Clarius User Manual Rev 11 Oct 2019

Table of Contents About This Manual ... 1 Target Audience...1 Document Conventions ...2

Chapter 1: About the Clarius Ultrasound Scanner ...5 Device Description ... 6 Scanner Dimensions... 7 Product Usage... 8 Indications for Use ...8 Contraindications ...14

Hardware... 15 Warranty...15 Disposal ...15

Security ... 16 Information Security...16 Network Security ...16 Confidentiality ...17 Integrity ...17 Availability...17 Accountability ...18

System Requirements... 18

Chapter 2: Using the Clarius Ultrasound Scanner...19 Downloading the Clarius App ... 19 Turning the System on & off ... 20 Starting the Clarius App...20 Exiting the Clarius App...20

Inserting & Removing the Battery ... 20 Inserting the Clarius Battery...20 Removing the Battery...21

A Quick Tour ... 21 Screen Overview ...21

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Clarius Ultrasound Scanner Connecting Your Smart Device to the Clarius Scanner...24

Managing Exams ...25 Error Messages ...26

Imaging ...27 Using the Measuring Tools ...27

Updating the Clarius Ultrasound Scanner ...28 Software Updates ...28 Firmware Updates...28

Maintenance ...29 Hardware Maintenance...29 System Maintenance ...31

Chapter 3: Accessories ... 32 Clarius Fan...32

Chapter 4: Cleaning & Disinfecting ... 33 Cleaning...34 Cleaning the Clarius Scanner ...34 Cleaning the Fan ...35

Disinfecting...36 Disinfecting the Clarius Scanner ...36 Disinfecting the Fan ...37

Spaulding Classification ...38

Chapter 5: Safety... 39 About Diagnostic Ultrasounds...39 Interactions with Matter...39 Studies...39 Benefits & Risks...40

Safety Topics ...40 Product Safety ...41 Battery Safety ...42 Cleaning Safety ...43 Clinical Safety ...45 Biological Safety ...45 ALARA Principle ...47 Fire & Electrical Safety ...57

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Clarius Ultrasound Scanner Electromagnetic Safety ...58

Chapter 6: References ... 63 Compliance Statement...63 The Clarius Ultrasound Scanner ...63 Product Classification ...63 Product Serial Number...63 System Specifications...64 Scanner Specifications ...65

Standards...66 Biocompatibility...66 Chemical ...66 Electrical Safety...66 Federal...67 Labeling...67 Quality ...67 Security & Privacy...69 Wireless...69

Doppler Sensitivity ...69 Acoustic Output Tables ...71 Clarius Scanner C3: B-Mode & M-Mode ...71 Clarius Scanner C3: Color Doppler Mode ...72 Clarius Scanner C3: Pulsed Wave Mode ...73 Clarius Scanner C7: B-Mode & M-Mode ...74 Clarius Scanner C7: Color Doppler Mode ...75 Clarius Scanner C7: Pulsed Wave Mode ...76 Clarius Scanner EC7: B-Mode & M-Mode ...77 Clarius Scanner EC7: Color Doppler Mode ...78 Clarius Scanner EC7: Pulsed Wave Mode ...79 Clarius Scanner L7: B-Mode & M-Mode ...80 Clarius Scanner L7: Color Doppler Mode ...81 Clarius Scanner L7: Pulsed Wave Mode ...82 Clarius Scanner L7: Needle Enhance Mode ...83 Clarius Scanner L7: Ocular (Ophthalmic) Mode ...84

Cleaners & Disinfectants ...85 Cleaner & Disinfectant Usage...85 Cleaner & Disinfectant Details ...86 Sterilization Systems ...86

Glossary of Terms ...86

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Clarius Ultrasound Scanner Acoustic Outputs...87 Acoustic Artifacts ...89

