bk ultrasound bk3500 User Manual

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bk3500 Ultrasound System

User Guide

16-01410-EN-04 April 2017

For Professional Users Only

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LEGAL MANUFACTURER

BK Medical ApS

Mileparken 34

2730 Herlev

Denmark

Tel.:+45 4452 8100/Fax:+45 4452 8199

www.bkultrasound.com

Email: info@bkultrasound.com

The serial number label on a BK product contains information about the year of manufacture.

BK Medical ApS Customer Satisfaction

Input from our customers helps us improve our products and services. As part of our customer satisfaction program, we contact a sample of our customers a few months after they receive their orders. If you receive an email message from us asking for your feedback, we hope you will be willing to answer some questions about your experience buying and using our products. Your opinions are important to us. You are of course always welcome to contact us via your BK service representative or by contacting us directly.

If you have comments about the user documentation, please write to us at the email address above. We would like to hear from you.

System Software

•

NOT FAULT TOLERANT

INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE, AND MS HAS RELIED UPON BK Medical TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR USE.

•

EXPORT RESTRICTIONS

with all applicable international and national laws that apply to Windows 8 Embedded, including the U.S. Export Administration Regulations, as well as end-user, end-use and country destination restrictions issued by U.S. and other governments. For additional information on exporting Windows 8 Embedded, see http:// www.microsoft.com/exporting/

•

The bk3500 Ultrasound System is closed. Any modification of or installation of software to the system may compromise safety and function of the system. Any modification of or installation of software without written permission from BK Medical will immediately void any warranty supplied by BK Medical. Such changes will also void any service contract and result in charges to the customer for restoration of the original bk3500 Ultrasound System.

DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information.

Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries.

. THE SOFTWARE IS NOT FAULT TOLERANT. BK Medical HAS

. You acknowledge that Windows 8 Embedded is of US-origin. You agree to comply

Trademarks:

bk3500 = Ref. Type 2300

Information in this document may be subject to change without notice.

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Chapter 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Modes of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Transducer Specific Considerations and Contraindications for T7P2m . . . . 7

Chapter 2 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

The bk3500 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Before You Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Turning System On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Connecting Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Barcode Reader. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Quick Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Quick Exam Start-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Starting an Exam Using the Touch Screen Buttons . . . . . . . . . . . . . . . . . . . 18

Monitor and Touch Screen Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Charging the Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Battery Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Information Available on the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Battery Life. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Chapter 3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Safety Symbols and Information on the Equipment . . . . . . . . . . . . . . . . . . . . . . 27

General Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Mechanical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Explosion Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Electrical Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

ESD Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Electrical Noise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

RF (Radio Frequency) Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Connecting Other Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Network Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Network Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Network Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

EMC Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Isolation of DICOM Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

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Wireless Networks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Medical Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Non-Medical Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Battery Support System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Computer Security. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Touch Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Service and Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

During an Examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Checking the Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Verifying the Transducer Type. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

VFI - Vector Flow Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Puncture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Acoustic Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Monitor Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Thermal and Mechanical Indices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Acoustic Output Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Functions Affecting Acoustic Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Default Acoustic Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Clinical Measurements: Ranges and Accuracies. . . . . . . . . . . . . . . . . . . . . . . . . 48

Geometric Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Time Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Doppler Measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Appendix A Warnings and Cautions Displayed on the System . . . . . . . . . . . . . . . . . . . . . . . . . 53

English source version

16-01410-EN-04

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Chapter 1 Introduction

This user guide is for the bk3500 ultrasound system.

Before using the equipment, please make yourself familiar with the information in the accompanying user information documents. Some documents are printed. Make sure that you also read the transducer user guide and specifications for each transducer that you use.

Document Information

System User Guide Introductory information, safety information, getting started.

Quick Start Guide

System Advanced User Guide

Product Data for system

Technical Data (BZ2100)

Care and Cleaning

Transducer User Guide

Product Data for each transducer

Table 1-1. User information documentation that accompanies the equipment.

Improper use

Failure to follow safety instructions or use for purposes other than those described in the user manuals constitutes improper use.

User interface, basic operating instructions.

Information about advanced functions, glossary.

Specifications for the system, including disinfection methods that can be used. Indications for use for each transducer that can be used with the system.

Acoustic output data, clinical measurements (ranges and accuracies), factory default power levels and data about EMC (electromagnetic compatibility) for all transducers. Pro Package calculation formulas.

Cleaning, disinfection, sterilization, checking, storing and disposing of BK medical equipment. Includes environmental limits.

Specific instructions for the transducer and puncture attachments.

Specifications for the transducer, including disinfection methods that can be used.

Essential Performance

bk3500 User Guide

(16-01410-EN-04) Introduction

The system can provide 2D ultrasound echo and flow imaging systems as an aid in diagnosis, data processing and -transfer, and guidance of puncture and biopsy.

The system can perform simple geometric measurements and calculations.

The system can guide biopsy- and puncture needles.

The system is free from artefacts or distortion in the image or error of a displayed value, which can be attributed to a physiological effect and which may alter the diagnosis.

The system displays correct numerical values associated with the diagnosis to be performed.

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The As Low As Reasonably Achievable (ALARA) principle is used and safety related indications (MI, TIS, TIB, etc) are displayed as worst-case values.

The system does not generate unintended or excessive ultrasound output or transducer surface temperature.

There is no unintended or uncontrolled motion of transducer assemblies intended for intra-corporeal use.

Intended Use

The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy.

The system performs simple geometric measurements and calculations in the following areas:

•

Emergency Medicine

Anesthesia

MSK

Va sc u la r

Cardiology

•

OB/GYN

Modes of Operation

•

B-Mode (including Tissue Harmonic imaging)

•

M-Mode

•

PWD Mode

•

CFM Mode

•

Power Doppler

•

CW Doppler

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Indications for Use

The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.

The clinical applications and exam types include:

•

Fetal (including Obstetrics)

•

Abdominal

•

Pediatric

•

Small Organ (also known as Small Parts)

•

Adult Cephalic (also known as Adult Transcranial)

•

Neonatal Cephalic

•

Transvaginal

•

Transrectal

•

Musculoskeletal (Conventional and Superficial)

•

Cardiac Adult

•

Transesophageal Cardiology

•

Peripheral Vessel (also known as Peripheral Vascular)

Indications for use are different for different transducers. The Product Data sheet for the system contains a table listing the indicated uses for each transducer that can be used with the system.

Contraindications

•

The bk3500 ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

•

The Cardiac Adult application is not intended for direct use on the heart.

Transducer Specific Considerations and Contraindications for T7P2m

Transesophageal or transgastric echocardiographs produce clinical data that are unavailable from any other view, but there are some considerations as to which patients you should use the T7P2m for. First of all, the ability of a patient to swallow or accommodate the transducer, but all gastro-esophageal diseases or abnormalities must be considered as well.

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Contraindications

•

Esophageal spasm

•

Esophageal stricture

•

Esophageal laceration

•

Esophageal perforation

•

Esophageal diverticula (e.g. Zenker’s diverticulum).

• Large diaphragmatic hernia may significantly hinder TEE imaging because

of lack of transducer mucosal approximation.

• Atlantoaxial disease and severe generalized cervical arthritis: TEE should

never be performed if there is any question about stability of cervical spine.

• Patients who received extensive radiation to the mediastinum: this can cause

significant difficulty in probe manipulation within the esophagus and is a relative contraindication if the anatomy of the esophagus is not known.

•

Upper gastrointestinal bleeding significant dysphagia and odynphagia are also relative contraindications.

NOTE:

These contraindications are typical examples of what the examining

physician must consider before the examination. The list is not all-inclusive.

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Chapter 2

Monitor

Control panel

Transducer

Touch scre en

Scan engine

Transducer

Battery cover

Battery display

Front handle with

release handles

Battery

sockets

holders

compartment

Endotransducer holder

Baskets for accessories

Lockable wheels

Getting Started

The bk3500 System

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Before You Start

Before you turn on the system, make sure that the installation has been approved by a qualified electrician or by hospital safety personnel.

Read the battery support warnings (warnings with BS numbers) in “Battery Support System” on page 40.

Turning System On and Off

When you turn the system on or off, you must give the system enough time to save and recover open files and unsaved data. Otherwise, a serious system failure may occur that requires technical support.

Make sure the battery is charged. (If it is not, plug in the imaging system to use it or to charge the battery.)

Figure 2-1. The power button on the scan engine.

To t ur n o n:

Press the power button

once

, then wait until startup screen disappears.

If the battery is empty, it is not necessary to turn off the imaging system. Plug the system into a power outlet to recharge the battery while you run on power from the mains power supply.

