iRay Technology Mars1717XF Series User manual

Mars1717XF
Wireless Digital Flat Panel Detector
User Manual
Document Version: R06
Document ID: 051-201-02
Release Date: 1/22/2024
E
0197

Mars1717XF User Manual To Customers
i
To Customers
Thanks you for purchasing the Mars1717XF Wireless Digital Flat Panel Detector (hereinafter referred to as Mars1717XF)
from iRay Technology Co., Ltd. (hereinafter referred to as iRay).
This manual contains all the general information about the Mars1717XF, which is intended to provide users with
instructions on installation, use and maintenance.
All information in this manual, including illustrations, is based on the equipment prototype. If your equipment does not
match with these contents, they will not apply to your equipment.
Information regarding the specifications, compositions, appearance, etc. of this product is subject to change without
prior notice.
Store this manual safely so that you can access it in the future.
Copyright
iRay Technology Co., Ltd. All rights reserved.
No part of this publication may be reproduced in any form or by any means without the written permission of iRay
Technology Co., Ltd.
Trademarks
The name and logo of iRay are registered trademarks of iRay Technology Co., Ltd.
Environmental Protection
This symbol indicates that this product cannot be disposed as domestic or commercial waste. Improper handling of this
type of waste may result in a negative impact on health and environment.
Some countries or regions, such as the European Union, have set up systems to collect and recycle electrical or electronic
waste items. Please contact your local authorities for information about practices established in your region. If collection
systems are not available, call iRay Customer Service for assistance.

Mars1717XF User Manual To Customers
ii
For Your Safety
 To avoid personal injury or product damage, be sure to read the user manual and all accompanying information
carefully and pay attention to all safety information before installing and using the detector.
 The installation, debugging, addition, modification and maintenance of this product can only be carried out by
operators who has accepted the professional training offered by the iRay's customer service staff.
 The equipment should be maintained in a safe and operable condition by maintenance personnel.
 Only a physician or a legally certified operator is allowed to use this product.
 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. For details, consult our sales representative or local iRay
dealer.
Disclaimer
 iRay will not bear any responsibilities for any abnormality, equipment damage and personal injury caused due to
your failure to follow the warnings and operating instructions in this manual.
 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.
 iRay shall not be liable to any damage, loss, or injury arising from unauthorized modifications, repairs, or
alterations to this product or failure to strictly comply with iRay’s operating and maintenance instructions.
 iRay shall not be liable for any damage or loss arising from the use of any options or consumable products other
than those dedicated as original iRay products.
 During X-ray imaging, collecting, processing, reading and storing of image data, the user should comply with the
law of the countries where the product is used.
 The users and operators of the product shall protect the privacy of image data.
 The clinician is responsible for providing medical service and erroneous treatment due to misdiagnosis.
Warning Symbols
The warning symbols that appear in this user manual are classfied as follows for better comprehension of their meanings.
Make sure that you fully understand them and obey the instructions they contain.
This indicates a potentially hazardous situation which, if ignored, may result in severe per-
sonal injury, death, or substantial product damage.
This indicates a potentially hazardous situation which, if ignored, may result in minor per-
sonal injury, or product damage.
This symbol is used to indicate a prohibited operation.
!
WARNING
!
CAUTION
PROHIBITED

Mars1717XF User Manual To Customers
iii
This emphasizes or supplements important information about the main text.
This symbol is used to indicate “please refer to accompanying documents attached to the CD
disk or sections in this manual”.
Abbreviations
Abbreviations Explanation
AC Alternating Current
AED Automatic Exposure Detection
AP Access Point
DC Direct Current
DR Digital Radiography
EMC Electro Magnetic Compatibility
FPD Flat Panel Detector
FTP File Transfer Protocol
HVG High Voltage Generator
IP Internet Protocol
IT Information Technology
LAN Local Area Network
LED Light Emitting Diode
PC Personal Computer
ROI Range of Interest
RF Radio Frequency
SAR Specific Absorption Rate
SDK Software Development Kit
SN Serial Number
SSID Service Set Identifier
TFT Thin Film Transistor
UI User Interface
WL Window Level
WW Window Width
NOTE
REFERENCE

