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CLARIUS EC7 User Manual

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Scanner User Manual

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Summary of Contents for CLARIUS EC7

  • Page 1 Clarius Ultrasound Scanner User Manual...
  • Page 2 Clarius Mobile Health Corp. (“Clarius“) and is provided for the sole use of the individual or entity to whom it is addressed and therefore these materials must be kept in the strictest confidence. No portion of this manual may be copied, reproduced, republished, modified, sold, disclosed, or distributed without the prior written permission of Clarius.

  • Page 3: Table Of Contents

    Table of Contents About This Manual ......................1 Target Audience........................1 Document Conventions .....................2 Icons............................2 Symbols Glossary........................2 Chapter 1: About the Clarius Ultrasound Scanner ........5 Scanner Description ....................6 Scanner Dimensions....................7 Product Usage......................8 Indications for Use ......................8 Contraindications ......................16 Hardware........................

  • Page 4: Table Of Contents

    Clarius Ultrasound Scanner A Quick Tour.......................23 Screen Overview ......................23 Connecting Your Smart Device to the Clarius Scanner.........26 Managing Exams .......................27 Error Messages .......................28 Imaging ........................29 Using the Measuring Tools ..................29 Updating the Clarius Ultrasound Scanner ............30 Software Updates ......................30 Firmware Updates......................30 Maintenance ......................30...

  • Page 5: Table Of Contents

    Clarius Ultrasound Scanner Disinfecting the Clarius Scanner ................47 Disinfecting the Fan ......................49 Disinfecting the Clarius Clip-on .................50 Spaulding Classification ..................51 Chapter 5: Safety..................52 About Diagnostic Ultrasounds................52 Interactions with Matter....................52 Studies..........................52 Benefits & Risks......................53 Safety Topics ......................53 Product Safety ........................54 Battery Safety .........................55...

  • Page 6: Table Of Contents

    Clarius Scanner C3: B-Mode & M-Mode ..............85 Clarius Scanner C3: Color Doppler Mode ..............86 Clarius Scanner C3: Pulsed Wave Mode ..............87 Clarius Scanner C3 with Clarius Clip-on C3-L: B-Mode ........88 Clarius Scanner C7: B-Mode & M-Mode ..............89 Clarius Scanner C7: Color Doppler Mode ..............90 Clarius Scanner C7: Pulsed Wave Mode ..............91...

  • Page 7: About This Manual

    To obtain a printed copy of this manual at no additional cost, go to www.clarius.com/contact and contact Clarius. This document is licensed as part of the purchase of the Clarius Ultrasound Scanner and meets applicable regulatory requirements. Use of this document by unauthorized persons is strictly prohibited.

  • Page 8: Document Conventions

    This icon indicates informative material or helpful suggestions. Symbols Glossary The symbols shown in this document and on the Clarius Ultrasound Scanner are compliant with current versions of the following standards: ISO 7000, ISO 7010, IEC 6417, (EN) ISO 15223-1, and EN 15986.
  • Page 9 General symbol for To indicate that the marked item or its material is part of a recovery or recovery/recyclable recycling process. You may see some of these standard symbols on your Clarius Scanner, accessories, and packaging: — G — R...
  • Page 10 Clarius Ultrasound Scanner You may see these other symbols on your Clarius Scanner, accessories, and packaging: THER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT Symbol Title Description Power connector Indicates a barrel-type power connector. RoHS compliant Identifies electrical and electronic equipment that meets the Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU.

  • Page 11: Chapter 1: About The Clarius Ultrasound Scanner

    • Product package must be maintained with medical device. Do not dispose. • Using the product incorrectly, or for purposes other than those intended and expressly stated by Clarius, may relieve Clarius or its agents from all or some responsibility for resultant noncompliance, damage, or injury.

  • Page 12: Scanner Description

    Scanner series of wireless scanners are Bluetooth and Wi-Fi-based scanners that communicate with a traditional tablet/smartphone via direct Wi-Fi to allow users to export ultrasound images and display in different modes of operation. The Clarius Scanner houses a battery and power generator, multichannel beamformer, prescan converter and Wi-Fi components. The battery is removable and comes with a separate charger.

  • Page 13: Scanner Dimensions

    Input: 100-240 VAC, 50/60 Hz, 0.5-0.2 A Output: 12 VDC, 1.5 A Scanner 7.2 V/2350 mAh Scanner Dimensions Item Length (in/mm) Width (in/mm) Height (in/mm) Weight (oz/g) Clarius Scanner C3 3.94/100 1.66/42 6.65/169 16.4/465 Clarius Scanner C7 3.94/100 1.66/42 6.89/175 15.7/445 Clarius Scanner L7 3.94/100...

