SONARA and SONARA-tek Systems User Manual Rev 09 Aug 2016

SONARA and SONARA/tek User Manual

Table of Contents

Chapter 1 ...1 Attention ... 3 Additional copies ... 3 Trademarks ... 3 Software copyright protection... 4 Customer responsibility ... 5 Function and intended uses... 6 Essential performance ... 7 Intended operator ... 7 About this manual ... 7 Serial numbers ... 7 Operating principles... 8 SONARA system function operation... 8 SONARA/tek system function operation... 8 Contact information ... 9 CE Mark... 9

Chapter 2 ... 11 Precautions... 13 Indications for use... 13 System safety information ... 14 Disposal at end of operating life ... 18 Definition ... 18 Rules for the user ... 18 Fuse rating specifications... 18 SONARA systems ... 18 SONARA/tek systems ... 18

Chapter 3 ...19 Unpacking the system ... 21 SONARA product description ... 22 Connecting the system ... 25

Chapter 4 ...27 Unpacking the system ... 29 SONARA/tek product description ... 29 Installing the system ... 31

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Chapter 5 ...33 Two-Button remote control...35 Multi-button remote control...36 Volume knob...37 Touchpad and Mouse Click Touchstrip ...37 User assignable buttons...37 Command buttons ...37 Spectrum control buttons ...37 Cursor and Control buttons ...37 Footswitch...38 Monitoring headset ...38 Isolation transformer ...38

Chapter 6 ...39 The Main Screen ...42 Maintain the ALARA principle, i.e., keep the ultrasound power and duration of measurement to As Low As Reasonably Achievable. ...49 Summary screen...51 Remote control...53 Footswitch...53

Chapter 7 ...55 Patient menu...57 Patient > New Examination ...58 Patient > DICOM Worklist ...61 Patient > GDT Import ...61 Patient > Load ...62 Patient > Delete...63 Patient > Edit Details ...63 Setup menu...63 Setup > Display...64 Setup > Monitoring ...71 Setup > Protocols ...76 Setup > Printer ...79 Setup > General...81 Database menu ...84 Database > Backup ...85 Database > Restore ...88 Database > DICOM Export ...88 Database > GDT Export...89 Database > Statistics ...90 Database > Import Examination ...91 Database > Export...92

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Table of Contents Help menu... 93 Help > SONARA (or SONARA/tek)... 93 Help > Free Space... 93 Help > License Manager ... 93 Help > Service Tools ... 94 Help > SW Update (SONARA only)... 94 Help > Desktop ... 94 Help > About... 94

Chapter 8 ...95 Cleaning and disinfecting ... 96 Probe Surface Disinfection ... 96 A guide to correct doppler signal acquisition ... 97 Ultrasound safety ... 98 ALARA principle... 98 Guidance to the Interpretation of Thermal Index (TI) and Mechanical Index (MI) ... 99 Ophthalmic examinations ... 100 Servicing ... 101 Troubleshooting ... 101 Error Messages and Explanations:... 101 Training... 102 Contact information ... 102 General specifications ... 103 System Specification... 103 Mains Supply Specification ... 105 Parameter limits (min/max) ... 106 Probe temperatures... 106 Acoustic output specification... 107 Measurement uncertainties ... 108 Acoustic Output in IEC 1157 Format ... 125 Electromagnetic compatibility (EMC) specification ... 127 SONARA and SONARA/tek EMC results... 128 SONARA (EMC) information... 128 SONARA/tek (EMC) information... 132 Environmental requirements specification ... 136 Labels and symbols... 137

Appendix A ...139 SONARA Setup ... 140 SONARA/tek Setup ... 141 To setup systems connected to a non-Natus Medical Incorporated supplied PC: ... 141 To setup systems connected to a Natus Medical Incorporated supplied laptop PC: ... 142

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Chapter 1

Introduction

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Introduction

Attention The information in this document is subject to change without notice. Natus Neurology Incorporated makes no warranty of any kind with regard to this material, including, but not limited to the implied warranties of merchantability and fitness for a particular purpose. Natus Neurology Incorporated assumes no responsibility for any errors that may appear in this document. Natus Neurology Incorporated makes no commitment to update, or to keep current the information contained in this document. No part of this document may be copied or reproduced in any form or by any means without prior written consent of Natus Neurology Incorporated.

