Clarius Ultrasound Scanner HD3 Scanners User Manual
Disclaimer: This disclaimer extends to all printed matter accompanying the Clarius Ultrasound Scanner. This manual is licensed under the Terms and Conditions available at clarius.com/terms. You may not use this manual except in compliance with the license. The information contained in these materials is proprietary and confidential to Clarius Mobile Health Corp.
Table of Contents About This Manual........................................................................................... 1 Target Audience ...................................................................................................2 Document Conventions ........................................................................................2 Chapter 1: About the Clarius Ultrasound Scanner ..................................... 6 Device Description................................................
Clarius Ultrasound Scanner - HD3 Scanners Firmware Updates .............................................................................................. 26 Using the Charger .......................................................................................... 26 About the Charger .............................................................................................. 26 Setting Up the Charger.......................................................................................
Clarius Ultrasound Scanner - HD3 Scanners Chapter 6: References ................................................................................ 63 Compliance Statement .................................................................................. 63 The Clarius Ultrasound Scanner ................................................................... 63 Product Classification ......................................................................................... 63 Product Serial Number ................
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner EC7 HD3: B-Mode ............................................................. 89 Clarius Scanner EC7 HD3: Color Doppler Mode ........................................ 90 Clarius Scanner EC7 HD3: M-Mode ............................................................ 91 Clarius Scanner EC7 HD3: PW Doppler Mode ............................................ 92 Clarius Scanner L7 HD3: B-Mode ................................................................
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 support.clarius.com/hc/en-us/articles/360020188352. This document is licensed as part of the purchase of the Clarius Ultrasound Scanner and meets applicable regulatory requirements.
Clarius Ultrasound Scanner - HD3 Scanners Target Audience This document is written for trained medical professionals who operate and maintain your Clarius Ultrasound Scanner. It contains instructions and reference material pertaining to the usage and maintenance of the product. Document Conventions Icons Icon Title of Icon Description Alert Possible risks beyond the reasonable control of Clarius. Do not do this This icon indicates actions to avoid.
Clarius Ultrasound Scanner - HD3 Scanners STANDARD: ISO 7000 — GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT — REGISTERED SYMBOLS 2493 Catalogue number Indicates the manufacturer's catalogue number so that the medical device can be identified. 2498 Serial number Indicates the manufacturer's serial number so that a specific medical device can be identified. 2609 Non-sterile Indicates a medical device that has not been subjected to a sterilization process.
Clarius Ultrasound Scanner - HD3 Scanners OTHER STANDARDS — GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT — REGISTERED SYMBOLS IEC 6417 5172 Class II equipment To identify equipment meeting the safety requirements specified for Class II equipment according to IEC 60536. IEC 6417 5957 For indoor use only To identify electrical equipment designed primarily for indoor use. IEC 6417 5333 Type BF applied part To identify a type BF applied part complying with IEC 60601-1.
Clarius Ultrasound Scanner - HD3 Scanners OTHER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT revision 1 n/a Recycle scanner in accordance with local, state, and federal regulation. Rx Only Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
About the Clarius Ultrasound Scanner Install, operate, and maintain this product according to the safety and operating procedures in this manual, and only for its intended purpose. Always use the information in this document with sound clinical judgment and best clinical procedures. This product is subject to the law in the jurisdiction that the product is used. Install, use, and operate the product only in ways that adhere to applicable laws or regulations, which have the force of law.
Clarius Ultrasound Scanner - HD3 Scanners Device Description devices to reduce the possibility of causing interference to radios, televisions, and other electronic devices. • Circumstances in the patient’s environment may negatively impact the scanner and the exam. For example: (1) Chemicals and gases in the operating room. (2) Altitudes below -382 m or above 4000 m.
Clarius Ultrasound Scanner - HD3 Scanners Product Dimension Product Dimension Item Length (in/mm) Width (in/mm) Thickness (in/mm) Weight (oz/g) Clarius Scanner C3 HD3 (CIDN 99-02-00074) 5.7/146 3.1/76 1.5/32 10.9/308 Clarius Scanner C7 HD3 (CIDN 99-13-00019) 5.9/151 3.1/76 1.5/32 10.2/289 Clarius Scanner EC7 HD3 (CIDN 99-13-00024) 12.2/310 3.1/76 1.5/32 11.5/326 Clarius Scanner L7 HD3 (CIDN 99-13-00020) 5.8/147 3.1/76 1.5/32 10.2/288 Clarius Scanner L15 HD3 (CIDN 99-13-00021) 5.