  • Page 14: Product Usage

    Product Usage Product Usage Indications for Use The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging 1 ,2 and fluid flow analysis in the following applications: ophthalmic...
  • Page 15 Clarius Ultrasound Scanner Product Usage Indications for Use Tables Clarius Ultrasound Scanner YSTEM LARIUS LTRASOUND CANNER NTENDED IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific B M Color...
  • Page 16 Clarius Ultrasound Scanner Product Usage Clarius Scanner C3 EVICE LARIUS CANNER NTENDED IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific B M Color Power Combined (Specify) Other* (Track 1 Only) (Tracks 1 &...
  • Page 17 Clarius Ultrasound Scanner Product Usage C3 Convex Scanner with C3-L Clip-on : C3 C C3-L C EVICE ONVEX CANNER WITH NTENDED IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General...
  • Page 18 Clarius Ultrasound Scanner Product Usage C3 Convex Scanner with C3-P Clip-on : C3 C C3-P C EVICE ONVEX CANNER WITH NTENDED IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General...
  • Page 19 Clarius Ultrasound Scanner Product Usage Clarius Scanner C7 EVICE LARIUS CANNER NTENDED IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific B M Color Power Combined (Specify) Other* (Track 1 Only) (Tracks 1 &...
  • Page 20 Clarius Ultrasound Scanner Product Usage Clarius Scanner EC7 EVICE LARIUS CANNER NTENDED IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific B M Color Power Combined (Specify) Other* (Track 1 Only) (Tracks 1 &...
  • Page 21 Clarius Ultrasound Scanner Product Usage Clarius Scanner L7 EVICE LARIUS CANNER NTENDED IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific B M Color Power Combined (Specify) Other* (Track 1 Only) (Tracks 1 &...

  • Page 22: Contraindications

    (for instructions see High-Level Disinfection on page 48), then cover the Clarius Scanner EC7 with a model #2220 sheath by Protek Medical Supplies Inc. Make sure the entire length of the end piece is protected.

  • Page 23: Hardware

    Using the Clarius Ultrasound Scanner for ophthalmic (ocular) indications is restricted to the Clarius Scanner L7 in B-Mode. No other model should be used for this indication or for any use causing the acoustic beam to pass through the eye. Doing so may result in serious and irreversible harm to the eye of the patient.

  • Page 24: Security

    Wi-Fi signals, perform harmful actions, and view communications between the two smart devices. When no secure access point is available, operate the Clarius App in Wi-Fi Direct mode, and it will automatically set up encryption.

  • Page 25: Confidentiality

    Wi-Fi Direct network, the image data is confidential. • If no images are exported to Clarius Cloud or DICOM, the Clarius App stores them in the Clarius Scanner indefinitely. If images are exported, these images will be deleted from the device 10 days after export by default.

  • Page 26: Accountability

    • Contrast ratio of 800:1 • Supports OpenGL ES 2.0 • Some sections of this User Manual may not apply to earlier versions of the Clarius Ultrasound Scanner. Make sure you have the latest version of the Clarius App. • Using a smart device that is too small may not have the necessary resolution for viewing small structures.

  • Page 27: Chapter 2: Using The Clarius Ultrasound Scanner

    Refer to Safety on page 52 before handling the Clarius Ultrasound Scanner. Your Clarius Scanner is already activated and ready for use. You just need to download the Clarius App on an Apple iOS device or an Android™-based device. Downloading the Clarius App Whether you are using Apple iOS or Android™, you must have an...

  • Page 28: Turning The System On & Off

    Turning the System on & off Starting the Clarius App Before you begin using the Clarius Ultrasound Scanner, make sure you have the Clarius Scanner, and also your smart device with the Clarius App installed on it.  To open the Clarius App on your smart device: Go to your smart device’s home screen and tap...

  • Page 29: Removing The Battery

    A Quick Tour Screen Overview Sign-in Page When you open the Clarius App, it displays a sign-in screen. To use the scanner and Clarius App, you must have a Clarius account.  To sign in: Open the Clarius App. It displays a sign-in screen for your user ID and password.
  • Page 30 Scanners Page When you sign in, the Clarius App displays the Scanners page. This page lists active scanners in your vicinity. If your Clarius App cannot locate your scanner, either because the scanner is powered off or because it is located outside its Bluetooth range, the scanner is grayed out on the list.
  • Page 31 Workflows guide you towards collecting all the information needed to produce a complete and accurate report for the reviewing physician. Only those exam types applicable to the selected Clarius Scanner are displayed in the Workflows page. User Manual revision 9...