To turn off:

Make sure system is running. Press the power button

Caution

Never shut down a system with a battery module simply by unplugging it from the wall. To preserve battery power, shut down the system properly.

BS-c2

once

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Connecting Transducers

Figure 2-2. Transducer plugs and sockets.

To connect:

Insert transducer plug into socket with locking lever to the right.

Turn locking lever on socket to the left.

To d is co nn ec t:

Freeze image.

Turn locking lever on socket to the right.

Remove plug from socket.

NOTE:

If more than one transducer is connected, select a different transducer before you disconnect. Otherwise, the following message will be displayed on the touch screen:

Figure 2-3. Message if the active transducer is disconnected.

bk3500 User Guide

Barcode Reader

To enter Patient Information with the barcode reader:

Tap the touch screen

With the cursor in the the barcode reader.

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Patient

Patient ID

button.

field, scan the relevant patient barcode with

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Continue entering the patient/exam data as required.

NOTE:

scanned with the barcode reader. Simply ensure that the cursor is located in the required field then scan the

Control Panel

Fields that will accept data entry via the keyboard will also accept data

relevant

WAR NI NG

To avoid personal injury, connecting/disconnecting the barcode reader and/or printer must be carried out only by BK personnel or authorized representatives.

SR-w2

barcode.

Figure 2-4. The control panel and touch screen.

Icon System Control Functionality

Trackbal l

QUICK ACCESS

button

Chapter 2 April 2017

Positions the mouse cursor, measurement cursor and label.

Opens the quick exam start-up workflow. When the exam has started, the Q button works as an button which will automatically optimize the image settings.

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Icon System Control Functionality

Live image: Stores a prospective video clip.

•

Button

SELECT

UPDATE

Button

Frozen image: Stores a retrospective video clip.

Provides a wide variety of functions depending on the imaging state, for example toggles between moving/resizing the color box and selects/sets measurements, labels, etc.

Provides a wide variety of functions depending on the imaging state, for example toggles between image views and image mode and rotates the transducer on the bodymark icon.

Stores the current image.

Quick Access

Quick Exam Start-Up

FREEZE

Touch Screen Dials

Touch Sc ree n

The

button provides the following basic functions:

•

Quick exam start-up

Once the Q button

Button

is selected, users can navigate through the Quick Exam Start-

up using the touch screen:

Freezes/unfreezes live imaging. A snowflake icon is displayed on the monitor when the image is frozen.

Five dials that control touch screen options, which change depending on the imaging mode/state. Once the touch screen option is tapped, turn the related dial to make the relevant adjustments.

Displays selectable options. Touch screen buttons may change depending on the chosen imaging mode/state or action.

bk3500 User Guide

Enter

Patient

Select

Select Imaging

Begin the exam.

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Trans ducer

Application

Information.

(Exam type).

Preset

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For the Quick Exam Start-Up:

Press the control panel Q button.

Enter The

Patient ID

Patient

information.

is filled in automatically with a timestamp, but you can change

this to a relevant ID or use a barcode reader. See “Barcode Reader” on page 11.

Figure 2-5. Patient window.

Swipe the screen from right to left to enter additional patient information.

Figure 2-6. Second screen in Patient window.

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Tap the tap

Exam Info

button to add specific information relevant for the exam, and

Figure 2-7. Exam Info window.

Select

Trans ducer

(in this case

6C2

is selected).

bk3500 User Guide

Figure 2-8. List of available transducers (those that are plugged in).

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Page 16

Select

Application

(the exam type you intend to perform). The applications

available depend on the selected transducer (in this case

6C2

Figure 2-9. List of available applications.

Select imaging

Preset

: The imaging presets available are dependent on the transducer and the application (exam type) selected.

Figure 2-10. Available presets.

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Begin the exam.

Figure 2-11. The Touch screen in Basic layout during an exam.

When you are finished, select

WAR NI NG

Exam-w2b

End Exam

If, after beginning an exam without entering any Patient information, you want to save an image, you must verify that the system auto-created a properly configured Patient ID before exiting the exam. Whenever possible, BK recommends that you also enter a complete Patient Name.

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Starting an Exam Using the Touch Screen Buttons

If you have several patients who need the same transducer/application/preset, you can choose not to use the Q workflow and use the touch screen buttons to go directly into the windows you need to update. You can also update details in the patient window and change transducer, application or preset during an exam.

Do as follows:

•Tap the Patient button on the touch screen.

• Enter patient information.

The

Patient ID

is filled in automatically with a timestamp, but you can change this to a relevant ID or use a barcode reader. See “Barcode Reader” on page 11.

Figure 2-12. Patient window when using the touch screen buttons.

• Swipe the screen from right to left if you need to add more information. Add exam info by tapping the Exam Info button. See steps 3 and 4 above.

• To use the transducer, application and preset already selected on the system, tap Start Exam. Otherwise, continue your selection by tapping the relevant main button (see Fig 2-18).

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• To select Transducer, tap the transducer you want. Alternatively, you can press the Smart button on the connected transducer to select it.

Figure 2-13. Transducer window when using the touch screen buttons.

• To use the application and preset already selected on the system, continue the exam. Otherwise, continue your selection.

• To select Application, tap the application you want.

bk3500 User Guide

Figure 2-14. Application window when using the touch screen buttons.

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To use the preset already selected on the system, continue the exam. Otherwise, continue your selection.

•

To sele ct

Preset

, tap the preset you want.

Figure 2-15. The preset window when using the touch screen buttons.

Figure 2-16. The touch screen in Basic layout during an exam.

•

The exam ends when you tap

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End Exam

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Monitor and Touch Screen Display

Tra nsducer

Review tab with browser

Exam type

Patient

Biopsy line

Image data including battery status

Measurement data

Hospital

Operator

Figure 2-17. Monitor (clinical display).

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Figure 2-18. Touch screen Advanced layout.

Mode function

buttons

Image parameter

buttons

Tou ch screen

dials

Mode buttons

Exam

Management

buttons

Function buttons, including the Home button.

Exam

Management

buttons

Function buttons, including the Home button.

Mode function

buttons

Image parameter

buttons

Mode buttons

Touch screen

dials

Chapter 2 April 2017

Figure 2-19. Touch screen Basic layout.

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Button Group Functionality

The exam management buttons follow the

Exam management buttons

Mode buttons

workflow to start an exam for a new patient, or allow the user to change the transducer, application or preset in an exam that has been started.

The mode buttons allow the user to select mode/modes for the exam. The modes are M-

mode, Doppler, Color and 2D (B-mode).

Battery

Mode function buttons

Image parameter buttons

Function buttons

•

You select or deselect a button by tapping it.

•

The buttons and window elements in the exam management and function button

The mode function buttons display the functions available for the selected modes.

The image parameter buttons display the image parameters that can be set for each mode/combination of modes. Tap the image parameter button and turn the related dial to set the parameter.

The function button group contains the

Measure, Label, Worksh eet, Report, Settings, Help and Home buttons. Tap the Home button

to return to default settings for the current exam type. The functions are described further in the bk3500 Advanced User Guide.

groups are highlighted in white when selected.

•

The buttons in the remaining groups are highlighted in green when selected in the live image and in blue when the image is frozen.

May need to

discharge

and recharge

bk3500 User Guide

Charging the Battery

The battery automatically begins charging when the system is plugged into a power outlet.

There is a battery display on the battery compartment. The battery will be fully charged from empty after approximately 4 hours.

If the Battery Appears Not to Charge to 100%

After repeated use, the battery may require a full discharge, full charge, and full

fully

(16-01410-EN-04) Getting Started

discharge in order to recalibrate the electronic fuel gauge so that the indication of how much charge is left in the battery is accurate.

Page 24

Battery Status

While the system is operating, battery status is visible both on the monitor (in the bottom right-hand corner) and on the display on the battery compartment.

•

NOTE:

imaging, the actual time available will be less than indicated on the display.

Information Available on the Monitor

The battery status indicator appears in the bottom right-hand corner of the monitor.

Figure 2-20. Battery level shown as % or as time available.

A message appears on the monitor when a battery reaches the end of its lifespan and needs replacing. For information about the disposal of depleted batteries, see page 40.

When the system is plugged into a power outlet, battery status is shown as percent (%) of capacity remaining.

When the system is running on the battery, battery status is shown as time remaining in “hours:minutes”.

The time displayed is an estimate based on typical use; for continuous

Low Battery

When battery capacity is very low,

•

An alarm sounds every 15 seconds

•

A message appears on the monitor

•

The on-screen battery indicator turns red

•

The display on the battery compartment blinks regularly

Figure 2-21. Low battery message.

