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Operator´s Manual

1000-095-071-EN Rev. 1.1

OMNERA®

2020-09-14

Page 147

5.1.1.2 2) Warning

A warning message will appear in a Warning information bar (lower part of the display), when
the handling of the System justifies that.

The Warning information bar will be cleared if/when a new warning is displayed, or after time.

The latest sent warning is shown.

110

250

Density

post mAs

mAs

AEC

DoB 1977-03-06
ID 987-65-4320

Hand AP

Age 36 Sex F
Acc No 987-65-4320

Jane Doe

SID

Fault message: Movement stopped, Button

Fig. 5-5 Warning information bar, Table

250

Density

post mAs

mAs

AEC

110

DFD

Jane Doe

ID 987-65-4320

Knee PA

Warning - Movement stopped, Button

Fig. 5-6 Warning information bar, Wall stand

Error Handling

Fault Handling

Summary of Contents for Omnera 500A

Page 1: ...Technical Publication Operator s Manual 1000 095 071 EN Rev 1 1 ...

Page 2: ...any form or by any means electronic mechanical magnetic optical chemical manual or otherwise without the prior written permission of Canon Medical Systems Note Photos and drawings used in this guide may be slightly different from the actual product Dispose of electronic equipment in accordance with local state and federal regulations THIS DOCUMENT CONTAINS PROPRIETARY INFORMATION AND SUCH INFORMAT...

Page 3: ...Revision history Chapter Pages Rev Date New Release 1 1 2020 09 ...

Page 4: ......

Page 5: ...Installation and repair 18 2 6 Safety and Warning Symbols 19 2 7 Safety and Warning Labels on the Equipment 20 2 8 Applied Parts 21 2 9 Emergency stop 22 2 10 Radiation and X ray tube 23 2 10 1 Radiation protection 24 2 11 Mechanical safety 29 2 11 1 General 29 2 11 2 Overhead tube crane 30 2 11 3 Cabinet 32 2 11 4 Table 33 2 11 5 Wall stand 39 2 12 Safety functions 41 2 12 1 System 41 2 13 Safety...

Page 6: ...tion 92 3 7 6 Table Hand Control 92 3 7 7 Moving Table Top 94 3 7 8 Vertical Travel Safety option 94 3 7 9 Attach Remove Accessories 95 3 7 10 Motorized Imaging Unit Movement 95 3 8 Wall stand Control Elements 97 3 8 1 Wall stand Controls 97 4 Operating the System 101 4 1 General 101 4 1 1 Applied Parts 101 4 2 Turn on the system 102 4 3 Turn off the system 104 4 4 Perform examination 106 4 4 1 Se...

Page 7: ...2 3 Remove detector 142 4 12 4 Exchange grid 143 5 Error Handling 145 5 1 Fault Handling 145 5 1 1 Notifications 145 5 2 Diagnostic 149 6 Cleaning 151 6 1 General 151 6 2 Collimator 152 6 3 Wall stand Table OTC and X ray Tube 153 7 Function and safety checks 155 7 1 Monthly Checks 155 7 1 1 General 155 7 1 2 OTC 155 7 1 3 Table 155 7 1 4 Wall stand 155 8 Technical specification 157 8 1 Electrical ...

Page 8: ...ght 163 8 6 3 Speed 163 9 Waste Disposal 165 10 Accessories 167 10 1 General 167 10 1 1 Table 167 10 1 2 Wallstand 168 10 1 3 Detector 168 10 1 4 Grid 168 11 Appendix A 169 11 1 Glossary 169 12 Appendix B 173 12 1 Monthly Checklist 173 12 1 1 OTC 173 12 1 2 Remark 176 12 2 Annual Checks 177 OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page iv 2020 09 14 ...

Page 9: ...warning label texts are shown in italic style in this manual All references are shown in italic style in this manual 1 1 3 Document producer This document has been produced by Arcoma AB Annavägen 1 S 352 46 VÄXJÖ Sweden www arcoma se 1 1 4 Copyright 2020 Arcoma Corporation all rights reserved The reproduction transmission or use of this document or its content is not permitted without express writ...

Page 10: ...al Page 2 2020 09 14 Note All texts labelled with NOTE contain additional information regarding the work step and is provided for a better understanding or as a warning about unnecessary and avoidable difficulties Introduction Document information ...

Page 11: ... Rev 1 1 OMNERA 2020 09 14 Page 3 1 2 Identification Labels The figure shows the location of the identification labels on the equipment 1000 1 2 3 3 4 4 5 7 6 5 10 3 11 15 16 12 13 14 4007 01 Fig 1 1 Introduction Identification Labels ...

Page 12: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 4 2020 09 14 1 10 2 11 3 12 4 13 5 14 Introduction Identification Labels ...

Page 13: ...Operator s Manual 1000 095 071 EN Rev 1 1 OMNERA 2020 09 14 Page 5 6 15 4041 1000 4102 OMNERA 500A 7 16 1000 Introduction Identification Labels ...

Page 14: ...nded Use The system is a stationary X ray system intended for obtaining radiographic images of vari ous portions of the human body in a clinical environment The system is not intended for mammography 1 3 3 Configuration The basic system consists of system Cabinet including generator Image acquisition sys tem Flat panel detectors and Overhead tube crane The basic system can be equipped with one of ...

Page 15: ...ev 1 1 OMNERA 2020 09 14 Page 7 1 3 4 System Overview 1 5 3 2 3 6 4 4008 01 Fig 1 2 System Overview 1 Overhead tube crane OTC 2 Table 3 Detector holder 4 Wall stand 5 System cabinet 6 Computer and monitor Introduction System Description ...

Page 16: ... 2020 09 14 1 3 5 Overhead Tube Crane overview Z Y X 0 1 2 4 7 3 6 8 5 4072 Fig 1 3 Overhead Tube Crane OTC 1 Ceiling rail Y 2 Traverse rail X 3 Ceiling wagon 4 Column Z 5 X ray tube 6 Manoeuvre handle 7 Collimator 8 Display Introduction System Description ...

Page 17: ...Fig 1 4 Table overview 1 Foot plate 2 Column 3 Table top 4 Table hand control X Y Z Ceiling tube pendulum movement 5 Detector holder 6 Brake release for detector holder 7 XY foot control strip type Option 8 Foot control table top X Y Z Option 9 Collimator hand control option 10 Head end 11 Foot end Introduction System Description ...

Page 18: ...ual Page 10 2020 09 14 1 3 7 Wall stand Overview Z T 2 1 5 3 4 2004 06 Fig 1 5 Wall stand overview T Tilt 1 Lateral armrest 2 Detector holder 3 Column 4 Foot plate 5 Hand control Collimator and movement adjustments Introduction System Description ...

Page 19: ...ts in IEC 60601 1 shall be kept outside the patient environment i e at least 1 5 m from the patient support Any person who connects external equipment to signal input signal output or other connec tors has formed a system and is therefore responsible for the system to comply with the requirements If in doubt contact qualified medical technician or your local representative If external equipment is...

Page 20: ... must not be removed or modified Any modification or removal will im mediately impair the safety WARNING All motorized movements shall be supervised by trained personnel WARNING Do not use non medical electrical devices in the X ray room CAUTION Do not use any flammable or explosive gases near the device CAUTION Before using this device read the manuals supplied with the devices in order to unders...

Page 21: ...up ply and other conditions are optimized for this device If you want to change any con dition contact your nearest service representative Otherwise the functions and performance of this device may be impaired CAUTION No objects shall be positioned within the working area If necessary they must be removable CAUTION Do not put liquids or foreign objects such as pins and clips into the equipment Oth...

