AeroDR SYSTEM Introduction Chapter 1 Safety Precautions and Warnings Chapter 2 Product Overview Chapter 3 Basic Operations Chapter 4 Troubleshooting Chapter 5 Maintenance Appendix CODE NO.
Disclaimer (1) This manual may not be reproduced in whole or in part without the permission of Konica Minolta Medical & Graphic, Inc. (2) The contents of this manual may be subject to change without prior notice. (3) Konica Minolta Medical & Graphic, 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.
Contents Introduction . . . . . . . . . . . . . . . . 5 Chapter 3 Basic Operations . . . . . . . . . . . 31 Application Specification Regarding Usability . . 5 Structure of This Manual . . . . . . . . . . . . . . . . . . 6 3.1 Explanation of Terms . . . . . . . . . . . . . . . . . . . . . 6 Structure of Pages . . . . . . . . . . . . . . . . . . . . . . . 7 3.2 Chapter 1 Safety Precautions and Warnings . . 9 1.1 Alert Symbols . . . . . . . . . . . . . . . . . . . . . 10 1.
Introduction Digital radiography AeroDR SYSTEM (hereafter referred to as this device) performs 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 image acquired with a digital image acquisition device is then transmitted to a filing system, printer, image display device as diagnostic image data.
Introduction Structure of This Manual This manual consists of the chapters listed below. Chapter 1 Safety Precautions and Warnings This chapter describes the precautions and warnings to be followed to use this device safely. Chapter 2 Product Overview This chapter describes the overview of this device. Chapter 3 Basic Operations This chapter describes the basic operations of this device.
Introduction Structure of Pages ① 3.4 ● Selection and Registration of AeroDR Detector By registering the AeroDR detector to the CS-7, it is possible to move it between different radiology rooms. 3.4.1 ② 3.4.2 Registering the AeroDR Detector Turn the power of the AeroDR detector ON. 2 Insert the AeroDR detector into the registration AeroDR battery charger. The AeroDR detector to be used is selected as follows depending on the number of registered AeroDR detectors.
Chapter 1 Safety Precautions and Warnings This chapter describes the precautions and warnings to be followed to use this device safely.
1.1 ● Alert Symbols 1.2 ● Warning Notice (Signal Word) Signal words designate a degree or level of hazard seriousness inherent in products. Signal words include the following three types, which are used according to risk of damage caused by danger and the severity of damage: Safety Alert Symbol This is a "safety alert symbol". This symbol alerts the user to matters and/or operations that present a hazard to the user and other people. Read these messages and follow the instructions carefully.
1.3 ● Warning Labels ※ If a warning label is too dirty or damaged to read, contact Konica Minolta technical representatives to have a new warning label attached. (There is a fee for this service) 1.3.1 AeroDR Detector 11 Chapter 1 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.
1.4 ● Safety Precautions 1.4.1 Precautions Before Usage 1.4.2 CAUTION Precautions for Usage WARNING • The users (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. • Perform the pre-operation check before using this device, and confirm that this device is operating normally.
1.4 Safety Precautions 1.4.3 WARNING EMC Statement The device has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2007. 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 the vicinity.
1.4 Safety Precautions Table 1 Guidance and manufactureís declaration - electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions Group 1 The device uses RF energy only for its internal function.
1.4 Safety Precautions Table 2 Guidance and manufacturer's declaration - electromagnetic immunity Immunity test Electrostatic discharge (ESD) IEC 60601 Compliance test level level +/- 6kV contact +/- 6kV contact +/- 8kV air +/- 8kV air Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment.
1.4 Safety Precautions Table 3 Guidance and manufacturer's declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
1.4 Safety Precautions Table 4 The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
1.4 Safety Precautions 1.4.4 Precautions Regarding Wireless FCC WARNING Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. CAUTION European Union • This device is equipped with communication function that operates via wireless LAN. • It is required to abide with the relevant regulations defined by the countries in which this device is to be used.
1.4 Safety Precautions Taiwan Chapter 1 Observe the following based on the regulations stated in Article 10 of Administration Measures for Low-power Radiation Electric Machines. Article 12 As for type-approval qualified low-power radiofrequency 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.
1.4 Safety Precautions China პפ ) ၏⊞ * 㡰优䶣児䩥ጥ䯺۩億ࡳ รԼԿ㦕 1. Clearly indicate the technical indicators and the scope of usage in the accompanying document, and explain the usage of all controls, adjustments, and switches, etc.
1.5 ● Precautions for Installing, 1.6 ● Cautions Regarding Care and Maintenance of the Device Moving, and Storing WARNING • Take note of the following when moving this device not including the AeroDR detector: Do not apply shocks or vibration. Do not start moving until the power is turned OFF, and operation has stopped completely. Do not move with the power cable or any other cable connected. • Perform the maintenance and inspection periodically.
1.7 ● Precautions for Parts Replacement and Regular Maintenance Name Service life AeroDR detector 6 years AeroDR interface unit 6 years AeroDR generator interface unit 6 years AeroDR battery charger 6 years HINT • The above service life is valid if the product has been properly operated while following the precautions for use. • The above service life is a guideline for replacement. • Based on the warranty, parts that are no longer under warranty (1 year) can be replaced for a fee.
Chapter 2 Product Overview This chapter describes the overview of this device.
2.1 ● Overview of This Device This section describes the functions and features of this device as well as a system configuration example using this device. 2.1.1 Functions and Features This device consists of AeroDR detector, AeroDR interface unit, AeroDR generator interface unit, AeroDR battery charger, AeroDR Access Point, etc. The AeroDR detector reads the diagnostics X-ray digital image data from the X-ray image exposed by the X-ray exposure device, and sends it to the CS-7. 2.1.
2.2 ● Component Names and Functions 2.2.1 AeroDR Detector ①White line ②Pressure adjustment window ④Power switch ⑤Exterior ⑤Exterior ⑦Selection switch ⑥LED ⑧Pad Number Name Functions ① White line Expose the body part with the white line located at the bottom (portrait) or with the white line located to the right of the upper edge that should be positioned at the top of the image field (landscape).
2.2 Component Names and Functions 2.2.2 AeroDR Interface Unit The AeroDR interface unit will supply power to the AeroDR generator interface unit, AeroDR Access Point, and supply power to and charge the battery of the AeroDR detector when an AeroDR I/F Cable or AeroDR UF Cable is used. It also has a hub function. ①Top cover ⑥Exhaust outlet ②Side cover ⑤Front cover ④LED Number Name ① Top cover ③Power switch Functions Protects the internal parts.
2.2 Component Names and Functions 2.2.3 AeroDR Generator Interface Unit The AeroDR generator interface unit relays signals between the X-ray generator device, the AeroDR detector, and the CS-7. ①Top cover ⑥Exhaust outlet Chapter 2 ②Side cover ⑤Front cover ④LED ③Cable outlet Number Name Functions ① Top cover Protects the internal parts. ② Side cover Protects the internal parts. ③ Cable outlet ④ LED ⑤ Front cover ⑥ Exhaust outlet Outlet for various cables.
2.2 Component Names and Functions 2.2.4 AeroDR Battery Charger The AeroDR battery charger charges the AeroDR detector. It also has the registration function for the AeroDR detector. There are two types of AeroDR battery charger: one with the AeroDR detector registration function and the other for charging only.
2.2 Component Names and Functions 2.2.6 AeroDR UF Cable ①Spring connector Number Name ① Spring connector ② Pad 2.2.7 Functions Connects with the pad of the AeroDR detector. Connects with the spring connector of an AeroDR I/F Cable. AeroDR I/F Cable ①Spring connector Number Name ① Spring connector Functions Connects with the pad of the AeroDR detector and AeroDR UF Cable.
Chapter 3 Basic Operations This chapter describes the basic operations of this device.
3.1 ● Startup and Shutdown Power for this device can be left ON during normal use. However, to turn on the power after not using for a long period of time, or to turn off the power when not intending to use for a long period of time, follow the procedures described below. Start the AeroDR Access Point. • When the power switch of the AeroDR interface unit is turned ON, power is supplied to the AeroDR Access Point, and the PoE LED on the AeroDR Access Point will light. Start the AeroDR battery charger.
3.1 Startup and Shutdown Start the AeroDR detector. 3.1.2 • If inserted into the AeroDR battery charger with the wireless connection, the AeroDR detector should be removed. For the wired connection, confirm that the AeroDR I/F Cable is connected securely to the pad of the AeroDR detector. Then, turn the power switch of the AeroDR detector ON, and confirm that the status LED (both green) is short flashing or lit. Power OFF Shut down the AeroDR detector.
3.2 ● Operation of AeroDR Detector 3.2.1 Exposure 3.2.3 High-dose exposure To expose X-ray images, check that this device is ready to expose images, and then perform the exposure operation using the X-ray exposure device. When the exposure is completed, image is stored in the AeroDR detector and will then be converted to digital data and sent to the CS-7 sequentially. When the data transfer is completed, the exposed image is displayed on the CS-7.
3.3 ● Charging Charge the AeroDR detector when the battery LED on the AeroDR detector lights or flashes (both blue), or when the battery level gets low in the AeroDR detector status display on the CS-7. There are two ways to charge the AeroDR detector. ③ Once the AeroDR detector is set correctly and the charging starts, the status LED on the AeroDR battery charger will light (green). ④ Once the charging of the AeroDR detector is completed, the battery LED on the AeroDR battery charger will turn off.
3.3 Charging 3.3.3 Charging Time Guide Charging status Charging time of the AeroDR detector when the power is OFF Using AeroDR battery charger Max. 30 min Using AeroDR I/F Cable Max. 90 min ※When the AeroDR detector is ON, charging time will be slightly longer as it depends on the operation status. CAUTION • If the AeroDR detector gets hot while charging on the AeroDR battery charger or AeroDR I/F Cable connection, immediately stop the charging.
3.4 ● Selection and Registration of AeroDR Detector By registering the AeroDR detector to the CS-7, it is possible to move it between different radiology rooms. 3.4.1 1 2 3.4.2 Registering the AeroDR Detector Selecting the AeroDR Detector The AeroDR detector to be used is selected as follows depending on the number of registered AeroDR detectors. Turn the power of the AeroDR detector ON.
3.5 ● Gain Calibration The AeroDR detector performs the gain calibration to provide the optimum image by adjusting image quality according to the characteristics of X-ray generator device. The correction data obtained by the gain calibration is saved in the system, and is used for exposure. Also, it is necessary to perform the gain calibration periodically to compensate for chronological change or change in the exposure environment. The gain calibration is performed with the CS-7.
3.6 ● Status Display 3.6.
3.6 Status Display Status LED type Error occurred Processing stop 3.6.
3.6 Status Display 3.6.
3.6 Status Display 3.6.
Chapter 4 Troubleshooting This chapter describes the corrective actions for the errors and lists the error messages.
4.1 ● Error Display and Solutions If an error message or warning appears on the CS-7, take the appropriate measures as described in the following tables. Error code CS-7 Meaning Corrective actions F0007 ERROR Abnormally high internal temperature of FPD Turn off the device, and contact service personnel. F0016 ERROR Abnormally high temperature of electrical component temperature sensor 1 Turn off the device, and contact service personnel.
4.1 Error Display and Solutions Error code CS-7 Meaning Corrective actions F2001 ERROR Internal communication error Contact service personnel. F2002 ERROR Internal communication error Contact service personnel. F2003 ERROR Internal communication error Contact service personnel. F2004 ERROR Internal communication error Contact service personnel. F204D WARNING Cannot perform exposure because the exposure stage is operating. Discontinue operation of the exposure stage.
4.2 ● Action to Be Taken When AeroDR 4.3 ● Fixing Problems Detector Is Malfunctioning When the exterior or protective cover is damaged extensively, or in the event of the AeroDR detector being dropped or having shock applied to it, contact Konica Minolta technical representative. 4.3.1 Phenomena or Conditions That Could Be Malfunctions The product may be malfunctioning if any of the following conditions are applicable. Contact the service personnel to check the corrective action.
Chapter 5 Maintenance This chapter describes the maintenance and inspection items required to use this device safely.
5.1 ● Maintenance and Inspection Items This describes the corrective actions to take in the event of a malfunction and cleaning required in order to maintain the use of this device in an optimum condition. 5.1.1 Maintenance Work of the Device To ensure optimum use of this device, be sure to perform the weekly maintenance.
5.1 Maintenance and Inspection Items 5.1.2 Cleaning 1. If bodily fluid or the blood of a patient has contaminated the surface of the AeroDR detector, clean it with a soft lint-free cloth dampened with a small amount of anhydrous ethanol and wrung well. 2. When cleaning the AeroDR detector to sterilize it, use ethanol for disinfection, isopropanol for disinfection, or hypochlorite solution. 3.
Appendix This appendix describes the specifications of this device.
Specifications Item Description Product name (model name) Premium: AeroDR 1417HQ (AeroDR P-11) Standard: AeroDR 1417S (AeroDR P-12) Type Portable flat panel detector based on amorphous silicon (a-Si) Scintillator CsI (Cesium Iodine) Premium or Standard efficiency External size 384.2 (w) X 460.2 (d) X 15.9 (h) mm ※ Equivalent to standard 14" X 17" cassette Weight 2.
Specifications Item Description Product name (model name) AeroDR generator interface unit (AeroDR X-1) External size 460 (w) X 180 (d) X 285 (h) mm Weight 10 kg Item Description Temperature Environment Humidity 80 %RH 10 to 30 °C degrees 35 to 80% RH 35 %RH 53
A20HYC220A 20100723MD