The low-battery message informs you that the battery level is low and that the system will shut down when the system monitor clock matches the time stamp in the message (shown here as 13:18:58).

The display on the battery compartment begins to blink regularly when the low battery threshold is met, and it continues to blink even after the critical low battery threshold is met and the system has shut down.

Caution

If the battery reaches the auto-shutdown level, plug in the system and keep it plugged in until the battery recharges to

Chapter 2 April 2017

BS-c1

at least

10 %.

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Critical Low Battery

The setting for critical low battery is 3 minutes. When the battery reaches the critical level, the system shuts down immediately.

When the system is plugged in, the display on the battery compartment is lit.

NOTE:

The time settings for low and critical low battery can be changed. Contact

your BK service representative.

Battery Life

Typical vs.

continuous

use

Battery

lifespan

With typical use (which includes imaging and freezing), a fully charged battery provides approximately 2 hours of operation. With a fully charged battery pack, you can scan continuously for approximately 1 hour 20 minutes.

When a battery reaches the end of its lifespan, the replace battery message appears on the monitor at start-up.

On average, a battery will need to be replaced after approximately 300 recharge and discharge cycles – the battery lifespan. Contact your BK service representative for replacement of batteries.

For information about the disposal of depleted batteries, see page 40.

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Chapter 3 Safety Information

The system can be used for continuous operation, but imaging duration for individual patients must not exceed 60 minutes. We recommend, however, that you turn off the system at the end of each workday.

Safety Information

This user guide contains cautions, warnings and other information about what you must do to ensure the safe and proper performance of the ultrasound system. You must also follow local government rules and guidelines at all times.

WAR NI NG

Warnings contain information that is important for avoiding personal injury.

Caution

Cautions contain information and instructions that must be followed to avoid damaging equipment, data, or software.

NOTE:

Notes contain information that you should be aware of.

Safety Symbols and Information on the Equipment

Table 3-1 contains brief explanations of the symbols and information used to label the equipment. (Some labels in the table may appear on the transducer.)

BK Medical ApS disclaims all responsibility for the operating safety, reliability and performance of the equipment if these symbols and warnings are disregarded in any way.

Symbol Name Description

Caution or Warning Consult accompanying user guides when you

encounter this sign on the instrument, to avoid reducing its safety.

Follow instructions for use

Pushing prohibited Do not use excessive force to push the system.

Read the user guide or other instructions for important safety warnings.

Consult user guide or other instructions.

Excessive force when pushing over uneven surfaces can cause the system to overbalance and tip.

bk3500 User Guide

Table 3-1. Symbols and information on the equipment.

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Page 28

Symbol Name Description

3D56

LI-ION

Keep hands clear Show caution when you adjust the system monitor.

Manufacturer Legal manufacturer.

UL Classification for

UL requirements are met for special conditions.

Canada and US

Rx only

United States law restricts this device to sale or use by or on the order of a physician.

Potential Equalization

Terminal connected to the chassis. Should be connected to corresponding terminals on other equipment to eliminate potential differences.

Ground (earth) Additional protective ground (earth).

Type BF BF: Isolated from ground.

Maximum patient leakage current under

•

Normal condition 100A

•

Single-fault condition  500A

Type BF BF, defibrillator-proof.

Type B B: Maximum patient leakage current under

•

Normal condition 100A

•

Single-fault condition  500A

Sealing Dust- and immersion-protected according to EN

60529.

Standby Symbol on Power button on side of scanner engine –

used to turn system on and off.

ESD (electrostatic discharge)

Do not touch pins in connectors with this symbol unless you follow ESD precautionary procedures.

WEEE waste Within the EU, when you discard the equipment, you

must send it to appropriate facilities for recovery and recycling.

Battery waste Dispose of used batteries properly. When you dispose

of the batteries, you must follow national rules. Within the EU, you must send them to appropriate facilities for recovery and recycling.

Battery recycle Recycle used batteries properly.

China ROHS 25 Years Lifetime

Table 3-1. Symbols and information on the equipment. (continued)

Environmentally Friendly Use Period for ROHS is 25 years.

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General Safety Precautions

The ultrasound system is designed and tested in accordance with EN/IEC 60601-1 (2012) (Part 1: General requirements for basic safety and essential performance) and EN 60601–2–37 (2008)/IEC 60601-2-37 (2007) (Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment).

The system also complies with ANSI/AAMI ES60601-1 (2012) and CAN/CSA C22.2 No.60601.1 (2008).

It fulfills the requirements for dust protection (IP20) for ordinary equipment specified in EN 60529.

Physicians

only

Proper

Training

Equipment

failure

Caution

Rx-c1

United States law restricts this device to sale by, or on the order of, a physician.

WAR NI NG

GS-w1

To ensure safe and proper use of the equipment, before you attempt to use BK equipment, you should be trained in ultrasonography or be under the supervision of someone who is trained in ultrasonography. You should also be thoroughly familiar with the safe operation of your ultrasound system: read all the user documentation that accompanies it.

In addition, if your system interacts with other equipment directly or indirectly, you need to make sure the interactions are both safe and secure.

No further training is required, but BK offers training in how to use the system. Consult BK for information.

WAR NI NG

GS-w2

If at any time the system malfunctions, or the image is severely distorted or degraded, or you suspect in any way that the system is not functioning correctly:

•

Remove all transducers from contact with the patient.

•

Turn off the system. Unplug the system from the wall and make sure it cannot be used until it can be checked.

•

Do not try to repair the system yourself.

•

Contact your BK service representative or hospital technician.

Isolating the

bk3500 User Guide

WAR NI NG

GS-w3

The power supply cord connects the equipment to the line voltage. To isolate the

system

equipment, you must unplug the power supply cord from the power source. Do this before you try to make any repairs to the system.

Caution

Spilled liquids

(16-01410-EN-04) Safety Information

The ultrasound system control panel is gel or moist substances on either the buttons or the touch screen.

S-c2b

not

watertight. Be careful not to spill any liquids,

Page 30

Caution

S-c3

Conden-

sation

Large variations in temperature or humidity may cause water to condense inside the system. If this happens, the system may fail to operate properly. Always let the system come to room temperature before you plug it in.

•

Wait at least 2 hours after the system has been subjected to major changes in temperature or humidity.

•

If there is visible evidence of condensation, wait at least 8 hours.

Before you use the equipment, make sure that all the safety requirements described in this chapter have been satisfied.

Mechanical Safety

Mechanical failure or unintended use of ultrasound equipment can result in physical injury to patients or operators.

WAR NI NG

Mechanical

injury

Be careful to avoid the following potential sources of injury:

•

Parts of the body can be pinched by moveable parts of the equipment, such as the control panel.

•

Tilting the system can cause it to be unstable and injure someone.

•

Do not lean or sit on the control panel or any other part of the system. The control panel or monitor can break if subjected to heavy weights or impact.

MS-w1

All parts must be

stable

Scan engine

can be hot

Don’t push

too hard

WAR NI NG

MS-w2

When parts of the equipment can be mounted individually (for example, for use in an operating room) each part must be securely mounted to a stable support so that it does not tip, fall or come loose and injure someone.

WAR NI NG

MS-w3

To avoid personal injury, be aware that the scan engine can become hot after prolonged use.

WAR NI NG

MS-w4

To avoid injury and equipment damage, do not push the system too hard, especially when you roll the system over an uneven surface. Applying excessive force near the top could cause the system to overbalance and tilt.

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Explosion Hazards

WAR NI NG

Explosion

hazards

The equipment is not designed to be used in potentially explosive environments. It should not be operated in the presence of flammable liquids or gases, or in oxygen-enriched atmospheres.

There is a possible explosion hazard if the equipment is used in the presence of flammable anesthetic. The system should be placed at least 25cm (10 inches) from the patient.

The ultrasound system contains a lithium battery. Never remove or replace this battery. The lithium battery must not be removed except by a BK service representative.

Electrical Safety

WAR NI NG

Do not use a

power strip

Do not plug the equipment into an ordinary power strip. If the ground connection fails, this is dangerous because

•

the total leakage current for all the connected equipment can exceed the limits specified in EN/IEC 60601-1

•

the impedance of the ground connection could exceed the limits specified in EN/IEC

60601-1.

EH-w1

ES-w1

(Part 1: General requirements for safety).

Electrical

shock

ESD Training

ESD

WAR NI NG

ES-w3

You risk electrical shock if you try to get inside the equipment (other than opening a cover to access connectors described in the user guide). Do not allow anyone but qualified service personnel to service the equipment.

