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Storz DUOLITH SD1 R-SW User Manual

Storz DUOLITH SD1 R-SW
93 pages
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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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Storz DUOLITH SD1 R-SW Specifications

General IconGeneral
TechnologyRadial Shock Wave
ManufacturerStorz Medical
Frequency1 - 21 Hz
Device TypeExtracorporeal Shock Wave Therapy (ESWT) Device
ApplicationOrthopedics, Sports Medicine, Rehabilitation
DisplayIntegrated touchscreen
User InterfaceTouchscreen interface
Power Supply100 – 240 V / 50/60 Hz
Treatment HeadsInterchangeable Focused and Radial Applicators
PortabilityMobile unit with integrated compressor

Summary

Preface and Safety Alerts

Warning Notes and Safety Symbols

Explains DANGER, WARNING, CAUTION, ATTENTION, and NOTE symbols used in the manual.

Instructions for Safe Use

Designated Use and Operational Safety

Outlines requirements for proper use, user qualifications, and applications.

Protection Against Electrical Hazard

Advises on connecting potential equalisation and handling electrical connectors safely.

Safety During Patient Treatment

Covers safe practices during patient treatment, observation, and approved therapies.

Protection Against Noise

Recommends ear protection to minimise exposure to noise.

Warning Against Damage

Electromagnetic Compatibility

Discusses EMC compliance, potential interference, and installation guidelines.

Setup, Storage, and Transport Precautions

Covers ventilation, storage, transport safety, and disposal considerations.

Principles

Physical Principles and Indications

Explains the device mechanism and lists its intended uses.

Contraindications and Safety Precautions

Lists conditions where device use is prohibited and provides critical safety warnings.

Preconditions for Operation

Operating Personnel and Training Requirements

Specifies user qualifications, abilities, and essential training for operating the device.

System Description

Overview of the System Components

Provides a visual overview of the DUOLITH® SD1 R-SW system.

Identification of System Components (Back View)

Identifies various device components from the back view.

Scope of Supply and Installation

Scope of Supply and Unpacking

Lists included accessories and guides on checking the device upon arrival.

Device Installation and Positioning

Covers professional installation and correct placement of the device.

Mounting the Handpiece Holder

Details attaching and adjusting the handpiece holder for convenient storage.

Electrical Connection and Safety

Covers connecting to mains power, potential equalization, and voltage checks.

Mains Voltage Adjustment and Power Connection

Guides on changing voltage settings and connecting the power cable.

Transport

Transport Preparation and Safety Measures

Outlines steps before transport, including removing accessories and securing parts.

Control Module Description

Control and Functional Elements

Identifies the standby switch and its role in controlling connected elements.

Control Module Connectors

Details the rear connectors (HDMI, USB, Audio, LAN) on the control module.

R-SW Module Rear Connectors

Describes the USB connector and foot switch connector on the rear of the R-SW module.

R-SW Module Description

R-SW Module Controls and Compatible Handpieces

Identifies module controls and lists handpieces compatible with the R-SW module.

R-SW Handpiece

R-SW Handpiece Operation and Controls

Explains the handpiece's control and display elements for standalone operation.

V-ACTOR Handpiece

V-ACTOR for Vibration Therapy

Describes the V-ACTOR handpiece for vibration therapy and its shock transmitter heads.

Connecting Handpieces

R-SW Module Handpiece Connections

Details the four connectors on the R-SW module for attaching handpieces.

Connecting VACU-ACTOR

VACU-ACTOR Hose, Cup, and Filter Setup

Guides on connecting the air hose, suction cup, and filter for VACU-ACTOR.

Connecting the Foot Switch

Foot Switch Connection to R-SW Module

Explains how to connect the optional foot switch to the R-SW module for US image control.

Operation

Switching On the Device

Provides steps to turn on the DUOLITH® SD1 R-SW using the main and standby switches.

