Storz MASTERPULS ONE User manual

29511.0002
OPERATING MANUAL
MASTERPULS®ONE
DS.#####
Part No. 27800
Published: 12.2020
Original language: German
29511

0000000068

19 800 0002 12.2020
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Medical devices identified with this CE mark are in accordance with the regu-
lations in EC Directive 93/42/EEC “Council Directive concerning medical devic-
es”
The operating manual, including all of its parts, is protected by copyright. Any use out-
side the narrow limits of copyright law without the written consent of the manufac-
turer is inadmissible and liable to prosecution.
This applies in particular to duplication, translation, microfilming as well as feeding and
distribution in electronic systems.
Manufacturer / Publisher
STORZ MEDICAL AG
Lohstampfestrasse 8 Telephone: [phone]
Postfach Fax: [phone]
CH-8274 Tägerwilen
Switzerland URL: www.storzmedical.com

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Contents
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 5
1 General Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 7
1.1 Intended use and operational safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 7
1.2 Safety during treatment of the patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 8
1.3 Warning against damage to equipment and the device . . . . . . . . . . . . . . . . . . . . .. 8
2 Principles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10
2.1 Physical principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10
2.1.1 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10
2.1.2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10
2.1.3 Side effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..10
2.2 Preconditions for operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 11
2.2.1 Operating personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 11
2.2.2 Training of the operator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 11
3 System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 12
3.1 Control device with handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 12
3.2 Scope of Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 12
3.3 Unpacking the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 13
3.3.1 Before start-up: Removing the transport base plate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 13
3.3.2 Before transport: Attaching the transport base plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 14
3.4 Installation Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 14
3.4.1 Handpiece components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 14
3.4.2 Assembling the handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 14
3.4.3 Connecting the electrical power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 16
3.4.4 Connecting Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 16
3.5 Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 16
4 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 17
4.1 Switching on and off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 17
4.2 Setting the intensity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 17
4.3 Resetting the counter reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 17
4.4 Reading out the device data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 18
4.5 Start-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 18
4.6 Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..18
5Cleaning, Maintenance, Overhaul. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 21
5.1 Cleaning and overhaul . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 21
5.1.1 Replacing the pulse transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 22
5.1.2 Cleaning the handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 23
5.1.3 Cleaning and disinfecting the pulse transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 24
5.1.4 Overhaul of the handpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 25
5.1.5 Mains fuse replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 27
5.2 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 28
5.3 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 28
5.4 Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 28

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Contents
5.5 Service life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
6 Trouble shooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
7 Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
8 Technical Specifications and Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
8.1 Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
8.2 Type plates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
8.3 Conformity with directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
8.4 Conformity with standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
8.4.1 EMC guidelines and manufacturer's declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
8.5 Certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
8.6 Symbols and labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
9 Warranty and service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
9.1 Warranty for the control device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
9.2 Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
10 System Book . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 40

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Introduction
Introduction
This operating manual contains certain types of text design intended to assist you in
comprehending the significance of the text based on its appearance.
Instructions for actions
• This text instructs you in how to operate your system correctly.
• This text subdivides an action into steps or comments on the action step.
This text shows the result of an action.
Lists
– This text is part of a list.
Menus and buttons
Names of MENUS and BUTTONS are greyed out and highlighted in small caps.
The operating procedure descriptions also contain references to the buttons that you
have to press and what you can expect to see in the text.
Cross references to other chapters
Cross references to other chapters are highlighted in bold and in small caps.
Warning notes
This manual contains warnings, safety instructions and specific operating instructions
in accordance with liability regulations.
DANGER refers to a situation of acute danger which, if not avoided, could lead to se-
rious or fatal injury.
DANGER
The source of the danger is stated here.
These are the possible consequences!
►The instructions for avoiding the danger are given here.
WARNING refers to a situation of potential danger which, if not avoided, could lead
to serious injury.
WARNING
The source of the danger is stated here.
These are possible consequences!
►The instructions for avoiding the danger are given here.