The ESD Symbol

Anyone using the equipment must be able to recognize the ESD symbol and understand how to take the necessary precautionary procedures, as described in the caution below.

Caution

Do not touch pins in connectors that have the ESD symbol . Do not connect anything to them unless you follow these ESD (electrostatic discharge) precautionary procedures:

•

ESD-c1

Discharge your body to ground before you touch the pins with your hand or a tool. For example, touch an unpainted metal part of the system cover.

You can use a wrist strap connected to the additional protective ground or potential equalization terminal on the system if that is more convenient.

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Page 32

Interference

Electrical Noise

The bk3500 Ultrasound System is suitable for use in most healthcare establishments, other than domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

Electrical

noise

Electromagnetic Interference

Other

equipment

nearby

WAR NI NG

Electrical noise from nearby devices such as electrosurgical devices – or from devices that ca n tr ansmit e lec trica l no ise to the AC line – may caus e di stu rba nces in ul trasound ima ges. This could increase the risk during diagnostic or interventional procedures.

EN-w1

Medical electrical equipment requires special precautions regarding EMC (electromagnetic compatibility). You must follow the instructions in this chapter when you install the system and put it into service.

If the image is distorted, it may be necessary to position the system further from sources of electromagnetic interference or to install magnetic shielding.

WAR NI NG

Do not use this equipment adjacent to other equipment. If you must place it next to or stacked with other equipment, verify that it operates normally there and neither causes nor is affected by electromagnetic interference.

EMC-w1

EMC noise can reduce the usable image depth. Therefore, to avoid having to repeat an ultrasound examination, you must make sure beforehand that the ultrasound system can be used for the examination. Repeating an examination can be regarded as a potential risk that should be avoided, especially if the examination involves transducers used intracorporeally or transducers used for puncture.

RF (Radio Frequency) Interference

Portable and mobile RF (radio frequency) communication equipment can affect the system, but the system will remain safe and meet essential performance requirements.

An ultrasound system intentionally receives RF electromagnetic energy for the purpose of its operation. The transducers are very sensitive to frequencies within their signal frequency range (0.3MHz to 80 MHz). Therefore RF equipment operating in this frequency range can affect the ultrasound image. However, if disturbances occur, they will appear as white lines in the ultrasound image and cannot be confused with physiological signals.

Caution

Possible

interference

sources

Chapter 3 April 2017

Other equipment may interfere with the system, even if that other equipment complies with CISPR (International Special Committee on Radio Interference) emission requirements.

Inter-c1

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Caution

Inter-c2

Use specified

equipment

only

Installation

safety

requirement

If you use accessories, transducers or cables with the system, other than those specified, increased emission or decreased immunity of the system may result.

WAR NI NG

I-w1

To ensure safe performance, a qualified electrician or hospital safety personnel must verify that the equipment is correctly installed and that it complies with the following safety requirements:

•

Use only the original power supply cord. In the USA, this is fitted with a hospital grade three-prong grounded power plug. Never try to remove or change the plug on the power supply cord.

•

All equipment must only be connected to a grounded AC power supply (or wall outlet) that meets EN/IEC/NEC requirements or applicable local regulations. The examination room’s grounding system should be checked regularly by a qualified electrician or hospital safety personnel.

•

Never use extension cords. The increased length of the cord will increase the resistance of the protective ground conductor and may increase the equipment’s leakage current beyond an acceptable level.

•

Keep power cords, sockets and plugs clean and dry at all times.

•

Make sure that the power supply cord cannot be accidentally disconnected from the power source or the equipment.

Original

power cords

If the original power cords are missing or damaged, you must order new ones from your BK service representative.

Additional Protective Ground and Potential Equalization

An additional protective ground can be connected to the terminal underneath the control panel, see Fig 3-1.

The potential equalization terminal underneath the control panel is connected to the system chassis. It can be connected to corresponding terminals on other equipment to eliminate potential differences. Do NOT use it for additional protective grounding.

bk3500 User Guide

Figure 3-1. The terminals for additional protective ground and potential equalization

are on each side of the stand underneath the control panel.

(16-01410-EN-04) Safety Information

Page 34

Connecting Other Equipment

For connection to other equipment, BK systems have a communication protocol on top of TCP/IP.

WAR NI NG

Connection

guidelines

Follow the guidelines in EN/IEC 60601-1 when you connect the system to other equipment.

Network Connection

BK’s range of ultrasound systems comply with the DICOM standard for handling, storing, printing and transmitting information in medical imaging. DICOM includes a file format definition and a network communication protocol which facilitates the exchange of data between electronic medical systems.

For detailed information about:

•

network requirements

•

network configuration

•

workflow between devices

•

technical specifications

•

safety specifications

see the DICOM conformance statement at

www.bkultrasound.com/support/bk/resources/DICOM

C-w1

Network Security

It is the responsibility of the on-site personnel or technician to maintain the ITnetwork and identify, analyze, evaluate and control new risks caused by a change in the network configuration.

If the applicable network connection does not meet the required characteristics of the IT-network, the following hazardous situations may occur:

•

Network

guidelines

NOTE:

ensure that your network is properly dimensioned and that critical equipment is placed on a separate network. Otherwise you could risk overloading the network and your equipment failing.

Network Printing

For printing on network printers, BK supports protocols PCL 5, PCL 6 and PS (Post Script).

Corrupt patient data due to network errors, see Warning Exam-w3 on page 42

System is unable to use the network due to faulty or overloaded network, see Warning GS-w1 on page 29

System overloads the network causing other equipment to fail.

If your system interacts with other equipment directly or indirectly you must

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Connectors

LAN Connector

Composite Connector

USB 2.0 Connector

USB 3.0 Connector

S-video Out

Microphone

Audio In

Audio Out

DVI or VGA Monitor

Wi-Fi Dongle

Transducer Sockets

As seen in Fig 3-2, the bk3500 ultrasound system has four transducer sockets on the side of the system.

PC connectors for connecting the system to equipment such as approved printers and video equipment are located on the rear of the system. Do not use connectors that are not labeled.

Information about the correct cables to use is in Table 3-4.

bk3500 User Guide

Figure 3-2.

(16-01410-EN-04) Safety Information

Transducer sockets and system connectors.

Page 36

Symbol Connector Additional Information

DVI-I Connector for auxiliary DVI or VGA

monitor

Composite Out RCA/Phono

S-video Out 4-pin S-video connector

Microphone Microphone connector

Audio In

DVI gives best

image quality

Table 3-2. System connectors.

Audio Out

4 USB 2.0 connectors and 2 USB

3.0 connectors (A-type)

10/100/1000 Ethernet LAN: 10/100/1000 LAN connector, RJ45

500mA current limit on each

Video Output

Although 4 different video output signal formats are available, the image quality is not the same for all of them.

To get the best image quality possible, connect your monitor or other video equipment using the output signal that gives the highest quality image. See the list below.

Output signal types (in order of quality, with digital DVI highest):

DVI - digital output that gives the best image quality.

VGA – this analog output from the DVI connector gives slightly poorer image quality than the digital DVI output.

S-video – analog output

Composite – signal with the most loss of information

If you must use a cable that does not have a DVI connector, you may need to use an adapter. Table 3-3 shows you which adapters can be used.

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Cable Connectors (in order of preference)

HDMI Adapter needed DVI-I

Adapter bk3500 Connector

DVI-D

15-pin (VGA)

S-video

BNC (Composite)

Phono RCA (Composite)

Not needed

DVI-I

DVI to VGA adapter (2 views)

DVI-I

Not needed

BNC (female) to Phono (male)

Not needed

bk3500 User Guide

Table 3-3. Video connectors and adapters.

EMC Requirements

To fulfill EMC requirements, cables attached to the system must be shielded and no longer than 5 m.

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Page 38

Connector Cable

DVI-I DVI-D Dual link Shielded 7.6 m

Composite Out

S-video Out

Audio In

Audio Out

10/100/1000 Ethernet

Table 3-4. List of cables used in testing for EMC compliance

Composite Video RCA Shielded 7.6 m

S-video 7.6 m

Audio Stereo, 3.5 mm plug, Shielded 5 m

Ethernet CAT6 5 m

Do not attach transducers and other accessories unless the user guide for the transducer or accessory states that it can be used with this system. Attaching other equipment may cause an increase in electromagnetic emissions or may cause the system to be more sensitive to electromagnetic interference.

Isolation of DICOM Network

The system must not be galvanically connected to a computer network (DICOM®) that has not been isolated. If the network is not isolated, the system must be connected via a network isolator DP0925 .

