Wireless Digital Flat Panel Detector
Mars1717V
User Manual
Document Version: A0
Document ID: 092-201-02
Release Date: 2019.05.27
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
At iRay, we strive to not only make the world-class products that deliver the best
value possible to our customers but also offer the highest quality of service and
customer care. Please take time to read through this user guide in order to utilize
Congratulations on your purchase of the Fixed Digital Flat Panel (hereinafter
referred to as Mars1717V) which is manufactured by iRay Technology Co.Ltd.
(Hereinafter referred to as iRay).
the product effectively. We hope you enjoy the experience with iRay Mars1717V
( configuration: Mars1717V3 ) .
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. Request your sales representative or local iRay dealer to install this product
。
iRay Technology Co. Ltd. 1
Mars1717V Digital Flat Panel Detector User Manual
This symbol indicates that this product is not to be disposed of with your
residential or commercial waste.
Caring for your environment
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
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.
iRay shall not be liable to any damage, loss, or injury arising from unauthorized
modifications, repairs, or alterations to this product or failure to strictly comply with
iRay’s operating and maintenance instructions.
iRay shall not be liable for any damage or loss arising from the use of any options
or consumable products other than those dedicated as Original iRay Products by
iRay Technology.
It is the responsibilities of the user/attending physicians for maintaining 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.
Information regarding specification, compositions, and appearance of this product
is subject to change without prior notice.
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 Mars1717V (configuration: Mars1717V3)
Trademarks
。
The iRay name and iRay logo are registered trademarks of iRay Technology
Co.Ltd.
iRay Technology Co. Ltd. 2
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
iRay Technology Co. Ltd. 3
Mars1717V Digital Flat Panel Detector User Manual
Caution: please refer to the instructions in the user manual.
This symbol is used to indicate that the equipment has passed
CE testing and it is followed by the CE number.
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.
This symbol is used to indicate the name and address of iRay
authorized representative in the European region.
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.
Safety Signs: Dangerous Voltage.
Labels and markings on the equipment
The contents of the labels and markings on iRay Mar1717V product are indicated below:
4 iRay Technology Co. Ltd..
To Customers
This symbol is used to indicate the operational temperature
limits.
This symbol is used to indicate the storage temperature limits.
Package symbol, keep away from sunlight.
Package symbol, keep dry.
Package symbol, this symbol is used to indicate the humidity
limits.
Package symbol, keep the equipment up right.
Package symbol, do not roll the transportation package.
Package symbol, this symbol is used to indicate stacking limit
number.
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Mars1717V Digital Flat Panel Detector User Manual
C o n t e n t s
TO CUSTOMERS
CONTENTS
1. SAFETY
1.1 Safety precautions
1.2 Notes for Using................................................................................................................................14
2. GENERAL DESCRIPTION
2.1 Scope................................................................................................................................................. 16
2.2 Model..................................................................................................................................................16
2.3 Characteristic
2.4 INTENDED USE...............................................................................................................................17
2.5 ESSENTIAL PERFORMANCE...................................................................................................... 17
2.6 Application specification
2.7 The relative position between patient and detector.................................................................... 18
2.8 Product Components....................................................................................................................... 19
2.9 Components Description and Specification
3. INSTALLATION................................................................................................................................... 34
3.1 Panel Installation
3.2 Battery Charger Installation
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17
17
22
35
40
1
6
8
9
4. SOFTWARE SETUP
4.1 System requirement
4.2 Environment setup......................................................................................................................... 42
4.3 Connetion Mode............................................................................................................................. 42
4.4 Wired Connection Setup (Service Only)
4.5 Wireless AP Mode Connection.................................................................................................... 44
4.6 Wireless Client Mode Conneciton............................................................................................... 54
4.7 iDetector software
4.8 List of the HAZARDOUS SITUATIONS resulting from a failure of the IT-NETWORK....... 67
5. OPERATION
5.1 Main Operation
5.2 Correction and Calibration Template Generation....................................................................... 79
5.3 Local Image Check
5.4 Firmware Upgrade
6. REGULATORY INFORMATION
6.1 Medical equipment safety standards
6.2 Guidance and manufacture’s declaration for EMC..................................................................90
6.3 Radio Frequency Compliance Information...................................................................................93
6.4 Battery Safety Standards
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41
42
43
62
68
69
83
85
87
88
94
7. TROUBLE SHOOTING....................................................................................................................... 96
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To Customers
8. SERVICE INFORMATION
8.1 Service Office Info
..................................................................................................................
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8.2 Product Lifetime................................................................................................................................98
8.3 Regular Inspection and Maintenance
8.4 Repair
.................................................................................................................................................
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8.5 Replacement Parts Support ........................................................................................................... 98
APPENDIX
..............................................................................................................................................
Appendix A Information of Manufactures..........................................................................................101
Appendix B Information of Medical Device Directive European Representative........................101
97
98
98
98
100
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Mars1717V Digital Flat Panel Detector User Manual
1. Safety
1.1 Safety precautions
1.2 Notes for Using................................................................................................................................14
..............................................................................................................................
9
8 iRay Technology Co. Ltd.
1. Safety
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.
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,
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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Mars1717V Digital Flat Panel Detector User Manual
resulting in fire or electric shock.
Never disassemble or modify the equipment. No
modification of this equipment is allowed. Parts of the
Mar1717V
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.
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.
10 iRay Technology Co. Ltd..
1. Safety
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.
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.
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.
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Mars1717V Digital Flat Panel Detector User Manual
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.
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 may be incorrect.
<Load Limit>
Uniform load :100 kg over the whole area of the
detector surface.
Local load :100 kg on an area 4 cm diameter.
12 iRay Technology Co. Ltd..
1. Safety
Be sure to use the equipment on a protected foam.
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 fall
over, resulting in injury to the user or patient, or may
flip over, resulting in damage to the inner device.
Keep the same load (same pressure) on the detector when
acquiring the image. Otherwise, the image will be incorrect.