Clarius Ultrasound Scanner - HD3 Scanners Product Usage Indications for Use Tables Clarius Ultrasound Scanner HD3 SYSTEM: CLARIUS ULTRASOUND SCANNER HD3 INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS: Clinical Application Mode of Operation General (Track 1 Only) Specific (Tracks 1 & 3) B M Color Power PW Combined (Specify) Doppler Doppler Doppler Ophthalmic Ophthalmic Fetal Imaging & Other Fetal B+M; B+CD; B+PD; B+PWD Abdomi
Clarius Ultrasound Scanner - HD3 Scanners Product Usage Clarius Scanner C3 HD3 DEVICE NAME: CLARIUS SCANNER C3 HD3 INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS: Clinical Application Mode of Operation General (Track 1 Only) B M Color Power PW Combined (Specify) Doppler Doppler Doppler Specific (Tracks 1 & 3) Ophthalmic Ophthalmic Fetal Imaging & Other Fetal B+M; B+CD; B+PD; B+PWD Abdominal B+M; B+CD; B+PD; B+PW
Clarius Ultrasound Scanner - HD3 Scanners Product Usage Clarius Scanner C7 HD3 DEVICE NAME: CLARIUS SCANNER C7 HD3 INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS: Clinical Application Mode of Operation General (Track 1 Only) Specific (Tracks 1 & 3) B M Color Power PW Combined (Specify) Doppler Doppler Doppler Ophthalmic Ophthalmic Fetal Imaging & Other Fetal B+M; B+CD; B+PD; B+PWD Abdominal B+M; B+CD; B+PD; B+PW
Clarius Ultrasound Scanner - HD3 Scanners Product Usage Clarius Scanner EC7 HD3 DEVICE NAME:CLARIUS SCANNER EC7 HD3 INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS: Clinical Application Mode of Operation General (Track 1 Only) Specific (Tracks 1 & 3) B M Color Power PW Combined (Specify) Doppler Doppler Doppler Ophthalmic Ophthalmic Fetal Imaging & Other Fetal B+M; B+CD; B+PD; B+PWD Abdominal B+M; B+CD; B+PD; B+PWD
Clarius Ultrasound Scanner - HD3 Scanners Product Usage Clarius Scanner L7 HD3 DEVICE NAME: CLARIUS SCANNER L7 HD3 INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS: Clinical Application Mode of Operation General (Track 1 Only) Specific (Tracks 1 & 3) B M Color Power PW Combined (Specify) Doppler Doppler Doppler Ophthalmic Ophthalmic Fetal Imaging & Other Fetal Other* Abdominal B+M; B+CD; B+PD; B+PWD Note 1 Intra-operative (A
Clarius Ultrasound Scanner - HD3 Scanners Product Usage Clarius Scanner L15 HD3 DEVICE NAME: CLARIUS SCANNER L15 HD3 INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS: Clinical Application Mode of Operation General (Track 1 Only) Specific (Tracks 1 & 3) B M Color Power PW Combined (Specify) Doppler Doppler Doppler Ophthalmic Ophthalmic Fetal Imaging & Other Fetal Other* Abdominal B+M; B+CD; B+PD; B+PWD Note 1 Intra-operative
Clarius Ultrasound Scanner - HD3 Scanners Product Usage Clarius Scanner L20 HD3 DEVICE NAME: CLARIUS SCANNER L20 HD3 INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS: Clinical Application Mode of Operation General (Track 1 Only) Specific (Tracks 1 & 3) B M Color Power PW Combined (Specify) Doppler Doppler Doppler Ophthalmic Ophthalmic Fetal Imaging & Other Fetal Other* Abdominal B+M; B+CD; B+PD; B+PWD Note 1 Pediatric
Clarius Ultrasound Scanner - HD3 Scanners Product Usage Clarius Scanner PA HD3 DEVICE NAME: CLARIUS SCANNER PA HD3 INDICATION FOR USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS: Clinical Application Mode of Operation General (Track 1 Only) B M Color Power PW Combined (Specify) Doppler Doppler Doppler Specific (Tracks 1 & 3) Other* Ophthalmic Ophthalmic Fetal Imaging & Other Fetal B+M; B+CD; B+PD; B+PWD Note 1 Abdominal B+M; B+C
Clarius Ultrasound Scanner - HD3 Scanners Product Usage Precautions For Use in Surgical Environments Before you use the Clarius Scanner HD3 for intra-operative procedures or in a surgical environment, follow the instructions for high-level disinfection (for instructions see High-Level Disinfection on page 36), then cover the Clarius Scanner HD3 with a sheath: • Use only CIVCO REF 610-1212, Safersonic DAN-33803-WG, and Safersonic DAN-33803-NT. • Follow the usage instructions provided by the manufacturer.
Clarius Ultrasound Scanner - HD3 Scanners Hardware For Use in Ophthalmic Procedures Using the Clarius Ultrasound Scanner - HD3 Scanners for ocular (ophthalmic) indications is restricted to the Clarius Scanner L7 HD3, L15 HD3, and L20 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. Doing so may result in serious and irreversible harm to the eye of the patient.
Clarius Ultrasound Scanner - HD3 Scanners Security Network Security When connecting your smart device, use a network that supports Wi-Fi 802.11n. We recommend that you secure this network using WPA (Wi-Fi Protected Access) or WPA2 (Wi-Fi Protected Access II) as your security protocol. For information on setting up your wireless network security, refer to your network equipment’s documentation. You may run into situations where no wireless access point is available.
Clarius Ultrasound Scanner - HD3 Scanners Security • Wi-Fi network where only trusted parties are permitted. The Wi-Fi network encrypts all image data sent from other Wi-Fi networks. • Wi-Fi Direct network. The Wi-Fi Direct network encrypts all image data, and because no other users are on the 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.
Clarius Ultrasound Scanner - HD3 Scanners System Requirements System Requirements Using the Clarius Ultrasound Scanner on a smart device that does not meet the minimum requirements may result in low-quality images, unexpected results, and possible misdiagnoses. To run the Clarius App, a smart device must meet or exceed the following minimum specifications: Technical Features: • Supports Bluetooth LE v4.0+ • Supports Wi-Fi 802.
Using the Clarius Ultrasound Scanner This chapter explains how to install and use your Clarius Ultrasound Scanner safely and effectively. Refer to Safety on page 39 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. Downloading the Clarius App Whether you are using Apple iOS or Android™, you must have an account and password set up with them.
Clarius Ultrasound Scanner - HD3 Scanners 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 HD3 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 . The Clarius App opens to the sign-in screen. For information on using the Clarius App and scanner, go to support.clarius.
Clarius Ultrasound Scanner - HD3 Scanners 1. Imaging After three seconds, it decreases frame rate. 2. After 30 seconds of decreased frame rate, it freezes. 3. After 10 seconds in freeze mode, it goes idle. 4. After 15 minutes of idle time, it shuts down When scanning for more than 15 consecutive minutes, with any Clarius Scanner HD3, the fan must be used. For information on the fan, see Fan on page 31.
Clarius Ultrasound Scanner - HD3 Scanners Imaging Status Lights The following table defines the Clarius Scanner HD3’s status lights: Color Display Meaning Blue Flashing Scanner is booting up. Blue Solid Scanner is ready for a Wi-Fi connection or has a connection and is not imaging. Green Solid Scanner is imaging. Orange Flashing Battery is low. Orange Solid Software error. Red Flashing Battery is critically low. Red Solid Hardware error.