Wireless Networks

The system can be connected to a wireless network for printing and archiving data. A Wi-Fi dongle and a 30 cm USB 3.0 extender cable are supplied with the system. Connect the dongle to the extender cable and insert into one of the USB 3.0 connectors (see Fig 3-3 on page 30).

Connecting to a Wireless Network

You must establish a secure wireless network at your hospital, clinic or institution, including a password for the network, before you can use the system’s Wi-Fi for printing and archiving.

For setting up a wireless network, see the

Caution

The network must be set up correctly so that data is sent to the correct location. Otherwise data can be lost or accessed by unauthorized people.

Caution

A safe encrypted protocol for data transmission, approved by the hospital, must be used. This is to prevent unauthorized people from getting access to the data.

Wifi-c1

Wifi-c2

bk3500 Advanced User Guide

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Medical Equipment

If any other electrical equipment/accessory is connected to the system, the system

including

systems must comply with

this equipment and/or accessory will become a medical system. Medical

EN/IEC 60601–1, ANSI/AAMI ES60601-1 or CAN/CSA

C22.2 No. 60601-1.

Non-Medical Equipment

WAR NI NG

Follow the guidelines in EN/IEC 60601–1.

If you connect non-medical equipment (instruments that do not comply with safety requirements for medical equipment, such as a video monitor, video recorder, endoscopic camera control unit or other documentation device), this equipment must be placed outside the patient environment (1.5m from the bed, for example). The equipment must fulfill the relevant EN standard or other applicable national or international standard.

One of the following conditions must be fulfilled:

•

The system and other equipment are plugged into an external common isolation transformer to control the leakage current during a ground connection fault.

•

The system is grounded with an additional safety ground connection (see “Additional Protective Ground and Potential Equalization” on page 33).

If in doubt, contact your BK service representative.

NME-w1

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Battery Support System

If you use a battery to supply power to the system, read the battery support chapter of this user guide.

Also observe the following warning for the battery:

WAR NI NG

To ensure proper ventilation and avoid overheating, keep both ends of the battery clear.

Battery

disposal

When you dispose of the batteries, you must follow national rules. Within the EU, you must send them to appropriate facilities for recovery and recycling.

Computer Security

When the ultrasound system is connected to a hospital network, BK Medical does not take any responsibility for computer viruses from the network that may infect the system.

Caution

Check

external

media

You must perform a virus check on any external storage medium (USB device or DVD) to make sure that it is virus-free before you connect it to the system.

Caution

BS-w6

CS-c1

CS-c2

See

Printer

Touch Screen

Touch scree n

must be

clean

We recommend that you perform regular backups to protect patient data.

Exporting Data

Caution

The quality of a printed ultrasound image may vary, depending on the printer.

WAR NI NG

To avoid misdiagnosis of an image, make sure the touch screen is clean before use.

Print-c1

TS-w1

in the

bk3500 Advanced User Guide.

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Service and Repair

Authorized

personnel

Transducers

Electrical

shock

WAR NI NG

Service and repair of BK electromedical equipment must be carried out only by the manufacturer or its authorized representatives. BK Medical reserves the right to disclaim all responsibility, including but not limited to responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties. After service or repairs have been carried out, a qualified electrician or hospital technician should verify the safety of all equipment.

WAR NI NG

To avoid personal injury, connecting/disconnecting the barcode reader and/or printer must be carried out only by BK personnel or authorized representatives.

WAR NI NG

The transducer sockets contain terminals with 3.3V. Do not touch the patient while you are touching an uncovered socket.

WAR NI NG

SR-w1

SR-w2

T-w1

T-w2

Type B

transducers

Electrical

burns

When using Type B (non-isolated) transducers, carefully check all electrical equipment within the patient area. Also, consider using additional protective grounding.

WAR NI NG

Do not leave transducers in contact with the patient when using HF electrosurgical equipment.

T-w3

BK transducers fulfill EMC requirements when they are outside as well as inside the patient’s body.

Surface

temperature

on array

WAR NI NG

Do not turn the transducer on and allow it to scan into mid-air without ultrasound gel applied to the surface of the array. Doing so may cause the surface temperature on the array to heat up to 27 °C above room temperature (measured according to EN 60601–2–

Particular requirements for the safety of ultrasonic medical diagnostic and monitoring

37 (

equipment

T-w4

)). To avoid this, freeze the image when the transducer is not used for imaging.

During an Examination

Checking the Date

bk3500 User Guide

Before you start imaging, verify that the date and time displayed on the monitor are correct.

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Page 42

WAR NI NG

Exam-w1

Date

Verifying the Transducer Type

Type

number

displayed

must match

number on

transducer

An incorrect date or time will make documentation of the image incorrect and may also cause some calculated values to be incorrect.

WAR NI NG

Exam-w2b

WAR NI NG

Exam-w3

Verify that the patient name and ID are correct.

WAR NI NG

Exam-w4

Before you start to image, verify that the type number on the transducer matches the number displayed on the monitor. In case of any inconsistency, stop imaging, turn off the system, and contact your BK service representative.

Measurements

Using

Doppler

curves

Nuchal

translucency

Pay careful attention when you position cursors to make measurements on a scanned image or on a Doppler curve.

WAR NI NG

Drawings of Doppler curves, manual and automatic, are meant as tools for positioning cursors so that measurements based on the curves can be calculated automatically. The system has no facilities for checking whether the automatic measurements are reasonable. Curves drawn on very noisy spectra may lead to misplacement of measurement cursors. Make sure that measurement cursors are positioned so that the results are reasonable. If they are not, you must adjust the position of the cursors manually.

M-w2

Nuchal Translucency

Caution

You must be adequately trained before you attempt to make nuchal translucency measurements.

NT-c1

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VFI - Vector Flow Imaging

Artifacts

Arrow

aliasing

Diameter

markers

Doppler gate

large

enough

WAR NI NG

VFI-w1

Before you turn on VFI, check the B-mode image to make sure there are no artifacts visible in the blood vessel. If there are strong artifacts in the B-mode image, the arrows in VFI may be pulled to point in a more axial direction (toward or away from the transducer), especially in low flow situations with correspondingly low PRF. These artifacts will not affect the color mode (CFM) image, so it is important to check in B-mode.

WAR NI NG

VFI-w2

Check to make sure the VFI arrows are not aliasing before you activate the assisted Doppler gate placement. Otherwise, the Doppler gate will not be positioned correctly.

WAR NI NG

VFI-w3

Check to make sure that the diameter markers correspond to the inner vessel wall and that the connecting line between the markers is perpendicular to the direction of the vessel. Otherwise, the real-time volume flow measurement may not be precise.

WAR NI NG

VFI-w4

Check to make sure that the Doppler gate covers the entire vessel. Otherwise, the realtime volume flow measurement may not be precise.

Doppler gate

over only

one vessel

Doppler

spectrum

aliasing

Puncture

Verify

transducer

type number

WAR NI NG

VFI-w5

Check to make sure that the Doppler gate only covers one vessel. Otherwise, the real-time volume flow measurement may not be precise.

WAR NI NG

VFI-w6

Check to make sure that the Doppler spectrum does not alias. Otherwise, the real-time volume flow measurement may not be precise.

WAR NI NG

P-w1

Before you start imaging, verify that the type number or name of the transducer and the type number or description of the needle guide you are using match the number displayed on the monitor. Also make sure that the needle guide is positioned correctly. If the numbers do not match, or if the needle guide position is not correct, the puncture line on the monitor may not correspond to the true puncture path in the tissue. In case of any inconsistency, stop imaging, turn off the system, and contact your BK service representative.

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WAR NI NG

P-w2

Verify

puncture

guide type

number

Watch the needle tip

Verify that the type number of the puncture guide displayed on the monitor corresponds to the puncture guide that you are actually using. If the number is incorrect, the puncture line on the monitor may not correspond to the true puncture path in the tissue.

WAR NI NG

The puncture line on the image is an indication of the expected needle path. To avoid harming the patient, the needle tip echo should be monitored at all times so any deviation from the desired path can be corrected.

NOTE:

high magnification), the needle tip echo can be outside the displayed image area. To see the needle tip in this case, zoom out so the full needle path is visible or pan the image to the side (to keep the high magnification).

Acoustic Output

General

Medical research has yet to prove whether or not ultrasound causes biological effects. Therefore, prudent use considerations require you to follow certain guidelines; see EN60601-2-37

medical diagnostic and monitoring equipment).

