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user's manual - Nova

1. NOTE A radiation shield e g the Planmed Radiation Shield PRS shown in above figure is required to build a complete system for digital mammographic imaging 12 Planmed Nuance amp Planmed Nuance Excel User s manual PLANMED FFDM SYSTEM MAIN PARTS 7 6 Planmed FFDM X ray unit A general side view of the Planmed FFDM X ray unit is shown below C arm Control panel User s manual Planmed Nuance amp Planmed Nuance Excel 13 PLANMED FFDM SYSTEM MAIN PARTS C arm overview The C arm includes the X ray generator and tube as well as the digital detector inside the carbon fibre Bucky The mechanical construction provides versatile and independent movements of the breast support table and the tube head C arm controls are located on both sides of the C arm with a total of 4 control positions for precise movement Ergonomic hand rail with a soft coating extends 360 around the breast support table providing a good grip in every view of the mammography examination Also the compression system including the Planmed MaxView Breast Positioning System is shown in the figure For detailed descriptions of the features please see the corresponding sections in this manual Tube head C arm controls Electromechanical compression control Chin guard MaxView Breast Positioning System Hand r
2. hold for 3 seconds NOTE This parameter functions in the AAEC mode and in the AEC mode when the Automatic kV Selection function is ON With the contrast dose C D parameter the user can set the desired mode of imaging from lower patient dose at lower image contrast to higher dose and contrast User s manual Planmed Nuance amp Planmed Nuance Excel 65 FLEX AEC PRINCIPLES AND USER SETTINGS Ocd E ine 35 The kV value is automatically adjusted to give the optimum exposure time If the kV value is increased the mAs value will decrease resulting in a lower radiation dosage and lower film contrast If the kV is decreased the mAs will increase resulting in a higher radiation dosage and a higher film contrast To adjust the C D setting Press the CTL key to enter the secondary function mode The indicator light will come on Press and hold down the automatic manual exposure key until the current contrast dose setting appears on the time force display and starts to flash Press either of the field light keys to change the setting of the contrast dose The right key will increase the film contrast and the radiation dose the mAs will increase and the kV will decrease and the left key will decrease the film contrast and the radiation dose the mAs will decrease and the kV will increase The highest setting is 4 and the lowest setting is 4 Press the CTL key to store th
3. Breast positioning and compression without MaxView on page 53 The degree of compression is limited by the compressibility of the implant Deliver just enough compression to immobilize the breast The manufacturer does not recommend using the MaxView Breast Positioning System on patients with implants 14 1 Breast positioning and compression with MaxView NOTE Field light The MaxView sheets can be pulled either during the compression procedure or after the breast has been compressed To position and compress the breast Position the breast on the Bucky The chest below the breast should be pressed against the front edge of the Bucky Manipulate and spread the breast forwards and outwards as much as possible on the lower sheet Start compression by pressing the rightmost switch paddle down on either foot control The field light will automatically come on for 25 seconds The compression paddle will start to descend while remaining parallel to the Bucky During this phase of the breast compression the maximum limit in dekanewtons at which the compression force is set will appear on the time force display and start to flash The compression can be stopped by releasing the foot control switch 5 To continue compression press it again 6 Press the field light key to switch the radiation field light on 50 Planmed Nuance amp Planmed Nuance Excel User s manual SCREENING MAMM
4. NOTE NOTE Left breast Right breast 3 selected selected Mwy OREADY PRET NOTE It is possible to select 11 standard views with the view selection keys on the X ray unit control panel View selection keys are divided according to the breast that is being examined that is left breast CC OBL and LAT views are selected with the keys on the left SIN side of the panel Accordingly the right breast views are selected with the keys on the right DEX side of the panel Each view selection key includes a normal view selection see section 13 3 Normal view selection on page 46 and a three second view selection function 13 4 Three second view selection on page 47 The default factory settings for the view selection keys are listed in Table 1 Default factory settings for the view selection keys on page 46 The key functions can be configured according to the user preferences Please contact your local sales representative The breast that is being examined is indicated with an arrow in the lower left or right corner of the angle display Note that this is not available with C arm angles above 99 Always select the correct view from the control panel before the exposure even if the C arm angle would be correct to ensure correct laterality in the image data If no view selection key is pressed before the exposure the X ray unit will use the previously selected view To select the desired view
5. OUTPUT 230V 50 60Hz 1250VA MODE OF OPERATION CONTINOUS OPERATION MANUFACTURED BY A PLANMED OY TAL bs 00880 HELSINKI FINLAND C US LBL 7807310 User s manual Planmed Nuance amp Planmed Nuance Excel 99 LIST OF ABBREVIATIONS 24 LIST OF ABBREVIATIONS Abbreviation Definition AAEC Advanced Automatic Exposure Control AEC Automatic Exposure Control Ag Silver Al Aluminum AWS Acquisition Workstation C D Contrast Dose CC Cranio Caudal CR Computed Radiography DICOM Digital Imaging and Communications in Medicine DQE Detective Quantum Efficiency EC European Community EEC European Economic Community EMC Electromagnetic Compatibility Er Error EXP Exposure FB From Below FDA Food and Drug Administration FFDM Full Field Digital Mammography HE Help HVL Half Value Layer IEC International Electrotechnical Commission LAT Lateral LCC Left Cranio Caudal LLM Left Latero Medial LLMO Left Latero Medial Oblique LM Latero Medial LMLO Left Medio Lateral Oblique MAG Magnification MAN Manual ML Medio Lateral Mo Molybdenum MTF Modulation Transfer Function NAS Nuance Acquire Station OBL Oblique PA Posterior Anterior PACS Picture Archiving and Communication System PRS Planmed Radiation Shield PIG Panel Image Grabber RCC Right Cranio Caudal RF Rad
6. Select the exposure view you require by pressing one of the view selection keys The C arm will move to the view selected if it is not already in that position If you wish to stop the C arm moving press the key again If you chose a wrong view press the correct view key and the C arm will move to the new view The different views are explained in the following pages The READY lights on the control panel and the exposure control holder will come on when the viewing angle has been selected and the C arm is in the correct position In some countries X ray units are set up so that the C arm will not automatically move to the view selected when the view key is pressed To move the C arm to the selected view press and hold down the paddle up or paddle down switch on the foot control To stop the C arm moving remove your foot from the foot control User s manual Planmed Nuance amp Planmed Nuance Excel 45 SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW Table 1 Default factory settings for the view selection keys Breast View selection key Normal selection Three second selection Left cranio caudal SIN CC Bi in AWS Left oblique SIN OBL LLMO Left lateral SIN LAT LLM Right cranio caudal DEX CC PA FB in AWS Right oblique DEX OBL RLMO Right lateral DEX LAT RLM 13 3 Normal view selection Cranio caudal view 1 Press the left CC key to select the l
7. The kV change in AAEC mode depends on the detected average tissue composition as described in the table below to keep the image contrast to noise ratio at its maximum User s manual Planmed Nuance amp Planmed Nuance Excel 67 FLEX AEC PRINCIPLES AND USER SETTINGS Glandularity kV change 0 15 2 16 35 1 36 70 0 71 100 1 The W target imaging performance can be further optimized with the CNR dose parameter The parameter range is from 4 to 4 and it adjusts the image signal level as a function of the compressed breast thickness as shown in the figure below Signal CM 4 cM 0 cp 4 40 50 70 At setting 4 the AEC aims at an equal signal level despite the breast thickness This however tends to excessively increase the glandular dose on a large breast Therefore it is beneficial to adjust the CNR dose parameter to optimize the image contrast to radiation dose The recommended setting is 0 68 Planmed Nuance amp Planmed Nuance Excel User s manual FLEX AEC PRINCIPLES AND USER SETTINGS The figure below demonstrates the effect that this setting has on the Average Glandular Dose It shows that there is only a slight change in the dose at ticknesses below 45 mm but the effect at breast thicknesses greater than that is remarkable The curves are for 50 glandular tissue Since larger breasts tend to be more fatty the three dott
8. M113 20 35 kV 2 kV M118T 28 35 kV 2 kV E7290 80 110 mA 5 mA M113 91 120 mA 5 mA M113T 91 114 mA 5 mA 96 Planmed Nuance amp Planmed Nuance Excel User s manual TECHNICAL SPECIFICATIONS Anode current 0 1mm mAs range Exposure time 0 3mm Exposure time 0 1mm Cooling Line voltage Fuses Power consumption Mode of operation Maximum apparent resistance of supply mains Maximum continuous heat dissipation NOTE tions C ARM Rotation Vertical movement SID Compression Detector Magnification The Lift and C arm rotation motors operation AUTOMATIC EXPOSURE CONTROL Detector areas MECHANICAL DATA Dimensions H x D x W Weight Colour E7290 20 35 mA 1 mA M113 31 42 mA 3 mA M113T 31 39 mA 3 mA E7290 5 660 mAs M113 M113T 5 720 mAs 0 1 5 seconds 5 0 1 9 9 seconds 5 automatically controlled 208VAC 50 60 Hz 240VAC 50Hz 2x15 AT 250V 250 VA 4500 VA max 5 seconds intermittent 0 5 ohm 250 W Complies with IEC 60601 1 safety and IEC 60601 2 7 radiation performance regula motorized range 135 180 motorized range 800 mm 1400 mm 31 5 in 55 1 in 650 mm motorized with manual fine tuning amorphous selenium flat panel detector 1 6 1 8 or 2 0 Intermittent operation The effective duty cycle is 8 25 sec ON 300 sec OFF 48 automatic detector areas 1026 mm x 994 mm x 755 mm minimum 40
9. ERROR ERROR MESSAGE CODE EXPLANATIONS CORRECTIVE ACTION Er61 Failure or sporadic disturbance in Clear the error message and check if the unit works serial communication between correctly If it does not switch the unit off from the main TUBE and REAR CPU or non power supply wait a few seconds and then switch the compatible software versions unit on again If the unit still does not work correctly contact your local sales representative Er62 Failure or sporadic disturbance in Clear the error message and check if the unit works serial communication between correctly If it does not switch the unit off from the main REAR CPU and external test device power supply wait a few seconds and then switch the unit on again If the unit still does not work correctly contact your local sales representative Er63 Error in STOP communication line Clear the error message and check if the unit works between TUBE and REAR CPU correctly If it does not switch the unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Ery Error in exposure communication Clear the error message and check if the X ray unit line between TUBE and REAR CPU works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still
10. TOD QB POCA WIOW poirien a a e a e a a a ie 47 13 6 Fine tuning the viewing angle cccecceesseeeenneeeeeeeeeeeeeneeeeeeeeeeeeeeeeeeeeseeeseeeneneeeetees 48 13 7 Adjusting the X ray unit height ecisevcius cieivevcs tate tated Gane pidevecheaewedeee pasate seu beavings 48 13 8 Side Access patient positioning ccceccessseecceeeeeeeeeeeeeeeeeeeeeeseneeeeeeeeeeesssuttaeeeeeeeseeee 49 14 SCREENING MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT 50 14 1 Breast positioning and compression with MaxView cccccccccceccceeceeeeeeeeeeeeeeeeeeeeeess 50 14 2 Breast positioning and compression without MaxView ccccccceeceecceeeeeeeeeeeeeeeteess 53 14 3 Imaging with the 18 x 24 cm Compression paddle cece eeeeeeeeeeeeeeeeeeetneeeeeeeeees 54 14 4 Emergency compression release ecceceeccneeeeeeeeeesee cee eeeeeeeneeeeeeeeeeeeeesseeseeeeeneeeneaes 54 14 5 Taking n xDOSuUre senie kep aaa AA KAAKE TTA AES TRENK ieee 55 14 6 After the OXPOSUIC net i O A E EEEE RI AE EE R 56 15 DIAGNOSTIC MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT 57 15 1 Planmed Nuance Excel magnification procedures optional ccccccceeeeeeeeeees 57 15 2 Planmed Nuance magnification procedures optional cccceeceeceeeceeeeeeeeeeeeteees 59 15 3 Emergency compression release in magnification mode c s ceccceeeceeeeeeeeeeeeeeees 60 15 4 C ntact spot MOUS seriinin ae a a aaa aeia aa aa E ad e
11. The field light will automatically come on for 25 seconds and the compression paddle will start to descend During this phase of the breast compression the maximum limit in dekanewtons daN at which the compression force is set will appear on the time force display and start to flash The compression can be stopped by releasing the foot control To continue compression press the foot control again Press either of the field light keys to switch the radiation field light on Adjust the size of the radiation field if necessary by pressing either of the field light keys The compression paddle can be moved upwards by pressing the paddle up switch on the foot control AS you start to compress the patients breast the compression force stop limit will clear from the display and be replaced 1with the actual compression force in dekanewtons The distance in centimeters between the compression paddle and the bucky breast thickness will appear on the breast thickness display When the compression force reaches the preset limit you will hear a tone and compression will stop 10 To continue compression stop and then start pressing the compression foot control again The paddle will start to descend again but this time at a slower speed User s manual Planmed Nuance amp Planmed Nuance Excel 53 SCREENING MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT To adjust the speed of compres
12. 24 LIST OF ABBREVIATIONG cccccccceccccessseeeeeeeeeecceesseeeeeeeeeeeeessseeeeeeeees 100 User s Manual Planmed Nuance amp Planmed Nuance Excel iii TABLE OF CONTENTS The manufacturer assembler and importer are responsible for the safety reliability and performance of the unit only if installation calibration modification and repairs are carried out by qualified authorized personnel electrical installations are carried out according to the appropriate requirements such as IEC 60364 equipment is used according to the operating instructions Planmed pursues a policy of continual product development Although every effort is made to produce up to date product documentation this publication should not be regarded as an infallible guide to current specifications We reserve the right to make changes without prior notice COPYRIGHT PLANMED PUBLICATION NUMBER 20005787 Revision 11 Released 13 August 2010 iv Planmed Nuance amp Planmed Nuance Excel User s Manual INTRODUCTION 1 INTRODUCTION NOTE NOTE CC NOTE 26 This manual describes how to set up and use the Planmed Nuance or the Planmed Nuance Excel Full Field Digital Mammography FFDM X ray Unit and the respective systems which are further in text jointly referred to as The Planmed FFDM X ray unit system or just The X ray unit system Where applicable any differences in the features or use of the
13. 61 15 5 BiOPSy PrOCECUreS 20 2 0 E E E E EE A E E E 61 16 FLEX AEC PRINCIPLES AND USER SETTINGS cccccccseeeeeeeeeeeeeeeeeeeeeeees 63 16 1 Principles of the Flex AEC operation ccceccccccceeeessenneceeeeeeessessenaeeeeeeessseseneseeeeeeess 63 16 2 Flex AEC Us rsetingS eiennenn n a Saa 63 17 SPECIAL FUNCTIONS cicsicicscttcnstataii sie teers eee meets 70 17 1 Automatic filter selection oo cececccceceneccecceecececceeceeccceceececesceeceeeceneceeeeeeeeeeeteeereeerens 70 17 2 Setting the oblique View angle ooo cece ee eeneeeeeeeeaeeeeeeneeeeeeeaaaeeeeesaaeeesneceeeeeeeaaeeees 71 17 3 Manual exposure procedure cccccceccecccecccecceeeeeeceeeceeeceeeeeeeeeeeeeneeeeeeeeeeeeeeeteeeinetes 72 17 4 Setting the correct time and date 0 eee cess ee eeeeeeeeeeeeeeeeeeeaaeeeeeeaaeeeeeeeeeeestenseeees 72 17 5 Setting the speed of the compression paddle movement sccceeeeeeeeseeteeeeeeeees 73 17 6 Setting the stop limit of the compression force ceeececcecececeeeneeeeeeeeeeeseesteeeeeeeeeeees 74 17 7 Adjusting the volume of the exposure indicator Signal ceeeeeseeeeeeeeeeeeeneeeeeeeeees 74 17 8 Enabling and disabling the Bucky grid MOVEMENT eee ceeeeeeeeeeeeeeeteeeeeeeteeeetnneeeeeeeeees 75 BL INP CUAL OnT A A MESA EE E E x sutertaduama sandce E nani Gayuncaes 75 1G HELP MESSAGES a cific a ae aaaea aaaea aa h a Ae ea ra nE Eai aaeei aaa 76 19 HELP MESSAGES STEREOTACTIC MOD
14. 74 Planmed Nuance amp Planmed Nuance Excel User s manual SPECIAL FUNCTIONS 17 8 Enabling and disabling the Bucky grid movement NOTE N i ODFFE lean ONG dan gi 17 9 mA limit on off OREG OFFC aan 3 oO Q S Zz iN Note that the grid movement is forced ON every time the X ray unit is turned on To enable and disable the Bucky grid movement Press the CTL key to select the secondary functions The indicator light will come on Press and hold down the right field light key for 2 seconds Press the field light keys to change the setting The time force display shows the current setting This message indicates that the grid movement is disabled This message indicates that the grid movement is turned on Press the CTL key to accept the new setting The indicator light will go out To switch the mA limit on and off Press the CTL key to select the secondary functions The indicator light will come on Press and hold down the kV down key for 2 seconds Use the field light keys to change the setting The time force display shows the current setting This message indicates that the mA limit is off The mA value is chosen to be the maximum allowed mA for the selected kV value This message indicates that the mA limit is on The maximum mA value that can be used is 80 mA Press the CTL key to accept the new setting The indicator light
