Vieworks FXRS-04A System Control Unit User Manual VIVIX S 1012N V1 0W16 EN

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Date Submitted	2015-02-12 00:00:00
Date Available	2015-02-12 00:00:00
Creation Date	2015-01-27 20:45:44
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Document Title	VIVIX-S 1012N User Manual V1.0W16_EN
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Document Author:	서병모

VIVIX-S 1012N User Manual
Mini SCU
[TBD]
If you use the DR Trigger mode, connect the one end of generator interface cable to the EXT_INF port
of SCU, and the other to the X-ray generator.

 If you use the AED mode, a generator interface cable is not needed as the detector
operates by detecting X-ray automatically.
Connect one end of the LAN cable to one of the LAN ports of SCU, and the other to the LAN Card
Connector of workstation assigned for data transfer.
To transmit image data using a Tether Interface, connect the one end of the tether interface cable to
the port of Mini SCU and the other to the detector.

 If you use the wireless communication method, a tether interface cable is not needed as
the image is transmitted wirelessly.
Rev.1.0
To supply power, connect the DC power cable to the DC power input port of SCU.
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4.2.2
Booting up SCU
Turn on the power switch at the front side of SCU.
Check if the power switch of SCU lights up green.
Check if the status indicator is blinking in green after the power switch of SCU is permitted.
Check if the status indicator of SCU is blinking in green and turns to light up in the same color.
Check if the status indicator of SCU is blinking in green and turns to light up in blue.

 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.

 If the status indicator lights up blue, SCU’s preparation for communication is completed.
4.2.3
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  for the detailed
information about the default setting status of a detector.
Attach a charged battery pack to the detector.
Press the power button of the detector for 1 second until the power LED is turned on.
When the power LED is on, check if it is lit green.
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.
Rev.1.0
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4.2.4
Checking Status LED of Detector
[TBD]
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.
The power LED is blinking when the detector is in the sleep mode.
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.
If the detector AP is on, the LED blinks for 5 times right after the booting.
Data LED
The data LED indicates status information about the data processing in blue.
The data LED lights up when the detector is available to make data communication.
If the detector is in the sleep mode, the data LED lights up.
The data LED is blinking while the detector transmits or saves data.
If the detector AP is on, the LED blinks for 5 times right after the booting.
Summary List of Detector Status LED
Information
Power lamp
Active lamp
Data lamp
Color
Green
Orange
Blue
When power is permitted
On
Off
Off
Boot-up completed (AP ON)
On
Blinking 5 times
Blinking 5 times
Boot-up completed (AP OFF)
On
On
Off
Ready for communication
On
On
On
Sleep mode
Blinking
On
On
On
On
Blinking
In process of wireless initialization
On
Blinking
Off
Power Off
Off
Off
Off
Data communication
(Send or Store)

 If the LED blinks abnormally, refer to  to check if communication or
system error is occurred.
Rev.1.0
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4.3
Software Installation
This section gives information about how to install the software on the workstation (PC) and how to
configure the environment for software operation and communication.

 Check suitability of acquiring, processing and adjusting of images by referring to the
recommended workstation specifications before the software installation.
4.3.1
Software Classification
[TBD]
Vieworks provides clients who purchase our detector system with software as below. You can choose and
use one of our softwares below.
Software
Description

 A program for acquiring and adjusting images developed by Vieworks.
VXvue
 Used for ViVIX-S detectors only.

 Unnecessary to develop a separate viewer program.
VIVIX Setup

 A program for setting and managing the detector and SCU.
VXvue (Viewer)

 Software for acquiring, adjusting and managing the image.
XIPL

 Image processing program
Document

 XIPL User Manual

 Software development kit for ViVIX-S detector only, provided by Vieworks.
VIVIX SDK

 You can develop your own software dedicated to ViVIX-S by using this kit.
SDK Package

 Development package
VIVIX Setup

 A program for acquiring, adjusting and managing the image.
Document
4.3.2

 VXvue Operation Manual

 VIVIX SDK Developer Manual
Software Installation
For a client who uses VXvue, install the VXvue program after reading VXvue Operation Manual
carefully.
For a client who uses VIVIX SDK, install the Setup program after reading VIVIX SDK Developer
Manual.

