Samsung S4343-W User manual

1
UMS4343-W
Digital Flat-Panel X-RAY Detector
User Manual for S4343-W
Samsung Electronics Co , Ltd
This manual is provided for the installation and operation of S4343-W
Please read this manual before the detector install and use
© 2013 Samsung Electronics Co , Ltd All rights reserved

2
Revision History
Version
Date
Page
Revision
1 0 2013 April - 1
st
Edition
1 1 2013 Dec ¤ 37 The main revised item are as below
- Table 1 O
PERATING TIME TABLE
1 2 2014 May ¤ 28
The main revised item are as below
- Changed Power Supply Box Input
1 3 2014 June ¤ 51
~
58
Add FCC Statement of Conformance
Add EMC Declaration

3
Table of Contents
About this Manual
.................................................................................................................................................................................................................................................................. 7
Symbols Used in This Manual ............................................................................................................................................................................................................................... 7
Intended for use......................................................................................................................................................................................................................................................... 8
User Requirements .................................................................................................................................................................................................................................................... 8
Service Center ............................................................................................................................................................................................................................................................. 8
1 Safety instructions ............................................................................................................................................................................................................................................................... 9
Safety Instructions .................................................................................................................................................................................................................................................... 9
System Symbols ............................................................................................................................................................................................................................................... 10
System Maintenance Checkpoints ............................................................................................................................................................................................................ 12
Genenral Safety ................................................................................................................................................................................................................................................ 13
Electrical Safety ................................................................................................................................................................................................................................................ 14
Mechanical Safety ............................................................................................................................................................................................................................................ 15
Fire Safety
............................................................................................................................................................................................................................................................ 15
Safety from Explosion
....................................................................................................................................................................................................................................... 15
EMC (Electromagnetic Compatibility) .......................................................................................................................................... Error! Bookmark not defined.
Label ...................................................................................................................................................................................................................................................................... 16
Maintenace, Cleaning and Disposal .......................................................................................................................................................................................................... 16
Disclaimer............................................................................................................................................................................................................................................................ 17
2
System Overview
................................................................................................................................................................................................................................................................. 18
System Overview ..................................................................................................................................................................................................................................................... 18
System Purposes .............................................................................................................................................................................................................................................. 18
Product components ....................................................................................................................................................................................................................................... 19
Examination Room Components ............................................................................................................................................................................................................... 20
Control Room Components .......................................................................................................................................................................................................................... 21
3
System Components
........................................................................................................................................................................................................................................................... 22
System Components ............................................................................................................................................................................................................................................... 22
Detector ............................................................................................................................................................................................................................................................... 22
Power Supply Box ............................................................................................................................................................................................................................................ 27
Main Cable .......................................................................................................................................................................................................................................................... 28
Battery Recharger ............................................................................................................................................................................................................................................ 29
Battery .................................................................................................................................................................................................................................................................. 32

4
4
Operating the System Hardware
..................................................................................................................................................................................................................................... 34
Operating the System Hardware ....................................................................................................................................................................................................................... 34
Checking Connection ...................................................................................................................................................................................................................................... 34
Operation ............................................................................................................................................................................................................................................................ 35
Operating description ..................................................................................................................................................................................................................................... 36
5 Appendices ........................................................................................................................................................................................................................................................................... 37
REQUIRED PUBLIC STATEMENT FOR GPL/LGPL/GPLv2/OpenSSL/CPOL LICENSED SOFTWARE USED IN THIS PRODUCT ............................................... 38
GNU GENERAL PUBLIC LICENSE .................................................................................................................................................................................................................................. 39
GNU LESSER GENERAL PUBLIC LICENSE ............................................................................................................................................................................................................... 44
BSD LICENSE ............................................................................................................................................................................................................................................................................. 49

