuracy of touchscreen input.

+
First accurately press the + symbol in the top left corner, then
accurately press the same symbol in the lower right corner.

Repeat the procedure to complete the touch calibration.

Alternative language The feature “Alternative language” is inactive.

Maintenance

The maintenance menu is only for use by customer service during

maintenance and repairs.

Page 10
 Operating Instructions
8.1 Description of the Device 8
Handpiece The handpiece (7) contains the shock wave generator, a fan to dissipate heat and the
slot for the various applicator heads. It is connected to the control unit (1).

Note: The shock wave generator in the handpiece is an expendable part and must be
replaced after a designated working life its functionality decreases over time.

Zimmer MedizinSysteme GmbH guarantees that each shock wave generator can be
used for at least 2 million shocks. Depending on the frequency and types of uses,
more than 2 million shocks can sometimes be delivered.

For more information on the need to replace the shock wave generator, see Section
18.

Before using the handpiece on the patient, it is essential that one of the applicator
heads is screwed tightly into the handpiece.

Temperature Generating mechanical shockwave energy creates considerable heat in the

monitoring/ handpiece. The integrated temperature switch helps maintain the useful life of the
regulation handpiece by automatically switching off the device if the temperature becomes too
handpiece high.

In addition to temperature monitoring, enPuls Version 2.0 also offers temperature

controlled with a temperature sensor in the handpiece. The fan in the handpiece is
activated when the foot switch is pressed and it stops automatically when a certain
temperature is reached.

When the temperature reaches a critical level, a cooling phase is initiated and a
Caution message is displayed. No pulse output is possible.

After confirming the message with “OK”, the therapy screen comes to the foreground,
with the message “Cooling Down” in the status line.

Once the handpiece has returned to the operating temperature, “Ready” replaces
“Cooling Down” in the status bar and therapy can be resumed.

Page 11
 Operating Instructions
8.1 Description of the Device 8
Applicator heads Three different applicator heads are available for therapy.

Changing the To change the applicator heads, hold the handpiece in one hand and unscrew the
applicator heads applicator head counter-clockwise with the other hand. Then screw in the desired
head clockwise until it stops.

Note: The applicator heads are expendable parts and must be replaced after a certain
number of uses (see Section 15.2 Maintenance).

Footswitch Place the footswitch so that it can be easily reached during therapy. The footswitch
can be used in any direction so exact placing is not necessary.

To avoid damage, ensure that only slight pressure is exerted on the switch. The
operation is done with the ball of the foot, not the heel.

The switch has no locking mechanism, i.e. it is only activated when pressure is
applied.

Page 12
 Operating Instructions
8.2 Basics of Operation 8
Therapy Hold the handpiece as shown below.

enPuls Version 2.0 operates with mechanical energy transmitted to the patient via a
handpiece.

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, the operator can work either steadily on a single
site or dynamically over an area. Using enPuls lotion (listed under accessories) is
recommended to reduce friction on the skin.

The weight of the handpiece means that it is usually not necessary to apply pressure
to the treatment area. The handpiece is placed on the treatment area and held
loosely in position with one hand. If required, additional pressure may be applied in
the direction of the tissue and the application angle can be varied.

!
When using enPuls Version 2.0 lotion or other lubricants, the applicator head must be
Caution covered with a silicone cap to protect it.

Note: Despite the high self-domping properties of the handpiece due to weight and design
vibrations may cause strain to the operator's hand.

Recommended protective measure:

- limit the duration of exposure
- passive support

Note: The patient should be carefully monitored throughout the treatment.

Page 13
 Operating Instructions
8.3 Performing Treatments 8
Note: The following descriptions are all based on the default factory settings.

Note: All buttons, menus and submenus are activated directly on the screen with a touch of
a finger or the touch pen.

Program start

Touch to open the therapy screen for programme P 02

Therapy screen

Page 14
 Operating Instructions
8.3 Performing Treatments 8
Selecting the Select the appropriate applicator head for your desired therapy and screw it correctly
applicator head into the handpiece.

Positioning the Position the handpiece on the selected treatment point/ field. Apply enPuls lotion to
handpiece and the treatment area before treatment to help prevent friction.
applicator head

!
If lubricants are used, the applicator head must be covered with the silicone protective
Caution cap.