 Be sure to install the software first with reading this manual before configuring Windows
environment.

 Apart from the detector and SCU, the software can be installed separately.
Rev.1.0
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4.4
Windows Environment Setting
This section gives information about configuring Windows to communicate with the detector and SCU after
installing the Setup program or Viewer.

 The contents in this chapter are made on the basis of Windows 7.

 Configuration environment can be different depending on network adaptor manufacturer
or models.
4.4.1
Network Configuration
[TBD]

 Communication disruption between the detector (Or SCU) and workstation occurs unless
the network adaptor is proper is set properly, it may cause serious repercussion to the
product and image quality.
Selecting Network Adaptor
Click Start  Control Panel  Network and Internet  Network and Sharing Center  Change
Adapter Setting.
Choose the networks adaptor for communicating with the detector and SCU, and then rename it.

 It is recommended to change the name of network adaptor to distinguish it from other
connection names.

 Even though the name is changed, it will not affect to the operation and communication
performance of the equipment.
Rev.1.0
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Click the chosen network adaptor with the right mouse button and click Properties to display the
Properties window.
Setting Network Adaptor
Click Configure button to open the following dialog box, and then go to the Advanced tab.
Set Jumbo Packet to the maximum value. (Recommended value: 9014 Bytes)
Choose Performance Options in the list of Settings and click Properties button on the right.
Choose Flow Control in the list of Settings and select Rx & Tx Enabled on the Value list as shown
below.
Rev.1.0
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Choose Interrupt Moderation Rate in the list of Settings and select Extreme on the Value list as
shown below.
Choose Receive Buffers and set it to the maximum value.
Click OK button.
Deactivate Power-Saving Mode on Network Adaptor
Click the Power Management tab and uncheck Allow the computer to turn off this device to save
power.
Click OK button.

 Viewer may not work normally if the power save mode is activated.

 Deactivate the power save mode of all the installed network adaptors.
Rev.1.0
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Protocol Selection and IP Address Setting
Choose Internet Protocol Version 4 (TCP/IPv4).and click Properties button.
Input the IP address and subnet mask as shown below, and then click OK button.

 ViVIX Device Driver is the image filter driver for acquiring images from a detector.

 It is recommended to uncheck the other items on the list except for ViVIX Device Driver
and Internet Protocol Version 4(TCP/IPv4), since they are not related with the detector
communication.
Summary of Network Configuration
Item
Value
Jumbo Packet
Maximum or 9014 Bytes
Flow Control
Rx & Tx Enabled
Interrupt Moderation Rate
Extreme
Receive Buffers
Maximum
Allow the computer to turn off this device to save power
Unchecked
IP Address
169.254.0.(50 ~ 254)
Subnet Mask
255.255.0.0

 It is recommended to set the IP address and subnet mask within the range presented in
this document.

 If you use IP address and subnet mask out of the suggested range, it could be difficult to
identify and resolve the cause of communication disorder.
Rev.1.0
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4.4.2
Disabling Sleep Mode of Monitor

 If you use the sleep mode, viewer may not work normally.
Click Start  Control Panel  Power Options and then move to the Choose when to turn off the
display tab.
Rev.1.0
Set Put the computer to sleep to Never to disable the sleep mode.
Click Save changes button.
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5. Setting
[TBD]
This section gives information about the product setting with using the Setup program.
Start Setting
VIVIX SCU Setting
Detector Setting
Rev.1.0
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5.1
Start Setting
5.1.1
Setup Program
The Setup program provides functions for setting and managing the internal data to make VIVIX-S 1012N
wireless detector and SCU work normally. In addition, The Setup program has diagnostic function for
checking performance and abnormality of the devices as well as the image calibration function for
improving the image quality.
5.1.2
Checking Devices
5.1.3
Getting into the Devices
Rev.1.0
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5.2
Rev.1.0
SCU Setting
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5.3
Detector Setting
5.3.1
Detector Configuration
5.3.2
Detector Power Save Function
Rev.1.0
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6. Calibration
[TBD]
This chapter gives information about the calibration methods after installing a detector.
Calibration Dialogue
Detector Configuration
Calibration Guide
Calibrating by Loading the Calibration Data
Direct Calibration
Rev.1.0
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6.1
Rev.1.0
Calibration Dialogue
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6.2
Rev.1.0
Detector Configuration
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6.3
Calibration Guide
The different installation environment of each detector and unique features of the X-ray generator device
can affect the acquired images. Therefore, the certified engineer from Vieworks should do the detector
calibration after installing it. Otherwise, the image quality can be affected seriously.
Vieworks provides two types of calibration for performing calibration.
Performing calibration by loading the calibration data CD provided by Vieworks.
The service engineer proceeds calibration and generate calibration data.

