Zimmer enPuls User manual

User Manual
enPuls
Version 2.0
USA

Illustrations
Front of the device
Fig. 1
Selection and
operating elements
1 Control unit
2 Pulse energy controller
3 Display
4Frequency controller
5Slot for SD card
Handpiece
6 Handpiece
7 Vent, front
8 Vent with fan, rear
Footswitch
9 Footswitch
2
3
4
5
6
7
8
9
1

Illustrations
Rear of the device
Fig. 2
Switches /
Connector sockets
10 Power switch
11 Mains fuse
12 Socket for mains cable
13 Socket for handpiece
14 Socket for footswitch
15 Identification plate
15
10
11
12
13
14

Illustrations
Screens / Displays
Fig. 3
Displays / Therapy
screen
16 On-screen buttons
17 Status bar
18 Navigation bar
Fig. 4
Navigation bar
Description of the
functions
(A) Back
Takes you back one step
(B) Therapy
Switches to the therapy screen
(C) Programs
Switches to the program list
(D) Favorites
Switches to the favorites area
(E) Scroll forward
Moves ahead one page
(F) Scroll backwards
Moves back one page
D
C
B
A
17
18
16
F
E

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 a "Caution" with regard to
possible damage of the device.
Socket for handpiece
Socket for footswitch
User Manual
Follow user manual
Serial number
Article number
Manufacturer
Date of manufacture
Applied part type BF
Value of accessible fuses
Interval operation - Follow user manual

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
enPuls Version 2.0 – in brief 6
6
Device Set-Up 7
7
Settings 8
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 Favorites List – Retrieving Programs, Editing Lists
10
12
13
14
16
17
9
Technical Information
9.1 9.1 Info-Chart Duration of Treatment
21
22
10
Cleaning / Disinfection 23

Contents
11
Scope of Delivery and Accessories 26
12
Device Combination 27
13
Safety and Maintenance
13.1 Safety
13.2 Maintenance
28
14
Function Test
30
15
Safety Check / Metrological Control 31
16
Error Messages / Troubleshooting / Disposal 32
17
Manufacturer´s EMC Declaration 33
Valid for the device enPuls Version 2.0 (NG).
This user manual is an integral part of the device.
It must be stored with the device and kept accessible at all times for anyone authorized to
operate this device. Full observation of these instructions is a requirement for the correct
application and operation of the equipment and for consequent safety for patient and
operator.
The user manual is valid as of February 2016.
U.S.A. Federal Law restricts this device to sale by or on the order of a practitioner
licensed by the law of the State in which he/she practices to use or order the use of
the device.

Indications / Contraindications
1
Page 1
Indications
•For relief of minor muscle aches and pains and for temporary increase in
local blood circulation.
Contraindications
•vascular diseases present in or near the treatment area
•local infections in the treatment area
•around malignant or benign tumours
•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 treatments
•if blood clotting disorde
rs are present or the patient is receiving treatment that
results in a change in the 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.
•on children, particularly around 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 enPuls Version 2.0 may occasionally cause irritation,
petechial, bruising, swelling or pain.

Application Information
3
Page 3
Before using the device on a patient, the user should become acquainted with
the operating instructions and individual treatment methods as well as the
indications / contraindications, warnings and application information. Additional
sources of information about types of therapy should be consulted.
Caution
!
Before use, ensure that the device is powered via a properly earthed plug with
a grounded outlet (electrical installation according to DIN VDE 0100 Part 710).
The device must only be operated with the supplied power cord. The power
cord must be protected against mechanical stress.
Caution
!
Operation of this equipment in the vicinity of strong electromagnetic fields (e.g.
tomography, 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.
When in operation, the device must be positioned in such a way that direct
access to the device's central power supply is possible, so that it can be
disconnected from the mains at any time.
To avoid the risk of electric shock, the device must be disconnected from the
mains supply before performing any maintenance or cleaning activities.
Inspect the device prior to use. If damaged, it must not be used.
Caution
!
Only accessories provided by Zimmer MedizinSysteme GmbH are to be used.
Caution
!
The device may cause malfunctions or may interfere with the operation of
equipment in the vicinity by electromagnetic effects. It may be necessary to
take appropriate remedial action, such as realignment, re-arrangement of the
device or the electromagnetic shielding.
Caution
!
The handpiece of the device is not designed for continuous operation. After
max. 6,000 shocks, a break of 15 min. must be observed.
Caution
!
If enPuls Version 2.0 is not mounted on the designated system cart, make sure
that enPuls Version 2.0 is placed on a stable surface.
Caution
!
To avoid heat accumulation in the handpiece, it is essential to ensure that your
hand or any other object does not block the ventilation openings on the top and
especially on the bottom of the handpiece.

