– Medical electrical equipment - part 1: General Requirements for Basic Safety and
Essential Performance [ANSI/AAMI ES60601-1:2005/(R)2012, AND C1:2009 AND A2:2010(R)2012]
– Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing [ISO 10993-1:
2009]
– Standard Means for Reporting the Acoustic Output of Medical Diagnostic Ultrasonic
Equipment [IEC 61157:2007]
Declarations
CSA mark with the indicators “C” and “US” means that the
product is certified for both US and Canadian markets according
to the applicable US and Canadian standards.
This mark certifies that the product conforms to applicable EEC
standards, and that it has been certified by the European
certification agency.
This is the manufacturer’s declaration of product compliance
with the applicable EEC directive(s).
This is the GMP symbol for Korean Good Manufacturing
Practice quality system regulation.
Precautions for Use
Be sure to read this Service Manual thoroughly to familiarize yourself with the operation of the
product and the relevant safety information before attempting to use the product.
• Keep this service manual near the product and refer to it when using the product.
• Be sure to familiarize yourself with the safety information contained in 'Chapter 2. Safety' and
'Chapter 10. Maintenance and Storage' in particular.
• This service manual does not include diagnosis results or opinions. In addition, please
consult the reference for each study area before evaluating the measurement result of an
application.
• This product is an ultrasound diagnostic system and cannot be used with your personal
computer. If you use this product in such an environment, we cannot be held responsible for
any resulting problems.
• This product must be used by a person who possesses clinical pathology training and/or
certification. Use by unqualified persons is prohibited.
• The manufacturer is not liable for any problems with the system caused by careless
operation and/or improper control by the operator.
• Product orders are based on individually agreed-upon specifications and may not include all
functions specified in this service manual.
• Some functions or options, probes, and the like may not be used in certain countries.
• All reference materials on standards, regulations, and related revisions are valid at the time
of publication of this service manual.
• Screen images in this service manual are examples only (may differ from the actual screen
or system).
• The content of this service manual is subject to change without prior notice.
• Products that are not manufactured by Samsung Medison are indicated with the trademarks
of their respective owners.
• The following terms are used to highlight the safety precautions that the user must be aware
of:
DANGER
Disregarding this instruction may result in death, serious
situations.
WARNING
Follow these instructions to prevent serious accidents or damage to property.
CAUTION
Follow these instructions to prevent minor accidents or damage to property.
A piece of information
related to any hazard.
injury, or other dangerous
useful for installing, operating, and maintaining a system; not
NOTE
Revision History
The revision history of this service manual is as follows:
Versi o n D AT E REASON FOR CHANGE
1.00.00 2016.07.15 Initial Release
If You Need Assistance
If you need a service manual or any assistance with the product, please contact the Samsung
Medison customer service department or your local vendor.
Patient Privacy Policy
Treatment of Patients' Personal Information
One of Samsung's social responsibilities is to recognize the importance of patient privacy and
handle and protect the personal information provided by patients in an appropriate manner.
Patient information stored in repaired and demo products should be handled as follows:
• Patient Information: IDs, names, DOBs, and images are information used to identify patients.
• Patient Information Management: Personal information provided by patients must be
protected during repairs and demonstrations. Do not use, distribute, or lose patient
information to third parties.
Management of Patient Information on Demo and Trade
Products
• Patient information stored on a product during the course of its use must be handled as the
patient desires. (delete or backup)
• When any demo or trade product is collected, patient information must be deleted if
requested by the patient to prevent its unintended distribution.
Management of Patient Information on Repaired Hospital
Products
• Before removing the product from hospital premises for repairs, all patient information should
be backed up to an external HDD or a memory device.
• Before removing the product from hospital premises, each patient should sign the patient
privacy agreement.
Request for Repairs and Patient Privacy Agreement
【Customer Information】
Hospital
Handler
【Product Information】
Product name
Software version
S/N
Symptom
Date: MM/DD/YY
Stored item
Outsourced product
【Administration】
Handling date MM/DD/YY
Customer service
representative
※ Please sign inside the box below if you agree to the following:
□ Data saved on memory devices -- for example, hard disks -- may be lost during tests and
repairs.