Setting the shock Adjust the shock energy using the left controler.
energy

Note: enPuls Version 2.0 provides two methods of pulse output.

Pulse output with pre-selected number of pulses

If this option is selected, the device will terminate the therapy upon reaching the pre-
set number of pulses.
The foot switch will be disabled and no further pulse output will be possible.
Therapy can continue by restarting or adjusting the current number of pulses.

Pulse output without pre-selected number of pulses

If this option is selected, the device will not terminate the therapy automatically. As
long as the foot switch is activated, the pulses will continue. When this option is
selected, pulses are counted only in ascending order.

Start therapy Activating the foot switch starts therapy.

The display in the status bar changes from “Ready” to “Active”.

Note: Use the foot switch to activate the shock wave only after positioning the handpiece on
the treatment area.

End therapy Deactivate the foot switch to pause or terminate therapy. The display in the status bar
changes from “Active” to “Ready”.

Note: Monitor the patient carefully during treatment and adjust or stop therapy as if problems
occur.

Page 15
 Operating Instructions
8.4 Display Screens and Buttons 8
Description of display
elements and buttons 9 8

1 2 3 4 5 6 7

(1) Shock energy Displays the shock energy that has been set. The bar graph displays during active
treatment. The shock energy can be adjusted before or during treatment. The shock
energy is adjustable from 60–185 mJ in 10 mJ increments.

(2) Number of shocks Displays the pre-set number of shocks and the number of shocks currently applied
and if the number of shocks has not been pre-set, the counter total number of shocks
already applied. The counting order (here descending) is also displayed.

When selected, the input menu appears.

The number of shocks can be set increments of 100 or 1000.

(3) Reset Resets the count to 0 if the counting order is ascending; resets to the pre-set number
of shocks if the counting order is descending.

Page 16
 Operating Instructions
8.4 Display Screens and Buttons 8
(4) Counting order Touching this button sets the order in which the number of shocks should be counted
(either ascending or descending).

(5) Therapy Touching this button opens a window with therapeutic information about the selected
information program.

(6) Frequency Displays the frequency that has been set.

Frequency range: 1 Hz–22 Hz, adjustable via the right controller. The maximum
selectable frequency depends on the selected energy level.

(7) Status display Displays information about the current status of therapy. If therapy is not being
performed, the text “Ready” appears, while “Active” appears while performing therapy.

(8) Title bar Displays the name of the current program.

(9) Mode Displays the selected operating mode. When touched, the selection menu appears.

Modes: Pulse series, burst 4 pulses, burst 8 pulses, burst 12 pulses

Page 17
 Operating instructions
8.5 SD Card 8
SD card User-defined settings and indications list are stored 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 Indications button will not
be displayed.

Deactivate the message as described in Section 18.

Page 18
 Operating Instructions
8.6 Therapy Recommendations 8
The “Therapy Recommendations” menu helps select the appropriate treatment
options.

Therapy

Touch to open the “Therapy Recommendation” window.

Note: The therapy menu offers two ways to select the desired therapy:
- by selecting the body region; or
- by selecting from a list

Selecting therapy by Select a body region by touching a blue circle.

body region

Selecting the body After selecting the desired body region (here elbow),
region the therapy recommendations for the elbow open in a new window.

Select the desired program by touching the appropriate row.

Page 19
 Operating Instructions
8.6 Therapy Recommendations 8
Selecting therapy from
the list

Touch to open the list of indications.

Note: Whether you select the therapy by body region or from the list of indications, the
program steps are the same and are therefore only described once below.

Differentiating the Differentiate the severity of the symptoms touching the appropriate row (acute in this
severity of symptoms example).

Therapy information After indicating the severity of the symptoms, another window opens showing detailed
therapeutic and treatment information.

Selecting the
therapy program

Press to open the therapy screen with the corresponding program.

Page 20
 Operating Instructions
8.7 Favourites and Memory lists – Saving and
Retrieving Programs, Editing Lists 8
The parameters of the pre-defined programs can be individually modified and saved.

Saving and naming a

program

Touching opens the field for entering the program name.