  • Page 32: Connecting Your Smart Device To The Clarius Scanner

     To connect your Apple iOS device to a Clarius Scanner: 1. From the Scanners page, tap the image or the name of the Clarius Scanner you want to select. This activates the selected Clarius Scanner and attempts to connect it to your smart device’s Wi-Fi.

  • Page 33: Managing Exams

    Clarius Ultrasound Scanner Managing Exams Once the checkmark appears in the status circle, the Clarius App displays the name of the selected Clarius Scanner’s Wi-Fi network and the password. Remember the network name. The Clarius App has copied the password, so you do not need to memorize it.

  • Page 34: Error Messages

    Clarius Ultrasound Scanner Managing Exams Error Messages The Clarius Ultrasound Scanner displays no error messages. Instead, the Clarius Scanner presents visual notifications in the form of status lights, and audible notifications in the form of status alerts. Status Lights The following table defines the Clarius Scanner’s status lights:...

  • Page 35: Imaging

    You are responsible for image quality and diagnosis. Ensure that the data used for inspection and diagnosis is sufficient, both spatially and temporally, for the measurement method. Measurement Accuracy Table Each figure below is derived from the sum of all parts of the Clarius Ultrasound Scanner. 2D M & A...

  • Page 36: Updating The Clarius Ultrasound Scanner

     To update the software: Go to the Apple Store App or the Google Play store. Firmware Updates If a Clarius Scanner software update is required, the Clarius App will notify you.  To update the firmware: Tap Update. During the updating process, do not remove the battery. If the battery level is too low, the system will decline the update.

  • Page 37: Hardware Maintenance

    Testing Scanners When you turn on the system, the scanner powers up and automatically tests its internal components. The Clarius Scanner’s LED will light up and you will hear a two-tone beep. The table below defines these conditions: Battery Condition...
  • Page 38 100% before use. Charge the battery using only the specified charger. If you turn on the Clarius Scanner and leave it untouched, it will go through the following modes to help reduce temperature and battery power: 1. After three seconds, it decreases frame rate.

  • Page 39: System Maintenance

    This downloads logs from the Clarius Scanner, then combines them with the logs from the Clarius App. This bundle is then sent to the Clarius Cloud where they can be retrieved by a Clarius Support staff. The log files contain diagnostic information.

  • Page 40: Chapter 3: Accessories

    • Clarius Stand: A roll stand with a basket. • assembly (CIDN 50-02-00040) • package (CIDN 99-03-00012) • Clarius Cart: A roll stand with a basket, a locking storage bin, and a Clarius Battery Charger Hub. • assembly (CIDN 50-02-00033) •...

  • Page 41: Clarius Cart

    It is not to be used in emergency medical services environments including during patient transport or the home healthcare environment. The Clarius Cart is to be used while attached to a roll stand. It is not to be placed within 1.5m of the examination table or patient bed.

  • Page 42: Technical Specifications

    Clarius Ultrasound Scanner Clarius Cart Technical Specifications • Input: 12 VDC, 11.5 A • Output: 8.4 VDC, 1.5 A x 5 (charger), 5.0 VDC, 2.3 A x 2 (USB) • Protection Against Electric Shock: Class II • Applied Part: None •...

  • Page 43: Setting Up

    • Do not touch the patient and the Clarius Cart at the same time. • If the AC power cord is damaged, contact Clarius for a replacement. • Do not move the Clarius Cart while the upper section is extended. Adjust the upper section to its lowest position before transport.

  • Page 44: Maintenance

    Ultrasound Scanner. The charger hub combines a battery charger that can charge up to five batteries and a USB charger that can charge two smart devices (smart phones and tablets). An external power supply is used to connect the Clarius Battery Charger Hub to the AC wall outlet using the supplied power cord.