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 battery
Do not beat battery
Do not stand on battery
Do not use battery out of rules
Do not dispose battery or change internal structure
Do not submerge battery in water, please keep dry in
storage and do not contact with water in use
Please charge battery with charger following IEC60601-
1 & IEC62133 Standards provide by us
Do not mix battery with ones not provided by our
company
Do not charge battery with broken charger.
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Mars1717V Digital Flat Panel Detector User Manual
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.
Be sure there be a battery installing on the Mars1717V to avoid the power off
suddenly
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 airconditioner 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 15 minutes before exposure or updating the
gain map or defect map.
During exposure
Do not move the power 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.
Disinfection and Cleaning (When in portable usage)
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.
14 iRay Technology Co. Ltd..
Mars1717V Digital Flat Panel Detector User Manual
2. General Description
2.1 Scope
2.2 Model..................................................................................................................................................16
2.3 Characteristic
2.4 INTENDED USE
2.5 ESSENTIAL PERFORMANCE...................................................................................................... 17
2.6 Application specification
2.7 The relative position between patient and detector
2.8 Product Components....................................................................................................................... 19
2.9 Components Description and Specification
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2.9.1 Detector................................................................................................................................... 22
2.9.2 Battery......................................................................................................................................25
2.9.3 Battery Charger...................................................................................................................... 28
2.9.4 Power supply.......................................................................................................................... 32
2.9.5 Recommended Application Condition.................................................................................32
2.9.6 Use Environment....................................................................................................................33
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17
17
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18
22
15 iRay Technology Co. Ltd.
2. General Description
Mars1717V(configuration:Mars1717V3, hereinafter referred as Mars1717V
cassette-size wireless X-ray flat panel detector based on amorphous silicon thin-film
transistor technologies. It is developed to provide the good quality of radiographic image,
which contains an active matrix of 3072×3072 with 139um pixel pitch. Panels’ scitinator is
CsI (Cesium Iodide). Mars1717V supports wireless communication between panel and
Workstation, and can be used as a real portable panel.
)
is a
2.1 Scope
This manual contains information about the Mars1717V. Information in the manual,
including the illustrations, is based on prototype. If your configuration does not have any
of these items, information about these items does not apply to your panel.
2.2 Model
Mars 1717 V - VSI
VSI - CsI Model
Product Application:Cassette size portable detector
Product dimension: 1717, 17inch×17inch
Product series:Wireless digital flat panel detector series
Product Type: Battery - KV---------Rechargeable lithium battery
Product Type: Charger - KV--------Battery charger
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2.3 Characteristic
Wireless static flat panel detector used for general radiography.
Cassette-size
Sync-shot exposure trigger
CsI scintillation screen.
Easy to upgrade firmware.
Battery recycling
16-bit AD
2.4 INTENDED USE
2. General Description
Mars1717V Wireless Digital Flat Panel Detector is indicated for digital imaging solution
designed for providing general radiographic diagnosis of human anatomy. It is intended
to replace radiographic film/screen systems in all general-purpose diagnostic procedures.
This panel provides digital X-ray imaging for diagnosis of disease, injury, or any
applicable health problem. The image is obtained as the result of X-ray passing through
the human body and detected by detector.
iRay would provide hardware and software support for integration of system.
This panel is not intended for mammography or dental applications.
2.5 ESSENTIAL PERFORMANCE
According to the Mars1717V series INTENDED USE and the result of risk management,
image acquisition and data transmission are defined as ESSENTIAL PERFORMANCE.
Getting dark image proves that ESSENTIAL PERFORMANCE does not influence
INTENDED USE. Method for getting dark image in detail refers to section “installation”
and “operation”
2.6 Application specification
PATIENT population:
Age: except for children
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Mars1717V Digital Flat Panel Detector User Manual
Weight: not relevant
Health: not relevant
Nationality: multiple
Gender: except for pregnant women
Intended OPERATOR:
All of use, maintenance and operation steps should be carried out by the operator
who has accepted the professional training offered by the company's customer
service staff.
Life-time:
Life-time: 5 years without frequency limit
2.7 The relative position between patient and detector
Because of the crosstalk effect of Amorphous silicon flat-panel detector, Pay
attention to the relative position of patient and detector, the recommended position
as shown below, Otherwise, the image is prone to abnormal light lines.
18 iRay Technology Co. Ltd..
2. General Description
Medical Adapter for
Detector and
Battery Charger
2.8 Product Components
Mars1717V comes with both DC power supply and battery package. Once
powered on, it would build a connection with Workstation through Ethernet cable
(only for service) or Wireless connection.
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Mars1717V Digital Flat Panel Detector User Manual
Ethernet Cable
(Only for service)
20 iRay Technology Co. Ltd..
2. General Description
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Mars1717V Digital Flat Panel Detector User Manual
2.9 Components Description and Specification
2.9.1 Detector
ExternalSignals Input
Control Panels
22 iRay Technology Co. Ltd..
Change the work mode of Panel, refer to 3.1.5
Detector indicator of control panel
Power button of control panel
For service engineer to maintenance
The lock button for detaching battery
Detector Specification
a-Si (Amorphous Silicon) TFT
Limiting Spatial Resolution
3.6 Lp/mm without phantom or grid
Image Acquisition Time (Wireless)
Client mode(5G)
Preview Acquisition Time: 3 sec.
Processed Acquisition Time : 5 sec. (including Preview Time)
Weight (with one battery)
Wireless : IEEE802.11 a/b/g/n/ac
2.412~2.472GHz, 5.18~5.22GHz; 5.745~5.85GHz
13dBm (Typ.) @802.11a
16dBm (Typ.) @802.11b
2. General Description
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Mars1717V Digital Flat Panel Detector User Manual
14dBm (Typ.) @802.11g
13dBm (Typ.) @802.11n HT20
11dBm (Typ.) @802.11n HT40
16dBm@2.4GHz
13dBm@5.8GHz
11b: DSSS (DBPSK, DQPSK and CCK)
11a/g/n: OFDM (BPSK, QPSK,16QAM, 64QAM)
2.4GHz≤40MHz
5.19GHz≤40MHz
5.8GHz≤40MHz
24 iRay Technology Co. Ltd..
