Vscan with Dual Probe Operating Document Rev 09

Regulatory requirement This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

0123

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

This manual supports the ultrasound system Vscan™ with Dual Probe, including the Vscan gateway software version 1.4.

Manual status: GM092407-09 2018 11 28 (YYYY MM DD) Manufacturer: GE VINGMED ULTRASOUND AS Strandpromenaden 45 N-3191 Horten, Norway Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350

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Regulatory Requirements

Conformance Standards

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

The GE product families are tested to meet all applicable requirements and relevant standards per the countries in which the product will be sold. Any changes to accessories, peripheral units or any other part of the system must be approved by the manufacturer: GE Vingmed Ultrasound AS. This product complies with the regulatory requirement of the following: Standard/Directive

Scope

93/42/EEC

Medical Devices Directive (MDD)

IEC* 60601-1 CAN/CSA-C22.2 No 601.1-M90 AAMI ES60601-1

Medical Electrical Equipment, Part 1. General Requirements for Safety

IEC* 60601-1-1

Safety requirements for medical systems

IEC* 60601-1-2

Medical Electrical Equipment - part 1-2. Collateral standard: Electromagnetic compatibility - Requirements and tests.

CISPR 11 EN55011

Emitted noise according to Group 1 Class B requirements

IEC* 60601-1-4

Medical Electrical Equipment - part 1-4. Collateral standard: Programmable electrical medical systems

IEC* 60601-1-6

Medical Electrical Equipment - part 1-6. Collateral standard: Usability.

IEC* 60601-2-37

Medical electrical equipment - Part 2-37. Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

NEMA UD2 NEMA UD3

Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment.

ISO10993-1

Biological evaluation of medical devices

* including national deviations

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Country Specific Approvals •

JAPAN MHLW Approved Number: 221ABBZX00252000

•

CHINA CFDA #: 20142235830 PRS#: YZB/NOR 7524-2014

•

KOREA

•

THAILAND

KFDA: 14-2865 NOR 5703636

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

Importer Information •

TURKEY

•

GE Vingmed Ultrasound AS is ISO 9001 and ISO 13485 certified.

Certifications

Classifications The following classifications are in accordance with the EN/ES/ IEC 60601-1. Type and degree of protection against electric shock: •

Vscan with Dual Probe is battery powered and classified as internally powered medical electrical equipment type BF applied part when not in the Docking station.

•

The AC/DC adapter and charger are Class II pieces of equipment (when charging the Vscan with Dual Probe also meets this class).

•

Degree of protection against harmful ingress of dust and water: Vscan with Dual Probe, parts and options except the probe are IPX0 (ordinary equipment): no protection against moisture or particulates.

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The probe and cable are IPX7: immersible.

Class II Equipment EQUIPMENT in which protection against electric shock does not rely on BASIC INSULATION only, but in which additional safety precautions such as DOUBLE INSULATION or REINFORCED INSULATION are provided, there being no provision for protective earthing or reliance upon installation conditions.

Type BF Applied part TYPE BF APPLIED PART providing a specified degree of protection against electric shock, with particular regard to allowable LEAKAGE CURRENT.

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

Normal mode Patient leakage current

<100 microA

Single fault condition <500 microA

Original Documentation •

The original document was written in English.

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Table of Contents

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-1 Country Specific Approvals - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Class II Equipment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Type BF Applied part - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3

Table of Contents Chapter 1 - Introduction General description Principles of operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Optional features - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Intended use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Indication for use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Contraindication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Intended users - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Operator Profile - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4

Warnings Conventions used in this manual Contact Information Contacting GE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8 Global ultrasound support center phone numbers - - - - - - - - - - - - - - - - 1-9 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-12

Chapter 2 - Safety Introduction Owner responsibility Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4

Important safety considerations Patient safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Electromagnetic Compatibility (EMC) - - - - - - - - - - - - - - - - - - - - - - - - - 2-9 Acoustic output- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Environmental protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-17

