Vieworks FXRD-1012NAW Users Manual
VIVIX-S 1012N User Manual
© Vieworks. 2015 All rights reserved.
Under copyright laws, this manual should not be reproduced, in whole or in part, without the written
permission of Vieworks.
VIVIX-S 1012N User Manual
Contents
1. Instruction ......................................................................................................................................... 8
1.1 Document Guide ..................................................................................................................................... 9
1.1.1 Caution Information ..................................................................................................................................................... 9
1.1.2 Ta rget ................................................................................................................................................................................... 9
1.1.3 Symbols .............................................................................................................................................................................. 9
1.1.4 Notations .........................................................................................................................................................................10
1.1.5 Contact Department ...................................................................................................................................................10
1.2 Product Use Guide ................................................................................................................................ 11
1.2.1 Product Usage ...............................................................................................................................................................11
1.2.2 Disclaimer ........................................................................................................................................................................11
1.2.3 Product Disposal ..........................................................................................................................................................12
1.2.4 Trademarks ......................................................................................................................................................................12
1.3 Safety Instruction .................................................................................................................................. 13
1.3.1 Management and Authority ...................................................................................................................................13
1.3.2 Power Supply .................................................................................................................................................................13
1.3.3 Handling ...........................................................................................................................................................................14
1.3.4 Battery Pack and Charger ........................................................................................................................................15
1.3.5 Environment of Use ....................................................................................................................................................16
1.3.6 Problem Management ...............................................................................................................................................17
1.3.7 Maintenance and Inspection ..................................................................................................................................17
1.4 Product Usage Guide ............................................................................................................................ 18
1.4.1 Calibration .......................................................................................................................................................................18
1.4.2 Length Measurement .................................................................................................................................................18
1.4.3 Left/Right Marker.........................................................................................................................................................18
1.4.4 Image Backup ................................................................................................................................................................18
1
.4.5 Use Limitations .............................................................................................................................................................19
1.4.6 Disposal ............................................................................................................................................................................19
1.4.7 Pediatric Application ..................................................................................................................................................19
1.4.8 Before Exposure ............................................................................................................................................................19
1.4.9 During Exposure ...........................................................................................................................................................20
1.4.10 Operating and Storage Environment .................................................................................................................20
1.4.11 Others................................................................................................................................................................................20
2. Product ............................................................................................................................................. 21
2.1 Overview ................................................................................................................................................. 22
2.1.1 Features ............................................................................................................................................................................22
2.2 Product Components ............................................................................................................................ 23
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2.2.1 Detector............................................................................................................................................................................23
2.2.2 SCU (System Control Unit) ......................................................................................................................................23
2.2.3 Battery & Charger .......................................................................................................................................................24
2.2.4 Accessaries ......................................................................................................................................................................25
2.3 VIVIX-S 1012N Detector ...................................................................................................................... 26
2.3.1 Specifications .................................................................................................................................................................26
2.3.2 Drawing Sheet ...............................................................................................................................................................27
2.3.3 Functions .........................................................................................................................................................................29
2.3.4 Deco Sheet .....................................................................................................................................................................31
2.3.5 Wireless Communication..........................................................................................................................................33
2.3.6 Use Environment ..........................................................................................................................................................33
2.4 SCU Basic (FXRS-02A) .......................................................................................................................... 34
2.4.1 Specifications .................................................................................................................................................................34
2.4.2 Drawing Sheet ...............................................................................................................................................................34
2.4.3 Functions .........................................................................................................................................................................35
2.5 SCU Basic (FXRS-03A) .......................................................................................................................... 37
2.5.1 Specifications .................................................................................................................................................................37
2.5.2 Drawing Sheet ...............................................................................................................................................................37
2.5.3 Functions .........................................................................................................................................................................38
2.6 SCU mini (FXRS-04A) ............................................................................................................................ 40
2.6.1 Specifications .................................................................................................................................................................40
2.6.2 Drawing Sheet ...............................................................................................................................................................40
2.6.3 Functions .........................................................................................................................................................................41
2.7 Battery Pack ........................................................................................................................................... 43
2.7.1 Specifications .................................................................................................................................................................43
.7.2 Drawing Sheet ...............................................................................................................................................................43
2
2.8 Battery Charger ..................................................................................................................................... 44
2.8.1 Specifications .................................................................................................................................................................44
2.8.2 Drawing Sheet ...............................................................................................................................................................44
