Instructions for Use
enPulsPro
EN
Illustrations
Front of the device
Fig. 1
Selection and
operating elements
1 Control unit
2 Pulse energy controller
3 Display
4 Frequency controller
5 Slot for SD card
6 Power switch
Handpiece
7 Handpiece
8 Vent, front
9 Vent with fan, rear
10 Holder for hand piece
Footswitch
11 Footswitch
Optional
accessories
12 Rotatable swivel foot
2
5
7
8
4
3
10
11
1
9
12
6
Illustrations
Rear of the device
Fig. 2
Switches/sockets
13 Socket for mains cable
14 Mains fuse
15 Socket for handpiece channel I
16 Socket for handpiece channel II
17 Socket for footswitch
18 Identification plate
16
15
17
13
18
14
Illustrations
Screens / Displays
Fig. 3
Display/
treatment screen
19 On-screen buttons
20 Status bar
21 Navigation bar
22 VAS- Pre scale
23 VAS- Post scale
Fig. 4
Navigation bar
Description of the
functions
(A) Back
Takes you back one step
(B) Therapy
Switches to the therapy screen
(C) History
(D) Protocols
Switches to the VAS evaluation
Switches to protocols
(E) Programs
Switches to the program list
(F) Favorites
Switches to the favorites area
20
21
19
F
E
D
C
B
A
22
23
Illustrations
Applicator heads and accessories
Fig. 5
Applicator heads
24 Applicator head, 25 mm
25 Applicator head, 15 mm
26 Applicator head, 6 mm
Accessories
27 Silicone protection cap
24
25
26
27
Explanation of Symbols
In the instructions for use, this symbol indicates danger.
Caution
!
In the instructions for use, this symbol indicates a "Caution" with regard to
possible damage of the device.
Socket for handpiece
Socket for footswitch
Instructions for use
Follow instructions for use
Serial number
Article number
Manufacturer
Date of manufacture
Applied part type BF
Value of accessible fuses
Interval operation - Follow instructions for use
Contents
Illustrations
Front of the device
Rear of the device
Screens / Displays
Applicator heads and accessories
Explanation of Symbols
Page
1
Indications / Contraindications 1
2
Side Effects 2
3
Application Information 3
4
Warnings 4
5
enPulsPro – in brief 5
6
Device Set-Up 6
7
Settings 7
8
Operating Instructions
8.1 Device Description
8.2 Notes on Operation
8.3 Performing the Treatment
8.4 Display and Buttons
8.5 SD Card
8.6 Protocols
8.7 Favourites List – Retrieving Programs and Editing Lists
8.8 VAS – Visual Analogue Scale
9
11
12
13
15
16
18
21
9
Technical Information
9.1 Info-Chart Duration of Treatment 25
27
10
Cleaning / Disinfection 28
Contents
11
CE mark 31
12
Scope of Delivery and Accessories 32
13
Device Combinations 33
14
Safety and Maintenance
14.1 Safety
14.2 Maintenance
34
35
15
Functional test 36
16
Safety Check / Metrological Control 37
17
Error Messages / Troubleshooting/ Disposal 38
18
Manufacturer’s EMC Declaration 41
Valid for the device enPulsPro (NG).
These instructions for use is an integral part of the device. They must be stored
with the device and be accessible at all times to anyone authorised to operate
the device.
The instructions for use is valid as of February 2016.
Indications / Contraindications
1
Page 1
Indications
• Radial and ulnar epicondylitis
• Calcifying tendonitis/shoulder problems
• Condition post blunt muscle injuries
• Chronic patellar tendon syndrome
• Patellar tendinitis
• Chronic tendinopathy of the Achilles tendon
• Plantar fasciitis
• Heel spurs
• Myofascial trigger point treatment, e.g. in the neck
• Myofascial trigger point treatment, e.g. the back in the case of muscular back
pain
• Trochanteric bursitis
• Periostitis/Tartan syndrome (condition post overloading)
Contraindications
• vascular diseases in or in the vicinity of the treatment area
• open wounds in or in the vicinity of the treatment area
• local infections in the treatment area
• Application in the area of malignant/benign tumours
• Application directly to cartilage surfaces or in the area of the
• small facet joints of the spine
• Application directly via implanted electronic devices, e.g. pacemakers or pain
pumps
• In areas where mechanical energy in the form of vibrations leads to damage
of the tissue, e.g. metal supply
• After fracture, in the case of torn muscle fibres or muscle tears
In general, treatments are not recommended
• For bleeding disorders or treatments that result in a change in blood
coagulation
• During pregnancy
• In diseases involving a disorder of the vasomotor system in the treatment
area
• Via air-filled spaces (e.g. treatment of the thoracic spine)
• Generalized pain syndromes, e.g. fibromyalgia
• In children, especially in the area of the epiphyseal plates
Care is required for patients
• with impaired sensibility
• with severe autonomic disorders
• under the influence of drugs and/or alcohol
as circulatory stresses and inadequate treatment responses cannot be
excluded.
