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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
Directive93/42/EEC on Medical Devices).

• IEC 62366

Safety

• IEC 60601-1
• IEC 60601-1-6

X-Ray Safety

• IEC 60601-2-54
• IEC 60601

‐

1

‐

3

Electromagnetic Compatibility

• IEC 60601-1-2

Restrictions on outdoor use

There are restrictions on the outdoor use of the U-NII Low (5150-5250 MHz)

and U-NII Mid (5250-5350 MHz) bandwidths of the WLAN module

incorporated in the device in the following Member States: Belgium (BE),

Bulgaria (BG), Czech Republic (CZ), Denmark (DK), Germany (DE), Estonia

(EE), Ireland (IE), Greece (EL), Spain (ES), France (FR), Croatia (HR), Italy

(IT), Cyprus (CY), Latvia (LV), Lithuania (LT), Luxembourg (LU), Hungary

(HU), Malta (MT), Netherlands (NL), Austria (AT), Poland (PL), Portugal

(PT), Romania (RO), Slovenia (SI), Slovakia (SK), Finland (FI), Sweden (SE)

and United Kingdom (UK).

Earthquake resistance

Earthquake resistance is available on system configurations containing the
earthquake kit.

• CBSC Title 24, Part 2 (OSHPD)

After an earthquake, preventive maintenance is recommended.

After an earthquake, the lifetime of the system may be reduced and there is no
warranty for the complete lifetime anymore.

DR 800 | Product Information |

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0392C EN 20210309 1049

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Summary of Contents for 6010/200

Page 1: ...DR 800 6010 200 User Manual 0392C EN 20210309 1049 ...

Page 2: ... images 34 DR detector switch 35 Collimator 36 Portable DR Detector 38 Compressor 39 FLFS overlay 40 Emergency stop button 41 Emergency shutdown power switch 42 Cabinets and power switch 43 Radiographic wall stand 44 Ceiling Suspension 49 Messages 52 Labels 53 Additional labeling of the radiographic table 56 Additional labeling of the positioning console 58 Additional labeling of the wireless cons...

Page 3: ...ections 87 Approved disinfectants 88 FLFS Overlay 89 Safety Directions 90 Dangerous areas 94 Patient visibility 98 Wireless console 100 Getting on and off the table 101 Preventing damage to the equipment 102 Attention to overhead loads 103 Full Leg Full Spine 104 Digital tomosynthesis 105 Ceiling suspension and radiographic wall stand 106 Basic Workflow 107 Starting the System 108 Warming up of X ...

Page 4: ...gs 167 Execute the exposure 169 Perform a quality control 170 Finalize the examination 173 Storing the FLFS overlay 174 Manually adjusting a DR Full Leg Full Spine image 175 To rotate all partial images 176 To stitch a set of partial images 177 To align the partial images based on their projection on the stitching grid 178 To align the partial images based on the analysis of the anatomical informa...

Page 5: ...nt age group 221 Sensor area 222 Radiographic Parameters for fluoroscopy 223 Automatic Brightness System ABS 224 Collimator camera 227 X ray modality controls 228 Positioning controls 229 Automatic position 230 Actual and target position parameters 231 Collimation controls 232 Wireless console status 234 Controls for digital tomosynthesis 235 Radiographic Parameters for digital tomosynthesis 236 P...

Page 6: ...ng fails 268 Only part of the full leg full spine image is displayed 269 Full Leg Full Spine examination is interrupted 271 Wireless console with position controls cannot restore connection 272 Problems with the ceiling suspension 273 Error messages on the ceiling suspension 274 Product Information 275 Compatibility 276 Compliance 276 General 277 Safety 277 X Ray Safety 277 Electromagnetic Compati...

Page 7: ...information IEC 60601 2 54 IEC 60601 1 3 303 Mains supply 307 Technical data of options and accessories 311 Remarks for HF emission and immunity radiographic table 312 Immunity to RF wireless communication equipment 314 Remarks for HF emission and immunity radiographic wall stand 315 Remarks for HF emission and immunity radiographic wall stand bucky with moving grid 319 DR 800 Contents vii 0392C E...

Page 8: ...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...

Page 9: ...Introduction to this Manual Topics Scope of this Manual About the safety notices in this document Disclaimer DR 800 Introduction to this Manual 9 0392C EN 20210309 1049 ...

Page 10: ...Scope of this Manual This manual contains information for safe and effective operation of the DR 800 system 10 DR 800 Introduction to this Manual 0392C EN 20210309 1049 ...

Page 11: ... 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...

Page 12: ...ions 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 on order ...

Page 13: ...Introduction Topics Intended Use Indications for Use Intended User DR 800 System Overview Messages Labels Installation Radiation Protection Maintenance DR 800 Introduction 13 0392C EN 20210309 1049 ...

Page 14: ...or rapid sequence applications The DR 800 will be used in a radiological environment by qualified staff to capture and route static and dynamic X ray images The DR 800 is not intended for cardiovascular and cerebrovascular contrast studies and mammography applications 14 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 15: ...ges obtained through image intensifier technology In addition the system is intended for projection radiography of all body parts In addition the system provides the Agfa tomosynthesis option which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X ray systems Digital tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep Not in...

Page 16: ...nt as well as the persons having 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 Only a physician or a legally certified operator should use this product 16 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 17: ...ube and collimator Radiographic wall stand with bucky In the bucky a DR Detector or a CR cassette can be inserted Monitor for displaying a reference image Duplicate operation controls in the examination room Wireless console with position controls Monitor for the NX workstation Monitor for displaying a reference image Double fluoroscopy and radiography foot pedal Accessories for the radiographic t...

Page 18: ...s Positioning controls Messages Figure 1 DR 800 configuration Topics Radiographic Table Position Controls Worklist window Software Console Exposure Controls Examination window Acquisition window Editing window Main Menu window Monitor for reference images DR detector switch Collimator Portable DR Detector Compressor FLFS overlay Emergency stop button Emergency shutdown power switch Cabinets and po...

Page 19: ... two variants Radiographic table with a built in set of focused grids Exposures can be made with or without a grid The grid is automatically selected based on the SID Radiographic table with removable grids The focal distance of the grid is detected in the bucky 1 2 3 4 5 6 6 1 Table height 2 Table tilting angle 3 Source image distance SID 4 X ray tube tilting angle coupled to a displacement of th...

Page 20: ...ngitudinal and transversal displacement of the tabletop 6 Longitudinal displacement of the X ray tube and the DR detector Figure 2 Radiographic table movements 20 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 21: ...e button 5 Transversal displacement of the tabletop Longitudinal displacement of the DR detector 6 Table tilting angle Table height 7 X ray tube tilting angle Source image distance SID 8 Collimator Figure 3 Position controls To allow movement using one of the joysticks keep the button on the joystick pressed while operating the joystick Movement may stop on preconfigured threshold positions and ca...

Page 22: ...R detector Figure 4 Position controls on the radiographic table A joystick console can be available on the radiographic table To allow movement keep the button pressed to release position control while operating the joystick 1 2 1 Transversal displacement of the tabletop 2 Longitudinal displacement of the DR detector Figure 5 Optional joystick on the radiographic table WARNING Incorrect installati...

Page 23: ...gle Figure 6 Digital read out of tilting angles Figure 7 Scale read out of source image distance SID Wireless console with position controls The wireless console has the same positioning controls except the control of automatic positioning The wireless console has indicators for the status of the battery and that status of the wireless connection to the radiographic table DR 800 Introduction 23 03...

Page 24: ...ndicator light is on when the wireless connection is active The indicator light blinks when the connection is lost To activate the wireless connection move the wireless console within the bluetooth communication range of the radiographic table Figure 8 Wireless console At the foot of the wireless console a power socket and a main power switch are available to connect the console to the mains power...

Page 25: ...Worklist window Figure 9 Worklist Window In the Worklist window you can view and manage the exams that are scheduled and that have been performed DR 800 Introduction 25 0392C EN 20210309 1049 ...

Page 26: ...tation next to the NX application The software console is used to control the X ray exposure settings The software console is used to adapt the parameters for automatic positioning on the full automatic configuration The software console contains the DR detector switch Figure 10 Software console examination overview 26 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 27: ...Figure 11 Software console controls for generator fluoroscopy X ray modality positioner and system messages Related Links Software Console on page 187 DR 800 Introduction 27 0392C EN 20210309 1049 ...

Page 28: ...uisition of the rapid sequence 2 The fluoroscopy pedal is used to acquire a fluo sequence The fluoroscopy pedal is available in the operator room as a single pedal or together with a radiography pedal Another fluoroscopy pedal can be located in the examination room together with a radiography pedal The fluoroscopy pedal is pressed during acquisition of the fluo sequence 3 The radiography pedal is ...

Page 29: ...tion the exposure button on the wireless console and the footswitch in the examination room are disabled when an examination for the ceiling suspension is selected Related Links Radiography imaging modes on page 206 Fluoroscopy imaging modes on page 220 Exposure control pedals on page 261 DR 800 Introduction 29 0392C EN 20210309 1049 ...

Page 30: ...n The drop down list in the title bar of the window shows the name of the patient for which the examination is performed You can select another name from the list to display the examination of the patient Also the most important tools to prepare the images for diagnosis are available here 30 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 31: ...low with fluoroscopy for positioning and contains a set of fluo sequences and a single static image A dynamic group supports a DR workflow for dynamic images and can contain fluo sequences rapid sequences and static images Fluo sequences and rapid sequences can be reviewed in a dynamic image viewer or a mosaic view and prepared for diagnosis DR 800 Introduction 31 0392C EN 20210309 1049 ...

Page 32: ...Editing window Figure 15 Editing window In the Editing window you can prepare the image for printing 32 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 33: ...in Menu window Figure 16 Main Menu window In the Main Menu window you can manage certain aspects of the NX Workflow which do not belong to the daily workflow DR 800 Introduction 33 0392C EN 20210309 1049 ...

Page 34: ...in the operator room and or in the examination room on which images can be displayed during the examination that have been acquired earlier on during the same examination Figure 17 Action button to display reference image 34 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 35: ...e console 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 Detector The DR detector switch can be switched to CR depending on the configuration Figure 18 DR detector switch DR 800 Introduction 35 0392C EN 20210309 1049 ...

Page 36: ...pen or close the Collimator blades 2 Indicator light that lights up while the X ray tube is selected 3 Collimator lamp push button Figure 19 Collimator controls Note Refer to the corresponding collimator manual for extended information about operation or technical description needed to maintain compliance with Standard IEC 60601 1 3 2008 Topics Collimator camera Collimator rotation Collimator came...

Page 37: ...r can be rotated around the axis of the X ray beam Note Black borders are not applied to dynamic images if the collimator is rotated Put the collimator in the default position for performing dynamic imaging examinations DR 800 Introduction 37 0392C EN 20210309 1049 ...

Page 38: ...marker 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 38 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 39: ...on force is 150 N The compressor is designed for mechanical and electrical safety as well as safety against wrong manoeuvres The compressor has a parking position from which it automatically moves in and out Figure 21 Compressor moving automatically into parking position DR 800 Introduction 39 0392C EN 20210309 1049 ...

Page 40: ...l images of the FLFS examination are automatically stitched to create the DR Full Leg Full Spine image Stitching is applied based on a grid of markers inside the stitching grid and a correction is applied based on the alignment of the anatomical information in the image 1 2 1 Mounting unit 2 Stitching grid Figure 22 FLFS overlay 40 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 41: ...e emergency stop buttons are available on the system The emergency stop buttons are red with the word STOP for easy recognition By pressing an emergency stop button electric power to the remote controlled tabletop is shut off thus stopping all table movements WARNING The emergency stop button must be unlocked pull the red button only after the cause of the hazard has been clearly identified and el...

Page 42: ...anization must be promptly contacted An installation must be fitted with two emergency stop buttons They must be effectively arranged so that the first button is close to the radiographic table and easily reached by the operator The second button must be in the operator room and also easily reached by the operator The emergency stop buttons are installed and labeled by customer WARNING It must be ...

Page 43: ...R 800 sync cabinet The DR 800 sync cabinet is installed on top of the generator cabinet or nearby the NX workstation These are the functions of the DR 800 sync cabinet connection between the NX workstation and the other cabinets synchronization of DR detector and generator The DR 800 sync cabinet has an on off switch Related Links Starting the System on page 108 Stopping the System on page 141 DR ...

