VIVIX-S 1012N Operation Manual

(FXRD-1012NA / FXRD-1012NAW / FXRD-1012NB /FXRD-1012NBW)

© Vieworks. 2022 All rights reserved.

Under copyright laws, this manual should not be reproduced, in whole or in part, without the written
permission of Vieworks.
The specifications and related information in this manual may be changed without notice. Refer to Vieworks
Download System (VDS) for the latest version of our manuals. This document is basically produced in English,
and can be produced in the language of the relevant country upon request of the customer.
 VIVIX-S 1012N Operation Manual (FXRD-1012NA /
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Contents

1. Instruction ......................................................................................................................................... 5

1.1 Document Guide ..................................................................................................................................... 6

1.1.1 Caution ............................................................................................................................................................................... 6
1.1.2 Target Audience .............................................................................................................................................................. 6
1.1.3 Symbols .............................................................................................................................................................................. 6
1.1.4 Notations ........................................................................................................................................................................... 6
1.1.5 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 and Charger ........................................................................................................................................15
1.6.5 Environment of Use ....................................................................................................................................................16
1.6.6 Temperature ...................................................................................................................................................................17
1.6.7 Problem Management ...............................................................................................................................................17
1.6.8 Maintenance and Inspection ..................................................................................................................................17

1.7 Product Usage Guide ............................................................................................................................ 18

1.7.1 Calibration .......................................................................................................................................................................18
1.7.2 Left/Right Marker.........................................................................................................................................................18
1.7.3 Image Backup ................................................................................................................................................................18
1.7.4 Use Limitations .............................................................................................................................................................18
1.7.5 Disposal ............................................................................................................................................................................19
1.7.6 Pediatric Application ..................................................................................................................................................19
1.7.7 Before Exposure............................................................................................................................................................19
1.7.8 During Exposure ...........................................................................................................................................................19

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1.7.9 Operating and Storage Environment .................................................................................................................20

1.7.10 Others................................................................................................................................................................................20

2. Product............................................................................................................................................. 21

2.1 Product Specifications .......................................................................................................................... 22

2.1.1 Detector............................................................................................................................................................................22
2.1.2 SCU (FXRS-03A) ............................................................................................................................................................22
2.1.3 SCU (FXRS-04A) ............................................................................................................................................................23
2.1.4 SCU (FXRP-02A) ............................................................................................................................................................23
2.1.5 Battery Pack ....................................................................................................................................................................23
2.1.6 Battery Charger.............................................................................................................................................................23

2.2 VIVIX-S 1012N Detector ...................................................................................................................... 24

2.2.1 Functions .........................................................................................................................................................................24
2.2.2 Deco Sheet .....................................................................................................................................................................26
2.2.3 Load Limit of Detector ..............................................................................................................................................28

2.3 SCU Basic (FXRS-03A) .......................................................................................................................... 29

2.3.1 Functions .........................................................................................................................................................................29

2.4 SCU mini (FXRS-04A) ............................................................................................................................ 30

2.5 SCU Lite (FXRP-02A) ............................................................................................................................. 31

2.6 Battery Charger (FXRC-02A) ............................................................................................................... 32

2.7 Battery Charger (FXRC-03A) ............................................................................................................... 33

3. Preparing for System Operation ................................................................................................. 34

3.1 Checking System Configuration ......................................................................................................... 35

3.2 Using the Battery Pack (Wireless models only) .............................................................................. 36

3.2.1 How to insert a battery pack .................................................................................................................................36
3.2.2 How to take out a battery pack ...........................................................................................................................37
3.2.3 How to charge a battery pack (FXRC-02A) .....................................................................................................38
3.2.4 How to charge a battery pack (FXRC-03A) .....................................................................................................40

3.3 Using SCU ............................................................................................................................................... 43

3.3.1 Booting up SCU Basic (FXRS-03A) .......................................................................................................................43
3.3.2 Booting up SCU mini (FXRS-04A) ........................................................................................................................44
3.3.3 Booting up SCU Lite (FXRP-02A) and Detector ............................................................................................44

3.4 Booting up the Detector ...................................................................................................................... 45

3.4.1 Checking Status LED of Detector .........................................................................................................................45

4. Inspection and Cleaning ............................................................................................................... 47

4.1 Product Inspection ................................................................................................................................ 48

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4.1.1 Daily Inspection ............................................................................................................................................................48

4.1.2 Performance Inspection ............................................................................................................................................48

4.2 Cleaning and Disinfection ................................................................................................................... 49

5. Regulatory Information ................................................................................................................ 50

5.1 Medical Equipment Safety Standards ............................................................................................... 51

5.1.1 Medical Equipment Classification ........................................................................................................................51
5.1.2 Product Safety Standards by Country ................................................................................................................51

5.2 Electromagnetic Compatibility and Guidance ................................................................................. 52

5.2.1 Electromagnetic Emissions ......................................................................................................................................52
5.2.2 Electromagnetic Immunity .......................................................................................................................................53

5.3 Radio Frequency Compliance Information ....................................................................................... 56

5.3.2 FCC Compliance ...........................................................................................................................................................56
5.3.3 FCC SAR ...........................................................................................................................................................................57
5.3.4 CE R&TTE SAR...............................................................................................................................................................57

5.4 Product Symbols ................................................................................................................................... 58

6. Information ..................................................................................................................................... 60

6.1 Service Information .............................................................................................................................. 61

6.1.1 Product Lifetime ...........................................................................................................................................................61
6.1.2 Regular Inspection and Maintenance ................................................................................................................61
6.1.3 Repair ................................................................................................................................................................................61
6.1.4 Replacement Parts Support ....................................................................................................................................61
6.1.5 Consumables..................................................................................................................................................................61

6.2 Warranty ................................................................................................................................................. 62

6.3 Revision History .................................................................................................................................... 63

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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 1012N detector made by Vieworks, X-ray interface
unit, and other peripheral equipment. Use this manual to set up the VIVIX-S 1012N detector as well as
understand its various functions.

