iRay Technology Venu1717M User manual

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003‐202‐0
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003‐202‐02A5
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To customers
Trademarks
The iRay name and iRay logo are registered trademarks of Shanghai iRay
Technology Ltd. (Hereinafter referred to as iRay)
Copyright
All rights reserved.
Under copyright laws, this manual may not be reproduced, in whole or in part,
without the written permission of iRay.
Thank you for purchasing iRay’s FPD Medical X-ray Radiography Flat
Panel Detector (Hereinafter referred to as FPD1M). This User’s Manual
explains the general usage of the detector and peripheral equipment.
Before using this product, please read this manual thoroughly. Any
abnormalities or malfunction or body harms caused by violations of the
user’s manual will not be responsible by our company, nor any warranties
will be made by iRay.
Important information on usage and management of equipment
1. Only a physician or a legally certified operator is allowed to use this product.
2. The equipment should be maintained in a safe and operable condition by
maintenance personnel.
3. Use only computers and image display monitors complying with IEC 60601-1 or
IEC 60950-1, and under a system configuration comply with IEC 60601-1. For
details, consult our sales representative or local iRay dealer.
4. User only the dedicated cables. Do not use any cables other than those supplied
with this product.
5. Opening the detector by the unauthorized personnel of our company is forbidden.
6. Prevent the liquid or electrical conductive substance entering into the detector.
7. The detector should not be used in the circumstance with flammable gas or
corrosive gas.
8. The detector with radiation protection in accordance with IEC 60601-1-3.

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9. To pull out the plug is the only way to cut down the main power supply.
10. Prevent the detectors from sharp/hard things, or the cover will be broken. If the
painting or the cover is broken, do not contact with surface directly.
Disclaimer
1. In no event shall iRay be liable for any damage or loss arising from fire,
earthquake, any action or accident by a third party, any intentional or negligent
action by user, any trial usage, or other usage under abnormal conditions.
2. Roentgenography, image processing , image reading, and image data storage must
be performed in accordance with the laws of the country or region in which the
product is being used. The user is responsible for maintaining the privacy of
image data.
3. In no event shall iRay be liable for personal physical harm or property damage
that is sustained when the instructions are not followed or the product is misused.
4. It is the responsibility of the attending physicians to provide medical care services.
iRay will not be liable for faulty diagnoses.
5. In no event shall iRay be liable for direct or indirect consequential damages
arising from the use or unavailability of this product. iRay shall not be liable for
loss of image for any reason.
6. In no event shall iRay be liable for any damage arising from moving, alteration,
inspection or repair by a person other than authorized service engineers.
7. Specifications, composition, and appearance of this product may change without
prior notice.

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Note on installation
Request your sales representative or local iRay dealer to install this product.
Note on disposal of this product
Disposal of this product in an unlawful manner may have a negative impact on
health and on the environment. When disposing of this product, therefore, be
absolutely sure to follow the procedure which is in conformity with the laws and
regulations applicable in your area.
European Union (and EEA) only.
This symbol indicates that this product is not be disposed of with
your household waste, according to the WEEE Directive
(2002/96/EC) and your national law. This product should be handed
over to a designated collection point, e.g., on an authorized
one-for-one basis when you buy a new similar product or to an
authorized collection site for recycling waste electrical and
electronic equipment(EEE). Improper handling of this type of waste
could have a possible negative impact on the environment and
human health due to potentially hazardous substances that are
generally associated with EEE. At the same time, your cooperation
in the correct disposal of this product will contribute to the effective
usage of natural resources. For more information about where you
can drop off your waste equipment for recycling, please contact your
local city office, waste authority, approved WEEE scheme or your
household waste disposal service.
For more information regarding return and recycling of WEEE
products, please visit www.iray-tech.com.
About Service Information
Refer instrument servicing to iRay or iRay’s authorized service personnel only.
iRay or iRay’s authorized agents provide telephone service and other
communication services, if it is determined necessary.. Local services are decided
by fact.
Some services need pay for service expense except components expense.
Any unauthorized attempt to repair instrument under warranty voids that

