Storz DUOLITH SD1 R-SW User manual

Operating Manual
DUOLITH® SD1 R-SW
Published: November 2020
Original language: German
Manufacturer / Publisher:
STORZ MEDICAL AG
Lohstampfestr. 8
CH-8274 Tägerwilen
Switzerland
32429.0002
BS.####
Part No. 19900.xxxx
Rx only

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Table of Contents
1 General Safety Information 7
1.1 Instructions for safe use 7
1.1.1 Designated use and operational safety. . . . . . . . . . . . . 7
1.1.2 Safety during treatment of the patient. . . . . . . . . . . . . 8
1.2 Warning against damage 9
2 Principles 11
2.1 Physical principles 11
2.2 Indications 11
2.3 Contraindications 12
2.4 Warnings and precautions 12
2.5 Preconditions for operation 13
2.5.1 Operating personnel . . . . . . . . . . . . . . . . . . 13
2.5.2 Training of the operator . . . . . . . . . . . . . . . . . 13
3 System Description 14
3.1 Overview of the system 14
3.2 Scope of supply 16
3.2.3 Unpacking the device . . . . . . . . . . . . . . . . . . 16
3.3 Installation 16
3.3.1 Correct positioning of the device . . . . . . . . . . . . . . 16
3.3.2 Mounting the handpiece holder . . . . . . . . . . . . . . 17
3.3.3 Potential equalisation connection . . . . . . . . . . . . . . 18
3.3.4 Electrical connection . . . . . . . . . . . . . . . . . . 18
3.4 Transport 20
3.5 Description of the Control module 21
3.5.1 Control and functional elements . . . . . . . . . . . . . . 21
3.5.2 Connectors . . . . . . . . . . . . . . . . . . . . . 22
3.6 Description of the R-SW module with accessories 23
3.6.1 Control and functional elements . . . . . . . . . . . . . . 23
3.6.1.1 Compatible handpieces . . . . . . . . . . . . . . . . . 23
3.6.2 R-SW handpiece . . . . . . . . . . . . . . . . . . . 24
3.6.3 V-ACTOR . . . . . . . . . . . . . . . . . . . . . 25
3.6.4 Connecting handpieces . . . . . . . . . . . . . . . . . 26
3.6.5 Connecting VACU-ACTOR . . . . . . . . . . . . . . . . 27
3.6.6 Connecting the foot switch . . . . . . . . . . . . . . . . 28

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4 Operation 29
4.1 Switching on 29
4.2 Operating the device using the CONTROL module 30
4.3 Operating the device over the handpiece 30
4.4 Displays and symbols 31
4.4.1 Module selection . . . . . . . . . . . . . . . . . . . 32
4.4.2 Parameter selection and counter readings. . . . . . . . . . . . 32
4.4.3 Contact intensity and Skin Touch display . . . . . . . . . . . . 35
4.4.4 Treatment menu bar . . . . . . . . . . . . . . . . . . 37
4.4.5 Device info and settings menu bar . . . . . . . . . . . . . . 38
4.5 Touch Screen operation 38
4.5.1 Password protection . . . . . . . . . . . . . . . . . . 38
4.5.2 Settings, brightness and volume . . . . . . . . . . . . . . 40
4.5.3 Selecting the operating mode . . . . . . . . . . . . . . . 41
4.5.4 Selecting treatment parameters . . . . . . . . . . . . . . . 41
4.5.5 Loading indications . . . . . . . . . . . . . . . . . . 42
4.5.6 Saving indications . . . . . . . . . . . . . . . . . . . 45
4.5.7 Copying indications . . . . . . . . . . . . . . . . . . 46
4.5.8 Deleting an indication. . . . . . . . . . . . . . . . . . 46
4.5.9 Editing indications . . . . . . . . . . . . . . . . . . . 46
4.5.9.1 Storing treatment notes . . . . . . . . . . . . . . . . . 47
4.5.9.2 Loading images and/or videos . . . . . . . . . . . . . . . 47
4.5.9.3 Creating, deleting or editing treatment steps. . . . . . . . . . . 48
4.5.10 Patient treatment report . . . . . . . . . . . . . . . . . 49
4.5.10.1 Loading patient data . . . . . . . . . . . . . . . . . . 49
4.5.10.2 Editing patient data . . . . . . . . . . . . . . . . . . 51
4.5.10.3 Load treatment parameters . . . . . . . . . . . . . . . . 51
4.5.11 Creating new patient data . . . . . . . . . . . . . . . . 52
4.5.12 Exporting treatment data. . . . . . . . . . . . . . . . . 53
4.5.13 Deleting patient datasets . . . . . . . . . . . . . . . . . 53
4.5.14 Resetting the treatment shock counter . . . . . . . . . . . . 53
4.5.15 Software updates . . . . . . . . . . . . . . . . . . . 54
4.5.16 Connecting an external display . . . . . . . . . . . . . . . 54
4.5.17 Saving image data with DICOM. . . . . . . . . . . . . . . 54
4.5.17.1 DICOMconguration . . . . . . . . . . . . . . . . . . 54
4.5.17.2 DICOM Worklist . . . . . . . . . . . . . . . . . . . 55
4.5.17.3 Saving/printing DICOM . . . . . . . . . . . . . . . . . 55
4.5.18 Data transfer via the GDT interface. . . . . . . . . . . . . . 56
4.5.18.1 GDTconguration. . . . . . . . . . . . . . . . . . . 56
4.5.18.2 Sending/receiving data or requests via GDT . . . . . . . . . . . 57
4.5.19 Visible Body - Anatomy Atlas . . . . . . . . . . . . . . . 58