Mars1717XF User Manual Contents
iv
Contents
TO CUSTOMERS .................................................................................................................................. I
CONTENTS ....................................................................................................................................... IV
1 SAFETY INFORMATION ................................................................................................................ 1
1.1 Label Description ................................................................................................................................... 1
1.2 Safety Precautions ................................................................................................................................. 4
1.2.1 Operation and Storage Environment .......................................................................................................... 4
1.2.2 Equipment, Interface, Power Source, and Cables ...................................................................................... 5
1.2.3 Handling ..................................................................................................................................................... 6
1.2.4 Failure Handling ......................................................................................................................................... 7
1.2.5 Battery Pack ................................................................................................................................................ 8
1.2.6 Maintenance and Inspection ....................................................................................................................... 8
1.3 Notes for Using the Equipment ............................................................................................................. 9
2 REGULATORY INFORMATION .................................................................................................... 11
2.1 Medical Equipment Classification ....................................................................................................... 11
2.2 Safety Standard Reference ................................................................................................................... 11
2.3 Guidance and Manufacturer’s Declaration For EMC ......................................................................... 12
2.3.1 EMI Compliance Table ............................................................................................................................ 12
2.3.2 EMS Compliance Table ........................................................................................................................... 12
2.4 Radio Frequency Compliance Information ......................................................................................... 14
2.5 Battery Safety Standards ..................................................................................................................... 15
2.6 Environmental Directive ...................................................................................................................... 15
2.7 Radio Frequency (RF) Energy ............................................................................................................. 16
2.8 FCC ...................................................................................................................................................... 16
2.9 IC Notice .............................................................................................................................................. 17
2.10 Remarque IC ........................................................................................................................................ 17
3 PRODUCT INTRODUCTION ........................................................................................................ 18
3.1 Overview .............................................................................................................................................. 18
3.2 Lineup .................................................................................................................................................. 18
3.3 Intended Use ........................................................................................................................................ 19
3.4 Characteristics ...................................................................................................................................... 19
3.5 Packing List ......................................................................................................................................... 19
3.6 Component Description ....................................................................................................................... 21

Mars1717XF User Manual Contents
v
3.6.1 Detector .................................................................................................................................................... 21
3.6.2 Battery Pack .............................................................................................................................................. 23
3.6.3 Battery Charger ........................................................................................................................................ 24
3.6.4 Power Adapter .......................................................................................................................................... 25
4 BASIC OPERATION .................................................................................................................... 26
4.1 Preparation ........................................................................................................................................... 26
4.1.1 Attaching Battery Pack to Detector .......................................................................................................... 26
4.1.2 Installing the Battery into the Charger ..................................................................................................... 27
4.2 Routine Operation ................................................................................................................................ 27
5 IT NETWORK ............................................................................................................................. 28
5.1 Purpose for IT Network ....................................................................................................................... 28
5.2 Required Characteristics ...................................................................................................................... 28
5.3 Required Configuration ....................................................................................................................... 28
5.4 Technical Specifications (Only for CE) .............................................................................................. 28
5.5 Intended Information Flow .................................................................................................................. 29
5.6 Hazardous Situations Resulting from Failure of the IT Network ....................................................... 29
5.7 Warning ............................................................................................................................................... 29
5.8 Changes to IT Network ........................................................................................................................ 29
6 TECHNICAL SPECIFICATIONS ...................................................................................................... 30
6.1 Detector ................................................................................................................................................ 30
6.2 Power Adapter ..................................................................................................................................... 31
6.3 Battery Charger .................................................................................................................................... 31
6.4 Battery Pack ......................................................................................................................................... 32
6.5 Environment Requirements ................................................................................................................. 32
7 SERVICE INFORMATION ............................................................................................................ 33
7.1 Product Life ......................................................................................................................................... 33
7.2 Sterilization and Shelf Life .................................................................................................................. 33
7.3 Regular Inspection and Maintenance .................................................................................................. 33
7.3.1 Daily Inspection ........................................................................................................................................ 33
7.3.2 Monthly and Yearly Inspection ................................................................................................................ 34
7.4 Troubleshooting ................................................................................................................................... 34
7.5 Customer Service ................................................................................................................................. 34
7.6 Manufacturer Information ................................................................................................................... 35

