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AGFA 5410/050, Руководство пользователя

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Compliance

The DX-D 100 has been designed in accordance with the MEDDEV Guidelines

relating to the application of Medical Devices and have been tested as part of

the conformity assessment procedures required by 93/42/EEC MDD

(European Council Directive 93/42/EEC on Medical Devices).
The system is compliant with specific directives and standards:

• IEC 60601-1
• IEC 60601-1-2

For USA

The system conforms to DHHS radiation Standards of 21CFR subchapter J as

of the date of manufacture.

DX-D 100 | Introduction | 

29

0187K EN 20191024 1609

Содержание 5410/050

Страница 1: ...DX D 100 5410 050 5411 050 5411 300 5411 400 User Manual 0187K EN 20191024 1609 ...

Страница 2: ... User Documentation contains 26 The Getting Started material contains 26 Product Complaints 27 Classification 28 Compliance 29 For USA 29 Connectivity 30 Connecting DX D 100 to a wired network 31 Connecting USB devices 32 Installation 33 Storage of Allen wrench 33 Labels 34 Messages 35 Cleaning and Disinfecting 36 Cleaning 37 Disinfecting 38 Approved disinfectants 39 Patient data security 40 RFID ...

Страница 3: ... Managing the access codes for the on off keypad 63 Managing the RFID reader for user authentication 65 Stopping DX D 100 68 Stopping NX by logging out of Windows 70 Problem solving 71 Corner area of detector not exposed 72 Motorized movement has stopped and unit cannot be moved 73 Technical Data 74 DX D 100 Technical Data 74 DR Detector Technical Data 75 Mobile X Ray Unit Technical Data 75 DX D 1...

Страница 4: ...purpose Products and services may not be available for your local area Please contact your local sales representative for availability information Agfa NV diligently strives to provide as accurate information as possible but shall not be responsible for any typographical error Agfa NV shall under no circumstances be liable for any damage arising from the use or inability to use any information app...

Страница 5: ...Introduction to this Manual Topics Scope About the safety notices in this document Disclaimer DX D 100 Introduction to this Manual 5 0187K EN 20191024 1609 ...

Страница 6: ...ntegrated mobile Digital Radiography X Ray System to be used as medical diagnostic aid in General Radiography and emergency departments It explains how the different components of the DX D 100 System work together 6 DX D 100 Introduction to this Manual 0187K EN 20191024 1609 ...

Страница 7: ... person CAUTION A caution safety notice indicates a hazardous situation which can lead to a potential minor injury to a user engineer patient or any other person An instruction is a direction which if it is not followed can cause damage to the equipment described in this manual or any other equipment or goods and can cause environmental pollution A prohibition is a direction which if it is not fol...

Страница 8: ...issions that may appear in this document To improve reliability function or design Agfa reserves the right to change the product without further notice This manual is provided without warranty of any kind implied or expressed including but not limited to the implied warranties of merchantability and fitness for a particular purpose Note In the United States Federal law restricts this device to sal...

Страница 9: ...ries Operation Controls System Documentation Product Complaints Classification Compliance Connectivity Installation Labels Messages Cleaning and Disinfecting Patient data security Maintenance Safety Directions Environmental protection DX D 100 Introduction 9 0187K EN 20191024 1609 ...

Страница 10: ...s and view static X ray radiographic images of the skeleton including skull spinal column and extremities chest abdomen and other body parts on adult pediatric or neonatal patients Applications can be performed with the patient in the sitting standing or lying position This device is not intended for mammography applications 10 DX D 100 Introduction 0187K EN 20191024 1609 ...

Страница 11: ...eceived proper training Users are those persons who actually handle the equipment and those who have authority over the equipment Before attempting to work with this equipment the user must read understand note and strictly observe all warnings cautions and safety markings on the equipment DX D 100 Introduction 11 0187K EN 20191024 1609 ...

Страница 12: ...Configuration DX D 100 is an integrated mobile Digital Radiography X Ray System Topics DX D 100 Integration 12 DX D 100 Introduction 0187K EN 20191024 1609 ...

