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CLARIUS HD3 User Manual

Ultrasound scanner
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Clarius Ultrasound Scanner -
HD3 Scanners User Manual

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Summary of Contents for CLARIUS HD3

  • Page 1 Clarius Ultrasound Scanner - HD3 Scanners User Manual...
  • Page 2 Listing of applicable U.S. Patents in compliance with 35 U.S.C. s. 287: www.clarius.com/patents. All names used in Clarius (whether online, in print, or any other media) are fictitious and are used herein for the purposes of example and demonstration on how to use the Clarius Ultrasound Scanner.

  • Page 3: Table Of Contents

    Table of Contents About This Manual................... 1 Target Audience ....................2 Document Conventions ..................2 Chapter 1: About the Clarius Ultrasound Scanner ........6 Device Description..................7 Product Dimension ..................8 Product Usage ....................8 Indications for Use....................8 Intended Patient Population................8 Precautions ......................18 Hardware ......................19 Warranty ......................19...
  • Page 4 Chapter 3: Accessories ................30 Clarius Charger HD3..................30 About the Clarius Charger HD3................. 30 Setting Up the Clarius Charger HD3 ..............32 Clarius Power Fan HD3.................. 32 About the Clarius Power Fan HD3..............33 Charging the Clarius Scanner HD3 ..............33 Chapter 4: Cleaning &...
  • Page 5 Clarius Scanner EC7 HD3 ................... 79 Clarius Scanner L7 HD3 ..................80 Clarius Scanner L15 HD3 ..................81 Clarius Scanner L20 HD3 ..................82 Clarius Scanner PA HD3 ..................83 Clarius Scanner PAL HD3 (Linear Array) ............84 revision 9...
  • Page 6 Clarius Scanner PA HD3: Transcranial PW Doppler Mode ......123 Clarius Scanner PAL HD3: B-Mode, Linear Array ..........124 Clarius Scanner PAL HD3: Color Doppler Mode, Linear Array ....... 125 Clarius Scanner PAL HD3: M-Mode, Linear Array ........... 126 Clarius Scanner PAL HD3: Needle Enhance B-Mode, Linear Array ....127...
  • Page 7 Clarius Scanner HD3 Clarius Scanner PAL HD3: Ocular (Ophthalmic) B-Mode, Linear Array ..128 Clarius Scanner PAL HD3: PW Doppler Mode, Linear Array ......129 Clarius Scanner PAL HD3: B-Mode, Phased Array .......... 130 Clarius Scanner PAL HD3: Color Doppler Mode, Phased Array ..... 131 Clarius Scanner PAL HD3: M-Mode, Phased Array .........

  • Page 8: About This Manual

    About This Manual To obtain a printed copy of this manual at no additional cost, go to clarius.com/contact and contact Clarius. This manual provides instructions for use on the Clarius Ultrasound Scanner - HD3 Scanners family of ultrasound scanners. For models that are not HD3, please refer to the appropriate user manual at clarius.com/manuals.

  • Page 9: Target Audience

    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 60417, and (EN) ISO 15223-1.
  • Page 10 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 HD3, accessories, and packaging: — G — R...
  • Page 11 5333 Type BF applied part To identify a type BF applied part complying with IEC 60601-1. You may see these other symbols on your Clarius Scanner HD3, accessories, and packaging: THER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT Symbol Title Description Power connector Indicates a barrel-type power connector.
  • Page 12 Clarius Scanner HD3 THER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT Symbol Title Description Do not stack boxes. Do not use knife to open. Recycle scanner in accordance with local, state, and federal regulation. Medical Device European Medical Device Regulation 2017/745.

  • Page 13: 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 14: Device Description

    • Unqualified/untrained personnel purchasing and using the Clarius Scanner HD3 may be unable to attain quality images. • Each Clarius Scanner HD3 contains a Li-ion battery. Treat the battery with precaution. Users should be trained medical professionals (e.g., doctors, nurses, technicians) with previous training in ultrasound.

  • Page 15: Product Dimension

    The system is intended for use for diagnostic ultrasound imaging and fluid flow analysis of anatomical structures and fluids of adult and pediatric patients. 1. Only applicable to the L7 HD3, L15 HD3, L20 HD3, & PAL HD3 scanners. revision 9...
  • Page 16 Clarius Scanner HD3 Product Usage Indications for Use Tables Clarius Ultrasound Scanner HD3 YSTEM LARIUS LTRASOUND CANNER NDICATION FOR IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific B M Color...
  • Page 17 Clarius Scanner HD3 Product Usage Clarius Scanner C3 HD3 C3 HD3 EVICE LARIUS CANNER NDICATION FOR IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific B M Color Power...
  • Page 18 Clarius Scanner HD3 Product Usage Clarius Scanner C7 HD3 C7 HD3 EVICE LARIUS CANNER NDICATION FOR IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific B M Color Power...
  • Page 19 Clarius Scanner HD3 Product Usage Clarius Scanner EC7 HD3 EC7 HD3 EVICE LARIUS CANNER NDICATION FOR IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific B M Color Power...
  • Page 20 Clarius Scanner HD3 Product Usage Clarius Scanner L7 HD3 L7 HD3 EVICE LARIUS CANNER NDICATION FOR IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific B M Color Power...
  • Page 21 Clarius Scanner HD3 Product Usage Clarius Scanner L15 HD3 L15 HD3 EVICE LARIUS CANNER NDICATION FOR IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific B M Color Power...
  • Page 22 Clarius Scanner HD3 Product Usage Clarius Scanner L20 HD3 L20 HD3 EVICE LARIUS CANNER NDICATION FOR IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific B M Color Power...
  • Page 23 Clarius Scanner HD3 Product Usage Clarius Scanner PA HD3 PA HD3 EVICE LARIUS CANNER NDICATION FOR IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific B M Color Power...
  • Page 24 Clarius Scanner HD3 Product Usage Clarius Scanner PAL HD3 PAL HD3 EVICE LARIUS CANNER NDICATION FOR IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific B M Color Power...