Maximum probe temperature Device labels and symbols Labels on the Vscan with Dual Probe and options - - - - - - - - - - - - - - - 2-19

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For China only - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25

Chapter 3 - Preparing the Vscan™ with Dual Probe for use Package contents Environmental requirements for the unit - - - - - - - - - - - - - - - - - - - - - - - 3-5

System description System overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-6

Battery Power plugs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-16 Voltage requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-17 Charging the battery using the Docking station - - - - - - - - - - - - - - - - - 3-17 Charging the battery using the optional External battery charging compartment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-18 Battery level indicator - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-18 Removing / inserting the battery (GM-BAT) - - - - - - - - - - - - - - - - - - - - 3-19 Battery (GM-BAT) specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-20 Recommendations concerning the battery (GM-BAT)- - - - - - - - - - - - - 3-20

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

The microSD card Removing / inserting the microSD card - - - - - - - - - - - - - - - - - - - - - - - 3-21 The microSD card memory indicator- - - - - - - - - - - - - - - - - - - - - - - - - 3-24 The microSD card handling recommendations- - - - - - - - - - - - - - - - - - 3-24

First time use Installing the battery - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-25

Vscan with Dual Probe activation Activation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-26 Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-26

Chapter 4 - Using Vscan™ with Dual Probe Switching on/off To switch on the Vscan with Dual Probe - - - - - - - - - - - - - - - - - - - - - - - 4-2 To switch off the Vscan with Dual Probe - - - - - - - - - - - - - - - - - - - - - - - 4-2

Scanning General scanning recommendations- - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5 Patient examination - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-6 Probe and presets - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-6 Black and white imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-8 Color imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9 Auto freeze - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-10 AutoCycle - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-10 Use of sterile sheath - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-10

Measurements Taking measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-11

Voice notations Recording Voice notations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-12

Review and storage Reviewing acquired images - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-13 Storage of images- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-13

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Recall of stored data Deletion of data To delete an examination - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-16 To delete a file - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-16

Chapter 5 - Vscan™ gateway software Overview About the files created in Vscan with Dual Probe - - - - - - - - - - - - - - - - - 5-2

Vscan gateway software installation Computer requirements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Installation and activation of Vscan gateway software - - - - - - - - - - - - - 5-5

Connection of Vscan with Dual Probe to a computer Using Vscan gateway software Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-20 Gallery screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Setup screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28

Chapter 6 - Configuring your Vscan™ with Dual Probe State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

Config menu System setup adjustment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3

Chapter 7 - Vscan™ with Dual Probe maintenance System care and maintenance Inspection Inspecting the Vscan with Dual Probe- - - - - - - - - - - - - - - - - - - - - - - - - 7-3 Inspecting the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-3

Cleaning and disinfection Cleaning - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-4 Disinfection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-5

Reinstallation of the factory software Procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-7

Troubleshooting Vscan with Dual Probe troubleshooting- - - - - - - - - - - - - - - - - - - - - - - - 7-9 Vscan gateway software troubleshooting - - - - - - - - - - - - - - - - - - - - - 7-10

Chapter 8 - Appendix Specifications Dimensions and Weight- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 Dual Probe characteristics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2

Acoustic Output Reporting Tables Definitions, symbols and abbreviations - - - - - - - - - - - - - - - - - - - - - - - - 8-3 Acoustic Output Reporting Tables for Track 3/EN/IEC 60601-2-37 - - - - 8-5

Measurement accuracy

Index

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Chapter 1

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

Introduction

Contents: ‘General description’ on page 1-2 ‘Warnings’ on page 1-5 ‘Conventions used in this manual’ on page 1-7 ‘Contact Information’ on page 1-8

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1-1

Introduction

General description

Vscan™ with Dual Probe is a battery operated pocket-sized general purpose ultrasound imaging system.

