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Operating Instructions

1. 12 6 Data import and export Injection programs succession of sequences which are saved on the terminal can be exported or imported via USB flash drive Therefore in sert USB flash drive in the integrated USB interface on the left side of the terminal housing Fig 12 5 In addition licence data and software updates are transferred via this USB slot as well Fig 12 5 USB slot 12 6 1 Data import 92 Programm data Insert USB flash drive as shown in Fig 12 5 Select Program gt Import Program data in the menu bar Injection programs which are saved on the USB flash drive can be imported and taken over by the program memory Attention Existing injection programs are completely overwritten by this process Licence file The following program options are additional elements Same pa tient Test bolus Last patient Stop watch These options are ac tivated by a licence file if they are subsequently purchased After insertion of the USB flash drive with the corresponding li cence file into the USB slot on the left side select Program gt Import gt Licence data The data is automatically copied onto the terminal The unlocked options are immediately available closing and restarting the application is not necessary Software update Software update is carried out exclusively by the manufacturer or the authorized distributor Not ev
2. 7 Start Up Press keys on the control unit very briefly only If the keys are operated repeatedly fault messages may be triggered exception Manual Delivery Do not trigger any functions on the terminal while keys on the injector are pressed mississippi missouri 7 Start up 7 4 User Interface on the Touch terminal The user interface is specially designed for the requirements of touch operation It offers an easy and comfortable handling Large coloured buttons 1 Large hose illustration 2 Symbols for roll pump patient and Luer Lock 3 Central alignment of add on options 4 Clear arrangement of status symbol bar 5 Menu bar 6 Sequence buttons 7 Real time counter for injection data 8 es Kirich mypection time SEQUENCE ner sequence s 28 0 1 Minimum injection time s 224 5 Total contrast agent rml 0 215 a rage ee CA tandem Total Naci m0 o 81 Oo em NaCl airbag Total injection mi 0 296 OK Cancel sel Clee AE SAY A isis 5 Gei ne Ce d A Fig 7 3 User interface on touchscreen 7 4 1 Menu Bar The menu bar is on top of the touchscreen Fig 7 3 no 6 ee Pc Licence fle o Software update Sg G Jrich medical 35 tlrich H medical mississippi missouri 7 Start Up Options Keep VeinOpen Last patient CA Tandem Operatina mode Patient hose NaCl airbao Na
3. Select button Test bolus continue with Section 8 4 1 z Injection with the same patient Select button Same patient continue with Section 8 4 2 64 mississippi missouri 8 Carrying out Injections 8 4 Programming Options 8 4 1 Test Bolus In the Patient hose changeover window Fig 8 15 select the Test bolus function and enter the injection data for a test bolus Do not yet fill new patient hose do not yet press the keys Release and Changeover yet Only Sequence 1 test bolus sequence is confirmed and blocked no more change possible by selecting OK The system does not yet switch to the injection screen Fig 8 16 regen ones tie ri CA RELS Injection time Manual Sequence ENEE TAS EE Flow m s eee nol en BS spe volume ml volume ml per sequence s start en 2 22 as 6 0 SW oone Her rich medical CA Nacl Injection time Manual Sequence EEN Ree eT ASS Bega at reese T rk Flow m s EE d SH volume ml volume ml per sequence s start C g Minimum Total cor AR D a i Sc R te i z s ml nea a 09 46 17 S N arz EJ soz emerge Control unit CA Na CA2 Injector Fig 8 16 Test bolus sequence line unblocked a and blocked b Test bolus in general Injection without test bolus Input screen gt OK gt Injection screen Injection with test bolus Input screen gt 2 x OK gt Injection screen With the first
4. The mississippi XD 2000 is used for the reproducible dosing of con trast agent from up to two mounted storage bottles of identical contrast agent and isotonic saline solution into a patient s peripheral vein via a sterile hose system The injector mississippi XD 2000 must be used only with accessories approved by the manufacturer Only the injection pump with specific disposables approved by the ma nufacturer is allowed to be placed in the patient area within a radius of 1 5 m The terminal including its power supply and where applicable mouse as well as the charging station including its power supply must be positioned outside the patient area and outside the MRI examina tion room Only medically trained and according to ulrich medical training materi als instructed professionals are allowed to operate the injector missis sippi XD 2000 According to the intended examination and the pa tient the injection parameters are to be determined by the medical pro fessional The injection pump is intended to be used in medical locations meeting the usage requirements for a type B applied part 1 2 Intended use CT injector missouri XD 2001 The injector missouri XD 2001 is designed for the intravenous ap plication of non radioactive contrast agent to improve image quality for computer tomography imaging with CT and PET CT scanners ex cept high pressure angiographic examinations The injector missouri XD 2001
5. 00nnnaannennnennnennoennnrnnnrrennnrerrnrrrnrrsnersnrrrnrrsrrnrnrrsnrennrrnerennnes 74 8 27 Pause window INACTIVE and achve 75 8 25 Enter pauso Ile EE 75 8 29 Defined pause after seuence 76 8 30 Manual start window INACTIVE ANC ACTIVE cc ccececeeceeeeeeeeeeeeeeeneeeeeeeeseeesaeeeseeeaes 76 8 31 Manual start gege geeegieue ege eteggtegete see biegeedebieue dee dleousiesunieoubine dileoubiesiualaoubiecaleubiecaieouniall 17 8 32 Manual start during mtechon 77 8 33 Start delay window INACTIVE ANC achve 78 8 34 Injection program with Start delay 78 8 35 Stop watch window inactive ANC ACTIVE cccceecccceeeeceeeeeseeeetaeeesseeeesaueessaeeesaaees 79 8 36 Stop watch in injection screen 79 9 1 Replacing empty contrast agent bottles ce ceccceeeeceeeeeeeeeeeeeseeeeeeeeseeeeseeesaeens 81 10 1 OMT GOWN Gy SUC oe c2sc2aceesecttaernactucseuachodseaschoseeuactolapneatnacsacSeseeoncesceneceosazenctosze esau 83 10 2 Remove piercing needles cccccecccseeceeeeccececeeecseeceucesseeecseeceusesseeeeeeesueensenseas 84 10 3 Remove Dotle le e EE 84 a IOAN OMNIS TAD ME 85 11 1 Remove battery E 86 11 2 Battery in Charging station ccccccceecceeeceeeeeeeseeeseeeseeeeeeeseeeseeeseeeteeseeeseeeteeeseeees 86 11 3 Bar indicator for battery charge ccccccccecccsececeeeeseeeseeceseeeeeeeesaueeseeeeseeeseeeeseeeeaes 87 12 MOUS DC AIC EE 88 122 DCT dale AIG UME sosprorippn ie a sactpansetiop
6. 8 Carrying out Injections even ons mn perch medical CA Nacl Injection time Flow mls Pause s volume ml volume ml per sequence s Minimum injection time s Total contrast agent ml 0 80 Total NaCl ml 30 0 imi P NaCl airbac d Total injection ml Continue SES y Control unit CAI NaCl CA2 Injector Fig 8 29 Defined pause after sequence 1 Press Continue to terminate the pause earlier and start the next se quence You can find further information about the status of activation and sav ing of this setting in the table Annex 9 8 4 8 Manual Start This function provides for the manual starting of individual sequences within an injection Select Options Manual start in the menu bar The Manual start window opens Activate function by selecting the button Fig 8 30 Manual start Manual start Activate function by clicking Activate function by clicking O Manual start Fig 8 30 Manual start window inactive and active K Manual start Press OK to accept The input screen will display an additional column Manual start The Manual start button is respectively set in between two open se quences Fig 7 30 76 G Jrich mississippi missouri 8 Carrying out Injections medical 8 31a zen options Hel C lich Program options Hel ich medical start z CA Nacl Injection time Manual hate bhlB volume ml volume mi Flow ml s quence start
7. OK the test bolus sequence is confirmed and blocked no further changes possible The system does not yet change over to the injection screen Fig 8 17 The window Patient hose changeover with test bolus appears on the screen The test bolus can be stacked in the still empty patient hose by pressing simultaneously the keys Release and Changeover v H Contrast agent is at the front of the patient hose on the Luer Lock 2 Fig 8 16 G Jrich medical The function Manual Delivery is blocked The test bolus loaded into the hose system would otherwise be discarded or injected into the patient before the diagnostic injection 65 g rich REN medical mississippi missouri Or the window Patient hose changeover with test bolus can be closed and the test bolus can be stacked in after having programmed further sequences Fig 8 17 ue rm prich CA Nacl Injection time Manual Flow ml s volume ml volume ml per sequence s start Information O Patient hose changeover with test bolus 4 Ai Yent patient hose Press simultaneously the keys Release and Changeover on injector Test bolus Same patient Total injection ml 0 24 14 46 26 06 03 2008 Fig 8 17 Patient hose changeover with testbolus The input screen displays an additional column Manual start If further sequences are programmed a Manual start is automatically set after the tes
8. Operating Instructions CT MRI Injector mississippi XD 2000 CT Injector missouri XD 2001 Software Version Injector 7 xx Touch terminal 7 xx Copyright 2008 ulrich GmbH amp Co KG All rights reserved XD 2500 E Rev 1 0 LE g rich mississippi missouri Introduction medical Dear Users rich a These operating instructions are to assist you with the utilization of the Be medica Contrast agent injectors mississippi and missouri We should like to enable you to operate the unit safely and reliably and to achieve the best possible work results After the installation of the injector you have received an introduction into the utilization of the unit Before you take the injector into operation you should also read carefully the warning and safety notes as well as the operating instructions in order to avoid damage by incorrect handling In case of contravention to the recommended handling of the manufacturer guarantee claims will expire In principle there is no guarantee for disposables and wear parts like e g batte ries and valve membrans How to use these operating instructions z Notes intended to facilitate the utilization of the injector are marked in orange For facilitating the operation of the unit or improving work procedures i Notes intended to draw attention to hazards and risks for patients and or users and or unit are written and marked in red To avoid or pr
9. Total injection ml emer Cancel 13 48 53 Ke lus a S Ei o lem SA Ze AIS Litt Fig 8 1 Numeric keypad for entering injection parameters m Input via numeric keypads Select numeric keys input appears in the display field above the scale s Input via scale Selection by finger or touch pen move stepwise Input appears in the display field above the scale Press OK to accept selected value Press Cancel to close the nu meric keypad and to get back to the input screen without accepting value Fig 8 1 The value to the right and left of the scale shows the respective per missible value range if this is exceeded a warning message plus warn ing sound will be issued The system refuses to accept a non permis sible value Fig 8 2 SE G Jrich mississippi missouri 8 Carrying out Injections medical room owtoe te rich medical s CA Nacl Injection time sche ate volume ml volume mi Flow ml s Flow 1 25 Minimum injection time s Total contrast agent ml 070 Total Nacl ml Total injection ml Fig 8 2 Maximum exceeded 8 2 Input Screen for Injection Programs The input screen on the touch terminal is the starting point for all fur ther actions O d Birch medical CA Nacl Injection time Flow mls volume ml volume ml per sequence s T a Minimum injection time s Total contrast agent ml 070 Total Nacl ml oo Total estan imi athe o 06 03 20
10. Fig 10 3 Remove bottle holder 84 mississippi missouri 10 Taking out of Service Do not use any sharp cleaning agents as this causes the surface of the unit to become dull and unattractive and may damage ultrasonic sensors The seals may also be destroyed No ultrasonic cleaning for any parts of the injector It is possible to disinfect the bottle holder for CA1 CA2 and NaCl with spray The valve door can be disin fected by wiping Do not apply disinfec tant directly onto the device or onto parts of it Use a cleaning cloth mississippi missouri 10 Taking out of Service Clean all removed parts in hot water Refit parts to injector only when they have been dried completely Clean injector with a soft cloth and warm soapy suds Use very hot wa ter to remove any resistant contrast agent residues If necessary completely disassemble difficult to operate pump flap to this end use special pump flap key to open pump flap and withdraw to ward front Fig 10 4 Fig 10 4 Clean pump flap Use water which is as hot as possible to make the joint easy to operate again and if necessary treat with silicon spray after drying Use moist cloth to wipe off pump wheel Refit pump flap and lock it with the pump flap key Pump flaps can become difficult to operate if the joint becomes conta minated by dripping contrast agent As a prevention use the swivel de vice when changing contr
11. Patient hose length 320 cm Minimum NaCl volume of sequence 1 25 ml MRI mode The maximum injection volume per patient is 400 ml CA plus NaCl with the maximum volume share for CA being 250 ml Before an injection the entire hose system is filled with salt solution That is in sequence 1 it is not possible to enter less salt solution than is actually contained in the hose system The smallest possible salt solution input therefore depends on the length of the patient hose Patient hose length 120 cm not available in MRI mode Patient hose length 150 cm Minimum NaCl volume of sequence 1 pre bolus 16 ml Patient hose length 250 cm Minimum NaCl volume of sequence 1 pre bolus 21 ml Patient hose length 320 cm Minimum NaCl volume of sequence 1 pre bolus 25 ml 5 ml e o ep BETTEL EA CEET EE ZP r e Am wm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm em mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm o S __s E lenght 320 cm Fig 8 7 ulrich patient hoses with minimal NaCl CA volume 57 G Jrich medical mississippi missouri 8 Carrying out Injections For CT plus and MRI mode Before the first administration of contrast agent the salt solution con tained in the hose must be injected NaCl pre bolus The button for contrast agent in sequence 1 is therefore blocked contra
12. rich medical g rich medical mississippi missouri 2 Description of Unit The unit of missouri XD 2001 is composed of 7 XD 2051 CT injector Mains operated version movable stand m XD 2101 1 Installation box m XD 2111 230V Connection cable m XD 2060 Touch Touch terminal E XD 2061 Touch XD 2061 M Touch Power supply unit of touch terminal XD 2062 Main cable for terminal In order to exclude reliably electromagnetic interactions with other units the data transmission between touch terminal and injector is affected via optical waveguides g rich medical mississippi missouri 2 Description of Unit Fig 2 2 Injector with opened battery compartment mississippi type plate and power switch G Jrich medical mississippi missouri 2 Description of Unit 2 2 Injector Depending on the examination to be carried out and the respective space available the injector is positioned in the examination room next to the patient bed either before or behind the gantry but outside of its pivoting radius The core of the injector is the roll pump with drive motor as well as the microprocessor control system Power supply a missouri mains current a mississippi battery current Roll pump a Multi dosing Several patients can be supplied one after another from one respectively two storage bottle s a Only one medium flow direction A contamination of the pump hose is re
