Storz DUOLITH SD1 R-SW User manual

Operating Manual
DUOLITH®SD1 Tower
BT.####
Published: March 2020
Original language: German
Manufacturer / Publisher:
STORZ MEDICAL AG
Lohstampfestr. 8
CH-8274 Tägerwilen
Switzerland
Part No. 19900.xxxx
29081.0002

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Preface

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Preface
Impressum
Operating manual for
DUOLITH®SD1 Tower
Manufacturer
STORZ MEDICAL AG
Lohstampfestrasse 8
CH-8274 Tägerwilen
Telephone: [phone]
Fax: [phone]
E-mail: [email protected]
URL: www.storzmedical.com
Medical devices identied with this CE mark are in
accordance with the regulations in EC Directive 93/42/EEC
"Council Directive concerning medical devices".
The operating manual, including all of its parts, is protected by
copyright. Any utilisation outside the strict limits of copyright law
without written permission from the manufacturer is prohibited
and punishable.
This applies in particular to duplication, translation, microlming as well
as input and processing in electronic systems.

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Preface
Structure of the operating manual
This operating manual contains all the information required for operating the
DUOLITH®SD1 Tower manufactured by STORZ MEDICAL AG.
All safety information is provided in Chapter 1 general safety infOrMatiOn..
Chapter 2 prinCiples contains the list of indications and contraindications as well as the
preconditions for using the entire device.
Instructions for installation and transport can be found in Chapter 3 systeM desCriptiOn.
Chapter 4 OperatiOn presents the controls of the various expansion variants as well as
treatment notes for the F-SW module and the R-SW module.
status Messages and errOr Messages you will nd in Chapter 5.
Information about cleaning, disinfection and maintenance as well as technical safety
checks can be found in Chapter 6 Cleaning and MaintenanCe.
A list of the available accessories can be found in Chapter 7 aCCessOries.
Chapter 8 teChniCal speCifiCatiOns contains the technical specications for all modules
and their handpieces.
Warranty conditions for the device and the handpieces can be found in Chapter 9
Warranty and serviCe.
Chapter 10 ultrasOund MOdule provides instructions for operating the integrated
ultrasound unit.
Important note
The DUOLITH® SD1 Tower is a medical device. Therefore, the shock wave
device is only allowed to be operated by trained personnel. The device is only
allowed to be used for the applications described in this operating manual.
In order to work with the ultrasound module, the user must possess the
necessary technical prociency in ultrasound diagnostics.
Safety information that indicates dangers for people and the device must be
followed at all times.
Preface
Before starting to work with the DUOLITH®SD1 Tower, familiarise yourself with the
content of the operating manual.
Text design
This operating manual contains certain types of text design intended to assist you in
comprehending the signicance of the text based on its appearance.

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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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Preface
Instructions for actions
• This text instructs you in how to operate your system correctly.
– This text subdivides an action into steps or comments on the action step.
hThis text shows the result of an action.
Lists
– This text is part of a list.
Menus and buttons
Names of menus and buttons are highlighted by being written in CAPITAL LETTERS.
The description of operating procedures contains the necessary buttons or the
expected displays in the text.
Cross references to other chapters
Cross references to other chapters are highlighted in bold and in small caps.
Example: Chapter 2.2 preCOnditiOns fOr OperatiOn.
Abbreviations
The following abbreviations are used in this book:
– R-SW Radial shock waves
– F-SW Focused shock waves
– IPP Induratio Penis Plastica
– US Ultrasound
– PE Potential equalisation