5
Table 1 Special Symbol........................................................................................................................................................................................................................................... 11
Table 2 System Maintenance Checkpoints ..................................................................................................................................................................................................... 12
Table 3 C
OMPONENTS
................................................................................................................................................................................................................................................. 19
Table 4 LED
S
TATUS
.................................................................................................................................................................................................................................................. 23
Table 5 P
OWER
S
UPPLY
B
OX
D
ESCRIPTION
............................................................................................................................................................................................................ 27
Table 6 B
ATTERY
R
ECHARGER
I
NDICATE
LED ........................................................................................................................................................................................................ 29
Table 7 B
ATTERY
R
ESIDUAL
D
ISPLAY
....................................................................................................................................................................................................................... 32
Table 8 B
ATTERY
I
NDICATE
LED .............................................................................................................................................................................................................................. 33
Table 9
CHECKING THE POWER STATUS OF COMPONENTS
(S4343-W) .............................................................................................................................................................. 35
Table 10 P
OWER
O
FF
S
TATUS
................................................................................................................................................................................................................................... 35
Table 11 O
PERATING TIME TABLE
............................................................................................................................................................................................................................. 36

6
Figure 1 Examination Room Components ...................................................................................................................................................................................................... 20
F
IGURE
2
R
ECHARGER
................................................................................................................................................................................................................................................... 21
F
IGURE
3
R
ECHARGER
A
DAPTER
.................................................................................................................................................................................................................................. 21
F
IGURE
4
W
IRELESS
D
ETECTOR
.................................................................................................................................................................................................................................. 22
F
IGURE
5
INDICATE
LED .............................................................................................................................................................................................................................................. 23
F
IGURE
6
D
O
N
OT
D
ROP
............................................................................................................................................................................................................................................ 24
F
IGURE
7 Be C
AREFUL OF
D
ETECTOR
L
OCATION
..................................................................................................................................................................................................... 25
F
IGURE
8 K
EEP
W
EIGHT
D
ISTRIBUTED
E
VENLY
....................................................................................................................................................................................................... 25
F
IGURE
9 A
VOID
L
OCALIZED
W
EIGHT
........................................................................................................................................................................................................................ 25
F
IGURE
10 P
OWER
S
UPPLY
B
OX
................................................................................................................................................................................................................................. 27
F
IGURE
11 M
AIN
C
ABLE
.............................................................................................................................................................................................................................................. 28
F
IGURE
12
B
ATTERY
R
ECHARGER
............................................................................................................................................................................................................................... 29
F
IGURE
13
B
ATTERY
I
NSERT
...................................................................................................................................................................................................................................... 30
F
IGURE
14
B
ATTERY
L
OCK
.......................................................................................................................................................................................................................................... 30
F
IGURE
15
B
ATTERY
...................................................................................................................................................................................................................................................... 32
Figure 16 IP
SET UP
.................................................................................................................................................................................................................................................. 34
F
IGURE
17
P
OWER APPLIED COMPONENTS
(S4343-W) ........................................................................................................................................................................................ 35
Figure 18: T
IMING CHART
.......................................................................................................................................................................................................................................... 36

7
About this Manual
Symbols Used in This Manual
The specifications and details of this manual may be changed in order to improve the product
or to enhance its performance
The following symbols are used throughout this manual to alert the user to the relevant safety
instructions or to any useful information when using this system
Symbol
Name
Description
Warning
Indicates content which, if you fail to follow the accompanying
instructions, may cause death or serious personal injury
Caution
Indicates content which, if you fail to follow the accompanying
instructions, may cause personal injury or damage to the product
Note
Provides users with additional information on the topic for better
understanding
Please note that our company does not take responsibility for any accidents and is not
obligated to do free repair service for any damage of the equipment due to the user's
negligence which results from failure to follow the contents in this manual Make sure you are
familiar with the safety precautions and usage procedures Also note that the product features
may slightly differ from the contents of this manual depending on the specifications

8
Intended for use
S4343-W, Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed
for providing general radiographic diagnosis of human anatomy targeting both adult and
children It is intended to replace film based radiographic diagnostic systems and provide more
precise case diagnosis and treatment planning on a real time basis for physicians and
radiologists Not to be used for mammography and direct cardiac application
User Requirements
□ This equipment should be only operated by users who have received professional medical
education and training, such as physicians, radiologists, and other medical specialists
□ Please read the user manual and the safety information carefully before using this
equipment Operating the equipment without reading the safety information may result in
personal injury to the patient or to yourself
Service Center
- Korea : Service Center 080-022-9797
- Overseas : Contact the local distributor
Head Quarters
- 129 Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea
Factory
129 Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea

9
1
S
AFETY INSTRUCTIONS
Safety Instructions
In this chapter, information of safety instructions and regulations are provided It is provided to protect
users of the system from unintended safety hazard and prevent property damage,
please read thoroughly and keep instructions If additional training is required, consult your dealer or the
service center of the manufacturer
Before using this system, please read safety instructions thoroughly The manufacturer is not responsible
for any damages and accidents caused by violating such safety instructions or regulations