Clarius Ultrasound Scanner - HD3 Scanners Updating the Clarius Ultrasound Scanner Updating the Clarius Ultrasound Scanner Software Updates To update the software: Go to the Apple App Store or the Google Play store. Firmware Updates If a Clarius Scanner HD3 software update is required, the Clarius App will notify you. To update the firmware: Tap Update. During the update, the Clarius Scanner HD3 emits a purple flashing light. Also, a purple indicator displays at the top right of the screen.
Clarius Ultrasound Scanner - HD3 Scanners Using the Charger • Clarius Scanner L15 HD3 (CIDN 99-13-00021) • Clarius Scanner L20 HD3 (CIDN 99-13-00022) • Clarius Scanner PA HD3 (CIDN 99-13-00023) The Charger 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 Charger. For cleaning instructions, see Cleaning the Charger on page 35.
Clarius Ultrasound Scanner - HD3 Scanners Using the Charger • wall power supply: 5 VDC, 3.2 A • charger: 5 VDC, 3.2 A • Protection Against Electric Shock: Class II / double insulated • Applied Part: None • Ingress Protection: IP00 • Mode of Operation: Continuous Setting Up the Charger To use the Charger: 1. Clean and disinfect the scanners before placing them in the Charger. For cleaning instructions, see Cleaning the Clarius Scanner HD3 on page 34.
Clarius Ultrasound Scanner - HD3 Scanners Maintenance You can continue scanning patients while the scanner charges via the Fan. Use only power supplies recommended by Clarius when plugging into an AC power outlet. Do not charge the scanner via the Fan in air ambulances, regular ambulances, or the EMS environment in general (including patient transportation and home healthcare). Maintenance The scanner routinely performs automated maintenance of the scanner itself.
Clarius Ultrasound Scanner - HD3 Scanners Maintenance The scanner may degrade in performance or become unusable if stored or transported in ambient temperatures below -20°C (-4°F) or above 50°C (122°F). System Maintenance To send activity logs, select the Support menu option to go to the Support page and select the Submit Logs button. This downloads logs from the Clarius Scanner HD3, then combines them with the logs from the Clarius App.
Accessories To order these additional accessories, go to clarius.com/contact: • Clarius Foot Pedal (CIDN 99-03-00018): A foot-controlled device that lets you freeze and capture images. • Fan (CIDN 50-02-00077) Fan Attach the Fan to the built-in heatsink of the Clarius Scanner HD3 to extend scanning time. To attach the Fan: 1. Align the top of the fan with the top of the scanner. Make sure the fan’s logo is facing towards you.
Clarius Ultrasound Scanner - HD3 Scanners Fan Clean and disinfect the Fan after each use. For cleaning instructions, see Cleaning the Fan on page 35. For disinfecting instructions, see Disinfecting the Fan on page 36.
Cleaning & Disinfecting It is important to clean and disinfect the Clarius Scanner HD3 immediately after use. 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 37. All compatible accessories may be cleaned using CaviWipes.
Clarius Ultrasound Scanner - HD3 Scanners Cleaning • Due to repeated use and cleaning, the cleanliness and sterility of the hardware deteriorates over its service life (five years for the scanner and fan). • Using incompatible solutions to clean the scanner may damage its surface. • Cleaning or disinfecting the scanner using IPA (isopropyl alcohol) may damage it.
Clarius Ultrasound Scanner - HD3 Scanners Disinfecting Cleaning the Fan To clean the Fan: 1. Remove the fan from the Clarius Scanner HD3. 2. Wipe down all surfaces using a premoistened disinfectant wipe. For a list of compatible cleaners, see Cleaners & Disinfectants on page 70. 3. Repeat with new cleaning material if necessary. 4. Air-dry the fan. Alternatively, use a non-linting cloth. When you are done, keep the two components separate. You will be disinfecting them individually.
Clarius Ultrasound Scanner - HD3 Scanners Disinfecting Intermediate Disinfection Refer to Cleaners & Disinfectants on page 70 for a list of disinfectants recommended for intermediate disinfection of the scanner. If the scanner has come into contact with broken skin, mucosal membranes, or blood, it is classified as semi-critical, and you must perform a high-level disinfection. See High-Level Disinfection on page 36 for steps. To disinfect your scanner (intermediate): 1.
Clarius Ultrasound Scanner - HD3 Scanners Spaulding Classification Because the Fan cannot be submerged in liquid, never use high-level disinfectants. Always use intermediate-level disinfectants. For a list of disinfectants recommended for intermediate disinfection of the Fan, refer to Cleaners & Disinfectants on page 70. To disinfect the Fan: 1. Make sure that the fan is detached from the scanner. 2. Disinfect the fan by wiping with a cloth moistened with a compatible disinfectant.
