All rights reserved. No part of this manual may be reproduced or copied in any form by any
means—graphic, electronic, or mechanical, including photocopying, typing, or information
retrieval systems—without written permission.
Notices and Conventions
The information herein is based on the experience and knowledge relating to the
subject matter gained by Carestream Health, Inc. prior to publication. No patent license
is granted by this information. Carestream Health reserves the right to change this
information without notice, and makes no warranty, express or implied, with respect to
this information. Carestream Health shall not be liable for any loss or damage,
including consequential or special damages, even if loss or damage is caused by
Carestream Health’s negligence or fault.
Note:
Notes provide additional information, such as expanded explanations, hints, or reminders.
Important:
Important highlights critical policy information that affects how you use this manual and this
product.
CAUTION:
Caution points out a potentially hazardous situation which, if not avoided, might cause minor
or moderate injury.
Authorized Representative (European Union)
Carestream Health France
1, rue Galilée
93192 NOISY-LE-GRAND CEDEX
FRANCE
Importer for European Union
Carestream Health Netherlands B.V.
Bramenberg 12
3755 BZ Eemnes
The Netherlands
AJ4312 | 2020-02-10
-iii
Notices and Conventions
Federal law restricts this device to sale by or on the order of a physician.
If you witness or become aware of a potential safety issue with this equipment, take the
appropriate safety measures and report this to your Carestream Service representative
immediately.
CAUTION:
CAUTION:
-iv AJ4312 | 2020-02-10
Disclaimer
•Carestream shall not be liable to the purchaser of this product or third parties for
any damage, loss, or injury incurred by the purchaser or third parties as a result of
re, earthquake, any accident, misuse, or abuse of the product.
•Carestream shall not be liable for any damage, loss, or injury arising from
unauthorized modications, repairs, or alterations to the product or failure to
strictly comply with Carestream’s operating and maintenance instructions.
•Carestream 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 products by
Carestream.
•It is the responsibilities of the user or physician to maintain the privacy of image
data and provide medical care services. Carestream shall not be responsible for the
legality of image processing, reading, and storage nor shall it be responsible for loss
of image data for any reason.
•Information regarding the specications, compositions, and appearance of this
product is subject to change without prior notice.
Notices and Conventions
Copyright
•All rights reserved.
•No part of this publication may be reproduced in any form or by any means without
the written permission of Carestream. The information contained herein is designed
only for use with TRIMAX 43C Detector.
Correction and Calibration Management.................................................................................A-XIX
Correction and Calibration Template Synchronization......................................................A-XIX
Correction and Calibration Management...........................................................................A-XIX
Update the Firmware.................................................................................................................. A-XX
Publication History
ii AJ4312 | 2020-02-10
1Safety and Regulatory Information
Symbols
Symbols and Conventions
WARNING:
This is used to identify conditions under which improper use of the
product may cause death or serious personal injury.
This is used to indicate a prohibited operation.
This is used to indicate an action that must be performed.
Labels and Markings on the Equipment
This indicates that the product has passed CE certication and is
followed by the CE number.
AJ4312 | 2020-02-101-1
Safety and Regulatory Information
This is used to identify the manufacturer’s series number, which is after,
below, or adjacent to the symbol. The series number usually consists of
19 digits as shown in the following example:
1A2A3A4 B1B2 C1C2 L M1M2 D1D2 Y1Y2 X1X2X3X4
•1A2A3A4 - Product code
•B1B2 - Derived classes
•C1C2 - Version
•L - Production site
•M1M2 - Month
•D1D2 - Day
•Y1Y2 - Year
•X1X2X3X4 - Numerical order
This indicates the name and address of the manufacturer.
This indicates the name and address of a Carestream authorized
representative in the European region.
This indicates consulting the user guide for general information.
Safety sign: Dangerous Voltage
Handle with care.
This indicates operational temperature limits.
1-2 AJ4312 | 2020-02-10
Safety and Regulatory Information
This indicates storage temperature limits.
This indicates the product radiates a wireless signal.
Package symbol: Fragile
Package symbol: Keep away from sunlight.
Package symbol: Keep dry.
This indicates the humidity limits.
Keep the product upright.
Do not roll the transportation packaging.
This indicates the stacking limit number.
FDP is allowed to withstand 100 kg on its surface.
Rx onlyDevice is for prescription use only.
IPIPX1 for working surface only.
AJ4312 | 2020-02-101-3
Safety and Regulatory Information
Cautions
Environment for Installation and Use
Environment for
Installation and Use
WARNING:
Do not use or store the product near ammable chemicals such as alcohol,
thinner, benzene, etc.
Chemicals that are spilled or evaporated may result in re or electric shock
through contact with electric parts inside the product. Also, some
disinfectants are ammable. Be sure to take care when using them.
WARNING:
Do not connect the equipment with anything other than the specied
connectors to avoid re or electric shock.
Installation and
Environment of Use
WARNING:
Keep all patients with active implantable medical devices away from the
product.
CAUTION:
Do not install the product in any of the locations listed below to avoid
failure, malfunction, falling, re, or injury.
•Close to facilities where water is used
•Where there is exposure 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 areas prone to vibration
•On an incline or in an unstable area
1-4 AJ4312 | 2020-02-10
Installation and
Environment of Use
Safety and Regulatory Information
CAUTION:
Do not allow cables to become tangled to avoid a malfunction of the
product.
Do not get your feet caught by a cable to avoid tripping and injury.
CAUTION:
Non-medical equipment such as battery chargers and access point and
infrared register tools cannot be used in the vicinity of a patient.
Power Supply
AJ4312 | 2020-02-101-5
Safety and Regulatory Information
Do not operate the product with a power supply other than the one
indicated on the rating label to avoid re or electric shock.
Do not handle the product with wet hands to avoid electric shock that could
result in death or serious injury.
Power Supply
Do not place heavy object on cables and cords. Co not pull, bend, bundle, or
step on them to prevent damage to the sheath. Do not alter them.
Avoid damage to the cords, which could result in re or electric shock.
Do not supply power from the same AC outlet to more than one product to
avoid re or electric shock.
WARNING:
WARNING:
WARNING:
WARNING:
Power Supply
WARNING:
Do not turn on system power when condensation has formed on the
equipment to avoid re or electric shock.
WARNING:
Do not connect multiple portable socket outlets or extension cords to the
system to avoid re or electric shock.
WARNING:
Connect this product only to a power supply with protective earth to avoid
re or electric shock.
WARNING:
Do not use the adapter cord when connecting the panel to a patient.
1-6 AJ4312 | 2020-02-10
Power Supply
Safety and Regulatory Information
WARNING:
Securely insert the power cord into the AC outlet to avoid a contact failure.
If a contact failure occurs or if metal objects come in contact with the
exposed metal prongs of the plug, re or electric shock may result.
WARNING:
Be sure to turn off the power before connecting or disconnecting the cords
to avoid an electric shock that could result in death or serious injury.
WARNING:
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 re or
electric shock.
Power Supply
CAUTION:
•Always connect a three-core power cord plug to a grounded AC power
outlet.
•Keep the outlet free of obstacles for easy access to disconnect the plug
at any time and in an emergency.
•Be sure to ground the product to an indoor grounded connector. Be sure
to connect all the grounds of the system to common ground.
CAUTION:
Do not use any power source other than the one provided with the product
to prevent leakage that could result in re or electric shock.
AJ4312 | 2020-02-101-7
Safety and Regulatory Information
Handling
No modication is allowed. Never disassemble or modify the product to
avoid re or electric shock.
The product incorporates parts that may be hazardous or cause electric
shock Touching them may cause death or serious injury.
Handling
Do not place an object on top of the product. The object may fall and cause
an injury.
Metal objects such as needles or clips that fall into the product or spilled
liquid may result in re or electric shock.
Do not strike, drop, or cause a strong jolt to the product to prevent damage
and avoid re or electric shock.
WARNING:
WARNING:
WARNING:
Handling
WARNING:
Do not place the product and pointed objects together to prevent damage.
If so, it should be used in Bucky.
WARNING:
Have the patient take a xed 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.
1-8 AJ4312 | 2020-02-10
Safety and Regulatory Information
CAUTION:
Do not spill liquid or chemicals onto the equipment. Do not allow an injured
patient’s blood or body uids contact with the equipment.
Doing so may result in re or electric shock.
Handling
Handling
In such a situation, protect the equipment with a disposable cover as
necessary.
CAUTION:
For safety Turn OFF the power and remove the plug for all equipment when
not used.
CAUTION:
Handle the product carefully.
Do not submerge the product in water.
