Operating Manual

MASTERPULS® MP200

BS.####
Part No. 23220.xxxx

Published: May 2016

Original language: German

Publisher:
STORZ MEDICAL AG
Lohstampfestr. 8
CH-8274 Tägerwilen
Switzerland

25294
 Table of Contents

1 General Safety Information 6

1.1 Instructions for safe use 6

1.1.1 Designated use and operational safety . . . . . . . . . . . . 6
1.1.2 Safety during treatment of the patient . . . . . . . . . . . . 7

1.2 Warning against damage to equipment and the device 7

2 Principles 9

2.1 Physical principles 9

2.1.1 Indications . . . . . . . . . . . . . . . . . . . . . 9
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 and functional elements 12

2
3.2 Scope of supply 13

3.3 Unpacking 13

3.4 Transport 14

3.5 Installation Instructions 14

3.5.1 Mounting the handpiece holders . . . . . . . . . . . . . . 14
3.5.1.1 Handpiece holder . . . . . . . . . . . . . . . . . . 14
3.5.1.2 Suction cup holder . . . . . . . . . . . . . . . . . . 15
3.5.2 Connecting the electrical power supply . . . . . . . . . . . . 15
3.5.3 Connecting the potential equalisation . . . . . . . . . . . . 16
3.5.4 Connecting handpiece . . . . . . . . . . . . . . . . . 16
3.5.5 Connecting Tablet (optional) . . . . . . . . . . . . . . . 16
3.5.6 Connecting VACU-ACTOR . . . . . . . . . . . . . . . . 17
3.5.7 Connecting the foot switch . . . . . . . . . . . . . . . 18

3.6 Compatibility 18
Table of Contents

3.7 Symbols 19

4 Operation 20

4.1 Switching on and off 20

4.2 Operation 20

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4.3 Operation of the handpiece 21

4.4 Operation of the Touch Screen of the Tablet PC 22

4.4.1 Module selection . . . . . . . . . . . . . . . . . . . 23
4.4.2 Parameter selection and counter display . . . . . . . . . . . . 24
4.4.3 Contact intensity and Skin Touch display . . . . . . . . . . . 26
4.4.4 Treatment menu bar . . . . . . . . . . . . . . . . . . 28
4.4.5 Device info and settings menu bar . . . . . . . . . . . . . 29

4.5 Touch screen operation 30

4.5.1 Set and reset device type . . . . . . . . . . . . . . . . 30
4.5.2 Password protection . . . . . . . . . . . . . . . . . . 31
4.5.3 Setting brightness and volume . . . . . . . . . . . . . . . 33
4.5.4 Selecting the operating mode . . . . . . . . . . . . . . . 33
4.5.5 Selecting treatment parameters . . . . . . . . . . . . . . 34
4.5.6 Loading indications . . . . . . . . . . . . . . . . . . 34
4.5.7 Saving indications . . . . . . . . . . . . . . . . . . 38
4.5.8 Copying indications . . . . . . . . . . . . . . . . . . 39
4.5.9 Deleting an indication . . . . . . . . . . . . . . . . . 40
4.5.10 Editing indications . . . . . . . . . . . . . . . . . . 40
4.5.10.1 Storing treatment notes . . . . . . . . . . . . . . . . . 41
4.5.10.2 Loading images and/or videos . . . . . . . . . . . . . . . 41
4.5.10.3 Creating, deleting or editing treatment steps . . . . . . . . . . 42
4.5.11 Patient treatment report . . . . . . . . . . . . . . . . 43
3
4.5.11.1 Loading patient data . . . . . . . . . . . . . . . . . 43
4.5.11.2 Editing patient data . . . . . . . . . . . . . . . . . . 45
4.5.11.3 Load treatment parameters . . . . . . . . . . . . . . . 45
4.5.12 Creating new patient data . . . . . . . . . . . . . . . . 46
4.5.13 Exporting treatment data . . . . . . . . . . . . . . . . 47
4.5.14 Deleting patient datasets . . . . . . . . . . . . . . . . 47
4.5.15 Resetting the treatment shock counter . . . . . . . . . . . . 47
4.5.16 Software updates . . . . . . . . . . . . . . . . . . 48
4.5.16.1 Software Update Tablet PC . . . . . . . . . . . . . . . . 48
4.5.16.2 Software Update MP200 . . . . . . . . . . . . . . . . 48
4.5.17 Changing software settings . . . . . . . . . . . . . . . 49
4.5.18 Visible Body - Anatomy Atlas . . . . . . . . . . . . . . . 49
4.5.18.1 Starting Visible Body . . . . . . . . . . . . . . . . . . 50
4.5.18.2 Marking treatment regions . . . . . . . . . . . . . . . . 51
4.5.18.3 Exiting Visible Body . . . . . . . . . . . . . . . . . . 52
Table of Contents

4.6 Setting treatment parameters 52

4.7 Start-up 53

4.8 Functional checks 53

4.9 Standard settings 54

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 4.10 Treatment with R-SW or V-ACTOR handpiece 54
4.10.1 Setting parameters . . . . . . . . . . . . . . . . . . 55
4.10.2 Coupling the handpiece . . . . . . . . . . . . . . . . 55
4.10.3 Triggering shocks . . . . . . . . . . . . . . . . . . 56
4.10.4 Functions overview of the handpiece R-SW . . . . . . . . . . . 56

4.11 Treatment with VACU-ACTOR 56

4.11.1 Using the foot switch . . . . . . . . . . . . . . . . . 57
4.11.2 Verwendung des Tablets (optional) . . . . . . . . . . . . . 57

5 Cleaning, Maintenance, Overhaul 58

5.1 Cleaning 58
5.1.1 Cleaning the handpieces . . . . . . . . . . . . . . . . 58
5.1.2 Reconditioning the VACU-ACTOR . . . . . . . . . . . . . 58
5.1.2.1 Preparation of cleaning . . . . . . . . . . . . . . . . . 59
5.1.2.2 Cleaning . . . . . . . . . . . . . . . . . . . . . 59
5.1.2.3 Disinfection . . . . . . . . . . . . . . . . . . . . 60
5.1.3 Fuse replacement . . . . . . . . . . . . . . . . . . 60

5.2 Maintenance and safety checks 61

5.3 Disposal 62

5.4 Repair 62

4 5.5 Service life 62

6 Accessories 63

7 Technical Specifications 64

7.1 Technical Specifications 64

7.2 Type plate MASTERPULS®MP200 65

7.3 Conformity with directives 65

7.4 Conformity with standards 66

7.4.1 EMC guidelines and manufacturer’s declaration . . . . . . . . . 66

7.5 Certificates 70

7.6 Symbols and labels 71

Table of Contents

8 Warranty and Service 72

8.1 Warranty for the control device 72

8.2 Warranty for the handpiece 72

8.3 Warranty for the VACU-ACTOR 72

8.4 Service 72

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 Preface
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
serious 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 the possible consequences!
• The instructions for avoiding the danger are given here.

5
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.

ATTENTION indicates that incorrect operation could lead to damage to the device.

ATTENTION!

The source of the danger is stated here.

These are the possible consequences!
• The instructions for avoiding the danger are given here.

Other instructions

NOTE
Preface

Additional information concerning specific features or operating instructions is

preceded by the term 'NOTE'.

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 1 General Safety Information

1.1 Instructions for safe use

The following chapter contains all safety information that has to be followed when
working with the MASTERPULS® MP200.

WARNING!

Incorrect handling of the device.

Possibility of injuries to the patient and the operating personnel!
• Read this chapter carefully before you start using the MASTERPULS®
MP200.
• Read the separate operating manuals for all devices associated
with the MASTERPULS® MP200.

1.1.1 Designated use and operational safety

In order for the user to use this device in accordance with its designated use, the user
must possess the necessary technical proficiency, and knowledge of the operating
manual.
The device is only allowed to be used for the applications described in Chapter 2.1.1
Indications.
• Only perform treatments approved by STORZ MEDICAL AG!
6
Furthermore, the device is only allowed to be operated by trained personnel who
comply with the Preconditions for operation in Chapter 2.2.

All status and error messages signaled during treatment must always be attended to
without delay.

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.
• It is essential to perform the functional checks after switching on the
MASTERPULS® MP200 before starting treatment. Read about this in Chapter 4.8
Functional checks.
General Safety Information

• Have the maintenance procedures recommended by the manufacturer carried out by

authorised personnel (see also Chapter 5.2 Maintenance and safety checks).

Protection against electrical hazard

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 physician and
the nursing staff.
• Therefore, always connect the potential equalisation connector of the
MASTERPULS® MP200 in accordance with national guidelines.

• Devices which are not medical products in accordance with EN 60601 must be set
up outside the vicinity of the patient.

