iRay Technology Co. Ltd. 1
Digital Flat Panel Detector
Mars1417XF
User Manual
Before operating, please read this user manual and pay attention to all safety precautions. Please
ensure that user manual is properly maintained so that it can be accessed at any time. Please use
correctly on the basis of full understanding of content.
To Customers
iRay Technology Co. Ltd. 2
To Customers
Congratulations on your purchase of Mars1417XF wireless digital flat panel
(hereinafter referred to as Mars1417XF) which is manufactured by iRay Technology
Co. Ltd. (Hereinafter referred to as iRay).
At iRay, we strive to not only make the world-class product that delivers the best
value to our customers but also offer the highest quality of service and customer
care. Please take time to read user guide in order to utilize product effectively. We
hope you enjoy experience with Mars1417XF.
If you have any questions or suggestions, please feel free to contact us.
About FCC
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions:
(1) This device may not cause harmful interference;
(2) This device must accept any interference received, including interference that may cause
undesired operation.
Attention that changes or modification not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
Note: This product has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This product generates,
uses, and can radiate radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this product does cause
harmful interference to radio or television reception, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more of
the following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
—Consult the dealer or an experienced radio/TV technician for help.
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,
To Customers
iRay Technology Co. Ltd. 3
About SAR
After the laboratory measurement, the max SAR value is 0.058mW/g for 2.4G WLAN and max
SAR value is 0.277mW/g for 5G WLAN which satisfies the RF exposure requirement.
Notes on usage and management of equipment
1. Read all instruction in user guide before operation. Pay 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 safe and operable condition by
maintenance person.
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 dedicated cables. Do not use cables other than those supplied with product.
6. Do not open cover of product without authority.
7. Request your sales representative or local iRay dealer to install this product.
Caring for your environment
This symbol indicates that product cannot 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 would produce a negative impact on health
and environment. Some countries or regions, such as European Union, has 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 any damage, loss, or injury incurred to purchaser
and the third parties as a result of fire, earthquake, any accident, misuse or
abuse of product.
• iRay shall not be liable to any damage, loss, or injury arising from unauthorized
modifications, repairs, or alterations or failure to strictly comply with iRay’s
operation and maintenance instruction.
To Customers
iRay Technology Co. Ltd. 4
• iRay shall not be liable to any damage or loss arising from use of any option or
consumer goods other than those dedicated as Original iRay product.
• It is the responsibilities of users and physicians for maintaining the privacy of
image data and providing medical care service. iRay shall not be responsible
for legality of image processing, reading and storage nor shall it be responsible
for loss of image data for any reason.
• Information regarding specification, components, and appearance of 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 included is designed only for use
with Mars1417XF.
Trademarks
The iRay name and iRay logo are registered trademarks of iRay Technology Co.
Ltd.
Symbols and Conventions
The following symbols and conventions are used throughout user guide.
This symbol is used to identify condition under
which improper use of product may cause death or
serious human injury.
This notice is used to identify condition under
which improper use of product may cause minor
human injury.
This notice is used to identify condition under
which improper use of product may cause property
damage.
This is used to indicate a prohibited operation.
This is used to indicate an action that must be
performed.
To Customers
iRay Technology Co. Ltd. 5
This is used to indicate important operation and
restriction.
This is used to indicate operation for reference and
complementary information.
Labels and markings on the equipment
The labels and markings on Mars1417XF product are indicated below:
Marking Description
Caution: please refer to instruction in user manual.
This symbol is used to indicate that equipment has passed
CE testing and it is followed by CE number.
This symbol is used to identify manufacture series number
which is after, below or adjacent to symbol. The series
number of iRay product is usually made of thirteen digits as
shown below:
This symbol is used to indicate name and address of
manufacturer.
This symbol is used to indicate name and address of iRay
authorized representative in European region.
This symbol is used to indicate consultation of user guide for
general information.
Numerical Order
Year
Date
Month
Version
Product Code
A1A2A3A4 C1C2 M DD Y XXX
To Customers
iRay Technology Co. Ltd. 6
Safety Signs: please refer to user guide for safety
instructions.
Safety Signs：Dangerous Voltage.
Stand-by.
Handle with care.
FPD is allowed to withstand 100kg on surface
This symbol is used to indicate operation temperature range.
This symbol is used to indicate storage temperature range.
Non-ionizing radiation
FCC
Federal Communications Commission certificate
Package symbol: fragile.
Package symbol: keep away from sunlight.
Package symbol: keep dry.
To Customers
iRay Technology Co. Ltd. 7
Package symbol: this symbol is used to indicate humidity
range.
Package symbol: keep equipment up right.
Package symbol: do not roll package.
Package symbol: this symbol is used to indicate stacking limit
number.
Detector symbol: the device passes IPX4 test
Contents
iRay Technology Co. Ltd. 8
Contents
1 Safety Information ...................................................................................................................... 11
1.1 Safety precautions 11
1.2 Notes for Using 15
2 General Description .................................................................................................................... 17
2.1 Scope 17
2.2 Model 17
2.3 Characteristic 18
2.4 Intended use 18
2.5 Product Components 18
2.6 Components Description 20
2.6.1 Detector ............................................................................... 20
2.6.2 Battery Pack ........................................................................ 21
2.6.3 Battery Charger ................................................................... 22
2.7 Product Specification 23
2.7.1 Detector ............................................................................... 23
2.7.2 Battery ................................................................................. 25
2.7.3 Battery Charger ................................................................... 26
2.7.4 SDK Recommended Condition ........................................... 26
2.7.5 Environment ........................................................................ 27
3 Installation .................................................................................................................................. 28
3.1 Detector Install 28
3.1.1 Attach Battery Pack ............................................................. 28
3.1.2 Booting Up .......................................................................... 28
3.1.3 Adapter ................................................................................ 31
3.2 Software Installation 31
3.3 Detector Installation 31
3.3.1 Configuration of External wireless AP ................................ 32
3.3.2 Wireless configuration of detector (if necessary) ................ 36
Contents
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3.3.3 Wireless configuration reset ................................................ 37
4 Operation .................................................................................................................................... 40
4.1 Main Operation 40
4.1.1 Software Mode .................................................................... 40
4.1.2 AED Mode .......................................................................... 42
4.2 Connection Build 44
4.3 Panel Configuration 45
4.4 Correction Template Generation 46
4.4.1 Pre-offset Template Generation ........................................... 47
4.4.2 Gain Template Generation ................................................... 48
4.4.3 Defect Template Generation ................................................ 51
4.5 Image Check and upload 53
4.5.1 Local Image Check .............................................................. 54
4.5.2 Panel Image Upload ............................................................ 54
4.5.3 Defect Template Check and Modification ........................... 56
4.6 Correction Template Management 58
4.6.1 Template Synchronization ................................................... 58
4.6.2 Correction Activation .......................................................... 62
4.7 Firmware Update 64
4.8 Short cut 67
4.9 Software 67
4.9.1 Main GUI ............................................................................ 67
4.9.2 Home Page .......................................................................... 68
4.9.3 Acquire Page ....................................................................... 68
4.9.4 SDK Page ............................................................................ 71
4.9.5 Detector Page ...................................................................... 72
4.9.6 Calibrate Page ..................................................................... 77
4.9.7 Local File Page .................................................................... 77
4.10 IT-network 78
Contents
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4.10.1 Purpose for IT-network........................................................ 78
4.10.2 Required characteristics ...................................................... 78
4.10.3 Required configuration ........................................................ 78
4.10.4 Technical specifications ...................................................... 78
4.10.5 Intended information flow ................................................... 79
4.10.6 hazardous situations resulting from failure of the IT-network
79
4.10.7 Warning ............................................................................... 79
4.10.8 Changes to IT-network include: .......................................... 80
5 Charger Installation ..................................................................................................................... 81
6 Regulatory Information ............................................................................................................... 82
6.1 Information of Registration 82
6.2 Information of Manufactures 82
6.3 Medical equipment safety standards 82
6.4 Guidance and manufacture’s declaration for EMC 84
6.4.1 EMI Compliance Table........................................................ 84
6.4.2 EMS Compliance Table ....................................................... 84
6.5 Radio Frequency Compliance Information 87
6.6 Battery Safety Standards 87
6.7 Product Label 87
7 Trouble shooting ......................................................................................................................... 92
8 Product Maintenance .................................................................................................................. 93
8.1 Regular inspection and Maintenance 93
8.2 Repairment 93
8.3 Replacement support 93
Safety Information
iRay Technology Co. Ltd. 11
1 Safety Information
1.1 Safety precautions
Follow these safe guides and properly use device to prevent injury and damage.