Known Issues ...92 Revision History...92

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About This Manual

To obtain a printed copy of this manual at no additional cost, go to www.clarius.com/contact and contact Clarius. This document is licensed as part of the purchase of the Clarius Ultrasound Scanner and meets applicable regulatory requirements. Use of this document by unauthorized persons is strictly prohibited. This document contains the following information: • About the Clarius Ultrasound Scanner: Describes the product, and lists technical specifications, and its intended use. • Using the Clarius Ultrasound Scanner: Shows you how to get started and begin scanning, introduces you to the features and concepts, and helps you set up your system. • Accessories: Describes additional accessories you can purchase for use with your Clarius Scanner. • Cleaning & Disinfecting: Explains how to clean and disinfect your scanner and its accessories. • Safety: Outlines important safety standards, principles, and policies to follow when using the product. • References: Offers information such as product standards, regulatory requirements, terms and conditions, glossary of terms, and acoustic output data.

Access to user documentation may be affected by: Internet availability and accessibility, website availability, and local electromagnetic interference.

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.

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Clarius Ultrasound Scanner

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.

Note

This icon indicates informative material or helpful suggestions.

Symbols Glossary The symbols shown in this document and on the Clarius Ultrasound Scanner are compliant with current versions of the following standards: ISO 7000, ISO 7010, IEC 6417, (EN) ISO 15223-1, and EN 15986.

STANDARD: ISO 7000 - GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS Symbol

Reference Title

Description

3082

Manufacturer

Indicates the medical device manufacturer, as defined in EU Directives 90/ 385/EEC, 93/42/EEC and 98/79/EC.

2497

Date of manufacture

Indicates the date when the medical device was manufactured.

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.

0621

Fragile; handle with care

Indicates a medical device that can be broken or damaged if not handled carefully.

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Clarius Ultrasound Scanner STANDARD: ISO 7000 - GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS 0626

Keep away from rain

Indicates a medical device that needs to be protected from moisture.

0632

Temperature limit

Indicates the temperature limits to which the medical device can be safely exposed.

0224

Measure humidity

Indicates the range of humidity to which the medical device can be safely exposed.

1641

Operator's manual; Indicates the need for the user to consult the instructions for use. operating instructions

0434A

Caution

Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

1135

General symbol for recovery/recyclable

To indicate that the marked item or its material is part of a recovery or recycling process.

You may see some of these standard symbols on your Clarius Scanner, accessories, and packaging:

OTHER STANDARDS - GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS Symbol

Standard Reference Title

Description

ISO 7010

M002

Refer to instruction manual/booklet

Indicates to read the instruction manual/booklet before starting work or before operating equipment or machinery.

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.

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Clarius Ultrasound Scanner

You may see these other symbols on your Clarius Scanner, accessories, and packaging: OTHER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT Symbol

Title

Description

Power connector

Indicates a barrel-type power connector.

RoHS compliant

Identifies electrical and electronic equipment that meets the Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU.

European Conformity

Conforms to European Council Directive 93/42/EEC.

FCC

Conforms to US Federal Communications Commission.

CSA certification

Certified by the Canadian Standards Association. The number below this symbol indicates the contract number.

Waste Electrical and Electronic Equipment

Requires separate collection for electrical and electronic equipment in compliance with the Waste Electrical and Electronic Equipment (WEEE). Directive. When accompanied by or , components of the device may contain lead or mercury, respectively, which must be recycled or disposed of in accordance with local, state, or federal laws. The backlight lamps in an LCD system monitor contain mercury.

Ingress protection rating

The equipment inside the enclosure is protected from tools and wires greater than 1.0 millimeters, is dust-tight, and is also protected from immersion up to 1 meter in depth for 30 minutes.

DC

Direct current.

GS1 DataMatrix

Identifies GS1 encoded DataMatrix.

Global Medical Device Nomenclature Code

A system of internationally agreed generic descriptors used to identify all medical device products.

Authorized representative in Indicates the Authorized representative in the European Community. the European Community ANATEL

Conforms to the Brazilian Agency of Telecommunications.

RCM

Regulatory Compliance Mark for Australia and New Zealand.