□ Data saved on a product being repaired must be backed up by the customer.
□ Samsung will not be held responsible for any loss of data that are not backed up.
□ Samsung neither uses nor modifies patient information nor provides it to third parties.
【Customer Signature】
□ None □ Main unit □ HDD □ DVD/CD
□ USB □ Photo □ Other ( )
□ None
□ Provide details if applicable ( )
I entrust my product to ( ) for repair and agree to the policies above.
This product consists of monitor, control panel, console, peripheral devices and probes.
① Monitor
② Monitor arm
③ Keyboard
④ Control panel
⑤ Lift
⑥ Probe holder
⑦ DVD drive
⑧ USB port
⑨ Speaker
⑩ Probe port
⑪ Wheel
[Figure 1.1 Front of the Product]
⑫ Location of ID Label
⑬ Brake
⑭ Gel warmer
⑮ Internal peripheral devices
outlet
1 - 6 HS50/HS60 Service Manual
① Handle
② Storage compartments
③ Ventilation
④ Rear panel
⑤ Power connection part
⑥ ID label
[Figure 1.2 Back of the Product]
Chapter 1. Introduction 1 - 7
1.2.1. Monitor
Ultrasound images and other information are displayed on the color LCD monitor.
1.2.1.1. Screen Layout
The monitor displays ultrasound images, operation menus and a variety of other information.
[Figure 1.3 Monitor Display]
① Title Area
Displays patient information, hospital name, application, frame rate, depth, probe
information, acoustic output information, and the current date and time.
② Image Area
Displays ultrasound images. Image information, annotation, and measurement
information are also displayed.
③ Thumbnail Area
Images saved by pressing the preset Store button are shown in the thumbnails. When
you save Single screens, up to 4 images are shown in a list; for Quad screens, up to 12
images are shown. Click it with the pointer to enlarge the preview image.
④ User Information and Status Information Area
Information that is useful to the user, such as current system status, image information,
selectable items, etc., is displayed.
⑤ User Key (User Defined Key) Area
Settings for User Defined Keys, including the positions of Set and Exit buttons, are
displayed. You can change the setting of each button in Setup > Customize > Buttons.
1 - 8 HS50/HS60 Service Manual
For information on User Key Setup, please refer to
manual.
NOTE
‘Chapter 3. Utilities’ in the user
TIP
Principles of Operation of the Diagnostic Ultrasound System
Medical ultrasound images are created by digital memory and computer when they convert
the high-frequency wave signals that are transmitted and received by the probe.
As ultrasound waves propagate through the human body, they generate reflected signals
whenever they encounter a change in density. For example, reflected signals are generated
when signals pass from fatty tissues to muscle tissues. Reflected signals return to the probe,
where they are converted into electronic signals. The reflected signals are amplified and
processed by analog and digital circuits that have filters for various frequencies and response
time options. Then they are again converted into high-frequency electronic signals, and
saved as a series of digital image signals. The monitor displays the image signals stored on
the storage device in real time. The entire process of transmitting, receiving, and processing
signals is controlled by the computer.
1.2.2. Control Panel
The system can be controlled by using the control panel.
Chapter 1. Introduction 1 - 9
[Figure 1.4 Control Panel]
The control panel consists of a keyboard, soft menus, buttons, dials, dial-buttons, a slider, and a
trackball.
The dial-button can be used both as a dial and a button.
1 - 10 HS50/HS60 Service Manual
1.2.2.1. Functions of the Control Panel
The following are the descriptions and instructions for the controls on the control panel. For
more information on controls with multiple functions, see ‘Chapter 3. Utilities’ and later in the
user manual.
Button Turns the system on/off.
On/Off
End Exam
SonoView
Report
Button
Finishes the exam of the currently selected patient and resets
the related data.
Button Displays the screen for viewing and managing stored images.
Button
Displays the Report screen that shows the measurement
results of the current application and other information.
When you press the dial-button, the menu items that are
Dial-
button
available in the current scan mode are shown on screen.
Rotating the Menu dial-button to the right selects the menu one
row above the current menu selected, and rotating it to the left
selects the menu one row below.
Dial-
button
– Marker: Allows the user to enter a BodyMarker over an
image.
