TELEMED UAB ClarUs, ClarUs EXT-1M User Manual

TELEMED ClarUs User Guide, REV 4.0 2013.12.04

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ClarUs

ClarUs EXT-1M

Ultrasound Diagnostic System

USER GUIDE

TELEMED ClarUs User Guide, REV 4.0 2013.12.04

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Manufactured by
TELEMED UAB
Dariaus ir Gireno str. 42
Vilnius LT-02189
Lithuania
Telephones: ([phone] ([phone]
Fax: [phone]
Internet: http://www.telemed.lt
E-Mail: [e-mail]

NOTE: Non-TELEMED product names may be trademarks or registered trademarks
of their respective owners.

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1. INTRODUCTION 5

1.1. About the system / Intended use 5

1.2. Delivery set 7

1.3. About the system software 7

1.4. Technical Specification 7

2. SAFETY 12

2.1. Electrical safety 12

2.2. Equipment protection 13

2.3. Biological safety 13

2.4. Ultrasound exposure and ALARA principle 14

2.5. Cyber security 15

2.6. Accuracy Measures 15

3. LABELING 17

4. SYSTEM OVERVIEW 18

4.1. Principle of operation 18

4.2. Components & Modifications 18

4.2.1. Basic unit/Beamformer 18

4.2.2. Probe Unit 18

4.2.3 ClarUs 19

4.2.4 ClarUs EXT-1M 19

4.3. Connection and Indication ClarUs 20

4.4. Peripherals/Compatibility 22

5. INSTALLATION WARNINGS 23

5.1. Getting started with ClarUs 24

5.2. Status Indicator 24

5.3. Ultrasound Scanner Monitor utillity 24

5.4. Windows configuring 26

6. TROUBLESHOOTING 27

6.1. FAQ 27

6.2. Fuses locations (ClarUs) 27

6.3. Contact with technical support service 28

7. WARRANTY AND SERVICE INFORMATION 29

7.1. Warranty 29

7.2. Warranty Shipments and Returns 29

7.3. Service Contract 29

8. MAINTENANCE 30

8.1. General cleaning 30

8.2. Inspecting the System 30

8.3. Probe maintenance and disinfection 30

8.3.1 Chemicals that Damage Transducers: 31

8.3.2 Recommended Procedures for Probe Processing 31

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8.3.3 General Cleansing for Transducers Used in Non-Invasive Procedures ....... 31

8.3.4 Cleansing and Disinfection of Transducers Used in Endocavity
Procedures 32

8.4. System accuracy / performance verification 32

9. TRANSPORTATION, STORAGE AND UTILIZATION 33

9.1. Transportation and storage 33

9.2. Utilization 33

10. ............ DECLARATION OF CONFORMITY 34

APPENDIX

1.Guidelines for the safe use of diagnostic ultrasound

2.Vigilance system

3. Returned product form

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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 ClarUs 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 probes support;
 Scan-converter free architecture;
 Industry standard tZIF-260 (Zero Insertion Force) probe connector;
 Digitally controlled acoustic power;
 Light weight, true mobility, flexible architecture.

Here in the User Guide you can find information about ClarUs and safety and

maintenance information.

Echo Wave II Software Operation Manual contains a description of the

controls.

1.1. About the system / Intended use

ClarUs system is intended to be used for applications in fetal, abdominal,

small organ (thyroid and breast), cardiac, peripheral vascular, musculo-skeletal
(conventional) and needle guidance. 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.

ClarUs 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, automatic image optimization,etc. 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 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 enables using other applications for viewing

stored data;

 using a variety of peripheral devices;
 direct echo image and video e-mail sending with one click.

A variety of available ultrasound probes provides many different applications
for examinations in therapy, obstetrics, gynecology, urology, pediatrics, oncology and
other areas.

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Common view of ClarUs shown below.

Figure 1

Common view of ClarUs EXT-1M shown below.

Figure 2

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1.2. Delivery set

ClarUs

ClarUs EXT-1M

Basic Unit ●

Beamformer ●

Operation manual

●

●

User guide ● ●

Software and manuals
(CD-ROM)

●

●

Power Cable ●

Standard USB cable

●

Power supply (medical)

●

Windows OS installation CD

●

MacBook Pro manual

●

Mac OS X Install DVD

●

Application Install DVD

●

Ultrasound probe

Types and quantity 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. Latest software versions
can be downloaded directly on the Internet from http://www.telemed.lt .