Page 44: ...tilting bucky 1 2 3 4 5 6 1 Wall stand column 2 Bucky 3 Patient hand grips 4 Bucky tray handle 5 Tilting brake 6 Vertical movement brake Figure 25 Wall stand with tilting bucky The bucky has two variants depending on the orientation for loading a detector or cassette Right hand side loading Left hand side loading Related Links Ceiling suspension and radiographic wall stand on page 106 Topics 44 DR...

Page 45: ...he bucky into position by turning the knob clockwise WARNING When the brakes are released the carriage tends to lift upward with the bucky This balancing helps the user to vertically position the bucky With empty bucky and no additional accessories mounted it is necessary to accompany the bucky along its vertical movement and to avoid violent collision when reaching the bumper at the upper end of ...

Page 46: ...until the lock closes WARNING Verify that the bucky tray has been blocked firmly into position when making rotations If the device has not been locked down it may be ejected from the rotation movement and fall to the ground causing damage to it or injury to the patient and or the operators WARNING Never extract bucky tray when the loading position is pointed towards the ground It can easily fall t...

Page 47: ...Vertical stop Figure 29 Bucky CAUTION Make sure your fingers are not crushed by components inside the bucky drawer Use the bucky drawer handle when opening or closing the drawer Securing the detector in the bucky To secure the removable DR detector in the bucky the bucky can be equipped with a number of locks Figure 30 Detector tray lock for tilting buckies DR 800 Introduction 47 0392C EN 20210309...

Page 48: ...uake resistance To secure the lock for earthquake resistance first turn the knob on the lever counterclockwise to allow the lock to be released Figure 32 Lock for earthquake resistance Press the lever to release the lock for the removable grid 48 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 49: ... Telescopic column 5 X ray tube head unit 6 Collimator Figure 33 Ceiling Suspension Topics Positioning the X ray tube of the ceiling suspension Collimator of the ceiling suspension Positioning the X ray tube of the ceiling suspension 1 2 3 DR 800 Introduction 49 0392C EN 20210309 1049 ...

Page 50: ... ray tube is perpendicular to the bucky of the radiographic wall stand This function does not account for physical alignment of the X ray source to the DR detector Always visually verify that the X ray source is aligned to the DR detector before taking exposures To avoid collisions the movement of the radiographic table is blocked until the X ray tube of the ceiling suspension is moved back into t...

Page 51: ...llimator lamp push button the collimator light turns on It remains lit for 30 seconds before it switches off automatically lighting time can be configured Exposure field on the receptor is adjusted by setting the two knobs The table on the front panel shows the number to set with the knobs to open the blades according to the SID and X ray field to be used 1 3 2 1 Knobs to open or close the Collima...

Page 52: ...r 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 Related Links System messages on p...

Page 53: ...cumentation before using the equipment Keep man ual for future reference Ionizing radiation Electrostatic sensitive devices Dangerous voltage Warning symbol that indicates that fingers may be crushed Laser Warning Indicates the presence of a laser device Don t push the unit except during movement with breaks re leased Do not sit Warning Indicates that sitting on a component can cause damage to the...

Page 54: ...companying documents means that used electrical and electronic products should not be treated as or mixed with general household waste Connector for fluoroscopy and radiography foot pedal Pollution Control Only applicable to People s Republic of China PRC This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese Standards It must not be dispo...

Page 55: ...ing of the wireless console Additional labeling of the DR 800 sync cabinet Additional labeling of the positioner cabinet Additional labeling of the radiographic wall stand Additional labeling of the collimator Additional labeling of the X ray tube ceiling suspension Additional labeling of the Full Leg Full Spine overlay Additional labeling of components with earthquake resistance DR 800 Introducti...

Page 56: ...he central table frame Warning symbol that indicates that fingers may be crushed Warning for maximum load on the table as specified in the technical data of the radio graphic table Release the compressor This mark indicates that this is a Type B Equipment Related Links Radiographic table on page 290 56 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 57: ...crushing by the longitudinal and transversal displacement of the tabletop 2 Warning for crushing by the transversal displacement of the tabletop 3 Warning for maximum load on the table Figure 37 Location of the labels DR 800 Introduction 57 0392C EN 20210309 1049 ...

Page 58: ... the type label Figure 39 Sample of type label Type label at the rear side of the positioning console WARNING This x ray unit may be danger ous to patient and operator un less safe exposure factors oper ating instructions and mainte nance schedules are observed Warning label in English on the front of the casing of the positioning console 58 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 59: ...Make sure to replace the battery with a battery of the same model or with a model recommended by the manufacturer Replaced batteries must be scrapped according to the maufacturer s instructions WARNING This x ray unit may be dangerous to patient and operator unless safe exposure factors operating instructions and maintenance schedules are ob served Warning label in English on the front of the casi...

Page 60: ...Additional labeling of the DR 800 sync cabinet Figure 41 Sample of type label Type label of the DR 800 sync cabinet is on the side of the cabinet 60 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 61: ...Additional labeling of the positioner cabinet Figure 42 Sample of type label Type label on the foot of the positioner cabi net DR 800 Introduction 61 0392C EN 20210309 1049 ...

Page 62: ...nd Figure 43 Sample of type label The type label of the radiographic wall stand is on top of the column Figure 44 Sample of maintenance label The maintenance label is on top of the column on the left side 62 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 63: ...Additional labeling of the collimator Figure 45 Sample of type label Type label of the collimator Laser power Laser source location DR 800 Introduction 63 0392C EN 20210309 1049 ...

Page 64: ...lumn Figure 47 Sample of maintenance label The maintenance label is on the front side of the telescopic column Figure 48 Sample of warning label Perform regular cable inspections Figure 49 Sample of warning label High voltage equipment Figure 50 Sample of warning label Maintenance must be performed by qualified personnel only 64 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 65: ...hows compliance of the equip ment with Regulation 2017 745 for Euro pean Union Type label on the reverse of the Ful Leg Full Spine overlay Type label on the rear side of the mounting unit Handle with care Tube side Top side according to patient orientation DR 800 Introduction 65 0392C EN 20210309 1049 ...

Page 66: ...ional labeling of components with earthquake resistance Figure 51 Example of the label The label indicates that the component is tested for earthquake resistance 66 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 67: ...r local support organization for more information The unit shall not be installed in wet enviroments like emergency operation rooms and operating theatre This unit shall not be installed in environments where there are explosion risks Topics Mains supply Radiation protection DR 800 Introduction 67 0392C EN 20210309 1049 ...

Page 68: ...llation must be in compliance with the IEC CEI or UL CSA prescriptions in force where requested The relevant national regulations must be applied in all countries Nonetheless compliance with the abovementioned standards is strongly recommended when they do not contradict the national regulations in force to ensure safety for the operator the patient and third parties 68 DR 800 Introduction 0392C E...

Page 69: ...Radiation protection The system is intended to be used in X ray rooms with appropriate shielding DR 800 Introduction 69 0392C EN 20210309 1049 ...

Page 70: ...exposure and the material of the object Protective measures have to be taken to prevent exposure through scattered radiation Protective measures include structural configuration of the X ray room e g lead shielded rooms radiation protection for the operators e g personal radiation dosimeters lead aprons radiation protection glasses mobile lead screens keep maximum distance from X ray source regula...

Page 71: ...opy requires that potential risks of exposure be carefully balanced by the benefits in terms of diagnosis that the examination is able to offer Despite trying to use reduced doses of radiation fluoroscopy sequence time can be rather long and the absorbed dose can be relatively high WARNING Repetitive or prolonged exposures may result in local skin dose levels that cause adverse tissue reactions DR...

Page 72: ...environment are adequate Inadequate or improper protection can lead to serious damage to the health To measure radiation personal radiation dosimeters are typically used They are worn on the body at all times during working in an environment where X ray radiation is applied They provide an indication for the amount of radiation the operator was exposed to 72 DR 800 Introduction 0392C EN 20210309 1...

Page 73: ...rols for the operator during exposure 6 1 2 3 4 1 X ray room 2 Patient environment 3 Workstation 4 Operator room protected area Figure 52 Protected area and significant zones of occupancy Warning The radiation protection has to be applied to the patient Significant zones of occupancy at the radiographic table If operator or staff needs to be close to the patient during normal use e g some pediatri...

Page 74: ... 2 Horizontal axis indicating the table height 3 Stray radiation in mGy measured at the operator position Figure 53 Significant zone of occupancy and stray radiation during examination with horizontal table Table 3 Conditions for measuring stray radiation values represented in the illustrations Workflow Fluoroscopy Object Anthropomorphic abdomen phantom SID 115 cm Exposure parameters 100 kV 50 mA ...

Page 75: ...operator position 1 Figure 54 Significant zone of occupancy and stray radiation during examination with vertical table Note The stray radiation will be significantly lower at a position at the left side of the tabletop indicated with number 2 in the illustration The operator should take this position during the exposure and still be able to give assistance to the patient Table 4 Conditions for mea...

Page 76: ...Total exposure time 200 s Inherent filtration 2 9 mm Al equivalent Total radiation dose 3000 cGy cm2 76 DR 800 Introduction 0392C EN 20210309 1049 ...

Page 77: ...f the system and lead to damages malfunctions or total failure Use only original spare parts provided by the manufacturer WARNING Improper changes additions maintenance or repair of the equipment or the software can lead to personal injury electrical shock and damage to the equipment Safety is only guaranteed when changes additions maintenance or repairs are carried out by an Agfa certified field ...

Page 78: ... or its agent Every 12 months Maintenance by the user Clean any residual contrast mediums from the tabletop Daily Do a visual check of the equipment movement the dis plays and the luminous signals Daily Make sure that the necessary accessories for immobiliz ing the patient are properly fixed to the equipment and particularly the handgrips Daily Check the correct functioning of the ceiling suspensi...

Page 79: ...tor requires regular calibration Calibra tion instructions are described in the DR Detector Cali bration Key User Manual doc 0134 A message is dis played on MUSI CA Acquisition Workstation indi cating that the DR detector must be recalibrated Topics Maintenance of the ceiling suspension and the radiographic wall stand Offset calibration Checking the automatic collimation DR 800 Introduction 79 039...

Page 80: ...everal kilograms of force in the telescope balancing system The braking system will compensate the force and keep the movement stable The ceiling suspension must not be used until the broken spring is replaced Table 6 Maintenance Periodic maintenance All steel cables winding drums pulleys and safety devices of the ceiling suspension and the radiographic wall stand shall be checked Every 12 months ...

Page 81: ...e console will start blinking to remind the user to manually trigger the offset calibration by pushing the button WARNING Image artifacts after delay of offset calibration Perform the manual offset calibration as soon as possible when the Offset Calibration button starts blinking WARNING Image artifacts after exposure of the system to foreign X ray radiation If another X ray device X ray tubes not...

Page 82: ...elect the third sensor area and check that the collimator automatically sets to the selected value 20x20 5 Vary the focal distance and check that the format remains unchanged even if the focal distance varies 6 Select the fourth sensor area and check that the collimator automatically sets to the selected value 15x15 7 Vary the focal distance and check that the format remains unchanged even if the ...

Page 83: ... by trained people with required knowledge to complete the cleaning and disinfecting task in a save and effective way The selection of the appropriate legally marketed disinfecting agents and procedures is the responsibility of the hospital The selection shall be performed according amongst others to the severity of the contamination Topics Cleaning Use of protective covers and sheaths Disinfectin...

Page 84: ...isinfectants or detergents directly on the equipment Do not pour liquid directly on the equipment CAUTION Do not use solvents such as anhydrous or high solvency alcohols thinner or benzine Do not use any corrosive dissolving or abrasive cleaning or polishing detergents Doing so may damage the surface of the equipment Using unsuitable cleaning agents or methods can damage the property when surface ...

Page 85: ...ent where disinfection is required or where it may get into contact with blood or other body fluids use covers or sheaths to protect the system from direct patient contact Only use legally marketed protective covers DR 800 Cleaning and Disinfecting 85 0392C EN 20210309 1049 ...

Page 86: ...n 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 having...

Page 87: ...ticed due to disinfection contact the medical device manufacturer To disinfect the device Do not use any corrosive soluble or gaseous disinfectants Consult the manufacturer s Material Safety Data Sheets MSDS and recommendations on the product label for additional information prior to use Use of spray disinfection can cause malfunctions due to ingress of the disinfectant into the equipment Disinfec...