Warnings
4
Page 4
Caution
!
In exceptional cases, 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.
Caution
!
Users of the enPuls Version 2.0 radial pulse therapy device must be instructed
in the proper use of the system and must possess the appropriate skills.
Caution
!
The device is intended to be used exclusively by medical professionals.
Caution
!
Any treatment instructions regarding treatment location, duration and intensity
require medical knowledge and should be given by authorised physicians,
therapists and health paraprofessionals. It is imperative that these instructions
are followed.
The patient must not be left unattended during therapy.
Persons undergoing simultaneous treatment involving the reduction and / or
alteration of blood clotting or the prolongation of the blood clotting time (e.g.
acetylsalicylic acid) should consult their therapist regarding a possible
suspension of this therapy, as the use of radial pulse in such patients may
cause bleeding and bruising in varying degrees.
Radial pulse become significantly scattered in air-filled areas and generate
reflections that can have negative effects.
Therefore, do not perform treatments directly above the lungs (intercostal
space) or the gastrointestinal area.
The use in wet areas is not permitted and may in case of non-compliance lead
to considerable damage to the device and endanger both the patient and the
user.
Dispose of the packaging material properly. Make sure that it is not accessible
to children.
On patients with implants or implanted electronic device do not conduct
treatment before the risk has been assessed and found negligible.
Patients may not be connected to a high-frequency surgical device at the same
time. This can lead to burns.
This device should not be used over swollen or inflamed areas or skin
eruptions. Do not use in presence of unexplained calf pain.
Consult a physician.

Warnings
4
Page 5
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.

enPuls Version 2.0 - in brief
5
Page 6
What is enPuls
Version 2.0?
A state of the art therapeutic massager.
Radial pulse therapy
Radial Pulse Therapy is a procedure for relief of minor muscle aches and
pains and for temporary increase in local blood circulation.
What does
enPuls Version 2.0
do?
The handpiece contains a projectile that is accelerated through the
electromagnetic transfer of kinetic energy. This kinetic energy is transferred
into impact energy in the applicator head. The impact energy delivered from
the applicator head results in radial pulses developed in the target tissue.
With enPuls Version 2.0, a maximum penetration depth of about 35 mm into
human tissue can be achieved.
How does
enPuls Version 2.0
generate radial
pulses?
An electromagnetic field is generated at the rear end of the handpiece by
means of a coil.
A projectile is accelerated through the field crashing into the applicator head
at the front of the handpiece generating radial pulses that spread radially into
the tissue.
Why enPuls Version
2.0?
The innovative technology allows for a compact design without a
compressor.
The modern multi-color display, showing all therapy-relevant parameters, the
modern touch operation and the ability to simultaneously connect 2
handpieces.
Customizable program startup settings and a clear, simple menu offer
maximum convenience for the user.
Adjustable frequencies and various applicators enable the therapy to be
tailored to the respective status of the patient.
Intended use
enPuls Version 2.0 is an electromagnetic therapy system for the generation
and application of radial pulses in orthopedics and physiotherapy.
Note:
The application of the device is reserved to medical professionals (such as
physicians, therapists and health paraprofessionals).
enPuls Version 2.0 has been constructed and designed solely for the
application on superficial skin problems in humans.
The device is intended for use mechanical massage devices.

Device Set-Up
6
Page 7
Note:
If enPuls Version 2.0 is not mounted on the designated system trolley, please
make sure that it is standing on a stable surface. We recommend using the
optional swivel base.
Note:
Make sure that the power switch on the device is set to "0".
Connecting the
power cable
Connect the power cable to the designated socket (12) on the device and
connect the cable to the mains.
Note:
The device must only be connected to power outlets with an earthing contact.
Connecting the
handpiece
Connect the handpiece to one of the designated socket (13) and set it down.
Note:
Make sure that an applicator head is placed inserted to handpiece and that it
is correctly and completely screwed in.
Connecting the
footswitch
Connect the footswitch to the designated socket (14) and place it on the floor.
Switching the device
on
Switch the device on using the power switch (10).
Switching the device
off
The device is switched off using the power switch (10).
In order to completely disconnect the device (all-phase) from the mains,
remove the power cord.
Caution
!
All cables must be protected against jamming or other mechanical damage.