 We strongly recommend the service engineer to carry out the calibration by oneself as
the detector condition and image quality can be different by the operation method or
use environment.
Rev.1.0
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6.4
Calibrating by Loading the Calibration Data

 Vieworks provides the offset calibration data as a CD with the detector. However, we
recommend the service enginner to carry out the calibration by oneself as the detector
condition can be different by the operating method or use environment.
6.4.1
Preparing Calibration Data
Prepare the calibration data CD provided with the detector.
Copy the calibration data files and save them to a safe route such as local HDD.
The calibration data CD is consisted of 4 data files as below.
File
Description
Pre-Offset
Detector Offset data 1
Post-Offset
Detector Offset data 2
Gain Offset
Image sensitivity Offset data
Defect Map
Defect calibration map data

 Each name of a data file is made with the combination of rules as follows.
 [Serial number]_[ Calibration data name].dat
Rev.1.0
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6.5
Rev.1.0
Direct Calibration
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7. Diagnosis, Inspection and
Maintenance
[TBD]
This section gives information about diagnosis, inspection & maintenance of the product.
Diagnosis
Product Inspection
Cleaning and Disinfection
Product Initialization
Replacing the Fuse of VIVIX SCU
Rev.1.0
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7.1
Diagnosis
7.1.1
Image Diagnosis

 Check the image quality through Diagnosis tools after installing the detector or before
usage. If the problems with regard to products or image occur during diagnosis, try to do
a calibration again. If the problems are not solved, consult the sales representative in
Vieworks or a service engineer.
You can acquire and review an image from the Diagnosis window in Setup program.
You can review images by acquiring them through real exposure or getting Dark image by clicking Get
Normal Image button.
7.1.2
The number of images, pixel value and ROI value will be displayed.
The effective area or whole area of an image can be checked.
It is also available to check the image by changing its direction.
Save the reviewed image as a raw one to analyze.
You can acquire an image either applying Offset / Gain data or not.
Battery Pack Diagnosis

 Install the battery pack to the detector and check the voltage and remaining amount of
the battery pack. Furthermore, always check the remaining amount of the battery pack
during use of the detector. If performance of the battery pack has some problems, consult
the sales representative in Vieworks or a relevant engineer.

 The battery pack belongs to consumables which performance will be decreased as time
passed. Make sure to check the battery life during usage.
Check Voltage of Battery Pack
[TBD]
Check remaining amout of battery pack
7.1.3
Wireless Communication Diagnosis

 In case of using the detector with wireless communication way, make sure to check the
status of wireless communication before starting to use. If the status of wireless
communication is bad, the speed of acquiring images will be very slow or failed to acquire
images. Try to check the surrounding wireless communication status not to occur
communication interference. If wireless communication module in the detector has
problems, consult the sales representative in Vieworks or a relevant engineer.
Rev.1.0
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Check the Connection Status
User can check the connection status of wired or wireless detector through VXvue or VIVIX SDK.
Check the Strength of Wireless Communication Signal
The signal strength of wireless communication is provided as 5 stages or percentage (%), user can check it
through VXvue (Vieworks Viewer) and VIVIX SDK.

