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General

• The product 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 Medical Device Directive (European Council Directive
93/42/EEC on Medical Devices).

Safety

• IEC 60601-1

Electromagnetic Compatibility

• IEC 60601-1-2

Laser Safety

• IEC 60825-1

| DR 100e (Digital Radiography) | Product Information

0365B EN 20181015 0853

Содержание 6012/001

Страница 1: ...DR 100e Digital Radiography 6012 001 6012 002 6012 003 6012 004 User Manual 0365B EN 20181015 0853 ...

Страница 2: ...26 Exposure button 27 Infrared remote control 28 Connectors for the hospital network and for registering a DR Detector 29 Led beacon light 30 Messages 31 Sound signals 32 Status messages 32 Warning messages 33 Error messages 35 Labels 37 General 38 Type label 41 Labeling of the collimator 42 Installation 43 Labeling the DR Detectors 44 Equipotential earth connection 45 Electrostatic discharge 46 R...

Страница 3: ...the device 80 Using the NX workstation with the X ray system switched off 81 Stopping the NX workstation and the DR Detector 82 Using the virtual keyboard 83 Restriction on the use of virtual keyboard software 84 Advanced Operation 85 Using a moving grid 86 Using a DAP meter 87 DAP value on the NX workstation 87 Hanging a leaded apron 88 Making an exposure using a cassette 89 Setting the exposure ...

Страница 4: ...eters 108 DAP meter 111 Collimator 112 X ray generator and X ray tube assembly 113 Remarks for HF emission and immunity 117 Enclosure Port Immunity to RF wireless communication equipment 122 Precautions on EMC 123 Cables transducers and accessories 124 iv DR 100e Digital Radiography Contents 0365B EN 20181015 0853 ...

Страница 5: ...oducts 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 apparatus met...

Страница 6: ...ting started Related Links Intended Use on page 13 Operation Controls on page 17 Safety Directions on page 58 Basic Workflow on page 62 6 DR 100e Digital Radiography Getting started 0365B EN 20181015 0853 ...

Страница 7: ...oduction to this Manual Topics Scope of this Manual About the safety notices in this document System Documentation Disclaimer DR 100e Digital Radiography Introduction to this Manual 7 0365B EN 20181015 0853 ...

Страница 8: ...ual This manual contains information for safe and effective operation of the DR 100e mobile X ray system further referred to as the device 8 DR 100e Digital Radiography Introduction to this Manual 0365B EN 20181015 0853 ...

Страница 9: ...UTION 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 followed can ...

Страница 10: ...n option or accessory described may have been purchased or licensed on a particular piece of equipment Technical documentation is available in the product service documentation which is available from your local support organization The most recent version of this document is available on http www agfahealthcare com global en library index jsp 10 DR 100e Digital Radiography Introduction to this Ma...

Страница 11: ...at 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 sale by or on...

Страница 12: ...d Use Intended User Configuration Operation Controls Messages Labels Installation Radiation Protection Cleaning and Disinfecting Patient data security Maintenance 12 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 13: ...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 DR 100e Digital Radiography Introduction 13 0365B EN 20181015 0853 ...

Страница 14: ...oper 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 14 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 15: ...DR 100e is an integrated mobile Digital Radiography X Ray System Figure 1 DR 100e mobile X Ray System with rotating column type 6012 004 or 6012 002 DR 100e Digital Radiography Introduction 15 0365B EN 20181015 0853 ...

Страница 16: ...Figure 2 DR 100e mobile X Ray System with fixed column type 6012 003 or 6012 001 16 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 17: ...aker and equipotential node 3 Power supply cable reel 4 Rotating column 5 Lock of the arm movement during transport 6 X ray generator and X ray tube assembly 7 Goniometer 8 Collimator 9 X ray tube handle DR 100e Digital Radiography Introduction 17 0365B EN 20181015 0853 ...

Страница 18: ...ht 5 X ray generator control panel 6 Handlebar with brake lever 7 Remote control receiver optional 8 DR detector holder 9 Tilting pedal The operation controls on the system with fixed column are similar apart from the brake that is operated by pedals and not at the handlebar 1 1 1 Brake pedals Topics 18 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 19: ...itch Portable DR Detector Circuit breaker X ray generator control panel Manual Collimator Exposure button Infrared remote control Connectors for the hospital network and for registering a DR Detector Led beacon light DR 100e Digital Radiography Introduction 19 0365B EN 20181015 0853 ...