NCC

Conforms to Taiwan’s National Communications Commission.

n/a

Do not stack boxes.

n/a

Do not use knife to open.

n/a

Recycle Li-ion battery in accordance with local, state, and federal regulation

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About the Clarius Ultrasound Scanner

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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.

• 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. • Using portable and mobile radio-frequency (RF) communications equipment can affect the operation of medical equipment. • Operating this system in the presence of flammable gases or anesthetics can cause an explosion. • Install and operate medical equipment according to electromagnetic compatibility (EMC) guidelines. • Users are responsible for image quality and diagnosis. • This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. • This product has demonstrated EMC compliance under conditions that included the use of compliant peripheral devices. It is important that you use compliant peripheral

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Clarius Ultrasound Scanner

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. • Vulnerable patients, such as children and pregnant/nursing women, may be more prone to the exposure of acoustic energy when the scanner is used for prolonged periods. • Biological incompatibility may exist between the scanner materials used and the biological tissues, cells, and body fluids of the patient/user, taking account of the intended purpose of the scanner. • Using the scanner in the patient environment may be unsafe if the following conditions exist: (1) Extremes in humidity (RH<15% and RH>90%). (2) Ambient temperatures that are excessively high (40°C / 104°F) or excessively low (0°C / 32°F). • Unqualified/untrained personnel purchasing and using the Clarius Scanner may be unable to attain quality images.

Users will be trained medical professionals (e.g., doctors, nurses, technicians) with previous training in ultrasound. Images produced by the scanner are transmitted wirelessly to the user’s smart device (tablet or smart phone). Caution: Federal law restricts this device to sale by or on the order of a physician.

Device Description The Clarius Ultrasound Scanner is a portable, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) Apple iOS or Android™ device. The Clarius Ultrasound Scanner series of wireless scanners are Bluetooth and Wi-Fi-based scanners that communicate with a traditional tablet/smartphone via direct Wi-Fi to allow users to export ultrasound images and display in different modes of operation. The Clarius Scanner houses a battery and power generator, multichannel beamformer, prescan converter and Wi-Fi components. The battery is removable and comes with a separate charger.

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Clarius Ultrasound Scanner

Scanner Dimensions

Battery manufacturer

Clarius

Battery chemistry

Li-ion

Battery management

JEITA guideline compatible charger, in-pack fuel gauge with protection circuitry, cell balancing, and temperature monitoring

Clarius Battery life

500 discharge cycles before reduction in charge

Clarius Battery Charger

Input: 100-240 VAC, 50/60 Hz, 0.5-0.2 A Output: 12 VDC, 1.5 A

Scanner

7.2 V/2350 mAh

Scanner Dimensions

Item

Length (in/mm)

Width (in/mm)

Height (in/mm)

Weight (oz/g)

Clarius Scanner C3

3.94/100

1.66/42

6.65/169

16.4/465

Clarius Scanner C7

3.94/100

1.66/42

6.89/175

15.7/445

Clarius Scanner L7

3.94/100

1.66/42

6.65/169

15.4/437

Clarius Scanner EC7

3.94/100

1.66/42

13.03/331

15.9/450

Clarius Battery

2.95/75

0.67/17

2.83/72

3.6/103

Clarius Battery Charger

3.15/80

3.50/89

1.26/32

1.9/55

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Clarius Ultrasound Scanner

Product Usage

Product Usage Indications for Use The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic1 ,2 , fetal, abdominal, intraoperative (non-neurological), pediatric, small organ, cephalic (adult)2, trans-rectal3 , transvaginal3, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body. The system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals4 .

1. Only applicable to the L7 scanner. 2. US, Canada, EU, and Singapore only. 3. Only in countries where Clarius Scanner EC7 is available. 4. IEC 60601-1-12 is valid in North America only.