  • Page 25: Precautions

    Cleaning the Clarius Scanner HD3 on page 36), followed by another high-level disinfection. If a Clarius Power Fan HD3 (CIDN 50-02-00077) was used, remove the fan prior to the high-level disinfection and follow the instructions for an intermediate-level disinfection (for instructions see Disinfecting the Clarius Power Fan HD3 on page 39).

  • Page 26: Hardware

    Using the Clarius Ultrasound Scanner - HD3 Scanners for ocular (ophthalmic) indications is restricted to the Clarius Scanner L7 HD3, L15 HD3, L20 HD3, and PAL HD3 (all 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.

  • Page 27: Network 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 28: Integrity

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

  • Page 29: System Requirements

    • Contrast ratio of at least 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.

  • Page 30: Chapter 2: Using The Clarius Ultrasound Scanner

    Scanner safely and effectively. Refer to Safety on page 41 before handling the Clarius Ultrasound Scanner. Your Clarius Scanner HD3 is already activated and ready for use. Just download the Clarius App on an Apple iOS device or an Android™- based device.

  • Page 31: Turning The System On & Off

    Down image (default setting). The Clarius Scanner HD3 can take up to 30 seconds to power up and prepare for imaging. If you turn on the Clarius Scanner HD3 and leave it untouched, it will go through the following modes to help reduce battery power and temperature:...
  • Page 32 • Using improper gel type or combining different gel types may expose patients to risks and produce poor-quality images. • When using PAL HD3 with dual array technology, there will be an offset on the transducer physical placement in the elevation axis. Due to the side-by-side physical arrangement of the transducers, refer to the transducer elevation width center line for the linear array when doing ultrasound guided injection procedure.

  • Page 33: Scanner Notifications

    Clarius Scanner HD3 Imaging Scanner Notifications The Clarius Ultrasound Scanner displays no error messages. Instead, the Clarius Scanner HD3 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 HD3’s status lights:...

  • Page 34: Voice Controls

    Clarius Scanner HD3 Voice Controls Voice Controls The Voice Controls feature shall be used in a reasonably quiet clinic or medical office setting. Users can be masked or unmasked and should speak the Voice Commands clearly. Excessive noise will affect the device's ability to hear the commands correctly.

  • Page 35: Turn Off Voice Controls

    Clarius Scanner HD3 light turns blue. Maintenance The scanner routinely performs automated maintenance of the scanner itself. Prior to and after use, you must clean and disinfect the Clarius Scanner HD3 according to the instructions in this User Manual. revision 9...

  • Page 36: Hardware Maintenance

    Submit Logs button. This downloads logs from the Clarius Scanner HD3, then combines them with the logs from the Clarius App. This bundle is then sent to Clarius Cloud where they can be retrieved by a Clarius Support staff. The log files contain diagnostic information.

  • Page 37: Chapter 3: Accessories

    • Clarius Charger HD3 • Clarius Power Fan HD3 Clarius Charger HD3 The Clarius App displays the scanner’s battery level on your smart device. Because the Clarius Scanner HD3 is battery-operated, you must recharge its battery when necessary. An empty battery takes approximately 1 ½...
  • Page 38 Clarius Scanner HD3 Clarius Charger HD3 The Clarius Charger HD3 is designed for use in professional healthcare facilities. The device is not intended to come in contact with the patient during normal use. For regular maintenance, clean and disinfect the Clarius Charger HD3. For cleaning instructions, see Cleaning the Clarius Charger HD3 on page 37.

  • Page 39: Setting Up The Clarius Charger Hd3

    The Clarius Charger HD3 is now ready to use. Clarius Power Fan HD3 Attach the Clarius Power Fan HD3 to the built-in heatsink of the Clarius Scanner HD3 to extend scanning time.  To attach the Clarius Power Fan HD3: 1.

  • Page 40: About The Clarius Power Fan Hd3

    • Clarius Power Fan HD3: 5 VDC, 3.2 A • Protection Against Electric Shock: Class II / double insulated • Applied Part: None Charging the Clarius Scanner HD3 Charge the Clarius Scanner HD3 using only the Clarius Charger HD3 or the Clarius Power Fan HD3. revision 9...
  • Page 41 For instruction on attaching the Clarius Power Fan HD3 to the scanner, see Clarius Power Fan HD3 on page 32. 3. Connect the Micro USB cable provided with the Clarius Power Fan HD3 to the Clarius Power Fan HD3. 4. Connect the USB A to a power supply.

  • Page 42: 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 HD3 comes into contact with. To find the correct classification, refer to Spaulding Classification on page 40.

  • Page 43: Cleaning

     To clean the Clarius Scanner HD3: 1. Make sure the Clarius Scanner HD3 is turned off. 2. Remove the fan from the scanner. 3. To clean the scanner, dampen a soft cloth using a compatible cleaner. Alternatively, use a premoistened disinfectant wipe.

  • Page 44: Cleaning The Clarius Power Fan Hd3

     To clean the Micro USB cable: 1. Detach the USB A to from the power supply. 2. Detach the Micro USB cable from the Clarius Power Fan HD3. 3. Wipe down all surfaces using a premoistened disinfectant wipe for one minute until visibly clean.

