SA80-PM-031 - Saturn 8000 1717V Service Manual - 1.2 - VW - 1.3 - 20211014 - NO GMP - Old Address

SATURN 8000 FXRD-1717V Service
Manual
© VIEWORKS. 2018 All rights reserved.

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.
Under copyright laws, this manual should not be reproduced, in whole or in part, without the written
permission of VIEWORKS.
SATURN 8000 FXRD-1717V Service Manual
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 ........................................................................................................................................................................ 6
1.2 Indications for Use .................................................................................................................................. 7

1.2.1 Intended Use ................................................................................................................................................................... 7
1.2.2 Features .............................................................................................................................................................................. 7
1.3 Product Use .............................................................................................................................................. 8

1.3.1 Product Usage ................................................................................................................................................................. 8
1.3.2 Disclaimer .......................................................................................................................................................................... 8
1.3.3 Product Disposal ............................................................................................................................................................ 8
1.3.4 Trademarks ........................................................................................................................................................................ 8
2. Product............................................................................................................................................... 9
2.1 Product Components ............................................................................................................................ 10

2.1.1 Detector............................................................................................................................................................................10
2.1.2 Accessories......................................................................................................................................................................10
2.2 SATURN 8000 FXRD-1717V Detector ................................................................................................ 13

2.2.1 Specifications .................................................................................................................................................................13
2.2.2 Functions .........................................................................................................................................................................14
2.2.3 Use Environment ..........................................................................................................................................................14
2.3 IO BOX (FXRI-01A) ................................................................................................................................ 15

2.3.1 Functions .........................................................................................................................................................................15
2.4 Others ...................................................................................................................................................... 16

2.4.1 X-ray Generator (Recommended Exposure Condition)..............................................................................16
2.4.2 Recommended Specifications of Workstation (PC) .....................................................................................16
2.4.3 Recommended Specifications of Grid ................................................................................................................16
3. System Configuration.................................................................................................................... 17
3.1 Detector Connection Methods ........................................................................................................... 18
3.2 Diagram................................................................................................................................................... 19
3.2.1 Block Diagram ...............................................................................................................................................................19
3.2.2 Wiring Diagram ............................................................................................................................................................19
Rev.1.2 Page 2 of 45 SA80-PM-031

3.3 Generator Interface............................................................................................................................... 20

3.3.1 AED (Auto Exposure Detection) Interface ........................................................................................................20
3.3.2 DR Trigger Interface ...................................................................................................................................................21
3.3.3 Passive Trigger Interface ...........................................................................................................................................21
3.4 Interface Configuration ........................................................................................................................ 22

3.4.1 D-SUB Generator Interface Connector Pin Map of FXRI-01A ................................................................22
3.4.2 D-SUB Interfacae Connector Pin Map of SATURN 8000 FXRD-1717V...............................................23
3.4.3 Input / Output Circuit ................................................................................................................................................24
4. Settings ............................................................................................................................................ 26
4.1 Device Installation ................................................................................................................................. 27

4.1.1 Connecting Devices ....................................................................................................................................................27
4.1.2 Booting up IO Box and Detector .........................................................................................................................28
4.1.3 Checking Status LED of Detector .........................................................................................................................28
4.1.4 Checking LED of IO BOX ..........................................................................................................................................29
4.2 Device Setting ........................................................................................................................................ 30

4.2.1 Software Installation ...................................................................................................................................................30
4.2.2 Setting Detector ...........................................................................................................................................................30
4.3 Diagnosis of Devices ............................................................................................................................ 31

4.3.1 Image Diagnosis ...........................................................................................................................................................31
5. Troubleshooting ............................................................................................................................. 32
5.1 Troubleshooting..................................................................................................................................... 33
5.1.1 Troubleshooting Guide ..............................................................................................................................................33
5.1.2 Fail to Turn the Detector On ..................................................................................................................................33
5.1.3 The Power Switch of IO BOX does not work ..................................................................................................33
5.1.4 Communication Test is failed .................................................................................................................................34
5.1.5 Errors in Detector LED ...............................................................................................................................................34
6. Regulatory Information ................................................................................................................ 35
6.1 Medical Equipment Safety Standards ............................................................................................... 36

6.1.1 Medical Equipment Classification ........................................................................................................................36
6.1.2 Product Safety Standard ...........................................................................................................................................36
6.2 Labels and Symbols .............................................................................................................................. 37