Mars1717XF User Manual Safety Information
1
Copyright © iRay Technology Co., Ltd.
1 Safety Information
1.1 Label Description
All labels shown below are for description and explanation only. The actual labels may vary due to product enhancement.
Packaging Box
Mars1717XF-GSI
5
5%
95%
55℃
-20℃
GSI
無線電子平板探測器
產品型號:
接入電源:
GSI
適配器供電輸入
電源供電輸入
iRay Technology Co. , Ltd.
RM202, Building 7, No. 590, Ruiqing RD.
Zhangjiang East, Pudong, 201201 Shanghai
P.R.China
www.iraygroup.com
上海奕瑞光電子科技股份有限公司
中國上海市浦東新區瑞慶路
CN
20XX-XX
UDI
(01)06970569090320(11)210618(17)280617(21)XXXXXXXXXXXXXX
Made in China
MD
590号9幢2層202室
4700
4700
Contains IC: 25116-01070189

Mars1717XF User Manual Safety Information
2
Copyright © iRay Technology Co., Ltd.
Mars1717XF-CSI
Battery Charger
Battery Pack
------------------
MD
CSI
無線電子平板探測器
產品型號:
接入電源:
CSI
適配器供電輸入
電源供電輸入
iRay Technology Co. , Ltd.
RM202, Building 7, No. 590, Ruiqing RD.
Zhangjiang East, Pudong, 201201 Shanghai
P.R.China
www.iraygroup.com
上海奕瑞光電子科技股份有限公司
中國上海市浦東新區瑞慶路590号9幢2層202室
CN
20XX-XX
UDI
(01)06970569090313(11)210618(17)280617(21)XXXXXXXXXXXXXX
Made in China
4700
4700
Contains IC: 25116-01070189

Mars1717XF User Manual Safety Information
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Copyright © iRay Technology Co., Ltd.
Symbol Explanation
This side up
Fragile, handle with care
Keep dry
Stacking limit by number
Temperature limits
Humidity limits
Keep away from direct sunlight
Indicates the manufacturer’s 19-digit serial number:
iRay Technology’s authorized representative in the European community
Indicates the information of the manufacturer, including the name and address of the manufacturer
Caution! Consult accompanying documents
Consult instructions for use
When the end user intends to discard the product, it must be sent to separate collection facilities
for recovery and recycling
Indicates the degrees of protection provided by enclosure (IP Code) against solid objects or liquids
is equivalent to IP56
Indicates the country (CN refers to China) where the product is manufactured
Use-by date
Non-ionized electromagnetic radiation
5
55℃
-20℃
5%
95%
A
1
A
2
A
3
A
4
B
1
B
2
C
1
C
2
L
M
1
M
2
D
1
D
2
Y
1
Y
2
X
1
X
2
X
3
X
4
Production Series No.
Production Date
Production Site
Production V
ersion No.
Derivative Type
Production Type
IP
56
CN
20XX-XX
20XX-XX-X
X

