Zimmer enPulsPro User manual

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 ofthe
functions
(A) Back
Takes you back one step
(B) Therapy
Switchesto the therapyscreen
(C) History
(D) Protocols
Switchesto the VAS evaluation
Switches to protocols
(E) Programs
Switchesto the programlist
(F) Favorites
Switchesto 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 EditingLists
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 tendinopathyof 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 muscularback
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 directlyto cartilage surfacesor in the area of the
•small facet joints of the spine
•Application directly via implanted electronicdevices,e.g. pacemakersor pain
pumps
•In areaswhere mechanicalenergy in the formof vibrations leads to damage
of the tissue, e.g. metal supply
•After fracture,in the case oftorn muscle fibres ormuscle tears
In general, treatments are not recommended
•For bleeding disorders or treatments that result in a change in blood
coagulation
•During pregnancy
•In diseases involvinga disorder of the vasomotor systemin the treatment
area
•Via air-filled spaces (e.g. treatment of thethoracic spine)
•Generalized pain syndromes, e.g. fibromyalgia
•In children, especially in the area of the epiphysealplates
Care is required for patients
•with impaired sensibility
•with severe autonomic disorders
•under the influence of drugs and/or alcohol
as circulatory stresses and inadequatetreatment responses cannot be
excluded.

Side Effects
2
Page 2
Side Effects
Treatments with the enPulsPro may occasionally cause irritation, petechiae,
haematoma, swelling, orpain.

Application Information
3
Page 3
Before using the device onpatients,users should familiarise themselves with
the operating instructionsand individual treatment methodsto 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 operatedvia a properly grounded socket
(electrical installation inaccordance with DINVDE 0100 Part 710). The device
may only be operated with the supplied power cable. The power cable mustbe
protected against mechanical stress.
Caution
!
The operation of devices with strong electromagneticfields (e.g. tomography,
X-ray, or diathermy equipment)may interfere with the operation ofthe device.
Please maintain a safe distance of several metres.
The enPulsPro is not suitable foruse in explosive, flammable, or combustive
environments.
During use, the device mustbe located in a position thatallowsdirect access to
the mainspower supply so that this canbe disconnected at anytime.
To prevent the risk of electric shock, the plug must be disconnectedfrom the
power supply before performing any maintenance orcleaning activities.
Inspect the device before use. Ifthere is anydamage,do notuse thedevice.
Caution
!
Only use accessories fromZimmer MedizinSysteme GmbH.
Caution
!
The handpiece ofthe device isnot designed for continuousoperation. After a
max. 6,000 strokes, a treatment pause of15 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 heataccumulationin 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 maximumtreatmenttime is limited to 4 min followed
by a breakof at least 15 min.
If the treatmenttime isexceeded,the handpiece may overheat.
Users of the enPulsPro shockwave treatment device must be instructed in the
properuse of the systemand have the appropriate knowledge.
Treatmentinstructionspertaining to the location,duration and intensity of
treatment require medical knowledge and may only be given by licensed
physicians, therapists and members of the medicalauxiliary professions.
These instructions must befollowed without fail.
The patient must notbe left unattended during treatment.
Personsundergoing simultaneous treatment with reduction and/oralteration of
blood clotting or a prolongation ofclotting 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 notbe performed above the lungs
(intercostal space) and gastrointestinal area.
Use in wetareas isnot permitted; thismay result in considerable damage and
endanger both the patient and the user.
Under certain circumstances, thetreatmenttime islimited to 4 min and a5
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 meansof an ergonomic handpiece and emits
shock waves through special applicators.
With the enPulsPro, a maximumpenetration depth of approx.35 mm can be
achieved in human tissue.
How are shock waves
generated with
enPulsProdo?
Using a coil, anelectromagnetic field is generated in the backend of the
handpiece.
A projectile isaccelerated through the field. This crashesagainst the
applicator headat the frontof the handpiece and generates shock waves that
spread radially in thetissues.
What are the
advantages of
enPulsPro?
The innovative technologyallowsfor a compact design withouta
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 startsettingsas well asclear and simple menu
navigation provide the user with the maximal comfort.
Different, continuously adjustable frequenciesallow 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
overviewof the time courseand outcome of the treatment.
Intended Use
enPulsPro isa treatment system forthe electromagnetic generation and
application of radial shockwaves in orthopaedics and physiotherapy.
Note:
The device mayonly be used byhealthcare professionals (e.g. physicians,
therapists, and trained medical assistants).
enPulsPro is designed and intended solely for the treatmentof superficial
orthopaedic problems in humans.

Device Set-Up
6
Page 6
Note:
If the enPulsPronot mounted onthe intended wagon,
ensure that the enPulsPro is placed on a stablesurface.
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 mayonly be connected to earthed sockets.
Connect handpiece
Connect the handpieceto one of the socketsprovided
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 onthe device with the powerswitch (6).
Switching the device
off
The device is switched off using the powerswitch (6).
In orderto completely disconnect the device (all-phase) from the mains,
remove the mainscable.
Caution
!
All cables must be protected against jamming or other mechanical damage.