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warranty.
Client must offer product’s serial number.
Under warranty, some damages don’t need take any service expense and
components expense because of unartificial factors.
Under warranty, some damages only need take components expense and need not
take any service expense because of artificialness.
Outside warranty, some damages need take service expense and components
expense because of artificialness.
Boards and components that come from repair belong to manufacturer all and
singular.
During the way which be sent to iRay or iRay’s authorized agent for examination
or repair, the customers should take the responsibility if the instruments damage
because of transportation or unartificial factors.
Symbols
The list of the symbols used in this instrument is as follows:
Symbol for “caution, consult accompanying documents”.
Symbol for “CE mark”
Symbol for Serial “number”
Numerical Order
Year
Date
Month
Ve r s i o n
Product Code
A1A2A3A4C
1C2M DD Y XXX

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Symbol for “the name and the address of the manufacturer”
Symbol for “The name and the address of the authorized representative in
the European Community”
Symbol for “consult instructions for use”, “consult operating instructions”.
Safety Signs: Symbol for “refer to instruction manual”
Safety Signs：Symbol for “Dangerous Voltage”
Symbol for “Equipotentiality”
Symbol for “Type B applied par”，applied part complying with the
specified requirements of EN IEC60601-1
Symbol for “ON” ( power )
Symbol for “OFF” ( power )
Symbol for Protective Earth Conductor(ground)
Symbol for “handled with care”

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Symbol for “The equipment shall be operated during the upper and lower
limits of temperature”
Package symbol, symbol for “Fragile, the package should be
handledwith care”
Package symbol, symbol for “Keep awayfrom sunlight”
Package symbol, symbol for “Keep dry”
Package symbol, symbol for “The humidity limitationshall be indicated
adjacentto the upper horizontal lines”
Package symbol, symbol for “The storage temperatureshall be indicated
adjacentto the upper horizontal lines”
Package symbol, symbol for “Indicates correctupright position of the
transportpackage”
Package symbol, symbol for “Transport packageshall not be rolled”
Package symbol, symbol for “Stacking limit by number”

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Contents
TO CUSTOMERS ..................................................................................................................................1
NOTE ON INSTALLATION.................................................................................................................3
ABOUT SERVICE INFORMATION ...................................................................................................3
SAFETY NOTICES ...............................................................................................................................9
1. SAFETY INFORMATION ..............................................................................................................10
2. GENERAL DESCRIPTION............................................................................................................18
2.1 SCOPE............................................................................................................................................18
2.2MODEL...........................................................................................................................................19
2.3 CHARACTERISTIC ..........................................................................................................................19
2.4INTENDED USE................................................................................................................................19
2.5 STANDARD CONFIGURATION ..........................................................................................................20
2.6MAIN SPECIFICATIONS ...................................................................................................................21
3. INSTALLATION AND OPERATION............................................................................................26
3.1QUICK START .................................................................................................................................27
3.2FIRST IMAGE ACQUISITION.............................................................................................................27
4. CONTROL BOX INTERFACE ......................................................................................................31
4.1POWER SUPPLY PORT .....................................................................................................................31
4.2 D-SUB SERIAL PORT ......................................................................................................................31
4.3 GIGABIT ETHERNET PORT..............................................................................................................33
4.4 HVG INTERFACE ...........................................................................................................................33
4.5 INNER DIGITAL SYNC-SHOT MODULE ............................................................................................34
4.6 X-RAY IMAGE ACQUISITION ..........................................................................................................34
5. REGULATORY INFORMATION..................................................................................................37
5.1 MEDICAL EQUIPMENT SAFETY STANDARDS....................................................................................37
5.2 GUIDANCE AND MANUFACTURE’S DECLARATION FOR EMC ..........................................................38
6. IMAGING SOFTWARE SDK.........................................................................................................44
6.1DESCRIPTION OF LIBRARY（IRAYACQUIRELIB.LIB）...................................................................44
6.2DESCRIPTION OF FUNCTION：.......................................................................................................46
6.3 DEMO ILLUSTRATION ....................................................................................................................51
7. SERVICE INFORMATION ............................................................................................................53
APPENDIX A INSTALLATION OF SDK..........................................................................................56
APPENDIX C FUNCTION LIST OF DIFFERENT HARDWARE/FIRMWARE VERSIONS....61
APPENDIX D RECOMMENDED COMPUTER PLATFORM ......................................................62

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APPENDIX F INFORMATION OF MANUFACTURE ...................................................................64
APPENDIX G INFORMATION OF SERVICE OFFICE ................................................................65

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Safety notices
The following safety notices are used to emphasize certain safety instructions. This
manual uses the caution symbol along with a caution message.
This notice 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. Be
sure to read this notice to prevent property damage or
malfunction.
This is used to indicate operations for reference and
complementary information. Users are recommended to read
this notice.

