AGFA DR 600 - Compliance

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Compliance

The system is compliant with specific directives and standards.

Topics:

• General

• Safety

• Electromagnetic Compatibility

• X-Ray Safety

• X-Ray Accuracy

• Environmental Compliance

• Biocompatibility

• Usability

• Earthquake resistance

268 | DR 600 | Product Information

3261K EN 20210708 0808

Main Page

Table of Contents2
Legal Notice9
Introduction to this Manual10
Scope of this Manual11
About the Safety Notices in this Document12
Disclaimer13
Introduction14
Intended Use15
Intended User16
Configuration17
Applied Parts19
Options and Accessories20
Operation Controls21
Radiographic Table22
Radiographic Wall Stand23
Control Panel of the X-Ray Tube Head Unit24
Remote Control for the X-Ray Tube Head Unit25
Tube Head Display27
MUSICA Acquisition Workstation (NX)28
Software Console29
Extra Monitor in the Examination Room30
DR Detector Switch31
Automatic Positioning Button32
X-Ray Generator Mini Console (Spellman)33
X-Ray Generator Mini Console (EMD)34
Exposure Button35
Automatic Collimator36
Collimator Camera37
Portable DR Detector39
Emergency Stop Button40
Emergency Shutdown Power Switch42
Power off Behaviour43
Installation44
HF-Emission and Immunity44
Radiation Protection45
Monitoring of Personnel46
Protected Area and Significant Zones of Occupancy47
Skin Dose Levels According to IEC 60601-2-5454
Ongoing Quality Control in Digital Radiography55
Labels56
Warning Labels on the Radiographic Table58
Warning Labels on the Radiographic Wall Stand58
Type Label59
DR Detector Identification Label60
Additional Labeling of the Tube Head Unit61
Additional Labeling of the Radiographic Table62
Additional Labeling of the Radiographic Wall Stand63
Labeling of the Bucky64
Labeling of the Automatic Exposure Control (AEC)66
Labeling of the DR Generator Sync Box67
Labeling of the X-Ray Generator (Spellman)68
Labeling of the X-Ray Generator (EMD)70
Labeling of the Remote Control71
Labeling of Components with Earthquake Resistance72
About the Software73
Cleaning and Disinfecting74
Cleaning75
Disinfecting77
Disinfecting Safety Directions78
Approved Disinfectants79
Maintenance80
Maintenance of the Radiographic Table, Radiographic Wall Stand and X-Ray Tube Head Unit80
Safety Directions84
General Safety Directions85
Safety Directions for the X-Ray System87
Safety Directions for the Radiographic Table89
Safety Directions for the Ceiling Suspension90
Basic Workflow91
Starting the System92
Automated Workflow for Warming-Up of X-Ray Tube92
Performing an Exposure Using the DR Detector94
Step 1: Retrieve the Patient Info95
Step 2: Select the Exposure96
Step 3: Prepare the Exposure97
Step 4: Check the Exposure Settings98
Step 5: Execute the Exposure99
Step 6: Perform a Quality Control100
Performing a Digital Tomosynthesis Examination101
Step 1: Prepare the Examination102
Step 2: Position the X-Ray System and the Patient105
Step 3: Check the Exposure Settings106
Step 4: Execute the Digital Tomosynthesis Exposure Sequence107
Step 5: Perform a Quality Control110
Performing an Exposure Using a CR Cassette111
Step 1: Retrieve the Patient Info112
Step 2: Select the Exposure113
Step 3: Prepare the Exposure114
Step 4: Check the Exposure Settings115
Step 5: Execute the Exposure116
Step 6: Repeat Steps 2 to 5 for the Next Subexposures117
Step 7: Digitize the Image118
Step 8: Perform a Quality Control119
Performing a Full Leg Full Spine Examination120
Stopping the System121
Guidelines for Pediatric Applications122
Software Console and Tube Head Display124
Action Buttons126
Planned Exposures127
Live Camera Image on the Tube Head Display128
Previewing the Position of the Collimation Area and the AEC Fields129
Prerequisites for Previewing Collimation and AEC Fields130
Non-Perpendicular Angles131
Image Preview Window132
Main Screen of the Tube Head Display133
Device Status Frame134
Ready for Exposure Status135
Modality Position136
DR Detector Switch137
Filter Status138
Grid Status139
Radiation Status140
Unknown Status141
Generator Controls142
One Point, Two Point and Three Point Working Modes143
Radiographic Parameters145
Focal Spot Indicator146
Automatic Exposure Control (AEC)147
X-Ray Tube Load152
DAP Value153
Heat Units154
DR Detector and X-Ray Tube Head Alignment155
X-Ray Modality Controls157
Positioning Controls158
