DUOLITH SD1 Tower Operating Manual March 2021

Preface

II

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Impressum Operating manual for

DUOLITH® SD1 Tower Manufacturer STORZ MEDICAL AG Lohstampfestrasse 8 CH-8274 Tägerwilen Telephone: +41 (0)71 677 45 87 Fax: +41 (0)71 677 45 09 E-mail: [email protected] URL: www.storzmedical.com

III 

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.

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Preface

This applies in particular to duplication, translation, microfilming as well as input and processing in electronic systems.

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. Status and error messages you will find 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 specifications for the modules and the handpieces. Warranty conditions for the device and the handpieces can be found in Chapter 9 Warranty and service. Important note

Preface

IV

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 proficiency 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 significance of the text based on its appearance.

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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.

CAUTION indicates that incorrect operation could lead to minor injuries.

CAUTION!

V

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

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Preface

Additional information concerning specific features or operating instructions is preceded by the term 'NOTE'.

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. h This 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: – F-SW

Focused shock waves

– PE

Potential equalisation

Preface

VI

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Table of Contents General Safety Information

1-1

1.1

Instructions for safe use

1-2

1.1.1

Designated use and operational safety... 1-2

1.1.2

Safety during treatment of the patient... 1-4

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... 2-2

2.1.2

Contraindications

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2-2

2.1.3

Side effects .

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2-2

2.1.4

Warnings... 2-2

2.1.5

Precautions .

2.2

Preconditions for operation

2.2.1

Operating personnel... 2-4

2.2.2

Training of the operator

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2-4

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

3.3

Installation

3.3.1

Adjusting the handpiece holder... 3-5

3.3.2

Potential equalisation connection... 3-6

3.3.3

Electrical connection... 3-7

3.4

Transport

3-8

3.5

Description of the Control module

3-9

3.5.1

Control and functional elements... 3-9

3.5.2

Connectors .

3.6

Description of the F-SW module with accessories

3.6.1

Control and functional elements... 2

3.6.2

Compatible handpieces... 2

3.6.3

F-SW SEPIA handpiece... 3

3.6.4

Handpiece connection... 4

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VII

Preface

VIII

Operation

4-1

4.1

Switching on and off

4-2

4.2

Operating the device using the CONTROL module

4-2

4.3

Operating the device using the handpiece

4-2

4.4

Displays and symbols

4-3

4.4.1

Module selection... 4-4

4.4.2

Parameter selection and counter reading .

4.4.3

Treatment menu bar... 4-6

4.4.4

Device info and settings menu bar .

4.5

Touch Screen operation

4.5.1

Setting brightness and volume... 4-8

4.5.2

Selecting the operating mode .

4.5.3

Selecting treatment parameters... 4-8

4.5.4

Loading indications... 4-9

4.5.5

Saving indications .

4.5.6

Copying indications .

4.5.7

Deleting an indication... 4-13

4.5.8

Editing indications

4.5.8.1

Storing treatment notes... 4-14

4.5.8.2

Loading images and/or videos .

4.5.8.3

Creating, deleting or editing treatment steps... 4-16

4.5.9

Patient treatment report .

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4-17

4.5.9.1

Loading patient data

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4-17

4.5.9.2

Editing patient data .

4.5.9.3

Load treatment parameters

4.5.10

Creating new patient data .

4.5.11

Exporting treatment data... 4-20

4.5.12

Deleting patient datasets... 4-20

4.5.13

Resetting the treatment shock counter... 4-21

4.5.14

Touch screen calibration .

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4-21

4.5.15

Software updates

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4-22

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4.5.15.1 Software Update Tablet PC... 4-22 4.5.15.2 Software Update Control device... 4-22 4.5.16

Changing software settings .

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4-23

4.5.17

Connecting an external display .

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4.5.18

Saving image data with DICOM... 4-24

4.5.18.1 DICOM configuration 4.5.18.2 DICOM Worklist

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4.5.19

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Data transfer via the GDT interface... 4-26

4.5.19.1 GDT configuration... 4-26

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4.5.19.2 Sending/receiving data or requests via GDT... 4-27 4.5.20

Visible Body - Anatomy Atlas... 4-28

4.5.20.1 Starting Visible Body... 4-28 4.5.20.2 Submenu... 4-29 4.5.20.3 Marking treatment regions... 4-32 4.5.20.4 Settings .

