Zimmer enShock User manual

Instructions for Use
enShock
EN

Figures
Front of the device
Fig. 1
1 Handpiece connector
2 Display
3 Central control knob
2
3
1

Figures
Rear of the device
Fig. 2
Switches and 4 Foot switch connector
connection ports 5 Earth connector
6 Speaker
7 Air vent
8 Fuse holder
9 Connection for power cable
10 On/off switch
5
4
6
10
9
7
8

Figures
Screens/display
Fig. 3
11 Indicator for the adjusted energy
12 Start/stop button
13 Store button
14 Switches to Protocols
15 Switches to Favourites
16 Switches to Therapy
17 Switches to Settings
13
11
14
15
16
12
17

Figures
Accessories
Fig. 4
Handpiece
18 Gel pad fixation ring 19 Therapy activation button
Gel pads
5 / 10 / 15 / 20 / 25 / 30 / 35 / 40 mm
Foot switch
(optional)
Conductive gel
Power cable

Explanation of symbols
General warning sign: this symbol points out hazards on the device.
In the instructions for use, this symbol indicates “Dangers and warnings”.
Caution!
In the instructions for use, this symbol indicates "Caution" with regard to
possible damage to the device.
Products which are marked with the adjacent symbol may not be disposed of in
household waste. The European WEEE Directive applies here.
Note the instructions for use.
Follow the instructions for use.
Switch on/switch off symbol.
Serial number.
Lot number.
Article number.
Manufacturer.
Date of manufacture.

Explanation of symbols
Indication of the quantity contained in the packaging.
Non-sterile.
Device type BF.
CE marking with the number of the notified body.
Medical device.
Protect from heat (sunlight).
Storage and transport temperature range.
Storage and transport air humidity range.
Storage and transport air pressure range.
This side up –indicates top side of the packaging.
Fragile, handle with care.
Protect from moisture.
Recyclable

Explanation of symbols
Unique Device Identification
Maximum stacking height

Contents
Schematic illustrations
Front of the device
Rear of the device
Screens/display
Accessories
Explanation of symbols
Page
1
Intended purpose, indications, contraindications and side
effects
1
2
Application information
3
3
Warnings
5
4
enShock –in brief
6
5
System set-up
7
6
Settings
8
7
Operation instructions
7.1 Application recommendations
7.2 Performing the treatment
7.3 Displays and buttons
7.4 Protocols
7.5 Favourites
9
10
11
13
14
8
Technical information
15
9
Reprocessing
Cleaning/disinfection
16
10
CE marking
19

Contents
11
Scope of delivery and accessories
20
12
Device combinations
21
13
Safety and maintenance
13.1 Safety
13.2 Maintenance
22
23
14
Functional testing
24
15
Safety checks/metrological checks
25
16
Error messages/troubleshooting/disposal
26
17
EMC declaration
28
Valid for the device enShock.
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.
The instructions for use are valid as of May 2021.

Intended purpose, indications,
contraindications and side effects
1
Page 1
Intended purpose
The enShock is intended to deliver focused shock waves for the treatment of
various indications of the musculoskeletal system.
Indications
The enShock provides focused shock wave therapy for people with
musculoskeletal disorders and other conditions as considered appropriate by
the health care professionals providing treatment.
The enShock is indicated for:
•Myofascial trigger points and the effects they have on back pain, neck pain
and myofascial pain syndrome
•Calcifying tendinitis of the shoulder and calcifying tendinopathy, calcific
tendinitis and rotator cuff disease with or without calcification
•Subacromial pain syndrome
•Lateral epicondylitis (lateral epicondylopathy of the elbow/tennis
elbow/mouse elbow/mouse arm), medial epicondylitis (golfer’s elbow)
•Patella tip syndrome (jumper's knee, patellar tendinopathy)
•Achilles tendinopathy
•Plantar fasciopathy and plantar fasciitis
•Pseudoarthrosis and bone non-union, delayed union and its causes,
osteochondritis dissecans and its causes, avascular necrosis (femoral
head necrosis, knee)
•Medial tibial stress syndrome
•Greater trochanteric pain syndrome
•Stress fractures
Contraindications
Local infections
Local tumour diseases
Coagulopathy (analysis of coagulation status is necessary before use)
Use of anti-coagulation medications
Pregnancy
Lung tissue or other hollow or air-filled organs in the treatment area
Children with open epiphyses
Epiphyseal plate in the treatment area
Treatment area in the region of the brain or spine
Treatment area in the region of the eyes/face

