Zimmer enPuls User manual

Instructions for Use
enPuls
GB

Diagrams
Front View / Handpiece / Footswitch
Front View
1 Control unit
2 Display
3 Shockwave meter / counting direction
4 Control for presetting number of shocks
5 Control for resetting number of shocks
6 Frequency display
7 Control for adjusting frequency
8 Energy level display
9 Control for adjusting energy levels
Handpiece
10 Handpiece with 25 mm applicator head
11 Air vents, front
12 Air vents with fan, rear
Footswitch
18 Footswitch
1
1
6
7
4
2
3
5
9
8
12
10
11
18

Illustrations
Rear View of Device / Accessories
Rear View
19 Main switch
20 Mains fuse
21 Port for mains cable
22 Port for footswitch
23 Port for handpiece
24 Standard rating plate
Accessories
16 Silicone cap standard
13 25 mm applicator head
14 15 mm applicator head
15 6 mm applicator head
16
14
15
13
24
23
22
21
20
19

Contents
Illustrations
Front View / Handpiece / Footswitch
Rear View / Accessories
Page
1.
enPuls - Summary
1
2.
Explanation of Symbols
2
3.
Quick start guide for the system
3
4.
Start-up / Function Test
4
5.
Description of Functions
6
6.
General Operating Instructions
8
7.
Errors / Troubleshooting
12
8.
Maintenance / Cleaning / Disinfection / Disposal
14
9.
Warnings
15
10.
Indications / Contraindications
16
11.
Technical Data
17
12.
Contents on delivery / Accessories
18
13.
Manufacturer's Declaration of Electromagnetic Compatibility
19
14.
Declaration of Conformity / Legal Information
23
These instructions are an integral part of the device. Strict adherence to these instructions is
a prerequisite for the prescribed use and correct handling of the device as well as to ensure
the safety of the patient and the user.
They must be stored with the device in order to be accessible at all times to anyone
appointed to operate this device.
These instructions contain general information on safety, operation, maintenance and care
for owners and users of the enPuls shockwave therapy device.
These instructions are valid at the date of printing. Requirements in terms of product and
therapy technique are subject to constant change; therefore we reserve the right to make any
technical and structural changes.
In order to ensure reliable and successful operation, please observe all the advice and
information in these instructions.
If you are operating the device, you must follow all the up-to-date instructions and
precautions for electrically operated radial (ballistic) shockwave therapy equipment.

1
enPuls
Summary
1.
What is enPuls?
A state of the art, innovative shockwave therapy device.
Shockwave therapy
Radial ballistic shockwave therapy is a versatile procedure for treating
conditions ranging from superficial orthopedic problems to myofascial trigger
points.
What does the
enPuls do?
The enPuls generates shockwaves by means of an ergonomic handpiece and
delivers shockwaves via special applicators.
It allows a maximum penetration depth of approximately 35 mm to be reached
in human tissue.
How are shockwaves
generated with
enPuls?
An electromagnetic field is generated via a coil at 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
advantages of
enPuls?
A large display showing all the parameters relevant to the treatment as well as
clear, simple menu navigation ensure optimal user comfort.
Different frequencies and applicators allow individual treatment adapted to the
particular condition of the patient.
Its lightweight and compact structure allows it to be used in the tightest of
spaces.
Note:
The device should only be used by medical specialists (e.g. physicians,
therapists and health paraprofessionals).
enPuls has been constructed and designed solely for the treatment of
superficial orthopedic problems in humans and animals.