13. 2 5 Injection Volumes CT mode The maximum injection volume per patient is 400 ml CA plus NaCl with the maximum volume share for NaCl as well as CA being 400 ml Before an injection the entire hose system is filled with contrast agent That is in sequence 1 it is not possible to enter less contrast agent than is actually contained in the hose system The smallest possible contrast agent input therefore depends on the length of the patient hose Patient hose length 120 cm Minimum CA volume of sequence 1 15 ml Patient hose length 150 cm Minimum CA volume of sequence 1 16 ml Patient hose length 250 cm Minimum CA volume of sequence 1 21 ml Patient hose length 320 cm Minimum CA volume of sequence 1 25 ml 56 G Jrich mississippi missouri 8 Carrying out Injections medical CT plus mode The maximum injection volume per patient is 400 ml CA plus NaCl with the maximum volume share for NaCl as well as CA being 400 ml Before an injection the entire hose system is filled with salt solution That is in sequence 1 it is not possible to enter less salt solution than is actually contained in the hose system The smallest possible salt solution input therefore depends on the length of the patient hose Patient hose length 120 cm Minimum NaCl volume of sequence 1 15 ml Patient hose length 150 cm Minimum NaCl volume of sequence 1 16 ml Patient hose length 250 cm Minimum NaCl volume of sequence 1 21 ml
14. 6 If CA bottles are mounted at the same time as NaCl air can no longer escape from the hose fault messages will occur n Switch on injector only after insertion of the pump hose as oth erwise an alarm is emitted on the touch terminal during the en tire insertion process due to open doors and flaps z Valve door pump flap and battery compartment lid may not be opened after the injector has been switched on or the particle filter must no longer be removed from the holder z Before any injection users must check whether the basic set tings operating mode length of patient hose are correct com pare Section 7 5 The operating mode CT CT plus or MRI can be changed only when the injector is switched off the patient hose length can be modified before each patient hose changeover i The length of the patient hose actually used must match the preset length The system determines the filling quantity in ac cordance with this length compare Section 7 5 2 An extended hose is not filled completely air remains in the hose In the case of a shorter hose some medium is discarded In the case of an incorrect hose length the volume counters on the touchscreen do not match the actually injected volume Briefly press the keys on the injector s control unit compare Section 6 4 Exception Manual Delivery Pressing the keys more than once may result in error messages z If the light emitting diode hour glass ill
15. Delete Injection Hrogram 56 S220 IMS UOV OUNMO ais E S E A 56 8 3 The Procedure of an Intechon 58 8 3 1 Punction of a Haten 58 8 3 2 Acknowledge Injection Program in Input Gcreen 58 GC EC SE de EE 59 8 3 4 Interrupt an Injection in Progress by PAUSE cccceeeceeeceeeeeeeeeeeeeeeeeeeseeens 60 8 3 5 Terminate an Injection in Progress by Cancel 60 8 3 6 Cancel an Injection in Progress by Emergency Stop n nnannnennnnnnennnnnnenennne 61 GO WAC CHOUM EG E 63 8 3 8 Patient Hose Changeover 64 Ce Programming e Le E 65 of a a Ke UE 65 oae SAET eS GN E 68 8 4 3 Keep Vein Open 70 SA NST USD EE 71 8 4 5 NaCl Airbag Automatic switchover oa 72 8 4 6 CA Tandem 74 oe P E gt ee eee eee ee eee ee eee eee 74 048 Manuali ota ageet 76 Sao DANDE aan ee eee 78 G Jrich mississippi missouri Contents medical 8410 STOO Be E 79 oa BUO ee E eee ee ree re 80 9 Changing Storage an UC 81 9 1 Cfo ig eege 81 92 Salt SOLUTION 20 0 ccc cccccseeceneeeeeeeeeeseeeeceeeteaeeseeeeeaeeseeeseeessneetaeeeeeeeteneeneeeteaeess 82 10 Taking out of Service oh csicesmetcaoente icnenavictenmevahsonncnvenesansahaumustuccdentaligusees bosuieeuebiaweunneasnadsoes 83 10 1 Shut down and switch off wmiector ccc eccccececeeeeceeeeeeeeceeeeseeeseeeseeeeseeeseeeeneeeeaes 83 10 2 Disassemble Injector sasiinniearienaiaraincnsnaisiionuedassiiaetiainewantoamitngaaisiiunsabeaihinyaaliiiunoabnshinyaabiines 83 Oo ORANO e e E
16. IN progress ssssssssnenesnneerrenrerrenrrerrerrrnne 60 Fig 1 Gane file e 61 Fig 8 12 Press emergency SIOD E 61 Fig 8 13 Emergency stop message on the termmmal 62 FIO G A ENG Ola IMC CUO EE 63 Fig 8 15 Patient hose changeover Window cccseccsececeeeneeeneeeneeeseeeneeeseeenaeeseeeneeeneeeneeenes 64 Fig 8 16 Test bolus sequence line unblocked a and blocked ni 65 Fig 8 17 Patient hose changeover with Iestbolus 66 98 Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig G Jrich mississippi missouri 14 Figures medical 8 18 Input of further sequences after test bolus seguence 66 8 19 SAME patient 0 0 ecccccecccsecceceeecceseeeseeeesseeeeseeesseeeeseueessaeeeseueesseeeseueesseeesseeeessnees 69 8 20 NaCl in the patient hose ccc cccccceeeccseeeeseeeeseeeeeseeeeseeeesseeeesseeesseueesseesseeeessaees 69 8 21 Keep VEIN open FUNCTION ccceecceecceeeceecceecceeeceueceueceueceeceueeeueeeueeeueseueseetsseeenass 70 8 22 Window Last Patient E 71 BZ ge AUIS UM ear tint ntiaentansniiooenlintniinsntiniilonetlintniinsttln aioottatniimeiiasiiins 71 8 24 Information about injected volumes nn nnnennannnnnnennsnenennnnnornnnnennnnerennnrnrrsnererrnnes 72 8 25 Select NACI atag nesidir es eidhinn idiniin 73 8 26 NaCl airbag active
17. Jrich medical mississippi missouri 14 Figures 14 Figures Fig 2 1 Injector with touch terminal and Control unt 9 Fig 2 2 Injector with opened battery compartment mississippi type plate and power e 9 Fig 2 3 Pump hose for ulrich contrast agent injectors eesseseeseeneeneeeesrerrererrerrerrererrerene 11 Fig 2 4 Patient hoses for ulrich contrast agent injectors 0 ccccceeesscesseseeesseseeeseeseeseenees 11 Fig 6 1 Installation box 23 Fig 6 2 Insert nt EE 23 Fig 6 3 Parts designaton 24 FO ele fei Tue e BEE 25 lef UNO NOSE XD 2c ces create mca EAEE EEEE EER 26 Fig 6 6 Guide tubes and ultrasonic sensore 27 Fig 6 Le ER WE 27 Fig 6 8 Insert piercing needles cccccceeccceeeeceeeceeeeceeeeaeeeseueeceeeeeeeeseueeseeeeaueeseeeeseeesneesanes 28 FIO len DUMP NOSE E 28 FOGA PAU OSO E 29 Fig 6 11 Pivoted hose holder and drip cup 30 FO Orie Change guide te 30 Fig 7 1 Power Switch touch Terminal 33 Fig 7 2 Control unit ON the miechor 34 Fig 7 3 User interface ON touchscreen 35 Fig 7 4 Opening of program sequences MRI mode 37 lef PO Se IMAC EE ER Fig 7 6 Status symbol bar inactive cc ceeccceeccceeeceeeeceeeeaeeeeeeeeseeeeeeeeseueeseessueeseeeseeesaueesaees 39 Fig 7 7 Status symbol bar and active containers vented and not vente 39 Fig 7 8 Select operating mode 41 Fig 7 9 Selected Operating mode 41 Fig 7 10 SeleCE patent Nose lengi NEE 42 Fig 7 11 Window Star
18. Notice the re commended procedure for a fast and drip free Remove patient hose from the pivoted hose holder Fig 6 11 place disassembly patient end side into waste bin or any other suitable collecting contain er for media that run out Initially open only valve door Fig 6 3 no 13 and pump flap Fig 6 3 no 9 Media runs out at the end of the patient hose Open NaCl shut off valve Fig 6 3 no 3 and NaCl sensor flap Fig 6 3 no 1 only when the contrast agent accesses have been completely emptied The residual fluid runs off Next the pump hose can be removed and that there will be no drip ping to this end grip the piercing needles underneath their edge and remove the same from the bottle holder Fig 10 2 83 g rich medical Fig 10 2 Remove piercing needles Discard entire hose system 10 3 Cleaning Before commencing any cleaning work power the system down switch off the injector and touch terminal and disconnect them from the mains Do not clean components in ultrasonic bath 10 3 1 Disconnect injector from mains Injector Remove boitles and hoses compare Section 10 2 Take off removable parts Remove guide tubes compare Section 6 3 Open rear eccentric closure devices by turning in a clockwise direction withdraw bottle holders Figs 6 6 nos 5 and 8 in an upward direction Fig 10 3 Withdraw particle filter mounting by pulling upwards and then towards the left
19. is used for the reproducible dosing of contrast agent from up to two mounted storage bottles of identical con trast agent and an isotonic saline solution into a patient s peripheral vein via a sterile hose system The injector missouri XD 2001 must be used only with accessories approved by the manufacturer Only the injection pump with specific disposables approved by the ma nufacturer is allowed to be placed in the patient area within a radius of 1 5 m The terminal including its power supply and where applicable mouse must be positioned outside the patient area Fs rich medical G rich eit eee medical mississippi missouri 1 Intended use Only medically trained and according to ulrich medical training materi als instructed professionals are allowed to operate the injector mis souri XD 2001 According to the intended examination and the pa tient the injection parameters are to be determined by the medical pro fessional The injection pump is intended to be used in earth grounded medical locations meeting the usage requirements for a type B applied part mississippi missouri 2 Description of Unit 2 Description of Unit wich contrast agent injectors have been used successfully for many years in radiological surgeries and clinics They ensure an opti mal contrast agent injection when computer or nuclear magnetic reso nance imaging examinations are carried out and thereby improve deci sively th
20. mode This function causes the entire hose system to be filled with salt solu tion following the final injection in a working day No contrast agent is discarded during hose disposal Activate the function in the input screen before the final injection in a working day Select Options Last patient Activate the function by selecting the button Fig 8 22 Last patient Release function by clicking When next injection is complete the entire hose system is filled with NaCl O Last patient Fig 8 22 Window Last Patient Press OK to confirm Last patient appears on the input screen ween e tee MCh CA Nacl Injection time Flow ml s volume ml volume ml 100 20 an 30 0 per sequence s Minimum injection time s 30 0 Last patient Total contrast agent ml Total NaCl ml 0 20 06 03 2008 150 cm eb A A f s LU IL Hu etting Fig 8 23 Last patient After the injection the injected volumes are displayed Press Return to return to the input screen press End to get to the message Do you really want to shut down the system Fig 8 24 Press Shutdown to confirm and terminate the operating system or if necessary cancel 71 G Jrich medical mississippi missouri 8 Carrying out Injections medical CA Nacl Injection time Manual volume ml volume ml Flow ml s per sequence s start Last patient e Injection completed In
21. parts must not be operated in environments where there is an explosion hazard and or in areas with combustible an aesthetics or cleaning agents Devices can only be disconnected from mains by removing the power plug completely from the wall socket The mains plug has to be easily accessible m Always disconnect the connecting cable Art No XD 2111 230V from the installation box first Only then it is safe to uncouple it from the injector n Place injector and connecting cable outside of pivoting radius of the gantry m Distance of the injector to the nuclear magnetic resonance tomo graph at least 30 cm measured from the rear of the injectors stand Philips Gyroscan 1 5 T at least 40 cm If the actual dis tance is less than the minimum distance the correct functioning of the injector cannot be assured see label on injector m CT Injector missouri touch terminal and charger as well as the associated power supply units must not be brought into the MRI examination room G Jrich mississippi missouri 4 Warning and Safety Notes medical x The injector may only be set up in accordance with the manufac turer s installation instructions Installation and repairs may be carried out by the manufacturer or authorized personnel only n The regular maintenance tasks or technical safety checks must be complied with and carried out 4 3 Disposables z Only use original disposables approved by ulrich medical Co p
22. pump pump flap valve door to avoid crushing x In case of several units do not mix up pump flaps as these are exactly adapated to the relevant units x Before using a defibrillator patients must be disconnected from the injector The injector is not protected against the effect of a defibrillation m Note the magnetic field in the nuclear magnetic resonance imaging compare Annex 10 Safety regulations for MRI plant No liability will be accepted if the warning and safety notes are not followed 21 G Jrich medical mississippi missouri 5 Manufacturer Customer Service 5 Manufacturer Customer Service Germany ulrich GmbH amp Co KG Customer Service injectors CT MRI Buchbrunnenweg 12 89081 Ulm Germany Phone 49 0 731 9654 0 Fax 49 0 731 9654 2805 injector ulrichmedical om www ulrichmedical com In the event of faults occurring always state the serial numbers of injector and touch terminal compare type plate on the rear side of injector and touch terminal as well as the fault code possibly issued at the touch terminal compare Annex 1 2 International Stamp contact data of authorized distributor 22 mississippi missouri 6 Preparation for Start Up 6 Preparation for Start Up 6 1 Power Supply and Data Transmission 6 1 1 missouri Power is supplied via the installation box with mains supply The connecting cable comprising optical waveguides and mains cable is connected to
23. the installation box Fig 6 1 but must be uncoupled for cleaning or maintenance Fig 6 1 Installation box 6 1 2 mississippi Turn rotary knob on battery compartment lid Fig 6 2 in an anti clockwise direction open lid Insert battery slowly and level note red marking Close flap the rotating knob must engage If necessary plug in optical waveguides at the rear of the injector and lock Fig 6 2 Insert battery g rich medical For safety rea sons always dis connect the con necting cable Art No XD 2111 230V from the installation box first Only then it is safe to uncou ple it from the injec tor Use a fully charged battery at the start of a working day 23 g rich medical mississippi missouri 6 Preparation for Start Up 6 2 Insert Hose System Fig 6 3 Parts designation Legend for figure 6 3 1 NaCl sensor with sensor flap 8 Pump wheel 2 Particle filter holder 9 Pump flap open 3 NaCl shut off valve with 10 Control unit oush in latch right 4 Valve door closure 11 Cross piece mounting 5 Pressure chamber 12 Hose guide 6 Ultrasonic air trap 13 Valve door opened 7 Rotational pump flap closure 14 Mounting groove for clamping 24 piece mississippi missouri 6 Preparation for Start Up 6 2 1 Pump Hose Pull valve door closure device in an outward direction Fig 6 3 no 4 open valve door Fig 6 3 no 13 Open pump flap Turn rota
24. 08 _150 cm l 3 A F eting TT Litt Fig 8 3 Input screen after filling process 53 G Jrich medical mississippi missouri 8 Carrying out Injections 8 2 1 New Injection Program There are two options for generating a new program n Select New in the menu bar Program m Select sequence 1 button Sequence 1 button is activated yellow marking sequence 1 is opened that is the buttons for injection parameter input appear grey start value 0 The button for opening sequence 2 appears Fig 8 4 Program Options Help d pich medical CA Nacl Injection time giereg ell volume ml volume ml Flow ml s GH Be per sequence s Je eg Minimum injection time s Total contrast agent ml 070 Total Nacl ml oo Lokal PSP imi Gs o 13 54 35 CTplus lip E 05 03 2008 150 cm Z A A etting ontrol unt Fig 8 4 New program with one sequence CT mode Select relevant button to input the injection parameters volumes and flow rate The numeric keypad is opened compare Section 8 1 2 A value can be changed again by selecting a button already written to Up to six sequences can be input s Open sequences Select last sequence button e g Fig 8 4 sequence button 2 Close unwritten sequences Select last but one sequence button e g Fig 8 4 sequence but ton 1 Empty sequences are not accepted by the system they must be writ ten to or closed Press OK to check
