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 Mains switch
Handpiece
7 Handpiece
8 Vents, front
9 Vents with fan, rear
10 Holder for handpiece
Foot switch
11 Foot switch
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 / ports
13 Port for power cable
14 Mains fuse
15 Port for handpiece channel I
16 Port for handpiece channel II
17 Port for foot switch
18 Serial no./identification plate
16
15
17
13
18
14

Illustrations
Screens / display
Fig. 3
Display/
therapy screen
19 Status line
20 Buttons on the screen
21 Heading
22 Navigation menu
Fig. 4
Navigation menu
Description of the
functions
(A) Home
Switches back to start page
(B) Back
Moves one step back
(C) Evaluation
(D) Memory
Switchesto the VAS evaluation
Switchesto the memory area
(E) Therapy
Switchesto the therapyrecommendation
(F) Programs
Switchesto the programlist
(G) Favourites
Switches to Favourites
(H) Scroll forwards
Goes forward one page
(I) Scroll backwards
Goes back one page
21
22
20
19
F
E
D
C
B
A
I
H
G

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 instructionsfor use this symbol indicates “Danger”.
Caution
!
In the instructionsfor 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
Schematic 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
enPulsPro – in brief 5
6
Device set-up 6
7
Default settings 7
8
Operation instructions
8.1 Device description
8.2 Informationon operation
8.3 Performing the treatment
8.4 Displays and buttons
8.5 SD card
8.6 Therapy recommendations
8.7 Favourites and memory lists – Retrieve programs, edit list
8.8 VAS – Visual analogue scale
10
12
13
14
16
17
17
19
9
Technical information
25
10
Cleaning/Disinfection 27

Content
11
CE mark / manufacturer 31
12
Scope of delivery and accessories 32
13
Device combination 33
14
Safety and maintenance
14.1 Safety
14.2 Maintenance
34
35
15
Functional test 36
16
Legal notice 37
17
Error messages / troubleshooting / disposal 38
18
Manufacturer's EMC declaration 41
Valid for the device enPulsPro.
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: November 2017

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 tendinopathyof 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 postoverloading)
Contraindications
•Vasculardiseasesin or inthe vicinity of the treatment area
•Open wounds inor in the vicinity of the treatmentarea
•Local infections in the treatment area
•Use in the region of malignant/benign tumours
•Application directlyto cartilage surfacesor in the area of the small
facet joints in the spine
•Application directly via implanted electronic devices, e.g. pacemakers, pain
pumps, etc.
•In areaswhere mechanical energy in the form of vibrations leads to damage
of the tissue, e.g. metal implants
•After fracture, in the case of torn musclefibresor 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 involvinga disorder of the vasomotor system in thetreatment
area
•Via air-filled spaces (e.g. treatment of the thoracic spineetc.)
•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 sensitivitydisorders
•who have significantvegetative 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 enPulsPro may occasionally cause irritation,petechiae,
haematoma, swelling, orpain.

Application information
3
Page 3
Priorto 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 alsobe followed.
Caution
!
Before use, ensure that the device is powered via aproperly grounded mains
socket (electrical installation according to DIN VDE 0100 Part 710). The device
must onlybe operated with the supplied power cable. The powercable must be
protected against mechanical stress.
Caution
!
Operation of this device in the vicinity of strong electromagneticfields (e.g.
tomographs, X-rayor diathermy equipment) may interfere with the operation of
the device. Please keep a safe distance ofseveral meters.
enPulsPro is not suitablefor use in areaswith an explosive, flammable or
combustive environment.
During use, the device is to be located in a positionallowing direct access to
the device´s central mains supply so that it can be disconnected from the mains
at any time.
To avoidthe risk of electricshock, the plug must be disconnected fromthe
power supply before performing any cleaning or maintenance activities.
Inspect the device before use. If there is anydamage,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 of15 min is required.
Caution
!
If the enPulsPro is not mounted on the intended system wagon,
ensurethat the device is placed on astable surface.
Caution
!
To avoidheat accumulation in the handpiece,ensure thatthe vents on the top
and especially the bottom of the handpiece are not blocked (i.e. bythe hand
holding it or otherwise).

