Eickemeyer FXRD-3643VAW User manual

USER MANUAL
DIGIVET DR
WLAN FLAT PANEL DETECTOR
Item no. 708485
TELEPHONE +49 7461 96 580 0
www.eickemeyer.com
USER MANUALUSER MANUAL
Item no. 708485Item no. 708485

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VIVIX-S VW Operation Manual
Contents
1. Instruction ......................................................................................................................................... 5
1.1 Document Guide ..................................................................................................................................... 6
1.1.1 Ta r g e t A u d ience..............................................................................................................................................................6
1.1.2 Symbols ..............................................................................................................................................................................6
1.1.3 Notations...........................................................................................................................................................................6
1.1.4 Contact Us ........................................................................................................................................................................7
1.2 Purpose of Use ........................................................................................................................................ 8
1.2.1 Intended Use ...................................................................................................................................................................8
1.2.2 Patient Group ..................................................................................................................................................................8
1.2.3 Contra-Indication ...........................................................................................................................................................8
1.3 Clinical Benefits of Product Use........................................................................................................... 9
1.4 Features................................................................................................................................................... 10
1.5 Product Use ............................................................................................................................................11
1.5.1 Product Usage...............................................................................................................................................................11
1.5.2 Disclaimer ........................................................................................................................................................................11
1.5.3 Outdoor Restrictions ..................................................................................................................................................12
1.5.4 Product Disposal ..........................................................................................................................................................12
1.6 Safety Instruction.................................................................................................................................. 13
1.6.1 Management and Authority ...................................................................................................................................13
1.6.2 Power Supply.................................................................................................................................................................13
1.6.3 Handling...........................................................................................................................................................................14
1.6.4 Battery Pack....................................................................................................................................................................15
1.6.5 Cradle ................................................................................................................................................................................16
1.6.6 Environment of Use ....................................................................................................................................................16
1.6.7 Temperature ...................................................................................................................................................................17
1.6.8 Problem Management...............................................................................................................................................17
1.6.9 Maintenance and Inspection..................................................................................................................................18
1.7 Product Usage Guide............................................................................................................................ 19
1.7.1 Calibration.......................................................................................................................................................................19
1.7.2 Left/Right Marker.........................................................................................................................................................19
1.7.3 Image Backup................................................................................................................................................................19
1.7.4 Use Limitations .............................................................................................................................................................19
1.7.5 Disposal............................................................................................................................................................................20
1.7.6 Pediatric Application ..................................................................................................................................................20
1.7.7 Before Exposure............................................................................................................................................................20
1.7.8 During Exposure...........................................................................................................................................................21