  • Page 45: Parts

    The Clarius Battery Charger Hub can be used as a stand-alone portable device, or it can be used while attached to the Clarius Cart or the Clarius Stand. It is not to be placed within 1.5m of the examination table or patient bed.
  • Page 46 • Do not place the Clarius Battery Charger Hub within 1.5m of the examination table/patient bed. • Do not touch the patient and the Clarius Battery Charger Hub at the same time. • If the AC power cord is damaged, contact Clarius for a replacement.
  • Page 47 Do not touch battery charger contacts. Only charge Clarius Rechargeable Li-ion Battery (CIDN 99-02-00001). Charging the Smart Device The Clarius Battery Charger Hub can charge any smart device that is used with the Clarius Ultrasound Scanners.  To charge your smart devices: 1.

  • Page 48: Clarius Fan

     To use the Clarius Clip-on: 1. Select the Clarius Clip-on you want to use. 2. Apply gel to the inside of the Clarius Clip-on. When you are ready to scan, you will apply gel to the outside also. 3. Align the Clarius Clip-on with the scanner head, as shown in the diagram below:...
  • Page 49 Clarius Clip-on • Clarius Clip-on C3-L • Clarius Clip-on C3-P 4. Snap the Clarius Clip-on into place. When you go to your Clarius App and begin an exam, select the exam matching the Clarius Clip-on being used: • Clarius Clip-on C3-L •...

  • Page 50: Chapter 4: Cleaning & Disinfecting

    This chapter will guide you through the cleaning and disinfecting process. The classification of cleaning and disinfecting you select will depend on the type of tissue the Clarius Scanner comes into contact with. To find the correct classification, refer to Spaulding Classification on page 51.

  • Page 51: Cleaning

     To clean the Clarius Scanner: 1. Make sure the Clarius Scanner is turned off. 2. Remove the battery and fan from the scanner. It is important that you clean the two pieces separately.

  • Page 52: Cleaning The Clarius Cart

    Cleaning the Clarius Battery Charger Hub  To clean the Clarius Battery Charger Hub: 1. Unplug the DC power connector from the Clarius Battery Charger Hub. 2. Wipe down all surfaces using a premoistened disinfectant wipe. For a list of compatible cleaners, see Cleaners & Disinfectants on page 100.

  • Page 53: Cleaning The Fan

    Cleaning the Fan  To clean the Clarius Fan: 1. Remove the fan from the Clarius Scanner. 2. Wipe down all surfaces using a premoistened disinfectant wipe. For a list of compatible cleaners, see Cleaners & Disinfectants on page 100.
  • Page 54 6. Examine the scanner for damage, such as cracks or splitting where fluid can enter. If damage is evident, do not use the scanner and contact Clarius Mobile Health. 7. Disinfect the battery and the battery connector by wiping with a cloth moistened with a compatible disinfectant.

  • Page 55: Disinfecting The Fan

    5. Air-dry both pieces. Alternatively, towel-dry with a clean, non-linting cloth. 6. Examine the parts for damage, such as cracks or splitting where fluid can enter. If damage is evident, discontinue use of the scanner and/or battery, and contact Clarius Mobile Health.

  • Page 56: Disinfecting The Clarius Clip-On

    Alternatively, use a premoistened disinfectant wipe. 3. Air-dry. Alternatively, towel-dry with a clean, non-linting cloth. 4. Examine the Clarius Clip-on for damage, such as cracks or splitting. If damage is evident, do not use the Clarius Clip-on and contact Clarius Mobile Health.

  • Page 57: Spaulding Classification

    Clarius Ultrasound Scanner Spaulding Classification 6. Examine the Clarius Clip-on for damage, such as cracks or splitting. If damage is evident, do not use the Clarius Clip-on and contact Clarius Mobile Health. Spaulding Classification The level of cleaning and disinfecting required for your Clarius Scanner is based on the Spaulding classification system.

  • Page 58: About Diagnostic Ultrasounds

    Safety This chapter provides instructions on the product's safe usage and offers information on safety guidelines. Pay special attention to warnings and cautions, and follow them before, during, and after operating the product: • Warnings indicate information vital to the safety of you, the operator, and the patient.

  • Page 59: Benefits & Risks

    -- AIUM Safety Topics Use the Clarius Ultrasound Scanner only if you have read and understood all the information in this section. Operating the system without proper safety awareness could lead to fatal or serious personal injury.

  • Page 60: Product Safety

    -- WHO (World Health Organization) Product Safety Clarius is responsible for the safety of the scanners. The safety of your smart device is your responsibility. Always follow the safety guidelines provided with your smart device before, during, and after use.

  • Page 61: Battery Safety

    The Clarius Ultrasound Scanner comes with a battery, a battery charger, and a power supply for the charger. Do not use your system or the Clarius Cart in combination with other products or components not made by Clarius, unless Clarius expressly recognizes those other products or components as compatible.