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Preface
Table of Contents
General Safety Information 1-1
1.1 Instructions for safe use 1-2
1.1.1 Intended use and operational safety . . . . . . . . . . . . . 1-2
1.1.2 Safety during treatment of the patient. . . . . . . . . . . . . 1-5
1.2 Warning against damage to equipment and the device 1-5
Principles 2-1
2.1 Physical principles 2-2
2.1.1 Indications . . . . . . . . . . . . . . . . . . . . . 2-3
2.1.2 Contraindications . . . . . . . . . . . . . . . . . . . 2-4
2.1.3 Side effects . . . . . . . . . . . . . . . . . . . . . 2-4
2.2 Preconditions for operation 2-5
2.2.1 Operating personnel . . . . . . . . . . . . . . . . . . 2-5
2.2.2 Training of the operator . . . . . . . . . . . . . . . . . 2-5
System Description 3-1
3.1 Overview of the entire system 3-2
3.2 Scope of supply 3-4
3.2.1 Unpacking the device . . . . . . . . . . . . . . . . . . 3-6
3.3 Installation 3-6
3.3.1 Correct positioning of the device . . . . . . . . . . . . . . 3-6
3.3.2 Mounting the handpiece holder . . . . . . . . . . . . . . 3-6
3.3.3 Potential equalisation connection . . . . . . . . . . . . . . 3-8
3.3.4 Electrical connection . . . . . . . . . . . . . . . . . . 3-8
3.4 Transport 3-9
3.5 Description of the Control module 3-11
3.5.1 Control and functional elements . . . . . . . . . . . . . . 3-11
3.5.2 Connectors . . . . . . . . . . . . . . . . . . . . . 3-12
3.6 Description of the F-SW module with accessories 3-13
3.6.1 Control and functional elements . . . . . . . . . . . . . . 3-13
3.6.2 Compatible handpieces . . . . . . . . . . . . . . . . . 3-13
3.6.3 F-SW handpiece . . . . . . . . . . . . . . . . . . . 3-14
3.6.4 F-SW SEPIA handpiece . . . . . . . . . . . . . . . . . 3-15
3.6.5 C-ACTOR II handpiece . . . . . . . . . . . . . . . . . 3-16
3.6.6 F-SW SEPIA / C-ACTOR SEPIA handpiece . . . . . . . . . . . . 3-17
3.6.7 Handpiece connection . . . . . . . . . . . . . . . . . 3-18

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3.7 Description of the R-SW module with accessories 3-19
3.7.1 Control and functional elements . . . . . . . . . . . . . . 3-19
3.7.1.1 Compatible handpieces . . . . . . . . . . . . . . . . . 3-20
3.7.2 R-SW handpiece . . . . . . . . . . . . . . . . . . . 3-20
3.7.3 V-ACTOR handpiece . . . . . . . . . . . . . . . . . . 3-21
3.7.4 Connecting handpieces . . . . . . . . . . . . . . . . . 3-22
3.7.5 Connecting VACU-ACTOR . . . . . . . . . . . . . . . . 3-23
3.7.6 Connecting the foot switch . . . . . . . . . . . . . . . . 3-24
Operation 4-1
4.1 Switching on 4-2
4.2 Operating the device using the CONTROL module 4-2
4.3 Operating the device over the handpiece 4-3
4.4 Displays and symbols 4-4
4.4.1 Module selection . . . . . . . . . . . . . . . . . . . 4-5
4.4.2 Parameter selection and counter readings. . . . . . . . . . . . 4-6
4.4.3 Contact intensity and Skin Touch display . . . . . . . . . . . . 4-8
4.4.4 Treatment menu bar . . . . . . . . . . . . . . . . . . 4-10
4.4.5 Device info and settings menu bar . . . . . . . . . . . . . . 4-11
4.5 Touch Screen operation 4-12
4.5.1 Password protection . . . . . . . . . . . . . . . . . . 4-12
4.5.2 Setting brightness and volume . . . . . . . . . . . . . . . 4-14
4.5.3 Selecting the operating mode . . . . . . . . . . . . . . . 4-14
4.5.4 Selecting treatment parameters . . . . . . . . . . . . . . . 4-15
4.5.5 Loading indications . . . . . . . . . . . . . . . . . . 4-15
4.5.6 Saving indications . . . . . . . . . . . . . . . . . . . 4-18
4.5.7 Copying indications . . . . . . . . . . . . . . . . . . 4-19
4.5.8 Deleting an indication. . . . . . . . . . . . . . . . . . 4-19
4.5.9 Editing indications . . . . . . . . . . . . . . . . . . . 4-19
4.5.9.1 Storing treatment notes . . . . . . . . . . . . . . . . . 4-20
4.5.9.2 Loading images and/or videos . . . . . . . . . . . . . . . 4-20
4.5.9.3 Creating, deleting or editing treatment steps. . . . . . . . . . . 4-21
4.5.10 Patient treatment report . . . . . . . . . . . . . . . . . 4-22
4.5.10.1 Loading patient data . . . . . . . . . . . . . . . . . . 4-22
4.5.10.2 Editing patient data . . . . . . . . . . . . . . . . . . 4-24
4.5.10.3 Load treatment parameters . . . . . . . . . . . . . . . . 4-24
4.5.11 Creating new patient data . . . . . . . . . . . . . . . . 4-24
4.5.12 Exporting treatment data. . . . . . . . . . . . . . . . . 4-25
4.5.13 Deleting patient datasets . . . . . . . . . . . . . . . . . 4-26
4.5.14 Resetting the treatment shock counter . . . . . . . . . . . . 4-26
4.5.15 Touch screen calibration . . . . . . . . . . . . . . . . . 4-26
4.5.16 Software updates . . . . . . . . . . . . . . . . . . . 4-27
4.5.17 Changing software settings . . . . . . . . . . . . . . . . 4-28