Use the keyboard to enter the program name.

There are 2 options for naming programs:

1. Use the program name appearing in the input field.

2. Enter an individual program name using the keyboard.

Note: To enter an individual program name, first delete the program name displayed in the
input field.

Page 21
 Operating Instructions
8.7 Favourites and Memory lists – Saving and
Retrieving Programs, Editing Lists 8
Note: The program can be saved in the favourites or memory lists. Up to 120 programs can
be saved.

Save in favourites or
memory list
1

Select button (1) to open the favourites list and automatically store the program under
“Favourites”. Select button (2) to open the memory list and store the program there.

Select the OK button to close the “Save As” screen and save the program in the list
selected.

The program is always stored in the first free position in the corresponding list.

Select button (3) to cancel the save process.

Note: If the “Save” button is touched without entering a program name, the following
message appears:

Close the message with OK, enter the program name and repeat the save process
described above.

Page 22
 Operating Instructions
8.7 Favourites and Memory lists – Saving and
Retrieving Programs, Editing Lists 8
Individual saved programmes are listed in the favourites list.

From here they can be:

1. retrieved for treatment; or

2. edited (by changing the order in which they appear or by deleting programs).

Note: The steps to retrieve and edit the favourites and memory lists are identical, so we
have only described the retrieve and edit process for the favourites list.

Selecting the favourites

list
Select to open the favourites list

Retrieving the program Select the desired programme by pressing the appropriate row.

Editing the favourites

list
3

2
1

Select buttons (1) and (2) to view the individual favourite programs that have been
stored. Button (1) scrolls down, while button (2) scrolls up.

Button (3) opens the Edit Favourites screen.

Page 23
 Operating Instructions
8.7 Favourites and Memory lists – Saving and
Retrieving Programs, Editing Lists 8
Edit favourites
1
2
3
4

Select button (1) to return to the program.

Select button (2) to move the program up the list.
Select button (3) to move the program down the list.
Select button (4) to delete the program.

Note: When button (4) is selected, a Caution message is displayed:

“Are you sure you want to delete the program?”

Select “yes” to delete the program.

Select “no” button to cancel the delete process.

Page 24
 Technical Information
9
Basic unit
Power supply 100 – 240 V / 50/60 Hz; 220 V / 60 Hz
Fuse 2 x T3A15L, 250V
Power consumption 250VA

Protection class I
Application class BF

Frequency 1 Hz – 22 Hz, adjustable in 1 Hz-steps

3 burst modes with 4, 8 or 12 pulses

Shock energy levels 60 – 185 mJ (at applicator) freely selectable in 10 mJ steps

at 22 Hz max. 90 mJ
at 16 Hz max. 120 mJ
at 10 Hz max. 185 mJ

Operating mode Interval max. 6000 beats / 15 min. pause

Accuracy ± 20%

Dimensions 322 mm x 235 mm x 130 mm

Weight 2.7 kg

Handpiece
Dimensions 230 mm long, diameter 50 mm
Weight 850 g

Useful life 2,000,000 shocks (minimum)

Applicator heads 6 / 15 / 25 mm diameter / changeable without tools

Complete device
Dimensions 580 mm x 250 mm x 470 mm (complete with case)

Total weight 13 kg (complete with case)

Operation 10 to 25°C, 20% to 80% rel. humidity, without condensation

at 700 hPa–1060 hPa

Transport -10 °C to +50°C, 10% to 90% rel. humidity, without condensation

at 700 hPa–1060 hPa

Storage -10 °C to +50°C, 10% to 90% rel. humidity, without condensation

at 700 hPa–1060 hPa

Note: Store and transport only in original packing.

Subject to technical changes!

Page 25
 Cleaning and Disinfecting
10
– Before carrying out maintenance and cleaning, the device must always be
switched off using the main switch and unplugged.

– Make sure that the labels on the device (e.g. Cautions, control labels,
nameplate) are not damaged during cleaning and disinfecting.

– Make sure that no liquid enters the device, the footswitch or the
handpiece during cleaning or disinfection. Do not use sprays.

– If liquid enters the device or handpiece during cleaning or disinfection, please

disable the device, ensure that it is not used and contact your service
representative.