  • Page 45: Disinfecting

    3. Air-dry. Alternatively, use a non-linting cloth. 4. 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. High-Level Disinfection Refer to Cleaners & Disinfectants on page 74 for a list of disinfectants recommended for high- level disinfection of the scanner.

  • Page 46: Disinfecting The Clarius Power Fan Hd3

    Disinfecting the Micro USB Cable  To disinfect the Micro USB cable: 1. Make sure the Micro USB cable is detached from the power supply and the Clarius Power Fan HD3. 2. Disinfect the Micro USB cable by wiping with a cloth moistened with a compatible disinfectant.

  • Page 47: Disinfecting The Clarius Charger Hd3

    3. Examine for damages, such as cracks or splits. If damage is evident, do not use the charger and contact Clarius Mobile Health. Spaulding Classification The level of cleaning and disinfecting required for your Clarius Scanner HD3 is based on the Spaulding classification system. Following the correct classification will help reduce cross- contamination and infection.

  • Page 48: Chapter 5: Safety

    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 49: 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 50: 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 51: Battery Safety

    Changes and additions to the system can be made only by Clarius or by third parties expressly authorized by Clarius to do so. Such changes and additions must comply with all applicable laws and regulations that have the force of law within the jurisdictions concerned, and best engineering practices.
  • Page 52 If you use an OPA-based disinfectant, residual solution may remain on your scanners 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: • Follow the disinfectant manufacturer's instructions very carefully.
  • Page 53 The following actions may damage your scanner: • Cleaning or disinfecting a scanner using methods unapproved by Clarius. • Using paper or abrasive products. They damage the soft lens of the scanner's acoustic window. If the lens is damaged to the point that the scanner elements are exposed, stop using the scanner.

  • Page 54: 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 HD3 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 55 Clarius Scanner HD3 Safety Topics after wearing latex gloves or inflating a toy balloon may be useful. For patients with positive histories, flag their charts. • If latex sensitivity is suspected, consider wearing a non-latex glove over the latex glove if the patient is sensitive.

  • Page 56: Alara Principle

    Clarius Scanner HD3 Safety Topics Mechanical (Non-Thermal) Mechanical bioeffects are threshold phenomena, such as cavitation, that occur when the output exceeds a certain level. This threshold varies by tissue type. Cavitation is the interaction of ultrasound with gas bubbles, causing rapid and potentially large changes in bubble size.
  • Page 57 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 58 Clarius Scanner HD3 Safety Topics The system does not exceed a spatial peak temporal average intensity (I ) of 720 mW/cm SPTA for all imaging modes. The system follows the Output Display Standard (IEC 60601-2-37) and falls within the Track 3 acoustic output limits.
  • Page 59 Clarius Scanner HD3 Safety Topics minimal exposure to the patient. The threshold at which ultrasound energy causes bioeffects for each individual patient is unknown, therefore, you must get the most information at the lowest possible output level by adjusting the output intensity of the equipment.
  • Page 60 Clarius Scanner HD3 Safety Topics • Approximate index for the application: TIS is used for imaging soft tissue, TIB for a focus at or near bone, and TIC for imaging through bone near the surface (for example, a cranial exam).
  • Page 61 Clarius Scanner HD3 Safety Topics Estimates of the MI and TI display accuracies are shown in the Acoustic Output Tables. The following factors are considered when estimating the accuracy of the displayed values: • hardware variations Variability among scanners and systems is a result of piezoelectric crystal efficiencies, process-related impedance differences, and sensitive lens-focusing parameter variations.
  • Page 62 Clarius Scanner HD3 Safety Topics Acoustic output defaults are set when you select an application. Factory defaults vary with scanner, application, and mode. Defaults have been chosen below the FDA limits for intended use. • Imaging Mode Controls: When a new imaging mode is selected, both the TI and MI may change to default settings.
  • Page 63 Clarius Scanner HD3 Safety Topics Acoustic Artifacts An acoustic artifact is information, present or absent in an image, which does not properly indicate the structure or flow being imaged. Examples of acoustic artifacts that hinder proper interpretation: • Added objects displayed as speckle, section thickness, reverberation, mirror image, comet tail, or ring down.
  • Page 64 Clarius Scanner HD3 Safety Topics Variable Value Heart 0.66 Kidney 0.79 Liver 0.43 Muscle 0.55 Skin line to measurement depth (cm) Center frequency of the scanner/system/mode combination (MHz) Because the ultrasonic path during an examination is likely to pass through varying lengths and types of tissue, it is difficult to estimate the true in situ intensity.
  • Page 65 Clarius Scanner HD3 Safety Topics amounts of fluid, as in many first- and second-trimester pregnancies scanned transabdominally, this model may underestimate the in situ acoustical exposure. The amount of underestimation depends on each specific situation. For example, when the beam path is longer than 3 cm and the propagation medium is predominantly fluid (conditions that may exist during transabdominal OB scans), a more accurate value for the derating term is 0.1 dB/...

  • Page 66: Fire & Electrical Safety

    Be alert to this unlikely but potential hazard and stop using the system if you notice it is interfering with a pacemaker. • Connecting accessories not supplied or approved by Clarius could result in electrical shock. • Electrosurgical units (ESUs) and other scanners intentionally introduce RF electromagnetic fields (currents) into patients.