15. Remove any dust gathered in the pad e g by shaking or blowing it off If the pad is very dirty replace it with a new one There is also an air filter at the side of the FFDM detector User s manual Planmed Nuance amp Planmed Nuance Excel 8 amp 9 MAINTENANCE 21 6 MaxView maintenance Removing sheet fragments from MaxView modules NOTE The MaxView sheets can break if they are misused This will happen for example if you try to pull the MaxView sheet out without pressing the eject sheets switch In this case the sheet is forced out when the module s four locking claws are holding it firmly in position Always use new sheets for every patient The sheets can break if they are not changed between patients If sheet fragments get into the MaxView module s you will have to open the module s and remove each sheet fragment separately Otherwise the module s will not work properly Removing sheet fragments from the upper MaxView module eps aohjain_yla Paddle down Both sheets in o 15 Traction distance Follow the procedure described below to first move the module s locking claws into a position where the sheet fragments can be easily removed To remove sheet fragments from the upper MaxView module Move the C arm to the vertical position by pressing the CC key Press the paddle down switch on the foot control to lower the compression paddle slightly Allow the paddl
16. air or with oxy gen or nitrous oxide 4 Planmed Nuance amp Planmed Nuance Excel User s manual WARNINGS AND PRECAUTIONS NOTE NOTE NOTE CAUTION CAUTION NOTE NOTE NOTE NOTE NOTE The computer and display are connected to mains via Nuance Isolation Transformer They must be IEC approved CE marked protectively earthed External equipment intended for connection to signal input signal output or other connectors shall comply with relevant IEC standard e g IEC 60950 for IT equipment and the IEC 60601 series for medical electrical equipment In addition all such combinations systems shall comply with the standard IEC 60601 1 1 Safety requirements for medical electrical systems Equipment not complying to IEC 60601 shall be kept outside the patient area Any person who connects external equipment to signal input signal output or other connectors has formed a system and is therefore responsible for the system to comply with the requirements of IEC 60601 1 1 If in doubt contact qualified technician or your local representative The multiple portable socket outlet MPSO must not be placed on the floor Do not connect another multiple portable socket outlet or extension cord to the sys tem Do not connect items that are not speci fied as a part of the system Maximum permitted load of the multiple portable socket outlet is 1250 VA Nuance Isolation Transformer may only b
17. bucky is correctly attached The grid of the bucky will emit a sound when the bucky has reached the back edge To remove the Bucky Turn the locking knobs upwards on both sides to disengage the locking mechanism Slide the Bucky out NOTE When you remove the Bucky a carbon fibre cover with a sensitive detector directly underneath is exposed Always keep the carbon fibre cover clean to prevent image artefacts 34 Planmed Nuance amp Planmed Nuance Excel User s manual PREPARING THE X RAY UNIT 10 2 Attaching and removing the compression paddle Lmam_pad_rel eps Lmam_pad_attc eps To attach the compression paddle Press the compression release key to move the paddle holder up This ensures that you will have enough space between the paddle holder and Bucky when attaching the compression paddle Place the compression paddle in the paddle holder in a downwards tilted position Pull up the paddle to lock it in position To remove the compression paddle Press the compression release key to move the paddle holder to the preset position Press the green unlock knob to release the paddle see paragraph 10 3 Paddle lock on page 36 Tilt the paddle down and lift it off User s manual Planmed Nuance amp Planmed Nuance Excel 35 PREPARING THE X RAY UNIT 10 3 Paddle lock The paddle lock pr
18. does not work correctly contact your local sales representative Er68 Both switches paddle down and Clear the error message and check if the X ray unit paddle up of one foot control are works correctly If it does not switch the X ray unit off pressed down from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er 1 Software chip Flash EEPROM Clear the error message and check if the X ray unit failure on TUBE CPU works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er72 Software chip Flash EEPROM Clear the error message and check if the X ray unit failure on REAR CPU works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er73 REAR CPU attempted to execute an Clear the error message and check if the X ray unit illegal program instruction works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local
19. force measurement calibration failure force signal out of range Clear the error message and check if the X ray unit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er29 Control panel key short circuited pressed or faulty display board during the self test Remove the obstruction Clear the error code and the X ray unit can be used If the error code reappears contact your sales representative for help Er30 X ray tube anode voltage kV missing dropping during exposure or lower than the setting Clear the error message and check if the X ray unit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er3l X ray tube anode current mA missing dropping during exposure or lower than the setting Clear the error message and check if the X ray unit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er32 X ray tube anode current higher than the setting m
20. magnification factors 1 6 1 8 and 2 0 18 cm x 24 cm multifunction magnification platform Chin guard The chin guard is attached to the C arm as shown in the figure T gt Chin guard Exposure button There are two alternative types of exposure buttons of which either is located behind the radiation protection screen The exposure buttons are shown in the figures Exposure O button Exposure button 18 Planmed Nuance amp Planmed Nuance Excel User s manual PLANMED FFDM SYSTEM MAIN PARTS 7 7 Planmed radiation shield optional Refer to Installation Guide for Planmed Radiation Shield 20006052 7 8 Planmed Nuance Acquire Station optional The Planmed Nuance Acquire Station NAS is a comprehensive and ergonomic approach to digital image acquisition Motorized height adjustment optio nal swivel display arm isolation transformer optional UPS Uninterruptible Power System and unique hygienic materials make the NAS a perfect solution for ergonomic and fast image acquisition It is primarily the technologist work center when performing mammography exam The NAS provides many functional features combined with ergonomic and elegant design thus complementing the Planmed FFDM working environment For further information refer to NAS users manual publication number 20006020 User s manual Planmed Nuance amp Planmed Nuance Excel
21. of the panels If needed you can pull only one sheet by pressing the corresponding sheet control switch on the Upper sheet in Upper sheet out panel The sheets can be pushed out when the breast is not being compressed by using both inner sheet control switches on one of the panels If needed you can push only one sheet out by pressing the corresponding sheet control switch on the panel 13 Stop the sheet movement by releasing the switch es 14 To continue pulling pushing press it again Lower sheet in ower sheet out NOTE If you try to pull the sheets when the compression paddle is up the sheets will be automatically moved back into the start up position when you release the switch es Lower the paddle first before you start pulling the sheets User s manual Planmed Nuance amp Planmed Nuance Excel 51 SCREENING MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT NOTE NOTE CAUTION 15 Traction distance Do not allow any skin folds during the breast positioning Any folded breast tissue must be straightened and flattened as much as possible The sheets must remain straight and free of wrinkles during the pulling Be careful not to pull the sheets too much Always observe the patient closely for signs of discomfort Never allow breast tissue to be pulled into the MaxView mod ules o 15 As you start to pull the sheets the angle degree will clear from the angle display and it will be replaced with the tract
22. will go out User s manual Planmed Nuance amp Planmed Nuance Excel 75 HELP MESSAGES 18 HELP MESSAGES A help message appears on the time force display if a key that has no function is pressed or if the function is not allowed for some reason The help messages disappear automatically when the key is released CODE HELP MESSAGE EXPLANATIONS HE 9 No view selected HE 11 The up down movement of the X ray unit is not allowed during the compression of the breast HE 14 The kV setting cannot be changed before you reduce the mAs setting HE 18 A higher mAs value is not allowed with the current kV setting HE 20 This key functions only in AEC mode HE 21 This key functions only in the manual exposure mode HE 23 This key has no function together with the CTL key HE 2U The C arm cannot be rotated with the C arm rotation switches the compression force is more than 5 daN HE 25 The error must be cleared first from the display CTL key HE 27 The exposure switch is still activated HE 28 The C arm is not allowed to continue to rotate without pressing any of the foot controls HE 35 You cannot select the Automatic Paddle Release function HE 36 You have to release the upper compression paddle before selecting the exposure view HE 37 No Bucky HE 39 The AAEC mode is not allowed with current kV setting OR A lower kV setting is not allowed in the AAEC mode HE U1 kV
23. 19 PLANMED FFDM SYSTEM MAIN PARTS 7 9 Main control panel Left cranio caudal key Left oblique key Left lateral key Stereotactic operation workflow key kV down key and display mAs down key and display Dose level down key and display CTL key secondary function Reduce field light key Paddle selection key Time force display Filter indicator lights Exposure ready indicator lights Stand by key Filtration spot key and indicator lights There are two control panels one on each side of the X ray unit They are identical and either or both of them can be used to operate the X ray unit CAUTION X RAYS ATTENTION RAYONS X Angle display Right cranio caudal key Right oblique key Right lateral key kV up key and display mAs up key and display Dose level up key and display Compression release key Expand field light key Breast thickness display Focal spot indicator lights Automatic manual exposure indicator lights Automatic manual exposure key Focal spot selection key press and hold NOTE The displayed value is always in dekanewtons daN even if indicated as dN on some displays One dekanewton equals to approximately one kilogram kg 20 Planmed Nuance amp Planmed Nuance Excel User s manual PLANMED FFDM SYSTEM MAIN PARTS Cranio caudal CC key left and right o Press the left CC key to select the left cranio caudal viewing angle and the rig
24. 4 in x 39 1 in x 29 7 in approximately 191 kg depending on configuration RAL 9016 421 Ibs User s manual Planmed Nuance amp Planmed Nuance Excel 97 TECHNICAL SPECIFICATIONS 23 2 Amorphous Selenium c Se Flat Panel detector ORIGINAL MANUFACTURER ANRAD Corporation 4950 Levy St SAINT LAURENT QUEBEC CANADA MODEL AND MECHANICAL DATA PLANMED NUANCE EXCEL Model Detector technology Overall dimensions L x W x H Power consumption Weight Bias voltage Pixel pitch Resolution Active area Selenium thickness Read time Time between X ray images LMAM amorphous selenium over transistor panels 354 x 368 x 72mm 13 94 x 14 5 x 2 84 in 60 W 2 73 kg 6 lbs unpacked 2000 V 85x85 um 2816 x 3584 pixels 239 36 x 304 64 mm 9 42 x 11 99 in 200 um 1 15 approx 30s thin film MODEL AND MECHANICAL DATA PLANMED NUANCE Model Detector technology Overall dimensions L x W x H Power consumption Weight Bias voltage Pixel pitch Resolution Active area Selenium thickness Read time Time between X ray images SMAM amorphous selenium over transistor panels 268 x 278 x 38 mm 10 6 x 10 9 x 1 5in 35 W 2 35 kg 5 2 Ibs unpacked 2000 V 85x85 um 2016 x 2816 pixels 171 x 239 mm 6 73 x 9 41 in 200 um 1 3s approx 30 s thin film 98 Planmed Nuance amp Planmed Nuance Excel User s manual TECHNICAL SPECIFICATIONS ENVIRONMENTAL
25. A Clear the error message and check if the X ray unit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er33 X ray tube filament voltage V out of range Clear the error message and check if the X ray unit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er3uy X ray tube bias voltage V out of range Clear the error message and check if the unit works correctly If it does not switch the unit off from the main power supply wait a few seconds and then switch the unit on again If the unit still does not work correctly contact your local sales representative Er35 The Mains sync signal from the SYNC PCB is not reaching the TUBE CPU Clear the error message and check if the unit works correctly If it does not switch the unit off from the main power supply wait a few seconds and then switch the unit on again If the unit still does not work correctly contact your local sales representative Er36 The REAR CPU detected a too long exposure gt 10sec and terminated it Clear the error message and check if the unit works correctly If
26. AY UNIT on page 50 17 4 Setting the correct time and date N 12 33 w Sz v a z YN 3 G e G aN The clock is set at the factory to the local time and should be set to show the correct time date before using the X ray unit To set the time and date Press the CTL key to select the secondary function mode The indicator light will come on Press and hold the stand by key until the current time appears on the time force display The minutes start to flash Press the stand by key to step to the parameter s to be adjusted the sequence is minutes hours day month years century minutes Press the field light keys to change the setting of the selected parameter Press the CTL key to accept the new time The invisible seconds counter is zeroed 72 Planmed Nuance amp Planmed Nuance Excel User s manual SPECIAL FUNCTIONS 17 5 Setting the speed of the compression paddle movement The initial descent speed During compression the compression paddle moves downwards at two different speeds e the speed of initial descent no compression e the rate at which the speed decreases during the compression stage These speeds can be adjusted To set the initial speed Press the CTL key to enter the secondary function mode The indicator light will come on Press and hold the mAs down key to select the initial speed of descent range The cu
27. E cccccceeceeeeeeeeeeeeeeeeeeseeeeeeeeees 77 20 ERRORS AND ERROR MESSAGES ccscccccsssseesseeseeesesssssssssssseeesessesseees 78 21 IAIN ENING Bits reo ois cates cece wnt aaaea ra aaia r Aaa aara daaa aaaeaii aaa aa 87 241 Daily heck m rei epedana EAE ET AAEE Tee AE AEGEE oe ae T EE 87 2127 CISA ea a ara a a a 87 21 3 Preventive maintenance o cccccccceecececcceceeceeecececcecececececeeeceececeseeeseeeceeeeeeeeeeeteeereetteeg 88 214 SEIVICING Sesera e a a A eE O rE Eia EEE dss nadeateetauedadersndcsene 88 21 5 FFDM Detector maintenance cceccsccesccceecceceeecceeceeceeecceeccecceeeeeeeeeceeeeeeeeeeereeereess 89 21 6 MaxView maintenance cc cecsecesecssecceeaeeeaaneaeecaecaaecaeeeaeccaeceeceeeceeeceeceeeeeeeceeeeeeeeeess 90 22 DISPOSAL OF THE X RAY UNIT wcccccccccciciccccetcccccrcccecctetecestassceeessesteccsences 94 ii Planmed Nuance amp Planmed Nuance Excel User s Manual TABLE OF CONTENTS 23 TECHNICAL SPECIFICATIONS snnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nenna 96 23 1 Planmed FFDM X ray unit siiecctictdget adindelinaen cei needa vida dere 96 23 2 Amorphous Selenium a Se Flat Panel detector c ccccccccccessesecceceeeeesseneeeeeeeeeeees 98 23 3 Planmed FFDM X ray unit device label cccceeceeeeenceeeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeeeeeneees 99 23 4 Planmed Nuance Isolation Transformer device label c cccccccccceceeecceeeeeeeeeeeeeeeees 99
28. HE31 In the stereotactic mode the ST key is used only for the synchronized ST rota tion movement from ST1 to ST2 posi tion Before the synchronized ST rotation enter the stereotactic mode by selecting the correct view and driving the X ray unit to the ST1 position HE32 In the stereotactic mode you cannot select the view before the X ray unit has been driven away from the ST position Before selecting the view drive the X ray unit to the upright position press the CTL key press and hold down the ST key and press the C arm up switch on the foot control HE34 In the stereotactic mode the C arm is not allowed to continue to rotate without pressing the middle switch ST drive on the foot control during the synchronized ST rotation movement from ST1 to ST2 position Press and hold down the ST drive switch on the foot control The patient may remain in position User s manual Planmed Nuance amp Planmed Nuance Excel 77 ERRORS AND ERROR MESSAGES 20 ERRORS AND ERROR MESSAGES If the X ray unit malfunctions or you make a mistake when using the equipment an error message appears on the display Before corrective actions can be taken press the CTL key to clear the error message from the display ERROR ERROR MESSAGE CODE EXPLANATIONS CORRECTIVE ACTION ErOoO Exposure switch was released too Clear the error message Remember to hold the e
29. L FUNCTIONS 17 6 Setting the stop limit of the compression force Ce Ol 10F lan z 4 To set the stop limit Press the CTL key to enter the secondary function mode The indicator light will come on Press and hold the left LAT key to select the compression force setting mode The current force in dekanewtons will appear on the display and start to flash Press either of the field light keys to select the stop limit of compression force The minimum limit is 1 daN and the maximum limit is 20 daN When you reach the preset limit during the compression you will hear a signal tone and compression will stop The compression can be continued after this but only at a very slow speed Press the CTL key again to accept the new stop limit for the compression force and exit the secondary function mode The indicator light will go out 17 7 Adjusting the volume of the exposure indicator signal g 0004 To adjust the volume Press the CTL key to select the secondary functions The indicator light will come on Press and hold down the dose level key above the CTL key until you hear the exposure indicator signal Press either of the field light keys to change the tone of the indicator signal The plus sign right will increase the tone and the minus sign left will decrease the tone Press the CTL key to accept the new or existing volume The indicator light will go out