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 • Do not touch electrical connectors while you are touching the patient.

• Disconnect the MASTERPULS® MP200 from the mains before starting any cleaning
or maintenance work!

• Disconnect the connected handpieces from the device before carrying out cleaning
and maintenance work. Do not reconnect them until they have been completely
reassembled!

• The optional KARL STORZ foot switch must not be used in potentially explosive
atmospheres according to classification AP as per IEC 60601.

Protection against noise

The noise level during administration of shock waves is within the safe area.
Nevertheless, we recommend wearing suitable ear protection during treatment in
order to minimise exposure to noise.

1.1.2 Safety during treatment of the patient

General note:
Organs with gas inclusions, in particular parts of the lung, are NOT allowed to be
exposed to shock waves.

As it passes through tissue, the shock wave’s energy is slightly reduced; this reduction
is significantly weakened by the bone structure.

Shock waves can give rise to undesirable heart reactions. The patient must be
continuously observed during the treatment.

Only perform treatments approved by STORZ MEDICAL AG! 7

The user is responsible for correctly positioning the handpieces and correctly selecting
the treatment zone.

No more than 6,000 shock waves are allowed to be administered without

interruption.

Treatment with the suction cup must be limited to 30 minutes.

1.2  arning against damage to equipment and

W
the device
General Safety Information

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
electromagnetic compatibility.
Nevertheless, portable and mobile HF communications equipment (e.g. mobile
phones) can interfere with medical electrical equipment.

This device is subjected to special precautions regarding EMC and needs to

be installed according the EMC guidelines in chapter 7.4.1 EMC guidelines and
manufacturer’s declaration.

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 The use of accessories or cables that are not authorised by the manufacturer can
result in increased interference emissions or reduced resistance to interference
emissions by the device.

The MASTERPULS® MP200 is not allowed to be positioned immediately next to

or jointly with other devices. If the operation near or jointly with other devices is
required, the MASTERPULS® MP200 must be tested in that particular environment to
ensure operation according to technical specification.

The system must only be connected to properly earthed and correctly installed
shockproof sockets!

Set-up and operation

There are ventilation slits on the left side of the device which must not be covered by
other objects.
• Check that the system is in perfect working order before each use. Read about this in
Chapter 4.8 Functional checks.

• Never cover the device when in use!

• Make absolutely sure that no liquid can seep into the system housing or
handpiece.

Storage and transport

Incorrect storage and transport can result in damage to the device and device failure.
• Make sure that no cables are crushed or sheared.

8 Disposal

• Comply with national disposal regulations when disposing of the MASTERPULS®

MP200 or individual components.

• Comply with the relevant information in the operating manuals for the additional
devices.
General Safety Information

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2 Principles

2.1 Physical principles

The MASTERPULS® MP200 is a compressed air–operated ballistic shock wave genera-
tor. The shock waves in the MASTERPULS® MP200 are generated with a precision
ballistic mechanism in the handpiece. A projectile is accelerated by compressed air.
The motion and weight of the projectile produce kinetic energy. When the projectile
impacts against an immovable surface, the shock transmitter, this 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 propa-
gates radially within the tissue and has a therapeutic effect on areas of the tissue near
the surface, in particular.

NOTE
Medical devices operating on the basis of the above principle are generally referred
to as radial shock wave systems in modern medical literature.

The MASTERPULS®MP200 in combination with VACU-ACTOR is a supplement to

the treatment with R-SW and V-ACTOR. Thereby tissue will be treated by means of
a suction cup in pulsating vibrations. Either it will be changed between vacuum (feel
stretching of the tissue) and pressure (expansion pressure) or between vacuum (feel
stretching of the tissue) and a short vent (athmospheric pressure). This function is
realized by a high-performance compressor.
9

2.1.1 Indications
–– Calcaneal spur / plantar fasciitis
–– Shoulder pain with or without calcifications
–– Achillodynia
–– Trochanteric bursitis / proximal iliotibial band friction syndrome
–– Radial/ulnar humeral epicondylitis
–– Patellar tip syndrome
–– Tibial edge syndrome
–– Insertion tendonitis in general
–– Treatment of deep muscle trigger points
–– Treatment of superficial muscle trigger points, myofascial trigger points
–– Superficial insertion tendonitis (paratendinary area)
–– Chronic back pain (cervical/lumbar parts of vertebral column)
–– Acupuncture shock wave therapy
Principles

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 Qualified training in acupuncture and acupuncture shock wave therapy (AkuST) is
required for therapeutic application of the MASTERPULS®MP 200 in the field of acu-
puncture.
A sound knowledge of trigger point therapy and trigger point shock wave therapy
(TrST) is required for therapeutic application of the MASTERPULS®MP 200 in the field
of trigger point shock wave therapy.

2.1.2 Contraindications

CAUTION!

No claims are made regarding the completeness or unlimited validity

of this list of contraindications.

Treatment with the STORZ MEDICAL MASTERPULS® MP200 is not permitted in the
following cases:

–– Coagulation disorders (haemophilia)

–– Use of anticoagulants, especially Marcumar
–– Thrombosis
–– Pregnancy
–– Cortisone therapy up to 6 weeks before first treatment
10

CAUTION!

Shock waves must not be applied to target areas located above air
filled tissue (lungs), nor to any regions near large nerves, vessels,
the spinal column or head (apart from the face).

2.1.3 Side effects

Treatment with the MASTERPULS® MP200 may cause the following side effects:
–– Swelling, reddening, haematomas
–– Petechiae
–– Pain
–– Skin lesions after previous cortisone therapy

These side effects generally abate after 5 to 10 days.

Principles

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2.2 Preconditions for operation

2.2.1 Operating personnel

The MASTERPULS® MP200 is intended exclusively for use by medical specialists and
may only be used by suitably qualified and trained medical personnel.
Such a specialist is expected to 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.
Users must have basic physical and cognitive abilities such as vision, hearing and
literacy, and have basic functional use of their upper extremities.
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® MP200 must have been adequately trained in
using this system safely and efficiently before they operate the device described in
this handbook. An introduction to the principles of operation will be provided by
your STORZ MEDICAL dealer with reference to this operating manual and will be
documented in the system logbook.

The operator must be instructed in the following points:

–– Instruction in the operation and designated use of the device with practical
exercises
–– Mechanism of action and function of the device and the energies delivered by it
–– All component settings
–– Indications for use of the device 11

–– Contraindications and side effects of the therapy waves

–– Explanation of the warnings in all operating modes
–– Instruction in how to perform the functional checks

Further training requirements vary from country to country. It is the operator’s

responsibility to ensure that the training meets the requirements of all applicable
local laws and regulations. Further information about training in the operation of this
system can be obtained from your STORZ MEDICAL dealer. However, you can also
contact the following address directly:

STORZ MEDICAL AG Telephone: +41 (0) 71 677 45 45

Lohstampfestrasse 8 Fax: +41 (0) 71 677 45 05
Postfach
CH-8274 Tägerwilen
Switzerland
Principles

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 3 System Description

3.1 Control and functional elements

The MASTERPULS® MP200 is exclusively controlled using the operating and display
elements on the handpiece.

1 Handpiece
connector
V-ACTOR
2 Handpiece
connector R-SW
3 Handpiece
connector R-SW
4 Connector
1 VACU-ACTOR
2
3
4

Fig. 3-1 Front and right side of MASTERPULS®MP200

1 A/B Switch
2 Mains connector
with mains switch
6 3 USB-B 1.1 Device
5 1
12 interface
2 4 Potential
3 equalisation
5 Footswitch
connector
6 USB-A 1.1 Host
interface
4

Fig. 3-2 Rear side MASTERPULS®MP200

NOTE

The USB-B1.1 connection (Fig. 3-2/3) is generally used for service purposes.
In addition it is possible to connect a Tablet PC.

The USB-A1.1 connection (Fig. 3-2/5) is only used for connecting a USB memory
stick for software update which supports the USB V1.1 protocol or higher.
System Description

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 1 Opening for the nebulizer
2 Openings for handpiece
1
holder

Fig. 3-3 Bottom side MASTERPULS®MP200

3.2 Scope of supply

The standard scope of supply of the MASTERPULS® MP200 includes the following
items:
–– MASTERPULS® MP200 control device
–– Mains cable (EU / USA)
–– Gel bottle
–– User manual (operating manual, systembook and training records)
–– R-SW handpiece set 13
–– Handpiece holder, complete
–– VACU-ACTOR start kit (4 suction cups different sizes,
depositing shelf,
holder for the suction cup,
transport case)

3.3 Unpacking
• Carefully remove the instrument and accessories from the packaging container.

• Check that all items are included in the packaging container and that they are not
damaged.