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4.5.18 Connecting an external display . . . . . . . . . . . . . . . 4-29
4.5.19 Saving image data with DICOM. . . . . . . . . . . . . . . 4-29
4.5.19.1 DICOM conguration . . . . . . . . . . . . . . . . . . 4-29
4.5.19.2 DICOM Worklist . . . . . . . . . . . . . . . . . . . 4-30
4.5.19.3 Saving/printing DICOM . . . . . . . . . . . . . . . . . 4-30
4.5.20 Data transfer via the GDT interface. . . . . . . . . . . . . . 4-30
4.5.20.1 GDT conguration. . . . . . . . . . . . . . . . . . . 4-30
4.5.20.2 Sending/receiving data or requests via GDT . . . . . . . . . . . 4-31
4.5.21 Visible Body - Anatomy Atlas . . . . . . . . . . . . . . . 4-32
4.5.21.1 Starting Visible Body . . . . . . . . . . . . . . . . . . 4-33
4.5.21.2 Submenu . . . . . . . . . . . . . . . . . . . . . 4-34
4.5.21.3 Marking treatment regions . . . . . . . . . . . . . . . . 4-36
4.5.21.4 Settings . . . . . . . . . . . . . . . . . . . . . . 4-37
4.5.21.5 Exiting Visible Body . . . . . . . . . . . . . . . . . . 4-38
4.6 Operation with the Module F-SW 4-39
4.6.1 Setting treatment parameters . . . . . . . . . . . . . . . 4-40
4.6.2 Start-up . . . . . . . . . . . . . . . . . . . . . . 4-42
4.6.3 Functional checks . . . . . . . . . . . . . . . . . . . 4-42
4.6.4 Standard settings . . . . . . . . . . . . . . . . . . . 4-43
4.6.5 Treatment . . . . . . . . . . . . . . . . . . . . . 4-43
4.6.6 Function overview of the handpiece F-SW SEPIA. . . . . . . . . . 4-45
4.7 Operation with the Module R-SW 4-46
4.7.1 Setting treatment parameters . . . . . . . . . . . . . . . 4-46
4.7.2 Start-up . . . . . . . . . . . . . . . . . . . . . . 4-47
4.7.3 Functional checks . . . . . . . . . . . . . . . . . . . 4-47
4.7.4 Standard settings . . . . . . . . . . . . . . . . . . . 4-48
4.7.5 Treatment . . . . . . . . . . . . . . . . . . . . . 4-48
4.8 Treatment with VACU-ACTOR 4-50
4.8.1 Using the foot switch . . . . . . . . . . . . . . . . . . 4-51
4.8.2 Using the Display . . . . . . . . . . . . . . . . . . . 4-51
4.8.3 Function overview of the handpiece R-SW . . . . . . . . . . . 4-51
Status Displays and
Trouble-shooting 5-1
5.1 Status messages 5-2
5.2 Trouble-shooting 5-4