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4.5.20.5 Exiting Visible Body... 4-33 4.6

Operation with the Module F-SW

4.6.1

Setting treatment parameters .

4.6.2

Start-up .

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4.6.3

Functional checks

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4.6.4

Standard settings... 4-37

4.6.5

Treatment... 4-37

4.6.6

Function overview of the handpiece F-SW... 4-39

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Status Displays and Trouble-shooting

5-1

5.1

Status messages

5-2

5.2

Trouble-shooting

5-4

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

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6.2.2

Water renewal .

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6-3

6.2.2.1

Draining the water circuit... 6-4

6.2.2.2

Filling the water circuit

6.3

Fuse replacement

6-7

6.4

Maintenance and safety checks

6-7

6.5

Disposal

6-8

6.6

Repair

6-8

6.7

Service life

6-8

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Accessories

7-1

7.1

7-2

Accessories

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IX

Preface

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4-33

Preface

X

Technical data, conformity and labelling

8-1

8.1

Technical data

2

8.2

Type plate DUOLITH® SD1

3

8.3

Conformity with standards

4

8.3.1

RFID immunity

8.3.2

EMC guidelines and manufacturer’s declaration .

8.4

Symbols and labels

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5 9

Warranty and service

9-1

9.1

Warranty for the DUOLITH® SD1

9-2

9.2

Warranty of the handpieces

9-2

9.3

Service

9-2

Ultrasound (optional)

3

10.1

Ultrasound

10-2

10.2

Connecting the ultrasound probe

10-2

10.3

Switching on the ultrasound module

10-3

10.4

Foot switch

10-4

10.5

Operating Manual Telemed Ultrasound device

10-4

Patient informations

11-1

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General Safety Information

1

1.1

Instructions for safe use The following chapter contains all safety information that has to be followed when working with the DUOLITH® SD1.

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. • Read the separate operating manuals for all devices associated with the DUOLITH® SD1.

1.1.1

General safety information

1-2

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! 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. While applying focused shockwaves at maximum adjustment, do not use more than 6.000 subsequent shocks and stick to a consecutive break of 5 minutes. 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“. • Have the maintenance procedures recommended by the manufacturer carried out by authorised personnel (see also Chapter „6.4 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 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 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!

Protection against high voltage High voltages are generated in the F-SW module when operating the device. High-voltage components are identified 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 open the device!

1-3

Explosion protection The DUOLITH® SD1 is not allowed to be used in potentially explosive atmospheres (according to classification AP and APG pursuant to IEC601-1), i.e. in the presence of flammable anaesthetic gas mixtures with air, oxygen or nitrous oxide.

WARNING!

Injuries to patients, therapists and third parties! • During operation, avoid using the substances specified in the following section. • Switch the device off before cleaning. • Refer to the information on cleaning in Chapter 6 „Cleaning, Maintenance, Overhaul“.

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General safety information

Risk of explosion due to flammable and explosive materials.

The following agents are NOT allowed to be used during operation: Highly inflammable and potentially explosive inhalation anaesthetics and mixtures of the same, such as – Ether pro narcosi (diethyl ether) – Cyclopropane Inflammable, highly volatile skin cleaning agents and skin disinfectants which can form a potentially explosive atmosphere, such as – Washing ether – Petrol ether 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 and interrupts the treatment.

1.1.2

General safety information

1-4

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 and attention must be paid to any reactions experienced by the patient. The patient must not be under anaesthesia. Only perform treatments approved by STORZ MEDICAL AG! The user is responsible for correctly positioning the handpieces 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“.

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1.2

 arning against damage to equipment and W 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 „8.3.2 EMC guidelines and manufacturer’s declaration“. The use of accessories or cabling not authorised by the manufacturer is not permitted. Increased electromagnetic interference may occur, 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.

1-5

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 disturbance 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.

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“. • Never cover the device when in use! • Make absolutely sure that no liquid can seep into the system housing or handpiece.

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General safety information

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

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 specified 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.