 Since the signal strength of wireless communication at the 1st stage is not good, it is
required to check the surrounding wireless communication status.
Rev.1.0
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7.2
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.
7.2.1
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.

 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.
7.2.2
Performance Inspection
Check the detector and other devices periodically as follows.
Item
Period
Self-Diagnosis Half-yearly
Resolution
Half-yearly
Description

 Conduct Self-Diagnosis of the Setup program for the internal devices of
the detector and check the status.

 Check the resolution of the detector through resolution chart or using a
phantom.

 Evaluate the characteristic of the detector through checking gray value
Sensitivity
of the images made by X-ray dose amount reaching to the surface of
Half-yearly
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.
Rev.1.0
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7.3
Cleaning and Disinfection
After using the detector and peripheral equipments for examination, use germicidal disinfecting wipes or
cloth with mild diluted disinfectant detergent to clean surfaces of the product.
Recommended Detergent Foam
Recommended disinfectant wipe
Wip’ anios manufactured by Anios
Sani-cloth Active Wipes by PDI
Recommended disinfectant product
Sulfa’safe
Storage temperature: 5°C ~ 35°C
How to Use Detergent Foam
Prepare the disinfectant detergent and a clean and dry non-woven cloth.
Use the spray bottle to spray detergent to the cloth and clean the equipment.
After it has been cleaned, leave the equipment un-used for 15 minutes.
Conduct cleaning once a week or in case of contamination.

 Do not re-use wipes.

 Be careful to use disinfectant detergent which can cause irritation to eyes and skin.

 Use in well-ventilated areas, and wear gloves at all times.

 Do not clean the equipment with its power on.

 Do not use abrasive brush and scraper to clean the product.

 Be careful not to make liquid soak when cleaning battery bay and the connector on the
side of products.

 Other Disinfectant detergent compliant to conditions listed below may be used following
proper procedures according to its own manual.
 European Biocidal Products designed for surface disinfection (Directive 98/8/EC)
 Detergent with composition of Didecyldimethylammonium chloride, polyhexamethylene
biguamide hydrochloride.
Rev.1.0
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7.4
Product Initialization
If the connection status of system is not stable or setting value is not correct, user can initialize the
products.
7.4.1
SCU Initialization
Click Configuration button of SCU after running the VIVIX Setup program.
Click Factory Reset button in Configuration dialogue.
Wait for SCU to be initialized and rebooted automatically.
Check whether SCU initialization is completed.
Default value of SCU initialization
Item
Default Value
Network
IP Address
Subnet Mask
Gateway
AP
AP On/Off
Frequency
Country
Band
Channel
SSID
Key
Security
GI (Guard Interval)
Tx Power
Test Mode
On/Off
Period
Trigger
Method
Polarity
Rev.1.0
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7.4.2
Detector Initialization
Click Configuration button of Detector after running the VIVIX Setup program.
Click Factory Reset button in Configuration dialogue.
Wait for Detector to be rebooted automatically.
Check whether detector initialization is completed.
Default value of detector initialization
Item
Default Value
Network
IP Address
Subnet Mask
Gateway
WNetwork
SSID
Key
AP Scan
AP
AP On/Off
Frequency
Country
Band
Channel
SSID
Key
Security
GI (Guard Interval)
Tx Power
Test Pattern Type
Image Timeout Time
Power Management
Sleep
Sleep After
Shut Down
Shut Down after
Power Off
Wireless Only
Rev.1.0
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7.4.3
Wireless Initialization of Detector
Turn off the detector.
Press and hold the power button while installing a battery into the battery compartment of the
detector.
Keep pressing the power button.
Keep pressing the power button until the orange LED flickers three times. (It will take about 15
seconds.)
Initialization will be conducted when orange LED is flickering, after that, the detector will be turned off
automatically.
Turn on the detector and check whether detector initialization is completed.
Default value of wireless initialization
Item
Default Value
IP Address
Subnet Mask
Gateway
AP ON/OFF
SSID
Key
Wireless Only

 When processing the wireless initialization of a detector, only the detector’s network
information is initialized as a default value.
Rev.1.0
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7.5
Replacing the Fuse of SCU (Basic SCU only)
There are 2 fuses attached on the standard SCU for the purpose of electrical accident precaution, in case of
over current from external power input. Stop using the SCU immediately when the fuse is blown.
Fuse Information
Item
Specifications
Model
Littelfuse® 218002 (2EA)
Type
Time Lag Cartridge Fuse
Amp Rating
2A
Voltage Rating
250V

 Pull the plug out and turn all the devices off before changing the fuse.