Clarius Ultrasound Scanner - HD3 Scanners revision 1 Spaulding Classification Class Use Method Non-Critical Class Touches intact skin Cleaning followed by intermediate disinfection Semi-Critical Class Touches mucous membranes and non-intact skin Cleaning followed by high-level disinfection (HLD) 38
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. • Cautions highlight possible damages to the product that may void your warranty or service contract or lose patient or system data.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics These mechanisms are discussed later. Benefits & Risks Ultrasound is widely used because it provides many clinical benefits to the patient and has an outstanding safety record. In more than three decades of use, there has been no known longterm negative side-effects associated to this technology.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics “Diagnostic ultrasound is recognized as a safe, effective, and highly flexible imaging modality capable of providing clinically relevant information about most parts of the body in a rapid and cost-effective fashion.” -- WHO (World Health Organization) Product Safety Clarius is responsible for the safety of the scanners. The safety of your smart device is your responsibility.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics other products or components not made by Clarius, unless Clarius expressly recognizes those other products or components as compatible. 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.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics Cleaners & Disinfectants • Use only cleaners and disinfectants recommended by Clarius. Avoid acetone, Methyl ethyl ketone (MEK), paint thinner, or other strong solvents and abrasive cleaners. • Always use protective eyewear and gloves when cleaning and disinfecting equipment. • Disinfectants are recommended based on their chemical compatibility (not their biological effectiveness) with product materials.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics • Organic and inorganic matter • Duration of exposure • Biofilms Scanner Care Lint, dust, and light (including sunlight) have no effect on the scanner’s basic safety and essential performance. • Avoid sharp objects, such as scissors, scalpels, or cauterizing knives, from touching the scanners. • Avoid bumping the scanner on hard surfaces. • Avoid surgeon's brushes when cleaning scanners. Even soft brushes can damage scanners.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics Defibrillator Safety If you are using the Clarius Ultrasound Scanner and defibrillation is required, use defibrillators that do not have grounded patient circuits. To determine whether a defibrillator patient circuit is grounded, see the defibrillator service guide, or consult a biomedical engineer. Before defibrillation, remove any part of the system that is in contact with the patient.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics Bioeffects Thermal Thermal bioeffects refers to heat generated whenever ultrasound energy is absorbed. The amount of heat produced depends on the ultrasound's intensity, exposure time, and the tissue's absorption characteristics. Tissue absorbs ultrasound energy to varying degrees depending on the tissue's absorption characteristics.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics Scientific evidence suggests that the onset of transient cavitation is a threshold phenomenon. There's a combination of rarefactional pressure values, ultrasonic frequency, and cavitation nuclei that are required for inertial cavitation to occur. If inertial cavitation is a threshold phenomenon, then exposure to pressure levels below the threshold will never induce such events, regardless of the length of exposure.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics Applying ALARA The system's imaging mode you select depends on the information needed. Understanding the nature of the imaging mode used, the scanner frequency, system setup values, scanning techniques, exposure time, system and scanner capabilities, and operator experience allows the sonographer to apply the ALARA principle with informed judgment and meet the definition of the ALARA principle.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics Controls indirectly affecting intensity: • Pulse repetition frequency: The higher the PRF, the more output pulses per second, increasing the temporal-average intensity. • Focusing depth: Setting the scanner focus at the proper depth improves the resolution of that structure, without the need to increase intensity to see it better.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics Additional considerations: • Minimize scan time by performing only medically required ones. • Use diagnostic ultrasounds efficiently and effectively, as all other medical tools. • Compromising the exam's quality by rushing the exam could result in a poor exam, which could require follow-up exams, which then adds exposure time. • Select the appropriate TI and MI range for the task at hand.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics The TI indicates any conditions that may lead to temperature increase on the surface of the body, within the body tissue, or at the point of focus of the ultrasound beam on bone. TI informs you of a potential rise in temperature of body tissue, by estimating temperature increases in those body tissue with specific properties. The actual temperature increase is influenced by factors such as tissue type, vascularity, and mode of operation.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics • measurement variability Inaccuracies in laboratory measurements can be caused by hydrophone calibration and performance, positioning, alignment, and digitization tolerances, and variability among test operators. 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.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics values associated with each mode and focal zone enabled. The system will return to the previously selected state if a mode is turned off and then reselected. • Scanner: Each scanner type has unique specifications for contact area, beam shape, and center frequency. Selecting a scanner initializes its default settings, which varies by scanner, application, and selected mode. These defaults are set below the FDA limits for intended use.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics • Incorrect object location due to refraction, multi-path reflections, side lobes, grating lobes, speed error, or range ambiguity. • Incorrect object size due to poor resolution, refraction, or speed error. • Incorrect object shape due to poor resolution, refraction, or speed error.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics 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. An attenuation factor of 0.3 is used for general reporting purposes. Therefore, the in situ value which is commonly reported uses the formula: In situ derated = Water [e-(0.069lf)] Because this value is not the true in situ intensity, the term “derated” is used.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics The maximum acoustic output levels of diagnostic ultrasound scanners extend over a broad range of values: • A survey of 1990-equipment models yielded MI values between 0.1 and 1 at their highest output settings. Maximum MI values of approximately 2 are known to occur for currently available equipment. Maximum MI values are similar for real-time B-Mode, M-mode, and PW Doppler.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics Fire & Electrical Safety Fire Safety Always have fire extinguishers available for both electrical and non-electrical fires. In the event of an electrical or chemical fire, use only extinguishers that are specifically labeled for such purposes. Using water or other liquids can cause fatal or other serious personal injury. To reduce the risk of electrical shock, try isolating the product, if safe to do so.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics Electromagnetic Compatibility The Clarius Ultrasound Scanner has been manufactured with existing electromagnetic compatibility requirements and have been tested and found to comply with electromagnetic compatibility standards to provide reasonable protection against harmful interference in a typical medical installation. Use of this system in the presence of an electromagnetic field can cause momentarily degraded image quality.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics To reduce ESD: • Use anti-static spray on carpets, linoleum, and mats. Or use a ground wire connection between the system and the patient table or bed. 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.
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics Power frequency magnetic field immunity test IEC 61000-4-8 30A/M 30A/M Voltage dips/ interruptions IEC 61000-4-11 0% for 0.5 cycle @ 0º, 45º, 90º, 135º, 180º, 225º, 270º, 315º 0% for 1 cycle @ 0º 70% for 25/30 cycles (50/60 Hz) @ 0º 0% for 250/300 cycles @ 0º 0% for 0.
Clarius Ultrasound Scanner - HD3 Scanners 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).
Clarius Ultrasound Scanner - HD3 Scanners Safety Topics Avoiding Electromagnetic Interference An ultrasound system is designed to receive signals at radio frequencies, making them susceptible to interference generated by RF energy sources. Other examples of interference are medical equipment, information technology products, and radio and television transmission towers.
References Compliance Statement Clarius products comply with international and national standards and laws. 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.
Clarius Ultrasound Scanner - HD3 Scanners The Clarius Ultrasound Scanner Product Serial Number Clarius has assigned a unique serial number on each scanner to track quality control. Clarius Scanner HD3s uses the format STRRYYMMzXXXX. We will use the serial number L7HD3012112A0004 as an example to explain how to interpret this. ST Stack type and scanner model. In our example, the stack type is “L7”. The scanner model “HD3” does not change. RR Two-digit assembly revision number. In our example, this is “01”.