  • Page 67: Electromagnetic Safety

    • A burn hazard may result from a surgical equipment with a defect in the high-frequency surgical neutral electrode connection. Do not use scanners with high-frequency surgical equipment. • Using accessories other than those specified for use with the Clarius Ultrasound Scanner may result in increased emissions of the system. Electromagnetic Safety The Clarius Scanner HD3 uses wireless technology to communicate with your smart device.
  • Page 68 • In Canada, the device for operation in the band 5150 – 5250 MHz is only for indoor use to reduce the potential for harmful interference to co-channel mobile satellite systems. Note: Settings for channel band selection of Clarius Ultrasound Scanner is managed by Clarius Mobile Health Corp. as per local wireless regulation. Channel band being selected can be found under the App "Status"...
  • Page 69 *For ETSI 301 489-1 and ETSI 301 489-17: Tested in transmit mode only, no idle mode exists for this product. Electromagnetic Interference The way an electromagnetic interference (EMI) from other equipment affects the Clarius Ultrasound Scanner depends on the system's operation mode, image control settings, and the revision 9...
  • Page 70 Clarius Scanner HD3 Safety Topics type and level of electromagnetic phenomena. Electromagnetic phenomena may be intermittent, making it difficult to identify the source. If you experience EMI, use caution if you continue using the system, or consider relocating your system.
  • Page 71 Clarius Scanner HD3 Safety Topics is used exceeds the applicable RF compliance level in the table, observe the system to verify normal operation. If abnormal performance is observed, apply additional measures, such as reorienting or relocating the system. At 80 MHz and 800 MHz, the higher frequency range applies.
  • Page 72 Clarius Scanner HD3 Safety Topics other medical equipment away from the location of the scanner or printer can result in reduced electromagnetic interference. If you find the interference's source, go to clarius.com/contact and contact Clarius. revision 9...

  • Page 73: Chapter 6: References

    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 74: Product Serial Number

    (NB xxxx). • Clarius Power Fan HD3 and Clarius Charger HD3 (accessories of Clarius Ultrasound Scanner HD3) are self-certified medical devices and do not require the oversight of a Notified Body. The devices are CE-marked without the NB xxxx. Product Serial Number Clarius has assigned a unique serial number on each scanner to track quality control.
  • Page 75 • PAL HD3 = 26.76°C (80.168°F) If the scanner reaches its maximum surface temperature, it automatically shuts down. To limit surface heating in the event of a single fault condition, the EC7 HD3 scanners automatically shut down. This icon, when blue, indicates that the scanner is cool. When this icon is red, it indicates that the scanner is warm.

  • Page 76: Environmental Specifications

    Clarius Scanner HD3 The Clarius Ultrasound Scanner Environmental Specifications C3 HD3, C7 HD3, EC7 HD3, L7 HD3, L15 HD3, L20 HD3, PA HD3, & PAL HD3 CANNERS Operating Limits Storage & Transportation Limits Transient Operating Conditions Temperature 0°C (32°F) to 40°C (104°F) -20°C (-4°F) to 35°C (95°F)

  • Page 77: Scanner Specifications

    Clarius Scanner HD3 Standards Scanner Specifications Scanner Clinical Usage Field of View Frequency Range Clarius Scanner C3 HD3 fetal, abdominal, intra-operative, pediatric, cephalic (adult), 73° 2 – 6 MHz musculo-skeletal (conventional), urology, gynecology, cardiac (adult, pediatric), peripheral vessel Clarius Scanner C7 HD3 fetal, abdominal, intra-operative, pediatric, small organ 112°...

  • Page 78: Electrical Safety

    Clarius Scanner HD3 Standards 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. Electrical Safety Reference No. Year Title IEC 61157 2013 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic...
  • Page 79 Clarius Scanner HD3 Standards Reference No. Year Title ANSI/AAMI/IEC 62304 2006 Medical device software – Software life cycle processes. A1:2015 CAN/CSA-C22.2 2011 Medical electrical equipment - Part 1-6: General requirements for basic safety and No. 60601-1-6:11 essential performance - Collateral standard: Usability (Adopted IEC 60601-1- 6:2010, third edition, 2010-01) CAN/CSA-C22.2...

  • Page 80: Security & Privacy

    Clarius Scanner HD3 Standards Reference No. Year Title IEC 60529 2013 Degrees of protection provided by enclosures (IP Code) IEC 62304 2006 Medical device software - Software life cycle processes A1:2015 IEC 62366 2014 Medical devices - Application of usability engineering to medical devices...

  • Page 81: Cleaners & Disinfectants

    Because of the large number of available cleaners and disinfectants, it is impossible to have an all-inclusive list. If you are unsure of the suitability of a particular product, go to clarius.com/ contact and contact Clarius for more information.

  • Page 82: Cleaner & Disinfectant Details

    1. AU = Australia, CA = Canada, US = United States, UK = United Kingdom Glossary of Terms For ultrasound terms, refer to Recommended Ultrasound Terminology, Third Edition, published by AIUM. Known Issues For a list of currently known issues with the Clarius Ultrasound Scanner, see support.clarius.com/hc/en-us/articles/360019807731. revision 9...

  • Page 83: Chapter 7: Measurement Accuracy Tables

    Measurement Accuracy Tables The Clarius Ultrasound Scanner can be used to make measurements on ultrasound images. These measurements can then be used with other clinical data to make a diagnosis. Never make a diagnosis based solely on measurements. When quantifying data, consider other factors. The accuracy of each...

  • Page 84: Clarius Scanner C3 Hd3

    Clarius Scanner HD3 Clarius Scanner C3 HD3 C3 HD3: B-M LARIUS CANNER Measurement Tolerance Range Axial Distance < ± 2% 0 – 30.5 cm Lateral Distance < ± 2% 0 – 30.5 cm C3 HD3: M-M LARIUS CANNER Measurement Tolerance...