2.9.2 Battery
Installation direction indicator
2. General Description
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Mars1717V Digital Flat Panel Detector User Manual
Min. 3950mAh, Typ. 4180mAh @ Discharge 0.2C
Charge 0℃ -+45℃ , Discharge-10℃ -+40℃
1 month-20℃ -+50℃
3 month -20℃ -+40℃
6 month -20℃ -+20℃
Dimension and Specification
26 iRay Technology Co. Ltd..
2. General Description
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Mars1717V Digital Flat Panel Detector User Manual
The indicator definition is as follow
The indicator definition is as follow
2.9.3 Battery Charger
Dimension and Specification
28 iRay Technology Co. Ltd..
2. General Description
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Mars1717V Digital Flat Panel Detector User Manual
30 iRay Technology Co. Ltd..
Firmware versions definition
No external DC adaptor input
External DC adaptor input
2. General Description
Power indicator definition:
The battery charging capacity indicator definition:
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Mars1717V Digital Flat Panel Detector User Manual
I grid blinking
II and III grid off
Battery Insert with capacity ≤30%,charging
II grid blinking
I and III grid off
Battery Insert with capacity >30% and
≤60%, charging
III grid blinking
I and II grid off
Battery Insert with capacity >60% and
≤95%, charging
I and II grid off
III grid on
Battery Insert with capacity >95% and
charging, when capacity = 100%,
charging stops
Battery enter into 2nd level protection,
automatic unlock with safety condition
Intel Pro EXP9301CT PRO
Gigabit Network Adapter with PCIe interface
2.9.4 Power supply
Mars1717V supports both DC Power and Battery package input.
2.9.5 Recommended Application Condition
32 iRay Technology Co. Ltd. .
2.9.6 Use Environment
<10kp/min
(1kp=1.0197E-5Pa)
<10kp/min
(1kp=1.0197E-5Pa)
The Mars1717V serial detectors shall operate at an altitude specified not more than 3000m, the environment
is only for detector.
2. General Description
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Mars1717V Digital Flat Panel Detector User Manual
3. Installation
3.1 Panel Installation ...........................................................................................................................35
3.1.1 Attach Battery Pack............................................................................................................... 35
3.1.2 Attach DC Power....................................................................................................................36
3.1.3 Booting Up
3.1.4 Indicator
3.1.5 Button function table
3.2 Battery Charger Installation
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36
36
39
40
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3. Installation
Make sure that the connectors on the battery
package are pointed to the cave in battery
compartment.
Slide battery package into battery
compartment(Make sure battery capacity
overpass 10%).
Slide the battery lock lever.
3.1Panel Installation
3.1.1 Attach Battery Pack
Mars1717V can be powered by both battery package and DC power. Once battery
package is inserted or DC power is on, Panel would be activated immediately. If
none of battery and DC power is on, Mars1717V would power off. Please see
below for battery installation.
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Mars1717V Digital Flat Panel Detector User Manual
Connect one end of DC Power Cable to the
Medical Adapter
As figure is power interface Ethernet
interface
Connect another end of DC Power Cable to
the DC input of the detector.
If panel is powered off, user can press the
button for 4 seconds to power on when
battery is inserted and battery capacity is no
less than 10%, or DC power is connected.
If panel is powered on, user can press the
button for 4 seconds to shut down. On the
other hand, it can also be used as reset inner
control IC when button is active for 8s.
3.1.2 Attach DC Power
Please see below for DC power installation.
3.1.3 Booting Up
On the control panel, user can press power button to power on/off.
3.1.4 Indicator
36 iRay Technology Co. Ltd. .
3. Installation
Power OFF,
Charging Finish
Power OFF,
Battery Charging
Green, Orange,
Blinking alternately
Power OFF,
Battery Charging
Power OFF
No Connection
Wireless Connection is built
Wired Connection is built
After booting up, users can check the status indication of LED as follows.
* Panel will be power off automatically after Battery Capacity <10%.
Link indicator is as table:
Mode indicator is as table:
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Mars1717V Digital Flat Panel Detector User Manual
Power OFF
Wired Connection(Service only)
AP Mode Connection is built
Client Mode connection is built
Panel Power OFF
Exposure Prohibited
Status indicator is as table:
38 iRay Technology Co. Ltd. .
3.1.5 Button function table
Hold for more than 7 seconds,
Release Power Key when the POWER
indicator is ON.
Hold for more than 7 seconds, when the
POWER indicator is OFF and then ON,
Release Power Key.
Release after two short presses (interval
<1s)
Hold for 4 seconds, Release Power Key
when the POWER indicator is OFF.
Wireless
Connection
Mode Switch
Long-Hold
and then
Short click
Hold MODE key for more than 7
seconds.
Release Mode KEY after Mode
indicator blinking, and then Press
again in 5 seconds. The Mode
starts switching.
Click Mode Key to switch mode,
Mode indicator blinks at
corresponding Colour
Wait at intended Mode, the Mode
will switch after Several secods.
Mode indicator Blue : Client
Mode indicator Green : AP
The Button function is shown as table below
3. Installation
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Unload Battery from battery charger.
Insert battery into battery charger.
Note the interface position as figure.
Press the battery to the bottom of
battery compartment.
3.2 Battery Charger Installation
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4. Software Setup
4.1 SYSTEM REQUIREMENT...........................................................................................................42
4.2 Environment setup
4.3 Connetion Mode............................................................................................................................. 42
4.4 Wired Connection Setup (Service Only).................................................................................... 43
4.5 Wireless AP Mode Connection
4.6 Wireless Client Mode Conneciton............................................................................................... 54
4.7 iDetector software.......................................................................................................................... 62
4.7.1 HomePage............................................................................................................................. 63
4.7.2 Acquire Page......................................................................................................................... 64
4.7.3 Detector Page
4.7.4 Calibrate Page
4.7.5 Local Page
4.8 List of the HAZARDOUS SITUATIONS resulting from a failure of the IT-NETWORK
.........................................................................................................................