25. 11 The piercing needles must Insert left hand and right hand piercing needles for contrast agents clearly engage into Fig 6 6 nos 4 and 7 complete with protective cap into bottle holder the guides on the for CA1 Fig 6 6 no 5 and CA2 Fig 6 6 no 8 in doing so align bottle holder venting filter green point on the piercing needles towards the front Fig 6 8 The cross piece must clearly engage into the mounting The hose must not be twisted in itself or become kinked in particular at the CA and NaCl accesses When inserting the pump hose around the pump set a roller of the pump wheel into an Fig 6 8 Insert piercing needles approx six o clock SS position approx Insert the two contrast agent accesses Fig 6 5 positively into the dry ultrasonic sensors CA1 Fig 6 5 no 6 and CA2 Fig 6 5 no 7 press each access fully to the rear Insert hose underneath the cross Insert pump piece into the hose guide Fig 6 3 no 12 hose positively into the air trap To this the lowest position Insert clamping piece into the mounting groove Fig 6 9 Place hose around pump wheel Fig 6 9 One roll of the pump wheel must be po si tioned in an approximately 6 o clock position Fig 6 9 end respectively use a finger above and below the air trap to press the hose fully to the rear Otherwise the pump hose can be damaged when closing the pump flap Do not use ultra
26. 5 TOLA jecka ml SE a 08 39 45 l e W Em SE Fig 8 36 Stop watch in injection screen An additional column Stop watch s appears on the right of the input screen which contains a separate button per selected sequence Select the button enter the desired time and select OK to continue The stop watch can be assigned to any sequence If the injection gets to the sequence with the stop watch it starts to count upwards or downwards according to selection After the selected time has ex pired there is an acoustic signal three short beeps The stop watch does not affect the process of the injection The stopwatch setting is saved with the relevant injection program 19 G Jrich medical mississippi missouri You can find further information about the status of activation and sav ing of this setting in the table Annex 9 8 4 11 Battery Compare Section 10 You can find further information about the status of activation and sav ing of this setting in the table Annex 9 80 8 Carrying out Injections g rich mississippi missouri 9 Changing Storage Bottles medical 9 Changing Storage Bottles The contrast agent and salt solution storage bottles are monitored by oe After mountin means of ultrasonic sensors below the piercing needles Fig 6 6 j new storage 9 1 C ontrast Ag ent bottles the relevant hose accesses If a contrast agent storage bottle runs empty then the relevan
27. 8 14 2 Riich medical Injection End Program Options Help CA Nacl volume ml volume ml Injection time Flow mls per sequence s 10 0 Information et Injection completed Injected volumes since patient hose changeover Contrast agent volume ml 20 NaCl volume ml 45 Total volume ml 65 5 eh Total Nacl ml Total injection ml as e EAA a eey 06 03 2008 _150 cm z err i IL H LU IL Litt Kb WW LUC L Fig 8 14 End of an injection If OK is pressed to confirm this information a prompt for changing the patient hose appears When an injection is complete the patient hose is filled automatically with salt solution so that when the patient hose is changed no contrast agent is discarded together with the patient hose When NaCl is filled in the system takes into account the patient hose length selected In the case of MRI mode and CT plus mode the pump hose is already filled with salt solution after patient hose changeover In the case of CT mode the pump hose is already filled with contrast agent after patient hose changeover g rich medical The length of the patient hose actually used has to correspond to the selected length on the terminal The automatic filling of the new patient hose after an injection is cal culated according to this length 63 G Jrich medical mississippi missouri 8 Carrying out Injections 8 3 8 Patient
28. E ance ca S E 84 E e e ere E Ect tinggi ttn E A tutes E N 84 10 3 2 NIC IA TITAN cnc tacos eaten aE ela eh EEEE EErEE 85 10 3 3 Battery And Charger 85 Tt SEENEN 86 Ted ee Eng 86 11 2 Check Battery Charging Gates 87 12 Software Further Settings and FUNCTIONS cccccsssceeeseeceneeeenseeeeneeeeneeseeeeesens 88 2A TOU CaO O EE 88 12 2 Loudepeaker 88 T23 Dae and NE aa E EE eee ee ee eee eee 89 E EE 90 Devo MANO AIS E 91 12 6 Data import and export cece ceececeeeceeeeceeeeseeeseeeeseeeeeeeeseueeseesaueesueeseeeseuteneeesaes 92 E Daa DO ee 92 1262 E ee E 93 13 HeD M TE 94 13 1 Summary Operating Insiruchons 94 be Na NR ele TEE e EE 94 13 1 2 Patient Hose Changeover after each Patient cc cc ccccceccceeeceeeceeeseeseeeees 95 13 1 3 Remove Air ALAIN EE 95 E E VIC E E 95 FOZ INIA Eet 96 Ee INO E 97 14 Ate Ul acces icc re enc ses cee cence ccc omer cis ome rset eiewes eee rset omen wees oem rseomee esau meee eesaneen 98 G Jrich medical mississippi missouri Contents mississippi missouri 1 Intended use 1 Intended use 1 1 Intended use CT MRI injector mississippi XD 2000 The injector mississippi XD 2000 is designed for the intravenous application of non radioactive contrast agent to improve image quality for nuclear magnetic resonance imaging respectively computer tomo graphy imaging with MRI CT and PET CT scanners except high pressure angiographic examinations
29. Hose Changeover Following the injection disconnect the salt solution filled patient hose from the patient and discard directly to waste bin Exception Same pa tient compare Section 8 4 2 Take new patient hose out of its ster ile packaging and connect to pump hose compare Section 6 2 2 The following message appears on the touchscreen Program Options Help Ir sl gy rich medical CA Nacl Inj ection time Flow ml s volume ml wolume ml per sequence s Information O Patient hose changeover JS Ai Yent patient hose Press simultaneously the keys Release and Changeover on injector Total injection ml EE UI OT LU Kb MUSELO Fig 8 15 Patient hose changeover window There are three options available m Preparation for next injection without test bolus Visual check of Simultaneously press the keys Release and Changeover on the patient hose by the control unit The patient hose will be filled automatically with the user during CA in CT mode with NaCl in MRI mode and CT plus mode The automatic filling is message on the touch terminal will be closed automatically absolutely necessary e o fthere is nota v H new patient hose connected immedi Connect next patient The parameters for the next injection can be defined in the input screen on the touch terminal compare Section 8 2 ately close the open end of the pump hose with a Injection with test bolus BESSE
30. Lock male Particle filter Pressure measurement system Piercing needle NaCl with protective cap 5 8 NaCl access Piercing needle CA1 with protective cap 6 gt 8 CA1 access Piercing needle CA2 with protective cap 7 gt 8 CA2 access Pump hose cross piece Clamping piece DO OO rd OO OF P Ga ND 26 G Jrich mississippi missouri 6 Preparation for Start Up medical If initially the NaCl piercing needle and the particle filter are inserted the hose ends are fixed and can no longer drop onto the floor pre venting hose con tamination Fig 6 6 Guide tubes and ultrasonic sensors Legend for figure 6 6 1 Piercing needle NaCl 6 Ultrasonic sensor CA1 2 Bottle holder NaCl 7 Piercing needle CA2 3 Ultrasonic sensor NaCl 8 Bottle holder CA2 4 Piercing needle CA1 9 Ultrasonic sensor CA2 5 Bottle holder CA1 Insert particle filter positively into the filter holder compare Fig 6 7 Filter holder has to be pushed firmly into housing Fig 6 7 Particle filter Insert centre piercing needle for NaCl Fig 6 6 no 1 complete with protective cap into bottle holder for NaCl Fig 6 6 no 2 insert NaCl access into the dry NaCl sensor Fig 6 6 no 3 close NaCl sensor flap and close the NaCl shut off valve with inserted hose 2 G Jrich medical mississippi missouri 6 Preparation for Start Up Insert cross piece of pump hose Fig 6 5 no 8 into cross piece mounting Fig 6 3 no
31. Nacl Injection time SE ml volume ml Flow ml s per sequence s Minimum injection time s 14 7 Same patient Total contrast agent ml Total Nacl ml 22744 Total injection mi 44 oO xK Cancel 14 51 16 CT plus SR lip a 06 03 2008 _150 cm Z A x LU OI UL etting Fig 8 19 Same patient After OK the safety prompt appears Are you sure that there is no air 2 Fig 8 8 If the answer is Yes then there will be the information with regard to the NaCl volume in the patient hose automatic NaCl fil ling of the patient hose after each injection compare Fig 8 19 and Fig 8 20 program Options met d Riich medical CA Nacl Injection time Flow mls Sequence volume ml volume ml per sequence s 20 10 3 0 10 0 Same patient Q NaCl in patient hose Inject NaCl with Continue Flow 2 ml s NaCl volume 7 ml Minimum injection t Total contrast AGE ping D g Total Nacl ml 25 42 Si SS ge aa Cee 08 44 29 ge e FACET Control unit Injector Fig 8 20 NaCl in the patient hose lf Return is pressed the system returns to the input screen Press Continue to inject the NaCl volume contained in the patient hose depending on the patient hose length at a flow rate of 2 ml s The system changes from the input screen to the injection screen 69 g rich EE ii medical mississippi missouri 8 Carrying out Injections Injections with the function Same
32. a Minimum injection time s Total contrast agent ml 0 100 i Nacl ml 0 60 15 57 48 cT Uug iho 06 03 2008 150 cm etting Q Al Na A recto Fig 8 31 Manual start Select button Manual start Fig 8 31a to activate function after a sequence Fig 8 31b The injector stops the injection at this point after the sequence has been injected the button flashes in orange Fig 8 32 Pagan en mm ey Kirich medical CA Nacl Injection time Manual volume ml volume ml Flow ml s per sequence s start fe Minimum injection time s 53 3 Total contrast agent ml 6Of T Total Mac ml 20 60 Total injection ml 80 160 C Cancel D CT KI EI A Ze etting ontrol unit Fig 8 32 Manual start during injection Press Continue to start the next Sequence You can find further information about the status of activation and sav ing of this setting in the table Annex 9 77 G Jrich medical mississippi missouri 8 Carrying out Injections 8 4 9 Start Delay With this function the injection is only started after a preset delay time Select Start delay in the menu bar Options gt Start delay The Start delay window opens Activate function by selecting the button Fig 8 33 Start delay Start delay Activate funtion by clicking Activate funtion by clicking O Start delay K Start delay Fig 8 33 Start delay window inactive and active Press OK to accept An ad
33. after each patient EEE TT Lange 120 cm TK Ee i 1 Lange 150 cm Lange 250 cm fis rich medical aad _ gt Lange 320 cm Fig 2 4 Patient hoses for ulrich contrast agent injectors G Jrich medical mississippi missouri 2 Description of Unit 2 4 Touch terminal The touch terminal is used for entering the injection parameters as well as for starting and monitoring the course of injection It is located out side the examination room next to the operating console of the tomo graph The touch terminal is identical for both injector models The housing contains the touchscreen as well as the single board computer inter face for an external data carrier and various interfaces E Touchscreen o TFT Display 12 1 m Power supply o Power supply unit with automatic adaptation to all mains voltages worldwide m User interface o Operating system QNX 6 3 similar to Windows o All relevant information at a glance o Realtime counters for the control of the ongoing injection m Data input o he touchscreen is designed for operation by finger If de sired a touch pen can be used for operation as well o A touch pen with carrier is included in the delivery of the touch terminal a Alternatively the terminal can also be operated by mouse via USB interface o Please note that any defects caused by incorrect handling of the touch terminal e g sharp objects ball point pens are expressl
34. ained When changing batteries check the high frequency seal on the battery compartment lid this must be clean and closed all around wipe off if necessary or inform Customer Service 11 2 Check Battery Charging Status There are three options for checking the battery capacity m Battery bar indicator on the touchscreen under Options Bat tery Select button OK to close the display again blocked for mis souri TN i Battery symbol in the status symbol bar on the touchscreen Battery light emitting diode on the control unit Chari Bits Ted TEL Fig 11 3 Bar indicator for battery charge Battery charge Bar indicator Battery symbol Light emitting status Touchscreen Touchscreen diode Options Status symbol Control unit bar More than 30 green continu continuously illu OK ously illuminated minated Under 30 criti green flashing flashing Cal Battery empty System blocks injection 87 G Jrich medical mississippi missouri 12 Software Further Settings and Functions 12 Software Further Settings and Functions 12 1 Touch calibration Occasionally a new calibration of the touch screen is necessary The calibration Due to this procedure a possible misalignment of touch point and cur of the touchscreen sor is corrected has to be executed Select Options Settings Touch calibration in the menu bar A Sly by finger or calibration template is displayed on the scr
35. ast agent bottles in order to avoid any defile ment of the unit Compare Section 9 1 lt is possible to disinfect the bottle holders for CA1 CA2 and NaCl by spray The valve door can be disinfected by wiping Do not apply disin fectant directly onto the device or onto parts of it Use a cleaning cloth lf disinfectant reaches behind between screwed on parts of the valve door this can cause cracks in consequence of surface tension 10 3 2 Touch terminal Shut down touch terminal and disconnect from mains Clean touchscreen only with soft and moist cloth water or special dis play screen cleaning agents Do not use disinfectants or alcoholic clea ning agents and do not apply water or display cleaning agent directly onto display and housing Wipe off housing but avoid interfaces for peripheral units 10 3 3 Battery and Charger Disconnect charger from mains Use moist cloth to wipe off battery and charger g rich medical Incase of several units do not mix up pump flaps as these are exactly adapated to the relevant units Use very little water only to clean the pump wheel with an open pump cover Only wipe off touch screen softly and do not apply water or cleaning agent directly onto display and housing 85 g rich medical 11 Batteries 11 1 Charge Batteries Remove battery from the injector at the close of a working day To this end remove waste basket turn rotary button on t
36. cal CT mode Luer Lock Fig 7 19 Filling of hose system in CT mode after patient hose changeover a MRI mode Entire hose system is filled with salt solution from the cross piece Only so much contrast agent volume is delivered as is necessary to fill the hose system according to the patient hose length minimum surplus is discarded into drip cup m CT plus mode Entire hose system is filled with salt solution from the cross piece Only so much contrast agent volume is delivered as is necessary to fill the hose system according to the patient hose length minimum surplus is discarded into drip cup 49 G Jrich medical mississippi missouri 7 Start Up MRI CT plus mode Fig 7 20 Filling of hose system in MRI and CTplus mode after patient hose changeover After the filling process is completed an injection can be started 7 6 5 Manual Delivery On completion of the filling process medium can be delivered at a flow rate of 2 ml s if required Manual delivery is not possible in Manual delivery by simultaneously pressing the keys Release and Delivery on the injector the case of Test bolus or the option D H t EE l n CT mode the In CT mode contrast agent is delivered in MRI and CT plus mode salt solution is delivered patient is injected contrast agent by Use of function Manual delivery Manual delivery n Deliver air from hose system patient not conne
37. circular symbol Information window Injector symbol flashes in blue operating note appears No injection is possible until the information has been acted upon Warning window plus alarm sound on the touch ter minal Injector symbol flashes in yellow note on fault removal appears No injection is possible until the in formation has been acted upon Service window plus alarm sound on the touch termi nal Injector symbol flashes in red Note fault code and re start injector In case of recurrence advise customer service Safety query before start of an injection Injection is possible only on confirmation that there is no air in the system The injector symbol in the status symbol bar down right on the touch terminal flashes with the colour of the circular symbol In formation warning and service windows can be closed by se lecting the button Close or OK The window is opened again by selecting the flashing injector if not the window opens again automatically after 2 minutes Window messages disappear automatically after they have been acted upon the injector symbol no longer flashes and is white again m Acoustic signals For a better differentiation of messages two different acoustic signals are integrated o Two short acoustic signals in case of end of injection o One short acoustic signal in case of expiration of se lected time for stop watch 38 G Jrich mississippi missouri 7 Sta