• Contact your supplier or the manufacturer immediately if any items are missing or
damaged.

• Retain the original packaging. It may prove useful for any later equipment trans-
System Description

port.

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 3.4 Transport
It requires two persons to transport the device after unpacking riskless and safe to the
treatment place.

NOTE
Make sure that your hands are dry and free of grease.

• Dismount the handpiece holder before transporting the device.

• Grip on the front and on the rear side with both hands on the bottom of the de-
vice as shown in in Fig. 3-4 and lift it carefully.

Fig. 3-4 Transporting the device

• Set the device slantly down in order to avoid squeezing the fingers.

14
3.5 Installation Instructions

3.5.1 Mounting the handpiece holders

There are openings for 6 handpiece holders and /or suction cup holder - 3 on the
right side and 3 on the left side of the MP200 in each case in the front, in the middle
and rear section.

3.5.1.1 Handpiece holder

There are two different handpiece holder:
–– for handpieces R-SW
–– for handpieces V-ACTOR.

1 Openings for insertion of the

System Description

handpiece and suction cup

holder

Fig. 3-5 Mounting the handpiece holder

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 The mounting of the handpiece holder is equal for both types.
• Push the holder into the provided openings at the Masterpuls®MP200.

3.5.1.2 Suction cup holder

1 Openings for insertion of the

handpiece and suction cup
holder

Fig. 3-6 Mounting the suction cup holder

• Push the holder into the provided openings at the Masterpuls®MP200.

3.5.2 Connecting the electrical power supply

• Connect the supplied mains cable to the mains connector on the rear side of the
device.
15
1 Mains connector
2 Connector for
1 potential equalisation

Fig. 3-7 Connecting the electrical power supply

• Insert the mains cable into the socket.

ATTENTION !
When setting up the instrument, make sure that the air outlets on the housing of
the MASTERPULS® MP200 are not blocked.
System Description

The instrument must only be connected to properly earthed and correctly installed
shockproof sockets!
The device must be positioned in a way so that disconnection from the mains is
easy to do.

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 3.5.3 Connecting the potential equalisation
At the rear side of the device a connection of a potential equalisation (Fig. 3-7/2) is
available if due to national regulations or room class a connection is required.
• Connect the cable for the potential equalisation to the PE connector of the MAS-
TERPULS MP200 (Fig. 3-7/2) and connect it to your PE connector.

3.5.4 Connecting handpiece

• Insert the plug of the handpiece into the corresponding handpiece connector on
the left rear side of the device.

1 Handpiece connector
V-ACTOR
2 and 3 Handpiece connector R-SW
4 connector VACU-ACTOR
1
2
3
4

Fig. 3-8 Connectors of the Handpieces and VACU-ACTOR

• Make sure that the red dot on the socket is aligned with the red dot on the
16 handpiece connector.

• Place the handpiece into the handpiece holder.

NOTE
Please also refer to the separate operating manual for your handpiece.

3.5.5 Connecting Tablet (optional)

1 USB connector to MP200
2 Main switch of the Tablet
1
2
System Description

Fig. 3-9 Tablet with charching device and USB cable

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 1 USB connector for
connecting Tablet PC
2 Footswitch connector
2
1

Fig. 3-10 Connection of tablet and footswitch - MP200 rear side

• Connect the USB connector of the tablet into the USB connector on the rear side
of the MP200.

3.5.6 Connecting VACU-ACTOR

1 Connection coupling for the
3
2 silicone hose
2 Hose
3 Coupling for connection the
1 suction cup
4 4 Suction cup
5 Bacteria filter

5 17

Grössenverhälnisse sind nicht real

Fig. 3-11 Connection VACU-ACTOR

NOTE
Immediately after the device output a one-sterile filter is used to avoid contamina-
tion of the device and to protect the following patients against comtamination.

• Insert the transparent suction cup into the coupling at the end of the longer hose
System Description

part.
–– There are suction cups in 4 different sizes to choose from.
• Insert the coupling of the shorter hose part into the connection clutch on the right
side of the MP200 (Fig. 3-8 / 4).

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 NOTE
The silicone air hose including the bacteria filter is a disposable part.
It must be disposed after each treatment to protect the patient and the system
against cross-contamination.

Fig. 3-12 available suction cups

3.5.7 Connecting the foot switch

The connector for an optional foot switch (article no. 10103) is located on the rear
side of the MP200 (Fig. 3-10).
• Plug the plug of the foot switch into the connector on the rear side of the MP200.

Treatment with the VACU-ACTOR can be activated and deactivated with the aid of
the foot switch.

18

Fig. 3-13 Optional Karl Storz foot switch

3.6 Compatibility
The STORZ MEDICAL Masterpuls MP200 is allowed to be operated with the following
handpieces:
System Description

–– handpiece R-SW part.no. 21700_xxxx

–– handpiece V-ACTOR part.no. 19365_0001

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3.7 Symbols

You must read the operating manual

Application unit of type B

Potential equalisation

Connector R-SW handpiece

Connector V-ACTOR handpiece

Connector VACU-ACTOR

USB-connector
CE mark
(in accordance with the Medical Device
Directive (MDD) 93/42/EEC)

CSA test mark

WEEE label

wearing ear protection 19

System Description

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 4 Operation

4.1 Switching on and off

• Switch on the device using the main switch on the rear side of the device.

1 main switch

Fig. 4-1 Main switch

4.2 Operation
The following options for operating the MP200 are available:
–– MP200 with R-SW handpiece
–– via the display of the handpiece
–– via the tablet touch screen

20 –– MP200 with V-ACTOR handpiece

–– via the tablet touch screen
–– MP200 with VACU-ACTOR
–– via the foot switch
–– via the tablet touch screen
Operation

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4.3 Operation of the handpiece
This device can be controlled directly using the handpiece. Corresponding setting
buttons can be used for selecting the treatment parameters. The indicator window
shows which setting has been selected.

1 2
1 decrease energy
6 2 increase energy
3 decrease frequency
7 4 increase frequency
10 11 5 Trigger button
8 6 Display energy
7 Set nominal shock
9 wave
3 4 8 Shock wave counter
9 Display frequency
10 key combination with
double function
11 key combination with
5 double function

(10 and 11 see separate

21
operating manual of the
handpiece )

Fig. 4-2 Display and setting buttons of the R-SW handpiece

For the total overview of the functions and the description of the handpiece please
read the seperate operating manual for your handpiece.

Operation

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 4.4 Operation of the Touch Screen of the Tablet PC
When using the handpiece R-SW handpiece or V-ACTOR handpiece as well as the
VACU-ACTOR the MP200 can also be controlled by a colour TFT monitor with touch
screen function. This allows individual adjustment of the parameters for the V-ACTOR
handpiece as well as the VACU-ACTOR.

The user interface is divided into various areas for displaying different information.

Menu bar: Monitor

Module selection

Parameter
selection

Monitor

Counter
display

Contact
pressure
Language Date / time Menu bar: Info & settings

22

Fig. 4-3 Structure of the user interface

Operation

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4.4.1 Module selection
The field at the top left is used for displaying the operating modes that can be se-
lected. Once a handpiece or the VACU-ACTOR is connected, it is possible to activate
the corresponding operating mode in the mode selection area. The active module
button is highlighted.

Fig. 4-4 Mode selection field

Symbols Meaning
Vibration therapy: Select V-ACTOR
23
R-SW mode: Select handpiece 1

R-SW mode: Select handpiece 2

suction cup therapy: Select VACU-ACTOR

Tabelle 4 -1 List of symbols for mode selection

Operation

19 600 02 0516
 4.4.2 Parameter selection and counter display
The PARAMETER SELECTION field is used for displaying and setting the treatment
parameters.

Operating mode R-SW

Here you define the energy level as well as the number and frequency of the pulses
before each treatment.

Fig. 4-5 Setting parameters - operating mode R-SW

Symbols Meaning
24
Set the energy level: increase / reduce
The set energy is displayed

Setting nominal SW value: increase / reduce

The set number of shocks is displayed
Nominal SW value set to ‚-‘ means SW limitation is switched
off

Set nominal frequency: increase / reduce

The set frequency is displayed
Display of the number of pulses administered
Press the Reset button to set the display to 0.
Tabelle 4 -2 Setting parameters

The desired energy level, nominal SW value and frequency can be achieved more quic-
kly by keeping the Increase/Reduce button pressed down.
Operation

19 600 02 0516
 Operating mode VACU-ACTOR

Fig. 4-6 Setting parameters- operating mode VACU-ACTOR

Symbols Meaning

Set intensity: decrease / reduce

It can be selected from 1 to 5. 25

Set time limit: decrease / reduce

The set time limit is displayed.

Set nominal frequency: decrease / reduce

The set frequency is displayed.