6.2.1 Label ..................................................................................................................................................................................37
6.2.2 Product Serial Number..............................................................................................................................................38
6.2.3 Product Symbols ..........................................................................................................................................................39
7. Information ..................................................................................................................................... 41
7.1 Service Information .............................................................................................................................. 42

7.1.1 Product Lifetime ...........................................................................................................................................................42

7.1.2 Regular Inspection and Maintenance ................................................................................................................42
7.1.3 Repair ................................................................................................................................................................................42
7.1.4 Replacement Parts Support ....................................................................................................................................42
7.2 Warranty ................................................................................................................................................. 43
7.3 Revision History .................................................................................................................................... 44

1. Instruction
This section gives basic information about this manual and safe product use.
Document Guide
Indications for Use
Product Use
Safety Instruction
Product Usage Guide

1.1 Document Guide
This User Manual explains how to use the SATURN 8000 FXRD-1717V detector made by VIEWORKS, X-ray
interface unit, and other peripheral equipment. Use this manual to install, set up and manage the SATURN
8000 FXRD-1717V 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 service engineers and users who install and set up the SATURN 8000 FXRD-
1717V 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.
1.1.5 Contact Us
For comments or inquiries regarding this document and relevant products, contact via email below.
Item Contents
Department Customer Support Team at NMI
E-mail techsupport@newmedical.com.tw

1.2 Indications for Use
SATURN 8000 FXRD-1717V series is used for the general-purpose diagnostic procedures, and as well as
intended to replace radiographic film/ screen systems. The SATURN 8000 FXRD-1717V series is not
intended for mammography applications.
 Federal law restricts this device to sale by or on the order of a physician.
1.2.1 Intended Use
The SATURN 8000 FXRD-1717V detector is a digital X-ray imaging solution that captures X-rays
transmitted through the human body and acquires images by wired connection. When X-ray photons pass
through the scintillator in the detector, the photons convert to visible ray, and the visible ray is converted
to electronic signals through TFTs – thin film transistors (a-Si). Then the detector digitalizes X-ray images
and transfers them to the PC (workstation) for diagnostic review using an image display monitor. Advanced
digital image processing also allows efficient diagnosis, information management, and sharing of image
information over the network.
1.2.2 Features
 Compatible with film cassettes (ISO4090 compliant), it can replace the conventional analog radiology
diagnostics.
 The new sensor with 140μm of pixel pitch produces high spatial resolution (approximately 9.4 Mega
pixels) digital images.
 You can choose between two scintillator types (CsI and Gadox) of a detector provided by VIEWORKS.
 SATURN 8000 FXRD-1717V CsI – CsI (Cesium Iodide, 428.4 x 428.4㎜)
 SATURN 8000 FXRD-1717V Gadox – Gadox (Gadolinium Oxysulfide, Min. 428.4 x 428.4㎜)
 This model does not provide wireless function.

1.3 Product Use
This chapter provides instructions about the use of the product, disposal and the liability limit of
VIEWORKS.
1.3.1 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.
1.3.2 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.
1.3.3 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.
1.3.4 Trademarks
The name “VIEWORKS” and the VIEWORKS logo are registered trademarks of VIEWORKS.
© VIEWORKS. 2018 All rights reserved.

2. Product
This section gives an instruction about the product components and their specifications.
Product Components
SATURN 8000 FXRD-1717V Detector
IO BOX (FXRI-01A)
Others

2.1 Product Components
2.1.1 Detector
Product Name Model / Description
 SATURN 8000 FXRD-1717V

SATURN 8000 FXRD- CsI (4.5kg)
1717V Wired Detector  SATURN 8000 FXRD-1717V
Gadox (4.5kg)
2.1.2 Accessories
Product Name Model / Description
 FXRI-01A (0.3kg)
IO BOX (Option)  DC Power Supply (24V)

 BridgePower Corp. /
BPM030S24F10
 AC Power Cable (2m)

 220V(1EA) or 110V (1EA)
Rev.1.2 Page 10 of 45 SA80-PM-031

Type Image Description
 IO Interface Cable (10m)
 Generator Interface Cable (5m)

Cable (Optional)
 Gigabit LAN Cable (15m, Direct)

 1000BASE-T
 CAT5E or CAT6
DxWorks
Hardware Manual  Detector Operation manuals

CD  Detector Service manuals
DxWorks
Software / Manual  Software files

CD (DxWorks)  Software manuals
 The use of accessories and cables other than those approved and sold by VIEWORKS Co.,
Ltd. may result in increased release of electromagnetic waves or decreased stability of the
equipment.
 Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC standards. All combinations of equipment must be in
compliance with IEC 60601-1-1 system requirements.
 Any person who connects additional equipment to the signal input or signal output ports
configures a medical system, and is therefore responsible for ensuring that the system
complies with the requirements of the system standard IEC 60601-1.
Rev.1.2 Page 11 of 45 SA80-PM-031