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Introduction
CAUTION indicates that incorrect operation could lead to minor injuries.
CAUTION
The source of the danger is stated here.
These are the possible consequences!
►The instructions for avoiding the danger are given here.
NOTICE indicates that incorrect operation could lead to damage to the device.
NOTICE
The source of the danger is stated here.
These are possible consequences!
►The instructions for avoiding the danger are given here.
Other instructions
This text indicates additional information concerning special features, etc. and/or op-
erating instructions.

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General Safety Information
1 General Safety Information
The following chapter contains all safety information that has to be followed when
working with the MASTERPULS®ONE.
WARNING
Incorrect handling of the device
Risk of injuries to the patient and the operating personnel!
►Read this chapter carefully before you start using the MASTERPULS®ONE.
►Read the separate operating manuals for all devices associated with the MASTER-
PULS®ONE.
1.1 Intended use and operational safety
To ensure this device is utilised in accordance with its intended use, the user must pos-
sess the necessary technical proficiency and knowledge of the operating manual.
The device is only to be used for the applications described in Chapter 2.1.1 INDICATI-
ONS.
• Only carry out treatments that have been approved by STORZ MEDICAL AG!
Furthermore, the device is only allowed to be operated by trained personnel who fulfil
the preconditions for operation in Chapter 2.2 PRECONDITIONS FOR OPERATION.
Checks and inspections prior to treatment
Before using the device, the user must make sure it is functioning safely and that it is
in proper condition.
Protection against electrical hazards
Sources of voltage can give rise to currents as a result of body resistance, which not
only flow through the patient but can also impair or even endanger the personnel ad-
ministering the treatment.
• Devices that are not medical products in accordance with EN 60601 must be set
up outside the patient environment.
• Do not touch electrical connectors while you are touching the patient.
• Disconnect the MASTERPULS®ONE from the mains plug before starting any clean-
ing or maintenance work.
• Disconnect the connected handpieces from the device before carrying out clean-
ing and maintenance work. Do not reconnect it until everything has been com-
pletely reassembled.
Protection against noise
The noise level during administration of pulses is within the safe range. Nevertheless,
we recommend wearing suitable ear protection during treatment in order to minimise
exposure to noise.

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General Safety Information
1.2 Safety during treatment of the patient
General note:
Organs with gas inclusions are NOT allowed to be exposed to pulses.
As it passes through tissue, the pulses' energy is slightly reduced; this reduction is sig-
nificantly weakened by the bone structure.
Pulses can give rise to undesirable reactions. The patient must be continuously ob-
served during the treatment and attention must be paid to any reactions experienced
by the patient. The patient must not be under anaesthetic.
Only perform treatments that have been approved by STORZ MEDICAL AG!
The user is responsible for correctly positioning the handpieces and correctly selecting
the treatment zone.
1.3 Warning against damage to equipment and the device
Any damage to the device resulting from incorrect operation is not covered by the
manufacturer's warranty.
Electromagnetic compatibility
This device complies with the requirements of the applicable standard on electromag-
netic compatibility (EMC). Nevertheless, portable and mobile RF communications
equipment (e.g. mobile phones) can interfere with medical electrical devices.
This device is subject to special precautionary measures regarding EMC and must be
installed in accordance with the EMC directives in Chapter 8.4.1 EMC GUIDELINES AND
MANUFACTURER'SDECLARATION.
The use of accessories or cabling not authorised by the manufacturer is not permitted.
Increased electromagnetic interference may occur, which may cause the device to op-
erate incorrectly.
The MASTERPULS®ONE is not allowed to be positioned immediately next to or jointly
with other devices. If operation near or jointly with other devices is required, the MAS-
TERPULS®ONE must be tested in that particular environment to ensure operation ac-
cording to technical specifications.
The use of RF communication devices in the vicinity is not permitted.
The device must only be connected to properly earthed and correctly installed shock-
proof sockets!
Setup and operation
There are ventilation slits on the rear of the device which must not be covered by other
objects.
• Never cover the device when in use!
• Make absolutely sure that no liquid can seep into the system housing or hand-
piece.
The third mains connecting cable must only be used as the functional earth.