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Preface
Cleaning, Maintenance, Overhaul 6-1
6.1 General information about cleaning 6-2
6.2 Modul F-SW 6-3
6.2.1 Cleaning the F-SW handpieces . . . . . . . . . . . . . . . 6-3
6.2.2 Water renewal . . . . . . . . . . . . . . . . . . . . 6-3
6.2.2.1 Draining the water circuit . . . . . . . . . . . . . . . . 6-4
6.2.2.2 Filling the water circuit . . . . . . . . . . . . . . . . . 6-5
6.3 Modul R-SW 6-7
6.3.1 Cleaning the R-SW handpieces . . . . . . . . . . . . . . . 6-7
6.3.2 Cleaning the V-ACTOR . . . . . . . . . . . . . . . . . 6-7
6.3.3 Cleaning the transmitters . . . . . . . . . . . . . . . . 6-8
6.3.4 Reconditioning the VACU-ACTOR . . . . . . . . . . . . . . 6-8
6.3.4.1 Preparation of cleaning . . . . . . . . . . . . . . . . . 6-8
6.3.4.2 Cleaning. . . . . . . . . . . . . . . . . . . . . . 6-9
6.3.4.3 Disinfection . . . . . . . . . . . . . . . . . . . . . 6-9
6.4 R-SW handpiece overhaul 6-10
6.5 Fuse replacement 6-10
6.6 Maintenance and safety checks 6-11
6.7 Disposal 6-11
6.8 Repair 6-11
6.9 Service life 6-12
Accessories 7-1
7.1 Accessories 7-2
Technical data, conformity and labelling 8-1
8.1 Technical data 8-2
8.2 Type plate DUOLITH®SD1 8-5
8.3 Conformity with directives 8-5
8.4 Conformity with standards 8-5
8.4.1 EMC guidelines and manufacturer’s declaration . . . . . . . . . . 8-6
8.5 Certicates 8-10
8.6 Symbols and labels 8-11

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Preface
Warranty and service 8-1
9.1 Warranty for the DUOLITH®SD1 8-2
9.2 Warranty of the handpieces 8-2
9.3 Warranty for the VACU-ACTOR 8-2
9.4 Service 8-2
Ultrasound (optional) 10-1
10.1 Connecting the ultrasound probe 10-2
10.2 Switching on the ultrasound module 10-3
10.3 Foot switch 10-4
10.4 Operating Manual Telemed Ultrasound device 10-4

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Preface

1
General Safety Information

1-2
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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 DUOLITH®SD1.
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 DUOLITH®SD1.
• Read the separate operating manuals for all devices associated
with the DUOLITH®SD1.
1.1.1 Intended 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.
When the maximum energy level is set, a break must always be inserted as soon as
the following values are reached:
treatment maximum number duration of the break
R-SW 10 000 pulses 5 min
F-SW 6 000 pulses 5 min
V-ACTOR 10 000 pulses 5 min
VACU-ACTOR 30 min treatment 5 min

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General safety information
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 DUOLITH®SD1,
before starting treatment. Read about this in
Chapter 4.6.3 funCtiOnal CheCks and
Chapter 4.7.3 funCtiOnal CheCks.
• Have the maintenance procedures recommended by the manufacturer carried out by
authorised personnel (see also Chapter 6.6 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 DUOLITH®SD1
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.
• Do not touch electrical connectors while you are touching the patient.
• Disconnect the DUOLITH®SD1 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 high voltage
Very high voltages are generated in the F-SW module when operating the device.
High-voltage components are identied as follows:
DANGER!
Opening the device and touching high-voltage parts can result in
serious or fatal injuries!
• Only operate the device if the housing is intact and closed.
• Do not start work in the high-voltage area before rst switching
off the electrical supply and waiting for 2 minutes.
• Work in the high-voltage area is only allowed to be performed by
personnel suitably authorised by the manufacturer.