2.9 Others ...................................................................................................................................................... 45
2.9.1 X-ray Generator (Recommended Exposure Condition)..............................................................................45
2.9.2 Recommended Specifications of Workstation (PC) .....................................................................................45
2.9.3 Recommended Specifications of Grid ................................................................................................................45
3. System Configuration ................................................................................................................... 46
3.1 Detector Connection Methods ........................................................................................................... 47
3.1.1 Wireless Connection ...................................................................................................................................................47
3.1.2 Wired Connection ........................................................................................................................................................48
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3.2 Diagram ................................................................................................................................................... 49
3.2.1 Block Diagram ...............................................................................................................................................................49
3.2.2 Wiring Diagram ............................................................................................................................................................49
3.3 System Configuration ........................................................................................................................... 50
3.3.1 AP Mode (SCU AP Mode)........................................................................................................................................50
3.3.2 Tether Interface Mode ...............................................................................................................................................51
3.3.3 External AP Mode ........................................................................................................................................................52
3.3.4 Detector AP Mode ......................................................................................................................................................53
3.3.5 Detector Stand-Alone Mode ..................................................................................................................................54
3.4 Generator Interface ............................................................................................................................... 55
3.4.1 AED (Auto Exposure Detection) Interface ........................................................................................................55
3.4.2 DR Trigger Interface ...................................................................................................................................................56
3.5 Configuring DR Trigger Interface ...................................................................................................... 57
3.5.1 Trigger Interface Way .................................................................................................................................................57
3.5.2 Packet Trigger ................................................................................................................................................................57
3.5.3 Line Trigger .....................................................................................................................................................................58
3.5.4 EXT_INF Port Pin Map ...............................................................................................................................................59
3.5.5 Input / Output Circuit ................................................................................................................................................61
4. Installation ....................................................................................................................................... 62
4.1 Battery Pack ........................................................................................................................................... 63
4.1.1 How to insert a battery pack .................................................................................................................................63
4.1.2 How to take out a battery pack ...........................................................................................................................64
4.1.3 How to charge a battery pack ..............................................................................................................................65
4.2 Product Installation .............................................................................................................................. 67
4.2.1 Connecting Devices ....................................................................................................................................................67
4.2.2 Booting up SCU ............................................................................................................................................................70
.2.3 Booting up the Detector ..........................................................................................................................................70
4
4.2.4 Checking Status LED of Detector .........................................................................................................................71
4.3 Software Installation ............................................................................................................................. 73
4.3.1 Software Classification...............................................................................................................................................73
4.3.2 Software Installation ...................................................................................................................................................73
4.4 Windows Environment Setting ........................................................................................................... 74
4.4.1 Network Configuration .............................................................................................................................................74
4.4.2 Disabling Sleep Mode of Monitor .......................................................................................................................78
5. Setting .............................................................................................................................................. 79
5.1 Start Setting ........................................................................................................................................... 80
5.1.1 Setup Program ..............................................................................................................................................................80
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5.1.2 Checking Devices .........................................................................................................................................................80
5.1.3 Getting into the Devices ..........................................................................................................................................82
5.2 SCU Setting ............................................................................................................................................ 83
5.2.1 SCU Configuration ......................................................................................................................................................83
5.2.2 SCU Diagnosis ...............................................................................................................................................................86
5.3 Detector Setting .................................................................................................................................... 87
5.3.1 Detector Configuration .............................................................................................................................................87
5.3.2 Detector Power Save Function ..............................................................................................................................90
5.4 Changing the Wireless Setting ........................................................................................................... 92
5.4.1 Switching to the Detector AP Mode ..................................................................................................................92
5.4.2 Synchronizing the Wireless Setting .....................................................................................................................92
6. Calibration ....................................................................................................................................... 93
6.1 Calibration Dialogue ............................................................................................................................. 94
6.1.1 System Configuration Dialogue ............................................................................................................................94
6.1.2 Offset Calibration Dialogue ....................................................................................................................................97
6.1.3 Defect Calibration Dialogue ...................................................................................................................................98
6.1.4 Gain Calibration Dialogue .......................................................................................................................................99
6.2 Detector Configuration ...................................................................................................................... 100
6.3 Calibration Guide ................................................................................................................................ 102
6.4 Calibrating by Loading the Calibration Data ................................................................................. 103
6.4.1 Preparing Calibration Data ................................................................................................................................... 103
6.4.2 Loading Defect Calibration Data ....................................................................................................................... 103
6.4.3 Loading Gain Calibration Data ........................................................................................................................... 104
6.5 Direct Calibration ................................................................................................................................ 105
6.5.1 Prepration ..................................................................................................................................................................... 105
6.5.2 Offset Calibration ...................................................................................................................................................... 105
6