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General Safety Information
Storage and transport
Incorrect storage and transport can result in damage to the device and device failure.
• Familiarise yourself with the ambient conditions for storage and transport in chap-
ter 8.1 TECHNICAL SPECIFICATIONS.
• Make sure that no cables are crushed or sheared.
• After transporting the device or a longer treatment break, check that the device is
working properly.
Disposal
• Comply with national disposal regulations when disposing of the MASTERPULS®
ONE or individual components.
• Comply with the relevant information in the operating manuals for the additional
devices.

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Principles
2 Principles
2.1 Physical principles
The MASTERPULS®ONE is a compressed air operated ballistic pressure wave genera-
tor. Kinetic energy is converted into sound energy. This acoustic pulse is transmitted
into the tissue to be treated either directly or via an acoustic impedance adapter with
the help of a gel.
Physically speaking, these are radial pressure waves. The applied pressure pulse prop-
agates radially within the tissue and has a therapeutic effect on areas of the tissue near
the surface, in particular.
Medical devices operating on the basis of the above principle are generally referred to
as radial shock wave systems in modern medical literature.
2.1.1 Indications
– Pain in the musculoskeletal system
– Aesthetic – non-medical – treatments to the skin, muscles, facial wrinkles, connec-
tive tissue and tendons
2.1.2 Contraindications
Treatments with the MASTERPULS®ONE are not permitted in the following cases:
– Brain or spinal column in the treatment area
–Pregnancy
– Malignant tumour in the treatment area
CAUTION
The MASTERPULS®ONE must not be used to treat regions near large nerves, vessels
or the head (except in the facial area).
2.1.3 Side effects
CAUTION
After treatment with the MASTERPULS®ONE
side effects may occur.
►Familiarise yourself with the list of side effects.
►Inform the patient of possible side effects.
Treatment with the MASTERPULS®ONE may cause the following side effects:
– Swelling, reddening, haematomas
– Petechiae
– Pain
These side effects generally abate after 5 to 10 days.

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Principles
2.2 Preconditions for operation
2.2.1 Operating personnel
CAUTION
If treatment is carried out by inadequately qualified users,
this can result in damage to the patient's health.
►Ensure that treatment is only performed by qualified and trained medical person-
nel.
►Observe the preconditions for operation that are detailed in this chapter.
The MASTERPULS®ONE is intended exclusively for use by healthcare professionals
who have read the supplied documents.
It is expected that this professional have practical knowledge of medical procedures
and applications as well as of the terminology and should be experienced in treating
the indications stated in Chapter 2.1.1 INDICATIONS.
The professional must have physical and cognitive prerequisites such as vision, hearing
and reading. Furthermore, the basic functions of the upper extremities must be guar-
anteed.
The device is designed for a demographic target group between 18 and 65 years.
2.2.2 Training of the operator
Operators of the MASTERPULS®ONE must have been trained in using this device safely
and efficiently as follows:
– the operating manual and all other attached documents must be read and ob-
served.
Further training requirements vary from country to country. It is the operator's respon-
sibility to ensure that the training meets the requirements of all applicable local laws
and regulations. Further information about training in the operation of this device can
be obtained from your STORZ MEDICAL dealer.

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System Description
3 System Description
3.1 Control device with handpiece
3.2 Scope of Supply
The standard scope of supply of the MASTERPULS®ONE includes the following items:
Cables and accessories other than those specified or supplied by the manufacturer
must not be used.
Fig. 3-1 Front MASTERPULS®ONE
1Handle
2Display
3 Trigger button
4 Handpiece connector
5 Handpiece with coloured hand-
piece cushion
6 Pulse transmitter
Fig. 3-2 Rear MASTERPULS®ONE
1 Ventilation slits
2 Mains connector with mains
switch and fuse
1
2
3
4
5
6
1
2
– MASTERPULS®ONE Control device – Operating Manual
– Mains cable – Gel bottle
– Handpiece – Open-end spanner
– 1 pulse transmitter – Allen key
– Standard hose – Cleaning brush
– Transport base plate