WARNING
Installation and environment
of use
Do not use or store device near flammable chemical such as
alcohol, thinner, benzene, etc.
If chemical is spilled or evaporated, it may result in fire or electric
shock through contact with electric parts inside device. Also,
some disinfectant is flammable. Be sure to take care when using
them.
Do not connect device with anything other than specified.
Doing so may result in fire or electric shock.
All patients with active implantable medical devices should be
kept away from device.
Power supply
Do not operate using any type of power supply other than
indicated on rated label.
Otherwise, it may result in fire or electric shock.
Do not handle 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
sheath from being damaged, and do not alter them neither.
Doing so may damage 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 system power when condensation has formed on
the devie.
Doing so may result in fire or electric shock.
Do not connect multiple portable socket-outlets or extension
cords to system.
Doing so may result in fire or electric shock.
To avoid the risk of electric shock, the device must be
connected to power supply with protective earth.
Not doing so may result in fire or electric shock.
Safety Information
iRay Technology Co. Ltd. 12
Securely plug power cord into AC outlet.
If contact failure occurs or metal objects contact with exposed
metal prongs of plug, may result fire or electric shock.
Be sure to turn off power to each piece of device before
connecting or disconnecting cords.
Otherwise, you may get electric shock that could result in death
or serious injury.
Be sure to hold plug or connector to disconnect cord.
If you pull cords, the core wire may be damaged, resulting in fire
or electric shock.
WARNING
Handling
Never disassemble or modify device. No modification is allowed.
Doing so may result in fire or electric shock. Also, since device
contains components that may cause electric shock and other
hazardous parts, touching them may cause death or serious
injury.
Do not place anything on top of device.
The object may fall and cause an injury. Also, if metal objects
such as needles or clips fall inside, it may result in fire or electric
shock.
Do not hit or drop device.
The device may be damaged if receiving a strong jolt, which may
result in fire or electric shock if the device is used without
repairing.
Do not put device and pointed objects together.
It may be damaged. Device is recommended to be used in
Bucky.
Have the patient take a fixed posture and do not let patient touch
unnecessary parts.
If patients touch connectors or switches, it may result in electric
shock or malfunction.
When problem occurs
Should any of the following occurs, immediately unplug the
power cord, and contact sales representative or local iRay
dealer:
When there is smoke, odd smell or abnormal sound.
When liquid has been spilled inside or metal object has entered
through an opening.
When the device has been dropped and damaged.
Maintenance and inspection
Please turn off the power of device and unplug 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 device.
Don’t dip the device into liquid.
Please make sure that the device’s surface & plug is dry before
turning on.
Otherwise, it may result in fire or electric shock.
Clean the plug of power cord periodically by unplugging it from
AC outlet and removing dust or dirt from plug, its periphery and
AC outlet with dry cloth.
Safety Information
iRay Technology Co. Ltd. 13
If 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 fire.
For safety reasons, be sure to turn off power to each piece of
device when performing inspections indicated in this manual.
Otherwise, electric shock may occur.
CAUTION
Installation and environment
of use
Do not install device in any of locations listed below. Doing so
may result in failure, malfunction, falling, fire or injury.
Close to facilities where water is used
Where it will be exposed to sunlight directly
Close to air outlet of air-conditioner or ventilation equipment
Close to heat source such as heater
Where power supply is unstable
In dusty environment
In saline or sulfurous environment
Where temperature or humidity is high
Where there is freezing or condensation
In areas prone to vibration
On incline or 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 malfunction of device or injury of user
due to tripping over cable.
Non-medical equipment such as battery charger and access
point cannot be used in patient’s vicinity.
Power supply
Always connect three-core power cord plug to grounded AC
power outlet.
To make it easy to disconnect plug at any time, avoid putting
any obstacles near outlet. Otherwise, it may be impossible to
disconnect plug in emergency.
Be sure to ground device to indoor grounded connector. Also,
be sure to connect all ground of system together.
Do not use any power source other than provided.
Otherwise, fire or electric shock may be caused due to leakage.
Handling
Do not spill liquid or chemicals onto device. In case the patient
is injured, iti is not allowed to contact with blood or other body
fluids.
Doing so may result in fire or electric shock.
In such situation, protect device with a disposable cover as
necessary.
Turn off power and pull out plug to each piece of for safety when
not used.
CAUTION
Safety Information
iRay Technology Co. Ltd. 14
Handling
Handle carefully.
Do not submerge device in water.
The internal image sensor may be damaged if something hits
against it or dropped. If itis dropped, shock label inside would
turn red and device would not be warranted by iRay.
Do not place excessive weight on device.
Otherwise, internal image sensor may be damaged and image
may be incorrect
Uniform load：150 kg over the whole area of the detector
surface
Local load：100 kg on an area 4 cm diameter
Be sure to use the equipment on flat surface so it will not bend.
Otherwise, the internal image sensor may be damaged.
Be sure to securely hold detector while using it in upright
positions. Otherwise, the detector may fall over, resulting in injury
to user or patient, or may flip over, resulting in damage to device.
Safety Information
iRay Technology Co. Ltd. 15
Keep the same load (the same pressure) on detector when
acquiring image. Or image will be incorrect.
CAUTION
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 provided by iRay
Do not mix battery with ones not provided by iRay
Do not charge battery with broken charger.
