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User Manual 1 | Users Manual | 3.84 MiB | December 02 2015 | |||
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User Manual 2 | Users Manual | 2.41 MiB | December 02 2015 | |||
1 2 | Attestation Statements | December 02 2015 | ||||||
1 2 | Cover Letter(s) | December 02 2015 | ||||||
1 2 | Cover Letter(s) | December 02 2015 | ||||||
1 2 | Cover Letter(s) | December 02 2015 | ||||||
1 2 | External Photos | December 02 2015 | ||||||
1 2 | Internal Photos | December 02 2015 | ||||||
1 2 | ID Label/Location Info | December 02 2015 | ||||||
1 2 | Test Report | December 02 2015 | ||||||
1 2 | Test Report | December 02 2015 | ||||||
1 2 | RF Exposure Info | December 02 2015 | ||||||
1 2 | Test Report | December 02 2015 | ||||||
1 2 | Test Setup Photos | December 02 2015 | ||||||
1 2 | Cover Letter(s) | December 02 2015 | ||||||
1 2 | Internal Photos | December 02 2015 | ||||||
1 2 | ID Label/Location Info | December 02 2015 | ||||||
1 2 | Test Report | December 02 2015 | ||||||
1 2 | Test Report | December 02 2015 |
1 2 | User Manual 1 | Users Manual | 3.84 MiB | December 02 2015 |
VIVIX-S 1012N User Manual Vieworks. 2014 All rights reserved. Under copyright laws, this manual should not be reproduced, in whole or in part, without the written permission of Vieworks. vice complie ons: (1) This erference rec es with part device may ceived, includ t 15 of the y not cause ding interfer FCC Rules. harmful int rence that m Operation terference, a may cause un is subject to and (2) this ndesired ope eration. o the follow device mus wing two st accept s or modific e users aut d in conjunc cations not e hority to op ction with an expressly ap perate the e ny other ant pproved by equipment. T enna or tran the party re This transmi nsmitter. esponsible fo tter must n or complian not be co-lo ce could ocated or 250 MHz ba and is restric ted to indoo or operation ns only. (for F FCC and CE)
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Host de Contains This equ FCC RF should b part of y VIVIX-S 1012N User Manual Contents 1. Instruction ......................................................................................................................................... 6 1.1 Document Guide ..................................................................................................................................... 7 Caution Information ..................................................................................................................................................... 7 Target ................................................................................................................................................................................... 7 Symbols .............................................................................................................................................................................. 7 Notations ........................................................................................................................................................................... 8 Contact Department ..................................................................................................................................................... 8 1.1.1 1.1.2 1.1.3 1.1.4 1.1.5 1.2 Product Use Guide .................................................................................................................................. 9 Product Usage ................................................................................................................................................................. 9 Disclaimer .......................................................................................................................................................................... 9 Product Disposal ..........................................................................................................................................................10 Trademarks ......................................................................................................................................................................10 1.2.1 1.2.2 1.2.3 1.2.4 1.3 Safety Instruction .................................................................................................................................. 11 1.3.1 Management and Authority ...................................................................................................................................11 Power Supply .................................................................................................................................................................11 1.3.2 Handling ...........................................................................................................................................................................12 1.3.3 1.3.4 Battery Pack and Charger ........................................................................................................................................13 Environment of Use ....................................................................................................................................................14 1.3.5 1.3.6 Problem Management ...............................................................................................................................................15 1.3.7 Maintenance and Inspection ..................................................................................................................................15 1.4 Product Usage Guide ............................................................................................................................ 16 Calibration .......................................................................................................................................................................16 1.4.1 Length Measurement .................................................................................................................................................16 1.4.2 Left/Right Marker.........................................................................................................................................................16 1.4.3 Image Backup ................................................................................................................................................................16 1.4.4 Use Limitations .............................................................................................................................................................17 1.4.5 Disposal ............................................................................................................................................................................17 1.4.6 Pediatric Application ..................................................................................................................................................17 1.4.7 Before Exposure ............................................................................................................................................................17 1.4.8 1.4.9 During Exposure ...........................................................................................................................................................18 1.4.10 Operating and Storage Environment .................................................................................................................18 1.4.11 Others................................................................................................................................................................................18 2. Product ............................................................................................................................................. 19 2.1 Overview ................................................................................................................................................. 20 2.1.1 Features
[TBD] ...............................................................................................................................................20 Rev.1.0 Page 2 of 109 RA14-14B-011 2.2 VIVIX-S 1012N User Manual Product Components ............................................................................................................................ 21 Detector............................................................................................................................................................................21 VIVIX SCU (VIVIX System Control Unit) .............................................................................................................21 Battery & Charger .......................................................................................................................................................22 Data ....................................................................................................................................................................................22 Other Accessories ........................................................................................................................................................22 2.2.1 2.2.2 2.2.3 2.2.4 2.2.5 2.3 VIVIX-S 1012N Detector ...................................................................................................................... 24 Specifications .................................................................................................................................................................24 Drawing Sheet ...............................................................................................................................................................25 Functions .........................................................................................................................................................................26 2.3.1 2.3.2 2.3.3 Deco Sheet 2.3.4
[TBD] ......................................................................................................................................27 2.3.5 Wireless Communication..........................................................................................................................................27 2.3.6 Use Environment ..........................................................................................................................................................28 2.4 VIVIX SCU (VIVIX System Control Unit) ............................................................................................ 29 Specifications .................................................................................................................................................................29 Drawing Sheet ...............................................................................................................................................................30 Function VIVIX SCU Basic ....................................................................................................................................31 Function VIVIX SCU Mini .....................................................................................................................................33 2.4.1 2.4.2 2.4.3 2.4.4 2.5 Battery Pack ........................................................................................................................................... 35 Specifications .................................................................................................................................................................35 Drawing Sheet ...............................................................................................................................................................35 2.5.1 2.5.2 2.6 Battery Charger ..................................................................................................................................... 36 Specifications .................................................................................................................................................................36 Drawing Sheet ...............................................................................................................................................................36 2.6.1 2.6.2 2.7 Others
[TBD] .......................................................................................................................... 37 X-ray Generator (Recommended Exposure Condition)..............................................................................37 Recommended Specification of Workstation (PC) .......................................................................................37 Recommended Specification of Grid ..................................................................................................................37 2.7.1 2.7.2 2.7.3 3. System Configuration ................................................................................................................... 39 3.1 Detector Connection Methods ........................................................................................................... 40 3.1.1 Wireless Connection ...................................................................................................................................................40 3.1.2 Wired Connection ........................................................................................................................................................41 3.2 Diagram ................................................................................................................................................... 42 3.2.1 Block Diagram ...............................................................................................................................................................42 3.2.2 Wiring Diagram ............................................................................................................................................................42 Rev.1.0 Page 3 of 109 RA14-14B-011 3.3 VIVIX-S 1012N User Manual System Configuration ........................................................................................................................... 43 AP Mode (SCU AP Mode)........................................................................................................................................43 Tether Interface Mode ...............................................................................................................................................44 External AP Mode ........................................................................................................................................................45 Detector AP Mode ......................................................................................................................................................46 Detector Stand-Alone Mode ..................................................................................................................................47 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.4 Generator Interface Mode ................................................................................................................... 48 AED (Auto Exposure Detection) Interface Mode ..........................................................................................48 DR Trigger Interface Mode .....................................................................................................................................49 3.4.1 3.4.2 3.5 Configuring DR Trigger Interface Mode ........................................................................................... 50 Trigger Interface Way .................................................................................................................................................50 Packet Trigger ................................................................................................................................................................50 Line Trigger .....................................................................................................................................................................51 EXT_INF Port Pin Map ...............................................................................................................................................52 Input / Output Circuit ................................................................................................................................................54 3.5.1 3.5.2 3.5.3 3.5.4 3.5.5 4. Installation
[TBD] .............................................................................................................. 55 4.1 Battery Pack
[TBD] ................................................................................................................... 56 How to insert a battery pack .................................................................................................................................56 How to datach a battery pack...............................................................................................................................57 4.1.1 4.1.2 4.1.3 How to charge a battery pack
[TBD] ..................................................................................................58 4.2 Product Installation .............................................................................................................................. 60 4.2.1 Connecting Devices
[TBD] .......................................................................................................................60 4.2.2 4.2.3 Booting up SCU
[TBD] ...............................................................................................................................62 Booting up the Detector ..........................................................................................................................................62 4.2.4 Checking Status LED of Detector
[TBD] ............................................................................................63 4.3 Software Installation ............................................................................................................................. 64 4.3.1 4.3.2 Software Classification
[TBD] ..................................................................................................................64 Software Installation ...................................................................................................................................................64 4.4 Windows Environment Setting ........................................................................................................... 65 Rev.1.0 Page 4 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 4.4.1 4.4.2
[TBD] .................................................................................................................65 Network Configuration Disabling Sleep Mode of Monitor .......................................................................................................................69 5. Setting
[TBD] ..................................................................................................................... 70 6. Calibration
[TBD] .............................................................................................................. 74 7. Diagnosis, Inspection and Maintenance
[TBD] ............................................................ 80 8. Troubleshooting
[TBD] .................................................................................................... 89 9. Regulatory Information ................................................................................................................ 94 9.1 Medical Equipment Safety Standards ............................................................................................... 95 9.1.1 Medical Equipment Classification ........................................................................................................................95 Product Safety Standard ...........................................................................................................................................95 9.1.2 9.2 Radio Frequency Compliance Information ....................................................................................... 97 FCC Compliance ...........................................................................................................................................................97 9.2.1 9.3 Labels and Symbols .............................................................................................................................. 98 Label ..................................................................................................................................................................................98 Product Serial Number........................................................................................................................................... 100 Product Symbols ....................................................................................................................................................... 101 9.3.1 9.3.2 9.3.3 9.4 Guidance and Manufacturers Declaration for EMC ..................................................................... 102 Electromagnetic Emissions ................................................................................................................................... 102 Electromagnetic Immunity .................................................................................................................................... 103 9.4.1 9.4.2 10. Information ................................................................................................................................ 106 10.1 Service Information ........................................................................................................................ 107 10.1.1 Product Lifetime ........................................................................................................................................................ 107 10.1.2 Regular Inspection and Maintenance ............................................................................................................. 107 10.1.3 Repair ............................................................................................................................................................................. 107 10.1.4 Replacement Parts Support ................................................................................................................................. 107 10.1.5 Consumables ............................................................................................................................................................... 107 10.2 Warranty ............................................................................................................................................ 108 10.3 Revision History ............................................................................................................................... 109 Rev.1.0 Page 5 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 1. Instruction This section gives basic information of this manual and products with the safety guide. Document Guide Product Use Guide Safety Instruction Product Operation Guide Rev.1.0 Page 6 of 109 RA14-14B-011 1.1 Document Guide VIVIX-S 1012N User Manual This User Manual explains how to use the VIVIX-S 1012N detector made by Vieworks, X-ray interface unit, and other peripheral equipment. With this user manual, you can install, set and manage the VIVIX-S 1012N wired/wireless detectors as well as use its various functions. 1.1.1 Caution Information If the user is not fully aquainted with this manual, the product can be malfunctioned or unsuspected problem can be happened due to carelessness. To prevent any medical accidents, the user should fully understand the instructions of this manual before operating this product. 1.1.2 Target This manual is intended for service enginneers who install and set the VIVIX-S 1012N detector. 1.1.3 Symbols This product should be operated under the safety instructions with the warning or caution symbol in this manual. It is important for you to read and understand the contents with the following symbol for operating the products safely. Caution and Warning Symbol
This symbol is used to indicate a potentially hazardous situation which may cause death, personal injury or substantial property damage if the instructions are ignored. Be sure to understand the instructions of this symbol for the safe operation. Information Symbol
This symbol is used to indicate reference and complementary information related to the product. Users should read the instructions of this symbol carefully. Symbol for Change
This symbol is indicated in the cases below.