Additional copies Additional copies of this manual or other Natus Neurology Incorporated literature may be obtained from: Natus Neurology Incorporated 3150 Pleasant View Road Middleton, WI. 53562-3530 USA US Toll Free:+1 800 356-0007 US Toll:608 829-8500 US Fax:608 829-8589 or persons explicitly authorized by the above.

Trademarks Microsoft, MS, MS-DOS, Excel, Windows, Windows NT, Windows 2000, Windows XP and Windows 7 are registered trademarks of Microsoft Corporation. Adobe and Acrobat are registered trademarks of Adobe Systems Inc. SONARA and SONARA/tek are registered trademarks of Natus Neurology Incorporated or one of its subsidiaries. Nicolet is a registered trademark of Natus Neurology Incorporated or one of its sub is diaries. Cidex is a trademark of Advanced Sterilzation. Dicom is a trademark of NEMA (National Electrical Manufacturers Association).

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Software copyright protection This software is protected by state, U.S. and international copyright treaty provisions. These copyright provisions apply to your use of this software regardless of whether or not you agree to the following terms. Under law, copyright infringers may be liable for actual damages sustained by the copyright owner and for punitive damages of up to $100,000 per infringement. Unauthorized copying of computer software, and attempts to do so, are also criminal violations, with penalties that may exceed $100,000 in fines and 10 years in prison. Transferring a copy of the SONARA and SONARA/tek software, or installation serial number to unauthorized people or entities is strictly prohibited. 1.

Unless restricted by an agreement with Natus Neurology Incorporated, you are permitted to: a.

Use this software on only one computer and by one user at a time.

b.

Make one copy of this software, provided that: i. The copy is created as an essential step in the utilisation of this software in conjunction with your machine and that it is used in no other manner, or ii. That the copy is for archival purposes only and that all archival copies are destroyed in the event that your continued possession of this software should cease to be rightful.

c.

2.

Sell this software, and any archival copy, only as part of the sale of all of your rights in this software, except that adaptations so prepared may be transferred only with the authorisation of Natus Neurology Incorporated.

You are not permitted to: a.

Make copies of this software or documentation except as described above.

b. Alter, modify or adapt this software or documentation except as described above. c.

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Distribute, lease, rent or sublicense this software or documentation.

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Customer responsibility This product and its components will perform reliably only when operated and maintained in accordance with the instructions contained in this manual, accompanying labels, and/or inserts. A defective product should not be used. Parts, which may be broken or missing or are plainly worn, distorted or contaminated should be replaced immediately with clean, genuine replacement parts manufactured by or available from Natus Neurology Incorporated. The responsibility of Natus Neurology Incorporated for a malfunctioning product is limited by the warranty set forth in this manual. Should repair or replacement of this product become necessary after the warranty period, the customer should seek advice from Natus Neurology Incorporated prior to such repair or replacement. If this product is in need of repair it should not be used until all repairs have been made and the unit is functioning properly and ready for use. The owner of this product has sole responsibility for any malfunction resulting from improper use or maintenance, or repair by anyone other than Natus Neurology Incorporated, and from any malfunction caused by parts that are damaged or modified by anyone other than Natus Neurology Incorporated. Any third party software, or OS updates and/or service packs installed may impinge on normal system functionality. Please contact Natus Neurology Incorporated or your authorized local representative for more information.

When configuring SONARA and SONARA/tek components with other components, you are creating a medical system and you must be aware and abide by the requirements of IEC 60101-1 Clause 16. This includes but is not limited to carts, power supplies, mains outlet connections, computers or other devices. Systems without a Natus Neurology Incorporated Isolation Transformer, or systems using non-Natus Neurology Incorporated approved components are at risk of increased leakage current and reduced dielectric strength, which could cause shock to the user or patient during user contact. It is the responsibility of the user to ensure that conformance with IEC/EN 60601-1 patient isolation requirements is maintained when patient-connected equipment or accessories NOT approved by Natus Neurology Incorporated or its authorized agents are used with Natus Neurology Incorporated equipment. Full compliance of SONARA and SONARA/tek systems cannot be ensured unless all components (leads etc.) are provided by Natus Neurology Incorporated or its authorized agents. Any non-medical equipment connected to medical equipment to form a medical electrical system must comply with an appropriate safety standard, for example IEC 60950, EN 60950, UL 1950, CAN/CSA 22.2 No 950. Items not specified as part of a SONARA or SONARA/tek system must not be connected to a SONARA or SONARA/tek system. Any High Frequency (HF) equipment (e.g., surgical diathermy, etc.) used in conjunction with SONARA or SONARA/tek systems must comply with IEC/EN 60601-2-2. If the system, or any component is repaired, it is recommended that all system functionality is checked and an electrical safety test performed prior to resuming use. Only power devices that are approved by Natus Neurology Incorporated with the isolation transformer provided with the SONARA or SONARA/tek system. Do not connect an additional multi-socket outlet or extension cord to the SONARA or SONARA/tek system.

