Zimmer enPulsPro User manual

Instructions for Use
enPulsPro
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 6 Power switch
6Mains on/off switch
Handpiece
7 Handpiece
8 Vents, front
9 Air vents with fan, rear 10 Holder for hand piece
10 Handpiece holder
Footswitch
11 Footswitch
Optional
accessories
12 Rotateable swivel base
2
5
7
8
4
3
10
11
1
9
12
6

Illustrations
Rear of the device
Fig. 2
Switches /
Connector 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 Serial number/name plate
16
15
17
13
18
14

Illustrations
Screens / Displays
Fig. 3
Displays / Therapy
screen
19 Status bar
20 On-screen buttons
21 Title bar
22 Navigation bar
23 VAS- Pre scale
24 VAS- Post scale
Fig. 4
Navigation bar
Description of the
functions
(A) Home
Returns to the home page
(B) Back
Takes you back one step
(C) History
(D) Memory
Switches to the VAS evaluation
Switches to the memory area
(E) Therapy
Switches to the indication menu
(B) Programs
Switches to the program list
(G) Favorites
Switches to the favorites area
(H) Scroll forwards
Moves forwards one page
(I) Scroll backwards
Moves back one page
21
22
20
19
F
E
D
C
B
A
I
H
G
23
24

Illustrations
Applicator heads and accessories
Fig. 5
Applicator heads
23 Applicator head, 25 mm
24 Applicator head, 15 mm
25 Applicator head, 6 mm
Accessories
26 Silicone protection cap
23
24
25
26

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.
Connector socket for handpiece
Connector socket for footswitch
Operation instruction
Follow instructions for use
Serial number
Article number
Manufacturer
Date of manufacture
Applied part type: BF
Value of accessible fuses
Interval operation - observe 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
enPulsPro –in brief
5
6
System 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 Favorites and memory lists –calling up programs, editing lists
8.7 VAS scale
9
11
12
13
14
16
19
9
Technical Information
9.1 Info-chart duration of treatment
22
23
10
Cleaning / Disinfection
24

Contents
11
Scope of Delivery and Accessories
26
12
Device Combination
27
13
Safety and Maintenance
15.1 Safety
15.2 Maintenance
28
14
Function Test
30
32
15
Safety Check / Metrological Control
31
16
Error Messages / Troubleshooting / Disposal
32
17
Manufacturer´s EMC Declaration
35
Valid for the enPulsPro device.
This instructions for use 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 instructions for use is valid from July 2014.
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 disorders 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 enPulsPro 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.
enPulsPro 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 enPulsPro is not mounted on the designated system cart, make sure that
enPulsPro 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!
Users of the enPulsPro 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.

enPulsPro - in brief
5
Page 5
What is enPulsPro?
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
enPulsPro 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 enPulsPro, a maximum penetration depth of about 35 mm into human
tissue can be achieved.
How does the
enPulsProgenerate
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 enPulsPro?
The innovative technology allows for a compact design without a
compressor.
The modern and clear color display, showing all therapy-relevant
parameters, the modern touch operation and the ability to simultaneously
connect 2 handpieces.
Customisable 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.
What else does
enPulsPro offer?
An integrated VAS scale provides an orienting overview of the chronological
progression and success of the therapy.
Intended use
enPulsPro is an electromagnetic therapy system for the generation and
application of radial pulses in orthopedics and physiotherapy.
Note:
Note: The application of the device is reserved to medical professionals
(such as physicians, therapists and health paraprofessionals).
enPuls Pro has been constructed and designed solely for the application on
superficial skin problems in humans.
The device is intended for use mechanical massage devices.

System Set Up
Installation of Cables
6
Page 6
Note:
If enPulsPro is not mounted on the designated system trolley, please make
sure that it is standing on a stable surface. We recommend using the optional
swiveling 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 (13) on the device and
connect the cable to the mains.
Note:
The device must only be connected to power outlets with a proctective
contact.
Connecting the
handpiece
Connect the handpiece to one of the designated sockets Channel I (15) or
Channel II (16) 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 (17) and place it on the floor.
Switching the device
on
Switch the device on using 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 power cord.
Caution!
All cables must be protected against jamming or other mechanical damage.