  • Page 85: Clarius Scanner C7 Hd3

    Clarius Scanner HD3 Clarius Scanner C7 HD3 C7 HD3: B-M LARIUS CANNER Measurement Tolerance Range Axial Distance < ± 2% 0 – 18.0 cm Lateral Distance < ± 2% 0 – 18.0 cm C7 HD3: M-M LARIUS CANNER Measurement Tolerance...

  • Page 86: Clarius Scanner Ec7 Hd3

    Clarius Scanner HD3 Clarius Scanner EC7 HD3 EC7 HD3: B-M LARIUS CANNER Measurement Tolerance Range Axial Distance < ± 2% 0 – 12.5 cm Lateral Distance < ± 2% 0 – 12.5 cm EC7 HD3: M-M LARIUS CANNER Measurement Tolerance...

  • Page 87: Clarius Scanner L7 Hd3

    Clarius Scanner HD3 Clarius Scanner L7 HD3 L7 HD3: B-M LARIUS CANNER Measurement Tolerance Range Axial Distance < ± 2% 0 – 11.0 cm Lateral Distance < ± 2% 0 – 11.0 cm L7 HD3: M-M LARIUS CANNER Measurement Tolerance...

  • Page 88: Clarius Scanner L15 Hd3

    Clarius Scanner HD3 Clarius Scanner L15 HD3 L15 HD3: B-M LARIUS CANNER Measurement Tolerance Range Axial Distance < ± 2% 0 – 7.0 cm Lateral Distance < ± 2% 0 – 7.0 cm L15 HD3: M-M LARIUS CANNER Measurement Tolerance...

  • Page 89: Clarius Scanner L20 Hd3

    Clarius Scanner HD3 Clarius Scanner L20 HD3 L20 HD3: B-M LARIUS CANNER Measurement Tolerance Range Axial Distance < ± 2% 0 – 4.0 cm Lateral Distance < ± 2% 0 – 4.0 cm L20 HD3: M-M LARIUS CANNER Measurement Tolerance...

  • Page 90: Clarius Scanner Pa Hd3

    Clarius Scanner HD3 Clarius Scanner PA HD3 PA HD3: B-M LARIUS CANNER Measurement Tolerance Range Axial Distance < ± 2% 0 – 30.5 cm Lateral Distance < ± 5% 0 – 30.5 cm PA HD3: M-M LARIUS CANNER Measurement Tolerance...

  • Page 91: Clarius Scanner Pal Hd3 (Linear Array)

    Clarius Scanner HD3 Clarius Scanner PAL HD3 (Linear Array) PAL HD3: B-M LARIUS CANNER INEAR RRAY Measurement Tolerance Range Axial Distance < ± 2% 0 – 7.0 cm Lateral Distance < ± 2% 0 – 7.0 cm PAL HD3: M-M...

  • Page 92: Clarius Scanner Pal Hd3 (Phased Array)

    Clarius Scanner HD3 Clarius Scanner PAL HD3 (Phased Array) PAL HD3: B-M LARIUS CANNER HASED RRAY Measurement Tolerance Range Axial Distance < ± 2% 0 – 30.5 cm Lateral Distance < ± 5% 0 – 30.5 cm PAL HD3: M-M...

  • Page 93: Acoustic Output Tables

    Clarius Scanner HD3 Acoustic Output Tables Clarius Scanner C3 HD3: B-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.682 0.190 0.306 Index Component Value 0.190 0.190 0.306 0.190 Acoustic (MPa) 1.28 Z MI Parameters (mW) 21.9 21.9...

  • Page 94: Clarius Scanner C3 Hd3: Color Doppler Mode

    Clarius Scanner HD3 Clarius Scanner C3 HD3: Color Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 1.04 0.409 0.669 Index Component Value 0.409 0.409 0.669 0.409 Acoustic (MPa) 1.94 Z MI Parameters (mW) 47.7 47.7 (mW) 24.9...

  • Page 95: Clarius Scanner C3 Hd3: M-Mode

    Clarius Scanner HD3 Clarius Scanner C3 HD3: M-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.682 0.012 0.027 Index Component Value 0.012 0.006 0.010 0.027 Acoustic (MPa) 1.28 Z MI Parameters (mW) 0.711 0.711 (mW) 0.711 0.711...

  • Page 96: Clarius Scanner C3 Hd3: Pw Doppler Mode

    Clarius Scanner HD3 Clarius Scanner C3 HD3: PW Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.734 0.231 0.604 Index Component Value 0.231 0.096 0.268 0.604 Acoustic (MPa) 1.17 Z MI Parameters (mW) 19.1 19.1 (mW) 19.1...

  • Page 97: Clarius Scanner C7 Hd3: B-Mode

    Clarius Scanner HD3 Clarius Scanner C7 HD3: B-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 1.10 0.137 0.211 Index Component Value 0.137 0.137 0.211 0.137 Acoustic (MPa) 2.44 Z MI Parameters (mW) 7.63 7.63 (mW) 5.81 5.81...

  • Page 98: Clarius Scanner C7 Hd3: Color Doppler Mode

    Clarius Scanner HD3 Clarius Scanner C7 HD3: Color Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 1.12 0.615 1.16 Index Component Value 0.615 0.615 1.16 0.615 Acoustic (MPa) 2.27 Z MI Parameters (mW) 41.8 41.8 (mW) 31.8...