Rev.1.8 Page 2of 78 D-19-591
VIVIX-S VW Operation Manual
Contents
1. Instruction ......................................................................................................................................... 5
1.1 Document Guide ..................................................................................................................................... 6
1.1.1 Ta r g e t A u d ience..............................................................................................................................................................6
1.1.2 Symbols ..............................................................................................................................................................................6
1.1.3 Notations...........................................................................................................................................................................6
1.1.4 Contact Us ........................................................................................................................................................................7
1.2 Purpose of Use ........................................................................................................................................ 8
1.2.1 Intended Use ...................................................................................................................................................................8
1.2.2 Patient Group ..................................................................................................................................................................8
1.2.3 Contra-Indication ...........................................................................................................................................................8
1.3 Clinical Benefits of Product Use........................................................................................................... 9
1.4 Features................................................................................................................................................... 10
1.5 Product Use ............................................................................................................................................11
1.5.1 Product Usage...............................................................................................................................................................11
1.5.2 Disclaimer ........................................................................................................................................................................11
1.5.3 Outdoor Restrictions ..................................................................................................................................................12
1.5.4 Product Disposal ..........................................................................................................................................................12
1.6 Safety Instruction.................................................................................................................................. 13
1.6.1 Management and Authority ...................................................................................................................................13
1.6.2 Power Supply.................................................................................................................................................................13
1.6.3 Handling...........................................................................................................................................................................14
1.6.4 Battery Pack....................................................................................................................................................................15
1.6.5 Cradle ................................................................................................................................................................................16
1.6.6 Environment of Use ....................................................................................................................................................16
1.6.7 Temperature ...................................................................................................................................................................17
1.6.8 Problem Management...............................................................................................................................................17
1.6.9 Maintenance and Inspection..................................................................................................................................18
1.7 Product Usage Guide............................................................................................................................ 19
1.7.1 Calibration.......................................................................................................................................................................19
1.7.2 Left/Right Marker.........................................................................................................................................................19
1.7.3 Image Backup................................................................................................................................................................19
1.7.4 Use Limitations .............................................................................................................................................................19
1.7.5 Disposal............................................................................................................................................................................20
1.7.6 Pediatric Application ..................................................................................................................................................20
1.7.7 Before Exposure............................................................................................................................................................20
1.7.8 During Exposure...........................................................................................................................................................21
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1.7.9 Operating and Storage Environment .................................................................................................................21
1.7.10 Others................................................................................................................................................................................22
2. Product.............................................................................................................................................23
2.1 Product Specifications..........................................................................................................................24
2.1.1 Detector (FXRD-3643VAW, FXRD-3643VAW PLUS)......................................................................................24
2.1.2 Detector (FXRD-4343VAW, FXRD-4343VAW PLUS)......................................................................................25
2.1.3 Detector (FXRD-2530VAW, FXRD-2530VAW PLUS)......................................................................................26
2.1.4 SCU.....................................................................................................................................................................................26
2.1.5 Battery Pack....................................................................................................................................................................27
2.2 FXRD-3643VAW, FXRD-3643VAW PLUS............................................................................................28
2.2.1 Functions .........................................................................................................................................................................28
2.2.2 Deco Sheet .....................................................................................................................................................................30
2.3 FXRD-4343VAW, FXRD-4343VAW PLUS............................................................................................32
2.3.1 Functions .........................................................................................................................................................................32
2.3.2 Deco Sheet .....................................................................................................................................................................34
2.4 FXRD-2530VAW, FXRD-2530VAW PLUS............................................................................................35
2.4.1 Functions .........................................................................................................................................................................35
2.4.2 Deco Sheet .....................................................................................................................................................................37
2.5 SCU Lite (FXRP-02A) –Option............................................................................................................38
2.6 SCU mini (FXRS-04A) –Option ..........................................................................................................39
2.7 Cradle (FXRR-01A) –Option ...............................................................................................................41
2.8 Others...................................................................................................................................................... 42
2.8.1 X-ray Generator (Recommended Exposure Condition)..............................................................................42
3. Preparing for System Operation.................................................................................................43
3.1 Checking System Configuration .........................................................................................................44
3.2 Charging the Battery Pack ..................................................................................................................45
3.2.1General Charging.........................................................................................................................................................45
3.2.2 Fast Charging.................................................................................................................................................................46
3.3 Using the Detector and SCU............................................................................................................... 48
3.3.1 Booting up SCU mini (FXRS-04A)........................................................................................................................48
3.3.2 Booting up SCU Lite...................................................................................................................................................49
3.3.3 Booting the Detector .................................................................................................................................................49
3.4 Checking External Buttons and Display of Detector......................................................................50
3.4.1 Power Button & Power Display LED ...................................................................................................................50
3.4.2 Charge Status LED.......................................................................................................................................................50