CAUTION:
The internal image sensor may be damaged if struck or dropped. If the
product is dropped, the drop sensor inside would record and the product
would not be under warranty.
AJ4312 | 2020-02-101-9
Safety and Regulatory Information
Do not place excessive weight on the panel to avoid damage to the internal
image sensor and an incorrect image.
Patients stand on the product temporarily, and the intended weight can be
135 kg.
Based on the internal TFT character, cannot load the dynamic forces due to
loading from persons
Load Limit
CAUTION:
Handling
Uniform load:150 kg over the whole area of the surface
Local load:100 kg on an area 4 cm diameter
1-10 AJ4312 | 2020-02-10
Handling
Safety and Regulatory Information
CAUTION:
Be sure to use the product on a at surface to prevent the product from
bending and doing damage to the internal image sensor. Be sure to securely
hold the product while using it in an upright positions to prevent the
product from tipping or ipping over, resulting in injury to the user or patient
damage to the inner device.
Keep the same pressure on the product when acquiring an image to avoid
an incorrect image.
AJ4312 | 2020-02-101-11
Safety and Regulatory Information
•Do not use the product close to re or in high temperature.
•Do not invert the positive and negative poles.
•Do not allow the product to make contact with metal to avoid a short
•Do not insert sharp objects into the battery.
•Do not strike the battery.
•Do not stand on the battery.
•Do not use the battery outside of the guidelines.
Handling
•Do not dispose of the battery or change the inner structure.
•Do not submerge the battery in water. When in use, do not allow the
•Use a charger to charge the battery following the GB 9706.1 Standards
•Do not replace the battery provided with one from another company.
•Do not use a damaged charger to charge the battery.
•Only qualied personnel may replace the battery inside the main unit.
•Do not touch the output connector for the adapter.
•Do not remove the battery when the detector is powered on only with
•Replace the DC power cable if either of the following occurs:
CAUTION:
circuit.
battery to have contact with water. Store the battery in a dry place.
provided.
the battery.
•An arc occurs at the detector interface when connecting the cable
•The power indicator is not illuminated after connecting the cable
1-12 AJ4312 | 2020-02-10
Maintenance and Inspection
WARNING:
•Turn off the power of the product and disconnect the power cord of the
adapter before cleaning.
•Never use alcohol, ether, and other ammable cleaning agent for safety.
Never use methanol, benzene, and acid to avoid corrosion on the
equipment.
•Do not place the product in liquid.
Safety and Regulatory Information
Maintenance and
Inspection
When a Problem Occurs
WARNING:
Make sure that the surface and connectors are dry before turning on the
product to avoid re or electric shock.
WARNING:
Clean the power cord connector periodically. Disconnect the connector from
the AC outlet. Use a dry cloth to remove dust or dirt from the connector, its
periphery, and the AC outlet.
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 re.
WARNING:
For safety reasons, be sure to turn off the power when performing the
inspections indicated in this manual to avoid electrical shock.
WARNING:
When a Problem Occurs
If any one of the following occurs, immediately disconnect the power cord
of the adapter or battery, and contact your sales representative or local
dealer:
•When there is smoke, an odd odor, or abnormal sound
•When liquid has spilled into the equipment or a metal object has entered
through an opening
•When the product has been dropped and damaged
AJ4312 | 2020-02-101-13
Safety and Regulatory Information
Medical Equipment Classication
Type of protection against electrical shock
Degree of protection against electrical shockType-B applied part
Degree of protection against ingress of waterIPX1
Mode of operationContinuous operation
Flammable anesthetics
External electrical power source equipment Class I
Equipment (medical approved adapter)
Internal electrical power source equipment (battery)
Not suitable for use in the presence of a ammable
anesthetic mixture with air or with oxygen or nitrous
oxide
Not suitable for use in an oxygen-rich environment
1-14 AJ4312 | 2020-02-10
Safety and Regulatory Information
Standards
ISO 13485:2016Medical devices — Quality management systems
— Requirements for regulatory purposes
IEC 60601-1:2005/AMD1:2012Medical electrical equipment — Part 1: General
requirements for basic safety and essential
performance
IEC 60601-1-2:2014/EN60601-1-2:2015Medical electrical equipment — Part 1-2: General
requirements for basic safety and essential
performance — Collateral standard:
Electromagnetic disturbances v Requirements and
tests
IEC 60601-2-54:2018/EN 60601-2-54:2019Medical electrical equipment — Part 2-54:
Particular requirements for the basic safety and
essential performance of X ray equipment for
radiography and radioscopy
IEC 62133-2:2017Secondary cells and batteries containing alkaline or
other non-acid electrolytes — Safety requirements
for portable sealed secondary lithium cells, and for
batteries made from them, for use in portable
applications — Part 2: Lithium systems
IEC 62220-1-1:2015/EN 62220-1-1:2015Medical electrical equipment — Characteristics of
digital X-ray imaging devices — Part 1-1:
Determination of the detective quantum efciency
The TRIMAX 43C Detector uses RF energy
only for its internal function. Therefore, its
RF emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
The TRIMAX 43C Detector is suitable for
use in all establishments, including
domestic establishments and those directly
connected to the public low voltage power
supply network that supplies buildings
used for domestic purposes.
Test Levels
Professional healthcare facility
environment
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Radiated RF EM eldIEC 61000-4-3
Proximity elds from RF wireless
communications equipment
Rated power frequency
magnetic elds
AJ4312 | 2020-02-101-17
IEC 61000-4-3
IEC 61000-4-8
3 V/m
80 MHz–2.7 GHz
80 % AM at 1 kHz
Refer to Proximity Fields From RF Wireless
Communications Equipment
30 A/m
50 Hz or 60 Hz
Safety and Regulatory Information
Proximity Fields From RF Wireless Communications Equipment
Test Frequency
(MHz)
Band (MHz)
Professional healthcare facility environment
Test Levels
385380–390Pulse modulation 18 Hz, 27 V/m
450430–470FM, ±5kHz deviation, 1 kHz sine, 28 V/m
710
704–787Pulse modulation 217 Hz, 9 V/m745
780
810
800-–960Pulse modulation 18 Hz, 28 V/m870
930
1720
1700–1990Pulse modulation 217 Hz, 28 V/m1845
1970
24502400–2570Pulse modulation 217 Hz, 28 V/m
5240
5500
5100–5800Pulse modulation 217 Hz, 9 V/m
5785
Input AC Power Port
Emissions TestEMC Standard
Electrical fast transients/burstIEC 61000-4-4
Test Levels
Professional healthcare facility environment
±2 kV
100 kHz repetition frequency
1-18 AJ4312 | 2020-02-10
Emissions TestEMC Standard
Safety and Regulatory Information
Test Levels
Professional healthcare facility environment
Surges
IEC 61000-4-5±0.5 kV, ±1kV
Line-to-line
Surges
IEC 61000-4-5±0.5 kV, ±1kV, ±2 kV
Line-to-ground
Conducted disturbances
IEC 61000-4-6
induced by RF elds
Voltage dips
IEC 61000-4-11
Voltage dipsIEC 61000-4-11
3 V, 0.15 MHz–80MHz
6 V in ISM bands between 0.15 MHz and
80 MHz
80 % AM at 1 kHz
0 % UT; 0.5 cycle
At 0 º, 45 º, 90 º, 135 º, 180 º, 225 º, 270 º and
315 º
0 % UT; 1 cycle
and
70 % UT; 25/30 cycles
Single phase: at 0 º
Voltage interruptionsIEC 61000-4-110 % UT; 250/300 cycles
Signal Input/Output Parts Port
Test Levels
Emissions TestEMC Standard
Professional healthcare facility environment
Electrostatic DischargeIEC 61000-4-2
±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV air
Electrical fast transients/burstIEC 61000-4-4
±1 kV
100 kHz repetition frequency
AJ4312 | 2020-02-101-19
Safety and Regulatory Information
Emissions TestEMC Standard
Test Levels
Professional healthcare facility environment
Conducted disturbances
IEC 61000-4-6
3 V, 0.15 MHz–80 MHz
induced by RF elds
6 V in ISM bands between 0.15 MHz and 80
MHz
80 % AM at 1 kHz
Reference Cables Provided Against EMC
Cable
Recommended
Cable Length
Shielded or
Unshielded
NumberCable Classication
AC Power Cable3 mUnshielded1 pcsAC Power
DC Power Cable3.5 mUnshielded1 pcsDC Power
LAN Cable
3 mShielded1 pcsSignal
(conguration mode)
Important Information Regarding Electromagnetic Compatibility (EMC)
TRIMAX 43C requires special precautions regarding EMC and needs to be installed only
by Carestream or authorized personnel and put into service according to EMC
information provided in the user manual.
