Samsung S4335-AW Series, S4343-AW, S4335-AW, S4335-AWV, SZ4343-W User Manual
1
User Manual
for S4335-AW series
S4343-AW/SZ4343-W
(S4335-AW/AWV, S4343-AW/SZ4343-W )
Digital Flat-Panel X-RAY Detector
Samsung Electronics Co., Ltd.
This manual is provided for the installation and operation of S4335-AW series，S4343-AW/SZ4343-W.
Please read this manual before the detector install and use.
© 2013 Samsung Electronics Co., Ltd. All rights reserved.
Document No. : 3200-01H1O1
2
Revision History
V
ersion Date
Page
Revision
1.0
Mar. 30,2018 - 1
st
Edition
1.1
June. 26,2018 13
15
16
20
25
28
34
39
40
A
DD WARNING
A
DD CAUTION(EMC)
A
DD Related comments on IP 54（Maintenance）
A
DD Version
Corrected LED STATUS
A
DD Maintaining Water and Dust Resistance
A
DD IP WARNING
A
DD Specifications
A
DD APPENDICES
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) ................................................................................................................................................................................................ 15
Label ............................................................................................................................................................................................................................................................. 16
Maintenace, Cleaning and Disposal ................................................................................................................................................................................................... 16
Disclaimer .................................................................................................................................................................................................................................................... 18
2.
System Overview
........................................................................................................................................................................................................................................................... 19
System Overview ............................................................................................................................................................................................................................................... 19
S4335-AW series ...................................................................................................................................................................................................................................... 19
S4343-AW/SZ4343-W ............................................................................................................................................................................................................................. 19
System Purposes ...................................................................................................................................................................................................................................... 19
Product components ............................................................................................................................................................................................................................... 20
Examination Room Components ......................................................................................................................................................................................................... 21
Control Room Components ................................................................................................................................................................................................................... 22
3.
System Components
..................................................................................................................................................................................................................................................... 23
System Components ......................................................................................................................................................................................................................................... 23
Detector ....................................................................................................................................................................................................................................................... 23
Power Supply Box .................................................................................................................................................................................................................................... 29
Main Cable .................................................................................................................................................................................................................................................. 30
4
Battery Recharger .................................................................................................................................................................................................................................... 31
Battery .......................................................................................................................................................................................................................................................... 33
4.
Operating the System Hardware
............................................................................................................................................................................................................................... 36
Operating the System Hardware ................................................................................................................................................................................................................. 36
Checking Connection .............................................................................................................................................................................................................................. 36
Operation .................................................................................................................................................................................................................................................... 37
Operating description ............................................................................................................................................................................................................................. 38
5. Specifications ............................................................................................................................................................................................................................................................... 39
6. Appendices .................................................................................................................................................................................................................................................................... 40
5
Table 1 Special Symbol .................................................................................................................................................................................................................................... 11
Table 2 System Maintenance Checkpoints ................................................................................................................................................................................................ 12
Table 3 COMPONENTS ........................................................................................................................................................................................................................................... 20
Table 4 LED STATUS ............................................................................................................................................................................................................................................ 25
Table 5 POWER SUPPLY BOX DESCRIPTION ....................................................................................................................................................................................................... 29
Table 6 BATTERY RECHARGER INDICATE LED ................................................................................................................................................................................................... 31
Table 7 CHECKING THE POWER STATUS OF COMPONENTS (S4335-AW series，S4343-AW/SZ4343-W) ........................................................................................... 37
Table 8 POWER OFF STATUS ............................................................................................................................................................................................................................... 37
Table 9 OPERATING TIME TABLE .......................................................................................................................................................................................................................... 38
6
Figure 1 Examination Room Components ................................................................................................................................................................................................. 21
F
IGURE 2.
Battery Recharger ............................................................................................................................................................................................................................ 22
F
IGURE 3
S4335-AW (CSI) & S4335-AWV (Gadox) Detector ................................................................................................................................................................. 23
F
IGURE 4
S4343-AW/ SZ4343-W (CSI) Detector ...................................................................................................................................................................................... 23
F
IGURE 5
Configuration of the Wireless Detector ................................................................................................................................................................................... 24
F
IGURE 6 DO NOT DROP
...................................................................................................................................................................................................................................... 26
F
IGURE 7
Location Considerations ................................................................................................................................................................................................................ 26
F
IGURE 8
Even Distribution of Weight ......................................................................................................................................................................................................... 27
F
IGURE 9
Localized Weight (Center) ............................................................................................................................................................................................................ 27
F
IGURE 10 POWER SUPPLY BOX
.......................................................................................................................................................................................................................... 29
F
IGURE 11
M
AIN CABLE
..................................................................................................................................................................................................................................... 30
F
IGURE 12 BATTERY RECHARGER
........................................................................................................................................................................................................................ 31
F
IGURE 13 BATTERY INSERT
............................................................................................................................................................................................................................. 32
F
IGURE 14 BATTERY
............................................................................................................................................................................................................................................... 33
F
IGURE 15 BATTERY INSTALLATION
..................................................................................................................................................................................................................... 33
F
IGURE 16 BATTERY COVER INSTALLATION
......................................................................................................................................................................................................... 34
F
IGURE 17 BATTERY COVER REMOVAL
................................................................................................................................................................................................................. 34
F
IGURE 18 BATTERY REMOVAL
............................................................................................................................................................................................................................. 34
Figure 19 IP
SET UP
............................................................................................................................................................................................................................................ 36
F
IGURE 20 POWER APPLIED COMPONENTS
(S4335-AW series，S4343-AW/SZ4343-W) .................................................................................................................... 37
Figure 18: X-ray exposure & image acquisition ...................................................................................................................................................................................... 38
Hereby, SAMSUNG ELECTRONICS CO., LTD. declares that the radio equipment type S4335-AW series, S4343-AW/SZ4343-W are in compliance with
Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address: https://www.samsungmedicalsolution.com
This product bears a CE marking in accordance with the provisions of the 93/42/EEC MDD.
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
S4335-AW series,S434AW/SZ4343-W, Digital Flat Panel X-Ray Detector are 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
Head Quarters
- 129 Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea
Contact Information
SAMSUNG ELECTRONICS Co., LTD.
129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea
SAMSUNG ELECTRONICS (UK) LTD.
Blackbushe Business Park Saxony Way, Yateley, Hampshire GU46 6GG, UK
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.
A
lternate 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 1 S
PECIAL SYMBOL
A
void 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
A
ppearance 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 2 SYSTEM MAINTENANCE CHECKPOINTS
□ 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: IEC609501, 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.
□ Do not keep patient contact for a long time for safe use.
Surface maximum temperature:41.3℃ (Conditions with an ambient temperature of 35℃)
WARNING
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.
EMC (Electromagnetic Compatibility)
□ Do not use any wireless devices, including cellular phones, near the system. All wireless devices, whether they comply
with the EMC standard or not, may emit electromagnetic interferences and cause the system to malfunction when they are
used nearby.
□ When using this system on a patient with an implantable pacemaker or an implantable cardioverter defibrillator, the
patient must be informed that continuous X-ray exposes in pulse form may cause the pacemaker or cardioverter
defibrillator to malfunction. When using this system, ensure that X-rays are not exposed directly onto the patient's
implantable pacemaker or cardioverter defibrillator, and that the exposure time is kept as short as possible.
□
This equipment should not be used adjacent to or stacked with other equipment;
if adjacent or stacked use is necessary, the equipment must be tested and verified in order to
ensure it operates normally in the configuration in which it will be used.
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
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