Zimmer enPuls User manual

Instructions for Use
enPuls
Version 2.0
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
Handpiece
6 Handpiece with applicator head 25 mm
7 Vents, front
8 Vents with fan, rear
Foot switch
9 Foot switch
2
3
4
5
6
7
8
9
1

Illustrations
Rear of the device
Fig. 2
Switches / ports
10 Mains switch
11 Mains fuse
12 Port for power cable
13 Port for foot switch
14 Port for handpiece
15 Serial no./identification plate
15
10
11
12
14
13

Illustrations
Screens / display
Fig. 3
Display/
therapy screen
16 Buttons on the screen
17 Status line
18 Navigation menu
Fig. 4
Navigation menu
Description of the
functions
(A) Back
Moves one step back
(B) Therapy
Switches to the therapy screen
(C) Protocols
Switches to Protocols
(D) Programs
Switches to the program list
(E) Favourites
Switches to Favourites
(F) Scroll forwards
Goes forward one page
(G) Scroll backwards
Goes back one page
17
18
16
E
D
C
B
A
F
G

Illustrations
Applicator heads and accessories
Fig. 5
Applicator heads
19 Applicator head, 25 mm
20 Applicator head, 15 mm
21 Applicator head, 6 mm
Accessories
22 Silicone protection cap
19
20
21
22

Explanation of symbols
In the instructions for use this symbol indicates “Danger”.
Caution
!
In the instructions for use this symbol indicates "Caution" with regard to
possible damage of the device.
Connection port for handpiece
Connection port for foot switch
Instructions for use
Follow instructions for use.
Serial number
Item number
Manufacturer
Date of manufacture
Applied part type BF
Rating of the accessible fuses
Interval operation - Follow instructions for use

Content
Illustrations
Front of the device
Rear of the device
Screens / display
Applicator heads and accessories
Explanation of symbols
Page
1
Indications / Contraindications 1
2
Side effects 2
3
Application information 3
4
Warnings 4
5
enPuls version 2.0 – in brief 5
6
System set-up 6
7
Default settings 7
8
Operation instructions
8.1 Device description
8.2 Information on operation
8.3 Performing the treatment
8.4 Displays and buttons
8.5 SD card
8.6 Protocols
8.7 Favourites list – Retrieve programs, Edit list
9
11
12
13
15
16
18
9
Technical information 21
10
Cleaning/Disinfection 22

Content
11
CE mark / manufacturer 25
12
Scope of delivery and accessories 26
13
Device combinations 27
14
Safety and maintenance
14.1 Safety
14.2 Maintenance
28
29
15
Functional test 30
16
Legal notice 31
17
Error messages / troubleshooting / disposal 32
18
Manufacturer's EMC declaration
Error!
Bookm
k t
Valid for the device enPuls version 2.0 (NG).
These instructions for use 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.
Last updated: April 2019

Indications / Contraindications
1
Page 1
Indications
•Radial and ulnar epicondylitis
•Calcifying tendonitis / shoulder problems
•Condition post blunt muscle injuries
•Chronic patellar tendon syndrome
•Patellar tendonitis
•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. in 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
•Use in the region of malignant/benign tumours
•Application directly to cartilage surfaces or in the area of the small
facet joints in the spine
•Application directly via implanted electronic devices, e.g. pacemakers, pain
pumps, etc.
•In areas where mechanical energy in the form of vibrations leads to damage
of the tissue, e.g. metal implants
•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 etc.)
•Generalised pain syndrome, e.g. fibromyalgia
•In children, especially in the area of the epiphyseal plates
Caution is indicated in the case of persons
•who have sensitivity disorders
•who have significant vegetative disorders
•who are under the influence of drugs and/or alcohol
since significant circulatory stress and inadequate treatment reactions cannot
be ruled out.

Side effects
2
Page 2
Side Effects Treatments with enPuls version 2.0 may occasionally cause irritation,
petechiae, haematoma, swelling, or pain.