30. N The AWS monitor must NOT be used for the final interpretation of examinations NOTE The FFDM detectors utilize amorphous Selenium a Se to directly convert the incoming X ray photon to an electrical signal The flat panel technology has been specially designed for digital mammography with very high DQE and MTF characteristics The fast acquisition and reading rates of the detector enable high X ray throughput mammographic screening with the Planmed FFDM X ray unit as well as high precision diagnostic mammography procedures The digital detector of the Planmed FFDM X ray unit is located on the lower shelf inside a carbon fibre Bucky The Bucky is designed to cover the sensitive electronics and it is also essential for optimal temperature regulation of the detector Please make sure that the Bucky is properly attached at all times also when the X ray unit is not operated or it is switched off Some accessories such as the magnification platform require a temporary removal of the Bucky see chapter 10 1 Attaching and removing the Bucky on page 34 Do not leave the detector uncovered for a prolonged time In addition ensure that the detector surface is clean and nothing is left between the Bucky and the detector surface During the first installation qualified Planmed representatives install the detector into the X ray unit Thereafter the detector is an integrated part of the X ray unit User s manual Pla
31. Nuance Acquire software application For more information see Planmed Nuance Acquire User s Manual and Planmed Nuance Nuance Excel Manager User s Manual 9 4 Shutting down the Planmed FFDM system To shut down the Planmed FFDM system Complete all image acquisition and maintenance operations before beginning the shutdown sequence Do not enter any commands during the system shutdown Close the image acquisition software see Nuance Acquire User s Manual for more details 3 Shut down Windows 4 Switch the Planmed FFDM X ray unit to the stand by NOTE NOTE mode by pressing the Stand by key for three seconds In stand by mode the detector fan remains operational in order to maintain the optimal detector temperature Make sure that ventilation is not obstructed and the Bucky is properly attached User s manual Planmed Nuance amp Planmed Nuance Excel 33 PREPARING THE X RAY UNIT 10 PREPARING THE X RAY UNIT This section explains how to prepare the X ray unit for your particular requirements In normal circumstances it only needs to be done if you are using the X ray unit for the first time changing compression paddles or if you are going to carry out some special procedures 10 1 Attaching and removing the Bucky To attach the Bucky 1 Slide the Bucky along the shelf surface as far as it slides 2 Turn the locking knobs backwards on both sides simultaneously NOTE Make sure the
32. OGRAPHY WITH PLANMED FFDM X RAY UNIT 7 Adjust the size of the radiation field if necessary by pressing either of the field light keys 8 The paddle can be moved upwards by pressing the paddle up switch on either foot control 9 As you start to compress the patient s breast the 16 daN 6 5 compression force stop limit will clear from the display o and it will be replaced with the actual compression Compression force Breast thickness force in dekanewtons The distance in centimeters between the compression paddles that is breast thickness will appear on the breast thickness display 10 When the compression force reaches the preset limit you will hear a tone and compression will stop 11 To continue compression stop and then start pressing the compression control again The paddle will start to descend again but this time at a slower speed To adjust the speed of compression refer to section 17 5 Setting the speed of the compression paddle movement on page 73 NOTE Detach the MaxView sheets from the suction cups before you start pulling the sheets CAUTION Be careful not to leave your hands between the MaxView modules or com pression paddles during compression 12 Pull as much breast tissue into the imaging field as possible by pressing the middle switch on the foot control Both sheets in The sheets can also be pulled simultaneously by pressing both outer sheet control switches on one
33. OY aay NOTE StOP am If the X ray unit has been totally out of power or switched off from the main power switch for more than 15 minutes the X ray unit must be allowed to warm up to operating temperature before starting the exposure to ensure best image quality To switch on the X ray unit Press the On Off switch which is located on the base behind the fixed column When the power is switched on the X ray unit will carry out an automatic self test that lasts about 10 seconds When the self test is being performed the message tESt appears briefly on the time force display The current time will then appear on the time force display This indicates that the X ray unit is ready for use If the letters Er error and a number error number appear on the display it means that there is something wrong with the X ray unit and it did not pass the self test Refer to section 19 HELP MESSAGES stereotactic mode on page 77 If the message StOP appears on the display it indicates that the emergency stop button on the hood has been pushed down Pull the button up to clear the display and allow the X ray unit to operate 32 Planmed Nuance amp Planmed Nuance Excel User s manual START UP OF PLANMED FFDM SYSTEM 9 3 Starting up the AWS After the Planmed FFDM X ray unit has been successfully started up press the power on key of the AWS computer to start up the Nuance Acquire acquisition workstation and the
34. Planmed Planmed Planmed Nuance amp Planmed Nuance Excel FFDM X ray Unit users manual LL 28250002 TABLE OF CONTENTS 1 INTRODUCTION isesccelaccssretcctecctelsetcscntsuidscensenssuedivnsvsdaneuahadersbharevanchasnessbhassecs 1 2 SYMBOLS a clan aceite ai Easa i A aE Fas aiii 3 3 WARNINGS AND PRECAUTIONG cccccccccesesssesssssssesseseeesensseeeeeeeeeeessssesseeeees 4 4 CHECKLIST BEFORE OPERATION inccsccssccccseccssccsecesstceccssscssoncnseassneessaseneeauese 6 5 RELATED MANUALS si iosisccisetsvstisentiacecceccewcecensnccieni cute lecceseedine codeccwentucsauecustnt 6 6 INTRODUCTION TO PLANMED FFDM SYSTEM ccccccssssssssessssssssessseeees 7 6 1 Indications fOr US ainiye aa i eiaeetetes at tesa eee ad aces Hee 7 6 2 CoftraindicationS so sccced cds loner Sete a ea co oat aati tread Se halal a EA EAS 7 6 3 Introduction to FFDM 2 ssiciciies eenean KEN as ead aaa haa AAAA on 7 7 PLANMED FFDM SYSTEM MAIN PARTS seeeseeeeeeeeeeeeeeeeeeeeeeees 8 7 1 Planmed FROM system setup iss aritete li aiahiccentteaut ze ceetviera tester cise etdeaeeape alan tenets 8 LA AWS isto tosinae A ds teeta eae R E aa aa a a a O ARE 9 7 3 FFOM detector sesso isao i eaan ERA eaS Eni riei a aeae TE AE aAa EE Sadeen 9 7 4 Maintenance of the FFDM detector ssssssssesssssssserrrrtsstettrrrttttetrtrinttesesrtnennnssssrrrennnt 10 7 5 Main parts of the Planmed FFDM system sssseseseseerrrrrrtererrrrrrrreesrrrirrrnsssrr
35. REQUIREMENTS Operating temperature 15 to 28 C 59 to 89 F Operating temperature gradient 2 C 3 6 F per hour maximum Operating humidity from 25 up to 80 non condensing Storage temperature 5 to 40 C 41 to 104 F Transportation temperature 5 to 40 C 41 to 104 F An air conditioning system MUST be installed at the site and operating as specified NOTE The technical specifications are subject to change without notice NOTE Refer to the Planmed Nuance amp Planmed Nuance Excel FFDM X ray Unit Technical Manual publication number 20005791 for the User s Statement 23 3 Planmed FFDM X ray unit device label MAMMOGRAPHY X RAY UNIT TYPE PLANMED _ NUANCE LI NUANCE EXCEL SN cal 208VAC 50 60Hz 240VAC 50Hz STANDBY 250VA 4 5kVA 5s MINIMUM OVERCURRENT RELEASE 16AT USA 15AT MAXIMUM APPARENT RESISTANCE OF SUPPLY MAINS 0 50 LIFT AND C ARM ROTATION MOTORS OPERATION Intermittent operation ED 8 25 sec ON 300 sec OFF 35 kV maximum TOTAL FILTRATION _ 30um Mo AND _ 0 5mm Alor 25ym Rh OR 60um Rh 75um Ag MANUFACTURED BY PLANMED OY 00880 HELSINKI FINLAND A C Complies with DHHS radiation performance os37 Standard 21 CFR subchapter J 23 4 Planmed Nuance Isolation Transformer device label ISOLATION TRANSFORMER TYPE NUANCE ISOLATION TRANSFORMER SN aa INPUT _ 100V 50 60Hz 1400VA L 115V 50 60Hz 1400VA C 230V 50Hz 1400VA
36. agnification platform in position slide the magnification platform along the shelf surface until it is in the bottom Turn the locking knobs backwards on both sides simultaneously Install the appropriate spot paddle in the paddle holder Select the spot collimator by pressing and holding the filtration spot key for 2 seconds In this mode only the area of the spot cone will be exposed The filtration spot indicator light will come on When using the spot collimator the breast thickness read out is adjusted for the spot paddle The X ray unit can be adjusted only for one type of spot paddle The X ray unit can be set up so that the standard rectangular collimator is selected in the spot mode instead of the spot collimator but the breast thickness read out is adjusted for the spot paddle Contact your sales representative User s manual Planmed Nuance amp Planmed Nuance Excel 59 DIAGNOSTIC MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT 5 You can now set the exposure parameters compress the breast and take an exposure in the same way as described in section 13 SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW on page 44 and section 14 SCREENING MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT on page 50 6 After the exposure carefully evaluate the image at the Planmed Nuance Acquire AWS see chapter 12 IMAGE EVALUATION AT AWS on page 43 and Planmed Nuance Acquire User s Manual 7 Remove th
37. agnostic value e Planmed FFDM X ray unit Nuance or Nuance Excel e Planmed Nuance Acquisition Workstation AWS with a high resolution monitor e Planmed Radiation Shield optional the required pro tection can also be provided by other means The optional Planmed Nuance Acquire Station NAS in which the AWS can be located is also shown in the above picture In the following paragraphs these components are introduced at a general level Later chapters in this manual will provide in depth views of the normal operation of the X ray unit both in screening and diagnostic mammography Maintenance of the FFDM detector including calibration and quality assurance procedures is 8 Planmed Nuance amp Planmed Nuance Excel User s manual PLANMED FFDM SYSTEM MAIN PARTS 7 2 AWS 7 3 FFDM detector described in Planmed Nuance Nuance Excel Manager User s Manual Please contact your local Planmed sales representative in case you have any questions regarding the Planmed products The images are acquired and optimized at the AWS and subsequently sent to the optional Planmed Nuance Nuance Excel Softview Review Workstation RWS or to any PACS storage The AWS features the Nuance Acquire image acquisition software for mammography including optional DICOM communication modules Please see the separate Planmed Nuance Acquire User s Manual and Planmed Nuance Softview optional Users Manual for details CAUTIO
38. ail Compression paddle C arm controls Bucky and detector breast support table OANDOARWN 14 Planmed Nuance amp Planmed Nuance Excel User s manual PLANMED FFDM SYSTEM MAIN PARTS Control panel overview The Nuance control panel is the centre of all operations of the Planmed FFDM X ray unit The buttons have been positioned in groups including the control keys for C arm operation kV mAs selection dose level keys and general operation keys Va CAUTION X RAYS ATTENTION RAYONS X a J 7 C arm control keys Stereotactic operation Workflow key kV and mAs selection keys Dose level keys QO apoge GDDD N Technique selection keys OExe OFfT 3 OR OAAEC OREADYOFILT 2 Om OAEC PRET OFILT 1 OMAN Lmam_keyboard_outlineep e Va XN Q o c 3 Q a oy Q a D The telescopic column provides motorized vertical movement of the C arm The base includes the main On Off switch of the X ray unit located behind the column a base display and connections for both foot controls located under the base cover Telescopic column Fixed column Foot control Base display Foot control User s manual Planmed Nuance amp Planmed Nuance Excel 15 PLANMED FFDM SYSTEM MAIN PARTS Compression paddles The standard compression paddles are equipped with the Flex AEC area mark
39. ange from conventional film based imaging to digital image acquisition and display After the initial delay in the digital transformation we have seen an explosion like expansion of digital mammography The FDA approved the first system in 2000 and subsequently large amount of literature has emerged showing that FFDM has many benefits compared to the film screen mammography Digital imaging provides faster and easier storage and communication enables fast images processing and optimal presentation and even computer aided detection systems to assist the radiologist in making the diagnosis On the other hand a digital image has better contrast resolution than before This means that a digital image has more shades of gray or in other words one can see even the smallest details or finest nuances of the image In addition to digital screening and diagnostic mammography the digital break through in mammography has opened doors for the development of advanced applications which will potentially improve breast cancer detection in the future User s manual Planmed Nuance amp Planmed Nuance Excel 7 PLANMED FFDM SYSTEM MAIN PARTS 7 PLANMED FFDM SYSTEM MAIN PARTS 7 1 Planmed FFDM system setup Se s A I w 1 Ci P ie ka Ss Pee ey A general Planmed FFDM system setup is shown above Typically only the following three components are required to generate digital mammography images with high di
40. angerous to both patient and operator unless correct oper ating procedures are observed Handle the Planmed FFDM X ray unit according to the instructions given in this manual Do not handle the Full Field Digital detector with sharp objects and do not place or drop anything on it The Planmed limited warranty does not cover damage which is due to misuse neglect or any cause other than ordinary application Ensure efficient air conditioning in the examination room It is recommended to keep the room temperature between 20 C and 25 C at all times Portable and mobile RF communication equipment can affect the Planmed FFDM X ray unit If you have any reason to believe that the detector might be faulty take a test exposure before taking a patient exposure The operator must protect himself against scattered radiation The minimum required protective shielding is 60 cm wide minimum 185 high and less than 15 cm above the floor The material used must have a minimum attenuation equivalent of 0 08 mm of lead and it must provide visibility to the patient and equipment Note that local regulations must be obeyed in case they differ from the above EMC requirements have to be considered and the equipment must be installed and put into service according to the specific EMC information provided in the accompanying documents The Planmed FFDM X ray unit is not suita ble for use in the presence of a flammable anaesthetic mixture with
41. anmed Nuance Acquire User s Manual Biopsy procedure with perforated biopsy paddle NOTE NOTE The radiation field must be collimated in accordance with the size of the biopsy paddle Install the perforated biopsy paddle in the paddle holder Make sure that the automatic compression release is NOT switched on The indicator light must be off You can now set the exposure parameters compress the breast and take an exposure Refer to section 13 SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW on page 44 and 14 SCREENING MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT on page 50 After the exposure carefully evaluate the image at the AWS see chapter 12 IMAGE EVALUATION AT AWS on page 43 and AWS User s Manual Do not release the compression after the exposure The pattern of the holes in the perforated paddle will be seen on the image Localize the position of the lesion and insert the needle into the lesion through an appropriate hole in the biopsy paddle User s manual Planmed Nuance amp Planmed Nuance Excel 61 DIAGNOSTIC MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT 6 Take a second exposure 7 After the exposure carefully evaluate the image at the AWS see section 12 IMAGE EVALUATION AT AWS on page 43 and Planmed Nuance Acquire User s Manual 8 If the needle is in the right place take the biopsy If the needle is not in the right place reposition the nee
42. are used The X ray unit has four C arm control panels two on each side of the C arm The switches towards the front of the tube head change the angle of the C arm Pressing the upper switch will rotate the tube head away from the user and pressing the lower switch will rotate the tube head towards the user The switches towards the rear of the tube head adjust the height of the X ray unit by moving the C arm up or down The switch in the middle drives the tube head to the Side Access position For more information see 13 8 Side Access patient positioning on page 49 It is recommended to use the view selection keys and only fine tune the desired angle with these switches In some countries X ray units are set up so that the C arm will not move up or down when the patient s breast is compressed The X ray unit has two foot controls that can be positioned on both sides of the X ray unit The foot controls are identical not mirror images of each other and both can be used to operate the unit Looking at either foot control with the cable to the rear the functions are from left to right C arm up C arm down MaxView compression paddle up compression paddle down The movement will stop when the switch is released Note that the compression paddle can be moved up at any time excluding the stereotactic view in which the foot controls are used for controlling the tube head movements but it will only move dow
43. arly during the exposure exposure button down for the duration of the exposure ErlO X ray tube anode voltage kV Clear the error message and check if the X ray unit overshoot works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Erll X ray tube anode voltage kV Clear the error message and check if the X ray unit dropped suddenly works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Erle X ray tube cathode filament pre Clear the error message and check if the X ray unit heating voltages are not calibrated works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Erl3 X ray tube anode current mA Clear the error message and check if the X ray unit sudden peak works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Ery AEC senso