Mars1717XF User Manual Safety Information
4
Copyright © iRay Technology Co., Ltd.
Symbol Explanation
For prescription use only
European conformance mark, followed by a CE number
Federal Communications Commission certificate
Indicates this product is a medical device
Unique Device Identification
Represents the NRTL certification mark, proving the product has passed the cTUVus certification,
only limited to NRTL certification
Indicates the degrees of protection provided by enclosure (IP Code) against solid objects or liquids
is equivalent to IPX4
Type B applied part, marked on the detector
Handle with care, marked on the detector
Indicates the maximum allowed weight over a 4cm diameter circular area, marked on the detector
Indicates the operating temperature limits, marked on the detector
A safety sign indicating “Refer to the user manual”, marked on the detector
Power off (disconnect from the main switch)
Power on (connect to the main switch)
Direct current
1.2 Safety Precautions
1.2.1 Operation and Storage Environment
 Do not operate or store the equipment in or around flammable or corrosive gases, gas
mixtures, liquids, chemicals, or other substances.
Ignoring this warning may result in an explosion, fire, or electric shock, which may result in
personal injury, death, or substantial product damage.
Rx only
0197
5
℃
30℃
!
WARNING

Mars1717XF User Manual Safety Information
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Copyright © iRay Technology Co., Ltd.
 Do not operate the detector in a location with the following conditions. Ignoring this
warning may result in equipment failure, fire, or personal injury.
 Close to fluid or places where fluid is used
 Where is will be exposed to direct sunlight
 Close to the air outlet of an air-conditioner or ventilation equipment
 Close to a 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 an area prone to vibration
 On an incline or in an unstable area
 Non-medical equipment, such as battery chargers, wireless routers, and infrared devices,
should not be used near patients.
 All patients using active implantable medical devices should stay away from this product.
 Do not turn on the power switch when there is condensation on the detector or any of its
components or accessories.
Ignoring this warning may result in an explosion, fire, or electric shock, which may result in
personal injury, death, or substantial product damage.
1.2.2 Equipment, Interface, Power Source, and Cables
 Do not connect the detector to any component or accessory other than the manufacturer’s
specified ones. Do not use any power source other than the one provided with the equip-
ment.
Ignoring this warning may result in an explosion, fire, or electric shock, which may result in
personal injury, death, or substantial product damage.
 Be sure to turn OFF the power of the detector, including turning off the power supply or
removing the battery (if applicable) before connecting or disconnecting the cables or ac-
cessories.
 Do not touch the power supply, battery pack, detector, cable, connector, or any other
components with wet hands.
Ignoring this warning may result in an explosion, fire, or electric shock, which may result in
personal injury, death, or substantial product damage.
 To avoid the risk of electric shock, this equipment must be connected to a power supply
with protective earth.
 When connected to patient, it is only allowed be powered by battery and shall disconnect
adapter cord.
 Use only dedicated cables for the device. Do not use any other cables.
!
CAUTION
!
WARNING

Mars1717XF User Manual Safety Information
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Copyright © iRay Technology Co., Ltd.
 Observe and follow all safety information in this manual and on the warning labels on
the battery (if applicable).
Ignoring warnings could result in personal injury or product damage.
 Do not modify the cables or subject the cable to external stress or damage. Avoid placing
anything heavy, including the detector, on the cable, stepping on the cable, pulling the
cable, or subjecting the cable to excessive bending or bundling.
Ignoring this warning may result in cable failure, which may result in personal injury, death,
or product damage.
 Do not place excessive heavy objects on the equipment.
Otherwise, the internal sensor may be damaged and the equipment may not work normally to
acquire images.
 Do not exceed the maximum uniform load weight of 150 kg distributed across the surface
of the X-ray detector.
 Do not exceed the maximum load weight of 100 kg distributed on an area of 40 mm in a
diameter of the X-ray detector surface.
 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 use any power source other than the one provided with this equipment.
Otherwise, improper power connection may lead to fire or electric shock.
 Only dedicated cables can be used on this equipment. Do not use any cable other than
those supplied with this product.
 The power cord plug must be firmly inserted into the power socket.
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.
 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 connect a multiple portable socket-outlet or extension cord to the equipment.
Otherwise, it may result in fire or electric shock.
 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 immediately in case of an emergency.
 Be sure to disconnect the power cable by holding the plug or connector, not by pulling
the cable.
If you pull the cable too hard, the core wire may be damaged, resulting in fire or electric shock.
1.2.3 Handling
 Personnel not authorized by iRay are prohibited to open the equipment enclosure.
Ignoring this warning may result in an explosion, fire, or electric shock, which may result in
personal injury, death, or substantial product damage.
 Do not touch the interface and power unit or cable and the patient at the same time. Do
not let the patient touch the interface and power unit or cable. Have the patient take a
fixed posture and do not let the patient touch parts unnecessarily.
!
CAUTION
!
WARNING