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Function and intended uses The SONARA and SONARA/tek are advanced Transcranial Doppler (TCD) ultrasound systems that allow for non-invasive assessment of blood flow velocities throughout the body. This method of measurement is particularly useful for examining the major arteries supplying blood to the brain. TCD is useful for evaluation of numerous neurological vascular problems such as vasospasm and intracranial stenosis. TCD is also extremely valuable for intraoperative monitoring to help detect sudden changes in flow and potential embolic events. Emboli are small particles of foreign matter (air, clots, etc.) within the bloodstream that can potentially cause obstructions in various arteries in the body and the brain. Such obstructions can often lead to stroke. The following non-invasive methodologies for adult and, paediatric are included: • Diagnostic cerebrovascular and extracranial investigation. • Extended-term unilateral, bilateral, and multilateral cerebrovascular monitoring. The systems may be used in vascular labs, operating rooms, intensive care units, emergency departments and physician offices for the following applications: • Intracranial stenosis. • Detection of vasospasm due to subarachnoid hemorrhage. • Ophthalmic examinations using 2 MHz probes (4 MHz and 8 MHz not recommended for ophthalmic use). • Detection of arteriovenous malformations (AVMs). • Detection of embolic events occurring during surgery or other monitoring applications. • Detection of PFO (Patent Foramen Ovale). • Assessment of collateral pathways. • Document important sudden changes in flow velocities. • Track and establish trends of flow velocities during drug administration in the operating room. • Help improve surgical techniques through immediate feedback of the results of interventional procedures, including the study and documentation of possible micro emboli that may result in stroke. • Demonstrate the resulting effects of new or experimental drugs on intracranial blood flow velocities. • Document the informative results of CO2 reactivity testing (VMR). SONARA and SONARA/tek systems are intended for use only on adults and children, and should not be used under any circumstances for foetal examinations.

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Introduction

Essential performance The essential performance of the SONARA and SONARA/tek systems are: • Free from noise on a waveform or artifacts or distortion in an image or error of a displayed numerical value, which cannot be attributed to a physiological effect and which may alter the diagnosis. • Free from the display of incorrect numerical values associated with the diagnosis to be performed. • Free from the display of incorrect safety-related indications. • Free from the production of unintended or excessive ultrasound output. • Free from the production of unintended or excessive TRANSDUCER ASSEMBLY surface temperature.

Intended operator The SONARA systems and SONARA/tek systems are intended for trained and skilled personnel in collecting transcranial data and peripheral Doppler ultrasound from a test subject. Natus Neurology Incorporated recommends that trained personnel ONLY use these systems.

About this manual This manual assumes that the reader is a trained professional, familiar with blood-flow velocity measurements. The manual does not provide any instructions relating to the techniques or methods of acquiring velocity measurements. The sole intention of this manual is to provide detailed operating instructions of the SONARA and SONARA/tek systems for optimal utilization of the devices, as well as important warnings and precautions that are related to the safe use of the systems. Before starting the SONARA and SONARA/tek systems for the first time, you must read this manual thoroughly, and ensure that you fully understand all the issues that are related to the safe operation of the device.

Serial numbers This manual covers Legacy SONARA systems, and Current Production versions of the SONARA system. They will be referenced as SONARA Version 1 (Legacy SONARA) and SONARA Version 2 (Current Production SONARA). Sonara Version 1 (legacy) systems are serial numbered PWL1000 and lower. Sonara Version 2 (current) systems are serial numbered TD120100 and greater.

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Operating principles The Sonara is a Transcranial and peripheral vascular Doppler system, which is designed to measure blood flow velocities and other hemodynamic parameters in a non-invasive manner, in intracranial, extracranial and peripheral blood vessels.