Application information
3
Page 3
Prior to using the device on a patient, the user should become familiar with the
instructions for use and individual treatment methods to be used as well as the
indications / contraindications, warnings and application information. Additional
sources of information about the treatment should also be followed.
Caution
!
Before use, ensure that the device is powered via a properly grounded mains
socket (electrical installation according to DIN VDE 0100 Part 710). The device
must only be operated with the supplied power cable. The power cable must be
protected against mechanical stress.
Caution
!
Operation of this device in the vicinity of strong electromagnetic fields (e.g.
tomographs, X-ray or diathermy equipment) may interfere with the operation of
the device. Please keep a safe distance of several meters.
enPuls version 2.0 is not suitable for use in areas with an explosive, flammable
or combustive environment.
During use, the device is to be located in a position allowing direct access to
the device´s central mains supply so that it can be disconnected from the mains
at any time.
To avoid the risk of electric shock, the plug must be disconnected from the
power supply before performing any cleaning or maintenance activities.
Inspect the device before use. If there is any damage, it must not be used.
Caution
!
Only accessories provided by Zimmer MedizinSysteme GmbH must be used.
Caution
!
The device handpiece is not designed for continuous operation. After a max.
6,000 strokes, a treatment pause of 15 min is required.
Caution
!
Remove the enPuls version 2.0 from the transport bag prior to starting up the
system. Operation in the case is not intended.
Ensure that enPuls version 2.0 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
holding it or otherwise).

Warnings
4
Page 4
In exceptional circumstances the treatment time is limited to 4 minutes followed
by a break of at least 15 minutes.
The handpiece can overheat if the treatment time is exceeded.
Treatment instructions regarding treatment location, duration and intensity
require medical knowledge and may only be given by authorised physicians,
therapists and medical paraprofessionals. These instructions must be followed.
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 their therapist about a possible discontinuation of this treatment as the
use of radial shock waves can readily lead to increased bleeding and bruising
in these patients.
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 and may in case of non-compliance lead to
considerable damage and endanger both the patient and the user.

enPuls version 2.0 – in brief
5
Page 5
What is enPuls
version 2.0?
An ultra-modern, innovative shock wave treatment device.
Shock wave treatment
Radial, ballistic shock wave treatment is a versatile method. From superficial
orthopaedic problems to myofascial trigger point treatment.
What does
enPuls version 2.0
do?
It generates shock waves by means of an ergonomic handpiece and emits
shock waves through special applicators.
The enPuls version 2.0 can penetrate human tissue for up to approximately
35 mm.
How are shock waves
generated with
enPuls version 2.0?
A coil generates an electromagnetic field in the rear 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 enPuls
version 2.0?
The innovative technology allows for a compact design without a
compressor.
The modern, clear colour display showing all therapy-related parameters and
the modern touch operation ensure enjoyment and motivation during
treatment.
Individual program start adjustment and clear, simple menus offer the user
maximum convenience.
Different, continuously adjustable frequencies and a choice of applicators
allow a treatment that is individually suited to the particular condition of the
patient.
The small design enables space-saving work in an office and is ideally suited
for use during house calls.
Intended use
enPuls version 2.0 is a treatment system for the electromagnetic generation
and application of radial shock waves in orthopaedics and physiotherapy.
Note:
The application of the device is reserved for medical professionals (such as
physicians, therapists and health paraprofessionals).
enPuls version 2.0 is designed and intended solely for the treatment of
superficial orthopaedic problems in humans.

Device set-up
6
Page 6
Note:
Remove the enPuls version 2.0 from the transport bag prior to starting up the
system. Operation in the case is not intended.
Ensure that enPuls version 2.0 is placed on a stable surface.
Note:
Make sure that the power switch of the device is set to “0”.
Connect power cable
Connect the power cable to the provided port (12) on the device and connect
the cable to the mains.
Note:
The device may only be connected to power outlets with a protective contact.
Connect handpiece
Connect the handpiece to the provided port (14) and set it down.
Note:
Ensure that an applicator head is inserted in the handpiece and that it is
screwed in correctly and completely.
Connect foot switch
Connect the foot switch to the port provided (13) and put it on the floor.
Switch device on
Switch on the device using the toggle switch (10).
Switch device off
The device is switched off using the toggle switch (10).
To fully (all poles) disconnect the device from the mains, the power cable must
be disconnected.
Caution
!
All cables must be protected from pinching or other mechanical damage.

Default settings
7
Page 7
Note:
Changes to the default settings can only be made from the start-up screen.
Start-up screen
After the device has been switched on and the self-test performed, the start-up
screen opens.
Note:
Activating the "therapy" button (1) switches immediately to the therapy screen.
Configuration menu
Factory settings can be changed and individually adjusted in the configuration
menu.
Select configuration
Activating the “Configuration” button (2) opens the “Configuration” screen.
The setting options are described below.
The default settings are pre-programmed in the factory as shown on the
screen.
1
2
3
8
4
5
6
7
2
1
10
11
9