2
Explanation of Symbols
2.
Danger / Warning
In the User Manual, this symbol stands for Danger / Warning.
Caution
!
In the User Manual, this symbol stands for 'Caution' with regard to possible
material damage.
Handpiece port
Footswitch port
Follow instructions for use.
Device type B: Protection level against electric shock
Value of accessible fuses

3
Quick start guide for the system
3.
Note:
Make sure that the main switch on the device is set to'0'.
Fitting the mains
cable
Connect the mains cable to the designated port on the device and then plug
into the mains.
Fitting the handpiece
Connect the handpiece to the designated port on the device.
Fitting the footswitch
Connect the footswitch to the designated port on the device.
Switching on the
device
Switch on the device using the rocker switch (I).
Setting treatment
parameters
Set the required frequency, energy level and meter mode according to
therapeutic criteria.
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 to the treatment area if
necessary.
Note:
When using enPuls Lotion, the applicator head must be covered with a silicone
cap to protect it.
Start of treatment
Treatment is started by activating the footswitch.
Note
Only activate the shockwave via the footswitch once the handpiece has been
positioned on the patient.
End of treatment
Treatment is interrupted or ended by releasing the footswitch.
Note:
During treatment, the patient must be observed closely and the treatment must
be adjusted if necessary or discontinued should any problems develop.

4
Start-up
Function Test
4.
Start-up
Note
To start up the device, remove it from its transport case and place it on a
suitable stable surface. This device is not designed for use in the case.
Make sure that the main switch on the device is set to '0'.
Note
Before connecting the mains cable, make sure there is a suitable power outlet
according to regulations, with the correct mains voltage. Once any mains plug
or adapter required by the country in question has been professionally fitted,
connect the mains cable to the device and the socket.
Fitting the mains
cable
Connect the mains cable to the designated port (21) on the device and then
plug into the mains.
Fitting the handpiece
Connect the handpiece to the designated port (23) on the device.
Put down the handpiece.
Fitting the footswitch
Connect the footswitch to the designated port (22) on the device.
Place the footswitch on the floor.
Note
The footswitch and handpiece connectors are both marked with arrows. These
arrows must be pointing exactly upwards during insertion. If the arrow is
aligned correctly, the connector can easily be pushed into the port. If
necessary, turn the connector until it can be inserted easily. Never force the
connector into the port if it is in any other position.

5
Start-up
Function Test
4.
Note:
Make sure that an applicator head is inserted into the handpiece and that this
is properly screwed in as far as it will go.
Switching on the
device
Switch on enPuls using the rocker switch (I).
System test
After power-up, enPuls runs a system test and if this is completed successfully
it is then ready for use.
Function test
Performance
Depress the footswitch briefly – the fan and shockwave generator will start
immediately, whereby the shockwave generator has to operate at the
frequency indicated on the display (5 Hz as default value).
Note:
On 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 3.

6
Description of Functions
5.
Shockwave meter
In the basic setting and after a reset (5), the central meter (3) on the display
counts the shocks delivered up to a maximum of 9999 and then starts again
from zero. Counting is summative, that is, the meter counts upwards as long
as the shockwave is activated by the footswitch (18) and stops if you remove
your foot from the switch. If you activate it again, the meter continues counting
from the current meter reading.
Button (5) allows you to zero the meter reading, if required.
Button (4) can be used to reverse the counting direction and preset the
system, in each case in increments of 100. Every time the button is pressed,
the presetting increases by 100 shocks. On activation using the footswitch
(18), the meter now counts down until the meter is at zero. The system then
stops and has to be reactivated.
Frequency setting
Button (7) is used to set the shockwave frequency. This function is only
available if the shockwave is not activated. It is possible to select a burst
program of 9 pulses as well as additional 4 programs with frequencies of 2 Hz,
5 Hz, 10 Hz and 16 Hz. Every time the button is pressed, the system
advances a stage further. Continuously variable adjustment is not possible.
The possible frequency setting depends on the selected energy level. The
frequency 16 Hz is only possible at the first three energy levels. At the highest
energy level, the maximum frequency setting that is possible is 10 Hz.

7
Description of Functions
5.
Energy level
Button (9) allows the energy level (that is, the impact hardness of the
shockwave generator in the handpiece) to be set at 4 fixed levels. The
function is only available when the shockwave is not activated. The amount of
energy which is delivered and transferred to the applicator head at every
impact is as follows:
Level 1: 60 mJ
Level 2 : 90 mJ
Level 3 : 120 mJ
Level 4 : 185 mJ
Note:
The set level always defines the impact of the shock through the shockwave
generator that is in turn transmitted to the applicator heads.
As the size of the contact surface varies between patients, the amount of
energy distributed is correspondingly more or less. This has an impact on the
effect of the treatment and therefore must be taken into consideration.