44. ate even if commanded from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative ErY7 Mains frequency out of range Clear the error message and check if the X ray unit 45 75 Hz or failure in frequency works correctly If it does not switch the X ray unit off measurement circuitry from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er50 Tube head assembly temperature Clear the error message and check if the X ray unit sensor short circuit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative User s manual Planmed Nuance amp Planmed Nuance Excel 81 ERRORS AND ERROR MESSAGES ERROR ERROR MESSAGE CODE EXPLANATIONS CORRECTIVE ACTON Er5 Tube head assembly temperature Clear the error message and check if the X ray unit sensor open circuit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your l
45. cannot be higher than the max value AAEC HE 43 The workstation is not ready for imaging yet HE YY Side Access drive not ready HE 45 The Side Access function is not available 76 Planmed Nuance amp Planmed Nuance Excel User s manual HELP MESSAGES stereotactic mode 19 HELP MESSAGES STEREOTACTIC MODE The following table lists the help messages that are related to the stereotactic mode CODE DESCRIPTION CORRECTIVE ACTION HE24 The C arm cannot be rotated with the C arm rotation switches when the compres sion force is more than 5 kg Select a view or decrease the compres sion force HE26 This key has no function in the stereotac tic mode Remove the stereotactic system first HE28 The C arm is not allowed to continue to rotate without pressing any of the foot controls Press and hold down one of the foot control switches to continue the move ment of the C arm HE29 You cannot move the C arm or the com pression paddles before the ST drive has been finished OR You cannot apply compression until the software is ready Use the middle switch ST drive of the foot control to finish the ST drive Wait until the cross disappears from top of status icon on AWS HE30 The Up Down movement of the C arm is not allowed in the stereotactic mode when the needle is inserted Remove the needle before repositioning the X ray unit
46. ce Acquire User s Manual for further details If the final image is acceptable you can directly proceed to the next view See chapter 13 SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW on page 44 Once all the images have been acquired accept the completed study by selecting Accept Study on the AWS screen The application returns to the Modality Worklist window or the Acquisition Console Patient Demographics dialog box where you can begin examining the next patient see chapter 11 PREPARING AWS FOR IMAGING on page 42 Alternatively you can display the Study List in order to review a saved study or you can log off the system The AWS monitor must NOT be used for the final interpretation of examinations User s manual Planmed Nuance amp Planmed Nuance Excel 43 SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW 13 SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW This section describes how to select the desired exposure parameters and viewing angle and how to prepare the X ray unit for patient positioning and exposure See also Planmed Nuance Acquire User s Manual 13 1 Setting the exposure values O AAEC 1 OAEC OMAN wina NOTE aa To set the exposure values Press the automatic manual exposure key to select the desired automatic exposure control AEC mode if it is not already selected With conventional AEC the correct kV must be selected before exposure and with
47. ction MUST NOT be activated if a biopsy is to be taken To activate the Automatic Paddle Release mode The indicator light will come on 2 Press the compression release key The indicator light will come on when the function is switched on gt function 1 Press the CTL key to activate the secondary function To deactivate the function 1 Repeat the above procedure The indicator light will go out 10 6 Preparing the X ray unit for MaxView Breast Positioning Attaching and removing the upper MaxView module If not already installed attach the upper MaxView module 1 Move the C arm to the vertical position by pressing the e CC key if it is not already in that position 2 Turn the safety release handle forwards 3 To place the upper MaxView module with a guide Guide plate plate in position hold it under the paddle holder and slide it upwards so that the MaxView module pins go into the corresponding holes in the paddle holder Upper MaxView module ps 4 Secure it by turning the two finger screws on the upper side of the paddle holder clockwise 5 Wait until the MaxView traction modules have been calibrated lasts approx 2 3 seconds Excel_MV_module e To remove the upper MaxView module 1 Move the C arm to the vertical position by pressing the Ce CC key if it is not already in that position 2 Turn the safety release handle forwards 3 Support the MaxView module from the bot
48. d 75 degrees To set the oblique view angle 1 Make sure that the C arm is in the vertical CC position Press the CTL key to activate the secondary function mode The indicator light will come on 2 Press the right OBL key to select the oblique view 45 The angle to which the C arm will rotate will appear on the angle display and start to flash 60 Press either of the field light keys to change the oblique angle The new angle will appear on the display 4 Press the CTL key to store the new oblique angle in the memory o oo User s manual Planmed Nuance amp Planmed Nuance Excel 71 SPECIAL FUNCTIONS 17 3 Manual exposure procedure O AAEC OAAEC 2 OAEC iz OMAN Om w Ll5 AN 7 65 ON To take exposures in the manual exposure mode Select the manual exposure mode by pressing the automatic manual exposure key The appropriate indicator light will come on Select the required focal spot by pressing and holding the automatic manual exposure key for 4 seconds The appropriate indicator light will come on Select the required kV value according to the build of the patient with the kV up and kV down keys Select the mAs value with the mAs up and mAs down keys You can now compress the breast and take an exposure in the same way as described in section 13 SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW on page 44 and section 14 SCREENING MAMMOGRAPHY WITH PLANMED FFDM X R
49. dle and take another exposure 9 Repeat the procedure until the biopsy can be taken Biopsy procedure with rectangular biopsy paddle optional NOTE The radiation field must be collimated in accordance with the size of the biopsy paddle Install the rectangular biopsy paddle in the paddle holder Make sure that the automatic compression release is NOT switched on the indicator light must be off You can now set the exposure parameters compress the breast and take an exposure in the same way as described in section 13 SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW on page 44 and section 14 SCREENING MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT on page 50 3 After the exposure do not release the compression The scale of the rectangular paddle will be seen on the image 4 Install the hair cursor alignement tool optional to the collimator slot and switch the field light on 5 Localize the lesion by moving the hair cursor wire to the lesion position When the field light illuminates the hair cursor the shadow will be cast on the breast tissue thus helping you to insert the needle into the lesion 6 Take a second exposure 7 After the exposure carefully evaluate the image at the AWS see section 12 IMAGE EVALUATION AT AWS on page 43 and Planmed Nuance Acquire User s Manual 8 If the needle cross is in the right place take the biopsy 9 If the needle cross is not in the right place
50. does not work correctly contact your local sales representative Er93 Error in the compression system end Clear the error message and check if the X ray unit limit sensors simultaneous signals works correctly If it does not switch the X ray unit off from both end limit sensors from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative ErQu Error in the C arm rotation sensor Clear the error message and check if the X ray unit system simultaneous signals from works correctly If it does not switch the X ray unit off the reference and or limit sensors from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er95 Error in the lift mechanism sensor Clear the error message and check if the X ray unit system simultaneous signals from both end limit sensors works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative User s manual Planmed Nuance amp Planmed Nuance Excel 85 ERRORS AND ERROR MESSAGES Boe a e CORRECTIVE ACTION Er96 Error in the Buc
51. e X ray unit in manual mode ErA8 The exposure button was released Clear the error message Remember to hold the too soon exposure button down for the duration of the exposure ErA9 Serious communication error Contact Planmed technical support requires technical maintenance ErEQ The detector temperature is too high Switch off Planmed FFDM X ray unit allow the X ray The detector power has been switched off to prevent damage unit to cool and switch it back on Check the air conditioning in the room and air flow around the Planmed FFDM X ray unit 86 Planmed Nuance amp Planmed Nuance Excel User s manual MAINTENANCE 21 MAINTENANCE The following maintenance work should be carried out See also the Quality Assurance protocol included in Planmed Nuance Nuance Excel Manager User s Manual NOTE Carry out all cleaning adjustment sterilization and disinfection procedures specified herein 21 1 Daily check A test exposure using a tissue equivalent test phantom should be taken at least once a day to ensure that the mAs and AEC exposure values remain consistent Check the condition of the compression paddles Buckys and magnification platform These parts can become brittle light parts and cracks after prolonged cleaning with wrong type cleaning solutions 21 2 Cleaning Compression paddles Buckys and magnification platform NOTE The compression paddles Buckys magnification p
52. e exposure contro older will come on and you wi hear two tones during the exposure period The first tone is the start up tone and the second a higher tone is the exposure tone When the exposure is complete the tone will stop User s manual Planmed Nuance amp Planmed Nuance Excel 55 SCREENING MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT 14 6 After the exposure Paddle up gt JE System not System ready ready If the Automatic Paddle Release function is switched on the compression paddle will automatically release after the exposure is completed If the Automatic Compression Release function is not activated press the compression release key to release the compression paddle The paddle will automatically move to the ready position You can also release the compression paddle by pressing and holding down the paddle up switch on the foot control Note however that the paddle will only move as long as you hold the switch down and the paddle will not automatically rise to the ready position When the paddle has risen to the ready position the MaxView sheets will be automatically moved into the start up position for another exposure Press the sheets onto the suction cups as described in section Attaching the MaxView sheets on page 39 Guide the patient away from the X ray unit The next exposure can be taken when the current time reappears on the time force display and when the System status bu
53. e magnification platform Spot paddle g 3 poi S 2 a E K g A S 3 S Za y Magnification platform 15 3 Emergency compression release in magnification mode In case of emergency turn the release knob to remove the spot paddle see figure knob 60 Planmed Nuance amp Planmed Nuance Excel User s manual DIAGNOSTIC MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT 15 4 Contact spot mode 20006185 Contact spot paddle 9x6 cm6 with rounded edges 15 5 Biopsy procedures Contact spot mode is used when the breast needs to be compressed within a small area only without the magnification platform When entering contact spot mode from normal mammography mode remove compression paddle When entering contact spot mode from magnification mode remove magnification platform magnification paddle and replace standard bucky Install the appropriate spot paddle see figure in the paddle holder In the Acquisition console window choose Coned down The application is now ready to acquire images You can now set the exposure parameters compress the breast and take an exposure in the same way as described in section 13 SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW on page 44 and section 14 SCREENING MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT on page 50 After the exposure carefully evaluate the image at the AWS see chapter 12 IMAGE EVALUATION AT AWS on page 43 and Pl
54. e new contrast dose setting into the memory The indicator light will stop flashing and go out This selection defines the kV at which the imaging is done based on the compressed object thickness The illustration below shows the dependence of the used kV on the object thickness and on the C D setting r rr 4 66 Planmed Nuance amp Planmed Nuance Excel User s manual FLEX AEC PRINCIPLES AND USER SETTINGS The kV value is altered depending on the C D parameter value as illustrated in the figure The AAEC kV change depends on the detected average tissue composition as described in the table below to keep the exposure time more or less constant independent of the tissue composition Glandularity kV change 0 8 3 9 22 2 23 36 1 36 64 0 65 78 1 79 92 2 93 100 3 16 2 4 Setting the CNR dose W target Cx B gt CH Ca hold for 3 seconds NOTE The automatic kV selection functions always in the AAEC mode but in the AEC mode only when the Automatic kV Selection is turned on With W target the kV is always selected for the maximum image contrast based on the compressed breast thickness The automatic kV selections are indicated in the table below Thickness mm kV 0 15 28 16 25 29 26 35 30 36 55 31 56 65 32 66 75 33 76 85 34 86 100 35
55. e that the exposure switch is installed behind a radiation protection screen Viewing facilities for the digital mammography should be available Make sure that the viewing conditions are optimal for the softcopy reading Planmed Nuance Nuance Excel Manager Users Manual publication part number 20003964 Planmed Nuance Acquire Users Manual publication part number 20004786 6 Planmed Nuance amp Planmed Nuance Excel User s manual INTRODUCTION TO PLANMED FFDM SYSTEM 6 INTRODUCTION TO PLANMED FFDM SYSTEM 6 1 Indications for use 6 2 Contraindications 6 3 Introduction to FFDM Thank you for choosing the Planmed FFDM system Please note that the X ray unit is equipped with highly sensitive electronics including the full field digital detector Please read this manual carefully before operating the X ray unit The Planmed FFDM system generates digital mammography images which can be used for screening and diagnosing breast cancer The Planmed FFDM system is intended to be used in the same clinical applications as traditional mammography film screen systems There are no known contraindications Mammography can be considered as one of the most challenging imaging modalities Early detection of breast cancer requires years of experience from the radiologist as well as trustworthy mammography X ray units and optimal image acquisition and displays This is also why mammography is the last imaging modality to ch
56. e to move downwards about 1 2 cm 3 Remove the paddle for better visibility 4 Press the both sheets in switch on the foot control until the value shown on the angle display traction distance is about 15 mm Remove the upper MaxView module as instructed in Section Attaching and removing the upper MaxView module on page 38 90 Planmed Nuance amp Planmed Nuance Excel User s manual MAINTENANCE Locking claw NOTE 1 Eject sheets To open the upper MaxView module lift the cover at the top of the module The sheet roller inside the module will now be positioned so that the locking claws and sheet fragments are easily accessible To remove a sheet fragment first gently press the locking claw down Slide the trapped sheet fragment sideways using for example a strip cut from a MaxView sheet You can now easily remove it by using a pair of tweezers or simply by shaking it out As the sheets are transparent the sheet fragments may be difficult to locate Check all four locking claws and make sure you remove all fragments trapped in the module 10 Attach the upper module to the X ray unit as described in section Attaching and removing the upper MaxView module on page 38 Test that the module functions properly using a MaxView sheet e Slide a MaxView sheet in e Try to pull the sheet towards yourself to make sure that it is properly attached e P
57. e used for powering equipment which forms a part of the system If a non medical equipment that has been supplied as a part of the system is connected directly to the wall outlet the leakage current of the system may increase over the limit Connecting an electrical equipment that has not been supplied as a part of the system to the MPSO may overload the MPSO causing a loss of power The Nuance Isolation Transformer the computer and the display that are parts of the system can be placed inside the patient area User s manual Planmed Nuance amp Planmed Nuance Excel 5 CHECKLIST BEFORE OPERATION 4 CHECKLIST BEFORE OPERATION A 5 RELATED MANUALS WARNING It is very important that the place where the X ray unit is to be used and the position from which the user operates the X ray unit are correctly shielded Since radiation safety requirements vary from country to country and state to state it is the responsibility of the user to ensure that all local safety requirements are met Make sure that you are fully acquainted with the appro priate radiation protection measures and these operat ing instructions before using the X ray unit The X ray unit is designed to operate using a line volt age between 187 and 265 V 50 60 Hz and a line cur rent of 15 A If the X ray unit is being used in a new location for the first time check that the power supply you intend to use is suitable for the X ray unit Make sur