Clarius Ultrasound Scanner - HD3 Scanners The Clarius Ultrasound Scanner To reach an operating temperature of 20°C (68°F), the Clarius Scanner HD3 requires approximately 30 minutes to: • Warm up from a storage temperature of -20°C (-4°F). • Cool down from a storage temperature of 50°C (122°F). Maximum scanner surface temperatures are: • C3 HD3 = 35.5°C • C7 HD3 = 35.5°C • EC7 HD3 = 35.5°C • L7 HD3 = 39.4°C • L15 HD3 = 39.4°C • L20 HD3 = 39.4°C • PA HD3 = 39.
Clarius Ultrasound Scanner - HD3 Scanners The Clarius Ultrasound Scanner CHARGER Operating Limits Transient Operating Conditions Storage & Transportation Limits Temperature 0°C (32°F) to 40°C (104°F) n/a -20°C (-4°F) to 50°C (122°F) Humidity 15% to 95% RH n/a 0% to 95% RH Pressure 620 hPa to 1060 hPa n/a n/a Scanner Specifications Scanner Clinical Usage Field of View Frequency Range Clarius Scanner C3 HD3 fetal, abdominal, intra-operative, pediatric, cephalic (adult), musculo-skeletal (
Clarius Ultrasound Scanner - HD3 Scanners Standards Standards Biocompatibility ANSI/ISO 10993-1:2009 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. GB / T 16886.1-2011 - Biological Evaluation Of Medical Devices - Part 1: Evaluation and testing within a risk management process GB / T 16886.5-2016 - Biological evaluation of medical devices - Part 5: In vitro cytotoxicity test GB / T 16886.
Clarius Ultrasound Scanner - HD3 Scanners Standards Quality Performance revision 1 Reference No. Year Title AIUM/NEMA UD 2-2004 2009 NEMA Standards Publication UD 2-2004 (R2009) Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment, Revision 3.
Clarius Ultrasound Scanner - HD3 Scanners Standards Risk, Product Specification, Design Review, & Verification/Validation Reference No.
Clarius Ultrasound Scanner - HD3 Scanners Cleaners & Disinfectants Wireless U.S. • FCC Part 15/C 15.247; Part 15/E 15.407 Canada • ISED RSS-Gen; RSS-247; RSS-210 Europe • ETSI EN 300 328:V2.1.1 - Electromagnetic compatibility and Radio spectrum Matters (ERM) • ETSI EN 301 489-1:V2.1.1- Electromagnetic compatibility and Radio spectrum Matters (ERM) • ETSI EN 301 489-17:V3.1.
Clarius Ultrasound Scanner - HD3 Scanners Cleaners & Disinfectants Sani-Cloth® AF3 Germicidal Disposable Wipe LLD, ILD Sani-Cloth® Plus Germicidal Disposable Cloth LLD, ILD Tristel Trio Wipes System HLDb a. CL = Cleaner, HLD = High-level disinfectant, ILD = Intermediate-level disinfectant, LLD = Low-level disinfectant, S = Sterilant b. EU only.
Clarius Ultrasound Scanner - HD3 Scanners Glossary of Terms 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.
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 measurement is highly dependent on image quality, which in turn is highly dependent on system design, operator scanning technique, familiarity with system controls, and patient echogenicity.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner C3 HD3 CLARIUS SCANNER C3 HD3: B-MODE Measurement Tolerance Range Axial Distance < ± 2% 0 – 30.5 cm Lateral Distance < ± 2% 0 – 30.5 cm CLARIUS SCANNER C3 HD3: M-MODE Measurement Tolerance Range Distance < ± 2% 0 – 30.5 cm Time < ± 2% minimum = 0 ms maximum = variablea Heart Rate minimum = ≤ 1 beat < ± 2% maximum = variablea a.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner C7 HD3 CLARIUS SCANNER C7 HD3: B-MODE Measurement Tolerance Range Axial Distance < ± 2% 0 – 18.0 cm Lateral Distance < ± 2% 0 – 18.0 cm CLARIUS SCANNER C7 HD3: M-MODE Measurement Tolerance Range Distance < ± 2% 0 – 18.0 cm Time < ± 2% minimum = 0 ms maximum = variablea Heart Rate minimum = ≤ 1 beat < ± 2% maximum = variablea a.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner EC7 HD3 CLARIUS SCANNER EC7 HD3: B-MODE Measurement Tolerance Range Axial Distance < ± 2% 0 – 12.5 cm Lateral Distance < ± 2% 0 – 12.5 cm CLARIUS SCANNER EC7 HD3: M-MODE Measurement Tolerance Range Distance < ± 2% 0 – 12.5 cm Time < ± 2% minimum = 0 ms maximum = variablea Heart Rate minimum = ≤ 1 beat < ± 2% maximum = variablea a.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L7 HD3 CLARIUS SCANNER L7 HD3: B-MODE Measurement Tolerance Range Axial Distance < ± 2% 0 – 11.0 cm Lateral Distance < ± 2% 0 – 11.0 cm CLARIUS SCANNER L7 HD3: M-MODE Measurement Tolerance Range Distance < ± 2% 0 – 11.0 cm Time < ± 2% minimum = 0 ms maximum = variablea Heart Rate minimum = ≤ 1 beat < ± 2% maximum = variablea a.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L15 HD3 CLARIUS SCANNER L15 HD3: B-MODE Measurement Tolerance Range Axial Distance < ± 2% 0 – 7.0 cm Lateral Distance < ± 2% 0 – 7.0 cm CLARIUS SCANNER L15 HD3: M-MODE Measurement Tolerance Range Distance < ± 2% 0 – 7.0 cm Time < ± 2% minimum = 0 ms maximum = variablea Heart Rate minimum = ≤ 1 beat < ± 2% maximum = variablea a.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L20 HD3 CLARIUS SCANNER L20 HD3: B-MODE Measurement Tolerance Range Axial Distance < ± 2% 0 – 4.0 cm Lateral Distance < ± 2% 0 – 4.0 cm CLARIUS SCANNER L20 HD3: M-MODE Measurement Tolerance Range Distance < ± 2% 0 – 77.0 cm Time < ± 2% minimum = 0 ms maximum = variablea Heart Rate minimum = ≤ 1 beat < ± 2% maximum = variablea a.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner PA HD3 CLARIUS SCANNER PA HD3: B-MODE Measurement Tolerance Range Axial Distance < ± 2% 0 – 30.5 cm Lateral Distance < ± 5% 0 – 30.5 cm CLARIUS SCANNER PA HD3: M-MODE Measurement Tolerance Range Distance < ± 2% 0 – 30.5 cm Time < ± 2% minimum = 0 ms maximum = variablea Heart Rate minimum = ≤ 1 beat < ± 2% maximum = variablea a.