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3.4.3 AP Button ........................................................................................................................................................................50
3.4.4 OLED Display .................................................................................................................................................................51
3.5 How to Replace the Battery Pack ......................................................................................................54
3.5.1 Replacing the Battery of FXRD-3643VAW / FXRD-3643VAW PLUS / FXRD-4343VAW / FXRD-
4343VAW PLUS................................................................................................................................................................................54
3.5.2 Replacing the Battery of FXRD-2530VAW / FXRD-2530VAW PLUS .....................................................56
4. Inspection and Cleaning...............................................................................................................57
4.1 Product Inspection................................................................................................................................ 58
4.1.1 Daily Inspection ............................................................................................................................................................58
4.1.2 Performance Inspection............................................................................................................................................58
4.2 Cleaning and Disinfection ...................................................................................................................59
5. Regulatory Information ................................................................................................................60
5.1 Medical Equipment Safety Standards ...............................................................................................61
5.1.1 Medical Equipment Classification ........................................................................................................................61
5.1.2 Product Safety Standard...........................................................................................................................................61
5.2 Guidance and Manufacturer’s Declaration for EMC....................................................................... 63
5.2.1 Electromagnetic Emissions ......................................................................................................................................63
5.2.2 Electromagnetic Immunity.......................................................................................................................................64
5.3 Radio Frequency Compliance Information....................................................................................... 67
5.3.1 FCC Compliance ...........................................................................................................................................................67
5.3.2 FCC SAR ...........................................................................................................................................................................68
5.3.3 CE R&TTE SAR...............................................................................................................................................................68
5.4 ANATEL ....................................................................................................................................................69
5.5 Labels and Symbols .............................................................................................................................. 70
5.5.1 Label ..................................................................................................................................................................................70
5.5.2 Product Symbols ..........................................................................................................................................................72
6. Information .....................................................................................................................................74
6.1 Service Information ..............................................................................................................................75
6.1.1 Product Lifetime ...........................................................................................................................................................75
6.1.2 Regular Inspection and Maintenance ................................................................................................................75
6.1.3 Repair ................................................................................................................................................................................75
6.1.4 Replacement Parts Support ....................................................................................................................................75
6.1.5 Consumables..................................................................................................................................................................75
6.2 Warranty .................................................................................................................................................76
6.3 Revision History ....................................................................................................................................77

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3.4.3 AP Button ........................................................................................................................................................................50
3.4.4 OLED Display .................................................................................................................................................................51
3.5 How to Replace the Battery Pack ......................................................................................................54
3.5.1 Replacing the Battery of FXRD-3643VAW / FXRD-3643VAW PLUS / FXRD-4343VAW / FXRD-
4343VAW PLUS................................................................................................................................................................................54
3.5.2 Replacing the Battery of FXRD-2530VAW / FXRD-2530VAW PLUS .....................................................56
4. Inspection and Cleaning...............................................................................................................57
4.1 Product Inspection................................................................................................................................ 58
4.1.1 Daily Inspection ............................................................................................................................................................58
4.1.2 Performance Inspection............................................................................................................................................58
4.2 Cleaning and Disinfection ...................................................................................................................59
5. Regulatory Information ................................................................................................................60
5.1 Medical Equipment Safety Standards ...............................................................................................61
5.1.1 Medical Equipment Classification ........................................................................................................................61
5.1.2 Product Safety Standard...........................................................................................................................................61
5.2 Guidance and Manufacturer’s Declaration for EMC....................................................................... 63
5.2.1 Electromagnetic Emissions ......................................................................................................................................63
5.2.2 Electromagnetic Immunity.......................................................................................................................................64
5.3 Radio Frequency Compliance Information....................................................................................... 67
5.3.1 FCC Compliance ...........................................................................................................................................................67
5.3.2 FCC SAR ...........................................................................................................................................................................68
5.3.3 CE R&TTE SAR...............................................................................................................................................................68
5.4 ANATEL ....................................................................................................................................................69
5.5 Labels and Symbols .............................................................................................................................. 70
5.5.1 Label ..................................................................................................................................................................................70
5.5.2 Product Symbols ..........................................................................................................................................................72
6. Information .....................................................................................................................................74
6.1 Service Information ..............................................................................................................................75
6.1.1 Product Lifetime ...........................................................................................................................................................75
6.1.2 Regular Inspection and Maintenance ................................................................................................................75
6.1.3 Repair ................................................................................................................................................................................75
6.1.4 Replacement Parts Support ....................................................................................................................................75
6.1.5 Consumables..................................................................................................................................................................75
6.2 Warranty .................................................................................................................................................76
6.3 Revision History ....................................................................................................................................77
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1. Instruction
This section gives basic information about this manual and safe product use.
Document Guide
Purpose of Use
Clinical Benefits of Product Use
Features
Product Use
Safety Instruction
Product Usage Guide