 First, resolve the cause why the fuse is blown. Replace the fuse to the one provided as an
option (1 set / 2 ea) or to the one with same specifications when the fuse is out.

 Be careful not to touch both the patient and the fuse holder at the same time or let the
patient touch the fuse holder.
How to Replace the Fuse
No.
Description
Separate the fuse from the holder located power input port on
the back side of standard SCU by pulling the fuse holder.
After checking, replace the fuse with correct specifications in
Rev.1.0
case of need.
Insert the fuse holder again.
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8. Troubleshooting
[TBD]
This section gives information about troubleshooting.
Troubleshooting
Rev.1.0
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8.1
Trobleshooting
When you encounter problems while using the equipment, search for the table below for the problem or
error messages and try the solutions.If the problem persists, turn off the detector and consult your sales
representative or a distributor. Please refer to the details of the following symptoms or error messages.

 Troubleshooting must be performed by service engineer who is authorized by Vieworks. If
an unqualified person performs troubleshooting on the system resulting in damaging the
detector, software or hardware, then the Vieworks or its representative is not responsible
for the detector repair regardless of remain warranty. For more detailed information, refer
to .
8.1.1
Failed to Turn the Detector On
Symptom
Failed to turn on the power of the detector.
Expected Causes
Not installing battery pack well
Dead battery pack
Battery pack or Detector is broken down
Solutions
8.1.2
Install battery pack
Charge battery pack
Check the result after getting rid of the battery pack and connecting the tether cable.
Replace other battery packs and check the result of it.
Replace other Detectors and check the result of it.
Replace corresponding devices.
The Power Switch of SCU or Status LED is not worked
Symptom
The power switch of Basic SCU or Mini SCU is not working.
The status LED of SCU is not responding.
Expected Causes
Rev.1.0
Power cable is broken down.
Errors in the fuse
Internal circuit is broken down.
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Solutions
8.1.3
Check the connection between AC power cable and basic SCU.
Check the connection between DC power cable and mini SCU.
Turn off the power switch and turn on again and then check the fan or status of back side.
Replace another SCU and check the result of it
Replace the fuse of standard SCU. (refer to Change fuse of SCU)
Replace corresponding devices.
Communication Test is failed
Symptom
Transmission error is occurred, failure of communication test is occurred.
Expected Causes
Network connection problem
Network setting problem
PC environment setting problem
Wireless environment environment problem
Devices failure
Solutions
Check the connection of network cable between Workstation and SCU.
Check if the accurate network cable is used or not. (CAT 5E or 6)
Set the network information of Workstation, SCU and detector again.
Check whole workstation environment again such as firewall setting and release the power save mode.
Check surrounding wireless communication environment.
Boot up detector and SCU again by processing initialization. (Refer to <오류! 참조 원본을 찾을 수
없습니다. 오류! 참조 원본을 찾을 수 없습니다.>.)
8.1.4
Replace other SCU and Detectors and check the result of it
Replace corresponding devices.
The Active LED and Data LED of the Detector are blinking
Symtom
The active LED and data LED is blinking when power LED is ON.
Expected Causes
Detector registeration error
Data transmission error
Solutions
Rev.1.0
Turn on SCU again
Check the network cable connection
Check the workstation environment and network information again
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8.1.5
Check if the surrounding wireless communication is good
Check cable connection again when connected with tether interface cabel
Replace other devices and check the result of it
Replace corresponding devices.