1-4
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General safety information
Explosion protection
The DUOLITH®SD1 is not allowed to be used in potentially explosive atmospheres
(according to classication AP and APG pursuant to IEC601-1), i.e. in the presence of
ammable anaesthetic gas mixtures with air, oxygen or nitrous oxide.
WARNING!
Risk of explosion due to ammable and explosive materials.
Injuries to patients, therapists and third parties!
• During operation, avoid using the substances specied in the
following section.
• Switch the device off before cleaning.
• Refer to the information on cleaning in Chapter 6 Cleaning,
MaintenanCe, Overhaul.
The following agents are NOT allowed to be used during operation:
Highly inammable and potentially explosive inhalation anaesthetics and mixtures of
the same, such as
– Ether pro narcosi (diethyl ether)
– Cyclopropane
Inammable, highly volatile skin cleaning agents and skin disinfectants which can
form a potentially explosive atmosphere, such as
– Washing ether
– Petrol ether
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.
Temperature
Shock wave triggering is stopped automatically if the water temperature in the water
circuit rises above 41 °C. The device generates an error message.
• Interrupt the treatment.

1-5
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General safety information
1.1.2 Safety during treatment of the patient
General note:
Organs with gas pockets, especially parts of the lungs, must NOT 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.
Pulses can result in adverse cardiac reactions. The patient must be continuously
observed during the treatment and attention must be paid to patient reaction. The
patient should not be under anaesthesia.
Only perform treatments approved by STORZ MEDICAL AG!
The user is responsible for correctly positioning the handpieces and suction cup and
correctly selecting the treatment zone.
Air bubbles reduce the effectiveness of shock waves. Therefore, air bubbles must
always be removed from the shock wave path.
Risk of transmission of microorganisms! Disinfect the handpiece after each use! For
information about this, see Chapter 6 Cleaning, MaintenanCe, Overhaul.
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), including antennas, can interfere with medical electrical equipment. They
should not be used less than 30 cm from the device - including the cables specied by
the manufacturer.
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.
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 DUOLITH®SD1 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
DUOLITH®SD1 must be tested in that particular environment to ensure operation
according to technical specication.

1-6
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General safety information
The separate operating manuals for all devices used in conjunction with the
DUOLITH®SD1 (localisation systems, ECG devices, etc.) must be viewed as part of
the complete operating manual. Always comply with all the information contained
therein.
The system must only be connected to properly earthed and correctly installed
shockproof sockets!
Set-up and operation
There are ventilation slits on the 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 4.6.3 funCtiOnal CheCks and
Chapter 4.7.3 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.
• Completely empty the water circuit and the handpiece of the F-SW module before
you transport the device or put it into storage.
Otherwise, there is a risk of the water freezing which will lead to damage. Please
contact your responsible service centre if this does happen.
• Comply with the ambient conditions specied in Chapter 8.1 teChniCal data.
• Make sure that no cables are crushed or sheared.
Disposal
• Comply with national disposal regulations when disposing of the DUOLITH®SD1 or
individual components.
• Comply with the relevant information in the operating manuals for the additional
devices.

2
Principles

2-2
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Principles
2.1 Physical principles
The DUOLITH®SD1 is a universal, modular shock wave generator that can be used
either for treatment involving medium- to high-energy electromagnetically generated
shock waves or low-energy pneumatically generated shock waves.
This multifunctionality is achieved by using different shock wave modules which
deliver two types of shock wave: focused shock waves – referred to below as F-SW –
and radial shock waves – referred to below as R-SW.
F-SW waves have a short pulse length and are concentrated on areas a few
millimetres in diameter, allowing shock waves to be applied to a tightly localised
area, even in deeper tissue layers. R-SW waves, by contrast, are, from a physical point
of view, classied as radial pressure waves. The applied pressure pulse propagates
radially within the tissue and has a therapeutic effect on areas of the tissue near the
surface, in particular.
The treatment region is diagnosed and/or localised using the optional ultrasound module.
The DUOLITH®SD1 in combination with VACU-ACTOR is a supplement to the treat-
ment 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.