.5.3 Gain Calibration ......................................................................................................................................................... 106
6.5.4 Auto Defect Correction .......................................................................................................................................... 107
6.5.5 Manual Defect Correction .................................................................................................................................... 111
7. Diagnosis, Inspection and Maintenance ................................................................................. 114
7.1 Diagnosis .............................................................................................................................................. 115
7.1.1 Image Diagnosis ........................................................................................................................................................ 115
7.1.2 Battery Pack Diagnosis ........................................................................................................................................... 117
7.1.3 Wireless Communication Diagnosis ................................................................................................................. 118
7.1.4 Communication Speed Diagnosis ..................................................................................................................... 119
7.2 Product Inspection .............................................................................................................................. 120
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7.2.1 Daily Inspection ......................................................................................................................................................... 120
7.2.2 Performance Inspection ......................................................................................................................................... 120
7.3 Cleaning and Disinfection ................................................................................................................. 124
7.4 Product Initialization .......................................................................................................................... 125
7.4.1 SCU Initialization ....................................................................................................................................................... 125
7.4.2 Detector Initialization .............................................................................................................................................. 126
7.4.3 Wireless Initialization of Detector ..................................................................................................................... 127
7.5 Replacing the Fuse of SCU (SCU Basic only) ................................................................................. 128
8. Troubleshooting ........................................................................................................................... 129
8.1 Trobleshooting ..................................................................................................................................... 130
8.1.1 Failed to Turn the Detector On .......................................................................................................................... 130
8.1.2 The Power Switch of SCU or Status LED is not worked ......................................................................... 130
8.1.3 Communication Test is failed .............................................................................................................................. 131
8.1.4 The Active LED and Data LED of the Detector are blinking ................................................................ 131
8.1.5 Errors in Detector LED ............................................................................................................................................ 132
8.1.6 Rapid Consumption of Battery ........................................................................................................................... 132
8.1.7 Battery Pack or Installation Part of Battery is Getting Hot ................................................................... 132
9. Regulatory Information .............................................................................................................. 133
9.1 Medical Equipment Safety Standards ............................................................................................. 134
9.1.1 Medical Equipment Classification ..................................................................................................................... 134
9.1.2 Product Safety Standard ........................................................................................................................................ 134
9.2 Radio Frequency Compliance Information ..................................................................................... 136
9.2.1 FCC Compliance ........................................................................................................................................................ 136
9.2.2 FCC SAR ........................................................................................................................................................................ 137
9.2.3 CE R&TTE SAR............................................................................................................................................................ 137
9.3 Labels and Symbols ............................................................................................................................ 138
.3.1 Label ............................................................................................................................................................................... 138
9
9.3.2 Product Serial Number........................................................................................................................................... 143
9.3.3 Product Symbols ....................................................................................................................................................... 144
9.4 Guidance and Manufacturer’s Declaration for EMC ..................................................................... 145
9.4.1 Electromagnetic Emissions ................................................................................................................................... 145
9.4.2 Electromagnetic Immunity .................................................................................................................................... 145
10. Information ................................................................................................................................ 148
10.1 Service Information ........................................................................................................................ 149
10.1.1 Product Lifetime ........................................................................................................................................................ 149
10.1.2 Regular Inspection and Maintenance ............................................................................................................. 149
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10.1.3 Repair ............................................................................................................................................................................. 149
10.1.4 Replacement Parts Support ................................................................................................................................. 149
10.1.5 Consumables ............................................................................................................................................................... 149
10.2 Warranty ............................................................................................................................................ 150
10.3 Revision History ............................................................................................................................... 151
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VIVIX-S 1012N User Manual
1. Instruction
This section gives basic information of this manual and products with the safety guide.
Document Guide
Product Use Guide
Safety Instruction
Product Operation Guide
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1.1 Document Guide
This User Manual explains how to use the VIVIX-S 1012N detector made by Vieworks, X-ray interface unit,
and other peripheral equipment. With this user manual, you can install, set and manage the VIVIX-S 1012N
wired/wireless detectors as well as use its various functions.
1.1.1 Caution Information
If the user is not fully aquainted with this manual, the product can be malfunctioned or unsuspected
problem can be happened due to carelessness. To prevent any medical accidents, the user should fully
understand the instructions of this manual before operating this product.
1.1.2 Targe t
This manual is intended for service enginneers who install and set the VIVIX-S 1012N detector.
VIVIX-S 1012N User Manual
1.1.3 Symbols
This product should be operated under the safety instructions with the warning or caution symbol in this
manual. It is important for you to read and understand the contents with the following symbol for
operating the products safely.
Caution and Warning Symbol
This symbol is used to indicate a potentially hazardous situation which may cause death,
personal injury or substantial property damage if the instructions are ignored. Be sure to
understand the instructions of this symbol for the safe operation.
Information Symbol
This symbol is used to indicate reference and complementary information related to the
product. Users should read the instructions of this symbol carefully.
Symbol for Change
This symbol is indicated in the cases below.
Items under consideration for adding, deleting or revising contents.
Items ready to review for the expected product change.
Items need a final review and approval.
Items which need to improve sentences or images.
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Item Contents
Department
Technical Support Division in Vieworks
E
techsupport@vieworks.com
1.1.4 Notations
Bold Types
We applied bold font style to the words which indicated products terms, or the words and sentences which
are needed to transmit clear meaning to the customers. This helps you to easily distinguish the words from
other technical ones for explaining functions.
1.1.5 Contact Department
For any comments or inquiries regarding this document, contact via email below.
VIVIX-S 1012N User Manual
-mail
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1.2 Product Use Guide
This chapter provides instructions about the use of product and disposal as well as the liability limit of
Vieworks.
1.2.1 Product Usage
1 Only a physician or a legally certified operator should use this product.
2 The equipment should be kept in a safe and operable condition by maintenance personnel.
3 Observe the contents written in this user manual when installing and using this product.
4 Use only specifications of computers and image display monitors recommended by this user manual.
5 Use only the dedicated cables provided with this product.
6 For details about installing and using this product, consult your sales representative or a distributor.
VIVIX-S 1012N User Manual
1.2.2 Disclaimer
1 In no event shall Vieworks be liable for damage or loss arising from a fire, earthquake, any intentional
or negligent action by users.