Page 88: ...n 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 88 DR 800 Cleaning and Disinfecting 0392C EN 20210309 1049 ...

Page 89: ...e If required wipe the patient contact surfaces of the FLFS overlay using disinfectants such as ethanol 70 to prevent the risk of infection Do not spray the equipment directly with disinfectants or detergents Wipe it with a cloth slightly damped with a neutral detergent Do not use solvents such as anhydrous or high solvency alcohols thinner or benzine Doing so may damage the surface of the equipme...

Page 90: ...d Doing so may result in fire or electric shock WARNING To avoid risk of electric shock do not remove any covers Changes additions maintenance or repairs must be carried out by an Agfa certified field service engineer WARNING The user must not touch part of the console or the X ray generator and patient simultaneously WARNING Ionizing radiation can lead to radiation injuries if handled incorrectly...

Page 91: ...G Do not subject the unit to dangerous stresses eg violently stopping the moving parts at the end of the movement range twisting the electrical cables excessively or forcing movements without having released the brakes WARNING The table can tilt in negative position head down This can create a hazardous situation where the patient can slip from the table Always verify the automatic position before...

Page 92: ...rresponds to the intended source image distance SID to which the grid is focussed Because of the focussing of the grids the tube unit must be centered onto the bucky CAUTION Laser radiation is potentially dangerous for 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 Do not stare at the c...

Page 93: ... off the table Preventing damage to the equipment Attention to overhead loads Full Leg Full Spine Digital tomosynthesis Ceiling suspension and radiographic wall stand DR 800 Safety Directions 93 0392C EN 20210309 1049 ...

Page 94: ... in the allowed movement area of the system Crushing may occur between the moving system and the operator the patient or other persons within the movement range of the system WARNING Before activating any movement of the system verify that no one but the patient is present within the machine moving area and that the patient is properly positioned and secured on the tabletop While controlling the p...

Page 95: ...DR 800 Safety Directions 95 0392C EN 20210309 1049 ...

Page 96: ...Figure 56 The cross hatched area indicates where there is a risk of collision or crushing depending on the position of the system 96 DR 800 Safety Directions 0392C EN 20210309 1049 ...

Page 97: ...s is a standard accessory of the system Make sure that these handgrips are always installed If the handgrips cannot be used pay particular attention to the potential threat of crushing between mobile parts and openings during the examination make sure the patient does not grasp the edge of the tabletop DR 800 Safety Directions 97 0392C EN 20210309 1049 ...

Page 98: ...le is installed in other positions for instance laterally with respect to the tabletop the operator and the patient are both exposed to risks caused by lack of visibility when the machine is moving To give the operator complete control of all movement activities following measures can be taken Remove the patient footrest when working in a horizontal direction with the patient on the tabletop If ne...

Page 99: ...safety a camera which displays the patient s image is built in the collimator so the operator can monitor the patient position This camera image is displayed on the software console DR 800 Safety Directions 99 0392C EN 20210309 1049 ...

Page 100: ...ment has been turned off WARNING When the charge of the battery is less than 10 it is necessary to recharge the battery by connecting the power cord and turning on the mains network switch WARNING The wireless console should not be left unattended when active Failure to do so may result in unintended movement of table WARNING When the wireless console is not in use turn it off and park it outside ...

Page 101: ...e WARNING With a patient weighing more than 265 kg up to max 320 kg the radiographic table must be in the lowest position and not moved while it is under load For patient weights higher than 265 kg up to max 320 kg it is necessary to place the table at its minimum height to position the mobile area based on the area to be examined and only later to allow the patient on the tabletop Related Links P...

Page 102: ...d break the material and damage it Do not place glasses for contrast liquids or other containers on the equipment the console or the cabinet The contrast liquid could penetrate some components of the equipment causing malfunctions or incorrect interpretation of the X ray images We suggest that you immediately eliminate contrast liquid stains The position controls prevent unintended movement and st...

Page 103: ...ces are located to avoid coming into accidental contact with them Always control the movements of the patient while in the working area to protect them and prevent their contact with the equipment This mobile equipment is designed to carry overhead loads the patient or operator should remain in the equipments vicinity on ly for the time necessary to perform examinations or to service the equipment...

Page 104: ...ng unit with care to avoid damage WARNING The FLFS overlay may slide off the radiographic table when tilting the table if it is not properly mounted causing injury or damage to the equipment Always consider the patient orientation head left or head right when mounting the FLFS overlay 104 DR 800 Safety Directions 0392C EN 20210309 1049 ...

Page 105: ...Digital tomosynthesis WARNING Metal structures in the image might affect the image quality of the tomosynthesis reconstruction DR 800 Safety Directions 105 0392C EN 20210309 1049 ...

Page 106: ...RNING In the bucky and in the bucky drawer there are metal protrusions and pinch points that can cause damage to the user s hands So use only the proper handle to pull out and insert the cassette tray from the bucky WARNING Do not try to force the X ray tube towards the bottom when the main rope is broken Never use the ceiling suspension after the safety device intervention Immediately contact ser...

Page 107: ... with fluoroscopy for positioning DR workflow for dynamic images DR workflow for digital tomosynthesis DR workflow for digital subtraction angiography DSA DR workflow for DSA roadmapping Stopping the System DR 800 Basic Workflow 107 0392C EN 20210309 1049 ...

Page 108: ...ion For detailed information about starting up NX refer to the NX User Manual document 4420 The NX application and the software console are available on the NX workstation 3 In a configuration with a wireless DR Detector 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 NX workstation For detailed...

Page 109: ...tube 1 Close the collimator blades fully 2 Set exposure settings 80 kV 200 mAs 100 mA and large focus 3 Ensure that no one will be exposed 4 Make a total of three exposures 30 seconds apart This procedure is used for a typical X ray tube Consult the X ray tube manufacturer instructions for the actual X ray tube in use and comply with the instructions if there is conflict with this procedure DR 800...

Page 110: ...tomated workflow for warming up of the X ray tube A table is displayed with a list of exposures 1 2 1 Table with list of exposures 2 Button to cancel the warming up procedure Figure 61 List of exposures for warming up of the X ray tube 5 Make sure that the collimator blades are fully closed and that no patient is present in the room To avoid radiation on a DR detector remove the detector turn the ...

Page 111: ...ecify the exam group and exam type by clicking on the buttons c Select an exam type that is configured as a fluo group and click OK The fluo group thumbnail is added to the Image Overview pane A fluo group thumbnail is indicated with an icon in the top right corner of the thumbnail Figure 63 Thumbnail for a fluo group 2 Select the thumbnail for the fluo group in the Image Overview pane of the Acqu...

Page 112: ... console b Check the exposure settings The fluo group contains settings for fluoroscopy and for the static image Figure 66 Generator controls for fluoroscopy Figure 67 Generator controls for the static image 3 Move the X ray system to the right position a Check if a correct automatic position is selected Figure 68 Positioning controls on the software console b Move to the selected automatic positi...

Page 113: ...ion is reached the movement stops and the indicator light on the console goes out c Adjust the position using the position controls 4 Position the patient a Press and hold down the fluoroscopy pedal to view a real time fluoroscopy image in the dynamic image screen Information about the dynamic image is displayed next to the image 1 2 3 4 1 Current frame number 2 Duration up till now of the current...

Page 114: ...of the sequence is visible in the thumbnail A fluo sequence thumbnail is indicated with a transparant Play icon in the center Figure 72 Thumbnail of a fluo sequence If required multiple fluo sequences can be made 5 After stopping a dynamic exposure the dynamic image screen remains visible and the acquired sequence is played continuously Table 7 Buttons in the dynamic image screen after stopping th...

Page 115: ...all images in the examination are OK click Close and Send All If configured the image is sent to the printer and or PACS archive The exam is placed in the Closed Exams pane Fluo sequences are by default deleted after the examination is closed and not stored and not sent to a PACS archive This is indicated by the yellow icon in the top right corner of the fluo sequence thumbnail To store and archiv...

Page 116: ...Resetting the fluo timer on page 203 116 DR 800 Basic Workflow 0392C EN 20210309 1049 ...

Page 117: ...clicking on the buttons c Select an exam type that is configured as a dynamic group and click OK The dynamic group thumbnail is added to the Image Overview pane A dynamic group thumbnail is indicated with an icon in the top right corner of the thumbnail Figure 76 Thumbnail for a dynamic group 2 Select the thumbnail for the dynamic group in the Image Overview pane of the Acquisition window The sele...

Page 118: ... a Check the X ray modality settings Figure 78 X ray modality controls on the software console b Check the exposure settings The fluo group contains settings for fluoroscopy for static images and for rapid sequence exposures Figure 79 Generator controls for fluoroscopy Figure 80 Generator controls for static images and for rapid sequence exposures 3 Move the X ray system to the right position a Ch...

Page 119: ...eters are displayed on the software console When the target position is reached the movement stops and the indicator light on the console goes out c Adjust the position using the position controls 4 Position the patient 5 Acquire a set of fluo sequences rapid sequences and static images Any number of fluo sequences rapid sequences or static images can be acquired in any order Table 8 Supported wor...

Page 120: ...his examination 4 Warning sign for delay on real time imaging Figure 83 Dynamic image screen A warning sign can be displayed if the real time imaging is not guaranteed 6 Acquire a fluo sequence a Press and hold down the fluoroscopy pedal to view a real time fluoroscopy image in the dynamic image screen b Release the fluoroscopy pedal to stop the fluoroscopy sequence The fluo sequence is stored and...

Page 121: ...equence thumbnail in the lower half of the Image Overview pane The last image of the sequence is visible in the thumbnail A rapid sequence thumbnail is indicated with a white Play icon in the center Figure 86 Thumbnail of a rapid sequence WARNING In exceptional occasions the last image of a rapid sequence may not be of appropriate quality due to an uncompleted exposure In this case the user can ch...

Page 122: ...thumbnail in the lower half of the Image Overview pane Figure 88 Thumbnail of a static image If required multiple static images can be made 10 Perform quality control 11 If all images in the examination are OK click Close and Send All If configured the fluo sequences static images and rapid sequences are sent to the printer and or PACS archive The exam is placed in the Closed Exams pane Depending ...

Page 123: ...DR 800 Basic Workflow 123 0392C EN 20210309 1049 ...

Page 124: ...es representing the 3D volume of the examined bodypart within a specified region of interest To perform a digital tomosynthesis examination 1 Add a digital tomosynthesis group to the Image Overview pane If a digital tomosynthesis group has already been added based on data from the RIS this step can be skipped a In the Examination window click Add Image The Add Image window appears Figure 89 Add Im...

Page 125: ...tion overview 1 3 2 1 X ray modality settings 2 Generator settings for the static image 3 Automatic position Figure 91 Examination overview a Check the X ray modality settings Figure 92 X ray modality controls on the software console b Check the exposure settings Figure 93 Generator controls for static images a Check the digital tomosynthesis settings The digital tomosynthesis group contains X ray...

Page 126: ...lance and to avoid injuries in patient hands or fingers 5 On the collimator switch on the light localizer Apply collimation 6 Acquire a static image If a reference image is required acquire a static image The images of the acquisition sequence should not be used to replace a static image Press and hold down the exposure button or the radiography pedal to make an exposure to acquire a static image ...

Page 127: ...ure 10 Press and hold down the exposure button to make a digital tomosynthesis acquisition sequence Hold the exposure button pressed until three beeps are heard to indicate that the examination has finished Together with the auditory signal messages are displayed on the software console to indicate that the examination has finished When the exposure button is released before the movement has finis...

Page 128: ...pane The middle slice of the sequence is visible in the thumbnail An acquisition sequence thumbnail is indicated with a white Play icon in the center Figure 100 Thumbnail of the reconstruction sequence After the reconstruction sequence becomes available the Acquisition window looks as follows 1 2 4 4 3 1 Digital tomosynthesis group thumbnail 2 Image thumbnail if a reference image is acquired 3 Acq...

Page 129: ...o the tabletop In the dynamic image player a dynamic image is played that is composed of all slices In the mosaic viewer all slices are displayed as separate images 12 If all images in the examination are OK click Close and Send All If configured the static images and reconstruction sequence are sent to the printer and or PACS archive The exam is placed in the Closed Exams pane Acquisition sequenc...