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System Description
3.3 Unpacking the device
• Remove the device and accessories from the packaging container. Proceed with
extreme caution.
• Check that all items are included in the packaging container and that they are not
damaged.
• Contact your supplier or the manufacturer/dealer immediately if any delivery items
are missing or damaged.
• Retain the original packaging. It may prove useful for any later equipment trans-
port.
A film with a symbol is affixed to the device display You must read the operating
manual .
• Read the operating manual and then remove the film from the device.
In order to protect it, the device is supplied mounted on a transport base plate, which
is secured with hook-and-loop tape. This must be removed before start-up of the de-
vice.
CAUTION
Equipment damage due to improper storage and transport
can result in damage to the patient's health.
►Familiarise yourself with the ambient conditions for storage and transport in chap-
ter 8.1 TECHNICAL SPECIFICATIONS.
►Make sure that no cables are crushed or sheared.
►After transporting the device or a longer treatment break, check that the device is
working properly.
3.3.1 Before start-up: Removing the transport base plate
• Undo the hook-and-loop tape.
• Lift the device from the base plate.
Fig. 3-3 Removing the transport base plate
1 Hook-and-loop tape
2 Transport base plate
3Ribs
4 Slits
1 2 3 4

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System Description
3.3.2 Before transport: Attaching the transport base plate
• To reattach the base plate, place the hook-and-loop tape underneath the base
plate.
• Lift the device onto the base plate so that the ribs on the transport base plate fit
into the slits on the bottom of the device (FIG. 3-3 ).
• Fasten the hook-and-loop tape around the transport handle.
NOTICE
►Always attach the transport base plate when repackaging the device for trans-
port.
3.4 Installation Instructions
3.4.1 Handpiece components
1 Handpiece handle
2 Projectile
3 Allen key (see Cleaning / Overhaul)
4 Guide tube
5Shaft
6 Open-end spanner
7 Pulse transmitter insert
8 Pulse transmitter screw caps
3.4.2 Assembling the handpiece
CAUTION
If the shaft of the handpiece is damaged or uneven, then when removing or screwing
in the shaft without a suitable tool,
minor scratching injuries may occur.
►Be sure to use the open-end spanner provided to remove or screw in the shaft.
1
2
45
7
8
36

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System Description
Assemble the handpiece as follows:
• Remove the guide tube and the projectile from the handpiece packaging.
• Unscrew the shaft from the handpiece and pull it out of the handpiece handle.
• Use the supplied open-end spanner for this purpose.
• Insert the projectile into the fitted guide tube.
• Screw the shaft onto the handpiece until finger-tight.
• Tighten the shaft using the supplied open-end spanner. It must no longer be pos-
sible to unscrew the shaft by hand.
• Insert the pulse transmitter insert into the corresponding pulse transmitter screw
cap.
• Screw the pulse transmitter screw cap onto the handpiece until finger-tight.
• Make sure that the cap parts of the pulse transmitter are screwed firmly in place
and that the pulse transmitter screw cap is screwed firmly to the shaft.
Depending on the pulse transmitter, the pulse transmitter screw cap is in one or two
pieces. Here, the images show how to assemble the handpiece with a two-piece pulse
transmitter screw cap.

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System Description
3.4.3 Connecting the electrical power supply
• Connect the mains cable to the mains connector on the left rear of the device (see
FIG. 3-2 /1).
• Insert the mains cable into the electrical socket.
NOTICE
►Maintain a minimum distance between the device and the wall so that the mains
plug can be pulled out without restrictions (disconnected from the power supply
network) and the ventilation slits on the rear are not blocked.
►The device must only be connected to properly earthed and correctly installed
shockproof sockets!
3.4.4 Connecting Handpiece
• Plug the hose into the corresponding connector on the handpiece or the connec-
tor on the front of the device:
Fig. 3-4 Connections between handpiece, hose and control device
1Hose
2 Connector
3Orangering
• To check that the components have been connected correctly, gently pull on the
hose.
You should not be able to pull the hose out.
• To disconnect the connections, slide the orange ring in the direction of the hand-
piece or device and pull the hose out of the connector at the same time.
3.5 Compatibility
The following handpieces may be operated with the MASTERPULS®ONE:
The handpiece is available in the colours grey, orange and green.
1
2313
Handpiece Article number
Handpiece »SPARROW« 30064.xxxx