Страница 20: ...NX Workstation all in one PC 1 2 3 4 1 Speaker volume 2 Display on off 3 Display brightness 4 Power button Figure 3 Control buttons 20 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 21: ...ion is used to define patient information select exposures and process images Figure 4 NX application The operation of the NX application is described in the NX User Manual document 4420 DR 100e Digital Radiography Introduction 21 0365B EN 20181015 0853 ...

Страница 22: ...or Switch can be used to activate another DR Detector Figure 5 DR Detector Switch DR Detector Status Battery status icon Meaning Full Medium Low Empty Connection status icon wifi wired Meaning Good Low Bad Wired DR Detector Panel status icon blinking blinking Meaning Ready Initializing exposure Starting up Error Sleep 22 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 23: ...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 DR 100e Digital Radiography Introduction 23 0365B EN 20181015 0853 ...

Страница 24: ... fixed column The equipment is protected by a circuit breaker against excessive mains fluctuations To restore operation of the equipment after activation of the circuit breaker return the switch to position I 24 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 25: ...xposure settings for mAs 9 Modify the exposure settings for kV 10 Switch to manual exposure mode and open the list of anatomical programs Scroll down 11 Activate remote control The indicator lights up when the remote control is enabled 12 Small focus and large focus The indicator light shows the active setting 13 Moving grid The indicator lights up when the signal for the moving grid is enabled 14...

Страница 26: ...before automatically switching off 3 Rails to insert a DAP meter or a filter 4 Measurement tape to measure the distance between the focal spot of X ray tube and the tabletop The measurement tape is at the rear side of the collimator 5 Transversal collimation 6 Filter selection Another button to switch on the light field is available on the X ray generator control panel 26 DR 100e Digital Radiograp...

Страница 27: ...Exposure button 1 2 1 Step 1 preparation of the X ray tube 2 Step 2 exposure Figure 8 Exposure button DR 100e Digital Radiography Introduction 27 0365B EN 20181015 0853 ...

Страница 28: ...tor red Figure 9 Infrared remote control The battery status indicator flashes once per second when the battery is near the end of life and twice per second when the battery must be replaced The transmission indicator lights up when one of the two buttons is pressed 28 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 29: ...r to connect the Registration Cable for registering a DR Detector Figure 10 System with rotating column 1 2 3 1 Network connector to connect the NX workstation to the hospital network 2 USB port to connect the IR Data Communication Unit for registering a DR Detector 3 Network connector to connect the Registration Cable for registering a DR Detector Figure 11 System with fixed column DR 100e Digita...

Страница 30: ...light green Table 1 Led beacon light Color Meaning Green The wireless DR Detector and the X ray generator are ready for mak ing an exposure Yellow X ray radiation is ongoing 30 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 31: ... certain conditions the system sounds a signal or shows a message on the display Topics Sound signals Status messages Warning messages Error messages DR 100e Digital Radiography Introduction 31 0365B EN 20181015 0853 ...

Страница 32: ...nished successfully 1 long beep 1 sec Alarm or malfunction Status messages Message Description Action READY The device is ready to perform an exposure WAITING Preparation phase Wait for the message in dicating that the device is ready MANUAL DAP READY Dosimeter ready 32 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 33: ...ay tube seasoning to avoid damage Press the reset button to continue Call Service for the tube seasoning HOT TUBE The temperature of the X ray tube has reached the maximum allowed value Wait for the monobloc to cool down EXPIRED TIME The exposure button has been pressed half way for preparing the X ray tube for more than 15 seconds Release the exposure button and repeat the X ray exposure sequence...

Страница 34: ... that can be dis played Press the F1 button and the reset button to reset the value DAP ERROR Dosimeter connected but in error Press the reset button and call Service DAP RESET The sum of the DAP val ues has been reset 34 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 35: ... appears gain call Service ERROR V2 Absent V2 power sup ply Switch off wait some minutes switch on if the error appears gain call Service LOCKED STARTER Error during the start ing up Press the reset button and repeat the expo sure FAULTY CHOPPER Error in the chopper Press the reset button and repeat the expo sure X RAY ERROR The kV value has not reached 75 of the re quested value within the first ...

Страница 36: ...e INV OVERLOAD Power to the inverter is out of range Press the reset button to continue INVERTER ERROR IGBT drivers error Press the reset button to continue TUBE CALIB ERR Error of X ray tube cali bration Call Service XR HANDSWITCH ERR Faulty exposure button Check the integrity of the exposure button switch off the device and switch it on try again if the error per sists call Service 36 DR 100e Di...

Страница 37: ...Labels Topics General Type label Labeling of the collimator DR 100e Digital Radiography Introduction 37 0365B EN 20181015 0853 ...