TRIMAX 43C in use may be susceptible to electromagnetic interference from portable
and mobile RF communications such as mobile (cellular) telephones. Electromagnetic
interference may result in incorrect operation of the system and create a potentially
unsafe situation. The minimum distance between the panel and other equipment
should be larger than 12 inch.
TRIMAX 43C conforms to this EN60601-1-2:2015 standard for both immunity and
emissions. Nevertheless, special precautions need to be observed.
The use of accessories, transmitters, and cables other than those specied by this user
manual, with the exception of accessories and cables sold by Carestream as TRIMAX
43C replacement parts for inner components, may result in increased emission or
decreased immunity.
1-20 AJ4312 | 2020-02-10
Radio Frequency Compliance
CountryItem
FCC Code CFR47 Part15B (2018)
ANSI C63.4(2014)
FCC CFR47 Part 15C (2018)Radio Frequency Devices
ANSI C63.10(2013)
KDB 558074 D01 15.247 Meas Guidance v05r02
FCC CFR47 Part 15E (2018) Unlicensed National information
infrastructure devices
ANSI C63.10(2013)
Safety and Regulatory Information
U.S.A
KDB 789033 D02 General UNII Test Procedures New Rules
v02r01
KDB 662911 D01 Multiple Transmitter Output v02r01
248227 D01 802.11 Wi-Fi SAR v02r02
447498 D01 General RF Exposure Guidance v06
648474 D04 Handset SAR v01r03
865664 D01 SAR measurement 100MHz to 6GHz v01r04
865664 D02 RF Exposure Reporting v01r02
941225 D06 Hotspot Mode v02r01
616217 D04 SAR for laptop and tablets v01r02
AJ4312 | 2020-02-101-21
Safety and Regulatory Information
CountryItem
ETSI EN 300 328 V2.1.1
ETSI EN 301 893 V2.1.1
ETSI EN 300 440 V2.1.1
ETSI EN 301 489-3 V2.1.1
Draft ETSI EN 301 489-1 V2.2.1
Draft ETSI EN 301 489-17 V3.2.0
European Union
EN 55032: 2015
EN 55035: 2017
EN 61000-3-2: 2014
EN 61000-3-3: 2013
EN 50566: 2017
EN 62209-2: 2010
EN 62479: 2010
FCC Compliance
•The panel has been tested to comply with limits for a Class B digital device,
pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation.
•Operation is subject to the following two conditions.
The panel may not cause harmful interference.
The panel must accept any interference received, including interference that may
cause undesired operation.
•The panel generates, uses, and radiates radio frequency energy and, if not installed
and used in accordance with the instruction, may cause harmful interference to
radio communications. However, there is no guarantee that interference will not
occur in a particular installation. If the panel does cause harmful interference to
radio or television reception, which can be determined by turning the panel off and
on, the user is encouraged to correct the interference by one or more of the
following measure.
•Reorient or relocate the antenna.
•Increase the separation between the panel and receiver.
•Connect the panel into an outlet different from the receiver is connected.
•Consult the distributor or an experienced radio/TV technician for help.
1-22 AJ4312 | 2020-02-10
Correction and Calibration Template Generation
Correction and calibration should be performed after installation and every six months.
The new correction and calibration should be performed after any major change on
the system settings and hardware conguration.
Safety and Regulatory Information
AJ4312 | 2020-02-101-23
Safety and Regulatory Information
Battery Safety Standards
StandardsDescription
Secondary cells and batteries containing alkaline or other non-
CAN/CSA E62133:13 1st Ed. Rev.
UL 62133, 1st Ed. Rev.
UL 2054Household and commercial batteries
IEC 62133-2:2017
acid electrolytes — Safety requirements for portable sealed
secondary cells, and for batteries made from them, for use in
portable applications First Edition
Secondary cells and batteries containing alkaline or other nonacid electrolytes — Safety requirements for portable sealed
secondary cells, and for batteries made from them, for use in
portable applications First Edition
Secondary cells and batteries containing alkaline or other nonacid electrolytes — Safety requirements for portable sealed
secondary lithium cells, and for batteries made from them, for
use in portable applications — Part 2: Lithium systems
UN38.3
United Nations Recommendations on the Transport of
Dangerous Goods Manual of Tests and Criteria ST/SG/
AC.10/11/Rev.5/Amend.1 and Amend.2
1-24 AJ4312 | 2020-02-10
Safety and Regulatory Information
Intended Use and Essential Performance
Intended Use
These devices are indicated for digital imaging solutions designed to provide general
radiographic diagnosis for human anatomy including both adult and pediatric patients.
They are intended to replace lm/screen systems in all general-purpose diagnostic
procedures. This device is not intended for mammography or dental applications.
Essential Performance
For TRIMAX 43C, the intended use and the result of risk management, getting imaging
and function of data transmission is dened as essential performance.
Getting qualied dark image proves that essential performance does not inuence the
intended use. For the method of getting dark image, see the Installation and
Operation sections.
Application Specication
Patient Population
•Adult and pediatric patients
•Weight: not relevant
•Health: not relevant
•Nationality: multiple
•Patient state: patient is not user
•Gender: except for pregnant women
Pediatric Use: Guidance & Considerations
Special care should be exercised when imaging patients outside the typical adult size
range, especially smaller pediatric patients whose size does not overlap the adult size
range (e.g.less than 50 kg (110 lb) in weight and 150 cm (59 in) in height,
measurements which approximately correspond to that of an average 12 year old.
The following ranges of pediatric subpopulations are to be used as a guide for
manufacturers in developing medical devices:
Pediatric SubgroupApproximate Age Range
Newborn (Neonate)From birth to 1 month of age
InfantGreater than 1 month to 2 years of age
ChildGreater than 2 to 12 years of age
AdolescentGreater than 12 through 21 years of age
AJ4312 | 2020-02-101-25
Safety and Regulatory Information
Exposure to ionizing radiation is of particular concern in pediatric patients because:
1. For certain organs and tumor types, younger patients are more radio sensitive than
adults (the cancer risk per unit dose of ionizing radiation is higher for younger
patients);
2. Use of equipment and exposure settings designed for adults of average size can
result in excessive and unnecessary radiation exposure of smaller patients;
3. Younger patients have a longer expected lifetime putting them at higher risk of
cancer from the effects of radiation exposure.
To help reduce the risk of excessive radiation exposure, you should follow the ALARA
(As Low As Reasonably Achievable) principle and seek to reduce radiation dose to only
the amount necessary to obtain images that are adequate clinically.
Additional guidance and recommendation are provided by the Alliance for Radiation
Safety in Pediatric Imaging (Image Gently Alliance) https://www.imagegently.org/
Table 1: Techniques for Typical Body Parts
Body PartsPatient SizekVpmAsSIDGrid
Abdomen AP/PA
Very Low Birth Weight (Less than
5511mno
1.5 Kg)
Low Birth Weight (Between 1.5
551.61mno
and 2.5 Kg)
Newborn (Age is less than 1
701.61mno
month and Weight above than
2.5 Kg)
Infant (Age is between 1 month
7321mno
and 2 years)
Child (Age is between 2 years
757.11myes
and 12 years)
Preadolescent (Age is between 12
75141myes
years and 13 years)
Adolescent (Age is between 12
75201myes
years and 21 years)
Adult Small75181myes
Adult Medium80221myes
Adult Large85321myes
1-26 AJ4312 | 2020-02-10
Safety and Regulatory Information
Body PartsPatient SizekVpmAsSIDGrid
Chest PA/AP
Very Low Birth Weight5011m
no
Low Birth Weight5511mno
Newborn6511mno
Infant701.61mno
Child701.61mno
Preadolescent9021myes
Adolescent9021myes
Adult Small1101.81.8myes
Adult Medium1102.81.8myes
Adult Large12041.8myes
Very Low Birth Weight5011mno
Low Birth Weight5511mno
Newborn5711mno
Infant571.21mno
Extremities AP/PA
Child581.21mno
Preadolescent621.61mno
Adolescent6221mno
AdultRegarding adult details techniques
of Extremities, please refer to the
table of “Techniques for Adult
Extremities”
Table 2: Techniques for Adult Extremities
Adult Extremities ListkVpmAsSIDGrid
Ankle - AP5841no
Ankle - Lateral5841no
no
AJ4312 | 2020-02-101-27
Safety and Regulatory Information
Adult Extremities ListkVpmAsSIDGrid
Femur - AP70161yes
Femur - Lateral70101yes
Hand - PA531.81no
Hand - oblique531.81no
Humerus - AP757.11yes
Humerus - Lateral703.21yes
Knee - AP65101yes
Knee - Lateral65101yes
Wrist - PA551.81no
Wrist - Lateral551.81no
Intended Operator
All procedures should be carried out by an operator who has completed the
professional training offered by the company’s customer service staff.