Default settings
7
Page 8
(1) Start settings Options to individually select the start-up settings.
The selection is made directly in the corresponding line.
(2) Language
Language selection.
The selection is made directly in the corresponding line.
(3) Welcome
Activating the “Welcome text” field opens a window with an alphabetical
keyboard to enter an individual welcome text in the start-up screen.
Activating the “OK” button saves the text entered.
Activating the “X” button leads back to the configuration menu.
(4) OK
Activating the button switches to the start screen.
(5) Version
Activating the “Version” button opens a window with information on the current
software version.
(6) Load default
Activating the “Load Default” button restores the factory default settings.
(7) Colour scheme
Activating the button switches between two screen settings. A bright or dark
screen background can be selected.
(8) Brightness
The brightness can be adjusted using the two arrow buttons.
(9) Sound
The volume can be adjusted using the two arrow buttons.
(10) Handpiece
counter status
In this display panel, the meter reading of the handpiece is shown.
(11) Service
Pressing button (12) in the service menu deactivates the service message
which appears whenever the device is switched on after 1.8 million and 2
million shocks.
Deactivation leads to a one-off service message after 1.8 million and 2 million
shocks.
The service message can only be deactivated by customer service.
12

Operation instructions
8.1 Device description
8
Page 9
Handpiece
The handpiece (6) contains the shock wave generator, a fan for heat
dissipation, and the ports for the different applicator heads. It is connected to
the control unit (1).
Note:
The shock wave generator in the handpiece is subject to wear and must be
replaced after a certain length of use because its functionality decreases with
time.
Zimmer MedizinSysteme GmbH guarantees unrestricted use at a rate of at
least two million shocks per shock wave generator. In some cases, depending
on power and frequency, well over
2 million shocks can be emitted.
More information on the need to replace the shock wave 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. Frictional heat causes
the temperature of the applicator head to rise with increasing duration of
treatment, so much so that thermal damage to the patient cannot be excluded.
Please comply with the warning in chapter 4. Treatment must be interrupted
once the time stated has been reached and can only be continued after the
applicator head has cooled down to room temperature.
Note:
Please note that the temperature monitoring of the handpiece described on
page 10 below is only a technical shutdown to protect the mechanical parts
inside the handpiece. It does not give any information about the temperature
of the applicator head.

Operation instructions
8.1 Device description
8
Page 10
Handpiece
temperature
monitoring /
regulation
The production of mechanical impact energy generates considerable heat
within the handpiece. A temperature switch has been integrated to prevent
damage to the life of the handpiece. In the case of overheating, this forces
cooling of the handpiece through an internal shutdown.
In addition to temperature monitoring, the enPuls version 2.0 regulates the
temperature using a temperature sensor in the handpiece. The fan in the
handpiece is started when activated by the foot switch and automatically stops
when it reaches a certain temperature.
If the temperature reaches a critical limit, a cooling phase is initiated. This is
indicated by the following message in the display:
“Overheating of the applicator. Please allow the applicator to cool down.”
Pulses can no longer be emitted.
After confirming the message with "OK", the therapy screen comes to the
foreground. The foot switch symbol changes to a deactivated handpiece, and
instead of the start button the display shows the time remaining until the
handpiece is ready for use again.
As soon as the handpiece has returned to operating temperature, the foot
switch symbol appears with the text “Start”, and treatment can continue.
Applicator heads
Three different applicator heads are available for treatment.
Changing the
applicator heads
To change the applicator heads, hold the handpiece with one hand and turn
the applicator head anti-clockwise with the other hand to remove it from the
handpiece. Then insert the head you wish to use by turning it clockwise until it
clicks into place.
Note:
The applicator heads are subject to wear and must be replaced after a certain
length of use (see chapter 14.2 Maintenance).
Foot switch
Place the foot switch so that it can be easily reached during treatment. The
operating element of the switch is independent of direction, and so precise
alignment of the foot switch is unnecessary.
To avoid damage, ensure that only slight pressure is exerted on the switch.
Use the forefoot rather than the heel to operate the switch.
The switch has no locking mechanism, and so operates only while pressure is
applied to the switch.

Operation instructions
8.2 Information on operation
8
Page 11
Therapy
Please hold the handpiece as shown in the picture below.
The enPuls version 2.0 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 shock wave application is activated, you can work either with the
handpiece stationary on one point, or dynamically across an area.
We recommend using the enPuls lotion supplied to reduce friction on the skin.
The weight of the handpiece means that it is usually not 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
!
Note:
The silicone protection cap must be pulled over the applicator head when
using lubricants in order to avoid soiling.
If the protective cap is not used, the lubricant can penetrate the applicator
head and the handpiece, which can lead to lasting soiling and malfunction.
This invalidates the warranty.
Note:
Despite high internal attenuation through the weight and construction of the
handpiece, the user's hand can suffer stress through vibrations.
Recommended protective measures:
- Limit exposure time
- Passive support
Note:
The patient should be carefully monitored during treatment.