P-w4

If the image depth is set very low (to see tissue close to the transducer with

(Particular requirements for the safety of ultrasonic

Exposure

level

Prudent Use

WAR NI NG

To avoid tissue damage, always keep the exposure level (the acoustic output level and the exposure time) as low as possible.

•

AO-w1

Image patients only when clinical reasons make it necessary.

Keep exposure time as short as possible.

Be careful to prepare the patient correctly so that you get the best possible image.

Start imaging at a low acoustic output level (see “Thermal and Mechanical Indices” on page 45) and increase the level only as much as necessary to obtain a satisfactory image.

If you switch from an application requiring high acoustic output levels (see “Functions Affecting Acoustic Output” on page 48), to one that requires lower levels (fetal imaging, for example), be sure to reset the levels before you image. (For example, start in B-mode.)

Take into account all the types of tissue that may be affected. For example, when imaging a breast, it may be appropriate to monitor the TI (Thermal Index)in bone rather than in soft tissue because the ribs will be subjected to ultrasound.

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WAR NI NG

AO-w2

Appropriate

transducer

Monitor Display

To avoid tissue damage, always use the transducer best suited to the examination.

Acoustic output data for transducers used with the system are given in the Technical Data (BZ2100) that accompanies this user guide. The uncertainty level for each parameter is also listed. For definitions of the parameters, refer to the Food and Drug Administration (FDA) Guide as well as EN 60601-2-37

the safety of ultrasonic medical diagnostic and monitoring equipment)

(Particular requirements for

and

AIUM/NEMA standards.

The routes (or tracks) available for clearance by the FDA are well-defined. Track 3 is for diagnostic ultrasound systems that follow the Output Display Standard. Under Track 3, acoustic output will not be evaluated on an application-specific basis, but the maximum derated Spatial Peak–Temporal Average Intensity (I



720mW/cm2, the maximum Mechanical Index (MI) must be 1.9, and the



maximum Thermal Index (TI) must be

6. All BK transducers for use with the

) must be

SPTA

bk3500 Ultrasound System are Track 3.

The Mechanical Index (MI) and Thermal Index (TI) can be viewed in all imaging modes.

Thermal and Mechanical Indices

The MI and TI indices are intended to allow users to implement the ALARA (As Low As Reasonably Achievable) principle using an indicator related to a potential bioeffect.

The MI can be adjusted by using the MI image parameter button and the touch screen dial:

bk3500 User Guide

Figure 3-3. The MI image parameter button.

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r0,3zsp



------------------------

deg

-------------=

Settings

(soft tissue).

, you can select TI tissue type between TIB (bone), TIC (cranial) or TIS

Figure 3-4. The General settings. Here, you can also select between Basic and Advanced lay-

out. See“Monitor and Touch Screen Display” on page 21.

The full details of the indices are given in references EN60601-2-37 and AIUM/NEMA standard, but the formulas are given below.

MI Formula

where the variables are defined in the table below.

Variable Definition

) Peak Rarefactional Pressure (MPa), derated by 0.3dB/cm·MHz, measured at zsp,

r0.3(zsp

the point on the beam axis where pulse intensity integral (PII

measured center frequency (in MHz)

0.3

) is maximum

TI Formula

where the variables are defined in the table below.

Variable Definition

Chapter 3 April 2017

time-averaged acoustic power of the source or other power parameter (W)

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Variable Definition

IIwexp 0,069fz–=

deg

estimated power necessary to raise the temperature of the target tissue one degree Celsius (W/°C)

Blood

perfusion and

Fever

Acoustic Output Measurement

I formula

As a rule of thumb, the Thermal Index (TI) indicates the highest expected temperature increase in degrees Celsius. It is based on an average level of blood perfusion. The displayed TI may underestimate the temperature rise in poorly perfused tissues; you must take this into account when deciding on the maximum TI you will allow. Conversely, in areas with a rich perfusion of blood the temperature increase will be less than the displayed TI indicates.

A temperature increase of one degree Celsius increase in a patient with fever may cause complications in certain circumstances; it may be safer to delay the investigation.

All values are measured in water according to the EN 60601-2-37 and AIUM/NEMA display standards. For some of the acoustic parameters, an estimated in situ derated value is given. This is derived assuming a tissue attenuation of 0.3 dB/(cm·MHz) when the estimated in situ derated value (I) is described by the following equation:

where the variables are defined in the table below.

Variable Definition

Fetal imaging

Intensity in water at the position where I is maximum

transducer frequency (in MHz)

distance (in cm) from the transducer face to the position where I is maximum

It should be stressed that the in situ values given are only applicable when there is attenuating tissue between the transducer face and the focal point.

Possibility of Adverse Effects

Although it is believed that diagnostic ultrasound causes no significant biological effects in mammalian tissue, the user should be aware of the hypothetical possibilities of adverse effects.

Current scientific and clinical concern over possible adverse effects is particularly focused on fetal ultrasound imaging. It is due to the increased sensitivity of mammalian cells and organs at this phase of their development and the fact that such a risk could have profound implications on public health. If you use high acoustic output levels for some reason (see “Functions Affecting Acoustic Output”, below), be sure to return to B-mode alone and turn down the power level before you do any fetal imaging.

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Functions Affecting Acoustic Output

The system has a control function that ensures that neither the I

nor MI nor TI

SPTA

value exceeds the maximum allowable value. When necessary, the system will reduce the output voltage and/or PRF (pulse repetition frequency) to the transducer to comply with requirements.

Some of the system functions can affect the acoustic output, as listed here. (Instructions for using these functions are given in the relevant sections of this user guide.)

•

Sizing functions such as ROI (Region Of Interest) – in general, smaller size results in higher acoustic intensity because the Pulse Repetition Frequency (PRF) is higher or the ultrasound beam is more strongly focused.

•

Focus – in general, strongly focusing the beam makes the acoustic intensity higher.

•

Frame rate – higher frame rate results in higher acoustic intensity.

•

Range – increasing the Doppler range increases the acoustic intensity by increasing the PRF.

•

CFM Resolution – higher resolution increases the acoustic output.

•

Color box size – narrowing the color box generally increases the acoustic output within it.

The user can set a Thermal Index limit. This will provide an upper limit for acoustic output.

Default Acoustic Output

After the system has been turned off, the transducers will start in the default setup when the system is turned on again. The default setup may be factory-defined or defined by the user.

The factory-defined default setup values of acoustic output for each transducer are listed in the Technical Data (BZ2100).

These setups have been optimized to give the best compromise between low acoustic output and enough power to obtain the image features as quickly as possible. The factory default setup for all transducers is B-Mode to ensure the lowest acoustic output when you start imaging.

When you enter a new patient ID, by default the transducer setup will be reset to the factory setup.

Fetal imaging

When you use transducers intended for fetal imaging, it is important to make sure that the default settings are appropriate and to reset to the default setting before imaging a new patient.

Clinical Measurements: Ranges and Accuracies

This section states the accuracies for measurements made using the BK range of ultrasound systems. A table containing accuracies for specific transducers can be found in the Technical Data (BZ2100) that accompanies this user guide.

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The measurement accuracies are based on the assumption of “ideal” tissue, that is, a tissue characterized by a sound velocity of 1540 m/s. When making clinical measurements with ultrasound, errors may arise which are not taken into account in this section. For example,

•

The sound velocity may vary from approximately 1450 m/s in fatty tissue to 1585 m/s in muscle. This can, in simple cases, give rise to errors of up to 6% for linear measurements. This inaccuracy may be further increased by refraction occurring at tissue boundaries.

•

The user can introduce errors when using approximate formulas, when positioning the system’s calipers with respect to the ultrasound image and when outlining structures in the image.

•

The ellipsoid volume approximation, described in this user guide, is only applicable when the cross section of the structure being studied approximates an ellipse (the circle being a special ellipse), and when the structure is roughly symmetrical about the selected axis of rotation.

NOTE:

The choice of the axis of rotation is important for the calculation of the

volume. A vertical axis gives a different volume than a horizontal axis.

The minimum requirement is that the cross section outlined by the user should be convex. If the user draws a non-convex outline, an inaccuracy is introduced which is not taken into account in this section. In this case, the system calculates and displays the convex hull of the figure, that is, the smallest convex figure containing the nonconvex figure outlined by the user (see Fig 3-5). The system bases the calculation of the ellipsoid volume on the convex hull.

bk3500 User Guide

Figure 3-5. The dotted line indicates the convex hull of the non-convex figure.

Measuring volume using a stepping method produces an approximation caused by the finite number of steps in the measurement. The user must always try to assess how large an inaccuracy is introduced by the selected step size, that is, the distance between organ cross sections.