Items under consideration for adding, deleting or revising contents.
Items ready to review for the expected product change.
Items need a final review and approval.
Items which need to improve sentences or images. Rev.1.0 Page 7 of 109 RA14-14B-011 1.1.4 Notations Bold Types VIVIX-S 1012N User Manual We applied bold font style to the words which indicated products terms, or the words and sentences which are needed to transmit clear meaning to the customers. This helps you to easily distinguish the words from other technical ones for explaining functions. 1.1.5 Contact Department For any comments or inquiries regarding this document, contact via email below. Item Contents Department Technical Support Division in Vieworks E-mail techsupport@vieworks.com Rev.1.0 Page 8 of 109 RA14-14B-011 1.2 Product Use Guide VIVIX-S 1012N User Manual This chapter provides instructions about the use of product and disposal as well as the liability limit of Vieworks. 1.2.1 Product Usage The equipment should be kept in a safe and operable condition by maintenance personnel. 1 Only a physician or a legally certified operator should use this product. 2 3 Observe the contents written in this user manual when installing and using this product. 4 Use only specifications of computers and image display monitors recommended by this user manual. 5 Use only the dedicated cables provided with this product. 6 For details about installing and using this product, consult your sales representative or a distributor. 1.2.2 Disclaimer 1 2 3 4 5 In no event shall Vieworks be liable for damage or loss arising from a fire, earthquake, any intentional or negligent action by users. In no event shall Vieworks be liable for damage or loss arising from any trial usage, or other usage under abnormal conditions. 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. In no event shall Vieworks be liable for direct or indirect consequential damages arising from the use of this product. In no event shall Vieworks be liable for any damage arising from moving, alteration, inspection or repair by a person other than authorized service engineers. In no event shall Vieworks be liable for loss of image data for any reason. 6 7 Roentgenography, image processing, image reading, and image data storage must be performed in 8 9 accordance with the laws of the country or region in which the product is being used. The user is responsible for maintaining the privacy of image data acquired from this product. It is the responsibility of the attending physicians to provide medical care services. Vieworks will not be liable for faulty diagnoses. 10 Specifications, composition, and appearance of this product may change without prior notice. Rev.1.0 Page 9 of 109 RA14-14B-011 1.2.3 Product Disposal VIVIX-S 1012N User Manual Disposal of this product in an unlawful manner may have a negative impact on human health and the environment. When disposing this product, therefore, be absolutely sure to follow the procedure which is in conformity with the laws and regulations applicable in your area. European Union (and EEA*) only This symbol indicates that this product is not to be disposed with your household waste, according to the WEEE Directive (2002/96/EC) and your national law. This product should be handed over to a designated collection point, e.g., on an authorized one-for-one basis when you buy a new similar product or to an authorized collection site for recycling electrical and electronic equipment (EEE). Improper handling of this type of waste could have a negative impact on the environment and human health due to potentially hazardous substances that are generally associated with EEE. At the same time, your cooperation in the correct disposal of this product will contribute to the effective usage of natural resources. For more information on where you can drop off your waste equipment for recycling, please contact your local city office, waste authority, approved WEEE scheme, or your household waste disposal service.
*EEA: Norway, Iceland, and Liechtenstein 1.2.4 Trademarks The name Vieworks and Vieworks logo are registered trademarks of Vieworks. Vieworks. 2014 All rights reserved. The copyright of this document is owned by Vieworks. Under copyright laws, this document cannot be reproduced, in whole or in part, without the written permission of Vieworks. Rev.1.0 Page 10 of 109 RA14-14B-011 1.3 Safety Instruction VIVIX-S 1012N User Manual This product is designed and manufactured to ensure maximum safety of operation and to meet all the safety requirements applicable to electronic medical equipment. Follow these safeguards while using the products. If not, severe personal injury or substantial property damage can be happened. It is important for you to read and understand the contents of this manual before attempting to use the product. 1.3.1 Management and Authority
The product should be installed, operated, and serviced according to Vieworks maintenance procedures and by personnel from Vieworks or distributor who providing purchase of the Vieworks product.
Operation and maintenance should be done in strict compliance with the operation instructions contained in the manual.
The system, in whole or in part, cannot be modified in any way without prior approval from Vieworks.
Before authorizing any person to operate the system, verify that the person has read and fully understood the User Manual. The owner should make certain that only properly trained and fully qualified personnel are authorized to operate the equipment. An authorized operators list should be made and maintained.
It is important that this User Manual be kept at hand, studied carefully, and reviewed periodically by the authorized operators.
If a malfunction occurs, do not use this device until qualified personnel corrects the problem. 1.3.2 Power Supply
Do not operate the equipment using any type of power supply other than the one indicated on the rating label. Otherwise, it may result in a fire or electric shock.
Do not supply power to more than one piece of equipment using the same AC outlet for this product. Doing so may result in a fire or electric shock.
Do not connect a multiple portable socket-outlet or extension cord to the system. Doing so may result in a fire or electric shock.
Always connect the three-core power cord plug to a grounded AC power outlet.
Be sure to ground the equipment to an indoor grounded connector. Also, be sure to connect all the grounds for the system to a common ground.
Do not use any power source other than the one provided with this product. Otherwise, a fire or electric shock may be caused due to a leakage.
The owner should ensure continuous power supply to the system, with voltage and current according to the product specifications. If the system is powered unstably during its operation, we recommend you to install UPS (Uninterrupted Power Supply) to avoid loss of data.
To make it easy to disconnect the plug at any time, avoid putting any obstacles near the Rev.1.0 Page 11 of 109 RA14-14B-011 VIVIX-S 1012N User Manual outlet. Otherwise, it may not be possible to disconnect the plug in an emergency.
Do not place a heavy object such as medical equipment on cables and cords, and do not pull, bend, bundle, or step on them. Doing so may damage their sheath. If you alter them, it may damage the cords which could result in a fire or electric shock.
Securely plug the power cord into the AC outlet. If contact failure occurs, or if dust/metal objects come into contact with the exposed metal prongs of the plug, fire or electric shock may result.
Be sure to turn OFF the power to each piece of equipment before connecting or disconnecting the cords. Otherwise, you may get an electric shock that could result in death or serious injury.
Be sure to hold the plug or connector to disconnect the cord. If you pull the cord, the core wire may be damaged, resulting in a fire or electric shock.
Do not handle the product with wet hands. You may experience an electric shock that could result in death or serious injury. 1.3.3 Handling
Never disassemble or modify the equipment. Doing so may result in a fire or electric shock. Also, since the equipment incorporates parts that may cause an electric shock as well as other hazardous parts, touching them may cause death or serious injury.
Do not connect any equipment which is not specified in this User Manual.
Do not place anything on surface of the equipment. The object may fall and cause an injury. Also, if metal objects such as needles or clips fall into the equipment, or if liquid is spilled, it may result in a fire or electric shock.
Do not hit or drop the equipment. The equipment may be damaged if it receives a strong jolt. If the equipment is used without being repaired, it may result in a fire or electric shock.
Do not place excessive weight on the detector. The internal image sensor may be damaged and it can affect to the image quality.
Have the patient take a fixed posture and do not let him or her touch parts unnecessarily. If the patient touches connectors or switches, it may result in electric shock or malfunction of the equipment.
Do not spill liquid or chemicals onto the detector. In cases where the patient is injured, protect the equipment with a disposable covering not allow to come in contact with blood or other body fluids. Otherwise, it may result in a fire or electric shock.
For safety reasons, be sure to turn OFF the power of the equipment when the inspections indicated in this manual are going to be performed.
Do not submerge the detector in water.
Be sure to use the detector on a flat surface so it will not bend. Otherwise, the internal image sensor may be damaged. Be sure to securely hold the detector while using it in upright positions. Rev.1.0 Page 12 of 109 RA14-14B-011 VIVIX-S 1012N User Manual
Because the equipment cable is long, take care that cables do not become tangled during use. Also, be careful not to get your feet caught in the cable. It may cause a malfunction of the equipment or injury to the user from tripping over the cable.
Do not block the ventilation ports of ViVIX SCU to prevent overheating. Overheating can cause products malfunctions and damages. 1.3.4 Battery Pack and Charger
Do not use the battery pack as a power source for equipment other than VIVIX-S 1012N detector. Be sure to use only the dedicated battery pack for the VIVIX-S 1012N detector.
The battery charger is designed for the dedicated battery pack. Do not use the battery charger other than the dedicated one. Otherwise, a battery explosion or a battery leak may occur, resulting in fire or electrical shock.
Do not operate the battery charger using any type of power supply other than the one indicated on the rating label.
Do not handle the product with wet hands.
Do not attempt to disassemble, alter, or apply heat to the product.
Avoid dropping or subjecting the product to severe impacts. To avoid the risk of injury, do not touch the internal parts of the battery if it has been cracked.
Stop using the battery pack immediately if it emits smoke, a strange smell, or otherwise behaves abnormally.
Do not let the battery pack and battery charger come into contact with water or other liquids and do not allow them to get wet.
Do not clean with substances containing organic solvents such as alcohol, benzene, thinner, or other chemicals. Otherwise, fire or electrical shock may result.
Do not allow dirt or metal objects (such as hair pins, clips, staples or keys) to contact the terminals. Otherwise, battery explosion or leakage of electrolyte may occur, resulting in fire, injury or pollution of surrounding area. If the battery leaks and the electrolytes come into contact with your eyes, mouth, skin or clothing, immediately wash it away with running water and seek medical attention.
Do not leave, store, or place the product in a location near heat sources, or in a place subject to direct sunlight, high temperature, high humidity, excessive dust, or mechanical shock. Otherwise, battery leakage, overheating or damage to the product may occur, resulting in electrical shock, burns, injury or fire.
Do not attempt to use a battery pack that has deteriorated. Using a battery pack that has exceeded its life cycle may lead to overheating, fire or explosion.
The Lithium ion battery is recyclable.
Battery slowly discharges even if not in use.
The battery pack may have expired if it discharges immediately after being fully charged. You can purchase an optional battery pack to replace an exhausted one.
The battery pack is a consumable item. If a fully charged battery is consumed quickly, use a new and fully charged battery pack.
Be sure to charge the battery periodically (once a year) if it is not used for an extended Rev.1.0 Page 13 of 109 RA14-14B-011 VIVIX-S 1012N User Manual period of time. The battery pack cannot be charged if it has been over discharged.
Before discarding the battery pack, cover the terminals with adhesive tape or other insulators. Contact with other metal materials may cause fire or explosion. 1.3.5 Environment of Use
Do not install the equipment in any of the locations listed below. Doing so may result in failure or malfuction, equipment falling, fire, or injury.
Close to facilities where water is used.
Where it will be exposed to direct sunlight
Close to the air outlet of an air-conditioner or ventilation equipment
Nearby the electric heating applicance such as a heater
Where the power supply is unstable
In a dusty environment
In a saline or sulfurous environment
Where temperature or humidity is higher than the operating temperature
Where there is freezing or condensation
In areas prone to vibration
On an incline or in an unstable area
This product may malfunction due to electromagnetic interference (EMI) caused by telecommunication devices, transceivers, electronic devices, etc. To prevent the electromagnetic wave from badly influencing the product, be sure to avoid placing it in close proximity to the product. Or, change direction or position of the product or move into the shielded place to reduce electromagnetic interference.