 Consult your sales distributor or manufacturer if you have any concerns.
Rev.1.2 Page 12 of 45 SA80-PM-031

2.2 SATURN 8000 FXRD-1717V Detector
2.2.1 Specifications
Item Specifications
 SATURN 8000 FXRD-1717V
Model  SATURN 8000 FXRD-1717V CsI
Gadox
Image Sensor  a-Si (Amorphous Silicon)
 SATURN 8000 FXRD-1717V CsI : Csl: TI (Thallium doped Caesuim
Iodide)
X-ray Scintillator Type
 SATURN 8000 FXRD-1717V Gadox : Gd2O2S:Tb (Gadolinium
oxysulfide)
Pixel Pitch  0.14㎜ (140㎛)
Field of View  17” x 17”
Active Area (H x V)  430.08㎜ × 430.08㎜
Active Array  3072 x 3072 pixels
 SATURN 8000 FXRD-1717V CsI: 426.72㎜ x 426.72㎜
Effective Area
 SATURN 8000 FXRD-1717V Gadox: 426.72㎜ x 426.72㎜ (Min.)
 SATURN 8000 FXRD-1717V CsI : 3048 x 3048
Effective Array
 SATURN 8000 FXRD-1717V Gadox : 3048 x 3048 (Min.)
Grayscale  16bit
Spatial Resolution  3.5 lp/㎜ (Min.)
Image Acquisition Time  2 sec. (Image acquisition / transfer time)
Recommended Cycle Time  15 sec.
 AED (Auto Exposure Detection)
X-ray Synchronization Control  DR Trigger (External line trigger)
 Passive Trigger (External line trigger)
 DC +24V, Max. 0.625 A
Rated Power Supply
 Power to detector from IO BOX via IO Interface cable.
Power Consumption  Max. 15 W
Dimensions (H × W × D)  460㎜ × 460㎜ × 15.5㎜
Weight  4.5 kg
Image Transfer  16 bit Digital Output Ethernet (1000BASE-T)
Data Transmission Rate (Wired)  Max. 1Gbps
 X -ray shooting time is not included in image acquisition time.
Rev.1.2 Page 13 of 45 SA80-PM-031

2.2.2 Functions
Name Description
 Gigabit Ethernet port (1000BASE-T)
1 LAN Port
 Data communication between the detector and PC
 D-SUB 9 pins, Male
 DC 24V Input & IO Interface
2 IO Port
 D-SUB connector Power Pin map (+24V Pin: 3, 8, GND Pin: 4, 9)
(24V, 0.625A or more recommended)
 Detector communication and transmission status (orange-green
Status Light [Transmission]
flashing)
3
Status Light [STATUS]  Detector boot status (orange)
Status Light [POWER]  Power on state (green)
2.2.3 Use Environment
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
 The use environment of a detector and IO BOX is same.
Rev.1.2 Page 14 of 45 SA80-PM-031

2.3 IO BOX (FXRI-01A)
Power is supplied to the detector via IO (Input / Output) BOX.
2.3.1 Functions
Front Side
No. Name Description

1 LINK LED  Indicates the status of power
2 POE Port  Power switch
3 DC Power Input Connector  DC +24V
 Interlocking with X-ray generator
4 Generator Connector
 D-SUB 15p, Female
 DC +24V output
 Power to the detector
5 DC Power Output Connector
 IO Interface
 D-SUB 9p, Female
Rev.1.2 Page 15 of 45 SA80-PM-031

2.4 Others
2.4.1 X-ray Generator (Recommended Exposure Condition)
Item Recommended condition

X-ray energy range  40kVp ~ 150kVp
Reliability (Lifetime Dose)  100Gy
2.4.2 Recommended Specifications of Workstation (PC)
Item Recommended specification

 DxSetup
 Microsoft Windows 7 SP1 (32bit / 64bit)
Operating System
 Microsoft Windows 8 / 8.1 / 8.2 SP1 (32bit / 64bit)
 Microsoft Windows 10 (32bit / 64bit)
CPU Intel Core i5 2600 or higher (or compatible CPU)
Memory 8GB or higher
Hard Disk 1TB or higher
 1000 BASE-T Gigabit Ethernet card
 Gigabit (for detector only)
 Intel® PRO 1000 Series (Gigabit LAN Card for network interface)
LAN Card (only for
 Minimum requirements
detector communication)
 Speed: 1Gbps or more
 Jumbo Frames: 9K
 Receive Descriptors: 2K (1024 or higher)
 Minimum: 1280 × 768 or higher
Monitor
 Recommended: 1680 x 1050 or higher
CD-ROM CD or DVD R/W
2.4.3 Recommended Specifications of Grid
Item Recommended specification