2 In no event shall Vieworks be liable for damage or loss arising from any trial usage, or other usage
under abnormal conditions.
3 In no event shall Vieworks be liable for personal physical harm or property damage that is sustained
when the instructions of this manual are not followed.
4 In no event shall Vieworks be liable for direct or indirect consequential damages arising from the use of
this product.
5 In no event shall Vieworks be liable for any damage arising from moving, alteration, inspection or repair
by a person other than authorized service engineers.
6 In no event shall Vieworks be liable for loss of image data for any reason.
7 Roentgenography, image processing, image reading, and image data storage must be performed in
accordance with the laws of the country or region in which the product is being used.
8 The user is responsible for maintaining the privacy of image data acquired from this product.
9 It is the responsibility of the attending physicians to provide medical care services. Vieworks will not be
liable for faulty diagnoses.
10 Specifications, composition, and appearance of this product may change without prior notice.
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1.2.3 Product Disposal
Disposal of this product in an unlawful manner may have a negative impact on human health and the
environment. When disposing this product, therefore, be absolutely sure to follow the procedure which is in
conformity with the laws and regulations applicable in your area.
European Union (and EEA*) only
This symbol indicates that this product is not to be disposed with your household waste,
according to the WEEE Directive (2002/96/EC) and your national law.
This product should be handed over to a designated collection point, e.g., on an authorized
one-for-one basis when you buy a new similar product or to an authorized collection site for
recycling electrical and electronic equipment (EEE). Improper handling of this type of waste
could have a negative impact on the environment and human health due to potentially
hazardous substances that are generally associated with EEE. At the same time, your
cooperation in the correct disposal of this product will contribute to the effective usage of
natural resources. For more information on where you can drop off your waste equipment
for recycling, please contact your local city office, waste authority, approved WEEE scheme,
or your household waste disposal service.
*EEA: Norway, Iceland, and Liechtenstein
VIVIX-S 1012N User Manual
1.2.4 Trademarks
The name “Vieworks” and Vieworks logo are registered trademarks of Vieworks.
© Vieworks. 2014 All rights reserved.
The copyright of this document is owned by Vieworks. Under copyright laws, this document cannot be
reproduced, in whole or in part, without the written permission of Vieworks.
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with voltage and current
1.3 Safety Instruction
This product is designed and manufactured to ensure maximum safety of operation and to meet all
the safety requirements applicable to electronic medical equipment. Follow these safeguards while
using the products. If not, severe personal injury or substantial property damage can be happened. It
is important for you to read and understand the contents of this manual before attempting to use the
product.
1.3.1 Management and Authority
The product should be installed, operated, and serviced according to Vieworks
maintenance procedures and by personnel from Vieworks or distributor who providing
purchase of the Vieworks’ product.
Operation and maintenance should be done in strict compliance with the operation
instructions contained in the manual.
The system, in whole or in part, cannot be modified in any way without prior approval
from Vieworks.
Before authorizing any person to operate the system, verify that the person has read and
fully understood the User Manual. The owner should make certain that only properly
trained and fully qualified personnel are authorized to operate the equipment. An
authorized operators list should be made and maintained.
It is important that this User Manual be kept at hand, studied carefully, and reviewed
periodically by the authorized operators.
If a malfunction occurs, do not use this device until qualified personnel correct the
problem.
VIVIX-S 1012N User Manual
1.3.2 Power Supply
Do not operate the equipment using any type of power supply other than the one
Do not supply power to more than one piece of equipment using the same AC outlet for
Do not connect a multiple portable socket-outlet or extension cord to the system. Doing
Always connect the three-core power cord plug to a grounded AC power outlet.
Be sure to ground the equipment to an indoor grounded connector. Also, be sure to
Do not use any power source other than the one provided with this product. Otherwise, a
The owner should ensure continuous power supply to the system
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indicated on the rating label. Otherwise, it may result in a fire or electric shock.
this product. Doing so may result in a fire or electric shock.
so may result in a fire or electric shock.
connect all the grounds for the system to a common ground.
fire or electric shock may be caused due to a leakage.
according to the product specifications. If the system is powered unstably during its
operation, we recommend you to install UPS (Uninterrupted Power Supply) to avoid loss
of data.
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To make it easy to disconnect the plug at any time, avoid putting any obstacles near the
outlet. Otherwise, it may not be possible to disconnect the plug in an emergency.
Do not place a heavy object such as medical equipment on cables and cords, and do not
pull, bend, bundle, or step on them. Doing so may damage their sheath. If you alter them,
it may damage the cords which could result in a fire or electric shock.
Securely plug the power cord into the AC outlet. If contact failure occurs, or if dust/metal
objects come into contact with the exposed metal prongs of the plug, fire or electric
shock may result.
Be sure to turn OFF the power to each piece of equipment before connecting or
disconnecting the cords. Otherwise, you may get an electric shock that could result in
death or serious injury.