Page 130: ...n of the mask image Blood vessels that contain the contrast medium become clearly visible without the interference of bones or dens soft tissue in the environment To perform a DSA examination 1 Add a DSA group to the Image Overview pane If a DSA group has already been added based on data from the RIS this step can be skipped a In the Examination window click Add Image The Add Image window appears ...

Page 131: ...ty settings 2 Generator settings for DSA image acquisition 3 Generator settings for fluoroscopy or for roadmapping image acquistion roadmapping is not part of this workflow 4 Automatic position Figure 104 Examination overview a Check the X ray modality settings Figure 105 X ray modality controls on the software console b Check the exposure settings The DSA acquisition group contains settings for f...

Page 132: ...ed the movement stops c Adjust the position using the position controls 4 Position the patient Use patient fixations available to avoid patient movement during interventional procedures The patient position can be verified using the collimator camera 5 On the collimator switch on the light localizer Apply collimation 6 Acquire a set of DSA sequences roadmapping examinations fluo sequences and stat...

Page 133: ...s manual 7 Select the DSA mode in the software console Figure 109 DSA mode WARNING The DSA image processing relies on absence of movement Do not change the position of the table X ray tube or collimator during the DSA examination 8 Press and hold down the radiography pedal or the exposure button A first set of frames is used to compose the mask image The subsequent frames are displayed with the ma...

Page 134: ... of a DSA sequence 11 Perform quality control DSA sequences can be post processed to change the mask image to apply pixel shift to correct for movement in the subtracted image or to apply landmarking by making anatomical background as visible as desired By modifying the MUSICA settings of the image the presentation of the DSA sequences can be fine tuned 12 If all images in the examination are OK c...

Page 135: ...ualized with maximum opacity The last image of this first sequence is used as a mask to subsequent fluoroscopy exposures during the same roadmapping session Blood vessels become clearly visible as a roadmap as well as catheters or guide wires that are moved through the vessels WARNING The user has to finish the roadmapping workflow completely before performing any other actions This means that e g...

Page 136: ...p right corner of the thumbnail Figure 113 Thumbnail for a DSA group 2 Select the thumbnail for the DSA group in the Image Overview pane of the Acquisition window The selected DR detector is activated The default X ray exposure parameters and X ray system position for the selected examination are sent to the modality The software console displays these settings in the examination overview 1 4 2 3 ...

Page 137: ...d for roadmapping 3 Move the X ray system to the right position a Check if a correct automatic position is selected Figure 118 Positioning controls on the software console b Move the X ray system to the selected automatic position The actual and target position parameters are displayed on the software console When the target position is reached the movement stops c Adjust the position using the po...

Page 138: ...opy pedal Roadmapping mask One or more roadmapping sequences DSA exposure button or ra diography pedal Static image exposure button or ra diography pedal Fluoro scopy not needed fluoroscopy pedal The workflow for performing a roadmapping examination is explained in the next steps The other workflows are explained in other sections in this manual 7 In the fluoroscopy screen of the software console ...

Page 139: ... syringe icon is shown WARNING Roadmapping does not work with negative contrast media The blood vessels gradually fill with contrast medium and become visible on the screen If the option max opacity is enabled the blood vessels stay visible even if the contrast medium has moved on 10 Release the fluoroscopy pedal when the blood vessels are sufficiently filled with contrast medium The roadmapping m...

Page 140: ...pping examination 15 To perform another roadmapping examination using a new mask start another roadmapping workflow in the software console If multiple roadmapping workflows are performed a filled or hollow triangle at the bottom of the thumbnails provides a visual link between roadmapping sequences that have been acquired using the same mask 16 Perform quality control Roadmapping sequences can be...

Page 141: ...dows taskbar and click the MUSICA Acquisition Workstation Control Center Stopping the NX software also triggers the shutdown of the DR 800 sync cabinet d In Windows perform a shutdown of the PC 2 In a configuration with a wireless DR detector power off the DR detector turn off the DR Detector remove the battery pack 3 Switch off the electrical room switch WARNING If the system has just been stoppe...

Page 142: ... Fine tuning the table position and centering of the examination area Gastrointestinal examinations oesophagus and stomach Gastrointestinal examinations small intestine and colon Skeleton Cervical spine Abdominal and lumbar region Upper limbs and lower limbs also with load Thorax and lungs Urography and pyelography Hysterosalpingography Guidelines for Pediatric Applications Typical examination set...

Page 143: ...trest instructions on how to assemble the footrest in stool mode are provided in the Accessories chapter This makes it easier to perform examinations such as the chest cervical spine and skull on patients who cannot maintain a standing position If projections are required on patients in wheelchairs it will be possible to approach the patient to the examination table removing the footrest instructi...

Page 144: ...etcher can be moved onto the examination table more easily by first moving the tabletop to the left or to the right Related Links Getting on and off the table on page 101 144 DR 800 Application Examples 0392C EN 20210309 1049 ...

Page 145: ... area If corrections are required to the focal distance the tilting angle the examination area centring and tube incidence the operator can use the main control console or the control panel onboard the machine DR 800 Application Examples 145 0392C EN 20210309 1049 ...

Page 146: ... group downwards The examination of the stomach can be executed by tilting the table a few degrees so that the patient can stand in a more comfortable position and at the same time better adhere to the tabletop so as to further reduce the distance between examination area and detector Possible angles of the X ray tube column can be useful to better put on evidence the little curve of the intestine...

Page 147: ...n an oblique position on the table top and with the table in a horizontal position The operator can inclinate the X ray tube to obtain the projections needed to provide the required examination results In addition medical staff can work in the room using the controls onboard the table to position the table as required DR 800 Application Examples 147 0392C EN 20210309 1049 ...

Page 148: ...or group group allows the operator to execute the most thorough analysis of the patient Examinations of the skull under any incidence of the back spine and of the lower and upper limbs can be performed with the table in both a horizontal and vertical position 148 DR 800 Application Examples 0392C EN 20210309 1049 ...

Page 149: ...cient to move the X ray tube and DR detector group towards the upper end of the examination table The optional possibility to change the focal distance from 115 cm to 180 cm also allows to further reduce the geometrical blurring ensuring a greater definition of the cervical bone structures DR 800 Application Examples 149 0392C EN 20210309 1049 ...

Page 150: ...e and DR detector group downwards it will be possible to execute examinations on the abdominal region as well as on the lumbar column even with oblique projections with no need to raise the patient 150 DR 800 Application Examples 0392C EN 20210309 1049 ...

Page 151: ...vement e g those in a wheelchair It is also possible to perform examinations on the knee or ankle under load using the footrest to support the patient Even without the displacement of the patient tabletop in a longitudinal direction optional it is possible to reach the ankle moving the column detector unit downwards and mounting the footrest in stool mode DR 800 Application Examples 151 0392C EN 2...

Page 152: ...Thorax and lungs The radiography of the thorax can be executed with a focus detector distance of 180 cm 152 DR 800 Application Examples 0392C EN 20210309 1049 ...

Page 153: ... ducts may require the Trendelenburg position Using accessories such as the shoulder rest or the compression belt guarantees the stability of the patient on the exam tabletop and optimising of image quality DR 800 Application Examples 153 0392C EN 20210309 1049 ...

Page 154: ...y tube and DR detector group towards the front end or the back end of the table allows the operator to easily execute any radioscopic examinations and radiographs of the uterine cavity and fallopian tube 154 DR 800 Application Examples 0392C EN 20210309 1049 ...

Page 155: ...it makes sense to provide aids to maintaining stable positioning It is strongly recommended the use of immobilizing devices such as bean bags and restraint systems foam wedges adhesive tapes etc to avoid the need of repeating exposures due to the movement of the pediatric patients Whenever possible use techniques based on the lowest exposure times Shielding We recommend you provide extra shielding...

Page 156: ... based on size of the child reducing tube output kVp and mAs limiting the duration of dynamic imaging Try to use always short exposure times large SID values and immobilizing devices Avoid multiple scans and use alternative diagnostic studies such as ultrasound or MRI when possible 156 DR 800 Application Examples 0392C EN 20210309 1049 ...

Page 157: ...r 65 x Shoulder ar thrography 65 16 Cervical spine 65 x Abdomen 80 x Lumbar spine 80 x Hand 50 2 5 Wrist 50 3 Wrist arthrogra phy 50 4 Chest 117 x Intravenous Pye logram IVP 75 x Hysterosalpin gography 85 x Table 13 Rapid sequence kV AEC mAs FPS Oesophagus 75 85 x 5 Stomach 90 x 2 Small intes tine 85 95 x 1 DR 800 Application Examples 157 0392C EN 20210309 1049 ...

Page 158: ...osal pingography 85 x 5 Table 14 Fluoroscopy kV ABS FPS Oesophagus 75 85 x 5 10 Stomach 85 95 x 5 10 Small intestine 85 95 x 5 Colon 90 110 x 5 Shoulder ar thrography 65 70 x 5 Wrist arthrogra phy 50 55 x 5 Hysterosalpin gography 75 90 x 5 158 DR 800 Application Examples 0392C EN 20210309 1049 ...

Page 159: ...tion Prepare the X Ray system for the examination Check the exposure settings Execute the exposure Perform a quality control Finalize the examination Storing the FLFS overlay Manually adjusting a DR Full Leg Full Spine image Rejecting a DR Full Leg Full Spine image Making measurements DR 800 Full Leg Full Spine 159 0392C EN 20210309 1049 ...

Page 160: ...info for the exam 2 Start the exam Select the exposure In the operator room at the NX workstation 1 In the Image Overview pane of the Examination window select the thumbnail for the DR Full Leg Full Spine FLFS examination 2 In the Image Detail pane click Start FLFS 160 DR 800 Full Leg Full Spine 0392C EN 20210309 1049 ...

Page 161: ...nt guide b Fasten the mounting unit by turning both the handle and the smaller knob thoroughly clockwise 1 2 4 4 Figure 124 Fastening the mounting unit head left c Put the overlay on the tabletop and slide it into the mounting unit until it automatically fixes 2 4 3 3 Figure 125 Mounting the overlay head left NX is configured for a specific patient orientation either head left default or head righ...

Page 162: ...The X Ray system moves to the default position for preparing the DR Full Leg Full Spine examination If the radiographic table is tilted to vertical position assure that the FLFS overlay remains flat against the tabletop CAUTION After doing vertical FLFS exposures the grid can swing away from the table and disturb the patient Set the inclination of the table to 89 instead of 90 degrees 162 DR 800 F...

Page 163: ... equipment WARNING Use always the hand grips to avoid injuries in patient hands or fingers when the tabletop is in movement Patient s hands must be kept far away from the tabletop edges in every moment 2 Move the tabletop longitudinally and make sure that the region of interest is within the travel area of the DR bucky 3 On the collimator switch on the light localizer If required collimate in tran...

Page 164: ...ware console Figure 128 Setting the top most position for the examination 5 Press the ROI 1 button to confirm the position 6 Move the X ray tube and DR detector to the position that matches the bottom most position for the examination Figure 129 X ray tube moved to bottom most position 164 DR 800 Full Leg Full Spine 0392C EN 20210309 1049 ...

Page 165: ... true size printed images estimate the distance between the FLFS overlay and the horizontal plane in which measurements are to be made This distance is used for calibrating distance measurements on the image in NX If no calibration is required leave the default value 9 Confirm the positioning Figure 131 Confirmation button Note The maximum size of the region of interest is approximately 140 cm For...

Page 166: ... Prepare the X Ray system for the examination Use the positioning console to move the X ray system to the automatic position The X Ray system moves to the starting position for the examination 166 DR 800 Full Leg Full Spine 0392C EN 20210309 1049 ...

Page 167: ...at are required for the examination 1 Check if the settings for patient size that are displayed on the console are suitable for the examination Figure 132 Exposure parameters for the partial images 2 If other exposure values are required edit the settings a Touch the displayed setting The editing screen is displayed DR 800 Full Leg Full Spine 167 0392C EN 20210309 1049 ...

Page 168: ...irmation button Figure 133 Edit exposure settings for partial images b Select the partial image for which settings must be changed c Modify the settings d Confirm the settings 168 DR 800 Full Leg Full Spine 0392C EN 20210309 1049 ...

Page 169: ...e examination has finished The partial images are sent to the NX workstation 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 In the operator room at the NX workstation A green OK mark appears on all thumbnails for which exposures are going to be made during the examinat...