Device Operation Modes

Operating via Control Module and Handpiece

Explains operation via touch screen and direct control using the handpiece.

User Interface and Displays

Structure of the User Interface

Details the division of the user interface into different areas for displaying information.

Module Selection and Parameter Settings

Explains selecting operating modes and setting treatment parameters like energy and pulse count.

Treatment Parameter Settings and Counter Readings

Details setting parameters and viewing pulse count and energy output.

VACU-ACTOR Setting Parameters

Covers setting intensity, time limit, frequency, and mode for VACU-ACTOR.

Contact Intensity and Skin Touch Display

Shows how to track contact intensity and indicates Skin Touch function status.

ATTENTION! Inadvertent Shock Triggering

Provides crucial warnings about accidental shock triggering and excessive pressure.

Treatment Menu Bar

Menu Bar Navigation and Indications

Explains how to access indications via the menu bar (Orthopaedics, Patients, VAS).

Device Information and Settings

Device Info and Settings Menu Bar

Describes the bottom navigation bar for accessing software updates, options, and service.

Touch Screen Operation and Password Protection

Introduces touch screen interaction and password protection.

Password Protection Activation and Deactivation

Details the steps for setting up and removing a password for the display.

Adjusting Settings, Brightness, and Volume

Explains how to access and adjust device settings, screen brightness, and volume.

Operation Modes and Parameter Selection

Selecting Operating Mode and Treatment Parameters

Guides on switching modes and setting treatment parameters manually or via indications.

Loading and Managing Indications

Loading All Indications and By Treatment Zone

Explains how to access and load indications, either all or specific to a zone.

Navigating Indication Lists and Detailed Views

Details list navigation and viewing magnified treatment photos.

Loading Treatment Steps and Patient Datasets

Guides on loading treatment steps and associated patient records.

Saving Indications

Creating and Saving New Indications

Details how to set parameters, name, and save custom indications.

Managing Indications

Copying, Deleting, and Editing Indications

Covers copying, deleting, and editing user-created indications.

Storing Treatment Notes and Loading Media

Explains adding notes and loading images/videos to indications.

Managing Treatment Steps

Covers creating, deleting, or editing individual treatment steps within an indication.

Patient Treatment Reports

Loading Patient Data

Guides on accessing and selecting stored patient records from a list.

Viewing Patient Treatment Details

Explains how to view detailed treatment parameters used for a specific patient.

Editing Patient Data and Loading Parameters

Guides on editing patient data and assigning treatment parameters.

Creating New Patient Data

Entering New Patient Information

Details the process of creating a new patient record with name, date of birth, and ID.

Data Management and Counters

Exporting Data, Deleting Datasets, and Resetting Counters

Covers exporting data, deleting records, and resetting the shock counter.

System Configuration and Updates

Software Updates and External Display Connection

Guides on updating software and connecting an external display.

DICOM Configuration

Explains how to configure DICOM settings, requiring an upgrade kit.

DICOM Worklist and Storage/Printing

Covers accessing the DICOM worklist and saving/printing DICOM images.

Data Transfer via GDT Interface

GDT Interface Configuration

Explains how to configure the GDT interface for data exchange with surgery EDP systems.

Sending and Receiving Data via GDT

Guides on initiating GDT requests and sending data back to the surgery system.

GDT Transfer Process

Illustrates the GDT transfer process, sending supplemented data back to the surgery system.

Visible Body - Anatomy Atlas

Introduction to Visible Body Atlas

Introduces Visible Body as an interactive 3D atlas for representing body systems and regions.

Starting the Visible Body Application

Details how to launch the Anatomy Atlas application.

Visible Body Submenu Navigation

Explains how to select and deselect body systems within the submenu.

Visible Body Toolbar and Symbol Guide

Describes the functions of toolbar symbols for navigation and interaction.

Marking Treatment Regions and Settings

Guides on marking regions and accessing application settings.

Exiting the Visible Body Application

Provides instructions on how to close the Visible Body application.