Errors in Detector LED
Symptom
All LED lamps of detector are blinking.
2 LED lamps of detector are blinking and remaining is blinking slowly.
Expected Causes
Internal hardware errors of the detector.
Solutions
8.1.6
Boot up the detector again and check the result of it
Replace the detector.
Rapid Consumption of Battery
Symptom
Consumption of fully charged battery pack is fast.
Expected Causes
Performance decrease caused by usage of long time.
Usage of battery pack in low temperature environment.
Solutions
Replace to new battery pack if the battery pack has been used for a long time. (Battery pack is
consumables)
Use battery pack in room temperature environment. Charging capacity of battery pack in low
temperature environment will be decreasing.
8.1.7
Battery Pack or Installation Part of Battery is Getting Hot
Symptom
Battery pack or compartment for installation of battery pack is getting hot.
Expected Causes
Battery pack failure
Detector Failure
Solutions
Rev.1.0
Do not use battery pack
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Rev.1.0
Consult with service engineers of Vieworks.
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9. Regulatory Information
This section gives explanation about the regulatory information and standard related to the
products
Medical Equipment Safety Standards
Radio Frequency Compliance Information
Labels and Symbols
Guidance and Manufacturer Declaration for EMC
Rev.1.0
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9.1
Medical Equipment Safety Standards
9.1.1
Medical Equipment Classification
Item
Description
Type of protection against electrical shock
Class Ⅰ equipment Internally powered
Degree of protection against electrical shock
Type B applied parts
Degree of protection against ingress of water
IPX0
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.
9.1.2
Product Safety Standard
South Korea
전기, 기계적 안전성에 관한 시험: IEC 60601-1과 식품의약품안전청고시 제 2009-137호에 따른다.
전자파장해방지에 관한 시험: IEC 60601-1-2에 따른다.
전자파 간섭 (EMI)
전자파 전도
전자파 방사
식품의약품안전청 고시 2009-54호 1종 A급 기기로서 별표 1의 5.1
식품의약품안전청 고시 2009-54호 별표 1의 전자파장해 (간섭)
식품의약품안전청 고시 2009-54호 1종 A급 기기로서 별표 1의 5.2
식품의약품안전청 고시 2009-54호 별표 1의 전자파장해(간섭)
전자파 내성 (EMS)
정전기방전(ESD) 시험
식품의약품안전청 고시 2009-54호 별표 2의 36.202/36.202.2/ KN61000-4-2
방사성 RF 전자기장 시험
식품의약품안전청 고시 2009-54호 별표 2의 36.202/36.202.3/ KN61000-4-3
전기적 빠른 과도현상 (EFT)
시험
서지(Surge) 시험
고시 2009-54호 별표 2의 36.202/36.202.5/KN61000-4-5
전도성 RF 전자기장 시험
식품의약품안전청 고시 2009-54호 별표 2의 36.202/36.202.6/ KN61000-4-6
전원주파수자기장 시험
고시 2009-54호 별표 2의 36.202/36.202.8/ KN61000-4-8
전원공급 입력선의 전압 강하,
순간정전 및 전압변동 시험
전원주파수 변동
Rev.1.0
고시 2009-54호 별표 2의 36.202/36.202.4/ KN61000-4-4
식품의약품안전청 고시 2009-54호 별표 2의 36.202/36.202.7/KN61000-4-11
IEC 60601-1:2007(ed.3) 10.2.2 power supply 및 식품의약품안전청 고시
2009-54호 별표 2의 36.202.14
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U.S.A / Canada
Item
IEC 60601-1(ed.2 am1+ am2+ co1) Medical electrical equipment- Part1: General requirements for safety
UL 60601-1(ed.2)
CSA-C22.2 No. 601-1-M90 (R2006)
IEC 60601-1-2: 2007 (ed.3)
IEC 60601-1-4: 2000 (ed.1.1)
Medical electrical equipment – Part 1: General requirements for safety
(adopted amendment 2:1995 to IEC60601-1)
Medical electrical equipment-Part 1-2: Collateral standard:
Electromagnetic compatibility
Medical electrical equipment- Part 1-4: Collateral Standard:
Programmable electrical medical systems
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)
EN ISO 13485:2012
EN 60601-1: 2007(ed.3)
IEC 60601-1-2: 2007(ed.3)
IEC 60601-1-4: 2000(ed.1.1)
Rev.1.0
93/42/EEC as amended by 2007/47/EC
Medical devices – Quality Management systems – Requirements for
regulatory purposes
Medical electrical equipment- Part1: General requirements for safety
Medical electrical equipment-Part 1-2: Collateral Standard :
Electromagnetic compatibility-Requirements and tests
Medical electrical equipment- Part 1-4: Collateral Standard :
Programmable electrical medical systems
IEC 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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9.2
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
European Union