Intended purpose, indications,
contraindications and side effects
1
Page 2
Caution is indicated in the case of persons:
With sensory disturbances
With strong autonomic dysfunction
With osteoporosis
Who are under the influence of drugs and/or alcohol
The device may not be used on injured skin or mucous membranes.
Side effects
Common side effects include:
(Transient) increased pain, radiating pain
Skin irritation, skin reddening, local skin damage such as skin
erythema, petechial skin bleeding, hematoma, local swelling, transient
numbness
Nausea
Headaches/migraines
Nerve irritation, nerve injury
Rare adverse events include:
Bone injury or fracture occurring post-treatment
Tendon rupture occurring post-treatment
Vascular injury
Exacerbation of the condition
Worsening symptoms
Local soft tissue damage.
Absence of bony connection (in the case of stress fractures)
Pseudathrosis
Intended user
enShock is intended for health care professionals, such as physiotherapists,
doctors and medical assistants.
Target patient
population
enShock should not be used on infants and young children.
enShock should not be used on patients who have any of the contraindications
listed.
Patients must be physically and mentally able to consciously perceive and
express the perception of pain stimuli.
Mode of
action/functional
principle
Piezoelectric crystals produce pressure waves when they are electrically
activated. The crystals are mounted in an array, so that the pressure waves
emitted by each crystal meet in a focal point. The penetration depth is
determined by the chosen gel pad spacer.

Application information
2
Page 3
Prior to using the device on a patient, the user should become familiar with the
instructions for use and the individual treatment methods to be used as well as
the indications/contraindications, warnings and application information.
Additional sources of information about the therapy should also be followed.
Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority of the Member State
in which the user and/or patient is based.
Caution!
enShock should not be placed and used in hygienically critical medical areas
such as operating rooms, intensive care units or emergency departments.
Caution!
Before use, ensure that the device is powered via a properly earthed mains
socket (electrical installation according to DIN VDE 0100 Part 710 or similar).
The device must only be operated using the supplied power cable. The power
cable must be protected against mechanical stress.
Caution!
Medical electric devices are subject to special precautionary measures with
regard to electromagnetic compatibility (EMC) and must be installed according
to the EMC information in the accompanying documentation. For more
information, see chapter 17 “Manufacturer's EMC declaration”.
Operation of this device in the vicinity of strong electromagnetic fields (e.g.,
tomographs, X-ray or diathermy equipment) may interfere with its operation.
Please keep a safe distance of 5 metres.
enShock 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 that allows 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 and applied parts before use. If there is any damage, the
device must not be used.
Caution!
Only accessories provided by Zimmer MedizinSysteme GmbH that are
intended for this device may be used. The enShock should not be combined
with any other medical or non-medical device.
During the service life of the device, no changes may be made to the device or
medical system.