SONARA system function operation For SONARA only, system operation can be performed through lightly touching the touch screen, by using a USB keyboard or mouse, or by using the Remote Control or Footswitch for certain specific functions. Wherever this manual relates to "clicking" or “pressing” on a certain Function key or button you should assume that touching the button would perform the same operation. Whenever text needs to be entered during program operation, a virtual keyboard is displayed on the screen. In this manual entering textual information relates to using the virtual keyboard by touching the screen, or to entering the information with a USB keyboard.

SONARA/tek system function operation For SONARA/tek systems only, system operation is performed in the way consistent with the platform to which the SONARA/tek is connected, as well as using the Remote Control or Footswitch for certain specific functions. The host system’s keyboard/mouse/trackball, etc., are used to control the SONARA/ tek.

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Contact information Technical Support Natus Neurology Incorporated 3150 Pleasant View Road Middleton, WI USA 53562-3530 608-829-8500 1 800-356-0007 Fax: 608-829-8589 Internet: www.natus.com Natus EU Authorized Representative Natus Manufacturing Limited IDA Business Park Gort, Co.Galway, Ireland

Domestic Natus Neurology Incorporated 3150 Pleasant View Road Middleton, WI USA 53562 1-800-356-0007 [email protected] www.Natus.com International Natus Neurology Incorporated Phone: 608-829-8500 Fax: 608-829-8775 [email protected] www.Natus.com

CE Mark Compliant to Medical Device Directive 93/42/EEC.

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Chapter 2

Safety Summary and Regulatory Information

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Safety Summary and Regulatory Information

Precautions IMPORTANT: Please read this manual carefully before setting up the systems or before connecting other instruments. Read and follow all WARNINGS CAUTIONS and NOTES provided in this user manual. To avoid the possibility of personal injury, damage to your system or lost data, observe these safety precautions during system operation. In this manual, two labels identify potentially dangerous or destructive conditions or procedures and one gives extra information: The WARNING label identifies conditions or practices that may present danger to the patient and/or user. The CAUTION label identifies conditions or practices that could result in damage to the equipment.

NOTES: These help you identify areas of possible confusion, and avoid potential problems during system operation.

Indications for use SONARA and SONARA/tek systems are medical ultrasound Doppler devices for measuring the blood flow velocities in arteries non-invasively.

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System safety information Take care to read the following section carefully. Additional warnings and cautions also appear in relevant places in other parts of this manual. SONARA and SONARA/tek are intended only for non-invasive medical diagnosis of intracranial and peripheral blood vessels. The devices must be used only in accordance with the provided product labeling. Only trained and authorised medical personnel may operate the systems. A new user must thoroughly read and understand this user manual before using the systems. Federal law in the U.S.A. and Canada restrict these devices to sale by or on the order of a medical practitioner licensed by the law of the state in which they practice to use or order to use these devices. Do not use any ultrasound transducers, or other accessories that are not supplied by Natus Neurology Incorporated with or for use with the SONARA and SONARA/tek systems. Inspect transducer assemblies and cables on a regular basis for possible damage, (cracks that could allow ingress of conductive fluids, cable or connector damage etc.). Never use a damaged transducer assembly. The ultrasound probes supplied with the SONARA and SONARA/tek systems are provided with protective means to reduce the risk of burns to the patient at the point of insonation when used with HF surgical equipment, (independently tested), but care should be taken when using the system in these circumstances. Immediately contact Natus Neurology Incorporated or your authorised local distributor if you should encounter any problems with the systems. Only trained and authorised personnel are allowed to service the systems or open the casing. Do not attempt to repair the systems. Do not attempt to install or revise the SONARA software. Do not modify or make changes to the SONARA/tek installation directory. The system must be earthed. Improper earthing of the system can result in an electric shock. Electric shock hazard! Do not remove the casing cover. For servicing, contact Natus Neurology Incorporated or an authorised service representative. During an examination, do not place the ultrasound probes over or near open wounds. Do not allow the probes to come into contact with body fluids. Use caution when monitoring febrile patients. Use of transcranial Doppler may raise the temperature of the skull or surrounding tissues. Whilst this is not believed to present a health risk for patients with normal body temperatures, use of the device on febrile patients may elevate the temperature above the level of the fever.

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