Page 170: ...the alignment of the anatomical information in the image The stitching parameters are displayed on the right side of the image Table 15 Stitching parameters Button Parameter 0 0 Vertical correction in respect to the stitching grid for the align ment of the anatomical information in the image 0 1 Horizontal correction in respect to the stitching grid for the align ment of the anatomical information...

Page 171: ...ys detected by the system The user is responsible for observation of the movement of the patient during the examination To perform quality control 1 If required adjust the stitching 2 Click Accept Depending on the configuration settings the stitching parameters are added to the image as a text annotation The text annotation contains following information Table 16 Annotations V Vertical correction ...

Page 172: ...ment of the anatomical information in the image Y Indication that patient movement is detected N Indication that no patient movement is detected Figure 135 Example of a text annotation containing stitching parameters 3 Prepare the image for diagnosis by using e g L R markers or annotations 4 If the image is OK send the image to a hardcopy printer and or PACS Picture Archiving and Communication Sys...

Page 173: ...m 1 Let the patient step down from the radiographic table The patient may need help to step down from the radiographic table 2 Remove the FLFS overlay from the radiographic table and store it DR 800 Full Leg Full Spine 173 0392C EN 20210309 1049 ...

Page 174: ...on the hook on the wall or on a flat surface When the overlay stays askew at a wall or is not fully supported on a table the overlay will be bent after some time A bent overlay cannot be used anymore due to possible distortions in the resulting image 174 DR 800 Full Leg Full Spine 0392C EN 20210309 1049 ...

Page 175: ...gn the partial images based on their projection on the stitching grid To align the partial images based on the analysis of the anatomical information in the image To manually align two partial images To turn the black borders or cropping on or off To save the stitched image DR 800 Full Leg Full Spine 175 0392C EN 20210309 1049 ...

Page 176: ...l partial images Click the following button to rotate 90 clockwise Figure 136 Rotate clockwise Click the following button to rotate 90 counterclockwise Figure 137 Rotate counterclockwise 176 DR 800 Full Leg Full Spine 0392C EN 20210309 1049 ...

Page 177: ...kers in the stitching grid and a correction is applied based on the alignment of the anatomical information in the image The area of the image where two partial images are stitched together is indicated by the stitching tools displayed on the right side of the image In this area the two partial images slightly overlap If the anatomical structures in the overlapping area are not aligned stitching c...

Page 178: ...38 Stitch mode grid The anatomical structure in the partial images may not be aligned due to patient movement during the examination The values of the horizontal and vertical correction are set to zero Next to the stitching areas the following label is displayed 0 0 0 1 Figure 139 Stitching tools align partial images 178 DR 800 Full Leg Full Spine 0392C EN 20210309 1049 ...

Page 179: ... structures in the overlapping areas are aligned by automatically shifting the partial images in vertical and horizontal direction The new alignment is applied to each stitching area Next to the stitching areas this label is displayed as well as the vertical and horizontal relative position of the partial images 0 0 0 1 Figure 141 Stitching tools align partial images via anatomical information DR ...

Page 180: ...ion of the lower im age Right click hold the image and drag the mouse arrow to any direction Press the SHIFT or CTRL button while dragging the mouse arrow to adjust the vertical or horizon tal alignment only Use the arrow keys on the keyboard Click the arrow buttons on the screen Roaming over the images Left click hold the image and drag the mouse ar row to any direction Zooming in out on the imag...

Page 181: ...yed in the image each of which is locked to the position of one of the partial images 3 If the anatomical structures in the partial images are aligned click Accept to confirm Next to the stitching areas this label is displayed as well as the vertical and horizontal relative position of the partial images 0 0 0 1 Figure 145 Stitching tools manual alignment DR 800 Full Leg Full Spine 181 0392C EN 20...

Page 182: ...o turn the black borders or cropping on or off To turn the black borders or cropping on or off Click the following icon Figure 146 Crop uncrop button 182 DR 800 Full Leg Full Spine 0392C EN 20210309 1049 ...

Page 183: ...ation Depending on the configuration settings the stitching parameters are added to the image as a text annotation Note After saving the DR Full Leg Full Spine image cannot be adjusted The same set of partial images can be used to create another DR Full Leg Full Spine image DR 800 Full Leg Full Spine 183 0392C EN 20210309 1049 ...

Page 184: ... Rejecting an image does not remove the image from the exam To reject a DR Full Leg Full Spine image 1 Reject each partial image 2 If the DR Full Leg Full Spine image was created reject this image also No images will be sent and a thumbnail for a new DR Full Leg Full Spine examination is created 184 DR 800 Full Leg Full Spine 0392C EN 20210309 1049 ...

Page 185: ...he measurement tools To modify the Estimated Radiographic Magnification Factor see the NX User Manual on Adding an Estimated Radiographic Magnification Factor ERMF 5 1 4 6 8 10 7 3 9 2 1 X ray tube 2 Patient location 3 Stitching grid 4 DR Detector 5 Distance to be measured on the object in a plane parallel to the stitching grid 6 Projection of the object on the stitching grid This is the measured ...

Page 186: ... on DR Full Leg Full Spine images The respective distances between the plane in which the measurement is made the stitching grid the DR Detector and the X ray tube are used to calculate the Estimated Radiographic Magnification Factor to calibrate the distance measurement on NX 186 DR 800 Full Leg Full Spine 0392C EN 20210309 1049 ...

Page 187: ...py or roadmapping X ray modality controls Positioning controls Digital tomosynthesis controls System messages Topics Examination overview Generator controls for static image rapid sequence or DSA Generator controls for fluoroscopy or roadmapping X ray modality controls Positioning controls Controls for digital tomosynthesis System messages DR 800 Software Console 187 0392C EN 20210309 1049 ...

Page 188: ... 10 1 X ray modality status frame navigate to the X ray modality controls by pushing this area 2 DAP value 3 Fluo timer 4 Generator controls for static image or rapid sequence navigate to the detailed controls by pushing this area 5 Generator controls for fluoroscopy navigate to the detailed controls by pushing this area 6 Positioning controls navigate to the detailed controls by pushing this area...

Page 189: ...or roadmapping on page 219 Positioning controls on page 229 Topics X ray modality status frame Ready For Exposure Status Modality Position DR detector switch DR Detector Status Performing offset calibration Unknown status Filter Status Grid Status Heat Units Radiation status DAP Value Fluo timer Resetting the fluo timer DR 800 Software Console 189 0392C EN 20210309 1049 ...

Page 190: ...xposure status 2 Modality position 3 DR detector switch 4 Filter status 5 Grid status 6 Heat units 7 Radiation status Figure 149 X ray modality status frame Related Links X ray modality controls on page 228 190 DR 800 Software Console 0392C EN 20210309 1049 ...

Page 191: ...rly set and there are no interlock failures or system faults Red Exposure not ready Check the message frame for more information It is not possible to perform an exposure due to an error The status will turn to green when problem is solved Blue Exposure not ready No examination defined DR 800 Software Console 191 0392C EN 20210309 1049 ...

Page 192: ...e image is planned for the radiographic table The image is planned for the radiographic wall stand The image is planned as a free exposure A manual X ray exposure can be made No image will be ac quired on the NX workstation The available workstations depend on the modality type and configuration On a configuration with a ceiling suspension a number 1 or 2 is displayed on the icon to identify the X...

Page 193: ...onsole 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 Detector The DR detector switch can be switched to CR depending on the configuration Figure 150 DR detector switch DR 800 Software Console 193 0392C EN 20210309 1049 ...

Page 194: ...Connection status icon wifi wired Meaning Good Low Bad Wired DR Detector DR detec tor status icon blinking Meaning Ready Initializing exposure Error Sleep Offset cali bration is ongoing One DR de tector must be selected 194 DR 800 Software Console 0392C EN 20210309 1049 ...

Page 195: ...bration automatically It is required to manually trigger the offset calibration in order to prevent image artifacts caused by delayed offset calibration 1 Press the offset calibration button in the DR Detector switch The X ray modality controls are displayed on the software console 2 Press the offset calibration button The offset calibration is performed DR 800 Software Console 195 0392C EN 202103...

Page 196: ...epending on the component for which the unknown status is displayed an action is required on the component or on the software to provide the system with the missing information E g to solve the unknown detector status one DR detector must be selected 196 DR 800 Software Console 0392C EN 20210309 1049 ...

Page 197: ...e modified on the software console Table 21 Collimator with automatic filter no icon No filter is used A filter is used Material and thickness of the filter are speci fied Table 22 Collimator with manual filter no icon No filter is required A filter is required Insert the filter manually DR 800 Software Console 197 0392C EN 20210309 1049 ...

Page 198: ... The correct grid type is not inserted A grid is inserted but no grid is required The SID does not correspond to the inserted grid The grid type is displayed inside the icon Table 24 Grid status automatic grid no icon No grid is required A grid is required 198 DR 800 Software Console 0392C EN 20210309 1049 ...

Page 199: ...ercentage of the thermal capacity of the X ray tube that is used For example a display of HU 0 would indicate that all the heat units capacity of the X ray tube remains A display of HU 100 would indicate that maximum heat capacity of the X ray tube is reached and no exposures can be made until the tube has cooled down DR 800 Software Console 199 0392C EN 20210309 1049 ...

Page 200: ...ase the ex posure controls The exposure button is pressed halfway and the X ray tube is pre pared The exposure button is pressed completely and the X ray exposure is made The indicator on the console will light up The examination room door is open Press the exposure button halfway Prep position to prepare the X ray tube for exposure The indicator will light up when the X ray tube is prepared and t...

Page 201: ...easurement values When the screen with generator controls is displayed more dose measurement values become visible DAPR Dose Area Product Rate in cGy cm2 s AK Air Kerma in mGy calculated value AKR Air Kerma Rate in mGy min calculated value Keep in mind that the Air Kerma value is not correct when using the optional ceilling suspension with extra filtration DR 800 Software Console 201 0392C EN 2021...

Page 202: ...can be configured When the alarm time is reached a sound signal is heard and the fluo timer is blinking orange When the maximum duration time is reached the fluoroscopy sequence is stopped There can be a difference of a few seconds between the value of the fluo timer in the software console and the value of the total duration of all dynamic images in the NX software 202 DR 800 Software Console 039...

Page 203: ... maximum duration time has been reached fluoroscopy can be continued by resetting the fluo timer To reset the fluo timer Press and hold the fluo timer icon The fluo timer is set to zero DR 800 Software Console 203 0392C EN 20210309 1049 ...

Page 204: ...the and buttons The values increase or decrease step by step each time the corresponding button is pushed To change a value without repeatedly pushing the buttons push the value twice The buttons change into arrow up and arrow down buttons Push and hold the button to change the value After exposure all values reflect the settings actually used by the generator Topics Radiography imaging modes Pati...

Page 205: ... Sensor area Radiographic Parameters Focal Spot Indicator Automatic Exposure Control AEC AEC field selection Dose Density Patient Size AEC dose failure DR 800 Software Console 205 0392C EN 20210309 1049 ...

Page 206: ...diography pedal will trig ger a rapid sequence of X ray exposures lasting until the button is released DSA mode Pressing the exposure button or radiography pedal will trig ger a DSA examination lasting until the button is released DSA mode uses the same radiographic parameters as rapid sequence mode If a mode is not available the icon is grayed out Related Links Exposure Controls on page 28 Fluoro...

Page 207: ...The pediatric patient age group can be configured with lower dose values when using AEC or ABS Table 27 Patient age group Adult Pediatric Related Links Dose on page 214 DR 800 Software Console 207 0392C EN 20210309 1049 ...

Page 208: ...ne point mode by selecting kV The exposure is controlled by AEC mAs mA ms Two point mode by selecting kV and mAs AEC is disabled mAs mA ms Three point mode by selecting kV mA and exposure time independent ly AEC is disabled To switch to one point mode activate one or more AEC fields Depending on the radiographic working mode some of the generator controls will be disabled 208 DR 800 Software Conso...

Page 209: ...vailable for fluoroscopy and for rapid sequence mode When you select a sensor area for fluoroscopy mode an equal or larger sensor area is automatically activated for rapid sequence mode The collimation is automatically adjusted to match the smallest sensor area and applies to both modes mAs mA ms Figure 155 Sensor area Related Links Dynamic imaging modes on page 293 DR 800 Software Console 209 039...