Страница 13: ...r DR Detector 1 2 3 4 5 1 DR Detector 2 X ray tube 3 Arm 4 Column 5 Mobile X ray unit Figure 1 DX D 100 configuration DX D 100 has four configurations configuration with portable DR Detector type number 5410 050 configurations with wireless DR Detector type numbers 5411 050 5411 300 and 5411 400 The DX D 100 configuration with wireless DR Detector has two variants of the vertical column DX D 100 I...

Страница 14: ...Figure 2 standard column Figure 3 telescopic column 14 DX D 100 Introduction 0187K EN 20191024 1609 ...

Страница 15: ...trols all actions on the X ray unit and induces the workflow The integration between the NX software and the X ray generator console is established by means of the X ray device interface software DX D 100 Introduction 15 0187K EN 20191024 1609 ...

Страница 16: ...nd Accessories Dose Area Product meter DAP Infrared remote control RFID reader for user authentication Barcode scanner for entering patient data Grids Allen Wrench 16 DX D 100 Introduction 0187K EN 20191024 1609 ...

Страница 17: ...rtable DR Detector 1 Control console 2 Control panel 3 Infrared remote control 4 DR Detector 5 Exposure button Figure 4 DX D 100 configuration with portable DR Detector Configuration with wireless DR Detector The main operation controls of the DX D 100 with wireless DR Detector Depending on the configuration not all controls may be available DX D 100 Introduction 17 0187K EN 20191024 1609 ...

Страница 18: ...e network connector is marked ETH 7 Grid holder with integrated charger for DR Detector battery Figure 5 DX D 100 configuration with wireless DR Detector The configuration with wireless DR Detector type number 5411 300 can alternatively be delivered with a fixed DR detector cable mounted to the mobile X ray unit In this configuration the wireless operation of the DR detector is not supported Topic...

Страница 19: ...DX D 100 software console Whenever you need to type text you can open the virtual keyboard Related Links Using the virtual keyboard on page 58 DR Detector Switch on the NX Workstation The DR Detector Switch is available in the title bar of the NX application The DR Detector Switch shows which DR Detector is active and shows its status The DR Detector Switch can be used to activate another DR Detec...

Страница 20: ...ed empty Meaning Good Low Bad Wired DR Detector DR Detec tor is off or disconnec ted DR Detec tor status icon blinking empty Meaning DR Detec tor is ready for expo sure DR Detector is initializing for exposure DR Detector is off or discon nected or in error DR Detector is inactive no thumbnail se lected 20 DX D 100 Introduction 0187K EN 20191024 1609 ...

Страница 21: ...lamp 5 Collimator lamp Figure 7 the control panel Figure 8 Optional keypad replacing the key to switch the unit on and off Following warning is printed on the Control Panel in English WARNING This x ray unit may be dangerous to patient and operator unless safe exposure factors operating instructions and maintenance schedules are observed DX D 100 Introduction 21 0187K EN 20191024 1609 ...

Страница 22: ...ol The infrared remote control consists of the following main elements 3 1 2 1 Collimator lamp button 2 Infrared window 3 Exposure button Figure 9 the infrared remote control 22 DX D 100 Introduction 0187K EN 20191024 1609 ...

Страница 23: ...arker For an overview of the operation controls of the DR Detector refer to the user manual of the DR Detector The DR Detector may come in contact with the patient Note DR Detectors that operate wireless contain an RF transmitter For detailed information refer to the DR Detector User Manual DX D 100 Introduction 23 0187K EN 20191024 1609 ...

Страница 24: ...tive bag 3 Detector batteries Battery size depends on detector model 4 Wireless DR Detector small format 5 Notepad Figure 10 Storage bin To cover the DR Detector in a protective bag Figure 11 DR Detector tilted forward in the front slot of the storage bin 1 Position the DR Detector tilted forward in the front slot of the storage bin 2 Take a protective bag 3 Slide the protective bag over the DR De...