Charge battery regularly to avoid over discharge failure.
Do not use battery when it is severe ballooning.
1.2 Notes for Using
When using device, take the following precautions. Otherwise, problems may occur and there
would be malfunction.
Before exposure
Be sure to check device daily and confirm that it works properly.
Be sure there is battery installed on Mars1417XF to avoid power off suddenly
Sudden heating of room in cold areas will cause condensation to form on device.
In this case, wait until condensation evaporates before performing an exposure.
If it is used while condensation is formed, problems may occur in the quality of
captured images. When air-conditioner is used, be sure to raise/lower the
temperature slowly so that difference of temperature in room and device does
not occur, to prevent condensation.
The detector should be warmed more than 20 minutes before exposure or
updating gain or defect template.
Safety Information
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During exposure
Do not move power cable during exposure, or it may cause image noise or
artifacts, even incorrect images.
Do not use equipment near detector generating strong magnetic field. Otherwise,
it may cause image noise, artifacts or even incorrect images.
Do not exposure in 60s after 4 times of full range exposure. Otherwise, image
would be incorrect. Neither do exposure in 30s after a full range exposure. The
larger dose using, the longer time should be waited before next exposure.
During image acquisition, Mars1417XF should not be influenced by physical or
electrical way.
If detector receives dose which is close to full range, clipping data lines appear in
full range area.
After exposure
If detector would not be used in 5 days, it is required to take out battery. If battery
would not be used at long time, it must be charged to 30%~50% every 3 month
or 50%~70% every 6 month.
Disinfection and Cleaning
After every examination, wipe patient contact surfaces with disinfectants such as
ethanol, to prevent the risk of infection. For details on how to sterilize, consult a
specialist.
Do not spray detector directly with disinfectants or detergents.
Wipe it with cloth slightly damped with neutral detergent. Do not use solvents
such as alcohol, thinner, benzene, acid and base. Doing so may damage surface
of detector.
It's recommended to use waterproof non-woven cover as isolated layer between
detector and blooding patient.
General Description
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2 General Description
Mars1417XF 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 2336×2836 with 150um pixel pitch. Detectors’
scintillator has two options which are GOS (Gadolinium Sulfoxylate) and CsI (CaesiumIodide).
However, the greatest improvement is wireless communication between detectors and PC.
Meanwhile it can be powered with battery for portable panel use.
2.1 Scope
This manual contains information about Mars1417XF. All operators must read and understand
this manual before using. All information in this manual, including illustrations, is based on
equipment prototype. If your configuration does not have any of these items, information about
these items in the manual does not apply to your detector.
Mars1417XF
Share Mars1417XF for different Radiography modality like an IP plate
2.2 Model
Mars □ □- □
GSI: GOS; CSI: CSI
XF
1417: 14-inch X 17-inch
Mars series
General Description
iRay Technology Co. Ltd. 18
2.3 Characteristic
Wireless static Flat Panel Detector used for general radiography.
14 × 17 inch
AED trigger
Easy to change cable and charge in tray.
Battery recycling
IPX4
2.4 Intended use
Mars1417XF 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 device is not
intended for mammography or dental applications.
The detector could be used for general X ray diagnosis of usual body part. It is not intended for
mammography, dental applications, neonatal and fluoroscopy. More care should be taken when
diagnosis with allergic constitution. Not only this but also prohibited for pregnant women and
children. Shield of none inspection body part is necessary during x ray exposure. There is no
contraindication.
According to Mars1417XF intended use and result of risk management, essential performance is
identified and described as following:
To acquire dark image, Mars1417XF shall be not influenced to imaging acquisition.
To maintain data transmission, Mars1417XF shall be not influenced to data and signal
transmission.
2.5 Product Components
Mars1417XF is configured with components bellowing
Item Description
General Description
iRay Technology Co. Ltd. 19
Mars1417XF Detector
Mars1417XF GSI/CSI
Medical adapter for
detector and battery
Charger
24V (DC) power adapter
Battery Pack
7.6V battery pack
Gigabit Ethernet cable
Ethernet cable for
wireless router
AC Power Cable
AC Cable for adapter
General Description
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Battery Charger
Battery charger
Note: Mars1417XF package may be different based on requirement.
2.6 Components Description
2.6.1 Detector
External Signals Input and Control Panel
Control Panel
NO. Item Description
A DC Input Interface 24V DC input
B Reserved Reserved
C Status Indicator Detector Status indicator
General Description
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D Reserved Reserved
E Link Indicator Detector Link indicator
F Power Indicator Detector Power indicator
G Power Button Power button
2.6.2Battery Pack
NO. Item Description
A Battery Label /
B Battery Interface 7 Pin Battery connector
C Guide block /
D Latch Attach the battery lock to the detector
D
E
A
B
C
General Description
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E Touch Display Show battery level after touching
2.6.3Battery Charger
Item Item Description
A Battery Slot 3 Batteries inserted
B Capacity Indicator The indicator definition is as follow
C DC Jack 24V DC input
The battery charging capacity indicator definition:
Indicator Lighting Status Operating Status
B
C
A
General Description
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OFF
No battery Insert
Green blinking
Battery Insert with capacity ≤95%，charging
Green ON
Battery Insert with capacity >95%
Orange blinking
Battery slot malfunction
2.7 Product Specification
2.7.1Detector
Item Specification
Model Mars1417XF-GSI (GOS)
Mars1417XF-CSI (CsI)
Pixel Size 150 μm
Effective Array 2336 x 2836(Note)
Effective Area (H x V) 350.4mmx 425.4 mm
Greyscales 16 bit
Image Transfer Wireless : IEEE802.11a/b/g/n
Wireless frequency range 2.412~2.462GHz, 5.18~5.24GHz;5.745~5.825GHz
Data Transmission Power 13dBm(Typ.) @802.11a
14dBm(Typ.) @802.11b
General Description
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13dBm(Typ.) @802.11g
13dBm(Typ.) @802.11n HT20
12dBm(Typ.) @802.11n HT40
Wireless Modulation 11b: DSSS (DBPSK, DQPSK and CCK)
11a/g/n: OFDM(BPSK,QPSK,16QAM,64QAM)
Wireless Band 2.4GHz≤40MHz
5.19GHz≤40MHz
5.8GHz≤40MHz
Note: Mars1417XF-GSI active area and defect calculation area 2336*2836, TFT module size is
2342*2840. Please see figure below
Mars1417XF-CSI defect calculation area is 2320*2818, active area is 2336*2836, TFT module size
11.5dBm(Typ.) @ 802.11n AC20
11.5dBm(Typ.) @802.11n AC40
General Description
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is 2342*2840
2.7.2Battery
General Description
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Item Specifications
Model Battery-KX
Rated Capacity Min. 3500mAh, Typ.3800mAh @ Discharge 0.5C
Rated Voltage 7.6V
2.7.3Battery Charger
Item Specifications
Model Charger-KX
Simultaneous Charging 3 battery packs
Full charging time 2.5 hours
2.7.4SDK Recommended Condition
Item Description
Operating System Windows 7 32/64bit
CPU Intel Core i5 3.6GHz
Memory 8G DDR3
Hard Disk 640 G
LAN Card Intel Pro EXP9301CT PRO
General Description
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2.7.5Environment
Temperature
Temperature
Variation
Humidity
Atmospheric
Pressure
Atmospheric
Pressure Variation
Operating 5~30℃ <1k/min
10%~80%
RH
700~1060hPa
<10kp/min
(1kp=1.0197E-5Pa)
Storage
(without
battery)
-20~50℃ <1k/min
10%~90%
RH
700~1060hPa
<10kp/min
(1kp=1.0197E-5Pa)
Mars1417XF detectors should operate at altitude specified not more than 3000m, the requirement is
only for detector.