Clarius Ultrasound Scanner - HD3 Scanners Acoustic Output Tables Clarius Scanner C3 HD3: B-Mode Index Label MI TIS At Surface Maximum Index Value 0.682 Index Component Value Acoustic Parameters Other Information pr,a at ZMI Below Surface (MPa) At Surface 0.190 0.190 Below Surface 0.306 0.190 0.306 (a) 0.190 P (mW) 21.9 21.9 P1x1 (mW) 11.4 11.4 zs (cm) zb (cm) ZMI (cm) 2.70 Zpii,a (cm) 2.70 fawf (MHz) 3.51 prr (Hz) 6144 srr (Hz) 32.0 Ipa,a at Zpii,a TIC 1.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner C3 HD3: Color Doppler Mode Index Label MI TIS At Surface Maximum Index Value 1.04 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.409 0.409 0.669 0.409 0.669 (a) 0.409 (MPa) P (mW) 47.7 47.7 P1x1 (mW) 24.9 24.9 zs (cm) zb (cm) ZMI (cm) 2.70 Zpii,a (cm) 2.70 fawf (MHz) 3.46 prr (Hz) 2560 srr (Hz) 32.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner C3 HD3: M-Mode Index Label MI TIS At Surface Maximum Index Value 0.682 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.012 0.012 0.027 0.006 0.010 (a) 0.027 (MPa) P (mW) 0.711 0.711 P1x1 (mW) 0.711 0.711 zs (cm) zb (cm) ZMI (cm) 2.60 Zpii,a (cm) 2.60 fawf (MHz) 3.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner C3 HD3: PW Doppler Mode Index Label MI TIS At Surface Maximum Index Value 0.734 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.231 0.231 0.604 0.096 0.268 P (mW) 19.1 19.1 P1x1 (mW) 19.1 19.1 zs (cm) zb (cm) ZMI (cm) 2.60 Zpii,a (cm) 2.60 fawf (MHz) 2.54 prr (Hz) 1000 srr (Hz) — 1.17 # 2.60 4.53 2.54 2.54 # 1 (W/cm2) 70.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner C7 HD3: B-Mode Index Label MI TIS At Surface Maximum Index Value 1.10 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.137 0.137 0.211 0.137 0.211 (a) 0.137 (MPa) P (mW) 7.63 7.63 P1x1 (mW) 5.81 5.81 zs (cm) zb (cm) ZMI (cm) 1.90 Zpii,a (cm) 1.90 fawf (MHz) 4.94 prr (Hz) 4800 srr (Hz) 25.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner C7 HD3: Color Doppler Mode Index Label MI TIS At Surface Maximum Index Value 1.12 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.615 0.615 1.16 0.615 1.16 (a) 0.615 (MPa) P (mW) 41.8 41.8 P1x1 (mW) 31.8 31.8 zs (cm) zb (cm) ZMI (cm) 1.50 Zpii,a (cm) 1.50 fawf (MHz) 4.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner C7 HD3: M-Mode Index Label MI TIS At Surface Maximum Index Value 1.10 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.008 0.008 0.038 0.004 0.009 (a) 0.038 (MPa) P (mW) 0.319 0.319 P1x1 (mW) 0.319 0.319 zs (cm) zb (cm) ZMI (cm) 1.90 Zpii,a (cm) 1.90 fawf (MHz) 4.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner C7 HD3: PW Doppler Mode Index Label MI TIS At Surface Maximum Index Value 0.814 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.284 0.284 1.20 0.153 0.391 P (mW) 12.0 12.0 P1x1 (mW) 12.0 12.0 zs (cm) zb (cm) ZMI (cm) 1.80 Zpii,a (cm) 1.80 fawf (MHz) 4.98 prr (Hz) 3000 srr (Hz) — 1.82 # 1.80 1.60 4.98 4.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner EC7 HD3: B-Mode Index Label MI TIS At Surface Maximum Index Value 0.729 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.069 0.069 0.076 0.069 0.076 (a) 0.069 (MPa) P (mW) 2.39 2.39 P1x1 (mW) 2.39 2.39 zs (cm) zb (cm) ZMI (cm) 1.07 Zpii,a (cm) 1.07 fawf (MHz) 6.05 prr (Hz) 4800 srr (Hz) 25.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner EC7 HD3: Color Doppler Mode Index Label MI TIS At Surface Maximum Index Value 0.920 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.492 0.492 0.647 0.492 0.647 (a) 0.492 (MPa) P (mW) 20.2 20.2 P1x1 (mW) 20.2 20.2 zs (cm) zb (cm) ZMI (cm) 0.900 Zpii,a (cm) 0.900 fawf (MHz) 5.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner EC7 HD3: M-Mode Index Label MI TIS At Surface Maximum Index Value 0.729 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.003 0.003 0.011 0.002 0.003 (a) 0.011 (MPa) P (mW) 0.099 0.099 P1x1 (mW) 0.099 0.099 zs (cm) zb (cm) ZMI (cm) 1.07 Zpii,a (cm) 1.07 fawf (MHz) 6.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner EC7 HD3: PW Doppler Mode Index Label MI TIS At Surface Maximum Index Value 0.768 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.115 0.115 0.376 0.059 0.189 (a) 0.376 (MPa) P (mW) 4.78 4.78 P1x1 (mW) 4.78 4.78 zs (cm) zb (cm) ZMI (cm) 1.90 Zpii,a (cm) 1.90 fawf (MHz) 5.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L7 HD3: B-Mode Index Label MI TIS At Surface Maximum Index Value 0.432 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.044 0.044 0.047 0.044 0.047 (a) 0.044 (MPa) P (mW) 1.66 1.66 P1x1 (mW) 1.25 1.25 zs (cm) zb (cm) ZMI (cm) 1.90 Zpii,a (cm) 1.90 fawf (MHz) 7.34 prr (Hz) 9600 srr (Hz) 25.