United Imaging Healthcare MARS1717XU User Manual

E
Wireless Digital Flat Panel Detector
Mars1717XU-VSI
User Manual
Before operating, please read this user manual and pay attention to all safety precautions. Please ensure that this user's manual is properly maintained so that it can be accessed at any time
( reserve ). Please use it correctly on the basis of full understanding of the content.
To Customers
Service Office
Tel: +86 21 50720560
Fax: +86 21 50720561
E-mail: service@iraychina.com
Location: 2F, Building 9, No.590, Ruiqing Rd, Pudong, Shanghai,
Congratulations on your purchase of the Mars1717XU-VSI Wireless Digital Flat Panel detector (hereinafter referred to as Mars1717XU) which is manufactured by iRay Technology Co.Ltd. (Hereinafter referred to as iRay).
Please take time to read through this user guide in order to utilize the product effectively. We hope you enjoy the experience with iRay Mars1717XU.
If you have any questions or suggestions, please feel free to contact us.
Notes on usage and management of the equipment
1. Read all of the instructions in the user guide before your operation. Give particular attention to all safety precautions.
2. Only a physician or a legally certified operator should use this product.
3. The equipment should be maintained in a safe and operable condition by maintenance personnel.
4. Use only computers and image display monitors complying with IEC 60601-1 or IEC 60950-1. For details, consult our sales representative or local iRay dealer.
5. Use only the dedicated cables. Do not use any cables other than those supplied with this product.
6. The equipment should not be used in inflammable gas or corrosive gas environment.
7. Give particular attention to avoiding liquid or conductive materials invading into inside of the equipment in order to prevent the equipment from short circuit.
8. House of the equipment forbids opening by unauthorized personnel.
9. Request your sales representative or local iRay dealer to install this product
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Mars1717XU Wireless Digital Flat Panel Detector User Manual
Caring for your environment
This symbol indicates that this product is not to be disposed of with your residential or commercial waste.
Recycling iRay Equipment
Please do not dispose of this product with your residential or commercial waste. Improper handling of this type of waste could have a negative impact on health and on the environment. Some countries or regions, such as the European Union, have set up systems to collect and recycle electrical or electronic waste items. Contact your local authorities for information about practices established in your region. If collection systems are not available, call iRay Customer Service for assistance.
Disclaimer
1. iRay shall not be liable to the purchaser of this product or third parties for any damage, losse, or injury incurred by purchaser or third parties as a result of fire, earthquake, any accident, misuse or abuse of this product.
2. iRay shall not be liable to any damage, loss, or injury arising from
3. iRay shall not be liable for any damage or loss arising from the use of
4. It is the responsibilities of the user/attending physicians for maintaining
5. Information regarding specification, compositions, and appearance of
Copyright
All rights reserved No part of this publication may be reproduced in any form or by any means
without the written permission of iRay. The information contained herein is designed only for use with iRay Mars1717XU.
unauthorized modifications, repairs, or alterations to this product or failure to strictly comply with iRays operating and maintenance instructions.
any options or consumable products other than those dedicated as Original iRay Products by iRay Technology.
the privacy of image data and providing medical care services. iRay shall not be responsible for the legality of image processing , reading and storage nor it shall be responsible for loss of image data for any reason.
this product is subject to change without prior notice.
Trademarks
The iRay name and iRay logo are registered trademarks of iRay Technology Co.Ltd.
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Symbols and Conventions
This symbol is used to identify conditions under which improper use of the product may cause death or serious personal injury.
This notice is used to identify conditions under which improper use of the product may cause minor personal injury.
This notice is used to identify conditions under which improper use of the product may cause property damage.
This is used to indicate a prohibited operation.
This is used to indicate an action that must be performed.
This is used to indicate important operations and restrictions.
This is used to indicate operations for reference and complementary information.
The following symbols and conventions are used throughout the user guide.
To Customers
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Mars1717XU Wireless Digital Flat Panel Detector User Manual
Symbol
Indication
This symbol is used to identify the manufactuer's series number which is after, below or adjacent to the symbol. The series number of iRay products is usually made of thirteen digits as shown below:
This symbol is used to indicate the name and address of the manufacturer,.the date of manufacture can be combined in this symbol.
This symbol is used to indicate consultation of the user guide for general information.
Safety Signs: please refer to the user guide for safety instructions.
This symbol is used to indicate detector is allowed to withstand 100 kg on the surface.
Caution: please refer to the instructions in the user manual.