1.1.1 Caution

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 Target Audience

This manual is intended for users who set up and operate the VIVIX-S 1012N detector.

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 to operate the products safely.

Caution and Warning

 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.

1.1.4 Notations

Bold Types
Words in bold indicate products terms, or the sentences which are needed to transmit clear meaning to the
customers.

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1.1.5 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 [email protected]

 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 1012N is a digital flat panel detector that is used for screening and diagnosis of disease of injury.
This detector is 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 1012N 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 she 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

 The new sensor with 124μm of pixel pitch produces high spatial resolution (approximately 5.2 Mega
pixels) digital images.
 This detector is developed and provided in two types according to its performance (CsI and Gadox).
 It adopts IEEE 802.11n, and is equipped with wireless communication function that enables quick image
acquisition without wired connection.
 Makes direct wireless communication with the built-in wireless AP function. (Inside APTM)
 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 for dental clinic, ENT, cephalo, etc.

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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

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 Follow the guidelines in this manual when installing and using this product.
4 Use only computers and image display monitors recommended in this manual.
5 Use only the dedicated cables provided with this product.
6 For details about installation and use of the product, consult your sales representative or a distributor.

1.5.2 Disclaimer

1 In 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.
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 any damage arising from moving, alteration, inspection or repair
the product by a person other than an authorized service engineers by Vieworks.
5 In no event shall Vieworks be liable for loss of image data for any reason while using this product.
6 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.
7 The user is responsible for maintaining the privacy of image data acquired from this product.
8 It is the responsibility of the attending physicians to provide medical care services. Vieworks will not be
liable for faulty diagnoses.
9 Specifications, 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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1.6 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 a Vieworks 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 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.

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-outlets or extension cords to 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 all 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

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operation, we recommend you install a UPS (Uninterrupted Power Supply) to avoid loss of
data.
 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.
 Do not alter the cords. Doing so 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.
 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 user’s 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 has 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.

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 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.

1.6.4 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.
 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.
 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.

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 Before discarding the battery pack, cover the terminals with adhesive tape or other
insulators. Contact with other metal materials may cause fire or explosion.

1.6.5 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.
 Non-medical devices such as a battery charger, wireless router and SCU (System Control
Unit) cannot be used in patient’s vicinity.

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1.6.6 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.

1.6.7 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.

1.6.8 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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1.7 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 the engineer mode operated by inputting the administrator password only.
 This mode should be operated by the person who is qualified by Vieworks.

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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 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.

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.

1.7.8 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.

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 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.

1.7.9 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.

Item Operation Storage & Transportation

Temperature +10 ~ +35℃ -15 ~ +55℃
Humidity 30 ~ 85% (Non-condensing) 10 ~ 90% (Non-condensing)
Atmospheric pressure 700 ~ 1060 hPa 500 ~ 1060 hPa
Shock 20G 30G
Vibration 2G 5G

1.7.10 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.

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2. Product

This section gives an instruction about the product components and their specifications.

Product Specifications
VIVIX-S 1012N Detector
SCU Basic (FXRS-03A)
SCU mini (FXRS-04A)
SCU Lite (FXRP-02A)
Battery Charger (FXRC-03A)

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2.1 Product Specifications

This chapter explains about the specifications of the products which make up the system.

2.1.1 Detector

Item Specifications
 FXRD-1012NA  FXRD-1012NB
Model
 FXRD-1012NAW  FXRD-1012NBW
Image Sensor  TFT: a-Si (Amorphous Silicon)
 FXRD-1012NA(W) : Csl: TI (Thallium doped Caesuim Iodide)
X-ray Scintillator Type
 FXRD-1012NB(W) : Gd2O2S:Tb (Gadolinium oxysulfide)
Pixel Pitch  0.124㎜ (124㎛)
Field of View  10” x 12”
Active Area (H x V)  253.95㎜ × 317.44㎜
Active Array  2048 x 2560 pixels
 FXRD-1012NA(W): 251.0㎜ x 314.5㎜
Effective Area
 FXRD-1012NB(W): 252.5㎜ x 316.0㎜
 FXRD-1012NA(W): 2024 x 2536
Effective Array
 FXRD-1012NB(W): 2036 x 2548
Operating Time  3 hrs. (Based on battery operation / when Sleep mode is released)
Grayscale  16bit
Spatial Resolution  Min. 4.0 lp/㎜
Power Consumption  Max. 19.2 W
Dimensions (H × W × D)  287.0㎜ × 350.0㎜ × 15.0㎜

2.1.2 SCU (FXRS-03A)

Item Specifications
Model  FXRS-03A
 Input: AC100 to 240V, 50/60㎐, Max. 2.0-0.8A
Power supply
 Output: DC +24V 3.25A, 78W
 Gigabit Ethernet port (3EA)
Cable connection port
 PoE (Power over Ethernet) Port (2EA)
Wireless communication  IEEE 802.11n (2.4 ㎓ / 5 ㎓)
Dimension (H × W × D)  210.0㎜ × 300.0㎜ × 58.0㎜
Antenna  137㎜ (2EA, Dual band)
Weight  2.8 ㎏

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2.1.3 SCU (FXRS-04A)

Item Specifications
Model  FXRS-04A
Power supply  Input: DC +24V 2A Max
 Gigabit Ethernet port (3EA)
Cable connection port
 PoE (Power over Ethernet) Port (1EA)
Wireless communication  IEEE 802.11n (2.4 ㎓ / 5 ㎓)
Dimension (H × W × D)  210.0㎜ × 170.0㎜ × 45.0㎜
Antenna  137㎜ (2EA, Dual band)
Weight  1.2㎏

2.1.4 SCU (FXRP-02A)

Item Specifications
Model  FXRP-02A
Power supply  Input: DC +24V 1.0A Max.
 Gigabit Ethernet port (1EA)
Cable connection port
 PoE (Power over Ethernet) Port (1EA)
Dimension (H × W × D)  108 ㎜ × 109 ㎜ × 29.5 ㎜
Weight  330g

2.1.5 Battery Pack

Model Specifications
FXRB-03A  Type: Lithium Ion (Output: DC +7.6V, 3,100㎃h)

2.1.6 Battery Charger

Model Specifications
FXRC-02A  Rated power supply: DC +24V, 2A Max.
 Rated power supply: DC +24V, 2A Max.
FXRC-03A  Dual charging
 Two battery packs (FXRB-01A (1ea) / FXRB-03A (1ea))

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2.2 VIVIX-S 1012N Detector

VIVIX-S 1012N detector is a device that acquires X-ray signals and digital images through various
conversion processes. You can utilize images obtained in 10 x 12 film size according to the purpose of use.

