iRay Technology VENU1012V User manual

Digital Flat Panel Detector
Venu1012V(A17)
User Manual
Version ：A0
Doc ID ：060-201-03
Release Date:：2020.12.30
Medical device registration certificate no:
Registered product standard no:
Before operating, please read this user manual and pay attention to all safety precautions.
Please ensure that this user's manual is properly maintained so that it can be accessed at any
time (reserve).
Please use it correctly on the basis of full understanding of the content.

To Customers
To Customers
Congratulations on your purchase of the Fixed Digital Flat Panel (hereinafter
referred to as VENU1012V) which is manufactured by iRay Technology Co.Ltd.
(Hereinafter referred to as iRay).
Please take time to read this user guide in order to utilize the product effectively.
We hope you enjoy the experience with iRay VENU1012V.
If you have any questions or suggestions, please feel free to contact us.
Notes on usage and management of the equipment
1. Read all of the instructions in the user guide before your operation.
Give particular attention to all safety precautions.
2. Only a physician or a legally certified operator should use this
product.
3. Maintenance personnel should maintain the equipment in a safe and
operable condition.
4. Use only computers and image display monitors complying with IEC
60601-1 or IEC 60950-1. For details, consult our sales
representative or local iRay dealer.
5. Use only the dedicated cables. Do not use any cables other than
those supplied with this product.
6. Request your sales representative or local iRay dealer to install this
product。
Caring for your environment
This symbol indicates that this product is not to be disposed of with your residential
or commercial waste.
Service Office
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Location: 2F, Building 9, No.590, Ruiqing Rd, Pudong, Shanghai,
User Manual of Venu1012V 1

Flat Panel Detector Venu1012V
Recycling iRay Equipment
Please do not dispose of this product with your residential or commercial waste.
Improper handling of this type of waste could have a negative impact on health and
on the environment. Some countries or regions, such as the European Union, have
set up systems to collect and recycle electrical or electronic waste items. Contact
your local authorities for information about practices established in your region. If
collection systems are not available, call iRay Customer Service for assistance.
Disclaimer
1. iRay shall not be liable to the purchaser of this product or third parties for any
damage, loss, or injury incurred by purchaser or third parties as a result of fire,
earthquake, any accident, misuse or abuse of this product.
2. iRay shall not be liable to any damage, loss, or injury arising from unauthorized
modifications, repairs, or alterations to this product or failure to strictly comply
with iRay’s operating and maintenance instructions.
3. iRay shall not be liable for any damage or loss arising from the use of any
options or consumable products other than those dedicated as Original iRay
Products by iRay Technology.
4. It is the responsibilities of the user/attending physicians for maintaining the
privacy of image data and providing medical care services. iRay shall not be
responsible for the legality of image processing, reading and storage nor it
shall be responsible for loss of image data for any reason.
5. Information regarding specification, compositions, and appearance of this
product is subject to change without prior notice.
6. Venu1012V has no applied parts. Be sure to check the connection of all the
parts are set properly & check the detector is kept in insulated cover that
operator or patient can’t touch the detector directly before powered up.
7. The voltage DIP, interruption or variation of the system power supply may
have impact on Venu1012V. So the uninterruptible power supply should be
considered.
8. Venu1012V is forbidden to use under oxygen-enriched conditions.
9. Venu1012V is forbidden to use near flammable objects.
Copyright
All rights reserved
No part of this publication may be reproduced in any form or by any means without
the written permission of iRay. The information contained herein is designed only
for use with iRay Venu1012V.
Trademarks
The iRay name and iRay logo are registered trademarks of iRay Technology Co.
Ltd.
2User Manual of Venu1012V

To Customers
Symbols and Conventions
The following symbols and conventions are used throughout the user guide.
This symbol is used to identify conditions under
which improper use of the product may cause death
or serious personal injury.
This notice is used to identify conditions under
which improper use of the product may cause minor
personal injury.
This notice is used to identify conditions under
which improper use of the product may cause
property damage.
This is used to indicate a prohibited operation.
This is used to indicate an action that must be
performed.
This is used to indicate important operations and
restrictions.
This is used to indicate operations for reference and
complementary information.
User Manual of Venu1012V 3