This symbol is used to indicate the operational temperature limits.
This symbol is used to indicate non-ionizing radiation.
Numerical Order
Year
Date
Month
Version
Product Code
A1A2A3A4 C1C2 M DD Y XXX
Labels and markings on the equipment
The contents of the labels and markings on iRay Mars1717XU product are indicated below:
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To Customers
This symbol is used to indicate when end-user plans to discard this product, this product should be sent to the appropriate facilities for recovery and recycling.
IPX4
This symbol is used to indicate the degrees of protection provided by enclosures.
This symbol is used to indicate B type applied part.
Handled with care.
Caution: refer to appending files for important information about safety, such as warnings and matters needing attention which is not suitable to be shown on the instrument for various reasons.
Package symbol, fragile, handle with care.
Package symbol, keep away from sunlight.
Package symbol, keep dry.
Package symbol on the the detector packing-case: storage temperature limits
Package symbol, this symbol is used to indicate the humidity limits.
Package symbol, keep the equipment up right.
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Mars1717XU Wireless Digital Flat Panel Detector User Manual
Package symbol, do not roll the transportation package.
Package symbol, this symbol is used to indicate stacking limit number.
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Catalogue
Contents
CONTENTS ....................................................................................................................... 7
1. SAFETY INFORMATION ............................................................................................ 9
1.1 Safety precautions ........................................................................... 10
1.2 Notes for Using ................................................................................ 14
2. GENERAL DESCRIPTION ........................................................................................... 16
2.1 Scope ............................................................................................... 17
2.2 Characteristic ................................................................................... 17
2.3 Intended use .................................................................................... 18
2.4 Standard Product Components ....................................................... 18
2.5 Components Description.................................................................. 19
2.6 Product Specification ....................................................................... 20
3. INSTALLATION ............................................................................................................ 24
3.1 Detector Installation ......................................................................... 25
3.2 Software Installation ......................................................................... 27
3.3 Detector Configuration ..................................................................... 27
4. OPERATION ................................................................................................................. 38
4.1 Main Operation ................................................................................. 39
4.2 Block diagram ................................................................................... 39
4.3 Work Flow ......................................................................................... 40
4.4 Description of workflow ..................................................................... 40
5. REGULATORY INFORMATION .................................................................................. 42
5.1 Registrant Information ....................................................................... 43
5.2 Manufacturer Information .................................................................. 43
5.3 Medical equipment safety standards ................................................ 43
5.4 References harmonized standards under Directive 93/42/EEC ....... 44
5.5 The compliance for each EMISSIONS and IMMUNITY standard or
test specified by IEC60601-1-2 standard ................................................ 45
5.6 Lithium-ion Capacitor Reference Standards ..................................... 47
5.7 Product Label .................................................................................... 48
5.8 Radio Frequency Compliance Information ....................................... 48
5.9 INFORMATION TO USER. ............................................................... 49
6. SOFTWARE OPERATION INFORMATION ................................................................ 51
6.1 Default Settings ................................................................................ 52
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Mars1717XU Wireless Digital Flat Panel Detector User Manual
7. TROUBLE SHOOTING ................................................................................................. 55
8. SERVICE INFORMATION ............................................................................................ 56
8.1 Product lifetime ................................................................................ 57
8.2 Regular inspection and Maintenance ............................................... 57
8.3 Repair ............................................................................................... 58
8.4 Replacement parts support .............................................................. 58
APPENDIX ........................................................................................................................ 59
Appendix A Information of Manufactures ................................................ 60
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1. Safety Information
1.1 Safety precautions ........................................................................... 10
1.2 Notes for Using ................................................................................ 14
1. Safety Information
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Mars1717XU Wireless Digital Flat Panel Detector User Manual
WARNING
Installation and environment of use
Do not use or store the equipment near flammable
chemicals such as alcohol, thinner, benzene, etc.
If chemicals are spilled or evaporate, it may result in fire or electric shock through contact with electric parts inside the equipment. Also, some disinfectants are flammable. Be sure to take care when using them.
Do not connect the equipment with anything other than
specified.
Doing so may result in fire or electric shock.
All the patients with active implantable medical
devices should be kept away from the equipment.
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 fire or electric shock.
Do not handle the equipment with wet hands.
You may experience electric shock that could result in death or serious injury.
Do not place heavy object such as medical equipment
on cables and cords. Do not pull, bend, bundle, or step on them to prevent their sheath from being damaged, and do not alter them neither.
Doing so may damage the cords which could result in fire or electric shock.