Mars1717XF User Manual Safety Information
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Copyright © iRay Technology Co., Ltd.
Ignoring this warning may cause electrical shock and/or unknown hazards, which may result
in severe personal injury, death, or substantial product damage.
 Do not handle the equipment with wet hands.
Otherwise, it may result in electric shock that could result in death or serious injury.
 Make sure the equipment is used on a flat and stable surface to prevent bending and
deformation of the equipment.
Otherwise, the internal image sensor may get damaged.
 If the detector is placed vertically or in any tilted position, the X-ray detector must be
securely placed in the Bucky tray or securely fastened to the X-ray detector enclosure or
support structure.
Otherwise, the detector may tip over, causing injury to the patient, or damage to internal equip-
ment.
 Keep the detector under even load (same pressure) during image acquisition.
Otherwise, the quality of acquired images is not guaranteed.
 Do not spill liquids or chemicals onto the equipment. Do not let the equipment come into
contact with the patient's blood or other body fluids.
Otherwise, it may result in fire or electric shock. For avoiding such contact, the disposable
protective covers should be used to protect the equipment.
 Do not place any superfluous objects within the moving range of the parts of this product.
 Disconnect the power supply when the equipment is not used for the sake of safety.
1.2.4 Failure Handling
 Turn off the detector, unplug the adapter or battery power cord immediately and contact
your sales representative or local iRay distributor if any of the following occurs:
 When there is smoke, an odd smell or abnormal sound
 When liquid has been spilled into the equipment or a metal object has entered the equip-
ment through an opening
 When the equipment has been dropped and is damaged
 When liquid has been spilled into or on any part of the X-ray detector or power supply
(if applicable), or when the X-ray detector, its component, or accessory is dropped, un-
plug the power supply from the AC outlet, and immediately contact your sales repre-
sentative or local iRay distributor.
Further use under abnormal conditions may result in severe personal injury, death, or substan-
tial product damage.
PROHIBITED
!
CAUTION

Mars1717XF User Manual Safety Information
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Copyright © iRay Technology Co., Ltd.
1.2.5 Battery Pack
 If the enclosure is broken or overheating, or emits unusual odors, smoke, or leaks any-
thing. Avoid contact with any material leaking from the battery pack.
If any liquid comes into contact with your skin or eyes, wash the affected area with clean
running water and seek immediate medical attention.
 If this device is not in use for a long period of time (more than 5 days), store it with the
battery pack moved. Make sure to recharge it to 30%~50% every 3 months, and 50%~
70% every 6 months to maintain its best performance.
 Do not hit or squeeze the battery. Do not insert any object into the battery or use any
device to pry open the battery pack case.
Attempting to doing so will damage the battery case, which may cause the battery to release
toxic and hazardous substances, resulting in injuries such as electric shock, burns, or fire, and
render the battery unusable.
 Keep the battery away from fire, do not use it at high temperature, and do not charge the
battery near flammable materials.
 Do not invert positive and negative poles.
 Do not touch the battery with metal to prevent short circuit.
 Do not use non-standard batteries.
 Do not change the internal structure of the battery.
 Do not immerse the battery in water or other liquids, keep it dry when using the battery.
 Do not use batteries not provided by iRay.
 Do not charge damaged batteries or charge batteries with damaged chargers.
 Do not use the battery charger around the patient.
 Please remove the battery when the detector is not used for a long time.
1.2.6 Maintenance and Inspection
 Be sure to turn off the power of detector when the inspections indicated in this manual
are going to be performed. If the detector is powered by AC power supply, turn off the
power switch and/or unplug the AC power cord. If the detector is powered by a battery,
remove the battery.
Ignoring this warning may result in an explosion, fire, or electric shock, which may result in
personal injury, death, or substantial product damage.
 NEVER use alcohol, ether and other flammable cleaning agent to clean the equipment
for the sake of safety. NEVER use methanol, benzene, acid, alkali or other corrosive liq-
uids to clean the equipment.
 The X-ray detector must be repaired by X-ray detector manufacturer authorized person-
nel only.
Ignoring this warning may result in explosion, fire, electric shock, or unknown hazards, which
may result in severe personal injury, death, or substantial product damage.
!
CAUTION
PROHIBITED
!
WARNING