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1.1 Document Guide
This operation manual explains how to use the VIVIX-S VW detector models made by Vieworks, X-ray
interface unit, and other peripheral equipment.Use this manual to set up the VIVIX-S VW detector as well
as understand its various functions.
1.1.1 Target Audience
This manual is intended for the users who set up and operate the VIVIX-S VW detector models.
1.1.2 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 to operatethe products safely.
Caution
This symbol is used to indicate a potentially hazardous situation that may cause death,
personal injury or substantial property damage if the instructions are ignored. Users
should be well acquainted with this symbol and the related contents.
Information
This symbol is used for indicating product related references and supplementary
information. Users are recommended to read the sentences with this notice carefully.
1.1.3 Notations
Bold Types
Words in bold indicate products terms, or the sentences which are needed to transmit clear meaning to the
customers.
Among the references specified in this document, some installations and settings are
performed by qualified service engineers. For proper product installation and setup,
please check the manuals listed in the references or contact your service engineer.

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VIVIX-S VW Operation Manual
1.1 Document Guide
This operation manual explains how to use the VIVIX-S VW detector models made by Vieworks, X-ray
interface unit, and other peripheral equipment.Use this manual to set up the VIVIX-S VW detector as well
as understand its various functions.
1.1.1 Target Audience
This manual is intended for the users who set up and operate the VIVIX-S VW detector models.
1.1.2 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 to operatethe products safely.
Caution
This symbol is used to indicate a potentially hazardous situation that may cause death,
personal injury or substantial property damage if the instructions are ignored. Users
should be well acquainted with this symbol and the related contents.
Information
This symbol is used for indicating product related references and supplementary
information. Users are recommended to read the sentences with this notice carefully.
1.1.3 Notations
Bold Types
Words in bold indicate products terms, or the sentences which are needed to transmit clear meaning to the
customers.
Among the references specified in this document, some installations and settings are
performed by qualified service engineers. For proper product installation and setup,
please check the manuals listed in the references or contact your service engineer.
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1.1.4 Contact Us
This manual is provided in print format upon request by the customer.
For comments or inquiries regarding this document and relevant products, contact via email below:
Item
Contents
Department
Customer Support Team
at Vieworks
E
-mail
You can download this manual from VDS (Vieworks Download System) website:
https://clouds.vieworks.com:5001/.
To obtain an ID and password for manual download,
please contact the customer support
team in Vieworks.

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1.2 Purpose of Use
1.2.1 Intended Use
VIVIX-S VW (FXRD-2530VAW(PLUS), FXRD-3643VAW(PLUS), and FXRD-4343VAW(PLUS)) detectors are
digital flat panel detector that is used for screening and diagnosis of disease of injury. These detectors are
intended for use by a qualified/trained doctor or technician on both adult subjects for taking diagnostic
radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
1.2.2 Patient Group
VIVIX-S VW is used to examine in patients with or suspected of muscle and bone injury, respiratory
diseases. It is intended for general patients such as adults, children, and infants, but all radiography should
be reviewed by a doctor in charge prior to beginning the examination.
The radiologist should use a proper technique considering the patient’s size to decrease the radiation dose
when he or sh acquires diagnostic images.
1.2.3 Contra-Indication
These detectors are not intended to be used for mammography applications.