  • Page 99: Clarius Scanner C7 Hd3: M-Mode

    Clarius Scanner HD3 Clarius Scanner C7 HD3: M-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 1.10 0.008 0.038 Index Component Value 0.008 0.004 0.009 0.038 Acoustic (MPa) 2.44 Z MI Parameters (mW) 0.319 0.319 (mW) 0.319 0.319...

  • Page 100: Clarius Scanner C7 Hd3: Pw Doppler Mode

    Clarius Scanner HD3 Clarius Scanner C7 HD3: PW Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.814 0.284 1.20 Index Component Value 0.284 0.153 0.391 1.20 Acoustic (MPa) 1.82 Z MI Parameters (mW) 12.0 12.0 (mW) 12.0...

  • Page 101: Clarius Scanner Ec7 Hd3: B-Mode

    Clarius Scanner HD3 Clarius Scanner EC7 HD3: B-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.729 0.069 0.076 Index Component Value 0.069 0.069 0.076 0.069 Acoustic (MPa) 1.79 Z MI Parameters (mW) 2.39 2.39 (mW) 2.39 2.39...

  • Page 102: Clarius Scanner Ec7 Hd3: Color Doppler Mode

    Clarius Scanner HD3 Clarius Scanner EC7 HD3: Color Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.920 0.492 0.647 Index Component Value 0.492 0.492 0.647 0.492 Acoustic (MPa) 2.07 Z MI Parameters (mW) 20.2 20.2 (mW) 20.2...

  • Page 103: Clarius Scanner Ec7 Hd3: M-Mode

    Clarius Scanner HD3 Clarius Scanner EC7 HD3: M-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.729 0.003 0.011 Index Component Value 0.003 0.002 0.003 0.011 Acoustic (MPa) 1.79 Z MI Parameters (mW) 0.099 0.099 (mW) 0.099 0.099...

  • Page 104: Clarius Scanner Ec7 Hd3: Pw Doppler Mode

    Clarius Scanner HD3 Clarius Scanner EC7 HD3: PW Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.768 0.115 0.376 Index Component Value 0.115 0.059 0.189 0.376 Acoustic (MPa) 1.73 Z MI Parameters (mW) 4.78 4.78 (mW) 4.78...

  • Page 105: Clarius Scanner L7 Hd3: B-Mode

    Clarius Scanner HD3 Clarius Scanner L7 HD3: B-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.432 0.044 0.047 Index Component Value 0.044 0.044 0.047 0.044 Acoustic (MPa) 1.17 Z MI Parameters (mW) 1.66 1.66 (mW) 1.25 1.25...

  • Page 106: Clarius Scanner L7 Hd3: Color Doppler Mode

    Clarius Scanner HD3 Clarius Scanner L7 HD3: Color Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.674 0.106 0.166 Index Component Value 0.106 0.106 0.166 0.106 Acoustic (MPa) 1.51 Z MI Parameters (mW) 5.84 5.84 (mW) 4.38...

  • Page 107: Clarius Scanner L7 Hd3: M-Mode

    Clarius Scanner HD3 Clarius Scanner L7 HD3: M-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.432 0.001 0.003 Index Component Value 0.001 0.000 0.001 0.003 Acoustic (MPa) 1.17 Z MI Parameters (mW) 0.035 0.035 (mW) 0.035 0.035...

  • Page 108: Clarius Scanner L7 Hd3: Needle Enhance B-Mode

    Clarius Scanner HD3 Clarius Scanner L7 HD3: Needle Enhance B-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.987 0.329 0.501 Index Component Value 0.329 0.329 0.501 0.329 Acoustic (MPa) 2.26 Z MI Parameters (mW) 17.6 17.6 (mW) 13.2...

  • Page 109: Clarius Scanner L7 Hd3: Ocular (Ophthalmic) B-Mode

    Clarius Scanner HD3 Clarius Scanner L7 HD3: Ocular (Ophthalmic) B-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.157 0.006 0.007 Index Component Value 0.006 0.006 0.007 0.006 Acoustic (MPa) 0.404 Z MI Parameters (mW) 0.245 0.245 (mW) 0.184...

  • Page 110: Clarius Scanner L7 Hd3: Pw Doppler Mode

    Clarius Scanner HD3 Clarius Scanner L7 HD3: PW Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.728 0.293 0.729 Index Component Value 0.293 0.147 0.256 0.729 Acoustic (MPa) 1.64 Z MI Parameters (mW) 12.3 7.57 (mW) 12.3...

  • Page 111: Clarius Scanner L15 Hd3: B-Mode

    Clarius Scanner HD3 Clarius Scanner L15 HD3: B-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.533 0.060 0.123 Index Component Value 0.060 0.060 0.123 0.060 Acoustic (MPa) 1.54 Z MI Parameters (mW) 2.43 2.43 (mW) 1.46 1.46...

  • Page 112: Clarius Scanner L15 Hd3: Color Doppler Mode

    Clarius Scanner HD3 Clarius Scanner L15 HD3: Color Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.945 0.190 1.01 Index Component Value 0.190 0.190 1.01 0.190 Acoustic (MPa) 2.58 Z MI Parameters (mW) 8.89 8.89 (mW) 5.33...

  • Page 113: Clarius Scanner L15 Hd3: M-Mode

    Clarius Scanner HD3 Clarius Scanner L15 HD3: M-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.533 0.004 0.005 Index Component Value 0.004 0.001 0.005 0.004 Acoustic (MPa) 1.54 Z MI Parameters (mW) 0.101 0.101 (mW) 0.101 0.101...