Page 210: ...re is made the actual exposure parameters are displayed in a message When using AEC the exposure is terminated by the detector ms or max mAs settings or by the AEC dose failure safety device even if the target dose is not reached Related Links System messages on page 239 Automatic Exposure Control AEC on page 212 AEC dose failure on page 218 Extra parameters in rapid sequence mode Following parame...

Page 211: ...e is set according to maximum power instantaneous power space charge etc When a focal spot is selected it sets the highest mA value available for the selected focal spot and the respective exposure time in order to keep constant mAs whenever the mA value does not exceed the maximum tube power and the exposure time value does not exceed the maximum integration time of the DR detector or the maximum...

Page 212: ...nd of the patient size To activate AEC mode push any of the three AEC field buttons mAs mA ms Figure 156 AEC field buttons To deactivate AEC mode select the two point or three point radiographic working mode mAs mA ms Figure 157 Buttons to select two point or three point radiographic working mode 212 DR 800 Software Console 0392C EN 20210309 1049 ...

Page 213: ... select or deselect it by touching it Any combination of fields can be selected and the color of the buttons changes highlighted when active The exposure is ended if any of the selected fields measures the AEC cut off dose Table 30 Automatic filter Left field Middle field Right field DR 800 Software Console 213 0392C EN 20210309 1049 ...

Page 214: ...on configuration at installation time and on the selected patient age group Each time a button is selected highlighted the others are automatically deselected Table 31 Automatic filter Dose low dose middle dose high dose Related Links Patient age group on page 207 214 DR 800 Software Console 0392C EN 20210309 1049 ...

Page 215: ...ased and decreased in a range of 4 to 4 representing a change of 50 to 100 in dose When disabled the density range number appears in black Table 32 Dose variation compared to reference dose D Dose 4 0 50 3 0 63 2 0 75 1 0 88 0 1 reference dose 1 1 25 2 1 50 3 1 75 4 2 00 DR 800 Software Console 215 0392C EN 20210309 1049 ...

Page 216: ...ient size kV Extra Small normal kV 0 9 Small normal kV 0 95 Medium normal kV Large normal kV 1 05 Extra Large normal kV 1 1 Patient Size using two point mode When using two point mode the patient size setting affects the mAs value Table 34 mAs variation over patient size Patient size mAs Extra Small normal mAs 0 25 Small normal mAs 0 5 Medium normal mAs Large normal mAs 2 216 DR 800 Software Conso...

Page 217: ...Patient size mAs Extra Large normal mAs 4 DR 800 Software Console 217 0392C EN 20210309 1049 ...

Page 218: ...y device terminates the X ray exposure when no radiation is detected in the ionization chamber or when the selected parameters short backup time mAs are not appropriate for an exposure with AEC 218 DR 800 Software Console 0392C EN 20210309 1049 ...

Page 219: ...lue use the and buttons The values increase or decrease step by step each time the corresponding button is pushed To change a value without repeatedly pushing the buttons push the value twice The buttons change into arrow up and arrow down buttons Push and hold the button to change the value Topics Fluoroscopy imaging modes Patient age group Sensor area Radiographic Parameters for fluoroscopy Auto...

Page 220: ...ger a fluoroscopy ex amination lasting until the button is released Roadmapping Pressing the fluoroscopy pedal will start fluoroscopy expo sure for generating the roadmapping mask Roadmapping mode uses the same radiographic parameters as pulsed fluoroscopy mode WARNING Unsharpness of moving objects when using continuous fluoroscopy can occur Sharpness of moving objects can be improved by switching...

Page 221: ...The pediatric patient age group can be configured with lower dose values when using AEC or ABS Table 36 Patient age group Adult Pediatric Related Links Dose on page 214 DR 800 Software Console 221 0392C EN 20210309 1049 ...

Page 222: ...vailable for fluoroscopy and for rapid sequence mode When you select a sensor area for fluoroscopy mode an equal or larger sensor area is automatically activated for rapid sequence mode The collimation is automatically adjusted to match the smallest sensor area and applies to both modes mAs mA ms Figure 159 Sensor area Related Links Dynamic imaging modes on page 293 222 DR 800 Software Console 039...

Page 223: ...iographic parameters are adjusted automatically and displayed in the software console Extra parameters for pulsed fluoroscopy Following parameters are only available for pulsed fluoroscopy ms shows the pulse width in milliseconds selected for the exposure FPS frames per second When the automatic brightness system is on an initial kV value is selected During the examination the radiographic paramet...

Page 224: ... brightness Brightness curve Region of interest Dose Fluoroscopy boost Lock brightness Table 37 Lock brightness When brightness is unlocked ABS is active The exposure parameters are adjusted automatically during the fluorosco py sequence When brignthess is locked ABS is deactivated The exposure parameters are fixed until brightness is unlocked again Brightness curve The X ray generator can be conf...

Page 225: ... configured sizes use the and buttons The size of the region of interest is displayed in cm Figure 163 Region of interest Dose Each of these buttons allows adjustment of the ABS dose depending on configuration at installation time Each time a button is selected highlighted the others are automatically deselected Table 38 Automatic filter Dose low dose high dose Fluoroscopy boost To temporarily inc...

Page 226: ...Table 39 Fluoroscopy boost Normal dose level Increased dose level The button is blinking 226 DR 800 Software Console 0392C EN 20210309 1049 ...

Page 227: ...on of interest on the software console while adjusting the patient position remotely To hide the camera image on the software console push the image To display the camera image push the camera icon Figure 164 Camera image is not displayed DR 800 Software Console 227 0392C EN 20210309 1049 ...

Page 228: ...lected modality position can be selected 3 Start the offset calibration The button is enabled when the DR detector for dynamic imaging is selected Push the button to manually trigger the offset calibration 4 Select the filter 5 Enable or disable the grid Figure 165 X ray modality controls Related Links Modality Position on page 192 DR detector switch on page 35 Filter Status on page 197 Grid Statu...

Page 229: ...arget position parameters 3 Collimation controls 4 Wireless console status Figure 166 Positioning controls Topics Automatic position Actual and target position parameters Collimation controls Wireless console status DR 800 Software Console 229 0392C EN 20210309 1049 ...

Page 230: ...tons A preview of the target automatic position is displayed Use the controls on the positioning console to move the system to the target position Push the preview image to disable automatic positioning and enable the manual controls on the positioning console Quickly select one of the default automatic positions D1 D2 or P parking position 230 DR 800 Software Console 0392C EN 20210309 1049 ...

Page 231: ...The target position parameters correspond to the selected automatic position Table 41 Position parameters Source image distance SID X ray tube tilting angle Table tilting angle Table height DR 800 Software Console 231 0392C EN 20210309 1049 ...

Page 232: ...ollimation setting after making adjustments to the col limation is displayed on the software console For rapid sequences the single collimation is applied Manual collimation Readout of the actual collimation setting For double collimation the preconfigured collimation setting is dis played instead Restore the collimation setting of the previous exposure Previewing Collimation After acquisition of ...

Page 233: ...ion borders that exceed the frame size of the dynamic image are drawn orange Note For oblique exposures the previewed collimation area may be smaller than the actually collimation area DR 800 Software Console 233 0392C EN 20210309 1049 ...

Page 234: ...20 It is necessary to power the console by connecting the power cord to continue its use Red Battery charge level below 10 It is necessary to power the console by connecting the power cord to continue its use A warning is displayed on the software console Green blink ing on Red blinking off The battery is being charged Green blink ing Battery charging is completed Off Battery status is unknown 234...

Page 235: ...s for acquisition 3 Recontruction parameters 4 Button to start the digital tomosynthesis workflow Figure 167 Positioning controls Topics Radiographic Parameters for digital tomosynthesis Position parameters for digital tomosynthesis Reconstruction parameters DR 800 Software Console 235 0392C EN 20210309 1049 ...

Page 236: ...ital tomosynthesis acquisition sequence kV shows the radiographic kV value X ray tube voltage for the exposure mAs shows the radiographic mAs value for the exposure FPS frames per second This value is fixed Related Links Focal Spot Indicator on page 211 Patient Size on page 216 236 DR 800 Software Console 0392C EN 20210309 1049 ...

Page 237: ... actual SID is displayed A warning sign is displayed if the ac quisition cannot be performed using the actual SID X ray tube sweep angle The range of the X ray tube tilting angle during the tomographic movement To select another angle use the and buttons DR 800 Software Console 237 0392C EN 20210309 1049 ...

Page 238: ... relative to the tabletop End Height cm The height of the last slice of the reconstruction sequence relative to the tabletop Slice Thickness mm The thickness of the slices Sharpness Increasing the sharpness will im prove the quality of the image but the image processing will take longer 238 DR 800 Software Console 0392C EN 20210309 1049 ...

Page 239: ...ge Error Messages that require feedback from the user contain a button that can be pressed Figure 168 Error message requiring user feedback More than one message can be active The number of active messages and the type of messages is indicated on the navigation button Figure 169 Icon indicating that messages are waiting DR 800 Software Console 239 0392C EN 20210309 1049 ...

Page 240: ...The system messages screen lists all messages since the last startup of the software Figure 170 Messages history 240 DR 800 Software Console 0392C EN 20210309 1049 ...

Page 241: ...mmetric movement Support for glass of barium Intercommunication system FLFS grid Topics Mounting the patient footrest Mounting the hand grips Mounting the shoulder rests Mounting the compression belt Mounting the lower limbs support ankle support or head contention device Mounting the lateral arm rest on the radiographic table Mounting the lateral arm rest on the radiographic wall stand Mounting t...

Page 242: ... footrest so that its guides are perfectly aligned with the guides of the tabletop 3 Insert the footrest in the guides 1 1 1 2 3 1 2 3 1 Footrest guides 4 Turn and press the knobs on both sides to release the locks 5 Make the footrest slide by keeping the knobs pressed until the footrest is almost completely inserted in the guides 1 1 1 2 3 1 2 3 1 Footrest guides 2 Turning the knob 3 Pressing the...

Page 243: ...g the locks If this is not the case it could come loose and cause injuries to persons and objects during machine tilting or movement WARNING Do not execute any adjustment of the footrest when the table is in the vertical position you would take the risk to make the patient fall or hurt your feet Table 46 Technical data Weight 6 kg Maximum load 265 kg Topics Mounting the patient footrest as a seat ...

Page 244: ... 1 Turn and press the knobs on both sides to release the locks 2 Push the footrest some centimetres onwards 3 Release the knobs and make the footrest slide some cm more until you can hear the click of the locking device of the footrest 4 Make sure that the footrest is firmly secured to the guides by bearing down and pressing on the longitudinal direction onwards and backwards 244 DR 800 Options an...

Page 245: ... the locks 2 Pull the footrest to draw it out from the guides in the opposite direction compared to the center of the table by keeping the knobs pressed at least until they are beyond the external edge of the tabletop guides DR 800 Options and accessories 245 0392C EN 20210309 1049 ...

Page 246: ...e the table in the horizontal position 2 Loosen the knob of the hand grip as much as it is necessary by turning it counter clockwise 3 Insert the hand grip support on the tabletop guide 4 Place the hand grip in the required position 5 Fasten the hand grip by turning the knob thoroughly clockwise 2 1 1 Inserting the hand grip 2 Fastening the hand grip 246 DR 800 Options and accessories 0392C EN 202...

Page 247: ...e shoulder rests it will be necessary to fix the hadgrips if they are not already mounted on the guides 1 Place the table in the horizontal position 2 Loosen the knobs of the shoulder rest 3 Insert the shoulder rest on the tabletop guide 4 Place the shoulder rest in the required position 5 Fasten the shoulder rest by turning the knob thoroughly clockwise 2 1 2 1 1 Inserting the shoulder rest 2 Fas...

Page 248: ...r to fix the support onto the guide in the requested position 3 Insert the other mechanical support in the opposite guide symmetrically to the first using the same precautions and locking it in the desired position 1 2 1 2 4 3 5 1 Inserting the mechanical support 2 Fastening the locking knob 4 Raise the pawl of the support containing the compression belt so that it is free to unwind 5 Make the fre...

Page 249: ...1 Raising the pawl 2 Free end of the belt 3 Bar at the opposite end 4 Cleft of the take up roller 5 Turning the knob of the take up roller DR 800 Options and accessories 249 0392C EN 20210309 1049 ...