38. cted z Checking the cannula position patient connected The volume counters on the touch terminal do not detect this volume The function Manual delivery is blocked after Patient hose change over with test bolus compare Section 8 4 1 and selection of the function Same patient compare Section 8 4 2 The test bolus filled into the hose system would otherwise be discarded or injected into the patient before the injection proper 50 G Jrich mississippi missouri 8 Carrying out Injections medical 8 Carrying out Injections 8 1 General Notes on Programming 8 1 1 General m On the touch terminal the term Flow rate is replaced by the short designation Flow m The data input on the touch terminal is independent of the current status of the injector The input screen for injection programs can be called up and edited at any time except while an injection is in progress if necessary select message window to close the same x An injection program can be started only after the filling process is complete e Button Cancel If Cancel is operated the system changes over to the patient hose changeover window Fig 7 18 The function Test bolus is released the function Same patient is blocked Exception In the case of keypads for entering characters or numbers the system changes back to the input screen n Options assigned to a program are also stored compare Annex 9 5 Input screen act
39. d medically trained personnel only x Do not use ball point pens or other sharp objects to operate touchscreen For operation solely use finger or delivered touch pen alternatively mouse via USB interface n The injector must only be operated with the relevant suitable guide tubes and bottle holders m Only use original disposables approved by ulrich medical Co pies and other brands are less resistant and are not tested for application with ulrich injectors The ulrich hose system has been tested and approved as an entity see MPG The manufac turer guarantees warranty only for injectors which are operated with ulrich disposables Valve door pump flap and battery compartment may not be opened after the hose system has been inserted the particle fil ter must no longer be removed from the holder z lf pump flap or valve door is to be opened disconnect patient from hose system first a Any combination with other devices may be affected only after prior consultation with the manufacturer Additional equipment which is connected to the analog and digital interfaces of the unit must be proven to meet the relevant EN specifications and sys tem standards EN 60601 1 1 as well as EN 55011 Whoever connects units to an injector is responsible for ensuring compli ance with the system standard EN 60601 1 1 7 Only use approved accessory parts and interfaces provided for the same compare Annex 8 3 z Equipment that emits el
40. ditional button Start delay s with the start value 0 appears on the right hand side in the input screen Select button enter required start delay interval and press OK to accept Program Options Help medical medical otal injec njection 08 37 05 11 04 2008 Settings a ei e 4 2A A999 Control unit CAI Nal CA2 Injector Total Nacl ml 0775 Total injection ml 0 125 ves Settings Control unit Total NaCl ml 0 75 Total injection ml 0 125 reent Fig 8 34 Injection program with Start delay lf the Start button is pressed after changeover to the injection screen the injection only starts after expiration of the delay time interval previ ously entered You can find further information about the status of activation and sav ing of this setting in the table Annex 9 78 G Jrich mississippi missouri 8 Carrying out Injections medical 8 4 10 Stop Watch Select Options gt Stop watch in the menu bar The Stop watch window opens Activate function count upwards or downwards by selecting the button Fig 8 35 Stop watch Activate function by clicking LI Count down O Count up Fig 8 35 Stop watch window inactive and active Press OK to confirm es d 14 77 CA Nacl Injection time volume ml volume rml Flow ml s per sequence s 25 0 0 Minimum injection time s Total contrast agent ml 0750 Total NaCl ml 077
41. e diagnostic accuracy of the images 2 1 General The injector described below for the intravenous administration of con trast agents is available in two model variants technical data may be subject to change CT MRI Injector mississippi XD 2000 for computer tomo graphy or nuclear magnetic resonance imaging examinations The injector mississippi is battery operated The magnetic field homogeneity of nuclear magnetic of resonance imaging units is not affected Compatibility tests were carried out success fully with up to 3 Tesla Special features and additions that only apply to the mississippi are shown in blue e CT Injector missouri XD 2001 for computer tomography examinations Special features and additions that only apply to the missouri or the mississippi in CT mode are shown in green In all other respects the two injector models feature a similar setup and are equipped with a mobile stand The explanations in these ope rating instructions usually apply to both variants During the development of the injectors a major focus was placed on maximum ease of operation The unit of mississippi XD 2000 is composed of m XD 2050 CT MRI injector Accumulator version movable stand a XD 2100 Installation set XD 2060 Touch Touch terminal m XD 2061 Touch XD 2061 M Touch Power supply unit of touch terminal a XD 2062 Main cable for terminal i XD 2170 24 3 Charger m XD 2171 9AH Battery fis
42. e injec tion procedure Contrast agent green NaCl blue Fig 8 9 no 1 The hose image Fig 8 9 no 2 maps the course of the injection The filling condition of the hose system with contrast agent green and NaCl blue is represented compare Section 7 4 2 In the bottom section of the touch terminal the real time counters pro vide information on the current status of an injection in progress Fig 8 10 no 3 The volume counters compare the actual values with the nominal values e g total contrast agent ml 90 100 that is 90 of 100 ml have so far been injected 59 G Jrich medical mississippi missouri 8 Carrying out Injections oo Birich Program Options Help We medical CA Nacl E Injection time volume ml wolume ml Flow ml s per sequence s 0 0 2 Minimum injection time s 25 0 Total contrast agent ml Total Nacl ml Total injection ml 14 04 06 Ea 06 03 2008 1m Fig 8 10 Injection screen while an injection is in progress 8 3 4 An injection in progress can be interrupted by selecting Pause on the touch terminal Fig 8 10 or pressing the pause key on the control unit compare Section 3 1 Interrupt an Injection in Progress by Pause The background for the volume which was being injected at the time of interruption flashes in orange previously green or blue compare Sec tion 8 3 3 To continue the injection release Pause on control unit or sel
43. ect Continue on the touch terminal 8 3 5 Terminate an Injection in Progress by Cancel If the interruption of an injection is necessary this is possible by click ing the red button Cancel as well as in a severe emergency by a shutdown of the terminal If an injection in progress is terminated in this way it cannot be continued afterwards The injected contrast agent NaCl and total volumes since the last pa tient hose changeover are shown in a warning window exception switch off of the terminal 60 After an injection is cancelled or after changing the patient hose length the function Same patient is blocked The interruption of an injection in progress by means of the Pause key is to be preferred to a cancellation Pause Injection can be continued Cancel Change of patient hose is required G Jrich mississippi missouri 8 Carrying out Injections medical I Birch CA Nacl Injection time Sequence volume ml volume mi Flow ml s oer sequence s Caution O Injection cancelled gt Injected volumes since patient hose changeover Contrast agent volume ml NaCl volume ml Total volume ml ota IULAI Nal Tag usf4oa Oe HED RAYA itt Le LAY HI Fig 8 11 Cancelling an injection If OK is pressed to confirm this information the prompt for changing the patient hose appears The function Same patient compare Sec tion 8 4 2 is blocked a
44. ectromagnetic waves can cause mal function if located close by the injector and the touch terminal This applies also in the inverse case e Do not use injector touch terminal charger and batteries if cable connectors housing or other components are visibly da maged m Perform a visual inspection of the hose system during or after au tomatic filling to ensure that it has no air in it G Jrich medical mississippi missouri 4 Warning and Safety Notes 7 Connect patient to injector only after venting the complete hose system e Check the position of the puncturing cannulas High delivery rates may cause injury to the veins of the patients x When changing the guide tube make sure that the piercing nee dles remain sterile x After mounting new storage bottles the relevant hose accesses must be carefully vented x Do not use ultrasound gel at the ultrasonic sensors as their func tioning thereby can be disrupted and air will not be detected any more z If the CA switchover is used the identical CA has to be mounted on each CA access a Before any injection check whether the basic settings operation mode patient hose length und if applicable additional options are correct and adjust them if necessary x In CT mode the patient is injected with contrast agent by Manual delivery 4 2 Installation Maintenance and Repair z Injector touch terminal and the batteries and charger including all accessory
45. een Only use finger or touch pen for clicking on the designated marks and confirm calibration by a selecting the blue button If the confirmation will not be executed within the given time the calibration has to be started again touch pen If the menu item Touch calibration can not be reached by finger or touch pen due to de calibration the menu item has to be activated by USB mouse The following process of calibration however has to be executed solely by finger or touch pen 12 2 Loudspeaker Select Options gt Settings gt Loudspeaker in the menu bar Press Loudspeaker test Fig 12 1 to test the acoustic warning signal beep Program Options Help gy rich medical CA Nacl Injection time o volume m volume mi Flow ml s ger sequence s Pause s Stoppuhr s Loudspeaker test Minimum injection time s 35 5 Total contrast agent ml 0745 Total Nacl ml en ZAY B vg Settings Control unit CAI NaCl CA2 Injector Fig 12 1 Loudspeaker test You can find further information about the status of activation and sav ing of this setting in the table Annex 9 88 G Jrich mississippi missouri 12 Software Further Settings and Functions medical 12 3 Date and time This function can be used to change date and time in the status symbol bar Select Options gt Settings gt Date and time The window for setting date and time is opened Fig 12 2 Set date and time by
46. emperature as they discharge automatically during storage m Keep batteries in a frost free location m Return batteries to the manufacturer for disposal battery regula tions 4 5 Other i All applicable national regulations with regard to installation in struction documentation and operation of a medical product are to be complied with m Do not control injector or trigger functions simultaneously via the touch terminal and the control unit m Injector and touch terminal simultaneously should only be opera ted by one person Only use the handles on the side to move the injector x The data transmission between touch terminal and injector is affected via optical waveguides In the event of major exposure to sun radiation at the optical waveguide input of the touch termi nal the data transmission can become defective a Do not look directly into the laser beam of the optical waveguide connection Bend optical waveguides with a large radius only for winding up the actual bending radius value must not be less than 5 cm risk of fracture m Do not roll the mobile stand of the injector across the optical waveguides and poss the mains cable If the connection or the optical waveguides of the unit become damaged they must be 20 G Jrich mississippi missouri 4 Warning and Safety Notes medical repaired by the manufacturer or the authorized Customer Ser vice x Take care with moving parts roll
47. ery USB flash drive is sup ported by the ter minal software gt compare Annex chapter 7 Spare Part List By the function ImMport injection programs which are saved on the memory are com pletely overwritten mississippi missouri 12 Software Further Settings and Functions 12 6 2 Data export m Program data Select Program Export Program data in the menu bar Injection programs can now be saved on the external data me dium Attention Existing injection programs on the USB flash drive are completely overwritten in this process G Jrich medical In case of data export existing injection programs on the USB flash drive are com pletely overwritten 93 G Jrich medical mississippi missouri 13 Help menu 13 Help menu 13 1 Summary Operating Instructions Select Help gt Summary operating instructions in the menu bar The window displays the summary operating instructions for preparing and assembling the injector SEENEN Kirich medical Summary operating instructions wilrich Summary operating instructions mississippi missouri Power Easa ee Caution Hour glass S be Air alarm A D if X Sarvice Contrast agent 1 CA1 Salina Solution NaCl 08 53 13 CT a i A j gy 07 03 2008 _150 cm lib A FR ouy Settings Control unit CAI NaCl CA2 Injector Fig 13 1 Summary operating instructions 13 1 1 Prepa
48. essaeeeseeeesseeeesaess 24 6 2 1 PUMO We Tei 25 622 OSG EE 29 Co Ude Mt 30 T DAT UD en E A 32 7 1 General Notes on Handling and Operation cccccccseeeeceeeeeeeeeeeeeeeseeeeeseeeeneeeeess 32 7 2 OW ir eeno ocer oes E R E ER E OE EE T EE RE ER ER 33 fed FOUNTO et 33 Teee NIM OC ON EE 33 7 3 Control Unit on the Injector ccc ccecccceeeeeceeeeceeeeeseeeeseeeeeseeeeseaeesaeeeeseeesaaeeesees 34 7 4 User Interface on the Touch Iermmmal 35 G Jrich medical mississippi missouri Contents Fe NN TR EE 35 7 4 2 Input Screen INjection SCreON ccccccssecccesceceseecceececeueeceeeeeceueeseueesseneessaeeees 36 LAS Status Symbol TEE 39 E E E a e E E E E E E A E A E A T 41 7 5 1 Operating Mode cc eccccccccceececseeeeceeeeeeeeeeseecesseeeeseeeesseeesseeeeseesetsneeeseeesaeeeeas 41 LoL Patient Hose ue LN 42 To e ele UE 42 46 Filing Hose Syste E 43 LOA all O E 43 FOL CaA EN aeie e e ie oe ee ee ee eee eee 45 7 6 3 Switchover between Contrast Agent Boitles 47 7 6 4 Filling of the Patient Hose 48 LOS Manual IO GUI EE 50 8 Carrying out IMISCUOINS iircicscecdscesccctecncscetsvescsetesecewotencessebeuesnmolsssueoeneucusneteunvdesnnseusneasaes 51 8 1 General Notes on Programmmg 51 okl e EE 51 St BANU e 52 8 2 Input Screen for Injection rograms 53 8 2 1 New Injection Hrogram reriket rirarei renier ieran kenker renani ii 54 822 Store injection Prograni tee Eeer 55 023 Op n injection Progra EE 55 8 2 4
49. event hazards for patients users or unit Our customer service will be pleased to answer any technical queries you may have with re gard to the units Consumables and replacement parts should be ordered from your local dealer compare section 5 for address Maintenance and repair have to be carried out by authorized service engineers only Please note that any defects caused by incorrect handling damage or third party re pair attempts are expressly excluded from our warranty This also applies to the use of incorrect accessory parts or normal component wear If you have any questions or suggestions with regard to these operating instructions or our units please contact the authorized distributor or the manufacturer directly ulrich GmbH amp Co KG Buchbrunnenweg 12 89081 Ulm Germany Phone 49 0 731 9654 0 Fax 49 0 731 9654 2805 e mail injector ulrichmedical com internet www ulrichmedical com An overview of injectors accessories and disposables for your order is specified in annex 7 G Jrich medical mississippi missouri Introduction Advice to copyright Copyright 2008 ulrich GmbH amp Co KG All rights reserved It is not allowed to reproduce the se operating instructions neither completely nor in extracts without prior agreement of ulrich GmbH amp Co KG in written form Printed in Germany G Jrich mississippi missouri Contents medical Contents Operating UNS d e de EC 1 CT MRI Injec