  • Page 62: Cleaning Safety

    Professionals in Infection Control, the U.S. Food and Drug Administration, and the U.S. Centers for Disease Control. • Clean the scanner and the Clarius Cart after each use. This is an essential step before disinfection. • When disinfecting the scanner or the Clarius Cart, ensure that the solution's strength and duration of contact are appropriate for disinfection.
  • Page 63 If you use an OPA-based disinfectant, residual solution may remain on your scanners or your Clarius Cart if you do not carefully follow the manufacturer's instructions. To minimize the effects from residual OPA, or any other disinfectant, Clarius recommends the following: •...

  • Page 64: Clinical Safety

    Syringe Safety • If the needle is not visible, do not perform the needle procedure. • Verify the location of the needle tip in the image. The Clarius Scanner cannot visualize a needle that is out of plane. • Thin needles can bend when entering tissue. Verify the needle's position by identifying the echoes from the needle.

  • Page 65: Biological Safety

    Latex Clarius Ultrasound Scanners do not contain natural rubber latex. Sheaths and biopsy guides you select to use with the Clarius Ultrasound Scanner may contain latex. Check with the manufacturer's safety information. The following are FDA recommendations on latex awareness: •...
  • Page 66 Clarius Ultrasound Scanner Safety Topics Tissue absorbs ultrasound energy to varying degrees depending on the tissue's absorption characteristics. Absorption characteristics are quantified by the absorption coefficient: • Fluids: Their absorption coefficient is almost zero. Fluids such as amniotic fluid, blood, and urine absorb very little ultrasonic energy.

  • Page 67: Alara Principle

    Clarius Ultrasound Scanner Safety Topics There are two categories of cavitation: • Stable: Stable cavitation is associated with vibrating gas bodies. In stable cavitation, a gas body oscillates or pulsates continuously around its equilibrium size. As the oscillations become established, the liquid-like medium around the gas body begins to flow or stream;...
  • Page 68 The system has no direct control for output, therefore the sonographer must control exposure time and scanning technique to implement the ALARA principle. To ensure that acoustic and thermal limits are not exceeded for all imaging modes, the Clarius Ultrasound Scanner is designed to automatically adjust output.
  • Page 69 Clarius Ultrasound Scanner Safety Topics • Dwell time: Scanned modes, such as B-Mode imaging, distribute the energy over a large volume. In scanned modes (equipment keeps the beam stationary), the highest temperature is frequently at the surface where the ultrasound enters the body.
  • Page 70 Clarius Ultrasound Scanner Safety Topics Output Display The output display provides the user with an indication of the potential for bioeffects that might be caused by the ultrasound energy being emitted. With this information, users can better control the diagnostic ultrasound equipment and examination to ensure that needed diagnostic information is obtained with a minimum of risk to the patient.
  • Page 71 Clarius Ultrasound Scanner Safety Topics You can choose to display one of the following types of TI indices: • TIS: Indicates potential for heating within soft homogeneous tissue. • TIB: Indicates potential for heating at or near the focus after the ultrasound beam has passed through soft tissue or fluid.
  • Page 72 Clarius Ultrasound Scanner Safety Topics Controls Affecting Display Indices Use system controls to change the TI and MI values. Power Controls Two real-time output values are on the display: TI and MI. These change as the system responds to power-control adjustments. In combined modes, the individual modes each add to the total TI.
  • Page 73 Clarius Ultrasound Scanner Safety Topics Example of reducing output: Imagine we are getting ready to do a liver scan. The first thing we need to do is select the appropriate scanner frequency. Next, we adjust the output intensity (or power) transmit setting.
  • Page 74 Clarius Ultrasound Scanner Safety Topics AIUM, NEMA, 2004), the “Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment” (Revision 2, AIUM, NEMA, 2004), and the September 2008 FDA document “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Scanners.”...
  • Page 75 Clarius Ultrasound Scanner Safety Topics Mathematical derating of water-based measurements using the 0.3 dB/cm MHz coefficient may yield lower acoustic exposure values than would be measured in a homogenous 0.3 dB/ cm MHz tissue. This is true because nonlinearly propagating acoustic energy waveforms experience more distortion, saturation, and absorption in water than in tissue, where attenuation present all along the tissue path will dampen the buildup of nonlinear effects.