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Clarius Ultrasound Scanner

Product Usage

Indications for Use Tables Clarius Ultrasound Scanner

SYSTEM: CLARIUS ULTRASOUND SCANNER INTENDED 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

P

Fetal Imaging & Other

Fetal

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Abdominal

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

Intra-operative (Abdominal organs & vascular)

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

Other*

Laparoscopic Pediatric

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

Small Organ (Thyroid, Prostate, Scrotum, Breast)

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

Neonatal Cephalic Adult Cephalic

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Trans-rectal

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Trans-vaginal

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Trans-urethral Trans-esophageal (non-Cardiac) Musculo-skeletal (Conventional)

P P P

P

P

B+CD; B+PD; B+PWD

Note 1

Musculo-skeletal (Superficial)

P P P

P

P

B+CD; B+PD

Note 1

Other (Urology, Gynecology)

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Cardiac Adult

P P P

P

B+M; B+CD; B+PD; B+PWD

Cardiac Pediatric

P P P

P

B+M; B+CD; B+PWD

Intravascular Cardiac

Intravascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac Other (specify) Peripheral Vessel Peripheral Vessel Other (Carotid)

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

N = new indication; P = previously cleared by FDA Note 1: Needle Enhancement in B-Mode.

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Clarius Ultrasound Scanner

Product Usage

Clarius Scanner C3

DEVICE NAME: CLARIUS SCANNER C3 INTENDED 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

P P P

P

P

Other*

B+M; B+CD; B+PD; B+PWD

Abdominal

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Intra-operative (Abdominal organs & vascular)

P P P

P

P

B+M; B+CD; B+PD; B+PWD

P P P

P

P

B+M; B+CD; B+PD; B+PWD

P P P

P

P

B+M; B+CD; B+PD; B+PWD

P P P

P

P

B+M; B+CD; B+PD; B+PWD

P

Laparoscopic Pediatric Small Organ (Thyroid, Prostate, Scrotum, Breast) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esophageal (non-Cardiac) Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Intravascular Cardiac

Other (Urology, Gynecology)

P P P

P

B+M; B+CD; B+PD; B+PWD

Cardiac Adult

P P P

P

B+M; B+CD; B+PWD

Cardiac Pediatric

P P P

P

B+M; B+CD; B+PWD

P

B+M; B+CD; B+PD; B+PWD

Intravascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac Other (specify) Peripheral Vessel Peripheral Vessel

P P P

P

Other (Carotid) N = new indication; P = previously cleared by FDA Note 1: Needle Enhancement in B-Mode.

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Clarius Ultrasound Scanner

Product Usage

Clarius Scanner C7

DEVICE NAME: CLARIUS SCANNER C7 INTENDED 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

P P P

P

P

Other*

B+M; B+CD; B+PD; B+PWD

Abdominal

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Intra-operative (Abdominal organs & vascular)

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Pediatric

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Small Organ (Thyroid, Prostate, Scrotum, Breast)

P P P

P

P

B+M; B+CD; B+PD; B+PWD

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Laparoscopic

Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esophageal (non-Cardiac) Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Intravascular Cardiac

Other (Urology, Gynecology)

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Cardiac Adult

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Cardiac Pediatric

P P P

P

B+M; B+CD; B+PWD

P

B+M; B+CD; B+PD; B+PWD

Intravascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac Other (specify) Peripheral Vessel Peripheral Vessel

P P P

P

Other (Carotid) N = new indication; P = previously cleared by FDA Note 1: Needle Enhancement in B-Mode.

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Clarius Ultrasound Scanner

Product Usage

Clarius Scanner EC7

DEVICE NAME: CLARIUS SCANNER EC7 INTENDED 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

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Abdominal

P P P

P

P

B+M; B+CD; B+PD; B+PWD

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Trans-rectal

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Trans-vaginal

P P P

P

P

B+M; B+CD; B+PD; B+PWD

P P P

P

P

B+M; B+CD; B+PD; B+PWD

Other*

Intra-operative (Abdominal organs & vascular) Laparoscopic Pediatric Small Organ (Thyroid, Prostate, Scrotum, Breast) Neonatal Cephalic Adult Cephalic

Trans-urethral Trans-esophageal (non-Cardiac) Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Intravascular Other (Urology, Gynecology) Cardiac

Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac Other (specify)

Peripheral Vessel Peripheral Vessel Other (Carotid) N = new indication; P = previously cleared by FDA Note 1: Needle Enhancement in B-Mode.