Set mode: decrease / reduce

Mode A or B can be selected.

The timer is running during treatment.

It is limited to 30 minutes.

Tabelle 4 -3 Setting parameters

Operation

19 600 02 0516
 Explanation of terms

Mode VI
The suction cup creates an interaction of vacuum and positive pressure with the adju-
sted frequency.
Mode VC
The suction cup creates a negative pressure. It pulsates between vacuum and ventila-
tion by different frequency settings.
Sizes of suction cups
Size XS
Size S
Size M
Size L

4.4.3 Contact intensity and Skin Touch display

You can track the contact intensity on a scale during the R-SW treatment.
The indicator of the intensity on the scale will begin to move as soon as you touch
the treatment zone with the R-SW shock transmitter. When the cursor is in the green
range, the contact intensity for the treatment corresponds to the recommended inten-
sity for the treatment.
You will also see whether the Skin Touch function is active.

26

Fig. 4-7 Contact intensity display

Symbols Meaning
Display of the contact intensity from yellow to green
(optimum pressure).
Skin Touch ON: the R-SW shocks are triggered without
activating the trigger button by simply pressing the shock
transmitter to the treatment zone.
Skin Touch OFF: the R-SW shocks are triggered only when
the trigger button is activated.
Tabelle 4 -4 Contact intensity and Skin Touch display

For operation with Skin Touch ON / OFF / AUTO please read the Operating Manual of
the R-SW handpiece.
Operation

19 600 02 0516
 For this purpose consider the following notes:

CAUTION!

Danger of injury from inadvertent shock triggering

Trigger shocks only when the handpiece is in contact with the in-
tended treatment zone.
Avoid accidental contact between the patient and the handpiece
when the Skin Touch function is activated.

• Avoid applying excessive contact pressure with the shock transmitter to the area to
be treated. Excessive pressure is not needed for the success of the treatment.

CAUTION!

The shock transmitter surface will become hot!

Extended skin contact can lead to minor burns!

• Interrupt treatment after a maximum of 6,000 shocks.

Do not apply more than 300-400 shocks to the same spot during treatment.
• Place the handpiece back in the handpiece holder after the treatment.

The Skin Touch option is switched off automatically after 10 minutes (with activation 27
of the screen saver) if no treatment has taken place during this time.

Operation

19 600 02 0516
 4.4.4 Treatment menu bar
Use the TREATMENT menu bar to call up stored treatment parameters and treatment
reports as indications.

Fig. 4-8 Treatment menu bar

Buttons Meaning
Markers for various The ANATOMY view appears automatically when the
treatment zones device is started. Press the corresponding markers to call
up factory-set or user-defined indications for the various
treatment zones.

28

The ORTHOPAEDICS menu contains an alphabetically

sorted list of factory-set or user-defined indications.
The PATIENTS menu contains an alphabetically sorted
list of stored patient records.
The VAS measures the patient‘s subjective pain sensati-
on on a scale within which the patient can classify his or
her pain intensity.
If you are in VAS mode, the Skin Touch button is inac-
tive.
Tabelle 4 -5 Treatment
Operation

19 600 02 0516
4.4.5 Device info and settings menu bar
The bottom navigation bar contains control buttons used for navigating through the
menus:

–– Software update
–– Options
–– Service
VERSIONS
–– Serial number and indices of the individual components

OPERATING DATA
–– Total pulse count and device operating hours (depending on
operating mode selected)
–– Total number of shocks delivered by the respective
handpiece, data on monitoring software, operating system,
hardware serial numbers and modification status

INSTRUCTIONS
–– Displays the operating manual
–– Select indication groups
–– Activate Skin Touch type ON - OFF
–– Activate Skin Touch type AUTO
–– Deactivate Skin Touch
–– Adjust volume
–– Adjust brightness
–– Back up data
–– Restore data
The flag on the right of the status bar displays the menu lan- 29
guage. Press the flag symbol to display the list of available menu
languages.
View treatment videos

Visible Body Anatomy atlas

–– Interactive 3D representation of the musculature
Tabelle 4 -6 Treatment

Operation

19 600 02 0516
 4.5 Touch screen operation

4.5.1 Configuration and reset

When starting the tablet the first time the touchscreen displays the content shown in
Fig. 4-9. While the first connection of the tablet to the device the tablet will be confi-
gured automatically for this device.

Fig. 4-9 Tablet - start page

Reset tablet to the factory default settings

30
• Press .

• Use the opened menu bar to select the function.

Fig. 4-10 Password screen for resetting the device type

• Type password „RESET“ ( in capital letters) and confirm with .

Operation

19 600 02 0516
 Fig. 4-11 Reset system configuration

• Confirm „Reset system configuration?“ by pressing .

–– The tablet will now be resetted and all stored patient and treatment data will
be deleted.
• Now start the tablet anew.

4.5.2 Password protection

It is possible to protect your SMAG tablet with a password.
If starting the tablet anew or if it is in screen saver mode so the display is locked and
can only be unlocked by entering the password.

Activate password protection

• Press several seconds on date and time field . 31

–– The following screen is shown.

Fig. 4-12 Activate password entry

• Press to activate password entry (the check mark needs to be set

after that).

• Press .

• Type now your password on the following screen and repeat it.
Operation

19 600 02 0516
 Fig. 4-13 Password entry

• Confirm with

hh Your password is activated.

Deactivate password protection

• Press several seconds on date and time field .

• Press to deactivate password entry (the check mark needs to be can-

celled after that).

• Type now your password on the following screen.

• Confirm with .

hh Your password is deactivated.

32
Forgot password?
If you forgot password,
• press “forgot password“.
On the following screen you get a random code.

Fig. 4-14 Forgot password

• Pass this random code to the Service.

Using this random code the service technician can generate a new password.
• Type this new generated password in the corresponding field.
Operation

• Confirm with .
hh All password settings are now resetted.

19 600 02 0516
4.5.3 Setting brightness and volume

• Select .

• Select in the open top menu bar.

Fig. 4-15 Options

• Tap on the scale at the desired position in order to adjust the brightness of the
screen or the volume.

• Press to save the settings.

If the menu is exited without saving the changes, the presettings will be reloaded.
33

4.5.4 Selecting the operating mode

Once the unit has been started, the display automatically shows the last setting.

To select a different operating mode:

• In the MODE SELECTION field, press the operating mode you want to activate.
–– The active mode button is highlighted.

Fig. 4-16 Mode selection field with F-SW mode activated

Operation

19 600 02 0516
 The operating mode is exited if you
–– select another mode
–– load an indication which requires working in another mode
–– operate another handpiece

4.5.5 Selecting treatment parameters

You can set the treatment parameters manually or load a predefined indication.

For manual selection

• Set the energy level as well as the number and frequency of the pulses using the
or buttons in the PARAMETER SELECTION field.

hh The treatment is now carried out with the displayed values.

4.5.6 Loading indications

The device makes it possible to load the default settings defined by the manufacturer
for typical indications.
You can also add your specific settings for these indications if you wish. Read about
this in Chapter 4.5.7 Saving indications.

To load all indications

• Press in the top menu bar.

34 –– The alphabetically sorted list of all indications is opened.

Fig. 4-17 List of stored indications

Operation

19 600 02 0516
 To load only the indications for a particular treatment zone

• Press the marker for the treatment zone.

Fig. 4-18 Selectable treatment zones

–– The alphabetically sorted list of indications for this treatment zone is

opened.

Navigating in the list

Use the navigation bar on the right edge of the display to move within the list. 35

1 Navigation bar

Fig. 4-19 List of stored indications

• Press the or button to scroll up or down.

or
• Call up a list filtered by initial letters by selecting the corresponding letter pairs.

• Load an indication using the button in front of it.

The following information is displayed about this indication in the overview
–– Treatment steps
Operation

–– Treatment notes (remarks)

–– Treatment pictures

19 600 02 0516
 Fig. 4-20 Overview - information about stored indications

Calling up detailed views:

For increased clarity, you can call up magnified views of the treatment photos as well
as the recommended shock transmitters and stand-off devices.
36
• Press the corresponding treatment photo.
–– The display shows a magnified view of the picture.

Fig. 4-21 Treatment photo detailed view

Operation

• Press the underlined shock transmitter or stand-off device name.

–– The display shows an image of the shock transmitter or stand-off device.

19 600 02 0516
 Fig. 4-22 D20 detailed view

Use the and buttons to switch to the display of the previous or next
element.

• Press to switch to the treatment step overview.

Loading treatment steps

• Load the first treatment step using the button in front of it.
–– The treatment parameters are accepted and displayed in the PARAMETER
37
SELECTION field of the display.