Flat Panel Detector Venu1012V
Labels and markings on the equipment
The contents of the labels and markings on iRay Venu1012V product are indicated below:
图 标 含 义
Caution: please refer to the instructions in the user manual.
This symbol is used to indicate that the equipment has passed
CE testing and it is followed by the CE Notified Body number.
This symbol is used to identify the manufacturer’s series
number which is after, below or adjacent to the symbol. The s
eries number of iRay products is usually made of thirteen digits
as shown below:
This symbol is used to indicate the name and address of the
manufacturer.
Manufacturing date of this product.
Expiring date of this product.
This symbol is used to indicate the name and address of iRay
authorized representative in the European region.
Numerical Order
Year
Date
Month
Version
Product Code
A1A2A3A4 C1C2 M DD Y XXX
4User Manual of Venu1012V

To Customers
This symbol is used to indicate consultation of the user guide
for general information.
This product is not to be disposed of with your residential or
commercial waste.
Safety Signs: please refer to the user guide for safety
instructions.
Safety Signs：Dangerous Voltage.
This symbol indicates load limit.
Handled with care.
This symbol is used to indicate the operational temperature
limits.
This symbol is used to indicate the storage temperature limits.
Package symbol, fragile.
Package symbol, keep away from sunlight.
Package symbol, keep dry.
Package symbol, this symbol is used to indicate the humidity
limits.
User Manual of Venu1012V 5

Flat Panel Detector Venu1012V
Package symbol, keep the equipment up right.
Package symbol, do not roll the transportation package.
Package symbol, this symbol is used to indicate stacking limit
number.
6User Manual of Venu1012V

Contents
Contents
TO CUSTOMERS................................................................................................................................1
CONTENTS .........................................................................................................................................7
1SAFETY INFORMATION..........................................................................................................10
1.1 SAFETY PRECAUTIONS...................................................................................................10
1.2 NOTES FOR USING .........................................................................................................15
2GENERAL DESCRIPTION.......................................................................................................18
2.1 SCOPE ............................................................................................................................18
2.2 MODEL............................................................................................................................18
2.3 CHARACTERISTIC............................................................................................................19
2.4 INTENDED USE ................................................................................................................19
2.5 PRODUCT SPECIFICATION..............................................................................................19
2.6 ENVIRONMENT REQUIREMENTS......................................................................................20
2.7 PRODUCT COMPONENTS................................................................................................21
2.8 COMPONENTS DESCRIPTION..........................................................................................22
3SOFTWARE INSTRUCTIONS...........................................................................................................26
3.1 SYSTEM REQUIREMENT..................................................................................................26
3.2 ENVIRONMENT................................................................................................................ 26
3.3 WIRED CONNECTION......................................................................................................26
3.4 NETWORK CONFIGURATION...........................................................................................29
3.5 USER INTERFACE..................................................................................................................30
3.6 CALIBRATION ......................................................................................................................31
4OPERATION.............................................................................................................................. 41
4.1 STEPS FOR ACQUIRING IMAGE.................................................................................................41
4.2INNER MODE OPERATION...............................................................................................41
4.3 FREESYNC MODE OPERATION.......................................................................................44
4.4 AFTER USE......................................................................................................................46
5REGULATORY INFORMATION .............................................................................................. 48
5.1 MEDICAL EQUIPMENT SAFETY STANDARDS....................................................................48
5.2 GUIDANCE AND MANUFACTURE’S DECLARATION FOR EMC.........................................49
5.3 PRODUCT LABEL.............................................................................................................52
6SERVICE INFORMATION ........................................................................................................ 54
6.1 PRODUCT LIFETIME........................................................................................................54
User Manual of Venu1012V 7

Flat Panel Detector Venu1012V
6.2 REGULAR INSPECTION AND MAINTENANCE ...................................................................54
6.3 REPAIR............................................................................................................................54
APPENDIX A INFORMATION OF MANUFACTURES.................................................................. 56
8User Manual of Venu1012V

1. Safety Information
1 SAFETY INFORMATION
1.1 SAFETY PRECAUTIONS...................................................................................................10
1.2 NOTES FOR USING .........................................................................................................15
User Manual of Venu1012V 9