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4.5.19.1 Starting Visible Body . . . . . . . . . . . . . . . . . . 59
4.5.19.2 Submenu . . . . . . . . . . . . . . . . . . . . . 60
4.5.19.3 Marking treatment regions . . . . . . . . . . . . . . . . 62
4.5.19.4 Settings . . . . . . . . . . . . . . . . . . . . . . 62
4.5.19.5 Exiting Visible Body . . . . . . . . . . . . . . . . . . 63
4.6 Operation with the Module R-SW 64
4.6.1 Setting treatment parameters . . . . . . . . . . . . . . . 64
4.6.2 Start-up . . . . . . . . . . . . . . . . . . . . . . 65
4.6.3 Functional checks . . . . . . . . . . . . . . . . . . . 65
4.6.4 Standard settings . . . . . . . . . . . . . . . . . . . 66
4.6.5 Treatment . . . . . . . . . . . . . . . . . . . . . 66
4.6.6 Function overview of the handpiece R-SW . . . . . . . . . . . 68
4.7 Treatment with VACU-ACTOR 68
4.7.1 Using the foot switch . . . . . . . . . . . . . . . . . . 69
4.7.2 Using the Display . . . . . . . . . . . . . . . . . . . 69
5 Status and Troubleshooting 70
5.1 Status messages 70
5.2 Trouble-shooting 71
6 Cleaning, Maintenance 72
6.1 General information about cleaning 72
6.2 Modul R-SW 73
6.2.3 Cleaning the R-SW handpieces . . . . . . . . . . . . . . . 73
6.2.4 Cleaning the V-ACTOR . . . . . . . . . . . . . . . . . 73
6.2.5 Cleaning the transmitters . . . . . . . . . . . . . . . . 74
6.2.6 Reconditioning the VACU-ACTOR . . . . . . . . . . . . . . 74
6.2.6.1 Preparation of cleaning . . . . . . . . . . . . . . . . . 74
6.2.6.2 Cleaning. . . . . . . . . . . . . . . . . . . . . . 75
6.2.6.3 Disinfection . . . . . . . . . . . . . . . . . . . . . 75
6.3 R-SW handpiece overhaul 76
6.4 Fuse replacement 76
6.5 Maintenance and safety checks 77
6.6 Disposal 77
6.7 Repair 77
6.8 Service life 78
7 Accessories 79
7.1 Accessories 79
8 Technical data 80

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8.1 Technical data 80
8.2 Type plate DUOLITH®SD1 R-SW 81
8.3 Conformity with standards 82
8.3.7 EMC guidelines and manufacturer’s declaration . . . . . . . . . . 83
8.4 Symbols and labels 87
9 Warranty and service 90
9.1 Warranty for the DUOLITH®SD1 R-SW 90
9.2 Warranty of the handpieces 90
9.3 Warranty for the VACU-ACTOR 90
9.4 Service 90
10 Ultrasound (optional) 91
10.5 Connecting the ultrasound probe 91
10.6 Switching on the ultrasound module 93
10.7 Foot switch 93
10.8 Operating Manual Telemed Ultrasound device 93

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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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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 DUOLITH®SD1 R-SW.
CAUTION!
Rx only :
Federal law restricts this device to sale by or on the order of a
practitioner licensed by the law of the State in which he/she practises to
use or order the use of the device.
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
R-SW.
• Read the separate operating manuals for all devices associated
with the DUOLITH®SD1 R-SW.
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 2.2
indiCatiOns.
• Only perform treatments approved by STORZ MEDICAL AG!
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 DUOLITH®SD1
R-SW before starting treatment. Read about this in Chapter 8.3.7 eMC guidelines
and ManufaCturer’sdeClaratiOn.
• Have the maintenance procedures recommended by the manufacturer carried out by
authorised personnel (see also Chapter 6.5 MaintenanCe and safety CheCks).