  • Page 114: Clarius Scanner L15 Hd3: Needle Enhance B-Mode

    Clarius Scanner HD3 Clarius Scanner L15 HD3: Needle Enhance B-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.620 0.090 0.657 Index Component Value 0.090 0.090 0.657 0.090 Acoustic (MPa) 1.69 Z MI Parameters (mW) 4.33 4.33 (mW) 2.60...

  • Page 115: Clarius Scanner L15 Hd3: Ocular (Ophthalmic) B-Mode

    Clarius Scanner HD3 Clarius Scanner L15 HD3: Ocular (Ophthalmic) B-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.087 0.004 0.004 Index Component Value 0.004 0.004 0.004 0.004 Acoustic (MPa) 0.280 Z MI Parameters (mW) 0.085 0.085 (mW) 0.085...

  • Page 116: Clarius Scanner L15 Hd3: Pw Doppler Mode

    Clarius Scanner HD3 Clarius Scanner L15 HD3: PW Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.819 0.615 1.60 Index Component Value 0.615 0.269 1.60 0.552 Acoustic (MPa) 2.23 Z MI Parameters (mW) 15.7 15.7 (mW) 15.7...

  • Page 117: Clarius Scanner L20 Hd3: B-Mode

    Clarius Scanner HD3 Clarius Scanner L20 HD3: B-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.564 0.045 0.063 Index Component Value 0.045 0.045 0.063 0.045 Acoustic (MPa) 1.91 Z MI Parameters (mW) 0.822 0.822 (mW) 0.822 0.822...

  • Page 118: Clarius Scanner L20 Hd3: Color Doppler Mode

    Clarius Scanner HD3 Clarius Scanner L20 HD3: Color Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.243 0.021 0.022 Index Component Value 0.021 0.021 0.022 0.021 Acoustic (MPa) 0.927 Z MI Parameters (mW) 0.298 0.298 (mW) 0.298...

  • Page 119: Clarius Scanner L20 Hd3: M-Mode

    Clarius Scanner HD3 Clarius Scanner L20 HD3: M-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.437 0.002 0.003 Index Component Value 0.002 0.001 0.002 0.003 Acoustic (MPa) 1.52 Z MI Parameters (mW) 0.028 0.028 (mW) 0.028 0.028...

  • Page 120: Clarius Scanner L20 Hd3: Needle Enhance B-Mode

    Clarius Scanner HD3 Clarius Scanner L20 HD3: Needle Enhance B-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.441 0.018 0.018 Index Component Value 0.018 0.018 0.017 0.018 Acoustic (MPa) 1.52 Z MI Parameters (mW) 0.319 0.319 (mW) 0.319...

  • Page 121: Clarius Scanner L20 Hd3: Ocular (Ophthalmic) B-Mode

    Clarius Scanner HD3 Clarius Scanner L20 HD3: Ocular (Ophthalmic) B-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.116 0.001 0.001 Index Component Value 0.001 0.001 0.001 0.001 Acoustic (MPa) 0.407 Z MI Parameters (mW) 0.017 0.017 (mW) 0.017...

  • Page 122: Clarius Scanner L20 Hd3: Pw Doppler Mode

    Clarius Scanner HD3 Clarius Scanner L20 HD3: PW Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.578 0.222 0.378 Index Component Value 0.222 0.120 0.378 0.262 Acoustic (MPa) 1.82 Z MI Parameters (mW) 4.71 4.71 (mW) 4.71...

  • Page 123: Clarius Scanner Pa Hd3: B-Mode

    Clarius Scanner HD3 Clarius Scanner PA HD3: B-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.972 0.150 0.276 Index Component Value 0.150 0.150 0.276 0.150 Acoustic (MPa) 1.64 Z MI Parameters (mW) 18.0 18.0 (mW) 11.2 11.2...

  • Page 124: Clarius Scanner Pa Hd3: Color Doppler Mode

    Clarius Scanner HD3 Clarius Scanner PA HD3: Color Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.891 0.514 0.790 Index Component Value 0.514 0.514 0.790 0.514 Acoustic (MPa) 1.62 Z MI Parameters (mW) 51.5 51.5 (mW) 32.2...

  • Page 125: Clarius Scanner Pa Hd3: M-Mode

    Clarius Scanner HD3 Clarius Scanner PA HD3: M-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.972 0.010 0.041 Index Component Value 0.010 0.006 0.011 0.041 Acoustic (MPa) 1.64 Z MI Parameters (mW) 0.748 0.748 (mW) 0.748 0.748...

  • Page 126: Clarius Scanner Pa Hd3: Pw Doppler Mode

    Clarius Scanner HD3 Clarius Scanner PA HD3: PW Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.725 0.092 0.262 Index Component Value 0.092 0.048 0.158 0.262 Acoustic (MPa) 1.14 Z MI Parameters (mW) 7.92 7.92 (mW) 7.92...

  • Page 127: Clarius Scanner Pa Hd3: Transcranial B-Mode

    Clarius Scanner HD3 Clarius Scanner PA HD3: Transcranial B-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.972 0.150 0.276 0.276 Index Component Value 0.150 0.150 0.276 0.150 Acoustic (MPa) 1.64 Z MI Parameters (mW) 18.0 18.0 18.0...

  • Page 128: Clarius Scanner Pa Hd3: Transcranial Color Doppler Mode

    Clarius Scanner HD3 Clarius Scanner PA HD3: Transcranial Color Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.666 0.963 1.55 1.55 Index Component Value 0.963 0.963 1.55 0.963 Acoustic (MPa) 1.04 Z MI Parameters (mW) 82.4...