8
General Operating Instructions
6.
For the user
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 vertical.
When the shockwave is activated it is possible to work both stationarily 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 work angle can be varied.
Note:
!
When using enPuls Lotion, 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 measures:
- Limit the duration of exposure
- Passive support

9
General Operating Instructions
6.
Handpiece
The handpiece (10) 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) by means of an extensible helix cable.
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 progressively
decreases.
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
Section 7.
To work with the handpiece on a patient, it is essential that one of the
applicator heads is screwed tightly into the handpiece as far as it will go.
The helix 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
air vents at the top and particularly on the base of the handpiece are not
blocked by the hand holding it or anything else.
Standby mode on
device and
handpiece
The fan in the handpiece is actuated by depressing the footswitch and stops
automatically 3 minutes after pressure on the footswitch is removed.
The control unit automatically switches to standby mode 10 minutes after the
last actuation, whereby the display is also deactivated. It can be reactivated by
pressing any one of the four buttons at the top of the device.

10
General Operating Instructions
6.
Applicator heads
There are 3 different applicator heads available for treatment.
Changing the
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 into 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.
Wear of the
applicator head
Minor/slight deformation or shortening of the rear impact dome
does not affect functionality.
In cases of greater deformation of the rear impact dome or
shortening 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 okay
Test Template
Template touching, no air gap, limit of wear reached

11
General Operating Instructions
6.
Footswitch
Place the footswitch so that it can be reached easily during treatment. The
footswitch control unit is non-directional so it is not necessary to align the
footswitch exactly.
To avoid damage please note that only slight pressure is needed or
should/must be exerted on the switch using the front part of your foot, not the
heel.
The switch does not have a detent which means that it only remains actuated
as long as pressure is applied to it.

12
Errors
Troubleshooting
7.
Failure or
malfunction of the
handpiece
Check to ensure that the handpiece plug is properly connected to the device.
It must be fully engaged.
Check the helix cable of the handpiece for any mechanical damage.
Irregular delivery of
shockwaves /
overheating of
handpiece
Possible cause 1: Wear of shockwave generator
The shockwave generator is an expendable part and should be replaced after
2 million shocks.
Check the total number of shocks of the device.
To check the total number of shocks, first press button 5 and keep it depressed
while pressing button 7. At the top of the shock meter (3), the display indicates
the total number of shocks delivered by the device.
Remedying
Cause 1
If the total number of 2 million shocks has been reached or exceeded, the
shockwave generator must be replaced.
To replace the shockwave generator, contact a qualified customer engineer or
the head office in Neu-Ulm, Germany.
Possible cause 2: Wear of the applicator head / stiffness due to abrasion
Applicator heads are expendable parts and must be replaced after a specific
number of shocks.
Remedying
Cause 2
Removal of parts subject to abrasion.
Remove the applicator head from the handpiece and clean the rear dome
thoroughly. Then hold the handpiece, without the applicator head, with the
opening downwards and, at 2 or 5 Hz frequency, release a few shocks
(maximum 10) at the lowest energy level. Then reinsert the applicator head.
If the error still occurs, the applicator head has to be changed.
gebraucht