Do not supply power to more than one piece of
equipment using the same AC outlet.
Doing so may result in fire or electric shock.
Do not turn ON the system power when condensation
has formed on the equipment.
Doing so may result in fire or electric shock.
Do not connect a multiple portable socket-outlet or
extension cord to the system.
Doing so may result in fire or electric shock.
To avoid the risk of electric shock, this equipment
must only be connected to power supply with protective earth.
Not doing so may result in fire or electric shock.
Securely plug the power cord into the AC outlet.
If contact failure occurs, or if 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 fire or electric shock.
1.1 Safety precautions
Follow these safeguards and properly use the equipment to prevent injury and damage to any equipment/data.
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1. Safety Information
WARNING
Handling
Never disassemble or modify the equipment. No
modification of this equipment is allowed. Parts of the Mars1717XU that are not serviced or maintained while in use with the patient.
Doing so may result in fire or electric shock. Also, since the equipment incorporates parts that may cause electric shock as well as other hazardous parts, touching them may cause death or serious injury.
Do not place anything on top 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 fire or electric shock.
Do not hit or drop the equipment.
The equipment may be damaged if it receives a strong jolt, which may result in fire or electric shock if the equipment is used without being repaired.
Do not put the equipment and pointed objects
together.
The equipment may be damaged. If so, the equipment should be used in bucky.
Have the patient take a fixed posture and do not let the
patient touch parts unnecessarily.
If the patient touches connectors or switches, it may result in electric shock or malfunction of the equipment.
When a problem occurs
Should any of the following occurs, immediately
unplug the power cord of Control Box, and contact your sales representative or local iRay dealer:
When there is smoke, an odd smell or abnormal sound. When liquid has been spilled into the equipment or a metal
object has entered through an opening. When the equipment has been dropped and damaged.
Maintenance and inspection
Please turn OFF the power of the equipment and
unplug the power cord of adaptor before cleaning.
NEVER use alcohol, ether and other flammable
cleaning agent for safety. NEVER use methanol, benzene, acid and base because they will erode the equipment.
DON'T dip the equipment into the liquid. Please make sure that the equipment's surface & plugs
are dry before turning ON.
Otherwise, it may result in 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; this could cause insulation failure that may result in a fire.
For safety reasons, be sure to turn OFF the power to
each piece of equipment when performing inspections indicated in this manual.
Otherwise, electric shocks may occur.
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Mars1717XU Wireless Digital Flat Panel Detector User Manual
CAUTION
Installation and environment of use
Do not install the equipment in any of the locations
listed below. Doing so may result in failure, malfunction, 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 Close to heat source 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 high Where there is freezing or condensation In areas prone to vibration On an incline or in an unstable area
Take care that cables do not become tangled during
use. Also, be careful not to get your feet caught by cable.
Otherwise, it may cause a malfunction of the equipment or injury of the user due to tripping over the cable.
Power supply
Always connect the three-core power cord plug to a
grounded AC power outlet.
To make it easy to disconnect the plug at any time,
avoid putting any obstacles near the outlet. Otherwise, it may not be possible to disconnect the plug in an emergency.
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 equipment.
Otherwise, fire or electric shock may be caused due to leakage.
Handling
Do not spill liquid or chemicals onto the equipment. In
case the patient is injured, it is not allowed to contact with blood or other body fluids.
Doing so may result in fire or electric shock. In such a situation, protect the equipment with a disposable
cover as necessary.
Turn OFF the power and pull out the plug to each piece
of equipment for safety when not used.
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CAUTION
Handling
Handle the equipment carefully. Do not submerge the equipment in water. The internal image sensor may be damaged if
something hits against it or it is dropped.
Do not place excessive weight on the equipment.
Otherwise, the internal image sensor may be damaged and image collection may be malfunction.
Be sure to use the equipment 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. Otherwise, the detector may flip over, resulting in injury to the user or patient as well as damage of the inner device.
Keep the same load (same pressure) on the detector when acquiring the image. Or the image will be incorrect.
CAUTION
<Load Limit> Uniform load135 kg over the whole area of the detector surface.
Local load100 kg on an area 4 cm diameter.