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L7 HD3: Color Doppler Mode Index Label MI TIS At Surface Maximum Index Value 0.674 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.106 0.106 0.166 0.106 0.166 (a) 0.106 (MPa) P (mW) 5.84 5.84 P1x1 (mW) 4.38 4.38 zs (cm) zb (cm) ZMI (cm) 1.43 Zpii,a (cm) 1.43 fawf (MHz) 5.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L7 HD3: M-Mode Index Label MI TIS At Surface Maximum Index Value 0.432 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.001 0.001 0.003 0.000 0.001 (a) 0.003 (MPa) P (mW) 0.035 0.035 P1x1 (mW) 0.035 0.035 zs (cm) zb (cm) ZMI (cm) 1.90 Zpii,a (cm) 1.90 fawf (MHz) 7.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L7 HD3: Needle Enhance B-Mode Index Label MI TIS At Surface Maximum Index Value 0.987 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.329 0.329 0.501 0.329 0.501 (a) 0.329 (MPa) P (mW) 17.6 17.6 P1x1 (mW) 13.2 13.2 zs (cm) zb (cm) ZMI (cm) 2.00 Zpii,a (cm) 2.00 fawf (MHz) 5.24 prr (Hz) 4800 srr (Hz) 25.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L7 HD3: Ocular (Ophthalmic) B-Mode Index Label MI TIS At Surface Maximum Index Value 0.157 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.006 0.006 0.007 0.006 0.007 (a) 0.006 (MPa) P (mW) 0.245 0.245 P1x1 (mW) 0.184 0.184 zs (cm) zb (cm) ZMI (cm) 1.57 Zpii,a (cm) 1.57 fawf (MHz) 6.58 prr (Hz) 9600 srr (Hz) 25.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L7 HD3: PW Doppler Mode Index Label MI TIS At Surface Maximum Index Value 0.728 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.293 0.293 0.729 0.147 0.256 P (mW) 12.3 7.57 P1x1 (mW) 12.3 7.57 zs (cm) zb (cm) ZMI (cm) 1.70 Zpii,a (cm) 1.70 fawf (MHz) 5.04 prr (Hz) 3500 srr (Hz) — 1.64 # 2.00 1.70 5.02 5.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L15 HD3: B-Mode Index Label MI TIS At Surface Maximum Index Value 0.533 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.060 0.060 0.123 0.060 0.123 (a) 0.060 (MPa) P (mW) 2.43 2.43 P1x1 (mW) 1.46 1.46 zs (cm) zb (cm) ZMI (cm) 1.40 Zpii,a (cm) 1.40 fawf (MHz) 8.33 prr (Hz) 4800 srr (Hz) 25.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L15 HD3: Color Doppler Mode Index Label MI TIS At Surface Maximum Index Value 0.945 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.190 0.190 1.01 0.190 1.01 (a) 0.190 (MPa) P (mW) 8.89 8.89 P1x1 (mW) 5.33 5.33 zs (cm) zb (cm) ZMI (cm) 1.47 Zpii,a (cm) 1.47 fawf (MHz) 7.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L15 HD3: M-Mode Index Label MI TIS At Surface Maximum Index Value 0.533 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.004 0.004 0.005 0.001 0.005 (a) 0.004 (MPa) P (mW) 0.101 0.101 P1x1 (mW) 0.101 0.101 zs (cm) zb (cm) ZMI (cm) 1.40 Zpii,a (cm) 1.40 fawf (MHz) 8.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L15 HD3: Needle Enhance B-Mode Index Label MI TIS At Surface Maximum Index Value 0.620 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.090 0.090 0.657 0.090 0.657 (a) 0.090 (MPa) P (mW) 4.33 4.33 P1x1 (mW) 2.60 2.60 zs (cm) zb (cm) ZMI (cm) 1.43 Zpii,a (cm) 1.43 fawf (MHz) 7.40 prr (Hz) 3456 srr (Hz) 18.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L15 HD3: Ocular (Ophthalmic) B-Mode Index Label MI TIS At Surface Maximum Index Value 0.087 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.004 0.004 0.004 0.004 0.004 (b) 0.004 (MPa) P (mW) 0.085 0.085 P1x1 (mW) 0.085 0.085 zs (cm) zb (cm) ZMI (cm) 2.00 Zpii,a (cm) 2.00 fawf (MHz) 10.3 prr (Hz) 3648 srr (Hz) 19.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L15 HD3: PW Doppler Mode Index Label MI TIS At Surface Maximum Index Value 0.819 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.615 0.615 1.60 0.269 1.60 P (mW) 15.7 15.7 P1x1 (mW) 15.7 15.7 zs (cm) zb (cm) ZMI (cm) 1.37 Zpii,a (cm) 1.37 fawf (MHz) 7.44 prr (Hz) 3500 srr (Hz) — 2.23 # 1.57 1.40 8.21 8.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L20 HD3: B-Mode Index Label MI TIS At Surface Maximum Index Value 0.564 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.045 0.045 0.063 0.045 0.063 (a) 0.045 (MPa) P (mW) 0.822 0.822 P1x1 (mW) 0.822 0.822 zs (cm) zb (cm) ZMI (cm) 1.00 Zpii,a (cm) 1.00 fawf (MHz) 11.4 prr (Hz) 7296 srr (Hz) 19.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L20 HD3: Color Doppler Mode Index Label MI TIS At Surface Maximum Index Value 0.243 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.021 0.021 0.022 0.021 0.022 (a) 0.021 (MPa) P (mW) 0.298 0.298 P1x1 (mW) 0.298 0.298 zs (cm) zb (cm) ZMI (cm) 1.00 Zpii,a (cm) 1.00 fawf (MHz) 14.6 prr (Hz) 2080 srr (Hz) 13.