50. for the standby bottle is continuously illuminated 7 6 4 Filling of the Patient Hose The following message appears on the touchscreen Information Patient hose changeover Z Ai Yent patient hose Press simultaneously the keys Release and Changeover on injector Fig 7 18 Patient hose changeover For filling the patient hose without test bolus and without the function Same patient briefly press the keys Release and Changeover si multaneously on the control unit of the injector eo v H The injector is prepared for the first injection a CT mode Entire hose system is filled with contrast agent from the cross piece previously delivered salt solution was discarded into drip cup Only so much contrast agent volume is delivered as is nec essary to fill the hose system according to the patient hose length minimum loss of contrast agent 48 Length of the patient hose actually used must match the preset length The filling quantity is measured by the system according to this length A longer hose is not completely filled air remains in the hose Incase of an incorrect hose length the volume counters on the display do not match the actually injected volumes Possibly the maximum injection volume per patient can be excessed If the actual hose length is shorter than the preset length medium is discarded G Jrich mississippi missouri 7 Start up medi
51. fore an alternative appli cation of two different CA is possible The injection will be exclusively performed from the selected CA bottle only 8 4 7 Pause This function can be used to program a time defined break between the sequences of an injection Select Options gt Pause in the menu bar The Pause window opens activate Pause by selecting the button Fig 8 27 74 G Jrich mississippi missouri 8 Carrying out Injections medical Activate function by clicking Activate function by clicking O Pause x Pause Fig 8 27 Pause window inactive and active Press OK to accept The input screen will display an additional column Pause s The Pause button with the start value O is respectively set in between two open sequences Select button enter pause duration required 1 to 999 sec Fig 8 28 Pauses can be placed independently after the se quences 1 to 5 Program Options Help Ach Injection time per sequence s Pause s 15 0 Delete m o Lo Je JL e a s oJ 10 D 999 yal EAA mu tine LU ITU mu KISI USCG Fig 8 28 Enter pause duration The injector stops the injection at this point after the sequence has been injected the button flashes in orange for the entered pause dura tion Fig 8 29 subsequently the injection is continued automatically with the next sequence 75 G Jrich medical mississippi missouri
52. from the input screen to the injection screen 58 Only usea indwelling I V cannula stable against pressure of the injector and without any component for add in injections for reasons of seal tightness Before the start of the injection the hose system must be carefully checked for freedom of air bubbles G Jrich mississippi missouri 8 Carrying out Injections medical Fig 8 8 The Start button is subsequently enabled to initiate the in jection the font changes colour from gray to black In the injection screen the injection parameters can no longer be changed the menu bar is blocked A return to the input screen is pos sible using the Back button Subsequently the injection parameters can be changed To reenter injection parameters the program must be terminated with the Cancel button The Patient hose changeover window appears After the patient hose has been changed new data can be entered To return to the input screen select No in the Caution dialog box 8 3 3 Start Injection Select Start button Fig 8 9 enen me mp sl AED CA Nacl Injection time volume ml volurne ml Flow ml s per sequence s Minimum injection time s Total contrast agent ml 070 Total NaCl ml Total injection ml eb ZA A Fig 8 9 Injection screen before the start of an injection The button for the volume just injected is left coloured during th
53. fter an injection is cancelled 8 3 6 Cancel an Injection in Progress by Emergency Stop In order to cancel an injection in progress in an acute emergency press the emergency stop button on the control unit Fig 8 12 red ar row Fig 8 12 Press emergency stop 61 g rich medical mississippi missouri 8 Carrying out Injections a Emergency stop button pressed on the control unit a Control unit Service light emitting diode continuously illuminated a Touchscreen Status symbol bar All bottle symbols crossed out injector symbol flash in red service symbol continuously illuminated Warning sound and warning message By closing the emergency stop information in the touchscreen the mes sage for two minutes and warning sound can be suppressed Program Options Help oo gz rich medical CA Nacl Injection time Flow mls volume ml volume ml per sequence s Error Emergency stop Stop key pressed on injector Injection cancelled Restart injector C e Minimum Total cc Total injection mi ab 2A 76 III H LU IL Litt Ri S UELL Fig 8 13 Emergency stop message on the terminal To release the emergency stop reset injector by switching it off and then back on again 62 mississippi missouri 8 Carrying out Injections 8 3 7 The injected contrast agent NaCl and total volumes since the last pa tient hose changeover are shown in an information window Fig
54. g 12 3 Set screen saver You can find further information about the status of activation and sav ing of this setting in the table Annex 9 90 G Jrich mississippi missouri 12 Software Further Settings and Functions medical 12 5 Language This function can be used to change the touchscreen language When changing Select Options gt Settings gt Language in the menu bar Select Me anguage on language required press OK to accept the changed setting The touch terminal is shut down automatically Restart the system by swit the touchscreen the communication ching the injector and touch terminal off and on again the preset lan With the switched guage selection is activated on injector is inter rupted Both injec ee gllrich tor and touch ter minal have to be CA Nacl Injection time volume ml volume ml Flow ml s D sst Language s Pause s Stoppuhr s per sequence restarted again German Deutsch Select the language The application is restarted automatically Minimum injection tim Total contrast agent ml 0 45 Total NaCl ml 07 03 2008 stem 2 A f A Zb Control unit CAI NaCl CA2 Injector Fig 12 4 Language You can find further information about the status of activation and sav ing of this setting in the table Annex 9 91 Irich medical mississippi missouri 12 Software Further Settings and Functions
55. g could start leaking Hose accesses on which an empty storage bottle is mounted must not be vented on any account Air ingresses into the hose system air alarm can be Change bottle for salt solution in good time If it runs empty during the injection injection is interrupted A vacuum may occur when the agent is being ex tracted from the NaCl bag If neces sary plunge a separate ventilation needle with sterile filter into the bag G Jrich mississippi missouri 10 Taking out of Service medical 10 Taking out of Service 10 1 Shut down and switch off injector To shut down the system select Program Shut down in menu bar Fig 10 1 confirm shut down and wait until the text message inform ing that the terminal may be switched off via power switch is dis played Progam options ve Kirch medical CA Nacl Injection time Manual Flow mls volume ml volume ml per sequence s start al Do you really want to shut down the system Minimum injection time s Total contrast agent ml Total Nacl ml Total injection ml CAI NaCl CA2 Injector Fig 10 1 Shut down system 10 2 Disassemble Injector Withdraw all storage bottles in order to avoid defilement by a dripping contrast agent use swivel device on the bottle holders compare Sec tion 9 1 and 9 2 Return bottle holder to initial position replace protec tion caps on piercing needles
56. gnal in function the injection can be started by an external device The injection can alternatively be initiated using the Start button on the touch terminal With the function send start signal out a start signal can be sent to an external device by selecting the Start button on the touch terminal Both signals are sent via Interface A The status in out in out or none is saved when the application is closed You can find further information about the status of activation and sa ving of this setting in the table Annex 9 7 6 Filling Hose System 7 6 1 Salt Solution Follow the Either NaCl bottles or NaCl pouches can be used Remove protective installation se cap from the NaCl piercing needle Fig 6 5 no 5 and keep itin a safe quence Load place NaCl fill the hose as NaCl pouch system with NaCl afterwards load Pierce pouch Attach swivelling hook at a suitable height to the CA If CA bottles rod for the NaCl container holder hook in pouch Fig 7 13 a are mounted at the NaCl bottle same time as NaCl l l E 7 l containers no Mount suitable guide tube onto bottle holder fix in position with eccentric lever Introduce NaCl bottle from the top into the guide tube centrally pierce rubber cap Fig 7 13 more air can es needles cape from the hose via the CA piercing 43 rich medical mississippi missouri 7 Start Up KL Place bottles
57. h at the rear of the unit All light emitting diodes on the control unit light up for a short time self test After the injector is switched on and put into operation refrain from opening any doors flaps and or removing particle filter from the mounting this causes a fault message or a cancellation of the func tion 33 g rich medical 7 3 Control Unit on the Injector The control unit provides information on the operating condition of the injector light emitting diodes as well as for the control of functions di rectly on the injector function keys compare Section 3 1 Filling pro cesses and the venting of the hose system are affected here Fig 6 6 The symbols of the operating panel are found in the status symbol bar of the touch terminal compare Section 7 4 3 Fig 7 2 Control unit on the injector All keys of the control unit respond to a light short press with the fin gers For the safety of patient and user the keys Delivery and H Changeover respond only if the key Release is pressed simultaneously Therefore the illustration on the touch terminal is as follows v v tt Release and Delivery Release and Changeover Until an active function has been completed the light emitting diode hour glass lights up that is the unit is operating temporarily no in put can be made except Pause and Emergency stop 34 mississippi missouri
58. h is as small as required Minimum total volume CA plus NaCl in sequence 1 is required gt Difference between CA test bolus and the minimum total vol ume for the test bolus sequence must be filled up with NaCl The minimum total volume for the test bolus sequence depends on the length of the patient hose Patient hose length Minimum total volume in sequence 1 CA plus NaCl You can find further information about the status of activation and sav ing of this setting in the table Annex 9 8 4 2 Same Patient Ifthe preceding Using this function it is possible to carry out several injections on the injection was same patient without the patient hose having to be changed cancelled or the Select the option Same patient in the patient hose changeover win patient hose length dow Fig 8 14 only possible when the preceding injection process changed the has been completed correctly The system changes to the input function Same screen for injection programs Define injection parameters compare patient is blocked Section 8 2 Inthe case of The volumes of the new injection program are added to the volumes al the function Same ready injected Fig 7 18 e g 120 ml contrast agent in total 60 ml at patient the patient the first injection 60 ml at the second injection hose length can no longer be changed 68 G Jrich mississippi missouri 8 Carrying out Injections medical program Den toe rich CA
59. he battery compart ment lid in an anti clockwise direction open lid and remove battery Fig 11 1 Connect power supply unit of charging station XD 2070 Fig 11 1 Fig 11 1 Remove battery Insert battery slowly into charging station from the top note red marking Fig 11 2 Charge battery for at least 4 hours Fig 11 2 Battery in charging station The operating states Mains Charge Charged and No Battery are shown by two light emitting diodes The charger automatically starts charging process Red check light on the power supply unit n Continuous light Charging in progress a Fast flash light Battery is totally discharged charging in progress 86 mississippi missouri 11 Batteries Change of batteries XD 2171 9AH can take place in the MRI examinations room Do not bring charger into the examinations room Battery has to be pressed hard into the charger Visual control of the red checklight is required Charge batteries for at least 4 hours otherwise no full capacity Store batteries only in a fully charged condition in a frost free location Re charge batteries at regular intervals if they are not used for extended periods every six months Return batteries to the manufacturer for disposal BaitV G Jrich mississippi missouri 11 Batteries medical a Slow flash light Battery is charged charging condition is maint
60. ies and other brands are less resistant and are not tested for application with ulrich injectors The ulrich hose system has been tested and approved as an entity see MPG The manufac turer guarantees warranty only for injectors which are operated with ulrich disposables The use of hose combinations or hose systems which are not approved by the manufacturer represent a hazard to the safety of patient and user and endangers the proper functioning of the device a Discard patient hose directly to the waste bin after each patient n Dispose of the pump hose no later than the end of each working day or when changing the contrast agent used 7 Observe the sterility requirements for the disposable articles Dis posable articles must not be used if protective caps have fallen off or become loose or if their packaging has become damaged x Lock the patient hoses over the drip cup and close to the Luer lock so that the hose ends on the patient s side not make any contact with the drip cup a Contaminated disposables and their packaging must be disposed in accordance with all applicable national regulations To puncture the patient use a pressure resistant indwelling ve nous cannula without an injection port air can penetrate m Correctly close the Luer lock between the pump and patient hose otherwise there is a risk of aspiration and injection of air In the case of guide tubes with a sufficiently large diameter re move
61. is displayed Fig 8 6 Select program by the relevant entry line is marked in blue Select Open button The input screen displays the values of the opened program By select ing the individual buttons all parameters can be individually adapted compare Section 8 1 2 and if required stored again Settings and acti vated options remain open 55 G Jrich medical mississippi missouri 8 Carrying out Injections lrich medical Options Help Program i uence 2 Sequence 3 Sequence Sequence 5 Sec Sequence o Sequence 4 SEQUENCE gt sequence 6 Nac CA CA G CA S Program Optig mit pause ohne pause Program ABDOMEN rinse 126 15 3 6 3 46 3 6 mit pause rinse 158 rinse 250 ohne pause pi Spuelprogramm PS 1 D 153 9 3 46 3 8 ns Lar em sare 9 e 9 UI LI OI ON Al Na 5 LUCCIO Led WE rinse 120 rinse 158 rinse 258 rinse 324 Spuelprogramm PS 1 13 57 42 CT plus 8 5 06 03 2008 IK amp A F etting ontrol unit Al Na A niecto Fig 8 6 Open or delete program 8 2 4 Delete Injection Program Select Program gt Delete in the menu bar The summary overview table of stored programs is opened The line to be deleted is to be marked in blue by selecting the same the button Delete is pressed to delete the relevant injection program from the memory without second request Fig 8 6 8