Life Time
Lifetime: 7 years without frequency limit
1-28 AJ4312 | 2020-02-10
2Overview
The TRIMAX 43C Detector is a cassette-size, wireless x-ray at panel detector based on
amorphous silicon thin-lm transistor technologies. It is developed to provide the
highest quality of radiographic images with an active matrix of 3072×3072 with 139 um
pixel pitch. The detector supports wireless communication between the panel and the
workstation and is powered by an internal battery.
Scope
This manual contains information about the TRIMAX 43C. Information in the manual,
including the illustrations, is based on a prototype. If your system conguration does
not have features described in this manual, the information does not apply to your
detector.
Features
•Wireless static at panel detector used for general radiography
•Cassette-size
•Sync-shot exposure trigger
•CsI scintillation screen
•Easy-to-change cable and easy-to-update rmware
•Battery recycling
AJ4312 | 2020-02-10
2-1
Overview
Components and Specications
Product Components
Component Description
Detector
ItemDescriptionNotes
BDC jackFor optional power input
AEthernet portFor service
CDetector indicatorDetector indicator of control panel
DPower buttonPower button of control panel
EMode buttonMode switch
2-2 AJ4312 | 2020-02-10
ItemDescriptionNotes
FPower indicatorThe other Power indicator
GHandleOptional
Battery
Overview
ItemDescriptionNotes
ABattery label
BBattery interface8 pin battery connector
CPilot pin
DIndicatorInstallation direction indicator
Battery Charger
AJ4312 | 2020-02-102-3
Overview
ItemDescriptionNotes
ABattery Interface A8 pin battery connector
BBattery Interface BNot used
CBattery Interface CNot used
DIndicatorThe indicator denition is as follow
EThe limit ball plug/
FHand Pull Position/
GAC Jack220V (ac) input
Battery Charger Indicator
ItemName
APower Indicator
BCharging Indicator
CCharge Full Indicator
2-4 AJ4312 | 2020-02-10
X IndicatorOperating Status
All offNo power input
Overview
A indicator on
•AC power input
•Multiple batteries inserted
A indicator on
Battery insertion self test
B and C alternately blink 2 times
A and B indicator onBattery charging
A and C indicator onBattery capacity full, charging
stops
A indicator on
Battery is not charging properly
B and C alternately blinking
Two or more batteries charging cannot be charged at the same time. Charging will
automatically stop if more than one battery is inserted.
AJ4312 | 2020-02-102-5
Overview
Product Specications
Detector
ItemSpecications
ModelTRIMAX 43C
Image Sensora-Si (amorphous silicon) TFT
Pixel Size139 µm
Active Array3072 x 3072
Active Area (H x V)427.0 x 427.0 mm (16.8 x 16.8 in.)
Gray Scales16 bit
Spatial Resolution3.6 Lp/mm
Cycle TimeMin. 8.5 sec.
Power ConsumptionMax. 20 W
Dimension (L × W × H)460.0 x 460.0 x 15.0 mm (18.1 x 18.1 x
0.6 in.)
Weight (with one battery)4.68 kg (10.32 lb)
Image TransferWireless: IEEE802.11a/b/g/n/ac
2-6 AJ4312 | 2020-02-10
ItemSpecications
Overview
Data Transmission Rate (Wireless)
Battery
802.11b: Max. 11 Mbps
802.11a/g: Max. 54 Mbps
802.11n: Max. 300 Mbps (MIMO 2 x 2)
802.11ac: Max. 867 Mbps(MIMO 2 x 2)
ItemSpecications
ModelBattery-KV
Rated capacityTyp. 4180 mAh @ Discharge 0.2C
Nominal voltage10.8 V
Charge voltage12.6 ± 0.05 V
Discharged end voltage9 V
Charging methodCC-CV
AJ4312 | 2020-02-102-7
Overview
ItemSpecications
Operating temperature
Charge 0–60 °C (32–140 °F)
Discharge 0–60 °C (32–140 °F)
Storage temperature
≤3 month -20 °- +45 ° (-4–113 °F)
≤6 month -20°- +35 ° (-4–95 °F)
Relative humidity5 %~95 %
Dimension (L × W × H)210.0 x 115 x 7.5 mm (8.3 x 4.5 x 0.30in.)
Weight0.28 kg (0.62 lb)
Battery Charger
ItemSpecications
ModelCharger-Combo
Simultaneous Charging1 Battery Pack
Full Charging Time≤ 3 hr
Rated Power Supply90~264 V (ac)
Dimension (L × W × H)
240.0 x 184.0 x 38.0 mm
(9.4 x 7.2 x 1.52 in.)
Weight0.55 kg (1.2 lb)
2-8 AJ4312 | 2020-02-10
Overview
Power Supply
ItemSpecications
DC Power (Optional)24V (dc), 0.8A
Battery Package10.8V (dc), 1.78A
CAUTION:
The charging cable can only be used in areas not are accessible to the patient, such as in the
Bucky.
The product must be used with the approved adapter and CB certicate number
SG PSB-MD-00191.
Wireless Communication
ItemSpecications
Wireless StandardIEEE 802.11 a/b/g/n/ac
Frequency Range
2.412~2.472 GHz: ch1~ch13
5.18~5.24 GHz: ch36~ch48
5.745~5.85 GHz: ch149~ch165
Data Transmission Rate
802.11b: Max. 11 Mbps
802.11a/g: Max. 54 Mbps
802.11n: Max. 300 Mbps (MIMO 2x2)
802.11ac: Max. 867 Mbps(MIMO 2x2)
Modulation
802.11b:
CCK, DQPSK, DBPSK
802.11a/g/n:
64 QAM, 16 QAM, QPSK, BPSK
802.11ac:
256 QAM, 64 QAM, 16 QAM, QPSK, BPSK
Transmission PowerMax.17 dBm
AJ4312 | 2020-02-102-9
Overview
ItemSpecications
SecurityWPA, WPA-PSK, WPA2, WPA2-PSK, WEP 64
bit & 128 bit
Antenna2 dual band inner antenna
Mechanical Outlines
Use Environment
Operating
TemperatureTemperature
Change
5–35 °C
< 1k/min10 %–90 %
HumidityAtmospheric
Pressure
700–1060 hPa<10 kp/min
RH
Pressure Change
(1 kp=1.0197E-5Pa)
(41–95 °F)
Storage
-20–55 °C
< 1k/min5 %–95 % RH700–1060 hPa<10 kp/min
(1 kp=1.0197E-5Pa)
(-4–131 °F)
2-10 AJ4312 | 2020-02-10
Overview
TemperatureTemperature
Change
HumidityAtmospheric
Pressure
Pressure Change
TRIMAX 43 detectors shall operate at a specied altitude of not more than 3000.0 m (9842.5 ft). The
environment specic is only for the detector.
IT Network
Purpose for IT-network
Transmission of image data and command/status communication between the detector
and the workstation.
Required Features
Wireless communication follows IEEE 802.11a/b/g/n/ac protocol. It works on 2.4 GHz
and 5 GHz.
It supports at least 2 routers.
Hazardous Situations from Failure of the IT Network
•Incompatibility of the operating system is not compatible
•Inability to update or change software
•Incompatibility of the interface
•Inconsistency of interface or format leads to data distortion
•Data transfer protocol error
•Data output failure
Required Conguration
The wireless card and the detector must work on the same IP segment such as
192.168.8.XXX.
They must support IEEE 802.11a/b/g/n/ac.
Technical Specications
ItemSpecications
Wireless StandardIEEE 802.11a/b/g/n/ac
Frequency Range
2.412-2.472 GHz: ch1-ch13
5.18-5.24 GHz: ch36-ch48
5.745-5.85 GHz: ch149-ch165
AJ4312 | 2020-02-102-11
Overview
ItemSpecications
Data Transmission Rate
802.11b: Max. 11 Mbps
802.11a/g: Max. 54 Mbps
802.11n: Max. 300 Mbps (MIMO 2x2)
802.11ac: Max. 867 Mbps (MIMO 2x2)
Modulation
802.11b: CCK, DQPSK, DBPSK
802.11a/g/n: 64 QAM, 16 QAM, QPSK, BPSK
802.11ac: 256 QAM, 64 QAM, 16 QAM, QPSK, BPSK
SecurityWPA, WPA-PSK, WPA2, WPA2-PSK, WEP 64 bit, and 128 bit
Intended Information Flow
The detector sends the acquired image data to the workstation. The workstation sends
the user's commands to the detector. Please refer to the operation manual of the
console for detail.