This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
Conductive fluids that drain into the active circuit components of the system may cause short circuits that can result in electrical fire. Therefore, do not place fluids or food on any part of the system.
To avoid electric shocks and burns caused by use of the wrong type of fire extinguisher, make sure that the fire extinguisher at the site has been approved for use on electrical fires.
The battery charger and ViVIX SCU (System Control Unit) cannot be used in patients vicinity. Rev.1.0 Page 14 of 109 RA14-14B-011 1.3.6 Problem Management VIVIX-S 1012N User Manual
Should any of the following occur, immediately turn OFF the power to each piece of equipment, unplug the power cord from the AC outlet, and contact sales representative or distributor.
When there is smoke, an odd smell or abnormal sound no period.
When liquid is spilled into the equipment or a metal object is entered through an opening.
When the equipment has been dropped and is damaged. 1.3.7 Maintenance and Inspection
Do not use or store the equipment near flammable chemicals such as acetone, benzene, thinner, etc. If chemicals are spilled or evaporated, it may result in a fire or electric shock through contact with electric parts inside the equipment.
If any flammable cleaning agent is used for the product, be sure to take care when using them.
When the equipment is going to be cleaned, be sure to turn OFF the power of the equipment and unplug the power cord from the AC outlet. Never use thinner, acetone, benzene or any other flammable cleaning agent. Otherwise, it may result in a fire or electric shock.
Clean the plug of the power cord periodically by unplugging it from the AC outlet and removing dust or dirt from the plug, its periphery, and AC outlet with a dry cloth. If the cord is kept plugged in for a long time in a dusty, humid or sooty place, dust around the plug will attract moisture, and this could cause insulation failure that could result in a fire.
Be sure to turn OFF the power of the equipment while cleaning. Otherwise, a fire or electric shock may occur. Rev.1.0 Page 15 of 109 RA14-14B-011 1.4 Product Usage Guide VIVIX-S 1012N User Manual
When using the equipment, take the following precautions. Otherwise, problems may occur and the equipment may not function correctly. 1.4.1 Calibration To ensure optimal system performance, it is important to verify that the system is calibrated correctly. Check if the calibration is performed after the equipment is completed to be installed or repaired. Do not try to use the system if the calibration has not been performed. You can process calibration with the calibration data CD (provided).
The calibration result can be different by the use environment. Therefore, if the result with the provided calibration data is not satisfied, you can create the data at the field in person by using VIVIX Setup, the calibration software.
1.4.2 Length Measurement Before taking any length measurement on an image, carry out the length calibration with a reference object and verify its results for correct measurement.
1.4.3 Left/Right Marker The operator is responsible for making a correct and clear mark on the left or right side of the image. The software includes a function to mark the image with L (left) or R (right) while acquiring the image through printing and archiving. Prepare an alternative way to prevent any confusion if the operator does not choose to use L/R marks.
1.4.4 Image Backup To avoid missing images which might result in a patient being exposed to additional dose of radiation, it is important to send images to PACS or backup images by using film or external storage media (CD, DVD, HDD, USB). If the hard disk of your workstation is about to be full, the operator should backup images to somewhere else and delete them to make storage (memory) space in the hard disk for new patients.
The image backup should be done as a routine operation for every patient and image.
Rev.1.0 Page 16 of 109 RA14-14B-011 1.4.5 Use Limitations VIVIX-S 1012N User Manual
Vieworks software has the engineer mode operated by inputting the administrator password only. This mode should be operated by the person who is qualified by Vieworks. 1.4.6 Disposal
Disposal of this product in an unlawful manner may have negative effects on human health and the environment. Be sure to follow the procedure which is in conformity with the laws and regulations applicable in your area. 1.4.7 Pediatric Application
Every request should be reviewed by a pediatric radiologist prior to beginning the examination to ensure that an appropriate study is being performed. If the technologist notices an unusual request, he or she must contact a radiologist in charge. Examples include orders- a Full Cervical, Thoracic, and Lumbar Spine series. The pediatric radiologist should contact the ordering physician and decide which study is best for the pediatric patient. The technologist should use a proper technique considering the patients size to decrease the radiation dose when he or she acquires diagnostic images. ALL pediatric patients shall be shielded for their X-ray examinations, except for when the shield will obscure the region of interest, as in a pelvic or SI joint X-ray for trauma or arthritis, or when it is physically or clinically unreasonable to shield the patient. For routine Hip X-Rays, ALL male children shall have their scrotum shielded using the small gonadal shield while females may not be shielded because doing so would obscure the hips. To minimize motion in infants and young children, swaddle the infant. Use distraction tools to improve cooperation and projectors with child-friendly themes, music, toys with flashing lights or music, child-
friendly images on the ceiling or walls, singing, counting, and a parent reading and talking to the child through the console all can help reduce anxiety and comfort the child. A scoliosis series will consist of a single frontal standing view of the spine. No lateral view or supine view is needed, unless specifically asked for by the Orthopedist or Radiologist. If the females breasts can be shielded without obscuring the spine, breast shields should be used. 1.4.8 Before Exposure
Be sure to check the equipment daily and confirm that it works properly. Sudden heating of the room in cold areas will cause condensation to form on the equipment. In this case, wait until the condensation evaporates before performing an exposure. If the equipment is used while condensation is formed in it, problems may occur in the quality of captured images.
When an air-conditioner is used, be sure to raise/lower the temperature gradually so that difference between the temperature in the room and in the equipment does not occur, to prevent condensation. Rev.1.0 Page 17 of 109 RA14-14B-011 1.4.9 During Exposure VIVIX-S 1012N User Manual This equipment is not protected (sealed) against liquids such as blood and medicine in the operating room. If necessary, wrap the equipment in a disposable cover when using it. Do not use the selected frequency channel (2.4 and 5 dual band) for other wireless devices. Mutual interference may affect the image data transmission rate. Do not use the detector near devices generating a strong magnetic field. Doing so may produce image noise or artifacts.
1.4.10 Operating and Storage Environment
This equipment is mainly used in the X-ray exposure room and hospital wards. To use it in other places, consult Vieworks sales representative or a distributor. Do not expose this equipment to high temperatures and/or high humidity. Malfunctions may occur.
When not in use, keep the products in a safe location.
Be sure to use and store this equipment under the conditions described below. Classification Temperature Humidity (Non-condensing) Atmosphere Operating Environment
+10 ~ +35 Storage Environment
-15 ~ +55 30 ~ 85%
10 ~ 90%
700 1060 hPa 500 1060 hPa 1.4.11 Others Do not use this equipment in combination with peripherals such as defibrillators or large electric motors as these may cause power-supply noise or power supply voltage variations. Doing so may prevent normal operation of this equipment and peripherals.
Rev.1.0 Page 18 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 2. Product This section gives an instruction about the product components and specifications. Overview Product Components VIVIX-S 1012N Detector VIVIX SCU Battery Pack Battery Charger Others Rev.1.0 Page 19 of 109 RA14-14B-011 2.1 Overview VIVIX-S 1012N User Manual ViVIX-S 1012N detector is the digital X-ray imaging solution. It acquires images by exposing X-ray which has been penetrated the human body. When X-ray photons pass through scintillator in the detector, the photons convert to visible ray, and the visible ray is converted to electronic signals through TFT (a-Si). Then the detector digitalizes x-ray images and transfers them to the computer (workstation) for radiography diagnostics. Users can perform image diagnosis easily through the image display monitor with this process. Advanced digital image processing also allows considerably efficient diagnosis, all kinds of information management, and sharing of image information on network.
This detector is used for the general-purpose diagnostic procedures, and it is intended to replace radiographic film / screen systems.
This detector is not intended for mammography applications. 2.1.1 Features
[TBD]
Since VIVIX-S 1012N detector is compatible with a conventional film cassette, it enables to replace the analog radiographic diagnosis (Supporting ISO4090 standard). The new sensor with 124m pixel pitch produces high spatial resolution (approx. 5.2 Mega pixels) digital images. Various applications such as neonatal, ENT, equine and cephalo Choose between two scintillator types (CsI and Gadox) of detector provided by Vieworks. The built-in wireless communication supports IEEE 802.11n to acquire images without a wired connection in anytime, anywhere.
Make direct wireless communication with the built-in wireless AP function. (Inside APTM)
Supports the stable and reliable AED (Auto Exposure Detection) function. (AnytimeTM) Designed as lightweight and thin with portability to allow easy exposure in anytime, anywhere. Used in various ways for infant / animals and in the dental clinic / ENT, etc. Rev.1.0 Page 20 of 109 RA14-14B-011 2.2 Product Components 2.2.1 Detector VIVIX-S 1012N User Manual Component Description VIVIX-S 1012N Detector Calibration DATA (CD)
FXRD-1012NAW (2.2kg)
FXRD-1012NBW (2.1kg)
Offset Calibration Data
Gain Calibration Data
Defect Map Data
[TBD]
A deco sheet attached on the detector can be different depending on each client company. 2.2.2 VIVIX SCU (VIVIX System Control Unit) Component Description VIVIX SCU Basic VIVIX SCU mini
FXRS-03A (2.5kg)
FXRS-03B (2.8kg)
AC Power Cable (2m)
FXRS-04A (1.2kg) Rev.1.0
You can choose either VIVIX SCU Basic or VIVIX SCU mini depending on the purpose of use. Page 21 of 109 RA14-14B-011 2.2.3 Battery & Charger Component VIVIX Battery VIVIX Charger 2.2.4 Data Component Calibration Data Resource 2.2.5 Other Accessories Component Cables Rev.1.0 VIVIX-S 1012N User Manual Description
FXRB-03A (0.12kg, 2EA)
FXRC-02A (0.8kg)
DC 24V Description
Pre-offset data
Post-offset data
Gain data
Defect map data
Software (Viewer or SDK)
Manuals Description
Tether Interface Cable (7m)
Ether Con Cable (7m, Option)
Generator Interface Cable (7m)
UTP LAN Cable (15m, Direct)
CAT 5E or CAT6
[TBD]
[TBD]
Page 22 of 109 RA14-14B-011 VIVIX-S 1012N User Manual
The use of accessories and cables other than those approved and sold by Vieworks Co., Ltd. may result in increased release of electromagnetic waves or decreased stability of the equipment.
Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards. All combinations of equipment must be in compliance with IEC 60601-1-1 system requirements.
Any person who connects additional equipment to the signal input or signal output ports configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 60601-1.
Consult your sales distributor or manufacturer if you have any concerns. Rev.1.0 Page 23 of 109 RA14-14B-011 2.3 VIVIX-S 1012N Detector VIVIX-S 1012N User Manual VIVIX-S 1012N is designed to acquire digital images by collecting x-ray signals and sereval conversion processes. You can use the acquired image (10 x 12 film size) diversely depending on the purpose of use.