  • Page 76: Fire & Electrical Safety

    Clarius Ultrasound Scanner Safety Topics obtained were approximately 1.5°C (2.7°F) for first-trimester fetal tissue and 7°C (12.6°F) for second-trimester fetal bone. Estimated maximum temperature elevations given here are for a “fixed-path” tissue model and are for scanners having I (derated) values...

  • Page 77: Electromagnetic Safety

    Electrical Safety • To reduce electrical shock hazards, inspect the scanner face and housing, and also the Clarius Cart before use. Discontinue use if the housing is damaged, or if the face is cracked, chipped, or torn. • All patient-contact scanners not specifically indicated as defibrillation-proof must be removed from the patient before applying high-voltage defibrillation pulse.
  • Page 78 • EMC precautions for medical equipment must be followed according to the EMC information provided in that system's accompanying documents. • The Clarius Ultrasound Scanner’s AC power supply cable is limited to 1.5 m (4.9 feet). Electrostatic Discharge Precautions Electrostatic discharge (ESD), or static shock, results from the flow of an electrical charge from a person or object of a higher charge to that of a lower charge.

  • Page 79: Electromagnetic Emissions

    Clarius Ultrasound Scanner Safety Topics Electromagnetic Emissions Ensure that the Clarius Ultrasound Scanner is used only in those operating environments indicated in the following table. Operating the system in an environment that does not meet these conditions may degrade system performance.
  • Page 80 Electromagnetic Interference The way an electromagnetic interference (EMI) from other equipment affects the Clarius Ultrasound Scanner and the Clarius Cart depends on the system's operation mode, image control settings, and the type and level of electromagnetic phenomena. Electromagnetic phenomena may be intermittent, making it difficult to identify the source.
  • Page 81 Clarius Ultrasound Scanner Safety Topics Separation Distance Recommended Separation Distance The following table shows recommended separation distances for the system to be kept away from any RF-transmitting equipment. To reduce the risk of interference, when using portable and mobile RF communications equipment, follow the recommended separation distance (calculated from the equation applicable to the frequency of the transmitter).
  • Page 82 If you find the interference's source, go to www.clarius.com/contact and contact Clarius. Regulation of Low-Power Motor for Radio Wave Range NCC Warning:...

  • Page 83: Compliance Statement

    Users are responsible for ensuring that the chosen smart device and scanner are compliant with the law in the jurisdiction where the product is used. Clarius meets all regulatory standards listed in this chapter. The Clarius Ultrasound Scanner...

  • Page 84: Product Serial Number

    The Clarius Ultrasound Scanner Product Serial Number Clarius has assigned a unique serial number on each scanner. This serial number, displayed in the format PT-R-YYMM-zXXXX, is used to track quality control. We will use the serial number L738-A-1803-A0100 as an example to explain how to interpret this.

  • Page 85: Scanner Specifications

    20°C (60°F). b. Transient Operating Conditions are applicable in North America only. To reach an operating temperature of 20°C (68°F), the Clarius Scanner requires approximately 30 minutes to: • Warm up from a storage temperature of -20°C (-4°F).

  • Page 86: Standards

    PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency The Clarius Ultrasound Scanner meets the minimum requirements for compliance with the European Union’s Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU and its amendments.

  • Page 87: Federal

    Clarius Ultrasound Scanner Standards IEC 62133 2012 Secondary cells and batteries containing alkaline or other non-acid electrolyte - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications ST/SG/AC.10/11/Rev.5 2009 Recommendations on the transport of dangerous goods - Manual of tests and criteria...
  • Page 88 Clarius Ultrasound Scanner Standards GB 9706.9 2008 Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment GB 10152 2009 B-Mode ultrasonic diagnostic equipment GB/T 14710 2009 Environmental requirement and test methods for medical electrical equipment.

  • Page 89: Security & Privacy

    Clarius Ultrasound Scanner Standards CMDR 2011 Canadian Medical Devices Regulations (CMDR): • Safety and Effectiveness Requirements (Sections 10-20) • Labeling Requirements (Sections 21-23) IEC 62304 2006 Medical device software - Software life cycle processes IEC 62366 2014 Medical devices - Application of usability engineering to medical devices...

  • Page 90: Doppler Sensitivity

    Clarius Ultrasound Scanner Doppler Sensitivity • ETSI EN 301 489-17:2009-05 - Electromagnetic compatibility and Radio spectrum Matters (ERM) Doppler Sensitivity The following table shows the Doppler sensitivity of the Clarius Scanners. Scanner Sensitivity Depth (cm) Flow (mL/sec) Clarius Scanner C3 Power/Color Doppler depth sensitivity 10.0 cm...