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1. Safety Information
Mars1717XU Wireless Digital Flat Panel Detector User Manual
Do not close to fire, do not use in high temperature Do not invert positive and negative pole Do not contact with metal in case of short circuit Do not insert sharp objects into the Lithium-ion
capacitor
Do not beat the Lithium-ion capacitor Do not squeeze the Lithium-ion capacitor Do not use the Lithium-ion capacitor out of rules Do not change internal structure of the Lithium-ion
capacitor
Do not submerge the Lithium-ion capacitor in
water, please keep dry in storage and do not contact with water in use
Please charge the Lithium-ion capacitor with
charger following IEC60601-1 Standards provide by us
Do not mix the Lithium-ion capacitor with ones not
provided by iRay
Do not charge the Lithium-ion capacitor already
damaged
Adverse events may be caused by the product
Due to operation or corresponding device malfunction, no valuable clinical image is acquired after exposure accomplished.
Due to disturbance from a device which does not complied with IEC60601-1-2 standard , functions of the product are abnormal, which results in no valuable clinical image is acquired after exposure accomplished
The product is intended to be used with registered
X-ray instruments. Please refer to this manual for installment and software operation part of the product.
For the rest part of operation, please refer to the
operation manual of the applied X-ray instrument.
Means for monitoring, evaluation, and control The product status indication is referred in
Product installation, connection part of this manual. If the indication is not correct, please do not use.
The measuring function must be re-calibrated after
exchanging or re-installation of FPD.
The measuring function should be calibrated every
half year if the product structure is not disassembled.
1.2 Notes for Using
When using the equipment, take the following precautions. Otherwise, problems may occur and the equipment may not function correctly.
Before exposure
Be sure to check the equipment daily and confirm that it works properly.
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1. Safety Information
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 on 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 a difference of temperature in the room and equipment does not occur, to prevent condensation.
The detector should warm up for 30 minutes before exposure or updating
the gain map or defect map.
During exposure
Do not move the power or Ethernet Cables during exposure, or it may
cause image noise or artifacts, even incorrect images.
Do not use the devices near the equipment generating a strong magnetic
field. Otherwise, it may cause image noise, artifacts or even incorrect images.
After exposure
Recommend to shut down the detectors power for storage when no use.
Disinfection and Cleaning
After every examination, wipe the patient contact surfaces of the detector
using disinfectants such as ethanol, to prevent the risk of infection. For details on how to sterilize, consult a specialist.
Do not spray the detector directly with disinfectants or detergents.  Wipe it with a cloth slightly damped with a neutral detergent. Do not use
solvents such as alcohol, thinner, benzene, acid and base. Doing so may damage the surface of the equipment.
It's recommended to use a waterproof non-woven cover as the isolated
layer between detector and the blooding patient.
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2. General Description
2.1 Scope ............................................................................................... 17
2.2 Characteristic ................................................................................... 17
2.3 Intended use..................................................................................... 18
2.4 Standard Product Components ........................................................ 18
2.5 Components Description .................................................................. 19
2. General Description
2.5.1 Detector .................................................................................. 19
2.5.2 Power Supply ......................................................................... 20
2.6 Product Specification ....................................................................... 20
2.6.1 Detector .................................................................................. 20
2.6.1.1 Basic ................................................................................... 20
2.6.1.2 MTF .................................................................................... 21
2.6.1.3 DQE .................................................................................... 21
2.6.2 Power supply ......................................................................... 21
2.6.3 AP Router (Optional) ............................................................. 22
2.6.4 Wireless Communication ...................................................... 22
2.6.5 Recommended Appliance Condition ..................................... 23
2.6.6 Use Environment ................................................................... 23
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Mars1717XU Wireless Digital Flat Panel Detector User Manual
Mars1717XU is a cassette-size wireless X-ray flat panel detector based on amorphous silicon thin-film transistor technologies. It is developed to provide the highest quality of radiographic image, which contains an active matrix of
3072×3072 with 139um pixel pitch. Detectors’ scintillator is CsI(Caesium
Iodide). The greatest improvement is Mars1717XU supports wireless communication between detectors and PC, and employs Lithium-ion capacitor, which makes Mars1717XU a real portable panel.
2.1 Scope
This manual contains information about the iRay Mars1717XU. All operators must read and understand this manual before using equipment. All information in this manual, including the illustrations, is based on equipment prototype. If configuration of your equipment does not have any of these items, information about these items in the manual does not apply to your equipment.
2.2 Characteristic
Mars
VSI- CsI scintillator screen Product ApplicationXU, cassette size detector Product dimension171717inch×17inch Product serialswireless digital flat panel detector
serials
Wireless static Flat Panel Detector used for general radiography.  17 × 17 inch
Built-in non-detachable Lithium-ion capacitor
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