VIVIX-S 1012N is one of the detector models produced by Vieworks. 2.3.1 Specifications Item Model Image Sensor X-ray Scintillator Type Pixel Pitch Field of View Specifications
FXRD-1012NAW (CsI, wireless)
FXRD-1012NBW (Gadox, wireless)
a-Si (Amorphous Silicon) TFT
Fill Factor : 60%
FXRD-1012NAW : Csl: TI (Thallium doped Caesuim Iodide)
FXRD-1012NBW : Gd2O2S:Tb (Gadolinium oxysulfide)
0.124 (124)
10 x 12 Active Area (H x V)
253.95 317.44 Active Array Effective Area Effective Array Grayscale Spatial Resolution
2048 x 2560 pixels
253.0 x 316.4
2040 x 2552
16bit
Min. 4.0 lp/
Image Acquisition Time (Wired)
1 sec. Image Acquisition Time (Wireless)
3 sec. Recommended Cycle Time
15 sec. X-ray Synchronization Control
AED (Auto Exposure Detection)
DR Trigger (External line trigger)
DC +24 V, Max. 0.7 A Rated Power Supply
Wired: Powered by VIVIX SCU with a tether interface cable.
Wireless: Powered by a battery pack (3,100 h) Power Consumption
Max. 17 W Dimensions (H W D)
287.0 350.0 15.2 Weight (including a battery pack)
FXRD-1012NAW : 2.2 kg
FXRD-1012NBW : 2.1 kg
Wired: Gigabit Ethernet (1000BASE-T) via PoE (Power over Image Transfer Ethernet)
Wireless: IEEE802.11n Data Transmission Rate (Wired)
Max. 1Gbps Data Transmission Rate (Wireless)
Max. 300Mbps (MIMO 2X2) Rev.1.0 Page 24 of 109 RA14-14B-011 2.3.2 Drawing Sheet VIVIX-S 1012N User Manual Item Description Dimensions (H W D) 287.0 350.0 15.0 Curvature of Edges R6.5
Under the ISO4090 regulation, the allowed tolerance of a thickness of detector is from -
2 ~ +1. Rev.1.0 Page 25 of 109 RA14-14B-011 VIVIX VIX-S 1012N User Manual 2.3.3 Functions A B C D Name Description Tether interface connector ether interface connector
Used for tighten the tether interface cable. Used for tighten the tether interface cable.
Used for wired connection between a detector and detector and VIVIX SCU. Tether interface holder Tether interface holder
Fix/release holder of the tether interface cable. Fix/release holder of the tether interface cable. Battery lock lever
Lock/unlock lever of the equipped battery pack. battery pack. Antenna for wireless LAN Antenna for wireless LAN
Antennas for wireless communication (2EA) Antennas for wireless communication (2EA) E Status indicator
Detector status indicator
DATA LED (Blue): Indicates communication and transmission Indicates communication and transmission
ACTIVE LED (Orange): Indicates ready to work Indicates ready to work
POWER LED (Green): Indicates power On/Off status Indicates power On/Off status Power button
Detector power button AP ON /OFF Button
F G Rev.1.0 Page 26 of 109 RA14-14B-011 2.3.4 Deco Sheet VIVIX-S 1012N User Manual A B C D E F Indication Info. Description Wireless communication logo Status indication logo Indicating image starting point Indicating center of the detector Vieworks logo Certification logo
Image starting point (0.0) of this detector is located nearby the tether interface connector. You can change the displayed direction of an image from the VIVIX Setup program, but it does not mean that the starting point and direction of the original image are changed. 2.3.5 Wireless Communication Item Specifications Wireless standard IEEE802.11n 2.412 ~ 2.472 (13 Channels) Frequency range 5.18 ~ 5.24 (4 Channels) 5.745 ~ 5.805 (4 Channels) Data transmission rate 802.11n: Max. 300Mbps (MIMO 2X2) Modulation BPSK, QPSK, 16-QAM, 64-QAM Transmission power Max. 17dBm Security Antenna WPA2-PSK Dual Band Antennas (2EA, inbuilt)
The specification of detector and SCU are same, but their location of antennas is different. Rev.1.0 Page 27 of 109 RA14-14B-011 2.3.6 Use Environment VIVIX-S 1012N User Manual Item Temperature Humidity Operation
+10 ~ +35 Storage & Transportation
-15 ~ +55 30 ~ 85% (Non-condensing) 10 ~ 90% (Non-condensing) Atmospheric pressure 700 ~ 1060 hPa 500 ~ 1060 hPa Shock Vibration 1.6G 0.7G 20G 0.7G
The use environment of detector and VIVIX SCU is same. Load Limit of Detector
[TBD]
Uniform load Local load Over the whole surface Max. ?? kg Center diameter 40mm Max. ?? kg
Do not let the paitent or object heavier than load limit be on the detector. Then, detector can be damaged.
Do not let the patient lie or get on the detector. Internal devices such as a sensor can be seriously damaged even if his/her weight is within the load limit. Rev.1.0 Page 28 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 2.4 VIVIX SCU (VIVIX System Control Unit) VIVIX SCU synchronizes the image and X-ray signal as locating among the detector, workstation and the X-
ray generator. You can use the SCU directly when the power supplies to SCU after connecting it under the VIVIX-S 1012N system environment.
VIVIX SCU is divided into VIVIX SCU Basic and VIVIX SCU mini depending on its size. 2.4.1 Specifications VIVIX SCU Basic Item Model Power supply Cable connection port Specifications
FXRS-04B
Input: AC100 to 240V, 50/60, Max. 200VA
Output: DC +24V 3.3A, 80W
Gigabit Ethernet port (3EA)
PoE (Power over Ethernet) Port (2EA) Wireless communication
IEEE 802.11n (2.4 / 5 ) Dimension (H W D)
210.0 300.0 58.0 Antenna Weight VIVIX SCU mini Item Model
105 (2EA, Dual band)
2.8 Specifications
FXRS-04A Power supply
Input: DC +24V 2A Max Cable connection port
Gigabit Ethernet port (3EA)
PoE (Power over Ethernet) Port (1EA) Wireless communication
IEEE 802.11n (2.4 / 5 ) Dimension (H W D)
210.0 170.0 45.0 Antenna Weight
109 (2EA, Dual band)
1.2 Rev.1.0 Page 29 of 109 RA14-14B-011 2.4.2 Drawing Sheet VIVIX SCU Basic VIVIX-S 1012N User Manual VIVIX SCU Mini Rev.1.0 Page 30 of 109 RA14-14B-011 2.4.3 Function VIVIX SCU Basic VIVIX SCU Basic Front Side VIVIX VIX-S 1012N User Manual No. Name Description 1 2 3 Power switch Turn on/off the power of VIVIX SCU. (Including Green LED Lamp)
(Including Green LED Lamp) Fan Antenna Expels the air inside of VIVIX SCU. Assists communications between the detector and between the detector and VIVIX SCU. Indicates the operation and connection status of VIVIX VIVIX SCU. 4 Status LED
Blinking green: Booting
Green: Completed to boot up
Blue: The detector is connected and ready to communicate ready to communicate. Rev.1.0 Page 31 of 109 RA14-14B-011 Rear Side VIVIX VIX-S 1012N User Manual No. Name Description 1 2 EXT_INF1 EXT_INF2 LAN port
(Port 1, 2, 3) X-ray generator interface connector (D-SUB 15pin x 2 EA, Female) SUB 15pin x 2 EA, Female)
EXT_INF1 : 1 ~ 15
EXT_INF2 : 16 ~ 30 Gigabit Ethernet port (1000BASE-T)
Port 1: Communication between the workstation and ommunication between the workstation and VIVIX SCU.
Port 2, 3: Communication between FXRD FXRD-1717S detector and VIVIX SCU when configuring multiple detectors when configuring multiple detectors. Indicats the status of PoE port (Port 4, Port 5 Port 5) 3 PoE status lamp
Green: 1 Gbps
Orange: 100 Mbps 4 PoE port
(Port 4, 5) 5 Detector power supply port Detector power supply port 6 P.E 7 AC input port PoE (Power over Ethernet) port (1000BASE-
-T)
Communication between the detector and and VIVIX SCU.
Supplies power to the detector. Max. DC +24V/24W (2 ports)
For FXRD-1717S detector only. Equipotential ground T2AL250V fuse (2 EA)
100 ~ 240V
50/60
Supplies power to VIVIX SCU. Rev.1.0
The P.E (Potential Equalization)
(Potential Equalization) port of VIVIX SCU is used to maintain potential is used to maintain potential qualization between VIVIX SCU and another grounded system. equalization between can be detached without the use of a tool. can be detached without the use of a tool
. Use the conductor that Page 32 of 109 RA14-14B-011 2.4.4 Function VIVIX SCU Mini VIVIX SCU Mini Front Side VIVIX VIX-S 1012N User Manual No. Name Description 1 2 Power switch Turn on/off the power of VIVIX SCU. (Including Green LED Lamp)
. (Including Green LED Lamp) Antenna Assists communications between the detector and between the detector and VIVIX SCU. Indicates status of VIVIX SCU operation and connectio operation and connection. 3 Status LED
Blinking green: Booting
Green: Completed to boot up
Blue: The detector is connected and ready to communicate. communicate. Rev.1.0 Page 33 of 109 RA14-14B-011 Rear Side VIVIX VIX-S 1012N User Manual No. Name 1 EXT_INF Description X-ray generator interface connector (D-SUB 15pin, Female) SUB 15pin, Female) Gigabit Ethernet port (1000BASE-T) 2 LAN port
(Port 1, 2, 3)
Port 1: Communication between the workstation and ommunication between the workstation and VIVIX SCU.
Port 2, 3: Communication between FXRD-1717S detector and VIVIX SCU when configuring multiple detectors. Indicats the status of PoE port. 3 PoE status lamp
Green: 1 Gbps
Orange: 100 Mbps PoE (Power over Ethernet) port (1000BASE-T) 4 PoE port
Communication between the detector and VIVIX VIVIX SCU. 5 DC power input port
Supplies power to the detector. DC +24V
Supplies power to VIVIX SCU Rev.1.0 Page 34 of 109 RA14-14B-011 2.5 Battery Pack 2.5.1 Specifications VIVIX-S 1012N User Manual Item Model Type Specifications FXRB-03A Lithium Ion Rated Power Supply Output: DC +7.6V Capacity Number of cell Life 3,100h 2S1P (2 Series 1 Parallel) Approx. 500 times (Fully charged/Discharged completely, 1cycle) Dimension (H W D) 160.0 61.8 5.7 Weight 114g 2.5.2 Drawing Sheet Rev.1.0 Page 35 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 2.6 Battery Charger 2.6.1 Specifications Item Model Specifications FXRC-02A Simultaneous Charging 2 battery packs Charging time 2 hours Rated power supply DC +24V, 2A Max. Dimension (H W D) 192.0 101.0 27.5 Weight 0.8 2.6.2 Drawing Sheet No. Name Description 1 2 Rev.1.0 Lock button Fixes a battery while it is in charging. Power input port Supplies electric power by connecting a power adapter to the battery charger. Page 36 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 2.7 Others
[TBD]
2.7.1 X-ray Generator (Recommended Exposure Condition) Item Recommended condition X-ray energy range
40kVp ~ 150kVp Reliability (Lifetime Dose)
74Gy or higher (35 uGy x 365days x 24hrs x 60min. x 60sec. / 15sec.) 2.7.2 Recommended Specification of Workstation (PC) Item Recommended specification
VIVIX Setup
Microsoft Windows 7 (32bit / 64bit) Operating System
Microsoft Windows Vista Service pack 1 or higher (32bit / 64bit)
Microsoft Windows 7 64bit SP1 (Professional Edition or higher)
Microsoft Windows 8 (32bit / 64bit) / 8.1 64bit SP1 (Professional CPU Memory Hard Disk Edition or higher
Microsoft Windows 8.2 (32bit / 64bit)
Intel Core i5 2600 or higher (or compatible CPU)
4GB or higher
1TB or higher
Gigabit (for detector only)
Intel PRO 1000 Series (Gigabit LAN Card for network interface) LAN Card (only for
Min.requiremetns detector communication)
Speed: 1Gbps or more
Jumbo Frames: 9K
Receive Descriptors: 2K (1024 or higher) Monitor CD-ROM
1024 x 768 or more
CD or DVD R/W 2.7.3 Recommended Specification of Grid Item SID Size Ratio Frequency INTER SPACER Recommended specification
100cm / 130cm / 150cm / 180cm
451mm x 365mm x 1.5mm
8.1 / 10:1 / 12:1
215 line/inch
AL Rev.1.0 Page 37 of 109 RA14-14B-011 VIVIX-S 1012N User Manual
Check the recommended specifications by Vieworks first before buying the generator, workstation and grid. Rev.1.0 Page 38 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 3. System Configuration This section gives information about the various connection / configuration ways among the detector, VIVIX SCU, workstaton and X-ray generator. You can figure out the most suitable way of system configuration through this instruction. Detector Connection Methods Diagram System Configuration Generator Interface Rev.1.0 Page 39 of 109 RA14-14B-011 3.1 Detector Connection Methods Methods VIVIX VIX-S 1012N User Manual You can organize wired or wireless connection can also choose other connection connection ways suitable for the use environment in case of need. ways suitable for the use environment in case of need. wired or wireless connection between the VIVIX-S 1012N detector detector and VIVIX SCU. You 3.1.1 Wireless Connection are transmitted between the VIVIX-S 1012N detector and detector and VIVIX SCU by wireless The images and data are transmitted between the connection.