Mars1717XF User Manual Safety Information
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Copyright © iRay Technology Co., Ltd.
 Clean the plug of power cord periodically by unplugging it from the AC outlet and re-
move dust and dirt from the plug, its periphery and AC outlet with a dry cloth.
If the power cord is left plugged in for an extended period of time in a dusty, dark and humid
environment, the dust around the outlet will absorb moisture, possibly causing insulation fail-
ure and a fire.
 Make sure that the equipment’s surface & plugs are dry before turning ON the power.
Otherwise, it may result in fire or electric shock.
1.3 Notes for Using the Equipment
Pay attention to the following precautions when using the equipment. Otherwise, the equipment 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 equipment daily and confirm that it works properly.
 When room is heated up suddenly in cold areas, it will cause condensation on the equipment. In this case, wait
until the condensation evaporates before performing an exposure. If condensation occurs during the use of the
equipment, the images captured may suffer from quality problems. When an air-conditioner is used, be sure to
raise/decrease temperature gradually to ensure that the temperature difference between room and equipment will
not cause condensation.
 The detector should be warmed up for 20 minutes before exposure or creation of calibration template.
 During Exposure
 Do not move the powecable or Ethernet cable during exposure. Otherwise, it may cause image noise, artifacts or
incorrect images.
 Do not use the equipment in areas with strong magnetic field. Otherwise, it may cause image noise, artifacts or
incorrect images.
 Do not make an exposure within 60 seconds after 4 full range exposures. Otherwise, the image will be incorrect.
Do not make an exposure within 30 seconds after a full-range exposure. The larger the dose used, the longer the
wait should be before the next exposure.
 During image acquisition, detector should not be influenced in a physical or electrical way.
!
CAUTION

Mars1717XF User Manual Safety Information
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Copyright © iRay Technology Co., Ltd.
 After Exposure
If the detector will not be used for 5 days, it is required to take out the battery. If the battery will not be used for a long
time, it must be charged to 30%~50% every 3 months or 50%~70% every 6 months.
 Disinfection and Cleaning
① ② ③
Dehydrated ethanol Yes Yes Yes
Isopropyl alcohol
(Concentration of 99.0% or more) Yes Yes Yes
After every examination, wipe the patient contact surfaces or any other surfaces of FPD with dehydrated ethanol or
isopropyl alcohol to prevent the risk of infection. The accessories include battery, charger, adaptor and DC adaptor can
also be cleaned by dehydrated ethanol or isopropyl alcohol. However, the cleaning must be operated under the condition
that the FPD and accessories are not electrified. The FPD and accessories cannot be electrified until the cleanser is fully
evaporated. For details on how to sterilize the device, consult a specialist.
① Do not spray the detector directly with disinfectants or detergents.
② Wipe it with a cloth slightly damped with a neutral detergent. Do not use solvents such as alcohol, thinner, benzene,
acid and base. Doing so may damage the surface of the equipment.
③ It’s recommended to use a waterproof non-woven cover as the isolated layer between detector and the blooding
patient.
2
3
41