Side Effects
2
Page 2
Side Effects
Treatments with the enPulsPro may occasionally cause irritation, petechiae,
haematoma, swelling, or pain.
Application Information
3
Page 3
Before using the device on patients, users should familiarise themselves with
the operating instructions and individual treatment methods to be used as well
as the indications/contraindications and warnings/instructions for use.
Additional sources of information about the treatment should also be observed.
Caution
!
Before use, ensure that the device is operated via a properly grounded socket
(electrical installation in accordance with DIN VDE 0100 Part 710). The device
may only be operated with the supplied power cable. The power cable must be
protected against mechanical stress.
Caution
!
The operation of devices with strong electromagnetic fields (e.g. tomography,
X-ray, or diathermy equipment) may interfere with the operation of the device.
Please maintain a safe distance of several metres.
The enPulsPro is not suitable for use in explosive, flammable, or combustive
environments.
During use, the device must be located in a position that allows direct access to
the mains power supply so that this can be disconnected at any time.
To prevent the risk of electric shock, the plug must be disconnected from the
power supply before performing any maintenance or cleaning activities.
Inspect the device before use. If there is any damage, do not use the device.
Caution
!
Only use accessories from Zimmer MedizinSysteme GmbH.
Caution
!
The handpiece of the device is not designed for continuous operation. After a
max. 6,000 strokes, a treatment pause of 15 min is required.
Caution
!
If the enPulsPro is not mounted on a designated wagon, ensure that the
enPulsPro is placed on a stable surface.
Caution
!
To avoid heat accumulation in the handpiece, ensure that the vents on the top
and especially the bottom of the handpiece are not blocked (i.e. by the hand or
otherwise).
Warnings
4
Page 4
In the extreme case, the maximum treatment time is limited to 4 min followed
by a break of at least 15 min.
If the treatment time is exceeded, the handpiece may overheat.
Users of the enPulsPro shockwave treatment device must be instructed in the
proper use of the system and have the appropriate knowledge.
Treatment instructions pertaining to the location, duration and intensity of
treatment require medical knowledge and may only be given by licensed
physicians, therapists and members of the medical auxiliary professions .
These instructions must be followed without fail.
The patient must not be left unattended during treatment.
Persons undergoing simultaneous treatment with reduction and/or alteration of
blood clotting or a prolongation of clotting time (e.g. acetylsalicylic acid) should
consult a health care professional about a possible discontinuation of this
treatment as the use of radial shock waves can readily lead to increased
bleeding and bruising.
Shock waves are strongly scattered in air-filled areas and produce reflections
that can have negative effects.
Direct treatments should therefore not be performed above the lungs
(intercostal space) and gastrointestinal area.
Use in wet areas is not permitted; this may result in considerable damage and
endanger both the patient and the user.
Under certain circumstances, the treatment time is limited to 4 min and a 5
minute break. If this cycle is exceeded, the handpiece can overheat.
enPulsPro – in brief
5
Page 5
What is enPulsPro?
An ultra-modern, innovative shockwave treatment device.
Shockwave treatment
Radial, ballistic shock wave treatment is a versatile method. From superficial
orthopaedic problems to myofascial trigger point treatment.
What does
enPulsProdo?
It generates shock waves by means of an ergonomic handpiece and emits
shock waves through special applicators.
With the enPulsPro, a maximum penetration depth of approx. 35 mm can be
achieved in human tissue.
How are shock waves
generated with
enPulsProdo?
Using a coil, an electromagnetic field is generated in the back end of the
handpiece.
A projectile is accelerated through the field. This crashes against the
applicator head at the front of the handpiece and generates shock waves that
spread radially in the tissues.
What are the
advantages of
enPulsPro?
The innovative technology allows for a compact design without a
compressor.
The clearly understandable colour display shows all parameters relative to
the treatment. The modern touch-screen controls and the simultaneous
connectivity of two handpieces facilitate treatment.
Individual programme start settings as well as clear and simple menu
navigation provide the user with the maximal comfort.
Different, continuously adjustable frequencies allow a treatment that is
individually suited to the particular condition of the patient.
Are there any other
advantages to using
enPulsPro?
An integrated VAS gives an
overview of the time course and outcome of the treatment.