A battry pack should be installed in the detector to use it under the A battry pack should be installed in the detector to use it under the wireless wireless configuration.
We recommend We recommend you to use the wireless connection method for the for the following cases.
When using the unfixed detector. When using the unfixed detector.
When the wired When the wired communication is in trouble by the interruption interruption of cables.
The wireless The wireless connection is more freely to operate than the wired connection. than the wired connection.
Use the wireless connection with a laptop computer to Use the wireless connection with a laptop computer to enhance mobility. mobility.
Be sure to operate the wireless commnunication Be sure to operate the wireless commnunication between the detector a within a maximum of a maximum of 8m. between the detector and VIVIX SCU
Use of multiple WLAN devices within the same frequency band may interfere Use of multiple WLAN devices within the same frequency band may interfere with each Use of multiple WLAN devices within the same frequency band may interfere wireless communication and cause a decline in transmission speed. wireless communication and cause a decline in transmission speed wireless communication and cause a decline in transmission speed
Do not cover or block the wireless module of the detector. Do not cover or block the wireless module of the detector. Also, do not put any shielding Also, do not put any shielding materials between the detector and operable distance may be reduced. operable distance may be reduced between the detector and VIVIX SCU. Otherwise, the transmission speed or Otherwise, the transmission speed or
Rev.1.0 Page 40 of 109 RA14-14B-011 3.1.2 Wired Connection VIVIX-S 1012N User Manual Connect ViVIX-S 1012N detector and VIVIX SCU with a tether interface cable to make a wired configuration.
As the tether interface cable supplies power to the detector, a battery pack is not needed to be installed in the detector.
We recommend you the wired connection method for the following cases.
When continuous power supply to the detector is needed.
When the detector is fixed in a bucky stand or on a table.
When you upgrade the detector firmware or change the inner configural information.
When you need the data communication to be faster than the wireless connection.
A battery pack in the detector keeps charging under the wired connection.
The wireless communication module of the detector maintains inactivation status.
Rev.1.0 Page 41 of 109 RA14-14B-011 3.2 Diagram 3.2.1 Block Diagram VIVIX-S 1012N User Manual 3.2.2 Wiring Diagram Rev.1.0 Page 42 of 109 RA14-14B-011 3.3 System Configuration System Configuration VIVIX VIX-S 1012N User Manual his section gives information about the configuration modes of VIVIX-S 1012N detector, This section gives information about workstation and the generator. generator. detector, VIVIX SCU, 3.3.1 AP Mode (SCU AP Mode) AP Mode (SCU AP Mode) SCU AP mode is the wireless connection center wirelessly. connection method that connecting the detector with with VIVIX SCU as the VIVIX SCU & Detector
The VIVIX-S 1012N detector and detector operate as AP (Access Point) and
(Access Point) and STATION respectively. detector and VIVIX SCU are connected wirelessly. In this case, In this case, VIVIX SCU and the VIVIX SCU & PC (Workstation) VIVIX SCU & PC (Workstation) VIVIX SCU and PC (Workstation) are and PC (Workstation) are connected with the LAN cable.
It is available available to connect VIVIX SCU and PC wirelessly. In this case, n this case, VIVIX SCU and the detector operate as AP (Access Point) and STATION respectively. detector operate as VIVIX SCU & Generator
Rev.1.0 VIVIX SCU and the generator can be connected with the generator interface cable. generator can be connected with the generator interface cable. generator can be connected with the generator interface cable.
It is unnecessary to connect It is unnecessary to connect VIVIX SCU and the generator with a cable if you use AED mode of the detector you use AED mode of the detector. a generator interface Page 43 of 109 RA14-14B-011 3.3.2 Tether Interface Mode VIVIX VIX-S 1012N User Manual r interface mode is the wired connection method that connecting the detector connecting the detector with VIVIX SCU as the Tether interface mode is the wired center. VIVIX SCU & Detector VIVIX SCU and the VIVIX VIVIX-S 1012N detector are connected with the tether interface cable are connected with the tether interface cable.
Other connection connection ways of the tether interface mode are the same same as the AP mode.
Rev.1.0 Page 44 of 109 RA14-14B-011 3.3.3 External AP Mode VIVIX VIX-S 1012N User Manual External AP mode is the wireless connection method that adding the external AP device instead of External AP mode is the wireless SCU. method that adding the external AP device instead of VIVIX External AP & VIVIX SCU
The external AP and VIVIX SCU VIVIX SCU are connected with a LAN cable. External AP & Detector The external AP and VIVIX and the detector operate as AP (Access Point) and STATION respectively. and the detector operate as VIVIX-S 1012N detector are connected wirelessly. In this c n this case, the external AP
Other connection connection ways of the tether interface mode are the same same as the AP mode.
Be sure to check the specifications of external AP device when configuring Be sure to check the specifications of external AP device when configuring the external Be sure to check the specifications of external AP device when configuring AP mode, since the wireless communication performance can be different by the AP mode, since the wireless communication performance can be different AP mode, since the wireless communication performance can be different specifications. specifications
Rev.1.0 Page 45 of 109 RA14-14B-011 3.3.4 Detector AP Mode VIVIX VIX-S 1012N User Manual Detector AP mode is the wireless connection method that connecting the PC (Workstation) Detector AP mode is the wireless detector as the center wirelessly wirelessly. method that connecting the PC (Workstation) with the Detector & PC (Workstation) Detector & PC (Workstation) The VIVIX-S 1012N detector operate as AP (Access Point) and
(Access Point) and STATION respectively. detector and PC are connected wirelessly. In this case, the detector n this case, the detector and the PC
Since VIVIX SCU VIVIX SCU is not used for configuring the detector AP mode, you mode without a wired connection. (Cannot use the DR Trigger is not used for configuring the detector AP mode, you can only use the Trigger mode.) AED mode without a wired
This mode can be used when mobility and portability are needed. This mode can be used when mobility and portability are needed. This mode can be used when mobility and portability are needed.
When configuring When configuring the detector AP mode, be sure to check the specifications of wireless e to check the specifications of wireless module installed in the PC. The wireless communication performance can be different module installed in the PC. The wireless communication performance can be different module installed in the PC. The wireless communication performance can be different depending on the specifications of the wireless module. depending on the specifications of the wireless module.
If the wireless If the wireless connection cannot be made normally because of unexpected p VIVIX SCU can be can be needed to check the detector condition. cannot be made normally because of unexpected problems,
Rev.1.0 Page 46 of 109 RA14-14B-011 VIVIX VIX-S 1012N User Manual 3.3.5 Detector Stand-Alone Mode Alone Mode You can use the Stand-Alone Alone mode without making a wired or wireless connection. mode without making a wired or wireless connection.
You should take images with take images with the AED mode only when using the using the Stand-Alone mode.
(Cannot use the DR Trigger mode.)
(Cannot use the
The acquired images are stored images can be transmitted to d images are stored in the internal storage of the detector be transmitted to the PC after connecting the detector the detector to the PC. the detector in order and the
The transmitted transmitted images are removed automatically from the detector. the detector. Rev.1.0 Page 47 of 109 RA14-14B-011 3.4 Generator Interface M Generator Interface Mode VIVIX VIX-S 1012N User Manual VIVIX-S 1012N detector provides images by detecting X-ray. detector provides DR Trigger mode and AED mode as a generator interface wa as a generator interface way to acquire Mode Description AED The detector detects X-ray exposure from the generator automatically and then performs The detector detects automatically and then performs image acquisition acquisition without any cable connection. enerator receive and send their signal to each other for image The detector and he detector and generator receive and send their signal to each other for acquisition. VIVIX interface cable. interface cable. VIVIX SCU and X-ray generator should be connected with enerator should be connected with the generator DR Trigger 3.4.1 AED (Auto Exposure Detection) Interface Mode AED (Auto Exposure Detection) Interface Mode If the VIVIX-S 1012N detector is used as generator to the detector with the detector with a generator interface cable. detector is used as the AED mode, you can acquire images without images without connecting the Cautions when using AED interface mode Cautions when using AED interface mode
Make sure to follow Make sure to follow the operating environmental condition (Temp:
(Temp: +10 ~ +35).
Do not give impact to the product. Do not give impact to the product. If it receives strong jolt, unwanted images may be If it receives strong jolt, unwanted images may be acquired without the X without the X-ray exposure because of the malfunction of the AED sensor. Rev.1.0
You may not acquire images You may not acquire images or horizontal artifacts may occur depending on environment such as exposure condition, thickness of object or environment such as exposure condition, thickness of object or the use of the use of grid. may occur depending on the external
When you set X When you set X-ray exposure area to the direction of the detector, the center of the ay 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 detector should be in ray exposure area. Otherwise, you may not acquire an image. Page 48 of 109 RA14-14B-011 3.4.2 DR Trigger Interface Mode DR Trigger Interface Mode VIVIX VIX-S 1012N User Manual Connect the detector and X-ray generator with a generator interface cable, and then ray generator with a generator interface cable, and then acquire images by ray generator with a generator interface cable, and then sending and receiving their signal signal. Signal Processing Steps EXP_REQ signal from the X-ray generator. completes to prepare image acquisition, it sends the EXP_OK EXP_OK signal to the X-ray The detector receives EXP_REQ 1 2 After the detector complete generator. The X-ray generator confirms The detector acquires image ray generator confirms EXP_OK signal and generates X-rays. images and then transmits the image data.
EXP_REQ is a sending signal from X is a sending signal from X-ray generator to the detector for requesting detector for requesting exposure.
EXP_OK is an exposure ready signal from the detector to X is an exposure ready signal from the detector to X-ray generator. ray generator. 3 4 Rev.1.0 Page 49 of 109 RA14-14B-011 VIVIX VIX-S 1012N User Manual 3.5 Configuring DR Trigger Interface Mode Configuring DR Trigger Interface Mode To configure the DR Trigger interface generator interface cable. Connect the one end of generator interface cable to and then connect the other end to the g then connect the other end to the generator. onnect the one end of generator interface cable to EXT_INF interface mode, VIVIX SCU and the generator should be connected with generator should be connected with a EXT_INF port of VIVIX SCU,
Up to three generators can be connected generators can be connected with VIVIX SCU Basic.