Fig. 4-23 Accepting the treatment parameters

Operation

19 600 02 0516
 Loading a patient dataset

You can now call up a patient record directly from the loaded indication.

• Press .

–– The list of stored patient data is opened.

• Load the required dataset by pressing .

–– The name of the patient is displayed in the status bar with the loaded
indication.

Fig. 4-24 Patient dataset has been loaded

The treatment now takes place with the loaded parameters and is recorded in the
patient data as a treatment report.

The and buttons can be used to switch back and forth between the
indication and the patient dataset.
More information about the patient record can be found in Chapter 4.5.11 Patient
treatment report.

is used to close the indication or patient dataset.

38 4.5.7 Saving indications

In addition to the preprogrammed indications, you can also save your own parameter
presets as an indication.
• Set the required parameters.

• Press .

• Press NEW INDICATION.

–– The dialog box for indications is opened.
Operation

Fig. 4-25 Creating a new indication

19 600 02 0516
 • Use the onscreen keypad to enter an indication name and treatment region.

• Save your entry by pressing OK.

• Create a treatment .step (see Chapter 4.5.10.3).

• Save your entry by pressing OK.

NOTE

An empty indication without any entryof a treatment step will not be saved.

hh Your indication is now created in the system. If you press the button to return
to the overview, you will see your new indication in the list.

4.5.8 Copying indications

A copy of a preprogrammed indication can also be created.
The copy will then be provided with an additional number when it is saved and will
contain all of the videos and images of the original indication.
• Load the desired indication (see Chapter 4.5.6 Loading indications).

39

Fig. 4-26 Copy indication

• Press the COPY INDICATION button.

hh The indication is now copied and can also now be edited (see Chapter 4.5.10
Editing indications).
Operation

19 600 02 0516
 4.5.9 Deleting an indication
• Press .

–– The list of indications is displayed.

• Select the indication that you want to delete by pressing the button in front of
it.
–– The indication is opened.

• Press DELETE INDICATION.

• Confirm your input by pressing OK.

NOTE

This only applies to your own indications. Standard indications preprogrammed

by the manufacturer cannot be deleted.

4.5.10 Editing indications

Once you have created an indication, you can edit it.

NOTE

This only applies to your own indications. Standard indications preprogrammed

40
by the manufacturer cannot be edited.

• To do this, set the indication to editing mode by pressing the

button.

The buttons with the pencil icon indicate the areas that can be edited.

Fig. 4-27 New indication in editing mode

You can now:

–– Store treatment notes
–– Load treatment images
–– Define treatment steps
Operation

19 600 02 0516
4.5.10.1 Storing treatment notes

• To add remarks to the indication, press in the line.

Using the onscreen keypad, you can now enter your remarks and notes in the text box.

• Save your text by pressing OK.

hh The text appears in the overview window of the indication.

4.5.10.2 Loading images and/or videos

Not only images but also videos can be loaded in WMV format.

• To add treatment pictures to the indication, press in the picture line .

Fig. 4-28 Editing pictures

• To add a picture or video, press .

41
• Select the desired picture or video on the USB stick and confirm your selection with
OK.
–– The picture or video is loaded and displayed in the picture line.

Newly loaded pictures and videos are automatically labelled with the date and time. If
you select the picture or video, you can have the picture caption displayed in the text
box under the picture bar.

Fig. 4-29 New image or video

• To change the label, press and enter your changes in the text box.

• Save by pressing OK.

Operation

19 600 02 0516
 Deleting pictures and/or videos

• To remove a picture or a video from the picture line, press on the symbol in
the picture and confirm your entry with OK.

hh The picture or video is deleted from the indication.

4.5.10.3 Creating, deleting or editing treatment steps

• Press to create a treatment step.

–– A window with an onscreen keypad and text boxes is opened.
• First select the working mode. To do this, press the arrow in order to open the
selection.

Fig. 4-30 Selecting the working mode

42 Depending on which working mode is selected, the unit above the ENERGY text box
changes from bar (R-SW / V-ACTOR) to mJ/mm2 (F-SW / C-ACTOR) and the SHOCK
TRANSMITTER text changes to STAND-OFF DEVICE.
• Enter the treatment parameters using the onscreen keypad.

• Save by pressing OK.

After the new treatment step has been saved, it appears in the overview.
Use the button to continue working on it at any time.

Deleting a treatment step

• Open the treatment step by pressing .

• Press to activate editing mode.

• Press DELETE STEP.

• Confirm your input by pressing OK.

Operation

19 600 02 0516
4.5.11 Patient treatment report
Each treatment of a patient can be recorded in a treatment report and stored.

4.5.11.1 Loading patient data

• Press in the top menu bar.

–– The alphabetically sorted list of patient data is opened.

Fig. 4-31 List of stored patient data

Navigating in the list

Use the navigation bar on the right edge of the display to move within the list.

• Press the or button to scroll up or down.

or
• Call up a list filtered by initial letters by selecting the corresponding letter pairs. 43

• Load a patient using the button in front of the name.

The following information is displayed about this patient in the overview

–– Name, date of birth and patient number
–– Notes
–– Pictures
–– Treatments performed
Operation

19 600 02 0516
 Fig. 4-32 Patient data

• In the TREATMENTS line, press the button to call up details.

–– You can now see which parameters have been used for the patient’s treat-
ment.
44
Operation

Fig. 4-33 Treatment parameters used

19 600 02 0516
4.5.11.2 Editing patient data
You can add additional notes or treatment pictures by setting the dataset to editing
mode.

• Press the button to do this.

The buttons with the pencil icon indicate the areas that can be edited.

You can now:

–– Store treatment notes
–– Load treatment images

4.5.11.3 Load treatment parameters

You can now assign an indication to the patient, indicating which parameters should
be used for the patient’s treatment.

• Press .

–– The alphabetically sorted list of indications is opened.

• Press to load an indication.

–– The loaded indication is displayed in the status bar next to the patient’s name.

Fig. 4-34 Indication has been loaded 45

–– The treatment parameters of the first treatment step are accepted and dis-
played in the PARAMETER SELECTION field of the display.
hh The treatment now takes place with the loaded parameters and is automatically
recorded in the patient record.

The patient record remains open as long as the patient’s name is displayed in
the status bar.

• Close the record by pressing the button.

Operation

19 600 02 0516
 4.5.12 Creating new patient data

• Press in the top menu bar.

–– The alphabetically sorted list of patients is opened.

• Press .
–– A window with a keypad and text boxes for the patient data is opened.

Fig. 4-35 Creating a new patient

• Enter the data.

46
• Save the entry by pressing .

• You can edit your new patient dataset to

–– Store notes
–– Add treatment pictures
For information about this, read Chapter 4.5.10.1 Storing treatment notes
and Chapter 4.5.10.2 Loading images and/or videos.

• Press the button to set the field you want to change to editing mode.

• Carry out your changes and save the entry by pressing .

Operation

19 600 02 0516
4.5.13 Exporting treatment data
This function can be used to export treatment data to a USB memory stick as
Excel-readable files.
• Ensure that your USB stick supports the USB V1.1 protocol. You can order a
validated USB stick from your dealer.

• Load the parameter record for a specific patient.

• Press .
–– You will be prompted to connect a USB stick.

• Confirm by pressing .
The data is transferred once the USB connection has been established. The export file
name of the patient record is protocol_name.csv.
• Wait until the ‘Export completed’ message appears on the display and then
remove the memory stick.

4.5.14 Deleting patient datasets

• Open the patient record to be deleted.

• Press .
–– The dataset is set to editing mode.

• Press . 47

• Confirm your input by pressing .

hh The patient dataset is deleted.

4.5.15 Resetting the treatment shock counter

• Press the RESET button in the COUNTER READINGS field to set the
display of applied shock waves back to ‘0’.

Fig. 4-36 Counter readings

hh The display of the number of pulses and the energy output per treatment is reset.
Operation

19 600 02 0516
 4.5.16 Software updates

4.5.16.1 Software Update Tablet PC

• Before performing software update download the update.

• Extract the files.

• Load the extracted files onto an USB stick.

• Connect the USB stick to the USB connector of the tablet PC.

• Press .

• In the open menu list, select the function.

• Confirm with .
–– The software will now be updated. A progress display in % informs you of
the progress of the update. You will receive a text message as soon as the
update has been completed.

• Confirm with .

hh To activate the software, you must restart the system after the update.

4.5.16.2 Software Update MP200

48 • Connect the USB stick to the left slot (USB-A, see Chapter 3.1 Control and functio-
nal elements) of the MP200.

• Connect the handpiece to the MP200.

• Switch on the MP200 - the update starts automatically.

–– On the display of the handpiece xxxxx is shown while the update will be
performed.
–– On the display of the handpiece the values of the energy are blinking if the
update is finished.
• Confirm the energy values.

hh Now you can go on with treatment.