General safety information

1-6

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Principles

2

2.1

Physical principles The DUOLITH® SD1 is a shock wave generator that can be used for treatment involving medium- to high-energy electromagnetically generated shock waves. This focused shock waves are referred to below as F-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. The treatment region is diagnosed and/or localised using the optional ultrasound module.

2.1.1

Indications The Storz Duolith® SD1 is indicated for extracorporeal shock wave treatment of heel pain due to chronic proximal plantar fasciitis for patients of age greater than 18 years with a history of failed alternative conservative therapies for at least six months. Chronic proximal plantar fasciitis is defined as traction degeneration of the plantar fascial band at the origin on the medial calcaneal tuberosity that has persisted for six months or more.

2.1.2

Contraindications – Over or near bone growth center until bone growth is complete – When a malignant disease is known to be present in or near the treatment area – Infection in the area to be treated

Principles

2-2

– Patient has a coagulation disorder or taking anti-coagulant medications – Patient has a prosthetic device in the area to be treated – Over ischemic tissue in individuals with vascular disease effects (e.g., foot ulcers, venous stasis etc.)

2.1.3

Side effects Treatment with the DUOLITH® SD1 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.

2.1.4

Warnings Treatment using the Duolith® SD1 should be performed by a physician or licensed medical professional under the direct supervision of a physician who is trained and experienced in the care of patients with foot and ankle and/or lower extremity disorders and who has completed a training course on the use of the Duolith® SD1 for treatment of heel pain due to chronic proximal plantar fasciitis.

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Patients may experience pain/discomfort during and after treatment. To minimize the potential for pain, the working pressure should be slowly increased to a level of 0.25 mJ/mm2 during the first 500 impulses. Treatment with analgesics may be appropriate. Careful positioning of the patient is required to avoid damage to vascular and nerve structures in the treatment area if inadvertently treated with shockwaves. Certain sources of EMI, such as electrosurgery, diathermy or magnetic resonance imaging equipment or similar sources, may exceed the EMC of the DUOLITH SD1. Install and operate DUOLITH SD1 no closer than 1m to EMI sources such as electrosurgery, diathermy or other medical devices producing excessive radiation during operation.

2.1.5

Precautions The safety and effectiveness of the Duolith® SD1 has not been demonstrated in patients with the following conditions/observations: 1 Children less than 18 years of age 2 Inflammation of the lower and upper ankle 3 History of rheumatic diseases, and/or collagenosis and/or metabolic disorders 4 History of hyperthyroidism 5 Paget disease or calcaneal fat pad atrophy 6 Osteomyelitis (acute, sub acute, chronic) 7 Fracture of the Calcaneus 8 Immunosuppressive therapy

2-3

9 Long-term (≥ 6 months duration) treatment with any corticosteroid 10 Insulin-dependent diabetes mellitus, severe cardiac or respiratory disease 11 Coagulation disturbance and/or therapy with anticoagulants or antiplatelet agents that may prolong bleeding time 12 Bilateral painful heel, if both feet need medical treatment 13 Previous surgery of the painful heel syndrome 14 Previous unsuccessful treatment of the painful heel with a similar shockwave device 15 History of allergy or hypersensitivity to bupivacaine or local anesthetic sprays 16 Significant abnormalities in hepatic function 17 Poor physical condition 18 Pregnant female 19 History or documented evidence of peripheral neuropathy such as nerve entrapment, tarsal tunnel syndrome, etc. 20 History or documented evidence of systemic inflammatory disease such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, aseptic bone necrosis, Reiter‘s syndrome, etc. 22 Open wounds or skin rashes 23 Tendon rupture, neurological or vascular insufficiencies of the painful heel, as assessed using the Semmes-Weinstein Monofilament test and the Ankle Brachial Index

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Principles

21 Implanted pacemakers, insulin pumps, defibrillators and/or neurostimulators

2.2

Preconditions for operation

2.2.1

Operating personnel The DUOLITH® SD1 is intended exclusively for use by healthcare professionals who have been trained to use the device. Such a specialist is expected to have practical knowledge of medical procedures and applications as well as of the technology, 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 DUOLITH® SD1 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

Principles

2-4

– 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 Lohstampfestrasse 8 Postfach CH-8274 Tägerwilen Switzerland

Telephone: Fax:

+41 (0) 71 677 45 45 +41 (0) 71 677 45 05

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