Only one generator generator can be connected with VIVIX SCU mini. 3.5.1 Trigger Interface Way The generator interface cable is connected differently depending on the Trigger interface ways. ed differently depending on the Trigger interface ways. The generator interface cable is Trigger Interface Description Description Handle andles exposure signal by exchanging packet. Handles exposure signal by exchanging electrical signal. signal. Handle Packet Trigger Line Trigger 3.5.2 Packet Trigger
Multipe detectors Multipe detectors share one generator signal together.
Connect a generator a generator interface cable to one of the pin groups.
The generator tramsmits and The generator tramsmits and receives signal with the one selected images. the one selected detector for taking Rev.1.0 Page 50 of 109 RA14-14B-011 VIVIX VIX-S 1012N User Manual
Each detector shares a signal ach detector shares a signal signal by being connected with generator generators separately.
Up to three X Up to three X-ray generators can be connected to SCU.
The connection connection of each detector and generator can be configured from ed from VIVIX Setup.
You should comprehend about a ou should comprehend about a detector and X-ray generator to make Otherwise, X-
-ray can be exposed to the detector in different location location. ray generator to make correct exposure.
The engineer who understand he engineer who understand the generator device and interface technology should be in generator device and interface technology should be in charge of interface work between VIVIX SCU and the generator. charge of interface 3.5.3 Line Trigger Rev.1.0 Page 51 of 109 RA14-14B-011 3.5.4 EXT_INF Port Pin Map VIVIX-S 1012N User Manual EXT_INF port is D-SUB 15 pin female connectors of VIVIX SCU, and used for the generator interface. EXT_INF1 port pin map definition (1 ~ 15) No. Signal name I/O Type Color Ch. Description EXP_REQ+_A EXP_REQ-_A Input Contact Red Input Contact Black EXP_REQ_TTL_A EXP_REQ_GND_A Input Input TTL TTL EXP_OK_POWER_A/B Input Orange Gray Yellow Green Brown Blue Pink
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A A A A Receives EXP_REQ Returns signal from EXP_REQ+_A Receives EXP_REQ Returns signal from EXP_REQ_TTL_A A/B Power of TTL signal A A B B
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B B Sends EXP_OK Returns signal from EXP_OK+_A Sends EXP_OK Returns signal from EXP_OK+_B Reserved for test only. Receives EXP_REQ Returns signal from EXP_REQ+_B
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Output Output Output Output
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Input Contact White Input Contact Purple EXP_OK+_A EXP_OK-_A EXP_OK+_B EXP_OK-_B Reserved EXP_REQ+_B EXP_REQ-_B EXP_REQ_TTL_B EXP_REQ_GND_B Reserved Input Input
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TTL TTL
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White/Red B Receives EXP_REQ White/Black B Returns signal from EXP_REQ_TTL_B
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Reserved for test only. EXT_INF2 port pin map definition (16 ~ 30) No. Signal name I/O Type Color Ch. Description EXP_REQ+_C EXP_REQ-_C Input Contact Red Input Contact Black EXP_REQ_TTL_C EXP_REQ_GND_C Input Input TTL TTL EXP_OK_POWER_C Input
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EXP_OK+_C EXP_OK-_C EXT_W+
Output -
Output -
Input Contact
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Orange Gray Yellow Green Brown C C C C C C C
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Receives EXP_REQ Returns signal from EXP_REQ+_C Receives EXP_REQ Returns signal from EXP_REQ_TTL_C Power of TTL signal Sends EXP_OK signal Returns signal from EXP_OK+_C User-defined Pin 1 Rev.1.0 Page 52 of 109 RA14-14B-011 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 VIVIX-S 1012N User Manual 24 25 26 27 28 29 30 EXT_W-
EXT_X+
EXT_X-
EXT_Y+
EXT_Y-
EXT_Z+
EXT_Z-
Input Contact Input Contact Input Contact Input Contact Input Contact Input Contact Input Contact
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Returns signal from EXT_W+
User-defined Pin 2 Returns signal from EXT_X+
User-defined Pin 3 Returns signal from EXT_Y User-defined Pin 4 Returns signal from EXT_Z+
Since VIVIX SCU mini has EXT_INF 1 port, only one generator can be connected with.
Up to three X-ray generators can be connected to EXT_INF1 and EXT_INF2 ports, and each generator should be connected with a same channel.
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
When you plan to add interface using a user-defined pin, contact to the person in charge of Vieworks. Rev.1.0 Page 53 of 109 RA14-14B-011 3.5.5 Input / Output Circuit Exposure Request Input Circuit (EXP_REQ) Exposure Respond Output Circuit (EXP_OK) VIVIX-S 1012N User Manual Rev.1.0 Page 54 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 4. Installation
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This section gives information about the installation process and method to use a detector. Battery Pack Product Installation Generator Connection Software Installation Windows Environment Setting Rev.1.0 Page 55 of 109 RA14-14B-011 VIVIX VIX-S 1012N User Manual 4.1 Battery Pack
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[TBD]
Detector and its attached devices should be and its attached devices should be installed by an authorized n authorized service engineer.
If you encounter any problems, consult If you encounter any problems, consult the sales representative in Vieworks engineer. in Vieworks or a relevant 4.1.1 How to insert a battery pack How to insert a battery pack 1 Open the battery cover. 2 3 Close the battery cover. Insert a battery into a slot until it clicks and push the battery into a slot until it clicks and push the lever to the right for fixing the battery fixing the battery.
Check if the Check if the battery is fully charged before using.
Make sure that the battery pack is securely Make sure that the battery pack is securely inserted.
The remaining battery can be checked from The remaining battery can be checked from the battery lamp on the side of detector from the VIVIX lamp on the side of detector or VIVIX Setup program. Rev.1.0 Page 56 of 109 RA14-14B-011 4.1.2 How to take out a battery pack a battery pack VIVIX VIX-S 1012N User Manual 1 Open the battery cover. 2 Push the lever to the left for taking out the battery. Push the lever to the left for taking out the battery. 3 Close the battery cover.
Make sure to turn off the detector by pressing and hold the power button for 3 seconds Make sure to turn off the detector by pressing and hold the power button for 3 seconds Make sure to turn off the detector by pressing and hold the power button for 3 seconds before detaching a battery pack. All status LED lamps are off and then before detaching a battery pack turned off. lamps are off and then the detector is Rev.1.0 Page 57 of 109 RA14-14B-011 4.1.3 How to charge a battery pack How to charge a battery pack VIVIX VIX-S 1012N User Manual The detector is battery-operated when it is connected wirelessly. C inserting it to the detector. operated when it is connected wirelessly. Charge the battery pack fully harge the battery pack fully before Charging type 1 Supply power to the charger with the power adapter before charging a battery turned to green, it means that the power is permitted. turned to green, it means that the power is permitted with the power adapter before charging a battery. When the power LED is When the power LED is 1 Open the cover at the lower side of charger. Open the cover at the lower side of charger. 2 Put the battery on the top of charger in Put the battery on the top of charger in the right direction. 3 Push the battery down until it is fixed in Push the battery down until it is fixed in the charging part. 4 Close the cover at the lower side of charger. ose the cover at the lower side of charger. Stimultaneous charging Charging time 2 battery packs
? hrs
? hrs Battery charger Tether interface cable 1 battery pack Rev.1.0 Page 58 of 109 RA14-14B-011 Charging type 2 VIVIX VIX-S 1012N User Manual Supply power to the charger with the power adapter before charging a battery turned to green, it means that the power is permitted. turned to green, it means that the power is permitted with the power adapter before charging a battery. When the power LED is When the power LED is 1 Open the cover at the lower side of charger. Open the cover at the lower side of charger. 2 Insert the battery into the slot until it clicks. Insert the battery into the slot until it clicks. 3 Close the cover at the lower side of charger. Close the cover at the lower side of charger.
The charging time can be The charging time can be different depending on temperature and battery. epending on temperature and charging status of a
While charging a battery pack, i While charging a battery pack, it is available to use the detector by connecting it with a t is available to use the detector by connecting it with a tether interface cable. tether interface cable
This detector is designed to make detector is designed to make a battery being discharged little by little off. Therefore, remove the battery pack when the detector is not battery being discharged little by little during the the detector is not used for detector is off some time. Otherwise, over discharge may occur resulting in the shortened battery life. some time. Otherwise, over discharge may occur resulting in the shortened b some time. Otherwise, over discharge may occur resulting in the shortened b
Do not use the charger around the paitent Do not use the charger around the paitent.
Charge the batter harge the battery with the charger provided by Vieworks.
Securely plug the power cord Securely plug the power cord of the charger into the AC outlet. If contact failure occurs, into the AC outlet. If contact failure occurs, or if dust/metal objects come into contact with the exposed metal prongs of the plug, fire or if dust/metal objects come into contact with the exposed metal prongs of the plug, fire or if dust/metal objects come into contact with the exposed metal prongs of the plug, fire or electric shock may result. or electric shock may result
Stop charging the battery when status LED of the charger turns to green as exceeding th Stop charging the battery when status LED of the charger turns to green as exceeding th Stop charging the battery when status LED of the charger turns to green as exceeding the specified charging time. Otherwise, the battery pack is overcharged and it causes smoke. specified charging time. Otherwise, the y pack is overcharged and it causes smoke. If the battery pack is overheating, it can be exploded and a fire may occur. If the battery pack is overheating, it can be exploded and a fire may occur. If the battery pack is overheating, it can be exploded and a fire may occur.
Use only a power adapter a power adapter complying with IEC 60601-1 or IEC 60950 1 or IEC 60950-1. Rev.1.0 Page 59 of 109 RA14-14B-011 4.2 Product Installation 4.2.1 Connecting Devices VIVIX VIX-S 1012N User Manual
Installation of this equipment should be made by licensed and authorized personnel Installation of this equipment should be made by licensed and authorized personnel by Installation of this equipment should be made by licensed and authorized personnel Vieworks.