SID 100cm / 130cm / 150cm / 180cm
Ratio 8.1 / 10:1 / 12:1
Frequency 215 line/inch
INTER SPACER AL
 Check the recommended specifications by VIEWORKS first before buying the generator,
workstation and grid.
Rev.1.2 Page 16 of 45 SA80-PM-031

3. System Configuration
This section gives information about the various connection / configuration ways among the
detector, IO BOX, workstaton and X-ray generator.
You can figure out the most suitable way of system configuration through this instruction.
Detector Connection Methods

Diagram
Generator Interface
Interface Configuration
Rev.1.2 Page 17 of 45 SA80-PM-031

3.1 Detector Connection Methods
SATURN 8000 FXRD-1717V

DxWorks
 The power of the SATURN 8000 FXRD-1717V detector is supplied through IO BOX.
 The SATURN 8000 FXRD-1717V detector and workstation are connected with a wired LAN
cable.
 The SATURN 8000 FXRD-1717V detector can be physically connected to the generator to
acquire images in DR Trigger or Passive Trigger mode.
 Without a separate physical connection, the SATURN 8000 FXRD-1717V detector and
generator can be set to AED mode.
Rev.1.2 Page 18 of 45 SA80-PM-031

3.2 Diagram
3.2.1 Block Diagram
SATURN 8000 FXRD-
3.2.2 Wiring Diagram
WORKSTATION
Flat Panel Detector (SATURN
(ViVIX-S)
8000)
X-RAY Video Output System Monitor
Generator FXRD-1717V
Generator Generator Interface Generator Image Grab

interface Cable (15m) interface
Gigabit Ethernet LAN Cable (15m)
Gigabit Ethernet
Video Output Reference Monitor
Mouse
USB
Keyboard
DICOM printer
Gigabit Ethernet LAN Cable DICOM storage
DICOM MWM
AC100 or 230V
Cables
DC 24V
VIEWORKS Cable
System Maker Cable
IO BOX (ViVIX-S) Parts
VIEWORKS System
FXRI-01A
System Maker
AC100 or 230V
Hospital System
Rev.1.2 Page 19 of 45 SA80-PM-031

3.3 Generator Interface
The shooting modes using the SATURN 8000 FXRD-1717V detector and X-ray generator have AED
interface, DR Trigger interface and Passive Trigger interface.
Mode Description
The detector detects X-ray exposure from the generator automatically and then performs
AED
image acquisition without any cable connection.
The detector and generator receive and send their signal to each other for image
DR Trigger acquisition.
 SCU and X-ray generator should be connected with the generator interface cable.
X-ray generates immediately after the X-ray generator sends the EXP_REQ signal to the
Passive Trigger detector, and the detector acquires the image.
Connect the generator interface cable between the detector and the X-ray generator
3.3.1 AED (Auto Exposure Detection) Interface
If the SATURN 8000 FXRD-1717V detector is used as the AED interface, you can acquire images without
connecting the generator to the detector with a generator interface cable.
Cautions when using AED interface
 Make sure to follow the operating environmental condition (Temp: +10℃ ~ +35℃).
 Do not give impact to the product. If it receives strong jolt, unwanted images may be
acquired without the X-ray exposure because of the malfunction of the AED sensor.
 You may not acquire images or horizontal artifacts may occur depending on the external
environment such as exposure condition, thickness of object or the use of grid.
 When you set X-ray exposure area to the direction of the detector, the center of the
detector should be involved in the X-ray exposure area. Otherwise, you may not acquire
an image.
Rev.1.2 Page 20 of 45 SA80-PM-031

3.3.2 DR Trigger Interface
Connect the detector and X-ray generator with a generator interface cable, and then acquire images by
sending and receiving their signal.
Signal Processing Steps