Page 22: ...nual always make sure to read the Safety Chapter Warnings and Cautions carefully in both the System Manual and the sub manuals Note Radio interference standard Federal Communications Commission FCC Part 15 Class B applies to this equipment Note The equipment may only be used as intended Safety Precautions safety ...

Page 23: ...d make sure to lock it so it cannot be mistakenly turned on The equipment shall be serviced only by service technicians who are completely familiar with the System have read and understood Operation Manual and Installation and Service Manual know how to remove power to the unit in case of an emergency are trained in the use of equipment and procedures of this type Failure to follow the instruction...

Page 24: ... shall only be performed when no patient is present The equipment must be checked according to the 7 Function and safety checks to maintain reliability and serviceability and to ensure the safety of the patients the operator and third parties If national rules or regulations specify more frequent checks and or maintenance such regu lations must be observed 2 4 1 Operation Installation and Repair W...

Page 25: ...facturer components are not replaced by original spare parts in case of a malfunction the electrical installation of the room concerned does not meet the requirements or the corresponding national regulations the product is not used in accordance with the operating instructions CAUTION Only service technicians are allowed to open the covers CAUTION When installing this equipment in a different loc...

Page 26: ...additions to the product must be made in accordance with the legal regu lations and generally accepted engineering standards The manufacturer cannot assume responsibility for the safety features and for the reliability and performance of the equipment if installation of equipment expansions or modification are not approved by the manufacturer installation of equipment expansions or modification ar...

Page 27: ...Protective earth terminal Earth terminal N Connection point for the neutral conductor on permanently installed equipment Squeezing hazard This symbol indicates compliance of the equipment with Directive 93 42 EEC Separate collection for electrical and electronic equipment Manufacturer Manufacture date producer To indicate the emission or the imminent emission of X radiation STOP Marking on the eme...

Page 28: ...ety and Warning Labels on the Equipment The figure shows the location of the safety and warning labels 4087 Max 300 kg Max 25 kg 25 kg 55 lbs Max 25 kg 25 kg 55 lbs 300 kg 661 lbs Fig 2 1 Locations of safety and warning labels Safety Safety and Warning Labels on the Equipment ...

Page 29: ...Operator s Manual 1000 095 071 EN Rev 1 1 OMNERA 2020 09 14 Page 21 2 8 Applied Parts Applied parts are intended for the patient to touch 4087 02 Fig 2 2 Applied parts System Safety Applied Parts ...

Page 30: ... movements The emergency stop is also connected to the generator The emergency stop prevents a new exposure and terminates an ongoing exposure A system message is displayed in OTC display when the button is activated To reset the emergency stop position turn the emergency stop button clockwise The button is released and the system is ready for use again When the emergency stop is activated it is p...

Page 31: ...X ray tube may be up to 85 C the collimator will not reach 60 C WARNING Verify that correct collimator filter is used during exposure CAUTION To minimize the X ray dose keep the distance between the focal spot and patient as large as possible The beam size should be as small as possible Note Audio and visual communication must be possible between the operator and the patient when exposure is perfo...

Page 32: ...ose limit regulations Exposure parameters time mA should be set as low as possible with an acceptable im age noise level Set focus to skin distance as large as possible Always collimate the exposure field to the area of interest This will both decrease the dose level and improve the image quality less scattered radiation If possible necessary use protective shielding 2 10 1 2 Protection against se...

Page 33: ... increases the scattered radiation slightly The dia gram also shows that the best way to minimize the effect of the scattered radiation is an in creased distance to the patient and by using a lead apron Central beam exposure parameters used KVP 70 100 120 kV Tube current 100 mA Exposure time 100 ms Field size 43x43 cm Film Focus distance 1 m Patient simulation 150 mm PMMA Filter 0 mm Central beam ...

Page 34: ... s Manual Page 26 2020 09 14 Fig 2 5 Zone of occupancy shows a top view of the table and the zone of occupancy the ar rows showing the direction of decreasing scatter radiation levels Fig 2 5 Zone of occupancy Safety Radiation and X ray tube ...

Page 35: ...igher kV increases the scattered radiation slightly The dia gram also shows that the best way to minimize the effect of the scattered radiation is with an increased distance to the patient and by using a lead apron Central beam exposure parameters KVP 70 100 120 kV Tube current 100 mA Exposure time 100 ms Field size 40x40 cm Film Focus distance 1 5 m Patient simulation 150 mm PMMA Filter 0 mm Cent...

Page 36: ...Residual radiation area Decreasing Decreasing Central beam S significant zone of occupancy S S Fig 2 7 Zone of occupancy 2 10 1 3 Protection against residual radiation The remaining part of the X ray beam after having passed the plane of the image reception area detector and detector holder can be significantly high Never stand behind the wall stand during an exposure see Fig 2 7 Zone of occupancy...

Page 37: ...hall be supervised by trained personnel WARNING Wheelchair patients shall always be placed outside the working area when operating any motorized movement Note Surrounding equipment are not subject of the collision warning 2 11 1 1 General It is the operator s duty before any movements are activated to ensure that any danger to the patient and or third person is prevented Safety Mechanical safety ...

Page 38: ...patient for support to avoid any risk of injury when handling the OTC WARNING Squeezing hazard can occur between column segments and beta rotational assembly interface WARNING Squeezing hazard can occur between the column and the plastic corner around the al pha movement WARNING Squeezing hazard can occur between support arm and high tension cable inlet to the tube Safety Mechanical safety ...

Page 39: ...Column Z 2 Cover 3 X ray tube 4 Column bottom plate Possible squeezing hazard areas and placement of warning label Squeezing hazard can occur between the column 1 and the column bottom plate 4 when the column is moving upward Z direction cover 2 and the column Z when the X ray tube is moving in beta β direction Safety Mechanical safety ...

Page 40: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 32 2020 09 14 2 11 3 Cabinet Placement of warning and safety label Max 25kg 3605 Fig 2 9 Cabinet mechanical safety Safety Mechanical safety ...

Page 41: ...he detector holder table top and the detector holder rail detector holder rail and the detector holder detector holder and the cover columns and the footplate cover and the column foot cover detector holder and vertical lift segment Possible squeezing hazard areas and placement of warning labels 3337 Fig 2 10 Squeeze hazard table Safety Mechanical safety ...

Page 42: ...e hospital bed and the table The hospital bed shall be placed in direct contact with and in the same height as the table The table top shall be locked WARNING Risk of squeezing hazards The patients shall always have their extremities placed over the table top Note Do not lean against the floating table top WARNING Wheelchair patients shall always be placed outside the working area when operating a...

Page 43: ...ient to the table The hospital bed shall always be placed in direct contact and in the same height as the table To reduce the lateral forces on the table the operator should be placed on the opposite longi tudinal side of the patient and the hospital bed The operator should drag the mattress with the patient from the hospital bed to the table Safety Mechanical safety ...

Page 44: ...g see Fig 2 12 Table top centered 002278_0072 MAX 200 kg 440 lb Fig 2 13 Table top outside table frame Table top positioned outside the table frame Maximum load of a patient lying on the table top 200 kg see Fig 2 13 Table top outside table frame Maximum load of at patient sitting on the table top 150 kg 002279 01 Fig 2 14 Maximum patient weight label The table frame is marked on the upper side wi...

Page 45: ...ide the working area or placed on the table when operating any motorized movement WARNING Risk of squeezing hazard All obstacles placed within the working area must be moveable for easy patient release CAUTION To avoid any injuries to patient user or damage to system peripherals should always be placed outside the working area Safety Mechanical safety ...