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Operation
4 Operation
4.1 Switching on and off
• Switch the control device on or off at the mains switch on the rear (see FIG. 3-2 ).
The device is operated via the touchscreen display.
4.2 Setting the intensity
The frequency changes automatically based on the intensity.
4.3 Resetting the counter reading
When the counter reading reaches 9999, the display starts from zero again when the
next pulse is triggered.
The display indicates the intensity (levels 1 – 6).
• Press to increase the intensity.
• Press to reduce the intensity.
Fig. 4-1 Graphical representation of the intensity levels
Relationship between inten-
sity and frequency
Intensity Frequency
1 18 Hz
2 16 Hz
3 10 Hz
49Hz
58Hz
66Hz
The display counts the pulses emitted.
• Press to reset the display to zero.

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Operation
4.4 Reading out the device data
To enable the operating hours, total number of pulses and the software version to be
read out, the device must be restarted.
• Press during the restart .
4.5 Start-up
• Set the intensity of the pulses to the required intensity level.
• Before each treatment, make sure that the pulse counter is set to zero.
If the pulse counter is not reset, the display will show more pulses than were actually
delivered during the treatment. This poses a risk of the treatment being stopped pre-
maturely by mistake.
• Press the trigger button on the device (FIG. 3-1 /2 ).
• When you press the trigger button again, the pulses will stop being emitted.
If 2000 pulses are reached during the treatment, the handpiece stops automatically.
Further treatment is possible.
4.6 Treatment
Safety information
Before using the device, the user must make sure it is functioning safely and in proper
condition.
• Read through Chapter 1 GENERAL SAFETY INFORMATION before beginning treat-
ment.
CAUTION
Equipment damage due to improper storage and transport
can result in damage to the patient's health.
►Familiarise yourself with the ambient conditions for storage and transport in chap-
ter 8.1 TECHNICAL SPECIFICATIONS.
►Make sure that no cables are crushed or sheared.
►After transporting the device or a longer treatment break, check that the device is
working properly.
The display will then show the operating hours, followed
by the total number of pulses and then the software ver-
sion. The numbers will scroll along the 4-digit display
from left to right.
– Operating hours, e.g. 3h
– Total number of pulses, e.g. 1000 “”
– Software version, e.g. 029 040-xx-xxxx

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Operation
CAUTION
If the handpiece is not positioned correctly, there is an
impairment to health due to ineffective treatment!
►Define the treatment zone and make sure that the handpiece position always cor-
responds to the treatment zone.
►Make sure that the treatment is only administered by users who meet the condi-
tions in Chapter 2.2 PRECONDITIONS FOR OPERATION.
For safety reasons, using the device for applications other than those specified in chap-
ter 1 GENERAL SAFETY INFORMATION is not permitted!
CAUTION
Over extended periods, the noise of the pulses
may be perceived as unpleasant!
►Offer ear protection to the patient.
►Recommendation: The user should also wear ear protection.
NOTICE
Danger from inadvertent pulse triggering.
►Only trigger pulses when the handpiece is in contact with the intended treatment
zone.
• Avoid excessive pressure of the pulse transmitter to the patient's skin! Excessive
pressure is not necessary for the success of the treatment.
CAUTION
If too many pulses are applied to the same spot,
there is a risk of swelling, petechiae and haematomas and it could lead to
heating.
►Do not apply more than 300-400 pulses to the same location.
• Apply enough coupling gel to ensure that the pulse transmitter glides smoothly
over the patient's skin.
Setting parameters
Treatment should always start at a low intensity level. This also applies when resuming
treatment after an interruption. The pulse energy should be increased gradually during
treatment.
The selection of intensity levels is based on the medical opinion of the person admin-
istering the treatment. The maximum intensity level used during treatment must not
cause the patient undue pain under any circumstances.