1 The detector receives EXP_REQ signal from the X-ray generator.
2 After the detector completes to prepare image acquisition, it sends the EXP_OK signal to the X-ray
generator.
3 The X-ray generator confirms EXP_OK signal and generates X-rays.
4 The detector acquires images and then transmits the image data.
 EXP_REQ is a sending signal from X-ray generator to the detector for requesting
exposure.
 EXP_OK is an exposure ready signal from the detector to X-ray generator.
3.3.3 Passive Trigger Interface
After connecting the generator interface cable between the detector and the X-ray generator, the detector
acquires the image immediately after receiving the EXP_REQ signal from the X-ray generator.
Signal Processing Steps

1 The detector prepares to acquire image immediately after receiving the EXP_REQ signal from X-ray
generator.
2 The X-ray generator generates X-rays.
3 The detector acquires the image and transmits the image data.
 EXP_REQ is the capture request signal sent by the X-ray generator to the detector.
Rev.1.2 Page 21 of 45 SA80-PM-031

3.4 Interface Configuration
To shoot images using the DR Trigger or Passive Trigger interface, you must connect the generator
interface cable between IO BOX and the X-ray generator. Connect one end of the generator interface cable
to the D-SUB generator interface connector of IO BOX and connect the other end to the X-ray generator
 Up to one X-ray generator can be connected to the D-SUB generator interface connector
of the SATURN 8000 FXRD-1717V detector.
 The interface connection between the X-ray generator and the detector must be handled
by an engineer who is familiar with the X-ray generator device and interface technology.
3.4.1 D-SUB Generator Interface Connector Pin Map of FXRI-01A
The D-SUB generator interface connector of FXRI-01A is a D-SUB 15-pin female connector.
Product Connector
IO BOX (FXRI-01A)
Definition of D-SUB Generator Interface Connector Pin Map (1 ~ 15)
No. Signal Name I/O Type Description

1 EXP_REQ+ Input Contact EXP_REQ signal + Transmit (+ 3.3V)
2 EXP_REQ- Input Contact Return signal of EXP_REQ signal
3 EXP_REQ_TTL Input TTL EXP_REQ signal + receive
4 EXP_REQ_GND Input TTL EXP_REQ signal - receive
5 EXP_OK_POWER Input - Pull up power for TTL signal
6 EXP_OK+ Output - EXP_OK signal transmission
7 EXP_OK- Output - Return signal of EXP_OK +
8~15 Reserved - - Do not connect.
 A maximum of one X-ray generator can be connected to the D-SUB generator interface
connector.
Rev.1.2 Page 22 of 45 SA80-PM-031

 There are Contact type (OPEN/ CLOSE) and TTL type (ON/ OFF) on the signal in/output
pin.
 TTL type information
 ON : VCC
 OFF : GND
 Current: 5 ㎃ ~ 10 ㎃
 Voltage: 12 V ~ 24 V
3.4.2 D-SUB Interfacae Connector Pin Map of SATURN 8000 FXRD-1717V
The D-SUB interface connector of SATURN 8000 FXRD-1717V is a D-SUB 9-pin male connector.
Product Name Connector
1 5
Detector (SATURN 8000 FXRD-1717V)
6 9
Definition of D-SUB Interface Connector Pin Map
No. Signal Name I/O Type Description

1 EXP_REQ_TTL Input TTL EXP_REQ signal + receive
2 EXP_OK+ Output - EXP_OK signal transmission
3,8 DC 24V Input - Detector power supply 24V
4,9 GND (EXP_REQ-) Input Contact Ground (return signal of EXP_REQ signal)
5 EXP_REQ+ Input Contact EXP_REQ Signal + Transmit (+ 3.3V)
6 EXP_REQ_GND Input TTL EXP_REQ Signal – receive
7 EXP_OK- Output - Return signal of EXP_OK+
 The signal input / output pins have contact type (OPEN / CLOSE) and TTL type (ON /
OFF).
 TTL types
 ON : VCC / OFF : GND
 Current: 5 ㎃ ~ 10 ㎃ / Voltage: 12 V ~ 24 V
Rev.1.2 Page 23 of 45 SA80-PM-031

3.4.3 Input / Output Circuit
The exposure request signal (EXP_REQ) input and the exposure response signal (EXP_OK)
output circuit
SATURN SATURN
8000 8000
SATURN SATURN
8000 8000
Rev.1.2 Page 24 of 45 SA80-PM-031

Pattern Diagram of detector and X-ray generator interface (Example)
SATURN 8000 Side
SATURN 8000 Side
Rev.1.2 Page 25 of 45 SA80-PM-031

4. Settings
This section gives information about the way of installation, setting, and diagnosis to use a
detector with IO BOX.
Product Installation
Device Setting
Diagnosis of Devices
Rev.1.2 Page 26 of 45 SA80-PM-031