Flat Panel Detector Venu1012V
1 Safety Information
1.1 Safety Precautions
Follow these safeguards and properly use the equipment to prevent injury and damage to
any equipment/data.
WARNING
Installation and
environment of
use
Do not use or store the equipment near flammable
chemicals such as alcohol, thinner, benzene, etc.
If chemicals are spilled or evaporate, it may result in fire or
electric shock through contact with electric parts inside the
equipment. Also, some disinfectants are flammable. Be
sure to take care when using them.
Do not connect the equipment with anything other than
specified.
Doing so may result in fire or electric shock.
All the patients with active implantable medical
devices should be kept away from the equipment.
Power supply
Do not operate the equipment using any type of power
supply other than the one indicated on the rating label.
Otherwise, it may result in fire or electric shock.
Do not handle the equipment with wet hands.
You may experience electric shock that could result in
death or serious injury.
Do not place heavy object such as medical equipment
on cables and cords. Do not pull, bend, bundle, or step
on them to prevent their sheath from being damaged,
and do not alter them neither.
Doing so may damage the cords which could result in fire
or electric shock.
Do not supply power to more than one piece of
equipment using the same AC outlet.
Doing so may result in fire or electric shock.
Do not turn ON the system power when condensation
has formed on the equipment.
Doing so may result in fire or electric shock.
10 User Manual of Venu1012V

1. Safety Information
Power supply
Do not connect a multiple portable socket-outlet or
extension cord to the system.
Doing so may result in fire or electric shock.
To avoid the risk of electric shock, this equipment
must only be connected to power supply with
protective earth.
Not doing so may result in fire or electric shock.
Securely plug the power cord into the AC outlet.
If contact failure occurs, or if metal objects come into
contact with the exposed metal prongs of the plug, fire or
electric shock may result.
Be sure to turn OFF the power to each piece of
equipment before connecting or disconnecting the
cords.
Otherwise, you may get an electric shock that could result
in death or serious injury.
Be sure to hold the plug or connector to disconnect
the cord.
If you pull the cord, the core wire may be damaged,
resulting in fire or electric shock.
WARNING
Handling
Never disassemble or modify the equipment. No
modification of this equipment is allowed. Parts of the
VENU1012V that are not serviced or maintained while
in use with the patient.
Doing so may result in fire or electric shock. Also, since the
equipment incorporates parts that may cause electric shock
as well as other hazardous parts, touching them may cause
death or serious injury.
Do not place anything on top of the equipment.
The object may fall and cause an injury. Also, if metal
objects such as needles or clips fall into the equipment, or if
liquid is spilled, it may result in fire or electric shock.
Do not hit or drop the equipment.
The equipment may be damaged if it receives a strong jolt,
which may result in fire or electric shock if the equipment is
used without being repaired.
Do not put the equipment and pointed objects
together.
The equipment may be damaged. If so, the equipment
should be used in bucky.
User Manual of Venu1012V 11

Flat Panel Detector Venu1012V
Have the patient take a fixed posture and do not let the
patient touch parts unnecessarily.
If the patient touches connectors or switches, it may result
in electric shock or malfunction of the equipment.
When a problem
occurs
Should any of the following occurs, immediately
unplug the power cord of Control Box, and contact
your sales representative or local iRay dealer:
When there is smoke, an odd smell or abnormal sound.
When liquid has been spilled into the equipment or a metal
object has entered through an opening.
When the equipment has been dropped and damaged.
Maintenance and
inspection
Please turn OFF the power of the equipment and
unplug the power cord of adaptor before cleaning.
NEVER use alcohol, ether and other flammable
cleaning agent for safety. NEVER use methanol,
benzene, acid and base because they will erode the
equipment.
DON'T dip the equipment into the liquid.
Please make sure that the equipment's surface & plugs
are dry before turning ON.
Otherwise, it may result in fire or electric shock.
Clean the plug of the power cord periodically by
unplugging it from the AC outlet and removing dust or
dirt from the plug, its periphery and AC outlet with a
dry cloth.
If the cord is kept plugged in for a long time in a dusty,
humid or sooty place, dust around the plug will attract
moisture; this could cause insulation failure that may result
in a fire.
For safety reasons, be sure to turn OFF the power to
each piece of equipment when performing inspections
indicated in this manual.
Otherwise, electric shocks may occur.
12 User Manual of Venu1012V