58. ed lines indicate the corresponding AGD levels for fatty breast The abrupt reduction in dose at 65 mm is due to the filter material change from rhodium to silver User s manual Planmed Nuance amp Planmed Nuance Excel 69 SPECIAL FUNCTIONS 17 SPECIAL FUNCTIONS 17 1 Automatic filter selection With Mo target With W target Ce 3 7 5 ldan This section describes the X ray uni s special functions This function automatically selects the rhodium Rh or the molybdenum Mo filter after the breast has been compressed The selection is based on the thickness of the compressed breast Above the preset breast thickness the rhodium filter Filter 3 is selected Otherwise the molybdenum filter Filter 1 is used This function automatically selects the rhodium Rh or the silver Ag filter after the breast has been compressed The selection is based on the thickness of the compressed breast Above the preset breast thickness the silver filter Filter 1 is selected Otherwise the rhodium filter Filter 3 is used To set the breast thickness limit and to switch the function on Press the CTL key to select the secondary function mode The indicator light will come on Press and hold the filtration spot key for 3 seconds The time force display will start to flash Press either of the field light keys to adjust the preset breast thickness limit at which the filter is changed The minimu
59. eeeeeeeee eee eeeneeeeeeeeneeeneaes 34 10 2 Attaching and removing the Compression paddle ccceeeeeeeeeeeeeeeeeeeeeeeetaeeeeeeeeeeee 35 10 3 Paddle lok iiron a e e Ea A a aaa T GEE edad adtaedepeadua nna eaaa i 36 10 4 Attaching and removing the magnification platform for magnification views only OPUONAl sh EEE E E A E 37 10 5 Automatic Paddle RelGaSe wicres ses suede ccncedasnosssuace sce yeesscsdeieeasadnseng fe onetedhstedededonneuetandent 38 10 6 Preparing the X ray unit for MaxView Breast Positioning eceseeeeeeeeeeeeeeeeeeeeeeeeees 38 10 7 Ejecting MaxView sheets sscrcdsersssaeditveal edad conpielayilalcaath weaved etna dee eee eds 41 11 PREPARING AWS FOR IMAGING 0 cccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 42 12 IMAGE EVALUATION AT AWS nssssssssssssssnnnnnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn nnna 43 13 SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW 44 13 1 Setting the exposure values x cisec ccs sieee chine aedocag eaeletet dae cadeeeien avant 44 13 2 Selecting the view 45 2 eto ctsecase nds oNeca slate ce seule F ail aanyoee sieanei no anata talons 45 13 3 Normal view selection sacs2c ceca ndeec at tes cnaumstte ea te iel coat tlas ot Ra sontetaneuns dae ee atest 46 User s Manual Planmed Nuance amp Planmed Nuance Excel i TABLE OF CONTENTS 13 4 Three Second view selection 2 0 0 ceecsecssceceeccaeeeeceeeeeeececeeceeeceeeceeeceeeeeeceeeeeeeeteeeeetetets 47
60. eft cranio caudal view or the right CC key to select the right cranio caudal view The C arm will remain in the vertical position or move to the vertical position from one of the other views Left CC key Left breast i l Press the left OBL key to select the medio lateral oblique view of the left breast or press the right OBL key to select the medio lateral view of the right breast The C arm will rotate to the previously selected angle either to the left or the right depending on which key you have pressed The angle will appear on the angle display Setting the preset angle is described in section 17 2 Setting the oblique view angle on page 71 Left breast SN aa view obl1 eps Medio lateral view Press the left LAT key to select the medio lateral view of the left breast or press the right LAT key to select Left LAT key the medio lateral view of the right breast The C arm will rotate to the horizontal position either T N to the left or right depending on which key you have I f N pressed The angle will appear on the angle display Left breast i l 46 Planmed Nuance amp Planmed Nuance Excel User s manual SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW 13 4 Three second view selection Posterior anterior view CC key Latero medial oblique view Left OBL key Left breast Latero medial view Left LAT key Left breast i 13 5 Special view P
61. el and to reduce it press the key on the left side The light will stay on for 25 seconds If you need more time press either of the keys again The field light will automatically come on when you start compression and can be adjusted with field light keys The field size will return to its maximum after exposure The field light keys are also used as minus and plus keys when changing parameter values In normal mode the current time is displayed on the time force display During compression the compression force in dekanewtons is shown on this display After taking an exposure a waiting time will appear on the display This indicates the delay before the next exposure can be taken If the X ray unit malfunctions or you make a mistake when using the equipment an error message will appear on the time force display See section 19 HELP MESSAGES stereotactic mode on page 77 The X ray unit has an additional time force display on the base The distance between the compression paddles i e breast thickness in centimeters is shown on the breast thickness display After the exposure the actual duration of the exposure in seconds is shown on the display The X ray unit has an additional breast thickness display on the base Automatic manual exposure key and indicator lights O AAEC O AEC OMAN The automatic manual exposure key is used to select either the manual exposure mode or either of the AEC automatic exp
62. en switch the unit on again If the unit still does not work correctly contact your local sales representative ErY2 Spurious pulses from C arm motor Clear the error message and check if the unit works rotation sensor or the motor rotates correctly If it does not switch the unit off from the main even if not commanded power supply wait a few seconds and then switch the unit on again If the unit still does not work correctly contact your local sales representative ErY3 No pulses from C arm rotation motor Clear the error message and check if the X ray unit rotation sensor or the motor does works correctly If it does not switch the X ray unit off not rotate even if commanded from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative ErYS Lift motor is rotating even if not Clear the error message and check if the X ray unit commanded or spurious pulses works correctly If it does not switch the X ray unit off from lift motor rotation sensor from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative ErY6 No pulses from lift motor rotation Clear the error message and check if the X ray unit detector or the motor does not works correctly If it does not switch the X ray unit off rot
63. es not work correctly contact your local sales representative Er2y Bucky grid motor time out The grid Clear the error message and check if the X ray unit does not move or there is no signal works correctly If it does not switch the X ray unit off from sensor within the specified from the main power supply wait a few seconds and time then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Ere6 X ray tube anode does not rotate Clear the error message and check if the X ray unit properly or a problem in the anode works correctly If it does not switch the X ray unit off motor rotation sensing from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er27 Compression motor time out The Clear the error message and check if the X ray unit mechanism does not reach the limit sensor within the specified time works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative User s manual Planmed Nuance amp Planmed Nuance Excel 79 ERRORS AND ERROR MESSAGES ERROR CODE ERROR MESSAGE EXPLANATIONS CORRECTIVE ACTION Er28 Compression
64. events any unintended release of the compression paddle Press to lock To lock the compression paddle 1 Attach the paddle to the X ray unit 2 Press the red lock knob Lmam_pad_lock eps To unlock the compression paddle Press the green unlock knob Lmam_pad_rel eps 36 Planmed Nuance amp Planmed Nuance Excel User s manual PREPARING THE X RAY UNIT 10 4 Attaching and removing the magnification platform for magnification views only optional Lmam_mag_removal eps Locking knob To attach the magnification platform Remove the Bucky Slide the magnification platform along the shelf surface until it is in the bottom Turn the locking knobs backwards on both sides simultaneously The magnification platform is correctly positioned when the magnification ratio is shown on the display To remove the magnification platform Turn the release knobs upwards on both sides Slide the magnification platform out Attach the Bucky User s manual Planmed Nuance amp Planmed Nuance Excel 37 PREPARING THE X RAY UNIT 10 5 Automatic Paddle Release To minimize patient discomfort you can set up the X ray unit so that the compression paddle will release automatically immediately after an exposure has been taken NOTE This fun
65. g angle in degrees and the side of the breast are shown on the angle display After the exposure has been taken the amount of radiation emitted from the tube during exposure will be shown on the angle display The value will remain on the display until a key is pressed If required the X ray unit can be set up so that the radiation display is switched off Contact your sales representative The X ray unit has an additional angle display on the base The angle display also shows the traction distance Refer to section 8 MAXVIEW BREAST POSITIONING SYSTEM on page 29 User s manual Planmed Nuance amp Planmed Nuance Excel 21 PLANMED FFDM SYSTEM MAIN PARTS kV keys and display The kV up and kV down keys allow you to select the Kw VN kV value The kV value is adjustable from 20 to 35 kV in steps of 1 kV mAs keys and display The mAs values can only be selected when the X ray unit is used in the manual mode Taking exposures in the manual mode is described in section 17 3 Manual exposure procedure on page 72 Select the mAs value with the mAs up and mAs down keys The mAs value is adjustable from 10 to 500 in some areas the maximum mAs value is 300 or 600 with the large focus and 10 to 400 with the small focus depending on the kV value selected In the AEC automatic exposure control modes the mAs value will appear on the display after the exposure has been taken Dose level keys and disp
66. ge and check if the X ray unit stand by Ni MH battery is drained or works correctly If it does not switch the X ray unit off has failed from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er86 Short mains voltage abruption or Clear the error message You can now continue to use drop was detected or error in the X ray unit detection circuitry Er87 Illegal country code or country code Clear the error message and check if the X ray unit not set works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er 88 Battery back up memory RAM is Clear the error message and check if the X ray unit erased works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er 89 Wrong type C arm rotation motor Clear the error message and check if the X ray unit sensor in the Flash EEPROM works correctly If it does not switch the X ray unit off memory from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still
67. ht CC key to select the right viewing angle The C arm will rotate to this position if it is not already there The posterior anterior viewing angle can also be selected using this key see section 13 4 Three second view selection on page 47 Oblique OBL key left and right Press the left or right OBL key to select the oblique viewing angle The C arm will rotate to the angle previously used either to the left or the right depending on which key you pressed The angle will appear on the angle display If you wish to stop the C arm moving before it reaches the correct position press the key a second time Press the key a third time to start the C arm moving in the same direction again Lateral LAT key left and right NOTE Angle display NOTE NOTE Press the left or right LAT key to select the lateral viewing angle The C arm will rotate to the horizontal position either to the left or the right depending on the key you pressed If you wish to stop the C arm moving before it reaches the correct position press the key a second time Press the key a third time to start the C arm moving in the same direction again In some countries X ray units are set up so that the C arm will not automatically move to the selected view when one of the view keys CC OBL LAT is pressed To start and stop the C arm moving the foot control must be pressed See section 13 2 Selecting the view on page 45 The viewin
68. in power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er78 Time of day clock oscillator 32768 Hz not oscillating or out of tolerance Clear the error message and check if the X ray unit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er79 TUBE CPU stack overflow please contact Planmed Clear the error message and check if the X ray unit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er80 Clear the error message and check if the X ray unit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er8l Clear the error message and check if the X ray unit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact y
69. ings Optional compression paddles include magnification spot and multihole and rectangular biopsy paddles 0 Magnification spot paddle with rounded edges 9 cm x 6 cm Compression paddle Compression paddle 18 cm x 24 cm 24 cm x 30 cm Contact spot paddle with rounded edges 9 cm x 6 cm NI Perforated biopsy paddle Perforated multihole hole diameter 20 mm biopsy paddle 18 cm x 24 cm hole diameter 8 mm Spot paddle 10 cm x 7 cm for contact view Rectangular biopsy paddle 18 cm x 24 cm biopsy opening 50 mm x 90 mm Spot paddle 10 cm x 10 cm for contact view 16 Planmed Nuance amp Planmed Nuance Excel User s manual PLANMED FFDM SYSTEM MAIN PARTS Planmed Nuance Excel Bucky Bucky for 24 cm x 30 cm detector y eps Lmam_buck Planmed Nuance Bucky Bucky for 18 cm x 24 cm detector Planmed Nuance Excel magnification platform for magnification views only The optional magnification platform is attached onto the detector like the normal Bucky The available magnification factors are 1 6 1 8 and 2 0 24 cm x 30 cm magnification platform g_main eps Lmam_mai User s manual Planmed Nuance amp Planmed Nuance Excel 17 PLANMED FFDM SYSTEM MAIN PARTS Planmed Nuance multifunction magnification platform for magnification views only The multifunction magnification platform is attached onto the lower shelf like the normal Bucky It provides
70. io Frequency 100 Planmed Nuance amp Planmed Nuance Excel User s manual LIST OF ABBREVIATIONS Rh Rhodium RLM Right Latero Medial RLMO Right Latero Medial Oblique RMLO Right Medio Lateral Oblique RWS Review Workstation SID Source to Image Distance ST Stereotactic WwW Tungsten WEEE Waste Electrical and Electronic Equipment User s manual Planmed Nuance amp Planmed Nuance Excel 101 Planmed Oy Asentajankatu 6 00880 Helsinki Finland tel 358 20 7795 300 fax 358 20 7795 664 sales planmed com www planmed com PLANMED Oys PLANMED Oys Environmental PLANMED Oys Quality System Management System Quatty Management Sys ISO 14001
71. ion distance The traction distance is measured in millimeters and it shows how much the upper or lower sheet has been pulled in according to the following rules e When you pull the sheets in using the foot control the traction distance displays how much both sheets have been pulled in e When you press one of the panel switches controlling the upper sheet the traction distance display shows how much the upper sheet has been pulled in e When you press one of the panel switches controlling the lower sheet the display shows how much the lower sheet has been pulled in If you then use the foot control switch again the display shows the traction distance for the sheet that has been pulled in most The maximum traction distance is 50 mm 52 Planmed Nuance amp Planmed Nuance Excel User s manual SCREENING MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT 14 2 Breast positioning and compression without MaxView Paddle up 16 4 5 daN Compression force Breast thickness To position and compress the breast Position the breast on the Bucky or on the magnification platform The chest below the breast should be pressed against the front edge of the Bucky Manipulate and spread the breast forwards and outwards as much as possible on the Bucky Position the foot control out to a suitable position and then start the compression by pressing the paddle down switch of either foot control
72. it does not switch the unit off from the main power supply wait a few seconds and then switch the unit on again If the unit still does not work correctly contact your local sales representative Er37 kV feedback signal open circuit Clear the error message and check if the unit works correctly If it does not switch the unit off from the main power supply wait a few seconds and then switch the unit on again If the unit still does not work correctly contact your local sales representative 80 Planmed Nuance amp Planmed Nuance Excel User s manual ERRORS AND ERROR MESSAGES ERROR ERROR MESSAGE CODE EXPLANATIONS CORRECTIVE ACTION Er38 mA feedback signal open circuit Clear the error message and check if the unit works correctly If it does not switch the unit off from the main power supply wait a few seconds and then switch the unit on again If the unit still does not work correctly contact your local sales representative Er39 Side panel switches on during self Remove the obstruction Clear the error code and the test unit can be used If the error code reappears contact your sales representative for help Er C arm angle lift mechanism height Clear the error message and check if the unit works or compression paddle position correctly If it does not switch the unit off from the main information was wrong power supply wait a few seconds and th
73. ky mechanism or in Clear the error message and check if the X ray unit the sensor or in the movement of the works correctly If it does not switch the X ray unit off mechanism This error is NOT from the main power supply wait a few seconds and displayed but is stored in the error then switch the X ray unit on again If the X ray unit still list does not work correctly contact your local sales representative ErAQ The tissue type is not recognized as Verify the amount of compression and patient human tissue positioning ErAl The exposure time will be too long Verify the amount of compression patient positioning the maximum limits are 5 seconds and exposure settings for the large focal spot and 10 seconds for the small focal spot ErAg The compression exceeds the Verify the amount of compression If the compression maximum compression 10 cm thickness is shown correctly on the display you can use the X ray unit in manual mode If the compression thickness is not shown correctly contact your local technical support ErA3 Abnormal AEC calibration values Contact your local technical support ErA Communication error between PIA Contact your local technical support and image grabber DSP ErAS The AWS is not ready to take Wait until the AWS is ready exposures ErfA6 Image grabber card is not ready to Wait until the PIG is ready take exposures ErA7 AEC is not calibrated Perform AEC calibration or use th