Warnings
4
Page 4
Treatment instructions regarding treatment location, duration and intensity
require medical knowledgeand may only be given by authorised physicians,
therapists and medical paraprofessionals. These instructions mustbe followed.
The patient must notbe leftunattended during treatment.
Personsundergoing simultaneous treatment with reduction and/or alteration of
blood clotting ora prolongation of clotting time (e.g.acetylsalicylic acid)should
consulttheir therapistabout a possible discontinuationof this treatmentas 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 notbe performed above the lungs
(intercostal space) and gastrointestinal area.
Use in wet areas is notpermitted and mayin case of non-compliance lead to
considerabledamage andendangerboth the patient and the user.
In exceptionalcircumstances the treatment time is limited to4 minutes followed
by a breakof at least 15 minutes.
The handpiece can overheat if the treatmenttime is exceeded.

enPulsPro – in brief
5
Page 5
What is enPulsPro?
An ultra-modern, innovative shock wave treatment device.
Shock wave treatment
Radial, ballistic shock wavetreatment is a versatile method. From superficial
orthopaedic problems to myofascial trigger point treatment.
What does
enPulsPro do?
It generates shock waves by meansof an ergonomic handpiece and emits
shock waves through special applicators.
The enPulsPro can penetrate human tissue for upto approximately35 mm.
How are shock waves
generated with
enPulsPro do?
A coil generates an electromagnetic field in the rear 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 the tissues.
What are the
advantages of
enPulsPro?
The innovative technologyallowsfor a compact designwithout a
compressor.
The modern, clear colour displayshowing all therapy-related parameters, the
modern touch operation and the ability to connect 2handpiecesat the same
time ensure enjoymentand motivation during treatment.
Individual program start adjustment and clear, simplemenus offer the user
maximum convenience.
Different, continuously adjustable frequencies and a choice ofapplicators
allow a treatment that is individually suited to the particularcondition of the
patient.
Are there any other
advantages to using
enPulsPro?
An integratedVAS scalegives anoverviewof the time course and success
of the treatment.
Intended use
enPulsPro is a treatment systemfor the electromagnetic generation and
application of radial shock waves in orthopaedics and physiotherapy.
Note:
The application of the device is reservedfor medical professionals (such as
physicians, therapists and health paraprofessionals).
enPulsPro is designed and intended solelyfor the treatment ofsuperficial
orthopaedic problems in humans.

Device set-up
Mounting the cables
6
Page 6
Note:
If the enPulsPro is not mounted on the intended system wagon,
ensurethat the enPulsPro is placed on a stable surface.
Note:
Make sure thatthe powerswitch of thedevice is set to “0”.
Connect power cable
Connectthe powercable to theprovided port (13)on the device and connect
the cable to the mains.
Note:
The device mayonly be connected to power outletswith a protective contact.
Connect handpiece
Connectthe handpiece toone of the ports provided channel I(15) or channel
II (16) and set itdown.
Note:
Ensurethat an applicatorhead isinserted in the handpiece and that it is
screwed in correctly and completely.
Connect foot switch
Connect the foot switchto the port provided (17) andput it on the floor.
Switch device on
Switch onthe device using the power switch (6).
Switch device off
The device is switched off using the powerswitch (6).
To fully (all poles) disconnect the device from the mains, the power cable must
be disconnected.
Caution
!
All cables must be protected from pinchingor other mechanicaldamage.

Default settings
7
Page 7
Note:
Changes to the default settings can onlybe made from the start-up screen.
Start-up screen
After the device has been switched on and the self-testperformed, the start-up
screen opens.
Note:
Activating the "instant start" button (2) switches immediately to the
therapy screen.
Configuration menu
Factorysettings can be changed and individuallyadjusted in theconfiguration
menu.
Select Activating the “Configuration” button opensthe “Configuration” screen.
configuration
The setting optionsare described below.
The default settingsare pre-programmed inthe factory asshown on the
screen.
1
2
3
4
5
6
7
2
1
8
9

Default settings
7
Page 8
(1) Start settings
1. Start menu:
Options to individually select the start-up settings.
2.Start-up image:
Option to select from two start-up images
The selection ismade directly in thecorresponding line.
3. Welcome text:
Activating the “Welcome text”field opens a windowwith analphabetical
keyboard to enter an individual welcometext in the start-up screen.
Activating the “OK” button saves the text entered.
Activating the “Cancel”button leadsback to the configuration menu.
(2) Language
Language selection.
The selection ismade directly in thecorresponding line.
(3) Setting the time
Activating the “Date” field opensthe time settingsinputmenu.
The current time anddate are displayed here.
The timeand date are changedby the two arrowkeys.
Activating the “OK” button saves the changed setting.
Activating the “Cancel”button leadsback to the configuration menu.
(4) OK
Activating the “OK”button switches to the start screen.
(5) Version
Activating the “Version”button opens a window with information on the current
software version.
(6) Standard settings
Activating the “Standard”button restores the factory default settings.
(7) Touch calibration
Activating the “Touch calibration” button opens the screen to performa touch
calibration. This can lead to an improvement in the event of insufficient
accuracyduring touch input.
Followthe instructionson screen fortouch calibration.
(8) Audio / video
settings
1. Brightness:
Option to adjust the brightness of the screen illumination.
2. Volume:
The volume of the signal sounds can be adjusted by activating the control
panels.
The adjustment can be made using the twoarrow buttons.