Page 46: ...re show the length of stroke in the X and Y direction The dimensions have some tolerances and can differ from the manufacturer Two column table X Y m m 0 0 6 m m 0 0 6 1 5 0 m m 1 5 0 m m 0 0 4 2 8 5 3 Fig 2 15 Table top stroke length 9 1 4 1 550 930 Fig 2 16 Working area underneath table The detector movement is up to 850 mm depending on detector type 850 mm Fig 2 17 Detector movement Safety Mech...

Page 47: ...5 2 Working area wall stand The wall stand working area is in front of the detector holder 3784 Fig 2 18 Working area wall stand 2 11 5 3 Standard version WARNING Risk of squeezing between the tilted image receptor holder and the floor Getting stuck in the detector holder slide opening causes squeezing hazard if the detector holder is moving downward Z direction Possible squeeze hazard areas and p...

Page 48: ...09 14 4011 Z 1 Max 25kg 55 lbs Max 10 kg 22 lbs Fig 2 19 Possible squeeze hazards 1 Slide opening of the detector holder 2 11 5 4 Motorized wall stand CAUTION Patients shall be outside the working area when operating any motorized movement Safety Mechanical safety ...

Page 49: ...ezoid shaped curve The movement is stopped when a collision or a faulty position transducer is detected A colli sion is detected if the control error is too large The control error is defined as the difference between the set point and the actual position The set point is given by the ramp generation and the actual position is given from the position transducer The maximum allowed differ ence is s...

Page 50: ...al position is not reached in time The position transducer has not moved although the drive unit has had an output voltage for a given time A detected collision makes the stand stop all movements and display an error message Quick abortion of an auto positioning When any of the buttons on the stand is pressed while the stand is moving toward its posi tion it has the same effect as when the servo b...

Page 51: ... re ceived or a node is removed it will be detected and measures will be taken A transmission error on the CAN bus will put the system in an ERROR state A missing watchdog message from a node on the internal bus will put the system in an ER ROR state A missing watchdog from a node will stop all motors The watchdog mechanism is also used for inhibiting uncommanded movements in case of software fail...

Page 52: ...g the guard to be active during movements the temperature deviation is inhibited A B B C D Fig 2 21 Collision detection A Zero force level B Hysteresis C Upper trig level D Lower trig level Table top crash guard The table top crash guard shall only be primarily used as a safety precaution for the system but will as well limit the risk of personal injury although the crash guard does not guarantee ...

Page 53: ...on This de celeration point is given by the current speed the rate of the deceleration and the desired final position of the ramp The dynamic calculation of the ramp makes it possible to change direction of an active ramp generation In this case the ramp will first decelerate using the deceleration value until zero speed is reached then the acceleration in the other direction will commence time sp...

Page 54: ...and The product is balanced with counterweights and whenever any item is removed from the wall stand it will become unbalanced If the brake is released when the wall stand is unbal anced the detector holder moves and can cause injury 4011 02 Fig 2 23 Wall stand Safety Safety functions ...

Page 55: ... passed the table top level on its way downwards the speed in creases to normal speed again 2 13 2 Two column table There is a squeezing risk when driving the table to a low position Within the safety zone the table moves at a low speed to increase the possibility for the user to react in case of a collision squeezing The safety zone appear 120 mm above the floor according to IEC 60601 1 The safet...

Page 56: ...vided by the manufacturer Such use could lead to increased electromagnetic emissions or decreased electro magnetic immunity of this equipment and result in improper operation WARNING Do not use portable RF communications equipment including peripherals such as antenna cables and external antennas closer than 30 cm 12 inches to any part of the system including cables specified by the manufacturer S...

Page 57: ... Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The system is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purpose For in formation purpose the system complies with IEC6...

Page 58: ...150 kHz to 500 kHz QP 100 20 average 90 500 kHz to 5 MHz QP 86 20 aver age 76 5 MHz to 30 MHz QP 90 20 at 5 MHz decreasing linearly to 73 20 at 30 MHz average 80 at 5 MHz decreasing linearly to 60 at 30 MHz 150 kHz to 500 kHz QP 100 20 average 90 500 kHz to 5 MHz QP 86 20 aver age 76 5 MHz to 30 MHz QP 90 20 at 5 MHz decreasing linearly to 73 20 at 30 MHz average 80 at 5 MHz decreasing linearly to...

Page 59: ... 90 180 270 degree phase angle 1 0 kV 1 2 kV 2 0 kV 0 90 180 270 degree phase angle Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interrup tions and voltage variations on power supply in put lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 0 45 90 135 180 255 270 and 315 degrees phase angle 5 UT 95 dip in UT for 1 cycle 70 30 dip in UT fo...

Page 60: ...d amateur radio bands 3 Vrms 150 kHz to 80 MHz 6 Vrms ISM and amateur radio bands d 1 2 p Radiated RF IEC 61000 4 3 3 V m 10 V m 80 MHz to 2 7 GHz 3 V m 10 V m 80 MHz to 2 7 GHz d 1 2 p 80 MHz to 800 MHz d 2 3 p 800 MHz to 2 7 GHz where p is the maximum output power rat ing of the transmitter in watts W accord ing to the transmitter manufacturer and d is the recommended separation distance in metr...

Page 61: ...d maximum output power of transmitter W Separation distance according to frequency of transmitter 150 kHz to 80 MHz d 1 17 p 80 MHz to 800 MHz d 0 35 p 800 MHz to 2 7 GHz d 0 7 p 0 01 0 12 0 04 0 07 0 1 0 37 0 11 0 22 1 1 17 0 35 0 7 10 3 69 1 11 2 21 100 11 67 3 5 7 For transmitters rated at a maximum output power not listed above the recommended separation dis tance d in metres m can be estimate...

Page 62: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 54 2020 09 14 Safety Electromagnetic compatibility EMC ...

Page 63: ...d can easily be changed from the OTC 3 1 1 Direction of Movement The figure below shows the movements of the OTC 4072 01 Alpha Beta Z X 0 Y Fig 3 1 OTC direction of movement Z Vertical movement Motorized Y Lateral movement Motorized and manual X Longitudinal movement Motorized and manual 3 1 2 Sound Signal One sound signal means that the OTC is in position and ready for exposure Two sound signals ...

Page 64: ...suspine Age 36 Sex F Acc No 987 65 4320 1 0 Al 0 1 Cu 43 0 cm 43 0 cm x i 2 1 2 2 1 4 3 5 6 7 9 6 1 6 6 8 1 Up 2 Down 3 Y direction 4 X direction 5 Emergency brake rear side 6 Release all directions rear side 7 Automatic collimator see 3 2 1 Auto matic collimator 8 Light indication see 3 2 14 Light indication 9 Display user interface see 3 2 2 Display user interface User Interface Overhead Tube Cr...

Page 65: ...ad tube crane from the hand control at the wall stand or from the control handle at the table option The following figure shows the functions of the automatic collimator 4077 60 60 cm 110 ms 20 mA 250 kV 50 Density 1 8 mAs AEC Jane Doe DoB 1977 03 06 ID 987 65 4320 Abdomen suspine Age 36 Sex F Acc No 987 65 4320 1 0 Al 0 1 Cu 43 0 cm 43 0 cm x i 3 4 4 2 1 5 Fig 3 2 Display automatic collimator 1 K...

Page 66: ... from the anatomical program The collimator light size can still be changed manually In manual mode the collimator light height and width is not set from the anatomical program 1 Automatic mode 2 Manual mode When Automatic mode is selected the predefined values of the collimator light x ray field size and the filter selection will be set automatically when the anatomical protocol is selected Both ...

Page 67: ...ed filtration Filter 1 1 mm Al 0 1 mm Cu Filter 2 1 mm Al 0 2 mm Cu Combined 2 mm Al 0 3 mm Cu The filters can be predefined in the anatomical protocol and also be changed if needed 3 2 1 4 Laser The laser can be switched off by applying a mechanical cover over the laser The cover is available underneath the collimator 3 2 1 5 Collimator functionality system When the OTC moves in a direction that ...