Hazardous Situations Resulting From Failure of the IT-network
•Failure of completing essential performance
•Failure of nishingconguration of product
•Incompatibility of operating system
•Failure of change or update to software
•Compatibility of interface
•Data transfer protocol error
•Inconsistency of interface or format leads to data distortion
•Data output failed
Warning
Connection of the main unit to an IT network that includes other equipment could
result in previously unidentied risks.
The manufacturer of the x-ray machine should identify, analyze, evaluate, and control
these risks; subsequent changes to the IT-network could introduce new risks and
require additional analysis.
Changes to the IT-Network
•Changes in the IT-network conguration
•Connection of additional items to the IT-network
•Disconnecting of items from the IT-network
•Update of equipment connected to the IT-network
2-12 AJ4312 | 2020-02-10
Service Information
Product Lifespan
The estimated product lifetime is up to 7 years under appropriate regular inspection
and maintenance (battery 5 years).
Regular Inspection and Maintenance
In order to ensure the safety of patients and operator, and to maintain the
performance and reliability of the panel, be sure to perform regular inspections at least
once a year. If necessary, clean the panel, make adjustments, or replace consumables
such as fuses etc. There may be cases where an overhaul is recommended depending on
conditions. Contact Carestream service or your local dealer for regular inspection or
maintenance.
Repair
If the problem cannot be solved, contact Carestream service or your local dealer for
repairs. Please refer to the label and provide the following information:
Overview
Product Name:
Series Number:
Description of Problem: (as clearly as possible)
Replacement Parts Support
Main parts (those required to maintain the function of the product) needed to repair
the product will be stocked for 5 years after discontinuance of production.
AJ4312 | 2020-02-102-13
Overview
Disposal
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. Contact your local authorities for information about dropping off
waste products for recycling. If collection systems are not available, call Carestream Customer
Service for assistance.
CAUTION:
In the European Union, this symbol indicates that when the last user
wishes to discard this product, it must be sent to appropriate facilities for
recovery and recycling. See http://recycle.carestreamhealth.com for
additional information on the collection and recovery programs available
for this product.
2-14 AJ4312 | 2020-02-10
3Installation
Panel Installation
Install the Detector Battery
The detector can be powered by the battery package or DC power. The detector will be
activated as soon as power is supplied and will power off as soon as power is removed.
AJ4312 | 2020-02-103-1
Installation
1. Make sure that the connectors for the battery and battery compartment are
aligned.
2. Slide the battery into the battery compartment.
Note:
Make sure the battery level is >10 % of full capacity.
3. Slide the two battery lock levers toward the center of the detector..
Power on the Detector
On the control panel, the power button is used to power the detector on and off.
3-2 AJ4312 | 2020-02-10
Installation
To power on the detector, press and hold the power button for 4 seconds. The detector
must either have a battery installed with >10 % charge or have the DC power
connected.
To power off the detector, press and hold the power button for 4 seconds.
To reset the detector, press and hold the power button for 8 seconds.
Power Indicator
After booting up, the user can check the status LED indicator.
Operating Status
Power IndicatorLighting Status
OperatingBattery CapacityDC Input
OFFPower OFF----
Orange ONPower ON≤20%No
Green ONPower ON
•Battery capacity ≥20 %, no DC
input
•DC input (Optional)
Orange BlinkingPower OFF<20 %Yes
Green and Orange
Power OFF≥20 % and <95 %Yes
Blinking
AJ4312 | 2020-02-103-3
Installation
Operating Status
Power IndicatorLighting Status
OperatingBattery CapacityDC Input
Green Fast BlinkingPower OFF≥95 % and <100 %Yes
OFFPower OFF=100 %Yes
Link Indicator
Power IndicatorLighting StatusDescription
Off
•Shut down
•Wired connection broken and wireless connection
not ready
Green OnWired connection is built
Blue On
•Client mode, wireless connection is built
•AP mode, wireless AP is ready (Not used)
Blue Blinking
Client mode, no connection is built
Green and Blue
Initialization
Blinking
Status Indicator
Power IndicatorLighting StatusDescription
Off
•Shut down
•Exposure prohibit
3-4 AJ4312 | 2020-02-10
Power IndicatorLighting StatusDescription
Green OnExposure enable
Installation
Green Blinking
Image transmission
Orange OnError
Orange BlinkingSafety mode
Mode Indicator
Power IndicatorLighting StatusDescription
Off
•Shut down
•Wired connection is built
Green OnAP mode, wireless AP is ready (Not used)
Blue OnClient mode, wireless client is ready
Blue and Green Blinking
Initialization
AJ4312 | 2020-02-103-5
Installation
Button Function
PowerModeNote
ActionFPD Status
Power ON
Short holdNo actionHold for 4 seconds
Forced restartLong holdNo action
Power OFF
Exit the battery from
ship mode
Press 3 timesNo action
Enter safety modeShort holdLong hold
Forced restartPower ONLong holdNo action
Hold for more than 7
seconds.
Release the power button
when the power indicator is
ON.
Release after two short
presses (interval < 1second).
Power button: hold for 4
seconds
Mode button: hold for 7
seconds
Hold for more than 7
seconds, when the Power
indicator is OFF and then ON,
release Power button.
Enter/exit sleep modeDouble clickNo action
Release after two short
presses (interval <1second)
Hold for 4 seconds, Release
Power OFFShort holdNo action
the Power button when the
power indicator is OFF.
1. Hold the Mode button
hold for 7 seconds.
Restore default
conguration
Triple check
Short hold
Long hold
2. Press the Power button 3
times.
3. Short hold the Power
button for 4 seconds.
3-6 AJ4312 | 2020-02-10
ActionFPD Status
Wireless
ConnectionMode
Switch
Power ON
PowerModeNote
1. Hold the Mode button
hold for 7 seconds.
2. Release the Mode button
after Mode indicator
starts blinking, and then
press again in 5 seconds.
The mode starts
switching.
3. Press the Mode button to
No action
Long hold and
then short click
switch modes.
The Mode indicator
blinks at the
corresponding color.
4. Wait at intended mode,
the Mode indicator will
switch color after several
seconds.
Installation
•Blue = client
•Green = AP (Not
used)
AJ4312 | 2020-02-103-7
Installation
Install the Detector Battery Charger
1. Remove the battery from the battery charger.
2. Insert battery into battery charger in the orientation shown below.
3. Press the battery down into the battery compartment.
3-8 AJ4312 | 2020-02-10
Detector Battery Lock and Activation
To ensure the safety of the battery during transportation or storage, the battery can be
set to ship mode where it is locked and will not provide any voltage output.
Enter Ship Mode
MethodSteps
Factory conguration
Installation
Web write in
Exit Ship Mode
Web exit
1. Connect the adapter to the detector and
power it on.
2. Connect the other end of the adapter to
the PC.
3. Insert the battery into the detector.
4. Open a web browser and enter the
following address: http://10.0.1.150/
cgi-bin/shipmode.cgi?action=on
The battery is placed in ship mode.
MethodSteps
1. Connect the adapter to the detector and
power it on.
2. Connect the other end of the adapter to
the PC.
3. Insert the battery into the detector.
4. Open a web browser and enter the
following address: http://10.0.1.150/
cgi-bin/shipmode.cgi?action=off
The detector exits ship mode.
Adapter + FPD
AJ4312 | 2020-02-103-9
1. Connect the adapter to the detector and
power it on.
2. Insert the battery into the detector.
3. Press the power button for approximately
4 seconds to shut down the detector.
4. In the shutdown state, press the power
button 3 times to exit ship mode.
Installation
MethodSteps
Charger
1. Power on the charger.
2. Insert the battery into the charger for 3
to 5 seconds to exit ship mode.
3-10 AJ4312 | 2020-02-10
4Operation
Notes for Using
Do the following to ensure that the detector functions correctly.
Before Exposure
Inspect the detector daily and conrm it is working properly.
Check that there is no condensation on the any of the surfaces of the detector.
Condensation can be caused by the sudden heating of the room in cold areas. If this
occurs, wait until the condensation evaporates before performing an exposure or
problems may occur with the quality of captured images. When changing the
temperature in an air-conditioner environment, be sure to raise or lower the
temperature gradually.
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 900 nGy/s @70 KV.