 Clause 3, Article 58-2 of Radio Waves Act
South Korea

 Clause 2, Article 58-2 of Radio Waves Act
Japan
9.2.1
[TBD]

 Article 2-1-19, 2-1-19-3, 2-1-19-3-2 of the Radio law (MIC)
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 the FCC is 1.6 W/kg.
 The highest SAR value for this model when tested for use at the front is 0.568 W/kg.

 The front side of a detector should be used for image acquisition.
Rev.1.0
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9.3
Labels and Symbols
The ViVIX-S 1012N detector and relevant components have labels attached on them. The contents and
locations of each label are indicated below.
9.3.1
Label
Detector
Battery
Rev.1.0
[TBD]
[TBD]
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VIVIX SCU (VIVIX System Control Unit)
Battery Charger
Rev.1.0
[TBD]
[TBD]
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Outer Box
9.3.2
[TBD]
Product Serial Number
Serial Number Composition
The serial numbers for each product or accessory are composed as follows.
Revision
Item
Composition
Year
Month
Serial number

 Revision will be updated in case of follows.
 Mass production or a large amount of order.
 Exterior alteration.

 Item code will be produced based on internal management standard of vieworks.

 Composition code is like follows.
 D: Detector
 S: VIVIX SCU
 C: Battery Charger

 Range of Serial Number is 001 ~ 999.
Initial Per Year
11
12
13
14
15
16
17
18
19
20
AA
AB
AC
AD
AE
AF
AG
AH
AI
BJ
Initial Per Month
10
11
12
Composition of Serial Number for Each Item
Rev.1.0
Model
Composition
Serial Number
1012NA
Detector
10-V5D??
1012NB
Detector
10-V6D??
FXRC-02A
Battery Charger
10-V5C??
FXRS-04A
VIVIX SCU
10-V5S??
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9.3.3
Product Symbols
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.
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 2002/96/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 2002/96/EC (WEEE) in the European
Union. (For European Union)
Rev.1.0
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9.4
Guidance and Manufacturer’s Declaration for EMC
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.
9.4.1
Electromagnetic Emissions
The Equipment Under Test (EUT) is intended for use in the electromagnetic environment specified below.
The customer or user of the EUT should assure that it is used in such an environment.
Immunity test
RF Emissions
(CISPR 11)
RF Emissions
(CISPR 11)
Harmonic emissions
(IEC 61000-3-2)
Compliance Electromagnetic Environment
The EUT uses RF energy only for its internal function. Therefore, its
Group 1
interference in nearby electronic equipment.
Class B
Class A
The EUT is suitable for use in all establishments other than domestic
and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Voltage fluctuations/
Flicker emissions
RF emissions are very low and are not likely to cause any
Complies
(IEC 61000-3-3)
Rev.1.0
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9.4.2
Electromagnetic Immunity
The ViVIX-S 1012N system is intended for using in the electromagnetic environment specified below. The
user of this system should assure that it is used in the following environment.
Electrostatic Discharge (ESD) IEC 61000-4-2
Item
Description
Immunity test

 Electrostatic discharge (ESD) IEC 61000-4-2
IEC 60601 test condition
Compliance Level
Electromagnetic Environment Guidance

 Contact ±6㎸

 Air ±8㎸

 Contact ±6㎸

 Air ±8㎸

 Floors should be wood, concrete or ceramic tile.