– Ref: Moves the reference slice horizontally in 3D View.
Dial-
button
Adjusts the angle of the sample volume in Spectral Doppler
mode. It is also used to adjust the Arrow’s angle or the probe
angle for a BodyMarker.
Button In this mode, only the image is displayed on the screen.
Button Compares four independent images.
Chapter 1. Introduction 1 - 11
Button
Button
Compares two independent images. The active image mode is
on the left.
Compares two independent images. The active image mode is
on the right.
Switch Adjusts the scanning depth of the image.
Switch Moves the focus to the target area for observation.
Dial-
button
Makes the Zoom Box appear.
In order to close the Zoom mode, press the Exit button.
Press this button to turn the Quick Scan function on. The ‘Q
Button
scan’ mark will appear at the top of an image. It can be used in
applications of all probes.
Button Pauses/resumes scanning.
Stands for User Key; functions can be assigned to these
Button
Dial-
button
buttons as desired. The function for each button can be
assigned in Setup > Customize > Buttons > User Key.
Start or end M Mode. Rotate this dial-button to adjust Gain.
Also, turning this dial-button when in 3D View rotates the
image along the x-axis.
Press this button to start/stop PW Spectral Doppler mode.
Dial-
button
Rotate this dial-button to adjust Gain.
Also, turning this dial-button, when in 3D View rotates the
image along the y-axis.
1 - 12 HS50/HS60 Service Manual
Press this button to start/stop Color Doppler mode. Rotate this
Dial-
button
Button Press this button to start/stop Power Doppler mode.
dial-button to adjust Gain.
Also, turning this dial-button when in 3D View rotates the
image along the z-axis.
Set/Exit
Clear
Pointer
Button
Dial-
button
Press this button to start/stop CW Spectral Doppler mode.
Available only with the phased array probe.
Press this button to start 2D mode. Rotate this dial-button to
adjust Gain.
Button Press this button to turn 3D/4D Mode on/off.
Set or Exit function may be assigned to this button. The
function for each button can be assigned in Setup > Customize
> Set/Exit Key.
Button
– Set: Select an item or value using the trackball. Also used
to change the function of the trackball.
– Exit: Exits the function currently being used and returns to
the previous state.
Button
Button
Deletes text, Arrow, BodyMarker, measurement results, etc.
displayed on an image.
When this is pressed, an arrow marker appears to point to
parts of the displayed image.
Change
Calculator
Trackball
Button Changes the current trackball function.
Button Allows the user to place text on an image.
Button Starts measurements by application.
Trackball
Moves the cursor on the screen. Also scrolls through Cine
images.
■Keyboard
The keyboard is used to type in text.
Help Displays the Help Manual on the screen.
Chapter 1. Introduction 1 - 13
[Figure 1.5 Keyboard]
Patient Displays the General Information on the screen.
Patient info. Shows or hides the patient information on the screen.
Image Info. Shows or hides the Image Parameters on the screen.
DICOM Spooler Displays the DICOM Spooler on the screen.
Arrow Initiates Arrow mode.
Home Moves the cursor to the Home position in Annotation mode.
Set Home Specifies the Home position in Annotation mode.
Delete Word Deletes the last text entered in Annotation mode.
Delete All Deletes all the text that has been entered in Annotation mode.
Setup This displays the Setup screen.
Insert Select an input method.
Delete Deletes text.
Turns up the speaker volume.
Turns down the speaker volume.
1 - 14 HS50/HS60 Service Manual
1.2.2.2. Touch Screen
The touch screen is an operating tool that can be touched by the user to input data. The
functions that are available in the current mode are shown in the form of buttons or a dialbutton.
■Touch Screen Layout
[Figure 1.6 Touch Screen Display]
① These buttons are always displayed on the touch screen. Buttons that are in use are
shown in blue and buttons that cannot be used are deactivated.
Patient
Probe
Quick
Preset 1–4
Setup
The Patient Information screen will appear, where you can select a
Patient ID in the list or enter new patient information.
It displays the Probe Selection screen where you can select and
modify the probe and application.
It shows up to 4 Preset buttons configured at Setup.
The general system settings that do not have a direct bearing on
imaging are explained below.
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