– The device and its handpiece are not considered critical in relation to hygiene
on account of their use on uninjured and healthy skin.

Housing / Footswitch Cleaning: In the event of visible contamination, the housing, the footswitch and all
cables can be cleaned using commercially available alcohol-free plastic cleaners.
Wipe the surfaces until the dirt is removed, using a cloth that has been dampened
according to the instructions given by the manufacturer of the cleaning agent, but that
is not dripping.

Disinfection: We recommend that disinfection be carried out at least once a week,

and also in the event of evidence of possible contamination. Consult with your hygiene
expert when doing so.
Always clean the device prior to disinfection.

The housing and footswitch can be disinfected using disinfectant wipes. To do so use
a commercially available alcohol-free disinfectant for metal and plastics, with
bactericidal, virucidal and fungicidal properties. Observe the manufacturer's directions
for use. Wipe all surfaces using a cloth that has been dampened according to the
instructions given by the manufacturer of the disinfectant, but that is not dripping, or
using pre-dampened cloths (so-called wipes).
If applicable, you must also observe the requirements regarding drying or re-cleaning.

Applicator head / Cleaning: Remove the silicone protection cap from the applicator head before
Handpiece cleaning. Then proceed as indicated under "Housing / Footswitch".

Disinfection: Remove the silicone protection cap from the applicator head before
cleaning. Then proceed as indicated under "Housing / Footswitch".

Caution: If flammable solutions are used for cleaning and disinfection, sufficient time
must be allowed for the solutions to evaporate before using the device in order to
avoid risk of fire!!

Note: Only use the device in a completely hygienic environment.

Caution ! When using lubricants, the silicone protection cap must be placed over the applicator
head in order to avoid contamination.
If the device is used without the cap, lubricant may enter the interior of the applicator
head and the handpiece, which can lead to permanent contamination and malfunction.
Page 26
 Cleaning and Disinfecting
10
Note: In this case, the warranty is null and void.

Page 27
CE - Mark
11
The product bears the CE-mark

according to EC Directive 93/42/EEC relating to medical devices.

Page 28
 Scope of Delivery
Accessories
12
Scope of Delivery
Article No.*
5411 1 control unit enPuls Version 2.0
5413 1 complete handpiece
1 applicator head 6 mm
1 applicator head 15 mm
1 applicator head 25 mm
10 silicone protection caps
1 enPuls lotion
1 foot switch
1 handpiece holder
1 mains cable
1 Instructions for Use
1 test template
1 transport case
2 touch pens
*see accessories

Accessories
Article No
5413 complete handpiece
93130312 handpiece holder
93133521 applicator head 6 mm
93133511 applicator head 15 mm
93133502 applicator head 25 mm
50500017 silicone protection cap
50500038 enPuls lotion
94130411 foot switch
118 mains cable
65800410 touch pen
87053010 transport case with foam insert
10101524 Instructions for use
63061010 test template

Page 29
Device Combinations
13
The device enPuls Version 2.0 is not intended by the manufacturer to be combined
with other devices.

Users operating this device in combination with other devices do so at their own risk.

Page 30
Safety and Maintenance
15.1 Safety 14
enPuls Version 2.0 is manufactured in accordance with the DIN EN 60601-1 safety
guidelines.

The manufacturer Zimmer MedizinSysteme is responsible for the device’s safety and
reliability only when

• the device is connected to an approved, grounded wall socket installed in

compliance with DIN VDE 0100 part 710 or corresponding national standards;
• the device is operated as instructed;
• expansions, reconfigurations or modifications are carried out only by persons
authorised by Zimmer MedizinSysteme to make such changes;
• the user ascertains that the device is operating correctly, is mechanically intact
and in good repair before use;
• the device is operated by properly trained personnel;
• the device is not used in areas with a risk of explosion or combustion;
• the device is immediately disconnected when penetrated by liquids

The device does not contain any parts that can be repaired by the operator.

Page 31
 Safety and Maintenance
15.2 Maintenance 14
Before any kind of cleaning and maintenance work, the device must always be turned
off at the main switch and the mains plug disconnected.