....................................................................................................
........................................................................................................................
.......................................................................................................................
.............................................................................................................................
.......
42
44
66
66
66
67
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4.1 System requirement
iDetector is developed and deployed on Windows Operation System, it can be run
on Windows XP/Windows 7/Windows 8/Windows 10, OS should install latest
service pack. And requires computer memory 4 GB minimum. Firewall should be
shut down to avoid commuication issue.
4.2 Environment setup
Setup files and download url are included in Software Development Kit(hereafter
refers as SDK) directory: Tools\env_setup.
1. Please install Microsoft .NET Framework 4.5(Windows XP only can install
V4.0 ). Download from Microsoft web site, please.
2. Visual C++ redistributed package need to be installed: vcredist_x86_2013(or
vcredist_x64_vs2013).
3. For Windows XP, full path should be used in file “bind.txt”.
4.3 Connetion Mode
Mars1717V supports two connection modes as follows, the IP address and other
information mentioned below is as the example, user should configure the
connection with the specific requirement.
1) Wireless Client Mode
2) Wireless AP Mode
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4.4 Wired Connection Setup (Service Only)
Select wired network
adapter that connected
to the detector.
Right click the network
adapter. Then select
properties.
4. Software Setup
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Double click IPV4 item
Default IP settings:
IP address:
192.168.8.188
Subnet mask:
255.255.255.0
The IP address should
be identical with
Cfg_HostIP item in
work_dir\Mar1717V3
\config.ini file.
4.5 Wireless AP Mode Connection
To complete wireless connection configuration, user has to finish actions listed
below.
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4.5.1 Get Start with Default AP setting
The Mars1717V detector
alows user to get start
with Default AP setting
User could config the
panel with default setting
as follows
Set the Panel to AP
mode, as the 3.1.5 Mode
key discription
Setup the Workstation IP
address
Open local network
management interface
Right click the wireless
adapter, select
properties and entered
the Wireless Connetion
Properties window as
shown left.
Double click IPV4 item
4. Software Setup
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Set the wireless adaptor
IP as follows
IP address:
192.168.8.188
Subnet mask:
255.255.255.0
Click OK to confirm the
settings
Open local wireless
signal list
Select SSID which
named as “FPD-detector
SN”.
Input Default Password
“12345678” and connect
the Panel AP.
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4. Software Setup
Select SSID which
belongs to detectors;
Input password and log
into system
Open SDK and choose
product start connection
After logging in the
detector, User can
Custom AP setting or
Set the Wireless Client
Mode
Connect panel to
Workstation with
Ethernet Cable like 4.4
4.5.2 Configuration of detector
Wired cable can be used to configure panel wireless AP mode. The wired
connection should be used by the service operator only. To start wired cable
configuration, users should finish 4.4, then proceed to the steps below.
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4. Software Setup
Click “Read Config” to
get default setting.
Change SSID and
password setting.
make sure SSID is
different from other
already exist;
Change channels and
frequency setting
Click ”Channel” and
choose a clean
frequency and channel
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Do not remove wired
cable until FPD status
from Busy become
“Ready”
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Configuration of external wireless card
Open local wireless
signal list
Select SSID which
belongs to detectors;
Input password and
log into system
4. Software Setup
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Open wireless card
configuration
IP setting as follows
IP address:
192.168.8.188
IP address: 192.168.8.188
Subnet mask: 255.255.255.0
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4. Software Setup
Subnet mask:
255.255.255.0
Open SDK and
choose product start
connection
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1. Setup physical
connection
Connect one end of
Gigabit Ethernet Cable to
Workstation,
Connect another end to
LAN port of External
wireless AP refer
to 4.4 and
4.5
2. AP setup
Set up the Wireless AP
to:
IP address 192.168.8.1
Subnet Mask
255.255.255.0
The setting process will
be virable depends on
AP model
Here shows the Netgear
Wireless Router setup
Open local network
management interface
4.6 Wireless Client Mode Conneciton
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4. Software Setup
Right click the network
adapter, select properties
and entered the Local
connetion Properties
window as shown left.
Double click IPV4 item
Select “Obtain an IP
address automatically”
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Open browser and type
192.168.1.1
Log into external wireless
AP
Configure 2.4GHz
wireless network
SSID: NETGEAR_BIG_24
Security: WPA2-PSK
Password: 12345678
Channel: [Please check the current Wi-Fi environment,
and choose a relatively clean channel]
Configure 5GHz wireless
network
SSID: NETGEAR_BIG_50
Security: WPA2-PSK
Password: 12345678
Channel: [Please check the current Wi-Fi environment,
and choose a relatively clean channel]
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4. Software Setup
LAN setup
Configure LAN IP
address
IP address: 192.168.8.1
Subnet Mask:
255.255.255.0
The AP setup is done
3. Workstation IP setup
After AP setup done, the
user can setup the
Workstation IP address
Open local network
management interface
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Right click the network
adapter, select properties
and entered the Local
connetion Properties
window as shown left.
Double click IPV4 item
Set the Default IP as
follows:
IP address:
192.168.8.188
Subnet mask:
255.255.255.0
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4. Software Setup
The IP address should be
identical with Cfg_HostIP
item in
work_dir\Mars1717V3\co
nfig.ini file.
4. Panel setup
Either Wired Cable or AP
mode can be used to
configure detector
To start configuration
with wired cable. It is
necessary to finish 4.4,
then proceed to the steps
below.
To start configuration
with AP. It is necessary
to finish 4.5, then
proceed to the steps
below.
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Connect panel to
Workstation like 4.4 or
4.5
Click “Detector”
Click “Read Config”
Choose Client mode
Click “Add”
Type SSID and
Password
Click “Apply”
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4. Software Setup
Choose SSID and
select(There will be √
occurred)
Click “write config” to
save parameters.
Turn on wireless router.
Make sure there are
wired connection
between router and work
station and IP
192.168.8.188.
Click “Read wifi Status”
to check wireless
transmission status,
numerical value occurred
means the link is up and
available.