Positioning Screen of the Tube Head Display159
Actual and Target Position Parameters160
Collimator Parameters161
Automatic Positions162
Tracking the Radiographic Table167
Tracking the Radiographic Wall Stand169
Automatic Centering171
Controls for Digital Tomosynthesis173
Radiographic Parameters for Digital Tomosynthesis174
Position Parameters for Digital Tomosynthesis175
Reconstruction Parameters176
Adjusting the Reconstruction Settings for Digital Tomosynthesis177
System Messages178
Ceiling Suspension180
Control Panel of the Tube Head Unit181
Positioning the X-Ray Tube182
Stop Positions184
Collision Indicator185
Positioning the X-Ray Tube Using the Remote Control186
Automatic Collimator189
Semi-Automatic Collimation Mode191
Manual Collimation Mode192
Collimation Area for Free Exposures193
Dose Area Product Meter (DAP)194
Effect of SID on Patient Dose195
Radiographic Table196
Positioning the Radiographic Table197
Positioning the Floating Tabletop198
Adjusting Height199
Collision Protection200
Positioning the Bucky201
Radiographic Table Accessories202
Mounting the Patient Hand Grips203
Mounting the Tabletop Hand Grips204
Foot Pedals at the Rear Side205
Mattress206
Lateral Cassette Holder207
Compression Belt208
Radiographic Wall Stand209
Positioning the Radiographic Wall Stand211
Radiographic Wall Stand Accessories213
Patient Hand Grips214
Mounting the Lateral Arm Rest215
Spacer216
Wall Stand Fixation Kit217
Bucky218
Bucky Configuration220
Rotating the Bucky221
Loading of the Bucky in the Radiographic Table222
Loading of the Bucky in the Radiographic Wall Stand223
Unloading of the Bucky in the Radiographic Table224
Unloading of the Bucky in the Radiographic Wall Stand225
Opening the Bucky Drawer Configured with an Earthquake Kit226
Automatic Cassette Size Sensing227
Bucky Types228
Cassette and Detector Formats230
Standard Cassette Formats231
DR Detector Formats and Orientation232
Orientation of DR 10S in the Bucky233
Orientation of DR 14S in the Bucky234
Orientation of DX-D 10C, DX-D 10G in the Bucky236
Using DX-D 45C, DX-D 45G, XD 10, XD⁺10 Only Outside the Bucky237
Grids238
Anti-Scatter Grids239
Grid Focal Distance Color Indication240
Grid Detection241
Storage Box for DR Detector and Grids242
Changing the Grid Configured with an Earthquake Kit243
Automatic Exposure Control (AEC)244
X-Ray Generator Mini Console245
Starting and Stopping the Generator246
X-Ray Tube Start-Up Modes247
X-Ray Generator Messages and Warning Signals (Spellman)248
X-Ray Generator Messages and Warning Signals (EMD)249
Exposure Parameters250
Radiographic Parameter Limits252
Exposure Termination254
Problem Solving255
Restoring Connection between Generator and NX after Generator Failure256
Automatic Collimation Always too Wide or too Narrow257
No Table Movement259
No Movement When Using Remote Control260
DR Detector Is Exceeding the Maximum Working Temperature261
DR Detector Must be Recalibrated262
Tube Head Display Shows Screen to Check Network Connection263
Radiographic Parameter Limits264
Product Information265
Compatibility266
Connectivity267
Compliance268
General269
Safety269
Electromagnetic Compatibility269
X-Ray Safety270
X-Ray Accuracy270
Environmental Compliance270
Biocompatibility270
Usability270
Earthquake Resistance270
Equipment Classification271
Patient Data Security272
Requirements on the Operating Environment272
Product Complaints274
Environmental Protection275
System Documentation277
Installing the Online Help277
Training279
Technical Data280
DR 600 Technical Data281
Generator Technical Data (Spellman)283
Generator Technical Data (EMD)284
Radiographic Table Technical Data285
Wall Stand Technical Data286
Ceiling Suspension Technical Data288
X-Ray Tube Technical Data289
Bucky Unit Technical Data291
Automatic Exposure Control (AEC) Technical Data293
Automatic Collimator Technical Data294
Dose Area Product Meter (IBA DAP) Technical Data295
Dose Area Product Meter (Vacutec DAP) Technical Data296
Fixed DR Detector297
Portable DR Detector Technical Data301
NX Workstation Technical Data302
DR Generator Sync Box Technical Data303
Remarks for HF-Emission and Immunity304
Immunity to RF Wireless Communication Equipment309
Precautions on EMC310
Cables, Transducers and Accessories311

AGFA DR 600 - Compliance

Table of Contents

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