Make sure the wave form of the energy going to the x-ray tube is square and not
pulse.
Check if the patient has recently been injected with a radio isotope; this may cause the
detector to transmit an image without performing an x-ray.
During Exposure
Important:
To prevent image noise, artifacts, or incorrect images, do not use the product near equipment
generating a strong magnetic eld.:
After Usage
Remove the battery from the detector if the detector will not be used for more than 5
days. If the battery is stored for an extended time, it should be charged (30 % to 50 %)
every 3 months or charged (50 % to 70 %) every 6 months.
Cleaning, Disinfection, and Sterilization of Patient Contact Surfaces
To prevent the risk of infection, wipe the patient contact surfaces after every
examination with a nonammable disinfectant, such as benzalkonium chloride or
benzalkonium bromide. For details on how to sterilize, consult a specialist.
AJ4312 | 2020-02-10
4-1
Operation
CAUTION:
Do not spray disinfectants or detergents directly onto the detector.
To prevent damage to the surface of the detector, wipe with a cloth slightly dampened with a
neutral detergent. Do not use solvents such as benzene and acid.
It is recommended to use a waterproof non-woven cover as the isolated layer between
the detector and a patient who is bleeding.
Applied Part
The front and back of the detector is an application part.
4-2 AJ4312 | 2020-02-10
Detector Position
To prevent abnormal light lines, place the detector behind the patient in the
orientation shown below.
Operation
AJ4312 | 2020-02-104-3
Operation
4-4 AJ4312 | 2020-02-10
Appendix (For Service Personnel Only)
Software and Settings
Main Interface
ButtonFunction
HomeHome page, shows the list of the detectors
AcquireAcquire images, free for use after connecting the detector
SDKCongure UI for SDK, free for use after connecting the detector
DetectorCongure UI for detector, free for use after connecting the detector
CalibrateCalibrate UI, for generation and management of the calibration template
Local FileImage management, free for use at any time
ConnectConnect the detector
CloseDisconnect the detector
SyncboxManage the syncbox
Message Box
Status Box
TabDescription
SNSerial number of the detector
StatusStatus of the detector, busy or ready
TaskThe task that is currently being executed
MessageInformation
AJ4312 | 2020-02-10I
Appendix (For Service Personnel Only)
TabDescription
Remaining power of the battery, shown as a percentage
Progress Bar
If the progress bar
•Is green while taking an x-ray, the image quality is acceptable
•Is not green while taking an x-ray, the image quality will be degraded
General Settings
ParameterDescriptionCan be Modied
Product No.Type number of the detectorNo
Sub Product No.Sub-type of the detectorNo
Serial No.Serial number of the panelNo
Main VersionVersion of the rmware of Main FPGANo
Main MB CPU VersionVersion of the MB CPU of Main FPGANo
MCU VersionVersion of the rmware of MCUNo
Arm VersionVersion of the App of ARMNo
Kernel VersionVersion of the Kernel of ARMNo
Inner SubowSub work-owYes
Prep CapModeReservedNo
Self CapEnableReservedYes
Self Cap Span TimeShould not be modied; keep the original valueYes
Trigger ModeTrigger modeYes
Sequence Interval TimeShould not be modied; keep the original valueYes
Set Delay TimeExposure window for Freesync modeYes
Exp Window TimeExposure Window for Software/Inner mode, the
Yes
value should not be larger than 10s
Acquire Delay TimeReservedYes
II AJ4312 | 2020-02-10
Appendix (For Service Personnel Only)
ParameterDescriptionCan be Modied
Integrate TimeShould not be modied; keep the original valueYes
Src PortPort number for detectorNo
Src IPIP address for detectorNo
Src MACMAC address for detectorYes
Dest PortPort number for PCNo
Dest IPIP address for detectorNo
Self Clear Enable
Related to Prep CapMode, the value should be
congured as On if Prep CapMode is congured
as PrepCapMode_ClearAcq. Otherwise, the value
should be Off
Yes
If the Trigger Mode is Software/Inner, the value
should be On
Self Clear Span TimeShould not be modied; keep the original valueYes
Hvg Prep OnReservedYes
Hvg XRay EnableReservedYes
Hvg XRay OnReservedYes
Tube Ready TimeReservedYes
Image Pkg Gap TimeReservedYes
Out Mode Cap TriggerReservedYes
SDK Settings
ParameterDescriptionCan be Modied
Host IPIP Address of local workstationYes
Host PortPort of local workstationYes
Ftp Download Host IPFTP download server IP; keep the same as Host IPYes
Ftp Download Host
Port
AJ4312 | 2020-02-10III
FTP download server Port; keep the same as Host
Port
Yes
Appendix (For Service Personnel Only)
ParameterDescriptionCan be Modied
Ftp Upload Host IPFTP upload server IP; keep the same as Host IPYes
Ftp Upload Host PortFTP upload server Port; keep the same as Host
Yes
Port
Network Settings
ButtonDescription
AddAdd the information of SSID and the AP Key
DelDelete the information of SSID and the AP Key
UpMove up the AP information
DownMove down the AP information
SelectSelect the AP
Read CongRead the parameters of the AP information when the detector is set as AP
Write CongWrite the parameters of the AP information when the detector is set as AP
Read Wi StatusRead the WIFI status of the current detector
Scan from FPDScan the AP
IV AJ4312 | 2020-02-10
Operating Modes
Software Mode
Block Diagram
Software mode is the basic way to acquire an x-ray image.
The workstation is a host device installed with iDetector and SDK. Installation describes
how to establish connections between the panel and workstation. In software mode,
the workstation does not control the x-ray generator. Users decide when to take x-rays.
Work Flow
1. Workstation receives prep request and sends clear command to the panel.
2. Panel receives clear from the workstation and starts clearing leakage from the
panel. Meanwhile, the panel sends an Exposure Prohibited message to the
workstation.
3. Panel nishesclear and sends an Exposure Enable message to the workstation.
4. Workstation shows Exposure Enable on the iDetector’s message bar to tell the
user to take the x-ray now.
5. User triggers the x-ray generator to initialize and do an anode rotation to prepare
for taking x-rays.
6. X-ray generator nishes preparation for taking x-rays and reminds the user to take
the x-ray.
7. X-ray generator starts releasing the x-ray.
8. X-ray generator nishes taking the x-ray.
9. Workstation receives acquire request and sends Data Acquisition command to
the panel.
10. Panel receives Data Acquisition from the workstation and starts data acquisition
operation.
11. Panel completes image acquisition and begins to send data to the workstation.
12. Workstation receives all image data from the panel after calibration if hardware
calibration is on.
Appendix (For Service Personnel Only)
Time Setting
To set a clear scenario for programming, see the diagram below.
AJ4312 | 2020-02-10V
Appendix (For Service Personnel Only)
Inner2 Mode
Block Diagram
The workstation is a host PC device installed with iDetector and SDK. Installation
describes how to establish connections between the panel and workstation. In inner2
mode, the workstation does not control the x-ray generator. Users decide when to take
x-rays.
Work Flow
1. Workstation receives prep request.
2. X-ray generator is ready to take x-rays and starts releasing the x-ray.
3. Panel starts uploading a Pre-dark image and a Light image to the workstation for
preview. If hardware offset is selected, panel rst performs an offset and then
uploads the preview image.
4. Panel starts uploading Post-dark image to the workstation. If hardware offset is
selected, panel rst performs correction and calibration and then uploads the
processed image to the workstation.
5. Workstation enters exposure prohibit state.
Time Setting
To set a clear scenario for program, see the diagram below.
Freesync Mode
Block Diagram
The workstation is a host PC device installed with iDetector and SDK. Installation
describes how to establish connections between the panel and workstation. In FreeSync
VI AJ4312 | 2020-02-10
Appendix (For Service Personnel Only)
mode, the user does not interact with the workstation. After taking x-rays, images
immediately appear on the screen.
Work Flow
1. X-ray generator is ready to take x-rays and starts releasing the x-ray.
2. Workstation receives Exposure Prohibited from the panel.
3. Panel starts uploading a Pre-dark image and a Light image to the workstation for
preview. If hardware offset is selected, panel rst performs an offset and then
uploads the preview image.
4. Panel starts uploading Post-dark image to the workstation. If hardware offset is
selected, panel rst performs correction and calibration and then uploads the
processed image to the workstation.
5. Workstation receives Exposure Enable from the panel.
Time Setting
AJ4312 | 2020-02-10VII
Appendix (For Service Personnel Only)
Software Installation
Do the following if the iDetector application is not working:
The iDetector application should not be used for a hospital terminal.