62. itchover The contrast agent storage bottles are monitored by means of ultrasonic sensors below the piercing needles If a contrast agent storage bottle runs empty then the relevant ultrasonic sensor Fig 6 6 detects air and switches over to the second contrast agent bottle without interrupting the injection After completion of the injection a message is displayed on the terminal This message points out that a new contrast agent bottle has to be mounted to guarantee the next automatic switchover if required The message has to be confirmed by the user Fig 7 17 If the second bottle is also empty or not pre pared the injection will be interrupted ae During injection the system automatically switched over to CA2 Check CA1 reservoir Fig 7 17 Automatic changeover CA A similar message also appears in case of switchover to CA1 with the request to check the CA2 reservoir G Jrich medical Light emitting diodes for storage bottles on the control unit off not vented empty flashing active continuously illuminated Standby mode Symbols for the storage bottles on the terminal grey and crossed out not vented empty flashing active continuously illuminated Standby mode 47 G Jrich medical mississippi missouri 7 Start Up Which contrast agent bottle is active can also be seen from the status symbol bar The active bottle symbol is flashing the symbol
63. ivated buttons Injection parameters are defined pressing OK to accept causes changeover to injection screen deactivated buttons no access to injection parameters programs options and help menu is possible OK button becomes green Start button In this screen a change of injection parameters is not possible If changes are necessary the user has to return to the input screen using the Back button a Injection screen Informs about injection procedure already per formed or waiting sequences For changes before start of injec tion the user has to return to the input screen using the Back button The hose system must be checked carefully for freedom from air bubbles before the start of an injection The volume counters on the touch terminal do not detect volume which is manually delivered compare Section 7 6 5 z The volume counters on the touch terminal do detect volume which is injected during the Keep Vein Open function compare Section 8 4 3 eh G Jrich medical mississippi missouri 8 Carrying out Injections 8 1 2 Data Input Values are input via a numeric keypad or scale Fig 8 1 Ex Input of CA1 volume program Options Help sO ich medical CA Nacl Injection time Sequence volume ml volume ml Flow mls Contrast agent volume 2 2 e e 3 Delete a 5 6 2 3 ve 3 Q Minimum injection time s Total contrast agent ml 0 0 Total NaCl ml
64. jected volumes since patient hose changeover Contrast agent volume ml NaCl volume ml Total volume ml 45 Minim E Total D Total NaCl ml 0 25 Total injection ml 0745 i Pause Cancel he 5 15 20 57 Iip E 06 03 2008 150 cm lt Z A A gt ontrol unnt gt etting Fig 8 24 Information about injected volumes MRI and CT plus mode The function Last patient is blocked in MRI and CT plus mode as the hose system is filled automatically with salt solution after each injection anyway You can find further information about the status of activation and sav ing of this setting in the table Annex 9 8 4 5 NaCl Airbag Automatic switchover to NaCl In the injector s basic function without airbag function a changeover is automatically made to a second contrast agent bottle when a CA container is emptied out If this is not possible due to the second con tainer also being empty or not mounted or the CA tandem function be ing activated the injection is interrupted Interruptions of injections may furthermore be caused by e Air bubbles in the CA solution n A malfunction of the CA sensor s because of defilement or a de fect If an interruption occurs the amount of CA remaining in the hose up to 25 ml depending on the length of patient hose used is not injected Activating the NaCl airbag function prevents the injection interrupted in case of empty CA due to a changeover to NaCl a
65. lect patient hose length Fig 7 10 Select patient hose length You can find further information about the status of activation and saving of this setting in the table of Annex 9 7 5 3 Start Signal Select Options Settings Start signal in the menu bar The Start signal window opens Start signal O Send start signal out Receive start signal in Fig 7 11 Window Start signal in out active You have the option of selecting one both or none of the two func tions If at least one function has been activated the respective set ting appears on the touch terminal Fig 7 11 42 mississippi missouri 7 Start Up The patient hose length can be changed during operation before each patient hose change over Exception In the case of the function Same patient Only use in conjunction with other devices after consultation with the manufacturer or an authorized dealer of the injec tor Please refer to Chapter 3 Warn ing and Safety Notes rich a mississippi missouri 7 Start up LH medic Program Options Help E gz rich medical CA Nacl Injection time Flow ml s volume ml volume ml per sequence s Minimum injection time s oo Total contrast agent ml Start signal in out IO Total Nacl ml Total BENE mi d Fig 7 12 Input screen with Start signal in out active With the Receive start si
66. liable excluded a Equipment a Contrast agent max 2 x 1000 ml for CT max 2 x 100 ml for MRI o Salt solution max 2000 ml a Bottle holder Can be swivelled for the drip free replacement of empty bottles Design o Attractive and functional based on a mobile stand a User friendly Clear control unit integraded elements such as tray or waste bin g Hygienic safety and reliability certified by an indepenedent Hygienic Institute 2 3 Hose System The special hose system consists of pump hose and patient hose The pump hoses for both injector models are equally Patient hoses are available in different lengths Pump hose a Suitability for an up to 24 hour use and any number of injec tions chemical resistance sterility compliance of delivered volume o Three piercing needles for storage bottles 2 x CA 1 x NaCl a Connects the storage bottles via the roll pump to the patient hose mississippi missouri 2 Description of Unit D Contains particle filter as well as a patented pressure sensor for flow rate and volume control Easy handling by guided hose insertion Only needs to be changed over once a day NaCl CA1 CA2 Luer Lock Particle filter Pump hose cross piece Pressure measurement system Fig 2 3 Pump hose for ulrich contrast agent injectors Patient hose Connects the pump hose in the injector to the patient Contains two integrated non return valves Needs to be replaced
67. nd the CA in the hose is injected Therefore the function NaCl airbag offers an optimal utilization of the remaining CA 72 G Jrich mississippi missouri 8 Carrying out Injections medical Requirement At least 80 of the programmed contrast agent volume can be injected the system takes the CA in the hose into consideration here Two scenarios are thus possible If at least 80 of the programmed contrast agent volume can be injected a changeover to NaCl is made if the CA bottle s run empty there are air bubbles in the CA there is a malfunction of the CA sensor s because of defile ment or a defect A meaningful contrast can be expected If less than 80 of the programmed contrast agent volume can be injected the injection in progress is interrupted A meaningful con trast is unlikely The patient is not stressed by the unnecessary in jection of the remaining CA in the hose Injectable CA Volume NaCl Airbag 100 of the programmed No changeover to NaCl CA amount 2 80 and lt 100 of the Changeover to NaCl without the programmed CA amount injection being interrupted The missing CA volume is replaced by NaCl lt 80 of the programmed The injection is interrupted CA amount Select Options Settings NaCl airbag in the menu bar The NaCl airbag window is opened Activate the function by selecting the button Fig 8 24 Select OK to continue The activated functi
68. nt green salt solution blue Image corresponds to the pump hose from the cross piece Fig 5 5 plus patient hose Fig 5 10 The gap corresponds to the junction between pump hose and patient hose Pump Patient hose hose E o eee ee Minimum injection time s 43 3 Total contrast agent ml 0 80 a Total Nacl ml 0750 D Heen Dm Gs o E ER ZN i i S C Settings Control unit Injector Minimum injection time s Total contrast agent ml p 2045 Total NaCl ml 95 61 Total injection ml FET Control unit 7 5b Fig 7 5 Hose image Fig 7 5a Hose filling before injection green Entire hose system filled with contrast agent in CT mode Fig 7 5b Hose filling while injection is in progress 37 G Jrich NEEN medical mississippi missouri 7 Start Up green CA volume still to be injected blue NaCl post rinsing for advancing the contrast agent and delimitating the bolus Real time counters Fig 7 3 Nr 8 The counter for the injection time period collects all sequences for the relevant injection The volume counters provide actual values volume so far injected since the patient hose change over against nominal values sum of all established sequences or all injections since the patient hose changeover in the case of the function Same patient n Window messages Four different types of windows can appear on the touchscreen Each window is assigned a coloured
69. of the Fig 7 15 Mount storage bottles function If the filling process was not The following message appears on the touchscreen correctly completed a fault message will appear at the terminal containing instructions for fault removal and a renewed request to 45 G Jrich medical mississippi missouri 7 Start Up progam mm wp ACH i medical Injection time per sequence s Information Continue filling process Vent CA Press key CA1 and or CA2 on injector Fill hose system Press simultaneously the keys Release and Delivery on injector Total injection ml 0 0 13 22 23 06 03 2008 150 cm Settings Control unit Cl NaCl CA2 Injector eg 7 16a KS 7 16b wee wee Fig 7 16 Continue filling process In the status symbol bar both contrast agent bottle symbols are crossed out Fig 7 16a Select the contrast agent bottle s at the control unit using the keys CA1 and or CA2 one after another CA1 CA2 The injector taps the remaining air in the CA accesses into the con trast agent containers After a contrast agent access has been vented the relevant bottle symbol in the status symbol bar on the touch terminal is no longer crossed out and it flashes Fig 7 16b status bar after pressing the CA1 key If the second contrast agent container is also vented the associated symbol will flash afterward The previously ventilated CA container is displayed in
70. olume ml volume ml Flow ml s per sequence s 2 Manufacturer 3 ulrich GmbH amp Co KG 2 Buchbrunnenweg 12 89081 Ulm Germany Phone 49 0 731 9654 234 Fax 49 0 731 9654 2706 injector ulrichmedical com ES l www ulrichmedical com Minimum injection time s i Total contrast agent ml a Ob Total NaCl ml Total injection ml 08 41 00 er FAL Settings Control unit Fig 13 2 Manufacturer 96 G Jrich mississippi missouri 13 Help menu medical 13 3 Info Select Help Info in the menu bar z No data transmission between touch terminal and injector The window only displays information on the serial number and software version of the touch terminal n Data transmission between touch terminal and injector The window displays information on the software version of the injector in addition to the serial number and software version of the touch terminal rayon omone Hep Kirich medical CA Nacl Injection time volume ml volume ml Flow ml s per sequence s Pause s Stoppuhr s Cam WS 20 15 0 Information Serial number terminal T0 790772 Software version terminal 7 7 15 00 Firmware version injector dE Minimum injection time Total contrast agent ml Total Nacl ml 08 55 07 CT tp Zz A Ze K SS 07 03 2008 lt lib A A Ze G euy H Settings Control unit CAI NaCl CA2 Injector Fig 13 3 Info serial number and software versions 97 G
71. on is displayed on the screen Fig 8 25 NaCl airbag Activate function by clicking OI Automatic switchover to NaCl Fig 8 25 Select NaCl airbag 73 G Jrich medical mississippi missouri 8 Carrying out Injections es d 171 CA Nacl Injection time Manual volume ml volume mli Flow mis per sequence s start Jee Minimum injection time s Total contrast agent ml 070 Total Nacl ml 0 0 NaCl airbag Total injection ml 0 0 Cancel 06 03 2008 150 cm ALE A d a ting OLLO Litt et Fig 8 26 NaCl airbag active In case of a switchover to NaCl the user is made aware of the change over via a message window with warning signal If a switch to NaCl is not desired the injection can be interrupted The Airbag function is displayed on the touch terminal and remains open when the application is closed This function can be activated for all operating modes You can find further information about the status of activation and sav ing of this setting in the table Annex 9 8 4 6 CA Tandem In case of the injectors mississippi and missouri this function is not activated CA tandem is part of the tuning kit for the injectors ohio tan dem and ohio M available at the manufacturer This function offers the possibility to block the automatic switchover to the second CA bottle when the first one runs empty So both accesses can be equipped with two different CA There
72. osed with the ordinary domestic waste In the context of the Electrical and Electronic Equipment Act ElektroG ulrich medical organizes the return and the waste disposal of our products that are placed on the market for the first time after march 24 2006 and that are designed for disposal For retraction declaration of serial number is necessary Caution Note Operating Instructions Unit type B 3 3 Hose Packagings REF E 24h d aa ie E Article number For disposable use only Insert pump hose one time only Can remain in the injector for any number of injections up to 24 hours Has to be discarded after removing from the injector Use by Sterilized by Ethylene Oxide Batch number Caution Note Operating Instructions LMrich 3 4 Other BattV CA CT LL MPBetreibV MR MRI NaCl mississippi missouri 3 Symbols and Abbreviations Battery Regulations Contrast agent Computer Tomography Luer Lock Medical Products Owner Regulations Nuclear Magnetic Resonance Imaging Salt solution 0 9 Marking for positioning the battery in the battery compartment and in the charger G Jrich mississippi missouri 4 Warning and Safety Notes medical 4 Warning and Safety Notes 4 1 Operation n Use injector exclusively for the intravenous application of kidney appliable and non radioactive contrast agents during CT and or MRI examinations m The injector may be operated by instructed an
73. patient can be affected up to the maximum possible injection volume per patient compare Section 8 2 5 You can find further information about the status of activation and sav ing of this setting in the table Annex 9 8 4 3 Keep Vein Open KVO With this function the patient will be injected every 20 seconds with 1ml contrast agent in CT mode or in MRI mode and CT plus mode every 20 seconds with 1 ml salt solution in order to keep the vein open Program Options Help E gy rich medical CA Nacl Injection time volume ml volume ml Flow ml s TE EM e Keep Vein Open per sequence s Injection parameters Time interval 20 sec Volume 1 ml Minimum CS SS Total cc Total NaCl ml 0 20 Total injection ml 0 20 oOx Cancel EAZA Fig 8 21 Keep vein open function Select Options Keep Vein Open The safety prompt appears Fig 8 8 Check hose if it is free of air bubbles press Yes to acknowledge Window for Keep Vein Open function is opened Fig 8 21 Activate function with Start stop with End Press Pause to interrupt the function and Continue to continue the same The volume injected during the KVO function is detected by the volume counter You can find further information about the status of activation and sav ing of this setting in the table Annex 9 70 G Jrich mississippi missouri 8 Carrying out Injections medical 8 4 4 Last Patient CT