Be sure to hold the plug or connector to disconnect the cord. If you pull the cord, the
core wire may be damaged, resulting in a fire or electric shock.
Do not handle the product with wet hands. You may experience an electric shock that
could result in death or serious injury.
1.3.3 Handling
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Never disassemble or modify the equipment. Doing so may result in a fire or electric
shock. Also, since the equipment incorporates parts that may cause an electric shock as
well as other hazardous parts, touching them may cause death or serious injury.
Do not connect any equipment which is not specified in this User Manual.
Do not place anything on surface of the equipment. The object may fall and cause an
injury. Also, if metal objects such as needles or clips fall into the equipment, or if liquid is
spilled, it may result in a fire or electric shock.
Do not hit or drop the equipment. It may be damaged if receiving a strong jolt. If the
equipment is used without being repaired, it may result in a fire or electric shock.
Do not place excessive weight on the detector. The internal image sensor may be
damaged and it can affect to the image quality.
Have the patient take a fixed posture and do not let him or her touch parts unnecessarily.
If the patient touches connectors or switches, it may result in electric shock or malfunction
of the equipment.
Do not spill liquid or chemicals onto the detector. In cases where the patient is injured,
protect the equipment with a disposable covering not allow to come in contact with
blood or other body fluids. Otherwise, it may result in a fire or electric shock.
For safety reasons, be sure to turn OFF the power of the equipment when the inspections
indicated in this manual are going to be performed.
Do not submerge the detector in water.
Be sure to use the detector on a flat surface so it will not bend. Otherwise, the internal
image sensor may be damaged. Be sure to securely hold the detector while using it in
upright positions.
Because the equipment cable is long, take care that cables do not become tangled during
use. Also, be careful not to get your feet caught in the cable. It may cause a malfunction
of the equipment or injury to the user from tripping over the cable.
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Do not block the ventilation ports of SCU to prevent overheating. Overheating can cause
product’s malfunctions and damages.
1.3.4 Battery Pack and Charger
Do not use the battery pack as a power source for equipment other than VIVIX-S 1012N
detector. Be sure to use only the dedicated battery pack for the VIVIX-S 1012N detector.
The battery charger is designed for the dedicated battery pack. Do not use the battery
charger other than the dedicated one. Otherwise, a battery explosion or a battery leak
may occur, resulting in fire or electrical shock.
Do not operate the battery charger using any type of power supply other than the one
indicated on the rating label.
Do not handle the product with wet hands.
Do not attempt to disassemble, alter, or apply heat to the product.
Avoid dropping or subjecting the product to severe impacts. To avoid the risk of injury,
do not touch the internal parts of the battery if it has been cracked.
Stop using the battery pack immediately if it emits smoke, a strange smell, or otherwise
behaves abnormally.
Do not let the battery pack and battery charger come into contact with water or other
liquids and do not allow them to get wet.
Do not clean with substances containing organic solvents such as alcohol, benzene,
thinner, or other chemicals. Otherwise, fire or electrical shock may result.
Do not allow dirt or metal objects (such as hair pins, clips, staples or keys) to contact the
terminals. Otherwise, battery explosion or leakage of electrolyte may occur, resulting in
fire, injury or pollution of surrounding area. If the battery leaks and the electrolytes come
into contact with your eyes, mouth, skin or clothing, immediately wash it away with
running water and seek medical attention.
Do not leave, store, or place the product in a location near heat sources, or in a place
subject to direct sunlight, high temperature, high humidity, excessive dust, or mechanical
shock. Otherwise, battery leakage, overheating or damage to the product may occur,
resulting in electrical shock, burns, injury or fire.
Do not attempt to use a battery pack that has deteriorated. Using a battery pack that has
exceeded its life cycle may lead to overheating, fire or explosion.
The Lithium ion battery is recyclable.
Battery slowly discharges even if not in use.
The battery pack may have expired if it discharges immediately after being fully charged.
You can purchase an optional battery pack to replace an exhausted one.
The battery pack is a consumable item. If a fully charged battery is consumed quickly, use
a new and fully charged battery pack.
Be sure to charge the battery periodically (once a year) if it is not used for an extended
period of time. The battery pack cannot be charged if it has been over discharged.
Before discarding the battery pack, cover the terminals with adhesive tape or other
insulators. Contact with other metal materials may cause fire or explosion.
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1.3.5 Environment of Use
Do not install the equipment in any of the locations listed below. Doing so may result in
failure or malfuction, equipment falling, fire, or injury.
Close to facilities where water is used.
Where it will be exposed to direct sunlight
Close to the air outlet of an air-conditioner or ventilation equipment
Nearby the electric heating applicance such as a heater
Where the power supply is unstable
In a dusty environment
In a saline or sulfurous environment
Where temperature or humidity is higher than the operating temperature
Where there is freezing or condensation
In areas prone to vibration
On an incline or in an unstable area
This product may malfunction due to electromagnetic interference (EMI) caused by
telecommunication devices, transceivers, electronic devices, etc. To prevent the
electromagnetic wave from badly influencing the product, be sure to avoid placing it in
close proximity to the product. Or, change direction or position of the product or move
into the shielded place to reduce electromagnetic interference.
