iRay Technology 01070189 Users manual

User Manual for the TRIMAX 43C Detector
Publication No. AJ4312 2020-02-10
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:
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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 modications, 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 specications, 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.
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Notices and Conventions
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Contents
Notices and Conventions
Disclaimer.......................................................................................................................................... -v
1 Safety and Regulatory Information
Symbols............................................................................................................................................1-1
Cautions...........................................................................................................................................1-4
Medical Equipment Classication................................................................................................1-14
Standards.......................................................................................................................................1-15
Emissions and Immunity Compliance to the IEC60601-1-2 Standard........................................ 1-17
Radio Frequency Compliance.......................................................................................................1-21
Correction and Calibration Template Generation................................................................ 1-23
Battery Safety Standards.............................................................................................................. 1-24
Intended Use and Essential Performance....................................................................................1-25
2 Overview
Components and Specications.....................................................................................................2-2
Product Components................................................................................................................ 2-2
Product Specications...............................................................................................................2-6
IT Network...............................................................................................................................2-11
Service Information...................................................................................................................... 2-13
Disposal......................................................................................................................................... 2-14
3 Installation
Panel Installation............................................................................................................................ 3-1
Install the Detector Battery...................................................................................................... 3-1
Power on the Detector............................................................................................................. 3-2
Install the Detector Battery Charger............................................................................................. 3-8
Detector Battery Lock and Activation........................................................................................... 3-9
4 Operation
Notes for Using............................................................................................................................... 4-1
Detector Position............................................................................................................................ 4-3
Appendix (For Service Personnel Only)
Software and Settings.....................................................................................................................A-I
Operating Modes...........................................................................................................................A-V
Software Mode........................................................................................................................ A-V
Inner2 Mode............................................................................................................................A-VI
Freesync Mode........................................................................................................................ A-VI
Software Installation.................................................................................................................. A-VIII
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Contents
Set the Connection Mode............................................................................................................ A-IX
Wireless Client Mode.............................................................................................................. A-IX
Wireless AP Mode.................................................................................................................... A-X
Shortcuts.......................................................................................................................................A-XII
Establish a Connection with the Detector.................................................................................A-XIII
Congure the Detector..............................................................................................................A-XIV
Correction and Calibration Template Generation.....................................................................A-XV
Pre-offset Template Generation........................................................................................... A-XV
Gain Calibration Template Generation................................................................................ A-XV
Defect Correction Template Generation..............................................................................A-XV
Image Check and Upload..........................................................................................................A-XVII
Local Image Check............................................................................................................... A-XVII
Panel Image Upload............................................................................................................ A-XVII
Defect Template Check and Modication.............................................................................. A-XVIII
Defect Template Check...................................................................................................... A-XVIII
Defect Template Modication...........................................................................................A-XVIII
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
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1 Safety 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 certication and is followed by the CE number.