1.4. Technical Specification

Table 1 contains technical specifications of ClarUs:
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)
 B+PWD (Duplex)
 B+CFM/PDI/DPDI+PWD (Triplex)

ULTRASOUND IMAGING

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 ultrasound image size: automatically

adjustable to screen resolution

 gray scale: 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, computer speed)

 cineloop recording/play: several

thousands 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
and 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 probes: ±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 probe

 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 probes: ±10°

 single click auto adjustment:

baseline, measurements, invert

 stereo sound: volume control
 PWD palette: 12 maps
 Doppler frequency selection:

2 frequencies / each probe

DEPTH SELECTION

 2 – 30 cm (depth range depends on probe type and scanner model)

PROBES

 probes:

o from 2 MHz to 12 MHz
o Multi-frequency

 Automatic probe recognition

FOCUSING

Digital transmit focusing

 Yes

Multi focus mode

 Transmit/receive focusing, max 4 points
 Programmable focus area presets

Dynamic focus mode

 Transmit variable focus, 8 points
 Dynamic receive focus, 8 zones

SIGNAL PROCESSING

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 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
 advanced gamma control: 8 fixed curves, 8 user defined (custom)
 scan direction, rotation, up-down controls
 negative / positive control
 bi-linear 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

Veterinary Calculations
Packages

 Obstetrics:

Canine / Feline / Ovine / Bovine / Equine / Llama / Goat

 Animal Cardiology

User Interface

 The set of predefined skin schemes for user interface
 User-friendly pop-up menus and dialogue boxes
 Unlimited programmable presets for clinically specific

imaging

 Image comment / save / recall browsing
 Anatomical Icons with probe position indicator

Indication

 Power LED indicator of system status

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

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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)

Plug-Ins

 ClearView plug-in (optional)
 3DView plug-in (optional)
 PanoView plug-in (optional)

Library for programmers

 SDK documentation / sample code
(available by agreement)

DIMENSIONS AND WEIGHT

Dimensions W x D x H
mm

 335 x 230 x 75 ClarUs
 62 x 210 x 165 ClarUs EXT-1M

Weight, kg

 4.5 ClarUs
 1.6 ClarUs EXT-1M

POWER ClarUs

100-240 VAC
47-63 Hz
100VA
Built-in 60 watt-hour

lithium-polymer battery

 battery life: 60 min (depending on scan mode)
 battery charging time: up to 2 hours

POWER ClarUs EXT-1M

12 VDC

2.5 A

 External AC medical grade power supply (100-240 VAC,

50-60 Hz)

SAFETY

Electromechanical safety

 IEC601-1-2 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 diagnostic

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ultrasound equipment.1992.

OPERATIONAL ENVIRONMENT

Nominal operational
environment

 Environment temperature : 10 - 40 ° C
 Relative humidity not to exceed: 85 %
 Atmospheric pressure: 70 - 106 kPa

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2. SAFETY

CAUTION :
Please read this information before using the diagnostic system. It
applies to the ultrasound system, transducers, accessories and
peripherals.

2.1. Electrical safety

This system complies with the applicable medical equipment requirements and
meets IEC601-1, Class I Type BF safety requirements.

NOTE :
All persons connecting computer equipment as medical appliance
are configuring a medical system and are therefore responsible for
ensuring that the system complies with IEC 601-1-1. The
achievement of PC compliance with the IEC 601-1 requirements is
based on electrical safety. A standard PC power supply is almost
certain to not comply with IEC 601-1 electrical requirements in
several ways , e.g. leakage current requirements, dielectric strength
requirements.
One possible solution is powering the PC (and computer monitor)
via a 1:1 medical insulation transformer, which has been designed
to meet IEC 60601-1 requirements. The best solution is a fully IEC
601-1 certified PC or a battery operated portable PC and wireless
peripheral devices.
All systems (including monitors and other connected parts) must
be configured to comply with IEC 601-1-1. If in any doubt please
contact the technical service department of your local
representative.
Note that regardless of the above stipulations all personal
computers used should be approved regarding the IT (information
technology) safety standards for electrical ) equipment (such as.
IEC 60950 or equivalent) .