Since we have chosen default SSID and password, it would connect to wireless AP
immediately after powered on next time.
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Connect FPD and view the connect state
Acquire image, select correction mode, save image and
process image
config.ini setting, log level setting
Configurate parameters for detector.
Generate calibration files and manage the calibration files
Open and view local images.
4.7 iDetector software
SDK supply iDetector as tool softwore:
32-bits iDetector.exe: Tools\iDetector\w32
64-bits iDetector.exe: Tools\iDetector\x64
Double click iDetector.exe to run the software. For different software version, the
UI maybe have little difference. If change, forgive us for not issuing a separate
notice.
Users can refer to 903-341-14_iDetector_UserManual_EN_A4 for specific
operation methods.
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4.7.1 HomePage
Display the name of detector
Display the SN of detector
Display the type of detector
Display the connection state (Bind,Unknown, Ready etc.)
Click this button to connect the selected detector.
Click this button to disconnect the selected detector.
Open Syncbox configuration window(Optional device)
The main function in this page is to connect detector.
4. Software Setup
A
B
C
The version of the SDK is displayed here, and the information will vary depending
on the SDK version.
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SN number of current connected detectors
Detectors state , e.g busy, ready
the current task of detector
feedback information of command,e.g. succeed,failed
4.7.2 Acquire Page
This page is used to acquire image under different work mode, and user can choose
correction mode too. When acquire image finished there will be a preview image
shown on the screen.The propertities of image is displayed on the left of preview
image. On the right of preview image there is a list to show thumbnail of images.
User can select it and double click to see for detail. User can rotate, reverse or
mirror image. User can get the value of AVG and SNR by ROI tool. The acquired
images can be save as raw, tiff or dicom formats. Both raw and tiff formats support
single frame and continuous frames save.
Status bar shows detector’s serial number, the current task and state of detector, and
feedback information of command. Status bar is also can be seen in other pages,
and they are all same.
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Functions in this Page.
Dohardware PostOffset correction for image if
checked(Only for Mars detector)
Do hardware Gain correction for image if selected
Do hardware defect correction for image if
checked(for Mars and Mercu detector)
Clear. Prepare to integrate.
Save image, the format is raw and tiff
Image Properties&
Image Process
X coordinates of the current cursor at the point
Y coordinates of the current cursor at the point
Value of the current cursor at the point
Rotate the image clockwise, 90 degrees every
time.
Rotate the image anticlockwise, 90 degrees every
time.
ROI tool ,to view the image of the AVG, SV, SNR
and other parameters. Press "ctrl" key, can create
4. Software Setup
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Auto adjust WW/WL based on selected area by
right button of mouse.
4.7.3 Detector Page
In Detector page, Detector Parameters, Sensor, Wifi and Images tab could be set.
Please refer to 903-341-14_iDetector_UserManual_EN_A4, for specific operation
guide.
4.7.4 Calibrate Page
Offset, Gain, Defect calibrate files can be generated and managed in this page.
Please refer to 903-341-14_iDetector_UserManual_EN_A4, for specific operation
guide. Users can also refers to chapter 5.2 for panel Correlation and Calibration
tutorial.
4.7.5 Local Page
The idetector Software includes a local images display tool that allows users to look
up local images.
Please refer to 903-341-14_iDetector_UserManual_EN_A4 for specific operation
methods.
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4. Software Setup
4.8 List of the HAZARDOUS SITUATIONS resulting from a failure of the
IT-NETWORK
a) The operating system is not compatibility;
b) Change or upgrade the software failed;
c) The compatibility of the interface;
d) The data transfer protocol error;
e) The inconsistent of interface or format leads to data distortion;
f) The data output failed;
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5. Operation
5.1 MAIN OPERATION
5.1.1 Steps for acquiring image...................................................................................................70
5.1.2 Software Mode........................................................................................................................71
5.1.3 Inner Mode.............................................................................................................................. 74
5.1.4 FreeSync Mode.................................................................................................................77
5.1.5 After Use............................................................................................................................ 78
5.2 Correction and Calibration Template Generation
5.2.1 HW pre-offset Template Generation
5.2.2 Gain Calibration Template Generation
5.2.3 Defect Correction Template Generation
5.3 Local Image Check......................................................................................................................... 83
5.4 Firmware Upgrade
............................................................................................................................
.......................................................................
...................................................................................
...............................................................................
.......................................................................
...........................................................................................................................
69
79
79
80
81
85
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5. Operation
Mars1717V provides SDK for user to integrate panel into their DR system.
Additionally, it also provides an application for demonstration, i.e. iDetector. User
can use iDetector to control panel without DR system.
5.1 Main Operation
To Acquire X-ray image is the main operation of Mars1717V. Most importantly,
panel should build synchronization with X-ray generator.Mars1717V is born with
four ways to acquire X-ray image that is Software Mode, Inner Mode, Prep Mode
and FreeSync Mode.
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5.1.1 Steps for acquiring image
Make sure the hardware is connected correctly and then power on.
Once powered off, please wait at least 60s before power on again
Wait until initialization is complete
Connect the software
choose the synchronization mode
Generate HWPreOffset, Gain and Defect template after the detector reaches
thermal equilibrium
Acquire images in the selected mode
To Acquire X-ray image is the main operation of Mars1717V. Most importantly,
detector should build synchronization with X-ray generator. Mars1717V has four
synchronization modes to acquire X-ray image, which is Software Mode, Prep
Mode, FreeSync Mode and Inner Mode.
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5.1.2 Software Mode
5.1.2.1 Block Diagram
Software mode is the basic way to acquire x-ray image. Please see figure below
for general feature
5. Operation
Workstation is a host device installed with iDetector and SDK. Chapter 3 has
described how to establish connection between panels and workstation. In
software mode, workstation does not control x-ray generator. Users would decide
when to shoot x-ray.
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Panel preparation, Wait until the warning message change from “Exposure
Prohibit” to “Exposure Enable”
Shoot X-ray at any time. However the longer time you wait. The worse
image would be. So please shoot once X-ray generator is ready.
