iRay Technology Mars1417X User manual

Wireless Digital Flat Panel
Mars1417X
User Manual
Version ：A1
Doc ID ：042-201-02
Release Date:：2020.10.13
Before operating, please read this user manual and pay attention to all safety precautions.
Please ensure that this user manual is properly maintained so that it can be accessed at any time
(reserve).
Please use it correctly based on full understanding of the content.
E

To Customers
Congratulations on your purchase of the Wireless Digital Wireless Digital Flat Panel Detector
(hereinafter referred to as Mars1417X) which is manufactured by iRay Technology Company Ltd.
(Hereinafter referred to as iRay).
Please take time to read through this user guide in order to utilize the product effectively. We hope
you enjoy the experience with iRay Mars1417X.
If you have any questions or suggestions, please feel free to contact us.
Notes on usage and management of the equipment
1. Read all of the instructions in the user guide before your operation. Give particular attention
to all safety precautions.
2. Only a physician or a legally certified operator should use this product.
3. The equipment should be maintained in a safe and operable condition by maintenance
personnel.
4. Use only computers and image display monitors complying with IEC 60601-1 or IEC 60950-1.
For details, consult our sales representative or local iRay dealer.
5. Use only the dedicated cables. Do not use any cables other than those supplied with this
product.
6. Request your sales representative or local iRay dealer to install this product。
User Manual of Mars1417X 1

Wireless Digital Flat Panel Detector Mars1417X
Caring for your environment
This symbol indicates that this product is not to be disposed of with your residential or
commercial waste.
Recycling iRay Equipment
Please do not dispose of this product with your residential or commercial waste. Improper
handling of this type of waste could have a negative impact on health and on the environment.
Some countries or regions, such as the European Union, have set up systems to collect and recycle
electrical or electronic waste items. Contact your local authorities for information about practices
established in your region. If collection systems are not available, call iRay Customer Service for
assistance.
Disclaimer
1. iRay shall not be liable to the purchaser of this product or third parties for any damage, 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.
2User Manual of Mars1417X

To Customers
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 Mars1417X.
Trademarks
The iRay name and iRay logo are registered trademarks of iRay Technology Co. Ltd.
User Manual of Mars1417X 3

Wireless Digital Flat Panel Detector Mars1417X
Symbols and Conventions
4User Manual of Mars1417X

To Customers
The following symbols and conventions are used throughout the user
guide.
Identify the conditions under which improper use of the
product may cause death or serious personal injury.
Identify conditions under which improper use of the
product may cause minor personal injury.
Identify conditions under which improper use of the
product may cause property damage.
Indicate a prohibited operation.
Indicate an action that must be performed
Indicate important operations and restrictions.
Indicate operations for reference and complementary
information.
User Manual of Mars1417X 5

Wireless Digital Flat Panel Detector Mars1417X
Labels and markings on the equipment
The contents of the label and mark on iRay Mars1417X product are
indicated as below:
Symbol
Description
Caution: please refer to the instructions in the user manual.
Indicates that the equipment has passed CE testing and the CE
Notified Body number follows it.
Serial number of the product.
Name and address of the manufacturer.
Manufacturing date of this product.
Expiring date of this product.
This symbol is used to indicate non-ionized electromagnetic
radiation.
Name and address of iRay authorized representative in the
European region.
Consultation of the user guide for general information.
This product is not to be disposed of with your residential or
commercial waste.
6User Manual of Mars1417X

To Customers
Safety Signs:
Please refer to the user guide for safety instructions.
B Type.
Load limit. (Central area)
Handled with care.
Operational temperature limits.
Storage temperature limits.
Fragile
Keep away from sunlight
Keep dry
Humidity limits.
Keep the equipment up right.
Do not roll the transportation package.
Stacking limit number.
IP56 IP56 for the detector
User Manual of Mars1417X 7

Wireless Digital Flat Panel Detector Mars1417X
Detector symbol : device is for prescription use only
8User Manual of Mars1417X

