Samsung WIDT30Q User Manual

UMS4335-W

Digital Flat-Panel X-RAY Detector

User Manual for S4335-W

Samsung Electronics Co., Ltd.

This manual is prov ided for the installation and operation of S4335-W.

P lease read this manual before the detector install and use.

© 2013 Samsung Electronics C o., Ltd. A ll rights reserv ed.

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Revision History

Version	Date		Page		Revision
1.0	2013	April		-	1st Edition
1.1	2013	July	¤	37	The main revised item are as below
					- Table 1 OP ERATING TIME TABLE
1.2	2014	May	¤	28	The main revised item are as below
					- Changed Pow er Supply Box Input
1.3	2014. June		¤	51	Add FCC Statement of Conformance
				~	Add EMC Declaration
				58

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			Table of Contents
	About this Manual ........................................................................................................................................................................................................................................................			7
		Sy mbols Used in This Manual......................................................................................................................................................................................................................		7
		Intended for use ...............................................................................................................................................................................................................................................		8
		User Requirements ..........................................................................................................................................................................................................................................		8
		Serv ice Center ...................................................................................................................................................................................................................................................		8
1.	Safety instructions .....................................................................................................................................................................................................................................................			9
		Safety Instructions...........................................................................................................................................................................................................................................		9
			Sy stem Sy mbols.....................................................................................................................................................................................................................................	10
			Sy stem Maintenance Checkpoints....................................................................................................................................................................................................	12
			Genenral Safety......................................................................................................................................................................................................................................	13
			Electrical Safety ......................................................................................................................................................................................................................................	14
			Mechanical Safety..................................................................................................................................................................................................................................	15
			F ire Safety .................................................................................................................................................................................................................................................	15
			Safety fro m E xplosion .............................................................................................................................................................................................................................	15
			EMC (Electromagnetic Compatibility ).....................................................................................................................................	Error! Bookmark not defined.
			Label...........................................................................................................................................................................................................................................................	16
			Maintenace, Cleaning and Disposal.................................................................................................................................................................................................	16
			Disclaimer .................................................................................................................................................................................................................................................	17
2.	Syste m Overvie w.......................................................................................................................................................................................................................................................			18
		Sy stem Ov erview ...........................................................................................................................................................................................................................................		18
			Sy stem Purposes....................................................................................................................................................................................................................................	18
			Product components.............................................................................................................................................................................................................................	19
			Examination Room Components ......................................................................................................................................................................................................	20
			Control Room Components ................................................................................................................................................................................................................	21
3.	Syste m Co mponents.................................................................................................................................................................................................................................................			22
		Sy stem Components.....................................................................................................................................................................................................................................		22
			Detector ....................................................................................................................................................................................................................................................	22
			Power Supply Box..................................................................................................................................................................................................................................	27
			Main Cable................................................................................................................................................................................................................................................	28
			Battery Recharger..................................................................................................................................................................................................................................	29
			Battery .......................................................................................................................................................................................................................................................	32
				3

4.	Operating the Syste m Hard ware ...........................................................................................................................................................................................................................		34
	 Operating the Sy stem Hardware..............................................................................................................................................................................................................		34
		Checking Connection............................................................................................................................................................................................................................	34
		Operation..................................................................................................................................................................................................................................................	35
		Operating description...........................................................................................................................................................................................................................	36
5.	Appendices................................................................................................................................................................................................................................................................		37
	REQ UIRED PUBLIC STATEMENT FOR GPL/LGPL/GPLv 2/OpenSSL/CPOL LICENSED SOFTWARE USED IN THIS PRO DUCT............................................		38
GNU GENERA L PUBLIC LICENSE ........................................................................................................................................................................................................................			39
GNU LESSER GENERA L PUBLIC LICENSE ......................................................................................................................................................................................................			44
BSD LICENSE..................................................................................................................................................................................................................................................................			49

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Table 1 Special Symbol.................................................................................................................................................................................................................................		11
Table 2 Sy stem Maintenance Checkpoints.............................................................................................................................................................................................		12
Table 3 COMPONENTS.......................................................................................................................................................................................................................................		19
Table 4 LED STATUS........................................................................................................................................................................................................................................		23
Table 5 POWER SUPPLY BOX DESCRIPTION....................................................................................................................................................................................................		27
Table 6	BATTERY RECHARGER INDICATE LED................................................................................................................................................................................................	29
Table 7	BATTERY RESIDUAL DISPLAY..............................................................................................................................................................................................................	32
Table 8	BATTERY INDICATE LED.....................................................................................................................................................................................................................	33
Table 9	CHECKING THE POWER STATUS OF COMPONENTS (S4335-W) .......................................................................................................................................................	35
Table 10 POWER O FF STATUS.........................................................................................................................................................................................................................		35
Table 11 O PERATING TIME TABLE....................................................................................................................................................................................................................		36