This equipment is not suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.
Conductive fluids that drain into the active circuit components of the system may cause
short circuits that can result in electrical fire. Therefore, do not place fluids or food on any
part of the system.
To avoid electric shocks and burns caused by use of the wrong type of fire extinguisher,
make sure that the fire extinguisher at the site has been approved for use on electrical
fires.
The battery charger and SCU (System Control Unit) cannot be used in patient’s vicinity.
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1.3.6 Problem Management
Should any of the following occur, immediately turn OFF the power to each piece of
equipment, unplug the power cord from the AC outlet, and contact sales representative or
distributor.
When there is smoke, an odd smell or abnormal sound no period.
When liquid is spilled into the equipment or a metal object is entered through an
opening.
When the equipment has been dropped and is damaged.
1.3.7 Maintenance and Inspection
Do not use or store the equipment near flammable chemicals such as acetone, benzene,
thinner, etc. If chemicals are spilled or evaporated, it may result in a fire or electric shock
through contact with electric parts inside the equipment.
If any flammable cleaning agent is used for the product, be sure to take care when using
them.
When the equipment is going to be cleaned, be sure to turn OFF the power of the
equipment and unplug the power cord from the AC outlet. Never use thinner, acetone,
benzene or any other flammable cleaning agent. Otherwise, it may result in a fire or
electric shock.
Clean the plug of the power cord periodically by unplugging it from the AC outlet and
removing dust or dirt from the plug, its periphery, and AC outlet with a dry cloth. If the
cord is kept plugged in for a long time in a dusty, humid or sooty place, dust around the
plug will attract moisture, and this could cause insulation failure that could result in a fire.
Be sure to turn OFF the power of the equipment while cleaning. Otherwise, a fire or
electric shock may occur.
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1.4 Product Usage Guide
When using the equipment, take the following precautions. Otherwise, problems may
occur and the equipment may not function correctly.
1.4.1 Calibration
To ensure optimal system performance, it is important to verify that the system is calibrated correctly.
Check if the calibration is performed after the equipment is completed to be installed or repaired.
Do not try to use the system if the calibration has not been performed.
You can process calibration with the calibration data CD (provided).
The calibration result can be different by the use environment. Therefore, if the result with
the provided calibration data is not satisfied, you can create the data at the field in
person by using VIVIX Setup, the calibration software.
VIVIX-S 1012N User Manual
1.4.2 Length Measurement
Before taking any length measurement on an image, carry out the length calibration with a reference
object and verify its results for correct measurement.
1.4.3 Left/Right Marker
The operator is responsible for making a correct and clear mark on the left or right side of the image.
The software includes a function to mark the image with L (left) or R (right) while acquiring the image
through printing and archiving.
Prepare an alternative way to prevent any confusion if the operator does not choose to use L/R marks.
1.4.4 Image Backup
To avoid missing images which might result in a patient being exposed to additional dose of radiation,
it is important to send images to PACS or backup images by using film or external storage media (CD,
DVD, HDD, USB).
If the hard disk of your workstation is about to be full, the operator should backup images to
somewhere else and delete them to make storage (memory) space in the hard disk for new patients.
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The image backup should be done as a routine operation for every patient and image.
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1.4.5 Use Limitations
Vieworks software has the engineer mode operated by inputting the administrator password only.
This mode should be operated by the person who is qualified by Vieworks.
1.4.6 Disposal
Disposal of this product in an unlawful manner may have negative effects on human health and the
environment.
Be sure to follow the procedure which is in conformity with the laws and regulations applicable in your
area.
1.4.7 Pediatric Application
Every request should be reviewed by a pediatric radiologist prior to beginning the examination to
ensure that an appropriate study is being performed.
If the technologist notices an unusual request, he or she must contact a radiologist in charge.
Examples include orders- a Full Cervical, Thoracic, and Lumbar Spine series. The pediatric radiologist
should contact the ordering physician and decide which study is best for the pediatric patient.
The technologist should use a proper technique considering the patient’s size to decrease the
radiation dose when he or she acquires diagnostic images.
ALL pediatric patients shall be shielded for their X-ray examinations, except for when the shield will
obscure the region of interest, as in a pelvic or SI joint X-ray for trauma or arthritis, or when it is
physically or clinically unreasonable to shield the patient.
For routine Hip X-Rays, ALL male children shall have their scrotum shielded using the small gonadal
shield while females may not be shielded because doing so would obscure the hips.
To minimize motion in infants and young children, swaddle the infant. Use distraction tools to improve
cooperation and projectors with child-friendly themes, music, toys with flashing lights or music, child-
friendly images on the ceiling or walls, singing, counting, and a parent reading and talking to the child
through the console all can help reduce anxiety and comfort the child.
A scoliosis series will consist of a single frontal standing view of the spine. No lateral view or supine
view is needed, unless specifically asked for by the Orthopedist or Radiologist. If the female’s breasts
can be shielded without obscuring the spine, breast shields should be used.