Страница 38: ...d on the inside and outside of the machine A brief overview of these markings and labels and their meaning is given below Figure 14 Position of the labels illustrated on a system with rotating column 38 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 39: ...abels specific for system with fixed column A Information label for the handlebar op eration B Overcoming of obstacles C Transport position D Exposure hand switch DR 100e Digital Radiography Introduction 39 0365B EN 20181015 0853 ...

Страница 40: ...d H Left pedal brake lock Right pedal brake lock X ray tube rotation lock By turning the knob clockwise the rota tion unlocks I USB connector L Wired network connector This connector is used to connect to the hospital network 40 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 41: ...label Figure 16 Example of type label X ray system Figure 17 Example of type label X ray generator and X ray tube assembly The INMETRO label DR 100e Digital Radiography Introduction 41 0365B EN 20181015 0853 ...

Страница 42: ...mitted from this opening A Laser radiation symbol B Warning label LED Radiation Risk group 2 IEC 62471 2006 CAUTION Do not stare at operating light source May be harmful to the eyes A Laser radiation symbol B Warning label Laser Radiation Do not stare into beam Class 2 LASER product IEC 60825 1 2007 Po 1mW λ 645 10nm 42 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 43: ...service engineer Contact your local support organization for more information Do not use the device in areas where there is a risk of fire Topics Labeling the DR Detectors Equipotential earth connection Electrostatic discharge DR 100e Digital Radiography Introduction 43 0365B EN 20181015 0853 ...

Страница 44: ...of the same type it is required to apply labeling to the DR Detector containing a unique nickname for each DR Detector The nicknames must be configured on the NX workstation The DR Detector Switch shows which DR Detector is active and shows its status by means of the nickname of the DR Detector 44 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 45: ...nd in environments suitable for medical activities An additional equipotential earth connection is provided because the equipment is movable and the reliability of the main equipotential earth connection point can be insufficient It is only possible to use this equipment in rooms that comply with IEC norm requirements DR 100e Digital Radiography Introduction 45 0365B EN 20181015 0853 ...

Страница 46: ... any warranty The electrostatic discharge can cause a remarkable voltage that could cause damages to printed circuit boards or to other equipment components Electrostatic discharge damages can accumulate and can initially not be visible such as a hardware failure but can reduce performances Therefore it is recommended to use proper electrostatic discharge handling procedures Electrostatic discharg...

Страница 47: ...radiation protection for the operators e g personal radiation dosimeters lead aprons keep maximum distance from X ray source regular training etc protection of patients against unnecessary radiation e g limitation of X ray field by collimation lead shielding lead aprons etc Monitoring of Personnel The monitoring checks the amount of X ray radiation the personnel has been exposed to It determines s...

Страница 48: ...ing 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 Disinfecting safety directions Approved disinfectants 48 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 49: ...ts or methods can damage the property when surface becomes dull and brittle e g alcohol containing agents 3 Start up the system Topics Cleaning chromed parts Cleaning plastic surfaces Cleaning enemaled or aliminum parts Cleaning chromed parts Chromed parts must be cleaned only with a dry woolen cloth Do not use polishing abrasives To protect the finish use a nonabrasive wax Cleaning plastic surfac...

Страница 50: ...scouring powders solvents abrasives detergents or polishing abrasive Do not use a special detergent if its properties are not sure 50 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 51: ...ction If you plan to use other disinfectants approval of Agfa is needed before use as most disinfectants 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 DR 100e Digital Radiography Introduction 51 0365B EN 20181015 0853...

Страница 52: ...ny corrosive soluble or gaseous disinfectants Use of spray disinfection can cause malfunctions due to ingress of the disinfectant into the equipment Disinfect all parts of the unit including the accessories and connection cables by just wiping them Switch off the system and cover the cooled system carefully before performing a room disinfection using nebuliser Using unsuitable disinfectants can ca...

Страница 53: ...e 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 DR 100e Digital Radiography Introduction 53 0365B EN 20181015 0853 ...

Страница 54: ...met and that the security of the patient 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 54 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 55: ...tor and the second are those tasks to be performed by qualified X ray service personnel The manufacturer is responsible for safety features of its own products only provided that maintenance repairs and modifications are performed exclusively by the manufacturer s personnel or by personnel expressly authorized by the manufacturer The manufacturer can t be considered responsible for any error damag...

Страница 56: ...Check for lack of oil and unusual noises in high voltage generator Daily Check the locking and braking systems 56 DR 100e Digital Radiography Introduction 0365B EN 20181015 0853 ...

Страница 57: ... The user must make sure that training is received in accordance with local laws or regulations that have the force of law Your local Agfa or dealer representative can provide further information on training The user must note the following information in the system documentation Intended Use Intended User Safety Directions DR 100e Digital Radiography Training 57 0365B EN 20181015 0853 ...