The electrical specification is shown below and can be found labelled on the
rear panel of scanner.

To avoid electrical shock only use the supplied power cables and connect it to
a properly earthed power socket. Do not use a three pin - two pin adapter. This
defeats the whole purpose of earthing for safety reasons. Systems should be
operated within the voltage limits.

WARNING:
In the event of detecting a discrepancy regarding patient safety
requirements (occurrence or probability of risk) you must to inform
the local dealer and the manufacturer immediately (for single
European customers – inform the EC representative labeled on the
rear panel).

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If the ultrasound scanner will be moved or left unused for a long period of time
without being switched on it is recommended that it be disconnected from power
supply. If a scanner is to be switched on, do not interrupt this while operating the
system and while the ultrasound software is being loaded. The time for this operation
is approximately 1 min.

To avoid the risk of electrical shock and fire hazard:

 before using the probe, inspect the probe face, housing, and cable and do not

use the probe if the probe or the cable is damaged;

 always disconnect the AC power supply from the system before cleaning the

system;

 do not use any probe that has been immersed beyond the specified cleaning

or disinfection level;

 inspect the power supply, AC power supply cable and electrical plug on a

regular basis to ensure they are not damaged;

 only use accessories and peripherals recommended by TELEMED.

WARNING:
To avoid the risk of electrical shock do not open the cover of
device/blocks. There are no parts that you can repair yourself. In
case of dificulties please contact the TELEMED service department
or your nearest local authorized distributor.

2.2. Equipment protection

To protect your ultrasound system, transducer and accessories, please follow
these precautions:

 excessive bending or twisting of electrical cables can cause a failure or

intermittent operation;

 incorrect cleaning or disinfecting of any system part can cause permanent

damage, for cleaning and disinfecting instructions see the relevant chapter

below;

 do not use solvents such as thinners/benzene or abrasive cleaners on any

parts of the system;

 do not spill liquids on the system;
 incorrect assembly or configuration and using an incorrect power source may

damage the system.

WARNING:
Ultrasound probes can easily be damaged by incorrect handling!
Failure to follow these precautions can result in serious injury and
equipment damage!

2.3. Biological safety

Observe the following precautions related to biological safety:

 do not use the system if it displays erratic or inconsistent behavior;

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 interuptions to the scanning sequence are signs of hardware failure that must

be corrected before use;

 do not use the system if it displays artifacts on the LCD screen, either within

the clinical image or on the area outside it;

 artifacts are indications of hardware and/or software errors that must be

corrected before use;

The hardware limits the maximum probe surface temperature
to a maximum of 43°C even in the event of a device malfunction.

2.4. Ultrasound exposure and ALARA principle

Perform ultrasound procedures prudently, use the ALARA (As low As Reasonably
Achievable) principle (see APPENDIX: 1.Guidelines for the safe use of diagnostic
ultrasound).
The interactive system features or user controls that may affect the acoustic output
are:

 acoustic output control,
 transmit frequency;
 scanning depth;
 transmit focal length;
 scanning angle.

Acoustic output also depends on the imaging mode selected. The choice of mode (B­Mode, M-Mode, B+M-Mode) determines whether the ultrasound beam is stationary or
in motion. B+M-Mode has the highest acoustic output.
The default output level is factory calibrated and is based on device settings that
yield an optimum image for the type of patient examination and do not exceed the
following FDA recommended limits.
This default level is set:

 when the system is first turned on;
 when the probe is first turned on.

It is highly recommended to set the default level:

 when changing from one exam category to another;
 when changing from one application to another;
 when changing from one probe to another;
 when a new patient is entered.

Once an optimal image is achieved, the need for increasing acoustic output or
prolonging the exposure cannot be justified. Watch the POWER level (on-screen
display) permanently. Whenever possible, controls and system features should be
used to optimize the image before increasing the acoustic output level. Follow the
ALARA principle during all patient examinations.
The ClarUs employs the ALARA principle in configuring factory defaults.

CAUTION:
Probe sheaths/covers may contain talc and natural rubber latex.
Examine the package labeling to confirm any latex content. We
strongly recommend that healthcare professionals identify their
latex-sensitive patients and refer to the FDA regulations.
NOTE: TELEMED diagnostic ultrasound systems and probes do not
contain natural rubber latex that comes into contact with humans.