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Geometric Measurements

cos  1,8+cos–

cos

------------------------------------------------









100 0,5+

2D Measurements

The geometric measurements performed by BK Ultrasound systems are distance, perimeter, area and ellipsoid volume. The accuracy of these measurements is influenced by the following factors:

•

Transducer geometry

•

Rounding of results

•

Resolution of digital image memory

Time Measurements

In M-mode and spectral Doppler mode, data is displayed along a time axis. It is possible to measure time differences. The accuracy for a time difference measurement is:

•

Rounded to the nearest: 0.01s

•

Accuracy: 0.01 x where t is the full time scale of the image field.

Doppler Measurements

In measuring blood flow velocity it is assumed that the measured power spectral distribution of the Doppler signal equals the blood cell velocity distribution.

The measurement accuracy of blood flow velocity is heavily dependent on the angle



between the ultrasound beam and the velocity vector of the blood cells. The velocity accuracies given in the Technical Data (BZ2100) are valid for  = 55. To find the percentage accuracy for other angles, multiply the stated accuracy by

If the blood velocity exceeds the selected velocity range, aliasing occurs, corresponding to an overload condition of the measurement system.

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Index

accuracy

2D geometric measurements clinical measurements explained Doppler measurements time difference measurements

acoustic output

default

factors affecting measurement

ALARA principle

48 47 6, 45

battery

battery life charging new battery disposal recycle symbol recycling status warnings waste symbol

28, 40

caution or warning, symbol 27 Cautions

about

displayed on the system center frequency charging battery connectors for other equipment

accessing

location

picture consult instructions for use (symbol) contraindications

DICOM

conformance statement

connection if network is not isolated

network isolator

standard disposing of the system distorted image Doppler measurements

accuracies

warnings Doppler mode

fetal imaging

earth. See ground. electrical noise electrical safety

electrical shock electromagnetic compatibility. See EMC. electromagnetic interference EMC

attaching cables data in BZ2100 noise, checking for

precautions equipment failure ESD

precautions

symbol

training essential performance explosion hazards exposure level extension cord, do not use

28, 31

fetal imaging, acoustic output settings for 48

ground (earth), additional protective

adding

symbol

HF electrosurgical equipment, warning 41

image distortion 29, 32 indications for use installation intended use isolation from line voltage

leakage current 31, 39 liquids, do not spill on system

magnetic shielding 32 manufacturer (symbol) measurements, Doppler warnings MI (Mechanical Index)

and ALARA

formula modes of operation

network

guidelines

isolator

printing, protocols for network security

Page 52

guidelines 34 responsibility for

noise

electrical EMC

non-medical equipment, connecting to system

security, network. See network security. service and repair standby (symbol) system

isolation from line voltage

malfunction

overbalance and tipping

warning warning symbol

Peak Rarefactional Pressure 46 potential equalization

symbol

terminal

power button

symbol on

power cord

keep clean and dry

original power plug power strip, do not use power supply cord

accidental disconnection

use original printing

quality of printed image prudent use puncture

warning to verify puncture guide number pushing prohibited, symbol

radio frequency interference. See RF interference. RF interference

safety

electrical

transducer sealing (symbol)

31, 33

Technical Data (BZ2100) 5, 45, 48 Thermal Index limit

setting

Thermal Index limit, setting TI (Thermal Index)

and ALARA

blood perfusion and time measurements tipping and overbalance

warning

warning symbol training before using equipment transducer sockets, warning about covering transducer, electrical safety Type B (non-isolated) transducers, warning about Type B (symbol) Type BF (symbol) Type BF, defibrillator-proof (symbol)

UL (symbol) 28

VFI (Vector Flow Imaging), warnings about 43 virus

checking external storage media

from network

Warnings

about

displayed on the system waste disposal symbol WEEE waste (symbol)

Page 53

Appendix A

Warnings and Cautions Displayed on the System

This appendix contains a list of warnings and cautions that may appear on the system if you perform an undesirable action or e.g. type in a wrong setting value. Contact a BK service technician if you encounter a persistent problem that can not be solved by the suggested action(s) below.

This list covers all warnings and cautions on systems bk3000, bk3500 and bk5000, so it may include warnings that are not relevant to your specific system.

The list also covers potential system and transducer malfunctions. Always contact a service technician if the system or the transducer malfunctions, see Warning GS-w2 on page 29.

Warning text Action (if necessary)

Current date and time (%s) are before the scanner was last run (%s). Check your system clock.

Failed to parse the prom received from the probe.

Failed to read general settings from database.

Failed to save bodymark catalog.

Note that changing the time zone requires restarting the scanner.

Probe prom read failed.

Sensor data from probe is not received. Scanning is stopped.

The probe could not be connected.

The Probe FW is obsolete.

The read probe prom has a wrong CRC.

The read probe prom was empty.

The system time is invalid and has been changed to %s %s. The system time can be set in the setup menu.

Try again.

Restart the system.

bk3500 User Guide

The system time %s is invalid and setting it to %s failed. The system time can be set in the setup menu.

Parking of the transducer %s failed. Try again.

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Caution text Action (if necessary)

%d text(s) has been truncated to %d characters.

"%s" is not a unique name. Type in a unique name.

"%s" is not a valid number.

A 3D volume was not acquired because no mover is connected. Please connect a mover.

A 3D volume was not acquired because the connected mover does not match the selected mover. The connected mover is %s and the selected mover is %s. \n

A curve cannot have itself as parent curve.

A formula in the measurement contains an invalid device attribute "%s.%s".

A formula in the measurement contains an invalid result name "%s".

A formula in the measurement contains an undefined measurement tool "%s".

A measurement cannot depend on itself.

Adjusting the guide's height.

Adjusting the guide's width.

Type in a valid number.

Make sure that connected mover matches the selected mover.

Use valid device attribute.

Use valid result name.

Use a defined measurement tool.

All available pro packs for %s has been hidden

An error occurred while the patient archiving database was being copied.

Another scanner is using this network drive for archiving. This can cause problems. For independent backups, each scanner must use a separate subdirectory.

Changes not in effect until transducer(s) has been reconnected.

Click Yes to clear the patient archive. All patients in the patient archive will be lost. Click No to cancel.

Could not create temporary subdirectory for outgoing mail data.

Curve name, x-axis and y-axis are required. Do not leave the fields empty.

Default LCD backlight has not been adjusted.

Try again.

Fill out required fields.

Adjust default LCD backlight.

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Caution text Action (if necessary)

Empty volume name is not allowed. Type in volume name.

Engine configuration validation failed. One or more Engine item versions are not valid.

Error opening database %s. %s

Error. The file did not contain a user-defined

Include user-defined puncture guide.

puncture guide.

Failed to acquire 3D volume. %s

Failed to calculate expression "%s": %s. Try again.

Failed to calculate measurement. Syntax error

Check formula.

in formula.

Failed to clear patient archive. Please contact a service technician.

Failed to clear the patient dialog cache.\n%s

Failed to configure the server. Try again.

Failed to connect to SMTP server "%s". (%s)

Failed to copy file: "%s" To: "%s" %s

Failed to copy.

Failed to create Diagnostic Setup ID: %s.

Failed to create new Pro Package %s.

Try again.

Failed to delete catalog in database.

Failed to delete curve in database.

Failed to delete measurement in database.

Failed to delete the server.

Failed to export table "%s". %s

Try again.

Failed to import license keys from ""%s"". It is not a valid license file.

Failed to import table "%s".\n%s Try again.

Failed to open file "%s". \n%s

Try again.

Failed to process 3D volume.

Failed to read catalog from database. Try again.

Failed to read deleted Presets.

Failed to read key action definitions from

Try again.

database.

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Caution text Action (if necessary)

Failed to read key assignments from

Try again.

database.

Failed to read key definitions from database.

Failed to read measurement list from

Try again.

database.

Failed to restore factory default catalogs in

Try again.

database.

Failed to restore factory default general

Try again.

settings.

Failed to restore factory default measurement

Try again.

groups.

Failed to save 3D volume.

Failed to save configuration "%s" in database. Try again.

Failed to save measurement in database.

Failed to send SMTP message (%s).

Failed to store catalog in database.

Try again.

Failed to store clip in file.

Failed to store curve in database.

Failed to store general settings in the

Try again.

database.

Failed to store key assignments in database.

Failed to store the curve "%s". Two curves cannot have the same Reference Name, and

Try again.

Use a different reference name to store the

curve. the imported curve's Reference Name "%s" is already used for the curve "%s".