Page 68: ...A long activation of the M button set the light field to max image size based on the pre programmed SID value and the selected receptor C Button for closing the format height collimation D Button for opening the format height collimation E Button for opening the format width collimation F Button for closing the format width collimation 3 2 1 7 Hand control Wall stand collimator adjustment C B A C ...

Page 69: ...x i 12 13 11 10 9 1 6 7 8 2 3 5 4 1 Patient information 2 Active protocol 3 Position information 4 Adjustment of generator parameters kV mA ms mAs 5 Select the settings menu 6 Hospital manual 7 Active System mode 8 Selection of Technique mode 9 Selection of active AEC field AEC mode only 10 Patient size 11 Collimator centering 12 Manual or Servo mode 13 Density See the following pages for detailed...

Page 70: ...ar The Patient information closes automatically or when the bar is pushed once again i Hand AP DoB 1977 03 06 ID 987 65 4320 Hand AP Age 36 Sex F Acc No 987 65 4320 Jane Doe Picture 2 Picture1 Fig 3 6 Patient information display 3 2 4 Position Information A B C Fig 3 7 Position information A Alpha angle B Beta angle C Source Image Distance SID or Height to floor H in Free or Auto Position Mode cm ...

Page 71: ... parame ters in the Image system before performing exposure 3 2 5 1 Exposure Index The exposure index EXI is a measure of the amount of exposure received by the detector and depends on mAs the total detector area irridiated respective the beam attenuation It is indicative of the image quality 3 2 6 Settings The Setting menu is reached by a activating the Setting button for 1 second Fig 3 9 Setting...

Page 72: ...3 06 ID 987 65 4320 Hand AP Age 36 Sex F Acc No 987 65 4320 Jane Doe Fig 3 11 Always On selected When the Always on is marked the Patient information is shown as soon as the infor mation is selected in the imaging display Fig 3 12 Always On not selected When the Always on is not marked the Pa tient information is shown when pushing the black field where the i is The Patient information closes auto...

Page 73: ...Operator s Manual 1000 095 071 EN Rev 1 1 OMNERA 2020 09 14 Page 65 ID Age Sex Accession number Examination Active Protocol User Interface Automatic Collimator Control ...

Page 74: ...ound On Off LCD brightness Plus Minus Arcoma logotype in display On Off Image preview on By selecting this a small preview image will be shown next to the Active Protocol name see figure on page Localization Changes between cm and inch for collimator light width and height values and SID H Audio Key Click By selecting this a key click will be heard when touching the System display Sound on By sele...

Page 75: ...review im age see Fig 3 14 Preview image dis played is shown on the touchscreen display when an exposure is performed Touch the small image on the display and the image is shown as a large image 60 60 cm 110 ms 20 mA 250 kV 50 Density 1 post mAs 5 8 mAs AEC Jane Doe ID 987 65 4320 Hand PA X Fig 3 15 Preview image enlarged By touching the zoom button it is possi ble to zoom in and out in the image ...

Page 76: ...2013 07 30 10 14 03 Error Heading Warning 4 2013 07 30 10 17 41 Warning Heading Warning 3 2013 07 30 10 13 02 Warning Heading Error 1 2013 07 30 10 11 02 Error Heading Info 2 2013 07 30 10 16 31 Information Heading Info 1 2013 07 30 10 15 05 Information Heading Warning 4 2013 07 30 10 17 41 Warning SETTINGS LOG DISPLAY SERVICE USER SETTINGS Heading Warning 1 2013 07 30 10 10 01 Warning Heading War...

Page 77: ... 0 Delete Log Fig 3 19 Delete log file Service Settings The Service menu shows system set up and system software versions A more detailed de scription can be found in the Service and installation manual 4078 SETTINGS LOG DISPLAY SERVICE USER SETTINGS Wallstand CONNECTED WS hand control SYSTEM SETUP SW VERSIONS Save setup System Master CAN Device XX XX X XX XX X Master Collimator XX XX X XX XX X X ...

Page 78: ... modes and actual configurations are available Free mode Auto position mode Wall flexible mode Table flexible mode Film tracking mode Pendulum mode Table Stitching mode toward the Table and Wall stand 3 2 7 1 Free Mode General Description The Free mode is the most basic mode in the System The mode holds no special features or functionality It is intended as a manual mode with a lot of freedom in p...

Page 79: ...and The wall stand detector angle is controlled from the APR The OTC will upon activation of the servo button move to the programmed position associ ated with Wall mode The stand will stop at the transport height and wait for a change in posi tion of the wall stand detector height When a change in position is detected the user moves drives the wall stand up or down the OTC will move downward and s...

Page 80: ... mode with added functionality for controlling the position of the detector in one direction The mode is intended for fast and easy position ing with the X ray tube always aimed at the center of the detector The motorized detector holder will move the detector to the right position The stand will upon activation of the servo button move to the pre programmed Film tracking position and start tracki...

Page 81: ...nd controlling the position of the detector a motorized detector holder is re quired The stand will upon activation of the servo button move to the programmed position associated with the Pendulum mode and start tracking the Table height thereby keeping the film focus distance constant All table handle bar buttons except move left and move right buttons will be deactivated when the Pendulum mode i...

Page 82: ...r an image with extended length In digital radiography the image size is limited due to the sensitive area of flat panel detectors In order to produce a large image images are assembled from multiple exposures with a small spatial overlap Stitching is possible at both Table and Wallstand Partial Image Height Composite Image Composite Image Height Overlap Partial Image Partial Image Partial Image F...

Page 83: ...e image by positioning the light field Note A patient protection shall always be used at Wallstand examinations when performing stitch ing examinations For detailed information about the stitching operation see the Operator s Manual Exposure Validation It is only possible to perform an exposure when the System is ready indication light is fixed generator is enabled The exposure will be blocked and...

Page 84: ... available Parameters not available for selection will be grayed out see the mAs selection button in Fig 3 25 mAs se lection button grayed out below In AEC mode the value that will be used as back up value ms mAs or fixed is indicated with the text AEC Backup CAUTION For avoiding unnecessary radiation make sure that the AEC back up values are prop erly defined AEC ms 6 0 mA 200 kV 150 AEC Backup D...

Page 85: ...eld button a pop up window with the different AEC fields accord ing to Fig 3 26 AEC field selection will appear The AEC fields are activated by a selection in the pop up window to the right 2 All activated AEC fields will be shown in the left picture 1 AEC fields are deactivated by selecting them again in the pop up window 2 1 2 Fig 3 26 AEC field selection User Interface Automatic Collimator Cont...

Page 86: ...ion 1 Paediatric 2 Small 3 Medium 4 Large Select the desired Patient size The pop up window will automatically close shortly after the selection Note The generator parameters and the collimator settings field size and filter will change to the defined values for the new Patient size If no generator parameters or collimator settings are defined for the new Patient size defined in APR the current va...

Page 87: ... The functionality of top and bottom centring is only available in Wall mode or Wall Flexible mode With top centring active is the light field always as high as it can be regarding size and position for the image Fig 3 28 Top and bottom centering of the collimator light field The collimator centering is adjusted by pressing the Collimator centering button A pop up window according to Fig 3 29 Coll...

Page 88: ... either Automatic mode 1 or Manual mode 2 A pop up window according to Fig 3 30 Servo state mode will appear with two al ternatives When the System is in Manual mode all movements are allowed and expo sure can be performed in any position also outside the detector For further information about Manual mode see corresponding section User Interface Automatic Collimator Control ...