4.1 Device Installation
4.1.1 Connecting Devices
 Installation of this equipment should be made by a person authorized by VIEWORKS.
1 Connect one connector of the IO Interface cable to the detector and the other to IO BOX.
2 Connect one end of the LAN cable to one of the LAN port of a detector, and the other to the LAN port
of workstation assigned for data transfer.
3 Connect the adapter to the DC 24 input port of the IO BOX.
Rev.1.2 Page 27 of 45 SA80-PM-031

4 When using the DR Trigger or Passive Trigger mode, connect one end of the generator interface cable to
the D-SUB 15-pin connector of the IO BOX and the other end to the X-ray generator.
 If you use AED mode, there is no need to connect the generator interface cable since the
detector automatically detects and operates the X-ray.
 Be sure to connect the IO Interface cable with the IO BOX power off.
4.1.2 Booting up IO Box and Detector
1 Turn on the power switch at the front side of IO BOX.

2 Check if the power switch of IO BOX lights up green.
3 Check if the status LED of detector is blinking in green
 When the power switch of IO BOX lights up green, it means that the power is applied
normally.
 When you boot the IO BOX, the detector also starts booting.
 If the LED of the detector lights green, it indicates that the power is normally applied.
 If the POWER LED on the detector does not light, check again that the IO Interface cable
is connected properly.
4.1.3 Checking Status LED of Detector
Power
 If the power is normally applied, the LED will light green.
Initializing
 The LED will light orange when the detector is in the initialization status.
 When the detector completes booting normally, the LED will light green.
Transmission
 When the detector transmits data, the LED flashes orange-green cross.
Rev.1.2 Page 28 of 45 SA80-PM-031

Summary List of Detector Status LED
Status LED
Power ON Lights green
Booting Lights in orange
Image Acquisition Green / orange cross flashing
Power OFF OFF
 If the detector LED blinks abnormally, refer to <5 Troubleshooting> to check if

communication or system error is occurred.
4.1.4 Checking LED of IO BOX
Status LED
Power ON Lights green
Power OFF OFF
Rev.1.2 Page 29 of 45 SA80-PM-031

4.2 Device Setting
4.2.1 Software Installation
1 After connecting all devices, prepare the following softwares to set, calibrate and operate the detector.
Software Description
VIVIX Device Driver (VDD) Image filter driver for acquiring images from a detector.
DxSetup A program for setting and managing the detector.
2 Install VIVIX Device Driver and DxSetupin sequence.
 It is not necessary to install VIVIX Device Driver and DxSetup separately in case of
installing the DxWorks program made by VIEWORKS.
3 Configure environment for the workstation.
4.2.2 Setting Detector
1 After executing DxSetup, access to the detector to set it properly.

2 Perform detector calibration to acquire images suitable for the installation environment.
3 Take radiographic images to check if the shooting is conducted normally.
 For details on device settings, refer to the DxSetup Operation Manual.
 Device configuration should be handled by an engineer who understands how to use

DxSetup, Windows system, wired network and related technologies. Failure to do so may
result in errors in the operation of the detector or may affect the image quality.
Rev.1.2 Page 30 of 45 SA80-PM-031

4.3 Diagnosis of Devices
Execute the DxSetupprogram to check if threre is any problem to operate the detector after installing and
setting devices.
Diagnosis Items
Items Description
Image Diagnoses the acquired images.
 Set the devices and perform calibration again if any problem is found during the
diagnosis. Contact the person in charge of service if the problem is not corrected.
4.3.1 Image Diagnosis
1 Execute DxSetupand move to the Image dialog.

2 Take an image and check if it has any problem.
3 Take a dark image and check if it has any problem.
4 Check the effective area and whole area of the image.
 Refer to DxSetup Operation Manual for the detailed information about the image
diagnosis.
 If any problem is found on the image, check if it is caused by the surrounding

environment and calibrate the detector again. Contact the person in charge of VIEWORKS
if the problem is caused by the performance of a detector.
Rev.1.2 Page 31 of 45 SA80-PM-031