If storage with battery, temperature should be in the range of -20℃~45℃ when expected time is less
than 3 months. Meanwhile, -20℃~25℃ for 12 months.
Installation
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3 Installation
3.1 Detector Install
3.1.1Attach Battery Pack
Mars1417XF could be powered by both battery pack and DC power. Once battery pack is
inserted or DC power is connected, Detectors would be turned on immediately. If neither battery
nor DC power is connected, Mars1417XF would power off. Please see below for battery
installation.
Make sure that connectors on battery pack are
pointed to the cave in battery compartment.
Slide battery package into battery compartment
(Make sure battery capacity overpass 15%).
Slide the battery lock lever.
3.1.2Booting Up
On control panel, users can press power button to turn on/off.
Installation
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When detector is powered down, users press
button and hold on 4 seconds to turn on detector if
battery is inserted and capacity is not less than
15%, or DC power is connected.
When detector is powered on, users press button
and hold on 4 seconds to shut down detector. On
the other hand, it can also be used as reset
internal control IC when button is activated for 8
seconds.
After booting up, users can check indicator of detector.
Power indicator
Power Indicator Lighting Status
Status
Battery Capacity DC Input Description
OFF
NO NO Detector is turned off
Orange ON
≥7% & ≤15% NO Detector is turned on
Green ON
>15% NO
Detector is turned on
NO YES
Orange Blinking
≥7% & ＜15% YES
Detector is turned on
Green Blinking
≥15% & ＜95% YES
Detector is turned on
or detector is in sleep
Link indicator:
Link Indicator Lighting Status Description
OFF
Detector is turned off
Wired connection broken and wireless
connection not ready
Installation
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Blue ON
wireless connection is built
Green ON
Wired Connection is built(Service Mode)
Blue blinking
Detector Initialization
Wireless configuration reset
Green blinking
Wireless configuration reset
Mode indicator:
Mode Indicator Lighting Status Description
Blue ON
Default
OFF
Detector is turned off
Status indicator:
Status Indicator Lighting Status Description
OFF
Detector is turned off
Exposure prohibit
Green ON
Ready for exposure
Orange blinking
Safety Mode
Orange ON
Fatal Error
Green blinking
Wireless configuration reset
Installation
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3.1.3Adapter
Mars1417XF supports external adapter powered, port defined as bellowing:
No. Definition Voltage Range Rated Current
P1 DC Power Negative 0~0.5V 0~0.42A
P2 DC Power Positive 23~25V 0~0.42A
P3 DC Power Positive 23~25V 0~0.42A
P4 DC Power Negative 0~0.5V 0~0.42A
In order to meet safety and function requirements of detector, the standard component is
recommended：
LXCP120-0240625(C005)
3.2 Software Installation
In case of iDetector malfunction, please install Microsoft .NET Framework 4.5 firstly，then
install vcredist_x86_2013 or vcredist_x64_vs2013.
3.3 Detector Installation
To complete Wireless configuration, users must follow steps bellowing.
Detector default mode: Client mode
Detector default SSID: XF-SN-5G (Serial NO. of detector)
Detector default Password：12345678
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3.3.1 Configuration of External wireless AP
Connect one end of Gigabit
Ethernet Cable to PC, Connect the
other end to LAN port of External
wireless AP
/
Open local network management
interface
Open local network configuration
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Open IPV4 setting
IP setting
Network mask setting
Select “Obtain an IP address automatically”
Open browser and type in
192.168.1.1
Log into external wireless AP
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Wireless setup
Configure 2.4GHz wireless network SSID: XF-SN-2G (No conflict in the air)
Security: WPA2-PSK
Password: 12345678
Channel: (Check Wi-Fi in the air, and choose a relatively clean
channel)
Configure 5GHz wireless network SSID: XF-SN-5G (No conflict in the air)
Security: WPA2-PSK
Password: 12345678
Channel: (Check Wi-Fi in the air, and choose a relatively clean
channel)
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LAN setup
Configure LAN IP address IP address: 192.168.100.1
Subnet Mask: 255.255.255.0
Reboot router Reboot router after setting
Recover Local Network IPv4
setting of PC wired Ethernet card
IP setting
Network mask setting
IP address: 192.168.100.188
Subnet mask: 255.255.255.0
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Open iDetector
Click “Connect” based on product
name “Mars1417XF_Client”
3.3.2 Wireless configuration of detector (if necessary)
Connect panel in wireless mode
Click “Detector”
Click “Read Config”
Click “Client mode”
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Click “Add”
Type in SSID and Password
Click “Apply”
Click new SSID and then click
“Select”, new SSID would be
activated.
Click “Write config” to save
parameter.
Wireless setting would be activated immediately. Default SSID and password is configured,
detector would connect to wireless router after powered on next time.
3.3.3 Wireless configuration reset
If users don’t know wireless configuration of detector. There provides a way to reset configuration
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Power on detector, wait for 60
seconds.
Press mode shift button.
Hold on until status indicator blinks.
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Press power button.
Hold on until it is powered off.
Wait for 5 seconds.
Press power button. Hold on until it
is powered on.
Scan Wireless SSID in air, there
would be “XF-SN”
Connect it with password
“12345678”
/
Change IP address of wireless
card in workstation to “192.168.8.8”
/
Connect detector with iDetector.
Select with”Mars1417XF_AP”
The same as chapter 3.3.2
/
Note: If users don’t want to use default IP address of workstation to build the connection, it is
necessary to close iDetector before changing IP address of workstation and iDetector configuration.
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4 Operation
Mars1417XF provides users SDK for integration into DR system. Additionally, it also provides
application demonstration, i.e. iDetector.
4.1 Main Operation
Mars1417XF mainly acquires x ray image. More importantly, detector should build
synchronization with X-ray generator, i.e. Software Mode and AED Mode.
4.1.1 Software Mode
4.1.1.1 Block Diagram
Software mode builds the first x ray image acquisition step. Please see figure below for general
feature, Software mode is configured by selecting “prep” in Trigger mode and
“prepcapmode_acq2” in Prep capmode.
Workstation means host PC device installed with iDetector or SDK. Chapter 3.3 has described
how to establish connection between detectors and workstation. In Software mode, workstation
does not control X-ray generator, users decide when to shoot X-ray.