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Figure 1 Examination Room Components..............................................................................................................................................................................................		20
FIGURE 2 RECHARGER.........................................................................................................................................................................................................................................		21
FIGURE 3	RECHARGER ADAPTER ........................................................................................................................................................................................................................	21
FIGURE 4 W IRELESS DETECTOR ........................................................................................................................................................................................................................		22
FIGURE 5	INDICATE LED....................................................................................................................................................................................................................................	23
FIGURE 6	DO NOT DROP..................................................................................................................................................................................................................................	24
FIGURE 7	Be CAREFUL OF DETECTOR LOCATION............................................................................................................................................................................................	25
FIGURE 8 KEEP WEIGHT DISTRIBUTED EVENLY...............................................................................................................................................................................................		25
FIGURE 9 AVOID LOCALIZED W EIGHT...............................................................................................................................................................................................................		25
FIGURE 10 POWER SUPPLY BOX........................................................................................................................................................................................................................		27
FIGURE 11 MAIN CABLE....................................................................................................................................................................................................................................		28
FIGURE 12 BATTERY RECHARGER......................................................................................................................................................................................................................		29
FIGURE 13 BATTERY INSERT.............................................................................................................................................................................................................................		30
FIGURE 14 BATTERY LOCK................................................................................................................................................................................................................................		30
FIGURE 15 BATTERY ...........................................................................................................................................................................................................................................		32
Figure 16 IP SET UP........................................................................................................................................................................................................................................		34
FIGURE 17 POWER APPLIED COMPONENTS (S4335-W)................................................................................................................................................................................		35
Figure 18: TIMING CHART................................................................................................................................................................................................................................		36

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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
		Indicates content which, if y ou fail to follow the accompanying
		instructions, may cause death or serious personal injury .
	Warning
		Indicates content which, if y ou fail to follow the accompanying
		instructions, may cause personal injury or damage to the product.
	Caution
		Prov ides users with additional information on the topic for better
	Note	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.

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Intended for use

S4335-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

Head Quarters

- 129 Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea

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1. SAFETY INSTRUCTIONS

Safety Instructions

□In this chapter, information of safety instructions and regulations are provided. It is provided to protect users of the systemfrom 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.

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 System Symbols

Table 1 shows the symbols related to maintaining the safety of the patient and the user.

Alternate current

Direct current

Protectiv e earth (Ground)

O ff (power : disconnect from the main switch)

O n (power : connect to the main switch)

Identifies terminals which, when connected together, bring various parts of a piece of equipment or of a sy stem to the same potential.

Indicates content which, if y ou 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

Mark s it contains radio transmitting dev ice.

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Av oid contact with water

No unauthorized or unlawful modification

Waste electrical and electronic equipment (WEEE)

Temperature limitation

Mark s fragile dev ice that requires full attention when handling.

Manufacturer

EC Representativ e

Table 2 SP E C IA L SYM BO L

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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	Chec k	Remark
					Interval

1	Noise / V ibration	In use	Check noise and v ibration from each	1 y ear
			operating parts of the sy stem.
2	Power Supply box	While in use	Check the power supply box v oltage	1 y ear
			while the equipment s turned off.
			Run a v isual inspection to check if the
			appearance shows any abnormalities,
3	Appearance	While in use	such as loosened bolts or had grips,	1 y ear
			transformation, etc. while the equipment
			is turned off.
			Check cable runs for worn out cables,
4	Cables	Before Using	damage or short circuited, broken wires,	6 months
			etc. while the equipment is turned off.
			Check the earth-grounding is intact, not
5	Grounding	While in use	brok en or loosened terminal. (Grounding	1 y ear
			resistance should be below 0.1Ω.)
6	Installation	When	When installing, check that the	1 y ear
	Checkpoints	Installing	equipment is lev eled and firmly fixed.

Table 3 SYSTEM MA INTENA NC E CH EC KP O INTS

□ 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

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Genenral Safety

WARNING

WARNING

WARNING

WARNING

WARNING

WARNING

WARNING

□ 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

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Electrical Safety

□ In compliance with IEC 60601-1, this medical equipment complies with the requirements for Safety class I, type B.

WARNING

□ This system must be used in an environment complying with the requirements of the IEC.

WARNING

WARNING

WARNING

WARNING

WARNING

WARNING

□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.

WARNING

WARNING

WARNING

WARNING

□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

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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.

WARNING

□ When an examination is in progress, auditory and visual communication between the patient and the systemuser must be possible at all times.

WARNING

□ Be careful not to pinch any part of your or the patient's body or clothing while using the system.

WARNING

□ 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.

WARNING

Fire Safety

□ Do not operate the system in a location where there is a danger of fire.

WARNING

□ 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

WARNING

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

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 Label

□ For information on the types and attachment locations of the Detector Component labels, refer to Labels.

WARNING

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.

WARNING

□ Do not open the cover and insert liquids into the system.

WARNING

WARNING

WARNING

WARNING

WARNING

□ 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.

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WARNING

WARNING

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.

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2. SYSTEM OVERVIEW

System Overview

 System Purposes

The S4335-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.

S4335-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.

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