  • Page 91: Acoustic Output Tables

    Clarius Ultrasound Scanner Doppler Sensitivity Acoustic Output Tables Clarius Scanner C3: B-Mode & M-Mode COUSTIC UTPUT EPORTING ABLE FOR RACK C3, B-M & M-M CANNER ODEL PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm >1 cm Maximum Index Value 0.863...

  • Page 92: Clarius Scanner C3: Color Doppler Mode

    Clarius Ultrasound Scanner Doppler Sensitivity Clarius Scanner C3: Color Doppler Mode COUSTIC UTPUT EPORTING ABLE FOR RACK C3, C CANNER ODEL OLOR OPPLER PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm >1 cm Maximum Index Value 1.10 1.37...

  • Page 93: Clarius Scanner C3: Pulsed Wave Mode

    Clarius Ultrasound Scanner Doppler Sensitivity Clarius Scanner C3: Pulsed Wave Mode COUSTIC UTPUT EPORTING ABLE FOR RACK C3, P CANNER ODEL ULSED PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm >1 cm Maximum Index Value 0.818 0.494 0.562...

  • Page 94: Clarius Scanner C3 With Clarius Clip-On C3-L: B-Mode

    Clarius Ultrasound Scanner Doppler Sensitivity Clarius Scanner C3 with Clarius Clip-on C3-L: B-Mode COUSTIC UTPUT EPORTING ABLE FOR RACK C3, C C3-L B-M CANNER ODEL LARIUS PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm >1 cm Maximum Index Value 0.283...

  • Page 95: Clarius Scanner C7: B-Mode & M-Mode

    Clarius Ultrasound Scanner Doppler Sensitivity Clarius Scanner C7: B-Mode & M-Mode COUSTIC UTPUT EPORTING ABLE FOR RACK C7 B-M & M-M CANNER ODEL PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm >1 cm Maximum Index Value 0.795 0.109...

  • Page 96: Clarius Scanner C7: Color Doppler Mode

    Clarius Ultrasound Scanner Doppler Sensitivity Clarius Scanner C7: Color Doppler Mode COUSTIC UTPUT EPORTING ABLE FOR RACK C7 C CANNER ODEL OLOR OPPLER PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm >1 cm Maximum Index Value 1.05 0.509...

  • Page 97: Clarius Scanner C7: Pulsed Wave Mode

    Clarius Ultrasound Scanner Doppler Sensitivity Clarius Scanner C7: Pulsed Wave Mode COUSTIC UTPUT EPORTING ABLE FOR RACK C7 P CANNER ODEL ULSED PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm >1 cm Maximum Index Value 0.861 0.093 0.338...

  • Page 98: Clarius Scanner Ec7: B-Mode & M-Mode

    Clarius Ultrasound Scanner Doppler Sensitivity Clarius Scanner EC7: B-Mode & M-Mode COUSTIC UTPUT EPORTING ABLE FOR RACK EC7, B-M & M-M CANNER ODEL PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm >1 cm Maximum Index Value 0.725 0.061...

  • Page 99: Clarius Scanner Ec7: Color Doppler Mode

    Clarius Ultrasound Scanner Doppler Sensitivity Clarius Scanner EC7: Color Doppler Mode COUSTIC UTPUT EPORTING ABLE FOR RACK EC7, C CANNER ODEL OLOR OPPLER PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm >1 cm Maximum Index Value 0.895 0.208...

  • Page 100: Clarius Scanner Ec7: Pulsed Wave Mode

    Clarius Ultrasound Scanner Doppler Sensitivity Clarius Scanner EC7: Pulsed Wave Mode COUSTIC UTPUT EPORTING ABLE FOR RACK EC7, P CANNER ODEL ULSED PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm > 1 cm Maximum Index Value 0.464 0.032...

  • Page 101: Clarius Scanner L7: B-Mode & M-Mode

    Clarius Ultrasound Scanner Doppler Sensitivity Clarius Scanner L7: B-Mode & M-Mode COUSTIC UTPUT EPORTING ABLE FOR RACK L7, B-M & M-M CANNER ODEL PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm >1 cm Maximum Index Value 1.00 0.235...

  • Page 102: Clarius Scanner L7: Color Doppler Mode

    Clarius Ultrasound Scanner Doppler Sensitivity Clarius Scanner L7: Color Doppler Mode COUSTIC UTPUT EPORTING ABLE FOR RACK L7, C CANNER ODEL OLOR OPPLER PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm >1 cm Maximum Index Value 0.84 0.159...