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4.1.1.2 Work flow
4.1.1.3 Timing Setting
To get a clear view of workflow, see diagram below for details
Clear Exposure Acquisition
Detector
Anode
Rotate
Exposure Enable
X ray
shooting
Exposure
Prohibited
Workstation
Xray
Generator
Process
Exposure
Prohibited
1
2
3
4
5
6
7 8
9
10 11
12
1. Workstation receives “Acquire” request, send command “Clear” to detector.
2. Detector receives “clear” from workstation and begin flushing panel. Meanwhile,
replies to workstation “Exposure Prohibited”.
3. Detector finishes “Clear” and sends message “Exposure Enable”
4. “Exposure Enable” is shown on iDetector’s bar, user shoots X-ray.
5. User triggers X-ray generator to initialize and do anode rotation to prepare for X-ray.
6. X-ray generator finishes preparation and replies to user
7. X-ray generator begins releasing X-ray
8. X-ray generator finishes X-ray shooting.
9. Workstation prepares receiving image.
10. Detector begins data acquisition after time limits.
11. Detector completes image acquisition and begins image transmission.
Detector clears until warning message changes
from “
Exposure prohibit
” to “
Exposure Enable
”
Click “Acquire”
Shoot x ray in exposure window. But the longer
time user waits, the worse image would be
Wait for image uploaded
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12. Workstation receives all image.
Image received would be preview image, preview image is image without much correction which
causes them some stripes, it cannot be used for final diagnosis.
Detector would do another dark image acquisition for offset correction. If Hardware Post offset
and Hardware calibration is selected, detector uploads processed image to workstation finally
after offset, gain and defect calibration.
If Software Post offset and Software calibration is selected, corrected image is shown on screen
after workstation finishes offset, gain and defect calibration.
Note: If wireless circumstance is bad, detector couldn’t send even one package in 30s. It would
stop trying sending image package. Users have to retrieve images from detector when wireless
is good enough.
4.1.2 AED Mode
4.1.2.1 Block Diagram
Please see figure below for general feature. AED mode is configured by selecting “inner” in
Trigger mode and “cycleacq” in inner trigger subflow.
Workstation means host PC device installed with iDetector or SDK. Chapter 3.3 has described
how to establish connection between detectors and workstation. In AED mode, workstation does
not control X-ray generator, user decides when to shoot X-ray.
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4.1.2.2 Work Flow
4.1.2.3 Timing Setting
To get a clear view of workflow, see diagram below for detail
Clear Exposure Acquisition
Detector
Anode
Rotate
Exposure Enable
X ray
shooting
Exposure
Prohibited
Workstation
Xray
Generator
Process
Exposure
Prohibited
1
2
3
4
5
6
7 8
11
9 10
12
1. Workstation receives “Acquire” request and sends “Clear” to detectors.
2. Detector receives “clear” from workstation and begin flushing panel. Meanwhile, replies to
workstation “Exposure Prohibited”.
3. Detector finishes “Clear” and sends message “Exposure Enable”.
4. “Exposure Enable” is shown on iDetector’s bar, user shoots X-ray.
5. User triggers X-ray generator to initialize and do anode rotation to prepare for X-ray.
Wait for image uploaded
Shoot x ray in exposure window.
Detector clears until warning message changes
from “
Exposure prohibit
” to “
Exposure Enable
”
Click “Acquire”
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6. X-ray generator finishes preparation and replies to user
7. X-ray generator begins releasing X-ray
8. X-ray generator finishes X-ray shooting.
9. Detector begins data acquisition after time limits.
10. Detector completes image acquisition and begins image transmission.
11. Workstation begins receiving all images.
12. Workstation finishes receiving all images.
Image received would be preview image, preview image is image without much correction which
causes them some stripes, it cannot be used for final diagnosis.
Detector would do another dark image acquisition for offset correction. If Hardware Post offset
and Hardware calibration is selected, detector uploads processed image to workstation finally
after offset, gain and defect calibration.
If Software Post offset and Software calibration is selected, corrected image is shown on screen
after workstation finishes offset, gain and defect calibration.
Note: If wireless circumstance is bad, detector couldn’t send even one package in 30s. It would
stop trying sending image package. Users have to retrieve images from detector when wireless
is good enough.
4.1.2.4 Abnormal Action
If users do not want to shoot X-ray, it is available to cancel exposure window manually.
4.1.2.5 Exposure Window
Exposure window can be configured with: 0.7s, 1.2s, 2.2s, 3.2s, 4.2s.
4.2 Connection Build
Open iDetector and click “Connect”
based on product name
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Note:
1. Users must re-connect detector with different IP address when changing connection
from different net card.
2. Switching between wired and wireless connection does not need any extra operation.
3. The rule of multi-share is based on IP address. The second terminal with different IP
address is not allowed to operate when the first is connected. If there is no command
transmission between detector and workstation over 5 minutes, detector releases access
authority.
4.3 Panel Configuration
Choose iDetector menu related modules
“Acquire” module:
Choose offset mode, load gain and
defect template
Acquire images: “Prepacq”, “Acquire”
and son on
“SDK” module:
IP address, MAC address and so on
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“Detector” module:
Trigger module, wireless configuration
and so on
“Calibrate” module:
Template generation and management.
“Local File” module:
Read raw or dcm image
4.4 Correction Template Generation
iRay recommends users correction template generation after installation, any major change on
system settings or hardware configuration. On the other hand, it is also recommended to do
template generation each 6 month.
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4.4.1 Pre-offset Template Generation
Pre-offset template is necessary for preview image. See below
Go to “Acquire” module, choose
“HWPostOffset”
Go to “Calibrate” module, click “Start
Generate Templates”
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click “UpdateHWPreOffset”, wait until
image acquisition ends
4.4.2 Gain Template Generation
Before Gain template generation, make sure SID=1.2m, no copper is required,
Go to “Acquire” module, choose
“HWPostoffset”
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Go to “Calibrate” module, click “Start
Generate Templates”
Click “ Create Gain”
Click “Start”
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Set x ray dose to meet the expected
value.
Click “PREP”, wait for exposure bar is
counting down. Before window ends,
shoot x ray.
There would be prompt in the region of
current value if dosage is improper.
(Note 1)
Change dosage and exposure again
until image is accepted.
Click “Accept” if box is green,
Click “PREP” to start another X ray
shoot.
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Gain calibration template needs 5 x
ray images.
After 5 images acquire, click
“Generate”, wait until “Task
succeed:FinishGenerationProcess”
Note:
1. X ray image has three states: green, yellow and red.
Green means image meets requirements.
Yellow means image does not meet requirements, but can generate template.
Red means image does not meet requirements, cannot generate template, must be
taken again.
4.4.3 Defect Template Generation
Before Defect template generation, make sure SID=1.2m, no copper is required,
Click” Create Defect”
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Click “Start”, Defect template needs 8
x ray images.
Set X ray dose according to expected
value.