74. lanmed Nuance Excel 39 PREPARING THE X RAY UNIT a 4 NOTE NOTE 5 Fold the free end of the sheet to the underside of Bucky Press down the handle and put the sheet between Bucky and handle Lift the handle up You may tighten the sheet by spinning the wheel To attach the upper sheet Place a radiolucent sheet on the underside of the compression paddle with the cut out corners towards the X ray unit Using both hands slide the sheet along the guide plate so that it goes into the slot in the upper MaxView module Keep sliding the sheet until it is locked into position i e when approx 5mm of the sheet has been pushed in Make sure that the sheet is positioned straight when you slide it in Use the edges of the compression paddle as a guideline If needed you can eject the sheet by pressing the center switch on one of the sheet control panels Pull the sheet out and wait for 5 seconds to allow the MaxView module to return to the start up position You can then slide the sheet in again Check that the sheet is properly locked in position by gently tugging it towards you The sheet must stay firmly in place when you try to pull it Otherwise you have to slide it in again 40 Planmed Nuance amp Planmed Nuance Excel User s manual PREPARING THE X RAY UNIT 4 Press the free end of the sheet onto the suction cups on the compression paddle lip After the exposure eject
75. latform must be cleaned according to the instructions given below Clean the surfaces first using a damp cloth soaked with mild soap solution and water Disinfect the surfaces with non alcoholic disinfection solution Planmed recommends Pharmaceutical Innovations Inc M SPRAY 2000 disinfectant and TriGene disinfectant wipes For painted surfaces use a damp cloth and a neutral disinfectant NOTE Do not use abrasive cleaning agents mechanical cleaning methods or cleaning equipment Do not immerse the parts in the cleaning agent Other X ray unit surfaces The X ray unit surfaces should be periodically wiped with a soft cloth damped in cleaning solution Optional Nuance isolation transformer The isolation transformer surfaces should be periodically wiped with a soft cloth damped in cleaning solution User s manual Planmed Nuance amp Planmed Nuance Excel 87 MAINTENANCE Display and NAS Computer 21 3 Preventive maintenance 21 4 Servicing If there are dust particles on the LCD display panel blow them away by using a dust remover e g DUST OFF 67 KONTAK Chemie For more information on cleaning of the display refer to the display s user s manual Vacuum clean dust from the NAS Clean the cabinet using a recognized cleaning product for medical equipment The cloth must be moist not wet Repeat with water only and wipe with a dry cloth Before you clean the computer disconnect it from the electrical ou
76. lay The default dose level can be modified using dose level up and down keys To decrease the dose level by one step press the dose level down key and to increase it press the dose level up key The dose level is adjustable within range 7 7 CTL secondary function key Press the CTL key to activate the secondary function Gen mode The indicator light will come on The CTL key is also used to clear error codes from the display Compression release key Press the compression release key after taking an exposure to release the compression paddle To minimize patient discomfort you can set the paddle to release automatically immediately after an exposure has been taken When the indicator light is on the Automatic Paddle Release function is activated and when the light is off the function is not activated NOTE When performing biopsy the Automatic Paddle Release function MUST be switched OFF Field light keys Press either of the field light keys to switch the field light on The light that appears on the Bucky corresponds to the radiation field The size of the light field and therefore the radiation field can be adjusted with these keys 22 Planmed Nuance amp Planmed Nuance Excel User s manual PLANMED FFDM SYSTEM MAIN PARTS NOTE NOTE Time force display 09 00 laan NOTE Breast thickness display T F NOTE To enlarge the field press the key on the right side of the control pan
77. lected when the spot collimator is selected Contact your sales representative READY indicator light The READY indicator light will come on when the SEOD breast and viewing angle have been selected and the 1U PRET Exposure indicator light KY OEXP ZpS C arm is in the correct position It indicates that the X ray unit is ready to compress the breast Note that the green indicator light on the exposure control holder will also come on The exposure indicator light will come on when you take an exposure You will also hear two tones during the exposure period The first tone is the start up tone and the second a higher tone is the exposure tone When the exposure is complete the tone will stop Note that the yellow indicator light on the exposure control holder will also come on Stereotactic operation Workflow key optional DE 2 When the stereotactic guide unit is attached the X ray unit can be driven to the stereotactic position Press the stereotactic operation toggle switch Press the foot control to drive the C arm to the desired stereotactic position User s manual Planmed Nuance amp Planmed Nuance Excel 25 PLANMED FFDM SYSTEM MAIN PARTS 7 10 X ray unit controls C arm controls C arm up Tube head away from user Side access 30 C arm down Tube head towards user NOTE NOTE Foot controls This section describes where the X ray unit controls are located and how they
78. m value is 4 0 cm and the maximum is 9 9 cm The selected breast thickness is shown in the time force display Press the CTL key to accept the new value and exit the secondary function mode 70 Planmed Nuance amp Planmed Nuance Excel User s manual SPECIAL FUNCTIONS To switch the function off 1 Press the CTL key to select the secondary function mode The indicator light will come on 2 Press and hold the filtration spot key for 3 seconds The time force display will start to flash 3 Press the field up key after the maximum breast thickness 9 9 cm has been reached This message indicates that the automatic filter z aan selection is switched off 4 Press the CTL key to accept the new value and to exit the secondary function mode NOTE After the patient s breast has been compressed the filter can still be changed manually If the Automatic kV Selection is on the filtration spot key must be pressed before the filter can be changed NOTE With W target the minimum kV should be limited to 28 kV with AEC and 26 kV with manual exposures Exposing at values lower than 26 kV will lead to inferior image quality and high radiation dose NOTE The recommended setting for the thickness at which the filter is changed is 55 mm with W target 17 2 Setting the oblique view angle The angle to which the C arm will rotate when an oblique view is chosen can be changed to any angle between 15 degrees an
79. n after the view has been selected and the C arm is in the required view position 26 Planmed Nuance amp Planmed Nuance Excel User s manual PLANMED FFDM SYSTEM MAIN PARTS MaxView C arm up C arm down Paddle up Paddle down Exposure button _ OS ye Eroo Holder Paddle safety release Lmam_paddle_safety_rel eps NOTE The X ray unit can be stopped while it is moving to the view position by pressing either paddle movement switch The exposure button and holder will be installed at a safe distance from the X ray unit The distance will depend on the local radiation safety regulations When you take an exposure you must hold the exposure button down for the duration of the exposure If the button is released before the exposure is complete the error code Er 00 will appear on the display Refer to section 19 HELP MESSAGES stereotactic mode on page 77 There are two indicator lights on the exposure control holder The green lower light will come on when the unit is ready to take an exposure and the yellow upper light will come on when X rays are emitted In case of emergency pull the handle towards the patient see figure This will release the compression paddle if the compression force has become too great To return the paddle to its normal position simply push down the paddle and then push back the handle In magnification view the ha
80. nd then push back the handle NOTE With a magnification platform the handle is not available see section 15 3 Emergency compression release in magnification mode on page 60 54 Planmed Nuance amp Planmed Nuance Excel User s manual SCREENING MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT 14 5 Taking an exposure To take an exposure 1 Before taking an exposure make sure that the patient s head or shoulder does not get in the way of the radiation beam 2 Protect yourself from radiation NOTE The minimum required protective shielding is 60 cm wide minimum 185 cm high and less than 15 cm above the floor The material used must have a minimum attenuation equivalent of 0 08 mm of lead and it must provide visibility to the patient and equipment Note that local regulations must be obeyed in case they differ from the above 3 Take the exposure by pressing the remote control button Note that the button must be held down for the duration of the exposure If you remove your finger from the exposure button before the exposure is complete an error code appears on the display For more information refer to section 19 HELP MESSAGES stereotactic mode on page 77 NOTE The exposure consists of 1 5 radiation pulses Hold the exposure button down until the exposure indicator signal has stopped completely CAUTION X RAYS Ww 4 Ue exposure ited i T the control panel ae ATTENTION RAYONS X one
81. ndle is not available see section 15 3 Emergency compression release in magnification mode on page 60 User s manual Planmed Nuance amp Planmed Nuance Excel 27 PLANMED FFDM SYSTEM MAIN PARTS Emergency stop button Emergency stop button StOP aan Cc BAC 7 11 Optional control panel The red emergency stop button is located on the hood Press the button to stop the X ray unit operating in an emergency The message StOP will appear on the display Pull the emergency stop button up to start the X ray unit again If there is no radiation protection screen available exposures must taken from a separate shielded room In this case an optional control panel has to be placed in the room The optional control panel is identical to the main control panel see section 7 9 Main control panel on page 20 28 Planmed Nuance amp Planmed Nuance Excel User s manual MAXVIEW BREAST POSITIONING SYSTEM 8 MAXVIEW BREAST POSITIONING SYSTEM The MaxView Breast Positioning System uses hygienic radiolucent sheets which not only pull more breast tissue into the imaging field but also help to flatten it out better The upper and lower sheet can be moved together or separately for optimum breast positioning Upper Max View module Excel_MV_main_parts eps Lower Max View sheet 8 1 MaxView accessories The MaxView Breast Positioning System has two traction m
82. nmed Nuance amp Planmed Nuance Excel 9 PLANMED FFDM SYSTEM MAIN PARTS NOTE Do not attempt to remove or otherwise manipulate the detector or the associated control electronics Always contact the Planmed representative if you feel the X ray unit does not operate properly or if you are unsure or do not understand how the X ray unit or the accessories should be operated See section 23 2 Amorphous Selenium a Se Flat Panel detector on page 98 for technical details of the digital detector 7 4 Maintenance of the FFDM detector Maintenance of the FFDM detector includes periodic calibration and quality assurance procedures Please see Planmed Nuance Nuance Excel Manager User s Manual for a complete description of the maintenance procedures 10 Planmed Nuance amp Planmed Nuance Excel User s manual PLANMED FFDM SYSTEM MAIN PARTS 7 5 Main parts of the Planmed FFDM system WS optional Private network F Radiation shield S Planmed FFDM X ray Y unit A Medical grade isolation User s manual Planmed Nuance amp Planmed Nuance Excel 11 PLANMED FFDM SYSTEM MAIN PARTS An optional setup of the Planmed FFDM system is presented in the picture below RWS optional ON ZA Planmed FFDM X ray unit Private network Medical grade isolation ve Ethernet Cable
83. nt that the tube head will move To activate Side Access Patient Positioning Press the Side Access switch 30 The tube head rotates sideways 30 around the isocentric centre of the X ray unit while the detector compression paddle system remains stationary The Side Access function turns the tube head according to the following sequence The tube head turns away from the O position dependent on the side of the switch The tube head stops at 30 4 When the switch is activated the tube head returns to the 0 position When the tube head has reached the 30 limit patient positioning can be optimized with improved access Thereafter the tube head is rotated back to the original position and the breast imaging can be continued normally The Side Access movement depends on the configuration of the system Please contact your local Planmed sales representative The field light is intended to be used as a general work light only when the X ray unit is in the Side Access position User s manual Planmed Nuance amp Planmed Nuance Excel 49 SCREENING MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT 14 SCREENING MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT NOTE Implant included views NOTE NOTE This section describes how to use the Planmed FFDM X ray unit for screening mammography examinations If you are not using the MaxView Breast Positioning System start the procedure from section 14 2
84. num Mo and tungsten W tubes Units with Mo tube OFILT 3 When this indicator light is on it indicates that the QFILT 2 30 um thick molybdenum Mo filter that can be used SOFT with any kV value is selected ZIN S EIT3 When this indicator light is on it indicates that the OFILT 2 optional 25 um thick rhodium Rh filter is on OFILT 1 OFILT 3 Filter 2 is reserved for possibe additional filter OFILT 2 OFILT 1 l The spot collimator with 30 um thick molybdenum is selected by pressing and holding the filtration spot key for 2 seconds The filtration spot key indicator light comes on The spot paddle should be used with the spot collimator 24 Planmed Nuance amp Planmed Nuance Excel User s manual PLANMED FFDM SYSTEM MAIN PARTS Units with W tube OFILT 3 When this indicator light is on it indicates that the OFILT 2 75 um thick silver Ag filter that can be used with any OFIT 1 kV value is selected JFT When this indicator light is on it indicates that the OFILT 2 60 um thick rhodium Rh filter is on OFILT 1 OFILT 3 Filter 2 is reserved for possibe additional filter OFILT 2 OFILT 1 The spot collimator with 60 um thick rhodium Rh filter is selected by pressing and holding the filtration spot key for 2 seconds The filtration spot key indicator light comes on The spot paddle should be used with the spot collimator NOTE The X ray unit can be set up so that the small focal spot is automatically se
85. ocal sales representative Er52 Filament voltage feedback open Clear the error message and check if the X ray unit circuit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er53 Power supply heatsink temperature Clear the error message and check if the X ray unit sensor short circuit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er5y Power supply heatsink temperature Clear the error message and check if the unit works sensor open circuit correctly If it does not switch the unit off from the main power supply wait a few seconds and then switch the unit on again If the unit still does not work correctly contact your local sales representative ErSS C arm rotation reference sensor Clear the error message and check if the unit works failure correctly If it does not switch the unit off from the main power supply wait a few seconds and then switch the unit on again If the unit still does not work correctly contact your local sales representative Er56 Error in the release limit sensor of Clear the error message and check if the unit works the compression m
86. ock Infection Skin irritation abrasions or puncture wounds 2 Planmed Nuance amp Planmed Nuance Excel User s manual SYMBOLS 2 SYMBOLS Type B equipment Standard IEC 60601 1 Alternating current Standard IEC 60417 Attention consult accompanying documents Standard IEC 60601 1 gt gt gt Electrostatic sensitive device Standard IEC 60417 Separate collection for electrical and electronic equipment according to Directive 2002 96 EC WEEE Notes Cautions and Warnings NOTE Note messages are used to indicate information which may be helpful or of special interest to the reader CAUTION Caution statements alert the user to the possibility of a problem with the unit asso ciated with its use or misuse Such prob lems include unit malfunction unit failure damage to the unit or damage to other property AN WARNING Warning statements alert the user to the possibility of personal injury to the user or the patient or other serious damage associated with the use or misuse of the unit User s manual Planmed Nuance amp Planmed Nuance Excel 3 WARNINGS AND PRECAUTIONS 3 WARNINGS AND PRECAUTIONS NOTE CAUTION NOTE NOTE NOTE NOTE NOTE NOTE CAUTION Planmed Nuance Acquire Planmed Nuance Softview and Planmed Nuance Nuance Excel Manager software applications have separate manuals which should be used in conjunction with this manual The X ray unit may be d
87. odules the upper and lower MaxView module The upper MaxView module is fitted with a guide plate The lower module is integrated to the X ray unit The upper module has two sheet control panels The third sheet control panel is located under the lower shelf see section 8 2 MaxView sheet controls on page 30 User s manual Planmed Nuance amp Planmed Nuance Excel 29 MAXVIEW BREAST POSITIONING SYSTEM The cover of the MaxView modules can be opened for cleaning purposes Refer to section 21 6 MaxView maintenance on page 90 There are two different radiolucent sheets upper and lower sheets NOTE Always use new sheets for every patient Only sheets provided by Planmed may be used NOTE MaxView sheets MUST NOT be used when performing biopsy CAUTION Sheet edges can be sharp MaxView upper and lower sheets 8 2 MaxView sheet controls Foot control Both MaxView sheets are pulled in by using the middle switch on the foot control Sheets in 30 Planmed Nuance amp Planmed Nuance Excel User s manual MAXVIEW BREAST POSITIONING SYSTEM Module control panel The upper MaxView traction module has two sheet control panels see figure below The third control O N panel is located under the lower shelf see figure beside The sheet control panels are mirror images of each Control other The lower switches on each side control the panel lower sheet and the upper s