Страница 58: ...plication before correctly performing all regular checks and updating the periodical maintenance If it is sure or probable that any part of the device is defective or wrongly adjusted don t use it before performing all repairs The use of a device with defective parts or adjusted in a wrong way can expose the user or the patient to ionizing radiations or to other dangers concerning safety This can ...

Страница 59: ...is necessary the device should be observed to verify normal operation in the configuration in which it will be used WARNING If the device doesn t work as usual or shows symptoms of a fault even if no error messages are displayed contact your local service organization for assistance WARNING System unavailability due to hardware or software failure If the product is used in critical clinical workfl...

Страница 60: ... not block the ventilation ports to prevent overheating Overheating can cause system malfunction and damages WARNING Always double check your exposure parameter settings prior to exposing the patient CAUTION Avoid unnecessary dose by checking before exposure if the DR Detector Switch displays the name of the DR Detector that is being used and if the status of the DR Detector is ready for exposure ...

Страница 61: ...r skin and eyes Do not stare directly or through optical instruments at the laser beam Do not point the laser beam on the face or the eyes of the patient CAUTION Strictly observe all warnings cautions notes and safety markings within this document and on the product DR 100e Digital Radiography Safety Directions 61 0365B EN 20181015 0853 ...

Страница 62: ...lecting the exposure Preparing the exposure Checking the exposure settings Executing the exposure Performing a quality control Stopping the device Using the NX workstation with the X ray system switched off Stopping the NX workstation and the DR Detector Using the virtual keyboard 62 DR 100e Digital Radiography Basic Workflow 0365B EN 20181015 0853 ...

Страница 63: ...to the NX User Manual document 4420 2 Power on the DR Detector a Attach a fully charged battery pack to the DR Detector b Turn on the DR Detector c If needed register the DR Detector to the DR 100e system For detailed information about powering on the DR Detector refer to the DR Detector user manual Related Links Connectors for the hospital network and for registering a DR Detector on page 29 NX W...

Страница 64: ...ons 2 In NX query the RIS 3 Define the patient info for the examination 4 Start the examination Note If the patient cannot be retrieved from the RIS you should enter patient data manually In that case you can use the virtual keyboard Related Links Connecting DR 100e to a wired network on page 97 64 DR 100e Digital Radiography Basic Workflow 0365B EN 20181015 0853 ...

Страница 65: ...only after bring it to transport position For safe transport switch off the equipment before transporting it and ensure that all system peripherals monitor mouse keyboard cables etc are disconnected To bring the device to transport position and move it 1 Make sure the device is switched off a Press the power off button Figure 19 Power off b Unplug the power supply cable c Wind the mains cable on t...

Страница 66: ...on handle F clockwise The device is now in transport position 6 Release the brake On a system with rotating column release the brake by pulling the lever on the handlebar On a system with fixed column release the brake pedal 7 Move the unit holding the handlebar 8 To overcome obstacles or small drops press with the foot on the pedal for the tilting and at the same time pull the handlebar 66 DR 100...

Страница 67: ...DR 100e Digital Radiography Basic Workflow 67 0365B EN 20181015 0853 ...

Страница 68: ...ure 20 Power on During the startup sequence a sound signal is heard and the display and indicator lights light up If a DAP meter is present the status of the DAP meter is displayed If the DAP meter is not present or not working properly an error message is dispayed To continue the startup press the reset button The DAP meter is inactive Figure 21 Reset While the device prepares the busy status is ...

Страница 69: ...mponents of the unit Intravenous tubing catheters and other patient connected lines should be routed away from moving equipment 1 Pull and rotate the knob A with the arrow towards the green dot to unlock the arm 2 Lift the arm 3 Position the X ray tube relative to the region of interest a Move the device b Rotate the column DR 100e Digital Radiography Basic Workflow 69 0365B EN 20181015 0853 ...

Страница 70: ... 102 degrees A Backward up to 49 degrees A To the side up to 180 degrees B The collimator can be rotated on its vertical axis up to 120 degrees in each direction To rotate the collimator grip it with both hands and rotate in the desired direction 70 DR 100e Digital Radiography Basic Workflow 0365B EN 20181015 0853 ...

Страница 71: ...ontrol panel The control panel can be used to set different exposure parameters The selected DR Detector is activated The DR Detector Switch shows which DR Detector is active and shows its status Flashing starting up Green constant ready for exposure 2 Adjust the exposure parameters Figure 22 kV and mAs Figure 23 Small focus and large focus Related Links X ray generator control panel on page 25 DR...