Contents
Contents
CONTENTS............................................................................................................................ 9
1. SAFETY INFORMATION...................................................................................10
1.1. Safety Precautions ..................................................................................11
1.2. Notes for Using........................................................................................20
2. GENERAL DESCRIPTION ................................................................................ 22
2.1. Product Description ...................................................................................23
2.2. Principle.....................................................................................................23
2.3. Scope.........................................................................................................23
2.4. Characteristics...........................................................................................24
2.5 Intended Use .............................................................................................24
2.6. Environment...............................................................................................29
2.7. Product Components.................................................................................29
2.8. Specification ................................................................................................31
3. BASIC OPERATION .......................................................................................... 33
3.1. Preparation................................................................................................34
3.2. Routine Operation .....................................................................................35
3.3. Battery Charger Installation........................................................................37
4. SOFTWARE SETUP .......................................................................................... 38
4.1. System requirement ................................................................................39
4.2. Environment setup...................................................................................39
4.3. Wired Connection (for setting&maintenance) .........................................39
4.4. Software UI..............................................................................................42
4.5. List of the HAZARDOUS SITUATIONS resulting from a failure of the IT-
NETWORK .........................................................................................................60
5. OPERATION INSTRUCTIONS FOR IMAGE ACQUISITION............................61
5.1. Steps for acquiring image........................................................................62
5.2. Software Mode ........................................................................................62
5.3. AED Mode ...............................................................................................64
5.4. After use ..................................................................................................65
5.5. Firmware Upgrade................................................................................... 65
6. REGULATORY INFORMATION........................................................................ 68
6.1. Medical Equipment Safety Standards.....................................................69
6.2. Guidance and Manufacture’s Declaration for EMC.................................69
6.3. Radio Frequency Compliance Information..............................................72
6.4. Battery Safety Standards ........................................................................75
6.5. Product Label ..........................................................................................75
7. TROUBLE SHOOTING...................................................................................... 78
8. SERVICE INFORMATION .................................................................................79
8.1. Service Office Information.......................................................................80
8.2. Product Lifetime.......................................................................................80
8.3. Regular Inspection and Maintenance......................................................80
8.4. Repair......................................................................................................80
8.5. Replacement Parts Support ....................................................................80
APPENDIX A INFORMATION OF MANUFACTURES.......................................................83
APPENDIX B INFORMATION OF EUROPE REPRESENTATIVE..................................... 84
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Wireless Digital Wireless Digital Flat Panel Detector Mars1417X
1. Safety Information
1.1. Safety Precautions ..................................................................................11
1.2. Notes for Using........................................................................................20
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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
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.
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Wireless Digital Wireless Digital Flat Panel Detector Mars1417X
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.
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.
12 User Manual of Mars1417X

1. Safety Information
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
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Wireless Digital Wireless Digital Flat Panel Detector Mars1417X
Handling
Never disassemble or modify the equipment. No
modification of this equipment is allowed. Parts of
the Mars1417X that are not serviced or maintained
while in use with the patient.
Doing so may result in fire or electric shock. Also, since the
equipment incorporates parts that may cause electric shock
as well as other hazardous parts, touching them may cause
death or serious injury.
Do not place anything on top of the equipment.
The object may fall and cause an injury. Also, if metal objects
such as needles or clips fall into the equipment, or if liquid is
spilled, it may result in fire or electric shock.
Do not hit or drop the equipment.
The equipment may be damaged if it receives a strong jolt,
which may result in fire or electric shock if the equipment is
used without being repaired.
Do not put the equipment and pointed objects
together.
The equipment may be damaged. If so, the equipment
should be used in bucky.
Have the patient take a fixed posture and do not let
the patient touch parts unnecessarily.
If the patient touches connectors or switches, it may result in
electric shock or malfunction of the equipment.
When a problem
occurs
Should any of the following occurs, immediately
unplug the power cord of Control Box, and contact
your sales representative or local iRay dealer:
When there is smoke, an odd smell or abnormal sound.
When liquid has been spilled into the equipment or a metal
object has entered through an opening.
When the equipment has been dropped and damaged.
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1. Safety Information
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.
User Manual of Mars1417X 15

Wireless Digital Wireless Digital Flat Panel Detector Mars1417X
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.
16 User Manual of Mars1417X

1. Safety Information
Power supply
Always connect the three-core power cord plug to
a grounded AC power outlet.
To make it easy to disconnect the plug at any time,
avoid putting any obstacles near the outlet.
Otherwise, it may not be possible to disconnect the
plug in an emergency.
Be sure to ground the equipment to an indoor
grounded connector. Also, be sure to connect all
the grounds for the system to a common ground.
Do not use any power source other than the one
provided with this equipment.
Otherwise, fire or electric shock may be caused due to
leakage.
Handling Do not spill liquid or chemicals onto the equipment.
In case the patient is injured, it is not allowed to
contact with blood or other body fluids.
Doing so may result in fire or electric shock.
In such a situation, protect the equipment with a disposable
cover as necessary.
Turn OFF the power and pull out the plug to each
piece of equipment for safety when not used.
CAUTION
Handling Handle the equipment carefully.
Do not submerge the equipment in water.
User Manual of Mars1417X 17

Wireless Digital Wireless Digital Flat Panel Detector Mars1417X
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.
Do not place excessive weight on the panel.
Otherwise, the internal image sensor may be damaged and
image may be incorrect.
Patients stand on the product temporarily, and the intended
weight can be 150kg.
Based on the internal TFT character, cannot load the
dynamic forces due to loading from persons
<Load Limit>
Uniform load：300 kg over the whole area of the surface.
Local load：150 kg on an area 4 cm diameter.
18 User Manual of Mars1417X