Settings
7
Page 8
Note:
Changes to the basic settings can only be made 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
The factory settings can be changed and adjusted individually using the
configuration menu.
Selecting
Configuration
Pressing the "Settings" button (2) opens the "Settings" screen.
The settings options are described below.
By default, the factory settings are pre-programmed as shown on the screen.
1
2
3
4
5
6
7
2
1
8
10
11
9

Settings
7
Page 9
(1) Startup settings
1. Start menu:
Individual startup settings options.
The selection is made directly in the corresponding row.
(2) Language
Selecting the language.
The selection is made directly in the corresponding row.
(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 button switches to the home screen.
(5) Version
Pressing the "Version" button opens a window with information regarding the
current software version.
(6) Load default
Pressing the "Load default" button restores the default factory settings.
(7) Colour scheme
Pressing the key switches between the two display settings. You can choose
from either a light or dark background.
(8) Brightness
The Adjustment of the brightness is made using the two arrow keys.
(9) Volume
The Adjustment of the volume is made using the two arrow keys.
(10) Counter status
of handpiece
In this display panel, the counter status of the handpiece 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 10
Handpiece
The handpiece (6) contains the radial pulse generator, a cooling fan for heat
dissipation and the socket for the various applicator heads. It is connected to
the control device (1).
Note:
The generator in the handpiece is a wear part and must be replaced after a
certain period of operation, as its ability to function decreases with time.
Zimmer MedizinSysteme GmbH guarantees unrestricted use of at least 2
million shocks per radial pulse generator.
Depending on power and frequency, the generator can produce far in excess
of 2 million radial pulses.
Further information regarding the need to replace the radial pulse generator
can be found in Chapter 16.
In order to use the handpiece on the patient, an applicator head must be
completely and securely screwed onto 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 to ongoing therapy in the case of treatments with more
than 6,000 shocks, the connection of a second hand piece is recommended.
During the cooling phase for one handpiece, you can switch to the second
hand piece and immediately continue the treatment.
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 11
Handpiece
temperature
monitoring /
regulation
The generation of mechanical shock energy causes substantial heat
generation within the handpiece. A thermal safety switch is integrated so that
the life of the handpiece is not affected. In the event of overheating, an internal
shut-off switch ensures the cooling down of the handpiece.
In addition to temperature monitoring, enPuls Version 2.0 features
temperature regulation by means of a temperature sensor in the handpiece.
The fan in the handpiece starts upon activation using the footswitch and
automatically stops when a certain temperature is reached.
When the temperature reaches a critical level, a cooling phase is initiated.
This is indicated in the display by the following message:
"Overtemperature in the applicator. Please allow the applicator to cool."
The emission of pulses is no longer possible.
After confirming the message with "OK", the treatment screen comes to the
foreground. The footswitch symbol changes to a disabled handpiece and
appears instead of the start key until the handpiece is once again ready for
operation.
Once the handpiece has reached operating temperature, the footswitch
symbol appears with the text "start", and the treatment can be resumed.
Applicator heads
There are 3 different applicator heads available for therapy.
Changing the
applicator heads
To change the different applicator heads, hold the handpiece with one hand
and unscrew the applicator head from the handpiece with the other hand,
turning in an anti-clockwise direction. Then screw in the desired head, turning
clockwise until it stops.
Note:
The applicator heads are subject to wear and must be replaced after a certain
period of operation (see Chapter 13.2 Maintenance).
Footswitch
Position the corresponding foot switch in such a way that is can be easily
reached during therapy. The control element of the switch is not direction-
dependent, meaning that the precise alignment of the footswitch is not
necessary.
To avoid damage, ensure that only light pressure is applied to the switch. The
switch should be operated with the front of the foot, not the heel.
The switch has no locking mechanism, i.e. it only remains activated for as long
as pressure is applied to the switch.

Operating Instructions
8.2 Notes on Operation
8
Page 12
Therapy
Please hold the handpiece as shown in the picture below.
enPuls Version 2.0 works using 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 the radial pulse is enabled, 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 enPuls lotion or other lubricants, the applicator head must be
covered using the silicone protection cap.
Note:
Despite the high level of self-damping provided by the weight and the design
of the handpiece, vibrations may cause strain to the hand of the user.
Recommended precautions:
- Restriction of the stress duration
- Passive support
Note:
The patient should be carefully monitored during the treatment.