88. osure control modes There are two AEC modes the conventional AEC and the advanced AEC AAEC The indicator light shows the selected exposure mode User s manual Planmed Nuance amp Planmed Nuance Excel 23 PLANMED FFDM SYSTEM MAIN PARTS For more information about the AEC modes and user settings see section 16 FLEX AEC PRINCIPLES AND USER SETTINGS on page 63 The focal spot size is changed by pressing and holding the automatic manual exposure key for 4 seconds The focal spot indicator lights show the selected focal spot Focal spot indicator lights When the lower focal spot indicator light is on it 3E indicates that the large focal spot has been selected ZIN When the upper focal spot indicator light is on it gt of indicates that the small focal spot has been selected Of The large focal spot is normally used for contact view procedures and the small focal spot for more detailed diagnostic procedures The focal spot size is changed with the automatic manual exposure key see above NOTE In magnification mode the small focal spot is automatically selected and when you exit the magnification mode the large focal spot is selected Filtration spot collimator key and indicator lights Select the filter by pressing the filtration spot key NOTE The filters in use depend on the type of X ray tube with which your mammography unit is equipped The selections below are given separately for molybde
89. otor during correctly If it does not switch the unit off from the main calibration power supply wait a few seconds and then switch the unit on again If the unit still does not work correctly contact your local sales representative Er57 Exposure switch failure short circuit Remove the obstruction Clear the error code and the or pressed during self test unit can be used If the error code reappears contact your sales representative for help Er58 Foot control switch failure short Remove the obstruction Clear the error code and the circuit or pressed during self test unit can be used If the error code reappears contact your sales representative for help Er59 Failure in internal emergency STOP Clear the error message and check if the unit works system correctly If it does not switch the unit off from the main power supply wait a few seconds and then switch the unit on again If the unit still does not work correctly contact your local sales representative Er60 TUBE CPU internal 15VDC Clear the error message and check if the unit works voltage is out of limits correctly If it does not switch the unit off from the main power supply wait a few seconds and then switch the unit on again If the unit still does not work correctly contact your local sales representative 82 Planmed Nuance amp Planmed Nuance Excel User s manual ERRORS AND ERROR MESSAGES
90. our local sales representative Er82 Clear the error message and check if the X ray unit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er83 REAR CPU parameter memory Flash EEPROM failure TUBE CPU parameter memory Flash EEPROM failure REAR CPU CONFIG register contains wrong data TUBE CPU CONFIG register contains wrong data Clear the error message and check if the X ray unit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative 84 Planmed Nuance amp Planmed Nuance Excel User s manual ERRORS AND ERROR MESSAGES ERROR ERROR MESSAGE CODE EXPLANATIONS CORRECTIVE ACTION Er8U REAR CPU parameter memory Clear the error message and check if the X ray unit Flash EEPROM is empty or works correctly If it does not switch the X ray unit off erased from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er85 Flat battery on REAR CPU RAM Clear the error messa
91. r s are not calibrated Clear the error message and continue to use the X ray unit in the manual mode Contact your sales representative for help Erl6 Compression requested for Clear the error message and continue to use the X ray operation of the Flex AEC system unit in the manual mode Contact your sales OR AEC feedback signal open representative for help circuit Erl7 Bias values were not set during Clear the error message and check if the X ray unit calibration of the tube head filament voltage tube type E or F works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative 78 Planmed Nuance amp Planmed Nuance Excel User s manual ERRORS AND ERROR MESSAGES ERROR ERROR MESSAGE CODE EXPLANATIONS CORRECTIVE ACTION Er 18 kV fine adjustment parameter values Clear the error message and check if the X ray unit in TUBE CPU differ from the values works correctly If it does not switch the X ray unit off in REAR CPU from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er20 Mirror motor time out The mirror Clear the error message and check if the X ray unit mechanism doe
92. reposition the needle and take another exposure 10 Repeat the procedure until the biopsy can be taken 62 Planmed Nuance amp Planmed Nuance Excel User s manual FLEX AEC PRINCIPLES AND USER SETTINGS 16 FLEX AEC PRINCIPLES AND USER SETTINGS 16 1 Principles of the Flex AEC operation 16 2 Flex AEC user settings The Flex AEC operation is based on a patented principle where the imaging chain components are all modelled into the system software Once the kV the mA the filtration the tube radiation output mAs the magnification ratio and the object thickness are all known it enables the system to define the tissue composition imaged and utilize optimal exposure parameters exactly Based on the detected object composition together with the other imaging parameters the signal that reaches the detector is calculated exactly and the optimal signal level is achieved Flex AEC consists of about 48 sensor areas that cover an area of 100 cm Therefore it is able to measure a well representative sample of the tissue to be exposed and to adjust the exposure parameters optimal for the tissue composition Sensor areas that measure a non human tissue composition during an exposure do not take part in the operation of Flex AEC Thus sensor areas that receive direct radiation or are lying underneath a breast implant do not even partially deteriorate the image quality The tissue compositions in this description are indicated a
93. ress and hold the CC key for three seconds and the C arm will rotate to the PA position Note that the physical limits of the X ray unit will not allow you to adjust the angle of the PA position in the clockwise direction Press and hold the left OBL key for three seconds to select the latero medial oblique view of the left breast or press the right OBL key for three seconds to select the latero medial view of the right breast The C arm will rotate to the previously selected angle either to the left or the right depending on which key you have pressed The angle will appear on the angle display Setting the preset angle is described in section 17 2 Setting the oblique view angle on page 71 Press and hold the left LAT key for three seconds to select the latero medial view of the left breast or press the right LAT key for three seconds to select the latero medial view of the right breast The C arm will rotate to the horizontal position either to the left or right depending on which key you have pressed The angle will appear on the angle display If the breast is imaged by using a special view the correct label should be selected at the AWS See Planmed Nuance Acquire User s Manual for further details User s manual Planmed Nuance amp Planmed Nuance Excel 47 SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW 13 6 Fine tuning the viewing angle The viewing angle can be adjusted by pressing the C arm ro
94. rrent speed number will appear on the time force display and start to flash Select the speed you require for the initial descent using the field light keys Number 1 is the slowest speed and the number 6 is the fastest speed The setting 0 zero should and can be used only if the compression force measurement is inoperative When the speed 0 is selected the force measurement is totally ignored Compression starts at a moderate speed and continues only at crawling speed after the compression movement is shortly interrupted by releasing the control switch Press the CTL key again to accept the new initial descent speed The indicator light will go out Compression speed decrease rate J op D To set the speed decrease rate Press the CTL key to re enter the secondary function mode The indicator light will come on Press and hold the mAs up key to select the rate at which the speed will decrease during the actual compression stage The current speed decrease number will appear on the display and start to flash Press either of the field light keys to select the speed decrease number you require The number 1 is the slowest speed decrease and the number 6 is the fastest speed decrease Press the CTL key again to accept the new speed decrease number and exit the secondary function mode The indicator light will go out User s manual Planmed Nuance amp Planmed Nuance Excel 73 SPECIA
95. rrerenen 11 7 6 Planmed FFDM X ray unit 3 4e Stace acaotaestltn sc dnan ee ceteccnrbeuis aces pe attteciauhide Wemeatenaate nnne 13 7 7 Planmed radiation shield Optional ccceccceeceeceee cece cece eeeeeeee eee egeeeeeeeeeeeeeeeeeeeeeeeees 19 7 8 Planmed Nuance Acquire Station Optional c ceccccccceeesseeneeeeeeeeeeeesssnaeeeeeeeseeeees 19 7 9 Main Controlipanel seient ea e i dated a aa aa EE E aaae 20 PAO X Fay UNtCOnNtOlS a aA a AE TA AAE a Eor aA 26 LAT Optional control Panel waccacvisssreivelenanditcadeasahmeactinadlisza stn A E aden 28 8 MAXVIEW BREAST POSITIONING SYSTEM cccsssssssssscesssesssssssssssssseeeees 29 8 1 MaxView accessories act csnivecad ehis edie eia uae ansaid ier Ueto tans 29 8 2 MaxView sheet Controls sch scence aida hie toe aden anes 30 9 START UP OF PLANMED FFDM SYSTEM cccccccccccsssessssesssssssessssssseeees 32 9 1 Starting up the X ray unit sores oye esipadd eet odioed coe eei bod ceed tenpded lec tea vere el oheeeded ad ia eek 32 9 2 Switching on the X ray unit civcccavesscesncsbceeedasigdeded icagaeosiaedetanestenaedabelascammaaeneannadees 32 9 3 Starting UP the AWS osne a a a care ie A a ete ecee 33 9 4 Shutting down the Planmed FFDM system c ccceceececeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaaeeeenee 33 10 PREPARING THE X RAY UNIT ieee eeeeeeeeeeeeeeeeeeeeeees 34 10 1 Attaching and removing the Bucky ccceceeeeeeeeeeeee cette eeeeee
96. s must be disposed of in accordance with local and national waste legislation and instructions issued by the environmental authorities The risks involved and the necessary precautions must be taken into account when handling waste products For more detailed information consult your Planmed representitive The X ray tube contains beryllium in solid form Inhaled Beryllium and its compounds are extremely poisonous and inhalation of beryllium containing dust or fumes can cause cancer Avoid skin exposure The X ray tube and its compounds must not be disposed of together with industrial or house hold waste All waste material must be carefully transported and disposed in accordance with local and national regulations Batteries must be disposed of following the requirements of Directive 2006 66 EEC and in accordance with waste legislation and instruction issued by the environmental authorities Table 2 Disposal of Planmed FFDM X ray unit Waste Hazardous Main materials Recyclable h waste Part H f disposal for disposal material separate site collection Frame and covers Aluminum x metal galvanized steel xX lead plastic PUR UP other plastics X rubber X glass Motors X Component X boards 94 Planmed Nuance amp Planmed Nuance Excel User s manual DISPOSAL OF THE X RAY UNIT Waste Hazardous Main materials Recyclable waste Par
97. s 0 to 100 glandular 0 represents a totally fatty radio translucent tissue type and 100 represents a totally glandular the most radio opaque tissue type The operation of Flex AEC is strongly dependent on the correct compression thickness indication Some spot paddle models are of different height compared to normal compression paddles When these spot paddles are used the spot filter must be selected so that the corresponding thickness parameters are used If in doubt compress an object of known thickness and verify that the thickness indication shows the same value A set of unique tuning parameters has been provided for the operator to tailor the operation of Flex AEC to meet all user requirements The Flex Setting parameter offers the operator a possibility to tune the AEC response to various object compositions and their mixtures in a way that has never been possible before User s manual Planmed Nuance amp Planmed Nuance Excel 63 FLEX AEC PRINCIPLES AND USER SETTINGS 16 2 1 Selecting the AEC mode OAAEC OAEC OMAN OAAEC OAEC OMAN VATION SO AAEC E AEC OMAN Ny a AAEC O AEC OMAN NOTE NOTE There are two AEC modes the conventional AEC and the advanced AEC AAEC and a manual MAN mode To change the AEC mode Press the automatic manual exposure key so that the appropriate indicator light will come on The exposure mode will change from the original setting to the new
98. s not reach the limit works correctly If it does not switch the X ray unit off sensor within the specified time from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Erel Filter motor time out The filter Clear the error message and check if the X ray unit mechanism does not reach the limit works correctly If it does not switch the X ray unit off sensor within the specified time from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Eree Collimator motor time out The Clear the error message and check if the X ray unit collimator mechanism does not works correctly If it does not switch the X ray unit off reach the limit sensor within the from the main power supply wait a few seconds and specified time OR cutter motor time then switch the X ray unit on again If the X ray unit still out The cutter mechanism does not does not work correctly contact your local sales reach the sensor within the specified representative time Ere3 Error in the Side Access motor Clear the error message and check if the X ray unit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still do
99. sales representative Er7u REAR CPU watchdog reset occurred Clear the error message and check if the X ray unit please contact Planmed works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative User s manual Planmed Nuance amp Planmed Nuance Excel 83 ERRORS AND ERROR MESSAGES ERROR CODE ERROR MESSAGE EXPLANATIONS CORRECTIVE ACTION Er75 REAR CPU illegal interrupt detected please contact Planmed Clear the error message and check if the X ray unit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er76 REAR CPU timer interrupt error please contact Planmed Clear the error message and check if the unit works correctly If it does not switch the X ray unit off from the main power supply wait a few seconds and then switch the X ray unit on again If the X ray unit still does not work correctly contact your local sales representative Er77 REAR CPU stack overflow please contact Planmed Clear the error message and check if the X ray unit works correctly If it does not switch the X ray unit off from the ma
100. sales representative If the rhodium filter is selected the advanced AEC cannot select kV values below 27 kV 28 kV with W target Value 27 kV 28 kV with W target is used instead 64 Planmed Nuance amp Planmed Nuance Excel User s manual FLEX AEC PRINCIPLES AND USER SETTINGS 16 2 2 Automatic kV Selection in AEC mode 19 This function automatically selects a recommended kV value after the breast has been compressed The kV value is based on the thickness of the compressed breast To activate Automatic kV Selection Press the CTL key to select the secondary function mode The indicator light will come on Press the kV up key and one of two messages will appear on the time force display and start to flash The message will depend on whether the Automatic kV Selection function was previously switched on or off This message indicates that the Automatic kV Selection function is switched off If the advanced AEC mode is selected the Automatic kV Selection function is on regardless of this setting Press the right field light key Press the CTL key to accept the new setting To switch the Automatic kV Selection off Perform steps 1 and 2 as above This message indicates that the Automatic kV Selection function is switched on Press the left field light key Press the CTL key to accept the new setting 16 2 3 Setting the contrast dose C D Mo target Cx o D gt CH gt
101. setting In manual mode the kV and mAs are selected by the operator In conventional AEC mode the mAs is defined by the desired signal value while the kV is either selected by the user or in Automatic kV selection mode see section 16 2 2 Automatic kV Selection in AEC mode on page 65 suggested by the AEC system as a function of the compressed object thickness With advanced AEC AAEC mode the Automatic kV Selection function is active but it can be overridden by the operator The kV value is selected after the patien s breast has been compressed and then this value is automatically corrected during the exposure The kV adjustment is based on the tissue density of the patient s breast At the beginning of the exposure the Flex AEC system defines and alters the kV optimal for the tissue composition detected If the tissue composition seen by the Flex AEC system is of the average in composition the kV will be kept unchanged For a fatty tissue the kV is lowered by up to 3 kV 2 kV with W target and for a glandular tissue it is raised by up to 3 kV lowered by 1 kV with W target The Flex AEC system selects an optimal kV value depending on the mixture of tissue compositions in the object aiming to keep the exposure time constant for all tissue compositions The minimum kV value that can be used in the AAEC mode is set at the factory to a value 20 kV 26 kV with W target If it needs to be adjusted contact your
