Storz MASTERPULS MP200 User manual

Operating Manual
MASTERPULS®MP200
Published: May 2016
Original language: German
Publisher:
STORZ MEDICAL AG
Lohstampfestr. 8
CH-8274 Tägerwilen
Switzerland
25294
BS.####
Part No. 23220.xxxx

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Table of Contents
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
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
3.7 Symbols 19
4 Operation 20
4.1 Switching on and off 20
4.2 Operation 20

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Table of Contents
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
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
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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Table of Contents
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
5.5 Service life 62
6 Accessories 63
7 TechnicalSpecications 64
7.1 TechnicalSpecications 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 Certicates 70
7.6 Symbols and labels 71
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
Preface
Warning notes
This manual contains warnings, safety instructions and specic 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.
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
Additional information concerning specic features or operating instructions is
preceded by the term 'NOTE'.

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General Safety Information
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 prociency, 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!
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.
• 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 ow 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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General Safety Information
• 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 classication 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 signicantly 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!
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 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
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’sdeClaratiOn.

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General Safety Information
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 specication.
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.
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.

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Principles
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.
2.1.1 Indications
– Calcaneal spur /plantar fasciitis
– Shoulder pain with or without calcications
– 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 supercial muscle trigger points, myofascial trigger points
– Supercial insertion tendonitis (paratendinary area)
– Chronic back pain (cervical/lumbar parts of vertebral column)
– Acupuncture shock wave therapy

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Principles
Qualied training in acupuncture and acupuncture shock wave therapy (AkuST) is
required for therapeutic application of the MASTERPULS®MP 200 in the eld 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 eld
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 rst treatment
CAUTION!
Shock waves must not be applied to target areas located above air
lled 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.

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Principles
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 qualied 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 efciently 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
– 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: [phone]
Lohstampfestrasse 8 Fax: [phone]
Postfach
CH-8274 Tägerwilen
Switzerland

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System Description
3 System Description
3.1 Control and functional elements
The MASTERPULS®MP200 is exclusively controlled using the operating and display
elements on the handpiece.
3
1
2
4
1 Handpiece
connector
V-ACTOR
2 Handpiece
connector R-SW
3 Handpiece
connector R-SW
4 Connector
VACU-ACTOR
Fig. 3-1 Front and right side of MASTERPULS®MP200
1
2
3
5
6
1 A/B Switch
2 Mains connector
with mains switch
3 USB-B 1.1 Device
interface
4 Potential
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.

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System Description
1 Opening for the nebulizer
2 Openings for handpiece
holder
1
2
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
– 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-
port.

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System Description
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 ngers.
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
1 Openings for insertion of the
handpiece and suction cup
holder
Fig. 3-5 Mounting the handpiece holder

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System Description
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
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.
1
1 Mains connector
2 Connector for
potential equalisation
2
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.
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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System Description
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
3
1
2
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
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
1 USB connector to MP200
2 Main switch of the Tablet
2
Fig. 3-9 Tablet with charching device and USB cable

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System Description
1
1 USB connector for
connecting Tablet PC
2 Footswitch connector
2
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
silicone hose
2 Hose
3 Coupling for connection the
suction cup
4 Suction cup
5 Bacteria lter
2
1
4
5
Grössenverhälnisse sind nicht real
3
Fig. 3-11 Connection VACU-ACTOR
NOTE
Immediately after the device output a one-sterile lter 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
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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System Description
NOTE
The silicone air hose including the bacteria lter 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.
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:
– handpiece R-SW part.no. 21700_xxxx
– handpiece V-ACTOR part.no. 19365_0001

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System Description
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

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Operation
4 Operation
4.1 Switching on and off
• Switch on the device using the main switch on the rear side of the device.
1
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
– MP200 with V-ACTOR handpiece
– via the tablet touch screen
– MP200 with VACU-ACTOR
– via the foot switch
– via the tablet touch screen