Intended Use
enPulsPro is a treatment system for the electromagnetic generation and
application of radial shockwaves in orthopaedics and physiotherapy.
Note:
The device may only be used by healthcare professionals (e.g. physicians,
therapists, and trained medical assistants).
enPulsPro is designed and intended solely for the treatment of superficial
orthopaedic problems in humans.
Device Set-Up
6
Page 6
Note:
If the enPulsPro not mounted on the intended wagon,
ensure that the enPulsPro is placed on a stable surface.
Note:
Make sure that the power switch on the device is set to "0" .
Connect mains cable
Connect the mains cable to the corresponding socket (13) on the device and
connect the cable to the power.
Note:
The device may only be connected to earthed sockets.
Connect handpiece
Connect the handpiece to one of the sockets provided
Channel I (15) or Channel II (16) and set it down.
Note:
Make sure that an applicator head is used in the handpiece and that this is
correctly and completely screwed on.
Connect the
footswitch
Connect the footswitch to the designated socket (17), and place it on the floor.
Switching the device
on
Switch on the device with the power switch (6).
Switching the device
off
The device is switched off using the power switch (6).
In order to completely disconnect the device (all-phase) from the mains,
remove the mains cable.
Caution
!
All cables must be protected against jamming or other mechanical damage.
Settings
7
Page 7
Note:
Changes to the default settings are only possible from the start-up screen.
Start-up screen
Once the device has been switched on and the self-test performed, the home
start – up screen opens.
Note:
Pressing the "Therapy" button (1) immediately switches to the therapy screen.
Configuration menu
In the configuration menu, the factory default settings can be individually
changed and adjusted.
Selecting
Configuration
Pressing the “Settings” button (2) opens the “Settings” screen.
The setting options are described below.
By default, the factory settings are pre-programmed as shown on the screen.
1
2
4
5
6
7
2
8
1
10
11
3
9
Settings
7
Page 8
(1) Start settings
1. Start menu:
Individual options for the start settings.
The selection is made directly on the corresponding line.
(2) Language
Selection of the language.
The selection is made directly on the corresponding line.
(3) Welcome
Pressing the "Welcome" field opens a window with an alphabetic keyboard to
enter a welcome message for the start-up screen.
Pressing the “OK” key saves the text that has been entered.
Pressing the “X” key returns you to the configuration menu.
(4) OK
Pressing the key switches to the start-up screen.
(5) Version
Pressing the “Version” key opens a window with information about the current
software version.
(6) Load default
Pressing the “Load default” key restores the default factory settings.
(7) Colour scheme
Pressing the key switches between the two display settings. A bright or dark
screen can be selected.
(8) Brightness
The brightness is adjusted via the two arrow keys.
(9) Volume
The volume is adjusted via the two arrow keys.
(10) Handpiece
counter status
In this display panel, the meter reading of any connected handpiece(s) is
shown.
(11) Maintenance
After pressing the (1) key in the maintenance menu, the maintenance
message, which appears after 1.8 and 2 million collisions, can be turned off.
Deactivation results in a one-time maintenance message after 1.8 and 2
million shocks.
The maintenance message can only be deactivated by customer service.
The following points are not relevant for the user. They are used only by
customer service.
1
Operating Instructions
8.1 Device Description
8
Page 9
Handpiece
The handpiece (7) contains the shock wave generator, a fan for heat
dissipation, and the sockets for the different applicator heads. It is connected
to the control device (1).
Note:
The shockwave generator in the handpiece is a wear part and must be
replaced after a certain service life because its functionality decreases with
time.
Zimmer MedicalSysteme GmbH guarantees the unrestricted use of at least
two million shocks per shockwave generator.
Depending on power and frequency, the generator can produce far in excess
of 2 million radial pulses.
More information on the need to replace the shockwave generator is given in
Chapter 17.
To work with the handpiece on the patient, one of the applicator heads must
be screwed firmly and completely into the handpiece.
Interval operation
The handpiece is not suitable for continuous operation. As a result of the
frictional heat, the temperature of the applicator increases with increasing
duration of treatment to the extent that thermal damage to the patient cannot
be excluded.
Please refer to the chart in Chapter 9.1 for the maximum values for treatment.
After reaching the specified values, the treatment must be interrupted; it can
be resumed only after the applicator has cooled to room temperature.
Note:
Please note that the temperature control of the handpiece (described on
page 11) is only a technical shutdown to protect the mechanical parts inside
the handpiece. It does not provide information about the temperature of the
applicator head.
Recommendation:
To avoid interruption in treatments with more than 6000 shocks, the
connection of a second handpiece is recommended.