 The VIVIX-S 1012N detector is one of the VIVIX-S detector models manufactured by
Vieworks Co., Ltd.

 Refer to VIVIX-S 1012N Specification for the detailed specifications and drawings.

2.2.1 Functions

FXRD-1012NAW / 1012NBW

Name Description
Used for tightening the tether interface cable.
A Tether interface connector
 Used for wired connection between a detector and SCU.
B Tether interface holder Fix/release holder of the tether interface cable.
C Battery lock lever Lock/unlock lever of the equipped battery pack.
D Antenna for wireless LAN Antennas for wireless communication (2EA)
Detector status indicator
 DATA LED (Blue): Indicates communication and transmission
E Status indicator
 ACTIVE LED (Orange): Indicates readiness status to work
 POWER LED (Green): Indicates power On/Off status
F Power button Detector power button
G AP ON /OFF Button Turns on / off the AP mode.
H Indicator of battery remains Notices the remaining of battery in 5 levels.

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FXRD-1012NA / 1012NB

With tether cable attached

Name Description
Used for tightening the tether interface cable.
A Tether interface connector
 Used for wired connection between a detector and SCU.
B Tether interface holder Fix/release holder of the tether interface cable.
Detector status indicator
 DATA LED (Blue): Indicates communication and transmission
C Status indicator
 ACTIVE LED (Orange): Indicates ready to work
 POWER LED (Green): Indicates power On/Off status
D Power button Detector power button

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2.2.2 Deco Sheet

FXRD-1012NAW / 1012NBW

Indication Info. Description

A Center of the detector Indicates the central position of detector.
Indicates the operating state of detector.
B Status indication logo
 AP Mode, DATA, ACTIVE, POWER
C Image starting point Indicates the starting point of an original image.
D~G Certification logo Indicates the certification logos relating to a medical device.
H Wireless communication logo Indicates that this model can be operated wirelessly.

 Image starting point (0.0) of this detector is located nearby the tether interface connector.
You can change the displayed direction of an image from the VIVIX Setup program, but
it does not mean that the starting point and direction of the original image are changed.

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FXRD-1012NA / 1012NB

Indication Info. Description

A Center of the detector Indicates the central position of detector.
B Image starting point Indicates the starting point of an original image.
Indicates the operating state of detector.
C Status indication logo
 DATA, ACTIVE, POWER
D~G Certification logo Indicates the certification logos relating to a medical device.

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2.2.3 Load Limit of Detector

Uniform load Local load

Over the whole surface Center diameter 40 ㎜
Max. 150 kg Max. 100 kg

 Do not let the paitent or object heavier than load limit be on the detector. Then, the
detector can be damaged.
 Do not apply excessive load to the product. The internal sensor may be damaged, or the
image quality may be affected.

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2.3 SCU Basic (FXRS-03A)

SCU Basic synchronizes the image and X-ray signal as locating among the detector, workstation and the X-
ray generator. You can use the SCU Basic directly when the power supplies to SCU Basic after connecting it
under the VIVIX-S 1012N system environment.

2.3.1 Functions

Front Side

No. Name Description

1 Power switch Turns on/off the power of SCU Basic. (Including Green LED Lamp)
2 Fan Expels the air inside of SCU Basic.
3 Antenna Assists communications between the detector and SCU Basic.
Indicates the operation and connection status of SCU Basic.
 Blinking green: Booting
4 Status LED
 Green: Completed to boot up
 Blue: The software is connected and ready to communicate.

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2.4 SCU mini (FXRS-04A)

SCU mini synchronizes the image and X-ray signal as locating among the detector, workstation and the X-
ray generator. You can use the SCU mini directly when the power supplies to SCU mini after connecting it
under the VIVIX-S 1012N system environment

Front Side

No. Name Description

1 Power switch Turns on/off the power of SCU mini.
2 Antenna Assists communications between the detector and SCU mini.
Indicates status of SCU mini operation and connection.
 Blinking green: Booting
3 Status LED
 Green: Completed to boot up
 Blue: The detector is connected and ready to communicate.

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2.5 SCU Lite (FXRP-02A)

SCU Lite synchronizes the image and X-ray signal as locating between the detector and the workstation.
You can use SCU Lite directly when the power supplies to SCU Lite after connecting it under the VIVIX-S
1012N system environment.

Front Side

No. Name Description

Indicates the status of PoE port.
1 LINK LED  Green : 1 Gbps
 Yellow : 100 Mbps
PoE (Power over Ethernet) port (1000BASE-T)
2 POE Port  Communication between the detector and SCU Lite.
 Supplies power to the detector.

Rear Side

No. Name Description

Gigabit Ethernet port (1000BASE-T)
1 LAN port
 Communication between the workstation and SCU Lite.
DC +24V
2 DC power input port
 Supplies power to SCU Lite.
3 Power Switch Turns on/off the power of SCU Lite.

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2.6 Battery Charger (FXRC-02A)

No. Name Description

1 Top / Bottom LED Indicates the location and status of a battery pack being charged.
2 Power input port Supplies electric power by connecting a power adapter to the charger.

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2.7 Battery Charger (FXRC-03A)

No. Name Description

Indicates the location and status of a battery pack being charged.
1 LED Window : FXRB-03A
: FXRB-01A
2 Power input port Supplies electric power by connecting a power adapter to the charger.
3 Mounting hall Screw holes for fixing the charger to the external device. (M5 x 8)

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3. Preparing for System Operation

This chapter guides you how to prepare the detector operation.