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

Principles of operation Medical ultrasound images are created by computer and digital memory from the transmission and reception of high-frequency pressure waves applied through a probe. The ultrasound waves spread through the body, producing an echo where density changes occur. The echoes return to the probe where they are converted back into electrical signals. These echo signals are amplified and processed by several analog and digital circuits having filters with many frequency and time response options, transforming the high-frequency electrical signals into a series of digital image signals which are stored in memory. Once in memory, the image can be displayed in real-time on the image monitor. A probe is an accurate, solid-state device, providing multiple image formats. The digital design and use of solid-state components provides highly stable and consistent imaging performance with minimal required maintenance.

Safety Read and understand all instructions in the User's Manual before attempting to use the ultrasound unit. Keep the manual with the equipment at all time. Periodically review the procedures for operation and safety precautions. All information in Chapter ‘Safety’ on page 2-1 should be read and understood before operating the ultrasound unit.

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General description Optional features The following features described in this manual are optional and may not be available on your Vscan with Dual Probe, depending on the options installed. •

Scanning presets: some scanning presets described in this manual may not be available.

•

Color imaging

•

Image storage

•

Measurement

•

Voice notation

•

Languages: some user interface languages listed in this manual may not be available.

•

Vscan gateway software

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

Intended use Vscan with Dual Probe is general purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid.

Indication for use Vscan with Dual Probe is general purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. With a single probe solution, the dual headed probe integrates both linear and phased array transducers that allows for a wide range of clinical applications: Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Peripheral Vascular Imaging (e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels (e.g. central lines, upper extremity); Imaging Guidance for Needle/Catheter Placement (e.g. paracentesis, thoracentesis, amniocentesis); Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); Thyroid and other Small Organs; Long Bone; Hip and Knee Joints; and Pediatrics. Its pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, triage

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Introduction assessments, and procedural guidance for adults and pediatrics.

Contraindication The Vscan with Dual Probe ultrasound unit is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

Intended users Vscan with Dual Probe is intended to be used by qualified and trained healthcare professionals that are legally authorized by law in the country, state or other local municipality in which he practices to use the device. The list of the potential users includes but is not limited to (based on title/geographical location): physicians, sonographers, medical healthcare technicians, nurses, midwives, paramedics, nurse practitioner, physician assistants, medical students. The users may or may not be working under supervision or authority of a physician.

Operator Profile •

Qualified and trained healthcare professionals with at least a basic level of general ultrasound training that includes limited image acquisition techniques and interpretation (i.e. position the probe correctly on the patient and determine at least normal vs. abnormal anatomy views during scanning).

•

The operator must have read and understood the user manual.

Contact GE sales representative for product training assistance and visit the Vscan web portal for reference materials.

Prescription Device For USA only: CAUTION: Federal law restricts this device to sale by or on the order of a physician.

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Warnings

Warnings

To prevent damage of the equipment or injury to yourself or others, read the following safety warnings before using the Vscan with Dual Probe.

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

WARNING

•

Vscan with Dual Probe is a precision instrument. Handle Vscan with Dual Probe and its optional accessories with care. Do not subject Vscan with Dual Probe to mechanical shock or impact.

•

Do not attempt to disassemble or alter any part of the unit including the probe, the battery, the AC/DC adapter, Docking station or any other option or accessory. Disassembly or modification may result in electrical shock.

•

Stop using the unit if it emits smoke or noxious fumes. Failure to do so may result in electrical shock or fire.

•

Stop using the unit if the casing is damaged, including the probe. Failure to do so may result in electrical shock.

•

Do not use the AC/DC adapter if showing visible damages.

•

Use only the designated power accessories (battery, AC/ DC adapter, Docking station and external battery charging compartment). Failure to do so may result in electrical shock or fire.

•

Do not place the battery near a heat source or expose it to direct flame. Such exposure may lead to corrosive liquid leakage, electrical shock or fire.