During the cooling phases, the unit can be switched to the second handpiece,
and treatment can be continued without delay.
Note:
When switching from one handpiece to another during ongoing therapy, the
pulse frequency and the number of shocks remain unchanged. The pulse
energy returns to 0 and must be reset.
Operating Instructions
8.1 Device Description
8
Page 10
Handpiece
temperature
monitoring /
regulation
The generation of mechanical impact energy generates considerable heat
within the handpiece. A temperature switch has been integrated to prevent a
reduction in the life of the handpiece. In the case of overheating, this forces
the cooling of the handpiece through an internal shutdown.
In addition to temperature monitoring, the enPulsPro regulates the
temperature using a sensor in the handpiece. The fan in the handpiece is
started when activated by the footswitch and automatically stops when it
reaches a certain temperature.
When the temperature reaches a critical limit, a cooling phase is initiated. This
is indicated in the display by the following message:
"Overheating of the applicator. Please allow the applicator to cool down. "
An output pulse is no longer possible.
After confirming the message with "OK", the treatment screen comes to the
foreground. In the selection window of the handpiece, the handpiece is shown
a deactivated. The time required for the applicator to cool down is displayed.
Applicator heads
Three different applicator heads are available for the treatment.
Changing the
applicator heads
To change the applicator head, hold the handpiece with one hand and turn the
applicator head anti-clockwise with the other hand. Turn the desired head
clockwise until it stops.
Note:
The applicator heads are wear parts and must be replaced after a certain
operating life (see Chapter 14.2 Maintenance).
Footswitch
Place the footswitch in such a way that it can be easily reached during the
treatment. The operating element of the switch is independent of direction; a
precise alignment of the footswitch is therefore unnecessary.
To avoid damage, ensure that only slight pressure is exerted on the switch.
The operation is done with the forefoot and not the heel.
The switch does not have any lock i.e. the activation remains only as long as
pressure is applied to the switch.
Operating Instructions
8.2 Notes on Operation
8
Page 11
Treatment
Please hold the handpiece as shown in the picture below.
The enPulsPro uses mechanical energy, which is transferred to the patient via
a handpiece.
In order to achieve this, the handpiece with the applicator head is placed
perpendicular to the treatment area or the point of treatment.
While applying shockwaves, it is possible to work either with the handpiece
stationary on one point, or dynamically, across a whole area.
In order to reduce friction on the skin, the use of the enPuls lotion provided is
recommended.
Due to the weight of the handpiece, it is usually not normally necessary to
press down firmly on the treatment area / point.
The handpiece is applied and held in position with the hand in a relaxed
posture.
If required, pressure can also be applied in the direction of the tissue and the
angle of use can be varied.
Caution
!
When using the enPuls Lotion or other lubricant, the applicator must be
covered with the protective silicone cap.
Note:
Despite high internal attenuation through the weight and construction of the
handpiece, the hand of the user can be strained through vibrations.
Recommended precautions:
- Limitation of the exposure time
- Passive support
Note:
During treatment, the patient should be carefully monitored.
Operating Instructions
8.3 Performing the Treatment
8
Page 12
Note:
All buttons, menus, and sub-menus can be activated directly on the screen by
finger pressure.
Program start-up
Pressing the "Therapy" button on the start screen opens the therapy screen.
Select applicator
Select an applicator to suit your desired treatment and screw it correctly into
the handpiece.
Attach
handpiece/applicator
Place the handpiece on the selected treatment point/area. To prevent friction
on the skin, the enPulse Lotion can be applied to the treatment area before
treatment.
Caution
!
When using lubricants, the applicator must be covered with the protective
silicone cap.
Set pulse energy
Set the pulse energy using the left controller.
Note:
The enPulsPro offers two methods of pulse emission.
Pulse emission with pre-set number of pulses
For pulse emission with pre-set number of pulses, the treatment is terminated
by the device after the pre-set number of pulses has been emitted.
The footswitch is deactivated and the emission of pulses is no longer possible.
Treatment can be continued by resetting the current pulse rate or by adjusting
the pre-set.
Pulse emission without pre-setting the number of pulses
With pulse output without pre-setting the number of pulses, the treatment is not
terminated by the device. Pulses are emitted as long as the footswitch is
activated.
For pulse emission without pre-set, only the ascending counting direction is
active.
Start of treatment
The treatment starts once the footswitch has been activated.
Note:
The shockwave should be activated via the footswitch only after placing the
handpiece on the patient.
End of treatment
By de-activating the footswitch, the treatment is interrupted or terminated.
Note:
During the treatment, the patient must be monitored carefully. If any issues
arise, the treatment should be adjusted or terminated.
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