13
Errors
Troubleshooting
7.
No response at
main switch
Display remains dark
Important:
!
Make sure that the mains plug is properly inserted in the power outlet and the
device connector is firmly plugged into the device port.
Check mains cable for any damage.
Check the power supply system and the power outlet.
Above the mains input socket of the device, there are fine-wire fuses which
isolate the mains voltage in the event of any electrical problem. Open the flap
and check the fuses. Replace any defective fuse if necessary.
Only replace a fuse with one of exactly the same name or one that is
equivalent. Before doing this, check the entire power supply for any possible
faults.
If the error occurs again, it is essential to inform the Customer Service
department.
Handpiece stops
operating, device
functioning
normally
The shockwave generator in the handpiece is fitted with a thermal switch which
automatically interrupts operation if there is a risk of overheating.
This can occur, for example, with applications of over 8,000 shocks at high
frequency and maximum energy level.
The integrated fan cools the handpiece down to regular temperature and then
normal operation can be resumed.
Display is working,
no reaction to
footswitch
Make sure that the footswitch is properly connected to the device – the
connector must engage fully in the port.
Check the footswitch cable for any damage or kinks.
Check whether the footswitch dome can be moved or whether it is blocked.
Appliance starts with
an error message in
the display
The device can usually be operated normally after pressing any button at the
top of the device.
This is most frequently caused by disconnecting accessories and the mains
cable while the device is still operating. This can happen especially in standby
mode, as the deactivated display is often interpreted as a sign of the device
being switched off.

14
Maintenance
Cleaning / Disinfection
Disposal
8.
Maintenance
Before starting any maintenance or cleaning, the device must always be
switched off at the main switch and the plug pulled out.
A separate service is not necessary with this product. You should, however,
check the enPuls (device / handpiece / footswitch and all cables) at regular
intervals (at least once every six months) to ensure that it is in mechanically
sound condition.
You should also check the applicator domes for any wear, as described in
Section 6.
Note
!
When using enPuls Lotion, it is essential to pull a silicone cap over the
applicator head.
If you do not use any protective cap, lotion can get inside the applicator head
and handpiece which can lead to permanent soiling and malfunctioning.
Cleaning /
disinfection
Clean the device and handpiece with just a damp cloth. We particularly
recommend using a commercially available microfiber cloth for this.
More stubborn soiling is easily removed by adding a mild cleaning agent.
Please note:
Only use washing lotions or alcohol-free or solvent-free cleaning
agents/disinfectants.
Do not use solvent, chloride, polish, synthetic cleaning agent, wax polish or
aerosol spray.
Note
It is essential to ensure that no moisture gets into the system when cleaning.
Disposal
Never dispose of the device or packaging in household waste. Zimmer
Medizinsysteme GmbH undertakes to dispose of any parts that cannot be
repaired.

15
Warnings
9.
Users of the enPuls shockwave therapy 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
authorized physicians, therapists and health paraprofessionals. It is
imperative that these instructions are followed.
Treatment must always be carried out under medical supervision.
Important:
Patients who are concurrently receiving treatment involving a reduction
and/or modification of blood clotting or prolongation of the blood clotting
time (e.g. with acetylsalicylic acid) should consult their therapist about
possibly stopping this treatment as these patients may be more prone to
greater hemorrhaging and bruising when radial shockwaves are applied.
Shockwaves are strongly scattered in air pockets and create reflections
that may have negative effects. You must therefore never perform any
direct treatments over the lungs (intercostal spaces) or the gastrointestinal
area.
Use in wet areas is inadmissible and, if ignored, can cause serious harm
and endanger both the patient as well as the user.
The equipment should only be operated with the mains cable provided. Protect
the mains cable from any mechanical stress.

16
Indications
Contraindications
10.
Indications
enPuls is designed to treat superficial orthopedic and neurological problems
such as the following:
Tendinitis
Bursitis
Insertion tendopathy
Calcaneal spurs
Myofascial trigger points, etc.
Contraindications
-vascular diseases present in or near the treatment area
-local infections in the treatment area
-around malignant or benign tumors
-directly on cartilage surfaces or near the small facet joints of the spinal
column
-directly over implanted electronic devices such as pacemakers, analgesic
pumps, etc.
-in areas in which mechanical energy in the form of vibrations may lead to
tissue damage such as metal implants after a fracture
In general, we advise against treatment
-in patients with blood clotting disorders or the patient is receiving treatment
that results in a change in the blood clotting behavior
-during pregnancy
-in 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.
-on children, particularly around the epiphyseal plate
Care is required for patients
-that present with impaired sensibility
-that present with severe autonomous disorders
-that are under the influence of drugs and/or alcohol
as circulatory stresses and inadequate treatment responses cannot be
excluded.