Application information
2
Page 4
The consistency of the gel in the gel pads changes due to heat, cold, direct
sunlight, mechanical damage or natural aging. Therefore, protect the gel pads
from natural environmental influences.
In order to achieve a uniform gel consistency and thus consistent success with
the treatment, always store the gel pads away during breaks in treatment and,
likewise, store away any gel pads not used during therapy. They should be
stored in the intended storage box, protected from direct sunlight and extreme
cold or heat, in a dry environment and not below 1°C and at a maximum of
30°C).
Only use gel pads for therapy that have been stored at room temperature for at
least 2 hours before the therapy.
Do not use visibly damaged gel pads. Replace the gel pads if they are
mechanically damaged or if the consistency has noticeably changed. The gel
pads should be replaced after one year of use, at the latest.
Remove any excess conductive gel from the gel pads and applicator
immediately after therapy has ended.
The applied parts may only come into contact with the patient’s uninjured skin.
Only use the conductive gel that is provided for this purpose and included in the
scope of delivery.
Do not perform therapy without conductive gel and an inserted gel pad.
Otherwise, no focused shock wave will be able to be applied to the patient. The
conductive gel is absolutely necessary for uniform energy transfer.
If the enShock is placed on a foreign equipment trolley or other storage surface,
care must be taken to ensure that it is designed for the maximum device
weight, with accessories, and that the device is positioned stably so that it does
not fall down, including during transport. The handpiece must also be secured
against falling.

Warnings
3
Page 5
Treatment instructions regarding the location, duration and intensity of the
treatment require medical knowledge and should only be given by medical
professionals. These instructions must be followed.
The patient must not be left unattended during therapy.
Performing intracranial, transcardiac and cervical-occipital treatments is
prohibited. Failure to follow this instruction may lead to hazards to the patient.
Use in wet areas is not permitted. Non-compliance may lead to considerable
damage to the device and endanger both the patient and the user.
Never use the handpiece without an appropriate gel pad or with a damaged gel
pad. Failure to follow this instruction may lead to hazards to the patient.
Patient body parts which contain (metal) implants (for example, a bone nail,
pacemaker, ICD, IUD, etc.) must be excluded from the treatment.
Cables leading to the applicator should be guided in such a way that contact
with the patient or with conductive or energy-absorbing objects is avoided.
Ensure that the handpiece and gel pad are never directed towards the eyes
during operation.
Ensure that the handpiece and gel pad are not directed at metallic surfaces
(such as a couch, washbasin, device housing, etc.).
Ensure that the device is not opened.
Ensure that the power cable is immediately disconnected from the mains if
liquid or foreign bodies penetrate the housing.
Ensure that the device is inspected by an authorised service employee before it
is put back into operation.
To completely disconnect the device from the mains, pull the power cable out of
the socket.
Ensure that the ventilation slots are not covered. Do not cover the ventilation
slots with objects.

enShock –in brief
4
Page 6
What is enShock?
An ultramodern, innovative therapy system for applying focused
extracorporeal shock waves.
What does enShock
do?
enShock is used to apply electrically activated pressure waves.
The individual pressure waves meet in a focal point. The penetration depth is
determined by the chosen gel pad.
What are the benefits
of enShock?
The modern, clear colour display shows all therapy-related parameters and
offers modern touchscreen operation; combined with the optional foot switch,
this ensures motivation on the part of the user and efficient patient treatment.
The compact design enables space-saving work in an office and is ideally
suited for mobile use.
The low-noise handpiece guarantees no disruptive side-effects for the
practitioner, even in the case of intensive use.
Note:
Use of the device is reserved for medical professionals
(such as physiotherapists, doctors and medical assistants).

System set-up
5
Page 7
Ensure that the device is placed on a stable surface.
No special training or instruction is required in order to use the device.
However, the device may only be used by medical professionals who have
previously familiarised themselves with the device and the instructions for use
and understand the intended use, application and warning notes outlined
therein.
Make sure that the power switch of the device is set to “0”.
Connect power cable
Connect the power cable to the provided port (9) on the device, and connect
the cable to the mains.
Note:
The device may only be connected to power outlets with an earthing contact.
Connect handpiece
Connect the handpiece to the handpiece connector (1).
Install gel pad
Only use the gel pads if they have been stored for at least 2 hours at room
temperature before therapy.
Rotate the gel pad fixation ring (18) anti-clockwise to remove it.
Select a gel pad and apply sufficient conductive gel to the back side of the
pad.
Place the back side of the gel pad into the handpiece, and put the gel pad
fixation ring (18) back on the handpiece
Fix the gel pad fixation ring (18) in place by rotating it clockwise.
Make sure to use sufficient conductive gel on the front side of the gel pad as
well as when performing a treatment.
Connect foot switch
The optional foot switch must be connected to the foot switch connector (4)
The foot switch has 3 buttons. The white button (left side) is used to apply the
set power. The middle button adjusts the energy downwards (blue). The
yellow button (right side) is used to adjust the applied energy upwards.
Switching device off
The device is switched off using the on/off switch (10).
In order to fully disconnect the device from the mains, the power cable must
be disconnected.
Caution!
All cables must be protected from pinching or other mechanical damage.