Checking System Configuration

Using the Battery Pack
Using SCU
Booting the Detector

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3.1 Checking System Configuration

You can organize wired or wireless connection between the VIVIX-S 1012N detector and SCU. You can
also choose other connection ways suitable for the use environment in case of need.

Check the connection method before operation. For a wireless connection, the detector must be equipped
with a battery.

 Refer to VIVIX-S 1012N Service Manual for the detailed information about system
configuration.

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3.2 Using the Battery Pack (Wireless models only)

 Detector and its attached devices should be installed by an authorized service engineer.
 If you encounter any problems, consult the sales representative in Vieworks or a relevant
engineer.

3.2.1 How to insert a battery pack

1 Open the battery cover.

2 Insert a battery into a slot until it clicks and push the lever to the right for fixing the battery.
3 Close the battery cover.

 Check if the battery is fully charged before using.

 Make sure that the battery pack is securely inserted.
 The remaining battery can be checked from the battery lamp on the side of detector or
from the VIVIX Setup program.

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3.2.2 How to take out a battery pack

1 Open the battery cover.

2 Push the lever to the left for taking out the battery.
3 Close the battery cover.

 Make sure to turn off the detector by pressing and hold the power button for 3 seconds
before detaching a battery pack. All status LED lamps are off and then the detector is
turned off.
 When removing the battery pack from the detector, remove it in the opposite direction.
Removing it in the left or right direction may damage the battery.

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3.2.3 How to charge a battery pack (FXRC-02A)

The detector is battery-operated when it is connected wirelessly. Charge the battery pack fully before
inserting it to the detector.

Charging type 1
Before charging a battery pack, supply power to the charger with a power adapter.

1 Open the cover at the lower side of charger.

2 Put the FXRB-03A battery pack on the top of charger in the right direction.
3 Push the battery down until it is fixed in the charging part.
4 Close the cover at the lower side of charger.

Stimultaneous charging Charging time

Battery charger 2 battery packs 2 1/2 hrs
Tether interface cable 1 battery pack 3 1/3 hrs

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Charging type 2
Before charging a battery pack, supply power to the charger with a power adapter.

1 Open the cover at the lower side of charger.

2 Insert the FXRB-03A battery pack into the slot until it clicks.
 Insert the battery pack in the direction of a ‘TOP’ printed part.
3 Close the cover at the lower side of charger.

 The charging time can be different depending on temperature and charging status of a
battery.
 While charging a battery pack, it is available to use the detector by connecting it with a
tether interface cable.

 This detector is designed to make a battery being discharged little by little during the
detector is off. Therefore, remove the battery pack when the detector is not used for
some time. Otherwise, over discharge may occur resulting in the shortened battery life.
 Do not use the charger around the paitent.
 Charge the battery with the charger provided by Vieworks.
 Securely plug the power cord of the charger 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.
 Use only a power adapter complying with one of IEC 60601-1, IEC 60950-1, and IEC
62368-1.

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3.2.4 How to charge a battery pack (FXRC-03A)

Charging type 1
Before charging a battery pack, supply power to the charger with a power adapter.

1 Put the FXRB-03A battery pack to the bottom of a charger until it clicks.
2 The battery is started charging automatically. The charger light turns orange / green color when the
battery is being charged / fully charged.
3 Disconnect the battery pack from the charger when the charging is completed.

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Charging type 2
Before charging a battery pack, supply power to the charger with a power adapter.

1 Put the FXRB-01A battery pack into the slot.

2 The battery is started charging automatically. The charger light turns orange / green color when the
battery is being charged / fully charged.
3 Disconnect the battery pack from the charger when the charging is completed.

 The charging time can be different depending on temperature and charging status of a
battery.
 While charging a battery pack, it is available to use the detector by connecting it with a
tether interface cable.

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 This detector is designed to make a battery being discharged little by little during the
detector is off. Therefore, remove the battery pack when the detector is not used for
some time.
 If you exceed the number of usage time of a battery described in this manual or do not
observe the related precautions, the battery life and use time may be shortened and
swelling may occur. In this case, remove the battery from the detector immediately and
replace it with a new one.
 Charge the battery with the charger provided by Vieworks.
 Securely plug the power cord of the charger 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.
 Use only a power adapter complying with one of IEC 60601-1, IEC 60950-1, and IEC
62368-1.

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3.3 Using SCU

 For detailed information on SCU configuration and connection, refer to the VIVIX-S
1012N Service Manual.

3.3.1 Booting up SCU Basic (FXRS-03A)

1 Turn on the power switch at the front side of SCU.

2 Check if the power switch of SCU lights up green.
3 Check if the status indicator is blinking in green after the power switch of SCU is permitted.
4 Check if the status indicator of SCU is blinking in green and turns to light up in the same color.

 When the power switch lights up green, it means that the power is applied normally.
 When the status indicator is blinking in green, the SCU is booting.
 If the status indicator lights up green, it indicates that the SCU is being operated normally
after booting up.

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3.3.2 Booting up SCU mini (FXRS-04A)

1 Turn on the power switch on the front of the SCU mini. (ON)
2 After turning on the power switch, check that the status indicator flashes green.

3.3.3 Booting up SCU Lite (FXRP-02A) and Detector

1 Turn on the power switch at rear side of SCU Lite.

2 Check if the LINK LED of SCU Lite lights up green.
3 Check if the power LED of the detector lights up in light green.
4 Check if the active LED of the detector lights up in light green.

 When the LINK LED of SCU Lite lights up green, it means that the power is approved
normally.
 The detector starts booting up when you turn on the power of SCU Lite.
 Refer to VIVIX-S 1012N Service Manual for the detailed information about the default
setting status of a detector.
 If the power LED of the detector does not light up, check if the tether interface cable is
connected to the PoE port of SCU Lite correctly.

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3.4 Booting up the Detector

 The procedures in this chapter are explained according to the default setting status of a
detector (factory reset) and the use of wireless connection.
 Refer to VIVIX-S 1012N Service Manual for the detailed information about the default
setting status of a detector.