VIII AJ4312 | 2020-02-10
Set the Connection Mode
The detector supports the following two connection modes and should be congured
per site requirements.
Wireless Client Mode
1. Connect one end of the Gigabit Ethernet cable to the workstation.
2. Connect another end to the LAN port of external wireless AP.
3. From the workstation, open the Control Panel and then the Network andSharing Center.
4. In the Connections:eld, click on Local Network.
5. Open the IPV4 settings.
6. For the IP and network mask setting, select Obtain an IP address automatically.
7. Open the browser and type 10.0.1.1 and log into external wireless AP.
8. Do the wireless setup.
Appendix (For Service Personnel Only)
9. Congure 2.4 GHz wireless network.
•SSID: NETGEAR_BIG_24
•Security: WPA2-PSK
•Password: 12345678
•Channel: Check the current Wi-Fi environment, and choose a relatively clean
channel.
10. Congure 5G Hz wireless network.
•SSID: NETGEAR_BIG_50
•Security: WPA2-PSK
•Password: 12345678
•Channel: Check the current Wi-Fi environment, and choose a relatively clean
channel.
11. Congure LAN IP address.
•IP address: 10.0.1.1
•Subnet Mask: 255.255.255.0
12. Do an external wireless AP reboot: Apply the above settings and reboot your
wireless router.
13. Recover the local network IPV4 setting.
•IP setting—IP address: 10.0.1.251
•Network mask setting—Subnet mask: 255.255.255.0
14. Connect the panel to the workstation with the Ethernet cable.
AJ4312 | 2020-02-10IX
Appendix (For Service Personnel Only)
15. Select:
•Detector
•Wi
•Read Cong
•Client
16. Select Add and enter the SSID and Password. Select Apply.
17. Choose SSID and select the one with a check mark. Select Write Cong to save the
parameters.
18. Turn on the wireless router.
a. Make sure there is a wired connection between the outer, work station, and IP
10.0.1.251.
b. Select Read Wi Status to check wireless transmission status, numerical value
occurred means the link is up and available.
The detector will connect to the wireless AP the next time it is powered on.
Wireless AP Mode
A wired cable can also be used to congure detector in wireless client mode. The wired
connection should only be used by the service operator.To start conguration with
wired cable, it is necessary to complete this procedure.
1. Connect the panel to the workstation with the Ethernet cable.
2. Select the Detector tab and then Wi.
3. In the Modeeld, select AP.
4. Select Read Cong to display the default settings.
5. Change the settings for SSID and password.
Important:
Make sure that the SSID is different from others already used.
6. In the Frequencyeld, click on the arrow and select a value from the drop-down
list..
7. In the Countryeld, click on the arrow and select a country from the drop-down
list.
8. In the Channeleld, click on the arrow and select a clean frequency and channel.
9. Select Write Cong to save the settings.
Note:
Do not remove the wired cable until the FPD status is Ready.
X AJ4312 | 2020-02-10
Appendix (For Service Personnel Only)
The detector will connect to the wireless AP the next time it is powered on.
10. Congure the external wireless card.
a. Open the local wireless signal list.
b. Select the SSID that belongs to the detectors. Enter the password and select OK.
c.Open the wireless card conguration.
d. Open the IPV4 setting and set the following values:.
•IP setting—IP address: 10.0.1.251
•Network mask setting—Subnet mask: 255.255.255.0
e. Open SDK and select the detector.
f.Select Connect.
AJ4312 | 2020-02-10XI
Appendix (For Service Personnel Only)
Shortcuts
ShortcutResult
Double-click the window using the left mouse button.The image is centered and displayed at the
maximum size.
Double-click the window using the right mouse
button.
Drag the left mouse button to move the displayed
image.
Drag the right mouse button horizontally to adjust the
window width, and drag the right mouse button
vertically to adjust the window level.
F3 key
The window level and width are adjusted to
WL: 32767/WW: 65535.
Quickly adjust the image window width and
window level.
XII AJ4312 | 2020-02-10
Appendix (For Service Personnel Only)
Establish a Connection with the Detector
1. Open SDK, select the detector, and select Connect.
2. Conrm that the values for IP address and Port are the same as the values in
cong.ini.
Note:
The value for Cfg_HostPort should be the default of 28000.
Note:
When the connection is changed to a different network card, the user must reconnect the
detector using a different IP address.
The rule of Multi-Share control is based on the IP address. The second terminal with a
different IP address is not allowed to operate a detector after the rst one is connected. If
there is no command transmission between the detector and workstation after 5 minutes,
the detector releases access authority.
AJ4312 | 2020-02-10XIII
Appendix (For Service Personnel Only)
Congure the Detector
1. From the iDetector menu, select the Acquire tab.
2. Acquire the module related setting, such as loading correction and calibration
template, acquiring images.
3. See the SDK module-related settings, such as IP address.
4. See the Detector module related settings, such as trigger module, wireless signal.
5. Calibrate the module related setting, such as making correction and calibration
template. The template in the panel could be uploaded to a workstation, and the
template in a workstation could also be downloaded to panel.
6. See the Local File module related setting, such as import a Raw or DCM image.
XIV AJ4312 | 2020-02-10
Appendix (For Service Personnel Only)
Correction and Calibration Template Generation
Correction and calibration should be performed after installation and every six months.
The new correction and calibration should be performed after any major change on
the system settings and hardware conguration.
Pre-offset Template Generation
If panel is congured to do Pre-offset correction, Pre-offset Template is necessary.
1. Select Calibrate.
2. Select Start Generate Templates.
3. Select Create Offset.
4. Select Start create offset template le.
The screen will display Offset Map Generating.
5. When complete, the screen will display Offset MAP Generated!
Gain Calibration Template Generation
Before doing this procedure, make sure SID1.2m, no copper is required.
Actual screens may be different from those shown in this procedure.
Note:
Use software post offset correction.
1. On the gain template generating page, ve images need to be created.
2. Select Start.
3. Select PREP and start the exposure.
4. When completed, select Acquire to get the light image.
5. If the value meets the expected value, select Accept, and then acquire the other
four images.
If the value does not meet the expected value, do not click Accept. Adjust the
exposure dose, and then click PREP to acquire the light image again.
6. When all ve images are created, select Generate to generate the gain template.
Defect Correction Template Generation
Before doing this procedure, make sure SID1.2m, no copper is required.
Actual screens may be different from those shown in this procedure.
Note:
Use software post offset mode.
AJ4312 | 2020-02-10XV
Appendix (For Service Personnel Only)
1. On the Defect Calibration page, start the exposure. Eight images need to be
captured.
2. Select Start.
3. Select PREP and start the exposure.
4. When completed, select Acquire to get the light image.
5. If the value meets the expected value, select Accept, and then acquire the other
seven images.
If the value does not meet the expected value, do not select Acquire. Adjust the
exposure dose, then select PREP to acquire the light image again.
6. When all eight images are created, select Generate to generate the gain template.
Note:
Make sure your x-ray dose is correct. If your dose is out of the range, iDetector will remind
you to adjust the dose. Then you can select start creating and try again.
If users operate with two panels, SDK has a probability of automatically quitting.
XVI AJ4312 | 2020-02-10
Image Check and Upload
OPEN provides two features for image check and uploading: Local Image Check and
Panel Image Upload. Local Image Check is used to check images saved in the
workstation. Panel Image Upload is used to upload images stored in the panel.
Local Image Check
1. From the Local File tab, select Load File. Choose the speciedle.
2. Choose the images stored in the workstation. The screen will display the images.
Panel Image Upload
Prerequisites:
Make sure the rewall is closed.
1. Select the Images tab from the Detector interface.
Appendix (For Service Personnel Only)
2. Select Query Images.
The images stored on the detector will be listed.
3. Select Upload Images and choose the specied image. Select OK.
When the state changes to Success, the image has been uploaded.
The upload process can be canceled by selecting Stop Upload.
The uploaded images are saved in the path of the detector serial number.
AJ4312 | 2020-02-10XVII
Appendix (For Service Personnel Only)
Defect Template Check and Modication
The iDetector software provides the ability to check the defect template. If the
template has updates, the user can add and delete pixels or defective lines by
modifying the opened defect template.
Defect Template Check
1. From the Local File page, select Load File.
2. Select the specied defect template, and select Open.
The defect template will be displayed.
Defect Template Modication
1. Open the specied defect template.
The defect management dialog box will be displayed.
2. Locate the pixel that needs to be managed, type the coordinates of the pixel, and
select Add. The information will be added to the template.
Note:
If Delete is selected, the information will be removed from the template.