10
System Symbols
Table 1 shows the symbols related to maintaining the safety of the patient and the user
Alternate current
Direct current
Protective earth (Ground)
Off (power : disconnect from the main switch)
On (power : connect to the main switch)
Identifies terminals which, when connected together, bring various parts of a
piece of equipment or of a system to the same potential
Indicates content which, if you fail to follow the accompanying instructions,
may cause personal injury or damage to the product
Indicates that the dangerous factors can be occurred caused by High Voltage
Indicates that the accompanying operating instructions in the manual must be
followed to operate the equipment safely
TYPE B
Applied part
Marks it contains radio transmitting device

11
Table 2
S
PECIAL
S
YMBOL
Avoid contact with water
No unauthorized or unlawful modification
Waste electrical and electronic equipment (WEEE)
Temperature limitation
Marks fragile device that requires full attention when handling
Manufacturer
EC Representative

12
System Maintenance Checkpoints
To ensure the system performance and usability along with safety, regular maintenance and checking the
condition are required To secure safety of both patient and operator and to ensure the performance of the
system, check the system on a regular interval For periodic inspection of the system, consult your dealer
or the manufacturer's service center
No
Item
Category
Checkpoints
Check
Interval
Remark
1 Noise / Vibration In use Check noise and vibration from each
operating parts of the system 1 year
2 Power Supply box While in use Check the power supply box voltage
while the equipment s turned off 1 year
3 Appearance While in use
Run a visual inspection to check if the
appearance shows any abnormalities,
such as loosened bolts or had grips,
transformation, etc while the equipment
is turned off
1 year
4
Cables
Before Using
Check cable runs for worn out cables,
damage or short circuited, broken wires,
etc while the equipment is turned off
6 months
5
Grounding While in use
Check the earth-grounding is intact, not
broken or loosened terminal (Grounding
resistance should be below 0 1Ω )
1 year
6
Installation
Checkpoints
When
Installing
When installing, check that the
equipment is leveled and firmly fixed 1 year
Table 3
S
YSTEM
M
AINTENANCE
C
HECKPOINTS
When inspecting on checkpoints requiring no power, please make sure to keep the system turned off
Classification
- The type of protection against electric shock: Class I equipment
- The degree of protection against electric shock: Type B applied part
- The degree of protection against ingress of water: Ordinary equipment
- The method(s) of sterilization or disinfection: Not applicable
- The degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR
or WITH OXYGEN OR NITROUS OXIDE: Not applicable
- Mode of operation: As momentary continuous operation

13
Genenral Safety
Before using the equipment, the user should check that:
• All components are connected correctly
• All components are operational when the system is powered on
• Neither the patient nor the user is present in the examination room when powering the equipment on
• If any electrical or mechanical fault occurs, stop using the system immediately.
You can identify faults from the display or warnings
• Please consult the manufacturer before connecting a component from another system to this system. Any auxiliary device
connected to the system must be IEC certified (data processing equipment IEC60950-1, medical electrical equipment
IEC60601-1). Also, if the auxiliary device is connected to a signal I/O port, it should comply with IEC60601-1 and/or
IEC60601-1-1.
• Do not connect the instrument with anything other than specified. Otherwise, it may result in fire or electric shock.
• Medical equipment requires periodic maintenance and management. For more information, refer to 1. Maintenance,
Cleaning and Disposal.
• If an error message appears while the system is in use, it may stop operating. When an error message appears, contact the
service center
• The manufacturer will not accept liability for
• Fault, damage or personal injury incurred as a result of the user incorrectly performing maintenance on the system
• Personal injury incurred due to the user’s carelessness
• Fault, damage or personal injury incurred due to use of an ancillary device which is not provided by the manufacturer
• When Problem Occurs
Should any of the following occur, immediately turn OFF the power of each instruments, unplug the power
cable from the AC outlet, and contact SAMSUNG representative or distributor
• When there is smoke, odd smell or abnormal sound
• When liquid has been spilled into the instrument or a metal object has entered through an opening
• When the instrument has been dropped and it is damaged
• This detector should be used by selected users. If not you fully aware of the factor of exposure, the manual, and the
schedule of organization, This could be dangerous for the patients and users.
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING

14
Electrical Safety
• In compliance with IEC 60601-1, this medical equipment complies with the requirements for Safety class I, type B.
• This system must be used in an environment complying with the requirements of the IEC.
• Do not remove the safety cover of this system needlessly. When it is removed, the high voltage current inside the system
may cause electric shock.
• Be careful to ensure that no liquids enter the system.
• If chemicals are spilled or evaporate, it may result in fire or electric shock through contact with electric parts inside the
instruments. Also, some disinfectants are flammable. Be sure to take care when using them.
• Be sure to turn OFF the power of each instrument before connecting or disconnecting the cables. Also, do not handle them
with wet hands. Otherwise, you may get an electric shock that may result in death or serious injury.
• Do not cut or process the cables. Also, do not place anything heavy, including the instrument on it, step on it, pull it, bend it,
or bundle it. Otherwise, the cable may be damaged, which may result in fire or electric shock.
• Be sure to hold the plug or connector to disconnect the cable. If you pull the cable, the core wire may be damaged,
resulting in fire or electric shock.
• Do not turn ON the system power when condensation is formed on the instrument. Otherwise, it may result in fire or electric
shock.
• Do not spill liquid or chemicals onto the instrument or, in cases where the patient is injured, do not allow it to become wet
with blood or other body fluids, as doing so may result in fire or electric shock. In such situation, protect the instrument with
disposable covering as necessary.
For safety reasons, be sure to turn OFF the power of each instrument when the inspections indicated in
this manual are going to be performed Otherwise, it may result in electric shock
When the instrument is going to be cleaned, be sure to turn OFF the power of each instrument, and
unplug the power cable from the AC outlet Otherwise, fire or electric shock may result
• Never disassemble or modify the product as it may result in fire or electric shock. Also, since the instrument incorporates
parts that may cause electric shocks and other hazardous parts, touching them may cause death or serious injury
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING

15
Mechanical Safety
• Never remove the cover (Detector, Power Box, Recharger, Battery Pack, and Adapter) or cables unless directed to do so by
a professionally trained engineer.
• When an examination is in progress, auditory and visual communication between the patient and the system user must be
possible at all times.
• Be careful not to pinch any part of your or the patient's body or clothing while using the system.
• Do not hit or drop the instrument. The instrument may be damaged if it receives a strong jolt, which may result in fire or
electric shock if the instrument is used without it being repaired.
Fire Safety
• Do not operate the system in a location where there is a danger of fire.
•
In the event of a fire, stop the entire system immediately and disconnect the power cable. Make sure to extinguish the fire
with a carbon dioxide fire extinguisher
Safety from Explosion
• Do not operate the system in a location where there is a danger of explosion. This system is not designed to be used in a
location where there is a danger of explosion, and does not comply with the AP/AGP standard.
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING

16
Label
• For information on the types and attachment locations of the Detector Component labels, refer to Labels.
Maintenace, Cleaning and Disposal
Maintenance
• Inspect the equipment periodically for patient and user safety.
• The instrument must be repaired by a qualified engineer only. If it is not repaired properly, it may cause fire, electric shock,
or accident.
Cleaning
• Always turn off the equipment completely before cleaning.
• Do not open the cover and insert liquids into the system.
• When cleaning the exterior of the system, use a soft cleaning cloth dampened with tepid Water and soap. Do not use
detergents or chemical solutions.
• While a maintenance personnel is cleaning the room, cables connected to the equipment may be lifted or pulled.
When lifting , or pulling cables, the connection with the equipment may be disconnected causing malfunction, electric
shock, or danger of fire Also, water may be absorbed into the equipment if mopped with a damp cloth, which may cause
electric shocks or fire
• If the equipment generates abnormal noises, contact the service center immediately. The user must not arbitrarily
disassemble, repair, or modify the equipment. Fire or electric shock may result.
• Always be sure to keep checking the condition of the system and the patient to ensure they are normal during the use of
the instrument. If any problem is found, take appropriate measures, such as stopping the operation of the instrument, as
required.
Correct Disposal of This Product (Waste Electrical & Electronic Equipment)
(Applicable in countries with separate collection systems)
This marking on the product, accessories or literature indicates that the product and its electronic
accessories should not be disposed of with other household waste at the end of their working life To
prevent possible harm to the environment or human health from uncontrolled waste disposal, please
separate these items from other types of waste and recycle them responsibly to promote the sustainable
reuse of material resources
Household users should contact either the retailer where they purchased this product, or their local
government office, for details of where and how they can take these items for environmentally safe
recycling
Business users should contact their supplier and check the terms and conditions of the purchase contract
This product and its electronic accessories should not be mixed with other commercial wastes for disposal
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING

17
Environment of Use and Storage
• Does not use or store the instrument near any flammable chemicals such as alcohol, thinner, benzene, etc. Also, this
instrument is not a category AP or APG equipment. If chemicals are spilled or evaporate, it may result in fire or electric
shock through contact with electric parts inside the instruments. Also, some disinfectants are flammable. Be sure to take
care when using them.
• Do not install the instrument in a location with the conditions listed below. Otherwise, it may result in failure or malfunction,
fall or cause fire or injury.
•
Close to facilities where water is used
•
Where it will be exposed to direct sunlight
•
Close to air-conditioner or ventilation equipment
•
Close to heat source such as a heater
•
Prone to vibration
•
Insecure place
•
Dusty environment
•
Saline or sulfurous environment
•
High temperature or humidity
•
Freezing or condensation
Do not place the storage case in a location with the conditions listed below
•
Where the cable of the sensor unit will be strongly pulled when the sensor unit is put into the case, otherwise, the
cable may be damaged, resulting in fire or electric shock
•
Where someone might get their foot caught in the cable of the sensor unit is put in the case Otherwise they could trip
over, resulting in injury
Disclaimer
•
The manufacturer assumes no liability for any failure or damage which may occur by using other
company's products
•
The manufacturer assumes no liability for any failure or damage that may occur from installing, relocating, modifying,
maintaining, or repairing the equipment by any personnel other than designated personnel by the manufacturer
•
The manufacturer assumes no liability for any accidents or damage on the equipment which may
occur due to operations performed without following the relevant precautions or instructions in this
manual
•
The manufacturer assumes no liability for any failure or damage due to natural disasters such as
fire, earthquake, flood, and lightning
•
The manufacturer assumes no liability for erroneous diagnostic criteria or results
•
The manufacturer assumes no liability for any failure or damage which may occur due to
operations performed for any purposes other than its intended use
•
This equipment should be operated under the specified conditions The manufacturer assumes no
liability for any failure or damage which may occur due to operations performed under conditions
other than those specified in this manual For more information on the operating conditions, refer
to Appendices
WARNING
WARNING

18
2
S
YSTEM
O
VERVIEW
System Overview
System Purposes
The S4343-W is a portable digital X-ray flat panel wireless detector that can generate Images of any part
of the body This X-ray imaging system consists of a scintillator directly coupled to an a-Si TFT sensor
S4343-W can be used for radiographic imaging of human body parts such as head, Chest, spinal,
abdominal, particular, hand, foot, and other internal organs However, do not use the system for
mammography purposes
Radiated X-rays through the body is processed to produce radiography by the detector Converted
electric signal is processed by the signal processor to amplify and digitize data And the result is
transferred to the workstation

19
Product components
Item
Part Name
Qty
Description
1 Detector 1 Front view of the device
2 Power Supply Box 1 Source of necessary electricity
3 Battery Recharger 1 To recharge an extra battery
4 Battery Pack 2 Source for wireless connection
5 Recharger Adaptor 1 Source of the battery pack recharger
•
6 Main Cable 1 To connect x-ray detector with Power
Supply Box
7
AC Adapter Cable
(Optional)
1 AC 110 / 220V power cable
For battery pack recharger adaptor
Table 4 C
OMPONENTS
Recharger Adapter
Battery
pack
Main Cable
AC Adapter Cable
(Optional)
※
Regularly changed parts : nothing
Detector Power Supply Bo Battery pack Recharger
Comment [
1]: DC 24V 삭제 사진

20
Examination Room Components
The components of S4343-W can be divided into the examination room components and the control room
Components in accordance with their installation locations
The below figure 1 shows S4343-W Examination Components
Figure 1 E
XAMINATION
R
OOM
C
OMPONENTS
All examination room components of the system should be used inside a shielded environment
Detector Power bo Main cable
Comment [
2]: DC 24V 삭제반영
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