Operation

19 600 02 0516
4.5.17 Changing software settings
This function enables you to activate or deactivate indication groups.

• Press .

• In the open menu list, select the function.

Fig. 4-37 Options: Orthopaedics active

You see the list of possible indication groups. 49

The symbol before an indication group indicates that it is activated.
• If you want to switch to another indication group, press the in front of it.

• Confirm by pressing the button.

4.5.18 Visible Body - Anatomy Atlas

Visible Body is an interactive 3D atlas of the human body with which the musculature
of the entire body and the individual muscle groups can be represented. Treatment
regions can be marked by the operator for the patient records and the image can be
saved afterwards as a screenshot.

Visible Body is available only in English.

Operation

19 600 02 0516
 4.5.18.1 Starting Visible Body

• To start Anatomy Atlas, press .

Fig. 4-38 Visible Body - Main menu

50

Fig. 4-39 Visible Body - Selection of the muscle region

Operation

19 600 02 0516
4.5.18.2 Marking treatment regions

• To load the marking pencil, press .

Fig. 4-40 Visible Body - Marking the treatment region

• Now draw your markings of the region on the control panel.

51

Fig. 4-41 Visible Body - Marked region

Operation

• Press the symbol to create a screenshot.

It will be saved automatically under the currently opened patient data.

19 600 02 0516
 4.5.18.3 Exiting Visible Body

• To exit the program, press on a module selection field (R-SW) or the empty area
located below on the left that is outside the Visible Body screen.

52

Fig. 4-42 Exit Visible Body

4.6 Setting treatment parameters

• Set the treatment parameters by pressing and buttons on the handpiece
display or on the tablet.

–– Each selected nominal value is shown on the display.

• Reset the shock wave counter while using a handpiece
by pressing button 1 and 3 simultaneously on the standard display (see
Fig. 4 - 2/10 key combination)
or
by pressing the button on the Tablet PC.

For the total overview of the functions and the description of the handpiece please
read the seperate operating manual for your handpiece.

• Reset the treatment time while treating with a suction cup by pressing the button
Operation

on the Tablet PC.

While treatment with a suction cup using the foot switch no treatment time is
displayed.

19 600 02 0516
4.7 Start-up
• Set the energy of the shocks to an initial value of 2 bar.

The maximum pressure is limited to 5.0 bar. The minimum pressure that can be set is
1.0 bar.
The R-SW handpiece can be operated in single shock mode and in continuous shock
mode.
• To work in R-SW single shock mode, select the ‘-’ symbol (dash) in the ‘Frequency’
selection box and activate the trigger button.

• To work in R-SW continuous shock mode, select a continuous shock frequency in

the range from 1,0 to 21 Hz in the ‘Frequency’ selection box.

• Activate the trigger button.

NOTE

If the set nominal shock value (e.g. 400 SW) is reached during treatment the
handpiece automatically stops releasing shocks. Further treatment is possible.

As soon as a multiple of the set nominal value is reached (e.g. 800 SW, 1,200 SW,
etc.) the handpiece stops anew.

4.8 Functional checks

Perform the following functional checks after the system has been installed: 53
• Check the device and the handpieces for any signs of damage.

• Put the device into operation.

• Set the energy level to 2 bar.

• Reset the treatment shock counter on the handpiece display.

• Release individual shocks in single shock mode.

• Release shocks in continuous shock mode (shock frequency 5 Hz/15 Hz).

• Press foot switch while the VACU-ACTOR is connected if it is used one.

• Check that the triggered shocks are correctly counted on the treatment shock counter.
Operation

19 600 02 0516
 4.9 Standard settings
• Before each treatment, make sure that the shock wave counter is set to zero.

NOTE
Set the nominal value counter to the required value.

R-SW

• Start the R-SW treatment at a pressure of 2 bar and a frequency of 5 Hz.

V-ACTOR

• Without Tablet:
The treatment parameters for the V-ACTOR ll are fixed at an energy level of
2,4 bar and a frequency of 31 Hz.

With Tablet:
The treatment parameter are adjustable in an energy level range from 1-5 bar and
frequency range from 1-35 Hz.

• The number of shocks for trigger point shock wave therapy (TrST) is different from
ESWT treatment. Such therapies must only be performed by personnel suitably
qualified and trained in TrST.

54
4.10 Treatment with R-SW or V-ACTOR handpiece
Safety information
Before using the device, the user must make sure it is functioning safely and in proper
condition.
• Read Chapter 1 General Safety Information before beginning treatment.

CAUTION!

Handpiece not positioned correctly.

Impairment to health due to ineffective treatment!
• Define the treatment zone and make sure that the handpiece
position always corresponds to the treatment zone.
• Make sure that the treatment is only administered by users who
meet the conditions in Chapter 2.2 Preconditions for operation.

• For safety reasons, using the device for applications other than those specified in
Chapter 1 General Safety Information is not permitted!
Operation

19 600 02 0516
 CAUTION!

Malfunction of the device or its components

Various injuries are possible!
• Immediately comply with all status and error messages which
appear during the treatment (see Operating Manual of the
handpiece).

CAUTION!

Over extended periods, the noise of the shocks can be per-

ceived as unpleasant!
• Offer ear protection to the patient.
• Recommendation: The user should also wear ear protection.

4.10.1 Setting parameters

Treatment should always start at a low energy level. This also applies to resuming
treatment after an interruption. The shock wave energy should be increased gradually
during treatment. The low levels are used less for therapy and more for familiarising
the patient.
• Select a low energy level and frequency (see Chapter 4.2 Operation).

NOTE 55

The selection of energy levels is based on the medical opinion of the doctor
administering treatment. The maximum energy level used during treatment
must not cause the patient undue pain under any circumstances.

4.10.2 Coupling the handpiece

R-SW

• Apply a sufficient amount of coupling gel to the patient’s skin in the treatment
area and to the shock transmitter.

• Avoid excessive pressure of the shock transmitter to the patient‘s skin. Excessive
pressure is not needed for the success of the treatment.

V-ACTOR

• Apply a sufficient amount of massage oil to the patient’s skin in the treatment area
and to the V-ACTOR II shock transmitter.
Operation

19 600 02 0516
 4.10.3 Triggering shocks
Once all necessary preparations have been taken, it is possible to start the treatment.
• Make sure that the shock wave counter is at zero and a low energy level has been set.

• Press the trigger button on the handpiece.

–– Pressing the trigger button anew stops the shock wave release.

4.10.4 Functions overview of the handpiece R-SW

For the total overview of the functions and the description of the handpiece please
refer to the seperate operating manual handpiece R-SW.

4.11 Treatment with VACU-ACTOR

CAUTION !

Do not apply the VACU-ACTOR in the face.

Do not apply the VACU-ACTOR longer than 30 minutes.
Do not use damaged suction cups.
Only perform treatment in a dry state.
Blood cupping is not allowed!
56 Only perform treatment at healthy and intact skin!
Avoid hematoma, pain and tissue damage!

• Connect the suction cup into the coupling of the air hose (see Fig. 3-11).

NOTE

The maximum underpressure of the compressor is -935 mbar.

While treatment pressures between -500 mbar and +200 mbar will be reached
depending on the adjusted intensity.
The vent hole limits the maximum underpressure to -500 mbar.
• In case of an error the vent hole can be opened.

Treatment with VACU-ACTOR can either be activated and deactivated with the
footswitch or optional can be switched on and off with the aid of the Tablet PC.
Using the Tablet PC the treatment parameters can be adjusted.
Operation

19 600 02 0516
4.11.1 Using the foot switch
When using the foot switch to activate the VACU-ACTOR the treatment is carried out
with intensity 3.

The treatment will always be carried out with mode VI in which alternately an under-
pressure and overpressure will be produced.
• Apply massage oil onto the area to be treated.

• Place the VACU-ACTOR air tight to the skin.

• Keep the vent hole closed with your finger.

• Pressing the foot switch --> treatment will be started.

• Pressing the foot switch a second time --> treatment will be stopped.

NOTE

Move the suction cup slowly over the area to be treated as long as the treat-
ment lasts.

4.11.2 Using the Tablet PC (optional)

When using the Tablet the preadjusted parameters can be varied. See for this Chapter
4.4 Operation of the Touch Screen of the Tablet PC.
• Adjust the intensity, the frequency and the time limit on the touch screen. 57

• Choose the mode.

• Apply massage oil onto the area to be treated.

• Place the VACU-ACTOR air tight to the skin.

• Keep the vent hole closed with your finger.

• Press ON underneath the parameter list. --> treatment swill be started.

• Press OFF underneath the parameter list. --> treatment will be stopped.