Testing the applicator During use, the rear part of the applicator head is prone to becoming deformed or
heads shortened. Minimal damage does not affect the functionality of the head.

If the damage is more significant, the applicator head must be replaced.

A test template has been supplied with the device that enables the user to test if the
wear limit has been reached.

The frequency of testing depends on the frequency of use, but should be at least
once a month.

For this purpose, the applicator is removed and checked using the enclosed test
template.

Test Template

Air gap  Applicator ok

Test Template

Template makes contact with the air gap at the tip 

Wear limit has been reached

Page 32
 Functional Test
15
When switched on, enPuls Version 2.0 runs a self-test that checks all internal
components.

An error message displays if there are any faults.

In addition, functionality can be tested by the operator as follows.

This test should be performed at least monthly or any time the proper
functionality of the device is in doubt.

Note: Before performing the function test, check whether the handpiece and the foot
switch are properly connected to the device.
Check for a proper mains connection and that mains is switched on.

Function test Switch on the device.

Briefly press down on the foot switch – the fan and shockwave generator will
start immediately; the shockwave generator must be running at the frequency
indicated on the display (5 Hz is the default value).

Note: Upon conclusion of the test, switch off the device at the main switch.

If a treatment is to be performed immediately afterwards, set the required

treatment parameters and proceed as described in Section 8.

Page 33
 Safety Inspection
Metorological Control
16
By German regulations neither safety checks (STK) nor a metorologial control (MTK)
is required for the device enPuls Version 2.0.

In Germany, among others, the “Medical Device Operator Ordinance” (MPBetreibV)

and the regulations on medical systems and equipment (BGV A3) apply in its current
version.

Note: These requirements apply to the operation of the device in Germany. Divergent
regulations may apply in your country.

Page 34
 Error Messages
Troubleshooting
Disposal
17
Handpiece fails to The status bar reads Ready, but no shock is triggered when activating the foot switch
deliver shocks

Possible cause 1
Handpiece / foot switch is not connected properly or is defective.
Fix for cause 1
Make sure that the foot switch and handpiece are connected correctly. The plug must
be fully inserted. Check the cable of the foot switch for damage or kinks. Check
whether the foot switch dome can be moved or is blocked.

Possible cause 2
Incorrect program settings.
Fix for cause 2
Check if the shock energy has been set.

Handpiece not Irregular delivery of shock waves / excessive heating of the handpiece
delivering shocks
correctly Possible cause 1
Wear to applicator head / abrasion is causing it to be move stiffly
Fix for cause 1
The applicator heads are expendables and must be replaced after a certain number of
shocks.
Remove wear debris: remove the applicator head from the handpiece and clean the
rear dome thoroughly. Then hold the handpiece without applicator with the opening
facing down and with 2 or 5 Hz frequency at the lowest energy level trigger some
shocks (maximum 10). Then reinsert the applicator head. If the error still occurs, the
applicator head must be changed.

Possible cause 2
Wear shock wave generator
Fix for cause 2
The shock wave generator is expendable and should be replaced after 2 million
shocks.
Check the total number of shocks the device has given in the settings menu.
If the total number of shocks has reached or exceeded 2 million, the shock wave
generator must be replaced. To replace the shock wave generator, please contact the
sales representative or the head office in Neu-Ulm, Germany.

Page 35
 Error Messages
Troubleshooting
Disposal
17
Applicator head not The message “Applicator head not found” appears in the status bar.
found

Possible cause
Handpiece not connected properly.
Fix for cause
Check if the handpiece is properly connected. The plug must be fully engaged.

Device malfunction No response to the main switch / display remains dark

Possible cause 1
Mains connection
Fix for cause 1
Check if the mains cable is properly plugged into the outlet and the plug is firmly
inserted into the socket of the device.
Check the mains cable for damage.
Check the mains and the outlet.

Possible cause 2
Fuse
Fix for cause 2
There are micro-fuses in the AC inlet of the device which disconnect the power supply
in the event of an electrical problem. Open the flap and check the fuses. If necessary,
replace the faulty fuse.

Replace the fuse only with exactly the same or equivalent type. First check the mains
supply completely for possible errors before replacing fuses.

If the error occurs again, be sure to inform customer service.