  • Page 129: Clarius Scanner Pa Hd3: Transcranial M-Mode

    Clarius Scanner HD3 Clarius Scanner PA HD3: Transcranial M-Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.972 0.010 0.041 0.011 Index Component Value 0.010 0.006 0.011 0.041 Acoustic (MPa) 1.64 Z MI Parameters (mW) 0.748 0.748 0.748...

  • Page 130: Clarius Scanner Pa Hd3: Transcranial Pw Doppler Mode

    Clarius Scanner HD3 Clarius Scanner PA HD3: Transcranial PW Doppler Mode Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.696 0.571 1.99 1.16 Index Component Value 0.571 0.327 1.16 1.99 Acoustic (MPa) 0.983 Z MI Parameters (mW) 60.0...

  • Page 131: Clarius Scanner Pal Hd3: B-Mode, Linear Array

    Clarius Scanner HD3 Clarius Scanner PAL HD3: B-Mode, Linear Array Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.349 0.046 0.067 Index Component Value 0.046 0.046 0.067 0.046 Acoustic (MPa) 0.989 Z MI Parameters (mW) 1.192 1.192 (mW) 1.192...

  • Page 132: Clarius Scanner Pal Hd3: Color Doppler Mode, Linear Array

    Clarius Scanner HD3 Clarius Scanner PAL HD3: Color Doppler Mode, Linear Array Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.395 0.072 0.117 Index Component Value 0.072 0.072 0.117 0.072 Acoustic (MPa) 1.013 Z MI Parameters (mW) 2.294...

  • Page 133: Clarius Scanner Pal Hd3: M-Mode, Linear Array

    Clarius Scanner HD3 Clarius Scanner PAL HD3: M-Mode, Linear Array Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.343 0.002 0.004 Index Component Value 0.002 0.001 0.004 0.004 Acoustic (MPa) 0.981 Z MI Parameters (mW) 0.061 0.061 (mW) 0.061...

  • Page 134: Clarius Scanner Pal Hd3: Needle Enhance B-Mode, Linear Array

    Clarius Scanner HD3 Clarius Scanner PAL HD3: Needle Enhance B-Mode, Linear Array Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.317 0.056 0.056 Index Component Value 0.056 0.056 0.056 0.056 Acoustic (MPa) 0.901 Z MI Parameters (mW) 1.464...

  • Page 135: Clarius Scanner Pal Hd3: Ocular (Ophthalmic) B-Mode, Linear Array

    Clarius Scanner HD3 Clarius Scanner PAL HD3: Ocular (Ophthalmic) B-Mode, Linear Array Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.066 0.002 0.002 Index Component Value 0.002 0.002 0.002 0.002 Acoustic (MPa) 0.211 Z MI Parameters (mW) 0.043...

  • Page 136: Clarius Scanner Pal Hd3: Pw Doppler Mode, Linear Array

    Clarius Scanner HD3 Clarius Scanner PAL HD3: PW Doppler Mode, Linear Array Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.414 0.292 0.616 Index Component Value 0.292 0.135 0.616 0.616 Acoustic (MPa) 1.067 Z MI Parameters (mW) 9.236...

  • Page 137: Clarius Scanner Pal Hd3: B-Mode, Phased Array

    Clarius Scanner HD3 Clarius Scanner PAL HD3: B-Mode, Phased Array Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.556 0.222 0.952 Index Component Value 0.222 0.222 0.952 0.222 Acoustic (MPa) 0.764 Z MI Parameters (mW) 24.744 24.744 (mW) 24.744...

  • Page 138: Clarius Scanner Pal Hd3: Color Doppler Mode, Phased Array

    Clarius Scanner HD3 Clarius Scanner PAL HD3: Color Doppler Mode, Phased Array Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.639 0.218 0.866 Index Component Value 0.218 0.218 0.866 0.218 Acoustic (MPa) 0.804 Z MI Parameters (mW) 28.893...

  • Page 139: Clarius Scanner Pal Hd3: M-Mode, Phased Array

    Clarius Scanner HD3 Clarius Scanner PAL HD3: M-Mode, Phased Array Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.559 0.017 0.071 Index Component Value 0.017 0.011 0.071 0.057 Acoustic (MPa) 0.771 Z MI Parameters (mW) 1.829 1.829 (mW) 1.829...

  • Page 140: Clarius Scanner Pal Hd3: Pw Doppler Mode, Phased Array

    Clarius Scanner HD3 Clarius Scanner PAL HD3: PW Doppler Mode, Phased Array Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.679 0.779 3.223 Index Component Value 0.779 0.497 2.570 3.223 Acoustic (MPa) 0.893 Z MI Parameters (mW) 94.638...

  • Page 141: Revision History

    May 2, 2022 Changed: Product Classification. November 1, 2022 Added: About the Clarius Power Fan HD3, Cleaning the Micro USB Cable, Disinfecting the Micro USB Cable. Changed: “Clarius Fan HD3” to “Clarius Power Fan HD3”, Charging the Clarius Scanner HD3, Cleaner & Disinfectant Usage, back page.
  • Page 142 Headquarters: Clarius Mobile Health Corp. #205 - 2980 Virtual Way Vancouver, BC, V5M 4X3 Canada 1-778-800-9975 clarius.com 2797 Emergo Europe, Westervoortsedijk 60, 6827 AT Arnhem, The Netherlands MedEnvoy Switzerland, Gotthardstrasse 28, 6302 Zug, Switzerland IMPORTADO POR: MOBISSOM COMÉRCIO DE EQUIPAMENTO LTDA - EPP 24.068.446/0001-16...

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