5. Troubleshooting
Rev.1.2 Page 32 of 45 SA80-PM-031

5.1 Troubleshooting
5.1.1 Troubleshooting Guide
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 <7.1 Service Information> and <7.2 Warranty>.
5.1.2 Fail to Turn the Detector On
Category Description
Symptom  Failed to turn the power of the detector.
 Poor power supply to the IO BOX.
Expected Causes  Bad connection of IO Interface cable.
 IO Interface cable breakage.
1 Make sure that the IO BOX is powered properly. If not, replace the IO BOX.
2 Make sure that the IO Interface cable is connected correctly. If not, connect it
Solutions correctly.
3 Check if the IO Interface cable is damaged. If damaged, replace with a new cable.
4 Replace with an extra detector and compare the results.
5.1.3 The Power Switch of IO BOX does not work
 The power LED does not respond even when the power switch of the IO BOX is
Symptom
turned on.
 Connection failure of DC 24V input adapter.
Expected Causes
 Internal circuit is broken down.
1 Check the adapter connection of IO BOX.
2 Turn off the power switch and turn it on again. Check the LED lighting status of
Solutions
the IO BOX.
3 Replace with an extra IO BOX and compare the results.
Rev.1.2 Page 33 of 45 SA80-PM-031

5.1.4 Communication Test is failed
Symptom  Transmission error occurred, and the communication test is failed.
 Network connection problem
 Network setting problem
Expected Causes  PC environment setting problem
 Wireless environment environment problem
 Errors in devices
1 Check the connection of network cable between workstation and IO BOX.
2 Check if the accurate network cable is used or not. (CAT 5E or 6)
3 Use recommended network card.
Solutions 4 Set the network information of workstation and detector again.
5 Check whole workstation environment again such as firewall setting and release
the power save mode.
6 Replace with an extra detector and compare the results.
5.1.5 Errors in Detector LED
Symptom  All LEDs of a detector are blinking in orange for more than 5 seconds.
Expected Causes  Internal hardware errors of a detector.
1 Reboot the detector and check the result.
Solutions
2 Replace the detector to another one.
Rev.1.2 Page 34 of 45 SA80-PM-031

6. Regulatory Information
This section gives explanation about the regulatory information and standard related to the
products
Medical Equipment Safety Standards

Labels and Symbols
Rev.1.2 Page 35 of 45 SA80-PM-031

6.1 Medical Equipment Safety Standards
6.1.1 Medical Equipment Classification
Item Description
Type of protection against electrical shock Class Ⅰ
Degree of protection against electrical shock Operator accessible
Degree of protection against ingress of IPX0 (Degrees of protection againt ingress of water and
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.
6.1.2 Product Safety Standard
South Korea
Electrical and mechanical safety tests shall be in accordance with IEC 60601-1.
Test for the prevention of electromagnetic interference: According to IEC 60601-1-2.
U.S.A / Canada
Item
IEC 60601-1: 2012 (ed.3.1) Medical electrical equipment- Part 1: General requirements for safety.
UL 60601-1 (ed.3.1) -
Medical electrical equipment –Part 1: General requirements for basic
CAN/CSA-C22.2 NO. 60601-1:14
safety and essential performance
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 Device Directive
Medical devices – Quality Management systems – Requirements for
EN ISO 13485:2012
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:
IEC 60601-1-2: 2014 (ed.4)
Electromagnetic compatibility-Requirements and tests
IEC 62304:2006 Medical device software-Software life cycle processes
ISO 14971: 2012 Medical device – Application of risk management to medical devices
Rev.1.2 Page 36 of 45 SA80-PM-031

6.2 Labels and Symbols
The SATURN 8000 FXRD-1717V detector and relevant components have labels attached on them. The
contents and locations of each label are indicated below.
6.2.1 Label
Detector
IO BOX
Rev.1.2 Page 37 of 45 SA80-PM-031

6.2.2 Product Serial Number
Composition
The product serial numbers are composed as follows.
V G D A B A 0 0 1
Item Composition Year Month Manufacturing number
 The serial number 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 consisted as;
 D: Detector
 I: IO BOX
 Range of manufacturing 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
1 2 3 4 5 6 7 8 9 10 11 12
A B C D E F U V W X Y Z
Composition of Serial Number for Each Item
Model Composition Serial Number

Detector VGDAGA001
CsI
Detector VHDAGA001
Gadox
FXRI-01A IO BOX VGIAGA001 / VHIAGA001
Rev.1.2 Page 38 of 45 SA80-PM-031

6.2.3 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.
Rev.1.2 Page 39 of 45 SA80-PM-031

Mark indicating compliance with RoHS 2 (China)
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
Rev.1.2 Page 40 of 45 SA80-PM-031

7. Information
This section gives overview information for service and warranty of the product.
Service Information
Warranty
Revision History
Rev.1.2 Page 41 of 45 SA80-PM-031