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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.
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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 only Device is for prescription use only.
IP IPX1 for working surface only.
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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 specied 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
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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
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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.
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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.
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Safety and Regulatory Information
Handling
No modication 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.
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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.
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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
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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.
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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 qualied 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
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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
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Safety and Regulatory Information
Medical Equipment Classication
Type of protection against electrical shock
Degree of protection against electrical shock Type-B applied part
Degree of protection against ingress of water IPX1
Mode of operation Continuous 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
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Safety and Regulatory Information
Standards
ISO 13485:2016 Medical devices — Quality management systems
— Requirements for regulatory purposes
IEC 60601-1:2005/AMD1:2012 Medical electrical equipment — Part 1: General
requirements for basic safety and essential performance
IEC 60601-1-2:2014/EN60601-1-2:2015 Medical 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 60601-2-54:2019 Medical electrical equipment — Part 2-54:
Particular requirements for the basic safety and essential performance of X ray equipment for radiography and radioscopy
IEC 62133-2:2017 Secondary 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 62220-1-1:2015 Medical electrical equipment — Characteristics of
digital X-ray imaging devices — Part 1-1: Determination of the detective quantum efciency
- Detectors used in radiographic imaging
IEC 62304:2006/AMD1:2015 Medical device software — Software life-cycle
processes
IEC 62366-1:2015/IEC 62366:2007/EN62366:2008 Medical devices — Part 1: Application of usability
engineering to medical devices
IEC 60601-1-6:2010+A1:2013 Medical electrical equipment — Part 1-6: General
requirements for basic safety and essential performance — Collateral standard: Usability
EN ISO14971:2012 Medical device — Application of risk management
to medical devices
ANSI/AAMI ES60601-1:2005/ (R)2012+A1:2012+C1:2009/(R)2012+A2:2010/ (R)2012
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Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
Safety and Regulatory Information
CAN/CSA-C22.2
Medical electrical equipment — Part 1: General requirements for basic safety and essential
No.60601-1:14
performance
ISO 15223-1:2016/ EN ISO 15223-1:2016 Medical devices — Symbols to be used with
medical device labels, labeling and information to be supplied-Part 1: General requirements
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Safety and Regulatory Information
Emissions and Immunity Compliance to the IEC60601-1-2 Standard
Electromagnetic Emissions
Emissions Test Compliance Electromagnetic Environment
RF emissions
Harmonic distortion
Voltage uctuations and icker
Electromagnetic Immunity
Emissions Test EMC Standard
Electrostatic discharge IEC 61000-4-2
CISPR 11
Group 1, Class B
IEC 61000-3-2
Class A
IEC 61000-3-3
Compliance
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 eld IEC 61000-4-3
Proximity elds from RF wireless communications equipment
Rated power frequency magnetic elds
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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
385 380–390 Pulse modulation 18 Hz, 27 V/m
450 430–470 FM, ±5kHz deviation, 1 kHz sine, 28 V/m
710
704–787 Pulse modulation 217 Hz, 9 V/m745
780
810
800-–960 Pulse modulation 18 Hz, 28 V/m870
930
1720
1700–1990 Pulse modulation 217 Hz, 28 V/m1845
1970
2450 2400–2570 Pulse modulation 217 Hz, 28 V/m
5240
5500
5100–5800 Pulse modulation 217 Hz, 9 V/m
5785
Input AC Power Port
Emissions Test EMC Standard
Electrical fast transients/burst IEC 61000-4-4
Test Levels
Professional healthcare facility environment
±2 kV
100 kHz repetition frequency
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Emissions Test EMC 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 dips IEC 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 interruptions IEC 61000-4-11 0 % UT; 250/300 cycles
Signal Input/Output Parts Port
Test Levels
Emissions Test EMC Standard
Professional healthcare facility environment
Electrostatic Discharge IEC 61000-4-2
±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV air
Electrical fast transients/burst IEC 61000-4-4
±1 kV
100 kHz repetition frequency
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Safety and Regulatory Information
Emissions Test EMC 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
Number Cable Classication
AC Power Cable 3 m Unshielded 1 pcs AC Power
DC Power Cable 3.5 m Unshielded 1 pcs DC Power
LAN Cable
3 m Shielded 1 pcs Signal
(conguration 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 specied 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.
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Radio Frequency Compliance
Country Item
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
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Safety and Regulatory Information
Country Item
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.
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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 conguration.
Safety and Regulatory Information
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Safety and Regulatory Information
Battery Safety Standards
Standards Description
Secondary cells and batteries containing alkaline or other non-
CAN/CSA E62133:13 1st Ed. Rev.
UL 62133, 1st Ed. Rev.
UL 2054 Household 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
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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 dened as essential performance.
Getting qualied dark image proves that essential performance does not inuence the intended use. For the method of getting dark image, see the Installation and
Operation sections.
Application Specication
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 Subgroup Approximate Age Range
Newborn (Neonate) From birth to 1 month of age
Infant Greater than 1 month to 2 years of age
Child Greater than 2 to 12 years of age
Adolescent Greater than 12 through 21 years of age
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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 Parts Patient Size kVp mAs SID Grid
Abdomen AP/PA
Very Low Birth Weight (Less than
55 1 1m no
1.5 Kg)
Low Birth Weight (Between 1.5
55 1.6 1m no
and 2.5 Kg)
Newborn (Age is less than 1
70 1.6 1m no
month and Weight above than
2.5 Kg)
Infant (Age is between 1 month
73 2 1m no
and 2 years)
Child (Age is between 2 years
75 7.1 1m yes
and 12 years)
Preadolescent (Age is between 12
75 14 1m yes
years and 13 years)
Adolescent (Age is between 12
75 20 1m yes
years and 21 years)
Adult Small 75 18 1m yes
Adult Medium 80 22 1m yes
Adult Large 85 32 1m yes
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Safety and Regulatory Information
Body Parts Patient Size kVp mAs SID Grid
Chest PA/AP
Very Low Birth Weight 50 1 1m
no
Low Birth Weight 55 1 1m no
Newborn 65 1 1m no
Infant 70 1.6 1m no
Child 70 1.6 1m no
Preadolescent 90 2 1m yes
Adolescent 90 2 1m yes
Adult Small 110 1.8 1.8m yes
Adult Medium 110 2.8 1.8m yes
Adult Large 120 4 1.8m yes
Very Low Birth Weight 50 1 1m no
Low Birth Weight 55 1 1m no
Newborn 57 1 1m no
Infant 57 1.2 1m no
Extremities AP/PA
Child 58 1.2 1m no
Preadolescent 62 1.6 1m no
Adolescent 62 2 1m no
Adult Regarding adult details techniques
of Extremities, please refer to the table of “Techniques for Adult Extremities”
Table 2: Techniques for Adult Extremities
Adult Extremities List kVp mAs SID Grid
Ankle - AP 58 4 1 no
Ankle - Lateral 58 4 1 no
no
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Safety and Regulatory Information
Adult Extremities List kVp mAs SID Grid
Femur - AP 70 16 1 yes
Femur - Lateral 70 10 1 yes
Hand - PA 53 1.8 1 no
Hand - oblique 53 1.8 1 no
Humerus - AP 75 7.1 1 yes
Humerus - Lateral 70 3.2 1 yes
Knee - AP 65 10 1 yes
Knee - Lateral 65 10 1 yes
Wrist - PA 55 1.8 1 no
Wrist - Lateral 55 1.8 1 no
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
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2 Overview
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 conguration 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
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2-1
Overview
Components and Specications
Product Components
Component Description
Detector
Item Description Notes
B DC jack For optional power input
A Ethernet port For service
C Detector indicator Detector indicator of control panel
D Power button Power button of control panel
E Mode button Mode switch
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Item Description Notes
F Power indicator The other Power indicator
G Handle Optional
Battery
Overview
Item Description Notes
A Battery label
B Battery interface 8 pin battery connector
C Pilot pin
D Indicator Installation direction indicator
Battery Charger
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Overview
Item Description Notes
A Battery Interface A 8 pin battery connector
B Battery Interface B Not used
C Battery Interface C Not used
D Indicator The indicator denition is as follow
E The limit ball plug /
F Hand Pull Position /
G AC Jack 220V (ac) input
Battery Charger Indicator
Item Name
A Power Indicator
B Charging Indicator
C Charge Full Indicator
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X Indicator Operating Status
All off No 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 on Battery charging
A and C indicator on Battery 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.
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Overview
Product Specications
Detector
Item Specications
Model TRIMAX 43C
Image Sensor a-Si (amorphous silicon) TFT
Pixel Size 139 µm
Active Array 3072 x 3072
Active Area (H x V) 427.0 x 427.0 mm (16.8 x 16.8 in.)
Gray Scales 16 bit
Spatial Resolution 3.6 Lp/mm
Cycle Time Min. 8.5 sec.
Power Consumption Max. 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 Transfer Wireless: IEEE802.11a/b/g/n/ac
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Item Specications
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)
Item Specications
Model Battery-KV
Rated capacity Typ. 4180 mAh @ Discharge 0.2C
Nominal voltage 10.8 V
Charge voltage 12.6 ± 0.05 V
Discharged end voltage 9 V
Charging method CC-CV
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Overview
Item Specications
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 humidity 5 %~95 %
Dimension (L × W × H) 210.0 x 115 x 7.5 mm (8.3 x 4.5 x 0.30in.)
Weight 0.28 kg (0.62 lb)
Battery Charger
Item Specications
Model Charger-Combo
Simultaneous Charging 1 Battery Pack
Full Charging Time ≤ 3 hr
Rated Power Supply 90~264 V (ac)
Dimension (L × W × H)
240.0 x 184.0 x 38.0 mm
(9.4 x 7.2 x 1.52 in.)
Weight 0.55 kg (1.2 lb)
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Overview
Power Supply
Item Specications
DC Power (Optional) 24V (dc), 0.8A
Battery Package 10.8V (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 certicate number SG PSB-MD-00191.
Wireless Communication
Item Specications
Wireless Standard IEEE 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 Power Max.17 dBm
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Overview
Item Specications
Security WPA, WPA-PSK, WPA2, WPA2-PSK, WEP 64
bit & 128 bit
Antenna 2 dual band inner antenna
Mechanical Outlines
Use Environment
Operating
Temperature Temperature
Change
5–35 °C
< 1k/min 10 %–90 %
Humidity Atmospheric
Pressure
700–1060 hPa <10 kp/min
RH
Pressure Change
(1 kp=1.0197E-5Pa)
(41–95 °F)
Storage
-20–55 °C
< 1k/min 5 %–95 % RH 700–1060 hPa <10 kp/min
(1 kp=1.0197E-5Pa)
(-4–131 °F)
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Overview
Temperature Temperature
Change
Humidity Atmospheric
Pressure
Pressure Change
TRIMAX 43 detectors shall operate at a specied altitude of not more than 3000.0 m (9842.5 ft). The environment specic 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 Conguration
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 Specications
Item Specications
Wireless Standard IEEE 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
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Overview
Item Specications
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
Security WPA, 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 nishing conguration 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 unidentied 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 conguration
Connection of additional items to the IT-network
Disconnecting of items from the IT-network
Update of equipment connected to the IT-network
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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.
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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.
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3 Installation
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.
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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.
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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 Indicator Lighting Status
Operating Battery Capacity DC Input
OFF Power OFF -- --
Orange ON Power ON ≤20% No
Green ON Power ON
Battery capacity ≥20 %, no DC input
DC input (Optional)
Orange Blinking Power OFF <20 % Yes
Green and Orange
Power OFF ≥20 % and <95 % Yes
Blinking
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Installation
Operating Status
Power Indicator Lighting Status
Operating Battery Capacity DC Input
Green Fast Blinking Power OFF ≥95 % and <100 % Yes
OFF Power OFF =100 % Yes
Link Indicator
Power Indicator Lighting Status Description
Off
Shut down
Wired connection broken and wireless connection not ready
Green On Wired 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 Indicator Lighting Status Description
Off
Shut down
Exposure prohibit
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Power Indicator Lighting Status Description
Green On Exposure enable
Installation
Green Blinking
Image transmission
Orange On Error
Orange Blinking Safety mode
Mode Indicator
Power Indicator Lighting Status Description
Off
Shut down
Wired connection is built
Green On AP mode, wireless AP is ready (Not used)
Blue On Client mode, wireless client is ready
Blue and Green Blinking
Initialization
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Installation
Button Function
Power Mode Note
Action FPD Status
Power ON
Short hold No action Hold for 4 seconds
Forced restart Long hold No action
Power OFF Exit the battery from ship mode
Press 3 times No action
Enter safety mode Short hold Long hold
Forced restart Power ON Long hold No 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 mode Double click No action
Release after two short presses (interval <1second)
Hold for 4 seconds, Release
Power OFF Short hold No action
the Power button when the power indicator is OFF.
1. Hold the Mode button hold for 7 seconds.
Restore default
conguration
Triple check
Short hold
Long hold
2. Press the Power button 3 times.
3. Short hold the Power button for 4 seconds.
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Action FPD Status
Wireless ConnectionMode Switch
Power ON
Power Mode Note
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 | 2020-02-10 3-7
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.
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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
Method Steps
Factory conguration
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.
Method Steps
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
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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
Method Steps
Charger
1. Power on the charger.
2. Insert the battery into the charger for 3 to 5 seconds to exit ship mode.
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4 Operation
Notes for Using
Do the following to ensure that the detector functions correctly.
Before Exposure
Inspect the detector daily and conrm 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 nonammable disinfectant, such as benzalkonium chloride or benzalkonium bromide. For details on how to sterilize, consult a specialist.
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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.
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Detector Position
To prevent abnormal light lines, place the detector behind the patient in the orientation shown below.
