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EN 02
Contents
Introduction � � � � � � � � � � � � � � � � 5
Summary of usability specifications (for IEC/
Warnings � � � � � � � � � � � � � � � � � 9
1.1 Symbols relating to safety 10
1.1.2 Warning notice (signal words) 10
1.1.3 Description of graphic symbols 10
1.3.1 Precautions before usage 12
1.3.2 Precautions for usage 12
1.3.3 Precautions regarding electromagnetic waves 15
1.3.4 Precautions regarding wireless communication 19
1.3.5 Precautions for installing, moving, and storing 20
1.3.6 Precautions regarding maintenance 21
1.3.7 Precautions on service life 21
Product Overview � � � � � � � � 23
2.1 Overview of this device 24
2.1.1 Basic configuration example 24
2.2 Component names and functions 26
General Operations � � � � � � � 29
3.1.1 Startup of this device 30
3.1.2 Shutdown of this device 30
3.2 Operation of DR Detector 32
3.2.1 Exposure with basic exposure 32
3.2.2 Exposure using Image Storage 32
3.2.3 DR Detector orientation 33
3.2.4 Precautions for exposure 33
33 Inserting and removing the Battery 36
3.4.1 Charging with Battery Charger 37
3.4.2 Charging with the DC Power Cable 38
3.5 LED display of respective devices 39
3.6 Position to affix DR Detector identification label 41
Troubleshooting � � � � � � � � � � 43
Various problems and countermeasures 44
Maintenance � � � � � � � � � � � � � 47
5.1 Maintenance and inspection items 48
5.1.3 Disinfection of the DR Detector 49
3
Contents
Specifications
6.2 Characteristics and performance of the
4
Introduction
The digital radiography SKR 4000 (hereinafter, both are referred to as this device) perform X-ray imaging of the human body using an X-ray planar detector that outputs a digital signal, which is then input into an image processing device, and the acquired image is then transmitted to a filing system, printer, and image display device as diagnostic image data.
• Diagnostic X-ray image data of this device does not provide mammographic images.
The ImagePilot (hereafter referred to as the image processing controller), which controls the receiving, processing, and output of image data, is required for operation. For the operation of the image processing controller, refer to the
"Operation Manual" of the image processing controller. Also, regarding the connectable devices, contact Konica Minolta technical representative.
This operation manual provides instructions on the basic functions for operation of this device. Those operating this device for the first time should read this manual beforehand.
Also, store this manual close to this device after reading it through, so it can be used as a guide to allow optimum operating conditions.
IMPORTANT
• This operation manual (English version) is effective only outside Japan.
• "AeroDR NS 1417" denoted in this document refers to the operation manual name of the product name P-41.
• If the pages of the operation manual are smudged and illegible, replace it with a new one. (There is a fee for this service.)
USA only
Indications for Use
This device is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in general-purpose diagnostic procedures.
This device is not indicated for use in mammography, fluoroscopy, and angiography applications.
CAUTION
• Federal law restricts this device to sale by or on the order of a physician.
5
Introduction
Summary of usability specifications (for IEC/EN 60601-1-6, IEC/EN 62366)
(1) Medical purposes
• Provision and reading of disease and injury diagnostic images.
(2) Patient groups
• No patient population exists who uses the device.
• Patient population for the X-ray images read is not specified.
(3) Parts of body or organizations to which the device is mounted or that interact with the device.
• DR Detector contacts the body surfaces of a patient and an operator.
• Devices other than DR Detector contact the body surface of an operator.
(4) Operating principle
• DR Detector forms the still images according to the X-ray energy passing through the human and animal body; after digitizing the exposed image, it is transmitted to the console (the image processing controller) with wireless communication.
There are two ways to supply the power to the DR Detector: from removable Battery and wired connection through the AC Adapter.
• Battery Charger charges Battery inserted.
(5) Significant physical characteristics
•
Refer to “6.1 Specifications”.
(6) Significant performance characteristics
•
Refer to “2.1 Overview of this device”.
(7) User of this device
• No special training is required to use this device. The intended users of this device are as follows.
A professional in good health with specialist knowledge/qualifications who has fully understood the content of this document. (Such as a doctor or radiological technologist)
Trademark
Company names and product names in this manual are trademarks or registered trademarks of their respective owners
Please note that ©, ® and ™ marks are omitted hereafter.
Copyright © 2019 - 2020 Konica Minolta, Inc. All Rights Reserved.
6
Introduction
Disclaimer
(1) This manual may not be reproduced in whole or in part without the permission of Konica Minolta, Inc.
(2) The contents of this manual may be subject to change without prior notice.
(3) Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage caused by installation, relocation, modification, maintenance, and repair made by anyone except Konica Minolta and contractors designated by Konica Minolta.
(4) Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage to Konica Minolta products, caused by third-party products not installed by Konica Minolta.
(5) Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage caused by maintenanc and repair using maintenance parts other than those specified by Konica Minolta.
(6) Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage caused by not observing the precautions and operation methods described in the operation manual.
(7) Konica Minolta, Inc. is not responsible for any claims made for malfunction or damage caused by the environment that is not suitable for the installation requirements such as power source and installation environment described in the Installation Requirement or operation manual.
(8) Konica Minolta, Inc. is not responsible for any claims for malfunction or damage caused by acts of nature such as fires, earthquakes, floods, or lightning strikes.
(9) Konica Minolta, Inc. is not responsible for any claims for malfunction or damage caused by using this device for any purpose other than that specified for this device.
(10) Diagnostic and treatment action is performed under the responsibility of the physician(s). Konica Minolta, Inc. is not responsible for any diagnostic/treatment conditions or diagnostic/treatment results.
(11) Konica Minolta, Inc. is unable to assume any liability relating to the following events arising due to systems infected by computer viruses, worms and other malicious software potentially harmful to computers (hereunderreferred to as "malwares"):
— The erasure, corruption, or unwanted disclosure of data stored within this device, including personal andsensitive patient information.
— Malfunction of the device or accidents occurring as a result of the malfunction of the device.
— Infection of other products upon connection with the device, or damages arising therefrom.
(12) Whenever you use this service, you are required to take some security or safety measures for the following items related to the service:
Please understand that Konica Minolta, Inc. is unable to assume liability for certain events, such as malfunctions or incidents of information leakage resulting from such events.
— Client and network equipment managed by our facility
— The network and ISP in our facility used for connection with this service
— Your equipment to be connected to the same network as that of this service
(13) When this device is used, various user and patient data stored within the device and external storage devices must be adequately managed under the full responsibility of the user. Konica Minolta, Inc. is unable to assume any liability relating to damages arising due to leakage of various data at the time of disposal.
Term description
Terms
DR Detector
Image processing controller
AED
Image Storage
Internal AP function
External AP function
Explanation
Collective term indicating AeroDR NS 1417.
The ImagePilot is referred to as the image processing controller.
• It used as an abbreviation of Automatic Exposure Detection.
• This is a mode in which exposure is performed without being synchronized with the X-ray device.
This function allows you to expose without using the image processing controller.
A function that enables radio communication utilizing the wireless communication functionality inside the DR Detector.
This function enables wireless communication by using a general purpose access point.
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Chapter 1 Safety Precautions & Warnings
Chapter 1
Safety Precautions & Warnings
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1�1 Symbols relating to safety
1�1�1 Safety alert symbol
This is a "safety alert symbol". This symbol alerts you to matters and/or operation potentially hazardous to yourself and other people. Read these messages and follow the instructions carefully.
1�1�2
Warning notice (signal words)
Signal words indicate the degree of potential hazards in the use of the product.
Signal words include the following three types, which are used according to risk of damage caused by danger and the severity of damage.
DANGER
Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.
WARNING
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if not avoided, could result in minor or moderate injury.
It may also be used to indicate hazardous situation where only physical damage is likely to occur.
1�1�3 Description of graphic symbols
Graphic symbols
Explanation
Indicates the on or standby position for the power switch of this device.
Indicates a B-type Applied Parts medical device.
Graphic symbols
Explanation
Indicates that full caution is required when handling this device.
This indicates to reference to the instruction manual for general information.
Indicates that it is necessary to read the
User's Manual before use or operation of this device.
Indicates devices including radio frequency transmitters
IPX1
IP20
Indicates that the level of water ingress protection is equivalent to IPX1.
It indicates that the protection level against intrusion of foreign solid object or water is equivalent to IP20.
It indicates the manufacturer.
It indicates the manufacturing date.
It indicates the serial number.
This is the recycle mark for the lithium ion batteries
0197 This symbol indicates that this device is in conformity with the Directive 93/42/EEC.
It means conformity with the Radio Equipment Directive 2014/53/EU.
This symbol means: Do not dispose of this product together with your household waste!
Please refer to the information of your local community or contact our dealers regarding the proper handling of end-of-life electric and electronic equipments.
Recycling of this product will help to conserve natural resources and prevent potential negative consequences for the environment and human health caused by inappropriate waste handling.
It indicates that the used batteries must be collected
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1�2 Warning labels
Various warning labels are attached to this device on the locations shown below. Do not remove these labels from this device. Warning labels are there to make sure that the user recognizes potential hazards when operating this device.
IMPORTANT
• If a warning label is too dirty or damaged to read, contact Konica Minolta technical representatives to have a new warning label attached, and redisplay by parts replacement. (There is a fee for this service.)
1�2�1
DR Detector
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XXXXXXXXXXXXXXXX
IPX1
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1�2�2 Battery Charger
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Bottom view
IP20
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1�3 Safety precautions
Read all safety precautions thoroughly before using this device.
Be sure to observe the safety precautions described in this section.
1�3�1 Precautions before usage
CAUTION
• The operators (hospitals and clinics) hold responsibility for the usage and maintenance of this device. Do not use this device unless you are a physician or certified person under law.
• This device excluding the image processing controller is suitable for use in the patient environment. (PC used for the image processing controller is not suitable for use in the patient environment.)
• Confirm that this device is operating normally before using.
• When a problem occurs with this device, turn the power off, attach an appropriate sign, such as "malfunction", on this device, and contact Konica Minolta technical representatives.
• This device is not explosion-proof, so do not use any flammable or explosive gas near this device.
• For the basic operation of the computer, display monitor, and optional parts for this device, refer to their operation manuals
• Please follow the rules and regulations of your relevant authorities in the disposal of this product, accessories, options, consumables, media and their packing materials
• A 15-minute warm-up operation is required before performing exposure.
• Please use an inverter type X-ray device.
1�3�2 Precautions for usage
WARNING
• The DR Detector is a precision instrument. If it is dropped or hit against any object, a failure may occur due to strong impact or excessive load.
• Take note of the following when using this device:
— Do not subject the DR Detector to strong shocks or excessive loads by dropping it, etc.
— Do not exceed the specified overall load range when applying a load to an DR Detector.
— Do not disassemble or modify this device.
— Do not connect any devices that were not purchased from Konica Minolta.
— Do not turn off the power switch or disconnect cables such as the power cable while the System is running.
— Be careful not to drop the DR Detector on any part of a person's body by catching the DC Power Cable on your feet
• The DC Power Cable is connected to the DR Detector using magnetic force. When moving the DR Detector, do not hold onto the DC Power Cable, and always hold on the DR Detector. Also, do not grasp and pull the DR
Detector forcefully
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WARNING
• If there is any smoke, odor, or abnormal sound, it may cause a fire if use is continued, so immediately turn the power switch off, unplug the power plug from the wall outlet, and contact Konica Minolta technical representatives.
• Take note of the following to reduce the risk of fire, electric shock, or electrical leakage:
— Use specified cables for the power cable, etc and AC adapter
— Use a wall outlet with the correct rating as a power source
— Confirm that the power plug is properly connected to the wall outlet without any slack.
— Use a grounded power source.
— If you do not plan to use this device for an extended period of time, unplug the power plug.
— The supplied power cable and AC adapter are dedicated for this device, so do not use it elsewhere.
— Avoid exposure to liquid such as water.
— Make sure that foreign material, such as pieces of metal or wire, does not get inside.
— Do not allow any metal or conductive objects to come into contact with the connector of the DC Power Cable.
— Do not handle the power plug with wet hands.
— Do not let soil or dust accumulate on the power plug,
DC Power Cable.
— Do not use extension cords.
— Do not connect many plugs to a single electrical outlet.
— Do not damage the power cable, AC adapter or DC
Power Cable. Also, do not use damaged cables.
— Do not apply a load on the power cable.
— Do not touch the output terminal of the DC Power Cable.
• If there is any abnormality in appearance such as deformation of the housing or a crack, stop using the device immediately and contact Konica Minolta technical representatives.
• Do not connect the wired connection connector of Battery with metal.
• Do not carry or store Battery with metal objects such as necklace, hair pins, coins, or keys.
• Do not leave Battery in a high temperature environment, such as a place under the direct sunlight or inside a car parked under the blazing sun. It may cause Battery to leak.
• In respect to Battery, pay attention to the followings to prevent heating, explosion, and fire:
— Do not expose Battery to strong impact (dropping the battery from an elevated location) or throw Battery.
— Do not nail Battery, hit Battery with a hammer, or step on Battery.
• Please pay attention on the followings when using the
Battery:
— Do not step on or place an object on the Battery.
— Use the specified Battery.
— Do not disassembly or alter the Battery.
— Do not submerge the Battery.
— The Battery in the storage should be kept dry and should not get wet.
— Use the Battery Charger and DC Power Cable shipped with this device for charging Battery.
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Safety precautions
• Do not turn off the power while this device is in operation
• Always turn off the power when connecting and disconnecting the AC Power Cable and Ethernet cable.
• When disconnecting the AC Power Cable, hold the connector housing, plug, or connector.
• During examination, pay attention and do not allow the patient to touch the DR Detector wired connection connector, the power switch, or the selection switches.
• Please pay attention on the followings when using this device: Comply with the load range for the DR Detector.
The load range is: 150 kg for the entire surface of the
DR Detector, 100 kg for a portion.
• Images exposed by the DR Detector alone using the Image
Storage are not linked to any patient information. When using the Image Storage for exposure, associate the exposed patient to the number of exposures to record the exposures. Also, use lead markers or similar objects to capture information that helps identify the exposed patients.
CAUTION
• Take note of the following when using this device:
— Do not use devices that emit electromagnetic waves such as high-frequency therapy equipment, mobile
— phones, or pocket pagers, close to this device.
Use under the specified environmental conditions.
Failure to do so may result in degradation of performance or malfunction
• Take the following notes when using the DR Detector:
— Use the DR Detector on a flat base. If the DR Detector is placed on a sloping surface and subjected to a load, its internal sensor may be damaged.
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Safety precautions
CAUTION
— When laying the patient onto the DR Detector during positioning, do so very slowly.
— When placing the DR Detector under the patient as part of the exposure process, insert and pull out the detector slowly.
— Use the adapter when you need to perform exposure on a stretcher or a place where load is to be applied locally.
— Exposing or immersing the DR Detector to patient body fluids, chemicals, water, etc. may allow such liquids to enter through exterior gaps and cause a failure. Make sure to cover the DR Detector with a vinyl sheet, etc.
— The exposure side of the DR Detector is designed to have waterproof capabilities. However, be careful when handling them because they are not guaranteed to be completely waterproof. Also, subjecting it to strong impacts or excessive loads by dropping or hitting it against other objects may diminish its waterproof capabilities
— Never leave DR Detectors in hot and humid environments for long periods of time.
— The DR Detector has wireless antennae positioned at 2 places. Do not block them with the body or metal because that will interfere with, disconnect or slow down wireless communication.
— Ensure that each LED turns on or flashes when the
DR Detector starts up.
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— The DR Detector is precision equipment, and therefore impact or vibration during radiography or image transfer may affect the image quality. Be careful when handling the DR Detector during and just after radiography.
— Never leave DR Detectors around heat generators such as electric carpet
— Do not damage or deform the DR Detector; doing so may have an effect on exposed images, or lead to injury.
— Do not use a sharp object to operate the switch; doing so may damage the DR Detector.
— The surface temperature of the DR Detector can rise up to 43 °C.
— When using multiple DR Detectors, keep a distance between each DR Detector for at least 30 cm.
• When using the DC Power Cable, observe the following:
— Remove the cable by holding the connector housing.
— Do not let the cable get pinched by doors and do not place heavy objects on it.
— Do not bend or pull the cable excessively.
— Make sure that the cable is properly connected to the
DR Detector without wobbling.
— When connecting the AC Adapter and the DC Power
Cable, ensure to insert the connectors until a click sound is heard.
• Take note of the following if the DR Detector is damaged and fluorescent medium or lead is exposed:
— Immediately stop using the device, and contact Konica
Minolta technical representatives.
— If the fluorescent medium gets in your eyes, do not rub and instead wash with running water immediately.
— If you have swallowed any of the fluorescent medium or if the fluorescent medium has gotten into your eyes, administer first-aid treatment immediately, and consult a doctor
— If the medium comes into contact with your skin directly, wash the affected area thoroughly with water.
— Use and store in a location inaccessible to children.
• When the DR Detector is used for exposure, pay attention to the following items.
— Start exposure after confirming on the display of the image processing controller that the machine is ready for exposure.
— Perform exposure under the X-ray imaging conditions that has been confirmed by us.
— Use the specified grid to perform exposure.
— Apply the specified operation methods to use the grid.
— Do not let the DR Detector vibrate or receive shock until the preview image is displayed.
— If the irradiation field is larger than DR Detector when you take an image, an artifact may occur due to the Xray backscatter effect. Adjust the irradiation filed to fit within the imaging range.
— Confirm that a confirmation is sounded from the image processing controller after the start of exposure.
— Confirm that the DR Detector's battery level is full before performing exposure.
— Use the system under the exposure condition confirmed prior to exposure.
CAUTION
• When using Image Storage, please pay attention to the followings:
— Before performing an exposure operation, ensure that the status LED of the DR Detector indicates that
— it is standing by.
After an exposure, do not give shocks and/or vibrations to DR Detector for 6 seconds.
— Before performing an exposure operation, ensure that the battery level of the DR Detector is more than
11 % level.
• When the radioactive substance remains in the patient's body, e.g., after a nuclear medicine examination, the system may recognize it as an X-ray exposure, transmitting images.
• Please check that the LED indicates recharging status when the Battery is inserted in the Battery Charger.
• Be careful not to get your hand caught when inserting the Battery into the Battery Charger.
• If you use Ethernet cables, please pay attention to the following.
— If the power of this device is on, do not connect nor remove the Ethernet cables.
— Install the cables so that you do not catch them on your feet and so on
— Do not apply a load
— Communication speed is low or communication is down, it is necessary to check the Ethernet cable replacement. Contact Konica Minolta technical representatives.
• As the Battery is a consumable part, replace with a new
Battery when the operating time of the DR Detector becomes shorter.
• Remove the Battery when the DR Battery is not used for a long period of time.
• While the network communication failure occurs, please check if any of the conditions shown below is present:
— The operating system is not compatible.
— Software modification or update has failed.
— An interface compatibility error occurred
— A protocol error occurred in data transfer
— Data distortion occurred due to the interface or format mismatch.
— Data output failed
• Please observe the notes below as image noise or artifact may occur, or inaccurate image may be generated:
— Do not move the power cables during exposure.
— Do not use this device near a device that generates strong magnetic field.
Safety precautions
1�3�3 Precautions regarding electromagnetic waves
EMC Statement
This device has been tested and found to comply with the limits for medical devices in IEC 60601-1-2: 2014.
These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. The device generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in its vicinity.
However, there is no guarantee that interference will not occur in a particular installation
Whether this device does cause harmful interference to other devices can be determined by turning this device off and on. If it causes harmful interference, the user is encouraged to try to correct the interference by
1 or more of the following measures:
• Reorient or relocate the receiving device.
• Increase the separation between the devices.
• Connect this device into a wall outlet on a circuit different from that to which the other devices are connected.
• Contact Konica Minolta technical representatives.
WARNING
• Do not use mobile RF communication devices such as mobile phones or pocket pagers in the vicinity of this device. Use of such RF devices near this device can cause errors in operation due to electromagnetic wave interference. When using a mobile RF device, ensure that the distance between the RF device in use and this device is at least 30 cm (12 inches).
• The use of accessories, transducers and cables other than those sold by Konica Minolta, Inc. as internal components, may result in increased emissions or decreased electromagnetic immunity of this device, possibly causing malfunction.
• Do not use this device adjacent to or stacked with other devices. If adjacent or stacked use is necessary, confirm normal operation in the configuration in which this device will be used.
Supplementary information regarding IEC
60601-1-2:2014
(1) Take precautions against this device especially regarding EMC. Install and put into service according to the electromagnetic compatibility (EMC) information provided in the manual (Table 1 - Table 2).
(2) This device is suitable for use in medical institutions such as hospitals and clinics. However, this device is not suitable for use in environments with high degree of electromagnetic wave interference (such as near an electric operation device in use for output, or near a high frequency treatment device).
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Safety precautions
(3) Cable list
• AC Power Cable (3 m/3-Wire/No Shielding)
• DC Power Cable (3.5 m/No Shielding)
• Ethernet Cable with USB type C connector (3.5 m/Shielding)
(4) Specifications regarding RF transmitters frequency:
• Wireless standard
— IEEE802.11a/b/g/n/ac
• Frequency
— 2.4G : 2.412 - 2.4835 GHz
— 5G : 5.15 - 5.85 GHz
• Modulation
— 802.11b : CCK, DQPSK, DBPSK
— 802.11a/g : 64 QAM, 16 QAM, QPSK, BPSK
— 802.11n : 64 QAM, 16 QAM, QPSK, BPSK
— 802.11ac : 256 QAM, 64 QAM, 16 QAM, QPSK,
BPSK
• Maximum effective radiation power
— +17 dBm
• This device may be interfered with by other devices that conform to CISPR emission requirements
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Safety precautions
Table 1 Emissions
Emissions test Compliance
RF emissions
CISPR 11
Group 1
Class B
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Class A
Complies
Electromagnetic environment - guidelines
Dedicated medical facility environment
Dedicated medical facility environment
Dedicated medical facility environment
Table 2 Immunity
Phenomenon
Basic EMC standard or test method
Immunity test levels
Electrostatic discharge
Radiated RF EM fields
IEC 61000-4-2
IEC 61000-4-3
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
3 V/m
80 MHz - 2.7 GHz
80 % AM at 1 kHz
Proximity fields from RF wireless communications equipment
IEC 61000-4-3
Electrical fast transients / bursts
Surges
Conducted disturbances induced by RF fields
IEC 61000-4-4
IEC 61000-4-5
IEC 61000-4-6
±2 kV input d.c. power port
±2 kV input d.c. power port
±1 kV signal input/output parts port
100 kHz repetition frequency
±0.5 kV, ±1 kV line-to-line
±0.5 kV, ±1 kV, ±2 kV line-to-ground
3 V
0.15 MHz - 80 MHz
6 V in ISM bands between 0.15 MHz and 80 MHz a
80 % AM at 1 kHz
Rated power frequency magnetic fields
IEC 61000-4-8 30 A/m
Voltage dips
Voltage interruptions
IEC 61000-4-11
IEC 61000-4-11
0 % U
T
; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0 % U
T
; 1 cycle and
70 % U
T
; 25/30 cycle b
Single phase: at 0°
0 % U
T
; 250/300 cycle b
[NOTE] U
T
is the a.c. mains voltage prior to application of the test level.
a The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b E.g. 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz.
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Safety precautions
Test specifications for Enclosure port immunity to RF wireless communications equipment
Test frequency (MHz)
385
450
Modulation
Pulse modulation
18 Hz
Frequency modulation
±5 kHz deviation
1 kHz sine
Immunity test level (V/m)
27
28
710
745
780
810
870
930
1720
1845
1970
2450
Pulse modulation
217 Hz
Pulse modulation
18 Hz
Pulse modulation
217 Hz
Pulse modulation
217 Hz
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28
5240
5500
5785
Pulse modulation
217 Hz
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1�3�4 Precautions regarding wireless communication
CAUTION
• This device is equipped with a communication function that operates via wireless LAN. Conformance is required with the relevant regulations defined by the countries in which this device is to be used.
• Inappropriate usage may cause interference in radio communication. Also, if this device is modified, approval and warranty according to the radio law of the applicable government will be voided.
• It may affect aeronautical systems, so do not use onboard airplanes
• This device may be affected by other wireless devices.
Make sure that the environment is free of wireless communications
• DR Detector has been confirmed to comply with the relevant regulations of the following countries:
United States & Canada
Federal Communications Commission Statement /
Canadian Department of Communications
• DR Detector complies with Part 15 of FCC Rules and
Industry Canada license exempt RSS standard(s). Operation is subject to the following 2 conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of this device.
• This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.
• The 5.15 GHz-5.35 GHz band is restricted to indoor operation only
• The available scientific evidence does not show that any health problems are associated with using low power wireless devices. There is no proof, however, that these low power wireless devices are absolutely safe.
Low power Wireless devices emit low levels of radio frequency energy (RF) in the micro-wave range while being used. Whereas high levels of RF can produce health effects (by heating tissue), exposure of low-level
RF that does not produce heating effects causes no known adverse health effects. Many studies of low-level
RF exposures have not found any biological effects.
Some studies have suggested that some biological effects might occur, but such findings have not been confirmed by additional research. DR Detector has been tested and found to comply with FCC/IC radiation exposure limits set forth for controlled equipment and meets the FCC radio frequency (RF) Exposure Guidelines and RSS-102 of the IC radio frequency (RF) Exposure rules
Safety precautions
• High-power radars are allocated as primary users (i.e. priority users) of the 5250 MHz-5350 MHz and 5650
MHz-5850 MHz bands, and these radars could cause interference and/or damage to LE-LAN devices.
• Compliance with FCC requirement 15.407(c): Data transmission is always initiated by software, which is passed down through the MAC, through the digital and analog baseband, and finally to the RF chip. Several special packets are initiated by the MAC. These are the only ways the digital baseband portion will turn on the
RF transmitter, which it then turns off at the end of the packet. Therefore, the transmitter will be on only while one of the aforementioned packets is being transmitted.
In other words, this device automatically discontinues transmission in case of either absence of information to transmit or operational failure
• Compliance with FCC requirement 15.407(g): Frequency Tolerance: 20 ppm
FCC WARNING
Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
European Union
European Union Directives Conformance Statement
DR Detector conforms with the Declaration of Conformity (DoC) to Radio Equipment Directive 2014/53/EU or
R&TTE Directive 1999/5/EC. This device purposely connects to an access point of a 5 GHz network.
The 5.15-5.35 GHz band is restricted to indoor operation only
Hereby, Konica Minolta, Inc., declares that the SKR 4000 is in compliance with Directive 2014/53/EU or 1999/5/EC.
The full text of the EU declaration of conformity is available at the following internet address: https://www.konicaminolta.eu/
South Korea
Because this wireless equipment may be affected by radio interference, it cannot provide services related with life safety.
Thailand
DR Detector conforms to NTC technical requirement.
Mexico
This equipment operates on a secondary basis; consequently, you must accept harmful interferences from equipment of the same type, and cannot cause interferences to systems operating on a primary basis.
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19
Safety precautions
Taiwan
Observe the following based on the regulations stat ed in Article 10 of Administration Measures for Lowpower Radiation Electric Machines.
Article 12
As for type-approval qualified low-power radio-frequency generator, no company, firm, or user may arbitrarily change the frequency, increase the power or alter the function or characteristics of the original design without prior permission
Article 14
The use of low-power radio-frequency electric machines shall not affect air flight safety or disturb lawful communication. If disturbance is found, the use of such electric machines shall be suspended immediately and such use shall not be resumed until the disturbance is eliminated.
Lawful communication mentioned in the preceding paragraph refers to wireless communication operation in accordance with the provisions of the Telecommunication
Law.
Low-power radio-frequency electric machines shall tolerate disturbance from lawful communication or from radiowave radiation electric machine for industrial, scientific or medical use
Brazil
This equipment operates secondarily, that is, it doesn’t benefit from protection against harmful interference, even from stations of the same type, and cannot cause interference to systems that operate primarily.
DR Detector has been approved by ANATEL in compliance with the procedures regulated by Resolution
242/2000 and complies with the applicable technical requirements.
This device fulfill the requirements set forth in INMET-
RO Ordinance No 350, dated 06/09/2010, and other regulations pertaining to compulsory certification of
Electrical Equipment Subject to Sanitary Surveillance by ANVISA (RDC No 27, dated 21/06/2011, and Normative Instruction No 11, dated 16/12/2014).
The highest SAR value reported during product certification when used properly on the body is 0.074 W/kg
(for P-41 model).
Konica Minolta hereby declares that this device products fulfill the biocompatibility aspects of ISO 10993-
1:2009.
This equipment operates with a voltage of AC 127V.
For more information, please visit: http://www.anatel.gov.br
1�3�5
Precautions for installing, moving, and storing
WARNING
• Take note of the following when installing and relocating the AC Adapter and Battery Charger:
— Do not subject to shocks or vibration .
— Do not move with the power cable or any other cable connected
— Do not install the power cable and DC Power Cable so that you do not catch them on your feet and so on.
— Be careful not to drop the DR Detector on any part of a person's body
— Install on a horizontal and stable surface.
CAUTION
• Contact Konica Minolta or dealers specified by Konica
Minolta to install or move this device.
• Take note of the following when installing or storing this device.
— Install or store this device within the specified storage and usage conditions and environment.
— Do not install or store in a location where it may be adversely affected by atmospheric pressure, temperature, humidity, ventilation, sunlight, dust, salt-air, or air containing sulfur.
— Do not install or store in a location where it is not stable, ventilation is insufficient, the difference in lightdark is great, electromagnetic waves are generated, or where subject to vibration or shock.
— Do not install or store in a location where chemical agents are used or stored.
— Do not install t his device facing up or upside down.
20
Safety precautions
1�3�6 Precautions regarding maintenance
1�3�7 Precautions on service life
WARNING
• Perform the maintenance and inspection periodically.
• If there are stains such as body fluids, clean and disinfect
CAUTION
• Based on the warranty, parts that are no longer under warranty (1 year) can be replaced for a fee.
• Turn off the power and disconnect the power plug from the wall outlet before cleaning or maintaining this device.
• Securely connect the power cable, DC Power Cable after cleaning and maintenance.
• Clean the dirt from the gaps between the exterior of DR
Detector, and the terminal using a commercial plastic brush. Do not clean with sharp or hard objects.
• Take care regarding the following when disinfecting the
DR Detector.
— For an antiseptic solution, use commercially available aqueous solution of benzalkonium chloride or benzalkonium bromide
— Never use flammable cleaning agents such as alcohol or ether.
— Never use methanol, benzene, or other acid solutions because they may erode the device.
— Please note that if you use chemical for disinfection other than the above, it may affect the quality, performance, and safety of the DR Detector.
— If you directly apply or spray disinfecting solution on the DR Detector, the solution will enter the instrument through exterior gaps, causing a failure. Dampen a lint-free, soft cloth with disinfecting solution, and use after wringing it thoroughly. Do not apply disinfecting solution onto the wired connection connector, LED
Power SW and Selection SW when cleaning.
CAUTION
Service life
Name
DR Detector
Battery Charger
AC Adapter
AC Power Cable
DC Power Cable
Service life
6 years
6 years
6 years
6 years
6 years
• The above service life is valid only if the product has been properly operated while following the precautions for use and performing the specified maintenance. (By self certification <our data>)
• The service life may differ depending on usage conditions and environment.
• Some component parts of this device are commercially available parts that have a short cycle of model changes, therefore, it might not be possible to supply service parts even within the service life. In addition, related component parts may need to be replaced to maintain compatibility at the time of model change.
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9
— Because the solution is a chemical agent, follow the precautions provided by the manufacturer.
• Fully charge the Battery once in every six (6) months even if the DR Detector is not used for a long time.
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22
Chapter 2
Product Overview
23
2�1 Overview of this device
2�1�1
Basic configuration example
Number
(1)
Name
DR Detector
(2)
(3)
Battery Charger
DC Power Cable
(4)
(5)
Access point
Image processing controller
Functions
• The Battery is removable.
• DR Detector is of B-type Applied Parts.
Charges the Battery.
Connects to the DR Detector and charges Battery.
• Communicates with the DR Detector.
• Provided by a general purpose product.
• Controls the reception, management, and output of image data.
• Up to 2 DR Detectors can be registered.
2�1�2
Connection examples
Connection example 1
Exposure room
Wireless connection
(1) DR Detector
Wireless connection
(1) DR Detector
X-ray Tube
(3) DC Power Cable
(4) Access point
Hub
(5) Image processing
controller
(2) Battery Charger
X-ray device operation panel
24
Connection example 2
Exposure room
Wireless connection
(1) DR Detector
Wireless connection
(1) DR Detector
X-ray Tube
(3) DC Power Cable
(2) Battery Charger
Overview of this device
(5) Image processing controller X-ray device operation panel
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2�2 Component names and functions
2�2�1
(1)
DR Detector
(2)
Exposure side
(3) (4) (5) (6) (6)
XXXXXXXXXXXXXXXX
(7)
Number
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
Power SW
Selection SW
Triangular mark
Name
Antenna
Exterior
Battery lock
LEDs
Wired connection connector
Battery
(8) (4) (9)
Functions
Used to turn the DR Detector on/off.
Toggles the DR Detector wireless modes.
Indicates the direction to place the DR Detector in during exposure.
Displays the place where a wireless antenna is attached.
Protects the internal parts.
A lug to prevent Battery from falling.
Display the DR Detector status.
The connection port for the DC Power Cable.
Used to supply the power to the DR Detector.
26
2�2�2 Battery
Number
(1)
(2)
Name
Battery connector port
LEDs
Component names and functions
Number
(1)
(2)
Name
Battery connector port
Insertion direction indication mark
(1) (2)
Functions
Connects to the DR Detector or Battery Charger.
Indicates the insertion direction of the Battery.
2�2�3 Battery Charger
(1) (2)
Functions
Connects to the Battery.
Display the Battery Charger status.
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5
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2
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Component names and functions
2�2�4 DC Power Cable
(1) (2) (3) (4)
Number
(1)
(2)
(3)
(4)
Name
Wired connection connector
LED
AC Adapter
AC Power Cable
Functions
Connects to the DR Detector.
Display the DC Power Cable status.
Used to supply power to the DC Power Cable.
28
Chapter 3
General Operations
29
3�1 Startup and shutdown
3�1�1 Startup of this device
DR Detector
IMPORTANT
• If the battery level is 0 %, this device does not start up.
1
Press and hold the Power SW for 4 sec onds to turn it on, and confirm that the
Battery LED (green/orange) is on.
DC Power Cable
1
Connect the AC Power Cable to a wall out let, and confirm that the LED (blue) is on.
LED (blue)
3�1�2 Shutdown of this device
Battery LED
(green/orange)
Power SW
HINT
• The following operations turn on this device when the power is off.
— Inserting a charged Battery to the DR Detector.
— Connecting the DC Power Cable to the DR Detector and the AC Power Cable to the power outlet.
Battery Charger
1
Connect the AC Power Cable to a wall out let, and confirm that the Power LED (green) is on�
Power LED (green)
DR Detector
1
Press and hold the Power SW for 4 sec onds to turn it off, and confirm that the
Battery LED (green/orange) is turned off.
Battery LED
(green/orange)
Power SW
30
Battery Charger
1
Disconnect the AC Power Cable from the wall outlet, and confirm that the Power
LED (green) is off.
Power LED (green)
DC Power Cable
1
Disconnect the AC Power Cable from the wall outlet, and confirm that the LED (blue) is off.
LED (blue)
Startup and shutdown
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3�2
Operation of DR Detector
3�2�1
Exposure with basic exposure
3�2�2
Exposure using Image
Storage
IMPORTANT
• When the battery runs down completely, all the LEDs of the
DR Detector go out.
• If the battery level is 0 %, exposure is not allowed.
• Confirm that the Battery LED (green) of the DR Detector either lights or flashes when you perform exposure.
• The DR Detector is precision equipment, and therefore impact or vibration during radiography or image transfer may affect the image quality. Be careful when handling the DR
Detector during and just after radiography.
1
Perform examination registration with the image processing controller�
2
Check that this device is ready to expose images, and then prepare for the exposure�
• Remove the DC Power Cable, if it is connected.
3
Push the exposure switch of the X-ray device to perform the exposure.
• When the exposure is completed, images are stored in the DR Detector and will then be converted to digital data and sent to the image processing controller sequentially.
4
Check that the exposed image is displayed on the image processing control ler�
HINT
• When inserting the DR Detector to the wall stand or table, an exposure operation can be performed with the DC Power Cable connected.
• Press the Power SW twice to enter the sleep mode.Press the button again to wake up the device.
IMPORTANT
• The DR Detector is precision equipment, and therefore impact or vibration during radiography or image transfer may affect the image quality. Be careful when handling the DR
Detector during and just after radiography.
• Images exposed by Image Storage are not linked to any patient information. Associate the exposed patient to the number of exposures to record the exposures.
• If the number of images stored in Image Storage exceeds
200 during exposure, the oldest images will be deleted.
1
Turn on Image Storage mode of the image processing controller�
2
Check that this device is ready to expose images, and then prepare for the exposure�
3
Push the exposure switch of the X-ray device to perform the exposure.
• After exposure, images are saved to DR Detector
4
Turn off Image Storage mode of the image processing controller�
5
Import the images using the image pro cessing controller�
32
3�2�3
DR Detector orientation
Change the orientation of the DR Detector according to the exposure body part.
Expose with the triangular mark upward when exposing in portrait, and with the triangular mark to the side when exposing in landscape.
IMPORTANT
• The side with the triangular mark is the exposure surface.
When exposing in portrait
The triangular mark is upward
X-ray
X-ray device
When exposing in landscape
Operation of DR Detector
3�2�4
Precautions for exposure
1
Exposure area
IMPORTANT
• If the irradiation field is larger than DR Detector when you take an image, an artifact may occur due to the X-ray backscatter effect. Adjust the irradiation filed to fit within the imaging range.
• The size lines of DR Detector indicate the exposure size.
• During exposure, place the exposure body part within the white lines on the four corners.
White lines
2
3
4
Size lines
5
Blue lines
6
7
X-ray
X-ray device
The triangular mark is to the left or right
HINT
• The blue lines also helps you identify the top-bottom orientation of the DR Detector.
• To carry out exposures in portrait orientation, turn the DR
Detector so that its blue lines comes to the bottom position.
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9
10
11
Blue lines
12
33
Operation of DR Detector
Wireless communications environment
• With a wireless environment, it is possible that errors such as no wireless connection, wireless communication terminates, and lengthened exposure cycle time might occur.
HINT
• Problems with a wireless communications environment can occur in the following conditions:
— Installed location of the access point is not good.
— When inserted in the wall stand, table, or stretcher, the opening in the wall stand or table is too small and there is no passage for the radio waves.
— The radio waves are not emitted due to metal parts close to the antenna, which changes the antenna characteristics.
— For exposures where the body touches the DR Detector directly, the radio waves may not be emitted if the body completely covers both antennas or either of the antennas.
— Other devices use the same radio band, and cause interference
— When the 2.4 GHz band is used, using high frequency therapy equipment will cause interference.
— When the DFS band is used, the access point changes channels if weather radar or air control radar is detected. This may cause communication to be temporarily disconnected
Grid
IMPORTANT
• A capped grid is recommended when laying the grid over the DR Detector on the table top or for exposure with the
X-ray device.
• Do not use a grid of which the antenna is covered with metal, as the quality of wireless communication may be significantly reduced.
• Use the following grid when exposing.
DR Detector
Grid density
AeroDR NS 1417 40 lp/cm
Grid ratio
Conver gence distance
Variety Variety
Angle error
5.0° or less
High-dose exposure
• When high-dose exposures are performed continuously, afterimages of the last exposure will occasionally be visible. The affect of afterimages in this device can be resolved by leaving longer intervals between exposures, so make the intervals between exposures longer than usual when performing highdose exposure.
• During high-dose exposure, continual use of a lead or other marker at the same position can cause burning in of the afterimage. Therefore, avoid using it in the same position. Also, if image burn-in is visible, contact Konica Minolta technical representatives.
Exposure time for basic connection
IMPORTANT
• If the conditions are not met, X-rays may not be detected or streaks may occur in the image.
• The maximum exposure time is as follows.
DR Detector
Maximum exposure time
AeroDR NS 1417 3.0 seconds
Minimum exposure time
2 milliseconds
• The exposure time for actual exposures should not exceed the maximum exposure time you have set.
Otherwise, exposure may fail or correct images may not be able to be obtained
Exposure with the X-ray automatic detection function
• To ensure X-ray detection, make sure the following conditions are met:
— When imaging the abdominal area, ensure the Xray exposure covers the entire DR Detector.
— For other body parts, perform X-ray exposure at a range of 15 cm square or more at the center of
— the DR Detector.
Ensure that the exposure time and the S value conditions satisfy the following conditions:
Exposure time
2.0 seconds or less
0.9 seconds or less
0.4 seconds or less
400 or less
S value
800 or less
2000 or less
34
X-ray automatic detection function exposure when radioactive substances remain
• When the radioactive substance remains in the patient's body, e.g., after a nuclear medicine examination, the system may recognize it as an X-ray exposure, transmitting images.
AED (Automated External Defibrillator)
• When an AED (Automated External Defibrillator) is used, move the DR Detector away from the patient.
High voltage and high current may result in a breakdown of the DR Detector.
The operating temperature environment of
DR Detectors
• If an DR Detector is left close to or in contact with a heat generator such as electric carpet, its safety device may be activated and the DR Detector may fail to work properly.
Electromagnetic waves
• If an exposure is performed at a location near a device that emits electromagnetic wave, noise may appear on the image. When performing exposure, turn off that device or move that device away from DR
Detector
Waterproof performance
• If there is a risk of the ingress of patient body fluids, chemicals, water, etc., make sure to put a cover with a vinyl sheet, etc. The ingress of patient body fluids, chemicals, water, etc. into the DR Detector cannot be prevented. In particular, if patient body fluids enter into the protective cover, for hygienic purposes, make sure to replace or clean the parts.
• Subjecting it to strong impacts or excessive loads by dropping or hitting it against other objects may diminish its waterproof capabilities.
• The exposure side of the DR Detector has IPX1 waterproof capabilities, but it is not guaranteed to be completely waterproof.
HINT
• IPX1 (protection level against vertically falling drops of water) ensures that no hazardous effects are generated by the vertical water droplet on the DR Detector (drip proof type I).
35
Operation of DR Detector
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3�3 Inserting and removing the Battery
IMPORTANT
• Handle the Battery carefully when inserting and removing the Battery. The battery connector port may be damaged.
• Turn off the device when inserting and removing the Battery
3�3�1 Insertion
1
Ensure that the Status LED of the DR Detector is turned off.
HINT
• When a Battery charged more than 11 % is inserted, the
DR Detector starts up and the Battery LED (green) turns on
3�3�2
Removal
1
Ensure that the Status LED of the DR Detector is turned off.
Status LED
(green/orange)
2
Align the insertion direction indication mark on the Battery with the DR Detector battery connector port, and then insert the
Battery�
Status LED
(green/orange)
2
Slide the battery lock to unlock the Bat tery�
Battery lock
Battery lock
3
Remove the Battery.
Insertion direction indication mark
Battery connector port
3
Slide the battery lock and lock the Battery�
Battery lock
Battery lock
36
3�4 Charging of Battery
Charge the Battery when the Battery LED (orange) on the DR Detector lights or flashes, or when the battery level gets low in the status display of the DR Detector on the image processing controller.
IMPORTANT
• During charging, if the Battery should become hot, stop charging immediately.
• Connectors may become warm immediately after charging.
This often occurs during charging and is not a malfunction.
HINT
• The DR Detector can be used while stopping charging in progress.
• The following charging time will be required to fully charge the Battery.
Charging status
Battery Charger
DC Power Cable
Charging time
3 hours or less
6 hours or less (if not expose)
• When charging completes, the charging LED
(orange) turns off, and the fully charged LED
(green) turns on.
Charging LED
(orange)
Fully charged LED
(green)
2
Remove the Battery when charging completes�
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3
4
5
6
3�4�1 Charging with Battery
Charger
IMPORTANT
• Handle the Battery carefully when inserting and removing the Battery. The battery connector port may be damaged.
• The battery connector port of the Battery may become warm right after charging on the Battery Charger. This often occurs during charging and is not a malfunction.
1
Align the insertion direction indication mark on the Battery with the battery con nector port of Battery Charger, and then insert the Battery�
• Charging starts.
• When charging starts, the charging LED (orange) of Battery Charger turns on.
Insertion direction indication mark
Battery
7
8
9
10
11
12
Battery connector port
37
Charging of Battery
3�4�2 Charging with the DC Power
Cable
IMPORTANT
• If the power is supplied through the DC Power Cable without inserting the Battery, the surface temperature of the DR
Detector may become high.
1
Make sure that the Battery is inserted to the DR Detector.
2
Connect the wired connection connector of the DC Power Cable to the wired con nection connector of the DR Detector.
• Charging starts.
Wired connection connector
DC Power Cable
DR Detector
Wired connection connector
• When charging starts, the Battery LED (green/ orange) on the DR Detector blinks.
• When charged more than 11 %, the Battery
LED (green) blinks.
Battery LED
(green/orange)
HINT
• The DR Detector will be charged when it is in the sleep mode or turned off.
• The wired connection connector of the DC Power Cable does not have an insertion direction.
• When inserting the DR Detector to the wall stand or table for exposure, confirm the level of battery power with the image processing controller.
• When the DR Detector is on, the charging time will be slightly longer as it depends on the operation status.
• Connecting the DC Power Cable when the DR Detector is off will turn the DR Detector on.
38
3�5
LED display of respective devices
Status of the respective devices can be confirmed with
LEDs.
Check the status of the respective devices, referring to the "LED display pattern".
LED display pattern
Notation Display pattern
Off
Slow flashing
Fast flashing
On
3�5�1
DR Detector
Mode LED
Status LED
LINK LED
Battery LED
:Battery LED
Display pattern
Lighting color
-
Status
Shutdown condition
Orange less than 11 %
Green
Green
(Flashes twice) more than 11 %
During sleep
HINT
• When the DC Power Cable is connected, the Battery LED blinks. Also, when the DR Detector power is on, the blink speed will decrease.
• When the Battery is removed, if the DC Power Cable is connected and the DR Detector is turned on, the Battery
LED (green) turns up.
:LINK LED
Display pattern
Lighting color
Blue
Blue
-
Status
• Shutdown condition
• Without connection
When using the external AP function: Waiting for the radio
• When using the external AP function: radio connection established
• When using the internal AP function: Access point ready
:Status LED
Display pattern
Lighting color
-
Status
Shutdown condition
Green Standing by
Green
Orange
Data transmission
Error occurred
:Mode LED
Display pattern
Lighting color
Blue
-
Green
Status
Shutdown condition
When the external AP function is in operation and waiting for the radio
When the internal AP function is in operation
When the external AP function is operation and radio connection established
10
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12
3
4
5
8
9
6
7
1
2
39
LED display of respective devices
3�5�2 Battery Charger
Charging LED
Power LED Fully charged LED
Power LED (green)
Display pattern
Status
Shutdown condition
Operating
Charging LED (orange) and Fully charged
LED (green)
Charging
LED
Fully charged
LED
Status
Battery not inserted
Charging
Charged
Error occurred
40
3�6
Position to affix DR Detector identification label
When using more than 1 DR Detector and affixing identification labels (stickers) to the outside of the DR
Detectors, it is recommended to affix the labels to the
2 places ((1), (2)) shown as follows.
IMPORTANT
• Affix the labels only in the recommended places. Failure to do so may cause the labels to come off or image unevenness to occur
Position to affix DR Detector identification label
(1) (2)
XXXXXXXXXXXXXXXX
HINT
• Use of commercially available vinyl (Tepra, etc.) labels are recommended for the identification labels (stickers). When possible, use labels that do not easily peel off.
• It is recommended to write the name and identification number registered in the image processing controller on the label.
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4
5
1
2
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42
Chapter 4
Troubleshooting
43
4�1
Various problems and countermeasures
If the following problems occur with any of these devices, consult the respective references for countermeasures.
IMPORTANT
• After performing countermeasures, if the problem does not go away, contact Konica Minolta technical representatives.
• If the exterior is damaged extensively, contact Konica Minolta technical representatives.
HINT
• When an error message has been displayed in the image processing controller, check the error description and countermeasures listed in the "Operation Manual" of the image processing controller.
• When using a general-purpose hub or access point, refer to its operation manual.
4�1�1
DR Detector
The Status LED (green) does not light.
("Ready" is not displayed on the image processing controller)
When the DR Detector is placed on a smooth surface, the DR Detector is not stably attached to the smooth surface.
The DR Detector will not go into the wall stand or table
Status
The DR Detector does not start up.
The DR Detector does not shut down.
The Status LED (orange) is flashing.
The Battery cannot be inserted.
DC Power Cable cannot be connected to the DR Detector.
Power does not go on even when the power switch is pressed for 4 seconds or longer.
Power does not go off even when the power switch is pressed for 4 seconds or longer.
Error description
System error is occurring.
System error is occurring.
DR Detector is warped.
DR Detector is warped.
The battery connector port of the DR Detector is deformed
The battery connector port of the Battery is deformed
A foreign object is present at the battery connector port of the DR Detector and/or the Battery.
The wired connection connector of the DR
Detector and/or the DC Power Cable is deformed
A foreign object is present at the wired connection connector of the DR Detector and/or the DC Power Cable.
Corrective actions
The Battery may not be inserted correctly, or the Battery may ran out. Insert a fully charged Battery.
If the symptom persists, the output from the Battery may be locked. To unlock it, charge the Battery for more than 30 seconds using the Battery Charger.
When the DC Power Cable is used, it may not be connected correctly. Connect the
DC Power Cable correctly.
It is not possible to shut down while exposing.
Shut down after exposure is ended.
If the status LED (green) does not turn on after approx. 10 minutes, restart the DR
Detector
Or, when "Ready" is not displayed on the image processing controller, restart it.
Restart the DR Detector.
If the DR Detector is still warped even after the detector is placed on a smooth surface, contact Konica Minolta technical representatives.
If the DR Detector is still warped even after the detector is placed on a smooth surface, contact Konica Minolta technical representatives.
Contact Konica Minolta technical representatives.
Replace the Battery.
Refer to “5.1.2 Cleaning” and remove the
foreign material.
Contact Konica Minolta technical representatives.
Refer to “5.1.2 Cleaning” and remove the
foreign material.
44
Various problems and countermeasures cannot be used
Status
Wireless connection with the DR Detector
Error description
There is an error in the access point.
The DR Detector and access point are being used under poor conditions.
•Wireless does not connect
•Wireless communication terminates
•Cycle time is extended
Corrective actions
Check that the Ethernet cable is properly connected to the access point.
Check the installation location of DR Detector and access point
When performance is noticeably lower than at the initial installation of this device, it is possible that the installation environment or usage environment have changed.
This is caused by charging and is not a malfunction
DR Detector wired connection connector is heated up.
The battery LED turns to orange too fast.
DR Detector wired connection connector is heated up immediately after charging with DC Power Cable.
Usage time with the battery has gotten shorter.
The number of images that can be exposed has decreased.
The charging time has gotten shorter.
It could be that the charging function of the battery has deteriorated.
Replace the Battery.
No image is acquired.
Reading has automatically started.
No image appears after X-ray exposure.
The machine starts reading the image without X-ray exposure.
(1) Check the following items.
• Did you perform exposure in "Ready" status?
• Are the exposure conditions correct?
• Was X-ray output lowered?
• Was X-ray voltage set to a lower value?
(2) Perform the following procedures.
• Increase the voltage of the X-ray before xposure.
(1) Check the following items.
• Was the DR Detector subjected to strong shocks or vibrations while
"Ready" was displayed or wasn't an Xray exposed nearby?
(2) Use caution to prevent strong shocks or vibrations and restart exposure.
4�1�2 Battery Charger
Status
Power LED (green) does not light.
The charging LED (orange) and fully charged LED (green) flash fast.
Error description
AC power not supplied.
System error is occurring.
Corrective actions
Make sure the power cable is connected correctly
If the Battery is inserted, remove it, and remove/connect the AC Power Cable from the wall outlet, then restart the Battery
Charger.
Charging does not start when the Battery is inserted
The battery is not inserted correctly.
The Battery cannot be inserted.
The battery connector port of the Battery
Charger is deformed.
The battery connector port of the Battery is deformed
A foreign object is present at the battery connector port of the Battery Charger and/ or the Battery.
Insert the Battery correctly.
Contact Konica Minolta technical representatives.
Replace the Battery.
Refer to “5.1.2 Cleaning” and remove the
foreign material.
1
2
3
4
5
6
7
8
9
10
11
12
45
46
Chapter 5
Maintenance
47
5�1 Maintenance and inspection items
This chapter describes the inspections and cleaning required in order to maintain the use of this device in an optimum condition
Quality Tool
HINT
• "Simple Check QC for ImagePilot" is available for checking of imaging quality. Please contact our customer service for the detail.
• For details, contact Konica Minolta technical representatives.
5�1�1 Maintenance schedule
The maintenance and inspection items that the user should perform are as follows.
IMPORTANT
• To ensure optimum use of this device, be sure to perform periodic maintenance
• The following task intervals are estimates and vary according to usage.
• If image burn-in or defect pixels in the image is visible, contact Konica Minolta technical representatives.
Maintenance task
Maintenance interval
Checking and cleaning the surface of the
DR Detector
Weekly
Checking for external damage to the DR
Detector
Cleaning the DR Detector and wired connection connectors
Cleaning the DC Power Cable and connectors
Cleaning the Battery Charger
Full charge of the Battery
Weekly
Weekly
Weekly
Weekly
6 months
5�1�2 Cleaning
IMPORTANT
• Be careful not to apply any cleaning chemical or liquid onto the wired connection connectors, the Power SW, the Selection SW, and the LEDs.
• Do not clean with sharp or hard metal objects. If you cannot remove stains, contact Konica Minolta technical representatives.
• Pay attention not to damage the wired connection connectors or the battery connectors port of the DR Detector, the
Battery, and the Battery Charger.
Exterior
IMPORTANT
• If you directly apply or spray antiseptic solution on the DR
Detector, the solution may enter the inside of the instrument through exterior gaps, causing a failure.
• Clean the exterior with a soft lint-free cloth dampened with a small amount of antiseptic solution and wrung well.
• To clean the gaps on the exterior of the DR Detector, remove dirt using a commercial plastic brush.
Wired connection connector
If foreign material has adhered to the wired connection connectors of the DR Detector and DC Power Cable, and/or the battery connector ports of the DR Detector, the Battery, and the Battery Charger, remove it with a commercial plastic brush.
DR Detector
Wired connection connector
48
Battery connector port
Battery
Battery connector port
Battery Charger
DC Power Cable
Battery connector port
Wired connection connector
49
Maintenance and inspection items
5�1�3
Disinfection of the DR
Detector
IMPORTANT
• Never use flammable cleaning agents such as alcohol or ether.
• Never use methanol, benzene, or other acid solutions because they may erode the device.
• Be careful not to apply any chemical for disinfection onto the wired connection connectors, the LEDs Power SW and
Selection SW.
• If you directly apply or spray chemical for disinfection on the DR Detector, the solution will enter the instrument through exterior gaps, causing a failure.
• Please note that if you use other chemical than instructed, it may affect the quality, performance, and safety of the
DR Detector.
• Because the antiseptic solution is a chemical agent, adhere to the precautions provided by the pharmaceutical manufacturer
• If bodily fluid or blood from a patient has contaminated the surface of the DR Detector, disinfect with a soft lint-free cloth dampened with a small quantity of the following disinfectant and wrung well.
— Commercially available aqueous solution of benzalkonium chloride
— Commercially available aqueous solution of benzalkonium bromide
5�1�4 Consumables
The approximate periodical replacement parts replacement cycle is as follows.
IMPORTANT
• The replacement cycle depends on the frequency of battery operation and conditions
• Refer to each device’s manual for information about periodic replacement parts and consumables for the image processing controller, etc.
Replacement parts
Battery 1 year
Estimated replacement
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2
3
4
5
6
7
8
9
10
11
12
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Chapter 6
Specifications
51
6�1
Specifications
IMPORTANT
• The following specifications described below are nominal values which may be different from actual values and may vary depending on environment and frequency of use. (These are not to provide any guarantees.)
• All specification regarding battery is for a fully-charged battery.
6�1�1
DR Detector
Item
Product name
Detection method
Scintillator
Power supply
P-41
Indirect conversion method
CsI (Cesium Iodide)
AC Adapter : DC 24 V 0.75 A
Battery : DC 11.5 V 1.5 A
384(W)×460(D)×15(H) mm
Description
460 mm
External dimensions 15 mm
384 mm
Weight
Pixel size
Image area size
AD conversion
3.6 kg (Including the Battery)
150 um
345.6×420 mm (2,304×2,800 pixels)
16 bit
Point load:100 kg@Φ40 mm
Maximum patient weight
Face load:150 kg@effective image area overall
Communication
Drive power
WLAN encryption
Wireless QoS
Patient doses
* Deadweight, even when loaded on the DR Detector, has no effect on images and the DR
Detector. The measurement method is based on KM standards.
Dedicated wired Ethernet connection / wireless LAN (IEEE802.11a/b/g/n/ac compliant)
* Dedicated wired Ethernet connection is reserved for service maintenance
Dedicated power cable drive / battery drive
Wireless encryption method : AES
Authentication method : WPA2-PSK
Should be provided with standard-compliant
Patient doses are equivalent to 500-1000 speed film/screen systems.
52
Item
Number of exposable images
Specifications
Description
90 images/2.5 hours (Without sleep)
212 images/5.9 hours (With sleep)
* Under conditions that the interval between studies is five minutes and three images are captured in each study, assuming 20 seconds for each exposure to position a patient (when connected to the ImagePilot).
1
2
6�1�2 Battery
Product name
Battery type
Rated capacity
Item Description
BATTERY-KV (made by iRay Technology Co., Ltd.)
Lithium Ion Battery
4180 mAh (standard)
115(W)×210(D)×7.5(H) mm
3
4
5
External dimensions
210 mm
Weight 0.3 kg
6�1�3 Battery Charger
Item
Product name
Battery charging system
Power requirements
Consumption current
Description
CHARGER-COMBO (made by iRay Technology Co., Ltd.)
Automatic charging
AC 100 V-240 V ±10 %, single phase, 50/60 Hz
1.0 A
240.4(W)×184.4(D)×38.1(H) mm
115 mm
75 mm
6
7
8
9
External dimensions
Weight 0.5 kg
240.4 mm
184.4 mm
38.1 mm 10
11
12
53
Specifications
6�1�4 AC Adapter
Item
Product name
Power requirements
Consumption current
External dimensions
Weight
Description
LXCP61-024300 (made by Shenzhen Longxc Power Supply Co.,LTD)
AC 100 V-240 V ±10 %, single phase, 50/60 Hz
1.5 A
124(W)×50(D)×33.5(H) mm
0.29 kg
6�1�5 DC Power Cable
Product name
Cable length
Item
DC Power Cable
35 m
Description
6�1�6
SKR 4000
Item
When operating
Description
Temperature
10 °C to 35 °C
35 °C
Humidity
35 %RH to 85 %RH
(ensure no water condensation)
35 %RH
10 °C
* Temperature change should be less than 1 °C/min
* Pressure change should be less than 1.0197×10 -4 Pa/min
85 %RH
Atmospheric pressure
700 hPa to 1060 hPa
700 hPa
1060 hPa
Recommended storage and usage environment conditions
Temperature
–20 °C to 50 °C
– 20 °C
50 °C
20 %RH to 90 %RH
(ensure no water condensation)
Humidity
20 %RH
90 %RH
Atmospheric pressure
700 hPa to 1060 hPa
700 hPa
1060 hPa
When not operating
* When the Battery is not operating, the device behaves as follows:
Temperature Humidity
45 °C
3 months
–20 °C to 45 °C
6 months
–20 °C to 35 °C
–20 °C
35 °C
20 %RH to 90 %RH
(ensure no water condensation)
20 %RH
90 %RH
Atmospheric pressure
700 hPa to 1060 hPa
700 hPa
–20 °C
1060 hPa
Classification Safety IEC60601-1 Class I
Operation mode
Continuous operation
54
6�2
Characteristics and performance of the DR Detector
Item
Dynamic range
Description
4 digits
00087 0087
4000
3000
2000
1000
Air Kerma [ μ Gy]
087 87 87
0
00001 0001 001 01 1
Exposure Dose [mR]
10
870 8700
05
100 1000
0
3
25
2
15
1
P-41
REGIUS210 (QR=250)
SRO-500/SR-G
(right axis)
MTF
10
08
06
04
02
00
0 1 2 3 4
Spatial Frequency [cycles/mm]
5
P-41
DQE
60
50
40
30
20
10
0
0 5
P-41
1 2 3
Spatial Frequency [cyc le/mm]
4
55
8
9
6
7
3
4
5
1
2
10
11
12
56
57
58
Konica Minolta Healthcare Americas, Inc.
411 Newark-Pompton Turnpike, Wayne, NJ 07470,
USA
TEL 973-633-1500
EU Authorized Representative:
Konica Minolta Business Solutions
Europe GmbH
Capellalaan 65,2132 JL, Hoofddorp,
The Netherlands
TEL +31-20-658-4100
Konica Minolta Healthcare India Private Ltd.
Office No201, 2nd Floor, Atrium 2,
Next to Courtyard Marriott Hotel, Andheri Kurla Road,
Chakala, Andheri (East), Mumbai - 400093, India
TEL +91-22-61916900
Konica Minolta Business Solutions (Canada)
Ltd.
5875 Explorer Drive, Mississauga,
Ontario, L4W 0E1, Canada
TEL 905-890-6600
Konica Minolta Medical & Graphic (SHANGHAI)
Co., Ltd.
Room1602, Tower B, Hongwell International Plaza,
1602 West Zhongshan Road, Xuhui District,
Shanghai 200235 China
TEL 021-6422-2626
ACNNBA01EN02
2020-02-17
(MA)
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