7.1 Service Information
7.1.1 Product Lifetime
The estimated product lifetime may be up to seven (7) years under the appropriate regular inspection and
maintenance.
7.1.2 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.
7.1.3 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
 SATURN 8000 FXRD-1717V CsI / SATURN 8000 FXRD-1717V Gadox Detector
 Serial number
 9 digit-number on the product label
 Explanation of problem
 Describe as detailed as possible.
7.1.4 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.
Rev.1.2 Page 42 of 45 SA80-PM-031

7.2 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
Rev.1.2 Page 43 of 45 SA80-PM-031

7.3 Revision History
Version Date Descriptions

1.0 2017-08-31  Initial Release
 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.
 Modified the chapter 2.4.2 Recommended Specifications of Workstation
1.1 2018-01-02
 Modified monitor resolution specification and added the
recommended specification.
 Changed the chapter 7.2 Warranty
 Removed the warranty period
 Changed the European agent address and contact information
 Changed the chapter 1.2 ‘Intended Use’ as ‘Indications for Use’
 Changed the chapter 2.2.3 Use Environment
1.2 2018-03-27
 Modified shock / vibration specifications for detector operation and
storage
 Changed the chapter 2.4.2 Recommended Specifications of Workstation
Rev.1.2 Page 44 of 45 SA80-PM-031

Sales Office
New Medical Imaging Co., Ltd.
3F, No.32 Zhongyang S. Road. Beitou Dist.
Taipei City 112 Taiwan
Tel: +(886) 2-2892-2275

Fax: +(886) 2-2892-2172
Homepage: http://www.nmi-dr.com
Manufaturer
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: mail@obelis.net
Rev.1.2 Page 45 of 45 SA80-PM-031

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SATURN 8000 FXRD-1717V Service

© VIEWORKS. 2018 All rights reserved.

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

1.2 Indications for Use .................................................................................................................................. 7

1.3 Product Use .............................................................................................................................................. 8

2.1 Product Components ............................................................................................................................ 10

2.2 SATURN 8000 FXRD-1717V Detector ................................................................................................ 13

2.3 IO BOX (FXRI-01A) ................................................................................................................................ 15

2.4 Others ...................................................................................................................................................... 16

3.1 Detector Connection Methods ........................................................................................................... 18

Rev.1.2 Page 2 of 45 SA80-PM-031

3.3 Generator Interface............................................................................................................................... 20

3.4 Interface Configuration ........................................................................................................................ 22

4.1 Device Installation ................................................................................................................................. 27

4.2 Device Setting ........................................................................................................................................ 30

4.3 Diagnosis of Devices ............................................................................................................................ 31

6. Regulatory Information ................................................................................................................ 35

6.1 Medical Equipment Safety Standards ............................................................................................... 36

6.2 Labels and Symbols .............................................................................................................................. 37

7.1 Service Information .............................................................................................................................. 42

Rev.1.2 Page 3 of 45 SA80-PM-031

7.1.1 Product Lifetime ...........................................................................................................................................................42

7.2 Warranty ................................................................................................................................................. 43

7.3 Revision History .................................................................................................................................... 44

Rev.1.2 Page 4 of 45 SA80-PM-031

Rev.1.2 Page 5 of 45 SA80-PM-031

1.1 Document Guide

1.1.2 Target Audience

Caution and Warning

Rev.1.2 Page 6 of 45 SA80-PM-031

1.2 Indications for Use

 Federal law restricts this device to sale by or on the order of a physician.

1.2.1 Intended Use

Rev.1.2 Page 7 of 45 SA80-PM-031

1.3 Product Use

1.3.1 Product Usage

1 Only a physician or a legally certified operator should use this product.

1.3.3 Product Disposal

© VIEWORKS. 2018 All rights reserved.

Rev.1.2 Page 8 of 45 SA80-PM-031

Rev.1.2 Page 9 of 45 SA80-PM-031

2.1 Product Components

Product Name Model / Description

 SATURN 8000 FXRD-1717V

Product Name Model / Description

IO BOX (Option)  DC Power Supply (24V)

 AC Power Cable (2m)

Rev.1.2 Page 10 of 45 SA80-PM-031

Type Image Description

 IO Interface Cable (10m)

 Generator Interface Cable (5m)

 Gigabit LAN Cable (15m, Direct)

Hardware Manual  Detector Operation manuals

Software / Manual  Software files

Rev.1.2 Page 11 of 45 SA80-PM-031

 Consult your sales distributor or manufacturer if you have any concerns.

Rev.1.2 Page 12 of 45 SA80-PM-031

2.2 SATURN 8000 FXRD-1717V Detector