NOTE

Move the suction cup slowly over the area to be treated as long as the treat-
ment lasts.
Operation

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 5 Cleaning, Maintenance, Overhaul

5.1 Cleaning
Regular cleaning of the system ensures perfect hygiene and operation of the
Masterpuls®MP200.

CAUTION!

Electrical hazard!

Disconnect the device and the accessories from the mains before
starting any cleaning and overhauling work!

Overall external cleaning depends on the frequency of use and application of the
device.

All parts which come into contact with the patient must be cleaned after each
treatment.
• Wipe down the device parts with a damp cloth.

• For cleaning, use a lukewarm, dilute solution of non-vegetable soapy water.

ATTENTION
It is essential that no fluid be permitted to penetrate either the device or its
58 tubing.

Ventilation slots

• Keep the ventilation slots clear.

5.1.1 Cleaning the handpieces

For information about cleaning and overhauling the handpieces, refer to the
Cleaning, Maintenance, Overhaul

corresponding chapters for the corresponding handpiece.

5.1.2 Reconditioning the VACU-ACTOR

ATTENTION !
After each application of the device with the suction cup all reusable parts which
have been in contact with the patient need to be cleaned and disinfected.

After each application of the device with the suction cup all reusable parts which have
been in contact with the patient need to be reconditioned for further application, to
get the parts free of microorganism.
The instructions must be strictly followed to exclude damage of the parts.

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5.1.2.1 Preparation of cleaning

Choose a clean, dust-free workplace, to perform the cleaning and disinfection.

Material required

Make sure that the following objects and tools for cleaning and disinfection are
available:
–– clean, soft and and lint-free cleaning tissues
–– cleaning agent suitable for polycarbonate .
–– surface disinfectant (recommended is Meliseptol)

Disassembly of the medical device

• Pull the suction cup off the air hose.

• Disconnect the air hose from the device.

The air hose as well as the bacteria filter are disposable parts and need to be disposed.
• Dispose the air hose including the bacteria filter in accordance with your hygiene
plan.

• Check the suction cup for damage or leakages.

Perform cleaning and disinfection as described in the following Chapters.

5.1.2.2 Cleaning
59
The suction cup made of polycarbonate has a pore-free surface so that dirt does not
cling easily to it.
• Wipe the suction cup with a soft tissue moistened with water (recommended is
microfibre), never rub with a dry tissue!

NOTE

Never rub the suction cup with a dry tissue.

For efficient cleaning we recommend using a non abrasive detergent suitable for Cleaning, Maintenance, Overhaul
polycarbonate.
• Oily dirt can be removed by gently rubbing with a soft tissue soaked with deter-
gent suitable for polycarbonate.

Polycarbonate has a good electrical insulation property which results in electrostatic

charging and attraction of dust.
Before treatment it is recommended to remove the surface adhering dust by blowing
with ionized air.

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 ATTENTION !
Avoid damaging the suction cup !

Sharp tools, abrasive or strongly alkaline detergents, solvents, leaded benzine and
carbon tetrachloride should not be used.
All mechanical cleaning systems for example brushes are not allowed.
Corrosive cleaning agents and sharp devices are not allowed.

ATTENTION !
The suction cup consists of polycarbonate.

Do not place in ultrasonic bath.

Do not place in a washing maschine.

5.1.2.3 Disinfection

• Wipe the suction cup with a soft tissue soaked with a suitable surface disinfectant
(microfibre is recommended).

• Inject the suction cup with a disinfection spray.

• Let the suction cup dry.

NOTE
60
The service life of the suction cup can only be reached, if no others as the re-
commended cleaning and disinfction agents are used.
After frequent cleaning and disinfection cycles a clouding of the suction cup
may occur, but does not affect the functioning.

5.1.3 Fuse replacement

The mains fuse holder is located on the rear of the Masterpuls®MP200 between mains
Cleaning, Maintenance, Overhaul

connector and mains switch.

• Press the two tabs from the open spaces (Fig. 5-1/1 and 2) of the fuse holder
inwards and pull out the fuse holder of the housing.

2 1 u 2 open spaces to pull out the fuse holder

Fig. 5-1 Mains connector, fuse holder, mains switch

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 Fig. 5-2 Fuse holder

• Pull the old fuses out of the mains fuse holder.

• Replace the fuses (T 8 AL / 250  VAC).

• Push the mains fuse holder back into the opening until it engages.

5.2 Maintenance and safety checks

Preventive maintenance is not necessarily required. However, regular maintenance
may help to identify possible defects at an early stage and thus increase the safety and
service life of the device.
Maintenance services can be ordered from our regional representatives in your area or
directly from STORZ MEDICAL AG.
Independently of the national accident prevention regulations and test and inspection
intervals prescribed for medical devices, we recommend that functional checks (see
Chapter 4.8 Functional checks) and safety checks in accordance with MPBetreibV
(Germany), MPBV (Austria), MepV (Switzerland) be performed at least once a year.
61
The following checks should be performed to ensure that the Masterpuls®MP200
operates safely.

1 Earth leakage current test according to national regulations.

2 Earth impedance test (with mains cable, incl. applicator housing) according to
national regulations.

NOTE

Cleaning, Maintenance, Overhaul

For further details on content and performance of the safety checks please contact
your local dealer.

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 5.3 Disposal
When disposing of this medical product, no special measures have to
be observed. Please proceed in accordance with applicable country-
specific regulations. After expiration of its service life, dispose of the
Masterpuls®MP200 as waste electronic equipment.

5.4 Repair
Repair work on defective devices must only be carried out by personnel suitably
authorised by STORZ MEDICAL. Only original STORZ MEDICAL spare parts may be
used for this purpose. The personnel suitably authorised can be from STORZ MEDICAL
or be representatives of STORZ MEDICAL agencies and dealers.

5.5 Service life

The average expected service life is approx.
–– 3,500 operating hours for the Masterpuls MP200
–– 100 cleaning and disinfection cycles for the suction cup

For information about the service life of the other handpieces, please refer to the
separate operating manuals for the respective handpiece.

Exceeding the service life can be expected to result in a failure of the device and
accessories. This also applies to handpieces.
62
No warranty claims shall be accepted beyond the information given in Chapter 8.1
Warranty for the control device of the Masterpuls MP200.
Cleaning, Maintenance, Overhaul

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6 Accessories

Mains cable CEE 4 m long 13455

Mains cable CH 3 m long 13448

R-SW »Falcon« handpiece set 21700.1001

R-SW »Falcon« overhaul kit 26894

A6 shock transmitter 17675

T10 shock transmitter set 13457

R15 shock transmitter 17638

C15 shock transmitter 19222

F15 shock transmitter 21356

DI15 shock transmitter 21374

D20-S shock transmitter 21004

D20-T shock transmitter 21125

D35-S shock transmitter 21122

V-ACTOR handpiece 19365.0001

V-ACTOR ball - V10 21348

63
Gel bottle 500 ml 18189

Suction cup set 26923

Sucion cup XS 26912

Sucion cup S 26913

Sucion cup M 26914

Sucion cup L 26915

Set 10 air hoses with bacteria filter 26421

Suction cup holder 26854

Foot switch 10103

mains adapter for the Tablet 26157

MASTERPULS®MP 200 operating manual 25294

Accessories

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 7 Technical Specifications

7.1 Technical Specifications

MASTERPULS®MP200

single shock, continuous shock

R-SW operating mode HP 21700.0001: 1-21 Hz / 1-5 bar in steps of 0.1 bar
HP 21700.1001: 1-21 Hz / 0.3-5 bareff
operating mode V-ACTOR:
- standard 31 Hz / 2,4 bar
- when using an 1 - 35 Hz / 1 - 5 bar
external display

operating mode VACU- with foot switch: // with tablet:

ACTOR: 3 - all values adjustabler
–– intensity according Table 4 -3

pressure VACU-ACTOR max 200 mbar

under pressure VACU-ACTOR min. - 500 mbar
Mains input voltage 220 - 230 VAC // 115 VAC
Mains frequency 50 - 60 Hz // 60 HZ
Mains fuse T8AL / 250 VAC
Power consumption max. 500 VA
64
Compressed air supply internal
Compressed air output 1 – 5 bar
Ambient temperature
10° – 40°C
during operation
Ambient temperature
0° – 60°C frost free
during storage and transport
Ambient pressure
800 – 1060 hPa
during operation

Ambient pressure
500 - 1060 hPa
during storage and transport

Air humidity 5 – 95%, non-condensing

Control device weight 25 kg
Technical Specifications

Housing dimensions (W x H x D) 487 x 191 x 465 mm

Classification according to MDD Class IIa device

Protection against the ingress

IPX1
of water

Subject to technical modifications

For the technical specifications of the handpieces, please refer to the operating
manual for your particular handpiece.