Страница 25: ...iece of equipment Technical documentation is available in the product service documentation which is available from your local support organization The user documentation consists of DX D 100 User Documentation CD digital media NX User Documentation CD digital media User documentation for the supported DR Detectors DX D 100 Owner s Manual paper binder Getting Started material Topics The DX D 100 U...

Страница 26: ... 0187 DX D 100 Mobile X Ray Unit User Manual document 0188 DX D DR Detector Calibration Key User Manual document 0134 The Getting Started material contains Getting Started with NX document 4417 Getting started with DX D 100 document 0186 26 DX D 100 Introduction 0187K EN 20191024 1609 ...

Страница 27: ... must notify Agfa If during the use of this device or as a result of its use a serious incident has occurred please report it to the manufacturer and or its authorised representative and to your national authority Manufacturer address Agfa Service Support local support addresses and phone numbers are listed on www agfa com Agfa Septestraat 27 2640 Mortsel Belgium Agfa Fax 32 3 444 7094 DX D 100 In...

Страница 28: ...ith oxy gen or with nitrous oxide Equipment for use in environments where no flammable gases or vapors are present Mode of operation Suitable for continuous operation with inter mittent load Labelling CE label 93 42 EEC Medical Devices Eu rope EN 60601 1 CUL label CSA 22 2 No 601 1 Canada Remarks for HF emission and immunity This equipment generates uses and can radiate radio frequency RF energy a...

Страница 29: ...the conformity assessment procedures required by 93 42 EEC MDD European Council Directive 93 42 EEC on Medical Devices The system is compliant with specific directives and standards IEC 60601 1 IEC 60601 1 2 For USA The system conforms to DHHS radiation Standards of 21CFR subchapter J as of the date of manufacture DX D 100 Introduction 29 0187K EN 20191024 1609 ...

Страница 30: ...n variable speed or subject to interruptions will cause delays on the NX workstation DX D 100 communicates with other devices in the hospital network using one of the following protocols DICOM IHE DX D 100 can be connected to a RIS system input scheduling a PACS system output image data management and to a hardcopy device output image Topics Connecting DX D 100 to a wired network Connecting USB de...

Страница 31: ...network 1 Place the unit in parking position Refer to the DX D 100 Mobile X Ray Unit User manual to find out how to do this 2 Extract the network cable and plug it into a network socket Figure 12 Indication of network cable DX D 100 Introduction 31 0187K EN 20191024 1609 ...

Страница 32: ... power supply is strictly forbidden CAUTION The USB device must have been certified acc to CISPR11 or CISPR22 or EN 55011 or EN 55022 accordingly class A minimum CAUTION If the USB device causes radio interference or disrupts the operation of nearby equipment it may be necessary re orient or relocate the device or shielding the location 32 DX D 100 Introduction 0187K EN 20191024 1609 ...

Страница 33: ...f the nickname of the DR Detector Storage of Allen wrench The unit is delivered with an Allen wrench that is used to uncouple the wheels from the motors in order to move the unit manually Store the Allen wrench on a fixed location in or near the unit where it can be easily retrieved in case the motorized movement fails and the unit must be moved manually The preferred location is the storage bin O...

Страница 34: ...nation of X ray tube and X ray generator is available in the technical data This mark shows compliance of the equip ment with Directive 93 42 EEC for Euro pean Union This mark indicates that this is a Type B Equipment Date of manufacture The 21 CFR Subchapter J label is positioned close to the type label The INMETRO label is positioned close to the type label 34 DX D 100 Introduction 0187K EN 2019...

Страница 35: ...oblem has occurred or that a requested action cannot be performed The user must read these messages carefully It will provide information on what to do from then on This will be either performing an action to resolve the problem or to contact the service organization Details on the contents of messages can be found in the service documentation which is available to service personnel DX D 100 Intro...

Страница 36: ...s and equipment All existing universal precautions should be extended to avoid potential contaminations and to avoid patients coming into close contact with the device The user is responsible for selecting a disinfection procedure Topics Cleaning Disinfecting Approved disinfectants 36 DX D 100 Introduction 0187K EN 20191024 1609 ...