Page 89: ...h incorrect grid status might affect the image quality negative The grid status is shown in the upper right corner of the Canon NE user interface When the correct grid is attached the grid name is written with black letters see Fig 3 32 When a grid is not needed for the examination Removed is shown with black letters in the same location see Fig 3 32 When a correction of grid status is needed this...

Page 90: ...d Grid shall be used for this examination 4080 Example 180cm_10 1_52 lp cm REMOVE THE GRID Pop up window in Canon will guide to remove the grid Remove the grid No grid shall be used for this examination 4082 Example 115cm_10 1_52 lp cm CHANGE GRID Pop up window in Canon will guide to exchange the grid inserted to the re quested grid according to the protocol Wrong grid inserted name of the attache...

Page 91: ...bdomen suspine Age 36 Sex F Acc No 987 65 4320 1 0 Al 0 1 Cu 43 0 cm 43 0 cm x i There is a light indication available around the overhead tube display No light Between examinations Yellow flashing Action needed by the user or system is moving Green flashing System is ready for exposure Green fixed Preparation before exposure Yellow fixed Exposure User Interface Automatic Collimator Control ...

Page 92: ...ex EXI and Deviation Index DI will be shown in the image in order to indicate the dose level See further description of the indexes below The exposure index is a measure of the amount of exposure received by the detector and depends on mAs the total detector area irradiated respective the beam attenuation It is indi cative of the image quality 3 3 3 Deviation Index The deviation index DI gives an ...

Page 93: ...Operator s Manual 1000 095 071 EN Rev 1 1 OMNERA 2020 09 14 Page 85 3 4 Image System For information about Image system functions see the Image System Manual User Interface Image System ...

Page 94: ...em num ber Use the enclosed labels to distinguish different system remotes from each other 5 6 7 3323 1 2 3 4 Fig 3 34 Remote control front and back Front 1 Servo button yellow 2 Indication diode green 3 Tube up 4 Switch On Off Collimator light Back 5 Fastening clip 6 On Off switch 7 Battery changing slot Servo button The servo button is yellow with a little peg making it easy to recognize the but...

Page 95: ...limator light The button turns the X ray field illumination and linear light localizer on off Automatic switch off via a time switch On Off switch There is an On Off switch for the remote control at the back of the remote control When the control is switched off all buttons are disabled Battery changing slot When the indication diode lights red changing of battery is needed The remote control uses...

Page 96: ...o button and an emergency stop The servo button is equipped with an indication light showing the system status See Fig 3 35 2030 01 1 2 Fig 3 35 External servo button module 1 Emergency stop 2 Servo button and Indication light 3 6 2 Indication Light WARNING Due to the squeezing hazard motorized movements are only allowed if patient and System are observed by personnel The Indicator light has 3 dif...

Page 97: ...t The figure below shows the directions of the table movement X Y Z Front Fig 3 36 Directions of movement Table Z Vertical movement Y Lateral movement X Longitudinal movement 3 7 2 Power Indication The green light indicates that the System is active 4017 Fig 3 37 Power indication light User Interface Table Control elements ...

Page 98: ...e top downwards B Press the button to release the brakes on the table top Y and X On activation the table top can be moved manually When the release button is activated the collimator light will be lit C Press button to move the table top upwards 3 7 4 Foot control wireless option CAUTION It is important to assure that the correct control is activated as there is one foot con trol for the table an...

Page 99: ...tion the table top or the wallstand detec tor holder can be moved manually When the release pedal is activated the collimator light will be lit Note The foot control must not be used outside the examination room The device has no applied parts and should not be accessible to patients 3 7 4 2 Battery The yellow battery indication LED will begin to flash once every two seconds when the re maining ba...

Page 100: ... Table top X Y 3 7 6 Table Hand Control Beside the functions for moving the table top the hand control also has functions for moving the imaging unit and performing a pendulum movement Handcontrol Fig 3 41 Table hand control location A C D E F G H B I Fig 3 42 Table hand control 3 7 6 1 How to Manoeuver A Press button to move the table top upwards B Press button to move the table top downwards C P...

Page 101: ... 14 Page 93 D Drive motorized image receptor holder to left E Drive motorized image receptor holder to right F Move the OTC to the left in Pendulum mode G Move the OTC to the right in Pendulum mode H Not used I Not used User Interface Table Control elements ...

Page 102: ...Directions of Movement The figure below shows the directions of the table movement X Y Z Front Fig 3 44 Directions of movement Table Z Vertical movement Y Lateral movement X Longitudinal movement 3 7 8 Vertical Travel Safety option The Table may as an option be equipped with a vertical travel safety system that protects the table top It activates if a collision is detected and the force exceeds 20...

Page 103: ...the table top 1 2 3 Click Attach Fig 3 45 Attaching accessories 1 2 3 Press Remove Fig 3 46 Removing accessories 3 7 10 Motorized Imaging Unit Movement The imaging unit can be moved in X direction motorized The motorized movement is man oeuvred from the table hand control see Fig 1 4 Table overview The function can synchron ize the imaging unit and follow the movement of the ceiling unit User Inte...

Page 104: ...een the tube and the table detector In Film tracking and Pendulum mode the detector holder may be moved manually in X direc tion If this is done the servo button will be deactivated and exposure is no longer possible To return to an activated servo button the detector holder shall be moved to the correct posi tion The correct position will be indicated by the lightning of the green detector holder...

Page 105: ... movement T Tilting movement A Light indication lit when the wallstand is selected as a work station B Hand control Adjustment of the automatic collimator vertical movement of the detector rotation of the detector and activation of pendulum mode The wall stand detector is tilted by activation of the hand control The detector can be tilted 20 to 90 User Interface Wall stand Control Elements ...

Page 106: ... H 4000 Fig 3 48 Hand control A Collimator light on off B Adjustment height collimation C Adjustment width collimation D Servo button see 3 6 Servo Button E Break release for manual movement of detector F Pendulum mode wall stand G Detector up down Motorized H Detector tilt and OTC tracking 20 to 90 User Interface Wall stand Control Elements ...

Page 107: ...rforms a pendulum movement in order to find correct angulation of the cen tral X ray 4006 01 Tilting 20 to 90 Button H Motorized Tilt OTC tracking wall stand detector when au to position active Button E Manual Note Armrest has to be removed to allow tilt movement 3 8 1 2 Light Indication A The selected Workstation is indicated in the imaging system and with a green light on the Wallstand User Inte...

Page 108: ...otorized vertical movement Consider the working area when the Wallstand detector is manoeuvred A C B 002049 Fig 3 49 Wallstand foot control manoeuvering A Z movement down B Brake release manual movement C Z movement up How to Manoeuver A Press the pedal to move the detector downwards B Press the pedal to release the brakes When activated the detector can be moved manually C Press the pedal to move...

Page 109: ...and live parts accessi ble even though the system is turned off CAUTION The Detector should be powered up at least half an hour before intended use If it is used sooner than half an hour after being powered up image quality may be affected 4 1 1 Applied Parts Applied parts are intended for the patient to touch 4087 02 Fig 4 1 Applied parts System Operating the System General ...

Page 110: ...t the emergency stop is not activated When the system starts up light indications and displays are lit Perform the following procedure when starting up the X ray system FF O N O 4039 01 A Fig 4 2 Power on button mini console 1 Press the power ON button A on the mini console 3673 Fig 4 3 Power button image control unit 2 Press the power button on the computer 3 Start the display Operating the Syste...

Page 111: ...eless detector option press the power button 1 The power LED 2 lights with a fixed light Fig 4 5 5 Log in on the computer 6 Type user name and password press Log in Fig 4 6 7 Confirm that the image system has started normally by checking the status icons Operating the System Turn on the system ...