19 600 02 0516
 Equipment safety (“essential performance“) according to IEC 60601-1, 3rd edition:
Applied acoustic energy does not exceed the specified limit of 6.5 bar with a tolerance
of 10%.
The applied underpressure with the suction cup is limited to -500 mbar.

NOTE
When the medical product is distributed to third parties, the following must be
observed:

–– The complete device documentation must be delivered together with the

medical product.
–– The medical product may only be exported to a foreign country when the
medical product and the corresponding indications are allowed there.

7.2 Type plate MASTERPULS®MP200

65

Fig. 7-1 Type plate voltage supply 220 - 230 VAC

Fig. 7-1 Type plate voltage supply 115 VAC

Technical Specifications

7.3 Conformity with directives

This medical product bears the CE mark in accordance with the
Medical Device Directive (MDD) 93/42/EEC

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 7.4 Conformity with standards
This device complies with the applicable standards EN 60601-1, CAN  /  CSA-C22.2 No. 601.1,
UL Std. No. 60601-1.

Acc. to EN 60601-1

- Type of protection against electric shocks: Protection class 1

- Application unit of type B

7.4.1 EMC guidelines and manufacturer’s declaration

Guidelines and manufacturer's declaration – emitted electromagnetic interference

The MASTERPULS® MP200 model is intended for operation in the electromagnetic environment specified
below. The customer or the user of the MASTERPULS® MP200 should ensure that it is used in such an
environment.

Interference emission
Compliance Electromagnetic environment – guidelines
measurements

66
HF emissions acc. The MASTERPULS® MP200 uses HF energy only for its
to CISPR 11 internal functioning. Therefore, its HF emissions are very
Group 1 low and are not likely to cause any interference in nearby
electronic equipment.

The MASTERPULS® MP200 is suitable for use in all

HF emissions acc.
Class B establishments, including domestic establishments and
to CISPR 11
those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.
Harmonic emissions
according to IEC 61000- Class A
3-2

Voltage fluctuations
/ flicker emissions
Complies
according to IEC 61000-
3-3
Technical Specifications

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 Guidelines and manufacturer's declaration –
Resistance to emitted electromagnetic interference

The MASTERPULS® MP200 model is intended for operation in the electromagnetic environment specified
below. The customer or the user of the MASTERPULS® MP200 should ensure that it is used in such an
environment.

IEC 60601 Compliance Electromagnetic environment –

Immunity tests
test level level guidelines

Electrostatic Floors should be wood, concrete or ceramic

discharge (ESD) acc. ±6 kV contact ±6 kV contact tile. If floors are covered with synthetic
to IEC 61000-4-2 discharge discharge material, the relative humidity should be at
±8 kV air ±8 kV air least 30%.
discharge discharge

Electrical fast Mains power quality should be that of a

transient ±2 kV for power ±2 kV for power typical commercial or hospital environment.
disturbances / supply lines supply lines
bursts according to ±1 kV for input/ ±1 kV for input/
IEC 61000-4-4 output lines output lines

Surges according to ±1 kV line(s) to ±1 kV line(s) Mains power quality should be that of a

IEC 61000-4-5 line(s) to line(s) typical commercial or hospital environment.
±2 kV line(s) to ±2 kV line(s)
earth to earth

Voltage drops, short Mains power quality should be that of a

interruptions and typical commercial or hospital environment.
< 5% UT < 5% UT
voltage variations on If the user of the MASTERPULS® MP200 67
power supply input (> 95% drop in (> 95% drop in requires continued operation during power
lines according to UT) for ½ period UT) for ½ period mains interruptions, it is recommended that
IEC 61000-4-11
40% UT 40% UT the MASTERPULS® MP200 be powered from
an uninterruptible power supply or a battery.
(60% drop in UT) (60% drop in UT)
for 5 periods for 5 periods

70% UT 70% UT

(30% drop in UT) (30% drop in UT)

for 25 periods for 25 periods

< 5% UT < 5% UT

(> 95% drop in (> 95% drop in

UT) for 5 s UT) for 5 s

Power frequency The mains frequency magnetic fields should

(50/60 Hz) magnetic be those of a typical business or hospital
field IEC 61000-4-8 3 A/m 3 A/m environment.
Technical Specifications

NOTE UT is the mains alternating voltage prior to application of the test level.

19 600 02 0516
 Guidelines and manufacturer's declaration –
Resistance to emitted electromagnetic interference

The MASTERPULS® MP200 model is intended for operation in the electromagnetic environment specified
below. The customer or the user of the MASTERPULS® MP200 should ensure that it is used in such an
environment.

IEC 60601 Compliance

Immunity tests test level level Electromagnetic environment – guidelines

Portable and mobile RF equipment should be used no

closer to any part of the MASTERPULS® MP200, including
cables, than the recommended safety distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended safety distance:

3 Vrms 3 Vrms
Conducted RF
150 kHz to 150 kHz to d = 1.2√P
IEC 61000-4-6
80 MHz 80 MHz

d = 1.2√P
Radiated HF for 80 MHz to 800 MHz
3 V/m 3 V/m
interference
80 MHz to 80 MHz to
according to
2.5 GHz 2.5 GHz d = 2.3√P
IEC 61000-4-3
for 800 MHz to 2.5 GHz

Where P is the rated power of the transmitter in watts (W)

according to the transmitter manufacturer and d is the
recommended safety distance in metres (m).
68
The field intensity of stationary radio transmitters, based
on an on-site inspection a, should be less than the
compliance level.b

Interference may occur in the vicinity of devices marked

with the following symbol.

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

a
Technical Specifications

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment with respect to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the MASTERPULS® MP200 is used exceeds the applicable HF compliance level above,
the MASTERPULS® MP200 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the MASTERPULS®
MP200.

b
Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

19 600 02 0516
 Recommended safety distances between portable and
mobile HF communications equipment and the MASTERPULS® MP200

The MASTERPULS® MP200 is intended for use in an electromagnetic environment in which radiated HF
disturbances are controlled. The customer or the user of the MASTERPULS® MP200 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile HF
communications equipment (transmitters) and the MASTERPULS® MP200 as recommended below,
according to the maximum output power of the communications equipment.

Safety distance according to frequency of transmitter [m]

Rated power
of transmitter
[W] 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2√P d = 1.2√P d = 2.3√P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended safety distance can
be estimated using the equation applicable to the frequency of the transmitter, where P is the rated power
of the transmitter in watts [W] according to the transmitter manufacturer.

NOTE 1
An additional factor of 10/3 was used for calculating the recommended safety distance of transmitters in 69
the frequency range from 80 MHz to 2.5 GHz in order to reduce the probability that a mobile/portable
communications device brought into the patient area might inadvertently lead to a malfunction.

NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

Technical Specifications

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 7.5 Certificates

70
Technical Specifications

Fig. 7-2 Declaration of conformity

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7.6 Symbols and labels
The following symbols and labels are attached to the Masterpuls®MP200:

2 1

Label Name

Type plate 220 - 230 VAC

71
Type plate 115 VAC

You must read the operating manual

2

WEEE symbol

Tabelle 7 -7 Labelling
Technical Specifications

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 8 Warranty and Service
ATTENTION
Modifications to the device are not permitted.
Any unauthorised opening, repair or modification of the device by unauthorised
personnel will relieve the manufacturer of its liability and responsibility for safe
system operation. This will automatically void the warranty even before the end of
the warranty period.

8.1 Warranty for the control device

During the two-year warranty period from the date of delivery of the product to
the end customer, defects will be remedied at no charge to the customer upon the
customer furnishing adequate proof that the defect is due to defects in material or
workmanship. The warranty does not extend to wear parts.
Transport costs and the risk of loss during the shipping of returned products shall be
borne by the customer.
Please complete the attached warranty card and return it as soon as possible to the
address below:

STORZ MEDICAL AG
Lohstampfestrasse 8
CH-8274 Tägerwilen

8.2 Warranty for the handpiece

72
The warranty conditions for the handpiece can be found in the operating manual for
the corresponding handpiece.
Warranty claims will only be accepted if the handpiece is returned in its complete and
original state, cleaned and in the case, with the repair label filled in completely.
Missing components will be replaced subject to charge. Accessories also sent will be
checked and, if necessary, replaced after we have assessed them.
Shock transmitters and overhaul kits are not covered by the handpiece’s warranty.

8.3 Warranty for the VACU-ACTOR

The air hose as well as the bacteria filter are disposable parts. The suction cup is a
consumable part. Therefore they are excluded from warranty claims.
Warranty and Service

8.4 Service
Should you have any further questions or require additional information, please feel
free to contact your dealer.

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