This equipment must only be connected to the power with protective earth This equipment must only be connected to the power with protective earth. This equipment must only be connected to the power with protective earth SCU Basic If you use the DR Trigger of SCU, and the other to the X-ray generator. of SCU, and the other to the X DR Trigger mode, connect the one end of generator interface cable to the onnect the one end of generator interface cable to the EXT_INF port 1
If you use the AED mode, a generator interface cable is not needed as the detector If you use the AED mode, a generator interface cable is not needed as the detector If you use the AED mode, a generator interface cable is not needed as the detector operates by detecting X-ray automatically. operates by detecting X 2 Connect one end of the LAN LAN cable to one of the LAN ports of SCU, and the other to the LAN Card of SCU, and the other to the LAN Card Connector of workstation assigned for data transfer. Connector of workstation assigned for 3 Stand the antenna of SCU upright antenna of SCU upright. 4 To transmit image data using a Tether Interface, connect the one end of the Tether Interface cable to To transmit image data using a Tether Interface, connect the one end of the Tether To transmit image data using a Tether Interface, connect the one end of the Tether the Port 4 or Port 5 of SCU and the other to the detector. the Port 4 or Port 5 of SCU and the other to the detecto 5 Rev.1.0
If you use the wireless communication method, a tether interface cable is not needed as If you use the wireless communication method, a tether interface cable is not needed as If you use the wireless communication method, a tether interface cable is not needed as the image is transmitted wirelessly. image is transmitted wirelessly. To supply power, connect the AC power cable to the AC power input port of SCU port of SCU. To supply power, connect the Page 60 of 109 RA14-14B-011
1 2 | User Manual 2 | Users Manual | 2.41 MiB | December 02 2015 |
VIVIX VIX-S 1012N User Manual Mini SCU
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1 If you use the DR Trigger of SCU, and the other to the X-ray generator. of SCU, and the other to the X DR Trigger mode, connect the one end of generator interface cable to the onnect the one end of generator interface cable to the EXT_INF port
If you use the AED mode, a generator interface cable is not needed as the detector If you use the AED mode, a generator interface cable is not needed as the detector If you use the AED mode, a generator interface cable is not needed as the detector operates by detecting X-ray automatically. operates by detecting X 2 Connect one end of the LAN LAN cable to one of the LAN ports of SCU, and the other to the LAN Card of SCU, and the other to the LAN Card Connector of workstation assigned for data transfer. Connector of workstation assigned To transmit image data using a Tether Interface, connect the one end of the tether To transmit image data using a Tether Interfa the port of Mini SCU and the other to the detecto SCU and the other to the detector. ether interface cable to
If you use the wireless communication method, a tether interface cable is not needed as If you use the wireless communication method, a tether interface cable is not needed as If you use the wireless communication method, a tether interface cable is not needed as the image is transmitted wirelessly. image is transmitted wirelessly. To supply power, connect the DC power cable to the DC power input port of SCU port of SCU. To supply power, connect the 3 4 Rev.1.0 Page 61 of 109 RA14-14B-011 4.2.2 Booting up SCU VIVIX VIX-S 1012N User Manual Turn on the power switch 1 2 Check if the power switch of SCU 3 Check if the status indicator is blinking in green after the power switch of SCU is permitted. Check if the status indicator is blinking in green after the power switch of SCU is permitted. Check if the status indicator is blinking in green after the power switch of SCU is permitted. 4 Check if the status indicator of SCU is blinking in green Check if the status indicator of SCU is blinking in green and turns to light up in t 5 Check if the status indicator of SCU is blinking in green and Check if the status indicator of SCU is blinking in green and turns to light up in at the front side of SCU. switch of SCU lights up green. to light up in blue. turns to light up in the same color.
When the power switch lights up green, it means that the power is applied normally. When the power switch lights up green, it means that the power is applied normally. 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 When the status indicator is blinking in green, the SCU is booting g.
If the status indicator lights up green, it indicates indicator lights up green, it indicates that the SCU is being operated normally the SCU is being operated normally after booting up. after booting up.
If the status indicator lights up blue, SCU indicator lights up blue, SCUs preparation for communication is completed. s preparation for communication is completed. 4.2.3 Booting up the Detector etector
The procedures in this chapter are explained according to the The procedures in this chapter are explained according to the default detector (factory reset) and the use of
(factory reset) and the use of wireless connection. default setting status of a
Refer to <Product Initialization Refer to <Product Initialization!
information about the default setting status of a detector. information about the
.> for the detailed 1 Attach a charged battery pack to the detector. charged battery pack to the detector. 2 Press the power button of the detector for 1 second until the power 3 When the power LED is on, check if it 4 Check if the active LED is lit orange on en the power LED is on, check if it is lit green. is lit orange on the detector. Press the power button of the detector for 1 second until the power LED is turned on. is turned on.
If the power LED the power LED lights up green, the DC power is permitted normally. normally.
If the active LED LED lights up orange, the detector is compeleted to boot up norm detector is compeleted to boot up normally. Rev.1.0 Page 62 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 4.2.4 Checking Status LED of Detector
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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 Color When power is permitted Boot-up completed (AP ON) Boot-up completed (AP OFF) Ready for communication Sleep mode Data communication
(Send or Store) In process of wireless initialization Power Off On On On On Blinking On On Off Power lamp Active lamp Data lamp Green Orange Off Blue Off Blinking 5 times Blinking 5 times On On On On Blinking Off Off On On Blinking Off Off
If the LED blinks abnormally, refer to <Troubleshooting> to check if communication or system error is occurred. Rev.1.0 Page 63 of 109 RA14-14B-011 4.3 Software Installation VIVIX-S 1012N User Manual 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
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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
VXvue Operation Manual
XIPL User Manual VIVIX SDK
Software development kit for ViVIX-S detector only, provided by Vieworks.
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
VIVIX SDK Developer Manual 4.3.2 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 Page 64 of 109 RA14-14B-011 4.4 Windows Environment Setting VIVIX-S 1012N User Manual 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 1 Click Start Control Panel Network and Internet Network and Sharing Center Change Adapter Setting. 2 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 Page 65 of 109 RA14-14B-011 3 Click the chosen network adaptor with the right mouse button and click Properties to display the VIVIX-S 1012N User Manual Properties window. Setting Network Adaptor 1 Click Configure button to open the following dialog box, and then go to the Advanced tab. 2 Set Jumbo Packet to the maximum value. (Recommended value: 9014 Bytes) 3 Choose Performance Options in the list of Settings and click Properties button on the right. 4 Choose Flow Control in the list of Settings and select Rx & Tx Enabled on the Value list as shown below. Rev.1.0 Page 66 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 5 Choose Interrupt Moderation Rate in the list of Settings and select Extreme on the Value list as shown below. 6 Choose Receive Buffers and set it to the maximum value. 7 Click OK button. Deactivate Power-Saving Mode on Network Adaptor 1 Click the Power Management tab and uncheck Allow the computer to turn off this device to save power. 2 Click OK button. Rev.1.0
Viewer may not work normally if the power save mode is activated.
Deactivate the power save mode of all the installed network adaptors. Page 67 of 109 RA14-14B-011 VIVIX-S 1012N User Manual Protocol Selection and IP Address Setting 1 Choose Internet Protocol Version 4 (TCP/IPv4).and click Properties button. 2 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 Jumbo Packet Flow Control Interrupt Moderation Rate Receive Buffers Allow the computer to turn off this device to save power IP Address Subnet Mask Value Maximum or 9014 Bytes Rx & Tx Enabled Extreme Maximum Unchecked 169.254.0.(50 ~ 254) 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 Page 68 of 109 RA14-14B-011 4.4.2 Disabling Sleep Mode of Monitor VIVIX-S 1012N User Manual
If you use the sleep mode, viewer may not work normally. 1 Click Start Control Panel Power Options and then move to the Choose when to turn off the display tab. 2 Set Put the computer to sleep to Never to disable the sleep mode. 3 Click Save changes button. Rev.1.0 Page 69 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 5. Setting
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This section gives information about the product setting with using the Setup program. Start Setting VIVIX SCU Setting Detector Setting Rev.1.0 Page 70 of 109 RA14-14B-011 5.1 Start Setting 5.1.1 Setup Program VIVIX-S 1012N User Manual 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 Page 71 of 109 RA14-14B-011 5.2 SCU Setting VIVIX-S 1012N User Manual Rev.1.0 Page 72 of 109 RA14-14B-011 5.3 Detector Setting 5.3.1 Detector Configuration 5.3.2 Detector Power Save Function VIVIX-S 1012N User Manual Rev.1.0 Page 73 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 6. Calibration
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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 Page 74 of 109 RA14-14B-011 6.1 Calibration Dialogue VIVIX-S 1012N User Manual Rev.1.0 Page 75 of 109 RA14-14B-011 6.2 Detector Configuration VIVIX-S 1012N User Manual Rev.1.0 Page 76 of 109 RA14-14B-011 6.3 Calibration Guide VIVIX-S 1012N User Manual 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 Page 77 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 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 1 Prepare the calibration data CD provided with the detector. 2 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 Pre-Offset Post-Offset Gain Offset Defect Map Description Detector Offset data 1 Detector Offset data 2 Image sensitivity Offset data 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 Page 78 of 109 RA14-14B-011 6.5 Direct Calibration VIVIX-S 1012N User Manual Rev.1.0 Page 79 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 7. Diagnosis, Inspection and
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Maintenance 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 Page 80 of 109 RA14-14B-011 7.1 Diagnosis 7.1.1 Image Diagnosis VIVIX-S 1012N User Manual
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. 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.
7.1.2 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 Page 81 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 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 Page 82 of 109 RA14-14B-011 7.2 Product Inspection VIVIX-S 1012N User Manual
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 Description Self-Diagnosis Half-yearly Resolution Half-yearly Sensitivity Half-yearly
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 of the images made by X-ray dose amount reaching to the surface of the detector.
Updating calibration data. (Offset Gain Defect) Calibration Half-yearly
Proceed to calibrate when X-ray Generator, Tube, Collimator or exposure environment are changed.
Self-diagnosis and resolution can be conducted by a user or a service engineer.
Sensitivity and calibration should be conducted by an authorized service engineer who Vieworks grants. Rev.1.0 Page 83 of 109 RA14-14B-011 7.3 Cleaning and Disinfection VIVIX-S 1012N User Manual 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
Sulfasafe Storage temperature: 5C ~ 35C
How to Use Detergent Foam 1 Prepare the disinfectant detergent and a clean and dry non-woven cloth. 2 Use the spray bottle to spray detergent to the cloth and clean the equipment. 3 After it has been cleaned, leave the equipment un-used for 15 minutes. 4 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 Page 84 of 109 RA14-14B-011 7.4 Product Initialization VIVIX-S 1012N User Manual 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 1 Click Configuration button of SCU after running the VIVIX Setup program. 2 Click Factory Reset button in Configuration dialogue. 3 Wait for SCU to be initialized and rebooted automatically. 4 Check whether SCU initialization is completed. Default value of SCU initialization Item Network AP IP Address Subnet Mask Gateway AP On/Off Frequency Country Band Channel SSID Key Security GI (Guard Interval) Tx Power Test Mode Trigger On/Off Period Method Polarity Default Value Rev.1.0 Page 85 of 109 RA14-14B-011 7.4.2 Detector Initialization VIVIX-S 1012N User Manual 1 Click Configuration button of Detector after running the VIVIX Setup program. 2 Click Factory Reset button in Configuration dialogue. 3 Wait for Detector to be rebooted automatically. 4 Check whether detector initialization is completed. Default value of detector initialization Item Network IP Address Subnet Mask Gateway WNetwork AP SSID Key AP Scan 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 Default Value Rev.1.0 Page 86 of 109 RA14-14B-011 7.4.3 Wireless Initialization of Detector VIVIX-S 1012N User Manual Turn off the detector. 1 2 Press and hold the power button while installing a battery into the battery compartment of the detector.
Keep pressing the power button. 3 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. 4 5 Default value of wireless initialization Item IP Address Subnet Mask Gateway AP ON/OFF SSID Key Wireless Only Default Value
When processing the wireless initialization of a detector, only the detectors network information is initialized as a default value. Rev.1.0 Page 87 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 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 Model Type Specifications Littelfuse 218002 (2EA) Time Lag Cartridge Fuse Amp Rating Voltage Rating 2A 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 case of need.
-
Insert the fuse holder again. 1 2 3 Rev.1.0 Page 88 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 8. Troubleshooting
[TBD]
This section gives information about troubleshooting. Troubleshooting Rev.1.0 Page 89 of 109 RA14-14B-011 8.1 Trobleshooting VIVIX-S 1012N User Manual 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 <Warranty>. 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 1 Install battery pack 2 Charge battery pack 3 Check the result after getting rid of the battery pack and connecting the tether cable. 4 Replace other battery packs and check the result of it. 5 Replace other Detectors and check the result of it. 6 Replace corresponding devices. 8.1.2 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 Power cable is broken down. Errors in the fuse Internal circuit is broken down.