Page 112: ...em Note Wait for two minutes or longer after the examination is completed before turning OFF the power 1 Move the OTC to a parking position for example over the table 2 Turn off the image system Select Fig 4 7 Fig 4 8 Shut down Confirmation Dialog Box Operating the System Turn off the system ...

Page 113: ...e 105 Fig 4 9 3 Turn off the wireless detector 1 FF O N O 4039 02 B 4 Press the power OFF button B on the mini console It is possible to turn off the power to the X ray system while the power to the image system is still on Operating the System Turn off the system ...

Page 114: ...ev 1 1 Operator s Manual Page 106 2020 09 14 4 4 Perform examination 4 4 1 Select patient 1 Select Exam and Worklist Fig 4 10 2 Sort the list in Search For Study List and select patient Operating the System Perform examination ...

Page 115: ...Start Exam Predefined protocols are activated automatically Patient data can also be added manually see Canon Operation Manual Fig 4 11 2 The indication light will be lit on the selected workstation 05 4001 4017 Wall stand indication light Table indication light Operating the System Perform examination ...

Page 116: ...shing light that the sytem reached correct position 3619 01 Fig 4 12 Indication light 4 4 4 Adjust position and collimator for chosen examination and patient Adjust the position of the OTC table top or wall stand according to 3 1 1 Direction of Movement Page 55 3 7 Table Control elements Page 89 3 8 Wall stand Control Elements Page 97 The light field should be reduced to the examination area Adjus...

Page 117: ...osition before the exposure CAUTION It is the responsibility of the user to ensure that the X ray field is within the active de tector area when exposing Note The operator is responsible for verifying the exposure parameters before exposure Check that the examination conditions are displayed on the image system without failure Exposures are done using either the hand control or the prep and X ray ...

Page 118: ... 071 EN Rev 1 1 Operator s Manual Page 110 2020 09 14 Exposure operator console A preparation exposure B exposure position C light indicating exposure Fig 4 14 Operator console Operating the System Perform examination ...

Page 119: ... the image is correct select End Exam or continue examination if more images are planned 2 If the image is not correct select Retake 3 Type reject reason and retake image 4 4 7 Change work space 1 Select Protocol Fig 4 15 2 Select detector or workspace Operating the System Perform examination ...

Page 120: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 112 2020 09 14 Fig 4 16 Operating the System Perform examination ...

Page 121: ...wall stand Is the indication light lit yel low LED in the control room or green light on the OTC Position the system correct by pressing the servo button on the remote control the operators console or on the OTC or Change from Auto to Man ual on the OTC display if the patient light field is in posi tion and you don t want to reposition the OTC Table examination Is the detector in the table detecto...

Page 122: ...ectangular cubes Short cut zones can be defined by a servcie technician To perform a short cut movement the following conditions must be fulfilled The System shall be positioned above the Table or at the specified short cut zone in front of the Wallstand At least one of the OTC corners must be inside the short cut zone at the start of the movement Outside these short cut zones the OTC will first m...

Page 123: ...nd Short cut Zone The Wallstand short cut zone is defined in front of the Wallstand OTC Fig 4 17 Wallstand short cut zone 4 5 2 Table Short cut Zone The Table short cut zone is defined above the table top OTC Fig 4 18 Table short cut zone Operating the System Movement Short cut Zones ...

Page 124: ...d lower limits are defined at System installation 4086 Max Min Transport interval zone Fig 4 19 When moving between positions outside the short cut zones the OTC will first move to the transport interval zone Inside the transport interval zone the OTC will move horizontally until it reaches the intended X Y position Then the OTC will move vertically to the intended Z position Operating the System ...

Page 125: ...anual Mode The servo state can be either Automatic mode or Manual mode A pop up window according to Fig 4 20 Servo state selection pop up window will appear with the two alternatives When the System is in Manual mode all movements are allowed and exposure can be performed in any position Fig 4 20 Servo state selection pop up window The Manual mode is activated by pressing the Servo state see Fig 4...

Page 126: ...s selected the Manual mode will be kept 4 7 1 2 Restrictions in Manual Mode In Manual mode the shown SID value is based on the assumption that the detector is posi tioned in the same way as it should have been in an active servo mode Note that the SID value will not be able to be calculated is some positions No SID value will be shown if the System is not in an active servo mode when Manual mode i...

Page 127: ...wing see Fig 4 22 Free mode display Fig 4 22 Free mode display The stand will display H distance to the floor All movements are available 4 8 1 3 Exposure Exposure is possible when the OTC is not moving Note The OTC will automatically enter the Free mode at start up 4 8 2 Auto Position Mode 4 8 2 1 General The Auto position mode is designed for emergency examinations or examination with a mo bile ...

Page 128: ...play H distance to the floor Activate the mode by pressing the servo button When auto positioning to a wall stand the wall stand detector unit will move into a basic position The OTC will automatically move to its programmed position The servo mode button light indication will be switched off All movements are available 4 8 2 4 Exposure Exposure is possible when the OTC is not moving Operating the...

Page 129: ...pressing the servo button The OTC will automatically move to its programmed position The OTC will move to the programmed SID Servo mode indication light fixed Adjust the table height The OTC will follow the Table to maintain the programmed SID Adjust the tube position The mode will stay activated detector holder will not follow Move the imaging unit manually if needed to assure that the x ray fiel...

Page 130: ...o the programmed SID Servo mode indication light fixed Adjust the table height The OTC will follow the Table to maintain the programmed SID Press the brake release button Move the OTC lengthwise the Table The imaging unit will follow the movement to stay aligned with the tube Press the button to deactivate the alpha brake Turn the tube in alpha direction The imaging unit will follow the movement t...

Page 131: ...able stand The OTC will follow the Table stand to maintain the programmed SID Press the arrow left or corresponding buttons on the table handle Press the buttons for moving the OTC to the right or left see item F and G at Fig 3 42 Ta ble hand control The tube move in the desired direction and the imaging unit move to stay aligned with the tube 4 9 3 3 Exposure Exposure is possible when the OTC is ...

Page 132: ...tion is reached Invite the patient and position the patient on the table Move the focus point to the middle of the planned composite image This could be done ei ther by moving the tabletop or by moving the column in X or Y direction Rotate the x ray tube in order for the right edge of the collimator light field to indicate the right limit for the composite image Press the button F1 to set the righ...

Page 133: ...t The servo mode indication light will be fixed Modify the exposure settings if necessary Activate the exposure button and keep it activated during the procedure The starting position is always at the left edge of the composite image Activate the expo sure button and keep it activated until the exposure procedure is completed The system will move to the correct starting position When the system is...

Page 134: ...parameters The Wall Flexible Movements shall be set at the installation and will thereafter be valid for all Auto positions using the Wall Flexible mode Fig 4 30 Adjust WallFlexible parameters Not Blocked All OTC movements are allowed Beta blocked and Sideways supervised Blocked beta movement movement will turn the servo off It is possible to move a distance of half the detector length landscape b...

Page 135: ... or wait in the transporta tion height until detector is moved wait or no wait selected The mode will stay activated The OTC beeps once and the servo mode indication light will flash Adjust the height of the wall stand Move the detector holder at the wall stand The OTC will move down and align with the wall stand The OTC will follow the wall stand to stay aligned The OTC turns on the collimator li...

Page 136: ...ill move down and align with the Wallstand detector The OTC will follow the Wallstand detector to stay aligned The OTC reaches the correct height and stops The SID value is changed to the new distance if selected distance towards the Wallstand is changed 4 10 2 1 Exposure Exposure is possible when the OTC stands still and the servo mode indication light is fixed 4 10 3 Stitching Wall Stand Mode No...