1 Attach a charged battery pack to the detector.

2 Press the power button of the detector for 1 second until the power LED is turned on.
3 When the power LED is on, check if it is lit green.
4 Check if the active LED is lit orange on the detector.

 If the power LED lights up green, the DC power is permitted normally.

 If the active LED lights up orange, the detector is compeleted to boot up normally.

3.4.1 Checking Status LED of Detector

Power LED
 The power LED indicates the power status information which is permitted to the detector in green.
 The power LED lights up when the power is permitted normally.
 If the detector is connected with a tether interface, the power LED lights up when power is permitted to
SCU because the detector is supplied power from SCU.

Active LED
 The active LED indicates status information about the possibility that the detector can be used normally
or not in orange.
 The active LED is blinking when the detector is completed to boot up normally.
 The active LED is blinking when the detector turns to sleep mode.
 The active LED is blinking when the wireless communication is being initialized.

Data LED
 The data LED indicates status information of the data processing in blue.
 The data LED lights up when the detector is available to make data communication.
 The data LED is blinking while the detector transmits or saves data.

Detector AP LED
 The AP LED lights up in blue when the detector AP is on.
 The AP LED is blinking in blue when the detector switches the AP status.
 The AP LED is blinking in orange while the detector is synchronizing the wireless settings.
 The communication status of detector is indicated when the detector AP is off.
 Wireless communication: Green LED at the 3rd level or higher / Orange LED under 2nd level.
 Wired communication: Green LED in case of 1Gbps / Orange LED in case of 100Mbps connection.

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Summary List of Detector Status LED

Information Power LED Active LED Data LED

In process of booting after the power
Blink OFF OFF
permission
Booting completed (Abnormal) ON - -
Booting completed (Normal) ON ON OFF
Ready for communication ON ON ON

Sleep Mode ON Blink OFF

In process of wireless initialization ON Blink OFF

Data Communication (Send or Store) ON ON Blink

Power OFF OFF OFF OFF

Summary list of the Detector AP LED

Information Detector AP LED

Detector AP OFF (Communication status: Good)
 Wireelss communication: 3rd level or higher ON
 Wired communication: 1000Mbps
Detector AP OFF (Communication status: Normal)
 Wireelss communication: Under 2nd level ON
 Wired communication: 100Mbps
Detector AP ON ON

Switching the status of detector AP Blink

The wireless setting is being synchronized Blink

Power OFF OFF

 If the LED blinks abnormally, refer to VIVIX-S 1012N Service Manual to check if
communication or system error is occurred.

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4. Inspection and Cleaning

This chapter provides instructions on how to inspect and clean the product.

Product Inspecction
Cleaning and Disinfection

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4.1 Product Inspection

 To use products safely, make sure to check the products before use. If problems occur
during inspection or the product is impossible to repair, consult the sales representative in
Vieworks or a relevant engineer.

4.1.1 Daily Inspection

Before or after using the detector and other surrounding devices, check below items daily.

Item Description
 Ensure that there are no loose screws or breaks.
Detector  Ensure that there is no dust or foreign matter on the battery bay connector.
 Ensure that there are no breaks or short-circuits in the battery bay connector.
SCU  Check if the antenna is damaged.
 Ensure that cables are not damaged and cable jackets are not torn.
Cable  Ensure that the power cord plugs are securely connected to both AC inlet and AC outlet
of the equipment.

4.1.2 Performance Inspection

Check the detector and other devices periodically as follows.

Item Period Description

 Conduct Self-Diagnosis of the VIVIX Setup program for the internal
Self-Diagnosis Half-yearly
devices of the detector and check the status.
 Check the resolution of the detector through resolution chart or using a
Resolution Half-yearly
phantom.
 Evaluate the characteristic of the detector through checking gray value
Sensitivity Half-yearly of the images made by X-ray dose amount reaching to the surface of
the detector.
 Updating calibration data. (Offset → Gain → Defect)
Calibration Half-yearly  Proceed to calibrate when X-ray Generator, Tube, Collimator or exposure
environment are changed.

 Self-diagnosis and resolution can be conducted by a user or a service engineer.

 Sensitivity and calibration should be conducted by an authorized service engineer who
Vieworks grants.

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4.2 Cleaning and Disinfection

 Refer to the relevant document for details.

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5. Regulatory Information

This section gives explanation about the regulatory information and standard related to the
products

Medical Equipment Safety Standards

Product Symbols

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5.1 Medical Equipment Safety Standards

5.1.1 Medical Equipment Classification

Item Description
Type of protection against electrical shock Class Ⅰ or Internally Powered
Degree of protection against electrical shock Type B applied parts
IP53 (Degrees of protection againt ingress of water and
Degree of protection against water and dust
dust provided by enclosure.)
Operation mode Continuous operation
NOT suitable for use in the presence of a flammable
Flammable anesthetics
anesthetic mixture with air or with oxygen or nitrous oxide.

5.1.2 Product Safety Standards by Country

South Korea
Electrical and mechanical safety tests shall be in accordance with IEC 60601-1.
Test for electromagnetic interference prevention shall be in accordance with IEC 60601-1-2.

U.S.A / Canada

Item
IEC 60601-1:2012 (ed. 3.1) Medical electrical equipment- Part1: General requirements for safety
Medical electronic equipment – Part 1: General requirements for
UL 60601-1 (ed.3.1)
safety
Medical electrical equipment – Part 1: General requirements for
CAN/CSA-C22.2 No. 60601-1(2008)
safety (adopted amendment 2:1995 to IEC60601-1)
Medical electrical equipment-Part 1-2: Collateral standard:
IEC 60601-1-2: 2014 (ed.4)
Electromagnetic compatibility
IEC 62304:2006 Medical device software-software life cycle processes
ISO 14971:2012 Medical Device- Application of risk management to medical devices

European Union

Item
MDD (Medical Device Directive) 93/42/EEC as amended by 2007/47/EC
Medical devices – Quality Management systems – Requirements for
EN ISO 13485:2016
regulatory purposes
IEC 60601-1: 2012(ed. 3.1) Medical electrical equipment- Part1: General requirements for safety
Medical electrical equipment-Part 1-2: Collateral Standard :
EN 60601-1-2: 2014(ed.4)
Electromagnetic compatibility-Requirements and tests
EN 62304:2006 Medical device software-Software life cycle processes
ISO 14971: 2012 Medical device – Application of risk management to medical devices.