Страница 37: ...nt if required Do not use any corrosive dissolving or abrasive cleaning or polishing agents Make sure no liquid gets in the device CAUTION Clean the equipment with only a little moisture Note Do not open the equipment for cleaning No components inside the device require cleaning by the user Using unsuitable cleaning agents or methods can damage the property when surface becomes dull and brittle e ...

Страница 38: ...ts can damage the device UV disinfection is also not allowed Perform the procedure following the instructions for use the disposal instructions and the safety instructions of the selected disinfectants and tools and of the hospital Items contaminated with blood or body fluids which may contain blood borne pathogens should be cleaned and then receive intermediate level disinfection with a product h...

Страница 39: ...ions on the disinfectants that have been found compatible with the cover material of the device and can be used on the outer surface of the device http www agfahealthcare com global en library overview jsp ID 41651138 DX D 100 Introduction 39 0187K EN 20191024 1609 ...

Страница 40: ...t data is guarded The user must define who can access patient data in which situations The user must have a strategy available on what to do with patient data in case of a disaster RFID key lost or stolen The user must have a process in place to revoke lost or stolen RFID keys 40 DX D 100 Introduction 0187K EN 20191024 1609 ...

Страница 41: ...Maintenance Maintenance procedures are described in the DX D 100 Mobile X Ray Unit User Manual and in the DR Detector user manuals DX D 100 Introduction 41 0187K EN 20191024 1609 ...

Страница 42: ...ertified field service engineer A non certified engineer performing a modification or service intervention on a medical device acts on his own responsibility and makes the warranty void WARNING System unavailability due to hardware or software failure If the product is used in critical clinical workflows a backup system has to be foreseen WARNING Do not connect the equipment with anything other th...

Страница 43: ...m a ramp To drive from a ramp safely reduce the speed by intermittently releasing the drive handle WARNING Do not operate the touch screen monitor with wet hands WARNING Do not let liquids come in contact with the touch screen while the system is powered on WARNING Always double check your exposure parameter settings prior to exposing the patient WARNING As the cables of the equipment are long be ...

Страница 44: ...t performance of DR Detectors and cause permanent damage to the equipment Refer to the related user manual for environmental conditions for the DR detector If ambient temperature and humidity is outside the specified range do not operate the system or use air conditioning Warranty will be void if it is obvious that operating conditions are not met CAUTION Damaged grid Reduced image quality Please ...

Страница 45: ... the DX D 100 User Documentation Disinfection of the system Shut down the system before cleaning Only those disinfection methods which satisfy the applicable regulations and directives as well as explosion protection may be used Refer also to the relevant modules of the DX D 100 User Documentation DX D 100 Introduction 45 0187K EN 20191024 1609 ...

Страница 46: ...on about the emergency button switch refer to the DX D 100 Mobile X Ray Unit User Manual document 0188 CAUTION Using the emergency stop also shuts down the NX application and can cause image loss CAUTION After an examination send images to a hardcopy printer and or PACS as soon as possible To stop DX D 100 under normal conditions refer to the procedure for stopping DX D 100 Related Links Stopping ...

Страница 47: ... service organization and or dealer By ensuring this product is disposed of correctly you will help prevent potential negative consequences for the environment and human health which could otherwise be caused by inappropriate waste handling of this product The recycling of materials will help to conserve natural resources Battery notice The battery symbol on the products and or accompanying docume...

Страница 48: ...Getting started Topics Starting DX D 100 Operating DX D 100 Stopping DX D 100 Stopping NX by logging out of Windows 48 DX D 100 Getting started 0187K EN 20191024 1609 ...

Страница 49: ...red on The Windows log in window appears 3 Log in to Windows To log in using your password enter your user name and password and click OK To log in using the optional RFID reader select the Aloaha login method touch the RFID reader with your personal RFID key and click OK The NX application and the software console become available on the control console For detailed information about starting up ...

Страница 50: ...d when the selected tube has not been in use for approximately one hour perform the X ray tube warm up as follows Close the collimator blades fully On the Control Console display the software console by clicking the SC button Select the free exposure workstation Select 70 kV 100 mAs 200 mA and 500 ms exposure Make sure that no one will be exposed Make a total of three exposures 15 seconds apart 50...