Page 137: ...nvite the patient and position the patient in front of the wall stand 4 Verify that the patient protection is placed in front of the wall stand by pressing thegreen check button on the display 5 Move the focus point to the middle of the planned composite image This could be done by moving the tube in Z direction 6 Rotate the x ray tube in order for the lower edge of the collimator light field to i...

Page 138: ...ivate the Exposure button and keep it activated during the procedure The starting position is always at the top edge of the composite image Activate the Expo sure button and keep it activated until the exposure procedure is completed The System will move to the correct starting position When the System is in the correct position for the first image the first image is captured After exposure the Sy...

Page 139: ...the power when changing a permanent detector Confirm that it is not possible to elevate If the detector holder elevates accidentally while work is being carried out it may fall against the worker and result in serious injury CAUTION Do not put any load on the detector tray It might be damaged CAUTION Always supervise movements of the detector to avoid collision with peripherals Note This instructi...

Page 140: ...at the detector holder is not possible to elevate If the detector holder elevates accidentally while work is being carried out it may fall against the worker and result in serious injury 4 11 1 1 Method to Load the 14x17 Detector Wallstand The method of setting the detector to the detector holder is as follows 1 Pull the detector tray toward you until it locks Note Install the detector with the de...

Page 141: ...OMNERA 2020 09 14 Page 133 CAUTION Confirm that the latch is going up firmly as shown below 3 While pressing and holding the button of the detector tray return it back to the inside of the detector holder Operating the System Detector Wallstand ...

Page 142: ...of the detector tray 1 in the direction of the arrow Note To set the detector pull the latch upward at upper position of the tray downward at the center of the tray Depending on left or right operated Wallstand the location of the detector tray and po sition of button and latches is different Centered or Top Rotation of the Detector In the landscape position there is a choice between having the de...

Page 143: ...s as follows 1 To remove the detector in the step 2 of Method to set the detector unlock the connector by pulling the latch of the detector tray in the direction of the arrow Note Depending on left or right operated Wallstand the location of the detector tray and position of button and latches is different Fig 4 37 Unlocking the detector latch Operating the System Detector Wallstand ...

Page 144: ...hanging the detector Confirm that the detector holder is not possible to elevate If the detector holder elevates accidentally while work is being carried out it may fall against the worker and result in serious injury Note Depending on left or right operated wallstand the location of the detector tray and posi tion of button and latches is different The method of setting the detector to the detect...

Page 145: ...holding the button of the detector tray return it back to the inside of the detector holder 4 Push the detector until the hold backs are set Then the detector is in the correct position Chargeable detectors will start charging when set in this position Operating the System Detector Wallstand ...

Page 146: ...t is important that the hold backs lock outside the detector end Failure to position the detector in the proper position will lead to incorrect images Note If the detector or the detector holder is not properly inserted a warning symbol will be shown at the display Operating the System Detector Wallstand ...

Page 147: ...the detector tray It might be damaged CAUTION Always supervise movements of the detector to avoid collision with peripherals Note If the System includes more than one detector assure that the active detector is used 4 12 1 Set the detector 1 Pull out the detector tray Fig 4 39 Releasing the detector tray Fig 4 40 Pulling out the detector tray Operating the System Portable detector table ...

Page 148: ...002070_x Fig 4 42 3 In this position exposure is possible in Free mode Table Flexible mode and Auto position mode 4 Press and hold the button of the tray and push it in 002072_x 002073_x Fig 4 43 Reinserting the detector tray To check if the detector is in the right position see the STATE Detector position present undefined at the display Operating the System Portable detector table ...

Page 149: ... Page 141 4 12 2 Change between portrait and landscape 1 Rotate the detector 90 2 Hold as shown below and turn the detector clockwise or anti clockwise Fig 4 44 Detector change between portrait and landscape Fig 4 45 Operating the System Portable detector table ...

Page 150: ...e detector 1 Withdraw the detector holder and rotate the detector if needed to remove the detector 002070_x Fig 4 46 2 Remove the detector by pulling it towards you according to Fig 4 47 Detector removal 002069_x Fig 4 47 Detector removal Operating the System Portable detector table ...

Page 151: ... imaging and additional ionising radiation exposure for the patient may be needed Ensure the grid is inserted in the correct way 1 Pull out the grid 002298 Fig 4 48 Pull out the grid 2 Exchange the grid Insert the grid with the tube side facing upwards towards the X ray source The tube side of the grid has the specification label and the grid centre line identification 3 Push in the grid until it ...

Page 152: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 144 2020 09 14 Operating the System Portable detector table ...

Page 153: ...ifications 5 1 1 1 1 Error When an error occurs an Error pop up window will appear in the display 60 60 cm 110 ms 20 mA 250 kV 50 Density 1 post mAs 5 8 mAs AEC DoB 1977 03 06 ID 987 65 4320 Hand AP Age 36 Sex F Acc No 987 65 4320 Jane Doe SID 60 60 cm 110 ms 20 mA 250 kV 50 Density 1 1 1 post mAs 5 8 mAs AEC SID ERROR X Checksum error The Node Name node has detected a parameter problem Restore ba...

Page 154: ...D 987 65 4320 Hand AP Age 36 Sex F Acc No 987 65 4320 Jane Doe SID Fault message Checksum error X Fig 5 3 Error information bar Table ms 20 mA 250 kV 50 Density 1 post mAs 5 8 mAs AEC 60 60 cm 110 DFD Jane Doe ID 987 65 4320 Knee PA Fault message Checksum error Fig 5 4 Error information bar Wall stand When the user pushes the red information bar the Error pop up window will appear again The Error ...

Page 155: ... is displayed or after time The latest sent warning is shown 60 60 cm 110 ms 20 mA 250 kV 50 Density 1 post mAs 5 8 mAs AEC DoB 1977 03 06 ID 987 65 4320 Hand AP Age 36 Sex F Acc No 987 65 4320 Jane Doe SID Fault message Movement stopped Button Fig 5 5 Warning information bar Table ms 20 mA 250 kV 50 Density 1 post mAs 5 8 mAs AEC 60 60 cm 110 DFD Jane Doe ID 987 65 4320 Knee PA Warning Movement s...

Page 156: ...on report problem to service Fig 5 7 Pop up window Warning information bar When the user closes the pop up window the Warning Information bar will appear again The Warning pop up window will also appear again when the user pushes the information bar ms 20 mA 250 kV 50 Density 1 post mAs 5 8 mAs AEC 60 60 cm 110 DFD Jane Doe ID 987 65 4320 Knee PA ms 20 mA 250 kV 50 Density 1 1 1 post mAs 5 8 mAs A...

Page 157: ...ator s Manual 1000 095 071 EN Rev 1 1 OMNERA 2020 09 14 Page 149 5 2 Diagnostic For System messages error messages and error handling see the System Installation and Service Manual Error Handling Diagnostic ...

Page 158: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 150 2020 09 14 Error Handling Diagnostic ...

Page 159: ...e operation the next time it is being used Note For a more detailed cleaning information see the Operation Manual for respective device Note Use a moderate amount of liquid when cleaning the product Surfaces that are in contact with the patient shall be cleaned with a lint free cloth and a small amount of soap water or cleaning spirit Cleaning General ...

Page 160: ...ollimator Use a damp soft cloth to clean the collimator This reduces the possibility for liquids to en ter the collimator Do not use abrasive cleaning products CAUTION Use of abrasive cleaning could result in deterioration of the collimator E g the cross hair window can be damaged resulting in reduction of light field illumination CAUTION Do not spray pour or soak the collimator with liquids Use a...

Page 161: ... Wall stand Table OTC and X ray Tube Preferred cleaning agents for cleaning X ray tube housing assemblies are Alcohol Methanol Hospital grade disinfectant The X ray tube assembly is not intended to come into contact with patients Cleaning Wall stand Table OTC and X ray Tube ...