After shooting, Click” Acquire”
5.1.2.2 Work flow
5.1.2.3 Timing Setting
To set a clear scenario for programming, see diagram below for details
1. Workstation receives “prep” request, send command “Clear” to panel.
2. Panel receives “clear” from workstation, starts clearing leakage of panel.
Meanwhile, panel send a message to workstation “Exposure Prohibited”.
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5. Operation
3. Panel finishes “Clear” and send a message to workstation “Exposure Enable”.
4. Workstation shows “Exposure Enable” on the IDetector’s message bar to tell
user shoot X-ray now.
5. User triggers X-ray generator to initialize and do anode rotation to prepare for
X-ray shooting.
6. X-ray generator finishes preparation for X-ray shooting and reminds user to
shoot.
7. X-ray generator starts releasing X-ray.
8. X-ray generator finishes x-ray shooting.
9. Workstation receives “Acquire” request, send command “Data Acquisition”
to panel.
10. Panel receives “Data Acquisition” from workstation, start data acquisition
operation.
11. Panel completes image acquisition and begins to send data to workstation.
12. Workstation receives all image data from panel
If Hardware Pre-offset and Hardware calibration is selected, image is the final
image.
If Hardware Post offset and Hardware calibration is selected, image got would be
preview image. After step12, panel would do another dark image acquisition.
With both light image and dark image, panel completes all the correction and
calibration process. Finally, panel uploads processed image to workstation.
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Panel preparation, Wait until the warning message change from “ Exposure
Prohibit” to “ Exposure Enable”
Shoot X-ray in exposure window. However the longer time user waits. the
worse image would be. So please shoot once X-ray generator is ready.
After shooting, X-ray sensor in panel would trigger panel to start image
5.1.3 Inner Mode
5.1.3.1 Block Diagram
Workstation is a host PC device installed with IDetector and SDK. Chapter 3 has
described how to establish connection between panels and workstation. In inner
mode, workstation does not control X-ray generator. Users would decide when to
shoot X-ray.
5.1.3.2 Work Flow
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5.1.3.3 Timing Setting
To set a clear scenario for program, see diagram below for details
1. Workstation receives “prep” request and sends “Clear” to panels.
5. Operation
2. Panel receives “clear” from Workstation, start clear operation. Meanwhile,
panel would send “Exposure Prohibited” to Workstation.
3. Panel finishes”Clear” operation and send “Exposure Enable” to Workstation.
4. Workstation shows “Exposure Enable” on the iDetector’s message bar to tell
user shoot X-ray.
5. User triggers X-ray generator to initialize and do anode rotation to prepare for
X-ray shooting
6. X-ray generator finishes preparation and reminds users.
7. X-ray generator begins releasing X-ray
8. X-ray generator finishes X-ray shooting.
9. X-ray sensor in panel triggers panel to start image acquisition operation.
10. Panel completes image acquisition and begins to send data to Workstation.
11. Workstation starts receiving image data from panel.
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12. Workstation receives all image data from panel which are after calibration is
Hardware calibration is on.
If Hardware Pre-offset and Hardware calibration is selected, image got is the final
image.
If Hardware Post offset and Hardware calibration is selected, image got from
detector would be preview image. After step12, Detector would do another dark
image acquisition. With both light image and dark image, detector completes all
the correction process. Finally, detector uploads corrected image and workstation
shows on screen.
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5. Operation
Check SDK to make sure panel is ready
X-ray sensor in panel triggers panel to stop flushing the panel
Panel starts image acquisition
5.1.4 FreeSync Mode
5.1.4.1 Block Diagram
Workstation is a host PC device installed with iDetector and SDK. Chapter 3 has
described how to establish connection between panel and Workstation. In
FreeSync mode, User doesn’t interact with Workstation. After shooting, images
would be shown on screen immediately.
5.1.4.2 Work Flow
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5.1.4.3 Timing Setting
1. X-ray generator is ready for X-ray shooting and begins to release X-ray.
2. Workstation receives “Exposure Prohibited” from Panel.
3. If hardware offset is selected, panel would do offset first, and then upload
preview image.
4. If hardware offset is chosen, panel would do correction and calibration first,
then upload processed image to Workstation.
5. Workstation receives “Exposure Enable” from Panel.
5.1.5 After Use
1. Disconnect the software
2. Power off
3. Keep it clean
4. Store under specified conditions
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5. Operation
Enter Acquire interface,
select HWPostOffset option
Enter Calibrate interface,
click UpdateHWPreOffset
button. Waiting until status
bar displayed: "Task
succeed:
HwGeneratePreOffsetTempl
ate”
5.2 Correction and Calibration Template Generation
The correction and calibration should be performed after installation and it is
recommended to perform the new correction and calibration after any major
change on the system settings and hardware configuration. On the other hand, it is
also recommended to do the correction and calibration in each 6 months.
5.2.1 HW pre-offset Template Generation
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Click "Start" button to start
process.
Click PREP button, acquire
image. Please exposure
after Acquire button enable.
And click Acquire button to
acquire image after
exposure end. Click Accept
button after acquired image.
If Current Value textbox is
yellow, click PREP button.
Re-acquire images after
adjust generator parameters.
Note: In different trigger
mode, the operation maybe
have little difference. Please
follow the UI tips.
5.2.2 Gain Calibration Template Generation
If the relative position between tube and detector changed or KV value changed, it
suggest to create gain template file.
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5. Operation
Create gain template need
several images. You can
click Generate button to
generate Gain template once
one image was captured.
But it may lead to imperfect
template quanlity.
Download template file
dialog will pop up if
"Download to FPD after
generation" option was
checked. Click Download
button to download the
template into the detector.
Select Mode&Files tab. Click
Read Status button to check
whether just downloaded
gain template is enable. If
not, please click Active
button to enable.
Enter Acquire UI. Choose
HWPostOffset.
Enter Calibrate UI. Select
5.2.3 Defect Correction Template Generation
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Click "Start" button to start
process.