Страница 51: ...ribed Whenever the situation with a wired network requires an exception this is clearly indicated Topics Displacement and positioning workflow Basic imaging workflow Using the virtual keyboard Operation controls of the barcode reader Charging a DR Detector battery Managing the access codes for the on off keypad Managing the RFID reader for user authentication DX D 100 Getting started 51 0187K EN 2...

Страница 52: ...ble must be unplugged to be able to perform this step 1 Grip and hold the locking bar towards the handlebar 1 2 1 Locking bar 2 Handlebar 2 Push the handlebar with both hands to drive forwards Apply different pressure on the left and the right to steer the unit 3 Release the locking bar to block motion Releasing the arm 1 Press the brake control at the tube collimator handles to release the arm fr...

Страница 53: ...rol the motion of each driving wheel forwards backwards 1 2 3 4 1 Backwards to the right 2 Forwards to the right 3 Forwards to the left 4 Backwards to the left Positioning the X ray tube and collimator Use the tube collimator handles to rotate the X ray tube on its transversal or horizontal axis or to rotate the collimator on its vertical axis Basic imaging workflow Topics Retrieving the patient i...

Страница 54: ...vated The DR Detector Switch shows which DR Detector is active and shows its status The DX D 100 software console is displayed and the default X ray exposure parameters for the selected exposure are displayed Preparing the exposure 1 Check the position of the X ray unit and the patient WARNING Liquids ingressing the DR Detector may cause malfunction and contamination If there is a chance that the ...

Страница 55: ...R Detector that has a status indicator Check if the status of the DR Detector is ready for exposure If the status is not ready for exposure the DR Detector cannot be used for making an exposure On the Software Console 1 Check if the exposure settings displayed on the console are suitable for the exposure If other exposure values are required than those defined in the NX exam use the console to ove...

Страница 56: ...l The acquired image may be linked to the wrong exposure In NX While the acquisition is ongoing the X ray on indicator is displayed on the software console The led beacon light lights up yellow The image is acquired from the DR Detector and displayed in the thumbnail The software console disappears If collimation is applied the image is automatically cropped at the collimation borders The actual X...

Страница 57: ... messages while working unplugged because it cannot send images To prevent error messages being displayed halt the send queue and restart it when plugging in the network cable Refer to the NX User Manual DX D 100 Getting started 57 0187K EN 20191024 1609 ...

Страница 58: ...ther text field to continue typing or hide the virtual keyboard by clicking the Enter button If the virtual keyboard is not displayed automatically or if the virtual keyboard is in the way click the floating virtual keyboard button Note Clicking the Close button may cause the virtual keyboard to remain hidden when entering the text field again 58 DX D 100 Getting started 0187K EN 20191024 1609 ...

Страница 59: ...ts licensed from Comfort Software Group These products may only be used as part of and in connection with DX D 100 Note For using the virtual keyboard it is recommended to use the IntelliTouch stylus pen that is delivered with the system DX D 100 Getting started 59 0187K EN 20191024 1609 ...

Страница 60: ...en when fully charged 2 Scan button To scan a barcode press the scan button while pointing the device to a barcode 3 Delete button Not used 4 Battery level indicators The battery level is indicated while charging 5 Battery level button 6 Bluetooth LED The bluetooth LED flashes every 4 seconds when the barcode reader is ready for operation The bluetooth LED flashes fast for a few seconds when it ha...

Страница 61: ...connection 1 Scan the barcode on the USB access point The bluetooth LED flashes every 4 seconds when the connection is restored 2 If the connection is not restored press and hold the bluetooth button for five seconds and scan again the barcode on the USB access point 3 If the connection is still not restored repeat the last step DX D 100 Getting started 61 0187K EN 20191024 1609 ...

Страница 62: ...Detector batteries To charge a DR Detector battery 1 Insert the battery in the charger 2 Lock the battery in place if it has a fixation mechanism The DR Detector battery is being charged while the mobile X ray unit is in operation or while it is connected to the mains power 62 DX D 100 Getting started 0187K EN 20191024 1609 ...