3. Select Save.
4. It is similar to manage the defect pixel. If the user needs to add the defect line, type
the coordinates of the line, and select Add. If the information needs to be deleted,
select Delete.
XVIII AJ4312 | 2020-02-10
Appendix (For Service Personnel Only)
Correction and Calibration Management
Correction and Calibration Template Synchronization
The detector supports correction and calibration template storage. Templates in the
detector can be uploaded to a workstation, and templates in a workstation can be
downloaded to a detector.
1. After generating the offset, gain, and defect templates, select the templates and
select Download to FPD.
2. Select Download.
3. Select Read Status.
4. If the Activity column shows disable, select the row and select Active to enable it.
Correction and Calibration Management
The detector supports the following ways to do correction and calibration:
•In software correction and calibration, the workstation completes all correction and
calibration.
•In hardware correction and calibration, the panel completes all correction and
calibration.
1. User can set the calibration method on the Detector page.
Note:
The hardware-based calibration is on.
2. Select:
•HWPostOffset
•HWGain
•HWDefect
Note:
The hardware-based calibration is on.
3. Select:
•SWPostOffset
•SWGain
•SWDefect
Note:
The software-based calibration is on.
AJ4312 | 2020-02-10XIX
Appendix (For Service Personnel Only)
Update the Firmware
The Internet can be used to upgrade the detector rmware.
This procedure applies to MCU, FPGA, and ARM.
1. Connect the panel to a PC.
2. Open a browser, type detector IP in the search bar, and then press Enter.
3. Enter the following and select login.
•User name: admin
•Password: admin
4. Click on the three squares located on the left side of the screen.
5. Select Upgrade and then Browse.
6. Select one the rmwareles from the list and select Open.
•1717V3TISA07_IMAGE_MCU_xxxx_xx_13.ifm
•1717V3TISA07_FPGA_xxxx_xx_13.ifm
•1717V3TISA07_IMAGE_ARM_xxxx_xx_13.ifm
Important:
Selecting 1717V3TISA07_IMAGE_ALL_xxxx_xx_13.ifm will allow all three versions of
rmware to be updated at the same time.
7. When the selected le name is displayed on the interface, select Upgrade.
8. Select Close when the Notice box is displayed.
The progress bar will be displayed.
9. If the upgrade is successful, the following interface screen will be displayed.
Note:
If the screen is not displayed, the upgrade has failed.
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and (2)
this device must accept any interference received, including interference that may
cause undesired operation.
This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential installation.
This equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
—Consult the dealer or an experienced radio/ TV technician for help.
Changes or modifications not expressly approved by the manufacturer could void the
user’s authority to operate the equipment.
W52/UNII I is in door use only
Radio Frequency (RF) Energy
This device is designed and manufactured not to exceed the emission limits for exposure
to radio frequency (RF) energy set by the Federal Communications Commission of the
United States.
During SAR testing, this device was set to transmit at its highest certified power level in all
tested frequency bands, and placed in positions that simulate RF exposure in usage
against the body with no separation. Although the SAR is determined at the highest
certified power level, the actual SAR level of the device while operating can be well below
This is because the device is designed to operate at multiple power levels so as to use
only the power required to reach the network. In general, the closer you are to a wireless
Base station antenna, the lower the power output.
The exposure standard for wireless devices employing a unit of measurement is known
as the Specific Absorption Rate, or SAR. The SAR limit recommended by the ICNIRP
used by the general public is 2.0W/kg averaged over ten grams of tissue and, is 1,6W/kg
Averaged over one gram of tissue by IEEE Std 1528.
The FCC has granted an Equipment Authorization for this product with all reported SAR
Levels evaluated as in compliance with the FCC RF exposure guidelines.
For this device, the highest FCC reported SAR value for usage is 0.042W/kg.
While there may be differences between the SAR levels of various product and at various
positions, they all meet the government requirements.
SAR compliance for body-worn operation is based on a separation distance of 0 mm
between the unit and the human body. Carry this device at least 0 mm away from your
body to ensure RF exposure level compliant or lower to the reported level. To support
body-worn operation, choose the belt clips or holsters, which do not contain metallic
components, to maintain a separation of 0 mm between this device and your body.
RF exposure compliance with any body-worn accessory, which contains metal, was not
tested and certified, and using such body-worn accessory should be avoided.
IC Notice
This device complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions:
(1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause
undesired operation of the device.
This Class B digital apparatus complies with Canadian ICES-003.
IC:25116-01070189
IC Radiation Exposure Statement
This EUT is in compliance with SAR for general population/uncontrolled exposure
limits in IC RSS-102 and had been tested in accordance with the measurement
methods and procedures specified in IEEE 1528 and IEC 62209. This equipment should
be installed and operated with minimum distance of 0 cm between the radiator and your
body. This device and its antenna(s) must not be co-located or operating in conjunction
with any other antenna or transmitter.
Cet appareil est conforme aux Normes RSS d'Industy Canada. Son utilisation est soumise à
deux conditions:
(1) Ce dispositif ne peut pas provoquer d'interférences, et
(2) Ce dispositif doit accepter toutes les interférences reçues, y compris les interférences
susceptibles de provoquer un fonctionnement non souhaité.
Cet appareil de classe B est conforme à la norme canadienne ICES-003.
IC:25116-01070189
Déclaration d'exposition IC
Cet EUT est conforme aux valeurs SAR à la norme SAR pour le grand public ainsi qu'aux
limites d'exposition non règlementée IC RSS-102 et a été testé selon les méthodes et
procédures spécifiées par les Normes IEEE 1528 et IEC 62209. Cet appareil devrait être
installé et utilisé en respectant une distance minimale de 0 cm avec votre corps. Cet
appareil et son (ses) antenne (s) ne doivent pas être situés à proximité l'un de l'autre et ne
doivent pas fonctionner en même temps qu'une autre antenne ou qu'un autre émetteur.
UNII I is in door use only
Les dispositifs RL- EL sont restreints à une utilisation à l’intérieur seulement dans la ba
nde de 5 150 à 5 250 MHz.
Cet appareil est conçu et fabriqué de façon à ne pas dépasser les limites d'émission pour
l'exposition à l'énergie de radiofréquence (RF) fixées par la Federal Communications
Commission des États-Unis et Industrie Canada.
Au cours des essais SAR, cet appareil est configuré pour transmettre des données à son
niveau de puissance le plus élevé à toutes les bandes de fréquences testées et placées
dans l'ensemble des positions simulant l'exposition aux radiofréquences contre la tête et
près du corps, avec une séparation de 0 mm. Bien que le DAS soit déterminé par le
niveau de puissance le plus élevé, le niveau SAR réel de l'appareil en fonctionnement peut
être bien inférieur à la valeur maximale indiquée. Cela est dû au fait que l'appareil est
conçu pour fonctionner à plusieurs niveaux d'alimentation, pour s'adapter aux capacités
des différents réseaux électriques. De manière général, plus vous vous trouverez pès
d'une station sans fil, plus la fréquence de transmission sera basse.
La norme d'exposition pour les dispositifs sans fil employant une unité de mesure est
connue sous le nom de taux d'absorption spécifique (SAR). La limite SAR fixée par la FCC
est de 1,6 W / kg et de 1,6 W / kg par Industry Canada.
Cet appareil est conforme à la norme SAR pour le grand public ainsi qu'aux limites
d'exposition non règlementées ANSI / IEEE C95.1-1992 et Canada RSS 102, et a été
testé conformément aux méthodes et procédures spécifiées par les Normes IEEE1528 et
Canada RSS 102. Ce dispositif a été testé et respecte les directives FCC et IC sur
l'exposition aux radiofréquences lorsqu'il est testé en contact direct avec le corps.
Pour cet appareil, la valeur SAR la plus élevée pour une utilisation près du corps est de
0.042 W/kg.
Bien qu'il puisse exister des différences entre les niveaux de SAR selon les dispositifs et
les emplacements où ils sont utilisés, tous répondent aux exigences Gouvernementales.
La valeur SAR déclarée conforme est une distance de 0 mm entre l'unité et le corps
humain. Eloignez cet appareil à une distance d'au moins 0 mm de votre corps pour vous
assurer que le niveau d'exposition aux RF est conforme ou inférieur au niveau indiqué.
Vous pouvez également opter pour un étui ne contenant aucun composant métallique,
pour maintenir une séparation de 0 mm entre cet appareil et votre corps.
Pour tout appareil contenant du métal, la conformité de l'exposition aux radiofréquences n'a
pas encore été testée / certifiée de manière précise.
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