Page 162: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 154 2020 09 14 Cleaning Wall stand Table OTC and X ray Tube ...

Page 163: ...or all units OTC table and Wallstand 1 Check the cable hose for damage 2 Check all outer cabling for damage 3 Clean all outer surfaces except for the lubricated column segments 4 Make sure that the Instruction for use is available and up to date 5 Check the emergency stop By activating the emergency stop all motorized movements are inhibited See Safety Chapter for information on how the Emergency ...

Page 164: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 156 2020 09 14 Function and safety checks Monthly Checks ...

Page 165: ...pation 1713 BTU H Generator Series and Mains Voltage Generator Momentary Line Current Apparent Mains Resistance Recommended Minimum Mains Disconnect to Generator 15 ft 5 m max Generator Service Rating Distribution Transformer Rating Ground Wire Size 50 kW 400 VAC 3p 100 A 0 17 Ω 13 3 mm2 100 A 65 kVa 13 3 mm2 65 kW 400 VAC 3p 125 A 0 13 Ω 85 kVa 80 kW 400 VAC 3p 155 A 0 10 Ω 105 kVa 50 kW 480 VAC ...

Page 166: ...mbient operating temperature 10 C 40 C Transport and storage humidity relative 10 90 non condensing Operating humidity relative 30 75 RH non condensing Maximum transport and storage altitude 3000 m Maximum operating altitude 3000 m Maximum air pressure 700 1060 hPa Noise 55dB or less except single noise Technical specification Environmental Requirements ...

Page 167: ...ssembly 4 m 95 kg Ceiling rail Y 4 m standard 28 kg each 8 3 4 Electrical Characteristics Mains voltage 230 VAC 50 60 Hz center tapped single phase 4 A 8 3 5 Classification Classification according to IEC 60601 1 Class Class I equipment All dead metal parts of the equipment are electrical connected to protective earth Applied part Type B Protection against ingress of water IPXO Mode of operation I...

Page 168: ...8 3 6 Speed Low speed Maximum speed Z movement 60 mm s X movement 250 mm s 500 mm s Y movement 250 mm s 500 mm s α movement 16 s β movement 16 s Image receptor holder movement with 50 kg mass 166 mm s 350 mm s Technical specification Ceiling suspended X ray tube support ...

Page 169: ...erator s Manual 1000 095 071 EN Rev 1 1 OMNERA 2020 09 14 Page 161 8 4 Cabinet 8 4 1 Dimensions Dimensions L x W x H mm 750 x 600 x 1125 mm 8 4 2 Weight Cabinet Max 134 kg Technical specification Cabinet ...

Page 170: ...1 5 mm Length of stroke X direction 600 mm Length of stroke Y direction 150 mm Movement range of the imaging unit 650 mm Movement range of the detector up to 850 mm 8 5 3 Weight Table Approximately 150 kg Imaging unit Approximately 21 kg Table top Approximately 47 kg Maximum patient load 300 kg 8 5 4 Electrical Characteristics Maximum power without external electronics 500 W 8 5 5 Attenuation Equi...

Page 171: ...tand Column Z stroke 1580 10 10 Rotation range detector holder wagon Only the tiltable detector holder wagon 20 90 8 6 1 Attenuation equivalent Detector holder 0 6 mm 8 6 2 Weight Wall stand 200 kg 10 8 6 3 Speed Maximum speed Z movement 200 mm s Technical specification Wall stand ...

Page 172: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 164 2020 09 14 Technical specification Wall stand ...

Page 173: ...njury we therefore request that you contact the Manufacturer or your dealer if you wish to cease operation of your product with the intention of disposal For disposal of other components refer to corresponding documentation Follow the rules and regulations of your relevant authorities in the disposal of this product accessories options consumables media and their packing materials Waste Disposal ...

Page 174: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 166 2020 09 14 Waste Disposal ...

Page 175: ...9 003 Mounting kit unistruts for rails 4x4m 0512 099 004 Mounting kit unistruts for rails 4x5m 10 1 1 Table Part no Description 0072 095 170 Patient kit incl Compression belt cost effective Patient handgrip 2 pcs Mattress 0072 099 014 Patient handgrip 0055 099 001 Mattress Comfort 0055 099 007 Mattress 2200 mm 0055 099 009 Hand control for automatic collimator 1 pc 0072 099 011 Lateral cassette ho...

Page 176: ...x43 Canon detector CXDI 701C wireless 35x43 Canon detector CXDI 702C wireless 35x43 Canon detector CXDI 710C wireless 35x43 Canon detector CXDI 810C wireless 28x35 Canon detector 10 1 4 Grid Part no Description 0180 099 050 Grid 40 lp cm 10 1 Ratio F115 Al type 0180 099 051 Grid 40 lp cm 10 1 Ratio F150 Al type 0180 099 052 Grid 40 lp cm 10 1 Ratio F180 Al type 0180 099 060 Grid 52 lp cm 10 1 Rati...

Page 177: ... product verifies that the Manufacturer guarantees that the product fulfils the EU fundamental health environment and security requirements Centering The field of image is centered over the detector Collision Either a physical collision with an obstacle or the node cannot reach its end position CR Image plates D DAP meter Dose Area Product meter The DAP meter is placed next to the colli mator and ...

Page 178: ...age receptor Receptor for images Film CR DR or Cassette Image receptor holder Holder for the image receptor Film CR DR or Cassette Index Mechanical position markings for instance alpha 0 90 and 90 Intermittence The number of repetitions unit of time Recurrent cycles ISO International Organization for Standardization J K L M Mechanical end stop A physical device that stops an automatic or manual mo...

Page 179: ...the active image receptor surface FFD is also used Software end stop A non physical device that stops an automatic or manual movement The software end stop is placed before the mechanical end stop SSW Service software Supplier The company that sells the System to the user hospital T Table frame The metallic frame that carries the Table top The frame is attached to the bottom of the Table top U V W...

Page 180: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 172 2020 09 14 Z node The Z node controls the Z movement Z movement The System moves in the Z direction Appendix A Glossary ...

Page 181: ...ure the tracking is activated Measure between the X ray tube focal spot and the ac tive image receptor surface of the image receptor holder The measured SID shall correspond with the displayed SID Move the OTC in X or Y direction and measure between the X ray tube focal spot and the active detector surface of the detector holder again The SID is allowed to differ 1 4 Check that the SID shown on th...

Page 182: ...he hoses for damage 3 Check all outer cabling for damage 4 Clean all outer surfaces except for the lubricated column segments See Operation Manual Chapter 6 Cleaning for cleaning instructions 5 Check the emergency stop By activating the emergency stop all motorized move ments are inhibited See Chapter 2 Safety for informa tion of how the Emergency stop should react on command Appendix B Monthly Ch...

Page 183: ... and observe any irregularities 12 1 1 3 Table 8 Move the Table in X Y and Z direction an make sure it runs smoothly and without any dissonance 9 Move the Table top in longitudinal direction and check that the mechanical end stops are not loose 12 1 1 4 Wallstand 10 Move the Wallstand up and down in Z direction and make sure it runs smoothly and sounds OK Appendix B Monthly Checklist ...

Page 184: ...OMNERA 1000 095 071 EN Rev 1 1 Operator s Manual Page 176 2020 09 14 12 1 2 Remark No Remark Action Int Note 1 2 3 4 5 6 7 8 9 10 Appendix B Monthly Checklist ...

Page 185: ...Operator s Manual 1000 095 071 EN Rev 1 1 OMNERA 2020 09 14 Page 177 12 2 Annual Checks Refer to Service and Installation Manual Appendix B Annual Checks ...

Page 186: ......

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