Rev.1.0 Page 90 of 109 RA14-14B-011 Solutions VIVIX-S 1012N User Manual Turn off the power switch and turn on again and then check the fan or status of back side. 1 Check the connection between AC power cable and basic SCU. 2 Check the connection between DC power cable and mini SCU. 3 4 Replace another SCU and check the result of it 5 Replace the fuse of standard SCU. (refer to Change fuse of SCU) 6 Replace corresponding devices. 8.1.3 Communication Test is failed Symptom
Transmission error is occurred, failure of communication test is occurred. Expected Causes
Network connection problem
Network setting problem
Wireless environment environment problem
PC environment setting problem Devices failure Solutions 1 Check the connection of network cable between Workstation and SCU. 2 Check if the accurate network cable is used or not. (CAT 5E or 6) 3 Set the network information of Workstation, SCU and detector again. 4 Check whole workstation environment again such as firewall setting and release the power save mode. 5 Check surrounding wireless communication environment. 6 Boot up detector and SCU again by processing initialization. (Refer to <!
. ! .>.) 7 Replace other SCU and Detectors and check the result of it 8 Replace corresponding devices. 8.1.4 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 Turn on SCU again 1 2 Check the network cable connection 3 Check the workstation environment and network information again Rev.1.0 Page 91 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 4 Check if the surrounding wireless communication is good 5 Check cable connection again when connected with tether interface cabel 6 Replace other devices and check the result of it 7 Replace corresponding devices. 8.1.5 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 1 Boot up the detector again and check the result of it 2 Replace the detector. 8.1.6 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 1 Replace to new battery pack if the battery pack has been used for a long time. (Battery pack is consumables) 2 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 1 Do not use battery pack Rev.1.0 Page 92 of 109 RA14-14B-011 2 Consult with service engineers of Vieworks. VIVIX-S 1012N User Manual Rev.1.0 Page 93 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 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 Page 94 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 9.1 Medical Equipment Safety Standards 9.1.1 Medical Equipment Classification Item Description Type of protection against electrical shock Class 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 Flammable anesthetics 9.1.2 Product Safety Standard South Korea NOT suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
, : IEC 60601-1 2009-137 .
: IEC 60601-1-2 .
(EMI)
(EMS) 2009-54 1 A 1 5.1 2009-54 1 () 2009-54 1 A 1 5.2 2009-54 1 ()
(ESD) 2009-54 2 36.202/36.202.2/ KN61000-4-2 RF 2009-54 2 36.202/36.202.3/ KN61000-4-3
(EFT) 2009-54 2 36.202/36.202.4/ KN61000-4-4
(Surge) 2009-54 2 36.202/36.202.5/KN61000-4-5 RF 2009-54 2 36.202/36.202.6/ KN61000-4-6 2009-54 2 36.202/36.202.8/ KN61000-4-8
, 2009-54 2 36.202/36.202.7/KN61000-4-11 IEC 60601-1:2007(ed.3) 10.2.2 power supply 2009-54 2 36.202.14 Rev.1.0 Page 95 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 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) Medical electrical equipment Part 1: General requirements for safety
(adopted amendment 2:1995 to IEC60601-1) IEC 60601-1-2: 2007 (ed.3) IEC 60601-1-4: 2000 (ed.1.1) IEC 62304:2006 ISO 14971:2012 European Union Item Medical electrical equipment-Part 1-2: Collateral standard:
Electromagnetic compatibility Medical electrical equipment- Part 1-4: Collateral Standard:
Programmable electrical medical systems Medical device software-software life cycle processes Medical Device- Application of risk management to medical devices MDD (Medical Device Directive) 93/42/EEC as amended by 2007/47/EC EN ISO 13485:2012 Medical devices Quality Management systems Requirements for regulatory purposes EN 60601-1: 2007(ed.3) Medical electrical equipment- Part1: General requirements for safety IEC 60601-1-2: 2007(ed.3) IEC 60601-1-4: 2000(ed.1.1) IEC 62304:2006 ISO 14971: 2012 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 Medical device software-Software life cycle processes Medical device Application of risk management to medical devices. Rev.1.0 Page 96 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 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 South Korea
[TBD]
Clause 3, Article 58-2 of Radio Waves Act
Clause 2, Article 58-2 of Radio Waves Act Japan
Article 2-1-19, 2-1-19-3, 2-1-19-3-2 of the Radio law (MIC) 9.2.1 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 users 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 Page 97 of 109 RA14-14B-011 9.3 Labels and Symbols VIVIX-S 1012N User Manual 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
[TBD]
Battery
[TBD]
Rev.1.0 Page 98 of 109 RA14-14B-011 VIVIX-S 1012N User Manual VIVIX SCU (VIVIX System Control Unit)
[TBD]
Battery Charger
[TBD]
Rev.1.0 Page 99 of 109 RA14-14B-011 Outer Box
[TBD]
9.3.2 Product Serial Number Serial Number Composition VIVIX-S 1012N User Manual The serial numbers for each product or accessory are composed as follows. 1 0 Revision
-
-
R 1 D A B J 0 0 1 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 AA 12 AB 13 AC 14 AD 15 AE 16 AF 17 AG 18 AH 19 AI 20 BJ Initial Per Month 1 A 2 B 3 C 4 D 5 E 6 F 7 U 8 V 9 W 10 X 11 Y 12 Z Composition of Serial Number for Each Item
[TBD]
Composition Serial Number Detector Detector Battery Charger VIVIX SCU 10-V5D??
10-V6D??
10-V5C??
10-V5S??
Model 1012NA 1012NB FXRC-02A FXRS-04A Rev.1.0 Page 100 of 109 RA14-14B-011 9.3.3 Product Symbols Symbol Description Direct current Alternating current Protective earth (Ground) VIVIX-S 1012N User Manual 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 Page 101 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 9.4 Guidance and Manufacturers 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 Compliance Electromagnetic Environment RF Emissions
(CISPR 11) RF Emissions
(CISPR 11) Harmonic emissions
(IEC 61000-3-2) Voltage fluctuations/
Flicker emissions
(IEC 61000-3-3) Group 1 Class B Class A Complies The EUT uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. 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. Rev.1.0 Page 102 of 109 RA14-14B-011 9.4.2 Electromagnetic Immunity VIVIX-S 1012N User Manual 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
Contact 6
Air 8
Contact 6
Air 8 Electromagnetic Environment -
Guidance
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 IEC 60601 test condition
Input / output lines
Power supply lines 2 Compliance Level Electromagnetic Environment -
Guidance Surge IEC 61000-4-5 Item Immunity test
1
Power supply lines 2
Input / output lines 1
Main power quality should be that of a typical commercial or hospital environment. Description
Surge IEC 61000-4-5
Differential mode 1 IEC 60601 test condition
Common mode Compliance Level Electromagnetic Environment -
Guidance
2
Differential mode 1
Common mode 2
Main power quality should be that of a typical commercial or hospital environment. Rev.1.0 Page 103 of 109 RA14-14B-011 VIVIX-S 1012N User Manual Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Input Lines IEC 61000-4-11 Item Immunity test IEC 60601 test condition Compliance Level Description
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
<5% U (>95% dip in U) for 0.5 cycle.
40% U (60% dip in U) for 5 cycles.
70% U (30% dip in U) for 25 cycles.
<5% U (<95% dip in U) for 5 sec.
<5% U (>95% dip in U) for 0.5 cycle.
40% U (60% dip in U) for 5 cycles.
70% U (30% dip in U) for 25 cycles.
<5% U (<95% dip in U) for 5 sec. Electromagnetic Environment -
Guidance
Main power quality should be that of a typical commercial or hospital environment.
If the user of the EUT image intensifier requires continued operation during power mains interruptions, it is recommended that the EUT image intensifier be powered from an uninterruptible power supply or a battery. U 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 Compliance Level
3 A/m
3 A/m Electromagnetic Environment -
Guidance
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Rev.1.0 Page 104 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 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 Electromagnetic Environment - Guidance
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.
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 Page 105 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 10. Information This section gives overview information for service and warranty of the product. Service Information Warranty Revision History Rev.1.0 Page 106 of 109 RA14-14B-011 10.1 Service Information 10.1.1 Product Lifetime VIVIX-S 1012N User Manual 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:
Serial number:
Explanation of problem: Describe as detailed as possible. FXRD-1012NAW / FXRD-1012NBW 12 digit-number on the product label 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.
Battery pack: FXRB-03A Rev.1.0 Page 107 of 109 RA14-14B-011 10.2 Warranty VIVIX-S 1012N User Manual 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 Page 108 of 109 RA14-14B-011 VIVIX-S 1012N User Manual 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 Page 109 of 109 RA14-14B-011
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2015-02-12 | 5190 ~ 5230 | NII - Unlicensed National Information Infrastructure TX | Original Equipment |
2 | 5745 ~ 5825 | DTS - Digital Transmission System |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2015-02-12
|
||||
1 2 | Applicant's complete, legal business name |
Vieworks Co., Ltd.
|
||||
1 2 | FCC Registration Number (FRN) |
0021983614
|
||||
1 2 | Physical Address |
41-3, Burim-ro170beon-gil, Dongan-gu
|
||||
1 2 |
Anyang-si, N/A 14055
|
|||||
1 2 |
South Korea
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
t******@timcoengr.com
|
||||
1 2 |
T******@TIMCOENGR.COM
|
|||||
1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 2 | Grantee Code |
PFR
|
||||
1 2 | Equipment Product Code |
FXRS-04A
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
J****** K******
|
||||
1 2 | Title |
Assistant Manager
|
||||
1 2 | Telephone Number |
+82-7********
|
||||
1 2 | Fax Number |
+82-3********
|
||||
1 2 |
t******@vieworks.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | NII - Unlicensed National Information Infrastructure TX | ||||
1 2 | DTS - Digital Transmission System | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | System Control Unit | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | Yes | ||||
1 2 | Grant Comments | Power listed is maximum combined output power conducted. When transmitting in the 5.15-5.25 GHz band, this device is restricted to indoor use only. Device operates with specific antennas in MIMO configurations as described in this filing. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20cm from all persons and must not transmit simultaneously with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. Users and installers must be provided with antenna installation instructions and transmitter operating conditions for satisfying RF exposure compliance. This device has 20 MHz and 40 MHz bandwidth modes. | ||||
1 2 | Power listed is maximum combined output power conducted. Device operates with specific antennas in MIMO configurations as described in this filing. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20cm from all persons and must not transmit simultaneously with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. Users and installers must be provided with antenna installation instructions and transmitter operating conditions for satisfying RF exposure compliance. This device has 20 MHz and 40 MHz bandwidth modes. | |||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
KES Co., Ltd
|
||||
1 2 | Name |
I****** R********
|
||||
1 2 | Telephone Number |
82-31********
|
||||
1 2 | Fax Number |
82-31********
|
||||
1 2 |
k******@kes.co.kr
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15E | 39 CC MO | 5180 | 5240 | 0.0211 | |||||||||||||||||||||||||||||||||||
1 | 2 | 15E | 39 CC MO | 5190 | 5230 | 0.0234 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC MO | 2412 | 2462 | 0.177 | |||||||||||||||||||||||||||||||||||
2 | 2 | 15C | CC MO | 5745 | 5825 | 0.306 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC