DIRECT DIGITIZER AeroDR SYSTEM 2 DIRECT DIGITIZER Operation Manual Operation Manual SYSTEM 2 0197 EN 01
Contents Introduction. . . . . . . . . . . . . . . . . 5 Chapter 3 General Operations. . . . . . . . . . 45 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . Summary of usability specifications (for IEC/EN 60601-1-6, IEC/EN 62366). . . . . . . . Disclaimer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Trademark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents 5.2.3 5.2.4 5.2.5 5.2.6 5.2.7 AeroDR Interface Unit2. . . . . . . . . . . . AeroDR Battery Charger. . . . . . . . . . . AeroDR Battery Charger2. . . . . . . . . . Access Point . . . . . . . . . . . . . . . . . . . . Image processing controller/Images. . . 78 79 79 79 80 Chapter 6 Maintenance. . . . . . . . . . . . . . . . 81 6.1 Maintenance and inspection items . . . . . . 82 6.1.1 6.1.2 6.1.3 6.1.4 Maintenance schedule. . . . . . . . . . . . . Cleaning. . . . . . . . . . . . . .
Introduction 5
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, and image display device as diagnostic image data. • Diagnostic X-ray image data of this device does not provide mammographic images.
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 or is in contact with 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. • AeroDR Detector contacts the body surface of a patient.
Introduction 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 © 2014 Konica Minolta, Inc. All Rights Reserved.
Introduction Structure of pages 3.1 (1) Startup and shutdown Normally, this device is used with the power on. When not used for more than 1 day, operate the startup/shutdown as follows. (4) 3.1.2 The startup methods of this device are as follows. Reference • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Refer to the "Operation Manual" of the image processing controller regarding on/off for the image processing controller.
Chapter 1 Safety Precautions & Warnings This chapter describes precautions and warnings to ensure safe use of this device.
1.1 1.1.1 Symbols relating to safety 1.1.3 Safety alert symbol Indicates the off position for the main power switch of this device. 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 Description of graphic symbols Indicates the on position for the main power switch of this device. Indicates the position where the ground is attached.
1.2 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, and redisplay by parts replacement. (There is a fee for this service.) 1.2.1 AeroDR Detector 13 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.
1.2 Warning labels 1.2.2 AeroDR Battery Charger 1.2.
1.3 Safety precautions 1.3.1 1.3.2 Precautions for usage WARNING Precautions before usage • The AeroDR 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 AeroDR Detector to strong shocks or excessive loads by dropping it, etc. CAUTION • The operators (hospitals and clinics) hold responsibility for the usage and maintenance of this device.
1.3 Safety precautions WARNING CAUTION • 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. – Use a wall outlet with the correct rating as a power source.
1.3 Safety precautions CAUTION CAUTION – If the AeroDR Detector is inserted into the AeroDR Battery Charger/AeroDR Battery Charger2, make sure that the AeroDR Battery Charger/ AeroDR Battery Charger2 will not tip over due to any shock applied to the AeroDR Detector. – Never leave AeroDR Detectors in hot and humid environments for long periods of time. – The AeroDR Detector has wireless antennae positioned at 2 places.
1.3 Safety precautions 1.3.3 CAUTION • Take note of the following if the AeroDR 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.
1.3 Safety precautions • • • • • • • Chapter 1 Supplementary information regarding IEC 606011-2: 2007 (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 4). (2) Do not use mobile phones or pocket pagers in the vicinity of this device.
1.3 Safety precautions Table 1 Guidelines and manufacture's declaration - electromagnetic emissions This device is intended for use in the electromagnetic environment specified below. The customer or the user of this device should assure that it is used in such an environment. Emissions test Compliance RF emissions Group 1 CISPR 11 Electromagnetic environment - guidelines The device uses RF energy only for its internal function.
1.3 Safety precautions Table 3 Guidelines and manufacturer's declaration - electromagnetic immunity Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidelines Portable and mobile RF communications equipment should be used no closer to any part of this device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=[1.
1.3 Safety precautions Table 4 Recommended separation distance between portable and mobile RF communications equipment and the device This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
1.3 Safety precautions 1.3.4 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 on-board airplanes.
1.3 Safety precautions Taiwan China Observe the following based on the regulations stated in Article 10 of Administration Measures for Low-power Radiation Electric Machines. 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.
1.3 Safety precautions South Korea 1.3.5 Precautions for installing, moving, and storing WARNING Thailand AeroDR Detector conforms to NTC technical requirement. • Take note of the following when moving this device not including the AeroDR Detector: – Do not subject to 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.
1.3 Safety precautions CAUTION CAUTION • Connect the AeroDR Interface Unit2/AeroDR Generator Interface Unit to an X-ray device that conforms to IEC 60601 or to an equivalent standard. • Do not use access points other than those on this device. 1.3.6 – If you directly apply or spray disinfecting solution on the AeroDR Detector, the solution will enter the instrument through exterior gaps, causing a failure.
1.3 Safety precautions 1.3.7 Precautions on service life 1.3.8 Service life Name Service life 6 years AeroDR Interface Unit 6 years AeroDR Interface Unit2 6 years AeroDR Generator Interface Unit 6 years AeroDR Battery Charger 6 years AeroDR Battery Charger2 6 years AeroDR I/F Cable 6 years AeroDR UF Cable 6 years For further assistance for the pediatric population includes neonates, please refer to the following Home Pages.
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Chapter 2 Product Overview This chapter describes the overview of this device.
2.1 Overview of this device This section describes the functions of this device as well as a system configuration and connection examples using this device. 2.1.1 Functions This device consists of AeroDR Detector, AeroDR Interface Unit/AeroDR Interface Unit2, AeroDR Generator Interface Unit, AeroDR Battery Charger/AeroDR Battery Charger2, Access Point, etc.
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2.2 Component names and functions 2.2.1 AeroDR Detector The component names and functions of the AeroDR Detector are as follows.
2.2 Component names and functions 2.2.2 AeroDR Interface Unit The component names and functions of the AeroDR Interface Unit are as follows. (5) Exhaust outlet (1) Top cover (4) Rear cover Chapter 2 (2) Side cover (3) Power switch (6) Front cover (9) Spacer (7) LEDs Number (8) Cable outlet Name Functions (1) Top cover Protects the internal parts. (2) Side cover Protects the internal parts. (3) Power switch Turns the AeroDR Interface Unit on/off.
2.2 Component names and functions 2.2.3 AeroDR Interface Unit2 The component names and functions of the AeroDR Interface Unit2 are as follows. (11) Hand switch (1) Exhaust outlet (3) Detector (2) Top cover Connection LEDs (6) Side cover (7) Spacer Number (5) Rear cover (1) Exhaust outlet (6) Side cover (4) Power switch (9) Generator Interface LEDs (10) Cable outlet (7) Spacer (8) Front cover Name Functions (1) Exhaust outlet Exhausts internal heat.
2.2 Component names and functions 2.2.4 AeroDR Generator Interface Unit The component names and functions of the AeroDR Generator Interface Unit are as follows. (4) Exhaust outlet (9) Hand switch (1) Top cover (3) Rear cover (2) Side cover Chapter 2 (8) Spacer (5) Front cover (6) LEDs Number (7) Cable outlet Name Functions (1) Top cover Protects the internal parts. (2) Side cover Protects the internal parts. (3) Rear cover Protects the internal parts.
2.2 Component names and functions 2.2.5 AeroDR Battery Charger The component names and functions of the AeroDR Battery Charger are as follows. (2) Slide cover (3) Top cover (4) Side cover (5) Charge/ registration label (1) Rear cover (6) AeroDR Detector insert table (front) (4) Side cover (10) Roller (7) AeroDR Detector insert table (side) (9) Front cover (8) LEDs Number Name Functions (1) Rear cover Protects the internal parts.
2.2 Component names and functions 2.2.6 AeroDR Battery Charger2 The component names and functions of the AeroDR Battery Charger2 are as follows.
2.2 Component names and functions 2.2.7 Access Point The component names and functions of the Access Point are as follows. HINT •• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • The illustrations and explanation merely shows an example.
2.2 Component names and functions 2.2.8 AeroDR I/F Cable The component name and function of the AeroDR I/F Cable are as follows. Chapter 2 (1) Spring connector Number (1) Name Spring connector 2.2.9 Functions Connects to the wired connection connector of the AeroDR Detector or AeroDR UF Cable. AeroDR UF Cable The component names and functions of the AeroDR UF Cable are as follows.