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Clarius Ultrasound Scanner

Product Usage

Clarius Scanner L7

DEVICE NAME: CLARIUS SCANNER L7 INTENDED 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

P

Fetal Imaging & Other

Fetal

Other*

Abdominal

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

Intra-operative (Abdominal organs & vascular)

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

Pediatric

P P P

P

P

B+M; B+CD; B+PD

Note 1

Small Organ (Thyroid, Prostate, Scrotum, Breast)

P

P

P

P

B+CD; B+PD; B+PWD

Note 1

Musculo-skeletal (Conventional)

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

Musculo-skeletal (Superficial)

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

Laparoscopic

Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esophageal (non-Cardiac)

Intravascular Other (Urology, Gynecology) Cardiac

Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac Other (specify)

Peripheral Vessel Peripheral Vessel Other (Carotid) N = new indication; P = previously cleared by FDA Note 1: Needle Enhancement in B-Mode.

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Clarius Ultrasound Scanner

Product Usage

Contraindications For Use in Surgical Environments

Before you use the Clarius Scanner for intra-operative procedures or in a surgical environment, follow the instructions for high-level disinfection (for instructions see High-Level Disinfection on page 37), then cover the Clarius Scanner 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.

When you have finished using the Clarius Scanner, immediately clean it (for instructions see Cleaning the Clarius Scanner on page 34), followed by another high-level disinfection. If the sheath breaks during the intra-operative procedure, dispose the sheath and follow the same cleaning and high-level disinfecting process as above, then cover the Clarius Scanner with a new sheath before continuing to use it. For Use in Endocavitary Procedures

Before using the Clarius Scanner for endocavitary procedures (trans-vaginal and/or transrectal), inspect the probe for any rough surfaces, sharp edges, or sharp corners that may cause harm to the patient. Next, you must perform a high-level disinfection (for instructions see High-Level Disinfection on page 37), then cover the Clarius Scanner EC7 with a model #2220 sheath by Protek Medical Supplies Inc. Make sure the entire length of the end piece is protected.

When you have finished using the Clarius Scanner EC7, immediately clean it (for instructions see Cleaning the Clarius Scanner on page 34), followed by another high-level disinfection. If a Clarius Fan (CIDN 99-02-00028) was used, remove the fan prior to the high-level disinfection

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Clarius Ultrasound Scanner

Hardware

and follow the instructions for an intermediate-level disinfection (for instructions see Disinfecting the Fan on page 37). If the sheath breaks during an endocavitary procedure, dispose the sheath and follow the same cleaning and high-level disinfecting process as above, then cover the Clarius Scanner with a new sheath before continuing use. When using a biopsy guide, use one of the following recommended products: • Civco Reusable Endocavity Needle Guide (Product Number 613-198) • Civco Disposable Endocavity Needle Guide (Product Numbers 667-089 and 667-090)

Follow the usage instructions provided by the manufacturer. Do not reuse biopsy guides unless instructed by the manufacturer. For Use in Ophthalmic Procedures

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

Hardware Warranty Your Clarius Scanner includes a one-year warranty. For full warranty details, go to https:// support.clarius.com/hc/en-us/articles/360019549672-Warranty-Coverage. To purchase extended warranty, go to www.clarius.com/contact and contact Clarius.

Disposal Clarius is an active participant in the protection of the natural environment. The equipment and its accessories are designed and manufactured according to environmental protection guidelines, and the disposal of this equipment is intended to follow the same principles. The equipment materials that are essential for functionality are also harmful to the natural environment, therefore, you must dispose these materials appropriately. For proper disposal of the Clarius Scanner or any of its accessories, dispose it in accordance with local, state, and federal regulations. Alternatively, you can return it to Clarius.

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