Страница 72: ...r must be wrapped in a protective plastic bag while performing the examination If a filter is used mount the filter to the collimator If a grid is used attach the grid to the detector 2 Switch on the light localizer on the collimator Adapt collimation if required Figure 24 Collimator light CAUTION Misalignment of the DR Detector and the X ray tube causes unnecessary exposure of the patient to radi...

Страница 73: ...posure settings Topics On the NX application On a DR Detector that has a status indicator On the X ray generator control panel On the control panel DR 100e Digital Radiography Basic Workflow 73 0365B EN 20181015 0853 ...

Страница 74: ...t be used for making an exposure On the X ray generator control panel Check if the exposure settings displayed on the control panel are suitable for the exposure If other exposure values are required than those defined in the NX exam use the control panel to overwrite the default defined exposure settings Related Links X ray generator control panel on page 25 On the control panel WARNING Check if ...

Страница 75: ...osure button go ends the exposure immediately and the exposure can be underexposed Press the reset button to repeat the exposure WARNING During exposure ionizing radiation is emitted by the X ray system To indicate the presence of ionizing radiation the radiation indicator on the control console lights up CAUTION Do not select another thumbnail until the preview image is visible in the active thum...

Страница 76: ...Topics Using the wired exposure button Using the remote control exposure button 76 DR 100e Digital Radiography Basic Workflow 0365B EN 20181015 0853 ...

Страница 77: ...tart the exposure directly after preparation of the X ray tube has ended immediately press the exposure button down fully 2 Press the exposure button down fully and keep it pressed until the exposure has ended When the X ray exposure is finished successfully three beeps are heard WARNING During exposure ionizing radiation is emitted by the X ray system To indicate the presence of ionizing radiatio...

Страница 78: ...re button on the remote control The X ray tube is prepared for performing an exposure 3 Press the exposure button withing 15 seconds and keep it pressed until the exposure has ended When the X ray exposure is finished successfully three beeps are heard WARNING During exposure ionizing radiation is emitted by the X ray system To indicate the presence of ionizing radiation the radiation indicator on...

Страница 79: ...tem Note If you use a wired network NX can only send images if the network cable is plugged in Note If you use a wired network NX may display error 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 Related Links Connecting DR 100e to a wired netwo...

Страница 80: ...dle connectors with care 1 Bring the device to transport position 2 Press the power off button Figure 26 Power off 3 Unplug the power supply cable 4 Wind the mains cable on the cable reel 5 Move the device to the location where a next exposure is planned or to a suitable place for parking 80 DR 100e Digital Radiography Basic Workflow 0365B EN 20181015 0853 ...

Страница 81: ...he NX workstation must be operated while the X ray device is switched off for a longer period of time e g for processing the images the mains cable must be plugged in to a mains socket while operating the NX workstation When stopping the NX workstation also disconnect the mains cable from the mains socket Related Links Connecting DR 100e to a wired network on page 97 DR 100e Digital Radiography Ba...

Страница 82: ...opped The all in one PC is switched off 4 Switch off the DR Detector For detailed information about switching off the DR Detector refer to the DR Detector user manual 5 Charge the battery of the DR Detector For detailed information about charging the battery of the DR Detector refer to the DR Detector user manual Related Links NX Workstation all in one PC on page 20 82 DR 100e Digital Radiography ...

Страница 83: ...l keyboard button After entering text select another 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 DR 100e Digital Radiography Basic Workflow 83 0365B EN 20181015 0853 ...

Страница 84: ...ng the text field again Restriction on the use of virtual keyboard software DR 100e contains software components licensed from Comfort Software Group These products may only be used as part of and in connection with DR 100e 84 DR 100e Digital Radiography Basic Workflow 0365B EN 20181015 0853 ...

Страница 85: ... Using a moving grid Using a DAP meter Hanging a leaded apron Making an exposure using a cassette Modifying the exposure parameters of an anatomic program DR 100e Digital Radiography Advanced Operation 85 0365B EN 20181015 0853 ...

Страница 86: ...he bucky Figure 27 Connector for moving grid on a system with rotating column Figure 28 Connector for moving grid on a system with fixed column 2 Activate the moving grid Figure 29 Activate moving grid The indicator lights up when the signal for the moving grid is enabled 3 Prepare the exposure 4 Execute the exposure If exposure is blocked check the error messages and the connection to the bucky 8...

Страница 87: ...ue by pressing the F1 and reset button simultaneously Figure 30 Reset the DAP value 2 Perform the examination by performing all exposures for the patient After each exposure the DAP value is incremented by the measured dose 3 Read the accumulated DAP value on the first line of the display Figure 31 DAP value DAP value on the NX workstation The DAP value for each exposure is sent to the NX applicat...