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5.2 Electromagnetic Compatibility and Guidance

 This device has been tested for EMI/EMC compliance, but interference can still occur in an
electromagnetically noisy location. Attempt to maintain a suitable distance between
electrical devices to prevent malfunction.

 Obtaining diagnostic images and transferring them to a PC (workstation) are the essential
performance of VIVIX-S 1012N. If the required performance is degraded or lost due to
electromagnetic interference, images that are not suitable for diagnosis may be obtained
or the image may be lost.

5.2.1 Electromagnetic Emissions

Equipment Under Test (EUT) is intended for use in the electromagnetic environment specified below.

Immunity test Compliance Electromagnetic Environment

This equipment (EUT) uses RF energy only for its internal function.
RF Emissions
Group 1 Therefore, its RF emissions are very low and are not likely to cause
(CISPR 11)
any interference in nearby electronic equipment.
RF Emissions This equipment (EUT) is directly connected to the low voltage power
Class A
(CISPR 11) supply network and can be used in all facilities except those that
High frequency supply voltage to household facilities or buildings.
emissions Class A
(IEC 61000-3-2) The EMISSIONS characteristics of this equipment make it suitable
for use in industrial areas and hospitals (CISPR 11 class A). If it is
used in a residential environment (for which CISPR 11 class B is
Voltage fluctuations/
normally required) this equipment might not offer adequate
Flicker emissions Complies
protection to radio-frequency communication services. The user
(IEC 61000-3-3)
might need to take mitigation measures, such as relocating or re-
orienting the equipment.

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5.2.2 Electromagnetic Immunity

The VIVIX-S 1012N system has secured the electromagnetic compatibility in the following environments. It
is recommended that you use the product only in the specified electromagnetic environment.

Electrostatic Discharge (ESD) IEC 61000-4-2

Item Description
Immunity Test  Electrostatic discharge (ESD) IEC 61000-4-2
 Contact ±8㎸
IEC 60601 Test Conditions
 Air ±15㎸
 Contact ±8㎸
Compliance Level
 Air ±15㎸
 Floors should be wood, concrete or ceramic tile.
Electromagnetic Environment
 If floors are covered with synthetic material, the related humidity
(Guidelines)
should be at least 30%.

Electrical Fast Transient/Burst IEC 61000-4-4

Item Description
Immunity test  Electrical fast transient/burst IEC 61000-4-4
 Power supply lines ±2㎸
IEC 60601 test condition
 Input / output lines ±1㎸
 Power supply lines ±2㎸
Compliance Level
 Input / output lines ±1㎸
Electromagnetic Environment -  Main power quality should be that of a typical commercial or hospital
Guidance environment.

Surge IEC 61000-4-5

Item Description
Immunity test  Surge IEC 61000-4-5
 Differential mode ±1㎸
IEC 60601 test condition
 Common mode ±2㎸
 Differential mode ±1㎸
Compliance Level
 Common mode ±2㎸
Electromagnetic Environment -  Main power quality should be that of a typical commercial or hospital
Guidance environment.

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Voltage drop, momentary power failure and voltage fluctuation of Power Supply Input Lines
IEC 61000-4-11

Item Description
 Voltage dips, short interruptions and voltage variations on power
Immunity test
supply input lines IEC 61000-4-11
 100% reduction for 0.5 cycle at 0, 45, 90, 135, 180, 225, 270 and 315
degrees
IEC 60601 test condition  100% reduction for 1 cycle
 30% reduction for 25/30 cycles at 0 degree
 100% reduction for 250/300 cycles (5 sec.)
 100% reduction for 0.5 cycle at 0, 45, 90, 135, 180, 225, 270 and 315
degrees
Compliance Level  100% reduction for 1 cycle
 30% reduction for 25/30 cycles at 0 degree
 100% reduction for 250/300 cycles (5 sec.)
 Main power quality should be that of a typical commercial or hospital
environment.
Electromagnetic Environment -  If the user of the EUT image intensifier requires continued operation
Guidance during power mains interruptions, it is recommended that the EUT
image intensifier be powered from an uninterruptible power supply or
a battery.

 Uт is the AC power prior to approving the test level voltage.

Power Frequency (50/60 ㎐) Magnetic Field IEC 61000-4-8

Item Description
Immunity test  Power frequency (50/60 ㎐) magnetic field IEC 61000-4-8
IEC 60601 test condition  30 A/m
Compliance Level  30 A/m
Electromagnetic Environment -  Power frequency magnetic fields should be at levels characteristic of a
Guidance typical location in a typical commercial or hospital environment.

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Conductivity RF IEC 61000-4-6 / Radioactive RF IEC 61000-4-3

Item Description
Immunity test  Conductivity RF IEC 61000-4-6  Radioactive RF IEC 61000-4-3
 3 Vrms 150 ㎑ to 80 ㎒
IEC 60601 test condition  6 Vrms in the ISM bands 150  3 V/m 80 ㎒ to 2.7 ㎓
㎑ to 80 ㎒
 3 Vrms 150 ㎑ to 80 ㎒
Compliance Level  6 Vrms in the ISM bands 150  3 V/m 80 ㎒ to 2.7 ㎓
㎑ to 80 ㎒
 The electromagnetic field strength of a stationary RF transmitter determined
by an electromagnetic test survey must be less than the compliance level of

Electromagnetic each frequency range.

Environment - Guidance
 Interference may occur in the vicinity of equipment marked with the symbol.

 At 80 ㎒ and 800 ㎒, the higher frequency range applies.

 These guidelines may not apply in all situations. Electromagnetic propagation may be
affected by absorption and reflection from structures, objects and people.