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L20 HD3: Ocular (Ophthalmic) B-Mode Index Label MI TIS At Surface Maximum Index Value 0.116 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.001 0.001 0.001 0.001 0.001 (b) 0.001 (MPa) P (mW) 0.017 0.017 P1x1 (mW) 0.017 0.017 zs (cm) zb (cm) ZMI (cm) 1.00 Zpii,a (cm) 1.00 fawf (MHz) 12.3 prr (Hz) 2080 srr (Hz) 13.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L20 HD3: M-Mode Index Label MI TIS At Surface Maximum Index Value 0.437 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.002 0.002 0.003 0.001 0.002 (a) 0.003 (MPa) P (mW) 0.028 0.028 P1x1 (mW) 0.028 0.028 zs (cm) zb (cm) ZMI (cm) 1.00 Zpii,a (cm) 1.00 fawf (MHz) 12.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L20 HD3: Needle Enhance B-Mode Index Label MI TIS At Surface Maximum Index Value 0.441 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.018 0.018 0.018 0.018 0.017 (a) 0.018 (MPa) P (mW) 0.319 0.319 P1x1 (mW) 0.319 0.319 zs (cm) zb (cm) ZMI (cm) 0.900 Zpii,a (cm) 0.900 fawf (MHz) 11.9 prr (Hz) 2304 srr (Hz) 12.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner L20 HD3: PW Doppler Mode Index Label MI TIS At Surface Maximum Index Value 0.578 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.222 0.222 0.378 0.120 0.378 (a) 0.262 (MPa) P (mW) 4.71 4.71 P1x1 (mW) 4.71 4.71 zs (cm) zb (cm) ZMI (cm) 0.900 Zpii,a (cm) 0.900 fawf (MHz) 9.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner PA HD3: B-Mode Index Label MI TIS At Surface Maximum Index Value 0.972 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.150 0.150 0.276 0.150 0.276 (a) 0.150 (MPa) P (mW) 18.0 18.0 P1x1 (mW) 11.2 11.2 zs (cm) zb (cm) ZMI (cm) 1.77 Zpii,a (cm) 1.77 fawf (MHz) 2.83 prr (Hz) 4800 srr (Hz) 30.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner PA HD3: Color Doppler Mode Index Label MI TIS At Surface Maximum Index Value 0.891 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.641 0.641 1.00 0.641 1.00 (a) 0.641 (MPa) P (mW) 65.2 65.2 P1x1 (mW) 40.8 40.8 zs (cm) zb (cm) ZMI (cm) 1.77 Zpii,a (cm) 1.77 fawf (MHz) 3.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner PA HD3: M-Mode Index Label MI TIS At Surface Maximum Index Value 0.972 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.010 0.010 0.041 0.006 0.011 (a) 0.041 (MPa) P (mW) 0.748 0.748 P1x1 (mW) 0.468 0.468 zs (cm) zb (cm) ZMI (cm) 1.40 Zpii,a (cm) 1.40 fawf (MHz) 2.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner PA HD3: PW Doppler Mode Index Label MI TIS At Surface Maximum Index Value 0.725 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.092 0.092 0.262 0.048 0.158 P (mW) 7.92 7.92 P1x1 (mW) 7.92 7.92 zs (cm) zb (cm) ZMI (cm) 3.00 Zpii,a (cm) 3.00 fawf (MHz) 2.45 prr (Hz) 500 srr (Hz) — 1.14 # 3.00 3.90 2.45 2.45 # 1 (W/cm2) 60.4 Ispta,a at Zpii,a or Zsii,a (mW/cm2) 45.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner PA HD3: Transcranial B-Mode Index Label MI TIS At Surface Maximum Index Value 0.972 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.150 0.150 0.276 0.150 0.276 0.276 0.150 (MPa) P (mW) 18.0 18.0 P1x1 (mW) 11.2 11.2 zs (cm) zb (cm) ZMI (cm) 1.77 Zpii,a (cm) 1.77 fawf (MHz) 2.83 prr (Hz) 4800 srr (Hz) 30.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner PA HD3: Transcranial Color Doppler Mode Index Label MI TIS At Surface Maximum Index Value 0.666 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.963 0.963 1.55 0.963 1.55 1.55 0.963 (MPa) P (mW) 82.4 82.4 P1x1 (mW) 82.4 82.4 zs (cm) zb (cm) ZMI (cm) 4.27 Zpii,a (cm) 4.27 fawf (MHz) 2.46 prr (Hz) 4800 srr (Hz) 30.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner PA HD3: Transcranial M-Mode Index Label MI TIS At Surface Maximum Index Value 0.972 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.010 0.010 0.041 0.006 0.011 0.011 0.041 (MPa) P (mW) 0.748 0.748 P1x1 (mW) 0.748 0.748 zs (cm) zb (cm) ZMI (cm) 1.40 Zpii,a (cm) 1.40 fawf (MHz) 2.
Clarius Ultrasound Scanner - HD3 Scanners Clarius Scanner PA HD3: Transcranial PW Doppler Mode Index Label MI TIS At Surface Maximum Index Value 0.696 Index Component Value Acoustic Parameters Other Information Below Surface At Surface 0.571 0.571 1.99 0.327 1.16 P (mW) 60.0 60.0 P1x1 (mW) 60.0 60.0 zs (cm) zb (cm) ZMI (cm) 3.53 Zpii,a (cm) 3.53 fawf (MHz) 2.00 prr (Hz) 4000 srr (Hz) — 0.983 60.0 3.53 4.20 2.00 2.00 2.00 1 (W/cm2) 42.
Clarius Ultrasound Scanner - HD3 Scanners Revision History User Manual Revision Revision Date Description 1 First official release.
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