1. Safety Information
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1. Safety Information
1.1 Safety precautions
Follow these safeguards and properly use the equipment to prevent injury and damage
to any equipment/data.
WA R N I N G
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.
Do not operate the equipment at an altitude more than 3000m.
Doing so may result electric shock or equipment failure.
Do not stand or sit on the detector directly, that may cause lose balance and hurt
patient.
Power supply
Do not operate the equipment using any type of power supply other than the one
indicated on the rating lable.
Otherwise, it may result in fire or electric shock.
Do not handle the equipment with wet hands.
You may experience an electric shock that could result in death or serious injury.
Do not place heavy object such as medical equipment on cables and cords, or do
not pull, bend, bundle, or step on them to prevent their sheath from being
damaged, and do not alter them neither.
Doing so many 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 connectedto a
supply mains with protective earth.

1. Safety Information
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Not doing so may result in fire or electric shock.
Securely plug the power cord into the AC outlet.
If contact failure occurs, or if metal objects come into contact with the exposed metal
prongs of the plug, fire or electric shock may result.
Be sure to turn OFF the power to each piece of equipment before connecting or
disconnecting the cords.
Otherwise, you may get an electric shock that could result in death or serious injury.
Be sure to hold the plug or connector to disconnect the cord.
If you pull the cord, the core wire may be damaged, resulting in fire or electric shock.
If the detector is intended to assemble mobile DR system, the sensor cable and Detector
cable must be ordered no longer than4m, and the cable must be collected in the fixed
position, not doing this may cause the DR system be toppled.

1. Safety Information
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WA R N I N G
Handling
Never disassemble or modify the equipment. No modification of this equipment is
allowed.
Doing so may result in fried 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 an needles or clips
fall into the equipment, or if liquid is spilled, it may result in fire or electric shock.
Do not hit or drop the equipment .
The equipment may be damaged if it receives a strong jolt, which may result in fire or
electric shock if the equipment is used without being repaired.
Do not put the equipment and pointed objects together.
The equipment may be damaged. If so, the equipment should be used in bucky.
Have the patient take a fixed posture and do not let the patient touch parts
unnecessarily.
If the patient touches connectors or switches, it may result in electric shock or
malfunction of the equipment.
When a problem occurs
Should any of the following occur, immediately turn OFF the power to each piece
of equipment, unplug the power cord from the AC outlet, 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 is damaged
Maintenance and inspection
When the equipment is going to be cleaned, be sure to turn OFF the power each
equipment, and unplug the power cord from the AC outlet. Never use alcohol,
benzene, thinner or any other flammable cleaning agent.
Otherwise, it may result in fire or electric shock.
Clean the plug of the power cord periodically by unplugging it from the AC outlet
and removing dust or dirt from the plug, its periphery and AC outlet with a dry
cloth.
If the cord is kept plugged in for a long time in a dusty, humid or sooty place, dust
around the plug will attract moisture, and this could cause insulation failure that
could result in a fire.
For safety reasons, be sure to turn OFF the power to each piece of equipment
when the inspections indicated in this manual are going to be performed.
Otherwise, electric shocks may occur.

1. Safety Information
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CAUTION
Installation and environment of use
Do not install the equipment in any of the locations listed below. Doing so may
result in failure or malfunction, equipment falling, or 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
Because the equipment cable is long, take care that cables do not become tangled
during use. Also, be careful not to get your feet caught in the cable.
Otherwise, it may cause a malfunction of the equipment or the injury of the user
due to tripping over the cable.
Non-medical equipment such as the battery charger, access point and IR data
communication unit cannot be used in patient’s vicinity.
Power supply
Always connect the three-core power cord plug to a grounded AC power outlet.
To make it easy to disconnect the plug at any time, avoid putting any obstacles
near the outlet, Otherwise, it may not be possible to disconnect the plug in an
emergency.
Be sure to ground the equipment to an indoor grounded connector. Also, be sure to
connect all the grounds for the system to a common ground.
Do not use any power source other than the one provided with this equipment.
Otherwise, fire or electric shock may be cause due to leakage.
Handling
Do not spill liquid or chemicals onto the equipment or, in cases where the patient is
injured, allow it to come in 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 covering as necessary.
Turn OFF the power to each piece of equipment for safety when not being used.

1. Safety Information
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CAUTION
Handling
Handle the equipment carefully.
Do not submerge the equipment in water.
The internal image sensor may be damaged if something hits against it, or if it is
dropped, the drop sensor will turn red and the equipment will not be warranted
by iRay.