Click “prep”, wait for exposure bar is
counting down. Before window ends,
shoot x ray.
There would be prompt in the box if
dosage is improper. (Note 1)
Change dosage and exposure again
until image is accepted.
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Click “Accept” if box is green,
Click “PREP” to start another X ray
shoot.
Calibration template needs 8 x ray
images.
After images acquire, click “Generate”,
wait until “Task
succeed:FinishGenerationProcess”
. Note:
1. X ray image has three states: green, yellow and red.
Green means image meets requirements.
Yellow means image does not meet requirements, but template can be generated.
Red means image does not meet requirements, template cannot be generated, must
take another shot.
4.5 Image Check and upload
“Local Image Check” defines function checking image saved in Workstation. “Panel Image
Upload” defines function uploading images stored in detector.
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4.5.1 Local Image Check
Choose “Local File”
Click “Local File” to open dicom, Raw
and tif file
Click “Open” /
4.5.2 Panel Image Upload
Double check firewall is closed
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Panel Image is uploaded as following.
Choose “Detector” -> “Images”
Click “Query Images”, image info listed
below
Click “Upload Images”
Input the index number of images
Click “OK”
Waiting for status from "Busy" into
"Ready"
Check upload images
Click "Stop Uploading" to stop image
upload
Images uploaded is stored in "work_dir \
Mars1417XF_Client \ upload \serial
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number"
4.5.3 Defect Template Check and Modification
iDetector provides function checking defect template. If defect template has updates, user could
add and delete defect pixel or lines.
4.5.3.1 Defect Template Check
Select “Local File” module
Click “Local File”
Choose template type “*.dft”, open it
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4.5.3.2 Defect Template Modification
Open defect template
If there are new defect pixels, type in
coordinates, click "Add";
If defect templates have dummy lines,
type in coordinates, click "Delete"
If there are new defect lines, type in
starting and ending coordinates, click
"Add".
If defect templates have dummy lines,
type in coordinates, click "Delete";
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Click "Save" to save modified defect
template
4.6 Correction Template Management
4.6.1 Template Synchronization
Detector supports correction templates storage which means templates could be transmitted not
only from detector to workstation, but also from workstation to detector.
Make sure firewall is turned off
Choose “Calibrate”,
Click “Start Generate Templates”
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Click “Read Status” besides “Subset
settings”
Click the template to be downloaded
Click “Download to FPD”
Check information whether it is right.
Change Index in FPD if necessary.
Click “Download”.
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Wait until “Task succeed: Download
CaliFile”
Click “Read Status” to read template
Choose template number according to
requirements
Click “Active” to activate template
Upload templates
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Make sure firewall is turned off
Choose “Calibrate”,
Click “Start Generate template”
Click “Read status” besides FPD
template file.
Click template which needs to be
uploaded.
Click Subset settings
Click “upload to Workdir”.
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If information listed is right, click “OK”.
Wait until “Upload FPD file succeed!”
Check template uploaded in
“work_dir\Mars1417XF_192.168.100.8\
Correct\Default”
4.6.2 Correction Activation
Detector supports two ways to do correction. Software correction defines scenario that
workstation finishes correction. If detectors do itself, that’s hardware Correction and Calibration.
4.6.2.1 Software Correction
Make sure templates saved in
“work_dir\Mars1417XF_192.168.100.8\
Correct\Default”
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Choose “Acquire”
Offset Mode:“SWPostOffset”,
Gain mode “SWGain”,
Defect mode “SWDefect”
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4.6.2.2 Hardware Correction
Click “Read Status” to read template
Choose template number according to
requirements
Click “Active” to activate template
Offset Mode “HWPostOffset”
Gain mode “HWGain”
Defect mode “HWDefect”
/
4.7 Firmware Update
Detector supports firmware updating with website, if user needs update firmware, please follow
steps below
Preparation before updating
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Go to page “Detector”
Change Trigger mode to
“TriggerMode_Prep”
Change Prep Capmode to
“PrepCapMode_Acq2”
Click “Write”
Firmware updating
Open IE browser.
Input 192.168.100.8
User name: admin
Password: iray
Click button in red box
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Choose “upgrade”
Click “browse” on the right
Choose”
Mars1417XF_IMAGE_41_ALL_XXXX
_XX_XX.ifrm”
Click “upgrade”
Click “close” when “upload image
success” pops up
Wait until upgrade is done.
Note:
1. please insert battery (more than 25%) in detector, in case power is down when
upgrading. On the other hand, detector should reboot after updating.
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4.8 Short cut
iDetector supports some shortcuts as follows:
Double-click left mouse: image displayed in center with maximum size.
Press and drag left mouse: drag image displayed.
“F3”: Quickly adjust the image window width and window level.
4.9 Software
4.9.1 Main GUI
Double-click iDetector, main interface is shown on screen. See table below for detailed function
description.
Item Function description
Home Connect detector, check connection status
Acquire Image acquisition, correction mode, image storage and processing
SDK Config.ini setting and Log level setting
Detector Detector configuration, synchronization methods, etc
Calibrate Correction template generation and management
Local File Local image check and image processing
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4.9.2 Home Page
Item and button description is shown as following.
Item Function description
Name Detector name
SN Detector SN number
Product Type Product type
State Three states: Bind, Unknown, Ready
Button Function description
Connect Build connection with specific detector
Close Disconnect with specific detector
Add Add additional working directory
Remove Delete working directory
4.9.3 Acquire Page
This page works for image acquisition mainly. In “operation” box, user chooses image correction
method according to requirements. “image properties” shows simple information of image
acquired. “Image list” shows lasted 5 images, if user wants to check some image, double click.
User can rotate images and do other image processing with “ROI”.
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Figure 4.13.2
State of detector, SN and Message is on the bottom of page.
Item Function description
SN Connected detector SN number
State Detector status, such as Busy or Ready
Task Event that detector is doing
Message Feedback of detector action, such as succeed or failed
Image operation and property of SDK is shown below
Correction Menu Function description
Offset
SWPreOffset Reserved
HWPreOffset Reserved
SWPostOffset Workstation does post offset correction
HWPostOffset Detector does post offset correction
Gain
SWGain Workstation does gain correction
HWGain Detector does gain correction
Defect
SWDefect Workstation does defect correction
HWDefect Detector does gain correction
Acquisition Functional description
PrepAcq Flush the panel and then do image acquisition
Acquire Start image acquisition
Stop Stop continuous image acquisition
Save Save images
SeqSaveSet Save image frames in continuous image acquisition
mode(documents type and path could be set)
Image Properties/
Image Process
Functional description
WW Window width
WL Window level
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PosX Cursor X coordination
PosY Cursor Y coordination
Value Value of cursor
Width Image width
Height Image height
FPS Frame rate
Frames Frame number
Rotate Rotate image 90 degrees at clockwise direction
Reverse Rotate image 90 degrees at counterclockwise direction
Mirror Mirror image horizontally
ROI Statistic of image such as AVG and SV
Image List Latest 5 images
Image preview shortcut is stated below：
• Double left click: image displayed in center with maximum size.