 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which EUT is used exceeds
the applicable RF compliance level above, EUT should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating EUT.
 Over the frequency range 150 ㎑ to 80 ㎒, field strengths should be less than [V1] V/m.
 Portable RF communications equipment (including peripherals such as antenna cables and
external antenns) should be used no closer than 30cm (12 inches) to any part of the
VIVIX-S 1012N, including cables specified by the Vieworks. Otherwise, degradation of the
performance of this equipment could result.

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5.3 Radio Frequency Compliance Information

Country Item
 FCC Part 15.107 Subpart (b) / 15.109(g) Subpart B
U.S.A  FCC Part 15 Subpart E 15.407
 FCC Part 15 Subpart C 15.247
 ETSI EN 301 489-1 V1.8.1
 ETSI EN 301 489-17 V2.1.1
European Union
 EN 300 328 V2.1.1
 EN 301 893 V2.1.1
 Clause 3, Article 58-2 of Radio Waves Act
South Korea
 Clause 2, Article 58-2 of Radio Waves Act
Japan  Article 2-1-19, 2-1-19-3, 2-1-19-3-2 of the Radio law (MIC)

5.3.2 FCC Compliance

 This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection against
harmful interference in a residential installation.
 Operation is subject to the following tow conditions.
 This device may not cause harmful interference.
 This device must accept any interference received, including interference that may cause undesired
operation.
 This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in
accordance with the instruction, may cause harmful interference to radio communications. However, there
is no guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the interference by one or more of the following
measure.
 Reorient or relocate the receiving antenna.
 Increase the separation between the equipment and receiver.
 Connect the equipment into an outlet on a circuit different from where the receiver is connected.
 Consult the distributor or an experienced radio/TV technician for help.

 Change or modification which is not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
 5.15-5.35G㎐ band is restricted to indoor operations only.

 The SAR limit set by FCC is 2W/kg (for EU and Japan) and 1.6W/kg (for USA and Korea).
 This equipment complies with FCC&CE SAR regulation.
 The front side of a detector should be used for image acquisition.

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5.3.3 FCC SAR

 OET Bulletin 65, Supplement C (Edition 01-01)

5.3.4 CE R&TTE SAR

Item
Assessment of electronic and electrical equipment related to human
EN 62311:2008
exposure restrictions for electromagnetic fields. (0 Hz - 300 GHz)
Human exposure to radio frequency fields from hand-held and body-
mounted wireless communication devices – Human models,
instrumentation, and procedures.
EN 62209-1:2006
 Part 1: Procedure to determine the specific absorption rate (SAR)
for hand-held devices used in close proximity to the ear (frequency
range of 300 MHz to 3 GHz).
Human Exposure to Radio Frequency Fields from Handheld and Body-
Mounted Wireless Communication Devices – Human models,
Instrumentation, and Procedures.
EN 62209-2:2010
 Part 2: Procedure to determine the specific absorption rate (SAR)
for mobile wireless communication devices used in close proximity
to the human body (frequency range of 300 MHz to 6 GHz).

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5.4 Product Symbols

The symbols related to VIVIX-S 1012N detector are indicated below:

Symbol Description

Direct current

Alternating current

Protective earth (Ground)

Equipotentiality

Power on

Power on for part of the equipment

Power off

Power off for part of the equipment

Attention, consult accompanying documents

General warning sign

Warning sign for electricity

This Mark shows compliance with both Canadian and U.S. safety requirements. With
Respect to electric shock, fire, and mechanical hazards only. In accordance with
UL60601-1 and CAN/CSA C22.2 No. 601.1.

This mark shows compliance of the essential requirement and other relevant
provisions of Directive 93/42/EEC as amended by 2007/47/EC.

Non-ionizing radiation

Read and understand all instructions and warning labels in the product
documentation before using the equipment. Keep manual for future reference.

Dealing with a medicine that can only be given by a prescription from a doctor and
you should use a certain medication that a doctor recommended.

Mark indicating compliance with RoHS 2 (China)

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Dustproof/waterproof test results based on IEC 60529

(Dustproof grade 6, Waterproof grade 7)

Indicates that this is a medical device

European Representative Information

General mandatory action sign

This mark indicates that this equipment must be handled with care.

Do not jolt or apply excessive load to the equipment.

This is a Type B Applied Part according to UL 60601-1 and EN 60601-1.

This mark indicates that the equipment must be collected separately under the
Directive on Waste Electrical and Electronic Equipment 2012/19/EC (WEEE) in the
European Union. (For European Union)
This mark indicates that the battery must be collected separately under the Directive
on Waste Electrical and Electronic Equipment 2006/66/EC in the European Union. (For
European Union)

Direct current

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6. Information

This section gives overview information for service and warranty of the product.

Service Information
Warranty
Revision History

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6.1 Service Information

6.1.1 Product Lifetime

The estimated product lifetime may be up to seven (7) years under the appropriate regular inspection and
maintenance.

6.1.2 Regular Inspection and Maintenance

To protect patients, product operators, and third parties, and to maintain the performance and reliability of
this equipment, perform at least one annual review. If necessary, clean and adjust the equipment and
replace consumable parts. Depending on the condition of the product, a full check may be recommended.
Please contact your dealer for regular maintenance and maintenance.

6.1.3 Repair

If troubleshooting does not resolve the problem, contact your dealer for product repair. Please refer to the
product label and provide the following information.

 Model
 FXRD-1012NA / FXRD-1012NB
 FXRD-1012NAW / FXRD-1012NBW
 Serial number
 9 digit-number on the product label
 Problem description
 Please include as much detail as possible.

6.1.4 Replacement Parts Support

Performance parts (parts required to maintain the functioning of the product) of this product will be
stocked for seven years after discontinuance of production, to allow for repair.

6.1.5 Consumables

The following consumable can deteriorate because of its characteristics and structure. For purchase of
consumables, contact your sales representative or distributor.
 Battery pack: FXRB-03A

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6.2 Warranty

Vieworks Co., Ltd. follows the contract with each customer regarding the product warranty period. If any
such product proves defective during this warranty period, Vieworks at its option, either will repair the
defective product without charge for parts and labor, or will provide a replacement in exchange for the
defective product. In order to obtain service under this warranty, Customer must notify Vieworks of the
defect before the expiration of the warranty period and make suitable arrangements for the performance of
service. Customer shall be responsible for packaging and shipping the defective product to the service
center designated by Vieworks with shipping charges prepaid.

Vieworks shall pay for the return of the product to customer if the shipment is to a location within the
country in which Vieworks designated service center is located. Customer shall be responsible for paying all
shipping charges, duties, taxes, and any other charges for products returned to any other locations.

This warranty shall not apply to any defect, failure, or damage caused by improper or inadequate
maintenance and care. Vieworks shall not be obligated to furnish service under this warranty to repair
damage resulting from attempts by personnel other than Vieworks or its representatives to install, repair, or
service this product, to repair damage resulting from improper use or connection to incompatible
equipment or power source; or to service a product that has been modified or integrated with other
products when the effect of such modification or integration increases the time or difficulty of servicing the
product.

THIS WARRANTY IS GIVEN BY VIEWORKS WITH RESPECT TO THIS PRODUCT IN LIEU OF ANY OTHER
WARRANTIES, EXPRESS OR IMPLIED. VIEWORKS AND ITS VENDOR DISCLAIM ANY IMPLIED
WARRANTIES OF MERCHANTABLILITY OR FITNESS FOR A PARTICULAR PURPOSE. VIEWORKS
RESPONSIBILITY TO REPAIR OR REPLACE DEFECTIVE PRODUCTS IS THE SOLE REMEDY PROVIDED TO
THE CUSTOMER FOR BREACH OF THIS WARRANTY. VIEWORKS AND ITS VENDORS WILL NOT BE
LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES IRRESPECTIVE OF
WHETHER VIEWORKS OR THE VENDOR HAS ADVANCE NOTICE OF THE POSSIBILITY OF SUCH
DAMAGES.

There are no warranties which extend beyond the description mentioned in this document

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6.3 Revision History

Version Date Descriptions

1.0 2017-03-09  Initial Release
 Changed) 5.4.1 Label
1.1 2017-05-29
- Design of battery label
1.2 2017-08-31  Changed) 5.4.1 Label
 Removed the following sentence in chapter 1.3.2 ‘Disclaimer’
 In no event shall Vieworks be liable for direct or indirect consequential
damages arising from the use or unavailability of this product.
 Changed the chapter 1.4 Safety Information
1.3 2018-01-02  Removed the chapter 1.5.2 Distance Measurement
 Changed the chapter 5.2 Guidance and Manufacturer’s Declaration for EMC
 Changed the chapter 6.2 ‘Warranty’
 Removed the warranty period
 Changed the European agent address and contact information
 Changed detector image according to deco sheet change.
 Added cautionary statement to chapter 1.4.2 'Power supply'
 Changed the chapter 1.5.9 Operating and Storage Environment
1.4 2018-05-08  Added the chapter 2.2.2. Deco Sheet
 Added cautionary statement to chapter 3.2.2 How to take out a battery pack
 Changed the chapter 5.1 Medical Equipment Safety Standards
 Changed the chapter 5.2 Guidance and Manufacturer’s Declaration of EMC
1.5 2018-10-05  Added instrunctions on wired detector models (VIVIX-S 1012NA / 1012NB).
1.6 2018-11-15  Changed the battery label in the chapter 5.4.1 Labels.
 Changed the chapter 5.1.2 Product Safety Standards by Country
1.7 2018-12-14
 Changed the chapter 5.4.1 Label
1.8 2019-05-21  Added the chapter 1.3.3 Outdoor Restrictions
 Changed the front cover image
1.9 2020-03-12
 Changed the chapter 2.2.2 Deco Sheet
 Changed the chapter 2.2.1 Functions
1.10 2020-11-23  Added the production plant address
 Changed the chapter 5.4.1 Label
 Changed the chapter 3.2.3 How to charge a battery pack (FXRC-02A)
 Changed the chapter 3.2.4 How to charge a battery pack (FXRC-03A)
1.11 2021-02-09  Changed the chapter 5.1.2 Product Safety Standards by Country
 Changed the chapter 5.3 Radio Frequency Compliance Information
 Changed the production plant address
 Changed the chapter 1.1.5 Contact Us
 Changed and added the chapter 1.2 Purpose of Use
 Changed the chapter 1.3.2 Disclaimer
2.0 2021-04-13
 Adde the sentence on the cover
 Changed the chapter 4.2 Cleaning and Disinfection
 Changed the chapter 5.4.1 Labels

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 Added the chapter 1.3 Clinical Benefits of Product Use

2.1 2021-06-17  Changed the chapter 1.5.4 Product Disposal
 Changed the chapter 5.4.2 Product Symbols
2.2 2021-07-15  Added the model name
 Changed) Document name
 Changed) 1.4 Features
 Added) 2.1.2 SCU (FXRS-03A)
2.3 2021-11-15
 Added) 2.1.3 SCU (FXRS-04A)
 Added) 2.1.4 SCU (FXRP-02A)
 Changed) 5.4.1 Labels
2.4  Deleted) 5.4.1 Labels

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Vieworks Co., Ltd.

Headquarter
41-3, Burim-ro 170beon-gil, Dongan-gu, Anyang-si,
Gyeonggi-do, 14055 Republic of Korea
Telephone: +82-70-7011-6161
Fax: +82-31-386-8631
Homepage: http://www.vieworks.com

Hwaseong Site
25-7, Jeongnamsandan 2-gil, Jeongnam-myeon, Hwaseong-si,
Gyeonggi-do, 18514 Republic of Korea
Telephone: +82-70-7011-6161
Homepage: http://www.vieworks.com

European representative: Obelis s.a

Bd. Général Wahis 53
1030 Brussels, BELGIUM
Tel: +(32) 2.732.59.54
Fax: +(32) 2.732.60.03
E-mail: [email protected]

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