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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 R-SW 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 R-SW 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 pulses 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:
As it passes through tissue, the pulse energy is slightly reduced; this reduction is
signicantlyweakenedbythebonestructure.
Pulses can give rise to undesirable reactions. The patient must be continuously
observed during the treatment and attention must be paid to patient reaction. The
patient should not be under anesthesia.
Only perform treatments approved by STORZ MEDICAL AG!
The user is responsible for correctly positioning the handpieces and correctly selecting
the treatment zone.

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Risk of transmission of microorganisms! Disinfect the handpiece after each use! For
information about this, see Chapter 6 Cleaning, MaintenanCe.
1.2 Warning against damage
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 to the EMC guidelines in Chapter 8.3.7 eMC guidelines and
ManufaCturer’sdeClaratiOn.
The use of accessories or cabling not authorised by the manufacturer is not permitted.
Increased electromagnetic interference may occure, which may cause the device to
function incorrectly.
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating
normally.
The use of RF communications equipment in the vicinity is not permitted.
These equipment may not be used closer than 30 cm to any part of the DUOLITH®
SD1 including the cables authorized by the manufacturer.
The device is not to be used within an MR environment.Within proximity of the device
to an Magnetic Resonance source device disturbances may occur. In case of distur-
bance consider repositioning of the device.
The emission characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for
which CISPR 11 class B is normally required) this equipment might not offer adequate
protection to RF communication services. The user might need to take mitigation
measures, such as relocating or re-orienting the equipment.

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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 8.3.7 eMC guidelines and ManufaCturer’sdeClaratiOn.
• 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 DUOLITH®SD1
R-SW or individual components.
• Comply with the relevant information in the operating manuals for the additional
devices.

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2 Principles
2.1 Physical principles
The DUOLITH®SD1 R-SW is a compressed air–operated ballistic pulse generator. The
pulses in the DUOLITH®SD1 R-SW are generated with a precision ballistic mecha-
nism 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 transmitter, this kinetic energy is converted into sound
energy. This acoustic pulse is transmitted into the tissue with the help of a gel.
2.2 Indications
The intended use of the DUOLITH®SD1 R-SW is as follows:
– to relieve minor muscle aches and pains.
– temporary increase in local blood circulation.
– activation of connective tissue.
NOTE
For the activation of connective tissue pressure not higher than 3bar and only
D-ACTOR transmitters with a diameter of 20mm and more shall be used.

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2.3 Contraindications
CAUTION!
The precautions listed here are examples. No claims are made re-
garding the completeness or unlimited validity of this list of precau-
tions.
Treatment with the STORZ MEDICAL DUOLITH®SD1 R-SW is not permitted in the
following cases:
– malignant tumor in the treatment area
– fetus in the treatment area
CAUTION!
Thisdeviceshouldnotbeusedoverswollenorinamedareasor
skin eruptions. Do not use in presence of unexplained calf pain.
There is a potential for discomfort when using the
DUOLITH®SD1 R-SW on bony surfaces.
Be aware of the potential for bruising and hematoma!
Never use this device on children, the unconscious, or anyone who
cannot give verbal consent or warnings about pain.
2.4 Warnings and precautions
– Do not use in the presence of unexplained pain.
– Ifapatientreportssignicantorunexpectedpain,immediatelystopthetreat-
ment and consult a physician.
– Do not apply pulses to any regions near large nerves, vessels, the spinal column
or head.
– ALWAYS move the handpiece over the treatment area. Continuous repetitive
pulses concentrated in one spot may lead to bruising.
– Use of this device may be painful or cause bruising. NEVER use this device on
children, the unconscious, or anyone who cannot give verbal concent or war-
nings about pain.
– Thisdeviceshouldnotbeusedoverswollenorinamedareasorskineruptions.
– Do not treat wounds, infected areas, skin tumors, open sores, or scars from
recent surgery.
– Caution should be used over joints or bony prominence such as vertebrae.