Страница 88: ...r directly on the X ray tube assembly could cause uncontrolled movements of the arm and trouble of positioning Don t hang a leaded apron to the arm Use only the proper hanger 2 1 1 Apron hanger 2 Leaded apron 88 DR 100e Digital Radiography Advanced Operation 0365B EN 20181015 0853 ...

Страница 89: ... parameters on the X ray generator control panel 1 Set the exposure parameters for an anatomic program For making a free exposure continue with the next step adjusting the exposure parameters a Press the button to open the list of anatomic programs Figure 34 Anatomic programs An anatomic group is displayed on the first line of the display with the anatomic programs listed below b To switch to anot...

Страница 90: ... exposure parameters are displayed The exposure parameters can still be adjusted 2 Adjust the exposure parameters Figure 38 kV and mAs Figure 39 Small focus and large focus To return to the list of anatomic programs press the F2 button Figure 40 Return to anatomic program list To leave the anatomic program and make a free exposure press the reset button Figure 41 Reset 90 DR 100e Digital Radiograp...

Страница 91: ...calizer on the collimator Adapt collimation if required Figure 42 Collimator light Related Links Anatomic program exposure parameters on page 108 Modifying the exposure parameters of an anatomic program on page 92 X ray generator control panel on page 25 DR 100e Digital Radiography Advanced Operation 91 0365B EN 20181015 0853 ...

Страница 92: ...n the list of anatomic programs Figure 43 Anatomic programs An anatomic group is displayed on the first line of the display with the anatomic programs listed below 2 Select the anatomic program for which new exposure parameters are required Figure 44 Select anatomic group Figure 45 Scroll pages Figure 46 Select anatomic program 3 Adjust the exposure parameters Figure 47 kV and mAs 92 DR 100e Digit...

Страница 93: ...3 button and simultanuously press the anatomic programs button Figure 49 Store exposure parameters The system sounds two beeps The new exposure parameters are stored in the anatomic program DR 100e Digital Radiography Advanced Operation 93 0365B EN 20181015 0853 ...

Страница 94: ...cessories Compatibility Compliance Connectivity Equipment Classification Product Complaints Environmental protection Technical Data Remarks for HF emission and immunity 94 DR 100e Digital Radiography Product Information 0365B EN 20181015 0853 ...

Страница 95: ...onents is available from Agfa service on request Changes or additions to the equipment must only be carried out by persons authorized to do so by Agfa Such changes must comply with best engineering practice and all applicable laws and regulations that have the force of law within the jurisdiction of the hospital Compliance Topics General Safety Electromagnetic Compatibility Laser Safety DR 100e Di...

Страница 96: ... have been tested as part of the conformity assessment procedures required by 93 42 EEC Medical Device Directive European Council Directive 93 42 EEC on Medical Devices Safety IEC 60601 1 Electromagnetic Compatibility IEC 60601 1 2 Laser Safety IEC 60825 1 96 DR 100e Digital Radiography Product Information 0365B EN 20181015 0853 ...

Страница 97: ...sing one of the following protocols DICOM IHE DR 100e can be connected to a RIS system input scheduling a PACS system output image data management and to a hardcopy device output image Connecting DR 100e to a wired network To connect DX D 100 to a wired network 1 Place the unit in parking position 2 Connect a network cable to the connector for the hospital network and plug it into a network socket...

Страница 98: ...provides a particular degree of protection against electric shock particularly re garding allowable leakage current and reliability of the pro tective earth protection Water ingress IPX0 This device does not have protection against ingress of wa ter Cleaning See section on cleaning and disinfecting Disinfection See section on cleaning and disinfecting Flammable anesthetics The equipment is not typ...

Страница 99: ...uct must notify Agfa If the device malfunctions and may have caused or contributed to a serious injury Agfa must be notified immediately by telephone fax or written correspondence to the following 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 DR 100e Digital Radiography Product Infor...

Страница 100: ...zation 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 documents means that ...

Страница 101: ...Technical Data Topics DR 100e Anatomic program exposure parameters DAP meter Collimator X ray generator and X ray tube assembly DR 100e Digital Radiography Product Information 101 0365B EN 20181015 0853 ...

Страница 102: ...ological data Nominal power IEC 60601 1 32 kW 100 kV 320 mA 100 ms kV values 40 125 kV at steps of 1 kV kV accuracy 5 IEC 60601 2 54 mA values 115 230Vac 50 400 mA mA accuracy 115 230Vac 10 IEC 60601 2 54 mAs values 115 230Vac 0 1 220 mAs mAs accuracy 10 IEC 60601 2 54 Exposure times 115 230Vac 0 001 2 2 s according to mAs Time accuracy 10 IEC 60601 2 54 Max mAs 40 kV max 220 mAs the optional seco...