Page 250: ... 2 Loosen the knob of the lower limbs support 3 Insert the lower limbs support on the tabletop guide 4 Fasten the lower limbs support by turning the knob thoroughly clockwise 2 1 1 Inserting the lower limbs support 2 Fastening the lower limbs support Mounting of ankle support and head contention device are done in the same manner as for the lower limbs support 250 DR 800 Options and accessories 03...

Page 251: ...ort a maximum weight of 30 kg WARNING Do not hang from the lateral arm rest Do not use the lateral arm rest as a holder for objects such as paper rolls or leaded aprons 1 2 3 1 Clamp for side rails of the radioagraphic table 2 Knob for loosening or fastening the rotation of the lateral arm rest 3 Knob for loosening or fastening the clamp on the side rails of the radiographic table Figure 171 Later...

Page 252: ...lateral arm rest The lateral arm rest can be rotated to adjust it to the preferred height a Loosen the round knob while supporting the lateral arm rest with your other hand b Place the lateral arm rest in the required position c Fix the position by turning the round knob thoroughly clockwise WARNING This adjustment should always be made with one hand acting on the knob and the other hand holding t...

Page 253: ...cky position tilting rotating that the lateral arm rest does not collide with the column of the wall stand Figure 172 Knob for locking the lateral arm rest To mount and position the lateral arm rest 1 Insert the lateral arm rest in the mounting slot at the top of the bucky frame 2 Turn the knob clockwise to lock the lateral arm rest DR 800 Options and accessories 253 0392C EN 20210309 1049 ...

Page 254: ...table in the horizontal position 2 Mount the detector holder on the table a Loosen the knob on the mount of the lateral detector holder b Insert the detector holder on the tabletop guide WARNING The detector holder must only be mounted such that the detector holder is positioned above the surface of the table c Fasten the detector holder by turning the knob thoroughly clockwise 3 Adjust the height...

Page 255: ...ector holder a Loosen the two knobs to release the two adjustable clamps b Widen the clamps enough to fit the detector size WARNING Hold the clamps on the outside to prevent crushing your hands c Insert the detector and close the clamps making sure it is properly secured and supported d Fasten the clamps by turning the two knobs thoroughly clockwise Related Links Mounting the lower limbs support a...

Page 256: ...the patient tabletop 2 1 Figure 173 Joystick inserted on the edge of the tabletop 2 Position the joystick at the required position on the length of the tabletop 3 Turn the knob clockwise to fasten it to the patient tabletop 4 Connect the plug to the connector at the foot of the radiographic table 256 DR 800 Options and accessories 0392C EN 20210309 1049 ...

Page 257: ...lcro strips on the cushion foot end 3 Press firmly the Velcro strips on the tabletop head end to fasten onto the Velcro strips on the cushion head end Figure 174 Attaching the cushion WARNING In order to ensure proper hygienic conditions the medical staff must make sure the parts of the device that come into contact with the patient such as examination tabletop tabletop and stretcher cushions are ...

Page 258: ...e perfectly aligned 3 Position the support on the tabletop and attach the two ends to the tube supports of the knobs 1 3 1 2 3 2 1 1 Special hand grips 2 Support for the contention structure 3 Hooks for attaching the support to the hand grips 4 Tighten the belts on both sides keeping the support in the middle and tighten the safety buckles 1 3 1 2 3 2 1 1 Belt 2 Safety buckle 5 Ensure it is firmly...

Page 259: ...at the cable has enough friction to prevent it from coming out spontaneously otherwise the metal cable must be replaced WARNING 16kg is the maximum weight allowed on the paediatric cradle for small patients Using the paediatric cradle in vertical position 1 Place the tabletop in the horizontal position 2 Mount the paediatric cradle 3 Mount the patient footrest as a seat 4 Make sure that the base o...

Page 260: ...1 Footrest 2 Base of the cradle 5 Place the tabletop in vertical position 260 DR 800 Options and accessories 0392C EN 20210309 1049 ...

Page 261: ...owered by three standard batteries It is the operator s responsibility to check the state of charge of the batteries and replace them if necessary Figure 175 Wireless double pedal Batteries 3 x LR14 1 5 V DC 7500 8000 mAh Table 47 Status indicator lights on the wireless double pedal Symbol Status Description Connection status Off and battery status off Footswitch in sleep mode Off and battery stat...

Page 262: ... V Blinking orange slowly Battery capacity 20 3 3 3 0 V Blinking orange fast Battery level below limit value 5 3 0 V deep sleep mode WARNING Store the wireless pedal when not in use in a safe area that excludes the risk of accidental activation Do not take the device out of the examination room Related Links Exposure Controls on page 28 262 DR 800 Options and accessories 0392C EN 20210309 1049 ...

Page 263: ...hing is not optimal Stitching fails Only part of the full leg full spine image is displayed Full Leg Full Spine examination is interrupted Wireless console with position controls cannot restore connection Problems with the ceiling suspension Error messages on the ceiling suspension DR 800 Problem solving 263 0392C EN 20210309 1049 ...

Page 264: ...ontrol of the compressor Brief Solu tion 1 Fetch the wrench The wrench is attached to the cable support turret Figure 176 Cable support turret with wrench attached to it 2 Turn the bolt on the rear side of the compressor carriage coun terclockwise seen from the rear The compressor moves upward as the bolt is turned Figure 177 Rear view of the compressor carriage 264 DR 800 Problem solving 0392C EN...

Page 265: ...ector must be recalibrated Cause A DR Detector must be recalibrated at regular interval Brief Solution Follow the instructions in the DR System Key User Man ual to calibrate the DR Detector DX D DR Detector Calibration Key User Manual document 0134 DR 800 Problem solving 265 0392C EN 20210309 1049 ...

Page 266: ... 800 sync cabinet is down Cause A shutdown of the NX workstation triggers the shutdown of the DR 800 sync cabinet Brief Solution Turn the power switch on the DR 800 sync cabinet off and on again 266 DR 800 Problem solving 0392C EN 20210309 1049 ...

Page 267: ...l in formation in the image is suspicious because of possible movement of the patient during the examination this icon is displayed in the Stitching pane Cause The patient has changed position during the examina tion Brief Solution Manually adjust the DR Full Leg Full Spine image If the partial images cannot be manually adjusted click Cancel in the Stitching pane No DR Full Leg Full Spine image is...

Page 268: ...ched because the grid markers in the stitching grid are not visible in the parti al images Cause The stiching grid was not used for the examination Brief Solution Click Cancel in the Stitching pane No DR Full Leg Full Spine image is available 268 DR 800 Problem solving 0392C EN 20210309 1049 ...

Page 269: ...ge Applying manual collimation To prevent this problem use the ROI detection exposure techniques as described in Working with collimation Solution Steps To turn the black borders and cropping on or off 1 Select an image in the Image Overview pane 2 From the first drop down list in the Image Process ing tool section select the following icon To draw a rectangular collimation area 1 Select an image ...

Page 270: ...rst drop down list in the Image Processing tool section select the icon below 3 Click to define the starting point 4 Move the pointer and click to define each corner 5 Click the starting point to close the polygon 6 To display the collimation area select the icon below 270 DR 800 Problem solving 0392C EN 20210309 1049 ...

Page 271: ...n is released by the user before the complete examination has finished Brief Sol ution If you release the exposure button by accident you can press it again to continue the examination If the exposure button remains released for more than 2 seconds the examination is aborted You can use the available partial im ages to create a DR Full Leg Full Spine image DR 800 Problem solving 271 0392C EN 20210...

Page 272: ...ss console is moved within the bluetooth commmunication range of the radiographic table again The indicator light for the status of the wireless connection keeps blinking indicating that the connection is not restored Cause Failure to setup the bluetooth connection Brief Sol ution Stop the wireless console using the power button at the foot of the console and start it again 272 DR 800 Problem solv...

Page 273: ...ware has failed or is not connec ted For system with automatic con trols only manual functions are allowed Contact technical serv ice for support to correct the hardware fault This function is ena bled only for compati ble Tubestands Verify that it is a supported op tion For version CS3101 it is not an option DR 800 Problem solving 273 0392C EN 20210309 1049 ...

Page 274: ...on unit con trolbox has stopped working Stop use of the system and call technical service This may require a PCB replace ment SHORT CIRC 567 Brake short circuit to ceiling suspension Stop use of the system and call technical service A hardware device has failed The lateral SID is un known The ceiling suspension must be set into one of three programmed positions to display the lateral SID with digi...

Page 275: ...ental protection System Documentation Training Performance Technical Data Remarks for HF emission and immunity radiographic table Remarks for HF emission and immunity radiographic wall stand Remarks for HF emission and immunity radiographic wall stand bucky with moving grid DR 800 Product Information 275 0392C EN 20210309 1049 ...

Page 276: ...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 X Ray Safety Electromagnetic Compatibility Earthquake resistance 276 DR 800 Product Informatio...

Page 277: ...he WLAN module incorporated in the device in the following Member States Belgium BE Bulgaria BG Czech Republic CZ Denmark DK Germany DE Estonia EE Ireland IE Greece EL Spain ES France FR Croatia HR Italy IT Cyprus CY Latvia LV Lithuania LT Luxembourg LU Hungary HU Malta MT Netherlands NL Austria AT Poland PL Portugal PT Romania RO Slovenia SI Slovakia SK Finland FI Sweden SE and United Kingdom UK ...

Page 278: ...ticular 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 type AP or APG Th...

Page 279: ... protected against dripping water Applied Parts Applied Parts refer to parts of the medical electrical equipment that in normal use necessarily comes into physical contact with the patient for the equipment to perform its function The tabletop is the applied part of this system DR 800 Product Information 279 0392C EN 20210309 1049 ...

Page 280: ...ents by the Customer Agfa reserves the right to revise these ISP Operating Environment Requirements and to make changes to them at any time Possible revisions of the ISP Operating Environment Requirements will only be available in an electronic form on request via our website by using the user documentation request form http www agfahealthcare com global en library index jsp The information presen...

Page 281: ...al devices is limited only to authorized individuals and that physical theft of the device is prohibited An incident response plan detailing responsibilities and how to react and recover from incidents shall be in place Staff involved in the incident response plan shall be trained to respond appropriately and effectively A formal user provisioning and de provisioning process shall be implemented t...

Page 282: ...n countries with identical regulatory regimes Regulation 2017 745 EU on Medical Devices 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 ...

Page 283: ...organization and or dealer The recycling of materials will help to conserve natural resources c2 caution 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 Battery notice The battery symbol on the products and or accompanying docu...

Page 284: ... every function 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 284 DR 800 Product Information 0392C EN ...

Page 285: ...ser must make sure that training is received in accordance with local laws or regulations that have the force of law Your local Agfa representative can provide further information on training The user must note the following information in the system documentation System overview Radiation protection Safety directions Application examples DR 800 Product Information 285 0392C EN 20210309 1049 ...

Page 286: ... dose or no anti scatter grid to reduce exposure to a pediatric patient The resulting image quality is generally suboptimal for most skeletal studies when compared to normal computed radiographic techniques The composite stitched image is created to allow accurate softcopy measurement of distances and angles by qualified medical practitioners WARNING Any incidental clinical findings that are seen ...

Page 287: ...llimator Technical Data Radiographic wall stand Ceiling suspension Workstation PC technical data DR 800 FLFS overlay Equivalent filtration Dosimetric and quantitative information IEC 60601 2 54 IEC 60601 1 3 Mains supply Technical data of options and accessories DR 800 Product Information 287 0392C EN 20210309 1049 ...

Page 288: ...ut power 50 kW 400 480 V 10 3 50 60 Hz 135 110 A Output power 65 kW 400 480 V 10 3 50 60 Hz 168 140 A Output power 80 kW Positioner cabinet type 6010 50 220 230 240 V 50 60 Hz 20 A Output power 5 kW DR 800 sync cabinet type 6010 300 100 240 V 50 60 Hz 3 A Weight Positioning console and ex posure controls base plate 0 15 m2 80 kg Generator cabinet base plate 0 21 m2 150 kg 288 DR 800 Product Inform...

Page 289: ... condensing between 30 and 75 relative humidity Atmospheric pressure between 80 and 101 5 kPa For overall system environmental conditions the environmental conditions of the DR Detector or image plate should be taken into account Refer to the related User Manual for environmental conditions for the DR Detector or image plate For overall system environmental conditions the environmental conditions ...