Страница 63: ... the access code and press the enter button The blue status indicator light is lit 5 Press and hold the number 2 button until the blue status indicator starts blinking fast 6 Dial the new four digit access code and press the enter button The green status indicator light is blinking The new access code replaces the original access code Adding an extra access code 1 Shut down the system 2 Press and ...

Страница 64: ...n until the green status indicator light starts blinking 3 Press and hold the enter button until the blue status indicator light starts blinking 4 Dial the access code and press the enter button The blue status indicator light is lit 5 Press and hold the number 3 button until the blue status indicator starts blinking fast The blue status indicator light is blinking fast for a while then the green ...

Страница 65: ... an RFID key card from the configuration of the RFID reader Copying the configuration of the RFID reader to another DX D 100 system Adding an RFID key card to the configuration of the RFID reader 1 On the NX workstation go to the Main Menu 2 Click the Show Desktop action button The Windows desktop is shown 3 Go to the Windows Start menu Aloaha Keycard Credentials and click Keycard Credentials The ...

Страница 66: ...ltiple RFID keys are linked to this Windows user account the procedure must be repeated for each RFID key To do this you need the user s keycard and the new password 1 Go to the Windows Start menu Aloaha Keycard Credentials and click Keycard Credentials The Keycard Credentials dialog is displayed Figure 19 Keycard Credentials 2 Touch the RFID reader with the user s RFID key 3 Enter PIN code 0102 4...

Страница 67: ...aha C Program files x86 Aloaha Keycard_ChangePIN exe Start the application apply a card to the reader and press the Serials button The serial number will be shown 2 Go to C Program Files x86 Aloaha SerialStore 3 Find the file that matches the card s serial number and delete the file Copying the configuration of the RFID reader to another DX D 100 system The configuration of the RFID reader can be ...

Страница 68: ...m when the telescopic arm is not fully retracted can trigger the handle bar and cause unintended displacement of the equipment Fully retract the telescopic arm before lowering the arm 3 Lock the device To lock the device using the key switch the key on the control panel to the OFF position 1 1 OFF position To lock the device using the on off keypad press and hold the power button until the green s...

Страница 69: ...b remove the battery pack DX D 100 Getting started 69 0187K EN 20191024 1609 ...

Страница 70: ...s 1 Go to the Main Menu 2 Click the Log Off button Figure 20 Log Off buton 3 The third step As a result NX is closed The Windows user is signed out It is still possible to drive the unit 70 DX D 100 Getting started 0187K EN 20191024 1609 ...

Страница 71: ...Problem solving Topics Corner area of detector not exposed Motorized movement has stopped and unit cannot be moved DX D 100 Problem solving 71 0187K EN 20191024 1609 ...

Страница 72: ... ex posed Cause When making an exposure with small source image distance e g 1 m and with the collimator in rotated position e g 45 the X ray field does not reach to the outer corners of the collimated area Solution Increase the source image distance 72 DX D 100 Problem solving 0187K EN 20191024 1609 ...

Страница 73: ...lose these screws and the spacers located behind the hubcap 1 1 Hubcap fixing screws 2 Remove the two clutch screws Allen type located on each wheel using the Allen wrench provided with the unit This will uncouple the wheels from the motors releasing the brakes allowing the free motion of the unit 1 1 Clutch screws 3 To reassemble the hubcap place the two spacers in the original position mount the...

Страница 74: ...Atmospheric pres sure between 50 and 106 kPa Environmental Conditions during normal operation Temperature am bient between 10 and 35 degrees Celsius Humidity non condensing between 30 and 75 relative humidity Atmospheric pres sure between 70 and 106 kPa For overall system environmental conditions the environmental conditions of the portable DR detector should be taken into account Refer to the DR ...

Страница 75: ...tector Technical Data Refer to the DR Detector User Manual Mobile X Ray Unit Technical Data Refer to the DX D 100 Mobile X Ray Unit User Manual document 0188 DX D 100 Technical Data 75 0187K EN 20191024 1609 ...

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