Страница 103: ...ing DAP meter 3 4 mm Al 75kV Product life Estimated product life if regularly serviced and maintained according to Agfa instructions Up to ten 10 years Topics Dimensions Environmental conditions Dimensions Table 4 Dimensions of the system with rotating column Dimensions DR 100e Digital Radiography Product Information 103 0365B EN 20181015 0853 ...

Страница 104: ...ns in transport position width x length x height 700 x 1489 x 1504 mm Handlebar height 932 mm Weight 240 kg without DR detector Focus floor distance Z axis 444 mm 2153 mm Maximum height 2393 mm 104 DR 100e Digital Radiography Product Information 0365B EN 20181015 0853 ...

Страница 105: ...tion of the monobloc around its axis γ swivel 151 102 ahead 49 back Movement manual with dead man parking brake Wheels diameter front swiveling double wheel Ø100 mm width 20 mm rear wheel Ø300mm width 45mm Table 5 Dimensions of the system with fixed column Dimensions DR 100e Digital Radiography Product Information 105 0365B EN 20181015 0853 ...

Страница 106: ...83 mm Handle height 949 mm Weight 170 kg without DR detector Focus floor distance Z axis 417 mm 2092 mm Maximum height 2333 mm Rotation of the monobloc around the arm axis α swivel 180 Rotation of the monobloc around its axis γ swivel 151 102 ahead 49 back 106 DR 100e Digital Radiography Product Information 0365B EN 20181015 0853 ...

Страница 107: ...nd 1060 hPa Environmental conditions during storage Temperature ambient between 25 C and 70 C Humidity non condensing between 10 and 90 non condensing Atmospheric pressure between 500 and 1060 hPa Overall system environmental conditions For overall system environmental conditions the environmental conditions of the portable DR detector should be taken into account Refer to the DR Detector User Man...

Страница 108: ...ay tube with a SID of 100 cm and without grid The dose measurement has been performed according to IEC 60601 1 3 5 2 4 2 with the dosimetric chamber supplied with the equipment and the collimator completely open Table 7 Anatomic group for examinations of the body Anatomic program Focus kV mAs µGym2 Chest AP Large 110 2 17 83 Abdomen AP Large 81 16 76 37 Abdomen LAT Large 90 20 118 94 Chest LAT Lar...

Страница 109: ...l 46 1 6 1 99 Table 10 Anatomic group for examinations of the lower extremities Anatomic program Focus kV mAs µGym2 Hip Femur Small 81 12 5 64 73 Knee Small 63 5 15 07 Kneecap Small 63 8 24 18 Leg Ankle Small 60 4 10 69 Foot Small 48 2 2 85 Toes Small 44 2 2 12 Table 11 Anatomic group for examinations of children I Additional filter 1 mm Al 0 2 mm Cu or 1 mm Al 0 1 mm Cu Anatomic program Focus kV ...

Страница 110: ... for examinations of children II Additional filter 1 mm Al 0 2 mm Cu or 1 mm Al 0 1 mm Cu Anatomic program Focus kV mAs µGym2 Chest 8 0 kg Small 76 0 4 1 08 Abdomen 4 5 kg Small 65 2 3 19 Abdomen 8 0 kg Small 65 3 2 5 13 Chest 10 kg Small 76 0 8 2 18 Abdomen 10 kg Small 70 2 4 16 Abdomen 15 kg Small 70 4 8 36 110 DR 100e Digital Radiography Product Information 0365B EN 20181015 0853 ...

Страница 111: ...ization chamber Measured quantity Dose area product Digital resolution 0 01 μGym2 Max linearity error 2 5 Nominal range of dose area prod uct rate 0 01 2500 μGym2 s Equivalent filtration of the cham ber 75kV 0 3 mm Al Max measurement field 118 mm x 118 mm Dimensions W x D x H 152 mm x 234 mm x 23 mm Weight 455 g DR 100e Digital Radiography Product Information 111 0365B EN 20181015 0853 ...

Страница 112: ...amp lighting time 30 s Light intensity IEC 60601 2 54 160 lux Minimum contrast ratio IEC 60601 2 54 4 1 Focal distance measurement Retractable tape measure maximum extension 3 m Inherent filtration 2 mm equivalent Al at 75kV Additional filtration Manual selection 0 mm Al 1 mm Al 0 1 mm Cu 1 mm Al 0 2 mm Cu 2 mm Al Rotation 120 Weight 5 5 kg Laser field to determine the focal dis tance at 1 m 112 D...

