TELEMED SmartUs EXT-1M Manual de usuario

TELEMED SmartUs User Guide, REV 3.10 2023.02.15

SmartUs EXT-1M

SmartUs EXT-3M

Ultrasound Diagnostic System

USER GUIDE

TELEMED SmartUs User Guide, REV 3.10 2023.02.15

Manufactured by

TELEMED, UAB

Savanoriu ave. 178A

Vilnius, LT-03154

Lithuania

Telephones: (+370-5) 2106272, (+370-5) 2106273

Fax: (+370-5) 2306733

Internet: https://www.pcultrasound.com

E-Mail: [email protected]

NOTE: Non-TELEMED product names may be trademarks or registered trademarks

of their respective owners.

TELEMED SmartUs User Guide, REV 3.10 2023.02.15 

 
INTRODUCTION 5 
1. About the system / Intended use 5 
2. Delivery set 7 
3. About the system software 7 
4. Technical Specification 7 
SAFETY 12 
1. Electrical safety 12
2. Equipment protection 13
3. Biological safety 13
4. Ultrasound exposure and ALARA principle 14
5. Cybersecurity 15
5.1 Information Security ...............................................................................15
5.2 Network Security....................................................................................15 
5.3 Confidentiality.........................................................................................16 
5.4 Integrity ..................................................................................................16 
5.5 Accountability.........................................................................................16
6. Accuracy Measures 16
LABELING 19 
SYSTEM OVERVIEW 21 
1. Principle of operation 21
2. Components & Modifications 21
2.1. Basic unit / Beamformer........................................................................21
2.2. Transducer Unit.....................................................................................22
3. Peripherals/Compatibility 23
INSTALLATION WARNINGS 24 
1. Getting started with 25
2. Ultrasound Scanner Monitor utility 26
3. Windows configuring 27
3.1 E-mail.....................................................................................................27 
3.2 Windows account...................................................................................28
3.3 Windows security ...................................................................................28
3.4 Antivirus .................................................................................................28 
3.5 Firewall...................................................................................................28
3.6 Windows updates...................................................................................29
3.7 Network communication.........................................................................29
3.8 Digital Signature.....................................................................................29
3.9 Windows AppsLocker.............................................................................29
3.10 Encrypted file system...........................................................................29
TROUBLESHOOTING 30 
1. FAQ 30
2. Contact with technical support service 30
WARRANTY AND SERVICE INFORMATION 31 
1. Warranty 31 

TELEMED SmartUs User Guide, REV 3.10 2023.02.15 

2. Warranty Shipments and Returns 31
3. Service Contract 31
MAINTENANCE 32 
1. General cleaning 32
2. Inspecting the System 32
3. Transducer maintenance and disinfection 32
3.1 Chemicals that Damage Transducers:...................................................33 
3.2 Recommended Procedures for Transducer Processing.........................33
3.3 General Cleansing for Transducers Used in Non-Invasive Procedures .33 
3.4 Cleansing and Disinfection of Transducers Used in Endocavity 
Procedures......................................................................................................34
4. System accuracy / performance verification 34
TRANSPORTATION, STORAGE AND UTILIZATION 35 
1. Transportation and storage 35
2. Utilization 35
........... DECLARATION OF CONFORMITY 36 
........... APPENDICES 37 
1. Guidelines for the safe use of diagnostic ultrasound 37
2. Acoustic Output 46
3. Vigilance system 95
4. Returned product form 97
 
 
 
 
 

TELEMED SmartUs User Guide, REV 3.10 2023.02.15

1. INTRODUCTION

CAUTION:

United States federal law restricts this device to be used by, or on the

order of, a licensed physician.

Dear customer,

Our SmartUs EXT-1M/3M system is intended for multipurpose ultrasound

examinations, based on electronic linear and convex scanning.

It is an ideal budget solution for hospitals, specialized diagnostic centers, and public

and private clinics.

Our new class of PC-based compact ultrasound scanners now features:

•Beamformer with multi-frequency transducers support;

•3 transducers ports - SmartUs EXT-3M

•Scan-converter free architecture, up to 192 element transducers connection;

•Industry standard ZIF-260 (Zero Insertion Force) transducer connector;

•Digitally controlled acoustic power;

•Lightweight, true mobility, flexible architecture.