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1.2 Purpose of Use
1.2.1 Intended Use
VIVIX-S VW (FXRD-2530VAW(PLUS), FXRD-3643VAW(PLUS), and FXRD-4343VAW(PLUS)) detectors are
digital flat panel detector that is used for screening and diagnosis of disease of injury. These detectors are
intended for use by a qualified/trained doctor or technician on both adult subjects for taking diagnostic
radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
1.2.2 Patient Group
VIVIX-S VW is used to examine in patients with or suspected of muscle and bone injury, respiratory
diseases. It is intended for general patients such as adults, children, and infants, but all radiography should
be reviewed by a doctor in charge prior to beginning the examination.
The radiologist should use a proper technique considering the patient’s size to decrease the radiation dose
when he or sh acquires diagnostic images.
1.2.3 Contra-Indication
These detectors are not intended to be used for mammography applications.
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1.3 Clinical Benefits of Product Use
Compared to X-ray exposure to a patient during X-ray imaging using this detector, the benefit of
diagnosing a patient's disease or injury is much greater. The digital flat panel detector has superior X-ray
image quality compared to the conventional analog film type and enables real-time image transmission
and image processing, so that the benefit is much greater in terms of ease of diagnosis and usability
compared to electrical risks that may occur.

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1.4 Features
Since VIVIX-S VW detectorsare compatible with a conventional film cassette, they enable to replace the
analog radiographic diagnosis.
VIVIX-S VW detectorsprovide high resolution digital images. The resolution varies depending on the
modelsas follows.
FXRD-3643VAW, FXRD-3643VAW PLUS : 140μm pixel pitch sensor (Approx. 7.9 Mega Pixels)
FXRD-4343VAW, FXRD-4343VAW PLUS : 140μm pixel pitch sensor (Approx. 9.4 Mega Pixels)
FXRD-2530VAW, FXRD-2530VAW PLUS : 124μm pixel pitch sensor,(Approx. 5.2 Mega Pixels)
The scintillator providestwo types of CsI, and you can use one of the detectors.
VIVIX-S VW detectorssupport IEEE 802.11n/ac to acquire images without a wired connection in anytime,
anywhere.
Checksthe connecting status of the detector and battery remains through OLED Display.
Makes direct wireless communication with the built-in wireless AP function. (Inside APTM)
Makes quick application of various functions with two buttons on the side of the detector.
Supports the stable and reliable AED (Auto Exposure Detection) function. (AnytimeTM)
Designed for easy carrying
You can use the product with cable connection (tether interface cable) depending on the using
environment.

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1.4 Features
Since VIVIX-S VW detectorsare compatible with a conventional film cassette, they enable to replace the
analog radiographic diagnosis.
VIVIX-S VW detectorsprovide high resolution digital images. The resolution varies depending on the
modelsas follows.
FXRD-3643VAW, FXRD-3643VAW PLUS : 140μm pixel pitch sensor (Approx. 7.9 Mega Pixels)
FXRD-4343VAW, FXRD-4343VAW PLUS : 140μm pixel pitch sensor (Approx. 9.4 Mega Pixels)
FXRD-2530VAW, FXRD-2530VAW PLUS : 124μm pixel pitch sensor,(Approx. 5.2 Mega Pixels)
The scintillator providestwo types of CsI, and you can use one of the detectors.
VIVIX-S VW detectorssupport IEEE 802.11n/ac to acquire images without a wired connection in anytime,
anywhere.
Checksthe connecting status of the detector and battery remains through OLED Display.
Makes direct wireless communication with the built-in wireless AP function. (Inside APTM)
Makes quick application of various functions with two buttons on the side of the detector.
Supports the stable and reliable AED (Auto Exposure Detection) function. (AnytimeTM)
Designed for easy carrying
You can use the product with cable connection (tether interface cable) depending on the using
environment.
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1.5 Product Use
This chapter provides instructions about the use of the product, disposal, and the liability limit of Vieworks.
1.5.1 Product Usage
1Only 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.
3Follow the guidelines in this manual when installing and using this product.
4Use only computers and image display monitors recommended in this manual.
5Use only the dedicated cables provided with this product.
6For details about installation and use of theproduct, consult your sales representative or a distributor.
1.5.2 Disclaimer
1In no event shall Vieworks be liable for damage or loss arising from a fire, earthquake, any action or
accident by a third party, any intentional or negligent action by users.
2In no event shall Vieworks be liable for damage or loss arising from any trial usage, or other usage under
abnormal conditions.
3In 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.
4In no event shall Vieworks be liable for any damage arising from moving, alteration, inspection or repair
the product by a person other than an authorized service engineer by Vieworks.
5In no event shall Vieworks be liable for loss of image data for any reason while using this product.
6Roentgenography, 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.
7 The user is responsible for maintaining the privacy of image data acquired from this product.
8It is the responsibility of the attending physicians to provide medical care services. Vieworks will not be
liable for faulty diagnoses.
9Specifications, composition, and appearance of this product may change without prior notice.
10 In the event of a serious accident involving the device, please report it to Vieworks and the country in
which you purchased the product.

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1.5.3 Outdoor Restrictions
There are restrictions on the outdoor use of the U-NII Low (5150-5250 MHz) and U-NII Mid (5250-5350
MHz) bandwidths of the WLAN module incorporated in the device in the following Member States:
Belgium (BE), Bulgaria (BG), Czech Republic (CZ), Denmark (DK), Germany (DE), Estonia (EE), Ireland (IE),
Greece (EL), Spain (ES), France (FR), Croatia (HR), Italy (IT), Cyprus (CY), Latvia (LV), Lithuania (LT),
Luxembourg (LU), Hungary (HU), Malta (MT), Netherlands (NL), Austria (AT), Poland (PL), Portugal (PT),
Romania (RO), Slovenia (SI), Slovakia (SK), Finland (FI), Sweden (SE) and United Kingdom (UK).
AT BE BG CY CZ
DE DK EE EL ES
FI FR HR HU IE
IT LT LU LV MT
NL PL PT RO SE
SI SK UK
1.5.4 Product Disposal
Disposal of this product in an unlawful manner may have a negative impact on health and on the
environment. When disposing of this product, therefore, be absolutely sure to follow the procedure that
conforms to 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 (2012/19/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

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1.5.3 Outdoor Restrictions
There are restrictions on the outdoor use of the U-NII Low (5150-5250 MHz) and U-NII Mid (5250-5350
MHz) bandwidths of the WLAN module incorporated in the device in the following Member States:
Belgium (BE), Bulgaria (BG), Czech Republic (CZ), Denmark (DK), Germany (DE), Estonia (EE), Ireland (IE),
Greece (EL), Spain (ES), France (FR), Croatia (HR), Italy (IT), Cyprus (CY), Latvia (LV), Lithuania (LT),
Luxembourg (LU), Hungary (HU), Malta (MT), Netherlands (NL), Austria (AT), Poland (PL), Portugal (PT),
Romania (RO), Slovenia (SI), Slovakia (SK), Finland (FI), Sweden (SE) and United Kingdom (UK).
AT BE BG CY CZ
DE DK EE EL ES
FI FR HR HU IE
IT LT LU LV MT
NL PL PT RO SE
SI SK UK
1.5.4 Product Disposal
Disposal of this product in an unlawful manner may have a negative impact on health and on the
environment. When disposing of this product, therefore, be absolutely sure to follow the procedure that
conforms to 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 (2012/19/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
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1.6 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 to prevent severe personal injury or substantial property damage. It is important
to read and understand the contents of this manual before using the product.
1.6.1 Management and Authority
The product should be installed, operated, and serviced according to Vieworks
maintenance procedures and by aVieworks service representative or a distributor who
provides 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 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 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.
1.6.2 Power Supply
Do not operate the equipment using any type of power supply other than the one
indicated on the rating label. Doing so may result in a fire or electric shock.
Do not supply power to more than one piece of equipment using the same AC outlet for
this product.Doing so may result in a fire or electric shock.
Do not connect multiple portable socket-outletsor extension cordsto the system. Doing
so may result in a fire or electric shock.
Always connect the three-core power cord plug to a grounded AC power outlet.
Ground the equipment to an indoor grounded connector. Connect a
ll the grounds for the
system to a common ground.
Do not connect the AC or DC power cable to the product with the power applied. Failure
to do so may result in damage to the product.
Do not use any power source other than the one provided with this product. Otherwise, a
fire or electric shock may be caused due to a leakage.
The owner should ensure continuous power supply to the system
with voltage and current
according to the product specifications. If the system is powered unstably during its
operation, we recommend you install a 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 heavy objects, such as medical equipment on cables and cords. Do not pull,
bend, bundle, or step on the cables and cords to protect their sheath from being
damaged.
Securely plug the power cord into the outlet. If contact failure occurs, or if dust/metal
objects encounter the exposed metal prongs of the plug, fire or electric shock may result.
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.
Hold the plug or connector when you 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.
1.6.3 Handling
Do not disassemble or modify the product. It can cause a product malfunction, electric
shock, or fire.
Only use the parts specified in this manual. If you want to use other parts, confirm with
the supplier of the parts in advance.
Be careful not to cause liquid or metal objects such as needles and clips that may damage
the product to get into the product.
If the product ha
s been affected by an impact or vibration due to the user’s misuse, make
sure that you perform a product inspection before using it again.
If an X-
ray is taken while the patient is moving, the quality of the picture may be affected.
Make sure that the patient maintains a fixed posture as much as possible.
If there is harmful liquid on the surface of the detector, the patient may be exposed to a
risk of infection or may suffer rashes. In this case, wash the detector or use a disposable
cover. When using the product for a bleeding patient, use a disposable cover whenever
possible.
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.
Soaking the detector in water can cause a product malfunction or electric shock. Follow
the instructions in “Cleaning and Sterilization” of this document to wash the detector.
It is recommended that the detector is used on a flat table. Especially, if the product is
used on an uneven surface such as a patient’s bed, it may be damaged, or its lifespan
may be affected when a load heavier than the specified limit is applied.
Organize the connecting cables while using the product so that they do not tangle with
the body of the user or the patient. Failure to do so may injure the user or the patient, or
cause the product to fall, which can result in a malfunction.
A product with a ventilation hole should be installed at a location that is ventilated well.
Otherwise, dust can pile up in the ventilation hole, causing a malfunction or damage by
overheat.