Do not place excessive weight on the detector.
Otherwise, the internal image sensor may be damaged.
Be sure to use the detector on a flat surface so it will not bend. Otherwise, the
internal image sensor may be damaged. Be sure to securely hold the detector
while using it in upright positions. 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. Or
the image will be incorrect.
<LoadLimit>
Uniformload：75kgoverthe
wholeareaofthedetector
surface

Localload：50kgonanarea40
mmdiameter

1. Safety Information
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1.2 Notes for using the equipment
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.
Check the cable MPN No. & control box version.
Sudden heating of the room in cold areas will cause condensation to form
on the equipment. In this case, wait until the condensation evaporates
before performing an exposure. If the equipment is used while
condensation is formed on it, problems may occur in the quality of
captured images.
When an air-conditioner is used, be sure to raise/lower the temperature
gradually so that a difference in temperature in the room and in the
equipment does not occur, to prevent condensation.
The detector should warm up for 25 minutes before exposure or updating
the gain map or defect map.
During exposure
Do not move the power, Cameralink, Ethernet or serial cables during
exposure. Doing so may causing image noise or artifacts, even error image.
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
After every examination, wipe the patient contact surfaces of the detector,
using European approved disinfectants, to prevent the risk of cross infection.
For details on how to disinfection, consult iRay’s specialist.


O
p
Operatin
g
Storage
Do n
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Wipe
solve
n
surfa
c
cover
s
p
eratin
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Be sure to
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Keep
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When
Be su
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se and sto
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e to use an
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:
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e
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ipment. It
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emperature
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store this
afety Inform
a
16/66
i
rectly with
c
loth wette
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b
’s recomm
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w
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t
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ment unde
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30~75%
≤93%
R
m
ent to hig
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tector and
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D
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b
r the condi
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ty At
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dity.
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ent
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ion.


1. Safety Inform
a
17/66
a
tion

2. General Description
18/66

2. General Description
FPD1M®is an advanced digital radiographic flat panel detector based on amorphous
silicon thin-film transistor technologies.FPD1M is a member of iRay’s detector family
for static x-ray imaging. FPD1M is designed to provide the highest quality of
radiographic image. FPD1M contains an active matrix of 3072 3072 pixels with
139μmpitch. Users can select GOS（Gadolinium Sulfoxylate）or CsI (Cesium Iodide)
as the scintillation screen. Camera link and Gigabit Ethernet interfaces are both
available for data transfer from the detector to a computer. In addition, FPD1M is
equipped with iRay’s unique sync-shot, SYNC-SHOT and binning functions to meet
users’ various needs.
Along with the detector, iRay also provides a Microsoft Visual Studio (2008) library
IrayAcquireLib.lib, and a demo program Demo® and its source code to assist users’
integration of the detector into their existing DR system. The library
IrayAcquireLib.lib contains functions for image acquisition and detector
configuration. iDemo demonstrates the usage of IrayAcquireLib.lib and provides a
simple user interface to acquire and preview x-ray images.
2.1 Scope
This manual contains information about the iRayFPD1M detector. All operators must
read and understand this manual before using the detector. All information in this
manual, including the illustrations, is based on detector model. If your detector
configuration lacks any of these options, then some information in this manual does
not apply.


2.
2
No.
1
2.
3






2.
4
Thi
s
app
pas
s
int
e
Fo
r
2
Model
Model
FPD1M
3
Chara
c
Fixed stati
Sync-Shot
Camera li
n
GOS or C
s
Support
m
Capable f
o
4
Intend
e
s
device p
r
licable he
a
s
ing throug
h
e
nded for m
a
r
DR S
y
ste
m
Brand N
a
Venu171
7
c
teristic
c Flat Pane
exposure t
r
nk
and Gig
a
s
I scintillat
i
m
ultiple typ
e
o
r tomosynt
e
d use
r
ovides dig
i
a
lth proble
m
h
the hum
a
a
mmograp
h
m
Maker
2. G
e
a
me Type
7
M Mov
e
l Detecto
r
u
r
igge
r
and/
o
a
bit Interne
t
i
on screen.
e
of Pixel bi
hesis and e
n
i
tal X-ray
i
m
. The im
a
a
n body an
d
h
y or denta
l
e
neral Descr
i
19/66
of Use
A
e
able
4
u
sed for ge
n
o
r Automat
i
t
interface.
nning mod
e
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ergy subtr
a
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maging fo
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