 If floors are covered with synthetic material, the relative humidity
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㎸
Compliance Level

 Power supply lines ±2㎸

 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㎸
Compliance Level

 Differential mode ±1㎸

 Common mode ±2㎸
Electromagnetic Environment - 
 Main power quality should be that of a typical commercial or hospital
Guidance
Rev.1.0
environment.
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Voltage Dips, Short Interruptions and Voltage Variations on 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

 <5% Uт (>95% dip in Uт) for 0.5 cycle.
IEC 60601 test condition

 40% Uт (60% dip in Uт) for 5 cycles.

 70% Uт (30% dip in Uт) for 25 cycles.

 <5% Uт (<95% dip in Uт) for 5 sec.

 <5% Uт (>95% dip in Uт) for 0.5 cycle.
Compliance Level

 40% Uт (60% dip in Uт) for 5 cycles.

 70% Uт (30% dip in Uт) for 25 cycles.

 <5% Uт (<95% dip in Uт) for 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

 3 A/m
Compliance Level

 3 A/m
Electromagnetic Environment - 
 Power frequency magnetic fields should be at levels characteristic of a
Guidance
Rev.1.0
typical location in a typical commercial or hospital environment.
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Conducted RF IEC 61000-4-6 / Radiated RF IEC 61000-4-3
Item
Description
Immunity test

 Conducted RF IEC 61000-4-6

 Radiated RF IEC 61000-4-3
IEC 60601 test condition

 3 Vrms 150 ㎑ to 80 ㎒

 3 V/m 80 ㎒ to 2.5 ㎓
Compliance Level

 3 Vrms 150 ㎑ to 80 ㎒

 3 V/m 80 ㎒ to 2.5 ㎓

 Portable and mobile RF communications equipment should be used no
closer to any part of the EUT, including cables, than the recommended
separation distance calculated from the below equations applicable to the
frequency of the transmitter.
Electromagnetic
Environment - Guidance

 P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended
separation distance in meters (m).

 Field strengths from fixed RF transmitters, as determined by an
electromagnetic site surveya, should be less than the compliance level in
each frequency range b.

 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 is 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.
Rev.1.0
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10. Information
This section gives overview information for service and warranty of the product.
Service Information
Warranty
Revision History
Rev.1.0
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10.1 Service Information
10.1.1 Product Lifetime
The estimated product lifetime may be up to five (5) years under the appropriate regular inspection and
maintenance.
10.1.2 Regular Inspection and Maintenance
In order to ensure the safety of patients, operating personnel and third parties, and to maintain the
performance and reliability of the equipment, be sure to perform regular inspection at least once a year. If
necessary, clean up the equipment, make adjustments, or replace consumables.
There may be cases where overhaul is recommended depending on the conditions. Contact your sales
representative or distributor for regular inspections or maintenance.
10.1.3 Repair
If a problem cannot be solved even after taking the measures indicated in Troubleshooting and contact
your sales representative or a distributor for repairs. Please refer to the name label and provide the
following information.
Model name:
FXRD-1012NAW / FXRD-1012NBW
Serial number:
12 digit-number on the product label
Explanation of problem: Describe as detailed as possible.
10.1.4 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.
10.1.5 Consumables
The following consumable can deteriorate because of its characteristics and structure. For purchase of
consumables, contact your sales representative or distributor.
Rev.1.0
Battery pack: FXRB-03A
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10.2 Warranty
Vieworks warrants that this product will be free from defects in materials and workmanship for a period of
24 months from the date of delivery. 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
Rev.1.0
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10.3 Revision History
Version
Date
Descriptions
1.0
2015-01-??

 Initial Release
Vieworks Co., Ltd.
(Gwanyang-dong) 41-3, Burim-ro 170beon-gil, Dongan-gu, Anyang-si,
Gyeonggi-do, 431-060 Republic of Korea
Telephone: +82-70-7011-6161
Fax: +82-31-386-8631
Homepage: http://www.vieworks.com
European representative: DONGBANG ACUPRIME
1 Forrest Units, Hennock Road East, Marsh Barton, Exeter EX2 8RU, UK
Telephone: +44(0)-1392-829500
Homepage: http://www.acuprime.com
Rev.1.0
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