Page 36
 Error Messages
Troubleshooting
Disposal
17
SD card error message If the SD card is not inserted, the message “No SD card found” will appear when the
Favourites and Memory buttons are selected.

Slide the card in and confirm with “OK”

Overheating Caution When the temperature of the handpiece reaches a critical limit, a cooling phase is
initiated and this message displays; no shock output is possible.

After confirming the message with “OK”, the therapy screen appears in the foreground.
When the handpiece reaches operating temperature again, this will be displayed.

For other malfunctions, switch the machine off, wait five seconds and switch back on.
Should the error persist, please contact customer service via the head office in Neu-
Ulm.

Head office Zimmer MedizinSysteme GmbH

Junkersstraße 9
D-89231 Neu-Ulm
Tel. +49 731. 9761-0
Fax +49 731. 9761-118
www.zimmer.de

Disposal The device may only be returned to the factory in the original packaging.
It must be disposed of by Zimmer MedizinSysteme GmbH.

In foreign (European) countries, please refer to national regulations.

Contact your distributor if necessary.

Page 37
 Manufacturer’s EMC declaration
18
Medical electrical devices such as enPuls Version 2.0 are subject to special precautions with regard to
electromagnetic compatibility (EMC) and must be installed and commissioned in accordance with the EMC advice
given in the instructions for use and accompanying documents.

Portable and mobile RF communication systems (e.g. mobile phones) may interfere with medical electrical
equipment.

enPuls Version 2.0 should only be operated with the original mains cable specified in the list of contents
delivered.
Operating the device with any other mains cable can lead to increased emissions or reduced interference
immunity of the device.

Guidelines and manufacturer's declaration – electromagnetic interference

The enPuls Version 2.0 device is intended for operation in an electromagnetic environment as indicated
below. The customer or user of the enPuls Version 2.0 should ensure that it is operated in such an
environment.
Interference tests
RF emissions according to CISPR 11
RF emissions according to CISPR 11
Harmonic emissions according to IEC
61000-3-2
Voltage fluctuation emissions and
flicker according to IEC 61000-3-3
Conformity Electromagnetic environment
guideline
Group 1 The enPuls Version 2.0 device uses RF
energy solely for its internal functioning.
Its RF emission is therefore very low and
it is unlikely that this will cause
interference to neighbouring electronic
equipment.
Class A The enPuls Version 2.0 device is suitable
for use in all installations including those
Class A in a residential environment and those
which are directly connected to the public
mains network which also supplies
Conforms
buildings which are used for residential
purposes.

The device should not be used when placed immediately next to or stacked on top of other devices. If operation is
necessary when immediately next to or stacked on top of other devices, the device should be monitored to
ensure it is operating as intended in this arrangement.

Page 38
 Manufacturer’s EMC declaration
18
Guidance and manufacturer’s declaration – Electromagnetic immunity
The enPuls Version 2.0 device is intended for use in the electromagnetic environment specified below. The
customer or the user of the enPuls Version 2.0 device should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
Guidance
Electrostatic discharge ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or
(ESD) to IEC 61000-4-2 ceramic tile. If floors are covered with
± 8 kV air ± 8 kV air synthetic material, the relative
humidity should be at least 30%.
Electrical fast transient / ± 2 kV for power ± 2 kV for power Mains power quality should be that of
burst to IEC 61000-4-4 supply lines supply lines a typical commercial or hospital
environment.
± 1 kV for input / not applicable
output lines
Surge IEC 6100-4-5 ± 1 kV differential ± 1 kV differential Mains power quality should be that of
mode mode a typical commercial or hospital
environment.
± 2 kV common ± 2 kV common mode
mode
Voltage dips, short <5% UT <5% UT Mains power quality should be that of
interruptions and (>95% dip in UT for (>95% dip in UT for 0.5 a typical commercial or hospital
voltage variations on 0.5 cycle) cycle) environment. The user of the enPuls
power supply input lines Version 2.0 requires continued
IEC 61000-4-11 40% UT 40% UT operation during power mains
(60% dip in UT for 5 (60% dip in UT for 5 interruptions. It is recommended that
cycles) cycles) the enPuls Version 2.0 be powered
from an uninterruptable power supply
70% UT 70% UT or a battery.
(30% dip in UT for 25 (30% dip in UT for 25
cycles) cycles)

<5% UT <5% UT
(>95% dip in UT for 5 (>95% dip in UT for 5
seconds) seconds)
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
(50/60 Hz) magnetic should be at levels characteristic of a
field to IEC 61000-4-8 typical location in a typical
commercial or hospital environment.
Note: UT is the AC mains voltage prior to application of the test level.