1. Safety Information
CAUTION
Installation and
environment of
use
Do not install the equipment in any of the locations
listed below. Doing so may result in failure,
malfunction, equipment falling, fire or injury.
Close to facilities where water is used
Where it will be exposed to direct sunlight
Close to the air outlet of an air-conditioner or ventilation
equipment
Close to heat source such as a heater
Where the power supply is unstable
In a dusty environment
In a saline or sulfurous environment
Where temperature or humidity is high
Where there is freezing or condensation
In areas prone to vibration
On an incline or in an unstable area
Take care that cables do not become tangled during
use. Also, be careful not to get your feet caught by
cable.
Otherwise, it may cause a malfunction of the equipment or
injury of the user due to tripping over the cable.
Power supply
Always connect the three-core power cord plug to a
grounded AC power outlet.
To make it easy to disconnect the plug at any time,
avoid putting any obstacles near the outlet. Otherwise,
it may not be possible to disconnect the plug in an
emergency.
Be sure to ground the equipment to an indoor
grounded connector. Also, be sure to connect all the
grounds for the system to a common ground.
Do not use any power source other than the one
provided with this equipment.
Otherwise, fire or electric shock may be caused due to
leakage.
User Manual of Venu1012V 13

Flat Panel Detector Venu1012V
Handling Do not spill liquid or chemicals onto the equipment. In
case the patient is injured, it is not allowed to contact
with blood or other body fluids.
Doing so may result in fire or electric shock.
In such a situation, protect the equipment with a disposable
cover as necessary.
Turn OFF the power and pull out the plug to each piece
of equipment for safety when not used.
CAUTION
Handling Handle the equipment carefully.
Do not submerge the equipment in water.
The internal image sensor may be damaged if
something hits against it or it is dropped.
Do not place excessive weight on the equipment.
Be sure to use the equipment on a protected foam.
Otherwise, the internal image sensor may be damaged.
Be sure to securely hold the detector while using it in
upright positions. Otherwise, the detector may fall
over, resulting in injury to the user or patient, or may
flip over, resulting in damage to the inner device.
Keep the same load (same pressure) on the detector when
acquiring the image. Or the 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
14 User Manual of Venu1012V

1. Safety Information
1.2 Notes for Using
When using the product, take the following precautions. Otherwise, problems may occur
and the product may not function correctly.
Before exposure
Be sure to check the connection of all the parts are set properly & check the
detector is kept in insulated cover that operator or patient can’t touch the
detector directly before powered up.
Be sure to check the product daily and confirm it work properly.
Sudden heating of the room in cold areas will cause condensation on the product.
In this case, wait until the condensation evaporates before performing an
exposure. If it is used when condensation is formed, problems may occur in the
quality of captured images. When an air-conditioner is used, be sure to
raise/lower the temperature gradually to prevent condensation.
The product should be warmed up for 15 minutes before exposure or updating the
gain map and defect map.
Make sure exposure rate is over 900nGy/s @70KV.
Make sure wave form of the energy going to the X ray tube is square not pulse.
Be cautious with circumstance that someone has radio isotope recently injected
into them, it may cause panel transmit image without x ray.
During exposure
Do not move Power Cable or Ethernet Cable during exposure, or it may cause
image noise or artifacts, even incorrect images.
Do not use the product near the equipment generating a strong magnetic field.
Otherwise, it may cause image noise, artifacts or even incorrect images.
After Usage
After every examination, wipe the 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 the product directly with disinfectants or detergents.
Wipe it with a cloth slightly damped with a neutral detergent. Do not use solvents
such as alcohol, benzene and acid. Doing so may damage the surface of the
product.
It’s recommended to use a waterproof non-woven cover as the isolated layer
User Manual of Venu1012V 15

Flat Panel Detector Venu1012V
between product and the blooding patient.
16 User Manual of Venu1012V

2. General Description
2 GENERAL DESCRIPTION
2.1 SCOPE ............................................................................................................................18
2.2 MODEL............................................................................................................................18
2.3 CHARACTERISTIC............................................................................................................19
2.4 INTENDED USE ................................................................................................................19
2.5 PRODUCT SPECIFICATION..............................................................................................19
2.6 ENVIRONMENT REQUIREMENTS......................................................................................20
2.7 PRODUCT COMPONENTS................................................................................................21
2.8 COMPONENTS DESCRIPTION..........................................................................................22
User Manual of Venu1012V 17

Flat Panel Detector Venu1012V
2 General Description
Venu1012V is a digital 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 2000×2400 with 125um pixel pitch.
2.1 Scope
This manual contains information about the Venu1012V. Information in the manual,
including the illustrations, is based on prototype. If your configuration does not have any of
these items, information about these items does not apply to your panel.
Figure 3.1.1
2.2 Model
Venu □ □ □
Model: TSI
Product Application: V series
Product dimension: 1012, 10inch×12inch
Product series: Venu
18 User Manual of Venu1012V