Страница 113: ...erformance According to the load curves of the x ray tube Housing Min inherent filtration 75 kV 1 1 mm Al Dimensions W x D x H 320 mm x 140 mm x 241 mm 324 5 mm x 145 mm x 244 5 mm Weight 19 4 kg 18 7 kg Thermal features Thermal capacity 500 kJ 600 kJ Thermal safety 60 C 5 C Thermal switch normally closed Lung 0 16 dm3 0 2 dm3 Continuous thermal dissi pation 55 W 60 W Max housing tempera ture 60 C...

Страница 114: ...l name Rotating anode X22 0 8 1 3 X22 0 6 1 3 Specifications X ray tube X22 Rotation speed 3000 min Nominal High voltage 130 kVp Nominal focus dim IEC 60336 0 8 mm small focus 0 6 mm small focus 114 DR 100e Digital Radiography Product Information 0365B EN 20181015 0853 ...

Страница 115: ...track Tung sten Rhenium TZM Anode mass mo lybdenum titanium zirconium RTM Anodic diameter 64 mm 2 52 inch Anodic angle 15 Thermal capacity of the anode 80 kJ 107 kHU Max continuous anode dis sipation 300 W Min inherent filtration IEC 522 0 7 mm Al eq Tube material glass Figure 55 X22 0 8 1 3 DR 100e Digital Radiography Product Information 115 0365B EN 20181015 0853 ...

Страница 116: ...V 70 kV 80 kV 90 kV 100 kV 110 kV 120 kV 130 kV CURVEDI CARICO SINGOLO SINGLELOAD RATING ABAQUEDECHARGEUNIQUE 1 3 3 3000 min 1 0 100 200 300 400 500 600 700 0 01 0 1 1 10 Tempo di esposizione Time Temps sec Corrente Anodica Tube Current Intensité Anodique mA 50 kV 60 kV 70 kV 80 kV 90 kV 100 kV 110 kV 120 kV 130 kV Figure 56 X22 0 6 1 3 116 DR 100e Digital Radiography Product Information 0365B EN ...

Страница 117: ...is device may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as re orienting or relocating the device or shielding the location WARNING The HF emission and immunity can be influenced by connected data cables depending on length and the manner of installation This device is intended for operation in the electromagnetic ...

Страница 118: ...C standards Electromagnetic Environ ment Guidelines Discharge of static electricity in accord ance with IEC 610004 2 8 kV contact dis charge 15 kV air dis charge Floors should consist of wood concrete or ceramic tiles The relative humidity must be at least 30 if the floor is made of synthetic material Fast transient electri cal disturbance varia bles bursts in accord ance with IEC 610004 4 2 kV ma...

Страница 119: ...vironment given below The user of the device should ensure that it is used in such an environment Tests of Resistance to Dis ruption Test level of profes sional medical equipment and ba sic EMC standards Electromagnetic Envi ronment Recommended protec tive distance Conducted high frequency disturbance variables in ac cordance with IEC 61000 4 6 6 V rms in ISM fre quency bands be tween 150 kHz and ...

Страница 120: ...nded below in accordance with the maximum output power of the communications equipment See also the section with precautions on EMC Recommended Protective Distances between Portable and Mobile High Frequency Communication Equipment and the Device Rated Power of the Transmitter W Protective Distance in accordance with RF emission Fre quency m 150 kHz to 80 MHz d 1 0 80 MHz to 800 MHz d 0 3 800 MHz ...

Страница 121: ... Precautions on EMC Cables transducers and accessories DR 100e Digital Radiography Product Information 121 0365B EN 20181015 0853 ...

Страница 122: ...0 FRS 460 0 3 28 704 787 LTE Band 13 17 0 3 9 800 960 GSM 800 900 TETRA 800 IDEN 820 COMA 850 LTE Band 5 0 3 28 1700 1990 GSM 1800 COMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS 0 3 28 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 0 3 28 5100 5800 WLAN 802 11 a n 0 3 9 122 DR 100e Digital Radiography Product Information 0365B EN 20181015 0853 ...

Страница 123: ...figuration in which it will be used CAUTION Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the system including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result DR 100e Digital Radiography Product Information 123 0365B EN ...

Страница 124: ...manual or spare parts not ordered from Agfa may cause a higher emission of electromagnetic phenomena and or may rise the susceptibility against it function type maximum length remark network con nection Network cable CAT5e F UTP shielded end with RJ45 10 m or original Agfa cable F7 0477 1052 5m shielded No additional accessories available 124 DR 100e Digital Radiography Product Information 0365B E...

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