Click PREP button, acquire
image. Please exposure
after Acquire button enable.
And click Acquire button to
acquire image after
exposure end. Click
Accept button after acquired
image. If Current Value
textbox is yellow , click
PREP button. Re-acquire
images after adjust
generator parameters.
Note: In different trigger
mode, the operation maybe
have little difference. Please
follow the UI tips.
You can click Generate
button to generate Gain
template after acquired
required images.
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5. Operation
Download template file
dialog will pop up if
"Download to FPD after
generation" option was
checked. Click Download
button to download the
template into the detector.
Select Mode&Files tab. Click
Read Status button to check
whether just downloaded
gain template is enable. If
not, please click Active
button to enable.
5.3 Local Image Check
“OPEN” provides two features for image check and uploading. Local Image
Check, Panel Image Upload. Local Image Check defines function to check image
saved in Workstation. Panel Image Upload defines function to upload images
stored in panel.
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Click “Local File” button in “Local
File” UI, choose the specified file
In this page user can open the
image files saved in local, the file
formate can be raw, tiff, dft. When
the software is disconnected to
detector, the file still can be
opened.
Click “Load File”, there will be an
open file wizard. Select file and
click open or double click the file.
The tiff file will be opened directly.
For the raw file or dft file there will
be a dialog to select image size.
Select correct size to open image
files. If the file is not correct user
will get an error message.
Mars1717V image size: 3072*3072
Image
Properties&
Image
Process
X coordinates of the current cursor at the point
Y coordinates of the current cursor at the point
This page provides ROI tool, which can see the AVG, SNR, and other properties
of the choosen image area by right mouse button.
This page provides WW/WL tool as Acquire page . Click this button to auto
adjust WW/WL based on selected area by right button of mouse.
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5. Operation
Value of the current cursor at the point
Rotate the image clockwise, 90 degrees every time.
Rotate the image anticlockwise, 90 degrees every time.
ROI tool , to view the image of the AVG, SV, SNR and
other parameters. Press "ctrl" key, can create several ROI
area.
Auto adjust WW/WL based on selected area by right
button of mouse.
After connecting the detector,
click the “Parameters” page in
“Detector”
User can enter the upgrade UI by
clicking “Upgrade Firmware”
button
5.4 Firmware Upgrade
Panel supports upgrading firmware with IDetector, also allows the use of the Web
way to upgrade the firmware, if a user needs to upgrade the firmware, please
complete the following steps.
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The dialog box shows the version
of the current firmware
Click “Browse” to choose the
firmware file to upgrade, the
extension of the file is .ifirm
After choosing the file, the lower
dialog box shows the version of
the new firmware, user should
check the information and click
“Start Upgrade”
After the upgrade process is
finished, power-cycle the detector
Note:
1. There is a progress bar for indication. Make sure battery is inserted and battery capacity is
over 25%
2. Please make sure that iDetector shows “Ready”. It can also be checked by click “Config”
button, there is firmware version.
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6. Regulatory Information
6.1 Medical equipment safety standards
6.2 Guidance and manufacture’s declaration for EMC..................................................................90
6.2.1 EMI Compliance Table
6.2.2 EMS Compliance Table
6.3 Radio Frequency Compliance Information ...................................................................................93
6.3.1 FCC Compliance.............................................................................................................. 94
6.4 Battery Safety Standards
..........................................................................................................
........................................................................................................
................................................................................................................
............................................................................................
88
90
90
94
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6.1 Medical equipment safety standards
Type of protection against electrical
shock
External electrical power source equipment Class I
Equipment (medical approved adaptor)
Internal electrical power source equipment (battery)
Degree of protection against electrical
shock
Degree of protection against ingress of
water
Not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous
oxide
Not suitable for use in the oxygen rich environment
Restriction of the use of certain hazardous
substances (RoHS)
Medical devices– Quality management systems–
Requirements for regulatory purposes
Medical device – Application of risk management to
medical devices
IEC 60601 1: 2005 + CORR. 1 (2006) +
CORR. 2 (2007) + AM1 (2012)
Medical electrical equipment –Part 1: General
requirements for basic safety and essential
performance
EN 60601-
1:2006+A11:2011+A1:2013+A12:2014
Medical electrical equipment – Part 1: General
requirements for basic safety and essential
performance
BS EN 60601-1:2006+A11:2011
Medical electrical equipment –Part 1: General
requirements for basic safety and essential
performance
Medical electrical equipment – Part 1: General
Medical equipment classification
6. Regulatory Information
Product safety standards r
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1:2005/(R)2012+A1:2012+C1:2009/(R)20
12+A2:2010/(R)2012
requirements for basic safety and essential
performance
CAN/CSA-C22.2 No.60601-1:14
Medical electrical equipment –Part 1: General
requirements for basic safety and essential
performance
IEC 60601-2-54:2009+A1:2015
Medical electrical equipment –Part 2-54: Particular
requirements for the basic safety and essential
performance of X-ray equipment for radiography and
radioscopy
CAN/CSA-C22.2 NO. 60601-2-54:11
Medical electrical equipment –Part 2-54: Particular
requirements for the basic safety and essential
performance of X-ray equipment for radiography and
radioscopy
IEC 60601-1-6:2010+A1:2013
Medical electrical equipment Part 1-6: General
requirements for basic safety and essential
performance — Collateral standard: Usability
CAN/CSA-C22.2 NO. 60601-1-
6:11+A1:2015
Medical electrical equipment Part 1-6: General
requirements for basic safety and essential
performance — Collateral standard: Usability
EN 60601-1-6:2010+A1:2015
Medical electrical equipment Part 1-6: General
requirements for basic safety and essential
performance — Collateral standard: Usability
Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential
performance– Collateral standard: Electromagnetic
disturbances– Requirements and tests
Secondary cells and batteries containing
alkaline or other non-acid electrolytes –
Safety requirements for portable sealed
secondary cells, and for batteries made from them,
for use in portable applications
Medical electrical equipment – Characteristics of
digital X-ray imaging devices–Part 1: Determination
of the detective quantum efficiency
Medical device software – Software life-cycle
processes
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Medical devices – Application of usability engineering
to medical devices
ANSI/AAMI ES60601-1:2005+
Amendment 1:2012+ Amendment 2:2010
Medical Electrical Equipment – Part 1: General
requirements for safety and essential performance
CAN/CSA C22.2 No. 60601-1-14
Medical Electrical Equipment – Part 1: General
requirements for safety and essential performance
Medical devices-symbols to be used with medical
device labels, labeling and information to be
supplied–Part1:General requirements
6.2Guidance and manufacture’ s declaration for EMC
Electromagnetic environment
CISPR 11
Group 1, Class B
Professional healthcare facility environment
Professional healthcare facility environment
Voltage fluctuations
and flicker
Professional healthcare facility environment
Professional healthcare facility environment
±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV air
6. Regulatory Information
6.2.1 EMI Compliance Table
Emissions
6.2.2 EMS Compliance Table
Enclosure Port
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Near fields from RF
wireless
communications
equipment
Refer to table “Near fields from RF wireless
communications equipment”
Rated power
frequency magnetic
fields
Professional healthcare facility environment
Pulse modulation 18Hz, 27V/m
FM, ±5kHz deviation, 1kHz sine, 28V/m
Pulse modulation 217Hz, 9V/m
Pulse modulation 18Hz, 28V/m
Pulse modulation 217Hz, 28V/m
Pulse modulation 217Hz, 28V/m
Pulse modulation 217Hz, 9V/m
Near fields from RF wireless communications equipment
Input a.c. power port
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6. Regulatory Information
Professional healthcare facility environment
Electrical fast
transients/burst
±2 kV
100kHz repetition frequency
Conducted
disturbances
induced by RF fields
3V, 0.15MHz-80MHz
6V in ISM bands between 0.15MHz and 80MHz
80%AM at 1kHz
0% UT; 0.5 cycle
At 0º, 45º, 90º, 135º, 180º, 225º, 270º and 315º
0% UT; 1 cycle
and
70% UT; 25/30 cycles
Single phase: at 0º
Recommende
d
cable length
Cable classification
AC Power Cable
Recommended separation distances between portable or mobile RF communication
device and detector:
Portable RF communications equipment, including antennas, can effect medical electrical
equipment. The warning should include a use distance such as “be used no closer than 30 cm
(12 inches) to any part of the [ME EQUIPMENT or ME SYSTEM], including cables specified
by the manufacturer”
The following shows information on reference cables provided against EMC
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LAN Cable
(configuration mode)
KDB 865664 D01
47 CFR part 15, subpart B
47 CFR part 15, subpart C 15.247
47 CFR part 15, subpart C 15.407
47 CFR §2.1091
KDB447498 D01 General Exposure Guidance v06
EN 301 489-1 V 2.1.1
EN 301 489-17 V 3.1.1
EN 300 440 V 2.1.1
EN 300 328 V 2.1.1;
EN 301 893 V 2.1.1
EN 62311:2008
EN 62209-2:2010
Important information regarding Electromagnetic Compatibility (EMC)
Mars1717V requires special precautions regarding EMC and needs to be installed only by iRay or
authorized personnel and put into service according to EMC information provided in the user
manual. Mars1717V in use may be susceptible to electromagnetic interference from portable and
mobile RF communications such as mobile (cellular) telephones. Electromagnetic interference may
result in incorrect operation of the system and create a potentially unsafe situation.
Mars1717V conforms to this EN60601-1-2:2015 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
The use of accessories, transmitters and cables other than those specified by this User Manual,
with the exception of accessories and cables sold by iRay of Mars1717V as replacement parts for
inner components, may result in increased emission or decreased immunity.
6.3 Radio Frequency Compliance Information
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6. Regulatory Information
EN 50566:2017
EN 62476:2010
EN 55032:2015
EN 61000-3-2:2014
EN 61000-3-3:2013
6.3.1 FCC Compliance
The panel has been tested to comply with 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 two conditions.
The panel may not cause harmful interference.
The panel must accept any interference received, including interference that may
cause undesired operation.
The panel generates, uses, and radiates 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 the panel does cause harmful interference to radio or
television reception, which can be determined by turning the panel off and on, the
user is encouraged to correct the interference by one or more of the following
measure.
Reorient or relocate the antenna.
Increase the separation between the panel and receiver.
Connect the panel into an outlet different from the receiver is connected.
Consult the distributor or an experienced radio/TV technician for help.
6.4 Battery Safety Standards
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Secondary cells and batteries containing alkaline or other non-
acid electrolytes
United Nations Recommendations on the Transport of
dangerous goods Manual of tests and Criteria
ST/SG/AC.10/11/Rev.5/Amend.1&Amend.2
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7. Trouble Shooting
TROUBLE SHOOTING.................................................................................................................. 96
Please refer to service manual. If the problem persists, turn off the panel and contact iRay
service department (
service@iraygroup.com
). We would provide the best service.
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8. Service Information
8.1 Product Lifetime
8.2 Regular Inspection and Maintenance........................................................................................... 98
8.3 Repair.................................................................................................................................................98
8.4 Replacement Parts Support
................................................................................................................................
...........................................................................................................
98
98
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8.1 Service Office Info
8.2 Product Lifetime
The estimated product lifetime is up to 5 years under appropriate regular
inspection and maintenance.
8.3 Regular Inspection and Maintenance
In order to ensure the safety of patients and operator, to maintain the
performance and reliability of the panel, be sure to perform regular inspection at
least once a year. If necessary, clean up the panel, make adjustments or replace
consumables such as fuses etc. There may be cases where overhaul is
recommended depending on conditions. Contact iRay service office or local iRay
dealer for regular inspection or maintenance.
8.4 Repair
If problem cannot be solved, contact your sales representative or local iRay
dealer for repairs. Please refer to the label and provide the following information:
Product Name:
Series Number:
Description of Problem: as clearly as possible.
8.5 Replacement Parts Support
98 iRay Technology Co. Ltd.