• Double right click: window level and width adjusted to WL: 32767/WW: 65535.
• Drag left mouse: drag image displayed.
• Lateral drag right mouse: adjust window width
• Vertical drag right mouse: adjust window level
• F3: Quickly adjust window width and level.
Note: correlation between image acquired and physical panel direction
Image Panel
A A
B D
C C
D B
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4.9.4 SDK Page
The page is used to configure config.ini and set log level in real time, as shown below
A B
C D
D
C
B A
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4.9.5 Detector Page
4.9.5.1 Parameters
Parameter tab is activated in default. Five boxes on page are defined as following:
Zone 1: parameters
Zone 2: parameters reading from detector
Zone 3: parameters which are written into detector
Zone 4: function button
Zone 5: simple message from detector and state
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Configuration parameter items
ParmName Description Modifiable
Main Version Detector FPGA version NO
Read Version Detector Read version NO
Product No Product number NO
SN Serial number NO
Trigger Mode Static X ray synchronization mode YES
Fluro Sync Dynamic X ray synchronization mode YES
Set Delay Time Delay time for “prepacq” YES
Acquire Delay Reserved YES
Integrate Time Reserved YES
Tube Ready Reserved YES
Function button description
Function Button Description
Reset Detector Reboot detector
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Read Read configuration
Write Write configuration
Upgrade Firmware Reserved
4.9.5.2 Sensor
This page includes temperature and humidity information.
Sensor Description Modifiable
Temperature Read temperature in detector NO
Humidity Read humidity in detector NO
4.9.5.3 Wireless configuration
Mode should be checked with Client.
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Parameters Description
Client
Add Add default SSID in wifi list
Del Delete specified SSID in wifi list
Up Move up
Down Move down
Select
Set specified SSID as default one which means it would be
loaded automatically after powering up
SSID Key List 10 optional SSID names
Others
Read Config
Read wireless configuration from detector
Write Config
Write wireless configuration to detector
Read WiFi Status
Check wireless link status in detector
Scan from FPD
Scan SSID in air with FPD wifi module
Wifi Status Info
Wireless link status is shown in this area
Wireless Network
Available wireless networks is shown in this area
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4.9.5.4 Images
Parameters Description
Query images Query image list in detector
Upload images Upload specific images in detector
Stop upload Stop uploading accidently
Index
Item NO. which is roll counting
Filename
Image NO. which is defined and saved in detector
Create time
Time image is saved
Delay time
Acquisition delay time
Image attr
Image type
Note:
1. If “HWPostoffset” is chosen, image saved in detector would be corrected one. If not or
“SWPostoffset” is chosen, it would be incorrected one.
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4.9.6 Calibrate Page
This page works for template management and generation.
Function Button Description
Start Generate Templates Start templates generation and templates management
4.9.7 Local File Page
This page works for local image check.
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Function Button Description
Rotate Rotate image 90 degree at clockwise direction
Reverse Rotate image 90 degree at counterclockwise direction
Mirror Mirror image horizontally
ROI Region of interest image statistic such as AVG and SV
Right press mouse draw a box
4.10 IT-network
4.10.1 Purpose for IT-network
Transmission between Detector and workstation is image data and command/status
communication.
4.10.2 Required characteristics
Wireless communication follows IEEE 802.11a/b/g/n protocol. It works on 2.4GHz and 5GHz.
It supports at least 2 routers.
4.10.3 Required configuration
Wireless card and detector must works on the same IP segment such as 192.168.100.XXX
They must support IEEE 802.11.a/b/g/n.
4.10.4 Technical specifications
Image Transfer Wireless : IEEE802.11a/b/g/n
Wireless frequency range 2.412~2.462GHz, 5.180~5.240GHz;5.745~5.825GHz
Data Transmission Power 14dBm(Max.) @802.11a
15dBm(Max.) @802.11b
14dBm(Max.) @802.11g
14dBm(Max.) @802.11n HT20
13.5dBm( Max.) @802.11n HT40
13.5dBm(Max.) @802.11n AC20/AC40
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Wireless Modulation 11b: DSSS (DBPSK, DQPSK and CCK)
11a/g/n: OFDM(BPSK,QPSK,16QAM,64QAM)
Wireless Band 2.4GHz≤40MHz
5.19GHz≤40MHz
5.8GHz≤40MHz
4.10.5 Intended information flow
Detector sends image data acquired to workstation. Workstation sends users’ command to
detector.
4.10.6 hazardous situations resulting from failure of the IT-network
failure of completing essential performance
failure of finishing configuration of product
The operating system is not compatibility;
Change or update software failed;
Compatibility of interface;
The data transfer protocol error;
The inconsistent of interface or format leads to data distortion;
The data output failed;
4.10.7 Warning
connection of main unit to an IT-network that includes other equipment could result in
previously unidentified risks.
manufacturer of x-ray machine should identify, analyze, evaluate and control these risks.
Subsequent changes to IT-network could introduce new risks and require additional
analysis.
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4.10.8 Changes to IT-network include:
changes in IT-network configuration;
connection of additional items to IT-network;
disconnecting items from IT-network;
update of equipment connected to IT-network;
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5 Charger Installation
Insert battery into battery charger
Note: insert direction as figure
Make sure battery is inserted on the bottom of
cave
Unload battery from charger after charging
completes.
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6 Regulatory Information
Mars1417XF safety regulatory includes safety of detector, charger and other accessory.
6.1 Information of Registration
REGISTRANT: iRay Technology Co., Ltd
ADDRESS: Rm. 202, Building 7, No. 590, Ruiqing Rd., Zhangjiang East,
Pudong, Shanghai, China
TELEPHONE: +86-21-50720560
SERVICE: Service Department of iRay
SERVICE TEL: +86-21-50720560
6.2 Information of Manufactures
COMPANY: iRay Technology Co., Ltd
ADDRESS: Rm. 202, Building 7, No. 590, Ruiqing Rd., Zhangjiang East,
Pudong, Shanghai, China
ZIPCODE: 201201
TELEPHONE: +86-21-50720560
6.3 Medical equipment safety standards
Medical equipment classification
Protection type against electrical shock
Class I Equipment, using medical approved adaptor
supply
Internally powered Equipment, using battery power
supply
Protection degree against electrical shock B Type
Protection degree against ingress of
water
IPX4 (Mars1417XF series panel)
IPX0 (Charger-KX)
Mode of operation Continuous operation
Flammable anesthetics Not suitable for use in situation with flammable anesthetic
mixture with air, oxygen or nitrous oxide
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Not suitable for use in oxygen rich situation
The detector is born with two power supply modes(power adaptor and battery pack) and a single way
of signal transmission(wireless)
Safety standards reference
Mars1417XF series wireless detector safety standards cover detector, charger, battery
pack and other accessory.