Failed to update Pro Package: %s.

Try again.

Failed to update the ICM file.

Failed to validate database %s. Reverting to the latest backup from %s.

Hard disk space on %s is critically low. Please clear some space on the hard disk or contact a service technician before proceeding.

Hard disk space on %s is getting low. Free up hard disk space.

Import of license keys from "%s" completed. The following license keys could not be imported: %s

April 2017

Try again.

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Caution text Action (if necessary)

Incorrect settings for HistoScanning acquisition. Data will be rejected by HistoScanning. Please adjust the scanner settings.

Invalid %s. Empty names are not allowed. Names must be shorter than %d characters. Names must not contain any of the following characters: %s

License already in use.

License key ""%s"" is invalid.

Licenses missing: No available pro packs for %s has valid licenses

Name and description are required. Do not leave the fields empty.

Name and formula are required. Do not leave the fields empty.

No available pro packages in database for transducer %s

No catalogs available. Assign catalogs in setup window.

Fill out the required fields according to the on

screen instructions.

Fill in name and description.

Fill in name and formula.

No default propackage available for the %s transducer choose a default propackage

No Preset name was specified.\nNothing will be saved.

One or more batteries are wearing out. Consider replacing the following batteries: %s (where 1 is the top battery).

Only %d fields can be selected for the Patient window. Deselect some of the fields.

Please disconnect all transducers, restart the scanner, and start the import again.

Please enter a number

Please enter an SMTP Server Address. It must be entered as a name or an IP address.

Please insert the archive disc labeled "%s" and try again.

Pro Package %s could not be deleted because it would leave some transducers without a Pro Package.

Specify a preset name.

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Caution text Action (if necessary)

Staging area is not ready. Try again later.

System restarts now.

Temperature in probe is elevated. Adjust patient temperature and/or reduce probe heating policy.

Temperature in probe is too high. Scanning is stopped and disabled until the temperature has come down.

The '%s' curve could not be found in the database.

The 3D volume is too big for the scanner memory. Please reduce the capture area or extent and try again.

The AE title is invalid.

The alias "%s" for the measurement "%s" is invalid. 1: Aliases cannot be empty. 2: Aliases must not contain any of the following characters: %s . 3: Aliases in each measurement must be unique.

The archived document (%s) was not found on the network drive.

The connected transducer cannot be used because there is a problem with its PROM. Please remove the transducer and contact a service technician.

The curve definition is not compatible with this software version.

Try again.

Fill out the required fields according to the on

screen instructions.

Upgrade software.

The curve definition must contain x and y values.

The Display Controller Board has no ICM file.

The document cannot be displayed because document data is corrupted

The document cannot be displayed.

The document cannot be displayed. Currently there is no viewer available.

The entered license key has expired: %s.

The entered license key is invalid. Type in valid license key.

The field must not be empty.

April 2017

Contact BK service technician.

Try again.

Install a viewer.

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Caution text Action (if necessary)

The file \\"%s\\" is too large to open. Max size

If possible, reduce the file size. is %d bytes.

The file does not contain a valid curve.

The file does not contain a valid

Use valid curve.

Use valid measurement. measurement.

The file size is too large to display on scanner

The following licenses have expired:\n%s. Install new license.

The formula exceeds the maximum length of

Reduce length. %d characters.

The guide's height is invalid.

The guide's horizontal holes/cm is invalid.

The guide's horizontal offset is invalid.

The guide's name is invalid.

The guide's vertical holes/cm is invalid.

The guide's vertical offset is invalid.

Use valid height setting.

Use valid horizontal holes/cm setting

Use valid horizontal offset setting.

Use valid guide name.

Use valid vertical holes/cm setting.

Use valid vertical offset setting.

The guide's width is invalid.

The host name is invalid.

The license could not be removed.

The measurement cannot be edited. The template contains errors.

The measurement contains an invalid procedure name "%s".

The measurement could not be found in the database.

The measurement definition is not compatible with this software version.

The measurement requires an unsupported measurement device type "%s".

The measurement type is invalid.

The media was not burned: %s

The name ""%s"" is already used.

Use valid guide width setting.

Contact service technician.

Use valid procedure name.

Try again.

Upgrade software.

Install supported measurement device type.

Use valid measurement type.

bk3500 User Guide

The name is invalid.

The port number is invalid

The procedure "%s" takes %d parameters.

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Caution text Action (if necessary)

The report cannot be saved before a patient ID is entered.

The report file cannot be generated: "%s" Try again.

The same CD cannot contain both archived and non-archived documents.

The scanner cannot communicate with the battery system. If you want to run the scanner using battery power, we recommend that you contact a service technician.

The scanner is ready to enter service mode. The next time it starts, the PC will start in Windows mode. Please press the standby switch to turn off the scanner.

The scanner is unable to communicate with other equipment through a COM port. %s

Use appropriate communication port(s). See

System User Guides

or contact service

technician.

The scanner's hardware does not support %s.

The selected curve is invalid. Use valid curve.

The system has not finished sending the last mail. Please try again later.

The system must be restarted for changes to take effect.

The system must be restarted to fully implement the language change.

The tool attribute %s is invalid. Use valid tool attribute.

The transducer button %d is stuck on the transducer connected to connector %s.

The two passwords you have typed are not identical.

The U SB De vi ce ca nn ot be sa fe ly re moved. Try again.

The user already exists. Enter a different username.

The value "%s" (%s) contains the invalid character(s) "%s".

The value "%s" (%s) is outside the legal range (%.2f - %.2f).

The volume name is already used in the patient archiving system. Please enter another name.

April 2017

Type in valid characters.

Keep value (s) within legal range.

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Caution text Action (if necessary)

The volume name is not valid. It contains only illegal character(s). Please enter the new volume name.

The volume name is too long. The name must be no longer than %d characters.

The width and height must be numbers between %d and %d.

There are no files to be burned to a CD.

There is no mail receiver (SMTP To-address) configured.\nTechnical service must configure this service before it can be used.

There is no USB Device connected to the scanner.

There was a problem saving the Diagnostic

Try again. Setup %s.

This scanner does not support CW Doppler.

Try again or contact BK service technician. (This may be because of the power supply version.)

Transducer "%s" cannot be used with this scanner.

Transducer "%s" cannot be used with this scanner. A hardware upgrade may solve the

Connect a compatible transducer. See

Product Data Sheet

Connect a compatible transducer. See

Product Data Sheet

problem.

Transducer ""%s"" is disabled for this scanner.

Unable to capture image. Try again.

Unable to connect remote control.

Unable to connect to the network drive. Check server (UNC path), username and password.

Unable to connect to the network drive. %s

for more details.

bk3500 User Guide

Unable to create backup of database because of %s. If the error persists, contact a service technician.

Unable to launch application ("%s") Try again.

You must end the on-going exam before you can clear the patient archive.

You must restart the scanner after you enable or disable the OEM interface.

Your old password is not valid. Create new password.

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Page 64

bk ultrasound bk3500 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

Essential Performance

(16-01410-EN-04) Introduction

Intended Use

Modes of Operation

Indications for Use

Contraindications

Transducer Specific Considerations and Contraindications for T7P2m

Getting Started

The bk3500 System

Before You Start

Turning System On and Off

Connecting Transducers

Barcode Reader

Control Panel

Quick Access

Quick Exam Start-Up

Starting an Exam Using the Touch Screen Buttons

Monitor and Touch Screen Display

Battery

Charging the Battery

Battery Status

Information Available on the Monitor

Battery Life

Safety Information

Safety Symbols and Information on the Equipment

(16-01410-EN-04) Safety Information

General Safety Precautions

Mechanical Safety

Explosion Hazards

Electrical Safety

ESD Training

Interference

Electrical Noise

Electromagnetic Interference

RF (Radio Frequency) Interference

Installation

Connecting Other Equipment

Network Connection

Network Security

Network Printing

Connectors

EMC Requirements

Isolation of DICOM Network

Wireless Networks

Medical Equipment

Non-Medical Equipment

Battery Support System

Computer Security

Printer

Touch Screen

Service and Repair

Transducers

During an Examination

Checking the Date

Verifying the Transducer Type

Measurements

VFI - Vector Flow Imaging

Puncture

Acoustic Output

General

Monitor Display

Thermal and Mechanical Indices

Acoustic Output Measurement

Functions Affecting Acoustic Output

Default Acoustic Output

Clinical Measurements: Ranges and Accuracies

Geometric Measurements

Time Measurements

Doppler Measurements

Index

Warnings and Cautions Displayed on the System