Operation
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Operation
4-4 AJ4312 | 2020-02-10
Appendix (For Service Personnel Only)
Software and Settings
Main Interface
Button Function
Home Home page, shows the list of the detectors
Acquire Acquire images, free for use after connecting the detector
SDK Congure UI for SDK, free for use after connecting the detector
Detector Congure UI for detector, free for use after connecting the detector
Calibrate Calibrate UI, for generation and management of the calibration template
Local File Image management, free for use at any time
Connect Connect the detector
Close Disconnect the detector
Syncbox Manage the syncbox
Message Box
Status Box
Tab Description
SN Serial number of the detector
Status Status of the detector, busy or ready
Task The task that is currently being executed
Message Information
AJ4312 | 2020-02-10 I
Appendix (For Service Personnel Only)
Tab Description
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
Parameter Description Can be Modied
Product No. Type number of the detector No
Sub Product No. Sub-type of the detector No
Serial No. Serial number of the panel No
Main Version Version of the rmware of Main FPGA No
Main MB CPU Version Version of the MB CPU of Main FPGA No
MCU Version Version of the rmware of MCU No
Arm Version Version of the App of ARM No
Kernel Version Version of the Kernel of ARM No
Inner Subow Sub work-ow Yes
Prep CapMode Reserved No
Self CapEnable Reserved Yes
Self Cap Span Time Should not be modied; keep the original value Yes
Trigger Mode Trigger mode Yes
Sequence Interval Time Should not be modied; keep the original value Yes
Set Delay Time Exposure window for Freesync mode Yes
Exp Window Time Exposure Window for Software/Inner mode, the
Yes
value should not be larger than 10s
Acquire Delay Time Reserved Yes
II AJ4312 | 2020-02-10
Appendix (For Service Personnel Only)
Parameter Description Can be Modied
Integrate Time Should not be modied; keep the original value Yes
Src Port Port number for detector No
Src IP IP address for detector No
Src MAC MAC address for detector Yes
Dest Port Port number for PC No
Dest IP IP address for detector No
Self Clear Enable
Related to Prep CapMode, the value should be congured as On if Prep CapMode is congured 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 Time Should not be modied; keep the original value Yes
Hvg Prep On Reserved Yes
Hvg XRay Enable Reserved Yes
Hvg XRay On Reserved Yes
Tube Ready Time Reserved Yes
Image Pkg Gap Time Reserved Yes
Out Mode Cap Trigger Reserved Yes
SDK Settings
Parameter Description Can be Modied
Host IP IP Address of local workstation Yes
Host Port Port of local workstation Yes
Ftp Download Host IP FTP download server IP; keep the same as Host IP Yes
Ftp Download Host Port
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FTP download server Port; keep the same as Host Port
Yes
Appendix (For Service Personnel Only)
Parameter Description Can be Modied
Ftp Upload Host IP FTP upload server IP; keep the same as Host IP Yes
Ftp Upload Host Port FTP upload server Port; keep the same as Host
Yes
Port
Network Settings
Button Description
Add Add the information of SSID and the AP Key
Del Delete the information of SSID and the AP Key
Up Move up the AP information
Down Move down the AP information
Select Select the AP
Read Cong Read the parameters of the AP information when the detector is set as AP
Write Cong Write the parameters of the AP information when the detector is set as AP
Read Wi Status Read the WIFI status of the current detector
Scan from FPD Scan the AP
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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 nishes clear 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.
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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
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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 | 2020-02-10 VII
Appendix (For Service Personnel Only)
Software Installation
Do the following if the iDetector application is not working:
1. Install MICROSOFT .NET Framework 4.5.
2. Install vcredist_x86_2013 (or vcredist_x64_vs2013).
Important:
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 congured 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 and Sharing 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. Congure 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. Congure 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. Congure 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 | 2020-02-10 IX
Appendix (For Service Personnel Only)
15. Select:
Detector
Wi
Read Cong
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 Cong 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 congure detector in wireless client mode. The wired connection should only be used by the service operator.To start conguration 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 Mode eld, select AP.
4. Select Read Cong 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 Frequency eld, click on the arrow and select a value from the drop-down list..
7. In the Country eld, click on the arrow and select a country from the drop-down list.
8. In the Channel eld, click on the arrow and select a clean frequency and channel.
9. Select Write Cong 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. Congure 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 conguration.
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 | 2020-02-10 XI
Appendix (For Service Personnel Only)
Shortcuts
Shortcut Result
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. Conrm that the values for IP address and Port are the same as the values in cong.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 | 2020-02-10 XIII
Appendix (For Service Personnel Only)
Congure 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 conguration.
Pre-offset Template Generation
If panel is congured 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 | 2020-02-10 XV
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 specied le.
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 specied 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 | 2020-02-10 XVII
Appendix (For Service Personnel Only)
Defect Template Check and Modication
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 specied defect template, and select Open. The defect template will be displayed.
Defect Template Modication
1. Open the specied 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 | 2020-02-10 XIX
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 rmware les 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.
XX AJ4312 | 2020-02-10
Publication History
Version Date Changes
A 2020-02-10 Initial release
AJ4312 | 2020-02-10 I
Carestream Health, Inc.
150 Verona Street
Rochester, NY, USA 14608
© Carestream Health, Inc., 2020
Made in China for Carestream Health, Inc.
TRIMAX is a trademark of Carestream Health.
Pub. No. AJ4312
Rev A.
FCC Regulations:
Contains module’s FCC ID2ACHK-01070189
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
1
..................................................................................................................................................KONICA
MINOLTA, INC.
the maximum value.
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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