  • Page 103: Clarius Scanner L7: Pulsed Wave Mode

    Clarius Ultrasound Scanner Doppler Sensitivity Clarius Scanner L7: Pulsed Wave Mode COUSTIC UTPUT EPORTING ABLE FOR RACK L7, P CANNER ODEL ULSED PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm >1 cm Maximum Index Value 0.669 0.475 0.882...

  • Page 104: Clarius Scanner L7: Needle Enhance Mode

    Clarius Ultrasound Scanner Doppler Sensitivity Clarius Scanner L7: Needle Enhance Mode COUSTIC UTPUT EPORTING ABLE FOR RACK L7, B-M CANNER ODEL PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm >1 cm Maximum Index Value 1.08 0.198 Associated (MPa) 2.48...

  • Page 105: Clarius Scanner L7: Ocular (Ophthalmic) Mode

    Clarius Ultrasound Scanner Doppler Sensitivity Clarius Scanner L7: Ocular (Ophthalmic) Mode COUSTIC UTPUT EPORTING ABLE FOR RACK L7, B-M CANNER ODEL PERATION Index Label Scan Non-scan Non- scan aprt aprt ≤1 cm >1 cm Maximum Index Value 0.187 0.004 Associated (MPa) 0.487...

  • Page 106: Cleaners & Disinfectants

    Cleaners & Disinfectants Cleaners & Disinfectants Cleaner & Disinfectant Usage The following table lists the cleaners and disinfectants compatible with your Clarius Ultrasound Scanner and accessories. The products listed in the following table are chemically compatible and have been tested for efficacy.

  • Page 107: Cleaner & Disinfectant Details

    Hydrogen Peroxide a. AU = Australia, CA = Canada, US = United States, UK = United Kingdom Sterilization Systems The following sterilization systems are approved for use with the Clarius Scanner and its batteries: Sterilization System For general reprocessing instructions, including...

  • Page 108: Acoustic Outputs

    Clarius Ultrasound Scanner Glossary of Terms Acoustic Outputs aprt Area of the active aperture measured in cm Equivalent beam diameter as a function of axial distance z, and is equal to [(4/π)(W (z))] where I (z) is the temporal-average intensity as a function of z in centimeters.
  • Page 109 Clarius Ultrasound Scanner Glossary of Terms TA.3 The derated spatial-peak temporal-average intensity at axial distance in units of milliwatts/ MI (mechanical index) An indication of the likelihood of mechanical bioeffects occurring. The higher the MI, the greater the likelihood of mechanical bioeffects.

  • Page 110: Acoustic Artifacts

    Clarius Ultrasound Scanner Glossary of Terms TIS (soft tissue thermal index) A thermal index related to soft tissues. scan The soft tissue thermal index in an auto-scanning mode. non-scan The soft tissue thermal index in the non-autoscanning mode. Derated ultrasonic power at axial distance z1 in units of milliwatts.
  • Page 111 Clarius Ultrasound Scanner Glossary of Terms continuing on the other side of the baseline. On the Color display an immediate change in color from one Nyquist limit to the other is seen. Comet tail A form of reverberation artifact produced when two or more strong reflectors are close together and have a high propagation speed.
  • Page 112 Clarius Ultrasound Scanner Glossary of Terms Reverberation The continuing reception of a particular signal because of reverberation rather than reflection from a particular acoustic interface. This phenomenon is analogous to the effect created by mirrors positioned on opposite walls when an object, a head for instance, is placed between the mirrors.

  • Page 113: Known Issues

    Clarius Ultrasound Scanner Known Issues Known Issues For a list of currently known issues with the Clarius Ultrasound Scanner, see www.clarius.com/ app/known-issues. Revision History User Manual Revision Revision Date Description December 21, 2016 First official release. (previously called v 2.1.0) February 14, 2017 Changed name from Clarius Ultrasound App to Clarius App.
  • Page 114 Tel: +86-512-62988311 0086 Emergo Europe, Prinsessegracht 20 2514 AP, The Hague, The Netherlands www.anatel.gov.br Nome técnico: APARELHO DE ULTRA-SOM Nome comercial: Clarius Ultrasound Scanner Registro Anvisa nº: 80117580628 Responsável técnico: Luiz Levy Cruz Martins / CRF-SP 42415 IMPORTADOR: Emergo Brazil Import Importação...