Mars1717XF User Manual Regulatory Information
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Copyright © iRay Technology Co., Ltd.
2 Regulatory Information
2.1 Medical Equipment Classification
Mars1717XF has two power supply modes (power adaptor and battery pack) and a single way for signal transmis-
sion (wireless).
Protection type against electrical shock Class I equipment, using medically approved adaptor supply
Internally powered equipment, using battery power supply
Degree of protection against electrical shock B Type
Protection degree against water penetration IPX4 (Detector)
IPX0 (Charger-KX)
Mode of operation Continuous operation
Flammable anesthetics
Not suitable for use in situation with flammable anesthetic mix-
ture with air, oxygen or nitrous oxide
Not suitable for use in oxygen-rich situation
2.2 Safety Standard Reference
The applicable safety standards for this product covers the product host, battery charger, rechargeable battery (if
applicable) and other accessories.
No. Standard
1 IEC 60601-1:2005 +CORR.1 (2006) + CORR. 2 (2007) + AM1 (2012)
2 EN 60601-1:2006+A11:2011+ A1:2013+A12:2014
3 BS EN 60601-1:2006+A11:2011
4 ANSI/AAMI ES60601-1:2005/(R)2012+A1:2012+ C1:2009/(R)2012+A2:2010/ (R)2012
5 CAN/CSA-C22.2 No.60601-1:14
6 KS C IEC 60601-1
7 SS-EN 60601-1:2006+A11:2011+A1: 2013+AC1: 2014+A12:2014
8 IEC 60601-2-54:2009+A1:2015
9 CAN/CSA-C22.2 NO. 60601-2-54:11
10 KS C IEC 60601-2-54:2012
11 SS-EN 60601-2-54:2010+A1:2015
12 IEC 60601-1-6:2010+A1:2013

Mars1717XF User Manual Regulatory Information
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Copyright © iRay Technology Co., Ltd.
No. Standard
13 CAN/CSA-C22.2 NO. 60601-1-6:11+A1:2015
14 KS C IEC 60601-1-6:2011
15 EN 60601-1-6:2010+A1:2015
16 EN 60601-1-2:2015/IEC 60601-1-2:2014
17 IEC 62133:2012
18 IEC 62366:2007, AMD1:2014
2.3 Guidance and Manufacturer’s Declaration For EMC
2.3.1 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
Voltage fluctuations and
flicker
IEC 61000-3-3
Compliance
2.3.2 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 mag-
netic fields IEC 61000-4-8 30A/m 50Hz or 60Hz

Mars1717XF User Manual Regulatory Information
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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 AC 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 in-
duced 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
At 0º, 45º, 90º, 135º, 180º, 225º, 270º and 315º
0% UT; 1 cycle
70% UT; 25/30 cycles
Single phase: at 0º
Voltage interruptions IEC 61000-4-11 0% UT; 250/300 cycles

Mars1717XF User Manual Regulatory Information
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Copyright © iRay Technology Co., Ltd.
 Recommended Separation Distances
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/Unshielded Number
(piece)
Cable
Classification
AC power cable 1.8m Unshielded 1 piece AC power
DC power cable 3m Unshielded 1 piece DC power
 Electromagnetic Compatibility (EMC)
The Mars1717XF series wireless flat panel detector needs special precautions regarding EMC, and should be installed
by local supplier or authorized personnel and follow EMC guidance in the user manual. The Mars1717XF series product
when in use may interfere with portable and mobile RF communication devices such as mobile (cellular) telephones.
Electromagnetic interference may result in incorrect operation of the system and a potentially dangerous situation.
The Mars1717XF series wireless flat panel detector should not be stacked with or adjacent to other devices. If inevitable,
verify the detector.
The Mars1717XF series wireless flat panel detector conforms to this EN 60601-1-2:2015/IEC 60601-1-2:2014 standard
on both immunity and emissions.
Accessories, transmitters and cables other than those specified by the user manual or sold by local supplier may result
in increased emissions or decreased immunity of the detector.
2.4 Radio Frequency Compliance Information
Country Item
U.S.A
KDB 865664 D01
47 CFR part 15, subpart B
47 CFR part 15, subpart C 15.247
47 CFR part 15, subpart E 15.407
KDB447498 D01 v06 General Exposure Guidance