102. sion refer to section 17 5 Setting the speed of the compression paddle movement on page 73 11 The compression can be fine adjusted manually by turning the manual compression knob CAUTION Be careful not to leave your hands between the compression paddle and the Manual compression knob Bucky during compression 14 3 Imaging with the 18 x 24 cm compression paddle To use the 18 x 24 cm compression paddle 1 Attach the paddle as described in section 10 2 Attaching and removing the compression paddle on page 35 2 Select the projection view 3 Collimate the radiation field with the Reduce field light key so that it corresponds to the size of the paddle 4 Take an exposure 5 Repeat this procedure in connection with every exposure 14 4 Emergency compression release mam_paddle_safety_rel eps To release the compression in an emergency 1 Press the compression release key or the paddle up switch on the foot control NOTE Do NOT press the emergency stop button in this situation as this will stop the X ray unit working If there is a power failure while you are examining a patient the quickest and easiest way to release the MaxView compression paddle is to pull the handle towards the patient see figure This will release the compression paddle if the compression force has become too great To return the paddle to its normal position simply push down the paddle a
103. stem configuration enter the patient information and the study data either automatically from the Modality Worklist or manually on the Acquisition Console Patient Demographics dialog box Follow the detailed instructions given in the separate Planmed Nuance Acquire User s Manual starting from Section 3 5 Using the Acquisition Console Dialog Box on page 20 42 Planmed Nuance amp Planmed Nuance Excel User s manual IMAGE EVALUATION AT AWS 12 IMAGE EVALUATION AT AWS oa fF OON NOTE CAUTION After the exposure the image appears at the AWS display The original image is unprocessed showing a general outline of the breast Thereafter image processing is applied to the image and a finalized enhanced image replaces the original image on the screen Always evaluate the final processed image carefully according to the following checklist Is the image displayed correctly Is the breast positioning acceptable Is the image contrast acceptable Are there motion artefacts Is the image marked with the correct view position Is the image processing acceptable If an error occurs during an exposure taken in AEC or in AAEC mode the unfinished image is shown on the AWS screen It is possible to reject the image and take a new one if necessary With the Planmed Nuance Acquire software tools you can for example adjust the image annotate and perform measurements Please see Planmed Nuan
104. t disposal for disposal material f separate site collection Cables Copper x transformers steel Xx transformer oil x PVC X X ray tube X Packing Wood X cardboard X paper X MaxView radiolucent plastic PET X sheets Detector Return the detector to Planmed Other parts X X action X action in cases where processing is available User s manual Planmed Nuance amp Planmed Nuance Excel 95 TECHNICAL SPECIFICATIONS 23 TECHNICAL SPECIFICATIONS 23 1 Planmed FFDM X ray unit MANUFACTURED BY Planmed Oy Asentajankatu 6 00880 Helsinki Finland MODELS Planmed Nuance Planmed Nuance Excel IEC safety class IEC degree of protection B IEC enclosure class IP20 X RAY TUBE ASSEMBLY MOLYBDENUM TARGET X ray tube Anode type Anode thermal capacity Target material Tube port material Focal spot size Filtration Toshiba E7290 Varian M113 see tube head label rotating anode 300 000 HU molybdenum Mo beryllium 0 1 0 3 mm 30 um Mo 25 um Rh X RAY TUBE ASSEMBLY TUNGSTEN TARGET X ray tube Anode type Anode thermal capacity Target material Tube port material Focal spot size Filtration GENERATOR ASSEMBLY Generator Anode voltage Anode current 0 3mm Varian M113T see tube head label rotating anode 300 000 HU tungsten W beryllium 0 1 0 3 mm 75 um Ag 60 um Rh constant potential microprocessor controlled high frequency E7290
105. tation switches see illustration below In cranio caudal view the C arm can be moved up to approximately 15 in both clockwise and counterclockwise directions In medio lateral oblique view and latero medial oblique view the viewing angle can be set between 15 and 75 If the new angle is between 30 and 75 it will be automatically stored in the memory and will be recalled by pressing the oblique key In medio lateral view and latero medial view the C arm can be rotated in both clockwise and counterclockwise direction The new angle will appear on the angle display 13 7 Adjusting the X ray unit height Tube head away from the user C arm rotation switches Tube head towards the user NOTE To adjust the X ray unit height to suit the patient Press the upper height adjustment switch to move the C arm up or press the lower height adjustment switch to move the C arm down The height of the X ray unit can also be adjusted by using the foot control switches Refer to section Foot controls on page 26 48 Planmed Nuance amp Planmed Nuance Excel User s manual SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW 13 8 Side Access patient positioning 30 Side Access Side Access positions CAUTION The Side Access Patient Positioning function improves positioning ergonomics by providing more space for the technologist Inform the patie
106. the AAEC mode the kV value will be automatically selected before and adjusted during the exposure When the AEC mode has been selected the correct mAs value will appear on the mAs display after the exposure For more information about the AEC modes and user settings see section 16 FLEX AEC PRINCIPLES AND USER SETTINGS on page 63 Select the focal spot you require The appropriate indicator light will come on Remember that when you change the focal spot the key must be pressed and held down for 4 seconds If you are using the conventional AEC mode select the kV value required for the patient to be examined When starting a new examination a message Caution Manual exposure mode on appears in case an exposure is not taken in AEC or AAEC mode The message will disappear automatically when pushing the exposure button Alternatively you may close the message window by clicking on the cross located in the upper right corner of the window You can set the X ray unit so that it will automatically display a recommended kV value after the breast has been compressed See section 16 2 2 Automatic kV Selection in AEC mode on page 65 Make sure that filtration you are using is appropriate for the kV value that you have selected If necessary change the filtration 44 Planmed Nuance amp Planmed Nuance Excel User s manual SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW 13 2 Selecting the view
107. the MaxView sheets To eject the sheets Press the center switch on one of the sheet control panels Pull the sheets out and wait for 5 seconds to allow the MaxView modules to return to the start up postion You can then slide new sheets into the modules for the next patient refer to section Attaching the MaxView sheets on page 39 If the sheets are not intact when you pull them out you will have to open the MaxView modules and remove any sheet fragments before you can use the system again Refer to 21 6 MaxView maintenance on page 90 User s manual Planmed Nuance amp Planmed Nuance Excel 41 PREPARING AWS FOR IMAGING 11 PREPARING AWS FOR IMAGING NOTE Fe n i aaor iepa pnl Nuance Acquire Quality Control Calibration _ Test Acquisition Tools Tal Nuance Acquire Start This section describes briefly how to prepare the AWS for imaging For further instructions on how to perform imaging with the Planmed FFDM system refer to the Planmed Nuance Acquire User s Manual and the Planmed Nuance Planmed Nuance Excel Manager User s Manual To prepare AWS for imaging Start the AWS The Planmed Nuance Manager main window opens autimatically Select the Nuance Acquire tab and click the Start button in the middle of the window to begin the image acquisition application The Planmed Nuance Acquire image acquisition software starts up Depending on your sy
108. tlet Clean the computer with a soft cloth dampened with water Do not use liquid or aerosol cleaning agents that may contain flammable substances For more information of cleaning the computer refer to the computer s user s manual The system does not require any additional safety measures during the preventive maintenance The following issues must be checked once a year e Leakage radiation e HVL measurement e Linearity and reproducibility also AEC e kV mAs e Exposure time e Automatic exposure control limits e lluminance of positioning light field e Alignment of visually defined X ray field and contrast of the light field e X ray field size e Compression force 88 Planmed Nuance amp Planmed Nuance Excel User s manual MAINTENANCE 21 5 FFDM Detector maintenance To keep the surface clean wipe with a soft clean cloth To remove dust and any loose particles use a dry cloth Use specified cleaning solutions only if needed Use a damp cloth and neutral cleaning solution such as M Spray 2000 or TriGene disinfectant wipes Do not use excessive force when cleaning The grid inside the Bucky can also be cleaned as described above Planmed Nuance air filter maintenance The air filter pads on the FFDM detector should be periodically checked dusted and changed if necessary Open the air filter cover with your fingers or a key and check the condition of the filter pad once a week
109. tom and turn the finger screws counterclockwise 38 Planmed Nuance amp Planmed Nuance Excel User s manual PREPARING THE X RAY UNIT Attaching the MaxView sheets NOTE NOTE There are two forms of radiolucent sheets upper and lower sheets Always use new sheets for every patient Only sheets provided by Planmed may be used MaxView sheets MUST NOT be used when performing biopsy CAUTION Sheet edges can be sharp Attaching the lower sheet NOTE NOTE 1 To attach the lower sheet Place a radiolucent sheet on the Bucky with the cut out corners towards the X ray unit 2 Using both hands slide the sheet along the Bucky surface so that it goes into the slot in the lower MaxView module Keep sliding the sheet until it is locked into position that is when about 5 mm of the sheet has been pushed in Make sure that the sheet is positioned straight when you slide it in Use the edges of the Bucky as a guideline If needed you can eject the sheet by pressing the center switch on one of the sheet control panels Pull the sheet out and wait for 5 seconds to allow the MaxView module to return to the start up position You can then slide the sheet in again 3 Check that the sheet is properly locked in position by gently tugging it towards you The sheet must stay firmly in place when you try to pull it Otherwise you have to slide the sheet in again User s manual Planmed Nuance amp P
110. tton is activated by the Planmed Nuance Acquire application The delay time shown on line on the time force display will depend on the exposure parameters used After the exposure carefully evaluate the image at the AWS See section 12 IMAGE EVALUATION AT AWS on page 43 and Planmed Nuance Acquire User s Manual 56 Planmed Nuance amp Planmed Nuance Excel User s manual DIAGNOSTIC MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT 15 DIAGNOSTIC MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT This section describes how to use the Planmed FFDM X ray unit for different diagnostic mammography examinations such as magnification and biopsy procedures 15 1 Planmed Nuance Excel magnification procedures optional 1 Install the appropriate spot paddle in the paddle holder 20005602 Magnification spot paddle with rounded edges 2 To place the magnification platform in position slide the magnification platform along the shelf surface until it is in the bottom Spot paddle Z Magnification platform User s manual Planmed Nuance amp Planmed Nuance Excel 57 DIAGNOSTIC MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT 3 g_pos eps Lmam_mai NOTE NOTE Turn the locking knobs backwards on both sides simultaneously Check the correct magnification ratio 1 6 1 8 or 2 0 is shown on the display Select the spot collimator by pressing and holding the filtration spot ke
111. two unit models are specified stating the respective unit model The Planmed FFDM X ray unit must only be used for mammography The use of Planmed FFDM X ray unit is allowed only under supervision of a health care professional The Planmed FFDM X ray unit fulfills the requirements of European Council Directive 93 42 EEC Class IIB This manual is valid provided that the following software revisions are installed in the Planmed FFDM X ray unit REAR CPU 1 22 OR LATER TUBE CPU 3 01 OR LATER SHELF CPU 1 07 OR LATER PIA CPU 1 34 OR LATER AND PIG DSP CPU 1 20 OR LATER All key illustrations indicate that the key should be pressed or where indicated pressed and held down Pressing a key will switch a function on or off depending on the original setting When a function is on or activated the key indicator light will either come on or start to flash The display values in this manual are only examples and should not be interpreted as recommended values unless otherwise stated User s manual Planmed Nuance amp Planmed Nuance Excel 1 INTRODUCTION NOTE NOTE Potential adverse events The pictures in this manual may represent any of the two unit models This manual includes also descriptions of optional items that vary from market to market The potential adverse events apply to mammography with the Planmed FFDM X ray unit Excessive breast compression Excessive X ray exposure Electric sh
112. ull the sheet in by pressing the both sheets in switch and resist the traction by pulling the sheet towards yourself The sheet should stay firmly attached to the module e Eject the sheet by pressing the eject sheets switch on the MaxView control panel User s manual Planmed Nuance amp Planmed Nuance Excel 91 MAINTENANCE Removing sheet fragments from the lower MaxView module Finger screws Front cover NOTE Eject sheets Locking claw Sheet roller The lower MaxView module is integrated into the X ray unit and cannot be removed The sheet fragments can be removed from the module by removing the lid and the front metal cover of the module To remove sheet fragmentis from the lower MaxView module Remove the lid of the lower MaxView module by lifting it up Loosen the two finger screws on the metal cover of the module Pull out the front cover you can now see the sheet roller and the four locking claws Press the eject sheets button in the middle of the MaxView sheet control panel and hold it for five 5 seconds after the MaxView rollers have stopped Thereby the MaxView rollers will remain in eject position and not return to the loading position The MaxView rollers will stay in eject position only if the button is held down continuously for 5 seconds The locking claws are now open and sheet roller positioned so that the sheet fragments are easily accessible Remo
113. ve them for example with tweezers a strip of a MaxView sheet or simply by blowing it out If a sheet fragment is trapped under a locking claw slide it away for example with a strip cut from a MaxView sheet Return the roller to normal position by pressing the Eject sheet button once 92 Planmed Nuance amp Planmed Nuance Excel User s manual MAINTENANCE 8 If you managed to move the fragment s away from the locking claw you can remove the fragments also by turning the sheet roller upside down Use the middle switch of the foot control to drive the sheet roller about 25 30 mm forwards and back The sheet fragments will drop out of the module NOTE Check that all sheet fragments have been removed from the module 9 Attach the front cover of the module 10 Tighten the finger screws on the metal cover 11 Attach the lid User s manual Planmed Nuance amp Planmed Nuance Excel 93 DISPOSAL OF THE X RAY UNIT 22 DISPOSAL OF THE X RAY UNIT In order to reduce the environmental load over the product s entire life cycle Planmed s products are designed to be as safe as possible to manufacture use and dispose of Parts which can be recycled should always be taken to the appropriate processing centres after hazardous waste has been removed Disposal of obsolete X ray unit is the responsibility of the possessor All parts and components containing hazardous materials such as oil and heavy metal
114. witches on each side under control the upper sheet the lower shelf To pull both MaxView sheets in Press the outer switches on both sides To push both MaxView sheets out Press the inner switches on both sides To move the sheets separately Press only one of the switches To eject both sheets Press the switch in the middle NOTE If you try to pull the sheets in when the compression paddle is up the sheets will be automatically moved back into the start up position when you release the switch Lower the paddle first before you start pulling the sheets Upper sheet in Upper sheet out Upper sheet out Upper sheet in UPPER SHEET Eject both sheets LOWER SHEET Lower sheet in Lower sheet out Lower sheet out Lower sheet in User s manual Planmed Nuance amp Planmed Nuance Excel 31 START UP OF PLANMED FFDM SYSTEM 9 START UP OF PLANMED FFDM SYSTEM 9 1 Starting up the X ray unit In normal operation it is recommended that the X ray unit is switched off from the main power switch at the end of each working day To start up the X ray unit Press the Stand by key on the Nuance control panel for three seconds All the X ray unit displays are lit and the X ray unit is ready for use Refer to section 9 3 Starting up the AWS on page 33 for the start up procedure of the AWS 9 2 Switching on the X ray unit NOTE On Off switch tESt aan 09 00 aan NOTE Er
115. y for 2 seconds In this mode only the area of the spot cone will be exposed The filtration spot indicator light will come on When using the spot collimator the breast thickness read out is adjusted for the spot paddle The X ray unit can be set up so that in the spot mode the standard rectangular collimator is selected instead of the spot collimator You may use either rectangular or spot collimator You can now set the exposure parameters compress the breast and take an exposure in the same way as described in section 13 SETTING THE EXPOSURE VALUES AND SELECTING THE VIEW on page 44 and section 14 SCREENING MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT on page 50 After the exposure carefully evaluate the image at the AWS see chapter 12 IMAGE EVALUATION AT AWS on page 43 and Planmed Nuance Acquire User s Manual Remove the magnification platform 58 Planmed Nuance amp Planmed Nuance Excel User s manual DIAGNOSTIC MAMMOGRAPHY WITH PLANMED FFDM X RAY UNIT 15 2 Planmed Nuance magnification procedures optional NOTE 2 0 80mm 18 45mm 16 Omm Handle 3 4 NOTE NOTE NOTE You can adjust the magnification by turning the handles on both sides inwards and consequently upwards or downwards The magnification alternatives are 1 6 1 8 and 2 0 The magnification value is shown on the MAG factor display To place the m

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