Page 39
 Manufacturer’s EMC declaration
18
The main features of the enPuls Version 2.0 are as follows: interference-free delivery of shockwaves,
interference-free control of all functions. Uninterrupted operation is not required with the use intended.

Guidelines and manufacturer's declaration – electromagnetic interference immunity

The enPuls Version 2.0 device is intended for operation in the electromagnetic environment specified below. The
customer or user of the enPuls Version 2.0 should ensure that it is used in such an environment.
Interference IEC 60601-test Compliance level Electromagnetic environment -
immunity tests level guidelines
Conducted RF 3 Veffective value 3 Veffektive value Portable and mobile radio equipment
disturbance variables 150 kHz to 80 150 kHz to 80 MHz should not be used any closer to the
according to IEC MHz enPuls Version 2.0, including cables, than
61000-4-6 the recommended separation distance
calculated from the equation applicable to
Radiated RF 3 V/m 3 V/m the transmission frequency.
disturbance variables 80 MHz to 2.5 80 MHz to 2.5 GHz
according to IEC GHz Recommended separation distance:
61000-4-3
d= 1.2 √P

d= 0.35 √P for 80 MHz to 800 MHz

d= 0,7 √P for 800 MHz to 2.5 GHz

Where P is the rated power of the

transmitter in Watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in
meters (m).

According to an investigation in situa, the

field strength of stationary radio
transmitters should be less than the
compliance level at all frequencies.

Interference may occur in the vicinity of

equipment which is marked with the
following symbol:

NOTE 1 At 80 MHz and 800 MHz the higher frequency range is applicable.
NOTE 2 These guidelines may not be applicable in all cases. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

Page 40
 Manufacturer’s EMC declaration
18
a Theoretically, it is not possible to exactly predict the field strengths of fixed transmitters such as base
stations for radio telephones and land mobile radios, amateur radio stations, AM and FM radio and TV
broadcasting. To determine the electromagnetic environment in relation to the fixed transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location where the enPuls
Version 2.0 device is to be used exceeds the above compliance levels, the enPuls Version 2.0 device should be
monitored in order to ensure that it is functioning as intended. If unusual features are noticed, additional
measures may be necessary such as re-orienting or relocating the enPuls Version 2.0 device.

b Above the frequency range from 150 kHz to 80 MHz the field strength should be less than 3 V/m.
Recommended separation distances between portable and mobile RF telecommunications equipment
and the enPuls Version 2.0 device
The enPuls Version 2.0 device is intended for operation in an electromagnetic environment where RF
disturbances are monitored. The customer or user of the enPuls Version 2.0 device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
telecommunications equipment (transmitters) and the enPuls Version 2.0 device – according to the output power
of the communications device, as indicated below.

Rated output of transmitter Separation distance according to frequency of transmitter

W m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d= 1.2 √P d= 0.35 √P d= 0.7 √P
0.01 0.12 0.035 0.07
0.1 0.38 0.11 0.22
1 1.2 0.35 0.70
10 3.8 1.1 2.2
100 12 3.5 7
For transmitters rated at a maximum output which is not listed above, the recommended separation distance d in
meters (m) can be determined using the equation applicable to the respective column, whereby P is the
maximum rated output of the transmitter in Watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz the higher frequency range is applicable.
NOTE 2 These guidelines may not be applicable in all cases. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

Page 41
 GB 10 101 524 UR 0615 I Version 2.1 I Right of modifications reserved
enPuls
Version 2.0

Instructions for Use

Zimmer MedizinSysteme GmbH

Junkersstraße 9
D-89231 Neu-Ulm
Tel. 07 31. 97 61-0
Fax 07 31. 97 61-118
info@zimmer.de
www.zimmer.de