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2.5 Preconditions for operation
2.5.1 Operating personnel
The DUOLITH®SD1 R-SW is intended exclusively for use by health care professional
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 2.2 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.
2.5.2 Training of the operator
Operators of the DUOLITH®SD1 R-SW 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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3 System Description
3.1 Overview of the system
1
2
Fig. 3-1 Frontside complete
1 CONTROL module with touch screen and integrated ultrasound unit.
(The ultrasound unit is optional and can be ordered with colour doppler
processing.)
2 R-SW module

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3
4
6
7
8
9
5
11
10
Fig. 3-2 Backside complete
3 Monitor
4 CONTROL module
5 Master switch
6 R-SW module
7 Mains connector with mains fuse holder
8 Voltage selector switch
9 Potential equalisation
10 Transport handle
11 Handpiece holder

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3.2 Scope of supply
Standard level Standard accessories
2)
Trolley & module CONTROL & mo-
dule R-SW
– R-SW handpiece set
– R-SW shock transmitters
– VACU-ACTOR start kit
– Mains cables
– Gel bottle
– User manual (operating manual,
system logbook)
– Ultrasonic (optional)
Table 3 -1 Scope of supply
Optional accessories, see Chapter 7.1 aCCessOries
3.2.3 Unpacking the device
• Check that all items are included in the packaging container and that they are not
damaged.
• Carefully remove the devices and accessories from the packaging container.
• Contact your supplier or the manufacturer/dealer immediately if any items are
missing or damaged.
• Retain the original packaging. It may prove useful for any later equipment
transport.
3.3 Installation
• Have the device installed by your dealer or by authorised personnel.
WARNING!
If there is a fault, the resulting contact voltage represents a risk
of injury to the therapist and the patient.
• Therefore, always connect the potential equalisation connector of
the DUOLITH®SD1 R-SW 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.
3.3.1 Correct positioning of the device
Make sure that the device is positioned at a distance from the wall so that the mains
plug can be pulled without restriction.

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3.3.2 Mounting the handpiece holder
The handpiece holder has storage locations for the following handpieces:
from left to right:
– VACU-ACTOR
– R-SW 1
– R-SW 2
– V-ACTOR
– US-Transducer
Fig. 3-3 Storage locations
Thehandpieceholderisxedinplaceonthedevicewithaclampingscrewandcanbe
height-adjusted to mount the handpiece holder
• Slide the end of the holding rod into the opening on the device column.
Fig. 3-4 Opening for the holding rod
Fig. 3-5 Handpiece holder
• Slide the holding rod to the desired height.
• Tighten the clamping screw once again.

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Fig. 3-6 Tightening the clamping screw
3.3.3 Potential equalisation connection
The DUOLITH®SD1 R-SW features a potential equalisation connection.
• Connect one end of the potential equalisation cable to the PE connection on the
DUOLITH®SD1 R-SW and the other end to your PE connection.
Fig. 3-7 Potential equalisation connection
3.3.4 Electrical connection
The device can be operated on a mains voltage of 230 V or 120 V.
ATTENTION!
Damage to the device may occur if the voltage setting on the device does not
match the local mains voltage.
Make sure that the device is operated with the correct mains voltage.
Checking the mains voltage
• Check the mains voltage setting on the voltage selector switch on the rear of the
device.Ondelivery,thedeviceisusuallyconguredforamainsvoltageof230V.

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Fig. 3-8 Voltage selector switch
Changing the mains voltage
• Move the switch with a screwdriver until the required value matches the
arrowmark.
Fig. 3-9 Mains voltage set to US-Voltage
• Adjust the fuse value of the mains fuse according to the selected mains voltage
(see chapter 6.4 fuse replaCeMent).
Connecting the electrical power supply
• Connect the mains cable to the mains connection on the rear of the device.
1 Mains connector
1
Fig. 3-10 Mains connector
• Insert the mains cable into the electrical socket.

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3.4 Transport
• Make sure there are no objects on the device.
• Remove the handpiece and, if supplied, the ultrasound probe and foot switch.
• Disconnect the mains plug.
• Remove the potential equalisation connector.
ATTENTION!
Incorrect handling during transport will damage the device!
• Only hold the device at the handle when transporting.
Do not use either the handpiece holder or the monitor for pushing or pulling
the device.
• Push the rod of the handpiece holder down.
• Turn the handpiece holder inward.
Fig. 3-11 Handpiece holder during transport
• Release the brake on the transport wheels by pressing lightly from below.
Fig. 3-12 Releasing the wheels
• Hold the device at the transport handle.