VIVIX-S 1012N User Manual
1.4.8 Before Exposure
Be sure to check the equipment daily and confirm that it works properly.
Sudden heating of the room in cold areas will cause condensation to form on the equipment. In this
case, wait until the condensation evaporates before performing an exposure. If the equipment is used
while condensation is formed in it, problems may occur in the quality of captured images.
When an air-conditioner is used, be sure to raise/lower the temperature gradually so that difference
between the temperature in the room and in the equipment does not occur, to prevent condensation.
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Classification
Temperature
Humidity (Non
Atmos
Operating Environment
+10 ~ +35
30
700
Storage Environment
-
10
500
1.4.9 During Exposure
This equipment is not protected (sealed) against liquids such as blood and medicine in the operating
room. If necessary, wrap the equipment in a disposable cover when using it.
Do not use the selected frequency channel (2.4 ㎓ and 5 ㎓ dual band) for other wireless devices.
Mutual interference may affect the image data transmission rate.
Do not use the detector near devices generating a strong magnetic field. Doing so may produce
image noise or artifacts.
1.4.10 Operating and Storage Environment
This equipment is mainly used in the X-ray exposure room and hospital wards. To use it in other
places, consult Vieworks’ sales representative or a distributor.
Do not expose this equipment to high temperatures and/or high humidity. Malfunctions may occur.
When not in use, keep the products in a safe location.
Be sure to use and store this equipment under the conditions described below.
VIVIX-S 1012N User Manual
1.4.11 Others
Do not use this equipment in combination with peripherals such as defibrillators or large electric
motors as these may cause power-supply noise or power supply voltage variations. Doing so may
prevent normal operation of this equipment and peripherals.
15 ~ +55℃
℃
~ 85%
~ 90%
-condensing)
phere
∼ 1060 hPa
∼ 1060 hPa
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VIVIX-S 1012N User Manual
2. Product
This section gives an instruction about the product components and their specifications.
Overview
Product Components
VIVIX-S 1012N Detector
SCU
Battery Pack
Battery Charger
Others
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2.1 Overview
ViVIX-S 1012N detector is the digital X-ray imaging solution. It acquires images by exposing X-ray which
has been penetrated the human body. When X-ray photons pass through scintillator in the detector, the
photons convert to visible ray, and the visible ray is converted to electronic signals through TFT (a-Si). Then
the detector digitalizes x-ray images and transfers them to the computer (workstation) for radiography
diagnostics. Users can perform image diagnosis easily through the image display monitor with this process.
Advanced digital image processing also allows considerably efficient diagnosis, all kinds of information
management, and sharing of image information on network.
VIVIX-S 1012N User Manual
This detector is used for the general-purpose diagnostic procedures, and it is intended to
replace radiographic film / screen systems.
This detector is not intended for mammography applications.
2.1.1 Features
Since VIVIX-S 1012N detector is compatible with a conventional film cassette, it enables to replace
the analog radiographic diagnosis (Supporting ISO4090 standard).
The new sensor with 124μm pixel pitch produces high spatial resolution (approx. 5.2 Mega pixels)
digital images.
Various applications such as neonatal, ENT, equine and cephalo
Choose between two scintillator types (CsI and Gadox) of detector provided by Vieworks.
The built-in wireless communication supports IEEE 802.11n to acquire images without a wired
connection in anytime, anywhere.
Make direct wireless communication with the built-in wireless AP function. (Inside AP
Supports the stable and reliable AED (Auto Exposure Detection) function. (AnytimeTM)
Designed as lightweight and thin with portability to allow easy exposure in anytime, anywhere.
Used in various ways for infant / animals and in the dental clinic / ENT, etc.
TM
)
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Component
Description
VIVIX
Wireless Detector
VIVIX
Wired Detector
Component
Description
SCU Basic
(FXRS
SCU Basic
(FXRS
2.2 Product Components
2.2.1 Detector
VIVIX-S 1012N User Manual
-S 1012N
-S 1012N
FXRD-1012NAW (2.2kg)
A deco sheet attached on the detector can be different depending on each client
company.
FXRD-1012NBW (2.2kg)
FXRD-1012NA (2.2kg)
FXRD-1012NB (2.2kg)
2.2.2 SCU (System Control Unit)
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FXRS-02A (2.5kg)
-02A)
-03A)
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AC Power Cable (2m)
FXRS-03A (2.8kg)
AC Power Cable (2m)
SCU mini
(FXRS
Component
Description
Battery
Charger
VIVIX-S 1012N User Manual
FXRS-04A (1.2kg)
-04A)
DC Power Supply (24V)
AC Power Cable (2m)
You can choose the type of SCU depending on the purpose of use.
2.2.3 Battery & Charger
FXRB-03A (0.12kg, 2EA)
FXRC-02A (0.8kg)
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DC Power Supply (24V)
Page 24 of 151 VW40-152-009
Component
Description
Resource
Cables
2.2.4 Accessaries
VIVIX-S 1012N User Manual
Software (Viewer or SDK)
Manuals
Tether Interface Cable (7m)
Ether Con Cable (7m, Option)
Generator Interface Cable (7m)
UTP LAN Cable (15m, Direct)
CAT 5E or CAT6
The use of accessories and cables other than those approved and sold by Vieworks Co.,
Ltd. may result in increased release of electromagnetic waves or decreased stability of the
equipment.
Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC standards. All combinations of equipment must be in
compliance with IEC 60601-1-1 system requirements.
Any person who connects additional equipment to the signal input or signal output ports
configures a medical system, and is therefore responsible for ensuring that the system
complies with the requirements of the system standard IEC 60601-1.
Consult your sales distributor or manufacturer if you have any concerns.
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Item Specifications
Model
Image
X
Pixel
Field of
Active
Active
Effective
Effective
Grayscale
Spatial
Image
Image
Recommended Cycle Time
X
Rated
Power
Dimensions
Weight
Image
Data
Data
2.3 VIVIX-S 1012N Detector
VIVIX-S 1012N is designed to acquire digital images by collecting x-ray signals and sereval conversion
processes. You can use the acquired image (10” x 12” film size) diversely depending on the purpose of use.
VIVIX-S 1012N is one of the VIVIX detector models produced by Vieworks.
2.3.1 Specifications
VIVIX-S 1012N User Manual
Sensor
-ray Scintillator Type
Pitch
View
Area (H x V)
Array
Area
Array
Resolution
Acquisition Time (Wired)
Acquisition Time (Wireless)
-ray Synchronization Control
FXRD-1012NA (CsI)
FXRD-1012NAW (CsI)
TFT: a-Si (Amorphous Silicon)
FXRD-1012NA(W) : Csl: TI (Thallium doped Caesuim Iodide)
FXRD-1012NB(W) : Gd2O2S:Tb (Gadolinium oxysulfide)
0.124㎜ (124㎛)
10” x 12”
253.95㎜ × 317.44㎜
2048 x 2560 pixels
252.5㎜ x 316.0㎜
2036 x 2548
16bit
Min. 4.0 lp/㎜
1.5 sec.
3 sec.
15 sec.
AED (Auto Exposure Detection)
DR Trigger (External line trigger)
FXRD-1012NB (Gadox)
FXRD-1012NBW (Gadox)
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Power Supply
Consumption
(H × W × D)
(including a battery pack)
Transfer
Transmission Rate (Wired)
Transmission Rate (Wireless)
DC +24V, Max. 0.8A
Wired: Powered by SCU with a tether interface cable.
Wireless: Powered by a battery pack (3,100 ㎃ h)
Max. 19.2 W
287.0㎜ × 350.0㎜ × 15.0㎜
2.2 kg
Wired: Gigabit Ethernet (1000BASE-T) via PoE (Power over
Ethernet)
Wireless: IEEE802.11n
Max. 1Gbps
Max. 300Mbps (MIMO 2X2)
Page 26 of 151 VW40-152-009
Item Description
Dimensions
287.0
Curvature of Edges
R6.5
2.3.2 Drawing Sheet
VIVIX-S 1012NAW / 1012NBW (Wireless Detector)
VIVIX-S 1012N User Manual
(H × W × D)
㎜ × 350.0㎜ × 15.0㎜
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Under the ISO4090 regulation, the allowed tolerance of a thickness of detector is from -
2㎜ ~ +1㎜.
Page 27 of 151 VW40-152-009
Item Description
Dimensions
287.0
Curvature of Edges
R6.5
VIVIX-S 1012N User Manual
VIVIX-S 1012NA / 1012NB (Wired Detector with a tether interface cable)
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(H × W × D)
㎜ × 350.0㎜ × 15.0㎜
Under the ISO4090 regulation, the allowed tolerance of a thickness of detector is from -
2㎜ ~ +1㎜.
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Name
Description
A T
B Tether interface holder
C B
D Antenna for wireless LAN
E Status indicator
F Power button
G AP ON /OFF Button
H Battery Remaining LED
2.3.3 Functions
VIVIX-S 1012NAW / 1012NBW (Wireless)
VIVIX-S 1012N User Manual
Used for tighten the tether interface cable.
ether interface connector
Used for wired connection between a detector and SCU.
attery lock lever
Fix/release holder of the tether interface cable.
Lock/unlock lever of the equipped battery pack.
Antennas for wireless communication (2EA)
Detector status indicator
DATA LED (Blue): Indicates communication and transmission
ACTIVE LED (Orange): Indicates ready to work
POWER LED (Green): Indicates power On/Off status
Detector power button
Turns on / off the AP mode.
Notices the remaining of battery in 5 levels.
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Name
Description
A T
B Tether interface holder
C Status indicator
D Power button
VIVIX-S 1012NA / 1012NB (Wired)
VIVIX-S 1012N User Manual
Used for tighten the tether interface cable.
ether interface connector
Used for wired connection between a detector and SCU.
Fix/release holder of the tether interface cable.
Detector status indicator
DATA LED (Blue): Indicates communication and transmission
ACTIVE LED (Orange): Indicates ready to work
POWER LED (Green): Indicates power On/Off status
Detector power button
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Page 30 of 151 VW40-152-009
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