MDD (93/42/EEC) Medical Device Directive
EN ISO 13485:2012/EN ISO
13485:2012/AC:2012
Medical devices --- Quality management systems --- Requirements
for regulatory purposes
EN ISO14971: 2012 Medical device – Application of risk management to medical devices
EN 60601-1:2006/A1:2013
IEC60601-1:2005/A1:2012
Medical electrical equipment -- Part 1: General requirements for basic
safety and essential performance
IEC60601-1:2005
EN 60601-1-2:2015
Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance -Collateral standard:
Electromagnetic compatibility disturbances – Requirements and tests
IEC60601-1-2:2014
EN 60601-2-54:2009
Medical electrical equipment -- Part 2-54: Particular requirements for
the basic safety and essential performance of X-ray equipment for
radiography and radioscopy
IEC 62133:2012
Secondary cells and batteries containing alkaline or other nonacid electrolytes – Safety requirements for portable sealed
secondary cells, and for batteries made from them, for use in
portable applications
EN 62220-1:2004
Medical electrical equipment - Characteristics of digital X-ray imaging
devices - Part 1: Determination of the detective quantum efficiency
EN 62304:2006/AC:2008 Medical device software - Software life-cycle processes
EN 62366:2008
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- Medical Electrical Equipment – Part 1: General requirements for
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1-14 safety and essential performance
ISO 15223-1:2016
Medical devices-symbols to be used with medical device labels,
labeling and information to be supplied-Part1:General requirements
6.4 Guidance and manufacture’s declaration for EMC
6.4.1 EMI Compliance Table
Emissions
Phenomenon Compliance Electromagnetic environment
RF emissions
CISPR 11
Group 1, Class B
Professional healthcare facility environment
Harmonic distortion IEC 61000-3-2
Class A
Professional healthcare facility environment
Voltage fluctuations
and flicker
IEC 61000-3-3
Compliance
Professional healthcare facility environment
6.4.2 EMS Compliance Table
Enclosure Port
Phenomenon Basic EMC standard Immunity test levels
Professional healthcare facility environment
Electrostatic
Discharge
IEC 61000-4-2
±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV air
Radiated RF EM field IEC 61000-4-3
3V/m
80MHz-2.7GHz
80% AM at 1kHz
Near fields from RF
wireless
communications
equipment
IEC 61000-4-3
Refer to table “Near fields from RF wireless
communications equipment”
Rated power
frequency magnetic
fields
IEC 61000-4-8 30A/m
50Hz or 60Hz
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Near fields from RF wireless communications equipment
Test frequency
(MHz)
Band
(MHz)
Immunity test levels
Professional healthcare facility environment
385 380-390 Pulse modulation 18Hz, 27V/m
450 430-470
FM, ±5kHz deviation, 1kHz sine, 28V/m
710 704-787 Pulse modulation 217Hz, 9V/m
745
780
810 800-960 Pulse modulation 18Hz, 28V/m
870
930
1720 1700-1990 Pulse modulation 217Hz, 28V/m
1845
1970
2450 2400-2570 Pulse modulation 217Hz, 28V/m
5240 5100-5800 Pulse modulation 217Hz, 9V/m
5500
5785
Input a.c. power port
Phenomenon
Basic EMC
standard
Immunity test levels
Professional healthcare facility environment
Electrical fast
transients/burst
IEC 61000-4-4
±2 kV
100kHz repetition frequency
Surges
Line-to-line
IEC 61000-4-5 ±0.5 kV, ±1 kV
Surges
Line-to-ground
IEC 61000-4-5 ±0.5 kV, ±1 kV, ±2 kV
Conducted
disturbances induced
by RF fields
IEC 61000-4-6
3V, 0.15MHz-80MHz
6V in ISM bands between 0.15MHz and 80MHz
80%AM at 1kHz
Voltage dips IEC 61000-4-11 0% UT; 0.5 cycle
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At 0º, 45º, 90º, 135º, 180º, 225º, 270º and 315º
0% U
T
; 1 cycle
and
70% U
T
; 25/30 cycles
Single phase: at 0º
Voltage interruptions IEC 61000-4-11 0% U
T;
250/300 cycles
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”.
Cable provided for EMC
Cable
Recommended
length
Shield/Unshield Number Cable classification
AC power cable 1.8m Unshielded 1 pcs AC power
DC power cable 3m Unshielded 1 pcs DC power
Electro Magnetic Compatibility (EMC)
Mars1417XF series wireless flat panel detector needs special precautions regarding EMC, be
installed by iRay or authorized personnel and follows EMC guide in user manual. Mars1417XF
series product in use may interfere with portable and mobile RF communication device such as
mobile (cellular) telephones. Electromagnetic interference may result in incorrect operation of
system and potentially danger situation.
Mars1417XF series wireless flat panel detector should not be stacked with or adjacent to other
device. If inevitable, verify detector.
Mars1417XF series wireless flat panel detector conforms to this EN60601-1-2:2007 standard on
both immunity and emission.
Accessories, transmitters and cables other than those specified by User Manual or sold by iRay
may result in increased emission or decreased immunity of detector.
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6.5 Radio Frequency Compliance Information
Country Item
U.S.A FCC Part 15.107 Subpart (b) / 15.109(g) Subpart B
FCC Part 15 Subpart E 15.407
FCC Part 15 Subpart C 15.247
SAR
European Union EVSI EN 301 489-1 V1.8.1 (EMC)
EVSI EN 301 489-17 V2.1.1 (EMC)
EN 300 328 V.1.8.1;
EN 301 893 V1.6.1 (RF)
EN 62311:2008 (RF Exposure)
6.6 Battery Safety Standards
Standards Description
UL1642 Component Recognition on the Secondary Li-ion cell
UL 2054:2004 R9.11 Household and commercial Batteries
IEC 62133:2012
Secondary cells and batteries containing alkaline or other non-
acid electrolytes
UN38.3 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
6.7 Product Label
Mars1417XF-GSI Detector Label
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Mars1417XF CSI Detector Label
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Battery Charger Label
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Battery Label
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Trouble shooting
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7 Trouble shooting
Please refer service manual. If problem unsolved, turn off detector and contact iRay service
department (service@iraychina.com). We would provide the best service.
Product Maintenance
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8 Product Maintenance
8.1 Regular inspection and Maintenance
Not only for safety of patients, operator and the third parties, but also performance and
reliability, detector needs regular inspection at least once a year. If necessary, clean up,
calibration and replace components such as fuses, detector cable. There would be case that
overhaul is recommended depending on conditions. Contact iRay service office or local iRay
dealer for regular inspection or maintenance.
There is a lithium battery in detector whose lifetime is more than 5 years, battery needs to be
replaced when time is over. Contact Shanghai IRay after-sales service departments or
authorized product distributors.
8.2 Repairment
If problem cannot be solved, contact your sales representative or local iRay dealer. Please
provide following information:
Product Name:
Series Number:
Description of Problem: as clearly as possible.
8.3 Replacement support
Performance parts (parts to maintain performance of product) will be stocked for 5 years after
discontinuance of production
Appendix
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