Page 290: ...y 55 55 or 80 80 or 100 20 long tabletop optionally 47 5 47 5 or 80 15 or 80 80 short tabletop Longitudinal movement of X ray tube and DR detector 161 cm system with fixed tabletop and remov able grid 154 cm system with fixed tabletop and auto matic grid 145 cm system with moving tabletop and re movable grid 138 cm system with moving tabletop and au tomatic grid Transversal tabletop move ment 35 c...

Page 291: ...avel range 55 cm Maximum load on the ta ble 265 kg up to 320 kg on condition that the radiograph ic table is in the lowest position and not moved while it is under load Weight Radiographic table base plate 1 00 m2 950 984 kg Tabletop X ray absorption 0 5 mm Al eq DR 800 Product Information 291 0392C EN 20210309 1049 ...

Page 292: ... according to Agfa instruc tions minimum 10 years or 100 Gy Pixel Matrix Pixel size 148 µm Pixel matrix 2840 x 2874 Active area size 43 x 43 cm Topics Fixed DR Detector environmental conditions Dynamic imaging modes Fixed DR Detector environmental conditions Pixium RF4343 FL Environmental Conditions during normal operation Temperature Humidity Atmospheric pressure Refer to environmental conditions...

Page 293: ...me rate 15 7 5 5 2 5 1 Binning 3x3 3x3 3x3 3x3 3x3 20 cm x 20 cm sensor area Frame rate 15 7 5 5 2 5 1 Binning 2x2 2x2 2x2 2x2 2x2 15 cm x 15 cm sensor area Frame rate 7 5 2 5 1 Binning 1x1 1x1 1x1 Table 56 Continuous fluoroscopy 43 cm x 43 cm sensor area Frame rate 15 7 5 5 Binning 3x3 3x3 3x3 28 cm x 28 cm sensor area Frame rate 30 15 7 5 5 Binning 3x3 3x3 3x3 3x3 20 cm x 20 cm sensor area Frame...

Page 294: ...2x2 Table 57 Rapid sequence 43 cm x 43 cm sensor area Frame rate 5 2 5 1 Binning 2x2 2x2 1x1 30 cm x 30 cm sensor area Frame rate 10 5 2 5 1 Binning 2x2 2x2 2x2 2x2 294 DR 800 Product Information 0392C EN 20210309 1049 ...

Page 295: ...0 Manufacturer Agfa NV Septestraat 27 2640 Mortsel Belgium Electrical connection Wireless console 100 240 V 50 60 Hz 240 100 mA Power 24 VA Battery life in standby mode 24 hours DR 800 Product Information 295 0392C EN 20210309 1049 ...

Page 296: ...ion leak age 150 kVp 4 mA Inherent filtration 2 mm Aluminum equivalent Added filtration 0mm Al 2mm Al 1mm Al 0 1mm Cu 3 8 mm Aluminum equivalent 1mm Al 0 2mm Cu 6 5 mm Aluminum equivalent Maximum field Size at SID of 100 cm 48 cm x 48 cm Dimensions 19 6 cm x 26 8 cm x 20 7 cm WxDxH Weight 9 5 kg 296 DR 800 Product Information 0392C EN 20210309 1049 ...

Page 297: ...ertical movement range 157 cm vertical bucky 140 cm tilting bucky Tilting angle range tilting bucky between 20 and 90 Tilting angle detents tilting bucky 20 0 90 Movement controls Manual movement balanced by counter weights and with mechanical brakes Weight 130 kg vertical bucky 190 kg tilting bucky Wall stand X ray absorption 0 6 mm Al eq Anti scatter grids 180 cm 71 inch 79 lines cm 200 lines in...

Page 298: ... with permanent magnet Telescopic column vertical range 150 cm Movement controls Manual movement spring loaded and with electrical brakes with permanent magnet X ray tube rotation vertical ax is between 135 and 200 X ray tube angle horizontal ax is between 190 and 150 Movement controls Manual movement with electrical brakes with permanent magnet Collimator of the ceiling suspension Technical Data ...

Page 299: ...ent Added filtration 0mm Al 2mm Al 1mm Al 0 1mm Cu 3 8 mm Aluminum equivalent 1mm Al 0 2mm Cu 6 5 mm Aluminum equivalent Maximum field Size at SID of 100 cm 48 cm x 48 cm Dimensions 19 6 cm x 26 8 cm x 20 7 cm WxDxH Weight 9 4 kg DR 800 Product Information 299 0392C EN 20210309 1049 ...

Page 300: ...r higher than Dual Intel Xeon E5 2637 v4 3 50 GHz minimum 8 physical cores of minimum 3 1 GHz Voltage 100 240 VAC 50 60 Hz Hard drive minimum requirement 4 x minimum 500 GB in RAID 1 0 con figuration RAM minimum size requirement 32GB minimum 2 4 GHz Standards IEC 60950 1 IEC 62368 1 NX software must only be used on PC models that have been tested and released by Agfa 300 DR 800 Product Information...

Page 301: ... FLFS overlay without the mounting unit 6 kg Weight of the mounting unit 3 5 kg X ray Absorption 0 1 mm Al Maximum patient weight 320 kg Environmental requirements storage Temperature 25 C to 55 C Relative humidity 10 to 95 Environmental requirements transport Temperature 25 C to 60 C Relative humidity Maximum 85 at 30 C DR 800 Product Information 301 0392C EN 20210309 1049 ...

Page 302: ...l Collimator inherent filtration 1 mm Al Additional filtration 0 3 mm Al 2 5 mm Al VARIAN housing inherent filtration 0 7 mm Al Collimator inherent filtration 1 mm Al Additional filtration 1 mm Al 2 7 mm Al DAP inherent filtration 0 2 mm Al 302 DR 800 Product Information 0392C EN 20210309 1049 ...

Page 303: ...A rectangular block with slides equal to or exceeding 25 cm 20 PMMA 1 cm thick and 50 cm wide plates have been used as representative of abdominal region Place the PHANTOM as close as possible to the X ray image receptor DOSIMETER with a measuring detector small enough to cover no more than 80 of the area of the X ray beam in the plane of measurement Measuring detector has to be positioned 20 cm f...

Page 304: ...0 Level 2 73 3 0 24 67 75 3 3 11 22 77 2 8 8 16 74 3 1 14 80 maximum field size Level 3 68 2 4 17 32 67 2 3 7 67 72 2 8 5 55 69 2 5 10 69 zoom 20x20 Level 3 73 3 0 37 00 79 3 8 18 13 85 4 2 13 44 81 4 0 23 68 ADDED FILTERS 0Al 1Al 0 1 Cu 1Al 0 2 Cu 2 Al PULSED RADIOSCOPY 4 frame sec Dose level kV mA Ak rate mGy min kV mA Ak rate mGy min kV mA Ak rate mGy min kV mA Ak rate mGy min maximum field siz...

Page 305: ...er extremities spine pelvis Values typical of abdomen and thorax examination The addition of a copper filter is typical of paediatric examination It is common knowledge that the ionization process can cause damages to cellular DNA See following information about deterministic effects on human body after localised and whole body irradiation by X ray data source ICRP International Commission on Radi...

Page 306: ...3 Epidermal necrosis 4 Skin atrophy with complications 25 10 12 1 Whole body Acute radiation sickness mild 1 0 306 DR 800 Product Information 0392C EN 20210309 1049 ...

Page 307: ... Hz Electrical current absorption 15 A Thermal dissipation 500 W Type of protection Class I Degree of protection Type B Degree of casing protection IPX0 Electromagnetic compatibility Equipment in compliance with EN 60601 1 2 standards Normally the power supply of the remote controlled table is picked up by a 16A delayed 400Vac nominal bipolar sectioning automatic switch placed in the mains supply ...

Page 308: ...ances for which it is designed Table 62 Power input requirements T1 VOLTAGE SUPPLY 230 VAC F1 FUSE TYPE 6 3 x 32 mm F1 FUSE RATING T 1 6 A VA 300 Located on the main electrical plate is power strip terminal ST2 This is provided for aftermarket connection to various collimation systems The circuit feeds 24 VAC and is able to power various collimation systems including lamps rated up to 150 watts Ve...

Page 309: ...r consumption of 185 VA By modifying the primary side of the T1 power transformer which is located on the main electrical plate it is possible to adapt the equipment to function with a tension of either 220 230 240VAC to better match the local electrical mains supply line If necessary reach the transformer and to make any changes See the electrical wire diagrams for specific connections The stand ...

Page 310: ...Verify that the connected auxiliary device power requirements are compatible with the output of this power supply unit 310 DR 800 Product Information 0392C EN 20210309 1049 ...

Page 311: ...2 Lower limbs support 6 49 290x210x450 each Ankle support 3 5 20 495x145x135 Head contention device 4 4 NA 830x390x207 Lateral arm rest on the radiographic table 2 9 30 628x362x70 Lateral cassette detector holder 4 5 7 5 485x262x255 closed Cushion for the tabletop 2 5 NA 1960x580x15 Paediatric cradle 7 16 1126x290x282 no handgrips Support for glass of bari um 0 5 0 5 237x180x345 DR 800 Product Inf...

Page 312: ...ents other than domestic those directly connec ted to the public low voltage power supply network that sup plies buildings used for domestic purposes Harmonic emissions in accordance with IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions in ac cordance with IEC 61000 3 3 Not applicable Annex B Guidance and manufacturer s declaration Electromagnetic immunity The system is intended...

Page 313: ... The quality of the voltage supplied should correspond to a typical commer cial or clinical envi ronment Impulse voltages surges in ac cordance with IEC 61000 4 5 0 5 1 kV differ ential mode 0 5 1 2 kV com mon mode IEC 60601 1 2 Test level The quality of the voltage supplied should correspond to that of a typical commercial or clini cal environment Conducted RF in acordance with IEC 61000 4 6 3 V ...

Page 314: ...EC 61000 4 8 30 A m IEC 60601 1 2 Test level Magnetic field at the network frequency should correspond to the typical values as they are in a com mercial and clinical environment REMARK Un is the alternating current in the network before the appli cation of the test level Immunity to RF wireless communication equipment ISM Band MHz Service Distance m Immunity test level V m 300 390 TETRA 400 0 3 2...

Page 315: ...ablishments other than do mestic and those directly con nected to the public low voltage power supply network that sup plies buildings used for domestic purposes Harmonic emissions in accordance with IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions in ac cordance with IEC 61000 3 3 Not applicable Annex B Guidance and manufacturer s declaration Electromagnetic immunity The system...

Page 316: ...wer supply iput lines in ac cordance with IEC 61000 4 11 0 Un for 0 5 cy cle 40 Un for 5 cy cles 70 Un for 25 cy cles 0 Un for 5 s IEC 60601 1 2 Test level Mains power qual ity should be that of a typical com mercial or hospital environment If the user of the sys tem requires con tinued operation during power mains interrup tions it is recom mended that the system be pow ered from an unin terrupti...

Page 317: ... distance d 1 2 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 2 3 800 MHz to 2 5 GHz where P is the maximum out put power rating of the trans mitter in watts W according to the transmitter manufac turer and d is the recommen ded separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each f...

Page 318: ...ut power not listed above the rec ommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the max imum output power rating of the transmitter in watts W according to the transmitter manufacturer REMARK 1 At 80MHz and 800MHz the separation distance for the higher frequency range applies REMARK 2 These Guidelines may no...

Page 319: ...e in all establishments other than do mestic and those directly con nected to the public low voltage power supply network that sup plies buildings used for domestic purposes Harmonic emissions in accordance with IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions in ac cordance with IEC 61000 3 3 Not applicable Annex B Guidance and manufacturer s declaration Electromagnetic immunit...

Page 320: ...ordance with IEC 61000 4 11 5 UT for 0 5 cycle 95 voltage dip in UT 40 UT for 5 cy cles 60 voltage dip in UT 70 UT for 25 cy cles 30 voltage dip in UT 5 UT for 5 s IEC 60601 1 2 Test level Mains power qual ity should be that of a typical com mercial or hospi tal environment If the user of the system requires continued opera tion during power mains interrup tions it is recom mended that the system ...

Page 321: ...separation distance d 1 2 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 2 3 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W ac cording to the transmitter manufacturer and d is the recommended separation dis tance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level i...

Page 322: ...ut power not listed above the rec ommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the max imum output power rating of the transmitter in watts W according to the transmitter manufacturer REMARK 1 At 80MHz and 800MHz the separation distance for the higher frequency range applies REMARK 2 These Guidelines may no...

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