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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 heavy objects, such as medical equipment on cables and cords. Do not pull,
bend, bundle, or step on the cables and cords to protect their sheath from being
damaged.
Securely plug the power cord into the outlet. If contact failure occurs, or if dust/metal
objects encounter the exposed metal prongs of the plug, fire or electric shock may result.
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.
Hold the plug or connector when you 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.
1.6.3 Handling
Do not disassemble or modify the product. It can cause a product malfunction, electric
shock, or fire.
Only use the parts specified in this manual. If you want to use other parts, confirm with
the supplier of the parts in advance.
Be careful not to cause liquid or metal objects such as needles and clips that may damage
the product to get into the product.
If the product ha
s been affected by an impact or vibration due to the user’s misuse, make
sure that you perform a product inspection before using it again.
If an X-
ray is taken while the patient is moving, the quality of the picture may be affected.
Make sure that the patient maintains a fixed posture as much as possible.
If there is harmful liquid on the surface of the detector, the patient may be exposed to a
risk of infection or may suffer rashes. In this case, wash the detector or use a disposable
cover. When using the product for a bleeding patient, use a disposable cover whenever
possible.
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.
Soaking the detector in water can cause a product malfunction or electric shock. Follow
the instructions in “Cleaning and Sterilization” of this document to wash the detector.
It is recommended that the detector is used on a flat table. Especially, if the product is
used on an uneven surface such as a patient’s bed, it may be damaged, or its lifespan
may be affected when a load heavier than the specified limit is applied.
Organize the connecting cables while using the product so that they do not tangle with
the body of the user or the patient. Failure to do so may injure the user or the patient, or
cause the product to fall, which can result in a malfunction.
A product with a ventilation hole should be installed at a location that is ventilated well.
Otherwise, dust can pile up in the ventilation hole, causing a malfunction or damage by
overheat.
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1.6.4 Battery Pack
The battery pack is built into the VIVIX-S VW detectors. Due to the life of the battery
pack, use only the battery pack designated for the VIVIX-S VW detectorswhen replacing
the battery pack.
If you use a battery pack other than the specified one, the battery pack may explode, or
electrolyte may spill out, resulting in a fire or electrical shock. Do not use the battery pack
with other power sources.
Always charge the battery pack by attaching it to the VIVIX-S VW detectors. Do not use
any other power supply to charge the battery pack.
Do not handle the battery pack with wet hands.
Do not attempt to disassemble, alter, or apply heat to the battery pack.
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 or damaged.
Stop using the battery pack immediately if it emits smoke, a strange smell, or otherwise
operates abnormally.
Do not let the battery pack encounter water or other liquids and do not allow the battery
to get wet.
Do not clean the battery pack 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 of the battery pack. Otherwise, battery may explode, or leakage of electrolyte
may occur, resulting in fire, injury or pollution of surrounding area. If the battery leaks and