Settings
7
Page 7
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 "instant start" button (2) immediately switches to the
therapy screen
Configuration menu
The factory settings can be changed and adjusted individually using the
configuration menu.
Selecting Pressing the "Configuration" button (1) opens the "Configuration" screen.
Configuration
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
9

Settings
7
Page 8
(1) Startup settings
1. Start menu:
Individual startup settings options.
2. Startup image:
Choice between two startup images.
The selection is made directly in the corresponding row.
3. Greeting:
Activating the "Welcome" field opens a window with an alphabetic keyboard
for entering a custom welcome message on the home screen.
Pressing the "OK" button saves the entered text.
Pressing the "Cancel" key returns you to the configuration menu.
(2) Language
Selecting the language.
The selection is made directly in the corresponding row.
(3) Setting the time
Activating the "Date" field opens the time settings input menu.
The current time and date are displayed here.
The time and date can be changed using the two arrow keys.
Pressing the "OK" button saves the changed setting.
Pressing the "Cancel" button returns you to the configuration menu.
(4) OK
Pressing the "OK" button switches to the home screen.
(5) Version
Pressing the "Version" button opens a window with information regarding the
current software version.
(6) Default settings
Pressing the "Standard" button restores the default factory settings.
(7) Touch-
Calibration
Pressing the "Touch calibration" button opens the screen for performing a
touch calibration. In the case of insufficient accuracy during touch input this
can result in an improvement.
To perform touch calibration, follow the on-screen instructions.
(8) Audio / Video
settings
1. Brightness:
Adjustment of the brightness of the screen backlight.
2. Volume:
Adjustment of the loudness of the signal tones when activating the operating
fields.
The adjustment is made using the two arrow keys.
(9) Handpiece
In this display field, the counter status of the connected handpiece/s is shown.
Maintenance
The "Maintenance" menu is not relevant to the user. The points listed here are
used only in the event of a service being performed by customer service.

Operating Instructions
8.1 Device Description
8
Page 9
Handpiece
The handpiece (7) 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 18
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. The heat resulting
from friction increases the temperature of the applicator head with increasing
duration of treatment, to such a degree that thermal damage to the patient
cannot be ruled out.
Please refer to the maximum values for the treatments in the figure in Chapter
9.1. After reaching the specified values, the treatment must be interrupted and
can only be resumed once the applicator head has cooled down to room
temperature.
Note:
Please note that the temperature monitoring of the handpiece described on
page 11 only demonstrates a technical shutdown to protect the mechanical
parts inside the handpiece. It provides no information regarding 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 10
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, enPulsPro 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 therapy screen moves to the
foreground with the message "Overtemperature" in the status bar as well as
information regarding when the handpiece will return to operating temperature.
Once the handpiece has reached operating temperature, the message
"Overtemperature" in the status bar is replaced by the message "Ready" and
therapy 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 14.2 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 11
Therapy
Please hold the handpiece as shown in the picture below.
enPulsPro 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 therapy.

Operating Instructions
8.3 Performing Treatment
8
Page 12
Note:
All of the buttons, menus and sub-menus can be activated directly on-screen
with a touch of your finger.
Program startup
Pressing the "Instant start" button on the home screen open the programs
screen.
Selecting an
applicator
Choose the applicator to suit your desired therapy and screw it correctly into
the handpiece.
Applying the
handpiece /
applicator
Place the handpiece on the selected treatment point / area. In order to avoid
friction on the skin, enPuls lotion can be applied to the treatment area prior to
treatment when necessary.
Caution!
When using lubricants, the applicator head must be covered using the silicone
protection cap.
Setting the pulse
energy
Set the pulse energy using the left controller.
Note:
enPulsPro offers two options for the pulse output.
Pulse output with a preset number of pulses
In the case of pulse output with a preset number of pulses, the device itself
stops therapy after reaching the preset number of pulses.
The footswitch is disabled and no further pulse output is possible.
It is possible to resume therapy by resetting the current pulse count or by
adjusting the present value.
Pulse output without a preset number of pulses
In the case of pulse output without a preset number of pulses, the device itself
does not stop the therapy. Pulses are emitted as long as the footswitch is
activated.
In the case of pulse output without a preset value, only the ascending pulse
count is active.
Therapy startup
Therapy is started by activating the footswitch.
The display in the status bar changes from "Ready" to "Active".
Note:
The radial pulse should only be activated via the footswitch once the
handpiece has been placed on the patient.
End of therapy
De-activating the footswitch interrupts and ends the therapy. The display in the
lower status bar changes from "Active" to "Ready".
Note:
During therapy, the patient must be carefully monitored and, should problems
arise, therapy must be adjusted or stopped as necessary.