Settings
7
Page 7
Note:
Changes to the default settings areonly possible from the start-up screen.
Start-up screen
Once the device hasbeen switched on and the self-testperformed, the home
start – up screen opens.
Note:
Pressing the "Therapy" button (1) immediately switches to the therapy screen.
Configuration menu
In the configurationmenu, the factory default settings can be individually
changed and adjusted.
Selecting
Configuration
Pressing the “Settings” button (2) opens the “Settings” screen.
The setting optionsare described below.
By default, the factory settings are pre-programmed asshown 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 ismade directly on the corresponding line.
(2) Language
Selection of the language.
The selection ismade directly on the corresponding line.
(3) Welcome
Pressing the "Welcome"field opensa window with an alphabetic keyboard to
enter a welcome message forthe start-up screen.
Pressing the “OK” key saves the text that has been entered.
Pressing the “X”key returnsyou to the configuration menu.
(4) OK
Pressing the key switches to the start-up screen.
(5) Version
Pressing the “Version” keyopens a window with information about the current
software version.
(6) Load default
Pressing the “Load default”key restores thedefaultfactory settings.
(7) Colour scheme
Pressing the key switches between the twodisplay settings. Abright ordark
screen can be selected.
(8) Brightness
The brightnessis adjusted via the two arrow keys.
(9) Volume
The volumeis adjusted via the two arrow keys.
(10) Handpiece
counter status
In thisdisplay panel, the meter reading of any connected handpiece(s) is
shown.
(11) Maintenance
After pressing the (1)key inthe maintenance menu, the maintenance
message, which appears after 1.8 and 2 million collisions, can be turned off.
Deactivation resultsin a one-time maintenance message after 1.8and 2
million shocks.
The maintenance message can only bedeactivatedby customerservice.
The following pointsare notrelevant forthe user. They are used only by
customer service.
1

Operating Instructions
8.1 Device Description
8
Page 9
Handpiece
The handpiece (7) containsthe shock wave generator, a fan forheat
dissipation, and the socketsfor the different applicatorheads.It is connected
to the control device (1).
Note:
The shockwavegeneratorin the handpiece is a wear part and mustbe
replacedafter a certain service life because its functionality decreases with
time.
Zimmer MedicalSysteme GmbH guarantees the unrestricted use of at least
two million shocks pershockwave generator.
Depending on power and frequency, the generator canproduce 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 headsmust
be screwed firmly andcompletely intothe handpiece.
Interval operation
The handpiece is not suitable for continuous operation.As a result of the
frictional heat,the temperature ofthe applicator increases with increasing
duration of treatmentto the extent that thermal damageto 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 mustbe interrupted; it can
be resumed onlyafter the applicatorhas cooledto room temperature.
Note:
Please note thatthe temperature control of the handpiece (described on
page 11)is onlya technicalshutdown to protectthe mechanicalparts 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 anotherduring ongoing therapy, the
pulse frequency and the number of shocks remain unchanged. The pulse
energy returnsto 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 preventa
reduction in the life of thehandpiece. In the caseof overheating, this forces
the cooling of the handpiece through an internal shutdown.
In addition totemperaturemonitoring,the enPulsProregulates the
temperature using a sensor in the handpiece. The fan in the handpiece is
started when activated by the footswitch andautomaticallystops when it
reachesa certain temperature.
When the temperature reaches a critical limit, a coolingphase is initiated. This
is indicated in the displayby the following message:
"Overheating of the applicator. Please allow the applicator to cool down. "
An output pulse is no longerpossible.
After confirming the message with "OK",the treatment screen comesto the
foreground. Inthe selectionwindow ofthe handpiece, the handpiece is shown
a deactivated. The time required forthe applicatorto cooldown is displayed.
Applicator heads
Three different applicator heads are available for the treatment.
Changing the
applicator heads
To change the applicatorhead, 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 applicatorheads are wearparts and mustbe replaced aftera 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 thefootswitch is therefore unnecessary.
To avoiddamage, ensure that only slightpressure isexerted on the switch.
The operation is done with the forefoot and notthe heel.
The switch does not have any lock i.e.the activation remains only as long as
pressure is applied tothe 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 tothe patientvia
a handpiece.
In orderto achieve this,the handpiece with the applicator head is placed
perpendicular to the treatment area orthe point of treatment.
While applying shockwaves,it is possible towork eitherwith the handpiece
stationary on one point, or dynamically, across a whole area.
In orderto reduce friction on the skin, theuse of the enPuls lotion provided is
recommended.
Due to the weight of the handpiece, it isusuallynot normally necessary to
press down firmly on the treatment area / point.
The handpiece is applied and held in position with thehand in a relaxed
posture.
If required,pressure can also be applied inthe directionof the tissue andthe
angle of use can be varied.
Caution
!
When using theenPuls Lotion orother lubricant, theapplicator mustbe
covered with the protectivesilicone cap.
Note:
Despite high internal attenuation through the weight and construction of the
handpiece, the hand ofthe user can bestrained 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 thetherapy 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 theselected treatment point/area. To prevent friction
on the skin, the enPulse Lotion can be applied to the treatmentarea before
treatment.
Caution
!
When using lubricants,theapplicatormust be coveredwith the protective
silicone cap.
Set pulse energy
Set the pulse energy using the left controller.
Note:
The enPulsPro offerstwo methods of pulse emission.
Pulse emission with pre-set number of pulses
For pulse emission with pre-set number ofpulses, the treatment is terminated
by the device after the pre-set numberof pulses has been emitted.
The footswitch is deactivated and the emission ofpulsesis no longerpossible.
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 treatmentis 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 activatedvia the footswitch only after placing the
handpiece on the patient.
End of treatment
By de-activating the footswitch, the treatmentis interrupted or terminated.
Note:
During the treatment, the patientmust bemonitored carefully. Ifany issues
arise, the treatmentshouldbe adjusted or terminated.