Here in the User Guide, you can find information about SmartUs EXT-1M/3M and

safety and maintenance information.

Echo Wave II Software Operation Manual contains a description of the controls.

1.1. About the system / Intended use

SmartUs EXT-1M/3M system is intended to be used for applications in fetal,

abdominal, pediatric, small organ (breast, thyroid, testicles), adult cephalic,

musculoskeletal (conventional), musculoskeletal (superficial) cardiac adult, cardiac

pediatric, peripheral vessel (B and M-mode, combined modes imaging, including

imaging for needle guidance), trans-rectal and trans-vaginal examinations. It is

possible to provide diagnostic information outside of an imaging lab, including at the

bedside systems, for navigated medical applications, and in operating rooms/critical

care units.

SmartUs EXT-1M/3M ultrasound systems provide many different scanning

technologies: B, B+B, 4B, B+M, M, CFM, PDI, DPDI, PWD, B+PWD (Duplex),

B+CFM/PDI/DPDI+PWD (Triplex), HPRF, Tissue Harmonic Imaging (THI), automatic

image optimization. Echo images can be either full-size or zoomed.

Unlike ordinary ultrasound devices, this scanner is based on modern digital

technologies. PC application enables many powerful innovative features such as:

•user friendly, easy-to-use intuitive graphic user interface;

•echo image storage on a hard disk or other devices;

•storage of a sequence of full-size echo images (cineloop) with the opportunity

to save it in video file format;

•image and cineloop file formats enable using other applications for viewing

stored data;

•using a variety of peripheral devices;

•direct echo image and video e-mail sending with one click.

TELEMED SmartUs User Guide, REV 3.10 2023.02.15

A variety of available ultrasound transducers provides many different applications for

examinations in therapy, obstetrics, gynecology, urology, pediatrics, oncology, and

other areas.

A common view of SmartUs EXT-1M is shown below.

A common view of SmartUs EXT-3M is shown below.

TELEMED SmartUs User Guide, REV 3.10 2023.02.15

1.2. Delivery set

Beamformer

●

Operation manual

●

User guide

●

Software and manuals

(eIFU)

●

Standard USB cable

●

Power supply (medical)

●

Ultrasound transducer

Types and quantities

defined by customer

1.3. About the system software

Your diagnostic system contains Echo Wave II software to control its operation.

TELEMED provides the latest Echo Wave II software version and drivers package

together with your system. In the software, the unique technologies making the

intellectual property of TELEMED company are used. The latest software versions

can be downloaded directly on the Internet from https://www.pcultrasound.com.

1.4. Technical Specification

Table 1 contains technical specifications of SmartUs EXT-1M/3M:

Table 1

IMAGING MODES

•B

•B+B

•4B

•B+M

•M Color Doppler (CFM)

•Power Doppler (PDI)

•Directional Power Doppler (DPDI)

Pulse Wave Doppler (PWD)

•Continuous Wave Doppler (CWD)

for Phased Array only

•B+PWD (Duplex)

•B+CFM/PDI/DPDI+PWD (Triplex)

•HPRF

•Tissue Harmonic Imaging (THI)

ULTRASOUND IMAGING

TELEMED SmartUs User Guide, REV 3.10 2023.02.15

•ultrasound image size:

automatically adjustable to screen

resolution

•grayscale: 256

•color scale: 256

•full motion and full-size real-time

ultrasound imaging, up to 120 fps

(depends on selected scan depth,

scan angle, focus mode, High Line

Density setting, and computer

speed)

•cineloop recording/play: several

thousand frames (depends on

computer memory size and scan

mode)

•zoom mode: from 60% to 600% in

all modes (Scan, Freeze, B, B+B,

4B, Doppler modes, M-zoom,

cineloop, etc)

•viewing area variable for frame

rate maximizing: 6 steps

•"FREEZE" mode

SCANNING METHOD

•Electronic linear

•Electronic convex

•Electronic micro-convex

COLOR DOPPLER

•PRF variable: 0.5-9 kHz

•wall filter settings: 3 steps

(5%, %10%, 15% PRF)

•gain control: 50 dB

•angle steering for linear transducers:

±10°

•real-time spatial filter: 3 values

•CFM palette: 10 maps

•B/Color priority control

•color threshold control

•CFM baseline control

•Doppler frequency selection:

2 frequencies / each transducer

•color frame averaging: 8 values

PULSED WAVE DOPPLER

•PRF variable:

0.3-10 kHz

•wall filter settings:

16 steps (2.5%-20% PRF)

•gain control: 50 dB

•angle steering for linear

transducers: ±10°

•single click auto adjustment:

baseline, measurements, invert

•stereo sound: volume control

•PWD palette: 12 maps

•Doppler frequency selection:

2 frequencies / each transducer

DEPTH SELECTION

•2 –30 cm (depth range depends on transducer type)

TRANSDUCERS

•from 2 MHz to 15 MHz

•Multi-frequency

•Automatic transducer recognition

FOCUSING

Digital transmit

focusing

•Yes

Multi focus mode

•Transmit/receive focusing, max 4 points

TELEMED SmartUs User Guide, REV 3.10 2023.02.15

•Programmable focus area presets

Dynamic focus mode

•Transmit variable focus, 8 points

•Dynamic receive focus, 8 zones

SIGNAL PROCESSING

•High Line Density scan mode for better resolution

•TGC Control, 5 sliders 40 dB

•dynamic range: 120 dB, 8 values

•overall gain control

•M - mode sweep speed control

•acoustic power control

•variable frame averaging

•brightness, contrast

•automatic image optimization - automatic adjustment:

oGain, Dynamic Range, and TGC adjustment in B mode

oPW PRF, PW baseline, and PW invert adjustment in PW mode

oCFM Gain adjustment in CFM mode

•advanced gamma control: 8 fixed curves, 8 user-defined (custom)

•scan direction, rotation, up-down controls

•negative/positive control

•bilinear interpolation

•echo enhancement control

•noise rejection function

•speckle reduction function (optional)

FUNCTIONS

General

Measurements and

Calculations

•Mouse/trackball/keyboard operation of multiple

calipers

•B-mode: Distance / Length / Area / Circumference /

Volume / Angle / Stenosis % / A/B Ratio

•M-mode: Distance / Time / Velocity / Heart Rate /

Stenosis % / A/B Ratio

Human Measurements

and Calculations

Packages

•General calculations package

•Obstetrics / Gynecology (OB / GYN) calculations

package

•Gynecology (GYN)

•Abdominal exam measurements and calculations

•Urology

•Endocrinology

•Vascular exam measurements and calculations

•Cardiology

User Interface

•The set of predefined skin schemes for the user

interface

•User-friendly pop-up menus and dialogue boxes

•Unlimited programmable presets for clinically specific

imaging

•Image comment / save/recall browsing

TELEMED SmartUs User Guide, REV 3.10 2023.02.15

•Anatomical Icons with transducer position indicator

Image and video save

/ load

•JPG BMP PNG TIF AVI DCM DCM(JPG) TVD TPD

Cineloop

•Recording up to 2048 frames to memory

•Play / Pause / Stop / Frame selection

•Saving ultrasound video file to disk

•Loading ultrasound video file from disk

Printing

•System printer

Internet

•Direct e-mail sending function

with image or video attachment

TV output

•Standard TV output using computer's display adapter

(option)

ULTRASOUND SOFTWARE

Drivers

•TELEMED Drivers Package

Software

•Echo Wave II software (B/W + Doppler modes)

DIMENSIONS AND WEIGHT

SmartUs EXT-1M

SmartUs EXT-3M

Dimensions W x D x

H, mm

158 x 219 x 54

160 x 215 x 90

Weight,

1.6

2.0

POWER SmartUs 128 EXT-1M

12 VDC

2.5 A

•External AC medical grade power supply (100-240

VAC, 50-60 Hz)

SAFETY

Electromechanical

safety

•IEC 60601-1 Medical electrical equipment part 1:

General requirements for safety.

Class I Type BF applied part

EMC/EMI standards

•European Norm EN 55011:1998 (CISPR 11:1999)

Industrial, scientific and medical (ISM) radio-

frequency equipment. Radio disturbance

characteristics. Limits and methods of measurement.

Ultrasound exposure

•CEI/IEC 61157:1992, International Electro technical

Commission, Requirements for The Declaration of

the Acoustic Output of Medical Diagnostic Ultrasonic

Equipment.

•AIUM/NEMA: Standard for real-time display of

thermal and mechanical acoustic output indices on

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