74. ration Assembly n Switch on touch terminal Insert pump hose close doors and flaps 7 Connect patient hose n Switch on injector n Mount NaCl container and press Delivery gt W s Mount CA container and vent gt J and or Fill pump hose gt d Fill patient hose gt wv Ai Connect patient m Select injection program and start injection 94 G Jrich mississippi missouri 13 Help menu medical 13 1 2 Patient Hose Changeover after each patient Disconnect and discard patient hose directly to waste bin Connect new patient hose Fill patient hose gt wv H m Connect patient Select injection program n Start injection 13 1 3 Remove Air Alarm i Disconnect patient hose from patient first e Acknowledge air alarm gt do __ _ u Deliver air out of the hose gt Jo Ai n Visual inspection of the hose system if necessary vent additionally gt wv Connect air free hose to patient n Start new injection 13 1 4 Service Fault m Restart injector s Leave bottles mounted Repeat shortcut of point Assembly m In case of recurrence Inform service technician 95 G Jrich medical mississippi missouri 13 Help menu 13 2 Manufacturer select Help Manufacturer in the menu bar The window displays the address and telephone number of the manufacturer Program Options Help oO el gy rich medical CA Nacl Injection time Stop watch v
75. rt Up See green orange red grey not active Pause Continue Connector mis Power supply OK Power supply is soun TN defect Battery Charge suffi Charge too low mississippi cient Flashing Charge low Pause activated Hour glass System fully loaded no further function possible Caution Flashing alarm sound Comply with note on touch terminal Service Flashing alarm sound Re start if nec inform cus tomer service Air alarm Flashing alarm sound Air in hose system discon nect patient and vent Storage container symbols D Sequence from left to right CA1 NaCl CA2 Crossed out not yet vented Flashing active Continuously illuminated standby compare Section 7 6 3 Injector symbol D White and crossed out injector switched off or no data transmission between injector and touch terminal White data transmission between touch terminal and injec tor ok Flashing in blue yellow red note message in the informa tion alarm service windows in case of closed window select the flashing injector symbol to open the message G Jrich mississippi missouri 7 Start up medical 7 5 Settings The most recently preset operating mode patient hose length NaCl Airbag and start signal are indicated on the user interface on the touch terminal and are retained when closing the application Before any injection check whether the 7 5 1 Operating Mode settings are correc
76. rt up medical n Warning signal Only in case of first time displaying of a warning message a re peated acoustic warning signal will be issued If the message is closed and afterwards opened again only the message window is displayed without the warning signal 7 4 3 Status Symbol Bar The status symbol bar for the continuous information of the user is lo cated at the bottom edge of the touchscreen Fig 7 3 no 5 z Status symbol bar is inactive Injector switched off or no data transmission between injector and touch terminal injector symbol crossed out 06 03 2008 1 299 cm Settings Control unit Cal NaclCA2 Injector Fig 7 6 Status symbol bar inactive n Status symbol bar is active Injector switched on or connection made between injector and touch terminal injector symbol on the touch terminal is not crossed out the symbols of the control unit appear 12 47 02 CT plus d vi CG we Lee ge Lem SA e 12 44 46 CT plus GN TET Setin gs Control unit CAL Macl CA Injector Injector Fig 7 7 Status symbol bar and active containers vented and not vented Elements of the status symbol bar from left to right a Time and date for setting compare Section 12 2 n Operating mode and patient hose length compare Section 7 5 The most recently selected settings are shown Symbols according to the control unit on the injector 39 fe 40 rich medical mississippi missouri 7 Sta
77. s vented If the filling function operates correctly the light emitting diode of the NaCl key flashes on the control unit The bottle symbol for NaCl in the status symbol bar is no longer crossed out and flashes 44 g rich mississippi missouri 7 Start up medical lf there should still be air in the NaCl access vent again by pressing the function key NaCl on the control unit 7 6 2 Contrast Agent The injector can be fitted with one or two contrast agent storage bot tles If after one of the contrast agent bottles has run empty there is to be an automatic switchover to another bottle two Identical bottles must be mounted and vented compare Section 7 6 3 f after one of the contrast agent bottles has run empty there is an After filling of the hose system with NaCl remove protective caps from automatic switch the CA1 and or CA2 piercing needles Fig 7 5 nos 6 and 7 and over to another keep in a safe place Mount suitable guide tubes onto the bottle hold bottle the identical ers Fig 7 12 Introduce bottles vertically from the top into the guide GR EE tubes centrally pierce rubber caps Fig 7 15 ania ane vented on both sides The injection is performed from the last vented CA bottle After the start of the filling process refrain from opening any doors flaps lids and or removing particle filter from the mounting this causes a fault message ora cancellation
78. se into the pivoted hose holder Fig 6 11 GJrich medical The special patient hoses are provided for use with the pump hose XD 2020 The use of other hose systems represents a hazard to the safety of patients and users Do not use the hose if the packaging is damaged or protective caps have fallen off or been removed Close Luer Lock between pump hose and patient hose well Otherwise danger of aspiration and injection of air Hose end on the patient s side Luer Lock 2 must not have any contact with the drip cup sterility 29 G Jrich medical mississippi missouri 6 Preparation for Start Up Fig 6 11 Pivoted hose holder and drip cup Remove protective cap 2 Fig 6 10 no 4 clamp patient end of hose above the drip cup so that the Luer Lock 2 Fig 6 10 no 3 sits closely underneath the mounting and the hose end does not have any contact with the drip cup 6 3 Guide Tubes By changing the guide tubes different size storage bottles can be used for salt solution and contrast agent Fig 6 12 Change guide tubes Use the eccentric lever on the bottle holder to arrest or release a mounted guide tube Fig 6 12 Eccentric lever in a horizontal position Holding device open on the bottle holder for CA1 at approx 9 o clock on the bottle holder for CA2 and NaCl at approx 3 o clock m Eccentric lever in a vertical position Holding device closed on all bo
79. seoeendeeecnnd cages OE REONE 89 RE EE E 90 12 4 Language ccccceecceecceeeseeeceeeceeeceeeseeeseeeseesseseseestesesaseseseseseseeeseseseseseeeseesseessaeees 91 12S UB SO oe pesca EEEE NDA A IEIR E R R E ERE IRTEN 92 13 1 Summary operating instructions ccccccccceececeeeceeeeeeeaeeeeseeeesaaeeeseeesseeeeseeeensaeeeas 94 Toe MaN aC O ea bere 96 13 3 Info serial number and software versions cccccseecceeeeceeeeeeeecaeeeceeeeaeeseueeneeeeaes 97 Fig 99 G Jrich medical CT MRI Injector mississippi XD 2000 CT Injector missouri XD 2001 Version of Software Injector 7 xx Touch terminal 7 xx ulrich GmbH amp Co KG Customer Service Injectorsystems CT MRI Buchbrunnenweg 12 89081 Ulm Germany Phone 49 0 731 9654 0 Fax 49 0 731 9654 2805 e mail injector ulrichmedical ccom internet www ulrichmedical com 100 mississippi missouri
80. sound gel at the ultrasonic sen First insert pressure measurement system Fig 6 5 no 4 into pres toning thereby can sure chamber Fig 6 3 no 5 then press pump hose into the air trap be disrupted and located underneath Fig 6 3 no 6 air will not be de tected anymore Close valve door Fig 6 3 no 13 Close pump flap Fig 6 3 no 9 check rotational closure device Fig 6 3 no 7 after engagement po 28 mississippi missouri 6 Preparation for Start Up sition must be horizontal re tighten in a clockwise direction Finally check all flaps doors and closure devices The injector is only functional if these are safely engaged or closed 6 2 2 Patient Hose Patient hoses are provided for a use per patient and must be discarded directly after disconnecting the patient In addition to the constructive safety only one medium flow direction the two check valves Fig 6 10 nos 5 and 6 provide for a further protection against pump hose contamination Remove protective cap at the pump hose Fig 6 5 no 1 Take patient hose out of its sterile disposable packaging Q 43 21 gt Fig 6 10 Patient hose Legend for figure 6 10 1 Protective cap 1 4 Protective cap 2 2 Luer Lock 1 female 5 Check valve 2 3 Luer Lock 2 male 6 Check valve 1 Remove protective cap 1 Fig 6 10 no 1 connect patient hose by means Luer Lock 1 Fig 6 10 no 2 to the pump hose Insert ho
81. st agent can only be injected in the sequence 2 The pre bolus can be affected directly before the contrast agent injec tion of sequence 2 or first discarded into the drip cup or injected by re leasing the function Manual Start compare Section 8 4 8 8 3 The Procedure of an Injection 8 3 1 The puncturing of the patient may only be affected by means of a in dwelling IV cannula stable against pressure of the injector and without any component for add in injections for reasons of seal tightness In order to avoid a paravasal injection the cannula position is to be checked compare Section 7 6 5 Punction of a Patient The vented patient hose will be connected to the indwelling V cannu la by means of the Luer Lock 2 compare Fig 6 10 no 3 8 3 2 Acknowledge Injection Program in Input Screen Press OK to acknowledge injection program shown in the input screen compare Section 8 2 The following prompt appears on the touchscreen Fig 8 8 Riich medical Program Options Help CA Nacl CA Injection time volume ml volume ml Flow ml s e per sequence s 10 0 Caution Are you sure that there is no air in the hose system Minimum injection time s 10 0 Total contrast agent ml 070 Total Nacl ml Total injection ml Fig 8 8 Prompt for freedom from air bubbles If the hose system is free of air select Yes in the Caution dialogue box The system switches
82. standby mode LED permanently lit If there is still air in the CA access vent again by selecting the button CA1 or CA2 at the control unit Next briefly press the keys Release and Delivery simultaneously on the control unit of the injector Y If the function operates correctly the light emitting diode for the most recently selected contrast agent bottle flashes on the control unit 46 mississippi missouri 7 Start up 7 6 3 Switchover between Contrast Agent Bottles On completion of the filling process the light emitting diodes on the control unit for the salt solution and the most recently vented contrast agent bottle are flashing The relevant bottles have been selected and are thus active during the following injection media are delivered from these bottles lf two contrast agent bottles were mounted and vented the light emitting diode for the initially selected contrast agent bottle illuminates continuously it is in standby mode that is it is prepared for the auto matic or manual switchover Manual switchover Brief operation of the relevant key on the control unit activates the standby bottle continuously illuminated light emitting di ode the currently active contrast agent bottle flashing light emitting diode returns automatically to standby mode The changeover between the contrast agent bottles can be affected at any time except while an injection is in progress Automatic sw
83. t The operating mode can only be changed from CT to CT plus or MRI or vice versa if there is no connection to the injector The CT plus mode differs from the MRI mode in the maximum injec tion volume per patient 400 ml per patient with CT plus 250 ml per patient with MRI In the modi CT plus and MRT the hose system is pre filled with NaCl from the cross piece in CT mode it is pre filled with CA after patient hose changeover Switch off injector Select Options gt Settings gt Operating Mode Fig 7 3 Nr 6 in the menu bar Select operating mode press OK to confirm Operating mode Select operating mode OCT mode x CT plus mode O MRI mode Fig 7 8 Select operating mode e Son mm d Riich medical Injection time Flow ml s per sequence s Minimum injection time s Total contrast agent ml 0 n 0 Total Nacl ml 070 12 53 21 CT plus 06 03 2008 920 cm Settings Control unit CA Na CA2 in jector Fig 7 9 Selected operating mode 41 G Jrich medical You can find further information about the status of activation and sa ving of this setting in the table of Annex 9 7 5 2 Patient Hose Length Following confirmation of the operating mode the selection window Patient hose length appears automatically Select length press OK to confirm Changing the length of the patient hose during ope ration is possible before patient hose changeover Patient hose Se
84. t bolus sequence to separate the injection of the test bolus from the injection of other sequences Sequences 2 to 6 can be opened and programmed if required Fig 8 18 ann emer Hele Less Kirich CA Nacl Injection time Manual Flow mls volume ml volume ml per sequence s start a Minimum injection time s 106 7 Test bolus Total contrast agent ml 0730 Total NaCl mi 0744 Total injection mi 0 74 o Cancel EE Fig 8 18 Input of further sequences after test bolus sequence Do not connect the patient to the patient hose before test bolus is filled in 66 8 Carrying out Injections Do not connect patient to the pa tient hose before test bolus is filled in mississippi missouri 8 Carrying out Injections With the second OK further sequences are confirmed the system changes over to the injection screen The injection parmeters can only be changed by selecting the button Back Inject test bolus with Start The injector stops after the injection of the test bolus sequence stand by position Start the following sequences by selecting Continue at the terminal or Pause at the control unit Test bolus in CT mode a Injection without test bolus Minimum CA volume in sequence 1 required compare Section 8 2 5 Injection with test bolus No minimum CA volume in sequence 1 required CA volume test bolus can be input which is as small as required Minim
85. t signal in out acive 42 Fig 7 12 Input screen with Start signal in out active nsaenneensneneneneeennerrrnrnrrerrrnrresreene 43 Fig 7 13 NaCl container pouch and bottle ee ccceeeeeceeeeeeeeeeceeeeeeeeeeseeeesseeeeseeeesseeeees 44 Fig 7 14 Fill hose system with NA Ol eccictes cece tensetecewncnivecdecntbacnsseiecgnsethes enced tedbesebesneaeiebeowtes 44 Fig 7 715 e tele Lee e Lu 45 Fig 7216 CONMMUCS TIMING lge el 46 Fig 7 17 Automatic Changeover CA 47 Fig 7 18 Patient NOSE chandeover 48 Fig 7 19 Filling of hose system in CT mode after patient hose changeover s sseesseeeenn 49 Fig 7 20 Filling of hose system in MRI and CT plus mode after patient hose changeover 50 Fig 8 1 Numeric keypad for entering injection parameters annennnnnsnnnnnnnnnnnnnnnnrnnreneene 52 left Vie UMUC XC CC OI EE 53 Fig 8 3 Input screen after filling process cee cceccseccseeeneeeneeeneeeneeeseeeseesaeeseeeseeeseeeneeeneeeses 53 Fig 8 4 New program with one sequence CT model 54 Fig 8 5 Character input Ted 55 Fig 6 6 Open or delete Drogi al ssisresirsssnreikernrin nianie EE EEEE 56 Fig 8 7 ulrich patient hoses with minimal NaCI CA VOIUME s sseseesesieeeeeeeieeieerierrerereeren 57 Fig 8 8 Prompt for freedom from air bubbles ccc cecccececeeeeceeeeeeeeceeeeseeeeeeeseueeseesaeeesaees 58 Fig 8 9 Injection screen before the Start Of AN miechon 59 Fig 8 10 Injection screen while an injection IS
86. t ultraso nic sensor detects air and switches over to the second contrast agent bottle without interrupting the injection The first bottle can be replaced compare Section 7 6 3 and must be subsequently vented must be carefully vented Do not use The special swivel device on the contrast agent bottle holders Fig 6 6 ultrasound gel at nos 2 5 and 8 provides for the drip free changeover of bottles the ultrasonic sen sors as their func tioning can be disrupted and air will not be detected anymore When changing a container which is not yet totally empty the light emitting diode on the control unit still flashes Vent the Fig 9 1 Replaci t bottles ig 9 eplacing empty contrast agen access Tilt bottle holder toward the front Withdraw the empty storage bottle nevertheless slowly by means of a slight rotary movement Restore the bottle holder to the perpendicular starting position again Mount new storage bottle in a centred fashion compare Section 7 6 because air can be in it or the piercing needle For venting the access press the relevant key CA1 and or CA2 on Mount bottles the control unit such that the label A CA1 Repeat venting process several times in order to ensure a sufficient degree of venting faces towards the L rear so that the CA2 residual volume can be detected from and or the control panel 81 oe The contrast agent bottle last vented is ac