the electrolytes encounter 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.
If the battery pack becomes heated or swollen, immediately replace the battery with a
new one before using it. Otherwise, overheat, smoke, explosion, or fire may occur.
The lithium ion battery is recyclable.
The 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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VIVIX-S VW Operation Manual
1.6.5 Cradle
When detaching the detector inserted in the cradle (optional accessory) by applying a
force in the vertical direction, shock may be applied to the detector. Please refer to the
image below to separate the detector from the cradle in the correct direction.
Fig.1 Correct Direction Fig.2 Wrong Direction
1.6.6 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 near
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.

Rev.1.8 Page 16 of 78 D-19-591
VIVIX-S VW Operation Manual
1.6.5 Cradle
When detaching the detector inserted in the cradle (optional accessory) by applying a
force in the vertical direction, shock may be applied to the detector. Please refer to the
image below to separate the detector from the cradle in the correct direction.
Fig.1 Correct Direction Fig.2 Wrong Direction
1.6.6 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 near
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.
Rev.1.8 Page 17 of 78 D-19-591
VIVIX-S VW Operation Manual
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.
Non-medical devices such as wireless router and SCU (System Control Unit)cannot be
used in patient’s vicinity.
1.6.7 Temperature
The product is not intended to supply heat to a patient.
The temperature of contact area with a patient will not be exceeded 48℃under the
normal user environment.
Do not use the equipment beyond the range of recommended operating temperature.
1.6.8 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.
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.

Rev.1.8 Page 18 of 78 D-19-591
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1.6.9 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.

Rev.1.8 Page 18 of 78 D-19-591
VIVIX-S VW Operation Manual
1.6.9 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.
Rev.1.8 Page 19 of 78 D-19-591
VIVIX-S VW Operation Manual
1.7 Product Usage Guide
When using the equipment, take the following precautions. Otherwise, problems may
occur, and the equipment may not function correctly.
1.7.1 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.
If it is difficult to perform the calibration directly, use calibration data in the detector.
The calibration result can be different by the use environment. Therefore, if the result
performed with the calibration data in the detector is not satisfied, you can create the
data at the field in person by using VIVIX Setup, the calibration software.
1.7.2 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.
1.7.3 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.
The image backup should be done as a routine operation for every patient and image.
1.7.4 Use Limitations
Vieworks software has thefactory mode and the engineer mode operated by inputting the administrator
password only.
These two modesshould be operated by the person in charge who is qualified by Vieworks., Co., Ltd.

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1.7.5 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.
1.7.6 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 aproper 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.
1.7.7 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.
This manual suits for next models
5
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