Settings
6
Page 8
Note:
The following descriptions are based on the factory settings.
Settings menu
Select settings
Factory settings can be changed and individually adjusted in the “Settings”
menu.
Activating the “Settings” button (A) opens the “Configuration" screen.
Welcome text
Language
Operating time
Total count
Admin
Software
Firmware
Probe counter
Volume
Brightness
Probe lifetime
Activating the “Welcome” button opens the alphabetical keyboard, with which
you can enter a welcome text for the start-up screen.
Activating the “Language” button opens a selection window with different
languages. Use the arrow buttons to scroll through the list. You can select
your desired language directly in the corresponding line.
Displays the total operating time of the device.
Total number of shock waves generated by the device.
Button to enter “Admin”mode (password-protected).
Displays the version of the currently installed software.
Displays the version of the currently installed firmware.
Total number of shock waves generated by the currently connected
handpiece.
Button to adjust sound volume.
Button to adjust screen brightness.
Displays the lifetime of the currently connected handpiece in %.
A

Operation instructions
7.1 Application recommendations
7
Page 9
Note:
The following recommendations are only guidelines and must, of course, be
adapted to the patient's individual situation.
Gel pads
Note:
Conductive gel
Treatment time:
Dosage:
Note:
enShock comes with 8 gel pads to ensure an optimal penetration depth. The
penetration depth in human tissue depends on the gel pad used. The diameter
of the gel pads reflects the penetration depth. Example: a gel pad with a
diameter of 20 mm leads to a maximum energy level at a depth of 20 mm. The
diameter of the gel pad can be read on the gel pad in question.
For a longer service life, we recommend storing the gel pads out of direct
sunlight and at a temperature of between 1°C and 30°C.
Optimal energy transfer can only be guaranteed when conductive gel is used.
Depending on the size of the treatment area and the disease status, the
recommended treatment time is between 5 and 20 minutes.
It is recommended to start with a low dose and to increase it until the patient
develops a clear perception of the shock waves.
The patient should be carefully monitored during therapy.

Operation instructions
7.2 Performing the treatment
7
Page 10
Note:
The following descriptions are based on the factory settings.
Note:
All buttons, menus and sub-menus can be activated directly on the screen by
pressing with the finger.
Open therapy screen
Activating the “Therapy” button opens the therapy screen.
Select gel pad
Select the appropriate gel pad and place this correctly into the handpiece.
Note:
To guarantee optimal energy transfer, use sufficient conductive gel between
the handpiece and the gel pad.
Adjust parameters
Adjust the desired energy level, number of shocks and frequency by selecting
the parameter in question and adjusting the value using the central control
knob.
If the optional foot switch is connected, the “-”and “+” pedals can be used for
adjustment as well.
Apply conductive
gel
Apply the conductive gel to the treatment area and spread the gel evenly over
the entire surface of the treatment area
Start of therapy
Note:
Note:
Start a treatment by selecting the “Start” button, immediately followed by
clicking the orange button on the handpiece (19) or pressing the “Shock” pedal
on the optional foot switch.
If the "Start" button is not activated, no power will be emitted.
The energy level and frequency can be increased or decreased during therapy
by selecting the parameter in question followed by using the central control
knob or the optional foot switch.
End of therapy:
Note:
An acoustic signal will sound after the therapy time has elapsed.
If the volume is set to “0” in the “Settings” menu, no acoustic signal will sound.