•

If any liquid from battery should come in contact with the eye, immediately wash the eye with plenty of water and seek medical advice as soon as possible.

•

Do not immerse or expose the battery to water.

•

To reduce risk for electrical shock, do not plug or unplug the AC/DC adapter from mains socket with wet hands.

•

Avoid dropping or subjecting the unit, including the probe, the battery, Docking station and accessories to severe impacts. This could result in electrical shock, corrosive liquid leakage and injury.

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Introduction

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WARNING

1-6

•

Do not short-circuit the battery terminal with metallic objects. This may result in overheating and burns.

•

Do not store or carry a battery loosely with metallic devices.

•

Disconnect the battery charger when not in use to avoid fire hazard.

•

Keep the charger dry. Failure to observe this precaution may result in fire and electric shock

•

Keep this unit out of reach of children. Strangulation resulting from baby or child entanglement in probe cable may occur.

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Conventions used in this manual

Conventions used in this manual

Buttons and other controls on the Control panel or on the monitor screen are indicated by bold type. Program windows, screens and Dialogue boxes are indicated by italic type.

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

The following icons, highlight safety issues as follow:

DANGER

Indicates that a specific hazard exists that, given inappropriate conditions or actions, will cause severe or fatal personal injury with or without substantial property damage.

WARNING

Indicates that a specific hazard exists that, given inappropriate conditions or actions, can cause severe or fatal personal injury with or without substantial property damage.

CAUTION

Indicates that a potential hazard may exist that, given inappropriate conditions or actions, can cause minor injury or property damage.

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Introduction

Contact Information

Contacting GE For additional information or assistance, please contact your local distributor or the appropriate support resource listed on the following pages:

Internet

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

https://vscan.gehealthcare.com http://www.gehealthcare.com

USA TEL: (1) 800-437-1171 Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226

Clinical Questions Please contact your local Applications or Sales Representative.

Accessories Catalog Requests To request the latest GE Accessories catalog or equipment brochures in the United States, call the Response Center TEL: (1) 800-643-6439 In other locations, contact your local Applications, Sales or Service Representative.

Placing an order To place an order, order supplies or ask an accessory-related question in the United States, call the GE Access Center

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Contact Information TEL: (1) 800-472-3666 In other locations, contact your local Applications, Sales or Service Representative.

Global ultrasound support center phone numbers For countries not listed in the tables below, please contact the local distributor. When contacting Support you will have to provide your system ID. If system ID is unknown, please give the Temporary System ID “VSCAN” to be properly routed for support.

Americas

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

Region

Telephone

United States

800-437-1171

Canada

800-668-0732

Mexico

0800 9043400

Puerto Rico

0800 4371171

Brazil

0800 122345

Argentina

0800 3331984

Chile

0800 367000

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Introduction Europe, Middle East and Africa

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process. See the GEHC Myworkshop System to determine the status of this document.

Region

Telephone

Algeria

+21321484612

Andorra

902 400 246

Austria

0800244260

Belarus

Contact local distributor

Belgium Dutch

+32 262 638 38

Belgium French

+32 262 638 39

Bulgarian

+35929712040

Denmark

80404944

Egypt

+202 19434 [hot line]

Finland

0981710182

France

0800139140

G. D. Luxembourg

080022973

Germany

08004373784

Greece

302109690660

Holy See

800 827168

Hungary

+36-23-410-510

Ireland

1800992557

Israel

Contact local distributor

Italy Central

800 827168

Italy North-East

800 827166

Italy North-West

800 827164

Italy South

800 827170

Liechtenstein

0041 44 809 9293

Monaco

0800139140

Netherlands

8000994442

Northern Ireland

08000720248

Norway

80062043

Portugal

800 834 004

Russia

+7 495 739 69 75

San Marino

800 827168

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Vscan with Dual Probe – User Manual

Approved Document - GM092407TPH_r9.pdf Page 21 of 158

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