Operation with the R-SW Module

Skin Touch Function and Parameter Setting

Covers activating Skin Touch and setting R-SW/V-ACTOR treatment parameters.

R-SW Module Start-up and Functional Checks

Details startup procedures and essential functional checks for the R-SW module.

Standard Settings and Treatment Safety

Specifies default settings and critical safety information for treatment.

Treatment Safety Precautions and Handpiece Coupling

Offers safety cautions and guides on applying coupling agents for handpieces.

R-SW Handpiece Functions and VACU-ACTOR Safety

Refers to handpiece manual and lists VACU-ACTOR safety cautions.

Treatment with VACU-ACTOR

VACU-ACTOR Safety Cautions

Lists important safety warnings for using the VACU-ACTOR, including application areas and duration.

VACU-ACTOR Operation via Foot Switch and Display

Guides on operating VACU-ACTOR using the foot switch or touch screen.

Status and Troubleshooting

Status Messages and Handling

Lists common status messages and their corrective actions.

Troubleshooting Common Device Faults

Provides a table of fault descriptions, causes, and corrective actions for system issues.

Cleaning and Maintenance

General Cleaning Information and Precautions

Covers general hygiene, electrical hazards, and cleaning procedures for device parts.

Cleaning R-SW and V-ACTOR Handpieces

Details thorough cleaning and disinfection procedures for R-SW and V-ACTOR handpieces.

Cleaning Transmitters and VACU-ACTOR Preparation

Refers to transmitter cleaning manual and outlines VACU-ACTOR part preparation.

Cleaning and Disinfection of VACU-ACTOR Suction Cup

Provides instructions for cleaning and disinfecting the polycarbonate suction cup.

Maintenance and Technical Procedures

R-SW Handpiece Overhaul and Fuse Replacement

Guides on overhauling the handpiece and replacing device fuses.

Maintenance, Safety Checks, Disposal, and Repair

Covers regular checks, disposal, and authorized repair procedures.

Service Life and Warranty Information

Expected Service Life of Device Components

Lists the average expected service life for the device, handpieces, and suction cup.

Accessories

Accessory Listing with Part Numbers

Provides a comprehensive list of available accessories and their part numbers.

Technical Data

DUOLITH® SD1 R-SW Specifications

Details operating modes, pressure, voltage, frequency, power, and environmental requirements.

R-SW Handpiece Specs and Type Plate Information

Lists handpiece specs and explains device type plate details.

Conformity and Standards

Compliance with Safety and Performance Standards

Lists applicable standards (EN 60601) and device compliance for safety and performance.

EMC Guidelines and Emissions Declaration

Details electromagnetic compatibility guidelines and emission characteristics.

EMC Immunity Tests and Environment Guidelines

Covers immunity tests (ESD, transients, surges) and recommended electromagnetic environments.

RF Interference Immunity and Safety Distances

Specifies immunity levels for RF interference and recommended safety distances for portable equipment.

Safety Distances for HF Equipment Calculation

Provides a table to calculate recommended safety distances based on transmitter power.

Symbols and Labels

Trolley Column Labelling

Identifies labels on the trolley column, including potential equalization and type plate.

R-SW Module Labelling (Right and Rear Sides)

Details the labels and connectors on the right and rear sides of the R-SW module.

R-SW Handpiece and Packaging Labels

Identifies the manual compliance label on the handpiece and packaging transport conditions.

Warranty and Service

Warranty Terms and Procedures

Outlines warranty terms for the device and accessories, and service contact information.

Ultrasound Module Operation

Connecting the Telemed Ultrasound Probe

Guides on connecting the ultrasound probe to the DUOLITH touch screen.

Disconnecting Ultrasound Probes

Details how to disconnect both Telemed ultrasound and Smart US probes.

Ultrasound Module Switching and Manual Reference

Explains switching on the module and references the separate ultrasound manual.

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