87. the protective caps from the piercing needles directly be fore mounting the storage bottle 7 The length of the patient hose actually used must match the length that has been set on the touch terminal Settings The fill ing volume of the hose system is calculated by the system accor ding to this length A longer hose is not filled completely Air re mains in the hose compare Section 7 5 2 n If a different patient hose length is used to the one on the touch terminal the volume counters on the touchscreen do not match the volume actually being injected It is possible to exceed the maximum injection volume per patient In case of using a longer G Jrich EE medical mississippi missouri 4 Warning and Safety Notes patient hose than the programmed one the patient hose will not be filled completely and air will remain inside the hose m To protect the open end of the pump hose from contamination connect a new patient hose directly after completion of injection 4 4 Batteries a When changing batteries check the high frequency seal on the battery compartment lid this must be clean and closed all around wipe off if necessary or inform Customer Service m The charging time for the lead battery XD 2071 is at least 4 hours E The batteries must be stored in a fully charged condition only a In the event of extended utilization breaks the batteries must be recharged periodically every six months when stored at room t
88. tional closure device Fig 6 3 no 7 in an anti clockwise direction and swing cover halves outward Fig 6 4 Turn pump wheel manually until a roller is in an approx 6 o clock posi tion lowest position Fig 6 4 Fig 6 4 Open pump flap Open NaCl sensor with sensor flap Fig 6 3 no 1 Open NaCl shut off valve Fig 6 3 no 3 by pressing the right hand push in latch Take pump hose Fig 6 5 out of its sterile disposable packaging Do not yet remove protective caps for reasons of sterility The pump hose XD 2020 is suitable for an up to 24 hour use and any number of injections chemical resistance sterility delivered volume The hygienic safety is poven by an independent test laboratory G Jrich medical The injector models mississippi and missouri must only be operated with the pump hose provided for this purpose The use of other hoses represents a hazard to the safety of patients and users as well as to the functioning of the unit The hoses must not be used if the packaging is damaged or protective caps have fallen off or have been removed Two Hands Two Ends When inserting the hose system into the injector keep both hose ends in your hands to prevent a contact with the floor 25 g rich medical mississippi missouri 6 Preparation for Start Up Fig 6 5 Pump hose XD 2020 Legend for figure 6 5 ol Protective cap Luer
89. tive To fully empty the other bottle first switch over to this by pressing the corresponding key on the control unit compare Section 7 6 3 If an injection was interrupted due to an empty bottle pause the injector after changing and venting the container The Pause LED on the control unit flashes orange Release pause on the control unit or select Continue on the touch ter minal injection is continued 9 2 Salt Solution Tilt bottle holder toward the left Withdraw the empty storage bottle slowly by means of a slight rotary movement Restore the bottle holder to the perpendicular starting position again Mount new storage bottle in a centred fashion compare Section 7 6 The new storage bottle must be vented by pressing the key NaCl on the control unit Air can accumulate in the NaCl access due to the change of bottles L NaCl Repeat process several times in order to ensure a sufficient degree of venting If an injection was interrupted due to the NaCl bottle having run empty the injector is in a pause condition after changing the bottle The light emitting diode Pause on the control unit and symbol Pause on the status symbol bar flash Release pause on the control unit or touch terminal injection is conti nued 82 mississippi missouri 9 Changing Storage Bottles Pierce rubber cap quickly and exactly in the centre Never turn full bottles on the piercing needle the rubber plu
90. tive start Start siqnal Loudspeaker Date and time Screen saver Lanquaqge The purchase options Same patient and Test bolus are selected in the window Patient hose changeover They are not shown in the menu bar When an injection program is open the program name appears on the right hand side of the menu bar provided the program was saved beforehand By selecting the right hand menu arrow the short term memory com pare Section 8 2 3 is opened You can find further information about the status of activation and sa ving of this setting in the table of Annex 9 7 4 2 Input Screen Injection Screen n Sequence button Fig 7 3 no 7 By selecting the button a sequence is opened colour change from grey to yellow Fig 6 4 injection parameters can be input compare Section 7 1 When a sequence is opened the button for the next sequence appears automatically six sequences maximum G Jrich mississippi missouri 7 Start up medical enen men Hee Le MICA CA Nacl Injection time Sequence volume ml volume my Flow ml s per sequence s Je i Minimum injection time s Total contrast agent ml 0 0 Total Nacl mil oo 06 03 2008 EA A A A Settings Control unit CAl NaCl CA2 Injector Fig 7 4 Opening of program sequences MRI mode Image of hose system Fig 7 3 no 2 Represents the current filling of the hose system in real time contrast age
91. tor mississippi XD 2000 ccccesseeceseeeeseeeeneeeenseseeneeseaseseeseseeneesonsenes 1 CT Injector missouri XD 2001 cccceeecnsscenseeeasecnseecnseensseonseeoasecnsseonseonsssonseeeaneonses 1 e E TE WC 5 1 1 Intended use CT MRI injector mississippi XD 2000 5 1 2 Intended use CT injector missouri XD 2001 5 Z e SCHIPUOM OT E 7 2 1 EEN 7 2 2 PG Ftc te teen le a ear le ner te ee de ee ta weg E a aces Li 10 2 3 We 10 GE D amp 93 61 RE un ln E erecta rier re rere ne arte erent re arte renee ne arte renee ert meen ne rte nee 12 3 Symbols and Abbrovtatl ttgoueekes eege AeeEu SEA eEEEA RENE EEeSESERNSAEENESENS Ee 14 3 1 Seidel EE 14 3 2 Injector touch terminal batteries ANd charger ssessssseeneenserrnsrrerrrrrrnrrerrrerrerrrene 14 3 3 laten AINA EEN 15 A 0 ee EE EAEE 16 4 Warning and Safety e 17 4 1 KEEN 17 4 2 Installation Maintenance ANd Repair nnanannnnannannnnnnnannnnnnnnnnnnnnnnrrnrnnrerrnrnrenrnnne 18 4 3 Reie 19 4 4 Eeer 20 A e E 20 5 Manufacturer Customer ServiCe cccscccceseccseseecceeeecessesenseecenessenseseeseesenseseeneesenees 22 E Au E 22 PLP te EE 22 6 Preparation for Start UP WEE 23 6 1 Power Supply and Data Transmission cccscccsceececeecesceeesceesesceeesceeeeseeeesceees 23 6 1 1 AEE S U K AEE E E E E E O E E A 23 6 1 2 TUSSI SSI BE 23 6 2 Insert HOSE System cece cseececeececeeeeceeeeseeeeceueeeeeeeeseueeeseueessaueeses
92. ttle holders at approx 6 o clock 30 Clamp patient hoses above the drip cup close to the Luer Lock 2 as it is mostly bent due to its packaging and would otherwise aim past the drip Cup In the case of guide tubes with a sufficiently large diameter remove the protective caps from the piercing needles directly before mounting the storage bottle If different bot tle sizes are being used during the day please ensure that the piercing G Jrich mississippi missouri 6 Preparation for Start Up medical Mount guide tube with the base notch located on the pivot in the bottle holder Turn eccentric lever to fix the guide tube in position 31 G Jrich medical mississippi missouri 7 Start Up 7 Start Up 7 1 General Notes on Handling and Operation n Only use original disposables approved by ulrich medical Co pies and other brands are less resistant and are not tested for application with ulrich injectors The ulrich hose system has been tested and approved as an entity see MPG The manu facturer guarantees warranty only for injectors which are oper ated with ulrich disposables The use of hose combinations or hose systems which are not approved by the manufacturer rep resent a hazard to the safety of patient and user and endan gers the proper functioning of the device z Maintain setup sequence Mount NaCl fill hose system with NaCl then mount CA compare Section 7
93. um total volume CA plus NaCl in sequence 1 is required gt Difference between CA test bolus and the minimum total vol ume for the test bolus sequence must be filled up with NaCl The minimum total volume for the test bolus sequence depends on the length of the patient hose Patient hose length Minimum total volume in sequence 1 CA plus NaCl Test bolus in MRI mode Injection without test bolus No CA volume input in sequence 1 possible CA volume is blocked Minimum CA volume in sequence 1 required compare Section 8 2 5 m Injection with test bolus CA volume in Sequence 1 test bolus sequence is released CA volume test bolus can be input which is as small as required Minimum total volume CA plus NaCl in sequence 1 is required gt Difference between CA test bolus and the minimum total vol ume for the test bolus sequence must be filled up with NaCl The minimum total volume for the test bolus sequence depends on the length of the patient hose fis rich medical 67 G Jrich medical mississippi missouri 8 Carrying out Injections Patient hose length Minimum total volume in sequence 1 CA plus NaCl Test bolus CT plus mode Injection without test bolus No CA volume input in sequence 1 possible Minimum CA volume in sequence 1 required compare Section 8 2 5 i Injection with test bolus CA volume in Sequence 1 test bolus sequence is released CA volume test bolus can be input whic
94. uminates compare Sec tion 7 3 the system is fully loaded and temporarily not avail able for operation By triggering further functions except Pause and Emergency Stop on the control unit fault mes sages may be displayed 32 G Jrich mississippi missouri 7 Start up medical m Do not control injector or trigger functions simultaneously via the touch terminal and the control unit m Injector and touch terminal should only be operated by one per son at the same time 7 2 Power On 7 2 1 Touch terminal Switch on touch terminal by means of the power switch at the lower right housing side see Fig 7 1 green operating LED is illuminated The system is brought up If the injector is switched off or there is no data transmission between injector and terminal the input screen without symbols in its status symbol bar is displayed If the injector is switched on or the connection is made between injec tor and terminal the symbols in the status symbol bar see Fig 7 7 and the request to start the filling process is displayed See operating instructions chapter 7 6 Ke al Fig 7 1 Power switch touch terminal 7 2 2 Injector Only switch on the injector after inserting the pump hose compare Section 6 2 1 because otherwise the touch terminal will emit a warn ing signal during the entire insertion process due to open doors and valves Turn on the injector by means of the power switc
95. using the scroll bars and press OK to accept Program Options Help mit pause gy rich medical CA Nacl Injection time volume ml volume mi Flow mls per sequence s Pause s Stoppuhr s Date and time Ka KE Ka Day Year Month A A A Vv Hour Minute Second Minimum injec To Total injection ml 0 106 f 07 03 2008 ten l ZA Se A a Control unit CAI NaCl CA2 Injector Fig 12 2 Set date and time The current date and time are preset in the factory The changeover from summer time to winter time must be affected by the user if neces sary You can find further information about the status of activation and sav ing of this setting in the table Annex 9 89 G Jrich medical mississippi missouri 12 Software Further Settings and Functions 12 4 Screen Saver This function can be used to change the screen saver settings The screen saver is deactivated in the factory Select Options gt Settings gt Screen saver in the menu bar The screen saver can be activated and be again deactivated or the time un til the screen saver starts automatically can be changed rogram Dn He Girich CA Nacl Injection time Flow mls s Pause s Stoppuhr s volume ml volume ml per sequence e ER TT 2 Screen saver a Minutes O Deactivate screen saver Cancel Minimum injection ti Total contrast age Total Nacl ml Control unit Injector Fi
96. whether the injection parameters are within the permissible range The system changes to the injection screen For changes the user has to return to the input screen using the Back button 54 g rich mississippi missouri 8 Carrying out Injections medical 8 2 2 Store Injection Program In the input screen a program name can be assigned by selecting a character input field via Program gt Save Select program name such that as roan men Hip rich i medical Save program under Abdomen 50 much information as possible is given on the program content e g thorax with test bolus 8 20 4 100 20 4 corresponds to elkel SUE EB0RORE DEORE HARES sequence 1 CA NaCl flow BONDONS n WE Sme 13 56 15 CT plus KS Eer CU H LU HOI LU KRISI CN niecto Fig 8 5 Character input field sequence 2 CA NaCl flow Press Save to accept entered name Options assigned to a program are also stored compare Annex 9 Press Cancel to close the input screen without accepting the new name 8 2 3 Open Injection Program There are two options for opening an existing program n Short term memory Menu bar select right hand arrow In the short term memory on ly the program names are displayed Select program by the rele vant entry line is marked in blue and open the same automati cally z Menu bar Program gt Open A summary table of stored programs with injection parameters
97. with their labels facing to the rear so that the residual volume can be seen from the front Quickly pierce the rubber cap in the middle Do not rotate mounted Fig 7 13 NaCl container pouch and bottle The following message appears on the touchscreen Fig 7 14 bottles on the Program Options Help D gz rich PRG neee iat medical this may cause the CA Nacl Injection time Flow mls rubber stoppers to volume ml wolume ml O1 Information D Start filling process per sequence s become perme able Initially mount Z Fill hose system with NaCl Press simultaneously the keys Release and Delivery on injector NaCl storage bottle only and press Release and Delivery Only then mount the contrast agents Total injection ml 0 0 13 19 54 CTplus Fee ei 2 AFA XX a Control unit CAI NaCl CA2 Injector Fig 7 14 Fill hose system with NaCl The bottle symbol for NaCl in the status symbol bar is still crossed out Briefly press the keys Release and Delivery simultaneously on the control unit of the injector j Salt solution is delivered from the storage container into the pump hose the air in the hose is displaced the hose i
98. y excluded from our warranty n Program memory a More than 100 injection programs storable with up to 6 se quences each with NaCl post rinsing n Programming o Easy programming and storing of new injection programs o Individual change of programs that have already been stored mississippi missouri 2 Description of Unit The software installed on the touch terminal consists of a basic version with several add on options Same patient Test bolus Last patient Stop watch In the event of subsequent purchase these options are released by means of a license file Fis rich medical rich MM medical mississippi missouri 3 Symbols and Abbreviations 3 Symbols and Abbreviations 3 1 Control Unit Light emitting Function keys with Function keys diodes integrated light emitting diodes Batter 1 CA1 Pa NaCl Pee Fl 2 CA2 13 Pause Continue 6 Pause 3 2 Injector touch terminal batteries and charger A Ampere or External Start COM Serial port Hz Hertz IPX1 Drip water protected LPT Parallel port REF Article number SN o S N Serial number VAC Alternating voltage VDC Direct current voltage mississippi missouri 3 Symbols and Abbreviations wD Gel Pb I A l G Jrich medical Recyclable Battery contains lead it must not be disposed of as household waste under any circumstances whatever Separate disposal This unit is not to be disp

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