Default settings
7
Page 9
(9) Handpiece
In thisdisplaypanel, the meterreadingof any connected handpiece(s)is
shown.
Maintenance
The “Service” menu is not relevant for the user. The points listed here are only
used in the event of service by customer service.

Operation instructions
8.1 Device description
8
Page 10
Handpiece
The handpiece(7) contains the shock wave generator, a fan forheat
dissipation, and the ports for the different applicatorheads. It is connected to
the control unit (1).
Note:
The shock wavegeneratorin the handpiece is subject to wearand mustbe
replacedafter a certain length of usebecauseits functionality decreaseswith
time.
Zimmer MedizinSysteme GmbH guarantees unrestricted use ata rate ofat
least two million shocksper shock wave generator.
In some cases,dependingon powerand frequency, wellover
2 million shockscan beemitted.
More information on the need to replace the shock wave generator is given in
chapter 17.
To workwith thehandpiece on the patient, one of the applicator heads must
be screwed firmly andcompletely intothe handpiece.
Interval operation
The handpiece is not suitable for continuousoperation. Frictional heat causes
the temperature of the applicatorhead to rise with increasing duration of
treatment, so much so that thermal damage to the patient cannot be excluded.
Please comply with the warning inchapter4. Treatment must be interrupted
once thetime stated hasbeen reached and canonly becontinued after the
applicator head has cooleddown to room temperature.
Note:
Please note that the temperature monitoring of the handpiece described on
page 11 below is onlya technical shutdown to protect the mechanicalparts
inside the handpiece. It does notgive any informationabout the temperature
of the applicator head.
Recommendation:
To avoid interruption in treatments with more than 6,000 shocks, the
connection of a second handpiece is recommended.
While onehandpiece is cooling the unit can be switched to the second
handpiece and treatment can be continued without delay.
Note:
When switching from one handpieceto another during a single session of
treatment, pulse frequencyand the number of shocks remain unchanged.
Pulse energy returns to 0
and must be reset.

Operation instructions
8.1 Device description
8
Page 11
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 tothe life of the handpiece. In the case of overheating,this forces
coolingof the handpiece through an internalshutdown.
In addition to temperature monitoring, the enPulsPro regulates the
temperature using a temperature sensor inthe handpiece. The fan in the
handpiece is started whenactivatedby the foot switch and automatically stops
when it reaches a certain temperature.
If the temperature reachesa critical limit, a cooling phase is initiated. This is
indicated by the following message in thedisplay:
“Overheating of the applicator. Please allow the applicator to cool down.”
Pulses can no longerbe emitted.
After confirming the message with "OK",the therapy screen moves to the
foreground with the “Overtemperature” message in the statusbar and a
notification when thehandpiece returns tooperating temperature.
Once thehandpiece has reached operating temperature, the message
"Overtemperature" in the status bar is replaced by the message "Ready" and
therapy can be resumed.
Applicator heads
Three different applicator heads are available for treatment.
Changing the
applicator heads
To change the applicatorheads, hold the handpiece with one hand and turn
the applicator head anti-clockwise with theother hand to remove it fromthe
handpiece. Then insert thehead you wish touse by turning itclockwise until it
clicks into place.
Note:
The applicatorheads are subject to wear andmust be replaced after a certain
length ofuse (see chapter 14.2 Maintenance).
Foot switch
Place the footswitch sothat it can beeasily reachedduring treatment. The
operating element of the switch is independent of direction, and so precise
alignment of the foot switch is unnecessary.
To avoiddamage,ensure that only slight pressure isexerted on the switch.
Use the forefoot rather than the heel to operate the switch.
The switch hasno locking mechanism, and so operates only while pressure is
applied to the switch.

Operation instructions
8.2 Information on operation
8
Page 12
Therapy
Please hold the handpiece as shown in the picture below.
The enPulsPro uses mechanical energy, which is transferred tothe patient via
a handpiece.
In orderto achieve this,the handpiece with the applicator head is placed
perpendicular to the treatmentarea or the point of treatment.
While shock wave application is activated, you can work either with the
handpiece stationaryon one point, or dynamically across an area.
We recommend using the enPuls lotion supplied to reduce frictionon the skin.
The weight of the handpiece means that it isusually not necessary topress
down firmly on the treatment area / point.
The handpieceis applied and held inposition withthe hand in a relaxed
posture.
If required,pressure can also be applied inthe directionof the tissue and the
angle of use can be varied.
Caution
!
Note:
The silicone protection capmust bepulled over theapplicator head when
using lubricants in order to avoid soiling.
If the protective cap is notused, the lubricantcan penetrate the applicator
head and the handpiece, which can lead tolasting soiling and malfunction.
This invalidates the warranty.
Note:
Despite high internal attenuation through the weight and construction of the
handpiece, the user'shandcan suffer stressthrough vibrations.
Recommended protective measures:
- Limit exposure time
- Passive support
Note:
The patient should be carefullymonitoredduring treatment.